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 .
Status of the Claims
Claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are currently pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record.
Notably, one or more of the disclosure statements filed to date lists the following documents: PCT Applications, copending applications, Search Reports, PCT Written Opinions, and International Preliminary Reports on Patentability (see IDS documents filed on 02 September 2022).
The listing of the document(s) noted above is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the document(s) noted above have not been considered.
Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the document(s) noted above are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Priority
The earliest effective U.S. filing date afforded the instantly claimed invention has been determined to be 06 December 2019, the priority date of PCT/US2020/063159 to which the instant national stage 371 application claims priority. PCT/US21/063159, filed on 03 December 2020, claims the benefit of priority to Provisional Patent Application No. 62/944,868, filed on 06 December 2019.
Claim Rejections - 35 USC § 103
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.
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 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Konto1 in view of Mujacic2, Kueberuwa3, Certo4, and Nicholson5.
Konto discloses treatment of cancer with CD19 CART cells having disrupted TCR used in immunotherapy, at a dose within the claimed range6, following lymphodepletion with fludarabine and cyclophosphamide at the claimed regimen7, wherein said lymphodepletion regimen excludes biological lymphodepletion agents8, wherein the cancer is cancer with B cell origin including those claimed (see Konto, e.g., at claims 1-134, Examples 1-5; reads on claims 1.a., 1.b., 4-5, 7, 9, 11-14, 18, 20, 30, 32-33, 35, 59, 62).
The prior art of Konto differs from the instantly claimed invention as follows: Konto does not expressly teach: the limitations set forth in claims 1.i-iv.; the sequences set forth in claims 31, 44, 65.
However, the disclosures/teachings of prior art references below remedy the deficiencies of Konto by disclosing/teaching the following:
Mujacic discloses: wherein at least 25-100%9 of the population of T cells to be administered are CAR+ T cells (see Mujacic, e.g., at para. [345]; reads on instant claim 1.i.); wherein the population of T cells to be administered has a CD4+:CD8+ T cell ratio of 0.2:1 to 5:1 (see Mujacic, e.g., at para. [346]; reads on instant claim 1.ii.); wherein the population of T cells to be administered has a CD4+CCR7+:CD8+CCR7+ T cell ratio of 1.1:1 (see Mujacic, e.g., at para. [346]);
Kueberuwa teaches CCR7 expression in a population of CD4+ and CD8+ T cells, wherein the percentage of CCR7+CD4+ and CCR7+CD8+ T cells was 40% and 35% respectively10 (see Kueberuwa at Fig. 3.E. and 3.F.; reads on instant claim 1.iii. and 1.iv.). Kueberuwa further teaches that CCR7 selection offers a means to enrich T cells of early differentiation status for Adoptive T cell immunotherapy (ACTC), and shares data that suggests that these T cells are likely to display enhanced engraftment and persistence in patients in vivo and could therefore improve therapeutic efficacy of ACTC (see Kueberuwa, e.g., at abstract; provides motivation for monitoring CCR7 expression in T cells for ACTC);
Certo discloses SEQ ID 8, identical to claimed CAR sequences of the present application as well as T cells containing an anti CD19 CAR integrated into the TCRa locus (See Certo, e.g., at Examples 1-4, SEQ ID NO: 8; SEQ ID NO: 8 shares 100% sequence id. with instant SEQ ID NO: 3, 4, and 5; reads on instant claims 44, 65).
Nicholson discloses SEQ ID 3, identical to the claimed meganuclease recognition sequence set forth in instant claim 31 (See Nicholson, SEQ ID NO: 3; SEQ ID NO: 3 shares 100% sequence id. with instant SEQ ID NO: 1; reads on instant claims 31).
Obviousness Analysis: In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than:
combining prior art elements (e.g., modifying the method of Konto, by incorporating the disclosures of Mujacic and Nicholson) according to known methods (e.g., selection of cells for administration; use of known meganuclease recognition sequence in CAR-T production) to yield predictable results (e.g., producing and selecting CAR-T cells for cancer treatment). See MPEP 2143(I)(A),(G); renders obvious claims 1.a., 1.b., 1.i., 1.ii., and 31; and
simple substitution of one known element for another (e.g., the known CAR sequence of Certo for the CAR sequence of Konto) to obtain predictable results; namely effectively treating cancer in a subject by administering CAR-T cells. See MPEP 2143(I)(A), (B), (G); renders obvious claims 44, 65.
