Prosecution Insights
Last updated: April 19, 2026
Application No. 17/631,830

T CELL RECEPTORS AND METHODS OF USE THEREOF

Final Rejection §112
Filed
Jan 31, 2022
Examiner
SHUPE, ELIZABETH A
Art Unit
1643
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
UNIVERSITY HEALTH NETWORK
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
37 granted / 59 resolved
+2.7% vs TC avg
Strong +47% interview lift
Without
With
+46.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
53 currently pending
Career history
112
Total Applications
across all art units

Statute-Specific Performance

§101
3.2%
-36.8% vs TC avg
§103
25.1%
-14.9% vs TC avg
§102
18.7%
-21.3% vs TC avg
§112
33.8%
-6.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 59 resolved cases

Office Action

§112
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. Application Status The amended claims filed January 5, 2026 are acknowledged. Claims 1, 16, 18, 24, and 37 have been amended. Claims 3-4, 6, 10, 29, 88, 98, 100, and 105 have been canceled. Claims 108-116 are newly added. Claims 1, 16, 18, 24, 26, 32, 37, 61, 68, 71, 85, and 108-116 are pending and under examination herein. Objections to the Specification Withdrawn All prior grounds of objection to the specification are withdrawn in view of Applicant's amendments thereto. Claim Objections Withdrawn All prior objections to claim 18 are rendered moot by the cancelation of the claims. The prior grounds of objection over claims 16 and 24 are withdrawn in view of Applicant's amendments thereto. Claim Rejections Withdrawn All prior grounds of rejection over claims 3-4, 6, 10, 29, 88, 98, 100, and 105 are rendered moot by the cancelation of the claims. The rejection of claims 16 and 18 under 35 U.S.C. § 112(b) is withdrawn in view of Applicant's amendments to the claims. The rejection of claims 1, 16, 18, 24, 26, 32, 37, 61, 68, 71, and 85 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement is withdrawn in view of Applicant's amendments to claim 1. The rejections of claims 1, 16, 18, 24, 26, 32, 37, 61, 68, 71, and 85 under 35 U.S.C. § 103 are withdrawn in view of Applicant's amendments to claim 1 to incorporate the subject matter of claim 10 (now canceled). NEW OBJECTIONS AND REJECTIONS NECESSITATED BY CLAIM AMENDMENT Claim Objections (New) Claims 16 and 11 4 -11 5 are objected to because of the following informalities: Claim 16 newly recites that the anti-MAGE-A2 TCR further comprises an alpha chain variable domain, wherein said alpha chain variable domain comprises the amino acid sequence “set forth SEQ ID in NO: 1”. It is suggested this be amended to “set forth in SEQ ID [[in]] NO: 1” for clarity. Claims 11 4 -11 5 recite that the cell of the previous claim is “an ILC cell”. The specification defines “ILC” as “innate lymphoid cell” (e.g., at ¶ 0165), which renders this phrasing redundant (i.e., “innate lymphoid cell cell”). Appropriate correction is required. Claim Rejections - 35 USC § 112 (b) (New) 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. Claim s 16 and 116 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 16 recites that the alpha chain variable domain of the anti-MAGE-A2 TCR comprises the amino acid sequence set forth in SEQ ID NO: 1, while the beta chain variable domain of the anti-MAGE-A2 TCR comprises the amino acid sequence set forth in SEQ ID NO: 2. However, the specification sets forth that SEQ ID NOs: 1 and 2 refer to (full-length) alpha and beta chains, respectively, which comprise both a variable domain and a constant domain. See, e.g., ¶ 0006-0020 or Table 3 (pages 26-27) of the specification . This fact pattern is also supported by the limitations set forth in claims 18, 24, and 108. Claim 16 is thus indefinite because it is unclear how the alpha and beta chain variable domains can comprise the amino acid sequences of SEQ ID NOs: 1 and 2, respectively, when these sequences a re not strictly variable domain sequences based on Applicant's disclosure. Regarding claim 116 , t he claim is indefinite because the claim recites “( including non T cell ALL )” in parentheses in line 12 and th ese term s are not defining the term preceding it . This renders the claim indefinite because it is unclear if the phrase in parentheses is limiting or merely exemplary of a species of acute lymphoblastic leukemia (ALL) that satisfies the limitations of the claim . Accordingly, the metes and bounds of