DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of claims 46, 56-64, 66-77, and 80-92 comprising SEQ ID NO:4587 and SEQ ID NO:4586 in the replies filed on August 8, 2025 and November 17, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 46 and 56-92 are currently pending in the instant application. Claims 65 and 78-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 46, 56-64, 66-77, and 80-92 are under examination on the merits in the instant application.
Specification
The abstract of the disclosure is objected to because it contains a strikethrough in line 2. However, the abstract filed on March 13, 2023 is not labeled as amended. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to because the x-axis and the y-axis of the graphs in Figures 6-7 are not labeled thus correct interpretation of the drawings is impossible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 46, 56-64, 66-77, and 80-92 are rejected under 35 U.S.C. 103 as being unpatentable over Barner et al. (US 2010/0291156 A1, applicant’s citation) in view of Fontin-Mleczek et al. (WO 2014/127917 A1) and de Fougerolles et al. (US 2013/0156849 A1).
Barner teaches a method of treating cancer by inducing “CD8+ T lymphocyte” responses in a subject comprising intravenous injection of a pharmaceutical composition comprising “at least two” mRNAs each encoding “MAGE-A3 and NY-ESO-1”, wherein the MAGE-A3 antigen is encoded by the codon-optimized mRNA of SEQ ID NO:17 and the NY-ESO-1 antigen is encoded by the codon-optimized mRNA of SEQ ID NO:21, wherein the mRNA further comprises a 5’ cap such as “m7G(5’)ppp” and a poly A tail sequence of up to “200 adenosine nucleotides”, wherein MAGE-A3 “is the melanoma antigen family A, 3” that is expressed in melanoma and non-small cell lung cancer (NSCLC) and NY-ESO-1 is also expressed in melanoma and lung cancer thus the antigens can be used to treat melanoma and NSCLC. See paragraphs 0037, 0040, 0172, 0174, 0176, 0240, 0498-0499, 0510-0512, 0584-0586, 0591-0594; claim 1.
Barner teaches that the mRNA encoding NY-ESO1 produces “IgG2a antibodies specific for the tumour antigen NY-ESO-1”. See paragraph 0634.
It is noted that Barner’s SEQ ID NO:17 is 100% identical to SEQ ID NO:4587 claimed in the instant case and that Barner’s SEQ ID NO:21 is 100% identical to SEQ ID NO:4586 claimed in the instant case.
Barner does not teach further administering a PD-1 inhibitor that is an antibody and a third RNA encoding a tyrosinase antigen.
Fontin-Mleczek teaches that PD-1 is involved in “an inhibitory signal that inhibits the proliferation of antigen-specific CD8+ cells” and that an antibody directed against PD-1 can “restore or enhance T cell function” for “anti-tumor T cells” that are not “sufficiently activated” by the tumor-specific antigen. See pages 1-2 and 77-78.
Fontin-Mleczek teaches that the anti-PD1 antibody can be sequentially “administered prior to the RNA vaccine” or concurrently with at least one RNA (e.g., mRNA or replicon RNA) encoding at least one tumor antigen including “MAGE-A3”, “NY-ESO-1”, and “tyrosinase”, wherein each of the antibody and tumor antigen RNA is administered via “intravenous” route such as “intravenous infusion” in order to provide “the treatment of melanoma”, wherein the RNA can be introduced to cells via “liposomes” and the combination of an mRNA vaccine and an anti-PD-1 antibody provided “an extremely advantageous inhibition of tumour growth resulting in enhanced survival” and “led to significant inhibition of tumor growth, indicating a synergistic effect.” See pages 1, 10, 21-22, 25-26, 59, 62-63, 79-80, 84-86, 89-90, and 95; Figure 1.
