RESEARCH DEVELOPMENT FOUNDATIONDownload PDFPatent Trials and Appeals BoardApr 9, 202014510203 - (D) (P.T.A.B. Apr. 9, 2020) Copy Citation 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. 14/510,203 10/09/2014 Beat A. IMHOF CLFR.P0410US 3768 52034 7590 04/09/2020 Parker Highlander PLLC 1120 South Capital of Texas Highway Bldg. 1, Suite 200 AUSTIN, TX 78746 EXAMINER HADDAD, MAHER M ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 04/09/2020 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): docket@phiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE _________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _________________ Ex Parte BEAT A. IMHOF, MARIJANA MILJKOVIC-LICINA, and PHILIPPE HAMMEL _________________ Appeal 2019-002357 Application 14/510,203 Technology Center 1600 _________________ Before DEBORAH KATZ, JOHN E. SCHNEIDER, and MICHAEL A. VALEK, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appellant1 seeks our review2, under 35 U.S.C. § 134(a), of the Examiner’s decision to reject claims 1–8, 10–15, and 19. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party-in-interest as Research Development Foundation. (Appeal Br. 3.) 2 We consider the Specification filed October 9, 2014 (“Spec.”), the Final Office Action issued August 2, 3017 (“Final Act.”), the Appeal Brief filed May 2, 2018 (“Appeal Br.”), the Examiner’s Answer issued on May 23, Appeal 2019-002357 Application 14/510,203 2 Appellant’s specification is directed to monoclonal antibodies against the protein Olfml-3 and methods for using these antibodies to treat angiogenesis-related conditions. (Spec. ¶ 3.) Appellants’ claim 1 recites: An isolated monoclonal antibody, wherein the antibody specifically binds to Olfml-3 and is selected from the group consisting of: (a) an antibody comprising a first VH CDR having the sequence of VH CDRl of SEQ ID NO: 7, a second VH CDR having the sequence of VH CDR2 of SEQ ID NO: 8, a third VH CDR having the sequence of VH CDR3 of SEQ ID NO: 9, a first VL CDR having the sequence of VL CDRl of SEQ ID NO: 10, a second VL CDR having the sequence of VL CDR2 of SEQ ID NO: 11, and a third VL CDR having the sequence of VL CDR3 of SEQ ID NO: 12; (b) an antibody comprising a first VH CDR having the sequence of VH CDRl of SEQ ID NO: 21, a second VH CDR having the sequence of VH CDR2 of SEQ ID NO: 22, a third VH CDR having the sequence of VH CDR3 of SEQ ID NO: 23, a first VL CDR having the sequence of VL CDRl of SEQ ID NO: 24, a second VL CDR having the sequence of VL CDR2 of SEQ ID NO: 25, and a third VL CDR having the sequence ofVL CDR3 of SEQ ID NO: 26; and (c) an antibody comprising a first VH CDR having the sequence of VH CDRl of SEQ ID NO: 13, a second VH CDR having the sequence of VH CDR2 of SEQ ID NO: 14, a third VH CDR having the sequence of VH CDR3 of SEQ ID NO: 15, a first VL CDR having the sequence of VL CDRl of SEQ ID NO: 16, a second VL CDR having the sequence of VL CDR2 of SEQ ID NO: 17, and a third VL CDR having the sequence ofVL CDR3 of SEQ ID NO: 18. 2018 (“Ans.”), and the oral argument held on April 1, 2020, in reaching our decision. Appeal 2019-002357 Application 14/510,203 3 (Appeal Br. 11.) Appellant’s claim 19 recites: “A method of treating an angiogenesis-related condition in a subject comprising administering to the subject an amount of an antibody in accordance with of claim 1 that is effective to treat the angiogenesis-related condition wherein the angiogenesis-related condition comprises cancer.” (Appeal Br. 13.) The Examiner provisionally rejected claims 1–8, 10–15, and 19 under the doctrine of obviousness-type double-patenting over claims 1, 3, 6, 9–11, and 15–27 of application 15/227,931. (See Ans. 3–4.) Application 15/227,931 was abandoned on September 12, 2019, after the Examiner’s Answer issued on May 23, 2018. Accordingly, this rejection is moot. The Examiner also rejected claims 1–8, 10–15, and 19 under the doctrine of obviousness-type double-patenting over claims 1–6 of U.S. Patent 9,096,662 B2, issued Aug. 4, 2015 (“the ’662 patent”) and over claims 1–15 of U.S. Patent 8,663,637 B2, issued Mar. 4, 2017 (“the ’637 patent”). (See Ans. 4.) The ’662 and ’637 patents name the same inventors as Appellant’s current application and list the same assignee. Appellant addresses claim 