Detailed 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11 July 2025 has been entered.
Election/Restrictions
The elected Species A is allowable. The species requirement among particular CTLA-4 antibodies, as set forth in the Office action mailed on 4 April 2024, has been reconsidered in view of the allowability of the elected species pursuant to MPEP § 821.04(a). The species requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the species requirement of a single and specific CTLA-4 antibody with no wildcard positions is withdrawn.
In view of the above noted withdrawal of the species 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Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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 1-48 were originally filed 13 March 2021. The preliminary amendment filed 19 March 2021 has been entered. In reply to Non-final (referred to herein as Remarks) received 6 January 2025 claims 2, 5, 8, 10, and 35-48 were canceled and claims 49-51 were added. In a Request for Continued Examination (RCE) received 11 July 2025 claims 7, 9, 11-16, and 49 were canceled while claims 52 and 53 are newly added. Claims 1, 3, 4, 6, 17-29, 34, and 50-53 are pending and under consideration.
Withdrawn Objections
In view of Applicant canceling claims 12 and 16 the claim objections over said claims are hereby withdrawn.
Withdrawn Rejections
In view of Applicant amending claims 1 and 34 and canceling claim 49 the 35 USC 112(a) rejections (i.e., enablement and written description) of claims 1, 3, 4, 6, 18-29, 34, and 50-51 are hereby withdrawn.
In view of Applicant amending claim 1 to recite particular sets of 6 CDRs with no wildcard positions and canceling claims 7-15 and 49 the 35 USC 112(b) rejection of claims 7, 9, 11-13, 15, 17, 18, and 49 are hereby withdrawn.
Claim Objections
Claims 1 and 34 are objected to because of the following informalities:
Claims 1 and 34 parts (c) and (d) recite identical sequences and therefore either part (c) or (d) should be removed.
Claim 34 recites, “which expresses a chimeric receptor” in lines 1-2 and should recite, “which expresses a chimeric antigen receptor”.
Appropriate correction is required.
Claims 3, 4, 6, 17-29, and 50-53 are objected to for depending from an objected claim.
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 22 and 23 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 22 recites the limitation "the antibody’s antigen binding site" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 is drawn to wherein the antibody is “masked to allow protease mediated activation”. The scope of the structure is unclear. For example, is the claim drawn to two structures (i.e., a complex) wherein a first protease susceptible structure (i.e., not connected to the antibody) is in complex with a second structure the antigen binding site, or alternatively, is the claim drawn to a single structure wherein the protease susceptible domain is linked to the monoclonal CTLA-4 antibody. Furthermore, it is unclear if the claim is drawn to structures wherein the antibody is actively masked or alternatively encompasses the antibody after protease mediated activation.
Claim 23 is drawn to wherein the antibody contains an altered IgG1 Fc fragment which comprises K214R. The scope of K214R is unclear. For example is K214R a position according to a full length antibody (i.e., heavy and light chain) starting with position 1 of the VH or VL, alternatively, is the position relative to a particular IgG1 sequence. In addition, there are several art recognized number schemes for various antibody regions and it is unclear which if any are being used. It is also unclear if the “altered IgG1 fragment” comprises the K214R substitution or alternatively is the K214R substitution in addition to an “altered IgG1 fragment”.
Conclusion
No claim allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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, Daniel E. Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.A.P./ Examiner, Art Unit 1644
/AMY E JUEDES/ Primary Examiner, Art Unit 1644