Wednesday, March 08, 2023

UMinnesota loses at CAFC. "Blaze marks" interpreted.

The outcome was appellant lost:

The Regents of the University of Minnesota (“Minnesota”) appeal from a final written decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (“the Board”) holding that claims 1−9, 11−21, and 23−28 of U.S. Patent 8,815,830 are unpatentable as anticipated by the asserted prior art. Gilead Scis., Inc. v. Regents of the Univ. of Minn., No. IPR2017-01712, 2021 WL 2035126 (P.T.A.B. May 21, 2021) (“Decision”). For the following reasons, we affirm.

Subject matter

This appeal pertains to an inter partes review (“IPR”) in which Gilead Sciences, Inc. (“Gilead”) filed a petition challenging claims of the ’830 patent directed to phosphoramidate prodrugs of nucleoside derivatives that prevent viruses from reproducing or cancerous tumors from growing.

"Blaze marks" again

The written description requirement of 35 U.S.C. § 112 reflects the basic premise of the patent system, viz., that one discloses an invention and, if it also fulfills the other requirements of the statute, one obtains a patent. Quid pro quo. Judicial gloss in the case law reflects the need that the disclosure show that one actually made the invention that one is claiming, i.e., that it possessed the invention as claimed. “The purpose of the written description requirement is to prevent an applicant from later asserting that he invented that which he did not.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1330 (Fed. Cir. 2003). Written description of an invention claimed as a genus of chemical compounds, as here, raises particular issues because, as we have held, written description of a broad genus requires description not only of the outer limits of the genus but also of either a representative number of members of the genus or structural features common to the members of the genus, in either case with enough precision that a relevant artisan can visualize or recognize the members of the genus. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350−52 (Fed. Cir. 2010) (en banc). A broad outline of a genus’s perimeter is insufficient. See id. But Minnesota is not arguing in this case that it described a sufficient number of species to constitute a written description of the claimed subgenus. Rather, Minnesota asserts that its earlier NP2-P1 applications literally described, or provided blaze marks to, the subgenus of the ’830 claims in its broad outlines. The Board held that they did not, and we agree.


Evaluating whether the written description requirement is satisfied involves “an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Ariad Pharms., 598 F.3d at 1351. For genus claims, which are present here, we have looked for blaze marks within the disclosure that guide attention to the claimed species or subgenus. In re Ruschig, 379 F.2d 990, 994–95 (CCPA 1967); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996); see also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir. 2000). (Here, the parties use language such as genus and subgenus to refer to the various disclosures involved in this inquiry. The disclosure of NP2-P1, being broader than claim 1 of the ’830 patent, has a relationship of genus to the narrower subgenus of the ’830 patent claims. We will use this language of the parties.) The primary considerations in a written description analysis are factual and must be assessed on a case-by-case basis. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562 (Fed. Cir. 1991). We thus review the Board’s decision regarding written description for substantial evidence. Gartside, 203 F.3d at 1316.

And "laundry list"

The same is true here. The claims of P1 recite a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group. Indeed, the listings of possibilities are so long, and so interwoven, that it is quite unclear how many compounds actually fall within the described genera and subgenera. Thus, we affirm the Board’s decision that there is no ipsis verbis written description disclosure provided by P1 claim 47 sufficient to support the ’830 patent’s claims.

Ariad again

Minnesota further argues that the Board erred in failing to consider the holdings in Ariad. In so doing, Minnesota mischaracterizes Ariad as holding that merely “disclosing ‘structural features common to the members of [a] genus’ demonstrates possession of, and thereby supports, the claimed genus.” Appellant’s Br. at 5. That is not what Ariad held. As the Board recognized, sufficiently describing a genus under Ariad requires a description of a claimed genus disclosing either (1) “a representative number of species falling within the scope of the genus,” which the parties do not dispute is lacking here, or (2) “structural features common to the members of the genus,” either of which must enable “one of skill in the art [to] ‘visualize or recognize’ the members of the genus.” Decision at *4; Ariad, 598 F.3d at 1350 (emphasis added). As indicated, the first requirement is not at issue here. As for the second, the Board addressed the question whether one of skill in the art would have been able to visualize or recognize the members of the claimed genus by “search[ing] for blaze marks that guide a skilled artisan to the claimed subgenera.” Decision at *10. That was not error. Regarding whether common structural features must exist between a claim and a putative priority disclosure, those features must constitute the near-entirety of the structures being compared. But the structures here are so extensive and varied that the structures of P1 claim 47, which, through its multiple dependencies, encompasses a significantly larger genus than that claimed in the ’830 patent, are not sufficiently common to that of claim 1 of the ’830 patent to provide written description support. Finding no adequate blaze marks, the Board concluded that NP2-P1 do not provide sufficient written description to support the ’830 patent claims.


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