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 .
Claims Status
The amendments and remarks filed 06/09/2026 are acknowledged.
Claims 21-40 are pending.
Claims 1-20 are cancelled.
Applicant’s election without traverse of Group I, claims 21, 25, 26, and 40 in the reply filed on 06/09/2026 is acknowledged.
Claims 22-24 and 27-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/09/2026.
Therefore, claims 21, 25, 26, and 40 are under examination.
Priority
The instant application claims priority to provisional applications 63/375,676 and 63/515,448. Priority is given with the earliest effective filing date of 09/14/2022.
Drawings
The drawings are objected to because Figures 1B, 2B, 2D, 3D, 4A-4C, 5, 6A-6B, 7B, 8A-8C, 9, 10, 13, 14, and 15 comprise multiple panels. 37 CFR 1.84(u) states that the different views must be numbered in consecutive Arabic numerals and that "partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter". Each panel should be separately numbered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: The specification lists SEQ ID NOs for skipped sequences (i.e. SEQ ID NOs: 14, 20, 27, and 43). See paragraphs 73-86. Applicant is required to remove the SEQ ID NOs for the skipped sequences and rely only upon the respective amino acid sequences. Appropriate correction is required.
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 21, 25, 26, and 40 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation of a PD-1 agonist antibody comprising SEQ ID NOs: 32, 35, and 34 for the VH CDRs 1-3, respectively, and SEQ ID NOs: 42, 43, and 45 for the VL CDRs 1-3, respectively. However, SEQ ID NO: 43 is a skipped sequence. While the specification does specify the three amino acid sequence for SEQ ID NO: 43 [see Table 1; paragraph 73], it is unclear if SEQ ID NO: 43 is referring to the respective amino acid sequence as listed in the specification or is referring to a different sequence since the sequence listing does not list the specific three amino acid sequence. Therefore, the scope of this claim is indefinite.
Claims 25, 26, and 40, which depend from claim 21, are therefore indefinite for the same reasons set forth above.
Applicant can overcome this rejection by amending claim 21 to recite the specific amino acid sequence instead of SEQ ID NO: 43.
Allowable Subject Matter
The Examiner searched SEQ ID NOs: 32, 35, and 34 for the VH CDRs 1-3 and SEQ ID NOs: 42, SAS, and 45 for the VL CDRs 1-3, respectively, for a PD-1 agonist antibody and found it to be free of the art. Therefore, if Applicant amends claim 21 to recite the three letter amino acid sequence instead of SEQ ID NO: 43, the pending claims would be allowable.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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