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. Claims 1-30, 32, and 35-36 are pending.
Election/Restrictions
3. Applicant's election with traverse of Group II, claims 4-21 and 35-36, in the reply filed on 12/08/2025 is acknowledged. The traversal is on the ground(s) that there is substantial overlap in claims common to both Groups I and II and that a search of Groups I and II can be accomplished without substantial or undue burden on the part of the Office. This is not found persuasive because Applicant is reminded that the evidence of burden of search does not apply to examination of PCT applications upon entering the national stage. MPEP § 1893.03(d) states"the principles of unity of invention are used to determine the types of claimed subject matter and the combinations of claims to different categories of invention that are permitted to be included in a single international or national stage patent application." See MPEP § 1850 for a detailed discussion of Unity of Invention. The basic principle is that an application should relate to only one invention or, if there is more than one invention, that applicant would have a right to include in a single application only those inventions which are so linked as to form a single general inventive concept." A group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature.
The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art. In the instant case, the technical feature of peptides for the inhibition of cancer considered as a whole does not make a contribution over the prior art for the reasons set forth in the Restriction Requirement mailed on 09/11/2025 and the rejections set forth below.
The requirement is still deemed proper and is therefore made FINAL.
4. Applicants’ election of nucleic acid encoding the peptide of SEQ ID NO: 7 in the response filed on 12/08/2025 is acknowledged. Upon a search of SEQ ID NO: 7, SEQ ID NO: 1 and SEQ ID NO: 4 were also found in the prior art. To this end, election of species requirement between the nucleic acid encoding SEQ ID NO: 1, 4, and 7 is hereby withdrawn.
In view of the above noted withdrawal of the election of species 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.
5. Claims 1-3, 22-30, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/08/2025.
Claims 4-21 and 35-36 will be examined to the extent that they read on a nucleic acid encoding the peptide comprising the amino acid sequence of SEQ ID NO: 1, 4, and 7.
Priority
6. Acknowledgement is made of applicants’ claimed domestic priority to U.S. Provisional Application No. 62/963,872, filed on 01/21/2020.
Drawings
7. The Drawings filed on 07/19/2022 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 101
8. 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.
9. Claims 4-6, 8-11 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more. The claim(s) 4 recite(s) a nucleic acid encoding the peptide of SEQ ID NO : 1, 4 and 7, wherein the peptide comprises no more than 21 amino acid residues, and wherein when the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues. Claims 5-6 are drawn to a vector comprising the nucleic acid of claim 4. Claims 8-10 are drawn to an isolated cell comprising one or more nucleic acids encoding the peptide of claim 1, or one or more vectors comprising a nucleic acid of claim 4. Claims 11 and 18 are drawn to a composition comprising one or more nucleic acids encoding the peptides of claim 1, vectors comprising a nucleic acid of claim 4, or cells comprising one or more of nucleic acids encoding the peptides of claim 1. This judicial exception is not integrated into a practical application because although the claimed nucleic acid has a different structural characteristic than the naturally occurring gene because the chemical bons at each end were broken in order to isolate it, the claimed nucleic acid has the same sequence of the naturally occurring sequence. The claimed sequences are endogenous retrovirus sequences that are remnants of retrovirus germ line infections early in primate evolution and represent 8% of the human genome as evidenced by applicants’ own disclosure set forth in paragraph 0004. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional features recited in the claims to sufficiently transform the natural product into something significantly more because a vector, cell and composition are recited at such a high degree of generality that they encompass the natural genome and cell in which the nucleic acid is found. Accordingly, the products of claims 4-6, 8-11 and 18 are not eligible subject matter under 35 U.S.C. 101. It is suggested that the claims be amended to recite features that would amount to significantly more than the natural product such as limitations recited in non-rejected claims.
Claim Rejections - 35 USC § 102
10. 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.
11. Claim(s) 4-13, 15-16, 18-20, and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raitano et al. (WO 01/62925 A2; examiner cited).
12. Claim 4 is drawn in relevant part to a nucleic acid encoding the peptide comprising the amino acid sequence of any one of SEQ ID NO: 1, 4, and 7, wherein the peptide comprises no more than 21 amino acid residues, and wherein when the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues.
Claims 5-7 are drawn in relevant to a vector comprising the nucleic acid of claim 4.
Claims 8-10 are drawn in relevant part to an isolated cell comprising one or more nucleic acids encoding the peptide comprising the amino acid sequence of any one of SEQ ID NO: 1, 4, and 7, wherein the peptide comprises no more than 21 amino acid residues, and wherein when the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues or one or more vectors comprising the nucleic acid.
Claims 11-13, 15-16, 18-20, and 35 are drawn in relevant part to a composition comprising one or more nucleic acids encoding the peptide comprising the amino acid sequence of any one of SEQ ID NO: 1, 4, and 7, wherein the peptide comprises no more than 21 amino acid residues, and wherein when the peptide comprises SEQ ID NO: 1, the peptide comprises at least 15 amino acid residues, one or more vectors comprising the nucleic acid, or cells comprising one or more of nucleic acids or vectors and a pharmaceutically acceptable carrier.
13. With respect to claim 4, 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].
With respect to claim 5, Raitano et al. teach a vector comprising the nucleic acid of claim 4 [see p. 19, bottom].
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].
With respect to claim 7, 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 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 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] and a pharmaceutically acceptable carrier [see p. 51, lines 21-27].
With respect to claim 12, Raitano et al. teach the composition further comprising a 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].
Claim Rejections - 35 USC § 103
14. 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.
15. Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raitano et al. (WO 01/62925 A2; examiner cited) in view of Fallon et al. (Oncotarget, 2014; examiner cited).
16. The relevant teachings of Raitano et al. as applied to claims 4-13, 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 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].
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.
17. Claims 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Raitano et al. (WO 01/62925 A2; examiner cited) in view of Schlom et al. (WO 97/35021; examiner cited).
18. The relevant teachings of Raitano et al. as applied to claims 4-13, 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.
19. Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Raitano et al. (WO 01/62925 A2; examiner cited) in view of Wang-Johanning et al. (WO 2014/004385 A2; cited on PTO-892 mailed on 09/11/2025).
20. The relevant teachings of Raitano et al. as applied to claims 4-13, 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.
Conclusion
21. Status of the claims:
Claims 1-30, 32, and 35-36 are pending.
Claims 1-3, 22-30, and 32 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 4-21 and 35-36 are rejected.
No claims are in condition for an allowance.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/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: 4
Query Match 100.0%; Score 41; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 LQLTLTAFL 9
|||||||||
Db 1 LQLTLTAFL 9