DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 13, 2026 has been entered.
Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment, and the declaration of Dr. Bertelsen filed under 37 CFR 1.132 showing unexpected results for the combination of AP205 capsid protein and HER-2 antigen.
Claims Summary
Claim 47 is directed to an immunogenic composition comprising:
AP205 (phage) capsid protein and a first peptide tag;
A HER-2 antigen or antigenic fragment thereof used to a second peptide tag;
wherein the HER-2 antigen or antigenic fragment thereof and the AP205 capsid protein are linked via an isopeptide bond between the first and second tag, forming a particles displaying the antigen. Claim 48 is directed to a method for the prophylaxis and/or treatment of cancer (claim 48 (elected species)), specifically breast cancer, gastric cancer, ovarian cancer, and/or uterine serous carcinoma (claim 49).
Claim 50 is directed to a vaccine comprising:
A virus capsid protein comprising a first peptide tag; and
HER-2 or an antigenic fragment thereof fused to a second peptide tag,
wherein the HER-2 antigen or antigenic fragment thereof and the virus capsid protein are linked via an isopeptide bond between the first and second tag, forming VLPs displaying the antigen.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New Rejection) Claims 48 and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inducing an immune response against HER-2, does not reasonably provide enablement for prophylaxis (prevention) or prophylaxis of any type of cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claims encompasses a method for preventing cancer in a subject, specifically breast cancer, gastric cancer, ovarian cancer and uterine serous carcinoma. Prevention encompasses embodiments wherein the subject never develops cancer, or the subject does not have recurring cancer.
The nature of the invention is the induction of an immune response to cancer antigen HER2, or an antigenic fragment thereof, that will serve to provide protection against the development of cancer prophylactically, or provide improvement in an existing cancer.
The specification mentions prevention of cancer and treatment of cancer but does not provide any examples of such. While the specification demonstrates that the compositions are immunogenic (see paragraphs [00572]-[00598] of the published applicant US 20230078675), immunogenicity alone is not a predictor of whether a human subject will be prevented from developing cancer, or whether an existing condition will be ameliorated. Mittendorf et al. (Cancer Immunol Immunother, 2008, 57:1511-1521) reports on experiments with a HER2 peptide (E75) to look at disease recurrence, concluding that while their single peptide composition shows promise because it is immunogenic, a multi-epitope strategy and adjuvant system should be considered for treatment and prevention of breast cancer (see abstract, and page 1519). Ladjemi et al. (Cancer Immunol Immunother, 2010, 59(9):1295-1312) notes that immunological tolerance to HER2 antigen is a barrier that must be addressed in developing a vaccine (see abstract). Zhu and Yu (Front. Immunol., 2022, Vol 13, Article 828386, 15 pages) confirms that HER2 peptides alone are not sufficient to induce a level of immunity that would qualify as protective (see section 4.1 on pages 7-8, including Table 2).
The declaration of Dr. Bertelsen filed under 37 CFR 1.132 on February 13, 2026 has been considered with respect to the animal experimentation performed with mice and the AP205-HER2 VLPs. The declaration demonstrates that the construct is immunogenic in mice and protects from tumor onset over the course of at least one year in some cases. In response to this data, despite these results, the concerns addressed in the art about HER2 immune tolerance are not addressed by these experiments since mice do not have natural immune tolerance to HER2.
In view of the breadth of the claims, the nature of the invention, the limited guidance in the specification, the limited working examples, the state of the art and low level of predictability (with regard to immunogenicity being extrapolated to treatment and protective efficacy), it would require undue experimentation to practice the claimed methods.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 47-50 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,086,056 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a species (particular sequences of AP205 and HER2) of the instantly claimed genus (generic AP205 and HER2). A species anticipates a genus.
Applicant’s argument filed February 13, 2026 is that the amended claims are patentably distinct. In response, the amendment to the claims specifies that the composition is immunogenic, changes some composition claims to method claims, and substitutes the phrase “particle-forming polypeptide” to “virus capsid protein”. These amendments do not have any impact on the merits of the rejection since the claimed subject matter is essentially the same, as outlined above. Therefore, the rejection is maintained.
Claims 47-50 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,526,376 B2 in view of Bachmann (US 20040076611, of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The patented claims do not specify the cancer antigen HER2. However, it would have been obvious to have claimed HER2 since patented claims 10 and 11 are directed to prophylaxis and/or treatment of cancer with a cancer-specific polypeptide. Given Bachmann’s disclosure of VLPs comprising HER2, it would have been obvious to have claimed HER2 in the patented claims, with a reasonable expectation of success.
Applicant’s argument filed February 13, 2026 is addressed above.
Claims 47-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,497,800 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The patented claims do not specify the cancer antigen HER2. However, it would have been obvious to have claimed HER2 since patented claims 10 and 11 are directed to prophylaxis and/or treatment of cancer with a cancer-specific polypeptide. Given Bachmann’s disclosure of VLPs comprising HER2, it would have been obvious to have claimed HER2 in the patented claims, with a reasonable expectation of success.
Applicant’s argument filed February 13, 2026 is addressed above.
Conclusion
No claim is allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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