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 .
1-9 and 20-22 are under consideration.
Priority
The Office acknowledges Applicant’s submission of the certified Priority Applications submitted with this response.
Rejection/Objections Withdrawn
The objection to the Specification has been withdrawn in view of the substitute Specification of 5/18/2026.
The 35 USC 112(a) rejection of claims 10-19 is mooted by cancelation of claims 10-19.
Rejections Maintained
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 and 5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomena without significantly more.
The claim(s) recite(s) an isolated amino acid sequence comprising the amino acid sequence of SEQ ID NO: 7 or 26. However UniProt (UniProt A0A202BAQ3 Entry (2024) URL: https://www.uniprot.org/uniref/UniRef100_A0A202BAQ3 ; Last updated 10/02/2024) ; Accessed 12/2/2025) teaches that the Chromobacterium violaceum protein DUF456 is a 159 amino acid protein and instant amino acids 49-57 of DUF456 are a 100% match for instant SEQ ID NO: 26 (uniport, p 1-2)
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Instant claim 1 is therefore directed to the naturally occurring protein DUF456, as DUF456 comprises instant SEQ ID NO: 26. Additionally, the instant Specification discloses that instant SEQ ID NO: 7 is a cancer-specific antigen transcript and instant SEQ ID NO: 26 is a subsequence found within instant SEQ ID NO: 7 (Specification, p 9, line 7 – p 10, line 14; p 107, Table 2). As such, instant claim 1 is also directed to these naturally occurring cancer transcripts.
In the same manner, instant claim 2 is directed to the naturally occurring nucleic acid sequence encoding DUF456, which, comprises a region of nucleic acids encoding the polypeptide sequence of instant SEQ ID NO: 26 and instant claim 2 is also directed to the nucleic acid encoding the naturally occurring transcript having instant SEQ ID NO: 7. Regarding claim 5, water is a pharmaceutically acceptable carrier and, as such, claim 5 is also directed to aqueous solutions comprising the naturally occurring DUF456 or the cancer specific transcript of instant SEQ ID NO: 7. This judicial exception is not integrated into a practical application because the claims are composition claims; no useful applications, methods or processes are mentioned. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 1, 2 and 5 are directed to naturally isolated peptides comprising instant SEQ ID NOs: 7 and 26 and nucleic acid sequences encoding such peptides without any substantive manipulation or changing of the instant claimed naturally occurring sequences.
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
Applicant provides a brief overview of the MHC class II processing of the instant claimed peptide and an overview of its use in vaccines. Applicant admits that the peptide of SEQ ID NO: 26 is derived from a peptide of SEQ ID NO: 7 (CLT antigen 7), a naturally found cancer-specific transcript found in tumor tissue in lung, kidney, liver, spleen, head/neck and breast tissue. Applicant argues that isolating a polypeptide of SEQ ID NOs: 26 or 7 changes the function of the molecule. Applicant argues that the isolated peptide could be used to generate a more extensive HLA Class II-based response than the peptide can in nature because of the high enrichment of the peptide in cancer cells in vivo. In response, Applicant’s arguments describe how one of skill in the art could take advantage of the differential expression of the instant claimed peptidic transcripts in cancer cells in vivo, not how the instant claimed subject matter (which are all composition claims) differs from the corresponding natural phenomena. If a peptide of SEQ ID NOs: 26 or 7 is capable of class II MHC binding, that peptide should be capable of class II MHC binding irrespective of if the peptide was made in a patient’s cells in vivo or in a production facility. Applicant’s arguments related to the potential for inclusion of the peptide of SEQ ID NOs: 26 or 7 into a vaccine are not relevant to the claims subject to this rejection because the claims subject to this rejection recite the naturally occurring peptide transcripts only and not any additional vaccine elements.
Allowable Subject Matter
Claim 3-4, 6-9 and 20-22 are allowed.
The following is an examiner’s statement of reasons for allowance:
As of the prior Office Action of 12/17/2025, SEQ ID NOs: 7 and 26 were indicated as free of prior art, with the claims 3-4, 6-9 and 20-22 being objected to for being dependent on rejected base claim(s) but would be otherwise allowable if rewritten in independent form. The claims have been rewritten in independent form without introducing any rejectable limitations and, as such, claims 3-4, 6-9 and 20-22 are allowable.
Conclusion
Claims 1-2 and 5 are rejected.
Claims 3-4, 6-9 and 20-22 are allowed.
THIS ACTION IS MADE FINAL. 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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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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