DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/02/2026 has been entered.
Claims 11-12, 15-18 and 20-21 are pending.
3. Claim 12 is objected to because of the reference to Table 1. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05(s).
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
5. Claims 11-12, 15-18 and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 11 is indefinite in the recitation of a method of “modulating” an immune response in a subject, because it is ambiguous as to the direction, positive or negative, of the effect on the immune response, and so the claim encompasses mutually exclusive outcomes.
(ii) Claim 11 is further indefinite in the recitation of “a somatic mutation or a germline mutation in SERPINB3 or SERPINB4,” because it is unknown which mutations are within the scope of the claim. The claim lists amino acid sequences of certain neoepitopes, but does not specify whether there is any relationship between the listed sequences and the mutations within the scope of the claim.
(iii) Claim 12 is indefinite, because the recitation of “the serpin” lacks proper antecedent basis in the base claim. Claim 11 recites SERPINB3 and SERPINB4, which is not equivalent in scope to the generic recitation of “the serpin” in claim 12.
(iv) Claims 12, 15-18 and 20 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. Claims 11-12, 15-18, and 20-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nguyen et al. (US 20180141998, of record).
Nguyen teaches a skin cutaneous melanoma epitope of SEQ ID NO: 1083451 (Table 1), which is identical to instant SEQ ID NO: 20 (see SCORE). SEQ ID NO: 20 is a 9-mer peptide carrying a mutation in SERPINB3 amino acid sequence (Table 4 of the present specification).
Nguyen further teaches a method which “allows to stimulate or even produce an immune response against a neoepitope in a patient where the immune system of that patient was not sufficient to generate a protective response (e.g., due to chemotherapy or immune suppression by the tumor or Tregs or myeloid-derived suppressor cells) [0051]. The method involves producing an antibody to the neoepitope (e.g. the Abstract), modifying the antibody with the immunogenic neoepitope antigen, and administering the modified antibody to the patient such that “the cancer cells with the neoepitopes are ‘painted’ with the modified antibody presenting the immunogenic antigen, which is particularly advantageous where an immune response to the original neoepitope was not immunogenic or suppressed” [0048]. In this method, the antibody to which the neoepitope peptide is conjugated functions as an immunological adjuvant.
Nguyen teaches that neoepitopes are identified by analyzing exome sequencing data and/or transcriptome data obtained from a tumor sample (e.g. [0010], [0023]) which, in the case of skin cutaneous melanoma, is or comprises epithelial tissue.
Accordingly, Nguyen teaches all of the limitations of instant claims 11-12, 15, 17-18, and 20-21, and as such anticipates the presently claimed invention.
Claim 16 is included in the rejection, because ctDNA sequence was routinely used in the art for identification of tumor neoepitopes, and as such would be at once envisaged by those skilled in the art.
8. Conclusion: no claim is allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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