Erasmus University Medical Center et al.Download PDFPatent Trials and Appeals BoardOct 1, 20212021001588 (P.T.A.B. Oct. 1, 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. 14/806,802 07/23/2015 Roger Kingdon Craig CARP0022-101-CON 2835 78905 7590 10/01/2021 Saul Ewing Arnstein & Lehr LLP (Philadelphia) Attn: Patent Docket Clerk Centre Square West 1500 Market Street, 38th Floor Philadelphia, PA 19102-2186 EXAMINER POPA, ILEANA ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 10/01/2021 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): patents@saul.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ROGER KINGDON CRAIG, FRANKLIN GERARDUS GROSVELD, RICHARD WILHELM JANSSENS, and MARINUS JOHANNES VAN HAPEREN ____________ Appeal 2021-001588 Application 14/806,8021 Technology Center 1600 ____________ Before DONALD E. ADAMS, CHRISTOPHER G. PAULRAJ, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 relating to a transgenic non- human mammal containing a heterologous lambda light chain gene locus, and/or a heterologous kappa light chain gene locus, and/or a heterologous heavy chain gene locus. Spec., Abstract. The Examiner rejected the claims on appeal on under 35 U.S.C. § 103 as obvious and on the ground of 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. According to Appellant, the real parties in interest are Erasmus University Medical Center and Roger Kindon Craig. Appeal Br. 3. Appeal 2020-001588 Application 14/806,802 2 obviousness-type, non-statutory double patenting. A hearing was held on August 10, 2021, the transcript from which has been entered into the record (“Tr.”). We affirm. STATEMENT OF THE CASE The Specification discloses that the “present invention relates to improved methods for the derivation and selection using transgenic non- human mammals of a diverse repertoire of functional, affinity-matured tetrameric immunoglobulins comprising heavy and light chains in response to antigen challenge and uses thereof.” Spec. 1. Claims 1–12 are on appeal. Claims 1 and 2 are representative and reads as follows: 1. A transgenic non-human mammal comprising a heterologous immunoglobulin heavy chain locus comprising from 18 to 39 different human VH gene segments, one or more human D gene segments, human J gene segments, and rat constant region gene segments, wherein the human VH gene segments comprise VH1-69, VH4-59, VH3-53, VH3-49, VH4- 34, VH3-48, VH3-33, VH3-30, VH3-23, VHl-18, VH3-15, VH4-39, VHl-8, VH3-07, VH2-5, VH4-4, VH1-2, and VH6-1, the human J gene segments comprise all six human J gene segments, and the rat constant region gene segments comprise at least Cμ and a Cγ. 2. A transgenic non-human mammal comprising a heterologous immunoglobulin kappa light chain locus comprising from 11 to 36 different human Vκ gene segments, human J gene segments, and a rat constant region gene segment, wherein the human Vκ gene segments comprise Vκ2-30, Vκ1- 39, Vκ2-28, Vκ1-27, Vκ3-20, Vκ3-15, Vκ3-l l, Vκ1-33, Vκ1-9, Vκ1-5, and Vκ4-l, the human J gene segments comprise all five Appeal 2020-001588 Application 14/806,802 3 human Jκ gene segments, and the constant region gene segment comprises Cκ. Appeal Br. 24. The claims stand rejected as follows: I. Claims 1 and 7–12 were rejected under 35 U.S.C. § 103(a) as obvious over the combination of Buelow,2 Jakobovits,3 and Brezinschek.4 II. Claims 1, 2, 4, and 7–12 were rejected under 35 U.S.C. § 103(a) as obvious over the combination of Buelow, Jakobovits, Brezinschek, de Wildt,5 Foster,6 and Lefranc.7 III. Claims 1–12 were rejected on the ground of non-statutory obviousness-type double patenting over claim 1 of U.S. Patent No. 9,980,470 (“the ’470 patent”) in combination with Buelow.8 2 Buelow, US Patent Publication No. 2009/0098134 A1, published Apr. 16, 2009 (“Buelow”). 3 Jakobovits et al., WO 98/24893, published June 11, 1998 (“Jakobovits”). 4 Brezinschek et al., Analysis of the Heavy Chain Repertoire of Human Peripheral B Cells Using Single-Cell Polymerase Chain Reaction, 155 J. Immunology 190–202 (1995) (“Brezinschek”). 5 De Wildt et al., Analysis of Heavy and Light Chain Pairings Indicates that Receptor Editing Shapes the Human Antibody Repertoire, 285 J. Mol. Biol. 895–901 (1999) (“de Wildt”). 6 Foster et al., Molecular Mechanisms and Selective Influences that Shape the Kappa Gene Repertoire of IgM+ B Cells, 99(7) J. Clin. Invest. 1614– 1627 (1997) (“Foster”). 7 Lefranc, Nomemclature of the Human Immunoglobulin Kappa (IGK) Genes, 18 Exp. Clin. Immunogenet 161–174 (2001) (“Lefranc”). 