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 02/27/26 is acknowledged.
2. Claims 1,4,6,9-12,14-18,24-27 are pending.
Claims 11, 12,14-16,18 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1, 4,6,9-10,17, 24 -27 read on a human immunophilin knockout cells that are T cell or NK cells are under consideration in the instant application.
The following new ground of rejection is necessitated by the amendment filed on 02/27/26
5. 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.
6. Claims 1-10,17 24 rejected under 35 U.S.C. 103 as obvious over WO 2014191128 or US Patent Application 20240024410 in view of newly cited US Patent Application 20210213062 and US Patent 12037583.
Applicant’s argument filed on 02/27/26 have been fully considered but have not been found convincing.
Applicant asserts that the amended claimed now recited a regulatory T cells and that knockout was done but using a sgRNA targeting the sequence of SEQ ID NO:1. None of the prior art references teaches said features. Applicant further asserts that WO’410 only merely states that the target gene may be an FKBP family and there is no experimental protocols or no specific sdRNA sequences to be used.
Newly cited US Patent ‘ 062 teaches a Treg for immunotherapy comprising specific mutation in FKBP 12 gene of said Treg. ( see entire document, paragraphs 0003, 0101, 0112, 0139 in particular).
Newly cited US Patent 583 teaches a T cells comprising a knockout FKBP12 gene, wherein said cells were obtained by using gRNA comprising targeting domain sequence that is 100% identical to the instantly claimed SEQ ID :1 ( see entire document, paragraphs 180, 191, 205, sequence alignmnent).
It is noted however, that the instant claims are drawn to a product, i.e. Treg with knockout ( mutated) FKBP12 gene, not a method of producing said cells and the patentability of the product does not depend on its method of production. In re Thrope,227 USPQ 964,966 (Fed. Cir. 1985). See MPEP 2113.
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 one type of T cells with knockout FKBP12 with another with a reasonable expectation of success because the prior art suggests that FKBP12 gene can be mutated in each of said T cells for immunotherapy.
With regards to Applicant’s comments that none of the prior art teaches the use of a sgRNA targeting the sequence of SEQ ID NO:1 for generating a Treg knockout cells.
It is noted that the instant claims are drawn to a product, i.e. Treg with knockout ( mutated) FKBP12 gene, not a method of producing said cells and the patentability of the product does not depend on its method of production. In re Thrope,227 USPQ 964,966 (Fed. Cir. 1985). See MPEP 2113.
With regards to Applicant’s statement that WO’ 128 “ only merely states that the target gene may be an FKBP family and there is no experimental protocols or no specific sdRNA sequences to be used.”
The Examiner disagrees with Applicant’s interpretation of the teaching of WO’128. In particular, WO’128 explicitly teaches that for immunotherapy T cells with knockout of target gene FKBP12 is preferred ( see page 29 in particular)
As has been stated previously, WO’128 teaches a human T cells for immunotherapy wherein FKBP gene family such as FKBP12 gene or cyclophilin gene family are knockout by using CRISPR/Cas editing. WO’128 teaches that said T cells can be virus-specific T cells (see entire document, pages 3, 27 29, 34 in particular).
US Patent Application’ 410 teaches a human T cells for immunotherapy wherein FKBP12 gene is knockout by using CRISPR/Cas editing ( see entire document, paragraphs 0044, 0138, 0143 in particular).
Claims 5-8,10 and 24 are included because it would be conventional and within the skill of the art to identify a type of antigen-specific T cells wherein immunophilin genes would be knockout 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).
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.
7. No claim is allowed.
8. 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.
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
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