The statute -

Section 292, the "false marking" statute, provides that:

(a) . . .
Whoever marks upon, or affixes to . . . any unpatented article, the word "patent" or any word or number importing that the same is patented, for the purpose of deceiving the public
. . .
Shall be fined not more than $500 for every such offense.
(b) Any person may sue for the penalty, in which event one-half shall go to the person suing and the other to the use of the United States.

Id. (emphasis added).

The action -

Brooks Brothers moved to dismiss Stauffer's complaint pursuant to Rule 12(b)(1) of the Federal Rules of Civil Procedure for lack of standing and pursuant to Rule 12(b)(6) for failure to allege an intent to deceive the public with sufficient specificity to meet the heightened pleading requirements for claims of fraud. The district court granted Brooks Brothers' motion pursuant to Rule 12(b)(1), concluding that Stauffer lacked standing. According to the court, all plaintiffs, including qui tam plaintiffs (or "relators"), must establish (1) that they have suffered an injury in fact (2) that is causally connected to the defendant, and (3) that is likely to be redressed by the court. Standing Op., 615 F. Supp. 2d at 253. The court further noted that the qui tam provision of section 292(b) operates as a statutory "assignment" of the rights of the United States, so Stauffer must prove that the government, rather than he, satisfies the requirements for standing, including that it has suffered an injury in fact. Id.

The district court further found Stauffer's allegation of injury insufficient.

Then the Feds weighed in, but the district court waved them off as well.

After the district court's decision on standing, Standing Op., 615 F. Supp. 2d 248, the government moved to intervene, arguing that the court's opinion called into question the constitutionality of section 292 and that the government was therefore entitled to defend the statute pursuant to Rule 24(a)(1) and 28 U.S.C. § 2403. The government also argued that its interest in seeing the patent laws enforced gave it a right to intervene pursuant to Rule 24(a)(2) and that it should be permitted to intervene pursuant to Rule 24(b)(1)(B). The court denied the motion, finding no basis for the government to intervene as of right and finding the showing for permissive intervention insufficient. Intervention Op., 2009 U.S. Dist. Lexis 51166.

The district court reasoned that it had not decided any constitutional issue that would give the government the right to intervene pursuant to Rule 24(a)(1), as it had only decided the case on its facts. Id. at *8-9. The court added that, contrary to the government's argument, it was entitled to rule on Brooks Brothers' motion before the government's deadline to decide whether it would seek to intervene had expired, as the court had not held the statute unconstitutional. Id. at *9-10 n.4. The court further found that the government did not have a sufficient interest in the action to have a right to intervene pursuant to Rule 24(a)(2) because the court had denied standing only to Stauffer, not to the United States itself. Id. at *12.

So, to appeal, where the government argued that Stauffer was an agent of lawfulness, not to mention the government's share of the loot from bow ties boldly proclaiming balderdash - patent protection long past.

The government asserts that Vermont Agency of Natural Resources v. United States ex rel. Stevens, 529 U.S. 765 (2000), controls the outcome in this case, and that decision held that a qui tam relator has standing without an injury to the relator himself, a proposition that, according to the government, the court stated but did not follow. Furthermore, the government argues that the United States' interest in seeing its laws enforced itself leads to an injury in fact when those laws are not obeyed. In other words, according to the government, in enacting the false marking statute, Congress determined that such conduct is harmful and should be prohibited, which is a sufficient injury in fact to confer standing on the government and therefore on Stauffer as the government's implicit assignee of the action to recover for injury. Finally, the government asserts that even if a proprietary injury involving the federal treasury's being directly diminished were required under Vermont Agency, as opposed to solely a sovereign injury based on the United States' interest in seeing its laws enforced, the United States has a proprietary interest in receiving half of the recovery in a suit under section 292.

Stauffer touted the travesty of false marking as economic injustice to bow tie wearers everywhere.

Stauffer separately argues that, according to this court's decision in Clontech Labs., Inc. v. Invitrogen Corp., 406 F.3d 1347 (Fed. Cir. 2005), the public is injured by false marking, which misleads and wrongly imposes the costs of evaluating patents on the public. Thus, he argues, the public has suffered an injury in fact sufficient to confer standing. Stauffer adds that his complaint alleged that Brooks Brothers had "wrongfully quelled competition with respect to . . . bow tie products thereby causing harm to the economy of the United States." J.A. 66, para. 129. That, he argues, further demonstrates an injury to the public. Stauffer also asserts that he has individually been injured as a member of the public, thereby demonstrating another injury to the public.

The appeals court stood by standing.

We agree with the government and Stauffer that Stauffer had standing to sue Brooks Brothers. "The question of standing to sue is a jurisdictional one, which we review de novo." Rite-Hite Corp. v. Kelley Co., 56 F.3d 1538, 1551 (Fed. Cir. 1995) (en banc) (citation omitted). Every plaintiff must demonstrate standing, a jurisdictional prerequisite under Article III's case-or-controversy requirement. Vermont Agency, 529 U.S. at 771. Thus, a plaintiff must show (1) that he has suffered an "injury in fact," an invasion of a legally protected interest that is "(a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical," (2) that there is "a causal connection between the injury and the conduct complained of," and (3) that the injury is likely to be redressed by a favorable decision. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992) (citations and quotations marks omitted); see Vermont Agency, 529 U.S. at 771. We conclude that Stauffer has met that test and hence has standing in this case.

We are all aggrieved: to an old patent in the weave; aghast to eye: false marking of a tie.

As the government points out, Congress has, by enacting section 292, defined an injury in fact to the United States. In other words, a violation of that statute inherently constitutes an injury to the United States. In passing the statute prohibiting deceptive patent mismarking, Congress determined that such conduct is harmful and should be prohibited. The parties have not cited any case in which the government has been denied standing to enforce its own law. Because the government would have standing to enforce its own law, Stauffer, as the government's assignee, also has standing to enforce section 292.

Further, the government had a right to intervene for bow tie booty, as it had skin in the game.

Furthermore, the government would not be able to recover a fine from Brooks Brothers if Stauffer loses, as res judicata would attach to claims against Brooks Brothers for the particular markings at issue. See United States ex rel. Mergent Servs. v. Flaherty, 540 F.3d 89, 94 (2d Cir. 2008) ("[T]he United States might become bound by res judicata or collateral estoppel as a result of the actions of a pro se in bringing and losing a qui tam action.") (citing Stoner v. Santa Clara County Office of Educ., 502 F.3d 1116, 1126-27 (9th Cir. 2007) ("[Q]ui tam relators are not prosecuting only their 'own case' but also representing the United States and binding it to any adverse judgment the relators may obtain.")).

Reversed and remanded.

Corporate patent push becomes shove when it moves off the square of ground the patent covers.

Patent misuse developed as a non-statutory defense to claims of patent infringement. In the licensing context, the doctrine limits a patentee's right to impose conditions on a licensee that exceed the scope of the patent right. Because patent misuse is a judge-made doctrine that is in derogation of statutory patent rights against infringement, this court has not applied the doctrine of patent misuse expansively. In this case, we adhere to that approach, and we sustain the decision of the International Trade Commission that the doctrine of patent misuse does not bar the intervenor, U.S. Philips Corporation, from enforcing its patent rights against the appellants Princo Corporation and Princo America Corporation (collectively, "Princo").

Patent misuse has been before the Supreme Court numerous times, many times finding patent misuse for improperly trying to restrict unrelated commercial activity by tying it to a patent license. In other words, companies trying for a monopoly beyond the scope of granted patent protection.

The doctrine of patent misuse has its origins in a series of Supreme Court cases, beginning with the 1917 decision in Motion Picture Patents Co. v. Universal Film Manufacturing Corp., 243 U.S. 502 (1917)... Since the Court regarded the requirement to use particular films as beyond the legitimate scope of the patent [for a film projector], it held that the patent could not be enforced against a purchaser who used the patented projector with unsanctioned films.

Fourteen years later, in Carbice Corp. of America v. American Patents Development Corp., 283 U.S. 27 (1931), the Court held that it was improper for the owner of a patent on "refrigerating transportation packages" for transporting and storing dry ice to insist that licensees of that patent purchase their dry ice from the patent owner or its affiliates.

In a third case, Morton Salt Co. v. G.S. Suppiger Co., 314 U.S. 488 (1942), the patentee owned a patent on a machine used to add salt to canned foods. The patented machines were leased to canners on the condition that the canners would use salt tablets purchased from the patentee. When one of the patentee's lessees used the machine with its own salt tablets, the patentee sued for infringement. The Supreme Court held that the patent was unenforceable on the ground that the patentee had unlawfully used the patent "to secure an exclusive right or limited monopoly not granted by the Patent Office and which it is contrary to public policy to grant." Id. at 492.

In those cases, and several others in the same line of authority, the Supreme Court established the basic rule of patent misuse: that the patentee may exploit his patent but may not "use it to acquire a monopoly not embraced in the patent." Transparent-Wrap Mach. Corp. v. Stokes & Smith Co., 329 U.S. 637, 643 (1947). As for the most common form of patent misuse--requiring the purchase of an unpatented product as a condition for obtaining a license to the patent, the Court observed, "He who uses his patent to obtain protection from competition in the sale of unpatented materials extends by contract his patent monopoly to articles as respects which the law sanctions neither monopolies nor restraints of trade." Id. at 644.

The Court applied the same reasoning to licenses requiring the payment of licensing fees after the expiration of the licensed patent and thus having the effect of extending the life of the patent beyond the statutory period. In Brulotte v. Thys Co., 379 U.S. 29 (1964), the Court explained that a patent "empowers the owner to exact royalties as high as he can negotiate with the leverage of that monopoly. But to use that leverage to project those royalty payments beyond the life of the patent is analogous to an effort to enlarge the monopoly of the patent by tieing the sale or use of the patented article to the purchase or use of unpatented ones." Id. at 33.

As applied to patent licensing agreements, the Supreme Court put the matter succinctly in Zenith, 395 U.S. at 136:

[T]here are established limits which the patentee must not exceed in employing the leverage of his patent to control or limit the operations of the licensee. Among other restrictions upon him, he may not condition the right to use his patent on the licensee's agreement to purchase, use, or sell, or not to purchase, use, or sell, another article of commerce not within the scope of his patent monopoly.

As is its wont, while adhering to the guideline of restrictive business practices unrelated to the scope of patented protection, the CAFC put its own twist on Supreme Court precedent by wandering into the weeds of "anticompetitive effect." This superfluous swagger mangles the thrust of determining patent misuse, creating complexity and convolution which the CAFC wrapped itself in, as herein.

In our cases applying the Supreme Court's patent misuse decisions, we have characterized patent misuse as the patentee's act of "impermissibly broaden[ing] the 'physical or temporal scope' of the patent grant with anticompetitive effect." Windsurfing Int'l, Inc. v. AMF, Inc., 782 F.2d 995, 1001 (Fed. Cir. 1986). When the patentee has used restrictive conditions on licenses or sales to broaden the scope of the patent grant, we have held that an accused infringer may invoke the doctrine of patent misuse to defeat the patentee's claim. See Monsanto Co. v. McFarling, 363 F.3d 1336, 1341 (Fed. Cir. 2004); Va. Panel Corp. v. MAC Panel Co., 133 F.3d 860, 870 (Fed. Cir. 1997); Senza-Gel Corp. v. Seiffhart, 803 F.2d 661 (Fed. Cir. 1986).

In B. Braun Medical, Inc. v. Abbott Laboratories, 124 F.3d 1419 (Fed. Cir. 1997), and Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 700 (Fed. Cir. 1992), we explained the rationale underlying the doctrine. As a general matter, the unconditional sale of a patented device exhausts the patentee's right to control the purchaser's use of the device thereafter, on the theory that the patentee has bargained for, and received, the full value of the goods. That "exhaustion" doctrine does not apply, however, to a conditional sale or license, where it is more reasonable to infer that a negotiated price reflects only the value of the "use" rights conferred by the patentee. Thus, express conditions accompanying the sale or license of a patented product, such as field of use limitations, are generally upheld. See Gen. Talking Pictures Corp. v. W. Elec. Co., 304 U.S. 175, 181 (1938) ("Patent owners may grant licenses extending to all uses or limited to use in a defined field."). When those contractual conditions violate public policy, however, as in the case of price-fixing conditions and tying restraints, the underlying patents become unenforceable, and the patentee loses its right to sue for infringement or breach of contract. B. Braun, 124 F.3d at 1426; Mallinckrodt, 976 F.2d at 706.

The doctrine of patent misuse is thus grounded in the policy-based desire to "prevent a patentee from using the patent to obtain market benefit beyond that which inheres in the statutory patent right." Mallinckrodt, 976 F.2d at 704. It follows that the key inquiry under the patent misuse doctrine is whether, by imposing the condition in question, the patentee has impermissibly broadened the physical or temporal scope of the patent grant and has done so in a manner that has anticompetitive effects. B. Braun, 124 F.3d at 1426. Where the patentee has not leveraged its patent beyond the scope of rights granted by the Patent Act, misuse has not been found. See Monsanto, 363 F.3d at 1341 ("In the cases in which the restriction is reasonably within the patent grant, the patent misuse defense can never succeed."); Virginia Panel, 133 F.3d at 869 (particular practices by the patentee "did not constitute patent misuse because they did not broaden the scope of its patent, either in terms of covered subject matter or temporally").

In determining whether a particular licensing condition has the effect of impermissibly broadening the patent grant, courts have noted that the patentee begins with substantial rights under the patent grant--"includ[ing] the right to suppress the invention while continuing to prevent all others from using it, to license others, or to refuse to license, . . . to charge such royalty as the leverage of the patent monopoly permits," and to limit the scope of the license to a particular "field of use." United States v. Studiengesellschaft Kohle, m.b.H., 670 F.2d 1122, 1127, 1133 (D.C. Cir. 1981). Given that the patent grant entitles the patentee to impose a broad range of conditions in licensing the right to practice the patent, the doctrine of patent misuse "has largely been confined to a handful of specific practices by which the patentee seemed to be trying to 'extend' his patent grant beyond its statutory limits." USM Corp. v. SPS Techs., Inc., 694 F.2d 505, 510 (7th Cir. 1982).

Recognizing the narrow scope of the doctrine, we have emphasized that the defense of patent misuse is not available to a presumptive infringer simply because a patentee engages in some kind of wrongful commercial conduct, even conduct that may have anticompetitive effects. See C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340, 1373 (Fed. Cir. 1998) ("Although the defense of patent misuse . . . evolved to protect against 'wrongful' use of patents, the catalog of practices labelled 'patent misuse' does not include a general notion of 'wrongful' use."). Other courts have expressed the same view. See Kolene Corp. v. Motor City Metal Treating, Inc., 440 F.2d 77, 84-85 (6th Cir. 1971) (There is no such thing as "mis-use in the air. The misuse must be of the patent in suit. An antitrust offense does not necessarily amount to misuse merely because it involves patented products or products which are the subject of a patented process." (citations omitted)); McCullough Tool Co. v. Well Surveys, Inc., 395 F.2d 230, 238-39 (10th Cir. 1968) (the defense of patent misuse has been allowed "only where there had been a misuse of the patent in suit"). While proof of an antitrust violation shows that the patentee has committed wrongful conduct having anticompetitive effects, that does not establish misuse of the patent in suit unless the conduct in question restricts the use of that patent and does so in one of the specific ways that have been held to be outside the otherwise broad scope of the patent grant.

Congress, ever-vigilant to avoiding statute creation the gets the job done, only put backspin on patent misuse. Sticking to its patented formula of "compromise solution", Congress stirred the muddle as to what was procompetitive versus anticompetitive.

Although patent misuse has been mainly a judicially created defense, Congress has not been entirely silent about the doctrine. However, instead of saying what patent misuse is, Congress has said what it is not. Thus, section 271(d) of the Patent Act sets forth five types of conduct that may not provide the basis for finding "mis-use or illegal extension of the patent right." The last two of the five, which were added in 1988, are

(4) refus[ing] to license or use any rights to the patent; or (5) condition[ing] the license of any rights to the patent or the sale of the patented product on the acquisition of a license to rights in another patent or purchase of a separate product, unless, in view of the circumstances, the patent owner has market power in the relevant market for the patent or patented product on which the license or sale is conditioned.

35 U.S.C. § 271(d).

Importantly, Congress enacted section 271(d) not to broaden the doctrine of patent misuse, but to cabin it. See Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176, 201 (1980) (addressing the role of section 271(d) in narrowing the scope of patent misuse). The 1988 amendment in particular was designed to confine patent misuse, with respect to certain licensing practices, to conduct having anticompetitive effects. See Ill. Tool Works Inc. v. Indep. Ink, Inc., 547 U.S. 28, 41 (2006); S. Rep. No. 100-492, at 9 (1988) (explaining that purpose of the amendment was to narrow the patent misuse doctrine, which "punish[es] innovators engaged in procompetitive distribution and licensing practices"); id. at 14 ("The lack of clarity and predictability in application of the patent misuse doctrine and that doctrine's potential for impeding procompetitive arrangements are major causes for concern."); 134 Cong. Rec. 32,471 (1988) (statement of Sen. Patrick Leahy) ("Reform of patent misuse will ensure that the harsh misuse sanction of unenforceability is imposed only against those engaging in truly anticompetitive conduct."); id. at 32,295 (statement of Rep. Robert Kasten-meier) ("[T]he proposed modifications should have a pro-competitive effect, insofar as they require some linkage between patent licensing practice and anti-competitive conduct.").

In its ruling, the CAFC admits that §271(d) is not on point, but wanted to robe itself in Congressional intent.

Section 271(d) is not directly implicated in this case because the conduct here at issue does not fall within any of the five statutorily defined categories. Nonetheless, the statute is pertinent because, as both the text and the legislative history of the 1988 amendment to section 271(d) make clear, Congress was concerned about the open-ended scope of the doctrine and sought to confine it to anticompetitive conduct by patentees who leverage their patents to obtain economic advantages outside the legitimate scope of the patent grant.

