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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Claims 1-30 are currently pending and examined on the merits.
Information Disclosure Statement
An IDS was received on 5/10/24. All references have been considered; however, due to the voluminous number of references in the IDS they have been only briefly considered. It is noted that the cloaking of a relevant reference by inclusion in a long list of citations may not comply with the Applicant’s duty of disclosure. Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948 (S.D. Fla. 1972). Therefore, the applicant is encouraged to present a concise statement as to the relevance of any particular documents known to be material for patentability as defined by 37 C.F.R. § 1.56.
Claim Rejections - 35 USC § 112
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 13-13, 30 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 13 recites the limitation "the AKT inhibitor". There is insufficient antecedent basis for this limitation in the claim.
Claim 30 contains the limitation “head and neck cancer (including head and neck squamous cell carcinoma (HNSCC))”. It is unclear if the limitations contained within the parentheses are required limitations of the claim. For examination purposes, this limitation is interpreted as “head and neck cancer,
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 10, 16-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fardis et al., PCT Publication No. WO2020/131547 (cited in parent application 18337454, hereinafter Fardis).
Regarding claim 1, Fardis discloses methods of producing and expanding therapeutic populations of tumor infiltrating lymphocytes (TILs) (Abstract). Fardis discloses processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor ([0005], [00431], [00460], [00506], Fig. 1). Fardis discloses performing a first priming expansion for about 1 to 7 days by culturing the first population of in a cell culture media containing IL-2, OKT-3, and antigen presenting cells (APCs) to produce a second population of TILs ([0005], [00431], [00506], Fig. 1). In a preferred embodiment, the first culture media contains between about 1000 IU/mL to about 8000 IU/mL, IL-2, preferably about 3000 IU/mL ([00510]). A second expansion is then performed to by culturing the second population of TILs for about 1 to 11 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs ([0005], [00431]). The TILs may then be harvested and transferred to an infusion bag ([0005], [00431], [00606]).
Regarding claims 2-4, the first expansion media may further contain between about 100 IU/mL to 500 IU/mL of IL-15 (equates to about 120.5 ng/mL to 602.4 ng/mL) and/or about 0.5 IU/mL to 20 IU/mL of IL-21 (equates to about 0.6 ng/mL to 24.1 ng/mL) [(00511]-[00512]).
Regarding claim 10, the IL-2 may be present in the first culture media at a concentration between about 1000 IU/mL to about 8000 IU/mL, preferably about 3000 IU/mL ([00510]). The first expansion media may further about 0.5 IU/mL to 20 IU/mL of IL-21equates to about 0.6 ng/mL to 24.1 ng/mL) [(00511]-[00512]).
Regarding claim 16, in some embodiments, the second expansion is performed during a period of up to 11 days [(00442]-[00444]).
Regarding claims 17-20, in some embodiments the first step of the priming expansion and the second period in the second expansion are individually performed within a period of 5 to 7 days ([0091]-[0094]).
Regarding claims 21-25, in some embodiments, the steps from the first step of the priming expansion through the harvesting step are performed with a period of about 14-16 days ([0095]-[0099]).
Regarding claims 26, and 29, the harvested therapeutic TILs may be further cryopreserved, such as through a cryopreservation process ([00100], [00928]-[00933]).
Regarding claim 27, following dissection of the tumor, the fragments may be enzymatically digested ([00466]-[00474]).
Regarding claim 28, the tumor sample may be obtained using methods known in the art, such as surgical resection or needle biopsy ([00465]).
Regarding claims 30, the tumor may be selected from the group consisting of melanoma, ovarian cancer, cervical cancer, non-small-cell lung cancer (NSCLC), lung cancer, bladder cancer, breast cancer, triple negative breast cancer, cancer caused by human papilloma virus, head and neck cancer (including head and neck squamous cell carcinoma (HNSCC)), renal cancer, and renal cell carcinoma ([00121]-[00122]).
Therefore, every limitation of claims 1-4, 10, 16-30 is present in Fardis, and the subject matter is anticipated.
