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 09/05/25 is acknowledged.
2. Claims 1, 4, 9,12,15,19,20-23,25,26,28,30,33,38-42 are pending.
3. Claims 1,4,9,12,15,19,20,21, 38-42 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 22,23,25,26,28,30,33 read on a method for making a composition comprising T cells 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. Claim(s) 22,23,25,26,28,30,33 are rejected under 35 U.S.C. 103 as been obvious over
US Patent Application 20210379168 , US Patent Application 20200384031, US Patent 8975069 (IDS) and US Patent 10316289 (IDS), US Patent Application 20180072990 (IDS), US Patent Application 20140127805(IDS) and US Patent 9,114,100 (IDS) for the same reasons set forth in the previous Office Action, mailed on 03/06/25.
Applicant’s arguments filed on 09/05/25 have been fully considered but have not been found convincing.
Applicant asserts that : (i) none of the prior art references teaches or suggest the use of tetrameric antibodies for T cell stimulation; (ii) the claimed methods were unexpectedly beneficial.
As initial matter it is noted that the arguments of counsel cannot take the place of evidence in the record. In re Schulze , 145 USPQ 716, 718 (CCPA 1965). See MPEP 716.01© Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long - felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
With regards to Applicant’s statement that “ none of the prior art references teaches or suggest the use of tetrameric antibodies for T cell stimulation”.
As is evidence from US Patent Application 20250313805, the use of tetrameric antibody that target CD3,CD28 and CD2 for polyclonal T cell stimulation was well know and routinely use by one skill in the art at the time the invention was made ( see paragraphs 0011 and 0019 in particular).
Thus it is the examiner’s position that it would be obvious , conventional and within the skill of the art to use tetrameric antibody for polyclonally stimulating of T cells with a reasonable expectation of success because use of tetrameric antibody for T cell stimulation was well know and routinely use by one skill in the art at the time the invention was made.
As has been stated previously, US Patent Application’168 teaches a method of isolating a selected population of T cells from initial population of cell population comprising T cells based on the expression of T cell activation marker. US Patent Application’168 teaches that said activation marker comprised one or more CD69, CD25, CD40L, CD45RO. US Patent Application’168 teaches that said population can be further expanded ex-vivo by stimulating with polyclonal stimulation with antibodies that binds CD3,CD28 and CD2 ( see entire document, paragraphs 0125, 0134, 135 in particular)
US Patent Application’031 teaches a method of isolating a selected population of T cells from initial population of cell population comprising T cells based on the expression of T cell activation marker. US Patent Application’168 teaches that said activation marker comprised one or more CD69, CD25, CD40L, CD45RO. US Patent Application’168 teaches that said population can be further expanded ex-vivo by stimulating with polyclonal stimulation with antibodies that binds CD3,CD28 and CD2 ( see entire document, paragraphs 0110, 0173, 0361, 0415 in particular)
US Patent’ 069 teaches a method of isolating a selected population of T cells from initial population of cell population comprising T cells based on the expression of T cell activation marker. US Patent Application’069 teaches that said activation marker comprised one or more CD69, CD25, US Patent Application’168 teaches that said population can be further expanded ex-vivo by stimulation with tetrameric antibodies that binds CD3,CD28 and CD2 ( see for example paragraphs 13, 39)
US Patent’ 289 teaches a method of polyclonal stimulation of T cell comprising exposing the cell population to beads that binds CD3,CD28 and CD2 beads ( see for example paragraph 6,65, 69, 74) US Patent’ 289 teaches that using said ImmunoCult beads might be more advantages over the use of anti-CD3/anti-CD28 beads (Dynobeads) for polyclonal stimulation of T cells.
US Patent Application ‘990 teaches a method of generation of antigen-specific T cells, comprising obtaining an initial population of cell comprising T cells and stimulation said T cells by culturing said cell in the culture medium comprising antigens of interest and cytokines. US Patent Application ‘990 teaches that said cytokines include but not limited to IL-2, IL-7, IL-15 etc. US Patent Application ‘990 teaches further stimulation of said antigen-specific T cells by exposing said cells to anti-CD3, anti-CD28 antibodies ( see entire document, paragraphs 0004, 0008, 0009, 0012 in particular).
US Patent Application ‘805 teaches a method of generation of antigen-specific T cells, comprising obtaining an initial population of cell comprising T cells and stimulation said T cells by culturing said cell in the culture medium comprising antigens of interest and cytokines. US Patent Application ‘805 teaches that said cytokines include but not limited to IL-2, IL-15 etc.
US Patent ‘100 teaches a method of generation of antigen-specific T cells, comprising obtaining an initial population of cell comprising T cells and stimulation said T cells by culturing said cell in the culture medium comprising antigens of interest and cytokines. US Patent ‘100 teaches that said cytokines include but not limited to IL-2, IL-7, IL-15 etc. US Patent ‘100 teaches further stimulation of said antigen-specific T cells by exposing said cells to anti-CD3, anti-CD28 antibodies ( see entire document, paragraphs 8, 12, 13, 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 at the time the invention was made to generate stimulated (activated) T cells, by exposing the initial population of cells comprising T cells to one or more of target antigen and to cytokines, selecting activated(stimulated) T cells based on the expression of T cell activation marker and further expanded said activated T cells with tetrameric antibodies that binds to CD3,CD28 and CD2 with a reasonable expectation of success because the prior art teaches a successful method of obtaining an antigen-specific T cells comprising exposing the initial population of cells comprising T cells to one or more of target antigen and to cytokines, selecting said activated T cells based on the expression on said T cell activation marker and further ex-vivo expanded said T cells with tetrameric antibodies that binds CD3,CD28 and CD2.
Claims 25, 30, 33 are included because it would be conventional and within the skill of the art to : (i) identify an optimal timing of selecting activated T cells based on the expression of T-cell activation markers or (ii) determine types of antigens to be used. 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 teachings of the references, it was 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.
6. No claim is allowed.
7. THIS ACTION IS MADE FINAL even though it is a first action in this case. 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, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
8. 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