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 and 32-36 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/25/2026 has been entered.
Rejections/Objections Withdrawn
The objection to the Specification has been withdrawn in view of amendments to Specification filed 11/20/2025.
The 35 USC § 112(a) scope of enablement rejection of claims 22-29 and 32-36 are withdrawn as indicated in the Advisory Action of 01/08/2026.
Rejections Maintained
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 and 32-36 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).
Juneja teaches on the subject of immunotherapeutic compositions comprising immunotherapeutic peptides comprising neoepitopes as well as polynucleotides encoding said peptides (Juneja, Abstract). Regarding claims 22 and 37, 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 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 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 specifically comprising peptides of instant SEQ ID NOs: 1, 2 and 3 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 3, then providing a vaccine comprising peptides of instant SEQ ID NOs: 1, 2 and 3. Juneja does not teach a single polypeptide comprising the sequences of instant SEQ ID NOs: 1, 2 and 3.
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 and 3 or nucleic acids encoding these peptides. 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 3 or nucleic acids encoding these peptides because: 1) Juneja teaches vaccine compositions comprising peptides of instant SEQ ID NOs: 1, 2 and 3 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, 2 and 3 are all ARID1A frameshift mutations associated with uterine cancer and 4) one of ordinary skill in the art would reasonably deduce that a vaccine comprising all of three neoantigenic peptide sequences would form a more effective uterine cancer vaccine than any single neoantigenic peptide because the three 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 3, then providing the vaccine comprising peptides of instant SEQ ID NOs: 1, 2 and 3. 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, 2 and 3. 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 3, provide the vaccine comprising peptides of instant SEQ ID NOs: 1, 2 and 3 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 3 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 3, then a peptide vaccine comprising instant peptides of instant SEQ ID NOs: 1, 2 and 3 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 3 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 3 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 3 because: 1) Juneja teaches that instant SEQ ID NOs: 1, 2 and 3 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 02/25/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are centered around Applicant’s contention that the peptides taught by Juneja comprising amino acid sequences of Juneja’s SEQ ID NOs: 84, 89 and 998, which are 100% matches for SEQ ID NOs: 2, 1 and 3, respectively are “mutation sequence contexts” and not neoantigenic peptides suitable for vaccination. Applicant further argues that Juneja’s affirmatively teaches that when multiple neoantigens are combined in the methods of Juneja, they are derived from the same mutation, with Applicant specifically referencing Juneja arguing that Juneja states that:
“a composition may comprise ‘a first peptide comprising a first neoepitope’ and ‘a second peptide comprising a second neoepitope’, ‘wherein the first neoepitope comprises a mutation and the second neoepitope comprises the same mutation’ (Juneja, col. I, II, 63-67, emphasis added)”
(p 6, ¶ 1, Remarks of 02/25/2026)
Note: Plain text = Applicant’s wording; Italicized text = direct quoting of Juneja by Applicant; Underlined text = emphasis added by Applicant
Applicant attempts to differentiate the instant claimed AR1DA peptide-based method from the AR1DA peptide-based method of Juneja by emphasizing that the claimed AR1DA peptides are derived from different frameshift mutations frequently shared among cancer patients. Applicant emphasizes that such a combination of antigens arising from different mutations is not disclosed or suggested by Juneja and that the claimed method comprising confers distinct and nonobvious advantage of Juneja—by targeting multiple prevalent AR1DA frameshift mutations, Applicant argues that the claimed vaccine may be prepared and tested in advance, enabling rabid administration following tumor sequencing and diagnosis. Applicant concludes by pointing out that nothing in Juneja teaches or suggests designing a vaccine suitable for patients with different AR1DA frameshift mutations nor does Juneja teach the relative frequency of mutations found in cancer patients and that Juneja’s individualized, mutation specific paradigm is fundamentally incompatible with the broad, population-based strategy of the instant claimed invention.
Regarding Applicant’s arguments Applicant’s arguments that the sequences of Juneja articulated in the prior Office Action (Juneja’s SEQ ID NOs: 84, 89 and 998) are “mutation contexts” and not neoantigenic peptide sequences suitable for an anti-cancer vaccine, Juneja teaches regarding longer peptides of Juneja that arise in frameshift mutations, t teaching that when sequencing reveals a long (>10 residue) neoantigenic sequence is present due to a frameshift mutation, a longer peptide of Juneja could comprise the entire stretch of tumor-specific amino acids, with the use of such longer peptides presumed to allow for endogenous processing by patient cells, leading to more effective antigen presentation (Juneja, col 107, lines 15-34). These teachings of Juneja clearly demonstrate that longer therapeutic peptides that comprise the entire stretch of the tumor-specific amino acid sequence are not excluded as therapeutic peptides of Juneja.
Regarding Applicant’s arguments that Juneja “teaches away” from vaccines comprising peptides derived from more than one mutation, Juneja also teaches that embodiments of the inventive peptides of Juneja comprise at least one additional mutation that is not a mutation in the first or second neoepitope (Juneja, col 109, line 7-27). As such, Juneja does not teach away from compositions comprising peptides from more than one mutation. Regarding Applicant’s arguments related to the “paradigm” of individualized medicine present in the instant claims, first and foremost this “paradigm” is not a requirement of the instant claims. Additionally, the rejection above is an obviousness type rejection and Juneja teaches three ARD1A mutations and indicates each of these mutations as being associated with uterine cancer. This shared property taught by Juneja creates sufficient motivation for one of skill in the art to combine these three neoantigenic mutations based on the fact that they are all associated with uterine cancer.
.
Conclusion
Claims 22-29 and 32-36 are rejected.
No claims are allowed.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643