With all that irrelevant backdrop, the CAFC angled to the Orange Book. The "Raaymakers" patents referred to were the ones covering technology adopted in the Orange Book standard, as opposed to a competing technique by Sony (the Lagadec patent) that lost out in creating the standard. Princo used the competition for Orange Book standards adoption as a wedge issue for patent misuse. It didn't work; at least, not as a majority opinion.

This case presents a completely different scenario from the cases previously identified by the Supreme Court and by this court as implicating the doctrine of patent misuse. Philips is not imposing restrictive conditions on the use of the Raaymakers patents to enlarge the physical or temporal scope of those patents.

Reduced to its simplest elements, the question in this case comes down to this: When a patentee offers to license a patent, does the patentee misuse that patent by inducing a third party not to license its separate, competitive technology? ... Such an agreement would not have the effect of increasing the physical or temporal scope of the patent in suit, and it therefore would not fall within the rationale of the patent misuse doctrine as explicated by the Supreme Court and this court.

Suddenly, competitive effect is shed like a skin to get back to the snake in the grass, or not, as the case may be. The CAFC whacks at nature of the snake backhanded, by what misconduct is not.

What patent misuse is about, in short, is "patent leverage," i.e., the use of the patent power to impose over-broad conditions on the use of the patent in suit that are "not within the reach of the monopoly granted by the Government." Zenith, 395 U.S. at 136-38. What that requires, at minimum, is that the patent in suit must "itself significantly contribute[] to the practice under attack." Kolene Corp., 440 F.2d at 85. Patent misuse will not be found when there is "no connection" between the patent right and the misconduct in question, see Republic Molding Corp. v. B.W. Photo Utils., 319 F.2d 347, 351 (9th Cir. 1963), or no "use" of the patent, see Virginia Panel, 133 F.3d at 870. In this case, there is no such link between the putative misconduct and the Raaymakers patents.

The en banc decision then wades into antitrust, particularly joint ventures, as, in this case, the ultimate cooperation between Philips and Sony in creating the Orange Book standard, even though niggling competition existed in determining the standard. The CAFC paid homage to economies of scale, the God of capitalistic endeavor, sweetly cloaked as "social benefit." What government does not, in its bones, understand that might makes right?!

Collaboration for the purpose of developing and commercializing new technology can result in economies of scale and integrations of complementary capacities that reduce costs, facilitate innovation, eliminate duplication of effort and assets, and share risks that no individual member would be willing to undertake alone, thereby "promot[ing] rather than hinder[ing] competition." Dep't of Justice & FTC, Antitrust Guidelines for the Licensing of Intellectual Property §§ 5.1, at 24; 5.5, at 28 (Apr. 6, 1995); see also Herbert Hovenkamp, Antitrust Law ¶ 2115a, at 110 ("[J]oint innovation often produces significant social benefits in relation to costs."); FTC & Dep't of Justice, Antitrust Guidelines for Collaborations Among Competitors § 2.1, at 6 (Apr. 2000); Thomas A. Piraino, Jr., The Antitrust Analysis of Joint Ventures After the Supreme Court's Dagher Decision, 57 Emory L.J. 735, 767-68 (2008); Joseph Kattan, Antitrust Analysis of Technology Joint Ventures: Allocative Efficiency and the Rewards of Innovation, 61 Antitrust L.J. 937, 938 (1993).

Affirmed (what was not clear before: no patent misuse).

This en banc decision left no stone unturned in being comprehensively boring, in the process reaching far beyond the merits of this case to expansive discussion of antitrust most unbecoming, as patent misuse and antitrust, though not unrelated, are two distinct issues. Patent misuse is rather straight-forward compared to the jurisprudential swamp of antitrust. Apparently, en banc is Latin for "take the bait." But we find the reason for cutting such a wide swath by what the outlier judges thought out loud.

Judge Prost, joined in part by Judge Mayer, pondered murk without thinking clearly.

This case arises at the uneasy intersection of anti-trust and patent law, in essence posing the novel question of whether (and if so, to what extent) patentee competitors may enter an agreement regarding the licensing of their patents.

While I find it significant that the putative agreement concerned patents rather than unpatented technology, I do not share the majority's apparent view that antitrust considerations are an entirely "different issue," separate and apart from the question of whether there has been patent misuse.

Off-kilter to the nth degree, Judge DYK, joined by Judge Gajarsa made no bones about where they stood, on a 32-page tear to do so.

The majority's strict standard fails to provide adequate protection against the suppression of nascent technology, and allows patent holders free rein to prevent the development of potentially competitive technologies except in the most extreme and unlikely circumstances. I respectfully dissent.

One wonders whether the dissent drove the majority opinion in covering antitrust ground that was off-point to patent misuse. More than perhaps.

The majority pointed out how the dissent was akimbo.

The dissent does not find fault with the terms of the licensing agreements between Philips and its licensees, but instead focuses its full attention on the purported horizontal agreement between Philips and Sony to suppress the Lagadec technology. The dissent then characterizes that agreement as invoking the doctrine of patent misuse because it is "part and parcel" of the licensing agreements between Philips and its licensees. That characterization, however, is incorrect. The Orange Book licensing agreements control what the licensees may do; the purported agreement between Philips and Sony controls what Sony may do. At bottom, Princo's complaint is not that its license to the Raaymakers patents is unreasonably conditioned, but that the Lagadec patent has not been made available for non-Orange-Book uses. And that is not patent misuse under any court's definition of the term.

The doctrine of patent misuse goes to whether a patent holder forces patent licensee behavior beyond what the patent covers. Antitrust is different, larger minefield - whether, by market power, a company stifles competition.

Princo succeeded, to some degree, in confusing those issues, thereby causing consternation at the CAFC, though ultimately failed to demonstrate patent misuse that did not occur. The practical problem for Princo was that antitrust cases are incredibly complex and expensive to prosecute. Princo decided to have a try at an antitrust case on the cheap by parading it as a patent misuse case. A few judges at least liked the show.

Pass & Seymour v. ITC and General Protecht Group and Wenzhou Trimone and Shanghai Ele (2009-1338, -1369) precedential

General Protecht Group and Wenzhou Trimone and Shanghai Ele v. ITC and Pass & Seymour (2009-1378, -1387, -1434) precedential

On '398 and '386 claims, a shocking switch at the ITC for P&S.

The asserted claims were initially construed and com-pared to the accused devices at issue here by an administrative law judge [ALJ]. The administrative law judge adopted P&S's proposed claim constructions of the disputed claim terms, and found that the defendant's products at issue here infringed the claims as construed. On review, the Commission modified the administrative law judge's constructions of certain terms and found that the accused devices did not infringe the construed claims as modified.

The CAFC agreed with the ITC regarding the plain meaning of disputed terms for '398.

The specification and prosecution history confirm that this plain meaning is appropriate in the context of this claim limitation. See Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en banc).

Because the accused products at issue here do not meet the "mounting means" limitation as properly construed, and thus do not meet every limitation of the asserted claims, there can be no infringement. See Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 15, 29 (1997). That some of the accused products also fail to meet the "a unitary, electrically conducting member" limitation as properly construed provides additional reason why those accused products do not infringe. See id.

The asserted '386 claim looked to be at fault: "not perfectly logical" "that a wiring state detection signal is generated when the device is properly wired."

On review, the Commission mostly agreed with the administrative law judge, though it noted that the claimed circuit interrupter had to be configured to trip in response to the actuator signal in the reset state. Since the asserted claim requires the actuator assembly to generate an actuator signal in response to the wiring state detection signal, it follows that generation of a wiring state detection signal ultimately causes the circuit interrupter to trip when in the reset state. Commission Op. at 18. The specification teaches that a wiring state detection signal is generated when the device is properly wired. Accordingly, under the Commission's interpretation of the claim the patented device must be configured to trip in response to a signal that the device is properly wired. Id. In so holding, the Commission acknowledged that such a claim requirement was not perfectly logical, and may have been the result of a claim drafting error. Id. Under the Commission's construction, the devices at issue were found not to infringe.

The CAFC majority went with the ITC over P&S's objections.

The plain language of the claims, however, does not allow for an exception to this consequence, and the intrinsic evidence of record supports the Commission's construction. The specification contemplates embodiments in which the wiring state detection signal trips the device in the reset state only once, until a fuse or resistor is burned out. See id. col.7 l.59-col.8 l.15.

Affirmed.

In concurrence, Judge Newman made sense of the claim while holding to non-infringement.

Claim construction requires conformity with the description of the invention in the specification. See Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc) ("[C]laims must be read in view of the specification, of which they are a part." (internal quotation omitted)); Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998) ("The best source for understanding a technical term is the specification from which it arose, informed, as needed, by the prosecution history.").

I would adhere to the Commission's construction, and affirm the finding of non-infringement based on the substantial evidence relied upon by the Commission.

For the '386 patent, the court has strayed from the Commission's correct rulings, although reaching the same result of non-infringement. The court errs in construction and application of the clause "circuit interrupter" in interaction with the "actuator assembly," for, as patentee P&S points out, it makes no sense to interpret the claims as requiring a miswiring protection device to trip a properly wired device but not an improperly wired device.

The court's understanding of the claims as requiring tripping of the circuit whenever the device is wired properly, is contrary to the purpose, function, and operation of the claimed device. It is not the claim that is not "logical," Maj. Op. at 13; it is the claim construction that defies the specification.

However, I agree that the accused devices do not embody these limitations as correctly construed by the Commission, and on this basis I concur in the conclusion of non-infringement.

A dispositive dispute to infringement of '340 went to ground over expert testimony. "ALJ" is the acronym for an ITC "administrative law judge," which makes a preliminary determination which is then reviewed by the commission.

The issue is thus whether the term "load terminals" in the '340 patent includes receptacle outlets.

We start with the '340 patent itself. A patent's specification "is the single best guide to the meaning of a disputed term." Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)) (quotation mark omitted). The '340 patent never describes receptacle outlets as load terminals. In fact, the circuit diagram drawings in the '340 patent all clearly label the load terminals separately from the receptacle outlets, as seen in the portion of Figure 1 above.

We have held that expert testimony can be useful in assisting a court "to establish that a particular term in the patent . . . has a particular meaning in the pertinent field." Phillips, 415 F.3d at 1318. However, we have cautioned that "conclusory, unsupported assertions by experts as to the definition of a claim term are not useful to a court." Id. The testimony relied on by the ALJ does not reveal that the term "load terminals" had a particular meaning in the art that included receptacle outlets. None of the experts identified a particular meaning in the art, and an expert's subjective understanding of a patent term is irrelevant. See Howmedica Osteonics v. Wright Med. Tech., 540 F.3d 1337, 1347 & n.5 (Fed. Cir. 2008) (holding that an inventor's subjective intent in using a term is irrelevant, but that the inventor may testify as an expert on the established meaning of particular terms in the relevant art); Symantec Corp. v. Computer Assocs. Int'l, 522 F.3d 1279, 1291 (Fed. Cir. 2008) (disregarding expert testimony that "simply recite[d] how each expert would construe [a] term . . . based on his own reading of the specification" because it did "not identify the 'accepted meaning in the field' to one skilled in the art"); Sinorgchem Co., Shandong v. Int'l Trade Comm'n, 511 F.3d 1132, 1137 n.3 (Fed. Cir. 2007) ("We attribute no weight to that testimony because the experts did not identify any evidence that those skilled in the art would recognize 'controlled amount,' or any term used in the specification, has an accepted meaning in the field of chemistry. Under such circumstances, testimony as to how one skilled in the art would interpret the language in the specification is entitled to little or no weight.").

Moreover, contrary to the ALJ's unsupported conclusion, the experts here never suggested that receptacle outlets, which they also called "user load terminals" or "user accessible load terminals," could be referred to as simply load terminals. Rather, they were fastidious in referring to them as separate elements.

Therefore, the ALJ erred in construing the term "load terminals" to also include receptacle outlets.

The CAFC short-circuited the ALJ's faulty finding of infringement.

Back to the '398 patent, where, in this case, claims were found by the ITC to have been infringed.

The claims use means-plus-function language to define several elements, pursuant to 35 U.S.C. § 112 ¶ 6.

"Literal infringement of a means-plus-function limitation requires that the relevant structure in the accused device perform the identical function recited in the claim and be identical or equivalent to the corresponding structure in the specification." Applied Med. Res. v. U.S. Surgical Corp., 448 F.3d 1324, 1333 (Fed. Cir. 2006). A structure in the accused device constitutes an equivalent to the corresponding structure in the patent only if the accused structure performs the identical function "in substantially the same way, with substantially the same result." Id.; see Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364 (Fed. Cir. 2000) (stating that in order to literally infringe, "the accused structure must either be the same as the disclosed structure or be a section 112, paragraph 6 'equivalent,' i.e., (1) perform the identical function and (2) be otherwise insubstantially different with respect to structure").

As we held in Toro Co. v. Deere & Co., 355 F.3d 1313 (Fed. Cir. 2004), one system that accomplishes a function mechanically and another system that accomplishes the same function using magnetic force "function in fundamentally different ways." Id. at 1324. The Commission and Pass & Seymour argue that the ALJ's decision was supported by substantial evidence because of the testimony of expert witnesses that one of ordinary skill in the art would have considered the magnetic matching structure to be interchangeable with the mechanical structure of the '398 patent. See Initial Determination, slip op. at 67. However, the experts merely testified that magnets were well known as latches, not that they performed the latching means function in substantially the same way as the mechanical latch disclosed in the patent. See J.A. 40,524 (testimony of Pass & Seymour expert Dr. Fred Stolfi) ("The use of a magnet as a latch is fairly common in other devices. You know, for example like a door latch often has a magnet catch. And there [are] patents that I have looked at that speak about a magnetic latch in a GFCI . . . ."); id. at 40,750 (testimony of ELE expert Kenneth Eugene Haynes) (agreeing that "permanent magnets were known in the art of latching structures and GFCIs in the late 1980s and 1990s"); id. at 40,979 (testimony of GPG expert Dr. James Roberge) (agreeing that permanent magnets had been used in "latching relays" in the electrical industry to perform latching functions). This testimony "goes to the function or result of these systems, and begs the issue of the way in which [the mechanical] systems and [magnetic] systems actually work." Toro, 355 F.3d at 1324. We therefore hold that substantial evidence does not support the Commission's finding that the magnetic latching structure of GPG's 2006 GFCI is equivalent to the mechanical structure disclosed in the '398 patent corresponding to the latching means.

Infringement reversed. Remanded.

Once again painting her colleagues as buffoons, Judge Newman severely scolded DYK and Prost in dissent. Below, the flavors of the great judge's remarks.

With all respect to my colleagues on this panel, they have erred in law and in procedure, in their reversal of the findings and rulings of the Commission on the issues presented in this appeal... This court now finds its own facts, applies theories that were not raised by any party, uses incorrect standards of review, and creates its own electrical technology contrary to the uniform and unchallenged expert testimony.

In the companion cross-appeal decided today by separate opinion, Appeal Nos. 2009-1338, -1369, taken by the patentee Pass & Seymour from the Commission's rulings adverse to it, the court deferentially affirms the Commission's findings of non-infringement, while in this appeal my colleagues act de novo to reverse the Commission's findings of infringement. In reversing the Commission, the court does not discuss the substantial evidence supporting the Commission's findings. In contrast to the companion appeal, the court bypasses the standards of APA review, and makes new finding and rulings on new theories, some of which were not presented and not argued by any party, and which are conspicuously incorrect. Further, despite its changes in claim construction, its new findings, and its de novo applications of law to fact, the court provides no opportunity for the patentee or the Commission to respond to the court's new arguments and adjudications.

Contrary to this unanimity of experts, my colleagues dispose of the experts with the statement that "an expert's subjective understanding of a patent term is irrelevant." However, an expert's testimony concerning the definition of a technological term in his field of expertise is highly relevant. An objective definition of a term of electrical art is not "subjective understanding."

['340] It is simply incorrect for this court now to hold that "load terminals" exclude user load terminals. The Commission's finding of infringement by the user load terminals is supported by substantial evidence; the court's contrary finding is totally devoid of support.

['398] The court rejects the Commission's finding of equivalency, without discussing the evidence for or against this finding. Instead, the court rules that there can never be equivalence between a mechanical latch and a magnetic latch, misciting Toro Co. v. Deere & Co., 355 F.3d 1313 (Fed. Cir. 2004). Toro did not so hold. My colleagues remove from its context Toro's quotation of the argument of the defendant Deere, viz. "Deere contends that this difference means the two systems accomplish clause(e)'s function in fundamentally different ways." Id. at 1324. This was not a pronouncement of law for all mechanical-magnetic substitutions. On the facts of that case, the mechanical cam-follower that travels a slope, used in the Toro patent to lift a valve stem, was found to operate in a substantially different way from the magnetic solenoid used by Deere to create a magnetic force that pulls open a liquid valve. Id. This court in Toro affirmed the district court's finding of non-equivalency for that system; the court did not establish a universal law of non-equivalence for all systems and all mechanical/magnetic facts.

Equivalence is a question of fact to be determined "against the context of the patent, the prior art, and the particular circumstances of the case." Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609 (1950). As explained in Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17, 36 (1997), "known interchangeability of substitutes for an element of a patent is one of the express objective factors noted by Graver Tank as bearing upon whether the accused device is substantially the same as the patented invention." Substantial evidence supports the Commission's finding that GPG's 2006 Interrupter contains structure equivalent to the latching means described in the '398 patent. There was no contrary evidence.

My colleagues on this panel disregard the rulings and findings of the Commission, and render de novo rules and findings on new theories to which the parties have had no opportunity to respond. This is an inappropriate appellate process.

No wonder patent litigation is a constant crap shoot, lousy lawyering by litigants aside. The grotesque discrepancies that regularly arise between judges, and courts, is a stale tradition, but the disturbance of discord, belying sensible jurisprudence, is frequently renewed afresh.

Continuing competence is rare in humans (and localized to a few), much rarer than the sometime appearance that suggests otherwise.