Furthermore, it would have been obvious to an artisan skilled in the field to have monitored CCR7 expression, as the prior art of Kueberuwa suggests CCR7+ T cells are likely to display enhanced engraftment and persistence, and therefore improved therapeutic efficacy in vivo. See MPEP 2143(I)(A), (C), (G); renders obvious claims 1.iii. and 1.iv.
Moreover, the ranges set forth in the claims, e.g., “said CAR T cells represent between 40 and 75%” in instant claim 1.i. and “between about 35 to about 75%... about 25% and about 50%” in instant claims 1.iii. and 1.iv., overlaps the ranges and/or values taught by prior art references, e.g., Mujacic and Kueberuwa, and therefore, is rendered obvious. (See MPEP § 2144.05 ; In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Additionally, while the cited prior art references render obvious the claimed percentage range of CAR+, CD4+CCR7+, CD8+CCR7+ T cells, as well as the ratio of CD4+:CD8+ T cells set forth in instant claim 1 as discussed above, it would also have been obvious to a skilled artisan to have optimized these percent ranges and ratios, as these proportions are known in the art to directly impact therapeutic efficacy. In other words, these proportions are result-effective variables, where the optimum ratio can be determined via routine optimization11. See MPEP 2144.05(II).
Lastly, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are rejected.
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.
Copending Application No. 19/214,811
Claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of copending Application No. 19/214,811 (reference application; unpublished) in view of Konto, Mujacic , Kueberuwa, Certo, Nicholson (supra).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The disclosures of cited prior art references are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65, claims 1-49 of the reference application explicitly claim a method of treating cancer in a subject comprising administering a population of CAR-T cells having an inactivated TCRa gene, and wherein at least 10-100% of the T cell population to be administered are CAR+ (see reference claims 1-49).
While the methods claimed by the reference application do not expressly claim the lymphodepletion regimen, CD4+:CD8+ ratio, or CCR7+ percentages, the prior art disclosures/teachings of Konto, Mujacic , Kueberuwa, Certo, Nicholson remedy these deficiencies, as discussed above. Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine the prior art elements set forth in the cited prior art references and the reference application by incorporating the lymphodepletion regimen and administering a population of cells with the claimed features, as these regimens and features are known in the art to improve therapeutic efficacy. See MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (D), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Patent No. 9,993,501
Claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of Patent No. 9,993,501 (reference patent;) in view of Konto, Mujacic , Kueberuwa, Certo, Nicholson (supra).
The disclosures of cited prior art references are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65, claims 1-13 of the reference patent explicitly claim a method of treating cancer in a subject comprising administering a population of CAR-T cells having an inactivated TCRa gene, and wherein between 20-65% of the T cell population to be administered are CAR+ (see reference claims 1-13).
While the methods claimed by the reference application do not expressly claim the lymphodepletion regimen, CD4+:CD8+ ratio, or CCR7+ percentages, the prior art disclosures/teachings of Konto, Mujacic , Kueberuwa, Certo, Nicholson remedy these deficiencies, as discussed above. Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine the prior art elements set forth in the cited prior art references and the reference application by incorporating the lymphodepletion regimen and administering a population of cells with the claimed features, as these regimens and features are known in the art to improve therapeutic efficacy. See MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (D), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Patent No. 9,993,502
Claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of Patent No. 9,993,502 (reference patent;) in view of Konto, Mujacic , Kueberuwa, Certo, Nicholson (supra).
The disclosures of cited prior art references are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65, claims 1-13 of the reference patent explicitly claim a pharmaceutical composition comprising a population of CAR-T cells directed to a cancer cell and having an inactivated TCRa gene, and wherein between 20-65% of the T cell population to be administered are CAR+ (see reference claims 1-13).
