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 09/23/25 is acknowledged.
2. Claims 17-20 are pending.
Claims 17-20 read on a method of treating a subject comprising co-administering a first non-autologous non-HLA -match immune effector cell expressing CAR and a second non-autologous non-HLA -match immune effector cell expressing CAR polypeptide comprising CD83 antigen binding domain are under consideration in the instant application.
3. 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.
4. Claims 17-20 are rejected under under 35 U.S.C. 103 as obvious over US Patent Application 20200277396 ( IDS) in view of US Patent Application 20190352409 (IDS) and WO2016164731 for the same reasons set forth in the previous Office Action, mailed on 06/24/25.
Applicant’s arguments filed on 09/23/25 have been fully considered but have not been found convincing.
Applicant asserts that none of the prior art references teaches or suggests that anti-CD83 CAR-T cells are HLA mismatches.
As initial matter it is noted that it has been recently stated that KSR forecloses the argument that a specific teaching, suggestion, or motivation are required to support a finding of obviousness See Board decision ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Moreover, as is evidence from the US Patent Application 20250161412, the use of non-autologous, HLA-mismatched genetically modified immune effector cells expressing CAR in immunotherapy was well know and routinely used along with allogeneic, syngeneic, related, unrelated HLA-match genetically modified immune effector cells expressing CAR (see entire document, paragraph 0010, and claims in particular).
Thus since none of the prior art references teaches away from using non-autologous, HLA-mismatched genetically modified immune effector cells expressing CAR in immunotherapy, it is the Examiner’s position that it would be conventional and within the skill of the art to determine which of the genetically modified immune effector cells expressing CAR to be used for treating a subject. 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.
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).
As has been stated previously, US Patent Application ‘396 teaches a method of treating a subject, comprising administering to said subject an effective amount of a first immune effector cell genetically modified to expressing CAR polypeptide, comprising CD83 antigen binding domain, transmembrane domain and intracellular signaling domain ( CD83 CAR T cells) ( see entire document, paragraphs 0006, 0058, 0061).
US Patent Application’396 does not explicitly teaches administering the second immune effective cells genetically modified to express a second CAR polypeptide
US Patent Application ‘409 teaches a method of treating and preventing disease including GVHS ( i.e. suppressing alloreactive donor cell) comprising administering to the subject a first population of genetically modified immune effective cells expressing CAR polypeptide and a second immune effective cells expressing a second CAR polypeptide. US Patent Application ‘409 teaches that said cells can be NK cells or T cells. US Patent Application ‘409 teaches the advantages and benefits of administration first and the second population of immune effector cells expression CAR for immune therapy. ( see entire document, Abstract and paragraphs 0050, 0108-0112, 0264, 0292).
WO’731 teaches a method of treating a subject comprising combination therapies with genetically modified immune effector cells expressing CAR that binds to CD19 antigen and a second genetically modified immune effector cells expressing CAR. ( see entire document, Abstract and Summary of the invention ( pages 3-10 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 obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to administer a first immune effector cells expressing CAR that binds to CD19 and a the second immune effector cells expressing second CAR in the method taught by US Patent Application’396 with a reasonable expectation of success because the prior art teaches the advantages and benefits of administration first and the second population of immune effector cells expression CAR for immune therapy
From the combined teaching of the references, it is 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.
5. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). A registered attorney or agent of record may sign a terminal disclaimer.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit https://www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer
6. The claims 17-20 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims 1-25 of copending Application No:18/19814; 1-25 of copending Application No:18/565831; claims 1-19 of copending Application 18/041542; 1-18 of copending Application No.17/635,119; claims 1-16 of US Patent Application 17/635,111; claims 1-18 of US Patent Application 16/969056. Although the conflicting claims are not identical, they are not patentably distinct from each other because 1-25 of copending Application No:18/19814; 1-25 of copending Application No:18/565831; claims 1-19 of copending Application 18/041542; 1-18 of copending Application No.17/635,119; claims 1-16 of US Patent Application 17/635,111; claims 1-18 of US Patent Application 16/969056 each recited a method of treating a subject, comprising administering an effective amount of genetically modified cells expressing CAR polypeptide comprising a CD83 antigen binding 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 to held this rejection in abeyance until the claims are found allowable.
7. No claim is allowed.
8. THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
9. 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