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 4, 30, 32-38, 52, 54-56 and 68-72 are under consideration.
Rejections/Objections Withdrawn
The objection to the Specification has been withdrawn in view of substitute Specification submitted 3/23/2026.
All rejections/objections of all canceled claims are rendered moot via claim cancelation.
The objection to claim 4 has been withdrawn in view of claim amendments.
The 35 USC 112(b) rejection of claims 35-36 has been withdrawn in view of claim amendments.
The 35 USC 101 rejection of claims 4, 30, 32-34, 38 and 68 has been withdrawn in view of claim amendments.
All 35 USC 102 rejections and 35 USC 103 rejections of all claims have been withdrawn in view of claim amendments.
New Rejections Necessitated by Amendment
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.
Claim(s) 52, 54-56 and 72 , is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stickel (Stickel, et al., WO2015193359A2; Published 12/23/2015; Priority to 6/20/2014 via US 62/014,849, of record).
Stickel discloses peptide comprising SEQ ID NO: 517, which is a 100% match for instant SEQ ID NO: 104 (Stickel, p 17, line 8). Regarding claims 52, 54 and 72, Stickel discloses the peptide is used as a medicament that is an active agent against cancer (Stickel, claims 1, 27 and 31), wherein said cancer is AML (Stickel, claim 32). Regarding claims 55-56, Stickel discloses the co-administration of a second compound that is a chemotherapeutic agent (Stickel, p 157, ¶ 4).
Response to Arguments
Applicant's arguments filed 3/23/2026 have been fully considered but they are not persuasive.
Applicant argues that, while Stickel does disclose that a peptide comprising SEQ ID NO: 517 (same as instant SEQ ID NO: 104) is an active agent against AML, Stickel provides no explicit disclosure of a method of treating AML by administering the peptide comprising SEQ ID NO: 517. Applicant also argues that the inclusion of Stickel’s peptide comprising SEQ ID NO: 517 in Table 1b (with a focus on CLL), but not in Tables 2-6 (with foci other than CLL). Applicant articulates that, given these disclosures of Stickel, that one of skill in the art would view SEQ ID NO: 517 as a viable treatment for CLL only and not AML.
These arguments are not persuasive because the rejection at hand is an anticipation-type rejection and not an obviousness-type rejection and claims 1, 27, 31 and 32 of Stickel do, in fact, collectively disclose a peptide comprising SEQ ID NO: 517 as an active anti-cancer agent for treating AML, of the the claimed embodiments of the invention of Stickel.
Claim Rejections - 35 USC § 103
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.
Claim(s) 4, 35-38 and 69-70, is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnea (Barnea, et al., WO 02/094981; Published 11/28/2002; Priority to 5/16/2001 via US 60/290,958, of record)
Barnea teaches on the subject of identification of MHC binding peptides as well as pharmaceutical compositions comprising such peptides as well as the use of such peptides in vaccination (Barnea, p 1, lines 5-10). Regarding claims 4 and 70, Barnea teaches peptide comprising SEQ ID NO: 73, which has the sequence ALASHLIEA (same as instant SEQ ID NO: 51) (Barnea , page 33, line 1). Regarding the adjuvant limitation of claim 4, Barnea teaches that the polypeptides or polynucleotides of Barnea can be administered after fusing the peptide or polynucleotide of Barnea to a heat shock protein (Note: HSPs act as adjuvants) (Barnea, p 37, lines 1-15). Regarding claims 35-36, Barnea teaches of the loading of a presenting cell with a polynucleotide that is RNA encoding a MHC peptide of Barnea (Note: this RNA would be mRNA because it encodes a peptide) (Barnea, p 37, lines 1-15). Regarding claim 38, Barnea teaches pharmaceutical composition is comprising the MHC peptides of Barnea and an acceptable carrier (Barnea, p 36, lines 26-30). Regarding claims 37 and 69, Barnea teaches that the MHC peptides of Barnea may be prepared as with liposome vehicles (Barnea, p 40, lines 19-30). Additionally, Barnea teaches a method of treating a pathology comprising administering a peptide of Barnea’s SEQ ID NO: 73 (Barnea, claims 35 and 37).
