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 .
Claims 22-29, 32-36, 38-39 are under consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/15/2026 has been entered.
Rejections/Objections Withdrawn
All 35 USC 103 rejections have been withdrawn in view of claim amendments.
New Rejections Necessitated by Amendment
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 22-29, 32-36 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over (Juneja, et al., US 11,793,867 B2; Issued 10/24/2023; Priority to 12/18/2017 by way of US 62/607,148, of record) in view of Fritsch (Frisch, et al., WO 2016/187508A2; Published 11/24/2016) in view of Takeda)
Juneja teaches on the subject of immunotherapeutic compositions comprising immunotherapeutic peptides comprising neoepitopes as well as polynucleotides encoding said peptides (Juneja, Abstract). Regarding the peptide sequence limitations of claims 22 exclusive of SEQ ID NO:5 of (iii) of claim 22 (SEQ ID NOS: 1 and 2 only) and claim 39 (SEQ ID NO: 3), Juneja teaches an ARID1A peptide sequence having Juneja’s SEQ ID NO: 84, which is a 100% match for instant SEQ ID NO: 2 (Juneja, Table 1, p 93, entry 2) as well as an ARID1A peptide having Juneja’s SEQ ID NO: 89, which is a 100% match for instant SEQ ID NO: 1 (Juneja, Table 1, p 97, entry 2), as well as an ARID1A peptide having Juneja’s SEQ ID NO: 998, which is a 100% match for instant SEQ ID NO: 3 (Juneja, Table 2, p 115, entry 1), with uterine carcinosarcoma (UCS) being listed as exemplary target diseases in the entry for each peptide (column 5 of each entry in Table 1 and 2) and with each of the ARID1A peptides of Juneja comprising multiple MHCI-binding motifs of 10 amino acid residues or more listed the entry for each of the ARD1A peptides of Juneja (column 5 of each entry in Table 1 and 2). Regarding claim 33, Juneja teaches that the ARD1A peptides of Juneja are administered in methods of treating cancers (Juneja, Col. 2, lines 58-65) and as discussed in the previous sentence, the peptides of Juneja’s SEQ ID NOs: 84, 89 and 998 are ARD1A frameshift mutations indicated for uterine carcinosarcoma. Regarding claims 25-26, Juneja teaches that the vaccine of Juneja is a polynucleotide vaccine comprising a vector that is a viral vector (Juneja, Col. 167, lines 1-36). Regarding claims 27 and 29, Juneja teaches that the composition of Juneja further comprises a vaccine adjuvant (Juneja, Col. 21, lines 5-25). Regarding claims 27-28, Juneja teaches that the composition of Juneja further comprises a checkpoint inhibitor, an antibody or a chemotherapeutic agent (Juneja, Col. 28, lines 1-18). Regarding claims 34-35, Juneja teaches that the vaccine of Juneja is an RNA-based vaccine that comprises mRNA (Juneja, Col 167, Lines 18-21). Regarding claim 36, Juneja teaches that the vaccine of Juneja is an RNA replicon (Juneja, Col. 138, Lines 27-29). Juneja also teaches that next generation sequencing (NGS) technology, which is capable of delivering nucleic acid sequence information of a whole genome in very short periods of time are used to identify the tumor-specific mutations in the method of Juneja (Juneja, Col. 105, lines. 38-63). Juneja also teaches compositions comprising multiple different protein (Juneja, col 108, lines 33-37).
Juneja does not teach a vaccine of instant claim 22 specifically comprising peptides of instant SEQ ID NOs: 1 and 2 are combined with peptidic vaccine component corresponding to SEQ ID NO: 5, a fragment comprising at least 10 consecutive amino acids of SEQ ID NO: 5 or one or more nucleic acid encoding each said peptide or nucleic acids encoding these peptides. Juneja does not teach a method for providing a vaccine for immunizing a patient against cancer comprising determining the sequence of ARID1A in cancer cells of said cancer and, when the determined sequence(s) produce neoantigens having amino acid sequences of instant SEQ ID NOs: 1, 2 and 5, then providing a vaccine comprising peptides of instant SEQ ID NOs: 1, 2 and 5. Juneja does not teach a single polypeptide comprising the sequences of instant SEQ ID NOs: 1, 2 and 5.
