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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 17, 2026 has been entered.
DETAILED ACTION
The amendment filed June 17, 2026 in response to the Office Action of March 17, 2026 is acknowledged and has been entered.
Claims 63, 65, and 83 have been amended.
Claims 85-100 have been added.
Claims 63, and 65-100 are pending.
Claims 66-80, 82, 84, 87-97, and 100 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim.
Claims 63, 65, 81, 83, 85, 86, 98, and 99 are currently under consideration as drawn to the elected invention.
Applicant has removed “SEQ ID NO:4” from claims 63 and 65.
In view of the claim amendments, the 102 rejection for claim 65 set forth in the previous Office Action is hereby withdrawn.
In view of the claim amendments, the 103 rejection for claims 63, 81, and 83 set forth in the previous Office Action is hereby withdrawn.
It is noted that the prior art does not teach or suggest an isolated polypeptide comprising or consisting of SEQ ID NO: 1, 2, or 3 in combination with an immunostimulant as recited by claim 63, or a fusion protein comprising SEQ ID NO: 1, 2, or 3.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/17/2026, 07/24/2026, and 07/31/2026 have been entered and considered by the examiner.
NEW REJECTIONS
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim 86 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhao (Zhao et al., WO 2020/257922 A1, with effective filing date: 06/25/2019, cited by IDS of 12/03/2024, of record).
Zhao teaches a tumor antigen peptide comprising the amino acid sequence of SEQ ID NO: 69 (see claims 1, 5, 27, 30). As shown below, SEQ ID NO: 69 of Zhao is identical to SEQ ID NO: 4 of the instant application, thus SEQ ID NO: 69 of Zhao consists of SEQ ID NO:4 of the instant application:
Alignment of SEQ ID NO: 69 of Zhao to SEQ ID NO: 4:
ALIGNMENT:
Query Match 100.0%; Score 51; Length 11;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATLQAAILYEK 11
|||||||||||
Db 1 ATLQAAILYEK 11
Zhao teaches the tumor antigen peptide and the MHC class I molecule (alpha chain) are produced as a synthetic fusion protein, typically with a short flexible linker or spacer (see page 18, para. 2).
Response to Arguments
For the rejection of claim 65 under 35 U.S.C. 102, Applicant argues:
In response, claim 65 is amended to be rewritten in independent form, without reference to SEQ ID NO: 4. As a result, claim 65 now exclusively covers fusion proteins comprising an isolated polypeptide with an amino acid sequence selected from SEQ ID NOs: 1, 2, and 3 – none of which is disclosed by Zhao. Therefore, Zhao cannot anticipate amended claim 65.
Applicant’s arguments have been fully considered but they are only partially persuasive. In view of the claim amendment, the rejection for claims 65 is withdrawn. However, claim 86 is still drawn to SEQ ID NO: 4, thus, the 102 rejection set forth above is 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.
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 85, 98, and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao (Zhao et al., WO 2020/257922 A1, with effective filing date: 06/25/2019, cited by IDS of 12/03/2024, of record) and in view of Khong (Khong et al., Journal for ImmunoTherapy of Cancer, (2016) 4: 56, Publication Date: 09/20/2016).
Regarding claims 85, Zhao teaches a tumor antigen peptide comprising the amino acid sequence of SEQ ID NO: 69 (see claims 1, 5, 27, 30). As shown below, SEQ ID NO: 69 of Zhao is identical to SEQ ID NO: 4 of the instant application, thus SEQ ID NO: 69 of Zhao consists of SEQ ID NO:4 of the instant application:
Alignment of SEQ ID NO: 69 of Zhao to SEQ ID NO: 4:
ALIGNMENT:
Query Match 100.0%; Score 51; Length 11;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATLQAAILYEK 11
|||||||||||
Db 1 ATLQAAILYEK 11
Zhao teaches a composition and a vaccine comprising the tumor antigen peptide and an adjuvant (e.g. SEQ ID NO: 69) (see claims 36 and 37).
Zhao teaches that the composition or vaccine further comprises an adjuvant which can enhance or potentiate an immune response (page 22, para. 1).
Zhao teaches the combination of a polypeptide comprising SEQ ID NO: 69 and a adjuvant (immunostimulant) as set forth above. However, Zhao does not explicitly teach wherein the immunostimulant is lipopolysaccharides or interferons.
Khong teaches that the goal of a therapeutic cancer vaccine is to induce the activation and proliferation of T cells, in particular cytotoxic T lymphocytes (CTL), which specifically recognize and kill cancer cells leading to improved therapeutic outcome for the patient (1st paragraph of Background).
Khong teaches various immunopotentiators (including interferons) which can be used in cancer vaccine (Table 2).
Khong teaches that IFNs are of great interest for adjuvant development, owing to their pleiotropic effect on different immune cells such as DC, B cells and T cells as well as non-immune cells. IFN-α and IFN-β promote DC maturation, including the up-regulation of MHC and costimulatory molecules (page 7, col. 2, para. 2).
Khong teaches that preclinical studies showed direct adjuvant efficacy of type I IFN in a peptide-based anti-melanoma vaccine, where it promoted T cell numbers, longevity and effector function, resulting in improved tumor control (page 7, col. 2, para. 2).
It would have prima facie been obvious to one of ordinarily skilled in the art before the time the invention was filed to combine teachings of Zhao and Khong to make a composition comprising a polypeptide comprising SEQ ID NO: 69 and an Interferon such as INF-α, or IFN-β. One of ordinary skill in the art would have a reasonable expectation of success for this combination because IFNs have been widely used as vaccine adjuvants and IFNs enhance antitumor reactions in several ways. The motivation would have been to generate a more effective vaccine.
Regarding claim 98, Zhao teaches combining an immunostimulant with the tumor antigen peptide (see the bridging paragraph of page 21-22).
Regarding claim 99, Zhao teach SEQ ID NO: 69 (consists of SEQ ID NO: 4 of instant application) is a novel aeTSA (see Table 3B on pages 38-39). The novel aeTSA can be used for vaccines (page 43, lines 14-16).
Conclusion
Claims 63, 65, 81 and 83 are drawn to allowable subject matters.
Claims 85, 86, 98 and 99 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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