de Fougerolles teaches expressing a polypeptide encoded by a modified mRNA encapsulated in a lipid nanoparticle (LNP) or lipoplex, wherein the mRNA comprises “Cap1” and a polyA tail of about 140-160 nucleotides comprising intravenously administering the mRNA formulation, wherein the 5’ cap structure is useful for “increasing mRNA stability” and includes “7mG(5’)ppp(5’)N”, “cap 0”, and “cap 1”. See paragraphs 0076, 0084, 0998-1000, 1177, 1285, 1295, 1307, 1312, and 1315.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Barner’s method by further administering an anti-PD1 antibody and an RNA encoding a tyrosinase antigen. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to enhance the antigen-specific anti-tumor T-cell immune response, thereby improving anti-cancer therapeutic effects in the melanoma subject being treated by Barner’s method comprising intravenously administering codon-optimized “MAGE-A3 and NY-ESO-1” antigen-encoding sequences of SEQ ID NO:17 and SEQ ID NO:21, which are each 100% identical to SEQ ID NO:4587 and SEQ ID NO:4586 claimed in the instant case, because the administration of an anti-PD1 antibody to a subject being treated with RNAs encoding tumor antigens including “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” was taught to “restore or enhance T cell function” in “antigen-specific CD8+ cells” that are not “sufficiently activated” by tumor-specific antigens in “anti-tumor T cells” as taught by Fontin-Mleczek, who thus taught a combination treatment method comprising administering an anti-PD1 antibody prior to or concurrently with the tumor-specific antigen-encoding RNAs including mRNA and replicon RNA provided “synergistic effect” in tumor growth reduction, which was deemed “an extremely advantageous inhibition of tumour growth resulting in enhanced survival”. In addition, since the inclusion of a 5’ cap such as the cap structures claimed in the instant case was known to be useful in “increasing mRNA stability” of an LNP-encapsulated mRNA that also comprises a polyA tail of about 140-160 nucleotides as taught by de Fougerolles, who also taught that Cap1 is an alternative 5’ cap structure to “7mG(5’)ppp(5’)N”, it would have been obvious to one of ordinary skill in the art to use Cap1 instead of Barner’s “m7G(5’)ppp” that is included in mRNAs encoding SEQ ID NO:17 (same as SEQ ID NO:4587 claimed in the instant case) encoding MAGE-A3 antigen and SEQ ID NO:21 (same as SEQ ID NO:4586) encoding NY-ESO-1, which was known to produce “IgG2a antibodies specific for the tumour antigen NY-ESO-1” as reported by Barner.
In view of the foregoing, claims 46, 56-64, 66-77, and 80-92 taken as a whole would have been prima facie obvious before the effective filing date.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,737,595 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘595 patent claims drawn to a method of stimulating an anti-tumor immune response in a subject comprising administering an mRNA encoding a tumor cell antigen, wherein the tumor cell antigen as broadly claimed in the ‘595 patent claims is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by the disclosure in column 11 of the ‘595 patent specification. It would have been obvious to further administer an anti-PD antibody in order to enhance the anti-tumor immune response stimulation in the subject of the ‘595 patent claims, wherein “MAGE-A3” and “NY-ESO-1” are encoded by prior art’s codon-optimized sequences, thereby arriving at the instant claims in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,974,845 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘845 patent claims drawn to a method of treating cancer comprising administering an immunogenic composition comprising at least one codon-optimized mRNA encoding “at least one tumor antigen” and a PD-1 pathway inhibitor antibody, wherein the “at least one tumor antigen” as broadly claimed in the ‘845 patent claims is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by the disclosure in column 42 of the ‘845 patent specification. It would have been obvious to use Barner’s codon-optimized sequences encoding MAGE-A3 and NY-ESO-1 for improved antigen expression and other limitations recited in the instant claims would have been obvious in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,117,920 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘920 patent claims drawn to a method of treating cancer comprising administering an immunogenic composition comprising at least one codon-optimized mRNA encoding “at least one tumor antigen” and a PD-1 pathway inhibitor antibody, wherein the “at least one tumor antigen” as broadly claimed in the ‘920 patent claims is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by the disclosure in column 42 of the ‘920 patent specification. It would have been obvious to use Barner’s codon-optimized sequences encoding MAGE-A3 and NY-ESO-1 for improved antigen expression and other limitations recited in the instant claims would have been obvious in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,307,472 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘472 patent claims drawn to a method of treating comprising administering an immunogenic composition comprising at least one codon-optimized mRNA encoding “at least one antigen”, wherein the “at least one antigen” as broadly claimed in the ‘472 patent claims is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by the disclosure in column 40 of the ‘472 patent specification. It would have been obvious to further administer an anti-PD antibody in order to enhance the treatment effect in the subject of the ‘472 patent claims, wherein “MAGE-A3” and “NY-ESO-1” are encoded by prior art’s codon-optimized sequences, thereby arriving at the instant claims in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 17-19 of U.S. Patent No. 10,434,158 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘158 patent claims drawn to a method of treating cancer comprising administering an immunogenic