Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. Claims 1-11 are pending.
2. Applicant’s election without traverse of Group II, claims 7-11 in response filed on 07/13/26 is acknowledged.
Upon further consideration the prior art search has been extended to include non-elected claims of Group I. The restriction requirement set forth in the previous Office Action, mailed on 04/23/26 is hereby vacated.
Claims 1-11 read on a method of generating cytotoxic T-lymphocytes (CTLs) are under consideration in the instant application.
3. The first sentence of the Specification should be amended to reflect the status of the parent case 18/062452, now abandon.
4. It is noted that during prosecution of the parent case 16246369, Applicant provided Declaration by Dr. Leen on 07/23/21. In said Declaration, Dr. Leen stated that the instantly claimed polyclonal CTLs obtained by the method recited in clam 1 are functionally and structurally different from polyclonal population of CTLs described in the prior art. In particular, Dr. Leen stated that “First, unlike any prior art populations, the claimed T cell populations are reactive against both immunodominant and subdominant viral antigens. Second, unlike any prior art populations, the claimed T cell populations have an advantageously higher CD4:CD8 T cell ratio and very few contaminating NK cells post-expansion”.
It is the Examiner’s position that said Declaration is applicable for the instant claims recited similar method steps using antigen-loaded DC and expanding obtained antigen-specific T cells in the culture medium comprising recited cytokines.
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. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 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 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over, claims 1-14 of US Patent US 11118164 B2; claims 1-28 of US Patent US 9963677 B2; claims 1-15 of US 10385316 B2 each in view of US Patent 8,481,051.
Claims 1-8 of US Patent12435,309, claims 1-14 of US Patent US 11118164 B2; claims 1-28 of US Patent US 9963677 B2; claims 1-15 of US 10385316 B2 each recited a method of generating antigen-specific cytotoxic T lymphocyte that recognize at least one antigen from two or more different antigens comprising contacting PBMCs with APC that present at least one epitope from at least two different antigens
US Patent ‘051 teaches a method of generating antigen-specific T lymphocytes that recognized at least two antigens from antigens comprising directly stimulating PBMCs with peptides comprising a sequence of amino acid spanning part different antigens. US Patent ‘051 teaches that stimulation of PBMCs in the medium comprising IL2 or IL-4, or IL-7 or IL12. US Patent’051 teaches that PBMCc can be stimulated either directly or using antigen-presenting cells(APC). ( see entire document, paragraphs 25,32, 98 , 241 in particular)
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 directly stimulate PBMCs with peptides comprising amino acid sequence at least one antigen from two viruses with a reasonable expectation of success because the prior art suggests successful use of either direct stimulation of PBMC or the use of APC to generate antigen-specific T lymphocyte that can recognize a cell that express different antigens.
7. The claims 1-11 provisionally rejected on the grounds of nonstatutory double patenting of the claim of copending Applications US 20110182870 A1, US 20150010519 A1; US 20210348127 A1; US 20230114971 A1; US 20230357721 A1, US 20260002129 A1 each in view of US Patent 8,481,051.
Claim of copending Applications US 20150010519 A1; US 20210348127 A1; US 20230114971 A1; US 20230357721 A1 US 20260002129 A1 each recited a method of generating antigen-specific cytotoxic T lymphocyte that recognize at least one antigen from different antigens comprising contacting PBMCs with APC that present at least one epitope from at least two different antigens.
US Patent ‘051 teaches a method of generating antigen-specific T lymphocytes that recognized at least two antigens from antigens comprising directly stimulating PBMCs with peptides comprising a sequence of amino acid spanning part different antigens. US Patent ‘051 teaches that stimulation of PBMCs in the medium comprising IL2 or IL-4, or IL-7 or IL12. US Patent’051 teaches that PBMCc can be stimulated either directly or using antigen-presenting cells(APC). ( see entire document, paragraphs 25,32, 98 , 241 in particular)
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 directly stimulate PBMCs with peptides comprising amino acid sequence at least one antigen from two antigens with a reasonable expectation of success because the prior art suggests successful use of either direct stimulation of PBMC or the use of APC to generate antigen-specific T lymphocyte that can recognize a cell that express different antigens.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
8. No claim is allowed.
9. 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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