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. Claims 1 – 18 are pending .
Claims 1- 18 read on a method of treating a disease in a patient comprising administering to the patient expanded population of T cell are under consideration in the instant application.
2. 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.
3. Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent US Patent Application 20220282285 (IDS), US Patent Application 20190062735 (IDS) in view of US Patent Application 20210260117 and US Patent Application 20240350603
US Patent Application ‘285 teaches a method of treating cancer in the patient comprising administering to the patient an expanded and stimulated population of T cells. US Patent Application ‘285 teaches that said T cells were obtained by an in vitro expanding primary T cells stimulated by anti CD3/CD28 antibodies and culturing said cells in the presence of IL-2, IL-7 and IL-15 in a medium comprising serum( see entire document, paragraphs, 0006, 0009, 0085, 0116, 0150, 0181 in particular).
US Patent Application ‘735 teaches a method of in vitro expanding primary T cells comprising stimulating said cells by antiCD3/CD28 antibodies and culturing said cells in the presence of IL-2, IL-7 and IL-15 ( see entire document, paragraph 0391 in particular).
US Patent Application ‘735 teaches that said T cells were obtained a method of in vitro expanding primary T cells stimulated by anti CD3/CD28 antibodies and culturing said cells in the presence of IL-2, IL-7 and IL-15 in the medium comprising serum ( see entire document, paragraphs 0121, 0123, 0127 in particular).
US Patent Application ‘285 and US Patent Application ‘735 do not explicitly teach that T cells are transfected to express TCR or that T cells are expanded using good Manufacturing practice (GMP) in- a- box system.
US Patent Application’ 117 teaches a method of using electroporation for transfecting expanded T cells with recombinant polynucleotide encoding TCR. US Patent Application’ 117 teaches that said modified T cells can be used for treating cancer in a patient ( see entire document, paragraphs 0005, 0008, 0052 in particular).
US Patent Application’ 603 teaches an advantage of GMP in a-box system for expanding immune cells, including T cells ( see entire document, paragraph 0018, 0062
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 using electroporation for transfecting expanded T cells with recombinant polynucleotide encoding TCR taught US Patent Application’ 117 in a method taught by US Patent Application ‘285 and US Patent Application ‘735 and expand the obtained T cells using GMP in a-box system taught by US Patent Application’ 603 with a reasonable expectation of success because the prior art suggests that T cells expressing TCR can be used for treating cancer and the advantages of GMP in a-box system for expanding said cells.
Claim 15 is included because it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories 58 USPQ2d 1508 (CAFC 2001). “{i}t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Thus, it is the Examiner’s position that the claimed at least 30 fold expansion would be an obvious results of the recited in prior art method for growth primary T cells because the claimed and recited method are essentially the same.
Granting a patent on the discovery of an unknown but inherent/obvious function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
Claims 8, 11, 16-18 are included because it would be conventional and within the skill of the art to : (i) determine an optimal dilution of T cells in the expansion method or (ii) determine the optimum means for freezing T cells. 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.
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.
4. No claim is allowed.
5. 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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