DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 8/28/26 has been entered in full. The specification is amended. Replacement sheets are filed for Figures 1B, 2D and 2E.
Claims 1, 6, 9 and 16-17 are amended. Claims 3-5 are canceled. Claims 1-2 and 6-25 are pending.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (5/28/26).
The objections to Figures 1B and 2E at page 2 are withdrawn in view of the replacement sheets for these figures.
The objections to Figures 2G, 6, 8-11, 13 and 14 are withdrawn in view of Applicants’ persuasive arguments.
The objections to the specification at pages 3 and 4 are withdrawn in view of the substitute specification filed on 8/28/26.
The objections to claims 6-15 at page 4 are withdrawn in view of the amendments to the claims.
All rejections of, and/or objections to, cancelled claims 3-5 are moot.
The rejection of claims 1-2 and 6-15 under 35 U.S.C. § 112(a) at pages 4-8 for failing to comply with the written description requirement is withdrawn in view of the amendments to the claims.
The rejection of claims 1-2 and 6-15 under 35 U.S.C. 102(a)(1) as being anticipated by Deniger, WO 2019067243, published 4/4/19, is withdrawn in view of the amendments to the claims.
Rejoinder of Non-Elected Species
The claims are directed to a method allowable with respect to the elected species. As such, the election of species requirement is hereby withdrawn, and the previously non-elected species are hereby rejoined and fully examined.
Rejoinder of Process Claims
Claims 1-2 and 6-15 are directed to an allowable product (Group I of the restriction requirement mailed on 3/12/26). Pursuant to the procedures set forth in MPEP § 821.04(B), claims 16-25, directed to the process of using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 3/12/26 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are 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 the 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.
New Objections
Specification
The disclosure is objected to because of the following informalities:
On page 11, line 16, “derive R248L d from a p53 polypeptide” should be “derived from a p53 R248L polypeptide”.
Appropriate correction is required.
Claim Objections
Claims 17-18, 22 and 25 are objected to because of the following informalities:
In claim 17, line 3, the acronym “HLA” should be accompanied by the full terminology; e.g., “human leukocyte antigen (HLA)”.
In claim 18, lines 1-2, “comprising or consisting essentially” should be “comprises or consists essentially”.
Claim 22, line 10, is missing the word “antibody” following “an anti-IL-35 (interleukin 35)”.
In claim 25, line 3, “an anti-CD27 (cluster of differentiation 27) antibodies antibody” should be “an anti-CD27 (cluster of differentiation 27) antibody”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
New Rejections Necessitated by Applicants’ Amendment
Claim Rejections - 35 USC § 112(b)
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.
Claims 17-18 and 24-25 are 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 pre-AIA the applicant regards as the invention.
Claim 17 recites the limitation “said p53 R248L peptide in a peptide-HLA complex” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Specifically, parent claim 16 refers to a “p53 polypeptide comprising a R to L substitution at amino acid residues 248 (R to L)”, which is a p53 R248L polypeptide, but does not refer to a “p53 R24L peptide” to provide support for the recitation in the dependent claim.
Claim 18 also recites “said p53 R248 L peptide” which lacks antecedent basis in parent claim 16 for the same reasons as claim 17.
Claim 24 recites the limitation “said co-stimulator molecule”” in line 1. There is insufficient antecedent basis for this limitation in the claim. Specifically, parent claim 23 refers to a “a co-stimulatory molecule” rather than a “co-stimulator molecule” and thus the specific recitation in the dependent claim lacks sufficient antecedent basis in the parent claim.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above and encompass the same indefinite subject matter.
Conclusion
Claims 1-2, 6-16, 19-21 and 23 are allowed.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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