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 1-10 are pending.
Claims 1-10 read on a method of producing CD8cytotoxic T lymphocytes 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. 16479575, filed on 07/19/2019.
3. The first sentence of the Specification should be amended to reflect the status of the parent case 16/479,575, now Patent 12,006,512
4. It is noted that during prosecution of the parent case,16479575, Applicant provided Declaration filed under 37 CFR1.132 by Dr. Yohel Kawai on 11/28/23. Said declaration stated and provided additional data that “ As can be seen in the data shown above, the production efficiency of CD8 gamma+ single positive cells was unexpectedly and significantly increased when CD4+CD+ double-positive T cells cultured in a medium comprising IL-7 and anti-CD3 antibody was followed by culturing the cells in a medium containing IL-7, but not containing anti-CD3 antibody in a culture vessel containing a fibronectin fragment and/or a Notch ligand compared to continuing to culture the cells in the presence of both IL-7 and anti-CD3. Those having ordinary skill in the art would have no basis to expect that the removal of anti-CD3 antibodies from the culture would have such a dramatic effect on the production of CD8gamma+ single positive cells. Thus, the unexpected results obtained when the step of culturing the cells in a medium containing IL-7, but not containing anti-CD3 antibody is conducted demonstrate the criticality of this step in obtaining high production efficiency of CD8 gamma + single positive cells.”
It is the Examiner’s position that said declaration is applicable for the instant case as well.
5. 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.
6. Claims 1 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20160194375, US Patent Application 20190300591 and US Patent Application20220088076
US Patent Application ’ 375 teaches a method of producing cytotoxic CD8 T cells comprising culturing CD8 T cells in the culture medium comprising IL-7 and IL-15 see entire document, paragraphs 0092 in particular).
US Patent ‘375 does not explicitly teach a method of producing cytotoxic CD8 T cells comprising culturing CD8 T cells in the culture medium comprising IL-21 and IL-18.
US Patent Application ‘591 teaches a method of producing cytotoxic CD8 T cells comprising culturing CD4+ and CD8+ T cells in the culture medium comprising IL-7 and IL-21( see entire document, paragraphs 0005, 0006, in particular).
US Patent Application ‘076 teaches a method of producing cytotoxicCD8 T cells comprising culturing CD4+ and CD8+ T cells in the culture medium comprising IL-18 , IL-21 and IL-15( see entire document, paragraphs 0003, 0007, 0010 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 the ordinary skill in the art before the effective filing date of the claimed invention to add IL-21 and IL-18 into the culture medium taught by US Patent Application ’ 375 with a reasonable expectation of success because the prior art suggests each of said cytokines have been used for culturing and production of cytotoxic T lymphocyte
“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).
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.
7. 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.
8. Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12/006512.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-15 of U.S. Patent No. 12/006512 recited a method of producing CD8 cytotoxic T cells comprising culturing cells in the culture medium comprising IL-7 and T-cell receptor activator following by in the culturing in the medium comprising IL-7, IL-21
Claim 1-10 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No.17/263,675.
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application No.17/263,675 recited a method of producing CD8 cytotoxic T cells comprising culturing cells in the culture medium comprising IL-7 and T-cell receptor activator following by in the culturing in the medium comprising IL-7, IL-21
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
9. No claim is allowed.
10. 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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