DETAILED ACTION
Claims 71-90 are currently pending.
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/17/2024 and 11/22/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 71-90 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to the claimed method for treating a subject with cancer, it is noted that claim 71 as currently drafted encompasses treating any type of cancer, e.g., non-tumor blood cancers, like Chronic Lymphocytic Leukemia or Acute Lymphocytic Leukemia.
Dependent claims 72-90 either depend directly from claim 71, or incorporate the method of claim 71.
Upon further review of the specification, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of treating any/all types of cancers, such as non-tumor hematologic cancers including Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia.
The specification at [0055]-[0060] does provide sufficient description of treating solid tumor cancers selected from melanoma, ovarian cancer, cervical cancer, non-small-cell lung cancer (NSCLC), lung cancer, bladder cancer, 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.
Although the specification at [00726] indicates that solid tumor cancers include chronic lymphocytic leukemia, acute lymphoblastic leukemia, it is noted that City of Hope, Acute Lymphocytic Leukemia (ALL) (see PTO-892) evidences that ALL doesn’t have a formal staging system, unlike solid tumor cancers (see Acute Lymphocytic Leukemia Diagnosis and Staging, page 1) and City of Hope, Chronic Lymphocytic Leukemia (CLL) (see PTO-892) evidences that blood cancers, such as CLL, do not form solid tumors (see Chronic Lymphocytic Leukemia Stages, page 3).
Thus, a review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of treating any/all types of cancers, such as non-tumor hematologic cancers including Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia.
Furthermore, clam 71 as currently drafted encompasses transient alteration of expression of any type of protein, including trypsin, albumin, hemoglobin, amylase, DNA polymerase, for example.
Upon further review of the specification, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of transient alteration of expression of any type of protein, including trypsin, albumin, hemoglobin, amylase, DNA polymerase, for example.
The specification at [0156], [0450] and [0463]-[0475] does provide sufficient description of transient alteration of expression of immune system-related proteins PD-1, TGFBR2, CBLB (CBL-B), CISH, CCRs (chimeric co-stimulatory receptors), IL-2, IL-12, IL-15, IL-21, NOTCH 1/2 ICD, TIM3, LAG3, TIGIT, TGFβ, CCR2, CCR4, CCR5, CXCR1, CXCR2, CSCR3, CCL2 (MCP-1), CCL3 (MIP-1α), CCL4 (MIP1-β), CCL5 (RANTES), CXCL1/CXCL8, CCL22, CCL17, CXCL1/CXCL8, VHL, CD44, PIK3CD, SOCS1, and cAMP protein kinase A (PKA).
Accordingly, the claims as currently drafted are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
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 72 is 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 72 recites the phrase “wherein the transient alteration of expression increases expression of the one or more proteins.”
The term “increases” in claim 72 is a relative term which renders the claim indefinite. The term “increases” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear if the claimed increase is in relation to endogenous protein expression for tumor infiltrating lymphocytes that have not been modified, or is in relation to a specific time period of culturing, e.g., tumor infiltrating lymphocytes that have been cultured for time periods longer that 14 days or cultured for time periods less than 3 days. Thus, one of ordinary skill in the art would not understand the metes and bounds of the term.
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 71, 73, 84-86 and 90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,495,791 (“US ‘792”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-5 of US ‘791 claim the following:
1. A method for treating a patient with cancer, with a therapeutic population of gene-edited tumor infiltrating lymphocytes (TILs), wherein the method comprises:
(a) adding tumor fragments processed from a tumor resected from a patient into a closed system to obtain a first population of TILs;
(b) 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 3-12 days to obtain the second population of TILs, wherein the transition from step (a) to step (b) occurs without opening the system;
(c) performing a second expansion of the second population of TILs in a cell culture medium comprising 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 7-12 days to obtain the third population of TILs, wherein the third population of TILs comprises a therapeutic population of TILs, wherein the second expansion is performed in a closed container providing a second gas permeable surface area;
(d) harvesting the therapeutic population of TILs obtained from step (c), wherein the transition from step (c) to step (d) occurs without opening the system;
(e) at any time before step (d) in the method, gene-editing at least a portion of the TILs; and
(f) administering to the patient a therapeutically effective dose of the therapeutic population of TILs obtained from step (d).
2. The method of claim 1, wherein the gene-editing is carried out on TILs from one or more of the first population, the second population, and the third population.
3. The method of claim 1, wherein the gene-editing is carried out on TILs from the first expansion, or TILs from the second expansion, or both.
