Anticipation requires that all of the limitations of the claim “arranged or combined in the same way as in the claim” is disclosed in the prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369–70 (Fed. Cir. 2008).

When a prior art reference describes a genus and the challenged claim recites a species of that genus, anticipation turns on whether the genus was of such a defined and limited class that one of ordinary skill in the art could have “at once envisaged” each member of the genus. Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1376 (Fed. Cir. 2006); Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006); Metabolite Lab'ys, Inc. v. Lab'y Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004)). Professor Crouch described this as a “forest-trees anticipation analysis” where the prior art discloses thousands of potential embodiments.

Anticipation is not shown by picking-and-choosing from the different teachings of a prior art reference to piece together the claimed invention. In re Arkley, 455 F.2d 586, 587–88 (CCPA 1972) (“reference must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference” (emphasis in original)).

Biodegradable Filler Gel

In Incept LLC v. Palette Life Sciences, Inc., No. 21-2063, — F.4th — (Fed. Cir. Aug. 16, 2023) (Majority by Judges Schall and Taranto; Dissent-in-part by Judge Newman), the Federal Circuit affirmed the PTAB's decision that although the prior art reference (Wallace) discloses various options for each component of its compositions, the characteristics of those compositions required for anticipation would remain, even if the degree to which those characteristics would be present could vary (in ways immaterial to anticipation). Palette Life Sciences had initiated IPR proceedings and the PTAB eventually found the challenged claims unpatentable as anticipated and/or obvious over Wallace.

The patents-in-suit (U.S. Patent Nos. 8,257,723 and 7,744,913) were directed towards a method for treating cancer in which a biodegradable filler gel is injected prior to radiation treatment so as to increase the space between the tissue being treated and the other body organs. The gel biodegrades afterwards.

Wallace expressly describes compositions that have the claimed characteristics of, and are used for the same displacement purpose as, the compositions referred to in the `723 patent claims challenged as anticipated.

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Incept cannot use the fact that Wallace describes multiple compositions to evade an anticipation finding where Wallace provides “as complete detail as is contained in the patent claim,” such that a skilled artisan would have understood that Wallace's compositions had the same generic properties as those in the `723 patent claims.

The Federal Circuit agreed that the patent claims were are not directed to a “species” of fillers that fall within the “genus” of compositions described in Wallace. Rather, the patent claims were directed to a method of introducing fillers having certain general qualities, which general qualities Wallace's compositions are also described as having—such that Wallace provides “as complete detail as is contained in the patent claim.” See Richardson v. Suzuki Motor Co., Ltd., 868 F.2d 1226, 1236 (Fed. Cir. 1989) (providing that, to anticipate, “[t]he identical invention must be shown in as complete detail as is contained in the patent claim”). The Federal Circuit found substantial evidence supporting the PTAB's finding that Wallace teaches compositions that have the only biodegradability properties required by the claims at issue.

Also, Obviousness

Anticipation is a question of fact. Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., 50 F.4th 147, 152 (Fed. Cir. 2022); 35 U.S.C. § 102.

Obviousness, on the other hand, is a question of law based on underlying factual determinations. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 427 (2007) (noting the underlying factual determinations include: (1) the scope and content of the prior art; (2) differences between the prior art and the claims at issue; (3) the level of ordinary skill in the pertinent art; and (4) secondary considerations such as commercial success, long felt but unsolved needs, and failure of others (citing Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966)); 35 U.S.C. § 103.

On appeal, legal conclusions are reviewed de novo, and factual findings are reviewed for substantial evidence. Becton, Dickinson & Co. v. Baxter Corp., 998 F.3d 1337, 1339 (Fed. Cir. 2021). “[T]he possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency's finding from being supported by substantial evidence.” Consolo v. Fed. Mar. Comm'n, 383 U.S. 607, 620 (1966); see also Roku, Inc. v. Universal Elecs., Inc., 63 F.4th 1319, 1326 (Fed. Cir. 2023).

In Incept, the Federal Circuit found there was substantial evidence supporting the PTAB's findings that Wallace did not teach away from biodegradable compositions.

In any event, “a reference does not teach away if it ‘merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.'” UCB, Inc. v. Actavis Laby's UT, Inc., 65 F.4th 679, 692 (Fed. Cir. 2023) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (2009)).

The Federal Circuit also found substantial evidence to support the PTAB's findings that Incept did not provide sufficient evidence to show commercial success. See Chemours Co. FC, LLC v. Daikin Industries, Ltd., 4 F.4th 1370, 1378 (Fed. Cir. 2021) (“The Board is certainly entitled to weigh evidence and find, if appropriate, that Chemours's gross sales data were insufficient to show commercial success without market share data.”).

To the extent Incept also contends that the Board improperly dismissed the market share data that Incept did provide, we defer to the Board's findings concerning the credibility of expert witnesses, see Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010), and Incept has not otherwise demonstrated that those findings are unsupported by substantial evidence.

The remaining dependent claims were also held invalid because Incept did not raise any arguments with respect to other claim limitations, or separately argue the dependent claims, so those dependent claims stand or fall together with the independent claim. Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1340 (Fed. Cir. 2020). The dependent claims recited various forms of the filler, such as thixotropic polymer, collagen, a polysaccharide, or hyaluronic acid.

Dissent by Newman

Judge Newman dissented from the holding regarding the remaining dependent claims.

The majority appears to hold that, when the broader claim is anticipated, the dependent claims are automatically anticipated. That is not the law. Each claim must be considered as a whole, including all its limitations. . . . A generic prior disclosure does not anticipate all of its embodiments, including novel specific embodiments, whether or not the facts are such that the generic disclosure may render the embodiment obvious.

Judge Newman's dissent also noted that it was “undisputed that the Incept product experienced regular increases in annual commercial sales, and at the time of trial Incept had obtained 55% of the market for comparable products”—notwithstanding the fact that Incept also gave free samples.

It is not correct that because free samples were provided, the commercial sales and market share data are not relevant measures of commercial success. . . . I respectfully dissent from the finding that there was not substantial evidence of commercial success, for commercial success is measured by commercial sales, not free samples. I would remand for the Board to apply the evidence of commercial activity and market growth to the determination of obviousness.

Judge Newman concurred in the invalidity of the independent claim but would have vacated the PTAB's decisions as to the dependent claims.

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