19 of the current application. (See Appeal Br. 17.) Accordingly, we focus on claim 19, which depends on claim 1, in our review. See 37 C.F.R. § 41.37(c)(1)(iv). Claim 1 of the ’662 patent is drawn to a pharmaceutical composition and claim 1 of the ’637 patent is drawn to a method of inhibiting angionesis in a subject with an angiogenic condition. (See ’662 patent 57:33–40 and ’637 patent 57:28–38.) Both claims recite an antibody “wherein the antibody recognizes and binds to (i) epitope within amino acid positions 86- 99 of SEQ ID NO:l (human Olfml3 protein), or (ii) an epitope within amino acid positions 390-403 of SEQ ID NO: 1, inhibits the binding of human Appeal 2019-002357 Application 14/510,203 4 Olfml3 protein to BMP4 protein, and reduces the number of pericytes in vessels.” (Id.) The Examiner cites Example 14 and Figure 25 of the ’662 and ’637 patents for the finding that claim 1 of both patents recite antibodies falling within the scope of Appellant’s currently pending claim 1 and, thus, claim 19. (See Ans. 4; see ’662 patent 39:37–44 (Example 14) and Fig. 25A–B; see ’637 patent 39:37–44 (Example 14), and Fig. 25A–B.) Specifically, Example 14 of both patents refers to monoclonal antibodies that recognize amino acids 390–403 of human/mouse Olfml3 and reduce tumor growth by half, citing Figures 25A and B. (See ’662 patent 39:37–44; see ’637 patent 39:37–44.) Figures 25A and B of both patents provide results from antibodies identified as “9F8BO” and “46A9BO.” Thus, Example 14 of the ’662 and ’637 patents indicates that monoclonal antibodies 9F8BO and 46A9BO recognize amino acids 390–403 of Olfml3. Because claim 1 of each of the ’662 and ’637 patents recite antibodies that recognize and bind to an epitope within amino acid positions 390–403 of human Olfml3, the record supports the Examiner’s finding that claim 1 of both patents encompasses monoclonal antibodies 9F8BO and 46A9BO. Appellant’s current Specification states in the Summary of the Invention: “In certain aspects, the antibody may comprise all or part of the heavy chain variable region and/or the light chain variable region of the 46A9BO, 9F8BO or Z14A7 monoclonal antibodies.” (Spec. ¶ 9.) Appellant’s Specification also provides Table 1, which recites the heavy chain and light chain CDR sequences (SEQ ID Nos: 7–9 and 10–12, respectively) of the monoclonal antibody 46A9BO and the heavy chain and light chain CDR sequences (SEQ ID Nos: 21–23 and 24–26, respectively) of Appeal 2019-002357 Application 14/510,203 5 the monoclonal antibody 9F8BO. (See Spec. 40; see also ¶ 123.) Thus, at least some of the SEQ ID NOs recited in claim 1 and claim 19 (SEQ ID NOs: 7–12 and 21–26) are the CDR sequences of monoclonal antibodies with the same designation as those encompassed by claim 1 of both the ’662 and ’637 patents. Genetic sequences of known proteins have previously been found to be obvious. See In re Kubin, 561 F.3d 1351, 1356 (Fed. Cir. 2009) (“[T]his court determines that the Board had substantial evidence to conclude that appellants used conventional techniques, as taught in Valiante and Sambrook, to isolate a gene sequence for NAIL.”). Appellant’s description of how the currently claimed genetic sequences were determined, using RNA extraction and PCR amplification with previously reported designations for CDR regions, provides a similar factual basis for the obviousness of the currently claimed sequences. (See Spec. ¶ 122.) In light of these facts, the Examiner’s finding is reasonable that even if the ’662 and ’637 patents do not teach the sequences for the CDRs recited in claim 1 of Appellant’s current application, these sequences are an inherent property of the 9F8BO and 46A9BO monoclonal antibodies recited in the claims of the ’662 and ’637 patents. (See Ans. 4.) Specifically, we agree that it is reasonable to assume that antibodies developed by the same inventors working for the same company and named with the same six- character combination of letters and numbers are the same antibodies, absent evidence to the contrary. Thus, we agree that claim 1 of both the ’662 and ’637 patents renders obvious claim 1 and claim 19 of Appellant’s currently pending application. Appeal 2019-002357 Application 14/510,203 6 Appellant argues that the ’662 and ’637 patents do not