Subject: PATNEWS: Getting a patent on adding a string to an existing product

!20100825 Getting a patent on adding a string to an existing product

For those of you on the verge of blowing your brains out after fighting too
many idiotic Office Action rejections over serious inventions, well here it
is, the last idiocy you need to pull the trigger:

PRIOR ART: a ball of tea wrapped in string

PROBLEM: how do you get the tea out of the cup after it soaks?

SOLUTION: ADD A FREAKIN STRING

or, in this universe, and at least a zillion nearly overlapping universes in
the multiverse:

U.S. Patent 7,779,753
TEA BALL WITH [A FREAKIN] STRING!!!!!!!!
(issued 24 Aug 2010, filed April 2006)
Inventor: Winnie Yu (Berkeley, CA)

Claim 1:

1. A tea serving comprising:

a plurality of generally whole tea leaves: a binding string that
encircles and binds tea leaves into a tea ball wherein said
binding string is in direct contact with said tea leaves;

The Background section, common sense, reality, and entire zipcode of San
Francisco (Chinatown) put this completely in the prior art.
Thus, THE IMPROVEMENT COMPRISING BEING:

a serving string having a length with a first end that is attached
to said tea leaves of said tea ball and a second end that is free
from and can extend a distance away from said tea ball,

THE FREAKIN INVENTION, somehow distinguished from when the white paper tab
on your Lipton teabag falls off, leaving you holding a string that is
attached to the tea binded by the teabag.

whereby said tea ball can be lowered into and removed from a
container of tea water by grasping the second end of said
serving string and lowering or raising it as desired.

Again, somehow distinguished from when the white paper tab on your Lipton
teabag falls off, leaving you holding a string that is attached to the
teabag.

So yes, aim, set the trigger, pull and blow your brains out to then never
have to deal with an idiotic Office Action while contemplating how this
patent issued.

Greg Aharonian
Internet Patent News Service

Mr. Aharonian might be well advised to take his own advice and put us out of his misery.

Bundle breakers of this sort were well known in the art when the application for the '566 patent was filed.

The problem '566 attempted to solve was uneven pressure in clamping cardboard logs/stacks for breaking.

The '566 patent describes the result of unequal pressure:

[M]ore pressure is exerted on the taller logs which can damage compressible material like corrugated cardboard. If the logs are not compressible, then insufficient pressure is placed on the shorter logs and shifting of the logs can occur when the bundles are broken off from the log . . . . In the industry, this problem is called a 'lack of compliance' problem; i.e., the force on all the side by side logs is not substantially equal.

'566 patent, col.2 ll.16-31.

The inventors of the '566 patent, Merrill Martin and Daniel Talken, came up with an improved clamp structure to solve the lack of compliance problem, which they called a "compliance structure."

Claim 1 of the '566 patent, the only independent claim, appears in Jepson form. In other words, the preamble describes prior art bundle breakers and then claims the compliance structure mounted on each upper clamp as an improvement. See The Manual of Patent Examining Procedure ("MPEP") § 2129 ¶ III (8th ed., rev.8, July 2010) (explaining Jepson claims).

The dependent claims add various limitations...

After four days of deliberation, the jury called it quits. The judge then found the claims "so lop-sided in favor of obviousness" under the crushing influence of Obzilla (KSR v. Teleflex).

This court reviews the grant of a JMOL motion without deference, Ericsson, Inc. v. Harris Corp., 352 F.3d 1369, 1373 (Fed. Cir. 2003), applying the law of the regional circuit, Riverwood Int'l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1352 (Fed. Cir. 2003). "A jury's inability to reach a verdict does not necessarily preclude a judgment as a matter of law." Headwaters Forest Defense v. County of Humboldt, 240 F.3d 1185, 1197 (9th Cir. 2000), vacated on other grounds, 534 U.S. 801 (2001). The test in the Ninth Circuit is "whether the evidence, construed in the light most favorable to the nonmoving party, permits only one reasonable conclusion . . . ." White v. Ford Motor Co., 312 F.3d 998, 1010 (9th Cir. 2002) (internal quotation marks omitted).

Under 35 U.S.C. § 103(a), a patent is invalid "if the differences between the [claimed] subject matter . . . and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." Whether a patent is invalid as obvious is ultimately a determination of law based on underlying determinations of fact. Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 881 (Fed. Cir. 1998). Those underlying determinations of fact relate to "the scope and content of the prior art, the differences between the prior art and the claimed invention, the level of ordinary skill in the art, and any relevant secondary considerations, such as commercial success, long-felt need, and the failure of others." Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d 1301, 1310 (Fed. Cir. 2009) (internal quotation marks omitted). Thus, this court will affirm a district court's judgment on obviousness as a matter of law if "the content of the prior art, the scope of the patent claim and the level of ordinary skill in the art are not in material dispute, and the obviousness of the claim is apparent in light of these factors." KSR, 550 U.S. at 427.

References for three prior art machines left the judge with the dispositive impression "that the differences between the prior art and the claimed improvement were minimal." The CAFC agreed.

Martin attacked one reference (the Visy machine) by alleging "that the machine did not work for its intended purpose."

The district court appropriately rejected that argument. Under an obviousness analysis, a reference need not work to qualify as prior art; "it qualifies as prior art, regardless, for whatever is disclosed therein." Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003). "Even if a reference discloses an inoperative device, it is prior art for all that it teaches." Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989).

To be clear, prior art must teach a person of ordinary skill to make an apparatus that works for its intended purpose. Beckman Instruments, 892 F.2d at 1551... The Visy machine simply did not work at "production speed." As discussed, however, the claims do not require a threshold throughput or commercial speed.

The secondary considerations of non-obviousness "could not overcome 'the fact that nearly every single person or entity who encountered the lack of compliance problems in the industry came up with the same general hydraulic design to manage it.'"

Secondary considerations of non-obviousness must be considered when present. Sud-Chemie, Inc. v. Multisorb Techs., Inc., 554 F.3d 1001, 1008 (Fed. Cir. 2009). As the Supreme Court recently reaffirmed, "'[s]uch secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented.'" KSR, 550 U.S. at 406 (quoting Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966)). In some rare instances, the secondary consideration of simultaneous invention might also supply "indicia of 'obviousness.'" Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1376, 79 (Fed. Cir. 2000) (quoting Graham, 383 U.S. at 17-18).

The commercial success of a product is relevant to the non-obviousness of a claim only insofar as the success of the product is due to the claimed invention. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006). Here, Alliance conclusively established that much of George Martin's commercial success was due to Martin's pre-existing market share in the stacker market, which, according to Martin's president, gave it a "huge advantage" in selling other products because it allowed Martin to sell a "single-source system." Thus, this factor carries little weight.

Evidence of a long-felt but unsolved need provides another secondary consideration of non-obviousness. Ecolochem, 227 F.3d at 1376-77. Where the differences between the prior art and the claimed invention are as minimal as they are here, however, it cannot be said that any long-felt need was unsolved.

Industry praise must also be linked to the patented invention. Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1352 (Fed. Cir. 2010). The only evidence of industry praise on which the Trust reasonably relies as opposed to self-serving statements by Martin's president that the patented feature offers "increased productivity and increased profitability" is an internal Alliance email in which an Alliance employee reports a customer's statement that "the Martin breaker is the cat's meow." But that same email notes that the customer also chose the Martin Quik-Break because "[t]he interface between the stacker and the breaker will be handled by a single vendor." As with the commercial success factor, this reference to Martin's market share in the stacker market reduces the impact that this evidence could have in establishing industry praise.

Martin's argument that Alliance copied its design went nowhere.

This court has noted, however, "that a showing of copying is only equivocal evidence of non-obviousness in the absence of more compelling objective indicia of other secondary considerations." Echolochem, 227 F.3d at 1380.

The fact that the prior art was contemporaneous damned supposed novelty.

Independently made, simultaneous inventions, made "within a comparatively short space of time," are persuasive evidence that the claimed apparatus "was the product only of ordinary mechanical or engineering skill." Concrete Appliances Co. v. Gomery, 269 U.S. 177, 184 (1925). But see Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1460 (Fed. Cir. 1984) ("Because the statute, 35 U.S.C. § 135, (establishing and governing interference practice) recognizes the possibility of near simultaneous invention by two or more equally talented inventors working independently, that occurrence may or may not be an indication of obviousness when considered in light of all the circumstances.").

The existence of the Pallmac and Visy machines, however, shows that the Tecasa machine was invented within a "comparatively short space of time." As discussed, the evidence reveals that the relevant Pallmac machine was first installed in 1998, and the Visy machine was first sold in 1996, approximately three and five years, respectively, before the Trust alleges its invention was reduced to practice. The district court was therefore correct to conclude that the invention of the Tecasa machine, occurring only a year later than the earliest possible reduction-to-practice date of the claimed invention, qualified as a simultaneous invention. As such, "'though not determinative of statutory obviousness, [it is] strong evidence of what constitutes the level of ordinary skill in the art.'" Ecolochem, 227 F.3d at 1379 (quoting The Int'l Glass Co. v. United States, 408 F.2d 395, 405 (Ct. Cl. 1969)).

Balancing all of the secondary considerations, this court agrees with the district court that, in light of the strong evidence of obviousness based on the Pallmac and Visy prior art coupled with the near-simultaneous invention of the Tecasa machine, the Trust's objective evidence of non-obviousness, even if fully credited by a jury, would fail to make a difference in this case.

Affirmed.

Invalidity

A patent shall not issue "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." 35 U.S.C. § 103(a); see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 40607 (2007). Obviousness is a question of law with underlying fact issues. Id. at 427; Dennison Mfg. Co. v. Panduit Corp., 475 U.S. 809, 811 (1986). What a particular reference discloses is a question of fact, see Para-Ordnance Manufacturing, Inc. v. SGS Imports International, Inc., 73 F.3d 1085, 1088 (Fed. Cir. 1995), as is the question of whether there was a reason to combine certain references, see McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1352 (Fed. Cir. 2001). Under the four part test for obviousness detailed in Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966), the court must consider (1) the scope and content of the prior art; (2) the difference between the prior art and the claimed invention; (3) the level of ordinary skill in the art; and (4) any objective evidence of nonobviousness. The objective evidence relevant to this appeal includes industry skepticism, long-felt industry need, commercial success, and copying. See Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 1344 (Fed. Cir. 2008); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir. 2005).

A combination of two prior art references (Lund & Horn) sunk Transocean's asserted rig at the district court. The CAFC also held that a prima facie case of obviousness had been established. But that should not have been "the end of the analysis."

Although we hold that Horn in view of Lund present a prima facie case of obviousness, this is not the end of the analysis. At the district court, Transocean presented significant objective evidence of nonobviousness. First, Transocean presented evidence of industry skepticism. A Transocean competitor, in an article discussing simultaneous drilling operations, stated that dual drill strings would be a "radical departure" from conventional systems and that there was a high potential for underwater collision. Others in the field described dual activity as "not being realistic" for the same reasons. Second, Transocean presented evidence of industry praise for its dual activity rig. An industry publication called the invention one of the top 50 innovations in offshore drilling history. Transocean also cites other examples of praise from clients and competitors, including Maersk USA. Third, Transocean presented evidence that its implementation of the dual activity invention has been a commercial success. It showed that its dual activity rigs command a higher licensing premium than standard rigs. Finally, Transocean presented evidence that the success of its invention caused others to copy it, including Maersk USA.

Naturally, Maersk disputed all that. And the district court...

In its opinion, the district court ignored this objective evidence of nonobviousness.

We hold that the district court erred by failing to consider Transocean's objective evidence of nonobviousness. Our case law is clear that this type of evidence "must be considered in evaluating the obviousness of a claimed invention." Iron Grip, 392 F.3d at 1323; Ruiz v. A.B. Chance Co., 234 F.3d 654, 667 (Fed. Cir. 2000); Richardson-Vicks, Inc. v. Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997). While it is true that we have held in individual cases that objective evidence of nonobviousness did not overcome the strong prima facie case - this is a case-by-case determination. See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007); Agrizap, 520 F.3d at 1344. To be clear, a district court must always consider any objective evidence of nonobviousness presented in a case. Iron Grip, 392 F.3d at 1323; Ruiz, 234 F.3d at 667; Richardson-Vicks, 122 F.3d at 1483.

Maersk USA is correct that in at least one instance, we considered this type of objective evidence for the first time on appeal and held that the failure to consider it below was not reversible error. See Iron Grip, 392 F.3d at 1324. But in the context of summary judgment, this is only proper if, drawing all justifiable inferences in favor of the patent owner, the objective evidence cannot rebut the prima facie case. We decline to make that holding in this case. If all of the factual disputes regarding the objective evidence resolve in favor of Transocean, it has presented a strong basis for rebutting the prima facie case. Viewing the objective evidence of nonobviousness in a light most favorable to Transocean, we cannot hold that the claims would have been obvious as a matter of law.

Obviousness on summary judgment reversed.

Enablement

Whether a claim satisfies the enablement requirement is a question of law that we review de novo. Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008). A patent specification must "contain a written description of the invention . . . to enable any person skilled in the art . . . to make and use the same." 35 U.S.C. § 112, ¶1. The specification must "enable one of ordinary skill in the art to practice the claimed invention without undue experimentation." Nat'l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999). Enablement under § 112 is a question of law with underlying questions of fact regarding undue experimentation. Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1377 (Fed. Cir. 2007); CFMT, Inc. v. Yieldup Int'l Corp., 349 F.3d 1333, 1338 (Fed Cir. 2003).

We agree with Transocean that factual issues regarding undue experimentation remain in this case that preclude summary judgment of no enablement. As an initial matter, the district court erred in requiring Transocean to enable the invention to allow a person of ordinary skill in the art to take advantage of the "timesaving" aspect of the invention. A patent specification only must enable one of ordinary skill in the art "to practice the claimed invention without undue experimentation." Nat'l Recovery Techs., 166 F.3d at 1196. It is not required to enable the most optimized configuration, unless this is an explicit part of the claims... It is irrelevant whether the enabling disclosure would provide the most efficient transfer. In requiring disclosure of "programming" and relying on the difficulty of constructing Transocean's first dual activity rig, the district court erroneously required Transocean to enable the most efficient commercial embodiment, rather than the claims. CFMT, Inc., 349 F.3d at 1338.

The court also erred in its determination that there is no genuine issue of material fact regarding undue experimentation. The parties do not dispute that the specification discloses two different types of transfer mechanism: a rail-mounted system and a crane. '781 patent, col.7 ll.21-26, 53-55; fig.7. But the parties heavily dispute whether the development of the transfer equipment would be "trivial," or a much more complex task based on the evidence presented below. Drawing all justifiable inferences in favor of Transocean, we cannot agree with the district court that these claims are not enabled as a matter of law. Therefore, we reverse the grant of summary judgment.

Patents enabled, a reversal of the district court.

Infringement

At issue was whether signing a foreign contract gets an infringer off the hook.

The infringement issues in this case are unusual and require a discussion of the factual background. Trans-ocean accused Maersk USA's DSS-21 rig of infringement. Maersk USA's Danish parent company, Maersk A/S, contracted with Keppel FELS Ltd. in 2005 to build the accused rig in Singapore. Later, Maersk A/S negotiated with Statoil ASA (a Norwegian company) for Statoil's use of the accused rig. The companies came to an agreement for use of the rig and Maersk USA and Statoil Gulf of Mexico LLC (Statoil), a Texas Corporation, signed a contract in Norway. The contract specified that the "Operating Area" for the rig was the U.S. Gulf of Mexico but that Statoil had the right to use the rig outside the Operating Area with certain limitations. J.A. 7167; 7211.

In a previous litigation, Transocean v. GlobalSantaFe (GFS), Transocean got an injunction against GSF. GSF created a non-infringing workaround, which involved installing a "casing sleeve" to prevent the drilling platform from advancing tubes to the seabed as claimed.

The contract also included mention of Transocean's U.S. patents. Maersk USA specifically retained the right to make "alterations" to the accused rig "in view of court or administrative determinations throughout the world." J.A. 7190. One of these "determinations" came when Transocean asserted the same patent claims in this case against another competitor, GlobalSantaFe Corp. (GSF). Transocean prevailed in that case and the court issued an injunction requiring GSF to install a "casing sleeve" on one of its two advancing stations. Transocean Offshore Deepwater Drilling, Inc. v. GlobalSantaFe Corp., No. H-03-2910, 2006 U.S. Dist. LEXIS 93408 (S.D. Tex. Dec. 27, 2006). This casing sleeve prevents the auxiliary advancing station from lowering a drill string into the water. Id. at *32-34. The district court in GSF held that this avoids infringement because the cased advancing station can no longer advance tubes to the seabed as the independent claims require. Before delivering the rig to the U.S., Maersk USA learned of the injunction against GSF and modified the accused rig with the same casing sleeve to prevent one of the stations from advancing pipes to the seabed.

The district court granted summary judgment of non-infringement after determining that there was no sale or offer to sell under 35 U.S.C. § 271(a). Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, No. 07-2392, D.I. 148, *8-9 (S.D. Tex. May 15, 2009) (Willfulness Order). The court relied on the undisputed facts that the negotiation and signing of the contract took place outside the U.S. and that the contract gave Maersk the option to alter the rig to avoid infringement. Id. The district court also held that Transocean was collaterally estopped from arguing that the modified rig that Maersk USA delivered to Statoil (that included the casing sleeve to prevent advancing tubular members to the seabed) infringed the patent claims because this design was adjudicated as noninfringing in the GSF litigation [a previous litigation involving the patents in dispute here]. Noninfringement/Invalidity Order at *12.

