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 .
DETAILED ACTION
The amendment filed February 12, 2026 in response to the Office Action of November 12, 2025 is acknowledged and has been entered.
Claim 63 has been amended.
Claims 63, 65-84 are pending.
Claims 66-80, 82, and 84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim.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 and 83 are currently under consideration as drawn to the elected invention.
Applicant has removed immunostimulants “TLR4 ligands” and “TLR9 ligands” from claim 63. In view of the claim amendments, the 102 rejection for claims 63, 81, and 83 set forth in the previous Office Action is hereby withdrawn.
MAINTAINED/MODIFIED 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 65 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 claims 63, 65, 81 and 83 under 35 U.S.C. 102, Applicant argues:
Applicant disagrees, but to facilitate prosecution, has amended claim 63 to remove the recitation of TRL4 ligands as the immunostimulant. Zhao does not teach the limitation of an immunostimulant selected from the group consisting of aminoalkyl glucosaminide 4-phosphates, lipopolysaccharides, TLR7 ligands, TLR8 ligands, and interferons, as recited in amended claim 63. Therefore, the claims cannot be anticipated by Zhao. Accordingly, Applicant submits that the claims are novel and respectfully requests the rejection be withdrawn.
Applicant’s arguments have been fully considered but they are only partially persuasive. In view of the claim amendment, the rejection for claims 63, 81 and 83 are withdrawn. However, claim 65 does not recite immunostimulant and the claim amendment does not overcome the 102 rejection set forth above.
NEW REJECTION
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 63, 81, and 83 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 Smits (Smits et al., The Oncologist, 2008; 13: 859-875, Publication Date: 08/13/2008).
Regarding claims 63, 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 to the agent such as a Toll-like receptor ligand (page 22, para. 1).
Zhao teaches the combination of a polypeptide comprising SEQ ID NO: 69 and a TLR ligand as set forth above. However, Zhao does not explicitly teach TLR7 ligands or TLR8 ligand.
Smits teaches using TLR7 and TLR8 ligands for the enhancement of cancer immunotherapy (Title and Abstract).
Smits teaches many examples of using different TLR7 and TLR8 ligands as vaccine adjuvants (Table 1).
Smits teaches that TLR7/8 agonists can be administered as cancer vaccine adjuvants, together with tumor associated antigens. The inclusion of TLR7/8 agonists in cancer vaccine protocols could be very advantageous because they influence antitumor reactions in several ways simultaneously. These mechanisms includes: (a) activation of
APCs, (b) stimulation of cross priming, (c) activation of CD4+ and CD8+ T cells, and NK cells, (d) creation of an inflammatory tumor microenvironment, (e) down regulation
of the suppressive mechanisms of Treg cells, (f) upregulation of tumor cell immunogenicity and apoptosis, and (g) prevention of angiogenesis (page 867, col. 1, para. 2 and Fig. 2).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to combine teachings of Zhao and Smits to make a composition comprising a polypeptide comprising SEQ ID NO: 69 and a TLR7/8 ligand such as imiquimod, resiquimod. One of ordinary skill in the art would have a reasonable expectation of success for this combination because TLR7/8 ligands have been widely used as vaccine adjuvants and TLR7/8 ligands enhances antitumor reactions in several ways simultaneously. The motivation would have been to generate a more effective vaccine.
Regarding claim 81, Zhao teaches combining an immunostimulant with the tumor antigen peptide (see the bridging paragraph of page 21-22).
Regarding claim 83, 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
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.
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