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 .
Comment
Several attempts were made to resolve the outstanding rejections via Examiner’s Amendment without success.
Allowable Subject Matter
Claims 92 and 95-100 are free of the prior art and allowable.
Rejoinder
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 The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 8/4/2023 is partially withdrawn.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preventing an HPV infection (claim 103) and directed to a method of preparing a composition (claim 104) are no longer withdrawn from consideration because the claims require all the limitations of an allowable claim. However, claim 93, directed to a different pool of peptides (a different product from elected Group I), remains withdrawn from consideration because claim 93 does not require all the limitations of an allowable claim. Further, claims 105-112, directed to a method of inducing proliferation of HPV-specific cytotoxic T cells, remain withdrawn from consideration because claims 105-112 do not require all the limitations of an allowable claim.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Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Status of the Claims
Claims 93 and 105-112 are withdraw. Claims 92, 95-100 and 104 are under examination at this time.
Withdrawn Rejections
The rejection of claims 92 and 95-100 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been withdrawn in view of applicant’s amendments to claim 92.
The rejection of claims 92 and 96-99 under 35 U.S.C. 103 as being unpatentable over Sette et al. (U.S. Patent No. 7026443; published April 11, 2006) has been withdrawn in view of applicant’s amendments to the claims to recite that the pool includes i) at least one peptide that “consists of” any one of SEQ ID NOs: 8, 12 and 25 and ii) at least one additional HPV peptide that “consists of” any one of SEQ ID NOs: 1, 4-19 and 22-23.
Claim Objections
Claim 92 is objected to because of the following informalities: Claim 92 should recite “any one of SEQ ID NOs: 1, 4-19, and 22-23”. Appropriate correction is required.
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 (claim 101), treating and/or preventing cancer (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 (claim 101), treating and/or preventing any known cancer (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, cancer, 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, to treat and/or prevent any type of cancer, 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, against cancer 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, cancer, 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.
Conclusion
According to MPEP 706.07(a), if rejoinder occurs after a first Office action on the merits and if any of the rejoined claims are unpatentable (e.g., a rejection under 35 U.S.C. 112(a) is made), the next Office action may be made final if the rejection of the rejoined claims was necessitated by applicant’s amendment, or based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 821.04 et seq. for more information on rejoinder.
ACCORDINGLY, 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 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.
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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