4. The method of claim 1, wherein the gene-editing is carried out before step (b), before step (c), or before step (d).
5. The method of claim 1, wherein the gene-editing causes expression of one or more immune checkpoint genes to be silenced or reduced in at least a portion of the therapeutic population of TILs.
Thus, claims 1-5 of US ‘791 renders obvious instant claim 71, that is, claims 1-5 of US ‘791 teaches the limitations required by current claim 71 and as all limitations are found in one reference it is held that the method of instant claim 71 is within the scope of the teachings of claims 1-5 of US ‘791, and thus renders the invention of claim 71 prima facie obvious. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by claims 1-5 of US ‘791.
Claim 16 of US ‘791 reads on instant claim 73.
Claim 21 of US ‘791 reads on instant claims 71 and 84.
Claim 22 of US ‘791 reads on instant claims 71 and 85.
Claim 23 of US ‘791 reads on instant claim 86.
Claim 24 of US ‘791 reads on instant claim 71.
Claims 71-73, 76, 78 and 84-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,642,268 (“US ‘268”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 20-21 and 24 of US ‘268 claims the following:
1. A method for treating a subject with cancer, the method comprising administering expanded tumor infiltrating lymphocytes (TILs) comprising:
(a) obtaining a first population of TILs from a tumor resected from a subject 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, 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; and
(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;
(g) optionally cryopreserving the infusion bag comprising the harvested TIL population from step (f) using a cryopreservation process;
(h) administering a therapeutically effective dosage of the third population of TILs from the infusion bag in step (f) or (g) to the patient; and
(i) at any time during the method steps (a)-(f), gene-editing at least a portion of the TILs.
20. The method according to claim 1, wherein the cell culture medium comprises OKT-3 beginning on the start day of the first expansion, and the gene-editing is carried out after the TILs have been exposed to the OKT−3.
21. The method according to claim 20 any of claims 1 20, wherein the gene-editing causes expression of one or more immune checkpoint genes to be silenced or reduced in at least a portion of the therapeutic population of TILs.
24. The method according to claim 1, wherein the gene-editing causes expression of one or more immune checkpoint genes to be enhanced in at least a portion of the therapeutic population of TILs, the immune checkpoint gene(s) being selected from the group comprising CCR2, CCR4, CCR5, CXCR2, CXCR3, CX3CR1, IL-2, IL-4, IL-7, IL-10, IL-15, IL-21, the NOTCH 1/2 intracellular domain (ICD), and/or the NOTCH ligand mDLL1.
Thus, claims 1, 20-21 and 24 of US ‘268 renders obvious instant claims 71-72, and 84-90, that is, claims 1, 20-21 and 24 of US ‘268 teaches the limitations required by current claims 71-72, and 84-90 and as all limitations are found in one reference it is held that the method of instant claims 71-72, and 84-90 is within the scope of the teachings of claims 1, 20-21 and 24 of US ‘268, and thus renders the invention of claim claims 71-72, and 84-90 prima facie obvious. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by claims 1, 20-21 and 24 of US ‘268.
Claim 27 of US ‘268 reads on instant claim 78.
Claims 71-72, 76, 84-87 and 90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 105-106, 138, and 148-149 of copending Application No. 18/262,843 (“copending ‘843”, reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 105 of copending ‘843 claims the following:
A method for treating a subject with cancer, the method comprising:
(a) obtaining a first population of tumor infiltrating lymphocytes (TILs) by processing a tumor sample obtained from resection of a tumor in the subject into multiple tumor fragments;
(b) expanding the first population of TILs into a therapeutic population of TILs;
(c) harvesting the therapeutic population of TILs obtained from step (b); and
(d) administering a therapeutically effective dosage of the therapeutic population of TILs from step (c) to the subject;
wherein, prior to step (a), the subject was administered an oncolytic herpes simplex virus type 1 (HSV1) encoding a fusogenic GALV-GP R- (gibbon ape leukemia virus envelope glycoprotein, R-peptide deleted) protein
(e) administering an immunomodulatory molecule to the tumor and/or an oncolytic virus to the subject before, after, or before and after step (a).
106. The method of claim 105, wherein expanding the first population of TILs into a therapeutic population of TILs in step (b) comprises:(ba) adding the tumor fragments into a closed system;
(bb) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2, 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, and wherein the transition from step (ba) to step (bb) occurs without opening the system; and
(bc) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, 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 (bb) to step (bc) occurs without opening the system.