8 In addition to arguing the Examiner’s three rejections, Appellant asserts that the Examiner made “several procedural errors” the result of which is that “Appellants have lost about a year of patent term that cannot be recaptured.” Appeal Br. 6. Because Appellant’s contentions regarding alleged “procedural errors” made by the Examiner are petitionable, rather than appealable, issues, we decline to address these contentions on this record (see Appeal Br. 6–9; cf. 37 C.F.R. § 1.181). Appeal 2020-001588 Application 14/806,802 4 OBVIOUSNESS OVER BUELOW, JAKOBOVITS, AND BREZINSCHEK Appellant argues claims 1 and 7–12 together. Appeal Br. 9–15. We designate claim 1 as representative. Buelow discloses “transgenic animals having one or more inactivated endogenous immunoglobulin loci” and “methods for the production of humanized and fully human antibodies using such transgenic animals.” Buelow ¶ 2. In rejecting claim 1, as obvious over the combination of Buelow, Jakobovits, and Brezinschek, the Examiner found that Buelow disclosed most of the requirements of claim 1. Ans. 4. The Examiner acknowledged that “Buelow does not specifically teach using all six human J genes,” as recited in claim 1, but found that “doing so was practiced in the prior art . . . and thus, obvious to one of skill in the art.” Id. (citing Jakobovits as evidence that using all six J genes was known). The Examiner also acknowledged that “Buelow does not specifically teach the human VH genes recited in claim 1.” Id. at 5. The Examiner relied on the combination of Jakobovits and Brezinschek to address this deficiency. According to the Examiner, Jakobovits taught that “including an array of VH and Vκ gene segments leads to enhanced antibody specificity and affinity against a wide variety of antigens,” and Brezinschek taught that “human B cell[s] only utilize about 30 functional VH genes to generate the antibody repertoire, wherein the 30 genes include all human VH genes recited in the instant claim 1.” Id. at 6. Based on the combined teachings of Jakobovits and Brezinschek, the Examiner concluded that it would have been obvious to “modify Buelow by using the functional VH genes taught by Brezinschek et al. to achieve the predictable result of obtaining a transgenic rodent Appeal 2020-001588 Application 14/806,802 5 capable of generating a diversity of humanized antibodies with enhanced specificity and affinity against a wide variety of antigens.” Id. We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art with respect to this rejection and agree that the claims would have been obvious over the cited art. We address Appellant’s arguments below. Appellant argues that Brezinschek is non-analogous art and thus cannot properly be used in an obviousness rejection. Appeal Br. 10. According to Appellant, Brezinschek is not in the same field of endeavor as are the pending claims because Brezinschek “describes the analysis of the heavy chain repertoire of human B cells from a single individual” while the pending claims “are directed to transgenic animals . . . and methods of making antibodies using the same.” Id. at 11. Appellant also asserts that Brezinschek is not reasonably pertinent to the problem solved by the claimed invention – “mak[ing] human/hybrid antibodies using transgenic animals” – because it “only discusses the repertoire of a single individual . . . and cannot, represent which VH gene segments are used the most in humans.” Id. at 11–12. We are not persuaded. “To be considered within the prior art for purposes of the obviousness analysis, a reference must be analogous.” Circuit Check Inc., v. QXQ INC., 795 F.3d 1331, 1335 (Fed. Cir. 2015). Whether a prior art reference is analogous is question of fact. Id. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the Appeal 2020-001588 Application 14/806,802 6 reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). We find that Brezinschek is reasonably pertinent to the particular problem with which the inventors were involved. As stated by Appellant, the particular problem faced by the inventors was “mak[ing] human/hybrid antibodies using transgenic animals.” Appeal Br. 11. We agree with the Examiner that the ordinary artisan would have considered Brezinschek reasonably pertinent to this problem because it “disclose[s] what specific VH . . . genes could be used to obtain a transgenic animal capable of generating a human-like antibody repertoire.” Ans. 11. We are not persuaded by Appellant’s argument that Brezinschek is not pertinent because