A. Offer to Sell

Section 271(a) defines infringing conduct: "whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States. . . infringes the patent." 35 U.S.C. § 271(a). An offer to sell is a distinct act of infringement separate from an actual sale. An offer to sell differs from a sale in that an offer to sell need not be accepted to constitute an act of infringement. See MEMC Elec. Materials, Inc. v. Mitsubishi Materials Silicon Corp., 420 F.3d 1369, 1376 (Fed. Cir. 2005). Moreover, the damages that would flow from an unac-cepted offer to sell and an actual sale would likely be quite different. See Timothy R. Holbrook, Liability for the "Threat of Sale": Assessing Patent Infringement for Offering to Sell an Invention and Implications for the On-Sale Patentability Bar and other Forms of Infringement, 43 Santa Clara L. Rev. 751, 791-92 (2003). We analyze an offer to sell under § 271(a) using traditional contract principles. Rotec Indus., Inc. v. Mitsubishi Corp., 215 F.3d 1246 (Fed. Cir. 2000). There is no dispute that there was an offer to sell in this case, but Maersk USA argues that the offer was made in Norway, not the United States, thereby absolving it of § 271(a) liability.

Maersk A/S (a Danish company) and Statoil ASA (a Norwegian company) negotiated the contract that is the subject of this alleged offer to sell. Their U.S. affiliates, Maersk USA and Statoil executed the contract in Norway. The contract included an "Operating Area" of the U.S. Gulf of Mexico. The district court held that because the negotiations and execution took place outside the U.S., this could not be an offer to sell within the United States under § 271(a).

This case presents the question whether an offer which is made in Norway by a U.S. company to a U.S. company to sell a product within the U.S., for delivery and use within the U.S. constitutes an offer to sell within the U.S. under § 271(a). We conclude that it does. Section 271(a) states that "whoever . . . offers to sell . . . within the United States any patented invention . . . infringes." In order for an offer to sell to constitute infringement, the offer must be to sell a patented invention within the United States. The focus should not be on the location of the offer, but rather the location of the future sale that would occur pursuant to the offer.

The offer to sell liability was added to the patent statute to conform to the April 1994 Uruguay Round's Trade-Related Aspects of Intellectual Property Agreement (TRIPS). The underlying purpose of holding someone who offers to sell liable for infringement is to prevent "generat-ing interest in a potential infringing product to the com-mercial detriment of the rightful patentee." 3D Sys., Inc. v. Aarotech Labs., Inc., 160 F.3d 1373, 1379 (Fed. Cir. 1998). The offer must be for a potentially infringing article. Id. We are mindful of the presumption against extraterritoriality. Microsoft Corp. v. AT&T Corp., 550 U.S. 437, 441 (2007). "It is the general rule under United States patent law that no infringement occurs when a patented product is made and sold in another country." Id. This presumption has guided other courts to conclude that the contemplated sale would occur within the United States in order for an offer to sell to constitute infringement. See, e.g., Semiconductor Energy Lab. Co. v. Chi Mei Optoelectronics Corp., 531 F. Supp. 2d 1084, 1110-11 (N.D. Cal. 2007). We agree that the location of the contemplated sale controls whether there is an offer to sell within the United States.

We hold that the district court erred because a contract between two U.S. companies for performance in the U.S. may constitute an offer to sell within the U.S. under § 271(a). The fact that the offer was negotiated or a contract signed while the two U.S. companies were abroad does not remove this case from statutory liability. We therefore vacate the district court's summary judgment of noninfringement.

B. Sale

As with the offer to sell, we hold that a contract between two U.S. companies for the sale of the patented invention with delivery and performance in the U.S. constitutes a sale under § 271(a) as a matter of law.

The sale was for a rig to be used in the Gulf of Mexico.

Our precedent establishes that a contract can constitute a sale to trigger infringement liability. See NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1319 (Fed. Cir. 2005). A "sale" is not limited to the transfer of tangible property; a sale may also be the agreement by which such a transfer takes place. Id. In this case, there was a contract to sell a rig that included schematics. On summary judgment, we must draw all justifiable inferences in favor of the non-movant, Transocean. Transocean argues that these schematics show sale of the patented invention. This is a genuine issue of material fact sufficient to withstand summary judgment.

We conclude that the district court erred in granting summary judgment that there was no sale within the U.S. in this case. As with the offer to sell, there remains a dispute over whether the unmodified rig that was sold was the patented invention, a question not reached by the district court thus far.

A previous litigation, referred to as GSF, held a particular design to be non-infringing.

We hold that the district court did not err in holding that Transocean is collaterally estopped from arguing that the rig modified in accordance with the GSF injunction infringes any of the asserted claims. On remand, Transocean may argue that the unmodified design (without the casing sleeve) was the subject of the Maersk USA/Statoil contract and that therefore there is infringement of the asserted claims based on both a sale and offer to sell. Transocean, however, is estopped from arguing infringement by the modified rig that Maersk USA actually delivered to the U.S.

Infringement back in play, with caveats, as the district court finding of noninfringement was reversed.

Willfulness

"Proof of willful infringement . . . requires at least a showing of objective recklessness." In re Seagate Tech., LLC, 497 F.3d 1360, 1371 (Fed. Cir. 2007) (en banc). The patent owner "must show by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent." Id. (citing Safeco Ins. Co. of Am. v. Burr, 551 U.S. 47 (2007)). This objective standard is a threshold. Once met, the patentee must show that the infringer knew or should have known of the objectively high risk. Seagate, 497 F.3d at 1371.

The district court granted summary judgment of no willfulness. The court held that because Maersk USA modified its design to conform to the GSF injunction, it could not be "objectively reckless," and thus could not be willful as a matter of law. Willfulness Order at *9.

We agree with the district court that, as a matter of law, there is no willfulness. Although the contract does show that Maersk USA knew of Transocean's patents, it also shows intent to avoid infringement. Maersk USA reserved the right to modify the rig in response to any court proceeding that favored "the validity or infringement arguments of Transocean." J.A. 7190. In fact, Maersk USA did modify its rig once the court in the GSF litigation issued an injunction defining a noninfringing alternative. We hold, as a matter of law, that Maersk's actions were not objectively reckless and thus affirm the district court's holding of no willfulness.

Maersk minded its manners on using a workaround in US waters. No willfulness affirmed.

Reversed-in-part, vacated-in-part, affirmed-in-part, and remanded.

It appears that Dr. Baran's counsel hadn't thought through claim construction and its implications on claim construction.

As an initial matter, we accept Dr. Baran's assertion that the '798 patent "never discloses a stylet that is joined to a cannula."... The fact that the stylet is not attached to the cannula, however, is not favorable to Dr. Baran. If anything, it lends further credence to the district court's construction of "detachable" as meaning "separation without loss or damage," because the stylet and cannula as described in the specification are readily separable without loss or damage.

Dr. Baran disclosed two embodiments: single use, and reusable. The difference between them made claim construction clear to the courts, but apparently not to Dr. Baran's lawyers.

The patentee used the term "detachably" in the specification to draw a direct contrast between the removable components of the reusable embodiment and the adhesively bonded components of the singleuse embodiment. That usage effectively concedes that adhesively bonded components--including the single-use embodiment--are not "detachable" components within the meaning of the patent. We agree with the district court that "[t]his distinction suggests that the patentee intended 'detachable' to mean capable of removal or separation without breaking or causing damage through the necessary use of undue force." Baran v. Med. Device Techs., Inc., 519 F. Supp. 2d 698, 724 (N.D. Ohio 2007); see also K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1365 (Fed. Cir. 1999) ("Screws, unlike rivets and [adhesive] laminates, are meant to be unscrewed, that is, to be removed. A rivet or a laminate, to the contrary, is meant to remain permanent, unremovable unless one is bent on breaking the permanent structure apart."). Incorporating the "without loss or damage" condition into the claim construction has the additional advantage of comporting with the plain meaning of "detachable," as expressed by the several dictionary definitions cited by the district court.

Another discovery by Dr. Baran and his attorneys was that using two terms interchangeably renders them interchangeable.

We also agree with the district court that the terms "releasably" and "detachable" have the same meaning in the '798 patent. Dr. Baran argues that the use of different terms implies that they have different meanings, see CAE Screenplates Inc. v. Heinrich GmbH, 224 F.3d 1308, 1317 (Fed. Cir. 2000), but that implication is overcome where, as here, the evidence indicates that the patentee used the two terms interchangeably. See Tehrani v. Hamilton Med., Inc., 331 F.3d 1355, 1361 (Fed. Cir. 2003).

In a final death throe, Dr. Baran argued improper exclusion of an embodiment.

In a final attempt to bring the single-use embodiment within the scope of the asserted claim, Dr. Baran argues that the district court's claim construction improperly excluded a preferred embodiment and ignored the Summary of the Invention. There is no force to either of those arguments. It is not necessary that each claim read on every embodiment. In this instance, while claim 2 reads on only the reusable embodiment, a different claim of the '798 patent (claim 18) reads on both the single-use and the reusable embodiments,. See Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1383 (Fed. Cir. 2008) ("It is often the case that different claims are directed to and cover different disclosed embodiments."); Intamin Ltd. v. Magnetar Techs., Corp., 483 F.3d 1328, 1336-37 (Fed. Cir. 2007) ("[A] claim need not cover all embodiments."). As for the excerpt from the Summary of the Invention, it simply repeats verbatim the claim language that the "stylet means is . . . detachable from the cannula" and that the "second connector . . . releasably and fixedly engages the first connector." '798 patent, col. 3, ll. 50-60. The fact that those claim terms were used in the Summary does not mean that they must be read to encompass all the embodiments of the invention.

Because we do not disturb the district court's construction of "releasably," or the related constructions of "first connector means" and "second connector means," Dr. Baran's stipulation of noninfringement of the '798 patent remains effective.

'797 went down similarly. Dr. Baran argued that the claimed "release" function was not a function, but a "characteristic."

Dr. Baran also appeals the two grounds on which summary judgment was entered as to the '797 patent. We conclude that no reasonable juror could find that MDTech's BioPince device satisfies the means-plus-function limitation of "release means for retaining the guide in the charged position." That determination is sufficient to affirm the district court's judgment of noninfringement; accordingly, we do not address Dr. Baran's additional arguments regarding the "charging member" limitation.

In construing a means-plus-function claim, the district court must first determine the claimed function and then identify the corresponding structure in the written description of the patent that performs that function. Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 F.3d 1324, 1332 (Fed. Cir. 2006). In order to prove literal infringement of a means-plus-function claim, the plaintiff must show that the accused device performs the recited function through structure that is the same as or equivalent to the corresponding structure set forth in the specification. 35 U.S.C. § 112, ¶ 6.

He urges that "release" should be construed to mean "releasable," which he explains is a characteristic and not a function. Presumably, Dr. Baran believes that distinction to be significant because a characteristic would describe something the structure is merely capable of performing, not something the structure must perform.

We agree with the district court that the claim language recites both a release function and a retention function. Dr. Baran's argument regarding the placement of the term "release" is unavailing. The relevant inquiry is whether the term at issue is purely functional. See Signtech USA, Ltd. v. Vutek, Inc., 174 F.3d 1352, 1356 (Fed. Cir. 1999) (construing "ink delivery means" to be equivalent to "means for ink delivery" because "ink delivery" was purely functional language); Al-Site Corp. v. VSI Int'l, Inc., 174 F.3d 1308, 1318 (Fed. Cir. 1999) ("[W]hen it is apparent that the element invokes purely functional terms . . . the claim element may be a means-plus-function element despite the lack of express means-plus-function language."). In the context of the '797 patent, the term "release" is not an idle description but a vital function to be performed by the means-plus-function element. The patent does not recite a biopsy instrument that retains indefinitely without release; rather, the contemplated function is to retain for the express purpose of producing a spring-loaded release on demand. The claim language ties both functions to the same means-plus-function element, so it is appropriate that the element be construed accordingly.

Not a close call at all.

Again, we find that the district court did not err in concluding that the accused structure was not equivalent to the structure described in the specification. The two structures rely on opposing principles: the lever facilitates the release by clearing the retention means from the path of the guide, while the locking tab mechanism achieves release only by overcoming the full resistance of the retention means. Because of that structural difference, the lever must be rigid to release the guide, while the locking tab must be flexible to do the same. The references to "flexibility" that Dr. Baran cites from the patent refer to the fact that the lever remains free to pivot flexibly along the fulcrum, not that the lever itself is made of flexible material. Indeed, it would be impossible to operate a lever if it were made of highly elastic material, just as it would be impossible to bypass a locking tab if it were made of stiff, unyielding material. Accordingly, we concur with the district court that the accused structure is substantially different from the disclosed structure and therefore does not infringe pursuant to section 112, paragraph 6.

Dr. Baran filed a declaration that read like an expert report. The district court ignored it for being late. Dr. Baran tried to revive it without success.

The court found that the "vast majority of [Dr.] Baran's declaration is opinion testimony based on 'scientific, technical, or other specialized knowledge within the scope of Rule 702,'" and that it was, "as a practical matter, an expert report in which he provides his infringement opinion." Baran v. Med. Device Techs., Inc., 666 F. Supp. 2d 776, 779 n.2 (N.D. Ohio 2009). The court further found that Dr. Baran had not identified himself as an expert, as required by Federal Rule of Civil Procedure 26(a)(2), and that his "expert report" was submitted well after the deadline for exchanging expert reports established by the court's case management plan. As a result, the court held that it would not consider Dr. Baran's declaration "to the extent it provides expert testimony." Id.

Affirmed.

King acquired the patent rights from Elan. Elan had sued Eon for an earlier accused infringement.

Under 35 U.S.C. § 102 a claim is anticipated "if each and every limitation is found either expressly or inherently in a single prior art reference." Celeritas Techs. Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354, 1360 (Fed. Cir. 1998). "[A]nticipation by inherent disclosure is appropriate only when the reference discloses prior art that must necessarily include the unstated limitation. . . ." Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d 1364, 1373 (Fed. Cir. 2002) (emphasis in original). A claim is obvious when "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." 35 U.S.C. § 103.

Moreover, "[t]he laws of nature, physical phenomena, and abstract ideas have been held not patentable." Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). While a process may be patentable if "(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing," In re Bilski, 545 F.3d at 954, there is no exclusive test for determining patentability under § 101, Bilski, 130 S. Ct. at 3226-27.

The inherent anticipation dispute was over eating food contemporaneous with taking the drug.

In its summary judgment opinion, the district court rejected King's argument and found claim 1's preamble inherently anticipated. See King Pharms., Inc., 593 F. Supp. 2d at 507-09. According to the district court, an increase in the bioavailability of metaxalone is an inherent property of taking metaxalone with food, which is disclosed in each of Fathie II, Albanese, and Abrams. See id.

As an initial matter, King's attempt to link an increase in metaxalone's bioavailability to specific food conditions is untenable. While the '128 patent's written description discloses specific conditions for food consumption, its claims only recite taking metaxalone "with food." It would be improper to limit the broad terms used in the '128 patent's claims to the specific food conditions disclosed in the written description. See Kara Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009) ("The claims, not specification embodiments, define the scope of patent protection. The patentee is entitled to the full scope of his claims, and we will not limit him to his preferred embodiment or import a limitation from the specification into the claims."). Moreover, the written description in no way suggests that the specific food conditions disclosed were necessary for increasing metaxalone's bioavailability. Rather, the written description teaches that the claimed increase in metaxalone's bioavailability can be achieved through the consumption of "a meal, such as breakfast, lunch or dinner." '128 patent col.2 ll.37-38. The district court was therefore correct in finding that "the '128 patent does not identify any additional conditions that must be present for the food effect to occur. Rather, it occurs naturally in most people when they take metaxalone with food." King Pharms., Inc., 593 F. Supp. 2d at 508; see also Verdegaal Bros., Inc. v. Union Oil Co. of California, 814 F.2d 628, 632 (Fed. Cir. 1987) (holding reliance on non-claimed distinction between prior art method and claimed method "inappropriate" and insufficient to save the claim from inherent anticipation).

We have held that "[i]t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Such newly discovered benefits are not patentable because they are inherent in the prior art. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). While inherent anticipation "may not be established by probabilities or possibilities," In re Oelrich, 666 F.2d 578, 581 (CCPA 1981), if "the [prior art's] disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well-settled that the disclosure should be regarded as sufficient," id. (alterations added).

According to the '128 patent, the natural result of taking metaxalone with food is an increase in the bioavailability of the drug. The prior art discloses taking metaxalone with food, but not the natural result of this process. However, because the prior art methods in their "normal and usual operation . . . perform the function which [King] claims in [the '128 patent], then such [patent] will be considered, to have been anticipated by the [prior art]." In re Ackenbach, 45 F.2d 437, 439 (CCPA 1930) (alterations added). As taught by the '128 patent, the only steps required to increase metaxalone's bioavailability are (1) ingesting metaxalone (2) with food. These steps are undeniably disclosed by the prior art. An increase in metaxalone's bioavailability is, therefore, an inherent aspect of the prior art. In other words, the increase in metaxalone's bioavailability is the "'natural result' flowing from the [prior art's] explicitly explicated limitations." Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 970 (Fed. Cir. 2001) (alterations added); see also MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1331, 1336 (Fed. Cir. 1999) ("[T]o the extent the embodiment in the patent achieves [the limitation], so does the [prior art].") (alterations added). Accordingly, claim 1's preamble is inherently anticipated.

King's experts' opinions that "even a disclosure of taking metaxalone with food would not inherently disclose increasing the bioavailability of metaxalone," do not undermine our analysis. To anticipate, the prior art need only meet the inherently disclosed limitation to the extent the patented method does. See Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314, 1326 (Fed. Cir. 2003) ("[A] prior art product that sometimes, but not always, embodies a claimed method nonetheless teaches that aspect of the invention."). Because the '128 patent discloses no more than taking metaxalone with food, to the extent such a method increases the bioavailability of metaxalone, the identical prior art method does as well. As the district court aptly stated, "to inherently anticipate, the prior art need only give the same results as the patent, not better." King Pharms., Inc., 593 F. Supp. 2d at 509.

For the foregoing reasons, the district court's inherent anticipation analysis was proper. The preamble to claim 1 is inherently anticipated. To hold otherwise would remove from the public a method of treating muscle pain that has been performed for decades. See Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1348 (Fed. Cir. 1999) ("The public remains free to make, use, or sell prior art compositions or processes, regardless of whether or not they understand their complete makeup or the underlying scientific principles which allow them to operate. The doctrine of anticipation by inherency, among other doctrines, enforces that basic principle."). Accordingly, the district court's finding that claim 1 is anticipated is affirmed.