Fritsch teaches on the subject of pharmaceutical compositions comprising neoantigenic peptides comprising tumor-specific neoepitopes (Fritsch, Abstract). Fritsch teaches that SEQ ID NO:286 of Fritch comprises a total of 79 contiguous amino acids from SEQ ID NO: 5 (qy = SEQ ID NO: 5), with SEQ ID NO 286 of Fritsch being a ARID1A frameshift mutation (see p 204 row 4).
Takeda teaches on the subject of ARID1A in uterine and endometrial cancer. Takeda teaches that there ais a high frequency in both ovarian and endometrial carcinomas (Takeda, p 609¶ 5). Takeda teaches that there is a strong correlation between ARID1A mutation and endometrial/uterine carcinomas., with AR1D1A mutations being present in 80% of uterine adenocarcinomas.
It would be prima facie obvious to one of ordinary skill in the art to form a vaccine composition specifically comprising peptides of instant SEQ ID NOs: 1, 2 or nucleic acids encoding these peptides aa well as comprising AA24- 83- of SEQ ID NO 298 of Fritsch, which comprises at least 10 contiguous amino acids of instant SEQ ID NO 5 in view of Takeda. One of ordinary skill in the art would be motivated to do this in order to better treat uterine cancer. One of ordinary skill in the art would have a reasonable expectation of success forming a vaccine composition specifically comprising peptides of instant SEQ ID NOs: 1, 2 and 5 or nucleic acids encoding these peptides because: 1) Juneja teaches vaccine compositions comprising peptides of instant SEQ ID NOs: 1, and 2 are ARID1A neoantigenic peptides individually as well as vaccine compositions comprising nucleic acids encoding such peptides individually, 2) Juneja teaches methods of treating uterine cancer comprising these neoantigenic sequences, 3) Juneja teaches that the peptides of instant SEQ ID NOs: 1 and 2 are all ARID1A frameshift mutations associated with uterine cancer and 4) one of ordinary skill in the art would reasonably deduce that a vaccine further comprising SEQ ID NO 298 of Fritch which is an ARID1A frameshift mutation comprising at least 10 sequential amino acids of instant SEQ ID NO: 5 because Takeda teaches that ARID1A mutations, especially frameshift mutations, such as SEQ ID NO: 298 of Fritch are peptide sequences would form a more associated with uterine cancer and, as such, the combination of the neoantigenic ARID1A peptide vaccine comprising multiple neoepitopes would be likely to be more effective than any single neoantigenic peptide because the three (for 4) neoantigen vaccine would give rise to antibodies recognizing a more diverse array of uterine cancer-associated ARID1A mutant epitopes.
