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 .
Claims 1-20, of record 9/21/23 are pending. Prosecution on the merits begins for claims 1-20.
PRIORITY
The instant application, filed 9/21/23, is a CONTINUATION of US Patent No. 11,802,295, filed 08/14/2019, which is a DIVISIONAL of US Patent No. 10,428,351, filed 11/04/2015, which claims priority to US Provisional Application No. 62/129,023, filed 03/05/2015 and US Provisional Application No. 62/075,801 filed 11/05/2014. Thus, the earliest possible priority for the instant application is 11/05/2015.
This application, which discloses and claims only subject matter disclosed in prior parent Application No. 16/541,083, filed 8/14/2019, now Patent No. 11,802,295 and grand-parent Application No. 14/932,660, filed 11/05/2014, now Patent 10,428351, appears to claim only subject matter directed to an invention that is independent and distinct from that claimed in the prior application, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a divisional application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
CLAIMS
Independent claims 1 and 15 are broadly drawn to compositions comprising at least 1 x 107 T-cells, wherein at least 10% of the T-cells encode and express a chimeric antigen receptor encoded on a viral vector (claim 1) or lentiviral vector (claim 15), and wherein the average copy number of the viral vector is limited to no more than 10 (claim 1) or no more than 6 (claim 15).
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Claim Objections
Claim 8 is objected to because of the following informalities:
Claim 8 should be amended to recite “wherein the T cells in the composition”. Appropriate correction is required.
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 3-6 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 3 requires “wherein at least 30% of the T cells in the composition express CD69 or TGF-beta-II.” Claim 3 is dependent upon claim 1, which is directed to a composition comprising at least 1 x 107 T-cells, wherein at least 10% of the T-cells express a CAR. Thus, claim 1 encompasses T-cells which do not express the CAR. It is not clear whether claim 3 is referring to 30% of the at least 1 x 107 T-cells of the total composition, or if the claim is requiring wherein 30% of the transduced T-cells express the claimed CD69 or TGF-beta-II proteins.
The lack of clarity could arise where a claim refers to "said lever" but two different levers are recited earlier in the claim. the recitation of "said lever" in the same or subsequent claim would be unclear where it is uncertain which of the two levers was intended. MPEP 2173.05(e). This is an antecedent basis rejection.
Claim 4 is rejected for the same reasons as stated for claim 3. Claim 4 requires “wherein at least 30% of the T cells in the composition do not express CD62L.”
Claim 5 is rejected for the same reasons as stated for claim 3. Claim 5 requires “wherein at least 30% of the T cells in the composition express CD25, ICAM, GM-CSF, IL-8, and/or IL-2.”
Claim 6 requires “wherein the composition comprises at least 1 x 108 cells.” Claim 6 is dependent upon claim 1, which minimally requires a “composition comprises at least 1 x 107 T cells.” It is not clear whether claim 6 is attempting to show the composition of claim 1 comprises additional non-T cells, or if the claim is attempting to require wherein the composition comprises composition comprises at least 1 x 108 T cells.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6-11, 13-14 and 17-18 are rejected under 35 U.S.C. 102(A)(1) and (A)(2) as being anticipated by US Patent Application Publication No. 2003/0147881 to Cheung.
With regard to claim 1, Cheung discloses compositions comprising T-cells, wherein a percentage of the T-cells in the population encode and express a chimeric antigen receptor (CAR) (scFv-TM-signaling domain) following transduction of the T-cells with a viral vector encoding the CAR (paragraphs [0021]-[0027], [0043]-[0044], [0052], [0057]-[0058], [0159]-[0202], [0206], [0212]-[0219], [0230], [0290]-[0310], [0314]). Cheung discloses at least 10% of the T-cells in the composition are transduced with the vector encoding the CAR (paragraphs [0024], [0159], [0194], [0197], [0230] FIG 4A [of Second series of experiments]). The composition comprising T-cells comprise at least 1 x 107 T-cells (paragraphs [0023], [0094], FIGs 3A, 3B [of Second series of experiments]). Cheung discloses the vector copy number in the T-cells averaged 4.5 gene copies per cell, ranging from 2-9 (paragraphs [0024], [0186]-[0187], [0194] FIG 4A [of Second series of experiments]). Thus, Cheung anticipates claim 1.
