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. Applicant's amendment, filed 04/28/26 is acknowledged.
Claims 1,2,4,5,9,12,14,16,17, 23-25,27,32,35,39, 41, 42,43 are pending.
2. Applicant's election with traverse of Group I, claims 1,2,4,5,9,12,14,16 and 17 in the reply filed on 04/28/26 is acknowledged. The traversal is on the ground(s) that all Groups of the present invention share a common special technical feature.
This is not found persuasive because ss was also found in the International Search Report, the Invention of Group I was found to have no special technical feature that defined the contribution over the prior art of US Patent Application 20170182096
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 23-25,27,32,35,39, 41, 42,43 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,2,4,5,9,12,14,16 and 17 read on a genetically modified lymphocyte are under consideration in the instant application.
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 1,2,4,5,9 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20170182096 in view of US Patent Application 20180369283.
US Patent Application’ 096 teaches a genetically modified lymphocyte comprising mutation in one or more cytotoxic proteins , wherein said proteins can be granozyme proteins , such as GZMA or GZMB or GZMK. US Patent Application’ 096 teaches that said mutation results in reducing or elimination of the expression of said cytotoxic proteins US Patent Application’ 096 further teach that said genetically modified lymphocyte can express CAR. US Patent Application’ 096 teaches that said genetically modified lymphocyte can also contain cargo molecule that can be expressed as a fusion proteins that comprises dGZMB. US Patent Application’ 096 futher teaches that said genetically modified lymphocyte can be used for immunotherapy ( see entire document, paragraphs 0009, 0030, 0047, 0057, 0060 0065 and 0067 in particular).
US Patent Application’ 096 does not explicitly teaches that CAR is anti-CD19 CAR.
US Patent Application’20180369283 teaches a genetically modified lymphocyte expressing anti-CAR 19 that can be used for immunotherapy (see entire document , paragraphs 0024, 0140, 0212 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 taught by US Patent Application’ 096 with CAR taught by US Patent Application’096 with a reasonable expectation of success because the prior art teaches that both types of genetically modified lymphocyte expressing CARs can be used for immunotherapy.
6. Claims 1214, 16, 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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, Gregory Emch can be reached on 571/ 272-8149
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