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 10/21/24 is acknowledged.
2. Claims 1- 6,8-20 are pending.
Claims 1-6, 8-20 read on a method for treatment cancer in an individual are under consideration in the instant application.
3.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.
4. Claims 1-6,8-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20250388869 and US Patent Application 20220081679 in view of US Patent Application 20250188413
US Patent Application’869 teaches a method of producing a population of tumor infiltrated lymphocyte (TIL) comprising co-culturing a tumor tissue sample in a air-liquid interface to obtain a patient-derived organoid (PDO) and a population of immune cells and an agent that that can modulate immune cell activity to generate a population of activated cells. US Patent Application’107 teaches that said agent can be immune checkpoint inhibitor, including anti-PD-1 antibody or anti-CD47 antibody. US Patent Application’107 teaches that activation of said immune cells can be measured by expression of mRNA. US Patent Application’869 teaches co-culturing activated immune cells in the presence of IL-2 ( see entire document, paragraphs 0004, 0012, 0020, 0046,0029, 0036, 0055 in particular)
US Patent Application’679 teaches a method of producing a population of TILs comprising co-culturing a tumor tissue sample in a air-liquid interface to obtain a patient-derived organoid (PDO) and a population of immune cells and an agent that that can modulate immune cell activity to generate a population of activated cells. US Patent Application’107 teaches that said agent can be immune checkpoint inhibitor, including anti-PD-1 antibody. US Patent Application’679 teaches that activation of said immune cells can be measured by measuring CTL activity ( see entire document, Abstract and paragraphs 0010, 0012 , 0042, 0080, 0085, 0097 paragraphs in particular).
US Patent Application’869 and US Patent Application’679 do not explicitly teaches a method of treating cancer comprising administering an effective dose of a population of tumor infiltrating lymphocytes.
US Patent Application’413 teaches a method of treating cancer in the patient including carcinoma, comprising administering to said patient TIL ( see entire document, paragraph 0060 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 use TILs produced by US Patent Application’869 and US Patent Application’679 in the method taught by US Patent Application’413 with a reasonable expectation of success because the prior art suggests TILs can be used for treating cancer in the patient.
Claims 5,11 and 19 are included because it would be conventional and within the skill of the art to : (i) identify a population of immune cells to be used or (ii) determine an optimal means of activation and measuring activation of said immune 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.
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.
5. No claim is allowed.
6.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
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