With regard to claims 2 and 6, Cheung discloses compositions comprising at least 5 x 107 T-cells and 1 x 108 T-cells (paragraphs [0023], [0094], FIGs 3A, 3B [of Second series of experiments]).
With regard to claims 7-8, Cheung discloses the cells are unfractionated, isolated CD8+ cells or CD4+ cells, as well as primary cells (paragraphs [0159], [0184]-[0185], [0194], [0294]).
With regard to claims 9-11, Cheung discloses at least 17-40%, 75-80%, and 99% of the T-cells are CAR positive on day 24 following transduction (paragraphs [0194]).
With regard to claim 13, Cheung discloses the CAR comprises an extracellular portion that binds a ligand, and intracellular CD28 costimulatory domain and a CD3zeta signaling domain (paragraphs [0161], [0193]).
With regard to claim 14, Cheung discloses the vector copy number in the transduced T-cells averaged 4.5 gene copies per cell, ranging from 2-9 (paragraphs [0024], [0186]-[0187], [0194] FIG 4A [of Second series of experiments]).
With regard to claim 17, Cheung discloses the cells are formulated with a pharmaceutically acceptable excipient when administered to mice, absent evidence to the contrary (paragraph [0295]).
With regard to claim 18, Cheung discloses the cells are cryopreserved (paragraph [0186]).
Claims 1-2, 4, 6-11, 14 and 17-18 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Pule et al. Virus-Specific T Cells Engineered to Coexpress Tumor-Specific Receptors: Persistence and Antitumor Activity in Individuals with Neuroblastoma. Nature Medicine, 2008. 14(11): 1264-1270, with Supplement.
With regard to claim 1, Pule discloses compositions comprising T-cells (activated T-cells (ATC) or cytotoxic T-lymphocytes (CTL)), wherein a percentage of the T-cells in the population encode and express a chimeric antigen receptor (CAR) (GD2-specific CAR) following transduction of the T-cells with a viral vector encoding the CAR (Abstract, “Methods” section page 1269). Pule discloses wherein at least 10% of the T- cells in the composition are transduced with the vector encoding the CAR (page 1265, left column, FIG 1a, 1b; FIG 2a, 2b, 2c). The composition comprises at least 1 x 107 T-cells (doses of 2 x 107 to 2 x 108 cells) (page 1265, Table 1). Pule discloses the vector copy number in the transduced T-cells ranged from 3.9-7.2 per cell (Supplement page 2, “Details of PCR Analysis and Quantification” section). Thus, Pule anticipates claim 1.
With regard to claims 2 and 6, Pule discloses the composition comprises at least 1 x 107 T-cells (doses of 2 x 107 to 2 x 108 cells; stocks of 1.7 x 108 to 1.4 x 109 ) (page 1265, Table 1; Supplementary Table 1).
With regard to claim 4, Pule shows that at least 30% of the composition are effector memory cells, with a phenotype of CD45RO+ CD62L- and CCR7- (42-76%) (page 1265, FIG 2b). Thus, at least 30% of the T-cells in the composition do not express CD62L.
With regard to claims 7-8, Pule discloses the composition comprising transduced T-cells are generated from PBMC isolated from peripheral blood (page 1269, Methods sections “Subjects” and “Generation and transduction of activated T cells and Cytotoxic T cells”). Pule shows the composition comprising transduced T-cells comprised CD4+, CD8+ and few NK cells (both ATC and CTL) (page 1266, FIG 2a). Pule further shows the transduced ATC population comprised naïve, central memory and effector memory T-cells (FIG 2b), whereas the transduced CTL population comprised central memory and effector memory T-cells (FIG 2b). Thus, the transduced ATCs and CTLs read on a composition comprising unfractionated, as well as isolated CD8+ cells or CD4+ cells, as well as primary cells, absent evidence to the contrary.
