CUREVAC GMBH

Patent Trials and Appeals Board

Jan 24, 2022

2021004269 (P.T.A.B. Jan. 24, 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. 13/709,897 12/10/2012 Ingmar HOERR CRVC.P0048US.C1 3067 174917 7590 01/24/2022 Parker Highlander PLLC 1120 South Capital of Texas Highway Bldg. 1, Suite 200 Austin, TX 78746 EXAMINER BURKHART, MICHAEL D ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 01/24/2022 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): docket@phiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte INGMAR HOERR, JOCHEN PROBST, and STEVE PASCOLO Appeal 2021-004269 Application 13/709,897 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 38-40, 46-48, 50, 52, 61, 62, 64-66, 72, 73, and 77-83.2 We have jurisdiction under 35 U.S.C. § 6(b).3 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as CureVac AG. Appeal Br. 3. 2 Claims 41-45, 53, 55-60, 63, and 67-71 are pending in the application but have been withdrawn from consideration. Final Act. 1. 3 Oral Arguments in this Appeal were heard on January 14, 2022. A copy of the hearing transcript will be made part of the record when it becomes available. Appeal 2021-004269 Application 13/709,897 2 We AFFIRM. CLAIMED SUBJECT MATTER The invention relates to an antibody-coding, non-modified or modified RNA and the use of the antibody for the treatment of tumors and cancer diseases, cardiovascular diseases, infectious diseases, auto-immune diseases, viral diseases as well as gene therapy. Spec. 1. Claim 38, reproduced below, is illustrative of the claimed subject matter: 38. A method of treating a tumour [sic] disease, genetic disease, neuronal disease, allergy, cancer disease, cardiovascular disease, infectious disease or autoimmune disease, the method comprising administering a pharmaceutical composition, the pharmaceutical composition comprising purified RNA molecules for intracellular expression of an antibody, wherein the RNA molecules code for (i) a first polypeptide comprising the variable domain heavy chain (VH) of an antibody; and (ii) a second polypeptide comprising the variable domain light chain (VL) of an antibody. Appeal 2021-004269 Application 13/709,897 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Carter et al. US 5,821,337 Oct. 13, 1998 Hoerr et al. US 2008/0025944 A1 Jan. 31, 2008 Lloyd et al., Oligonucleotide analysis by anion exchange HPLC, 2 Bioseparation 207 (1991) Azarani et al., RNA analysis by ion-pair reverse-phase high performance liquid chromatography, 29 Nucleic Acids Research 2 (2001) Noel et al., High In Vivo Production of a Model Monoclonal Antibody on Adenoviral Gene Transfer, 13 Human Gene Therapy 1483 (2002) Tjelle et al., Monoclonal Antibodies Produced by Muscle after Plasmid Injection and Electroporation, 9 Molecular Therapy 328 (2004) Albrecht et al., Recombinant Antibodies: From the Laboratory to the Clinic, 21 Cancer Biotherapy and Radiopharmaceuticals 285 (2006) REJECTIONS The Examiner has rejected the claims as follows: Claims 38-40, 46-48, 50, 52, 61, 62, 64, 65, 72, 73, 77-79, and 82 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Albrecht in view of Tjelle, Noel, Hoerr, and Carter. Claims 80, 81, and 83 have been rejected under 35 U.S.C. § 103(a) as unpatentable over Albrecht in view of Tjelle, Noel, Hoerr, and Carter in further view of Azarani and Lloyd. Claims 38, 39, 46-48, 50, 52, 61, 62, 64-66, 72, 73, and 77-83 have been rejected under 35 U.S.C. § 112, first paragraph, for lack of enablement. Claims 77 and 78 have been rejected for statutory “same invention” double patenting. Claims 38-40, 46-48, 50, 52, 61, 62, 64-66, 72, 73, and 77-83 have been rejected on the ground of non-statutory obviousness-type double Appeal 2021-004269 Application 13/709,897 4 patenting as being unpatentable over claims 1, 4, 9, 13-16, 18, 26, 28, 38, 40, 41, 44, 45 of co-pending Application No. 12/522,214. Claims 38-40, 46-48, 50, 52, 61, 62, 64-66, 72, 73, and 77-81 have been rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 4, 6-13, 15-20, 22, and 23 of co-pending Application No. 15/015,657. OPINION First Obviousness Rejection Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 38-40, 46-48, 50, 52, 61, 62, 64, 65, 72, 73, 77-79, and 82 would have been obvious to one of ordinary skill in the art at the time the invention was made over Albrecht combined with Tjelle, Noel, Hoerr, and Carter. The Examiner finds that Albrecht teaches that recombinant antibodies such as trastuzumab have been expressed in both prokaryote and eukaryotes as well as their use in various therapies such as the treatment of breast cancer. Ans. 3-4. The Examiner finds that Albrecht teaches that the structure of antibodies requires both VH and VL chains. Id. at 4. The Examiner finds Tjelle teaches long term expression of antibodies following injection of plasmid DNA encoding for the antibodies. Id. The Examiner finds Noel teaches in vivo expression of antibodies via gene transfer using adenoviral vectors. Id. The Examiner finds Hoerr teaches “administration of at least one mRNA containing a region which codes for at least one antigen of a tumor Appeal 2021-004269 Application 13/709,897 5 antigen, wherein the mRNA sequences have an increased G/C content compared to the wild-type mRNAs.” The Examiner finds Instant SEQ ID NO: 15 is a G/C optimized sequence for the trastuzumab monoclonal antibody. The relevant sequences for trastuzumab are taught by Carter et al (5,821,337). Given the teachings of Hoerr and Albrecht et al above, G/C optimization of the trastuzumab sequence would have been an obvious route to efficient expression of an anti-cancer antibody. Id. The Examiner concludes: The claimed methods are essentially disclosed by Albrecht, Tjelle and Noel et al with the exception of the mRNA and SEQ ID NO: 15 limitations. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of the prior art to use a mRNA for in vivo expression of a therapeutic antibody, such as trastuzumab, in view of the cited prior. One would have been motivated to do so with a reasonable expectation of success because Noel and Tjelle et al have shown that in vivo expression of antibodies from DNA vectors is efficient and long-term. Further, Albrecht and Carter et al teach the many applications and efficacy of using monoclonal antibodies for therapy of, e.g., breast cancer. One skilled in the art would consider that modified mRNA is a good alternative for in vivo production of recombinant therapeutic antibodies and has advantages for the in vivo expression of therapeutic antibodies given the teachings of Hoerr et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of appellants' invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention. Further, it would have been obvious to one of ordinary skill in the art to have substituted the mRNA expression systems of Hoerr et al for the DNA-based systems taught by Appeal 2021-004269 Application 13/709,897 6 Tjelle and Noel et al. The substitution of one known element (mRNA antigen or protein expression) for another (DNA-based expression) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the mRNA methods of Hoerr et al would have yielded predictable results, namely, in vivo expression of antibodies. Id. at 5-6. Appellant contends that one skilled in the art would not have been motivated to combine the teachings of the references to produce the claims invention nor would they have had a reasonable expectation of success in doing so. Appeal Br. 4. In support of this contention Appellant points to the Declaration of Dr. George Georgiou.4 Citing Dr. Georgiou, Appellant contends there is no teaching in the art to suggest using mRNA to express antibodies for therapeutic purposes. Id. Appellant contends that Tjelle and Noel actually teach away from the invention in that they both teach that antibodies are rapidly removed from circulation. Id. at 5. Appellant contends that both Tjelle and Noel teach that long term expression of antibodies is desirable and that one skilled in the art would understand that RNA-expressed method would produce transient, short term expression. Id. at 6. Appellant contends that one skilled in the art would have been dissuaded from using antibody-based therapies because of the potential for anti-idiotype immune response which could adversely affect the efficacy of the antibodies. Id. Appellant contends this would lead one skilled in the art away from applying the teachings of Hoerr which are designed to invoke an immune response. 4 Second Declaration of George Georgiou Under 37 C.F.R. § 1.132, filed August 5, 2019. (“Georgiou Decl.”). Appeal 2021-004269 Application 13/709,897 7 Appellant also contends that one skilled in the art would not have been motivated to use mRNA to produce antibodies as there is no teaching in the references that the mRNA could achieve a sufficiently high level of expression to be therapeutically effective. Id. at 8. Appellant contends that the various challenges associated with using antibodies and the use of mRNA to produce antibodies would have deterred one skilled in the art from the approach taught in the instant Specification and recited in the claims. Id. at 9-11. Appellant also contends that there is evidence of unexpected results sufficient to rebut the Examiner’s prima facie case of obviousness. Id. at 12. In support of the contention, Appellant cites to the Declaration of Dr. Hoerr.5 Appellant contends that the experiment reported by Dr. Hoerr showed that mRNA could produce significant amounts of antibodies while reducing the production of anti-drug antibodies. Id. at 13. Appellant contends that this result was both surprising and unexpected. Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions as set out in the Final Office Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been obvious over Albrecht combined with Tjelle, Noel, Hoerr, and Carter to a person of ordinary skill in the art at the time the invention was made. Appellant has not produced persuasive evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. 5 Declaration under 37 C.F.R. 1.132, filed July 22, 2016. (“Hoerr Decl.”). Appeal 2021-004269 Application 13/709,897 8 Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 38 as representative; therefore, all claims fall with claim 38. We address Appellant’s arguments below. Appellant contends that the references cited by the Examiner would not have led one skilled in the art to the present invention and that one skilled in the art would not have been motivated to create the claimed invention. Appeal Br. 4-5. Appellant supports these arguments with the Declaration of Dr. Georgiou. Id. Dr. Georgiou opines that even considering the additional cited references [Tjelle and Noel], there remains no teaching in any of the art that suggests attempting to therapeutically express antibody polypeptides from an administered mRNA. In fact, if anything the additional Tjelle et al. and Noel et al. references teach away from the use of mRNA-based expression methods. Georgiou Decl. ¶ 5. Dr. Georgiou goes on to testify that both Tjelle and Noel teach that it is desirable for the therapeutic antibodies to be expressed over a prolonged period of time and that it was known that mRNA expression was only transient deterring one skilled in the art from using mRNA to produce antibodies in vivo. Id. Dr. Georgiou also testifies that Tjelle and Noel teach that an issue with antibody-based therapies is the anti-idiotype immune response to the administered antibodies which can adversely affect the therapeutic effect of the antibodies. Id. ¶ 6. Dr. Georgiou testifies that given this teaching against stimulating an immune response, one skilled in the art would not look to the teachings of Hoerr which is expressly directed to stimulating an immune response. Id. Appeal 2021-004269 Application 13/709,897 9 We have considered Appellant’s argument and the testimony of Dr. Georgiou and are not convinced that the rejection is in error. While we agree that none of the references exemplifies the use of mRNA to produce antibodies in vivo, we agree with the Examiner that given the combined teachings of the references, one skilled in the art would have been led to use mRNA to produce therapeutic antibodies in vivo. Ans. 5-6. We do not agree with Appellant’s contention Noel and Tjelle teach away from the use of mRNA to produce antibodies in vivo. Appeal Br. 5. Appellant argues that both Noel and Tjelle teach the need for the antibodies to persist for a long period and that mRNA has only a transient effect. Id. Dr. Georgiou testified that this would discourage one skilled in the art from using mRNA to produce antibodies in vivo. We begin by noting that while Dr. Georgiou testified that mRNA would have a transient effect, Dr. Georgiou offers no evidence to support this opinion. See In re Beattie, 974 F.2d 1309, 1313 (Fed. Cir. 1992) (opinion evidence in declarations has little value without factual support). In addition, claim 38 only calls from administering purified mRNA, it does not recited any limit on how often the mRNA should be administered nor does it recited any duration for the treatment. See Appeal Br. 19 (Claims Appx). Thus Appellant is arguing a limitation that is not in the claims. In re Self, 671 F.2d 1344, 1348 (CCPA 1982). Moreover, as the Examiner points out, Hoerr teaches a means to avoid mRNA degradation and alleviate the unwanted side effects of DNA-based method. Ans. 15. Appeal 2021-004269 Application 13/709,897 10 Dr. Georgiou also testified that the potential for anti-idiotype responses adversely impacting the effectiveness of antibody-based therapies would dissuade one skilled in the art from using mRNA to produce antibodies in vivo. Georgiou Decl. ¶ 6. We are not persuaded by this argument. While both Tjelle and Noel mention the issue, both references teach that the approaches used in each case lead to little or no anti-idiotype response