DETAILED ACTION
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 .
Priority
The instant application is a continuation of US Application No. 18/454288, filed 23 August 2023 (now US Patent 12,144,829 B2), which is a divisional of US Application No. 17/320663, filed 14 May 2021 (now US Patent 11,766,457 B2).
Status of the Claims
Claims 1-20, of record 30 October 2024, are pending. Therefore, prosecution on the merits commences for claims 1-20.
Drawings
Acknowledgment is made of Applicants’ granted petition, filed 11 December 2024, for the colored drawings filed 30 October 2024.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. More specifically, the name of the XML file and date of creation does not match that of the instant sequence listing.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Double Patenting
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-10 of U.S. Patent No. 12,448,829 B2 (of record on IDS filed 06 June 2025). It is of note that the instant application is a CONTINUATION of U.S. Patent No. 12,448,829 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims either anticipate or render obvious the instant claims. More specifically, in regards to the obviousness nonstatutory double patenting rejections, the patent claims are not identical because no single patent claim discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate patented claims. The fact that each of the elements were claimed in the patent, just not in a single claim, still renders obvious the instant invention because each of the features, though separately claimed, can be physically combined into a single embodiment.
Patent claim 1 is directed to an immunoresponsive cell comprising: a chimeric antigen receptor (CAR) that binds to glutamic acid decarboxylase 65 kDA (GAD65) in the cell;
the CAR comprising:
a) an intracellular signaling domain of a CD3ζ polypeptide and an intracellular signaling domain of CD28 hinge-transmembrane-intracellular region, and
b) an extracellular polypeptide comprising an amino acid sequence that is a GAD65 MAb antigen binding domain;
wherein the extracellular polypeptide comprises SEQ ID NO: 8, or an amino acid sequence having at least 95% identity to SEQ ID NO: 8.
This therefore anticipates the immunoresponsive cells of instant claims 1 and 17, as patent SEQ ID NO: 8 has 100% sequence identity to instant SEQ ID NO: 8. See sequence alignment at end of document.
With that, each of patent claims 2-5 and 8-10 directly read on the limitations of instant claims 2-9 and 18-20.
Furthermore, patent claim 1 as modified by patent claim 8 render obvious the immunoresponsive cell of instant claim 10, as patent claim 8 further limits the immunoresponsive cell of patent claim 1 to be a regulatory T cell.
With that, each of patent claims 2-5 and 9-10 directly read on the limitations of instant claims 11-16.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-10 of U.S. Patent No. 11,766,457 B2 (of record on IDS filed 06 June 2025). It is of note that the instant application does not get the benefit of the “121 shield” as being a continuation of the divisional of U.S. Patent No. 11,766,457 B2, as the instant claims do not maintain the consonance between the divided groups. See MPEP § 804.02(II).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims either anticipate or render obvious the instant claims. More specifically, in regards to the obviousness nonstatutory double patenting rejections, the patent claims are not identical because no single patent claim discloses all of the limitations of any of the instant claims; however, each of the limitations of the instant claims are disclosed by separate patented claims. The fact that each of the elements were claimed in the patent, just not in a single claim, still renders obvious the instant invention because each of the features, though separately claimed, can be physically combined into a single embodiment.
Patent claim 1 is directed to an immunoresponsive cell comprising: a chimeric antigen receptor (CAR) that binds to glutamic acid decarboxylase 65 kDA (GAD65) in the cell;
the CAR comprising:
a) an intracellular signaling domain of a CD3ζ polypeptide and an intracellular signaling domain of CD28 hinge-transmembrane-intracellular region, and
b) an extracellular polypeptide comprising an amino acid sequence that is a GAD65 MAb antigen binding domain;
wherein the extracellular polypeptide comprises SEQ ID NO: 7, or an amino acid sequence having at least 95% identity to SEQ ID NO: 7.
