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 .
Response to Applicants Instant Set of Claims
The examiner has considered applicants amendments and remarks. Some claims now recite an engineered T cell that does not express cyclin-dependent kinase inhibitor 2A (CDKN2A), cyclin-dependent kinase inhibitor 2B (CDKN2B), and S-methyl-5’-thioadenosine phosphorylase (MTAP). The examiner found additional art which indicates that deletions in cdkn2a, cdkn2b, and mtap genes can be present in a T cell cancer type. Therefore, a new 101 rejection is put forward. The claims not rejected are allowable because a T cell that does not express the combination of specific proteins/markers described in the allowed claims could not be found in the prior art.
The double patenting rejections are maintained since terminal disclaimers have not been filed. Examiner’s docketing system shows that both 18/583,233 and 18/583,213, cited in the double patenting rejections, belong to assignee AstraZeneca Application number 18/583,233 is listed as attorney docket number BCMA-UEC-100-US-NP.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 71,73, 77-78, and 80 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. Claim 71 recites a T cell that does not express cyclin-dependent kinase inhibitor 2A (CDKN2A), cyclin-dependent kinase inhibitor 2B (CDKN2B), and S-methyl-5’-thioadenosine phosphorylase (MTAP) which can be found in some T cell cancer types involving a deletion in a region of chromosome 9. The genes responsible for the expression of CDKN2A, CDKN2B, and MTAP are located near one another. The 101 analysis will be conducted using the 2019 Revised Patent Subject Matter Eligibility Guidance Analysis.
Step 1: Is the claim drawn to a process, machine, manufacture, or composition of matter?
Answer: The claim is drawn to a T cell that does not express cyclin-dependent kinase inhibitor 2A (CDKN2A), cyclin-dependent kinase inhibitor 2B (CDKN2B), and S-methyl-5’-thioadenosine phosphorylase (MTAP).
Step 2A (Prong One)
Does the claim recite an abstract idea, law of nature, natural product, or natural phenomenon?
Answer: The claim recites a natural product because T cells from patients with pediatric T cell acute lymphoblastic leukemia have been known to have deletions of the following genes: cdkn2a, cdkn2b, and mtap (Yeh “Clinical and biological relevance of genetic alterations in pediatric T-cell acute lymphoblastic leukemia in Taiwan”—Figure 1) Pediatr Blood Cancer, 2018 Such deletions would inherently result in T cells incapable of expressing CDKN2A/CDKN2B and MTAP.
Step 2A (Prong Two)
Does the claim recite additional elements that integrate into a practical application?
The instant claim recites a T cell that is incapable of expressing CDKN2A/CDKN2B and MTAP. T cells exist in cancer patients which have deletions in the following genes: cdkn2a, cdkn2b, and mtap which would inherently make such cells unable to express CDKN2A, CDKN2B and MTAP. Instant claim 71’s T cell is not distinct structurally and/or functionally from T cells present in cases of pediatric T cell acute lymphoblastic leukemia patients as discussed in Yeh Figure 1. Instant claim 71 fails to integrate the natural product in a meaningful way that further limits the scope of the natural product in a way that does not monopolize the natural product itself. Therefore, the claims do not recite elements that integrate the natural product into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The T cell recited in the claim 71 can be found in patients with pediatric T-cell acute lymphoblastic leukemia in which the T cells are incapable of expressing CDKN2A/CDKN2B and MTAP (Yeh Figure 1). Claim 71 fails to impart a structure and/or function that would be capable of transforming the T cell recited in claim 71 to anything markedly different from T cells derived from T-cell acute lymphoblastic leukemia patients. Dependent claims 77-78,80 describe inherent characteristics and markers present in T cells and do not impart structure, function, and/or elements that amount to significantly more than a natural product (a cancer cell).
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 71,73,77-78, and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeh “Clinical and biological relevance of genetic alterations in pediatric T-cell acute lymphoblastic leukemia in Taiwan” Pediatr Blood Cancer, 2018
Yeh discloses a T cell that does not express cyclin-dependent kinase inhibitor 2A (CDKN2A), cyclin-dependent kinase inhibitor 2B (CDKN2B), and S-methyl-5’-thioadenosine phosphorylase (MTAP) (Abstract and Figure 1 of Yeh) as in instant Claim 71. The genes responsible for CDKN2A, CDKN2B, and MTAP expression are located next to one another and are taken out with a big deletion in the DNA. Any other gene located within the deleted material would be absent as well including immune related genes as in instant Claim 73. Both CD4+ and CD8+ T cells from the patients mentioned in Yeh would have the same deletions as in instant Claims 77-78. The samples collected in Figure 1 are from a human as in instant Claim 80.
The reference anticipates the instant claims.
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 claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims. 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 and 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-42 of copending Application No. 18,583,233 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 41-42 of application 18,583,233 are a species of instant claims 71 and 81. Claims 41-42 recite a CAR T cell with a knock out (gene edit) of cyclin-dependent inhibitor 2A, cyclin-dependent inhibitor 2B, or S-methyl-5’-thioadenosine phosphorylase (MTAP) expression. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 71-88 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 119,122,124-125,127-128,134,138,141-145 of copending Application No. 18,583,213 (reference application). Claim 119 of Application 18,583,213 is a species of instant claims 71 and 81 because it includes all the limitations of the instant claims (an engineered T cell that does not express cyclin-dependent kinase inhibitor 2A (CDKN2A), cyclin-dependent kinase inhibitor 2B (CKN2B), and/or S-methyl-5’thioadenosine phosphorylase) and also recites introducing a transgene encoding TERT. Claim 122 of Application 18,583,213 corresponds to instant claims 72 and 88. Claim 124 of Application 18,583,213 corresponds to instant claims 74 and 81. Claim 125 of Application 18,583,213 corresponds to instant claims 75 and 82.
Claim 127 of Application 18,583,213 is a species of instant claims 71 and 81 because claim 127 of Application 18,583,213 recites “an engineered T cell that does not express cyclin-dependent kinase inhibitor 2A (CDKN1A), cyclin dependent kinase inhibitor 2B, and/or S-methyl-5’thioadenosine phosphorylase (MTAP), wherein the engineered T cell comprises a transgene encoding MYC.” Claim 128 corresponds to instant claim 88. Claims 134 of Application 18,583,213 recites the limitations of claims 71 and 81 by reciting “an engineered T cell that does not express cyclin-dependent kinase inhibitor 2A (CDKN2A), cyclin-dependent kinase inhibitor 2B (CDKN2B) and/or S-methyl-5-thioadenosine phosphorylase (MTAP), and comprises a transgene encoding TERT.” Claim 138 of Application 18,583,213 corresponds to instant claims 73. Claim 139 of Application 18,583,213 corresponds to instant claims 74 and 81. Claim 141 of Application 18,583,213 corresponds to instant claims 76 and 83. Claim 142 of Application 18,583,213 corresponds to instant claims 77-79 and 84-86. Claim 143 of Application 18,583,213 corresponds to instant claims 78 and 85. Claim 144 of Application 18,583,213 corresponds to instant claims 79 and 86. Claim 145 of Application 18,583,213 corresponds to instant claims 80 and 87. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights