INSERM (INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE) et al.Download PDFPatent Trials and Appeals BoardDec 23, 20212020004283 (P.T.A.B. Dec. 23, 2021) 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. 15/500,615 01/31/2017 Carole GUILLONNEAU 11450412US 3705 30743 7590 12/23/2021 W&C IP 11491 SUNSET HILLS ROAD SUITE 340 RESTON, VA 20190 EXAMINER JUEDES, AMY E ART UNIT PAPER NUMBER 1644 MAIL DATE DELIVERY MODE 12/23/2021 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte CAROLE GUILLONNEAU and IGNACIO ANEGON ____________ Appeal 2020-004283 Application 15/500,615 Technology Center 1600 ____________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and ULRIKE W. JENKS, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 1–4, 8, 13, 15, 21–25, and 27 (Final Act.2 1).3 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 as “INSERM (INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE) of Paris, France; and UNIVERSITE DE NANTES of Nantes, France” (Appellant’s January 23, 2020, Appeal Brief (Appeal Br.) 3). 2 Examiner’s July 26, 2019, Final Office Action. 3 Appellant’s claims 9–12 and 16–20 stand withdrawn from consideration (Final Act. 1). Appeal 2020-004283 Application 15/500,615 2 STATEMENT OF THE CASE Appellant’s disclosure “relates to an isolated anti-CD45RC antibody for use in preventing or treating transplant rejection, autoimmune diseases, unwanted immune responses against proteins expressed in the course of gene therapy and/or therapeutic proteins, allergy as well as lymphoma or cancer which are associated with CD45RC+ cells” (Spec.4 1). Appellant’s claims 1, 3, 4, 13, 22, 23, and 27 are reproduced below: 1. A method of preventing or reducing allogeneic transplant rejection in a patient in need thereof by expanding and/or potentiating regulatory T cells in said patient, comprising administering to the patient a therapeutically effective amount of an anti-CD45RC+ cell-depleting antibody sufficient to expand and/or potentiate regulatory T cells and a therapeutically effective amount of rapamycin, wherein said anti-CD45RC+ cell-depleting antibody is an antihuman CD45RC monoclonal antibody or a fragment thereof and wherein said anti-CD45RC+ cell-depleting antibody is administered every 2.5 to 3 days, for 10 to 20 days post- transplantation. (Appeal Br. 33.) 3. The method according to claim 1, wherein said allogeneic transplant rejection is GVHD. (Id.) 4. The method according to claim 2, wherein said allogeneic transplant rejection is cardiac allotransplant rejection. (Id.) 13. A method for expanding and/or potentiating regulatory T cells in a transplant patient in need thereof, comprising a step of administering to said patient a therapeutically effective amount of an anti-CD45RC+ cell-depleting antibody sufficient to expand and/or potentiate the regulatory T cells and a 4 Appellant’s January 31, 2017, Specification. Appeal 2020-004283 Application 15/500,615 3 therapeutically effective amount of rapamycin, wherein said anti-CD45RC+ cell-depleting antibody is an anti-human CD45RC+ cell-depleting antibody or a fragment thereof and wherein said anti-CD45RC+ cell-depleting antibody is administered every 2.5 to 3 days, for 10 to 20 days post- transplantation. (Id. at 33–34.) 22. The method of claim 1, wherein the step of administering does not compromise immunity and capacity of the patient to mount antibody responses against cognate antigens. (Id. at 34.) 23. The method according to claim 1, wherein said anti- CD45RC+ cell-depleting antibody mediates antibody- dependent cell mediated cytotoxicity (ADCC) and/or complement dependent cytotoxicity (CDC). (Id. at 35.) 27. The method according to claim 1, wherein said anti- CD45RC+ cell-depleting antibody mediates inhibition of CD45RC+ cell proliferation and/or induction of CD45RC+ apoptotic cell death. (Id.) Claims 1–4, 8, 13, 15, 21–25, and 27 stand rejected under 35 U.S.C. § 103 as unpatentable over the combination of Lazarovits5 and SantaCruz.6 5 Lazarovits et al., WO 98/11918, published Mar. 26, 1998. 