In re Martin Gleave and Maxim Signaevsky (CAFC 2008-1453) precedential

On appeal, the issue was whether a comprehensive reference listing of every relevant antisense "oligodeoxynucleotide in a known nucleic acid sequence anticipates or renders obvious claims to specific antisense sequences having particular properties."

§ 102(b) copiously defined:

A reference is anticipatory under § 102(b) when it satisfies particular requirements. First, the reference must disclose each and every element of the claimed invention, whether it does so explicitly or inherently. Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1375 (Fed. Cir. 2006). While those elements must be "arranged or combined in the same way as in the claim," Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008), the reference need not satisfy an ipsissimis verbis test, In re Bond, 910 F.2d 831, 832-33 (Fed. Cir. 1990). Second, the reference must "enable one of ordinary skill in the art to make the invention without undue experimentation." Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008); see In re LeGrice, 301 F.2d 929, 940-44 (CCPA 1962). As long as the reference discloses all of the claim limitations and enables the "subject matter that falls within the scope of the claims at issue," the reference anticipates--no "actual creation or reduction to practice" is required. Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380-81 (Fed. Cir. 2003); see In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). This is so despite the fact that the description provided in the anticipating reference might not otherwise entitle its author to a patent. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562 (Fed. Cir. 1991) (discussing the "distinction between a written description adequate to support a claim under § 112 and a written description sufficient to anticipate its subject matter under § 102(b)").

[A]nticipation is a question of fact, including whether an element is inherent in the prior art. Eli Lilly, 471 F.3d at 1375. And as with 35 U.S.C. § 112, "[w]hether a prior art reference is enabling is a question of law based upon underlying factual findings." Minn. Mining & Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002).

A prior art reference must be enabling, but need say nothing of its usefulness.

We have at times framed the issue of enablement under § 102 as a question of whether one of ordinary skill in the art would know how to "make and use" the invention based on the reference's disclosure. See, e.g., Impax Labs., Inc. v. Aventis Pharms., Inc., 468 F.3d 1366, 1381 (Fed. Cir. 2006) ("[A] prior art reference must be enabling so that the claimed subject matter may be made or used by one skilled in the art."); Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1374 (Fed. Cir. 2001) ("To anticipate, the reference must also enable one of skill in the art to make and use the claimed invention."). Taken out of context, these formulations of our § 102 enablement standard arguably support a use or utility requirement divorced from any "make" requirement. A thorough reading of our case law, however, makes clear that a reference need disclose no independent use or utility to anticipate a claim under § 102. E.g., Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005) ("The standard for enablement of a prior art reference for purposes of anticipation under [§] 102 differs from the enablement standard under 35 U.S.C. § 112."); Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) ("[A] prior art reference need not demonstrate utility in order to serve as an anticipating reference under [§] 102."); In re Hafner, 410 F.2d 1403, 1405 (CCPA 1969) ("[Section] 112 provides that the specification must enable one skilled in the art to 'use' the invention whereas § 102 makes no such requirement as to an anticipatory disclosure.").

So, for chemical compounds, only knowledge of their existence in the prior art is required.

[E]vidence as to whether particular compounds work for their intended purpose is irrelevant to our § 102(b) analysis. Certainly where the claims themselves do not require a particular activity, we have no call to require something more from the anticipating reference.

Anticipation of a method requires only that the method was known.

The confusion stems from the fact that where a method claim is at issue, it is a largely meaningless formulation of the standard to require a reference to disclose how to "make" that method in order to anticipate. For method claims, the "make" requirement becomes, in effect, a "use" requirement. The only way one can show that a reference enables the method is to show that a person of ordinary skill would know how to use--in other words, to practice or to carry out--the method in light of the reference. This does not mean, however, that the prior art reference must demonstrate the invention's utility. For instance, in the context of a claimed method for treating a disease, a prior art reference need not disclose "proof of efficacy" to anticipate the claim. Impax Labs., 545 F.3d at 1315; Rasmusson, 413 F.3d at 1326.

Gleave argued, citing Wiggins, that an entry in a list of compounds was insufficient as prior art.

(citing In re Wiggins, 488 F.2d 538, 543 (CCPA 1973) (quotations omitted)).

In Wiggins, the Court of Customs and Patent Appeals stated:

In our view, [the alleged anticipatory reference's] listing of the compounds by name constituted nothing more than speculation about their potential or theoretical existence. The mere naming of a compound in a reference, without more, cannot constitute a description of the compound, particularly when, as in this case, the evidence of record suggests that a method suitable for its preparation was not developed until a date later than that of the reference.

If we were to hold otherwise, lists of thousands of theoretically possible compounds could be generated and published which, assuming it would be within the level of skill in the art to make them, would bar a patent to the actual discoverer of a named compound no matter how beneficial to mankind it might be.

488 F.2d at 543 (emphases added).

But Wiggins went to an unenabling reference.

Gleave reads Wiggins to suggest that a description of a compound cannot be anticipatory where it appears in a long list of other compounds. That conclusion, however, ignores the facts at issue in that case. Contrary to Gleave's representations, no evidence existed that a person of ordinary skill in the art could make the compounds disclosed in the alleged anticipatory reference at the time of disclosure. The reference, published in 1957, mentioned by name two compounds that fell within the scope of Wiggins's claims. But the reference also noted that the synthesis of these compounds had been unsuccessful; further, the only publication of record that disclosed a method of making the compounds was not published until two years later. In short, the reference was not an enabling reference--no person of ordinary skill in the art could make the claimed invention in 1957.

The Wiggins court stated that "[t]he mere naming of a compound in a reference, without more, cannot constitute a description of the compound." 488 F.2d at 543. We agree. The mere naming of a theoretical compound, without more, cannot constitute a description under § 102(b). "Without more" is the key phrase, and read as a whole Wiggins makes clear just what this something "more" is--a person of ordinary skill in the art's ability to make the claimed compound. See also Donohue, 766 F.2d at 533-34; In re Samour, 571 F.2d 559, 562-64 (CCPA 1978); In re Brown, 329 F.2d 1006, 1009-10 (CCPA 1964) (discussing In re Von Bramer, 127 F.2d 149 (CCPA 1942)). This point is underscored by the excerpt: not once, not twice, but three times the court pointed out that its discussion was in the context of "potential or theoretical" compounds. That was the issue presented to the court, and that was the issue it decided.

In sum, "[t]he discovery of a new property or use of a previously known composition, even when that property and use are unobvious from the prior art, can not impart patentability to claims to the known composition." In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).

When a genus is comprehensible as to its species, "a reference describing the genus anticipates every species within the genus."

For the purposes of whether they are anticipatory, lists and genera are often treated differently under our case law. Compare Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1376 (Fed. Cir. 2005) (rejecting "the notion that [a compound] cannot anticipate because it appears without special emphasis in a longer list") with Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006) ("It is well established that the disclosure of a genus in the prior art is not necessarily a disclosure of every species that is a member of that genus."). This distinction collapses when the class of compounds that falls within the genus is so limited that a person of ordinary skill in the art can "at once envisage each member of this limited class." Eli Lilly, 471 F.3d at 1376. In that limited circumstance, a reference describing the genus anticipates every species within the genus. See Perricone, 432 F.3d at 1377.