It would be prima facie obvious to one of ordinary skill in the art to use the NGS sequencing technology taught by Juneja to determine the sequence of ARID1A in cancer cells of a patient and, if the determined sequence(s) produce neoantigens having amino acid sequences of instant SEQ ID NOs: 1, 2 and 5, then providing the vaccine comprising peptides of instant SEQ ID NOs: 1, 2 and 5. One of ordinary skill in the art would be motivated to do this in order to better treat uterine cancer. Juneja teaches vaccines comprising ARID1A uterine tumor-specific neoantigenic peptides that are the same as the instant SEQ ID NOs 1 and 2 and Fritsch teaches an ARD1A neoantigenic peptide comprising at least 10 AAs from instant SEQ ID NO: 5. Juneja also teaches that the NGS sequencing technology also taught by Juneja is used to identify the tumor-specific mutations in the method of Juneja and that the NGS sequencing technology of Juneja is capable of sequencing entire genomes in very short periods of time. One of skill in the art would have a reasonable expectation of success using the NGS sequencing technology taught by Juneja to determine the sequence of ARID1A in cancer cells of a patient and, if the determined sequence(s) produce neoantigens having amino acid sequences of instant SEQ ID NOs: 1, 2 and 5, provide the vaccine comprising peptides of instant SEQ ID NOs: 1, 2 and 5 because: 1) Juneja teaches that the NGS sequencing technology of Juneja can sequence very large (genome-sized) sequences very quickly, 2) One of ordinary skill in the art would reasonably deduce that the NGS sequencing of Juneja could tell whether or not the cancer cells comprise the mutations that give rise to the sequences of instant SEQ ID NOs: 1, 2 and 5 and 3) one of ordinary skill in the art would reasonably deduce that the presence of ARID1A mutations giving rise to sequences of instant SEQ ID NOs: 1, 2 and 5, then a peptide vaccine comprising instant peptides of instant SEQ ID NOs: 1, 2 and 5 would be effective in that specific patient.
It would be prima facie obvious to one of ordinary skill in the art to link the peptides of instant SEQ ID NOs: 1, 2 and together to form a single polypeptide in view of the teachings of Juneja. One of ordinary skill in the art would be motivated to do this in order to treat uterine cancer. Juneja teaches that instant SEQ ID NOs: 1, 2 and 5 are all neoantigens arising from mutations to ARID1A and are all associated with uterine cancer. Juneja also teaches that the composition of Juneja may comprising a single polypeptide containing multiple different neoantigen associated with the same protein as the first. One of ordinary skill in the art would have a reasonable expectation of success forming a single polypeptide comprising instant SEQ ID NOs: 1, 2 and 5 because: 1) Juneja teaches that instant SEQ ID NOs: 1 and 2 and Fritsch teaches a sequence having 10 more AAs contiguous with SEQ ID NO: 5 are all neoantigens of the ARID1A gene and are associated uterine cancer, 2) Juneja teaches single polypeptides containing multiple different neoantigen from the same protein, 3) one of ordinary skill in the art would reasonably deduce that the resultant single peptide comprising the three neoantigens would be useful for treating uterine cancer because the single polypeptide comprising the three neoantigens would give rise to antibodies against all three neoantigens and that this means the single polypeptide comprising the three neoantigens would produce an anti-cancer immune response against cancer cells having only one of the neoantigens.
Response to Arguments
Applicant's arguments filed 7/15/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are entirely related to the applicant’s amendment of component (iii) of the multi-component vaccine of instant claim 22 to specify a peptidic vaccine component of instant SEQ ID NO: 5 or a collection of 10 more consecutive AAs. Applicant’s amendments have been addressed via inclusion of the Fritsch reference with teaches an ARID1A peptide reading on claim (iii) as well as the Takeda reference which supplies rationale for combination of ARID1A neoantigenic peptides, especially frameshift mutations, for combination of uterine cancer.
Subject Matter of Free of Prior Art
Claim 38 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 38 is dependent on claim 22. Regarding component (iii) of the vaccine component of the vaccines of claims 22 and 38, instant claim 22 requires only 10 more consecutive amino acids of SEQ ID NO: 5, whereas instant claim 38 requires the peptide component (iii) of the vaccine of claim 38 to consist of instant SEQ ID N:8 , and such SEQ ID NO: 298 of Fritsch does read on component (iii) of instant claim 22 because it comprises 10 more AA matches with instant SEQ ID NO: 5. But the ARID1A neoantigenic peptide of SEQ ID NO: 298 does not read on component (iii) of instant claim 38. As such, a peptide consisting of instant SEQ ID NO: 5 is not an obvious variant of Fritsch’s SEQ ID NO 298 because SEQ ID NO: 298 of Fritch comprises portions of instant SEQ ID NO: 5.
Conclusion
Claims 22-29, 32-36 and 39 are rejected.
Claim 38 is objected to
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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