DETAILED CORRESPONDENCE
Application Status
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. Applicant’s amendment to the claims filed on 04/16/2026 in response to the Non-Final Rejection mailed on 01/16/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 4-5 are cancelled.
4. Claims 1-3, 6-30, 32, and 35-36 are pending.
5. Applicant’s remarks filed on 04/16/2026 in response to the Non-Final Rejection mailed on 01/16/2026 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Election/Restrictions
6. Claims 4-5 have been cancelled. Claims 1-3 (originally part of Group I in the Restriction Requirement mailed on 09/11/2025) have been amended to recite a “vector comprising nucleic acid encoding a peptide…” as opposed to being drawn to a peptide. As such, claims 1-3 are part of the technical feature of a nucleic acid as set forth in Group II of the Restriction Requirement mailed on 09/11/2025.
The restriction requirement, as set forth in the Office action mailed on 09/11/2025, has been reconsidered in view of the amendment to the claims as set forth above. Specifically, the restriction requirement between Group II and claims 1-3 is withdrawn. Claims 1-3, directed to a vector comprising a nucleic acid encoding a peptide are no longer withdrawn from consideration.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
7. Claims 22-30 and 32 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-3, 6-21 and 35-36 are pending and examined to the extent they read on the species SEQ ID NO: 1, 4, and 7.
Information Disclosure Statement
8. The IDS filed on 04/22/2026 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Claim Rejections - 35 USC § 101
9. The rejection of claims 4-6, 8-11 and 18 under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more is withdrawn in view of applicants’ amendment to the claims to cancel claims 4-5 and to recite a “vector comprising…, wherein the vector is selected from the group consisting of bacterial, yeast, adenovirus, adeno-associated virus, and poxvirus vectors”, which is significant to transform the claims into something that is markedly different from its natural counterpart.
Claim Rejections - 35 USC § 102
10. The rejection of claims 4-6 under 35 U.S.C. 102(a)(1) as being anticipated by Raitano et al. (WO 01/62925 A2; cited on PTO-892 mailed on 01/16/2026) is withdrawn in view of applicants’ amendment to the claims to cancel claims 4-5 and to remove the species of SEQ ID NO: 4.
11. The rejection of claims 7-13, 15-16, 18-20 and 35 under 35 U.S.C. 102(a)(1) as being anticipated by Raitano et al. (WO 01/62925 A2; cited on PTO-892 mailed on 01/16/2026) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to incorporate claims 1-2, which is necessitated by applicants’ amendment to the claims to recite “a vector comprising nucleic acid encoding a peptide…” in claims 1-2.
Claims 1-2, 7-13, 15-16, 18-20 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raitano et al. (WO 01/62925 A2; cited on PTO-892 mailed on 01/16/2026).
12. With respect to claims 1 and 2, Raitano et al. teach a vector comprising a nucleic acid encoding peptides of the genes 103P2D6 that comprise the amino acid sequence that is 100% identical to SEQ ID NO: 1, wherein the peptide comprises no more than 21 amino acids and wherein the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues [see Abstract; p. 2-3; p. 13; alignment attached as APPENDIX A]. Raitano et al. teach the vector wherein the vector is selected from adenovirus and poxvirus vectors [see p. 19, bottom; p. 47].
With respect to claim 7, Raitano et al. teach the vector wherein the vector is selected from adenovirus vector [see p. 19, bottom; p. 47].
With respect to claim 8, Raitano et al. teach an isolated cell comprising the one or more nucleic acids or vectors comprising the nucleic acid [see p. 19, bottom].
With respect to claim 9, Raitano et al. teach the cell wherein the cell is a human prostate cancer cell [see p. 19, bottom to top of p. 20].
With respect to claim 10, Raitano et al. teach the cell wherein the cell is a antigen presenting cell or tumor cell [see p. 19, bottom to top of p. 20; p. 27, top].
With respect to claim 11, Raitano et al. teach a composition comprising the a nucleic acid encoding peptides of the genes 103P2D6 that comprise the amino acid sequence that is 100% identical to SEQ ID NO: 1, wherein the peptide comprises no more than 21 amino acids and wherein the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues [see Abstract; p. 2-3; p. 13; alignment attached as APPENDIX A] and a pharmaceutically acceptable carrier [see p. 51, lines 21-27].
With respect to claim 12, Raitano et al. teach the composition further comprising an immune modulator [see p. 44, bottom].
With respect to claim 13, Raitano et al. teach the composition wherein the immunostimulatory/regulatory molecule is IL-2 or dendritic cells that express IL-12 [see p. 44, bottom; p. 47-48].
With respect to claim 15, Raitano et al. teach the composition further comprising a chemotherapeutic drug, radioactive agent, and hormone antagonist [see p. 8, lines 3-14; p. 43].
With respect to claim 16, Raitano et al. teach the composition further comprising doxorubicin (topoisomerase inhibitor) and taxol (spindle poison) [see p. 8, lines 3-14].
With respect to claim 18, Raitano et al. teach the composition further comprising one or more adjuvants [see p. 61].