While the reference claims do not expressly claim the treatment method, lymphodepletion regimen, CD4+:CD8+ ratio, or CCR7+ percentages, the prior art disclosures/teachings of Konto, Mujacic , Kueberuwa, Certo, Nicholson remedy these deficiencies, as discussed above. Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine the prior art elements set forth in the cited prior art references and the reference application by incorporating the lymphodepletion regimen and administering a population of cells with the claimed features, as these regimens and features are known in the art to improve therapeutic efficacy. See MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (D), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Patent No. 10,093,899
Claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of Patent No. 10,093,899 (reference patent;) in view of Konto, Mujacic , Kueberuwa, Certo, Nicholson (supra).
The disclosures of cited prior art references are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65, claims 1-9 of the reference patent explicitly claim a method of treating cancer in a subject comprising administering a population of CAR-T cells having an inactivated TCRa gene, (see reference claims 1-9).
While the methods claimed by the reference application do not expressly claim the lymphodepletion regimen, CD4+:CD8+ ratio, or CCR7+ percentages, the prior art disclosures/teachings of Konto, Mujacic , Kueberuwa, Certo, Nicholson remedy these deficiencies, as discussed above. Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine the prior art elements set forth in the cited prior art references and the reference application by incorporating the lymphodepletion regimen and administering a population of cells with the claimed features, as these regimens and features are known in the art to improve therapeutic efficacy. See MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (D), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Patent No. 10,093,900
Claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of Patent No. 10,093,900 (reference patent;) in view of Konto, Mujacic , Kueberuwa, Certo, Nicholson (supra).
The disclosures of cited prior art references are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an obviousness analysis.
Obviousness analysis: Regarding instant claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65, claims 1-9 of the reference patent explicitly claim a pharmaceutical composition comprising a population of CAR-T cells directed to a cancer cell having an inactivated TCRa gene, (see reference claims 1-9).
While the methods claimed by the reference application do not expressly claim the treatment method, lymphodepletion regimen, CD4+:CD8+ ratio, or CCR7+ percentages, the prior art disclosures/teachings of Konto, Mujacic , Kueberuwa, Certo, Nicholson remedy these deficiencies, as discussed above. Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine the prior art elements set forth in the cited prior art references and the reference application by incorporating the lymphodepletion regimen and administering a population of cells with the claimed features, as these regimens and features are known in the art to improve therapeutic efficacy. See MPEP § 804(II)(B)(3)(C)-(D); see also MPEP § 2143(A), (B), (D), (G)).
Accordingly, the instant claims are not patentably distinct relative to the reference claims.
Conclusion
Claims 1, 4-5, 7, 9, 11-14, 18, 20, 30-33, 35, 44, 59, 62, and 65 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00AM - 5:00PM PT.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 WO2019089650A1; cited on the IDS
2 WO2019032927A1
3 Kueberuwa et al. “CCR7+ selected gene-modified T cells maintain a central memory phenotype and display enhanced persistence in peripheral blood in vivo”. J. Immunotherapy Cancer 5, 14 (Feb 2017). https://doi.org/10.1186/s40425-017-0216-7
4 WO2017177137A1; cited on the IDS
5 WO2017062439A1
6 1E6 cells/kg, see Konto at para. [00357], falls within the claimed range 3E4 to 1E7 cells/kg, and therefore, is rendered obvious.
7 See, e.g., Konto at para. [000343]- “treatment with fludarabine (total dose about 30 to 150 mg/m2) and cyclophosphamide (total dose about 300 to 4000 mg/m2)”, and para. [00355]
8 See Konto at para. [00355], [00378]
9 The claimed range of 40-75% CAR+ T cells in the population of T cells to be administered overlaps the range of 25-100%, set forth by Mujacic, and therefore, is rendered obvious.
10 Falls within the claimed range of 35-75% CD4+CCR7+ T cells and 25-50% CD8+CCR7+ T cells in the population of T cells to be administered, and therefore, is rendered obvious.
11 It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Prosecution Insights