Other claims fell by their dependence on claim 1. "Like claim 1, these claims are anticipated because their sole source of novelty is inherently disclosed by the prior art."

Still other dependent claims were more specific with regard to time lapse between drugging and munching.

On appeal, King argues that none of the claims' specific timeframe requirements is disclosed in [the prior art references] Fathie II, Albanese, or Abrams. Yet, according to King's own experts, "with food" could mean taking metaxalone "1 hour prior to up to about 2 hours after eating." J.A.3221 (Decl. of Dr. Elia). Under this common-sense definition of "with food," the prior art discloses a timeframe for ingesting metaxalone in relation to consuming food that falls within the timeframes claimed by claims 4-6. The district court's finding that claims 4-6 are anticipated is therefore affirmed. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) ("[It is] an elementary principle of patent law that when, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is 'anticipated' if one of them is in the prior art."); Fresenius USA, Inc. v. Baxter Int'l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009).

King had a better argument for the downfall of '128 dependent claim 21 with its jazzy "informing" limitation: look at the claim as a whole, not just one limitation. But the argument didn't go far enough to save the claim.

On appeal, King contends it was legal error for the district court to focus solely on the "informing" limitation in invalidating the claim. Instead, according to King, the district court should have examined the claim as a whole to determine whether it recited patent eligible subject matter. King is correct.

The Supreme Court has stated that a § 101 patentability analysis is directed to the claim as a whole, not individual limitations. See Parker v. Flook, 437 U.S. 584, 590 (1978) ("[A] process is not unpatentable simply because it contains a law of nature or a mathematical algorithm." (alterations added)); see also In re Bilski, 545 F.3d at 958 ("[T]he [Supreme] Court has made clear that it is inappropriate to determine the patent-eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter." (alterations added)). Contrary to the Supreme Court's instructions, the district court ignored the claim as a whole and improperly focused on one limitation, the "informing" limitation, in invalidating the claim under § 101. Such an analysis is improper.

The CAFC pats itself on the back for "the wisdom behind" its Bilski ruling.

Reviewed as a whole, claim 21 teaches a method of treating patients with metaxalone, whereby the patient is administered metaxalone with food and informed that such treatment increases the bioavailability of the drug. Prior to the Supreme Court's decision in Bilski, this court held that such medical treatment methods were patentable processes under § 101 because they fell squarely within the machine-or-transformation test applied in In re Bilski. Specifically, we held that methods of treatment "are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition," because such methods transform the human body. Prometheus Labs., Inc. v. Mayo Collaborative Serv., 581 F.3d 1336, 1346 (Fed. Cir. 2009), cert. granted and vacated, No. 09-490, 78 U.S.L.W. 3254 (U.S. June 29, 2010). While the Supreme Court in Bilski made clear that our machine-or-transformation test is not the exclusive test for patentability, Bilski, 130 S. Ct. 3226-27, it also made clear that the test "is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101," id. at 3227. We therefore understand the Supreme Court to have rejected the exclusive nature of our test, but not necessarily the wisdom behind it.

The CAFC panel goes after § 101 sideways, and roundabout, to come to the conclusion that "informing" isn't patentable.

The specific question before us is whether an otherwise anticipated method claim becomes patentable because it includes a step of "informing" someone about the existence of an inherent property of that method. We hold it does not. The "informing" limitation adds no novelty to the method, which is otherwise anticipated by the prior art. In other words, in light of our holding that the method of taking metaxalone with food to increase the drug's bioavailability, as recited in claim 1, is not patentable, it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.

In an analogous context, we have held that "[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability." In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (alterations added). In such cases, we have recognized that the printed matter is not independently patentable, but have cautioned that the limitation must not be excised from the claim. See id. at 1385 ("[T]he board cannot dissect a claim, excise the printed matter from it, and declare the remaining portion of the mutilated claim to be unpatentable. The claim must be read as a whole.") (alterations added). Instead, the relevant question is whether "there exists any new and unobvious functional relationship between the printed matter and the substrate." Id. at 1386 (citing In re Miller, 418 F.2d 1392, 1396 (CCPA 1969)). The rationale behind this line of cases is preventing the indefinite patenting of known products by the simple inclusion of novel, yet functionally unrelated limitations. See In re Nagi, 367 F.3d at 1339.

Although these "printed matter" cases involved the addition of printed matter, such as written instructions, to a known product, we see no principled reason for limiting their reasoning to that specific factual context. See In re Ngai, 367 F.3d at 1338-39; In re Gulack, 703 F.2d at 1385-87. Rather, we believe that the rationale underlying these cases extends to the situation presented in this case, wherein an instructional limitation is added to a method, as opposed to a product, known in the art. Thus, the relevant inquiry here is whether the additional instructional limitation of claim 21 has a "new and unobvious functional relationship" with the known method of administering metaxalone with food. See In re Ngai, 367 F.3d at 1338 (quoting In re Gulack, 703 F.2d at 1386).

King contends that there is a functional relationship between the "informing" limitation and the method. Specifically, at oral argument, King's counsel argued that the "informing" limitation increases the likelihood that the patient will take metaxalone with food, thereby in-creasing the efficiency of the method. See Oral Arg. at 7:30-8:26. This relationship, however, is not functional. Informing a patient about the benefits of a drug in no way transforms the process of taking the drug with food. Irrespective of whether the patient is informed about the benefits, the actual method, taking metaxalone with food, is the same. In other words, the "informing" limitation "in no way depends on the [method], and the [method] does not depend on the ['informing' limitation]." In re Nagi, 367 F.3d at 1339 (alterations added). "It is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945).

The district court's obviousness finding with respect to claim 5 of '102 was affirmed. The magic wand doctrine of inherent obviousness is that no articulated reasoning is needed to account for "a person of ordinary creativity."

Turning to the district court's obviousness analysis, the district court held that a prior art reference, Dent, disclosed taking metaxalone in a single 400 mg tablet four times a day. King Pharms., Inc., 593 F. Supp. 2d at 511. Dent does make such a disclosure. It would be obvious to a person of ordinary skill in the art to combine Dent's teaching of taking a tablet dosage of metaxalone four times a day with Albanese's teaching of administering metaxalone with food. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2008) ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").

The bottom line -

In summary, while the district court erred in invalidating several of the claims as unpatentable under § 101, all the claims of the '128 and '102 patents are ultimately anticipated under 35 U.S.C. § 102 or obvious under 35 U.S.C. § 103 in light of the prior art. Additionally, the district court erred in entering a judgment of invalidity against Elan because no case or controversy currently exists between Elan and Eon.

Affirmed and vacated-in-part.

At trial, the dispute with respect to the '159 patent centered on whether Sprint Nextel's iDEN system contained the structure corresponding to the "means to resolve" limitation.

The district court found that "means to resolve" in [claim 1 of] the '159 patent invoked 35 U.S.C. § 112, ¶ 6. The court then proceeded to determine that the claimed function was "to resolve a global position from satellite or earth based communication means." Based on its examination of the specification, the court determined that the corresponding structure for this function was a "transceiver, connecting circuitry, CPU, satellite receiving means, terrestrial receiving means, decoders, and temporary storage." Neither party objected to how the district court construed this means-plus-function limitation, or suggested a more specific definition of its structure was necessary. Sprint Nextel's pre-trial briefs, proposed jury instructions, and pre-verdict JMOL were similarly devoid of any argument that the "connecting circuitry" portion of the structure should be limited to the specific embodiment in Figure 2 of the '159 patent. See '159 patent col.5 l.48-col.6 l.5.

Sprint Nextel waived any claimed error associated with the "connecting circuitry" structure: Here, as in Eli Lilly & Co. v. Aradigm Corp., Sprint Nextel never requested the district court construe "connecting circuitry," or offered a construction of the term. 376 F.3d 1352, 1360 (Fed. Cir. 2004). Rather, the district court's claim construction order notes that "the parties are not in dispute" as to the "means to resolve" structure, which included the now-disputed "connecting circuitry." Though it had ample opportunity to do so, at no time before or during trial did Sprint Nextel object to the district court's claim construction, request clarification, or offer the construction it now advances on appeal. Indeed, Sprint Nextel's own expert testified that the district court's claim construction was "fine." See Broadcom, 543 F.3d at 694; see also Conoco, Inc. v. Energy & Envtl. Int'l, L.C., 460 F.3d 1349, 1358-59 (Fed. Cir. 2006).

With regards to the '461 patent, the parties disputed whether Sprint Nextel's iDEN and CDMA systems satisfied the "preauthorized" limitation in the asserted claims.

In construing "pre-authorized," the district court largely adopted Sprint Nextel's proposed construction.

The district court construed "pre-authorized" in both claims of the '461 patent to mean "authorized to submit a request in advance of determining whether the request will be granted." Sprint Nextel did not object to this definition. Similarly, at no time before or during the trial did Sprint Nextel ask the district court to clarify whether the preauthorization was for access to the network or only for access to a particular mobile device.

Sprint Nextel waived its right to argue its new claim construction of "pre-authorized" by waiting until after the jury returned its verdict. See Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1357 (Fed. Cir. 2003).

Otherwise, Sprint Nextel moved to dismiss the case for lack of standing because Enovsys pooh-bah Mundi Fomukong did not have his ex-wife join the action. Mundi was married when he filed the patents. The district court waved that off because Mundi got possession of the patents in the divorce. The CAFC agreed.

Affirmed.

Judge Newman dissented over waiver by Sprint Nextel. The majority waived too much away.

I write separately because the court, in reviewing the question of infringement, confounds "claim construction" with "infringement," and on this confusion, rules that the defendant waived critical aspects of its defense of non-infringement simply because those aspects were not raised in the guise of "claim construction." Thus the court holds that because the district court's claim construction was not specific to certain details of the defendant's system, the defendant "waived" its defense that these elements of its system are not within the scope of the claims. From this novel position I must, respectfully, dissent.

Amid the complexities of the procedures of "claim construction" as a prologue to determination of infringement, it is not unusual to see an intermingling or misplacement of the relationship between the claim as construed in light of the description of the invention in the specification, and the question of infringement by the accused device. Questions of infringement may sometimes be decided as claim construction, whereby the claim is construed with so tight a tie to the structure of the accused device that infringement vel non is immediately apparent - and summarily resolved. And questions of claim construction sometimes arise as questions of infringement, whereby the trier of fact (as distinguished from the giver of law) must decide whether the claim reads on the accused device. In either situation, any flaw is more a matter of procedural imprecision, not substantive "waiver," and any error is normally tolerable, for in either situation the decisionmaker studies the claim, understands the accused device, and decides the relationship between them as a matter of substance, not technicality.

However, as with any tolerant relationship, intolerant situations may arise. Here, for example, the defendant Nextel presented a straightforward defense to the charge of infringement, by arguing that certain aspects of the patentee's invention are not present in the accused system. Yet my colleagues on this panel hold that this defense is "waived."

A district court ordinarily does not resolve all infringement issues through a narrowly targeted claim construction focused on the accused device. Claim construction is derived from the specification of the patent, not the accused device.

The claim construction and the jury instructions correctly limited the patented structures to those described in the specification. In raising its defense that its "connecting circuitry" was different from that in the specification, Nextel conformed with law and protocol. Thus Nextel presented evidence and argument at trial that its accused iDEN system did not meet the "means to resolve" limitation because it did not have the same "connecting circuitry" described in the specification. Although the jury rejected Nextel's position, it was considered, and this issue was raised on motion for JMOL. The judge denied Nextel's JMOL motion, and disagreed with Nextel's argument that the claim construction required "the exact connecting circuitry in the '159 patent." The trial judge did not treat Nextel's argument as a "waived" claim construction argument. However, my colleagues hold that the question of infringing this claim element should have been raised as an appeal from the claim construction. Indeed, whether this question could have been raised in this manner does not mean that defense to infringement is deemed waived and cannot be presented or appealed, on the apparent theory that the defendant was required to request a claim construction in terms of its own circuitry.

Any lapse of precision between fact and law does not lead to "waiver" of the right to defend or the right to judicial review (although it may affect the standard of review). It is incorrect, and a negation of the processes of law, to hold that such a defense against infringement was waived because it was not presented, resolved, or appealed as a matter of claim construction.

The accused infringers are emsCharts and Softtech. emsCharts produces a web-based medical charting program called emsCharts. The emsCharts program charts patient information and provides integrated billing. Softtech produces computer-aided flight dispatch software called Flight Vector, which coordinates flight information, such as patient pickup and delivery, and flight tracking. The two companies formed a strategic partnership, enabled their two programs to work together, and collaborated to sell the two programs as a unit.

Joint Infringement

Where joint infringement occurs, one must be the puppet master, or so the majority of Judges DYK and Friedman held.

Where the combined actions of multiple parties are alleged to infringe process claims, the patent holder must prove that one party exercised "control or direction" over the entire process such that all steps of the process can be attributed to the controlling party, i.e., the "mastermind." Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1329 (Fed. Cir. 2008) (citing BMC Res., Inc. v. Paymentech, L.P., 498 F.3d 1373, 180-81 (Fed. Cir. 2007)). Here, the district court concluded that the evidence of control or direction was insufficient as a matter of law to uphold a finding of joint infringement. We agree with the district court that the evidence here was insufficient for jury to infer control or direction. We see no need for extended discussion of this issue and we affirm the district court's grant of JMOL as to the process claims the jury found to be jointly infringed (claims 15-22).

Queen Pauline had a different take. As usual, the right take.

The court rules that when two entities collaborate to infringe a patent, such that one performs some steps of the claim and the other performs the other steps, there cannot be any infringement, on any theory, unless one entity "controls or directs" the activity of the other. As the majority opinion reports, here the defendants "formed a strategic partnership, enabled their two programs to work together, and collaborated to sell the two programs as a unit." Maj. Op. at 8. The court now holds that such a relationship avoids all liability for infringement, even when the defendants collaborate to practice every limitation of the claims. That ruling is incorrect as a matter of law.

The evidence showed that emsCharts and Softtech integrated the functions of their software programs, and sold the ensuing system as a package.

A collaborative effort as here, a "strategic partnership" to sell the infringing system as a unit, is not immune from infringement simply because the participating entities have a separate corporate status... The panel majority acknowledges that the defendants in collaboration infringed the claims, but without discussion overturns the jury verdict.

The court now holds that such a relationship avoids all liability for infringement, even when the defendants collaborate to practice every limitation of the claims. That ruling is incorrect as a matter of law.

Inequitable Conduct

At the time of the filing of the application [that lead to '073], [patent co-inventor and Golden Hour CEO] Hutton believed that Air Medical Software ("the AeroMed system") was the system most similar to the subject matter of the application.

After filing the application, Hutton got a copy of an undated brochure describing the AeroMed system. Hutton gave the brochure to the prosecutor, who filed an IDS on it.

The IDS did not disclose the integrated billing system described in the brochure. At no time during prosecution of the application was the brochure or the billing system information provided to the examiner.

After the jury verdict in favor of Golden Hour, the district court held a bench trial to consider the issue of inequitable conduct. The brochure that the jury had found not to anticipate was a central feature of the inequitable conduct trial.

The court found that the information inside of the brochure "was inconsistent [with] the disclosure in the IDS, and inconsistent with how [Hutton and prosecution counsel] had described the AeroMed system in the original application." Id. at 10. Therefore because "Fuller selected that part of the brochure to disclose that did not threaten patentability" and "excluded . . . the entire teaching that would have been a serious obstacle to patentability," the district court found that "[t]here can be no question" that the withheld information is "highly material." Id. at 15.

With respect to intent, the court found that Golden Hour's nondisclosure of the brochure and selective disclosure of the contents of the brochure evidenced intent to deceive the PTO. The court concluded that Fuller must have been aware of the contents of the brochure. Id. at 12-13. The court reiterated that "Golden Hour and its counsel selected the one part of the AeroMed brochure to disclose [that] was consistent with how it had described AeroMed to the PTO" and found that "[s]uch selectivity is strong evidence of intent to mislead the patent office about the relevant prior art system as described by its competitor." Id. at 13. The court therefore concluded that "the single most reasonable inference to be drawn is that Golden Hour intended to deceive the patent office." Id. at 14. The court then balanced the high level of materiality with the evidence of deceptive intent and concluded that Golden Hour committed inequitable conduct, rendering the '073 patent unenforceable.

On appeal -

"A patent may be rendered unenforceable due to inequitable conduct if an applicant, with intent to mislead or deceive the examiner, fails to disclose material information or submits materially false information to the PTO during prosecution." Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1313 (Fed. Cir. 2006). The party seeking to render a patent unenforceable due to inequitable conduct must prove both materiality and intent by clear and convincing evidence. Id. The court must then weigh the levels of materiality and intent to determine whether the conduct at issue amounts to inequitable conduct. Id. We review the district court's factual findings as to materiality and deceptive intent for clear error and the ultimate decision on inequitable conduct for abuse of discretion. Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008); Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc in relevant part).

A. Materiality

"[W]e have held that information is material when a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent." Star Scientific, 537 F.3d at 1367 (citations omitted). The PTO Rules also aid in the definition of materiality. Rule 56 provides that an applicant has a duty to disclose information that is material to patentability and states that

(b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of un-patentability relied on by the [PTO], or
(ii) Asserting an argument of pat-entability.

37 C.F.R. § 1.56(b). The PTO rules clearly require the submission of known information that contradicts material information already submitted to the PTO. See Monsanto Co. v. Bayer Bioscience N.V., 514 F.3d 1229, 1239-40 (Fed. Cir. 2008); Pharmacia Corp. v. Par Pharm., Inc., 417 F.3d 1369, 1373 (Fed. Cir. 2005). If a misstatement or omission is material under the Rule 56 standard, it is material for the purposes of inequitable conduct. Digital Control, 437 F.3d at 1316.

The majority found the brochure material, even if not prior art, which oddly remained an open question.

Further, our prior cases make clear that information may be material even if it does not qualify as prior art. As we held in Duro-Last, Inc. v. Custom Seal, Inc., 321 F.3d 1098, 1107 (Fed. Cir. 2003),

[t]his court has long held that whether a prior reference is material, i.e., whether there is a substantial likelihood that a reasonable examiner would have considered the reference important in deciding whether to allow the application to issue as a patent, is not controlled by whether that reference actually anticipates the claimed invention or would have rendered it obvious.

See also Digital Control, 437 F.3d at 1318 ("[A] misstatement or omission may be material even if disclosure of that misstatement or omission would not have rendered the invention unpatentable."); Li Second Family Ltd. P'ship v. Toshiba Corp., 231 F.3d 1373, 1380 (Fed. Cir. 2000). The information in the brochure here was clearly material.

First, the brochure may well have been prior art. While the district court made no finding as to the prior art status of the brochure, we note that there is substantial evidence in the record that the brochure is indeed prior art... A reasonable examiner would likely wish to inquire into the prior art status of the system disclosed in the brochure in light of the representations as to the system appearing in the specification. Indeed Golden Hour itself admits that an examiner "might have been curious about the brochure because it related to the same subject matter as the earlier recitation of prior art." Pl.-Appellant's Br. 25.

Second, the brochure and the information contained therein were material because they contradicted other representations to the PTO, even if the brochure was not itself prior art.

In the IDS, prosecution counsel stated that "[a]pplicants are aware of AeroMed Software" and listed the attributes of the software found on the front of the brochure, but did not disclose the integrated billing found on the inside of the brochure. J.A. 4944-45 (emphasis added). Given the significance of integrated billing to patentability, the failure to disclose the billing characteristics of the AeroMed system in the IDS was also highly material. The failure to disclose the integrated billing would lead one to believe that the AeroMed system did not provide comprehensive integration with billing. The brochure's recitation of integrated billing, which applicants failed to disclose, would undoubtedly have been material to a reasonable examiner.

Thus materiality was affirmed.

B. Intent

The intent element is a separate component of an inequitable conduct determination. Star Scientific, 537 F.3d at 1366. To prove intent, "the involved conduct, viewed in light of all the evidence, including evidence of good faith, must indicate sufficient culpability to require a finding of intent to deceive." Digital Control, 437 F.3d at 1319 (citations omitted). Intent need not be proven by direct evidence; it can be inferred from indirect and circumstantial evidence. Star Scientific, 537 F.3d at 1366 (citing Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1364 (Fed. Cir. 2007)); Merck & Co. v. Danbury Pharmacal, Inc., 873 F.2d 1418, 1422 (Fed. Cir. 1989). An inference of intent "must not only be based on sufficient evidence and be reasonable in light of that evidence, but it must also be the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard." Star Scientific, 537 F.3d at 1366.

In sum, prosecution counsel failed to provide any explanation for withholding the missing information from the brochure, assuming he was aware of the brochure's contents.

The district court also did not err in finding that "[e]ven the most cursory of reviews would have revealed the description of AeroMed's billing and integration--the only thing described in the center column of the one page brochure," i.e., that it was inconsistent with the representations in the specification. See Inequitable Conduct Order, slip op. at 13.

The key question then is whether [prosecutor] Fuller and/or Hutton in fact read the brochure. Fuller testified that he did not remember the circumstances regarding the brochure and the preparation of the IDS... Fuller never testified definitively that he did not read the brochure in full.

The district court "discredited Fuller's testimony," and "found [Hutton's] testimony to be incredible."

But the district court did not actually find that either Fuller or Hutton was aware of the inside contents of the brochure. As findings of intent so often turn on a district court's credibility determinations, see, e.g., Monon Corp. v. Stoughton Trailers, Inc., 239 F.3d 1253, 1263-64 (Fed. Cir. 2001), it is essential that the court provide detailed factual findings with respect to crucial facts--such as whether Fuller and/or Hutton read the entire brochure; whether, knowing the information to be material, they deliberately withheld it; or whether they deliberately refused to read the entire brochure in order to avoid learning damaging information.

Golden Hour argues that no remand is necessary because the record evidence could not, in any event, support a finding of intent. We disagree. Quite apart from the highly material nature of the withheld reference, the suspicious late production of the brochure, and the district court's findings as to witness credibility, there is ample evidence that could support finding that Fuller or Hutton or both actually read the brochure and determined to withhold its contents from the PTO, knowing it to be material. First, Hutton regarded AeroMed as his primary competitor.

During the preparation of the application, Hutton conveyed this knowledge of the AeroMed system to prosecution counsel and was "pretty involved in the process of drafting and prosecuting" the application. J.A. 4726. The imprecise nature of the earlier information received by Hutton might suggest that Hutton and/or Fuller would carefully review the Aero brochure.

Third, representations as to the AeroMed system were central to the claim of patentability in the original application. This centrality was demonstrated by the filing of an IDS based on the brochure. This again suggests that Fuller and/or Hutton would be interested in reading the brochure.

Fourth, it might seem unlikely that a patent practitioner would make representations as to the brochure in an IDS without reading the entire brochure and would not be interested in reading the entire brochure to determine whether there was anything in it that might disclose its prior art status.

For all that, what would "the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard"? Yet the CAFC majority found it plausible, though "Hutton regarded AeroMed as his primary competitor," that he did not read the brochure, nor that the prosecutor would have read the brochure. Some brushing up on human proclivities may be in order. Like some kind of obsessive-compulsive Sherlock Holmes gone beserk, the majority demanded "more data."

Therefore we must remand to the district court for it to make detailed factual findings in the first instance.

Queen Pauline had a different take. As usual, the right take, as a matter of law, however counter-intuitive to the evidence extant.

The charge of inequitable conduct carries high stakes for both the attorney, whose career it can threaten, and the applicant, who can lose a perfectly valid patent.

[I]f deceptive intent was not established at the trial of this issue, by the party with the burden to do so, it is inappropriate for this court to remand for another shot at it.

For the Golden Hour patent, the question of patentability in view of the AeroMed brochure was before the jury, and the jury verdict of validity despite the AeroMed brochure is not challenged. Since intent to deceive was not established before the trial judge, and materiality is reasonably disputed, there is no basis for a second-bite ruling of inequitable conduct. I would lay the matter to rest or, at a minimum, stay the proceedings until conflicting precedent is clarified in accordance with the pending en banc hearing of the Therasense appeal.

Put differently, the judge is not responsible for developing the record. That's counsel's role. The hand played is the hand to decide. If defense counsel put forth everything they could, all the cards are on the table. From there the court calls prevailing party. If defense counsel failed to draw or turn over all the cards they could have played, they have only themselves to blame.

Inequitable Conduct

We have established a twopart test for determining whether a patent is rendered unenforceable for inequitable conduct. To successfully prove inequitable conduct, the accused infringer "must present evidence that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the [PTO]." Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1365 (Fed. Cir. 2008) (citation omitted). The accused infringer must prove "at least a threshold level of each elementi.e., both materiality and intent to deceive . . . by clear and convincing evidence." Id. If the accused infringer meets this evidentiary burden with respect to both materiality and intent, "the district court must still balance the equities to determine whether the applicant's conduct before the PTO was egregious enough to warrant holding the entire patent unenforceable." Id.

Where a district court has made fact findings as to materiality and deceptive intent after a bench trial, we review those findings for clear error and the ultimate decision on inequitable conduct for abuse of discretion. Larson Mfg. Co. of S.D. v. Aluminart Prods., 559 F.3d 1317, 1327 (Fed. Cir. 2009).

The controversy swirled over two patent references that were disclosed in the background of '608, but which weren't formally cited in the applicant's IDS.

At trial, Cingular claimed that applicants misrepresented the substance of two references, U.S. Pub. No. 2001/0051517 (Strietzel) and U.S. Patent No. 4,811,382 (Sleevi).1 Cingular alleged that applicants misrepresented these references at two points: first, in the Background of the Invention of the '608 patent; and second, in an amendment submitted during prosecution (Amendment B). In the Background, applicants identified Strietzel and Sleevi as related art and stated that "[i]n each of the aforesaid [Strietzel and Sleevi references], there is no algorithm or software proposed for operating the telephone system. Thus, Streitzel [sic] and Sleevi both propose hardware based systems, but no software to operate those systems." '608 patent col.3 ll.2529 (emphasis added). In Amendment B, applicants asserted that they had "very carefully examined" Strietzel and Sleevi and noted that "one of the distinctions between the applicant's system and . . . any other reference known to the applicant is the fact that the applicant's system only generates [a] message when the phone line between the caller and the recipient is not busy." J.A. 10363. The court found that Strietzel and Sleevi disclose software-based algorithms and playing a sound presentation only when the recipient line is not busy. Therefore, the court found that applicants' statements in the Background and Amendment B were material misrepresentations.

To state, as the CAFC did, that the prior art references did not "explicitly" disclose software, breaks the back of the word "explicitly," to put it mildly.  Strietzel repeatedly references to a database. Sleevi is hardware oriented, but anyone familiar with telephone systems of the period knows that the engine of Sleevi's disclosed "telecommunications network" ticks over on software.

Neither Strietzel nor Sleevi explicitly discloses software for operating a telephone system. However, as the district court observed, both references describe components that are generally understood by persons of skill in the art to be associated with computers and software. The references also disclose methods for operating a telephone system. Although the disclosure of software is certainly not express in either Strietzel or Sleevi, we cannot say that the court clearly erred in finding that a person of skill in the art would have understood the references to disclose software-based algorithms. Therefore, the court did not clearly err in finding that applicants' Background statement was a misrepresentation.

Prosecutor's amendment statements were a continuation of the misrepresentation made in the application. The CAFC cut Ring Plus serious slack by not backing the district court.

However, we agree with Ring Plus that the district court clearly erred in finding that applicants' statement in Amendment B was a misrepresentation. The court found that both Striezel and Sleevi disclose playing a sound presentation only when a called line is not busy. Contrary to the court's finding, however, Strietzel states unambiguously that "the busy tone can be replaced by one or more advertisements." Para.[0064]. Sleevi is altogether silent as to whether the status of the recipient's line affects system operation. The court did not cite to any portion of Sleevi to support its finding, relying instead on conclusory testimony from witnesses who also failed to identify any support for their positions in Sleevi. Ring Plus, 637 F. Supp. 2d at 438. Cingular points to Sleevi's disclosure that "[i]f the called address is busy, the calling customer line is connected to a busy tone generator" as supporting the court's finding. Sleevi col.5 ll.7-9. However, this portion of Sleevi describes the general operation of a prior art telephone system; it does not disclose generating a message only if the line is not busy. See id. fig.1, col.10 ll.38-41, col.12 ll.42-44. Sleevi does not disclose a telephone system that only presents messages when the line is not busy. The court clearly erred in finding that Striezel and Sleevi disclose playing a sound presentation only when a called line is not busy and, therefore, clearly erred in finding that applicants' statement in Amendment B was a misrepresentation.

Ring Plus also argues that the district court clearly erred in finding that applicants' statements were material. Because we find that applicants' statement in Amendment B was not a misrepresentation, we need only address the materiality of the Background statement. Information is material when "a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent." Symantec Corp. v. Computer Assocs. Int'l, Inc., 522 F.3d 1279, 1297 (Fed. Cir. 2008). The district court found that the misrepresentation in the Background was not only material, but highly so. The court credited deposition testimony from Mr. Schaap that Strietzel and Sleevi were among the most relevant prior art references. The court also pointed to a patentability opinion in which Mr. Schaap informed applicants that he had found no prior art references "more pertinent" than Strietzel and Sleevi and that Sleevi, in particular, "fairly well precludes broad patent protection." J.A. 10423. In view of the evidence showing the particular relevance of Strietzel and Sleevi to the '608 patent, the court did not clearly err in finding that applicants' Background statement regarding the substance of those references was highly material.

The prosecutor did get an admonition: his "statement was outside the bounds of permissible attorney argument." Ouch.

Ring Plus argues that because Strietzel and Sleevi were before the examiner during prosecution, the Background statement was merely attorney argument and cannot be a material misrepresentation. Although an attorney is free to argue vigorously in favor of patentability without being subject to allegations of inequitable conduct, "the law prohibits genuine misrepresentations of material fact." Rothman v. Target Corp., 556 F.3d 1310, 1328 (Fed. Cir. 2009). Because we uphold the district court's finding that applicants' Background statement was a misrepresentation, this statement was outside the bounds of permissible attorney argument. Ring Plus also argues that the examiner did not consider Strietzel and Sleevi to be important because he did not cite them during prosecution. However, the materiality standard is an objective one: the issue is what a reasonable examiner would have found important, not whether the reference in question was specifically considered during prosecution. Therefore, we conclude that the court did not clearly err in determining that applicants' statement in the Background that Sleevi and Strietzel propose "no algorithm or software . . . for operating the telephone system" was a material misrepresentation.

With materiality established, though on shifted ground, the CAFC sang a different song on the intent prong than the district court.

Cingular, as the party seeking to establish inequitable conduct, bore the burden of establishing by clear and convincing evidence that applicants specifically intended to deceive the PTO in making the misrepresentation in the Background. Star Scientific, 537 F.3d at 1365; Larson Mfg., 559 F.3d at 1340. Although intent to deceive can be inferred from circumstantial evidence, the evidence must still be clear and convincing; "a showing of materiality alone does not give rise to a presumption of intent to deceive." Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1313 (Fed. Cir. 2008); see also Kingsdown Med. Consultants v. Hollister, Inc., 863 F.2d 867, 876 (Fed. Cir. 1988) (en banc in relevant part) (holding that even "'gross negligence' does not of itself justify an inference of intent to deceive"). Any inference of deceptive intent must be "the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard." Star Scientific, 537 F.3d at 1366.

The district court found that Cingular made a sufficient showing of deceptive intent. The court acknowledged that applicants' disclosure of Sleevi and Striezel "is inconsistent with an intent to hide those references." Ring Plus, 637 F. Supp. 2d at 439. The court went on to find, however, that the statement in the Background that "Streitzel and Sleevi both propose hardware based systems, but no software to operate those systems" was made with an intent to deceive. Mr. Schaap, the prosecuting attorney, testified that he believed the Background statement to be accurate because he viewed Strietzel and Sleevi as ambiguous and insufficiently detailed as to software. Id. at 439-40. The court found Mr. Schaap's belief "not credible" because he was a highly experienced patent prosecutor and because "even a cursory review" of Strietzel shows that the reference discloses software based algorithms. Id. at 440. Based on its view that the references clearly disclose software, the court found that applicants' purported belief in the truth of their representation was not plausible. From this evidence, the court concluded that "[t]he single most reasonable inference . . . is that the applicants intended to deceive." Id. at 440.

The CAFC panel of Judges Moore, Lourie and Gajarsa demonstrated that logical inference wasn't their strong suit. Not to mention self-contradiction in finding misrepresentation by the prosecutor, but then finding there was no intent. However sly in skirting, what should have been abundantly apparent wasn't. "Even though it looks like an polecat and smells like an polecat, it has not been unambiguously disclosed as a polecat." Please.

Ring Plus argues that the court clearly erred in finding that Cingular presented clear and convincing evidence of applicants' specific intent to deceive the PTO. We agree. The court premised its finding of intent almost entirely on its view that the references unambiguously disclose software. We disagree that the disclosure of software is so plain. Neither Strietzel nor Sleevi mentions software, and neither identifies any code or software mechanism for operating the disclosed systems. Moreover, there is no record evidence that one of skill in the art would consider the references to unambiguously disclose software. Although the references disclose isolated components that tend to be associated with computer operation, the references do not unambiguously disclose software for operating a telephone system.

Even the prosecutor, at deposition, paved the path to inequitable conduct.

Mr. Schaap testified that during prosecution he believed Strietzel and Sleevi related to hardware-based systems. In his view, Strietzel's "program processing means" could refer to hardware, and switching networks such as Sleevi's could be "programmed" mechanically or manually. Ring Plus, 637 F. Supp. 2d at 431. Though Mr. Schaap conceded at deposition that software-operated switches would, in practice, be used to implement the Strietzel and Sleevi inventions--primarily because mechanical switches "went out in the 1940s"--he nonetheless testified that neither reference discloses what the operating software is or how it might work. Id. at 437. For this reason, Mr. Schaap viewed his statement that "both [Strietzel and Sleevi] proposed hardware based systems, but no software to operate those systems" as accurate. Id. at 437 n.4. Cingular failed to present any evidence to rebut this testimony. "When examining intent to deceive, a court must weigh all the evidence, including evidence of good faith." Akron Polymer Container Corp. v. Exxel Container, 148 F.3d 1380, 1384 (Fed. Cir. 1998). "Whenever evidence proffered to show either materiality or intent is susceptible of multiple reasonable inferences, a district court clearly errs in overlooking one inference in favor of another equally reasonable inference." Scanner Techs. Corp. v. Icos Vision Sys. Corp. N.V., 528 F.3d 1365, 1376 (Fed. Cir. 2008).

Mr. Schaap's testimony gives rise to the inference that applicants believed that Strietzel and Sleevi did not disclose software for operating a telephone system. Based on the evidence of record, this inference is as reasonable as the court's inference of deceptive intent, particularly in view of the references' ambiguity as to operating software. Thus, the district court clearly erred in finding clear and convincing evidence of deceptive intent.

The CAFC ignores that was no evidence of good faith on the part of the prosecutor. Since when is "inference" "evidence"? This is scary, the CAFC turning the inequitable conduct standard on its head. "Any inference of deceptive intent must be "the single most reasonable inference able to be drawn from the evidence to meet the clear and convincing standard." Star Scientific, 537 F.3d at 1366." The single most reasonable inference was that prosecutor Schaap thought that Strietzel and Sleevi were damning, and tried to sneak them by (mention in the background), but not call attention to them (by IDS citation), as required by law.