it relies on data from a single individual. Regardless of the sample size, Brezinschek is pertinent to the problem faced by the inventors. Jakobovits, a paper relating to “transgenic non-human animals that are engineered to contain human immunoglobulin gene loci” (Jakobovits, at Abstract), cites Brezinschek, further supporting its pertinence to the problem of making human/hybrid antibodies using transgenic animals (id. at 37). Appellant argues that Brezinschek “does not even describe which fragments, i.e., VH gene segments, could be used successfully in humans, much less which fragments could be used successfully in a transgenic animal.” Appeal Br. 12. We do not find this persuasive because Appellant is attacking the references individually. In re Keller, 642 F.2d 413, 426 (CCPA1981) (“[O]ne cannot show non-obviousness by attacking references individually where . . . the rejections are based on combinations of references.”). As the Examiner explains, “[b]oth Buelow and Jakobovits provide evidence that the human VH genes could be successfully used in Appeal 2020-001588 Application 14/806,802 7 transgenic animals.” Ans. 12. We agree with the Examiner that Buelow and Jakobovits support that the ordinary artisan “would have reasonably expected to be successful in obtaining transgenic animals expressing the VH genes taught by Brezinschek.” Id. Appellant argues that Jakobovits is “more pertinent” to the problem to be solved than Brezinschek. Appeal Br. 12. According to Appellant, this is significant because “10 of the [VH] segments recited in claim 1 are not listed in Table III of Jakobovits et al. as selectively used by their transgenic animals . . . and three of the segments listed in Table III of Jakobovits et al. are not recited in claim 1.” Appeal Br. 12–13. Based on this imperfect identity of VH segments, Appellant argues, “[i]n continuing to favor Brezinschek et al. over Jakobovits et al., the Examiner is clearly employing knowledge gleaned only from Appellants’ specification.” Id. at 13. Appellant does not contend that Jakobovits teaches away from the claimed VH segments (Tr. 4; Supp. Br. 3), but rather argues that the “Examiner has not explained why a person of ordinary skill in the art would have been motivated to alter what Jakobovits et al. describes in favor of what the [alleged] nonanalogous art describes.” Supp. Br. 3. We are not persuaded. As explained above, the Examiner provided persuasive reasoning why the person of ordinary skill in the art would use the VH segments disclosed in Brezinschek. See supra p. 4 (referencing Brezinschek’s teaching that human B cells utilize only about 30 VH genes, including each of the VH genes recited in claim 1, to generate an antibody repertoire and the Examiner’s reasoning that the ordinary artisan would have found it obvious to include Brezinschek’s VH genes to obtain a transgenic rodent capable of generating a Appeal 2020-001588 Application 14/806,802 8 diversity of humanized antibodies with enhanced specificity and affinity against a wide variety of antigens); Ans. 5. Appellant does not identify, and we do not find, anything in Jakobovits that discourages using the claimed VH segments. Even if we accept Appellant’s premise that Jakobovits discloses transgenic mice that use different VH genes than were identified in Brezinschek or in claim 1, Jakobovits also discloses that “the inclusion of a diverse array of genes from the VH and Vκ genome leads to enhanced antibody specificity and ultimately to enhanced antibody affinities” (Jakobovits 17) and that “XenoMouse II utilizes at least 11 out of the 37 functional VH genes present on yH2” (id. at 36–37 (emphasis added)). We agree with the Examiner that “[t]he teaching of ‘at least’ in Jakobovits suggests that the data presented [regarding VH genes] is not exhaustive and that the transgenic animal could utilize more than 11 functional VH genes.” Ans. 13. The evidence of record thus does not support a contention that the ordinary artisan would limit themselves to the VH genes identified in Jakobovits. With respect to Appellant’s argument that the Examiner’s reliance on Brezinschek constitutes hindsight, our reviewing court’s predecessor stated in In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971): Any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper. We find no evidence that the Examiner gleaned anything from Appellant’s disclosure in reaching the conclusion that claim 1 would have been obvious. It is clear from the Examiner’s discussion of the