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 .
DETAILED ACTION
1. Claims 1,17-20,67-70 are pending.
2, Applicant’s election without traverse of Group I, claims 1,17,18 67-70 in the reply filed on 11/05/25 is acknowledged.
Claims 19 and 20 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,17,18 67-70 read on a nucleic acid encoding CAR are under consideration in the instant application.
3. Claim 67 is objected to because of the following informalities: There are two repetitive recitation of CD28 transmembrane domain . It is suggested that one recitation of CD28 transmembrane domain should be corrected to CD8 transmembrane domain for clarity and consistence with the disclosure of the specification.
4. 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.
5. Claims 1,17,18 67-70 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 10253086 in view of US Patent 9745368, US Patent 7446190, UA Patent 9574014, US Patent 9708384 and US Patent 12281151
US Patent’ 086 teaches a CAR targeting CD19 and nucleic acid encoding said CAR, comprising scFvthat binds CD19 a spacer a transmembrane domain, cytoplasmic domain and CD3 zeta signaling domain. US Patent’ 086 teaches that transmembrane domain can be CD28 or CD4 or CD8. US Patent’ 086 teaches that scFv comprises SEQ ID NO114 that is 100% identical to the instantly claimed SEQ ID:102. US Patent ‘368 teaches that said CAR can be used for immunotherapy in treating cancer. ( see entire document, paragraphs (6, 82, 84, 85 117, 131, 168, 214) and sequence alignment in particular).
US Patent ‘086 does not teach CAR comprising cytoplasmic domain comprising CTLA-4 of SEQ ID:17 and CD3 zeta signaling domain comprising SEQ ID N:137 , as recited in claim 1, spacer domain comprising amino acid of SEQ ID N:116, as recited in claim 68 and CD28 transmembrane domain of SEQ ID N:129 or CD4 transmembrane domain of SEQ ID N:131, as recited in claim 69.
US Patent ‘368 teaches a nucleic acid encoding CAR comprising CTLA-4 cytoplasmic domain of SEQ ID NO:15 that is 100% identical to the instantly claimed SEQ ID N:17. US Patent ‘368 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 134, 204 and sequence alignment in particular.)
US Patent ‘190 teaches a nucleic acid encoding CAR comprising CD3 zeta signaling domain of SEQ ID NO:14 that is 100% identical to the instantly claimed SEQ ID N:137. US Patent ‘190 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 8 , 12 and sequence alignment in particular.)
US Patent ‘014 teaches a nucleic acid encoding CAR comprising spacer region domain of SEQ ID NO:21 that is 100% identical to the instantly claimed SEQ ID N:116. US Patent ‘014 teaches that the presence of said spacer region increases binding affinity of said CAR. US Patent ‘014 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 10, 162, 163 and sequence alignment in particular.)
US Patent ‘384 teaches a nucleic acid encoding CAR comprising CD28 transmembrane domain of SEQ ID NO:22 that is 100% identical to the instantly claimed SEQ ID N:129. US Patent ‘014 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 3,10, and sequence alignment in particular.)
US Patent ‘151 teaches a nucleic acid encoding CAR comprising CD4 transmembrane domain of SEQ ID NO:10 that is 100% identical to the instantly claimed SEQ ID N:131. US Patent ‘151 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 58,117, 119 and sequence alignment in particular.)
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute CAR cytoplasmic domain, CD3 zata signaling domain , spacer domain and transmembrane domain taught by US Patent ‘086 with corresponding domains taught by US Patent 9745368, US Patent 7446190, UA Patent 9574014, US Patent 9708384 and US Patent 12281151 from with a reasonable expectation of success because the prior art teaches that each of the CARs comprising said domains were well known in the art and have been successfully used for immunotherapy in treating cancer.
Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
6. 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.
7. The claims 1,17, 18, 67-70 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications 18/284,413, 17/256,786 and 19/178682 each in view of US Patent 10253086 , US Patent 9745368, US Patent 7446190, UA Patent 9574014, US Patent 9708384 and US Patent 12281151
Claims of copending Applications 18/284,413, 17/256,786 and 19/178682 each recited a nucleic acid encoding CAR comprising scFv targeting CD6, a spacer domain a transmembrane domain a CTLA4 cytoplasmic domain and CD3 zeta signaling domain.
US Patent’ 086 teaches a CAR targeting CD19 and nucleic acid encoding said CAR, comprising scFvthat binds CD19 a spacer a transmembrane domain, cytoplasmic domain and CD3 zeta signaling domain. US Patent’ 086 teaches that transmembrane domain can be CD28 or CD4 or CD8. US Patent’ 086 teaches that scFv comprises SEQ ID NO114 that is 100% identical to the instantly claimed SEQ ID:102. US Patent ‘368 teaches that said CAR can be used for immunotherapy in treating cancer. ( see entire document, paragraphs (6, 82, 84, 85 117, 131, 168, 214) and sequence alignment in particular).
US Patent ‘368 teaches a nucleic acid encoding CAR comprising CTLA-4 cytoplasmic domain of SEQ ID NO:15 that is 100% identical to the instantly claimed SEQ ID N:17. US Patent ‘368 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 134, 204 and sequence alignment in particular.)
US Patent ‘190 teaches a nucleic acid encoding CAR comprising CD3 zeta signaling domain of SEQ ID NO:14 that is 100% identical to the instantly claimed SEQ ID N:137. US Patent ‘190 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 8 , 12 and sequence alignment in particular.)
US Patent ‘014 teaches a nucleic acid encoding CAR comprising spacer region domain of SEQ ID NO:21 that is 100% identical to the instantly claimed SEQ ID N:116. US Patent ‘014 teaches that the presence of said spacer region increases binding affinity of said CAR. US Patent ‘014 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 10, 162, 163 and sequence alignment in particular.)
US Patent ‘384 teaches a nucleic acid encoding CAR comprising CD28 transmembrane domain of SEQ ID NO:22 that is 100% identical to the instantly claimed SEQ ID N:129. US Patent ‘014 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 3,10, and sequence alignment in particular.)
US Patent ‘151 teaches a nucleic acid encoding CAR comprising CD4 transmembrane domain of SEQ ID NO:10 that is 100% identical to the instantly claimed SEQ ID N:131. US Patent ‘151 teaches that said CAR can be used for immunotherapy in treating cancer.( see entire document, paragraphs 58,117, 119 and sequence alignment in particular.)
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute CAR cytoplasmic domain, CD3 zata signaling domain , spacer domain and transmembrane domain recited in claims of copending Applications 17/256,786 and 19/178682 with corresponding domains taught by US Patent 10253086 , US Patent 9745368, US Patent 7446190, UA Patent 9574014, US Patent 9708384 and US Patent 12281151 from with a reasonable expectation of success because the prior art teaches that each of the CARs comprising said domains were well known in the art and have been successfully used for immunotherapy in treating cancer.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
6. No claim is allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644