Claim(s) 1-8, 10, 13, 15-16, 18, and 26-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chartier-Courtand et al., PCT Publication No. WO2020/096927 (cited in parent application 18337454, hereinafter Chartier-Courtand)
Regarding claims 1 and 5, Chartier-Courtand discloses methods of producing and expanding therapeutic populations of tumor infiltrating lymphocytes (TILs) using AKT inhibitors (Abstract). Chartier-Courtand discloses resecting a tumor sample obtained from a subject to obtain a first population of TILs from the tumor ([0004], Fig. 1). Chartier-Courtand discloses performing a first priming expansion for less than 21 days by culturing the first population of in a cell culture media containing IL-2, an AKT inhibitor, and a tumor necrosis factor receptor superfamily (TNFRSF) agonist to produce a second population of TILs ([0004], [00367], [00510]-[0051Fig. 1). In a preferred embodiment, the first culture media contains between about 1000 IU/mL to about 10000 IU/mL IL-2, preferably about 8000 IU/mL ([00371]). A second expansion is then performed to by culturing the second population of TILs for less than 14 days in a media containing IL-2, OKT-3, and peripheral blood mononuclear cells (PBMCs; an antigen presenting cell type) to produce a third population of therapeutic TILs ([0004]). The TILs may then be harvested ([0005]). In some embodiments the harvested TILs may be transferred to an infusion bag ([0007]).
Regarding claims 2-4, the first expansion media may further contain between about 100 IU/mL to 500 IU/mL of IL-15 (equates to about 120.5 ng/mL to 602.4 ng/mL) and/or about 0.5 IU/mL to 20 IU/mL of IL-21 (equates to about 0.6 ng/mL to 24.1 ng/mL) [(00372]-[00373]).
Regarding claims 6-8, the AKT inhibitor may be selected from Ipatasertib, AT7867, AT13148, MK-2206, or other functionally useful AKT inhibitors ([00314]-[00335], [00510]-[00511]). The AKT inhibitor may be added to the first or second expansion media at a concentration of between about 0.01 µM to 100 µM ([00515]-[00525]).
Regarding claim 10, the IL-2 may be present in the first culture media at a concentration between about 1000 IU/mL to about 8000 IU/mL, preferably about 3000 IU/mL ([00510]). The first expansion media may further about 0.5 IU/mL to 20 IU/mL of IL-21 equates to about 0.6 ng/mL to 24.1 ng/mL) [(00372]-[00373]).
Regarding claims 15, and 18, in some embodiments the first expansion may proceed for between 1 and 11 days ([00379]).
Regarding claim 16, in some embodiments, the second expansion is performed during a period of up to 14 days [(00391]).
Regarding claims 26, and 29, the harvested therapeutic TILs may be further cryopreserved, such as through a cryopreservation process ([00535]-[00541]).
Regarding claim 27, following dissection of the tumor, the fragments may be enzymatically digested ([00344], [00356]).
Regarding claim 28, the tumor sample may be obtained using methods known in the art, such as surgical resection or needle biopsy ([00353]).
Regarding claims 30, the tumor may be selected from the group consisting of melanoma, ovarian cancer, cervical cancer, non-small-cell lung cancer (NSCLC), lung cancer, bladder cancer, breast cancer, triple negative breast cancer, cancer caused by human papilloma virus, head and neck cancer (including head and neck squamous cell carcinoma (HNSCC)), renal cancer, and renal cell carcinoma ([0030).
Therefore, every limitation of claims 1-8, 10, 13, 15-16, 18, and 26-30 is present in Chartier-Courtand, and the subject matter is anticipated.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chartier-Courtand as applied to claims 1-8, 10, 13, 15-16, 18, and 26-30, and in view of Zhang et al., (2016) A novel AKT inhibitor, AZD5363, inhibits phosphorylation of AKT downstream molecules, and activates phosphorylation of mTOR and SMG-1 dependent on the liver cancer cell type. Oncology Letters, 11:1685-1692 (hereinafter Zhang).
Regarding claim 9, Chartier-Courtand does not disclose that the AKT inhibitor may be AZD5363. However, Chartier-Courtand explains that the AKT inhibitor may be selected from functionally useful AKT inhibitors ([00314]-[00335], [00510]-[00511]). AZD5363 is known as a an AKT inhibitor useful in inhibiting the phosphorylation of downstream molecules in the AKT signal pathway, and suppresses proliferation of cancer cells as demonstrated by Zhang. It would be obvious to one of ordinary skill in the art that the AKT inhibitor of Chartier-Courtand could be substituted for another functionally useful AKT inhibitor such as AZD5363 as a simple substitution of one known AKT inhibitor for another, with a reasonable expectation of success. A skilled artisan would be motivated to use AZD5363 of Zhang as Chartier-Courtand suggests utilizing any functionally useful AKT inhibitors.
Double Patenting
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 11-14 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 3, 7, 9 of prior U.S. Patent No. 11,981,921. This is a statutory double patenting rejection.
Non-statutory
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 1-4,15-16, 21, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 12-15, 18-19, 27, U.S. Patent No. 12,473,532 in view of Chartier-Courtand. The claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 14 days by culturing the first population of TILs in a cell culture media containing IL-2 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 14 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs , harvesting the TILs and transferring to an infusion bag.
The present application does not disclose that the process is conducted in a closed system, or that the subject is pre-treated with a kinase inhibitor or ITK inhibitor. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that the methods may be performed in a closed system, and that the subject may be pre-treated with an ITK inhibitor (see e.g., [0007], [00598]).
This is a nonstatutory double patenting rejection.
Claims 1-2, 15-16, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9, 17-20 of U.S. Patent No. 11,168,304 (reference application) in view of Chartier-Courtand. The claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 14 days by culturing the first population of TILs in a cell culture media containing IL-2 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 14 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs, harvesting the TILs and transferring to an infusion bag.
The present application does not disclose that the process is conducted in a closed system. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that the methods may be performed in a closed system (see e.g., [0007]).
This is a nonstatutory double patenting rejection.
Claims 1-4, 15-16, 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 26-29 of U.S. Patent No. 11,168,303 (reference application) in view of Chartier-Courtand. The claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 14 days by culturing the first population of TILs in a cell culture media containing IL-2 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 14 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs, harvesting the TILs and transferring to an infusion bag.
The present application does not disclose that the process is conducted in a closed system. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that the methods may be performed in a closed system with a gas-permeable surface (see e.g., [0007]). Further in some embodiments, the culture media may contain a 4-1BB agonist (see e.g., [00375]).
This is a nonstatutory double patenting rejection.
Claims 1, 15, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 20-21, 25-26 of U.S. Patent No. 11,713,446 (reference application). in view of Chartier-Courtand. The claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 7 days by culturing the first population of in a cell culture media containing IL-2, OKT-3 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 11 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs , harvesting the TILs and transferring to an infusion bag. The claims of the present application are broader than that of the copending application and therefore encompass it.
The present application does not disclose that the TILs genetically engineered to alter protein expression in a transient manner. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that in some embodiments, the TILs are further genetically engineered to alter protein expression in a transient manner (see e.g., [00905]). Chartier-Courtand also discloses that the methods may be performed in a closed system (see e.g., [0007]).
This is a nonstatutory double patenting rejection.
Claims 1-4, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 71, 73, 79-80, 86 of copending Application No. 16/960,310 (reference application) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 12 days by culturing the first population of TILs in a cell culture media containing IL-2 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 11 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs.
The present application does not disclose that the cells are genetically engineered to transiently alter protein expression. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that in some embodiments, the TILS are further genetically engineered to alter protein expression in a transient manner, such as TCF-1, NOTCH 1/2 ICD, or MYB (see e.g., [00905], [00927]).
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17-20 of copending Application No. 17/148,508 (reference application) in view of Chartier-Courtand. The claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 14 days by culturing the first population of TILs in a cell culture media containing IL-2 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 14 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs, harvesting the TILs and transferring to an infusion bag.
The present application does not disclose that the process is conducted in a closed system. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that the methods may be performed in a closed system (see e.g., [0007]).
This is a provisional nonstatutory double patenting rejection.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 26-29 of copending Application No. 17/148,475 (reference application) in view of Chartier-Courtand. The claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 14 days by culturing the first population of TILs in a cell culture media containing IL-2 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 14 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs, harvesting the TILs and transferring to an infusion bag.
The present application does not disclose that the process is conducted in a closed system. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that the methods may be performed in a closed system (see e.g., [0007]). Further in some embodiments, the culture media may contain a 4-1BB agonist (see e.g., [00375]).
This is a provisional nonstatutory double patenting rejection.
Claim 1-4, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 22, 35 of copending Application No. 17/147,080 (reference application) in view of Chartier-Courtand. The claims are all directed to methods of producing and expanding therapeutic populations TILs by processing a tumor sample obtained from a subject into multiple tumor fragments to obtain a first population of TILs from the tumor, performing a first priming expansion for about 3 to 14 days by culturing the first population of TILs in a cell culture media containing IL-2 to produce a second population of TILs, performing a second expansion by culturing the second population of TILs for about 7 to 14 days in a media containing IL-2, OKT-3, and APCs to produce a third population of TILs, harvesting the TILs and transferring to an infusion bag.
The present application does not disclose that the process is conducted in a closed system. As disclosed in the art rejections above, Chartier Courtand also discloses the same method of producing a population of TILs. Chartier-Courtand also discloses that the methods may be performed in a closed system (see e.g., [0007]).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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