references that the Appeal 2020-001588 Application 14/806,802 9 Examiner relied only on what was known to one skilled in the art prior to the time the invention was made. Finally, Appellant argues that “none of the references cited by the Examiner disclose or suggest the recitation in claim 1 regarding the range for the number of VH gene segments to be included in the locus, i.e., from 18 to 39.” Appeal Br. 13. Appellant argues that the Examiner incorrectly relied on the disclosure of a single point within the claimed range – Brezinschek’s disclosure of 30 VH segments – as rendering this limitation obvious. Id. at 14. Appellant analogizes obviousness to anticipation arguing that “[i]f a rejection for anticipation of a claimed range is defeated when all other claim limitations are not met in a single reference, a rejection for obviousness must be as well, especially one relying upon more than one reference.” Reply Br. 6. We are not persuaded. Brezinschek discloses that the human B cells from one donor use 30 VH segments. Brezinschek 196, Table 5. This value falls within the claimed range of “18–39 different human VH segments.” Jakobovits and Buelow also disclose ranges that overlap with the claimed range. Jakobovits 6 (“In another preferred embodiment, the number of VH genes is greater than about 20”); Buelow ¶ 184 (“Preferably, the V-region includes at least about 5–100 human heavy V (or VH) gene segments.”). Each of these disclosures creates a prima facie case of obviousness that Appellant has not rebutted. In re Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003) (“[T]he existence of overlapping or encompassing ranges shifts the burden to the applicant to show that his invention would not have been obvious.”); Tr. 6–8. Appeal 2020-001588 Application 14/806,802 10 Accordingly, we affirm the Examiner’s rejection of claim 1 as obvious over the combination of Buelow, Jakobovits, and Brezinschek. Because they were not argued separately, claims 7–12 fall with claim 1. OBVIOUSNESS OVER BUELOW, JAKOBOVITS, BREZINSCHEK, DE WILDT, AND FOSTER Claims 1, 4, 11, and 12 Appellant argues claims 1, 4, and 11–12 together. In rejecting these claims, the Examiner applied Buelow, Jakobovits and Brezinschek as discussed in connection with the Examiner’s first rejection. Ans. 6. Appellant does not offer any new arguments as to why these claims are non- obvious in connection with this ground of rejection. Appeal Br. 15. Accordingly, we affirm the Examiner’s rejection of claims 1, 4, 11, and 12 over the combination of Buelow, Jakobovits, Brezinschek, de Wildt, and Foster for the reasons discussed above. Claims 2 and 7–12 Appellant argues claims 2 and 7–12 together. We designate claim 2 as representative. In rejecting claim 2 the Examiner applied Buelow, Jakobovits, and Brezinschek, as discussed above. Ans. 6. The Examiner acknowledged, however, that Buelow, Jakobovits, and Brezinschek “do not specifically teach the Vκ genes recited in claim[] 2.” Id. To address this deficiency, the Examiner relied upon de Wildt, and Foster. The Examiner found that de Wildt taught that “A17, O12, A19, A20, A27, L2, L6, O18, L8, L12, and B3 are among the most productively rearranged Vκ genes” and that Foster taught that “30 Vκ genes (including A17, O12, A19, A20, A27, L2, L6, O18, L8, L12, and B3) are productively rearranged to produce the human antibody repertoire.” Id. The Examiner further found that Foster taught that Appeal 2020-001588 Application 14/806,802 11 “only the productively arranged genes are translated into functional proteins.” Id. Based on these teachings, the Examiner concluded that the ordinary artisan would have understood that “only the productively-arranged genes are needed to generate antibodies.” Id. The Examiner then determined that it would have been obvious to “modify the teachings of Buelow, Jakobovit[s] et al., and Brezinschek et al. by using the functional human Vκ genes taught by de Wildt et al. and Foster et al. to achieve the predictable result of obtaining a transgenic rodent capable of generating a diversity of antibodies with enhanced specificity.” Id. at 6–7. We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art with respect to this rejection and agree that the claims would have been obvious over the cited art. We address Appellant’s arguments below. Appellant argues that de Wildt and Foster are non-analogous art and thus cannot properly be used in an obviousness rejection. Appeal Br. 16. According to Appellant, neither de Wildt nor Foster is in