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 05/21/2026, has been entered.
Claims 2-6, 8-9, 12-20, 23-28, 30-32, 34-36, 40-96, 99-104, 107-114, 118-137, 139-147, 150-202 have been canceled.
Claims 203-208 have been added.
Claims 1, 7, 10-11, 21-22, 29, 33, 37-39, 97-98, 105-106, 110-111, 115-117, 138, 148-149 and 203-208 are pending and currently under examination.
This Office Action will be in response to Applicant’s arguments/remarks, filed 05/21/2026.
The Rejections of Record can be found in the previous Office Action, mailed 03/17/2026.
The previous rejection under 35 U.S.C. 112(b) has been withdrawn in view of Applicant’s amendment, filed 05/21/2026.
The previous rejection under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Guo et al. has been withdrawn in view of Applicant’s amendment, filed 05/21/2026.
The previous rejection under 35 U.S.C. 103 as being obvious over Chartier-Courtaud et al. in view of Guo et al. has been withdrawn in view of Applicant’s amendment, filed 05/21/2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7, 10-11, 21-22, 29, 33, 37-39, 97-98, 105-106, 110-111, 115-117, 138, 148-149 and 203-208 are rejected under 35 U.S.C. 103 as being obvious over Chartier-Courtaud et al. (WO 2019/210131 A1) in view of Guo et al. (US 2020/0000862 A1) and Thomas et al. (JITC 2019 7:214).
New Grounds of Rejection are necessitated by Applicant’s amendment, filed 05/21/2026.
Chartier-Courtaud et al. taught a method of expanding TILs and producing therapeutic population comprising (a) obtaining a first population of TILs from a tumor resected from a patient by processing a tumor sample obtained from the patient into multiple tumor fragments; (b) adding the tumor fragments into a closed system; (c) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2, and optionally OKT-3, to produce a second population of TILs, wherein the first expansion is performed in a closed container providing a first gas-permeable surface area, wherein the first expansion is performed for about 3-14 days to obtain the second population of TILs, wherein the second population of TILs is at least 50-fold greater in number than the first population of TILs, and wherein the transition from step (b) to step (c) occurs without opening the system; (d) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, optionally OKT-3, and antigen presenting cells (APCs), to produce a third population of TILs, wherein the second expansion is performed for about 7-14 days to obtain the third population of TILs, wherein the third population of TILs is a therapeutic population of TILs, wherein the second expansion is performed in a closed container providing a second gas-permeable surface area, and wherein the transition from step (c) to step (d) occurs without opening the system; (e) harvesting the therapeutic population of TILs obtained from step (d), wherein the transition from step (d) to step (e) occurs without opening the system; (f) transferring the harvested TIL population from step (e) to an infusion bag, wherein the transfer from step (e) to (f) occurs without opening the system; and (g) at any time during the method, gene-editing at least a portion of the TILs, wherein said gene-editing cause silencing of an immune checkpoint gene (see, e.g., paragraphs 0005, 0055-0058). Furthermore, Chartier-Courtaud taught the step of cryopreserving the therapeutic population of TILs harvested using a 1:1 ratio of TIL population to cryopreservation media (paragraph 0006-0007). Moreover, Chartier-Courtaud taught a method of treating a subject with cancer comprising administering the therapeutic population of TILs harvested from the expansion steps mentioned above in combination with a checkpoint inhibitor such as pembrolizumab (paragraph 00574).
Chartier-Courtaud did not teach conditioning the tumor by administering an an oncolytic virus to the subject as recited in the present claim (e.g., claim 1 step a). However, it would have been obvious to one of ordinary skill in the art to perform set conditioning step because it was well known in the art before the effective filing date of the claimed invention. For example, Guo teaches conditioning a tumor prior to TIL harvest by administering an oncolytic HSV, specifically HSV1716, to the subject, wherein TILs are subsequently obtained from the conditioned tumor and expanded ex vivo for therapeutic administration (see Summary of the Invention and paragraphs 0012-0017; 0019-0020, 0086, 0145, 0153, 0157, 0162, 0165).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the TIL expansion method of Chartier-Courtaud by conditioning the tumor with the oncolytic HSV1716 virus taught by Guo prior to obtaining the tumor sample for TIL expansion, because Guo teaches that such conditioning enhances antitumor immune response and provides tumor tissue suitable for subsequent TIL isolation and expansion.
