Office Action Predictor
Application No. 17/856,806

PROCESSES FOR PRODUCTION OF TUMOR INFILTRATING LYMPHOCYTES AND USES OF SAME IN IMMUNOTHERAPY

Non-Final OA §DP
Filed
Jul 01, 2022
Examiner
BELYAVSKYI, MICHAIL A
Art Unit
1644
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Iovance Biotherapeutics, INC.
OA Round
4 (Non-Final)
64%
Grant Probability
Moderate
4-5
OA Rounds
3y 1m
To Grant
91%
With Interview

Examiner Intelligence

64%
Career Allow Rate
697 granted / 1091 resolved
Without
With
+27.2%
Interview Lift
avg trend
3y 1m
Avg Prosecution
75 pending
1166
Total Applications
career history

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
29.0%
-11.0% vs TC avg
§102
9.7%
-30.3% vs TC avg
§112
10.9%
-29.1% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§DP
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 . RESPONSE TO APPLICANT’S AMENDMENT 1. Applicant’s submission of Terminal Disclaimers on 01/05/26 is acknowledged. 2. Upon discussion with the Examiner’s supervisor Dan Kolker, the following rejection remains: 3. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp. 3. Claims 1-30 are rejected, or provisionally rejected in the case where the reference is a pending application, on the ground of nonstatutory double patenting as being unpatentable over the claims of the U.S. Patents and copending applications listed below. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case they claim either: Methods of expanding tumor infiltrating lymphocytes comprising successive culturing steps, wherein there are al least two consecutive steps of culturing in media for a total of 22 days or less, Cells and compositions comprising such cells made by those culturing methods, wherein the cells are suitable for treating cancer, and/or methods of treating subjects with cancer comprising administering such TILs or compositions. To the extent that the claims in the conflicting patents or applications are drawn to methods of treatment or the TILs cell cultured, as opposed to the now-claimed methods of expanding TILs the underlying specifications disclose the same method of expanding as instantly claimed. See MPEP 804(II)(B)(1). US Patents 17856,793 16969362 17050552 17290705 17415175 17610671 17771723 18551138 17856793 4. No claim is allowed. 5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181 The fax number for the organization where this application or proceeding is assigned is 571/273-8300 Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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Prosecution Timeline

Jul 01, 2022
Application Filed
Feb 27, 2023
Non-Final Rejection — §DP
Jun 02, 2023
Response Filed
Jul 13, 2023
Examiner Interview Summary
Jul 13, 2023
Examiner Interview (Telephonic)
May 22, 2025
Non-Final Rejection — §DP
Sep 26, 2025
Response Filed
Nov 04, 2025
Final Rejection — §DP
Jan 05, 2026
Response after Non-Final Action
Jan 19, 2026
Non-Final Rejection — §DP (current)

Precedent Cases

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Patent 12589113
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2y 5m to grant Granted Mar 31, 2026
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Patent 12577581
USE OF PRE T ALPHA OR FUNCTIONAL VARIANT THEREOF FOR EXPANDING TCR ALPHA DEFICIENT T CELLS
2y 5m to grant Granted Mar 17, 2026
Patent 12570959
PROCESSES FOR PRODUCTION OF TUMOR INFILTRATING LYMPHOCYTES AND USES OF SAME IN IMMUNOTHERAPY
2y 5m to grant Granted Mar 10, 2026
Patent 12566181
METHODS AND COMPOSITIONS FOR DETERMINING THE POTENCY OF A THERAPEUTIC CELLULAR COMPOSITION
2y 5m to grant Granted Mar 03, 2026

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Prosecution Projections

4-5
Expected OA Rounds
64%
Grant Probability
91%
With Interview (+27.2%)
3y 1m
Median Time to Grant
High
PTA Risk
Based on 1091 resolved cases by this examiner