6 SANTA CRUZ BIOTECHNOLOGY, INC., CD45RC (OX22): sc-53049 product data sheet, available at www.scbt.com, last accessed (2018). See Examiner’s August 2, 2018, PTO-892, Notice of References Cited. Appeal 2020-004283 Application 15/500,615 4 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Lazarovits discloses, “[a] method for the prevention or reversal of transplant rejection, or for therapy for autoimmune diseases, is provided comprising administering compounds such as monoclonal antibodies, that bind specifically to one or more preselected CD45R leukocyte antigens” (Lazarovits Abstr.; see also id. at 3 (Lazarovits discloses that its method “comprises administering to a patient in need of such treatment, an effective immunosuppressive amount of at least one compound which binds specifically to a CD45 leukocyte antigen present on T-cells”); id. at 13–14 (Lazarovits discloses that its method is useful for treating “allo-or xeno- transplant rejection” and “graft-versus-host disease (GvH)”); id. at 33–34 (Lazarovits discloses treatment of mouse cardiac allografts); id. at 2 (Lazarovits discloses “a method for in vivo immunosuppression in humans and mammals”); Ans.7 3–4). FF 2. Lazarovits discloses that its method “may lead to T-cells having a receptor for the antigen becoming anergized, so that the T-cell clones are functionally, if not actually, deleted” (Lazarovits 5; see also Ans. 4 (Examiner finds that Lazarovits discloses that its method “induces transitory cell depletion, but avoids the risk of overall immunosuppression (i.e. the method does not compromise capacity to mount an antibody response”)). 7 Examiner’s March 23, 2020, Answer. Appeal 2020-004283 Application 15/500,615 5 FF 3. Lazarovits discloses that the compound, within the scope of its disclosed method, is preferably an antibody and “[m]ore preferably, the antibody administered will be capable of binding to . . . the CD45RC leukocyte antigen” (Lazarovits 3; see also id. at 9 (Lazarovits discloses the anti-CD45RC monoclonal antibody OX22); see also Ans. 4 (Examiner finds that Lazarovits “discloses OX22 as a species of anti-CD45RC antibody for use in [its] disclosed methods”)). FF 4. Lazarovits discloses that compounds within the scope of its disclosure “may be administered daily or every other day or less frequently at diminishing dosages to maintain a minimum level of compound in the blood during the antigen challenge, e.g., following organ transplant or during the acute phase of an autoimmune disease” (Lazarovits 15; see id. at 32 (Lazarovits exemplifies the administration of a compound within the scope of its disclosure “on Monday, Wednesday and Friday for each of . . . two weeks”); see also Ans. 4). FF 5. Lazarovits discloses that effective dosages of its compounds are “on the order of from 0.01 to 2.5 up to 5 mg/kg” (Lazarovits 15; cf. Spec. 24 (Appellant discloses that “[a]n effective amount of the [administered] drug is ordinarily . . . from 0.0002 mg/kg to about 20 mg/kg of body weight per day”)). FF 6. Lazarovits discloses that its method comprises the administration of an anti-inflammatory or immunosuppressive drug, such as rapamycin, “prior to, following, or concurrently with” a compound within the scope of its disclosure (Lazarovits 4; see also Ans. 3 (Examiner finds that Lazarovits discloses “concurrent administration of CD45RC antibody and another drug including rapamycin”)). Appeal 2020-004283 Application 15/500,615 6 FF 7. Examiner relies on SantaCruz to disclose “that OX22 binds human CD45RC and is an IgG1 antibody, i.e. an antibody isotype that mediates ADCC” (Ans. 4 and 8). ANALYSIS Examiner concludes that, before the effective filing date of Appellant’s claimed invention, the combination of Lazarovits and SantaCruz makes obvious Appellant’s claimed invention (see Ans. 4–5; FF 1–7). In support of its conclusion of obviousness, Examiner reasons that because Lazarovits discloses the administration of a compound within the scope of its disclosure “every other day or less frequently,” and exemplifies administration over a period of two weeks, the combination of Lazarovits and SantaCruz makes obvious the administration of the administration of an anti-CD45RC antibody every 2.5 to 3 days, for 10 to 20 days post- transplantation as required by Appellant’s claimed invention (see Ans. 4–5). See In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”). In addition, Examiner reasons that “cell depleting function would be a latent property” of the OX22 antibody disclosed by Lazarovits (Ans. 8; see also id. (citing Spec. 8 and 31–32) (Examiner finds that Appellant discloses that the OX22 antibody is suitable for use in its claimed invention)). Claim 1: Appellant’s claim 1 is reproduced above. “[I]n a section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, Appeal 2020-004283 Application 15/500,615 7 including unpreferred embodiments, must be considered.’” Merck & Co. Inc. v. Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976).); see also In re Mills, 470 F.2d 649, 651 (CCPA 1972) (“[A] reference is not limited to the disclosure of specific working examples.”). Therefore, we are not persuaded by Appellant’s contention that “the general[] teaching of Lazarovits . . . revolves around the use of anti-CD45RB antibodies . . . which may optionally be administered in further combination with anti-CD45RC antibodies” (Appeal Br. 16; see also id. at 17 (Appellant contends that Lazarovits “remains totally silent as to any hypothetical possibility that anti-CD45RC antibodies might be efficient to prevent or reduce allogeneic transplant rejection or improve transplant survival” and “provides no data whatsoever to support the use of anti-CD45RC antibodies for any purpose”); id. at 17–18; Reply Br.8 2–3; First Guillonneau Decl.9 1– 2; cf. FF 1–7). Appellant’s claim 1, reproduced above, is not limited to a method of preventing transplant rejection, but instead encompasses a method of reducing allogeneic transplant rejection in a patient in need thereof. In addition, Appellant’s claim 1 is not limited to any particular amount of allogeneic transplant rejection reduction. As Appellant recognized, it was known in the art that “mAb directed to CD45RC isoforms . . . moderately inhibit[] human T cell activation’” (Appeal Br. 18 (citing Bedke10 37) 8 Appellant’s May 20, 2020, Reply Brief. 9 Declaration of Carole Guillonneau, signed Feb. 20, 2018. 10 Bedke et al., Modulation of Human Anti-Pig T Cell Responses by Monoclonal Antibodies Directed to Porcine CD45 Molecules, 8 Annals of Transplantation 35–38 (2003). Appeal 2020-004283 Application 15/500,615 8 (emphasis omitted); see also First Guillonneau Decl. 2–3 (citing Bedke)). Stated differently, the prior art recognized that antibodies directed to CD45RC isoforms would have been expected to reduce, to some degree, allogeneic transplant rejection. Thus, we are not persuaded by Appellant’s contention that the prior art taught “away from the use of anti-CD45RC antibodies to” reduce allogenic transplant rejection (Appeal Br. 18; see id. (Appellant contends that “[b]ased on Bedke, one of skill in the art would thus consider that anti-CD45RC antibodies would not be suitable for preventing transplant rejection”); see also Reply Br. 2–3 (Appellant contends that the prior art teaches away from Appellant’s claimed invention)). For the foregoing reasons, we are not persuaded by Appellant’s contention that “the present inventors who discovered that administering a therapeutically effective amount of an anti-CD45RC+ cell-depleting antibody to a transplant patient could effectively . . . reduce allogeneic transplant rejection associated with CD45RC+ cells” (Appeal Br. 19). As discussed above, Examiner finds that the OX22 anti-CD45RC antibody disclosed by Lazarovits is a cell-depleting antibody (see Ans. 8 (citing Spec. 8 and 31–32) (Examiner finds that Appellant discloses that the OX22 antibody is suitable for use in its claimed invention)). In addition, Appellant failed to direct our attention to persuasive evidence on this record to support a finding that any of the anti-CD45RC antibodies disclosed by Lazarovits are not cell-depleting antibodies. Therefore, we are not persuaded by Appellant’s contention that “[a]t no time nor by any means does Lazarovits . . . mention, or merely suggest, a possible cell-depleting effect of anti-CD45RC antibodies” (Appeal Br. 19). Appeal 2020-004283 Application 15/500,615 9 Lazarovits discloses that effective antibody dosages are “on the order of from 0.01 to 2.5 up to 5 mg/kg,” which falls within Appellant’s disclosed effective range of “from 0.0002 mg/kg to about 20 mg/kg of body weight per day” (FF 5). Further, even if, Appellant discovered that administration of an anti-CD45RC antibody, such as OX22, resulted in expansion and potentiation of regulatory T cells, we find “that the mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not cause a claim drawn to those things to distinguish over the prior art.” In re Swinehart, 439 F.2d 210, 212–13 (CCPA 1971); Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”) Therefore, we are not persuaded by Appellant’s contention that the combination of Lazarovits and SantaCruz “does not teach or suggest administering an anti-CD45RC antibody in an amount sufficient