Prosecution Insights
Last updated: April 19, 2026
Application No. 18/556,172

CHIMERIC ANTIGEN RECEPTORS TO SIALYL-TN GLYCAN ANTIGEN

Non-Final OA §112§DP
Filed
Oct 19, 2023
Examiner
WEN, SHARON X
Art Unit
1641
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Yeda Research & Development Co. Ltd.
OA Round
1 (Non-Final)
57%
Grant Probability
Moderate
1-2
OA Rounds
3y 9m
To Grant
88%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allow Rate
349 granted / 613 resolved
-3.1% vs TC avg
Strong +32% interview lift
Without
With
+31.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
40 currently pending
Career history
653
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
20.8%
-19.2% vs TC avg
§102
23.1%
-16.9% vs TC avg
§112
30.4%
-9.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 613 resolved cases

Office Action

§112 §DP
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Applicant’s amendment, filed 10/19/2023, has been entered. Claims 1-41 have been canceled. Claims 42-61 are pending and currently under examination. Independent Claim 42. A chimeric antigen receptor (CAR) comprising an antigen- binding domain that binds specifically to Sialyl Tn glycan (STn), wherein the antigen-binding domain comprises three complementarity determining regions (CDRs) of a heavy-chain variable domain (VH) having an amino acid sequence as set forth in SEQ ID NO: 1 and three CDRs of a light-chain variable domain (VL) having an amino acid sequence as set forth in SEQ ID NO: 2. 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. Claim 61 is 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 present claims are drawn to a method of treating cancer comprising administering cells comprising STn-specific CAR . The breadth of the claims encompasses treating any cancer. However, the instant specification, as filed, does not provide sufficient enabling description for treating the full scope of the diseases encompassed by the claims because there does not appear to be sufficient in vitro or in vivo evidence to support administering the cells comprising STn-specific CAR to prevent or ameliorate the symptoms of all the diseases encompassed by the claims. For example, the instant specification disclosed that cancer include “ endometrial carcinoma, ovarian carcinoma, prostate adenocarcinoma, seminoma, diffuse type gastric adenocarcinoma, pancreatic and colon adenocarcinomas, lung adenocarcinoma and mantle cell lymphoma. According to some embodiments, cancer is pancreatic colon. ” (see S pecification paragraph 0084 ). One of skill in the art is well-aware that uterine carcinosarcoma, a species of endometrial carcinoma , is a rare and very aggressive tumor that is difficult to treat (see Cantrell et al.). However, the instant disclosure does not provide sufficient in vitro or in vivo evidence showing the administration of a cell comprising STn-specific CAR can counter-act the manifestation of uterine carcinosarcoma in order to treat the cancer. Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, i.e. the protein may not be able to cross the mucosa or the protein may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal , 23 USPQ2d 1334 (PTO Bd. Pat App. & Inter. 1992). The specification does not adequately teach how to effectively prevent or treat the breadth of diseases or reach an appropriate beneficial therapeutic endpoint in by administering the antibody. The specification does not teach how to extrapolate data obtained from various in vitro or in vivo observations as well as clinical experience with the fusion protein to the development of effective methods of preventing or treating plethora of the diseases broadly encompassed by the claimed invention. There is insufficient guidance and direction as well as objective evidence provided for treating the scope of diseases encompassed by the claimed method. In view of the lack of predictability of the art (e.g., treating a cancer) to which the invention pertains, undue experimentation would be required to practice the claimed method of treating any cancer with a reasonable expectation of success, absent a specific and detailed description in applicant's specification of how to effectively use the claimed agent and absent working examples providing evidence which is reasonably predictive that the claimed agent is effective for treating any cancer commensurate in scope with the claimed invention. Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute ) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claim s 42-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 53-72 of copending Application No. 18/556,161 . The copending claims of the reference application disclosed a CAR comprising scFv comprising the same VH and VL domain sequences as presently claimed CAR (see e.g., claim 57 of copending application) . The VH and VL sequences of the scFV recited in the copending claims are the same as those claimed in the present applications (i.e., same SEQ ID NOs: 1 and 2). Furthermore, the disclosed monoclonal antibody by the copending claims would also have rendered obvious of the presently claimed CAR given that the antigen binding domain of a CAR is derived from the antigen binding domains of the monoclonal antibody. The co-pending claims also disclosed a method of treating cancer comprising administering the CAR. Therefore, the copending claims would anticipate the present claims. This is a provisional nonstatutory double patenting rejection. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SHARON X WEN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3064 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 8-5 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Misook Yu can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0839 . 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. /SHARON X WEN/ Primary Examiner, Art Unit 1641
Read full office action

Prosecution Timeline

Oct 19, 2023
Application Filed
Mar 21, 2026
Non-Final Rejection — §112, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
57%
Grant Probability
88%
With Interview (+31.5%)
3y 9m
Median Time to Grant
Low
PTA Risk
Based on 613 resolved cases by this examiner. Grant probability derived from career allow rate.

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