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 APPLICANT’S AMENDMENT
1. Applicants amendment filed on 05/11/26 is acknowledged.
2. Claims 1-8, 18-24, 29,31 and 32 are pending.
3. Claims 29,31 and 32 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-8, 18-24 read on a therapeutic cell that expresses a fusion protein are under consideration in the instant application.
The following new ground of rejection is necessitated by the amendment filed on 05/11/26
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 1-8,18-24 are rejected under 35 U.S.C. 103 as being unpatentable US Patent Application 20160272718 in view of US Patent Application 20220025341 , US 20220098258 and 20110275146
US Patent’ 718 teaches a therapeutic CAR-T cell expressing a fusion protein comprising antigen-binding domain, degradation domain comprising degron, wherein degron is RRRG transmembrane domain and a linker between the target-binding domain and degradation domain ( see entire document, paragraphs 003, 0034, ,0051, 0056, 0060 and 0061 in particular).
US Patent Application’718 does not explicitly teaches a fusion protein comprising degradation domain comprisng E3 ligaze-recruting domain or wherein target-binding domain is a synthetic leucine zipper.
US Patent Application’341 teaches a fusion protein comprising targeting domain and degradation domain comprisng E3 ligase-recruiting domain. US Patent Application’341 teaches a fusion protein can be used for targeting protein degradation ( see entire document, abstract and paragraphs 0011, 0015 in particular).
US Patent Application 258 teaches a fusion protein comprising leucine zipper domain and degradation domain. US Patent Application’258 teaches a fusion protein can be used for targeting protein degradation ( see entire document paragraphs 0006, 0081, 0180 in particular).
US Patent Application 146 teaches a fusion protein comprising leucine zipper domain and degradation domain. US Patent Application’146 teaches a fusion protein can be used for targeting protein degradation ( see entire document paragraphs 0121, 0124, 0259 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 a fusion protein taught by US Patent Application’718 with a a fusion protein comprising degradation domain comprisng E3 ligase-recruiting domain or a fusion protein comprising leucine zipper domain and degradation domain in a with a reasonable expectation of success because the prior art suggests each of said fusion proteins can be used for degradation of the target protein
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 1-8,18-24 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application Nos. 18/835,327; 18/728067, 18/278379; 18/278,377;
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application Nos. 18/835,327; 18/728067, 18/278379; 18/278,377 each recited a therapeutic cells expressing a fusing protein comprising target-binding domain and a degradation domain.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant requested that said rejection be hold in abeyance until patentable subject matter is identified.
8. No claim is allowed.
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. 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
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
Prosecution Insights