Cingular did try to connect the dots. The controversial prior art references should have been disclosed in an IDS. Certainly the prosecutor found them relevant, and so had a duty to disclose them (37 CFR Section 1.56). The "the single most reasonable inference" from the prosecutor not bringing them to the examiner's attention by IDS citation, but mention them in the background, is intent to downplay attention.

Cingular points to other evidence in the record, not cited by the district court, to establish intent. Cingular relies on applicants' statement in Amendment B that they examined Strietzel and Sleevi "very carefully." This statement is not indicative of intent. Reasonable minds could examine Strietzel and Sleevi and conclude, as applicants purportedly did, that the references do not disclose software for operating a telephone system. Cingular also relies on the prior art search report letter in which Mr. Schaap opined that Sleevi "fairly well precludes broad patent protection in the [relevant] field." J.A. 10423. Although this statement supports the finding that the references are material, it does not establish intent to deceive with regard to the statement in the Background of the Invention. The prior art search letter does not reflect that Mr. Schaap understood these references to disclose software, only that he thought they precluded broad patent protection. Cingular notes that the applicants prepared, but decided not to file, an IDS that listed both Strietzel and Sleevi. Again, this evidence relates to materiality, but not intent. While it may have been relevant if this was a nondisclosure case, it is not; Sleevi and Striezel were disclosed in the application itself. Failure to file an IDS says nothing about whether Mr. Schaap believed that the references disclose software. Finally, Cingular asserts that Ring Plus's failure to call Mr. Schaap or the inventor of the '608 patent at trial supports an inference of intent. Although it is true that "if [a] party chooses to not call [witnesses within his control to produce], the fact finder may draw the inference that the testimony would be unfavorable," see Brasseler, U.S.A. I., L.P. v. Stryker Sales Corp., 267 F.3d 1370, 1385 n.7 (Fed. Cir. 2001), the district court drew no such inference here. We decline to do so in the first instance on appeal.

While not explicitly changing the bar for inequitable conduct, the bar was raised here.

Because the district court clearly erred in finding that Cingular introduced clear and convincing evidence of deceptive intent, we reverse the court's judgment of unenforceability for inequitable conduct. See Star Scientific, 537 F.3d at 1367 ("If a threshold level of intent to deceive . . . is not established by clear and convincing evidence, the district court does not have any discretion to exercise and cannot hold the patent unenforceable regard-less of the relative equities or how it might balance them.").

Inequitable conduct reversed.

Claim Construction

The claimed process steps necessarily being performed in order is unusual.

The district court determined that the plain language of claims 1 and 9 shows that the claimed steps must be performed in a certain order. The court held that the step of "determining whether the telephone line of the recipient telephone is busy" must be performed before the step of "terminating the telephone call and generating no sound presentation if the telephone line is busy and allowing for a sound presentation if the telephone line is not busy." Further, the court held that the step of "allowing for a sound presentation" must be performed before the step of "play[ing] the introduced message to the caller or the recipient or both." Because Cingular's Answer Tones service plays a sound presentation before it determines whether the recipient's line is busy, the court concluded that Answer Tones does not satisfy the required order of the steps. The court therefore granted Cingular's motion for summary judgment of noninfringement.

On appeal, Ring Plus challenges the court's claim constructions. Claim construction is a matter of law, and we review the court's claim construction without deference. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1451 (Fed. Cir. 1998) (en banc). We read the claims "in view of the specification," which is "the single best guide to the meaning of a disputed term." Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc).

Ring Plus did not dispute "that the claim steps must be performed in order." The CAFC chided Cingular for making sure that point was driven home.

Ring Plus does not contest the court's conclusion that the claim steps must be performed in order, that step 1c must be performed prior to step 1d. Ring Plus Reply Br. at 26 ("Cingular unnecessarily presented argument about the order of the claim steps. Ring Plus did not appeal the order of the claim steps.").

Ring Plus argued a subtle twist on timing. So subtle it didn't make sense.

Ring Plus argues that the claimed algorithm and method only apply during the ring-back signal period and the ringing signal period. Ring Plus argues that if the claim is limited to that time period, then "it simply does not matter what Defendants do or do not do before that period of time." Ring Plus argues that Cingular's Answer Tones service can infringe even if it plays a sound presentation prior to determining whether the line is busy because, according to Ring Plus, that time period is not covered by the claims. To this end, Ring Plus argues that the district court erred in its construction of "allowing" and "sound presentation."

We conclude that the district court correctly construed these claim terms. The court construed "allowing" as "allow to begin." Ring Plus argues that the term should be construed as "allow to continue or to begin." Ring Plus's proposed construction conflicts with the required order of the claimed steps, which it does not appeal. The claimed algorithm (1c)) determines whether the line is busy, (1d)) allows a sound presentation if the line is not busy, and then (1e)) initiates the actions to play the message. The court held that the step of "allowing for" a sound presentation must be performed before the step of playing that presentation. Because a sound presentation cannot be "allowed to continue" before the presentation is first played, the required order of the steps necessarily indicates that "allowing" a sound presentation means allowing the presentation to begin. Indeed, if we construed "allowing" as Ring Plus proposes, the claims would recite the illogical sequence of allowing a sound presentation to continue before initiating the playing of that presentation. Step 1e) states "initiating those actions to play." If the sound presentation was playing in advance of or during the determination regarding whether the line is busy (step 1c)), then the "initiating those actions to play" required by 1e) would have already occurred. You cannot initiate the playing of the message as required by step 1e), if it has been playing all along. The court's construction is further supported by the specification, which consistently teaches that a sound presentation is not generated at all until after the algorithm determines that the recipient line is not busy. Id. col.6 l.62-col.7 l.2.

Thus, the court did not err in construing "allowing" as "allowing to begin."

Ring Plus also tried its luck to limit the claimed "sound presentation" to being "during the usual ring-back period." No takers on that.

Ring Plus fails to identify any portion of the specification that limits the claimed sound presentation to an audible communication played during a specific time period. The court did not err in construing "sound presentation" consistent with its plain meaning, "an audible communication."

Noninfringment affirmed.

Finally, the courts denied Ring Plus's attempts to disqualify Cingular's counsel by purported misconduct.

After construing the claims (as discussed below), the district court granted summary judgment of noninfringement with respect to all claims. Adams appeals.

First, construction of the claim term "equivalent."

This court reviews a grant of summary judgment de novo. Immunocept, L.L.C. v. Fulbright & Jaworski, L.L.P., 504 F.3d 1281, 1286 (Fed. Cir. 2007). "Summary judgment is appropriate when there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." Id.

We also review claim construction de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 145556 (Fed. Cir. 1998) (en banc). The words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history. See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc).

The parties dispute the meaning of the term "equivalent" in claim 24, from which asserted claims 26, 33, 34, and 39 depend.

The district court construed "equivalent" as "within 80% to 125% of the value with which it is being compared, at a 90% confidence interval." Adams, Civ. No. 1:07-CV-993, D.I. 176 at 36 (W.D. Mich. July 24, 2009) (Claim Construction Order). The court based its construction on Adams' statements during reexamination, concluding that "Adams explicitly stated during reexamination that 'equivalent' meant 'the FDA bioequivalence guidelines.'" Id.

On appeal, Adams challenges the requirement of a 90% confidence interval. It notes that the specification does not require or even mention any confidence interval. Adams argues that during reexamination, it expressly, consistently, and repeatedly defined equivalent to mean within the 80 to 125% range, but it never included in that definition a 90% confidence interval. It asserts that the 90% requirement makes sense in the context of drug approval, where the FDA is concerned with safety and consistency. But in the context of proving infringement, Adams argues that it must simply show that it is more likely than not that Perrigo's ANDA, if approved, would permit Perrigo to market a product that infringes the '252 patent.

We construe "equivalent" to require a C_max that is 80% to 125% of the value to which it is being compared. Contrary to Perrigo's assertion, Adams did not define equivalent as meeting all of the requirements of the FDA's bioequivalence guidelines. When Adams referred to the FDA guidelines in the context of defining the term equivalent, it referred specifically to the 80 to 125% range... Adams never adopted or even mentioned the 90% confidence interval. The range and the confidence interval are independent concepts. The range reflects "a medical decision that, for most drugs, a -20%/+25% difference in the concentration of the active ingredient in blood will not be clinically significant." FDA Guidelines at ix. On the other hand, the 90% confidence interval reflects the FDA's concern that a generic drug consistently match the performance of the branded drug. See id. at x. Patent infringement does not require bioequivalence, and Adams did not import the 90% confidence interval into its claim. Requiring a 90% confidence interval would inappropriately raise the bar for establishing infringement. Adams must show that it is more likely than not that Perrigo's ANDA product will have a C_max within the 80 to 125% range.

Then the issue of infringement. As with claim construction, the district court put up a higher bar than legally correct, requiring a "two-way crossover study" that Adams did not do, "and thus the court concluded that it could not establish infringement literally or under the doctrine of equivalents."

Adams asserts that it raised a genuine issue of material fact on infringement, sufficient to preclude summary judgment. Adams argues that there is no absolute bar against comparing an accused product to a commercial embodiment of the claimed invention. It asserts that where the commercial product meets the claim limitations, a comparison to that product may be used to establish infringement, citing Glaxo Wellcome, Inc. v. Andrx Pharmaceuticals, Inc., 344 F.3d 1226, 1234 (Fed. Cir. 2003), and Glaxo Group Ltd. v. Torpharm, 153 F.3d 1366, 1373 (Fed. Cir. 1998).

We agree. Our case law does not contain a blanket prohibition against comparing the accused product to a commercial embodiment.

Perrigo has not explained why, as a factual matter, Adams' evidence necessarily fails to establish infringement under the correct construction of equivalent.

Therefore, Adams has raised a genuine issue of material fact on infringement under the proper construction of the term equivalent, sufficient to preclude summary judgment.

Adams' construction--requiring release and availability for absorption--covers the preferred embodiment. Perrigo's construction--requiring both release and actual absorption--excludes the preferred embodiment and essentially all guaifenesin formulations, as the specification explains that absorption occurs in the intestinal tract. A claim construction that excludes the preferred embodiment "is rarely, if ever, correct and would require highly persuasive evidentiary support." Vitronics Corp. v. Conceptronic Inc., 90 F.3d 1576, 1583-84 (Fed. Cir. 1996). We therefore agree with the district court...

The district court got "bioavailable" right.

The district court correctly construed the term "immediate release form which becomes fully bioavailable in the subject's stomach" to mean "a form intended to rapidly release in the stomach substantially all of the active pharmaceutical ingredient for absorption." Perrigo and Adams each proposed a reasonable construction of the term bioavailable in the abstract. Adams' construction is consistent with the use of this term in the specification; Perrigo's is not. Claim terms are not construed in a vacuum divorced from the specification. Although the specification never expressly defines bioavailable, it uses the term when describing the availability of the drug for absorption, not the actual absorption.

In the finale was whether doctrine of equivalents could "could apply to claims requiring a specific numeric range," as Adams argued.

We previously determined that the doctrine of equivalents may apply to claims containing specific numeric ranges. See Philips, 505 F.3d at 1378 (concluding that "resort to the doctrine of equivalents is not foreclosed with respect to the claimed concentration range"); Abbott, 287 F.3d at 1107-08 ("The fact that a claim recites numeric ranges does not, by itself, preclude Abbott from relying on the doctrine of equivalents."); Jeneric/Pentron, Inc. v. Dillon Co., 205 F.3d 1377, 1383 (Fed. Cir. 2000) (noting that "the district court will have the opportunity to adjudicate fully the merits of infringement under the doctrine of equivalents" of a claim to composition comprising specific weight percentages of various oxides).

The fact that the claim does not contain words of approximation (i.e., "about at least 3500 hr*ng/mL") does not affect the analysis--"terms like 'approximately' serve only to expand the scope of literal infringement, not to enable application of the doctrine of equivalents." Philips, 505 F.3d at 1379. The proper inquiry is whether the accused value is insubstantially different from the claimed value.

Vacated and remanded.

Claim construction is a question of law that is reviewed de novo. Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc). To the extent possible, claim terms are given their ordinary and customary meaning, as they would be understood by one of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 131213 (Fed. Cir. 2005) (en banc). Idiosyncratic language, highly technical terms, or terms coined by the inventor are best understood by reference to the specification. Id. at 1315. Such understanding is informed, as needed, by the prosecution history, if it is in evidence. Id. Construing the claims in light of the specification does not, however, imply that limitations discussed in the specification may be read into the claims. It is therefore important not to confuse exemplars or preferred embodiments in the specification that serve to teach and enable the invention with limitations that define the outer boundaries of claim scope. Id. at 1323.

Merial had a genus claim, after disclosing five genetic sequences (and depositing them with the USPTO). The district court limited claim scope to those five sequences.

The district court was persuaded by Intervet's arguments that the patent specification defined the invention as being these five sequences, and contained no disclosure from which to infer that any other sequences were also part of the invention.

It is clear enough to us, however, that the patent states that the five deposited strains and listed sequences are "representative of" a "type of porcine circovirus," and thus do not constitute the entire scope of the invention. '601 patent col.1 ll.6061 (emphases added). Sequences are representative of the scope of broader genus claims if they indicate that the patentee has invented species sufficient to constitute the genera. Enzo Biochem, Inc. v. GenProbe, Inc., 323 F.3d 956, 967 (Fed. Cir. 2002); In re Smythe, 480 F.2d 1376, 1383 (C.C.P.A. 1973). Here, the deposited strains are representative species of the larger "type II" genus, where the genus is identified and claimed as the invention.

Claims properly directed to a genus may be adequately supported by the patent disclosure if a sufficient number of species is disclosed so as to properly identify the scope of the genus. Id. Here, the patentee has disclosed five species of PCV2, provided the full sequences for four, and identified the potential coding portions of the sequences. The patentee also provided a counterexample, PCV1, that by definition lies outside the scope of the claimed genus, as well as a representative species of the counterexample, its sequence, and potential coding portions for the representative.

The district court failed to get a grip on what constitutes prosecution estoppel, and the scope of its effect.

The district court found that prosecution history estoppel precluded Merial from invoking the doctrine of equivalents.

Whether prosecution history estoppel applies to a particular argument, and thus whether the doctrine of equivalents is available for a particular claim limitation, is a question of law. Bai v. L & L Wings, Inc., 160 F.3d 1350, 1354 (Fed. Cir. 1998); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1460 (Fed. Cir. 1998) (en banc). Where an amendment narrows the scope of the claims, and that amendment is adopted for a substantial reason related to patentability, the amendment gives rise to a presumption of surrender for all equivalents that reside in "the territory between the original claim and the amended claim." Festo Corp. v Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 740 (2002) (Festo VIII). This presumption can be overcome by showing that "at the time of the amendment one skilled in the art could not reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent." Id. at 741. One way to make this showing is to demonstrate that "the rationale underlying the narrowing amendment bore no more than a tangential relation to the equivalent in question." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1368 (Fed. Cir. 2003) (en banc) (Festo IX). Although there is no hard-and-fast test for what is and what is not a tangential relation, it is clear that an amendment made to avoid prior art that contains the equivalent in question is not tangential. See Pioneer Magnetics, Inc. v. Micro Linear Corp., 330 F.3d 1352, 1357 (Fed. Cir. 2003).

The applicability of prosecution history estoppel does not completely bar the benefit of the doctrine of equivalents from all litigation related to the amended claim. See Festo VIII, 535 U.S. at 73738 ("There is no reason why a narrowing amendment should be deemed to relinquish equivalents . . . beyond a fair interpretation of what was surrendered.") The scope of the estoppel must fit the nature of the narrowing amendment. A district court must look to the specifics of the amendment and the rejection that provoked the amendment to determine whether estoppel precludes the particular doctrine of equivalents argument being made.

Merial was estopped by claim amendment, but not so broadly as the district court found.

The district court thus erred in finding that prosecution history estoppel precluded Merial from arguing that the accused product is equivalent to one of the exemplary embodiments of the asserted claim. The district court is thus instructed on remand to compare the accused product with the claims as construed herein for a determination of infringement literally or pursuant to the doctrine of equivalents, if applicable.

Claim construction reversed, noninfringement vacated, remanded for another round of infringement analysis.

Judge DYK dissented in part, most interestingly on whether claim 32 wandered outside the realm of patentable subject matter.

I write separately primarily to make clear that in construing the claims, we are not deciding that the claims as construed are limited to patentable subject matter. As we noted in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), we do not take validity into account in construing claims, unless "the court concludes, after applying all the available tools of claim construction, that the claim is still ambiguous." Id. at 1327 (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004) (quotation marks omitted)). That is not the case here.

At least claim 32 of the '601 patent raises substantial issues of patentable subject matter under 35 U.S.C. § 101. That claim is not limited to the use of a particular isolated DNA molecule in a vaccine or other application. Rather, it broadly encompasses "[a]n isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1." '601 patent col.28 ll.40-42 (emphasis added). Neither the district court nor the parties provided a precise definition of "isolated" DNA. In order to analyze the DNA or use it for applications (for example, the production of vaccines), DNA must be extracted from the cell of the living organism and separated from other cell components, such as RNA, protein, lipids, or in the case of plasmid DNA isolation, from chromosomal DNA. See generally, Peter B. Kaufman et al., Handbook of Molecular and Cellular Methods in Biology and Medicine 1-26 (1995). DNA "isolation" applies generally to the process of extracting DNA from a cell for purposes of genetic analysis. See James D. Watson et al., Molecular Biology of the Gene 740 (6th ed. 2008); see also Kaufman et al., supra, at 1-2. Isolation also encompasses techniques for selective ampli-fication or cloning of such fragments, which allows for a large number of fragments to be available for analysis and sequencing. See Watson et al., supra, at 746. The '601 patent indicates that the isolation of the genomic DNA of the viral strains was performed by a method well known in the art. See '601 patent col.10 l.5-col.11 l.43.

Patent claim 32 reads on an isolated DNA molecule that comprises a nucleotide sequence that encodes an epitope unique to PCV-2, which is defined with respect to its homology with the known PCV-1 virus. Thus, under the majority's claim construction, claim 32 covers DNA sequences that were not in fact isolated by the inventor and are distinct from the five isolated strains disclosed in the '601 patent.

