Gilead Sciences, Inc.

Patent Trials and Appeals BoardAug 26, 2020

15340538 - (D) (P.T.A.B. Aug. 26, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/340,538 11/01/2016 Manoj C. DESAI 724312004105 7135 144119 7590 08/26/2020 FISH & RICHARDSON P.C. (Gilead) P.O. BOX 1022 MINNEAPOLIS, MN 55440-1022 EXAMINER OTTON, ALICIA L ART UNIT PAPER NUMBER 1699 NOTIFICATION DATE DELIVERY MODE 08/26/2020 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PATDOCTC@fr.com ipdocketing@gilead.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MANOJ C. DESAI, ALLEN YU HONG, HON CHUNG HUI, HONGTAO LIU, RANDALL W. VIVIAN, and LIANHONG XU __________ Appeal 2020-000201 Application 15/340,538 Technology Center 1600 __________ Before ERIC B. GRIMES, LINDA M. GAUDETTE, and FRANCISCO C. PRATS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 42–53. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest in this appeal as Gilead Sciences, Inc., the assignee of this application. Appeal Br. 2. Appeal 2020-000201 Application 15/340,538 2 STATEMENT OF THE CASE The following rejections are before us for review:2 (1) Claims 42–49, under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre- AIA), second paragraph, as being indefinite (Ans. 3–4); and (2) Claims 50–53, under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1–4 of U.S. Patent No. 8,067,449 B2, issued Nov. 29, 2011 (Ans. 5–6). Appellant’s claims 42, 50, and 51 illustrate the subject matter on appeal and read as follows: 42. An in vivo metabolic product of Compound P: . 50. A prodrug of Compound P: . 2 The Final Action included a rejection under 35 U.S.C. § 101. See Final Act. 7–9 (entered April 25, 2018). The Examiner has withdrawn the rejection under § 101. Ans. 6. Appeal 2020-000201 Application 15/340,538 3 51. The prodrug of claim 50 which is an ester of Compound P. Appeal Br. 8, 9. INDEFINITENESS The Examiner’s Prima Facie Case The Examiner concluded that Appellant’s claim 42 is indefinite “because of the recitation of a[n] ‘in vivo metabolic product’ of the claimed compound P.” Ans. 3. In particular, the Examiner reasoned that “[w]ith respect to the claimed metabolites, this term includes any compound which can be produced from the in vivo breakdown or metabolism of the claimed compounds.” Id. at 3–4. The Examiner determined, however, that “there is no disclosure of the particular metabolic pathway of the instant compounds, nor would it be possible to know every single enzyme which could potentially react with and thus transform the instant compounds in vivo.” Ans. 4. Therefore, the Examiner reasoned: Without the particular information including which enzymes will necessarily act on the claimed compound, and what particular chemical transformation occurs as a result of this action, it is not possible for the skilled artisan to determine which particular compounds are embraced by the claimed “metabolite” and the use of the term renders the claim indefinite. Since dependent claims 43–49 do not provide any additional clarification, the dependent claims are also rejected for the same reasons. Id. Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . Appeal 2020-000201 Application 15/340,538 4 After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. A claim does not comply with 35 U.S.C. § 112, second paragraph, “when it contains words or phrases whose meaning is unclear.” In re Packard, 751 F.3d at 1310, 1314 (Fed. Cir. 2014) (approving, for pre- issuance claims, the standard from MPEP § 2173.05(e)); see also Ex parte McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (adopting the approach for assessing indefiniteness approved by the Federal Circuit in Packard). That is, “claims are required to be cast in clear—as opposed to ambiguous, vague, indefinite—terms.” Packard, 751 F.3d at 1313. In the present case, we are not persuaded that Appellant has explained persuasively why the Examiner erred in determining that the language at issue in the rejected claims is unclear. The language at issue appears in independent 42, and recites “[a]n in vivo metabolic product of Compound P.” Appeal Br. 8. Appellant does not dispute the Examiner’s finding that “[n]either the claims nor the [S]pecification set forth specifically, or even suggest, how the structure is modified from the depicted Compound P upon administration in vivo.” Ans. 8. Rather, Appellant argues that a skilled artisan “does not need to know a metabolic pathway in order to recognize a metabolite. Metabolites of drugs are routinely identified from the administration of pharmaceutical compounds to humans and animals without full knowledge of the metabolic pathway.” Appeal Br. 5. Further, Appellant argues, a skilled artisan need not know every enzyme that could transform claim 42’s Compound P into a Appeal 2020-000201 Application 15/340,538 5 metabolite because “[t]he metabolite is recognized as a derivative of a drug compound after administration to a human or animal, and just as the metabolic pathway need not be known, the enzymes transforming the drug need not be known in order to identify a metabolite.” Appeal Br. 5. Appellant, however, does not direct us to any specific evidence supporting its assertion that identifying metabolites in the posited manner is routine. Appellant’s contentions in that regard are therefore unsupported attorney argument, which we do not find persuasive of error by the Examiner. “Attorneys’ argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Appellant fails to explain, moreover, how the alleged ability to generate metabolites by administering compound P to a human or animal establishes that the language at issue in claim 42 clearly delineates, with reasonable certainty, between compounds encompassed by claim 42, and compounds falling outside of the claim. Absent some reasonably clear delineation between compounds that fall within the scope of the language at issue in claim 42, and compounds that fall outside of claim 42’s scope, Appellant does not persuade us of error in the Examiner’s conclusion of indefiniteness. See Miles Labs. Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir. 1993) (“The test for definiteness is whether one skilled in the art would understand the bounds of the claim when read in light of the specification.”). Given the undisputed absence in the Specification of any specific guidance explaining the particular modifications resulting from in vivo metabolism of compound P, Appellant does not persuade us that the language at issue in claim 42, even when read in light of the Specification, clearly informs a skilled artisan about the scope of the claims. Appeal 2020-000201 Application 15/340,538 6 In sum, for the reasons discussed, Appellant does not persuade us that the Examiner erred in concluding that the language at issue in claim 42 is unclear, ambiguous, and vague. We therefore affirm the Examiner’s rejection of claim 42, and its dependent claims, for indefiniteness. DOUBLE PATENTING The Examiner’s Prima Facie Case In rejecting Appellant’s claims 50–53 for obviousness-type double patenting over claims 1–4 of U.S. Patent No. 8,067,449 (“the ’449 patent”), the Examiner determined that the rejected claims are not patentably distinct from the patented claims because claim 2 of the ’449 patent recites a compound having the same structural formula as Compound P, the compound recited in Appellant’s claim 50. See Ans. 5. Further, the Examiner reasoned, “the patented claims also recite ‘stereoisomers thereof’ of the claimed compounds, which encompasses the instantly claimed compound.” Id. at 5–6. Therefore, the Examiner reasoned, “[b]ecause the instant claims are encompassed by the claims of the ’449 patent, with the specifically claimed compound taught as compound P in the patent, a nonstatutory double patenting rejection is proper.” Id. Further, the Examiner notes, “the claim also recites ‘and/or esters thereof.’ The instant claims recite prodrugs thereof of Compound P, where dependent claim 51 specifically recites that the compound is an ester of Compound P.” Id. at 10. Analysis The doctrine of obviousness-type double patenting “prohibits the issuance of claims in a second patent that are not patentably distinct from the claims of the first patent. A later patent claim is not patentably distinct from an earlier claim if the later claim is obvious over, or anticipated by, the Appeal 2020-000201 Application 15/340,538 7 earlier claim.” In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (internal quotations and citations removed). In the present case, Appellant does not persuade us that the Examiner erred in determining that Appellant’s claims 50–53 are not patentably distinct from the claims of the ’449 patent. Appellant contends that rejected claims 50–53 “are directed to prodrugs of Compound P, not Compound P itself. So the allegation that the claims of the ’449 patent encompass the instant claims is not correct.” Appeal Br. 6. In addition, Appellant contends, the Examiner “has not pointed to any motivation or reasoning that would lead one of skill in the art to modify the subject matter of the claims of the ’449 patent to arrive at the subject matter of the instant claims.” Id. We acknowledge that rejected claim 50 recites “[a] prodrug of Compound P.” Appeal Br. 9. As noted above, rejected claim 51 recites “[t]he prodrug of claim 50 which is an ester of Compound P.” Id. Thus, rejected claim 50’s recitation of a prodrug of Compound P encompasses an ester of Compound P. It is undisputed that claim 2 of the ’449 patent recites a compound that has the same structural formula as compound P, except for the stereochemical specificities shown in rejected claim 50. As the Examiner found, however, in addition to the compounds listed, claim 2 of the ’449 patent recites “pharmaceutically acceptable salts, esters, and/or stereoisomers thereof.” The ’449 patent, 267:26–27 (emphasis added). Because rejected claim 50’s recitation of a prodrug of Compound P encompasses esters of Compound P, and because claim 2 of the ’449 patent recites esters of a compound undisputedly having the same structural formula as Compound P, and stereoisomers of those compounds, Appellant Appeal 2020-000201 Application 15/340,538 8 does not persuade us that the Examiner erred in determining that the prodrug of Compound P recited in rejected claim 50 would have been obvious over claim 2 of the ’449 patent. We therefore affirm the Examiner’s rejection of Appellant’s claim 50 for obviousness-type double patenting. Claims 51–53 fall with claim 50. See 37 C.F.R. 41.37(c)(1)(iv). DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 42–49 112(b) or 112, second paragraph Indefiniteness 42–49 50–53 The ’449 Patent; Obviousness-Type Double Patenting 50–53 Overall Outcome 42–53 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED