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
Applicant's amendment, filed 03/03/26 is acknowledged.
1. Claims 10,12,13,26, 35-49 are pending.
Claims 10,12,13,26, 35-49 read on a method of treating a subject having solid cancer comprising administering to the subject immune effector cell expressing CAR are under consideration in the instant application.
2. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
The following new ground of rejection is necessitated by the amendment filed on 03/03/26
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. Claim(s) 10,12,13,26, 35-49 are rejected under under 35 U.S.C. 103 as obvious over US Patent Application 20230056345 and US patent Application 20250043243 in view of US Patent Application 20190374486 and newly cited US Patent Application20230158164.
Applicant’s arguments filed on 03/03/26 have been fully considered but have not been found convincing.
Applicant asserts that as amended the claims now recited administering sub-therapeutic amount of immune effector cells. None of the prior art references teach the administering of sub-therapeutic amount of CAR-T cells.
Newly submitted US Patent Application’164 teaches an administering of a sub-therapeutic amount of immune effector cells, such as CAR-T cells in a method of treating cancer. US Patent Application’164 teaches that said sub-therapeutic amount can be 0.8x106 cells. US Patent Application’164 teaches that said sub-therapeutic dose can be done together with additional treatment( see entire document paragraphs 0017,0073,0185, 0186).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to administered CAR-T cells in sub-therapeutic dose with a reasonable expectation of success because the prior art suggests that even sub-therapeutic dose of CAR-T cells can be effectively used for treating solid cancer.
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).
US Patent Application’345 teaches a method of treating solid cancer in the individual comprising administering to said individual immune effector cells genetically modified to express an antigen receptor ( CAR-T cells) ( see entire document, paragraphs 0003, 0036, 0059 in particular).
US Patent Application’243 teaches a method of treating solid cancer in the individual comprising administering to said individual immune effector cells genetically modified to express an antigen receptor ( CAR-T cells) ( see entire document, paragraphs 0222, 0235, 0340, 0347 in particular).
US Patent Application’345 and US Patent Application’243 do not explicitly teaches administering a tumor antigen or polynucleotide encoding said antigen to treat cancer.
US Patient Application’486 treating solid tumors comprising administering to the patient a combination therapy comprising an tumor antigen or polynucleotide encoding said antigen together with second therapeutic agent used for treating the same tumor ( see entire document, paragraphs 0015, 0116, 0121.
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 administered CAR-T cells together with tumor antigen or polynucleotide encoding said antigen with a reasonable expectation of success because the prior art suggests that each of said compound can be used for treating solid tumors.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Claims 11, 39, 42 and 49 are included because it would be conventional and within the skill of the art to (i) determine an effective amount of administered CAR-T: (i) identify the best means and forms of administering tumor antigen. 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).
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. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). 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. 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 filing date of the application will determine what form 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 10-13, 23 ,26 35-48 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application Nos: US 20230049655; US 20250025505 in view of US Patent Application 20190374486 and newly cited US Patent Application 20230158164
Claims of copending Application Nos: 20230049655; US 20250025505 each recited method of treating solid tumor comprising administering to the subject genetically modified immune effector cell expressing CAR.
US Patient Application’486 treating solid tumors comprising administering to the patient a combination therapy comprising an tumor antigen or polynucleotide encoding said antigen together with second therapeutic agent used for treating the same tumor ( see entire document, paragraphs 0015, 0116, 0121.
Newly submitted US Patent Application’164 teaches an administering of a sub-therapeutic amount of immune effector cells, such as CAR-T cells in a method of treating cancer. US Patent Application’164 teaches that said sub-therapeutic amount can be 0.8x106 cells. US Patent Application’164 teaches that said sub-therapeutic dose can be done together with additional treatment( see entire document paragraphs 0017,0073,0185, 0186).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to administered CAR-T cells in sub-therapeutic dose with a reasonable expectation of success because the prior art suggests that even sub-therapeutic dose of CAR-T cells can be effectively used for treating solid cancer.
It would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to administered CAR-T cells together with tumor antigen or polynucleotide encoding said antigen with a reasonable expectation of success because the prior art suggests that each of said compound can be used for treating solid tumors.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
6. No claim is allowed.
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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.
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
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