the same field of endeavor as are the pending claims. Appellant characterizes de Wildt as “describe[ing] VH and VL chain pairings in 365 human B cells from peripheral blood from three donors” and Foster as “describ[ing] the analysis of the human kappa repertoire using peripheral mononuclear cells from two donors.” Id. Appellant asserts that these are different fields than the pending claims, which are directed to transgenic animals and methods of making antibodies using the same. Appellant also argues that neither de Wildt nor Foster are reasonably pertinent to the problem solved by the invention. Appellant asserts that de Wildt and Foster “do not even describe which Vκ gene segments could be Appeal 2020-001588 Application 14/806,802 12 used successfully in humans, much less which gene segments could be used successfully in a transgenic animal.” Id. at 17. According to Appellant, because de Wildt and Foster “discuss the repertoire of three and two individuals . . . [t]hey do not, and cannot represent which Vκ gene segments are used the most in humans.” Id. Thus, Appellant argues, de Wildt and Foster “are not reasonably pertinent to the problem to be solved.” Id. We are not persuaded. We find that both de Wildt and Foster are reasonably pertinent to the particular problem with which the inventors were involved. As stated by Appellant, the particular problem faced by the inventors was “mak[ing] human/hybrid antibodies using transgenic animals.” Appeal Br. 11. We agree with the Examiner that the ordinary artisan would have considered de Wildt and Foster reasonably pertinent to this problem because they “disclose[s] what specific . . . Vκ genes could be used to obtain a transgenic animal capable of generating a human-like antibody repertoire.” Ans. 11. As to Appellant’s argument that de Wildt and Foster are not pertinent because they rely on data derived from a limited number of donors, we are not persuaded because, regardless of the sample size, de Wildt and Foster are still pertinent to the problem being solved. As to Appellant’s argument that de Wildt and Foster do not teach “which gene segments could be used successfully in a transgenic animal” (Appeal Br. 17), we are not persuaded because Appellant is attacking the references individually. In re Keller, 642 F.2d at 426. As the Examiner explains, “[b]oth Buelow and Jakobovits provide evidence that the human Vκ genes could be successfully used in transgenic animals.” Ans. 16. We agree with the Examiner that Buelow and Jakobovits support that the Appeal 2020-001588 Application 14/806,802 13 ordinary artisan “would have reasonably expected to be successful in obtaining transgenic animals expressing the Vκ genes taught by de Wildt and Foster” Id. Appellant argues that Jakobovits is “more pertinent” to the problem to be solved than de Wildt and Foster. Appeal Br. 17. According to Appellant, this is significant because “Table IV of Jakobovits at al. lists the human Vκ gene segments (8) used by their transgenic mice” and “[s]ix of the segments recited in claim[] 2 . . . are not included in this list” and “three of the segments included in this list are not recited in claim[] 2.” Id. Based on this imperfect identity of Vκ segments, Appellant argues, “[i]n continuing to favor de Wildt et al. and Foster et al over Jakobovits et al, the Examiner is clearly employing knowledge gleaned only from Appellants’ specification.” Id. at 13. Appellant does not contend that Jakobovits teaches away from the claim Vκ segments (Tr. 4; Supp. Br. 3), but rather argues that the “Examiner has not explained why a person of ordinary skill in the art would have been motivated to alter what Jakobovits et al. describes in favor of what the nonanalogous art describes.” Supp. Br. 3. We are not persuaded. As explained above, the Examiner provided persuasive reasoning why the person of ordinary skill in the art would use the Vκ segments disclosed in de Wildt and Foster. See supra p. 10–11 (referencing de Wildt’s and Foster’s teachings identifying “the most productively rearranged Vκ genes” and the Examiner’s reasoning that the ordinary artisan would have found it obvious to include the functional human Vκ genes taught by de Wildt and Foster to obtain a transgenic rodent capable of generating a diversity of humanized antibodies with enhanced specificity and affinity against a wide variety of antigens); Ans. 6–7. Appeal 2020-001588 Application 14/806,802 14 Appellant does not identify, and we do not find, anything in Jakobovits that discourages