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 11/24/25 is acknowledged.
2. Claims 1, 7, 9,14, 15,20, 36,37,43,51,54,58, 68, 75, 78 are pending.
3. Claim 78 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1, 7, 9,14, 15,20, 36,37,43,51,54,58, 68, 75 read on a composition comprising at least 108 antigen-specific CD8+ T cells are under consideration in the instant application.
4. The following is a quotation of the appropriate paragraphs of pre-AIA U.S.C. §101 that form the basis for the rejections under this section made in this Office action:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1, 7, 9,14, 15,20, 36,37,43,51,54,58, 68, 75 do not recite something significantly different than a judicial exception for the same reasons set forth in the previous Office Action mailed on 05/23/25.
Applicant arguments filed on 11/24/25 have been fully considered but have not been found convincing.
Applicant asserts that as amended claims now recited that CD8+ T cells are produced by expansion of CD8+ T cells specific for a target peptide antigens from source cells.
Contrary to Applicant’s assertion it is noted that Applicant provide no evidences and/or Declaration that the claimed expanded cells are structurally/functionally are different from the naturally existing CD8+ T cells.
As has been stated previously, claims 1, 7, 9,14, 15,20, 36,37,43,51,54,58, 68, 75 as written, do not sufficiently distinguish over antigen-specific CD8+ T cells as they exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements Thus, the claimed composition comprising at least 108 antigen-specific CD8+ is not markedly different from what exists in nature.
While claim 1 require that at antigen-specific CD8+ T cells are isolated, purified ,expanded and are present in certain concentrations, merely isolating concentrating and expanding the cells does not make them markedly different from what occurs in nature. See MPEP 2106.04(c)(II), subsections (A) and (B), as well as Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013) and University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 760, 113 USPQ2d 1241, 1241 (Fed. Cir. 2014) cited therein and 2106.04(c)(II)(C)(2). As both sets of cells are not markedly different from what occurs in nature, the claims recite a natural product judicial exception.
The claims do not integrate the exception into a practical application, as there are no additional elements which rely on, use, or apply the exception. See MPEP 2106.04(d), in particular second paragraph.
The Supreme Court has recently articulated a two part test for distinguishing patents that claim one of the patent-ineligible exceptions from those that claim patenteligible applications of those concepts. Id. (citing Mayo, 132 S. Ct. at 1294, 1296-97). Step one asks whether the claim is “directed to one of [the] patent-ineligible concepts.” Id. If the answer is no, the inquiry is over: the claim falls within the ambit of § 101. If the answer is yes, the inquiry moves to step two, which asks whether, considered both individually and as an ordered combination,
“the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo, 132 S. Ct. at 1297). Step two is described “as a search for an ‘inventive concept.’” Id. (quoting Mayo, 132 S. Ct. at 1294). At step two, more is required than “wellunderstood, routine, conventional activity already engaged in by the scientific community,” which fails to transform the claim into “significantly more than a patent
upon the” ineligible concept itself. Mayo, 132 S. Ct. at 1298, 1294.
2014 Interim Guidance states “To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (‘‘[The inventor did] not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.’’)" and "… a difference in a characteristic that came about or was produced independently of any effort or influence by applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because ‘‘any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’ ’’ and were ‘‘uninfluenced by Roslin’s efforts’’, they ‘‘do not confer eligibility on their claimed subject matter’’ (quoting Funk Bros.))."
Based on the analysis of factors in the Myriard-Mayo, the Examiner determiners that factors against eligibility are satisfied.
The following new ground of rejection is necessitated by the amendment filed on 11/24/25 .
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) 1, 7, 9,14, 15,20, 36,37,43,51,54,58, 68, 75 are rejected under 35 U.S.C. 103 as obvious over US Patent Application 20210253707 or US Patent 9688982 or US Patent 9790467 or US Patent Application 20210170002.
US Patent Application ‘ 707 teaches a composition comprising tumor antigen-specific CD8 T cells that has been activated and expanded ex vivo suitable for adoptive immunotherapy. US Patent Application ‘ 707 teaches that said tumor antigen can be not oncoviral proteins( see entire document, paragraphs 0004, 0030, 0106, 0128).
US Patent ‘982 teaches a composition comprising tumor antigen-specific CD8 T cells that has been activated and expanded ex vivo suitable for adoptive immunotherapy. US Patent ‘ 982 teaches that said tumor antigen can be not oncoviral proteins( see entire document, paragraphs 0005, 257, ).
US Patent 467 teaches a composition comprising tumor antigen-specific CD8 T cells that has been activated and expanded ex vivo suitable for adoptive immunotherapy. US Patent ‘467 teaches that said tumor antigen can be not oncoviral proteins( see entire document, paragraphs 23,24,27,50 in particular).
US Patent Application ‘ 002 teaches a composition comprising tumor antigen-specific CD8 T cells that has been activated and expanded ex vivo suitable for adoptive immunotherapy. US Patent Application ‘ 002 teaches that said tumor antigen can be not oncoviral proteins( see entire document, paragraphs 003,0032, 0045, 0050 in particular).
Though US Patent Application 20210253707 or US Patent 968982 or US Patent 9790467 or US Patent Application 20210170002 does not explicitly recited the claimed dosage of at least 108 CD8+ T cells, said dosing regimens were obvious at the time the invention was made, given that it was well known and practice before the effective filing date of the claimed invention as evidenced by the teachings of the prior art.
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).
Claims 20, 36, 37, 75, are included because the claimed structural limitation would be an obvious properties of the recited isolated antigen-specific CD8+ T cells, because the claimed and recited antigen-specific CD8+ T are the same. Since the office does not have a laboratory to test the reference antigen-specific CD8+ T it is applicant’s burden to show that the reference antigen-specific CD8+ T cells do not have the same structural features as recited in the claims. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
Claims 43, 51, 58, 68, are included because the instant claims are drawn to a product (antigen-specific CD8+ T) and the patentability of the product does not depend on its method of production in the absence of evidence of structural/functional difference. In re Thrope,227 USPQ 964,966 (Fed. Cir. 1985). See MPEP 2113.
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. The following is a quotation of the first paragraph of 35 U.S.C. 112:
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 of carrying out his invention.
7. Claims 1, 7, 9,14, 15,20, 36,37,43,51,54,58, 68, 75 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
“ wherein the target peptide antigens are tumor associated antigens and which are not oncoviral antigens” claimed in 1 represent a departure from the specification and the claims as originally
The passages pointed by the applicant do not provide a clear support for the newly claimed wherein the target peptide antigens are tumor associated antigens and which are not oncoviral antigens ( emphases added).
The specification and the claims as originally field only support “ specific for one or more target peptide antigen, wherein target peptide antigen are tumor associated antigen (original claim 4) or bacterial viral, fungal or parasitic antigen ( original claim 6).
8. 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 registered attorney or agent of record may sign a terminal disclaimer.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit https://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 [ 1 ].
10. The claims 1, 7, 9,14, 15,20, 36,37,43,51,54,58, 68, 75 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims 1,4,7,9,11,15,16,18,20,23,24,26,27,33,39,42,47,53 and 55 of copending Application No.16/678,366.
Although the conflicting claims are not identical, they are not patentable distinct from each other because claims 1,4,7,9,11,15,16,18,20,23,24,26,27,33,39,42,47,53 and 55 of copending Application No.16/678,366 recited an isolated cell composition comprising at least 106 CD8+ antigen-specific T cells.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
Applicants indicated that if it is the only remaining rejections and since the present application has the earlier filing date, said rejection should be withdrawn.
It is noted that said rejection is no the only remaining rejection.
11. No claim is allowed.
12. 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.
13. 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