the claims cannot be determined and the invention is not set forth with the clarity and particularity necessary to satisfy the requirement set forth in 35 U.S.C. § 112(b) so as permit the skilled artisan to know or determine infringing subject matter. Allowable Subject Matter Claims 1, 18, 24, 26, 32, 37, 61, 68, 71, 85, and 108-11 3 are allowable . The instantly claimed nucleic acid molecule recited in claim 1 , comprising ( a ) a first nucleotide sequence encoding a recombinant TCR or antigen-binding portion thereof that specifically binds to an HLA-DP-restricted MAGE-A2 epitope consisting of the amino acid sequence of instant SEQ ID NO: 13, wherein the recombinant TCR comprises an alpha chain variable region comprising CDRs having the amino acid sequences of SEQ ID NOs: 5-7, respectively, and a beta chain variable region comprising CDRs having the amino acid sequences of SEQ ID NOs: 8-10, respectively, and ( b ) a second nucleotide sequence that inhibits the expression of an endogenous TCR, appears to be free of the prior art. Chinnasamy ( The Journal of Immunology (2011) 186: 685-696; cited in PTO-892 mailed September 5, 2025) discloses TCR constructs targeting HLA*A0201-restricted epitopes of MAGE-A3 that showed co-reactivity to a subsequence (residues 112-120) of the MAGE-A2 epitope consisting of instant SEQ ID NO: 13 . However , Chinnasamy does not disclose that the earlier taught TCR constructs comprise the specifically claimed combination of alpha chain and beta chain CDRs set forth in the instant claims. With respect to the presently claimed TCRα chain comprising the amino acid sequences of SEQ ID NO: 1, Bear (US 2022/0088190 A1; earliest priority date: January 25, 2019) discloses a TCR construct “TCR896” that specifically binds to mutant RAS peptide having a G12V mutation, wherein the TCR896 construct comprises a TCRα chain compris ing the amino acid sequence of SEQ ID NO: 61 (e.g., Abstract; ¶ 0257-0279) , which shares 98.9% sequence identity to instant SEQ ID NO: 1 . For said TCRα chain, r esidues 47-53 share 100% sequence identity to instant SEQ ID NO: 5, residues 71-78 share 100% sequence identity to instant SEQ ID NO: 6, and residues 112-124 share 77.7% sequence identity to instant SEQ ID NO: 7. With respect to the presently claimed TCRβ chain comprising the amino acid sequence of instant SEQ ID NO: 2, van Dijk (US 2020/0308246 A1; earliest priority date: September 4, 2018) discloses a TCR construct “TCR0084” that specifically binds to an RVR[ pS ]PTRSP-peptide complex , wherein the TCRβ chain comprises the amino acid sequence of SEQ ID NO: 69 (e.g., Abstract; ¶ 0035-0042; Table 1 at page 26), which shares 97.9% sequence identity to instant SEQ ID NO: 2 . For said TCRβ chain, residues 27-32 share 100% sequence identity to instant SEQ ID NO: 8, residues 49-54 share 100% sequence identity to instant SEQ ID NO: 9, and residues 92-106 share 61.9% sequence identity to instant SEQ ID NO: 10 . Taken together, Bear and van Dijk do not teach or suggest a recombinant TCR having the specifically claimed combination of three TCRα CDRs and three TCRβ CDRs set forth in the present claims, having specificity for a specific epitope of MAGE-A2. Conclusion 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 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 FILLIN "Enter examiner's name" \* MERGEFORMAT Elizabeth A Shupe whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703) 756-1420 . The examiner can normally be reached FILLIN "Work schedule?" \* MERGEFORMAT Monday to Friday, 9:30am - 6:00pm 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, FILLIN "SPE Name?" \* MERGEFORMAT Julie Wu can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-5205 . 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. /ELIZABETH A SHUPE/ Examiner, Art Unit 1643 /JULIE WU/ Supervisory Patent Examiner, Art Unit 1643
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Prosecution Timeline

Jan 31, 2022
Application Filed
Aug 29, 2025
Non-Final Rejection — §112
Jan 05, 2026
Response Filed
Mar 30, 2026
Final Rejection — §112 (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

3-4
Expected OA Rounds
63%
Grant Probability
99%
With Interview (+46.9%)
3y 6m
Median Time to Grant
Moderate
PTA Risk
Based on 59 resolved cases by this examiner. Grant probability derived from career allow rate.

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