This therefore anticipates the immunoresponsive cells of instant claims 1 and 17, as patent SEQ ID NO: 7 has 100% sequence identity to instant SEQ ID NO: 7. See sequence alignment at end of document.
With that, each of patent claims 2-5 and 8-10 directly read on the limitations of instant claims 2-9 and 18-20.
Furthermore, patent claim 1 as modified by patent claim 8 render obvious the immunoresponsive cell of instant claim 10, as patent claim 8 further limits the immunoresponsive cell of patent claim 1 to be a regulatory T cell.
With that, each of patent claims 2-5 and 9-10 directly read on the limitations of instant claims 11-16.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA G WESTON/Examiner, Art Unit 1633
SEQUENCE ALIGNMENT
Query Match 100.0%; Score 1443; DB 1; Length 268; Best Local Similarity 100.0%;
Matches 268; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAWTVLLLGLLSHCTGSVTSYVLTHPPSVSVAPGKTGTITCGGSNIGSKSVHWYQQKPGQ 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAWTVLLLGLLSHCTGSVTSYVLTHPPSVSVAPGKTGTITCGGSNIGSKSVHWYQQKPGQ 60
Qy 61 APKLVIYYDSDRPSGIPERFSGSTSGNTATLTISSVEAGDEADYYCQVWDSSGDHMVVFF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 APKLVIYYDSDRPSGIPERFSGSTSGNTATLTISSVEAGDEADYYCQVWDSSGDHMVVFF 120
Qy 121 GGTKLTVLPPPPRPPPPRPPPPRQVQLVESGGGVVQPGRSLRLSCAASGLTFSHHGMHWV 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GGTKLTVLPPPPRPPPPRPPPPRQVQLVESGGGVVQPGRSLRLSCAASGLTFSHHGMHWV 180
Qy 181 RQAPGKGLEWVAFISYDETKKYYVKSVMGRFTIARDNSKNTLYLHLKSLRPDDAAVYYCA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 RQAPGKGLEWVAFISYDETKKYYVKSVMGRFTIARDNSKNTLYLHLKSLRPDDAAVYYCA 240
Qy 241 KAFSTTIFGVVTYGMDVWGQGTTVIVSS 268 (INSTANT SEQ ID NO: 8)
||||||||||||||||||||||||||||
Db 241 KAFSTTIFGVVTYGMDVWGQGTTVIVSS 268 (US 12144829 B2 SEQ ID NO: 8)
Query Match 100.0%; Score 1444; DB 1; Length 271; Best Local Similarity 100.0%;
Matches 271; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MDMRVPAQLLGLLLLWLPGAKCDIQLTQSPTFLSASVGDRVTITCRASQGISSYLAWYQQ 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MDMRVPAQLLGLLLLWLPGAKCDIQLTQSPTFLSASVGDRVTITCRASQGISSYLAWYQQ 60
Qy 61 KPGKAPNLLIYVASTLQSGVPSRFSGSGSGTEFTLTISSLQPEDFATYYCQQLNNYPLTF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 KPGKAPNLLIYVASTLQSGVPSRFSGSGSGTEFTLTISSLQPEDFATYYCQQLNNYPLTF 120
Qy 121 GGGTKVEIKRPPPPRPPPPRPPPPRQLQLQESGPGLLKPSETLSLTCSVSGGSIGSSSYS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GGGTKVEIKRPPPPRPPPPRPPPPRQLQLQESGPGLLKPSETLSLTCSVSGGSIGSSSYS 180
Qy 181 WGWIRQPPGKGLEYIGIIYHSGRTYYNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAMY 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 WGWIRQPPGKGLEYIGIIYHSGRTYYNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAMY 240
Qy 241 YCARQVPYQPLLDGGNWFDPWGQGTLVTVSS 271 (INSTANT SEQ ID NO: 7)
|||||||||||||||||||||||||||||||
Db 241 YCARQVPYQPLLDGGNWFDPWGQGTLVTVSS 271 (US 11766457 B2 SEQ ID NO: 7)
Prosecution Insights