ETAILED 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/4/2026 has been entered.
Status of the Claims
Claims 93 and 105-112 are withdraw. Claims 92, 95-100 and 104 are under examination at this time.
Rejoinder
Product claims 92 and 95-100 are allowable. The restriction requirement among Groups I to VII, as set forth in the Office action mailed on 8/4/2023, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 8/4/2023 is partially withdrawn. Claims 101-104, directed to a method of treating and/or preventing a precancerous condition (claim 101), treating and/or preventing cancer (claim 102) and treating and/or preventing an HPV infection (claim 103) and directed to a method of preparing a composition (claim 104) are no longer withdrawn from consideration because the claims require all the limitations of an allowable claim. However, claim 93, directed to a different pool of peptides (a different product from elected Group I), remains withdrawn from consideration because claim 93 does not require all the limitations of an allowable claim. Further, claims 105-112, directed to a method of inducing proliferation of HPV-specific cytotoxic T cells, remain withdrawn from consideration because claims 105-112 do not require all the limitations of an allowable claim.
In view of the above noted partial 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.
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.
Claims 101-103 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the nature of the invention, the state of the prior art, the breadth of the claims, the amount of guidance in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, and the quantity of experimentation necessary. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention. The claims are drawn to a method of treating and/or preventing a precancerous condition where the precancerous condition expresses a HPV epitope (claim 101), treating and/or preventing cancer where the cancer expresses a HPV epitope (claim 102) and treating and/or preventing an HPV infection (claim 103).
Breadth of the claims. The claims are very broad, encompassing a method of treating and/or preventing any known precancerous condition expressing an HPV epitope (claim 101), treating and/or preventing any known cancer expressing an HPV epitope (claim 102) and treating and/or preventing any HPV infection (claim 103).
Guidance in the Specification. There is insufficient disclosure to reasonably predict that the claimed peptide pool would treat or prevent a precancerous condition where the precancerous condition expresses a HPV epitope, cancer where the cancer expresses a HPV epitope, or an HPV infection. In addition, the disclosure fails to provide any guidance pertaining to the correlates of human protection. To date, it is not clear what type of immune response is required to provide a therapeutic benefit.
The disclosure also fails to provide any guidance pertaining to the development of a persistent and protective HPV-specific immune response using the claimed peptide pool. It is not readily apparent if the recited peptide pool will generate an HPV-specific immune response of sufficient magnitude and duration that long-lasting protection against HPV infection.
Working examples. There are working examples demonstrating the ability of certain HPV peptides to expand CD8+ and CD4+ T cells. However, there are no working examples demonstrating the use of the claimed peptide pool to treat and/or prevent any precancerous condition where the precancerous condition expresses a HPV epitope, to treat and/or prevent any type of cancer where the cancer expresses a HPV epitope, or to treat and/or prevent any type of HPV infection.
Amount of experimentation. Applicants have shown in vitro immunogenicity studies. It is not known whether the claimed pool of peptides has any effect against a precancerous condition where the precancerous condition expresses a HPV epitope, against cancer where the cancer expresses a HPV epitope or against HPV.
While the specification does contain statements regarding the use of the peptide pool as a vaccine, there is no indication that an HPV-specific immune response has been generated and that such a response, if generated, would be protective following exposure to HPV. Applicant has not provided any evidence in the instant specification that the disclosed peptides can treat or prevent a precancerous condition where the precancerous condition expresses a HPV epitope, cancer where the cancer expresses a HPV epitope, or an HPV infection following the administration of said peptide pool.
Given the breadth of the claims, the lack of guidance in the specification, and the lack of predictability of the art, it would require undue experimentation for one skilled in the art to use the claimed composition and method.
Accordingly, when all the aforementioned factors are considered in toto, it would require undue experimentation for one skilled in the art to practice the claimed invention.
Response to Arguments
In the reply dated 4/20/2026, applicant first argues that the specification provides an extensive and detailed disclosure that is sufficient to practice the claimed method without undue experimentation. Applicant’s arguments have been fully considered and not found persuasive.
The examples, which are directed to identification of HPV epitopes, generation of immunogenic compositions, demonstrating the ability of certain HPV peptides to expand CD8+ and CD4+ T cells, and immunogenicity studies, do not provide evidence that the claimed peptide pool can actually treat and/or prevent any precancerous condition where the precancerous condition expresses a HPV epitope, actually treat and/or prevent any type of cancer where the cancer expresses a HPV epitope, or actually treat and/or prevent any type of HPV infection.
While the specification does contain statements regarding the use of the peptide pool as a vaccine, there is no indication that an HPV-specific immune response has been generated in vivo and that such a response, if generated, would treat and/or prevent precancerous conditions related to HPV or cancer related to HPV or be protective following exposure to HPV. Applicant has not provided any evidence in the instant specification that the disclosed peptides can treat or prevent a precancerous condition where the precancerous condition expresses a HPV epitope, cancer where the cancer expresses a HPV epitope, or an HPV infection following the administration of said peptide pool.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 101 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 101 recites “wherein the precancerous condition expresses a HPV epitope”. Cells express proteins (epitopes). It is not clear how a “precancerous condition” expresses a HPV epitope. Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
Allowable Subject Matter
Claims 92, 95-100 and 104 are free of the prior art and allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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, 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.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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