composition comprising at least one codon-optimized mRNA encoding “at least one tumor antigen” and a PD-1 pathway inhibitor antibody, wherein the “at least one tumor antigen” as broadly claimed in the ‘158 patent claims is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by the disclosure in column 42 of the ‘158 patent specification. It would have been obvious to use Barner’s codon-optimized sequences encoding MAGE-A3 and NY-ESO-1 for improved antigen expression and other limitations recited in the instant claims would have been obvious in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-25 of U.S. Patent No. 11,458,195 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘195 patent claims drawn to a method of treating cancer comprising administering an immunogenic composition comprising at least one codon-optimized mRNA encoding “at least one tumour-specific antigen” and a PD-1 pathway inhibitor antibody, wherein the “at least one tumour-specific antigen” comprises “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by claims 5 and 20-25 of the ‘195 patent. It would have been obvious to use Barner’s codon-optimized sequences encoding MAGE-A3 and NY-ESO-1 for improved antigen expression and other limitations recited in the instant claims would have been obvious in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 7-20 of U.S. Patent No. 11,559,570 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘570 patent claims drawn to a method of inducing an tumor antigen-specific immune response in a subject comprising administering an antigenic composition comprising at least one codon-optimized mRNA encoding at least one “tumor antigen”, wherein the “tumor antigen” as broadly claimed in the ‘570 patent claims is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by the disclosure in column 92 of the ‘570 patent specification. It would have been obvious to further administer an anti-PD antibody in order to enhance the tumor antigen-specific immune response in the subject of the ‘570 patent claims, wherein “MAGE-A3” and “NY-ESO-1” are encoded by prior art’s codon-optimized sequences, thereby arriving at the instant claims in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,178,863 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘863 patent claims drawn to a method of treating cancer including melanoma comprising administering an immunogenic composition comprising at least one mRNA encoding “at least one antigen that is expressed in a cancer cell”, wherein the broadly claimed antigen is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by column 40 of the ‘863 patent specification. It would have been obvious to further administer an anti-PD antibody in order to enhance the cancer treatment effect in the subject of the ‘863 patent claims, wherein “MAGE-A3” and “NY-ESO-1” are encoded by prior art’s codon-optimized sequences, thereby arriving at the instant claims in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 12,447,209 B2 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘209 patent claims drawn to a method of treating cancer including melanoma comprising administering an immunogenic composition comprising at least one mRNA encoding a “tumour-specific antigen (TSA)” and a PD-1 pathway inhibitor antibody, wherein the TSA is defined to encompass “MAGE-A3”, “NY-ESO-1”, and “tyrosinase” as evidenced by column 42 of the ‘209 patent specification. It would have been obvious to use Barner’s codon-optimized sequences encoding MAGE-A3 and NY-ESO-1 for improved antigen expression and other limitations recited in the instant claims would have been obvious in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-50 of copending Application No. 18/929,823 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘823 claims drawn to a method of treating cancer comprising administering purified RNAs comprising SEQ ID NO:19538 (at least 80% identical to SEQ ID NO:4587) and SEQ ID NO:28796 (at least 80% identical to SEQ ID NO:4586), which encode therapeutic proteins. It would have been obvious to further administer an anti-PD antibody and an RNA encoding tyrosinase in order to enhance the cancer treatment effect in the subject of the ‘823 claims in view of the teachings of Fontin-Mleczek. In addition, it would have been obvious to use prior art’s codon-optimized sequences encoding MAGE-A3 and NY-ESO-1 for improved antigen expression and other limitations recited in the instant claims would have been obvious in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Claims 46, 56-64, 66-77, and 80-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 64, 67-69, and 74-86 of copending Application No. 19/086,551 in view of Barner et al. (US 2010/0291156 A1, applicant’s citation), Fontin-Mleczek et al. (WO 2014/127917 A1), and de Fougerolles et al. (US 2013/0156849 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘551 claims drawn to a method of treating a solid tumor comprising administering “at least a first artificial RNA molecule” encoding an antigen complexed with lipid nanoparticles and a PD-1 pathway inhibitor antibody, wherein the RNA molecule is defined to read on SEQ ID NO:2230 (at least 80% identical to SEQ ID NO:4587) and SEQ ID NO:2913 (at least 80% identical to SEQ ID NO:4586) as evidenced by the disclosure of the ‘551 specification. It would have been obvious to further administer an anti-PD antibody and an RNA encoding tyrosinase in order to enhance the cancer treatment effect in the subject of the ‘551 claims in view of the teachings of Fontin-Mleczek. In addition, it would have been obvious to use prior art’s codon-optimized sequences encoding MAGE-A3 and NY-ESO-1 for improved antigen expression and other limitations recited in the instant claims would have been obvious in view of the teachings of Barner, Fontin-Mleczek, and de Fougerolles as explained in the §103 rejection above, which is fully incorporated by reference thus will not be repeated herein.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635