Barnea does not explicitly teach a vaccine comprising mRNA encoding the peptide of instant SEQ ID NO: 51 fused to a HSP adjuvant, wherein the vaccine comprises a pharmaceutically acceptable carrier.
It would be prima facie obvious to one of ordinary skill in the art to select the peptide of instant SEQ ID NO: 51 taught by Barnea and prepare a vaccine comprising mRNA encoding the peptide of instant SEQ ID NO: 51 fused to an HSP adjuvant, wherein the vaccine comprises a pharmaceutically acceptable carrier. One of ordinary skill in the art would be motivated to do this in order to enhance the immunogenicity of the peptide of instant SEQ ID NO: 51 present in the vaccine. One of ordinary skill in the art would have a reasonable expectation of success preparing a vaccine comprising mRNA encoding the peptide of instant SEQ ID NO: 51 fused to an HSP adjuvant, wherein the vaccine comprises a pharmaceutically acceptable carrier because: 1) Barnea teaches that a peptide of Barnea’s SEQ ID NO: 73 (Same as instant SEQ ID NO: 51) is a MHC binding molecule useful in methods of treating a pathology, 2) Barnea teaches that the method of Barnea works with both MHC peptides as well as mRNA encoding such peptides and 3) Barnea teaches fusion of the antigenic peptides/nucleic acids to a HSP carrier.
Response to Arguments
Applicant did not supply any arguments specific to this rejection and instead relies on the claim amendment deleting instant SEQ ID NO: 77 from the Markush group of Claim 4. In response, the new rejection articulated above is centered around instant SEQ ID NO: 51 and does not require or mention instant SEQ ID NO: 77.
Allowable Subject Matter
Claims 30, 32-34, 68 and 71 are 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:
The following table has been reproduced from the Office Action of 1/5/2026 and contains a list of amino acid sequences indicated as being free of prior art in the previous Office Action (Note: this table will be referred to as “Table 1”):
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The following table has been reproduced from the Office Action of 1/5/2026 and contains a list of sequences recited in instant claim 4 as well as the genetic loci for each recited sequence (Note: this will be referred to as “Table 2”):
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Claims 30 and 32-34
Claims 30 and 32-34 are all directly or indirectly dependent on instant claim 4. Instant claim 4 is directed to a vaccine comprising an HLA-A*02:01-binding TAP sequence selected from the list of TAP sequences recited in instant claim 4 as well as an adjuvant. Claim 30 further limits claim 4 by specifying that the TAP is encoded by a sequence in a non-protein coding locus of the genome. Claim 32 further limits claim 30 by specifying that the non-protein coding locus of the genome is an intron. Claim 33 further limits claim 30 by specifying that the non-protein coding locus of the genome is an intergenic region.
Table 2 shows that, of the TAP sequences recited in instant claim 4, the following TAP sequences are derived from non-protein coding loci: SEQ ID NOs: 7, 11, 27, 32-35, 43, 108, 119, 123, 130, 132, 146, 150, 167-169, 171, 183 and 188. As shown in Table 1, all of these TAP sequences are free of prior art. As such, claims 30 and 32-33 are free of prior art because all of the TAP sequences recited in claim 4 that are derived from non-protein coding genetic loci are free of prior art. Regarding claim 34 specifically, the only standing rejection of claim 34 as of the previous Office Action was a 35 USC 101 rejection, which has been obviated by the inclusion of the adjuvant limitation into claim 4.
Claims 68 and 71
Claims 68 and 71 are both dependent on instant claim 4. Claims 68 and 71 both further limit claim 4 by specifying that the TAP is selected from sequence listings that are subsets of the TAP sequence listing of instant claim 4. All of the TAP SEQ ID NOs permitted by claims 68 and 71 are sequences present in Table 1 above, which means that all of the TAP sequences recited in claims 68 and 71 are free of prior art.
Conclusion
Claims 4, 35-38, 52, 54-56 and 69-70 and 72 are rejected.
Claims 30, 32-34, 68 and 71 are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SYDNEY VAN DRUFF/ Examiner, Art Unit 1643
/JULIE WU/ Supervisory Patent Examiner, Art Unit 1643
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