35 U.S.C. § 112, ¶ 1:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

One could contend that "a written description of the invention, and of..." are divisible into two, as case law has appeared to develop, but that is insensible (and thus, so is case law by such bifurcation). A written description by itself has no heft with regard to requirement. The qualities of the written description requirement are only grounded by enablement: "of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art..."

Boston Scientific (BSC) v. Johnson & Johnson (CAFC 2010-1230, -1231, -1233, -1234) precedential; Judges Bryson, Gajarsa (concurring-in-part), Moore (author)

Johnson & Johnson's 7,217,286; 7,223,286; 7,229,473; and 7,300,662 had a collective heart attack over summary judgment variously "for lack of adequate written description and lack of enablement." All descend from a common provisional. All are junk patents, demonstrating sloppy USPTO examination, not to mention greedy disingenuity by J&J.

The patents-in-suit relate to drug-eluting coronary stents used in the treatment of coronary artery disease. Coronary artery disease is caused, in part, by atherosclerosis, a build-up of arterial plaque. Atherosclerosis limits the flow of blood and oxygen to the heart and can result in chest pain, blood clots, heart attacks, and other ailments.

Coronary disease is a lifestyle disease, with a dash of genetic predisposition. Lack of exercise and vegetables coupled to ingesting meat and fried foods, a la Jay Leno, puts you in line for middle-aged suffering and early death, though not necessarily Leno's lame jokes.

The warm-up to blowing this family's porch lights.

We review a district court's grant of summary judgment de novo, reapplying the appropriate standard applicable before the district court. See, e.g., Univ. of Rochester v. G. D. Searle & Co. 358 F.3d 916, 919-20 (Fed. Cir. 2002). Because issued patents are presumed valid, 35 U.S.C. § 282, a party seeking to invalidate a patent must submit clear and convincing evidence of invalidity. Id. at 920. In deciding a motion for summary judgment, "[t]he evidence of the nonmovant is to be believed, and all justifiable inferences are to be drawn in his favor." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). "Compliance with the written description requirement is a question of fact but is amenable to summary judgment in cases where no reasonable fact finder could return a verdict for the non-moving party." PowerOasis, Inc. v. TMobile USA, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008).

Section 112, paragraph 1, requires that the specification contain a written description of the invention. 35 U.S.C. § 112, ¶ 1. "[T]he hallmark of written description is disclosure." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A specification adequately describes an invention when it "reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Id. at 1351. "A 'mere wish or plan' for obtaining the claimed invention is not adequate written description." Centocor Ortho Biotech, Inc. v. Abbott Labs, 636 F.3d 1341, 1348 (Fed. Cir. 2011).

The dispute was over written description support for "the claimed genus of macrocyclic lactone analogs of rapamycin." Researchers discovered rapamycin from the natural labs of the soil-dwelling bacterium Streptomyces hygroscopicus, who are fond of forming a biofilm. Those clever microbes. Not having a brain proper really rids one of abstractions and distractions, putting a hard-edged focus on survival of the fittest. No burgers or fries for those little guys.

Researchers first investigated rapamycin as a potential antifungal. Later, researchers discovered that rapamycin exhibited other properties, including anti-tumor activity and immunosuppressant activity.

On to the patents, where the specifications do "not include any experiments using a macrocyclic lactone analog or even provide a single example of a macrocyclic lactone analog." Other claimed elements were missing. These omissions damned the three patents with a 1997 priority date, '7286, 3286, and '473.

CIP '662 had a later priority date, and was rigged to target an infringer. A natural grasping for a rapacious competitor, as mega-corporations such as J&J are so inclined. The pathology of corporate sociopathy involves economy of scale. Little corporate terrors simply get noticed for their moxy, while the brutality goes underappreciated. As Bruce Springsteen put it: "poor man wanna' be rich man; rich man wanna' be king; and a king ain't satisfied until he rules everything."

All of the data in the '662 patent relate to studies done with rapamycin coated stents - there is no data on stents using any rapamycin analog. As with the 1997 patents, Cordis added claim language specifying "macrocyclic triene analogs" only after Guidant received approval for an everolimus coated stent.

Needless to say, the patents' claims were overreaching, in not having possession of the invention for the heart in hand.

A written description of an invention involving a chemical genus, like a description of a chemical species, "requires a precise definition, such as by structure, formula, [or] chemical name," of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997) (hereinafter, Eli Lilly).

We have "held that a sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Ariad, 598 F.3d at 1350. Because each individual invention "has a novel relationship with the state of the art from which it emerges" we have declined to "set out any bright-line rules governing, for example, the number of species that must be disclosed to describe a genus claim . . . ." Id. at 1351. The appropriate number of species that one must disclose when claiming a genus "necessarily changes with each invention, and it changes with progress in a field." Id.