to expand and/or potentiate regulatory T cells” and “is completely silent about the fact that the administration of an anti-CD45RC antibody may result in expanding and/or potentializing regulatory T cells” (Appeal Br. 20; see also id. at 23). Lazarovits discloses that compounds within the scope of its disclosure, i.e. an anti CD45RC antibody, such as OX22, “may be administered daily or every other day or less frequently at diminishing dosages to maintain a minimum level of compound in the blood during the antigen challenge, e.g., following organ transplant or during the acute phase of an autoimmune disease” and exemplifies the administration of a compound within the scope of its disclosure “on Monday, Wednesday and Appeal 2020-004283 Application 15/500,615 10 Friday for each of . . . two weeks” (FF 4). Thus, we find no error in Examiner’s conclusion that the combination of Lazarovits and SantaCruz makes obvious a dosing regimen within the scope of Appellant’s claim 1. See In re Aller, 220 F.2d at 456 (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”). Therefore, we are not persuaded by Appellant’s contention that the combination of Lazarovits and SantaCruz fails to make obvious the dosage regimen set forth in Appellant’s claim 1 (see Appeal Br. 20–22; see also Reply Br. 3). Lazarovits discloses that its method comprises the administration of an anti-inflammatory or immunosuppressive drug, such as rapamycin, “prior to, following, or concurrently with” a compound within the scope of its disclosure, i.e., an anti-CD45RC antibody, such as OX22 (FF 6). As Examiner explains, Lazarovits exemplifies the treatment of a xenograft with a synergistic combination of an anti-CD45 antibody and anti- inflammatory/immunosuppressive drug (specifically anti-CD45RB mAb and cyclophosphamide (CyP)) and, thus, those of ordinary skill in this art would have reasonably expected “similar results using the other types of CD45 antibodies and immunosuppressive drugs specifically disclosed as suitable for use [in Lazarovits’ method], i.e. CD45RC and rapamycin” (see Ans. 11; see also Lazarovits 35). In addition, in order to be persuasive of non- obviousness, “[e]vidence of secondary considerations must be reasonably commensurate with the scope of the claims.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). Guillonneau testifies that a combination of (a) anti-CD45RC antibody and (b) 0.4 or 0.8 mg/kg/day rapamycin Appeal 2020-004283 Application 15/500,615 11 exhibited a synergistic treatment effect (see Second Guillonneau Decl.11 1– 5; see also Anegon Decl. ¶ 2 (citing Second Guillonneau Decl.) (Anegon declares that those of ordinary skill in this art would have recognized that the results the combination treatment reported in the Second Guillonneau Declaration “is enabled over the full scope of the present claims, i.e. all types of transplant rejection”)). Even if those of ordinary skill in this art would have reasonably expected synergy between an anti-CD45RC antibody and 0.4 or 0.8 mg/kg/day rapamycin to be effective against all types of transplant rejection, we find no persuasive evidence on this record to support a finding that the rapamycin dosage reported in the Second Guillonneau Declaration, as relied upon in the Anegon Declaration, is commensurate in scope with the rapamycin required by Appellant’s claim 1 which is unlimited as to its amount or concentration range. Therefore, we are not persuaded by Appellant’s contention that the method set forth in its claim 1 exhibits unexpected results (see Appeal Br. 22–23). Although Appellant contends that “the specific time frame of 10-20 days provided unexpectedly superior results that could not be predicted from the prior art” (Reply Br. 4; see also Appeal Br. 30), Appellant failed to direct attention to an evidentiary basis to support this assertion. We are not persuaded by the unsupported assertions of Appellant’s counsel. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). Further to the extent that Appellant’s counsel’s assertion is based on the Second Guillonneau and Anegon Declarations, we are not persuaded for the reasons set for the above. 