The question is whether the isolated DNA molecule, separate from any applications associated with the iso-lated nucleotide sequence (for example, the production of a vaccine) is patentable subject matter. Neither the Supreme Court nor this court has directly decided the issue of the patentability of isolated DNA molecules. Although we have upheld the validity of several gene patents, see, e.g., In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995); In re Bell, 991 F.2d 781 (Fed. Cir. 1993); Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.3d 1200 (Fed. Cir. 1991), none of our cases directly addresses the question of whether such patents encompass patentable subject matter under 35 U.S.C. § 101. Although the U.S. Patent and Trademark Office ("PTO") believes that at least some of these patents satisfy section 101, see Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5, 2001),² thus far the question has evaded judicial review.

² In response to comments urging the PTO not to issue patents for genes on the ground that genes are products of nature, the PTO remarked:

An isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because (1) an excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, or (2) synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.

I think that such patents do in fact raise serious questions of patentable subject matter. The Supreme Court's recent decision in Bilski v. Kappos has reaffirmed that "laws of nature, physical phenomena, and abstract ideas" are not patentable. No. 08-964, slip op. at 5 (U.S. June 28, 2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain, see Bilski, slip op. at 13, so too would allowing the patenting of naturally occurring substances preempt the use by others of substances that should be freely available to the public. Thus, "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Chakrabarty, 447 U.S. at 309. These aspects are properly conceptualized as representing a public domain, "free to all men and reserved exclusively to none." Id. (quoting Funk Bros., 333 U.S. at 130) (quotation mark omitted).

Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with "markedly different characteristics from any found in nature." It is far from clear that an "isolated" DNA sequence is qualitatively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

The syringe had a safety guard, where the needle cannula (shaft leading to the tip) was exposed by movement of a hinged arm via a spring.

The safety shield, or needle guard, of the patented invention is initially positioned at the base of the needle, next to the needle hub... The guard is mounted on or close to the needle cannula and is attached to the needle hub by a hinged arm. When the guard is in the first position, the hinged arm is folded. When the needle has been removed from a patient, the health care worker pushes the hinged arm forward, causing the hinged arm to unfold and the guard to move along the needle cannula toward the tip of the needle.

To facilitate the movement of the guard toward the needle tip, the '544 patent discloses a "spring means" for "urging [the] guard along [the] needle cannula." The specification describes two embodiments in which a spring moves the guard down the needle cannula. The specification does not attribute any movement of the guard to the hinged arm of the safety needle.

Majority opinion penned by Judge Mayer, joined by Judge Linn.

Claim construction contention centered on the hinged arm and spring being separate structures.

Claim construction "begins and ends in all cases with the actual words of the claim." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). The unequivocal language of the asserted claims of the '544 patent requires a spring means that is separate from the hinged arm.

Claims must be "interpreted with an eye toward giv-ing effect to all terms in the claim." Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006). If the spring means limitation contained in claims 1 and 24--but not in claim 17--is not to be read out of the asserted claims, it must require an additional element beyond that which is already called for by the hinged arm limitation. See Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871, 885 (Fed. Cir. 2008) (refusing to adopt a claim construction which would render a claim limitation meaningless); Elekta Instrument S.A. v. O.U.R. Scientific Int'l, Inc., 214 F.3d 1302, 1305-07 (Fed. Cir. 2000) (refusing to adopt a claim construction which would render claim language superfluous). Simply put, a claim construction that does not require a spring member in addition to the hinged arm structure renders the spring means limitation functionally meaningless. See Bicon, 441 F.3d at 950 ("Allowing a patentee to argue that physical structures and characteristics specifically described in a claim are merely superfluous would render the scope of the patent ambiguous, leaving examiners and the public to guess about which claim language the drafter deems necessary to his claimed invention . . . .").

Indeed, Becton's assertion that the spring means and the hinged arm can be the same structure renders the asserted claims nonsensical... A claim construction that renders asserted claims facially nonsensical "cannot be correct." Schoenhaus v. Genesco, Inc., 440 F.3d 1354, 1357 (Fed. Cir. 2006); see Bd. of Regents v. BENQ Am. Corp., 533 F.3d 1362, 1370 (Fed. Cir. 2008) (refusing to adopt a claim construction that "would effect [a] nonsensical result").

By its plain terms, this construction contemplates that the spring means and the hinged arm are separate structures which are "connected to" each other. The district court erred, however, when it later held that its claim construction did not require a spring means that was a distinct structural element from the hinged arm.

Furthermore, if the hinged arm and spring means are not separate structures, then the asserted claims are clearly invalid as obvious over the prior art. See Whittaker Corp. v. UNR Indus., Inc., 911 F.2d 709, 712 (Fed. Cir. 1990) ("[C]laims are generally construed so as to sustain their validity, if possible."). The first three elements of Becton's claimed invention--the needle, the protective guard, and the hinged arm--were disclosed in several prior art patents... What distinguished the claimed invention from the prior art was the addition of a spring means separate from the hinged arm.

The CAFC majority found infringement lacking by Tyco's accused products not having the claimed spring element.

To establish literal infringement, "every limitation set forth in a claim must be found in an accused product, exactly." Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995). Thus, "[i]f any claim limitation is absent from the accused device, there is no literal infringement as a matter of law." Amgen Inc. v. F. Hoffmann-La Roche, Ltd., 580 F.3d 1340, 1374 (Fed. Cir. 2009). Tyco argues that its Monoject Magellan™ safety needle and blood collection devices do not literally infringe the '544 patent because they lack the added spring member required by the asserted claims. We agree. The unambiguous language of the asserted claims, as well as the disclosure in the specification, requires an added spring element that moves the safety guard toward the tip of the needle.³

³ Tyco also contends that a separate spring is required because the spring means limitation is in means-plus-function format, see 35 U.S.C. § 112, ¶ 6, and the only structures disclosed in the specification for performing the recited function of moving the guard toward the tip of the needle are added spring members. We need not reach this argument, however, because we conclude that--regardless of whether the asserted claims invoke section 112, paragraph 6--an added spring element is required by the plain language of the claims.

There can be no literal infringement where a claim requires two separate structures and one such structure is missing from an accused device... Because the unequivocal language of the asserted claims of the '544 patent requires both a hinged arm and a spring means, there can be no literal infringe-ment by Tyco's accused products which, as the district court correctly concluded, do not contain a spring means that is a separate structural element from the hinged arm and its hinges.

Reversed.

Judge Gajarsa was vexed that "the majority sweeps and brushes aside the means-plus-function analysis as unnecessary in light of the 'plain language of the claims.'"

The majority avoids the critical issue upon which this decision turns; i.e., whether 35 U.S.C. § 112, ¶ 6 governs the claim construction of the "spring means" limitation... Without having analyzed the scope of the claims, the majority somehow concludes that the claim language covers only devices having separate "spring means" and "hinged arm" structures. Then applying this simplistic claim construction to analyze the sufficiency of the evidence, the majority improperly overturns the jury's verdict finding infringement.

First, it is unclear what the majority means by "an added spring element." An "added spring element" does not appear in the "plain language of the claims," specification, or prosecution history of the patent. Second, claim construction is necessary to determine the scope of the claims. Markman v. Westview lnstruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The majority opinion injects ambiguity into the claims and fails to construe the claims as re-quired by our case law. See, e.g., Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996). It is impossible for the majority to determine the scope of the claims without undertaking a means-plus-function analysis. Accordingly, the majority's claim construction is premised upon an inadequate foundation.

If a claim element "contains the word 'means' and re-cites a function," there is a presumption that the claim is in means-plus-function form. Envirco Corp. v. Clestra Cleanroom, Inc., 209 F.3d 1360, 1364 (Fed. Cir. 2000). That presumption can be rebutted, however, if the claim also "recites sufficient structure to perform the claimed function." Id. If the claim term "is one that is understood to describe structure . . . [it] is simply a substitute for the term 'means for.'" Lighting World, Inc. v. Birchwood Lighting, Inc., 382 F.3d 1354, 1360 (Fed. Cir. 2004).

To determine whether the claim term should be con-strued as a means-plus-function limitation, we begin by evaluating how the term "spring" is used in the specifica-tion and the intrinsic record. Phillips, 415 F.3d at 1315 ("[T]he specification is always highly relevant" and is "the single best guide to the meaning of a disputed term"). Next, the court should consider whether the "spring means" limitation contains additional structure to rebut the means-plus-function presumption. See Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1427 (Fed. Cir. 1997) (holding that where a claim recites a function, but goes on to elaborate sufficient structure, the claim is not in means-plus-function format).

Judge Gajarsa's in-depth analysis comes to a startling conclusion.

Accordingly, the intrinsic evidence demonstrates that the '544 patent defines "spring means" as a particular structure--a spring.

That springs to Becton's favor, according to Gajarsa, as the spring and arm work together to rebut "means-plus-function presumption."

Next, the court in a proper claim analysis should con-sider whether the claims elaborate sufficient structure to rebut the means-plus-function presumption. The '544 patent claims state that the function of the "spring means" is for "urging the guard along said needle cannula." Id. at col.7 ll.34-35. The claims go on to recite additional structure to achieve that function. Claim 1 recites "spring means connected to said hinged arm," id. at col.7 ll.34-35 (emphasis added), and claim 24 recites "spring means extending between said mounting means and said hinged arm," id. at col.10 ll.17-20 (emphasis added). Thus, the claim language demonstrates that the combination of the "spring means" and "hinged arm" perform the "urging" function. Accordingly, the claims include additional structural limitations to rebut the means-plus-function presumption.

Here, the means-plus-function presumption is rebutted and the claims should not be construed according to § 112, ¶ 6. Therefore, the district court correctly con-strued the "spring means" limitation according to its ordinary meaning: "[t]he hinged arm is connected to a spring that moves the guard along the cannula toward the second position." Becton, Dickinson & Co. v. Tyco Healthcare Group, LP, No. 02-1694-GMS, 2004 WL 2075413, at *4 (D. Del. Sept. 16, 2004).

Requiring separate structures imports "an extraneous limitation into the claims."

The majority first approves of the district court's claim construction, see Maj. Op. 8-9, but then proceeds to improperly import an extraneous limitation into the claims, which is contrary to our case law. See Comark Commc'ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed. Cir. 1998). The majority asserts that "the unequivocal language of the asserted claims of the '544 patent requires a spring means that is separate from the hinged arm" because they are written as separate limitations in the claim language. Maj. Op. 9. However, the unequivocal language articulates no requirement for separate structures. It merely recites "a spring means connected to said hinged arm for urging said guard along said needle cannula toward said second position." The majority's limitation requiring two separate structures is not supported anywhere in the intrinsic or extrinsic record. Such a claim interpretation violates our established tenants of claim construction prohibiting the court from reading extraneous limitations into the claims. E.I. du Pont de Nemours & Co. v. Phillips Petroleum, 849 F.2d 1430, 1433 (Fed. Cir. 1998) ("It is entirely proper to use the specification to interpret what the patentee meant by a word or phrase in the claim . . . . But this is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.") (citation omitted).

In the '544 patent, nothing in the claim language, written description or prosecution history requires that the "spring means" and "hinged arm" be separate structures. The plain language of the claims includes no such "separate structures" limitation. To the contrary, the written description contemplates that the "spring means" and "hinged arm" be included as part of the same "hinged arm assembly."

Judge Gajarsa's disgust glowers behind his "respectful dissent."

In conclusion, the majority opinion is severely flawed in several aspects. Most importantly, it fails to conduct a claim construction analysis to determine whether construction of the "spring means" limitation is governed by § 112, ¶ 6. Indeed, the majority puts the cart before the horse by concluding that the claim language covers only devices having two separate structures, but fails to under-take a proper claim construction analysis. The majority then applies its simplistic claim construction to its infringement analysis in reviewing the denial of JMOL. Contrary to Third Circuit law, the majority fails to view the evidence in the light most favorable to Becton and improperly overturns the jury's verdict finding infringement. The majority climbs Jacob's Ladder in search of perfection in the jury verdict, but, by substituting its own fact finding for that of the jury, it fails to allow the jury to perform its proper function.

In 2006, Sun filed an ANDA to market a generic version of gemcitabine, and smartly filed a declaratory judgment against Lilly. In summary judgment, '826 claims were  found invalid for obviousness-type double patenting over '614. Lilly appealed.

"The doctrine of double patenting is intended to pre-vent a patentee from obtaining a timewise extension of [a] patent for the same invention or an obvious modification thereof." In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1375 (Fed. Cir. 2008). The proscription against double patenting takes two forms: (1) statutory double patenting, which stems from 35 U.S.C. § 101 and prohibits a later patent from covering the same invention, i.e., identical subject matter, as an earlier patent, and (2) obviousness-type double patenting, which is a judicially created doctrine that prevents a later patent from cover-ing a slight variation of an earlier patented invention. Perricone, 432 F.3d at 1372-73; see Geneva, 349 F.3d at 1377-78.

The second type of double patenting, obviousness-type double patenting, prohibits "claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent." In re Basell, 547 F.3d at 1375. An obviousness-type double patenting analysis, which "compares claims in an earlier patent to claims in a later patent or application," Geneva, 349 F.3d at 1378 n.1, consists of two steps, Pfizer, 518 F.3d at 1363. First, the court "construes the claim[s] in the earlier patent and the claim[s] in the later patent and determines the differences." Id. Second, the court "determines whether those differences render the claims patentably distinct." Id. "A later claim that is not patentably distinct from," i.e., "is obvious over[] or anticipated by," an earlier claim is invalid for obviousness-type double patenting. Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001).

Our prior obviousness-type double patenting decisions in Geneva and Pfizer, which addressed factual situations closely resembling that presently before the court, control this case. In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. We held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use." Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86.

Lilly's argud that the facts of this case were somehow different. The CAFC panel found that "factually erroneous."

Thus, the holding of Geneva and Pfizer, that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," extends to any and all such uses disclosed in the specification of the earlier patent. Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. Indeed, as both cases recognized,

[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.

Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 (CCPA 1931)).

Both Geneva and Pfizer make clear that, where a patent features a claim directed to a compound, a court must consider the specification because the disclosed uses of the compound affect the scope of the claim for obviousness-type double patenting purposes. In Geneva, we acknowledged the general rule that an earlier patent's specification is not available to show obviousness-type double patenting. 349 F.3d at 1385. We have held, however, that there are "certain instances" where the specification of an earlier patent may be used in the obviousness-type double patenting analysis. In re Basell, 547 F.3d at 1378. Specifically, the specification's disclosure may be used to determine whether a claim "merely define[s] an obvious variation of what is earlier disclosed and claimed," "to learn the meaning of [claim] terms," and to "interpret[] the coverage of [a] claim." Id. As we recognized in Geneva, a court considering a claim to a compound must examine the patent's specification to ascertain the coverage of the claim, because a claim to a compound "[s]tanding alone . . . does not adequately disclose the patentable bounds of the invention." 349 F.3d at 1385. In examining the specification of the earlier patent, the court must consider "the compound's disclosed utility." Id.

We affirmed this holding in Pfizer by rejecting the patentee's objection to our reliance on the specification of the earlier patent that claimed the compounds at issue and explaining that "[t]here is nothing that prevents us from looking to the specification to determine the proper scope of the claims." Pfizer, 518 F.3d at 1363 (citing Geneva, 349 F.3d at 1386). Thus, we have expressly held that, where a patent claims a compound, a court performing an obviousness-type double patenting analysis should examine the specification to ascertain the coverage of the claim.

Lilly had an insensible argument to ignore context and all relevant subject matter. The Court retort: "[T]he double patenting doctrine is concerned with the issued patent and the invention disclosed in that issued patent, not earlier drafts of the patent disclosure and claims."

In response to Lilly's arguments, we determine that where such examination of the specification is appropriate in an obviousness-type double patenting analysis, the specification that must be considered is that of the issued patent. Lilly contends that the district court should have evaluated the '614 patent's claim to gemcitabine based on the specification that existed as of the undisputed effective filing date of the '614 patent, namely the specification of the original '883 application. The original '883 application disclosed only gemcitabine's antiviral use, not its anticancer use; Lilly added a description of gemcitabine's anticancer use to the specification in a continuation-in-part application that eventually resulted in the '614 patent. Lilly therefore asks this court to ignore the '614 patent's description of gemcitabine's use in cancer treatment, because this disclosure was not part of the original '883 application.

To support this argument, Lilly cites only the basic tenet of claim construction, as stated in Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005), that claim terms should be given their ordinary and customary meaning and this meaning is the one that "the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips, however, does not support the proposition that a court should ignore portions of the patent specification in construing claims. Instead, Phillips makes clear that claim terms must be construed in light of the entirety of the patent, including its specification, and that the specification to be consulted is that of the issued patent, not an earlier application.

Specifically, Phillips, as well as the rest of our claim construction precedent, expounds that a "person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1374 (Fed. Cir. 2009) (emphasis added); Aquatex Indus., Inc. v. Techniche Solutions, 419 F.3d 1374, 1380 (Fed. Cir. 2005); Phillips, 415 F.3d at 1313. In other words, "the 'ordinary meaning' of a claim term is its meaning to the ordinary artisan after reading the entire patent." ICU Med., 558 F.3d at 1375 (emphasis added); Phillips, 415 F.3d at 1321. Phillips further explains the "fundamental rule" that claim terms "are construed with the meaning with which they are presented in the patent document." 415 F.3d at 1316 (emphasis added). As such, "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be . . . the correct construction." Id. (emphasis added).

In sum, our claim construction precedent establishes that claim terms must be construed in light of the entire issued patent. This precedent leaves no room for debate that the relevant specification for claim construction purposes is that of the issued patent, not an early version of the specification that may have been substantially altered throughout prosecution. There is no support for Lilly's argument that the district court should have consulted the specification of the original '883 application, which was changed before the '614 patent issued, to construe the issued patent claims. Lilly cannot avoid portions of the specification of the '614 patent by resorting to the specification as originally filed.

Affirmed.