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 40-62 are pending.
Claims 40-62 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.
2. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/164,995, filed on 10/19/2018.
3. The first sentence of the Specification should be amended to reflect the status of the parent case 16/164,995, now allowed.
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
6. Claim 46 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Dependent claim 46 recites “ the antigen binding unit”. There is insufficient antecedent basis for this limitation in the claims, since base Claim 40 does not recite “antigen binding unit”. 49-
7. 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.
8. Claims 40-45,49- 62 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20170369561(IDS) or US Patent Application 20190262397(IDS) each in view of US Patent Application 20100247579(IDS) and US Patent Application 20240408200.
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).
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 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. 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.
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claims 40-62 are on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No.12,178,786, claims 1-27 of US Patent 11,596,653
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of U.S. Patent No.12,178,786, claims 1-27 of US Patent 11,596,653 each recited a method of treating a subject with cancer, comprising administering anti-GPC3 chimeric antigen receptor immunoresponsive cells and cyclophosphamide.
11. No claim is allowed.
12. 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