With regard to claims 9-11, Pule discloses at least 20%, 40% and 50% of the T-cells are CAR positive following transduction with the viral vector (FIG 1a, 1b).
With regard to claim 14, Pule discloses the vector copy number in the transduced T-cells ranged from 3.9-7.2 per cell (Supplement page 2, “Details of PCR Analysis and Quantification” section).
With regard to claim 17, Pule discloses the cells are necessarily formulated with a pharmaceutically acceptable excipient when administered to patients, absent evidence to the contrary (page 1265, 1269, Table 1).
With regard to claim 18, Pule discloses the cells are cryopreserved on day 15 or day 45 after culture (page 1269).
Claims 1-2 and 6-20 are rejected under 35 U.S.C. 102(A)(1) and (A)(2) as being anticipated by US Patent Application No. 2014/0050708 to Powell (published 2/20/2014).
With regard to claims 1, 12 and 15, Powell discloses a composition comprising T-cells, wherein a percentage of the T-cells in the composition encode and express a chimeric antigen receptor (CAR) following transduction of the T-cells with a lentiviral vector encoding the CAR (paragraphs [0031], [0037], [0039], [0066]-[0067], [0133], [0173], [0252]-[0255], [0259]). Powell discloses the composition comprises 104 to 109 T-cells, comprises specific T-cells of up to 1-100% of the composition, including at least 40-50% CAR positive T-cells in the composition (paragraphs [0039], [0041], [0186], [0192]-[0194], [0213], [0254]-[0255], [0259], [0270], [0269], [0270], [0290]). Powell discloses the vector copy number in the T-cells averages ≥ 0.2 copies per cell, and is limited to 0.2-5 copies per cell (paragraphs [0263], [0267], [0281]). Thus, Powell anticipates claims 1, 12 and 15.
With regard to claims 2 and 6, Powell discloses composition comprises at least 104 to 109 T-cells (paragraphs [0192], [0213]).
With regard to claims 7-8, Powell discloses the cells are unfractionated, isolated CD8+ cells or CD4+ cells, as well as primary cells (paragraphs [0039], [0041], [0186], [0192], [0213], [0254]-[0255], [0259], [0270], [0269], [0270], [0290], [0316]).
With regard to claims 9-11, Powell discloses the composition comprises at least 40-50% and >60% CAR positive transduced T-cells (paragraphs [0269], [0270]).
With regard to claims 13 and 16, Powell discloses the CAR comprises an extracellular portion that binds a ligand, and intracellular CD28 costimulatory domain and a CD3zeta signaling domain (paragraphs [0135]-[0164]).
With regard to claim 14, Powell discloses the vector copy number in the T-cells is limited to 0.2-5 copies per cell (paragraphs [0263], [0267]).
With regard to claims 17 and 19, Powell discloses the cells are formulated with a pharmaceutically acceptable excipient (paragraph [0211]).
With regard to claims 18 and 20, Powell discloses the cells are cryopreserved (paragraph [0261]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application No. 2014/0050708 to Powell (published 2/20/2014) as applied to claims 1-2, and 6-20 above, further in view of Tal et al. An NCR1-Based Chimeric Receptor Endows T-Cells with Multiple Anti-Tumor Specificities. Oncotarget, April 2014. 5(21):10949-10958. Claims 3 and 5 encompass embodiments wherein at least 30% of the T-cells express CD69 or CD25.
The disclosure of Powell is applied as in the 102 rejection above, the content of which is incorporated herein in its entirety.
