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 09/24/25 is acknowledged.
2. Claims 40-53, 56, 63-67 are pending.
Claims 40-53,56,63-67 read on a method of treating a subject exhibiting a solid tumor, comprising administering anti-GPC3 chimeric antigen receptor immunoresponsive cells 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 40-51,56,63, 64,66, 67 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20170369561(IDS) each in view of US Patent Application 20100247579(IDS) and US Patent Application 20240408200 and US Patent 12168061 for the same reasons set forth in the previous Office Action, mailed on 01/31/25.
Applicant’s argument has been fully considered but have not been found convincing.
Applicant asserts that a person of ordinary skill in the art would not have a reasonable expectation of successes in arriving at he claimed method given the highly unpredictable nature of the CAR immunoresponsiveness cell therapy.
The Examiner disagrees with applicants assertion of the knowledge of one skill in the art. It is the Examiner’s position that one skill in the art would know that CAR immunotherapy is widely and successfully used in the method of treating patients with solid tumor that expresses GPC3 ( see prior art reference).
Moreover it is noted that Declaration filed under 37 CFR1.132 by Dr. Gao on 09/20/22 in the parent case 16/164,995, it was clearly stated that " Before filing the '995 application, as far as I knew, a single chemotherapeutic agent was used to reduce lymphocytes before CAR-T treatments and has been proven sufficient to enhance CAR-T treatments “.
Thus it is the Examiner’s position that one skill in the art would have reasonable expectation of successes in arriving at the claimed method.
As has been stated previously, US Patent Application’561 teaches a method of treating a subject comprising administering to the subject in need an effective amount of anti-GPC3-CAR T cells. US Patent Application’561 teaches that antigen-recognition domain of the CAR comprises a fully human anti-GPC3. US Patent Application’561 teaches that said subject exhibiting cancer ( see entire document, paragraphs 0039, 0041,0043, 0060 and 0105 in particular).
US Patent Application’397 teaches a method of treating a subject comprising administering to the subject in need an effective amount of anti-GPC3-CAR T cells. US Patent Application’397 teaches that antigen-recognition domain of the CAR comprises a fully human anti-GPC3. US Patent Application’397 teaches that said subject exhibiting cancer ( see entire document, paragraphs 0052, 0072,0740, 0800, 0813, 0843 in particular).
US Patent Application’561 and US Patent Application’397 do not explicitly teach subjecting a subject to lymphocyte reduction treatment such as administering cyclophosphamide , fludarabine etc. or administering immunostimulatory agent, such as IL-2 or GM-CSF
US Patent Application ‘579 teaches a method of treating the cancer patient comprising a step of lymphocyte reduction treatment following administering lymphocytes to a patient. US Patent Application ‘579 teaches the advantage of using said lymphopenia treatment prior to administering lymphocytes for cancer treatment. US Patent Application ‘579 teaches the use of cyclophosphamide, etoposide, fludarabine as lymphocyte reduction treatment ( see entire document, Abstract and paragraphs 0017- 0020, 0031; 0042 in particular).
US Patent Application’ 200 teaches the advantages of administering immunostimulatory agents such as IL-2, GM-CSF together with immunoresponsiveness cells such as T cell or NK cells during cellular immunotherapy ( see entire document, paragraphs 0098, 0138, 0143 in particular).
US patent ‘061 teaches an antigen binding unit comprising a SEQ ID N:4 that is 100% identical to the instantly claimed SEQ ID NO:1
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 ordinary skill in the art before the effective filing date of the claimed invention to use cyclophosphamide, etoposide, fludarabine as lymphocyte reduction treatment prior or concurrent with administering anti-GPC3-CAR T and immunostimulatory agents such as IL-2 or GM-CSF in the method of treating cancer disclosed in US Patent Application’561 and US Patent Application’397 with a reasonable expectation of success because the prior art suggests the advantage of using lymphopenia treatment prior to administering anticancer treatment including immunotherapy with lymphocytes and advantages of administering immunostimulatory agents such as IL-2, GM-CSF together with immunoresponsiveness cells such as T cell or NK cells .
Claims 42, 43, 44, 63, 64,67 are included because it would be conventional and within the skill of the art to : (i) determine the optimum amount of administered GPC3-CAR T or (ii) type of cancer to be treated or means for lymphocyte reduction treatment and immunostimulatory agents. (iii) optimal schedule and concentration for administering immunoresponsive cells; (iv) optimal concentration of cyclophosphamide to be administered 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 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.
5. Claims 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.
6. THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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