What is required to meet the written description requirement "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). As our en banc court explained in Ariad, "[f]or generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including 'the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue.'" Ariad, 598 F.3d at 1351 (citing Capon, 418 F.3d at 1359).

Although examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.

Unpredictability augers lack of enablement, as does how a specification reads to one of skill in the art. After all, the litmus test is "enable... to make and use...."

At the effective filing date, very little knowledge existed regarding the use of drug-eluting stents to inhibit restenosis. In fact, Cordis's Cypher® stent, which employs the patented technology, was the first drug-eluting stent marketed and approved in the United States. Appellants' own expert declarations detail the failure of others to develop drug-eluting stents to inhibit restenosis and evidenced the "highly unexpected" and "remarkable clinical results seen in Cordis's Cypher® stent." J.A. 14739-46; J.A. 14872-73. Appellants also argued in their briefing in opposition to BSC's § 103 summary judgment motion that the state of the art was highly unpredictable. J.A. 14698 ("[P]ersons of ordinary skill were faced with a multitude of possible therapeutic approaches and a multitude of possible drug and polymer combinations. Additionally, these proposed solutions were anything but predictable. Researchers in the field had little idea which, if any would prove successful.").

With no guidance at all in the specification as to how to properly identify or choose the claimed analogs, and in light of the unpredictability and nascent state of using drug-eluting stents to treat restenosis, we agree with the district court that appellants have failed to create genuine issues of material fact.

Although it is true that functional claim language can meet the written description requirement when there is an established correlation between structure and function, Appellants fail to establish any such correlation.

When determining whether a specification contains adequate written description, one must make an "objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art." Ariad, 598 F.3d at 1351. Because the specification is viewed from the perspective of one of skill, in some circumstances, a patentee may rely on information that is "well-known in the art" for purposes of meeting the written description requirement. See Falko-Gunter Falkner v. Inglis, 448 F.3d 1357 1366-68 (Fed. Cir. 2006). However, when the four corners of the specification directly contradict information that the patentee alleges is "well-known" to a person of skill at the effective filing date, no reasonable jury could conclude that the patentee possessed the invention. Here, the specification of the 1997 patents itself refutes any conclusion that "the structural elements of rapamycin and its mechanism of action and biological activity was known." See Univ. of Rochester, 358 F.3d at 930 ("Although section 282 places the burden of proof on the party seeking to invalidate a patent, it does not foreclose the possibility of that party demonstrating that the patent in suit proves its own invalidity."). Thus, there is insufficient correlation between the function and structure of rapamycin and its analogs to provide adequate written description support for the entire genus of macrocyclic lactone analogs of rapamycin.

Affirmed.

While the majority was in the ballpark, Judge Gajarsa threw the perfect pitch.

The claimed invention is a combination of a stent, polymeric carrier, and therapeutic agent. The majority focuses solely on the written description aspect of whether the therapeutic agent's analogs were adequately described and ignores that in nearly all of the asserted claims, the agents must effectively inhibit neointimal proliferation. Because undue experimentation was required to practice the 1997 patents, the district court's grant of summary judgment of invalidity should have been affirmed on enablement grounds.

The enablement requirement of 35 U.S.C. § 112 ¶ 1 is the appropriate tool for invalidating claims that are broader than their disclosure. The majority blurs the line between enablement and written description and does not address the claim language that "rapamycin, or a macrocyclic lactone analog thereof, and is present in an amount effective to inhibit neointimal proliferation." '7286 patent, col.8 ll.15-23 (emphasis added).

The majority's opinion further extends the written description requirement into the realm of enablement. Much of the confusion in this case is due to the difficulty of determining what constitutes a genus or a subgenus, the relationship between the structure and the function of compounds, and how the written description requirement applies to novel compounds as opposed to novel combinations of known elements. These are legal inquiries predicated on disputed issues of material fact. Applying the enablement requirement would help to clear the thicket of jurisprudence regarding § 112 ¶ 1. As discussed briefly below, in this case, the enablement analysis is simpler and more appropriate.

The relevant test for enablement is whether the specification enables one of skill in the art to practice the claimed invention without undue experimentation. In re Wands lists the factors to be considered in determining whether a disclosure would require undue experimentation. 858 F.2d 731, 737 (Fed. Cir. 1988).

Because no one knew of any rapamycin analogs with the desired efficacy when delivered by stents as of the filing date of the 1997 patents, Appellants' claims are not enabled.