With regard to claim 1, Powell discloses compositions comprising at least 1 x 107 T-cells, wherein at least 10% of the T-cells in the composition encode and express a chimeric antigen receptor (CAR) following transduction of the T-cells with a viral vector encoding the CAR, and wherein the vector copy number is no more than 10.
Powell discloses the CAR can be targeted to any antigen on one or more tissues, cell or tumor (paragraphs [0133], [0138]-[0144], [0202]-[0204]). Powell discloses in vitro and in vivo activation and expansion methods results in CD4+ and/or CD8+ CAR T-cell populations, but influences the phenotypes of the enriched/expanded T-cells (paragraphs [0186]-[0194], [0198]-[0200], [0214], [0252]-[0260], [0290], [0316]-[0317]). Transduced, activated and expanded CAR T-cells are assessed for phenotype, proliferation (i.e. activation), and immune function (cytokine release, lysis of target cells) in response to antigen (paragraphs [0075], [0227], [0258]-[0271], [0276]). Phenotypic markers assessed include memory T-cell markers (such as CCR7, CD62L, CD45RA, CD27, CD28, etc.) and effector cell markers (CD45RO, CCR6, CD25, CD38, HLADR, GITR, PD1, etc.) (paragraph [0438]). Identification of the phenotypic markers of the expanded functional T-cells allows for the ability to tailor an activated CAR T-cell product for a specific purpose (paragraphs [0194], [0438]).
However, Powell does not disclose wherein at least 30% of the T-cells express CD69 or CD25 in the composition comprising activated T-cells as required by instant claims 3 and 5, respectively.
Tal produces compositions comprising T-cells, wherein 93.8% of the T-cells in the composition encode and express a chimeric antigen receptor (CAR) targeting NCR1 ligands, following transduction of the T-cells with a viral vector encoding the CAR N1/28z (abstract, page 10950, 10953, 10955 “Transduction of PBLs” section, FIG 2A, FIG. 4A). Tal assesses the phenotype, proliferation and function of the CAR-T cells in response to antigen. Tal shows at least 30% of the N1/28z CAR-T cells upregulated activation markers CD69 and CD25 when co-cultured in the presence of target tumor lines (page 10951, FIG. 3A; FIG. 4C). Tal discloses assessment of the surface expression of the CAR on the T-cell alone is not sufficient to predict function of the CAR T-cell, emphasizing CAR expressing T-cells need to be tested for function (page 10954, end of first column bridging second column).
It would have been obvious to combine the disclosure of Powell on compositions comprising transduced T-cells expressing CARs, wherein the phenotype and function of the CAR T-cells are assessed by marker expression and function in response to antigen, further with the disclosure of Tal on compositions comprising transduced T-cells expressing CARs, wherein the phenotype and function of the CAR T-cells are assessed by marker expression and function in response to antigen. A skilled artisan would have been motivated to include at least 30% of the T-cells in the composition express CD69 or CD25 because Tal shows the upregulation in these markers are reflective of a functional response of the CART cells in response to antigen, and Powell teaches characterization of the phenotype and function of the CART cells allows for tailored CAR T products capable of functional response to antigen. A skilled artisan would have had a reasonable expectation of success in practicing the claimed invention as assessing CAR T-cells for phenotypic markers and their function in response to antigen was known at the time of the invention.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,802,295 in view of US Patent Application No. 2014/0050708 to Powell (published 2/20/2014) and Tal et al. An NCR1-Based Chimeric Receptor Endows T-Cells with Multiple Anti-Tumor Specificities. Oncotarget, April 2014. 5(21):10949-10958.
The disclosures of Powell and Tal are applied as in the 102 and 103 rejections above, the content of which are incorporated herein in their entirety.
As noted above, the instant application is a CONTINUATION of patent US Patent No. 11,802,295 (application No. 16/541,083). A Restriction Requirement, mailed 6/20/2022, was made in the prosecution of the parent patent application 16/541,083. Instant claims 1-20 are directed to a composition comprising transduced T cells and appear to be consonant with non-elected invention IV identified in the restriction requirement. However, because the instant application is filed as a continuation rather than a divisional application, the pending claims are not shielded from a non-statutory double patenting rejection.