138. The method of claim 105, wherein the method further comprises at any time during the method steps (a)-(d), gene-editing at least a portion of the TILs.
148. The method of claim 138, wherein the gene-editing causes expression of one or more immune checkpoint genes to be silenced or reduced in at least a portion of the therapeutic population of TILs, wherein the one or more immune checkpoint genes is/are selected from the group comprising PD-1, CTLA-4, LAG-3, HAVCR2 (TIM-3), Cish, TGF3, PKA, CBL-B, PPP2CA, PPP2CB,PTPN6, PTPN22, PDCD1, BTLA, CD160, TIGIT, CD96, CRTAM, LAIR1, SIGLEC7,SIGLEC9, CD244, TNFRSF lOB, TNFRSF10A, CASP8, CASP 10, CASP3, CASP6, CASP7, FADD, FAS, SMAD2, SMAD3, SMAD4, SMAD10, SKI, SKIL, TGIF1, IL10RA, IL10RB, HMOX2, IL6R, IL6ST, EIF2AK4, CSK, PAG1, SIT1, FOXP3, PRDM1, BATF, GUCYlA2,GUCYlA3, GUCYlB2, and GUCYlB3.
149. The method of claim 138, wherein the gene-editing causes expression of one or more genes to be enhanced in at least a portion of the therapeutic population of TILs, the one or more gene(s) being selected from the group comprising CCR2, CCR4, CCR5, CXCR2, CXCR3, CX3CR1, IL-2, IL-4, IL-7, IL-10,IL-12, IL-15,IL-21, the NOTCH 1/2 intracellular domain (ICD), and/or the NOTCH ligand mDLL 1.
Thus, claims 105-106, 138, and 148-149 of copending ‘843 renders obvious instant claims 71-72, 76, 84-87 and 90, given that claims 105-106, 138, and 148-149 of copending ‘843 teaches the limitations required by current claims 71-72, 76, 84-87 and 90 and as all limitations are found in one reference it is held that the method of instant claims 71-72, and 84-90 is within the scope of the teachings of claims 105-106, 138, and 148-149 of copending ‘843, and thus renders the invention of claims 71-72, 76, 84-87 and 90 prima facie obvious. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by claims 105-106, 138, and 148-149 of copending ‘843.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: claim 71 recites the following method:
A method for treating a subject with cancer, the method comprising administering expanded tumor infiltrating lymphocytes (TILs) comprising:
(a) obtaining a first population of TILs from a tumor resected from a subject;
(b) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2 for a period of about 3-14 days to produce a second population of TILs;
(c) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, 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 in order to obtain the third population of TILs, wherein the third population of TILs is a therapeutic population of TILs;
(d) harvesting the therapeutic population of TILs; and
(e) administering a therapeutically effective dosage of the therapeutic population of TILs to the subject;
wherein the first population of TILs is modified to effect transient alteration of expression of one or more proteins before or during the first expansion in step (b), the second population of TILs is modified to effect transient alteration of expression of one or more proteins before or during the second expansion in step (c), or the third population of TILs is modified to effect transient alteration of expression of one or more proteins after the second expansion in step (c) and before step (d).
Claim 1 of related Application No. 17/736953 (now U.S. Patent No. 11,713,446) claims the following method:
1. A method for expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs comprising:
(a) obtaining a first population of TILs from a tumor resected from a patient;
(b) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2 for a period of about 3-14 days to produce a second population of TILs;
(c) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, 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 in order to obtain the third population of TILs, wherein the third population of TILs is a therapeutic population of TILs; and (d) harvesting the therapeutic population of TILs;
wherein the first population of TILs is modified to effect transient alteration of expression of one or more proteins before or during the first expansion in step (b), the second population of TILs is modified to effect transient alteration of expression of one or more proteins before or during the second expansion in step (c), or the third population of TILs is modified to effect transient alteration of expression of one or more proteins after the second expansion in step (c) and before step (d).
As set forth in the Reasons for Allowance in related application 17/736953 (March 30, 2023), Applicant persuasively argued that the cited prior art to Simpson-Abelson (WO 2019/1000023) was not available as prior art.
None of the references cited by the Applicant nor those reviewed by the Examiner upon searching the appropriate data bases teach or would have suggested Applicant’s claimed subject matter.
Instant claim 71 incorporates the allowable subject matter of U.S. Patent No. 11,713,446. Therefore, claims 71-90 are free of prior art.
Conclusion
No claim is allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633
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