provide the sequences of the 9F8BO or 46A9BO antibodies and, therefore, one of ordinary skill in the art could not be put in possession of these antibodies and their sequences. (See Appeal Br. 8.) According to Appellant, the terms “9F8BO” and “46A9BO” are merely laboratory designations that do not convey information about how to obtain the antibodies or their sequences. (See Appeal Br. 8.) We are not persuaded by these arguments because there is sufficient basis for the Examiner’s finding that the CDR sequences recited in claim 1 are an inherent property of the 9F8BO and 46A9BO monoclonal antibodies. Although “9F8BO” and “46A9BO” are merely laboratory designations, as Appellant argues, absent evidence to the contrary, it is reasonable to find that one would use the same designation for the same antibody. Therefore, it is reasonable to find that the antibodies provided as an embodiment of Appellant’s current claims are the same antibodies described as having the attributes of those recited in the ’662 and ’637 patents. Under In re Best, 562 F.2d 1252, 1255 (CCPA 1977), [w]here . . . the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra [441 F.2d 660 (CCPA 1971)]. Whether the rejection is based on ‘inherency’ under 35 USC 102, on “prima facie obviousness” under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. Appeal 2019-002357 Application 14/510,203 7 Given the support in the record that the monoclonal antibodies encompassed by claim 1 of both the ’662 and ’637 patent are the same as antibodies with the CDRs recited in Appellant’s current claim 1, it is Appellant’s burden to present evidence if they are different. Appellant fails to direct us to such evidence. Appellant argues that an allegedly inherent feature must be enabled for there to be anticipation, citing Toro Co. v. Deere & Co., 355 F.3d 1313, 1320 (Fed. Cir. 2004). (See Appeal Br. 8.) According to Appellant, the elements of the 9F8BO and 46A9BO antibodies that are recited in Appellant’s current claims are not actually described or enabled in the cited patents and, therefore, cannot form the basis for an inherent anticipation rejection. (See Appeal Br. 8.) We are not persuaded by this argument because there is sufficient support in the record for the Examiner’s finding that monoclonal antibodies within the scope of Appellant’s current claim 1 are described and enabled in the ’662 and ’637 patents. Whether or not antibodies must be sequenced to be sufficiently described and enabled, there is sufficient support for the Examiner’s finding that the monoclonal antibodies discussed in the ’662 and ’637 patents would have the CDRs recited in Appellant’s currently pending claim 1, even if the sequences of those CDRs was not known when the applications that became those patents were filed. Appellant argues further that a prior art generic claim cannot anticipate a claim to a species falling within that claim, given that the genus recited in the claims of the ’662 and ’637 patents do not specifically name the currently claimed species. (See Appeal Br. 9–10.) We are not persuaded by this argument because the Examiner’s rejection is not based on Appeal 2019-002357 Application 14/510,203 8 anticipation, but rather on obviousness-type double patenting. As here, where the genus of antibodies recited in the prior claims includes specific antibodies expressly provided in the specification of both the prior art patents and the current application, and it would have been obvious to determine the sequence of the CDRs of those antibodies, we are not persuaded that the prior claims cannot render the current claims obvious. Conclusion Upon consideration of the record and for the reasons given, we affirm the Examiner’s rejection. In summary: Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 1–8, 10– 15, 19 Obviousness-type Double Patenting over claims 1, 3, 6, 9–11, 15–27 of application 15/227,931 – rendered moot by the abandonment of application 15/227,931 1–8, 10– 15, 19 Obviousness-type Double Patenting over claims 1–6 of the ’662 patent and over claims 1–15 of the ’637 patent 1–8, 10–15, 19 Overall Outcome 1–8, 10–15, 19 Appeal 2019-002357 Application 14/510,203 9 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136. AFFIRMED Copy with citationCopy as parenthetical citation