With respect to claim 19, Raitano et al. teach the composition wherein the one or more adjuvants is incomplete Freund’s adjuvant [see p. 61, top].
With respect to claim 20, Raitano et al. teach the composition further comprising granulocyte colony stimulating factor [see p. 44, bottom].
With respect to claim 35, Raitano et al. teach the composition further comprising doxorubicin [see p. 8, lines 3-14].
RESPONSE TO REMARKS: Beginning on p. 8 of applicants’ remarks, applicants in summary contend that Raitano et al. discloses certain polypeptide fragments, but as it relates to SEQ ID NO: 1, does not teach comprising at least 15 amino acids as recited by the claim.
This argument is found to be not persuasive because MPEP 2123.I states "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed.Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").” In the instant case, the reference as a whole teach the peptide comprises at least 15 amino acid residues [see Abstract; p. 2-3; p. 13]. Furthermore, Raitano et al. teach on p. 11 that “the proteins of the invention include those specifically identified herein, as well as allelic variants, conservative variants, analogs and homologs”.
Claim Rejections - 35 USC § 103
13. Claims 3 and 6 are newly rejected under 35 U.S.C. 103 as being unpatentable over Raitano et al. (WO 01/62925 A2; cited on PTO-892 mailed on 01/16/2026). This new grounds of rejection is necessitated by applicants’ amendment to the claims to exclude the species, SEQ ID NO: 4.
14. With respect to claim 3, Raitano et al. teach a vector comprising a nucleic acid encoding peptides of the genes 103P2D6 that comprise the amino acid sequence that is 100% identical to SEQ ID NO: 1, wherein the peptide comprises no more than 21 amino acids and wherein the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues [see Abstract; p. 2-3; p. 13; alignment attached as APPENDIX A]. Raitano et al. teach the vector wherein the vector is selected from adenovirus and poxvirus vectors [see p. 19, bottom; p. 47]. Raitano et al. further teach a peptide of the gene 103P2D6 having at least 93.2% identity with SEQ ID NO: 7 with the exception of a leucine in place of the valine in position 9 [see alignment attached as APPENDIX A].
With respect to claim 6, Raitano et al. teach a vector comprising a nucleic acid that encodes at least two peptides of the genes 103P2D6 [see p. 16, lines 21-29; p. 19, bottom].
Although Raitano et al. does not explicitly teach the peptide comprises or consists of SEQ ID NO: 7, Raitano et al. does teach the proteins of the invention include those specifically identified herein, as well as allelic variants, conservative variants, analogs and homologs [see p. 11]. As such, it would have been obvious for one of ordinary skill in the art to substitute a valine in place of a leucine in position 9 of the peptide of SEQ ID NO: 7 because one of ordinary skill in the art would recognize that a valine is a conservative substitution for a leucine. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
15. The rejection of claim 14 under 35 U.S.C. 103 as being unpatentable over Raitano et al. (WO 01/62925 A2; cited on PTO-892 mailed on 01/16/2026) in view of Fallon et al. (Oncotarget, 2014; cited on PTO-892 mailed on 01/16/2026) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in view of the modified 102 rejection set forth above.
16. The relevant teachings of Raitano et al. as applied to claims 1-2, 7-13, 15-16, 18-20 and 35 are set forth in the 102(a)(1) rejection above.
With respect to claim 14, Raitano et al. teach a nucleic acid encoding peptides of the genes 103P2D6 that comprise the amino acid sequence that is 100% identical to SEQ ID NO: 1, wherein the peptide comprises no more than 21 amino acids and wherein the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues [see Abstract; p. 2-3; p. 13; alignment attached as APPENDIX A] in combination with immune modulators for use in cancer therapeutics such as vaccines [see Abstract; p. 3, top; p. 44, bottom].
However, Raitano et al. does not teach the composition of claim 14, wherein the IL-12 is in the form of an immunocytokine composed of two IL-12 heterodimers fused to the NHS76 antibody.
Fallon et al. teach fusion of two heterodimers of IL-12 to the NHS76 antibody and combining with a cancer vaccine, radiation, or chemotherapy resulted in greater antitumor effects than each individual therapy alone [see Abstract; p. 1870; Figure 1].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Raitano et al. and Fallon et al. according to the teachings of Fallon et al. to include two heterodimers of IL-12 to the NHS76 antibody in the compositions of Raitano et al. because Raitano et al. teach immune peptides in combination with immune modulators for cancer vaccines. Fallon et al. teach fusion of two heterodimers of IL-12 to the NHS76 antibody and combining with a cancer vaccine, radiation, or chemotherapy resulted in greater antitumor effects than each individual therapy alone. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability and would be motivated to combine the teachings of Raitano et al. and Fallon et al. because Fallon et al. acknowledges that fusion of two heterodimers of IL-12 to the NHS76 antibody and combining with a cancer vaccine, radiation, or chemotherapy resulted in greater antitumor effects than each individual therapy alone. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 9 of applicants’ remarks, applicants in summary contend that Fallon et al. does not remedy the deficiencies of Raitano et al.