11 Carole Guillonneau Declaration, signed Mar. 7, 2019. Appeal 2020-004283 Application 15/500,615 12 For the foregoing reasons, we are not persuaded by Appellant’s contention that Examiner’s rejection is based on improper hindsight (id. at 16). For the reasons set forth above, we are not persuaded by Appellant’s contention that SantaCruz, as relied upon by Examiner, fails to make up for Appellant’s alleged deficiencies in Lazarovits (id. at 23–24). For the foregoing reasons, we are not persuaded by Appellant’s contention that Lazarovits presumptively enabled disclosure is not enabled for all that is discloses (see Reply Br. 2). See In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (“[A] prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant or patentee.”). Claim 3: Appellant’s claim 3, reproduced above, depends from and further limits Appellant’s claim 1 to require that the allogeneic transplant rejection is GVHD. As discussed above, the combination of Lazarovits and SantaCruz makes obvious the subject matter of Appellant’s claim 1. As Examiner further explains, “Lazarovits explicitly teache[s] that anti-CD45 antibodies can treat transplant rejection and graft-versus host disease, and that [Lazarovits’] antibodies . . . are indicated for the prevention of GVHD” (Ans. 11; see also FF 1–7). Appellant fails to direct our attention to an evidentiary basis on this record to support a finding that “[i]t is recognized in the art that solid organ transplantation differs from allogeneic hematopoietic stem cell Appeal 2020-004283 Application 15/500,615 13 transplantation in many aspects” and, therefore, “data related to models of solid organ transplant rejection are not transposable to the case of GVHD occurring after allogeneic hematopoietic stem cell transplantation” (Appeal Br. 24; see also id. at 25 (Appellant contends that “data related to solid organ transplant rejection are not transposable to GVHD”)). We are not persuaded by the unsupported assertions of Appellant’s counsel. See In re Pearson, 494 F.2d at 1405 (Attorney’s argument in a brief cannot take the place of evidence.”). For the reasons set forth above, with respect to Appellant’s claim 1, we are not persuaded by Appellant’s contention that Lazarovits “does not provide any experimental data with anti-CD45RC antibody” (Appeal Br. 25). See generally In re Mills, 470 F.2d at 651 (“[A] reference is not limited to the disclosure of specific working examples.”). Claim 4: Appellant’s claim 4, reproduced above, depends from and further limits Appellant’s claim 2 to require that the allogeneic transplant rejection is cardiac allotransplant rejection. Lazarovits discloses a method of treating allograft rejection, including cardiac allografts, comprising administering an immunosuppressive amount of at least one compound that binds specifically to a CD45 leukocyte antigen present on T-cells, such as an anti-CD45RC antibody, in combination with an anti-inflammatory or immunosuppressive drug, such as rapamycin (FF 1– 7; see also Ans. 11–12). Therefore, we are not persuaded by Appellant’s contention that the combination of Lazarovits and SantaCruz does not make obvious the subject matter of Appellant’s claim 4 (see Appeal Br. 26). Appeal 2020-004283 Application 15/500,615 14 Further, as discussed above, “a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d at 651. Therefore, we are not persuaded by Appellant’s contention that because Lazarovits does not exemplify the use of an anti-CD45RC antibody, in combination with an anti-inflammatory or immunosuppressive drug, such as rapamycin for the treatment of cardiac allograft rejection, the combination of Lazarovits and SantaCruz fails to make obvious such subject matter (see Appeal Br. 26). Claim 13: Appellant’s claim 13 is reproduced above. As discussed above, the combination of Lazarovits and SantaCruz makes obvious a method that comprises administering an effective amount of an anti-CD45RC antibody, which falls within the scope of Appellant’s disclosed effective amount, in combination with rapamycin to a human patient in need thereof to treat transplant rejection (see FF 1–7). As further discussed above, the combination of Lazarovits and SantaCruz makes obvious the administration regime set forth in Appellant’s claim 13 (id.). Thus, the evidence on this record supports a finding that practicing the method made obvious by the combination of Lazarovits and SantaCruz would inherently expand and/or potentiate regulatory T cells in a transplant patient by administering OX22. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious”). Appeal 2020-004283 Application 15/500,615 15 Therefore, we are not persuaded by Appellant’s contention that the combination of Lazarovits and SantaCruz fails to make obvious the subject matter of Appellant’s claim 13, because Lazarovits “is completely silent about the fact that administration of any anti-CD45 antibody, whatever the isoform, results in expanding and/or potentializing regulatory T cells” and is “even more silent about the fact that administration of an anti-CD45RC antibody results in the induction of CD8+CD45RClow regulatory T cells with a strong suppressive capacity” (Appeal Br. 29; see also Reply Br. 3–4). Claim 22: Appellant’s claim 22, reproduced above, depends from and further limits Appellant’s claim 1 to require that the administration step does not compromise immunity and capacity of the patient to mount antibody responses against cognate antigens. As discussed above, the combination of Lazarovits and SantaCruz makes obvious the subject matter of Appellant’s claim 1. As Examiner explains, Appellant’s claim 22 recites an inherent result of administering the OX22 antibody in the method made obvious by Lazarovits and SantaCruz (see Ans. 12 (Examiner finds that “the limitations of claim 22 would . . . be latent properties of the method of Lazarovits”)). See Ex parte Obiaya, 227 USPQ at 60 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious”). Therefore, we are not persuaded by Appellant’s contention that the combination of Lazarovits and SantaCruz fails to make obvious the subject matter of Appellant’s claim 22, because Lazarovits “is completely Appeal 2020-004283 Application 15/500,615 16 silent regarding the capacity of the recipients to mount antibody responses against cognate antigens” (Appeal Br. 27). Claim 23: Appellant’s claim 23, reproduced above, depends from and further limits Appellant’s claim 1 to require that the anti-CD45RC+ cell-depleting antibody mediates antibody-dependent cell mediated cytotoxicity (ADCC) and/or complement dependent cytotoxicity (CDC). As discussed above, the combination of Lazarovits and SantaCruz makes obvious the subject matter of Appellant’s claim 1. In addition, Examiner explains that the OX2 anti-CD45RC antibody “is an IgG1 isotype, which is an antibody isotype that mediates ADCC” and, thus, the ability of mediate ADCC and/or CDC “is a latent property of [the] OX22” anti- CD45RC antibody (Ans. 12). See Ex parte Obiaya, 227 USPQ at 60 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious”). Therefore, we are not persuaded by Appellant’s contention that the combination of Lazarovits and SantaCruz fails to make obvious the subject matter of Appellant’s claim 23, because Lazarovits “is completely silent regarding the mediation of ADCC or CDC” (Appeal Br. 27). Claim 27: Appellant’s claim 27, reproduced above, depends from and further limits Appellant’s claim 1 to require that the anti-CD45RC+ cell-depleting Appeal 2020-004283 Application 15/500,615 17 antibody mediates inhibition of CD45RC+ cell proliferation and/or induction of CD45RC+ apoptotic cell death. As discussed above, the combination of Lazarovits and SantaCruz makes obvious the subject matter of Appellant’s claim 1. The ability of the anti-CD45RC+ cell-depleting antibody to mediate inhibition of CD45RC+ cell proliferation and/or induction of CD45RC+ apoptotic cells death is an inherent or latent property of administering OX22 in the method made obvious by the combination of Lazarovits and SantaCruz. See Ex parte Obiaya, 227 USPQ at 60 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious”). Therefore, we are not persuaded by Appellant’s contention that the combination of Lazarovits and SantaCruz fails to make obvious the subject matter of Appellant’s claim 27, because Lazarovits “is completely silent regarding induction of apoptotic cell death, and even more regarding induction of CD45RC+ apoptotic cell death” (Appeal Br. 28). CONCLUSION The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claims 1, 3, 4, 13, 22, 23, and 27 under 35 U.S.C. § 103 as unpatentable over the combination of Lazarovits and SantaCruz is affirmed. Claims 2, 8, 15, 21, 24, and 25 are not separately argued and fall with Appellant’s claim 1. Claim 21 is not separately argued and falls with Appellant’s claim 13. Appeal 2020-004283 Application 15/500,615 18 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 8, 13, 15, 21–25, 27 103 Lazarovits, SantaCruz 1–4, 8, 13, 15, 21–25, 27 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) (2019). AFFIRMED Copy with citationCopy as parenthetical citation