With regards to the newly added limitation of oncolytic virus being an HSV1 virus encoding a fusogenic GALV-GP R- protein, it is noted that Thomas teaches an oncolytic HSV1 immunotherapy platform engineered to express fusogenic GALV-GP R-. Thomas teaches that incorporation of GALV-GP R- into an HSV1 backbone increases tumor cell fusion, enhances tumor cell killing, increases immunogenic cell death, promotes release of tumor antigens, and enhances anti-tumor immune response (Abstract, pp 1-3, 6-8). Furthermore, Thomas teaches an HSV1 construct comprising deletions of ICSP34.5 and ICP47 and that said construct further expresses human GM-CSF (Figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art to substitute the HSV1-GALV-GP R- construct taught by Thomas for the HSV1716 virus used in Guo’s conditioning step because both Guo and Thomas employ HSV1-based oncolytic viruses for cancer immunotherapy, and Thomas expressly teaches that the GALV-GP R- modification enhances the immunostimulatory and oncolytic properties of HSV1. One of ordinary skill in the art would have reasonably expected that utilizing the enhanced HSV1-GALV-GP R- platform of Thomas in Guo’s tumor-conditioning regimen would improve tumor destruction, immunogenic cell death, and immune activation prior to TIL harvest, thereby providing the known advantages taught by Thomas.
The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements were known in the prior art and one of skilled in the art would have arrived at the claimed invention by substituting one known HSV1-based oncolytic virual platform (HSV1716) with another known HSV1-based oncolytic viral platform (HSV1 encoding GALV-GP R-, GM-CSF, and containing ICP34.5 and ICP47 deletions) to obtain the known benefits expressly taught by Thomas, namely enhanced tumor cell killing, syncytia formation, immunogenic cell death, antigen release, and antitumor immune activation. Such modification using known methods with no change in their respective function and the combination would have yielded nothing more than the predictable result.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1, 7, 10-11, 21-22, 29, 33, 37-39, 97-98, 105-106, 110-111, 115-117, 138, 148-149 and 203-208 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of US Patents in view of Chartier-Courtaud et al. (WO 2019/210131 A1), Guo et al. (US 2020/0000862 A1) and Thomas et al. (JITC 2019 7:214).
New Grounds of Rejection are necessitated by Applicant’s amendment, filed 05/21/2026.
Patent
Claims
US 12570959 B2
1-30
US 12553029 B2
1-20
US 12516291 B2
1-20
US 12473532 B2
1-29
US 12343380 B2
1-28
US 12226522 B2
1-15
US 12104172 B2
1-13
US 11981921 B2
1-29
US 11713446 B2
1-26
US 11433097 B2
1-23
US 11384337 B2
1-28
US 11357841 B2
1, 4-5, 8, 10, 11
US 11254913 B1
1-28
US 11220670 B2
1-18
US 10517894 B2
1-22
US 10130659 B2
1-29
US 10166257 B2
1-20
US 10272113 B2
1-23
US 10363273 B2
1-29
US 10398734 B2
1-15
US 10420799 B2
1-11
US 10463697 B2
1-21
US 10537595 B2
1-22
US 10639330 B2
1-11
US 10646517 B2
1-23
US 10653723 B1
1-30
US 10695372 B2
1-15
US 10894063 B2
1-46
US 10905718 B2
1-24
US 10918666 B2
1-30
US 10925900 B2
1-15
US 11007226 B2
1-20
US 11007225 B1
1-29
US 11013770 B1
1-24
US 11040070 B2
1-14
US 11052116 B2
1-24
US 11052115 B2
1-22
US 11083752 B2
1-20
US 11168304 B2
1-30
US 11168303 B2
1-29
US 11202804 B2
1-20
US 11202803 B1
1-20
US 11241456 B2
1-20
US 11273181 B2
1-19
US 11273180 B2
1-19
US 11291687 B2
1-16
US 11304979 B2
1-19
US 11337998 B2
1-19
US 11344579 B2
1-20
US 11517592 B1
1-27
US 11529372 B1
1-23
US 11541077 B2
1-24
US 11998568 B2
1-23
US 12121541 B2
1-35
US 12194061 B2
1-22
US 12226434 B2
1-13
US 12485145 B2
1-21
US 12558375 B2
1-23
The patent claims listed above disclosed a method of expanding TILs from a tumor into therapeutic population of TILs, method of treating cancer comprising administering the therapeutic population of TILs, and/or a composition comprising said therapeutic population of TILs. Therefore, it would have been obvious for one of ordinary skill in the art to arrive at the presently claimed methods in view of the teachings by Chartier-Courtaud, Guo and Thomas
as discussed above in 103. Therefore, the patent claims render obvious of the present claims in view of Chartier-Courtaud, Guo and Thomas.
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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached 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, Misook Yu can be reached at 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
Prosecution Insights