The United States of America,as represented by the Secretary,Department of Health and Human Services

Patent Trials and Appeals Board

Feb 16, 2022

2021002653 (P.T.A.B. Feb. 16, 2022)

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. 16/047,929 07/27/2018 Adrian U. Wiestner 739729 2997 45733 7590 02/16/2022 LEYDIG, VOIT & MAYER, LTD. TWO PRUDENTIAL PLAZA, SUITE 4900 180 NORTH STETSON AVENUE CHICAGO, IL 60601-6731 EXAMINER HUFF, SHEELA JITENDRA ART UNIT PAPER NUMBER 1643 NOTIFICATION DATE DELIVERY MODE 02/16/2022 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): Chgpatent@leydig.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ADRIAN U. WIESTNER, MARTIN W. SKARZYNSKI, MARGARET A. LINDORFER, RONALD P. TAYLOR, CHRISTOPH RADER, and BERENGERE VIRE1 Appeal 2021-002653 Application 16/047,929 Technology Center 1600 Before ERIC B. GRIMES, ULRIKE W. JENKS and JOHN E. SCHNEIDER, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of killing a cancer cell, which have been rejected based on obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real parties in interest as the U.S. Department of Health & Human Services and University of Virginia Patent Foundation, d/b/a University of Virginia Licensing & Ventures Group. Appeal Br. 2. “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2021-002653 Application 16/047,929 2 STATEMENT OF THE CASE Claims 15, 39-46, 48, 49, and 51-57 are on appeal.2 Claim 15, reproduced below, is illustrative (emphasis added): 15. A method of killing a cancer cell having C3d complement protein on the surface thereof in a subject, the method comprising administering to the subject (1) an anti-C3d antibody or antibody fragment comprising a heavy chain variable region comprising SEQ ID NO: 1 as heavy chain complementary determining region-1 (CDRH1); SEQ ID NO: 2 as heavy chain complementary determining region-2 (CDRH2); and SEQ ID NO: 3 or 4 as heavy chain complementary determining region-3 (CDRH3); and a light chain variable region comprising SEQ ID NO: 5 as light chain complementary determining region-1 (CDRL1); SEQ ID NO: 6 as light chain complementary determining region-2 (CDRL2); and SEQ ID NO: 7 as light chain complementary determining region-3 (CDRL3), and (2) an antibody or antibody fragment to a cell surface protein other than C3d, wherein the antibody or antibody fragment to a cell surface protein other than C3d is an anti- CD33 antibody or antibody fragment, an anti-CD38 antibody or antibody fragment, an anti-EGFR antibody or antibody fragment, or an anti-ERBB2 antibody or antibody fragment, and wherein administration of the antibody or antibody fragment to a cell surface protein other than C3d induces 2 Claims 47 and 50 are also pending and have been objected to but not rejected. Final Action 4. Appeal 2021-002653 Application 16/047,929 3 formation of C3d complement protein the surface of the cancer cell. OPINION Claims 15, 39-46, 48, 49, and 51-57 stand rejected “on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10035848.” Final Action 3.3 The Examiner reasons that, [a]lthough the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the two sets of claims is the scope. Specifically, the scope of the claims in the patent is broader because, in the patent, the antibody that binds to a cell surface protein that is not Cd3 is not limited to anti-CD33, anti-CD38, anti-EGFR or anti-ERBB2 (as it so limited in the instant set of claims). Ans. 3. The Examiner notes that an “Examiner is permitted to look at the specification (see MPEP 804(II)(B)(2)(a), fifth paragraph) to determine what is meant by ‘an antibody . . . to a cell-surface protein other than C3d’ (patent claim 13).” Id. at 4-5. The Examiner cites “col. 12-13 and col. 13, lines 32+ of the patent” as showing that the quoted phrase includes “the specific antibodies for claims 48, 51, 54 and 57” of the instant application. Id. at 5. Appellant argues that “the phrase ‘an antibody or antibody fragment to a cell-surface protein other than C3d’ does not have any special meaning. . . . The phrase refers quite plainly to antibodies or antibody fragments to any cell-surface protein other than C3d.” Appeal Br. 7. Appellant argues that the Examiner “is doing much more than simply 3 Office Action mailed June 30, 2020. Appeal 2021-002653 Application 16/047,929 4 consulting the specification to learn the meaning of the claim language of the reference patent.” Id. at 8. Rather, Appellant argues, the Examiner “is importing into the claims the species of the genus, which are not otherwise recited in the claims, and then using that importation as a grounds for the obviousness-type double patenting rejection.” Id. “Accordingly, the Office has improperly based the obviousness-type double patenting rejection on the specification of the reference patent, not upon the claims of the reference patent.” Id. We agree with Appellant that the Examiner’s rejection improperly relies on the specification of the ’848 patent as evidence that antibodies to CD33, CD38, EGFR, and ERBB2 are obvious species within the genus of “an antibody . . . to a cell-surface protein other than C3d” recited in claim 13 of the ’848 patent. “Generally, an obviousness-type double patenting analysis entails two steps. First, . . . a court construes the claim in the earlier patent and the claim in the later patent and determines the differences. Second, the court determines whether the differences in subject matter between the two claims render the claims patentably distinct.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001) (citation omitted). The same analysis applies at the USPTO. See In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (“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.’”). Determining whether a later-filed claim is patentably distinct from an earlier, patented claim must be based on evidence that qualifies as prior art. Appeal 2021-002653 Application 16/047,929 5 See Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385 (Fed. Cir. 2003) (“Because nonstatutory double patenting compares earlier and later claims, an earlier patent’s disclosure is not available to show nonstatutory double patenting . . . [unless] that patent qualifies as prior art under 35 U.S.C. § 102, which is generally not the case.”) Here, the Examiner’s analysis conflates the two steps of a proper obviousness-type double patenting analysis. As the Examiner correctly noted, construing the claims of the ’848 patent in light of its specification is permissible. Thus, the phrase “an antibody . . . to a cell-surface protein other than C3d” recited in the ’848 patent’s claim 13 is properly interpreted to encompass an anti-CD33 antibody, an anti-CD38 antibody, an anti-ERBB2 antibody, and an anti-EGFR antibody, because those species are described in the ’848 patent as antibodies that bind to cell-surface proteins other than C3d and induce formation of C3d on the surface of the cell. ’848 patent, col. 13, lines 33-49. But “obviousness is not demonstrated merely by showing that an earlier expiring patent dominates a later expiring patent. . . . It is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus.” AbbVie Inc. v. The Mathilda and Terrence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1379 (Fed. Cir. 2014). The Examiner’s rejection fails to address the second step of a proper double patenting analysis: “whether the differences in subject matter between the two claims render the claims patentably distinct.” Eli Lilly, 251 F.3d at 968. That is, the specification of the ’848 patent can properly be relied on to show that the species recited in the claims on appeal are Appeal 2021-002653 Application 16/047,929 6 encompassed by the genus recited in the ’848 patent’s claims, but it cannot be relied on as evidence of the obviousness of those species. The evidence of obviousness must come from some source that qualifies as prior art with respect to the instant claims. Such evidence is lacking on this record. Therefore, because the Examiner has not shown, based on prior art evidence, that an anti-CD33 antibody, an anti-CD38 antibody, an anti- ERBB2 antibody, or an anti-EGFR antibody would have been obvious species within the genus of antibodies that bind to cell-surface proteins other than C3d, as recited in the claims of the ’848 patent, the Examiner has not made out a prima facie case of obviousness-type double patenting. The rejection on appeal is reversed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 15, 39-46, 48, 49, 51- 57 Obviousness-type Double Patenting 15, 39-46, 48, 49, 51- 57 REVERSED