and where there was a response, it had no effect on the activity of the antibodies produced. See Tjelle 334; Noel, Abst. In addition, as the Examiner points out, the potential for an anti-idiotype response has not deterred the development of numerous antibody based therapies. Ans. 15. Appellant also contends that Hoerr is directed to the production of antigens and not antibodies. Appeal Br. 7-8. Appellant contends that while they are both polypeptides, there are differences in how they are used therapeutically. Id. Appellant contends that the teachings regarding antigens would not lead one skilled in the art to select mRNA as a vehicle to produce a therapeutic amount of antibodies in vivo. Id. Again, we are not persuaded by this argument or Dr. Georgiou’s testimony on this point. Hoerr teaches the production of antigens, polypeptides, in vivo for therapeutic purposes. Hoerr, Abst. Albrecht and Carter teach that antibodies, also polypeptides, can be used therapeutically against certain diseases. See generally Albrecht; Carter, col. 1, ll. 13-15. Noel and Tjelle also teach that therapeutically effective amount of antibodies can be produced in vivo using DNA that is then necessarily expressed as mRNA that is translated into the antibody proteins. Tjelle, Abst.; Noel, Abst. Based on the teachings of the references, we agree with the Examiner that it Appeal 2021-004269 Application 13/709,897 11 would have been obvious to one skilled in the art to adapt the method of Hoerr to produce antibodies in vivo. Ans. 5-6. Appellant contends that there is evidence of unexpected results sufficient to overcome the Examiner’s prima facie case of obviousness. Appeal Br. 12-14. In particular Appellant points to the experiments reported in Dr. Hoerr’s Declaration where it shows a very low level of anti-drug antibodies when mRNA is used to generate antibodies as compare to when DNA id used to generate antibodies. Id. Dr. Hoerr testified that these results were surprising and unexpected. Id.; Hoerr Decl. 14. We have considered Appellant’s argument and the evidence offered by Dr. Hoerr, and we are not persuaded that the evidence is sufficient to overcome a finding of obviousness. We begin by noting that the evidence offered only relates to a single antibody, a smallpox antibody. Hoerr Decl. ¶ 10. Claim 38 is directed to a broad class of antibodies. Thus the evidence is not commensurate with the scope of the claims. “The evidence presented to rebut a prima facie case of obviousness must be commensurate in scope with the claims to which it pertains.” In re Dill, 604 F.2d 1356, 1361 (CCPA 1979). Moreover, the claims do not recite any limitation relating to the reduced production of antibodies. Conclusion Based on the foregoing we conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 38-40, 46-48, 50, 52, 61, 62, 64, 65, 72, 73, 77-79, and 82 would have been obvious to one of ordinary skill in the art at the time the invention was made over Albrecht combined with Tjelle, Noel, Hoerr, and Carter. Appeal 2021-004269 Application 13/709,897 12 Second Obviousness Rejection Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 80, 81,6 and 83 would have been obvious to one of ordinary skill in the art at the time the invention was made over Albrecht combined with Tjelle, Noel, Hoerr, Carter, Azarani, and Lloyd. The Examiner reiterates the findings regarding the teachings of Albrecht, Tjelle, Noel, Hoerr, and Carter. Ans. 6. The Examiner finds that these references do not teach purification of mRNA via reverse phase chromatography. Id. The Examiner finds Azarani teaches purification of mRNA via Ion- pair reverse-phase high performance liquid chromatography. Id. The Examiner finds Lloyd teaches the use of reverse phase chromatography for analysis and purification of oligonucleotides. Id. at 6-7. The Examiner concludes The claimed methods are essentially disclosed by Albrecht, Tjelle, Hoerr, Carter and Noel et al with the exception of the reverse phase chromatography limitation. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of the prior art to use the IP RP HPLC methodology for mRNA purification in view of the cited prior art. One would have been motivated to do so with a reasonable expectation of success because Azarani and Lloyd et al have shown that IP RP HPLS is an efficacious means for purifying mRNA, taught by 6 We note that Appellant’s claim 81 depends from itself. For this Appeal, we interpret Appellant’s claim 81 as depending from claim 82. In the event of further prosecution, we encourage Examiner and Appellant to work together to clarify the dependency of Appellant’s claim 81. Appeal 2021-004269 Application 13/709,897 13 Hoerr et al to be a step in the use of such mRNA in vivo. Further, it would have been obvious to one of ordinary skill in the art to have substituted the IP RP HPLC or PLRP-S for the anion exchange chromatography taught by Hoerr et al. The substitution of one known method mRNA chromatography for another would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the IP RP HPLC or PLRP-S would have yielded predictable results, namely, mRNA purified sufficiently for in vivo use. Id. at 7. Appellant reiterates the arguments presented with respect to the teachings of Albrecht, Tjelle, Noel, Hoerr, and Carter. Appeal Br. 15. Appellant also contends that neither Azarani nor Lloyd teach purification of relatively large mRNA molecules such that they could be formulated into a pharmaceutically acceptable composition. Id. Appellant further contends that there is evidence of unexpected results sufficient to support a finding of non-obviousness. Id. Appellant points to the Declaration of Dr. Theß7, which reports the results of a series of experiments using various techniques to purify mRNA. Id. Analysis We have considered the arguments presented by the Examiner and Appellant and conclude that the Examiner’s determination with respect to the patentability of claims 81 and 83 is correct however, we find that the evidence of record supports the patentability of claim 80. As the Examiner points out, Hoerr teaches the purification of mRNA using chromatography and Azarani and Lloyd teach the use of reverse phase chromatography to purify RNA. Ans. 6-7. Thus, we agree with the 7 Declaration of Andreas Theß Under 37 C.F.R. § 1.132, filed March 4, 2020. (“Theß Decl.”) Appeal 2021-004269 Application 13/709,897 14 Examiner that the use of chromatography generally would have been obvious. While the data in the Theß declaration shows improved antibody expression for all the different purification techniques, only the data for Reverse Phased Chromatography shows a significant and unexpected improvement versus the other techniques that is commensurate with the claimed scope. Theß Decl. Fig. 4. Thus while we agree there is evidence of unexpected results sufficient to demonstrate patentability, that finding is only applicable to claim 80 which refers to reverse phase chromatography. We therefore affirm the rejection of claims 81 and 83 and reverse the rejection of claim 80. Enablement The issue with respect to this rejection is whether the Examiner properly determined that the Specification does not enable one skilled in the art to practice the invention commensurate with the scope of the claims. The Examiner finds that the Specification is enabling for the use of recombinant antibodies to treat cancer, but there is inadequate disclosure to enable one skilled in the art to apply the technology to the treatment of the other disorders recite in claim 38. Ans. 8-9. Specifically, the Examiner finds there is no evidence that the method contemplated would actually produce any tangible results, particularly in diseases not based on antigen expression or for which efficacious antibodies are not known in the art (e.g. bacterial and viral infections, uncharacterized tumors, Alzheimer's disease, etc.). Thus, in order to make and use the invention as claimed, the skilled artisan would have to further develop the methods and reagents (e.g. novel antibodies) capable of functioning in the wide variety of diseases recited in the claims. Appeal 2021-004269 Application 13/709,897 15 Id. at 9. The Examiner also finds Although the level of skill in the art of using antibodies for the treatment of cancer is high, the level of skill in the art of using such antibodies for the treatment of any other disease is low. One of skill in the art would not be able to make and use mRNA-encoded antibodies operable in the treatment of any known disease given no more than the teachings available at the time of filing without undue experimentation. The art of record does not provide a single working example of treating a disease, other than cancer, using a DNA or RNA-encoded antibody. Likewise, all of the teachings in the instant application are specifically directed to expressing antibodies in vivo, with additional prophetic statements suggesting how such antibodies might be further developed for treatment methods. Given the broad scope of the claims, the early developmental stage and the unpredictability of the art at the time of filing, making embodiments of the claimed invention that are operative in diseases other than cancer would clearly require undue experimentation. Therefore, the claims are properly rejected under 35 USC 112, first paragraph, as lacking enablement. Id. at 10. Appellant contends Appellants have demonstrated that, when administered as a RNA, antibodies can be effectively and efficiently expressed. In view of this, a skilled worker would immediately have recognized that any condition treatable with an antibody (administered as a polypeptide) would now be treatable by mRNA administration. Given that a wide range of conditions were known to be treatable by antibody administration, a skilled worker would indeed have recognized that the full scope of the claims as presented are enabled by the disclosure of the application. Appeal Br. 17. We have considered the arguments presented by the Examiner and Appellant and find the Examiner has the better position. Claim 38 as drafted Appeal 2021-004269 Application 13/709,897 16 covers the use of mRNA encoding for antibodies to treat a broad range of diseases and disorders including “a tumour [sic] disease, genetic disease, neuronal disease, allergy, cancer disease, cardiovascular disease, infectious disease or autoimmune disease.” Appeal Br. 19. (Claims App.). As the Examiner points out, this list of diseases and disorders includes those that do not involve an antigen/antibody interaction or where antibodies are not known to be efficacious. Ans. 9. Determining if an antibody might work for those disorders and applying mRNA to produce such antibodies would involve undue experimentation. We therefore affirm the rejection for lack of enablement. Double Patenting Claim 8 has been provisionally rejected for same invention patenting under 35 U.S.C. § 101 over claim 77. The Examiner finds that claim 78 is a duplicate of claim 77. Ans. 11. Appellant has not addressed this rejection on appeal. See Appeal Br. 17. Therefore we summarily affirm this rejection. Obviousness-Type Double Patenting Claims 38-40, 46-48, 50, 52, 61, 62, 64-66, 72, 73, 77-83 have been provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 4, 9, 13-16, 18, 26, 28, 38, 40, 41, 44, and 45 of copending Application No. 12/522,214 and claims 1, 4, 6-13, 15-20, 22, and 23 of copending Application No. 15/015,657. Appellant has not represented any arguments with respect to these rejections other than state that the rejections are not ripe for appeal. Appeal Br. 17. We therefore summarily affirm these rejections. Appeal 2021-004269 Application 13/709,897 17 CONCLUSION The Examiner’s rejections are affirmed. More specifically, The rejection of claims 38-40, 46-48, 50, 52, 61, 62, 64, 65, 72, 73, 77-79, and 82 under 35 U.S.C. § 103(a) as unpatentable over Albrecht in view of Tjelle, Noel, Hoerr and Carter is affirmed. The rejection of claims 80, 81, and 83 under 35 U.S.C. § 103(a) as unpatentable over Albrecht in view of Tjelle, Noel, Hoerr and Carter in further view of Azarani and Lloyd is affirmed with respect to claims 81 and 83, but reversed as to claim 80. The rejection of claims 38, 39, 46-48, 50, 52, 61, 62, 64-66, 72, 73, and 77-83 under 35 U.S.C. § 112, first paragraph for lack of enablement is affirmed. The rejection of claims 77 and 78 for statutory “same invention” double patenting under 35 § 101 is affirmed. The rejection of claims 38-40, 46-48, 50, 52, 61, 62, 64-66, 72, 73, and 77-83 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 4, 9, 13-16, 18, 26, 28, 38, 40, 41, 44, 45 of co-pending Application No. 12/522,214 is affirmed. The rejection of claims 38-40, 46-48, 50, 52, 61, 62, 64-66, 72, 73, and 77-83 on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1, 4, 6-13, 15-20, 22, and 23 of co- pending Application No. 15/015,657 is affirmed. Appeal 2021-004269 Application 13/709,897 18 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 38-40, 46- 48, 50, 52, 61, 62, 64, 65, 72, 73, 77-79, 82 103(a) Albrecht, Tjelle, Noel, Hoerr, Carter 38-40, 46- 48, 50, 52, 61, 62, 64, 65, 72, 73, 77-79, 82 80, 81, 83 103(a) Albrecht, Tjelle, Noel, Hoerr, Carter, Azarani, Lloyd 81, 83 80 38, 39, 46- 48, 50, 52, 61, 62, 64- 66, 72, 73, 77-83 112, 1st paragraph Enablement 38, 39, 46- 48, 50, 52, 61, 62, 64- 66, 72, 73, 77-83 77, 78 101 Statutory Double Patenting 77, 78 38-40, 46- 48, 50, 52, 61, 62, 64- 66, 72, 73, 77-83 Obviousness-Type Double Patenting USSN 12/552,214 38-40, 46- 48, 50, 52, 61, 62, 64- 66, 72, 73, 77-83 38-40, 46- 48, 50, 52, 61, 62, 64- 66, 72, 73, 77-81 Obviousness-Type Double Patenting USSN 15/015,657 38-40, 46- 48, 50, 52, 61, 62, 64- 66, 72, 73, 77-81 Overall Outcome 38-40, 46- 48, 50, 52, 61, 62, 64- 66, 72, 73, 77-83 Appeal 2021-004269 Application 13/709,897 19 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