35 U.S.C. 121 authorizes the Director to restrict the claims in a patent application to a single invention when independent and distinct inventions are presented for examination. The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. The 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction. The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that "the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008). MPEP 804.01.
Therefore, the double patenting rejection is proper.
Claimed in the ‘295 patent:
Independent Claim 1 is directed to a method of transducing cells with a viral vector, wherein the method produces cells transduced with the viral vector.
Claims 10-11 require wherein 1 viral vector is included for every one cell to be transduced, and the number of viral vectors ranges from 1 x 106 to 1 x 108.
Claim 19 requires wherein the transduced cells comprise T cells.
Claims 22-23 require wherein the viral vector encodes a CAR.
Claim 24 requires wherein the viral vector is a lentiviral vector.
Instant independent claims 1 and 15 are directed to compositions comprising at least 1 x 107 T-cells, wherein at least 10% of the T-cells encode and express a CAR encoded on a viral vector (claim 1) or lentiviral vector (claim 15), and wherein the average copy number of the viral vector is limited to no more than 10 (claim 1) or no more than 6 (claim 15).
Thus claims 1, 10-11, 19 and 22-23 of the ‘295 Patent render obvious a method of making a composition comprising at least 1 x 107 T-cells, wherein the T-cells encode and express a CAR encoded on a viral vector or lentiviral vector.
However, the claims of the patent do not require wherein at least 10% of the T cells encode and express the CAR, or wherein the average copy number of the viral vector is limited to no more than 10, or no more than 6, as required by instant claims 1, 12 and claim 15.
Powell discloses a composition comprising T-cells, wherein a percentage of the T-cells in the composition encode and express a chimeric antigen receptor (CAR) following transduction of the T-cells with a lentiviral vector encoding the CAR (paragraphs [0031], [0037], [0039], [0066]-[0067], [0133], [0173], [0252]-[0255], [0259]). Powell discloses the composition comprises 104 to 109 T-cells, comprises specific T-cells of up to 1-100% of the composition, including at least 40-50% CAR positive T-cells in the composition (paragraphs [0039], [0041], [0186], [0192]-[0194], [0213], [0254]-[0255], [0259], [0270], [0269], [0270], [0290]). Powell discloses the vector copy number in the T-cells averages ≥ 0.2 copies per cell, and is limited to 0.2-5 copies per cell (paragraphs [0263], [0267], [0281]).
It would have been obvious to modify the claims of the patent directed to a method of making a composition comprising T cells transduced with a viral vector to claims direct to the composition made by that process.
It would have been further obvious to require wherein at least 10% of the composition comprises T-cells transduced by the viral/lentiviral vector because Powell discloses methods of transducing T cells result in at least 10% of the T cells are successfully transduced.
It would have been further obvious to require wherein the average copy number of the viral vector is limited to no more than 10, or no more than 6, from the claims of the patent take in view of Powell. Claims 10-11 of the patent require wherein 1 viral vector is included for every one cell to be transduced, and the number of viral vectors ranges from 1 x 106 to 1 x 108. Thus, at least a 1:1 ratio of viral vector to T cell is available for transduction. Further, Powell discloses the viral copy number per cell is limited to 0.2-5 in order to minimize the number of insertions for safety (paragraphs [0267], [0281]).
The subject matter encompassed by claims 2-11 and 13-14 and 16-20 are not disclosed in the claims of the patent.
However, claims 2-11, 13-14 and 16-20 are anticipated by Powell, or rendered obvious by Powell in view of Tal for the reasons stated above in the 102 and/or 103 rejections above.
Conclusion
No claims are allowed. No claims are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY A ARON whose telephone number is (571)272-2789. The examiner can normally be reached Monday-Friday 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAA
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Prosecution Insights