using the claimed Vκ segments. Even if we accept Appellant’s premise that Jakobovits discloses transgenic mice that use different Vκ genes than were identified in de Wildt, Foster and/or claim 1, Jakobovits also discloses that “the inclusion of a diverse array of genes from the VH and Vκ genome leads to enhanced antibody specificity and ultimately to enhanced antibody affinities” (Jakobovits 17) and, as the Examiner points out, “[t]here is nothing in Jakobovit[s] teaching or even suggesting against using more than the disclosed 8 Vκ genes to generate a human-like antibody repertoire.” Ans. 17. The evidence of record thus does not support a contention that the ordinary artisan would limit themselves to the Vκ genes identified in Jakobovits. With respect to Appellant’s argument that the Examiner’s reliance on de Wildt and Foster constitutes hindsight, we find no evidence that the Examiner gleaned anything from Appellant’s disclosure in reaching the conclusion that claim 1 would have been obvious. It is clear from the Examiner’s discussion of the references that the Examiner relied only on what was known to one skilled in the art prior to the time the invention was made. Finally, Appellant argues that “none of the references disclose the range regarding the number of Vκ gene segments recited in claim[] 2 . . . , i.e., from 11 to 36.” Appeal Br. 18. Appellant does not dispute that de Wildt and Foster disclose the Vκ segments recited in claim 2, but argues that the Examiner incorrectly relied on the disclosure of a single point within the claimed range – de Wildt’s and Foster’s disclosure of 30 Vκ segments – as rendering this limitation obvious. Reply Br. 6. Appellant argues that “[i]f Appeal 2020-001588 Application 14/806,802 15 all the other claim limitations are not met in a single reference, a single point within a range cannot defeat the patentability of the claimed range, under either anticipation or obviousness.” Reply Br. 6–7. We are not persuaded because, as discussed above, these disclosures create a prima facie case of obviousness that Appellant’s have not rebutted. In re Peterson, 315 F.3d at 1329-30; Tr. 6–8. Accordingly, we affirm the Examiner’s rejection of claim 2 as obvious over the combination of Buelow, Jakobovits, Brezinschek, de Wildt, Foster, and Lefranc. Because they were not argued separately, claims 7–10 fall with claim 2. DOUBLE PATENTING The Examiner rejected claims 1–12 on the ground of non-statutory obviousness-type double patenting over claim 1 of the ’470 patent in view of Buelow. The ’470 patent includes a single claim. It reads: 1. A transgenic non-human mammal comprising an immunoglobulin kappa light chain locus comprising the sequence of SEQ ID NO:2, wherein the transgenic mammal is capable of expressing the Ig kappa chain encoded by SEQ ID NO:2 in response to an antigen challenge, wherein said locus is randomly integrated into the genome of said transgenic mammal. ’470 patent, 327:20–328:21. The Examiner finds that “SEQ ID NO:2 recited in the [reference] patent claim comprises the Vκ, J and C segments recited in the instant claims 2 and 4.” Ans. 8. The Examiner further finds that the specification of the ’470 patent discloses that “the transgenic animal also comprises the segments recited in the instant claims 1, 3, 5, and 6.” Id. Appeal 2020-001588 Application 14/806,802 16 We adopt the Examiner’s findings of fact and reasoning regarding this rejection and agree that the claims would have been obvious over the ’470 patent and Buelow. We address Appellant’s arguments below. Appellant argues that the ’470 patent is not a proper reference patent with respect to the current application. Appeal Br. 19–20. Although the ’470 patent issued before the present application, it was filed after the pending application and received a 736 day patent extension, giving it an expiration date in March of 2036. Id. at 19. According to Appellant, “the expiration date of any patent to issue from the present application, without any term adjustment added, is November 30, 2029 . . . almost seven years earlier than the expiration date of the ’470 patent.” Id. Appellant acknowledges that the present application may be “eligible for some patent term adjustment,” but argues that it is “unlikely” that adjustment would “be over six years.” Id. at 19–20. Thus, according to Appellant, “the present application could be a reference against the ’470 patent once it issues,” but not vice versa. Id. at 20. We do not find this argument persuasive because Appellant fails to direct us to evidence that if the currently pending claims issue, their term will necessarily expire before the terms of the ’470 patent. Indeed, in arguing only that it is “unlikely” that any patent term adjustment would cause any patent issued from the pending claims to expire after the ’470 patent, Appellant effectively concedes some degree of uncertainty regarding the term of any patent that would issue from the present application. Thus, we decline to speculate on what the term of a patent issued from this application would be. Furthermore, Appellant does not direct us to a requirement in the Appeal 2020-001588 Application 14/806,802 17 MPEP or elsewhere for an examiner to make a patent term assessment before issuing an obviousness-type double-patenting rejection and we are not aware of any such requirement. Thus, we are not persuaded by Appellant’s contentions to the contrary. Claim 2 and 7–10 Appellant concedes that SEQ ID NO:2 recited in claim 1 of the ’470 patent comprises the Vκ, J, and C segments recited in claim 2. Appeal Br. 21. Claim 2 is also a base claim for claims 7–10, each of which depends from “any one of claim 1–3.” Appellant does not offer any additional arguments as to why the Examiner’s rejection of claims 2 and 7–10 is in error beyond arguing that the ’470 patent is not a proper reference patent with respect to the current application. Id. Accordingly, we affirm the Examiner’s rejection of claim 2 and 7–10 on the ground of non-statutory, obviousness-type double patenting over the combination the ’470 patent and Buelow. Claims 1, 3–6, 11, and 12 Appellant argues that the Examiner inappropriately relied on the specification of the ’470 patent to identify certain limitations of claims 1, 3– 6, 11, and 12. Id. at 22. We are not persuaded. The Examiner explains that the reference claim is a genus claim and that she relied upon the specification of the ’470 patent to identify species encompassed by that genus. Ans. 18. We agree that the Examiner’s reliance on the specification of the ’470 patent was appropriate. See MPEP 804 II(B)(2)(a) (“If the reference patent includes a disclosure of several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to determine whether the reference patent claim, as Appeal 2020-001588 Application 14/806,802 18 properly construed in light of that disclosure, anticipates or renders obvious the claim in the application being examined.”); see also In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1375 (Fed. Cir. 2008) (In the context of an obviousness-type double-patenting rejection, a patent’s disclosure may be used to determine whether a claim “merely define[s] an obvious variation of what is earlier disclosed and claimed,” “to learn the meaning of [claim] terms,” and to “interpret [ ] the coverage of [a] claim.”). Appellant argues that claim 1 of the ’470 patent “recites a transgenic animal having a Vκ transgenic locus of a specific sequence” and thus “cannot . . . represent a genus claim for a Vκ locus.” Reply Br. 9. We agree that claim 1 of the ’470 recites a specific sequence. But claim 1 is a “comprising” claim drawn broadly to a “transgenic non-human mammal.” ’470 patent, 327:20. Accordingly, claim 1 encompasses a genus of transgenic non-human mammals including additional gene sequences beyond the single sequence recited in claim 1. The Examiner thus did not err in turning to the specification to identify species of transgenic non- human mammals encompassed within claim 1. See In re Schneller, 397 F.2d 350 (C.C.P.A. 1968) (affirming double patenting rejection of claim directed to elements A, B, C, and Y over reference patent claiming elements A, B, C, and X, explaining that appellant’s argument was “flawed” in assuming that “the [reference] patent claims cover only ABCX” given that the reference claims were comprising claims that encompassed AXCXY). Accordingly, we affirm the Examiner’s rejection of claims 1, 3–6, 11, and 12 on the ground of non-statutory, obviousness-type double patenting over the combination the ’470 patent and Buelow. Appeal 2020-001588 Application 14/806,802 19 CONCLUSION In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 7–12 103(a) Buelow, Jakobovits, Brezinschek 1, 7–12 1, 2, 4, 7–12 103(a) Buelow, Brezinschek, Foster, Lefranc 1, 2, 4, 7–12 1–12 Obviousness-type double patenting over U.S. Patent No. 9,980,470 and Buelow 1–12 Overall Outcome 1–12 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 Copy with citationCopy as parenthetical citation