DETAILED ACTION
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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by June et al (WO 2016/126608, of record in the International search report, US 2018/0044424 is the USPGPUB equivalent).
June et al teach a genetically engineered natural killer cell expressing a TCR-based molecule for the treatment of cancer (Abstract; Pg. 49, Lns. 27-28; Pg. 37, Lns. 8-10). The cells comprise a recombinant nucleic acid encoding a protein complex having an alpha chain T cell receptor, a beta chain T cell receptor, at least a portion of CD3gamma, and at least a portion of CD3delta (Pg. 139, Lns. 16-17; Pg. 50, Lns. 16-26; Pg. 103, Lns. 1-17). At least a portion of the alpha chain T cell receptor or a beta chain T cell receptor is specific to a patient- or tumor-specific neoepitope, or a tumor associated antigen (Pg. 24, Lns. 6-7; Pg. 47, Lns. 15-17). June et al teaches a portion of CD3gamma or CD3delta comprises an immunoreceptor tyrosine-based activation motif (ITAM) (Pg. 103, Lns. 5-17). June et al teaches the NK cells can be from an NK-92 cell line (¶[0534] of the ‘424 publication). Pharmaceuticals comprising the cells are taught in, e.g. ¶[0746]. The cells are administered in an effective amount to induce an immune response to a tumor (abstract, claim 75 of ‘424).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over June et al (WO 2016/126608, of record, US 2018/0044424 is the USPGPUB equivalent) in view of Birnbaum et al (PNAS, 2014, of record) and Loew et al (WO 2017/027392, of record).
The teachings of June et al are as above and applied as before. June et al further teaches a nucleic acid segment encoding an alpha chain T cell receptor and a beta chain T cell receptor, the alpha and beta chain receptor being separated by a first self-cleaving 2A peptide sequence (Pg. 51, Lns. 6-8). June et al teaches the use of autologous T or NK cells (¶[0064]), which are considered to express T cell receptors that are “homologous” to other T cell receptors because they comprise TCR alpha, beta and CD3 chains
June et al do not teach a second nucleic acid segment encoding at least a portion of CD3delta and at least a portion of CD3gamma, the at least a portion of CD3delta and the at least a portion of CD3gamma being separated by a second or third self-cleaving 2A peptide sequence.
Birnbaum teaches a nucleic acid sequence encoding CD3delta and CD3gamma separated by a self-cleaving 2A peptide sequence ( Fig. 2A, Pg. 17578, left column, first paragraph; Pg. 17580, left column, final paragraph).
Loewe et al teaches a single construct comprising a TCR and CD3 domains that could be separated by a self-cleaving 2A peptide sequence (Pg. 51, Lns. 18-20; Pg. 3, Lns. 12-13; Pg. 51, Lns. 2-4). Pg. 26, Ln. 29 - Pg. 27, Ln. 3).
The claimed NK cells are essentially disclosed by June et al with the exception of the second and third 2A peptide limitation. The ordinary skilled artisan, seeking to prepare antigen-specific NK cells, would have been motivated to use the 2A cleavage sites of Birnbaum and Loew et al with the NK cells of June et al because Birnbaum and Loew et al teach them to be a well-known cleavage sites that have utility and specificity for cleaving fusion proteins. It would have been obvious for the skilled artisan to do this because of the known benefit of generating NK cells for administration in the treatment of cancer as taught by June and Loew et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Allowable Subject Matter
Claims 7-11 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638
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