Carnegie Mellon University v. Roche (CAFC 2007-1266)

Section 112, paragraph 1 of the Patent Act sets forth the written description requirement as follows:

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.

35 U.S.C. § 112, ¶ 1 (emphasis added). Thus, paragraph 1 of § 112 requires a written description of the invention--a requirement separate and distinct from the enablement requirement. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991); see Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 736 (2002) (noting that "a number of statutory requirements must be satisfied before a patent can issue" including that the patent application "describe, enable, and set forth the best mode of carrying out the invention") (emphasis added); see also In re Curtis, 354 F.3d 1347, 1357 (Fed. Cir. 2004) ("We interpret 35 U.S.C. § 112, ¶ 1 to require a written description requirement separate and apart from the enablement requirement."); In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967) (holding that the written description requirement is a requirement separate from enablement under 35 U.S.C. § 112, paragraph 1).

The basic function of a patent specification is to disclose an invention. It has long been the case that a patentee "can lawfully claim only what he has invented and described, and if he claims more his patent is void." O'Reilly v. Morse, 56 U.S. (15 How.) 62, 121 (1853). The written description serves a quid pro quo function "in which the public is given 'meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.'" Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 922 (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)). To satisfy the written description requirement, "the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996) (citing In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)) (quotations omitted). In other words, the applicant must "convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention," Vas-Cath Inc., 935 F.2d at 1563-64, and demonstrate that by disclosure in the specification of the patent. Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention, Enzo, 323 F.3d at 963, and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed. Such knowledge may change as time progresses. See In re Wallach, 378 F.3d 1330, 1334 (Fed. Cir. 2004) (discussing how it is now a "routine matter" to convert between an amino acid sequence and the DNA sequences that can encode it such that an applicant need not specify each possible permutation of nucleic acid sequences for a particular protein).

More specific to biotechnological invention relevant to this case, Regents of University of California v. Eli Lilly held that, to claim DNA work, precision and disclosure of a representative sample are required. In a classic "species disclosed, genus claimed" grab, the Regents, dirty rats, had only disclosed rats, but claimed the mammalian kingdom, and so their patents failed § 112, ¶ 1.

In Eli Lilly, we held that "the claimed genera of vertebrate and mammal cDNA [were] not described by the general language of [a] patent's written description supported only by the specific nucleotide sequence of rat insulin." 119 F.3d at 1569. That holding was premised on the basic principle that a person of skill in the art must be able to "visualize or recognize the identity of the members of the genus." Id. Thus, to satisfy the written description requirement for a claimed genus, a specification must describe the claimed invention in such a way that a person of skill in the art would understand that the genus that is being claimed has been invented, not just a species of the genus.

Our case law has examined compliance with the written description requirement in the context of biotechnological inventions in the past. In Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), we held, inter alia, that generic claims directed to recombinant prokaryotic microorganisms comprising any vertebrate and mammalian cDNA were not adequately supported by the specification that only disclosed rat insulin cDNA. Id. at 1568. We stated that "[a]n adequate written description of a DNA, such as the cDNA of the recombinant plasmids and microorganisms of the claimed invention, requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Id. at 1566 (internal quotations omitted). We further held that "[a] description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus." Id. at 1569.

The appeals court took in USPTO examiner guidelines.

The Guidelines for Examination of Patent Applications under the 35 U.S.C. § 112, ¶ 1, "Written Description" Requirement, 66 Fed. Reg. 10-99 (Jan. 5, 2001) ("Guidelines"), which we find to be an accurate description of the law by the agency responsible for examining patent applications, and thus persuasive authority, provide further guidance for determining whether the written description requirement is met for claims drawn to a genus. The Guidelines state:

The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species . . . by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.

A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.

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Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.

In this case, "the disclosure of the E. coli polA gene was not representative of and failed to adequately support the entire claimed genus."

U.S. courts are notorious for lack of clarity, case law as hieroglyphics. In this case, the district court was snared by Gentry Gallery, which has been misread before, as requiring an "essential element" test, "mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements." The CAFC now reads that ruling as unhelpful.

As we said in Cooper Cameron Corp. v. Kvaerner Oilfield Products, Inc., 291 F.3d 1317 (Fed. Cir. 2002), in Gentry Gallery "we did not announce a new 'essential element' test mandating an inquiry into what an inventor considers to be essential to his invention and requiring that the claims incorporate those elements." Id. at 1323. Rather, "we applied and merely expounded upon the unremarkable proposition that a broad claim is invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope." Id.

If Gentry Gallery was "unremarkable," how did it generate so much remark?! Such as, from MPEP 2163.05, part of USPTO examiner guidelines that the CAFC left unremarked in its exposition:

Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor had possession of a broader, more generic invention. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998).

(In Gentry Gallery, the "court's determination that the patent disclosure did not support a broad meaning for the disputed claim terms was premised on clear statements in the written description that described the location of a claim element--the 'control means'--as 'the only possible location' and that variations were 'outside the stated purpose of the invention.' Gentry Gallery, 134 F.3d at 1479, 45 USPQ2d at 1503. Gentry Gallery, then, considers the situation where the patent's disclosure makes crystal clear that a particular (i.e., narrow) understanding of a claim term is an 'essential element of [the inventor's] invention.'");

Invalidity via Eli Lilly affirmed. Gentry Gallery sent gently into repose.