This argument is found to be not persuasive for the reasons set forth above regarding Raitano et al.
17. The rejection of claims 17 and 21 under 35 U.S.C. 103 as being unpatentable over Raitano et al. (WO 01/62925 A2; cited on PTO-892 mailed on 01/16/2026) in view of Schlom et al. (WO 97/35021; cited on PTO-892 mailed on 01/16/2026) is maintained for the reasons for the reasons of record and the reasons set forth below.
18. The relevant teachings of Raitano et al. as applied to claims 1-2, 7-13, 15-16, 18-20 and 35 are set forth in the 102(a)(1) rejection above.
With respect to claims 17 and 21, Raitano et al. teach a nucleic acid encoding peptides of the genes 103P2D6 that comprise the amino acid sequence that is 100% identical to SEQ ID NO: 1 and 4, wherein the peptide comprises no more than 21 amino acids and wherein the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues [see Abstract; p. 2-3; p. 13; alignment attached as APPENDIX A] in combination with immune modulators for use in cancer therapeutics such as vaccines [see Abstract; p. 3, top; p. 44, bottom]. Raitano et al. further teach that nucleic acids encoding peptides are analogous to well established methods similarly employed using PSA polynucleotides [see p. 12-14].
Although Raitano et al. does not explicitly teach the composition of claim 17, further comprising a vector comprising a nucleic acid encoding a PSA and liposomes of claim 21 this modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of Schlom et al. Schlom et al. teach vectors comprising nucleic acids encoding PSA epitopes used in combination with adjuvants and liposomes for the treatment of prostate cancer [see Abstract; p. 3-4; p. 19]. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine the teachings of Raitano et al. and Schlom et al. because Schlom et al. acknowledges that vectors comprising nucleic acids encoding PSA epitopes are suitable for cancer treatment for prostate cancer. Therefore, the above invention would have been prima facie to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 10 of applicants’ remarks, applicants in summary contend that Schlom et al. does not remedy the deficiencies of Raitano et al.
This argument is found to be not persuasive for the reasons set forth above regarding Raitano et al.
19. The rejection of claim 36 under 35 U.S.C. 103 as being unpatentable over Raitano et al. (WO 01/62925 A2; cited on PTO-892 mailed on 01/16/2026) in view of Wang-Johanning et al. (WO 2014/004385 A2; cited on PTO-892 mailed on 09/11/2025) is maintained for the reasons for the reasons of record and the reasons set forth below.
20. The relevant teachings of Raitano et al. as applied to claims 1-2, 7-13, 15-16, 18-20 and 35 are set forth in the 102(a)(1) rejection above.
With respect to claim 36, Raitano et al. teach a nucleic acid encoding peptides of the genes 103P2D6 that comprise the amino acid sequence that is 100% identical to SEQ ID NO: 1 and 4, wherein the peptide comprises no more than 21 amino acids and wherein the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues [see Abstract; p. 2-3; p. 13; alignment attached as APPENDIX A] in combination with immune modulators and adjuvants for use in cancer therapeutics such as vaccines [see Abstract; p. 3, top; p. 44, bottom].
However, Raitano et al. does not teach the composition of claim 36, wherein one or more adjuvants is selected from the group consisting of aluminum phosphate, aluminum hydroxide, aluminum silica, and combinations thereof.
Wang-Johanning et al. teach nucleic acids encoding peptides of no more than 21 residues in length for the use in vaccine formulations comprising aluminum hydroxide adjuvants for stimulating antigenic response to cancer cells [see Abstract; p. 3; p. 15; p. 28].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Raitano et al. and Wang-Johanning et al. according to the teachings of Wang-Johanning et al. to include aluminum hydroxide adjuvants in the compositions of Raitano et al. because Raitano et al. teach compositions comprising nucleic acids encoding peptides in combination with adjuvants for the treatment of cancer. Wang-Johanning et al. teach similar compositions and teach that aluminum hydroxide is a suitable adjuvant for these compositions. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine the teachings of Raitano et al. and Wang-Johanning et al. because Wang-Johanning et al. acknowledges that aluminum hydroxide is a suitable adjuvant. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 10 of applicants’ remarks, applicants in summary contend that Wang-Johanning et al. does not remedy the deficiencies of Raitano et al.
This argument is found to be not persuasive for the reasons set forth above regarding Raitano et al.
Conclusion
21. Status of the claims:
Claims 1-3, 6-30, 32, and 35-36 are pending.
Claims 22-30 and 32 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-3, 6-21 and 35-36 are rejected.
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 PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656
APPENDIX A
Raitano et al. with SEQ ID NO: 1
Query Match 100.0%; Score 44; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RLLEGNFSL 9
|||||||||
Db 1 RLLEGNFSL 9
Raitano et al. with SEQ ID NO: 7
Query Match 93.2%; Score 41; Length 9;
Best Local Similarity 88.9%;
Matches 8; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RLLEGNFSV 9
||||||||:
Db 1 RLLEGNFSL 9
Prosecution Insights