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
Claim status
Claims 1-28 are pending
Claims 1-28 are under examination
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/04/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objection to Specification
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in Table 1 directed to SEQ ID NO: 5 corresponding to the amino acid sequence “DTS”, and Tables 2-5 directed to SEQ ID NO: 7 corresponding to the amino acid sequence “LGS”, but do NOT appear in the Sequence Listing.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Allowable Subject Matter
The prior art does not teach or fairly suggest a method of producing an immunoresponsive cell comprising a CAR comprising an extracellular antigen-binding that binds CD56 with an immunoglobulin variable region comprising either
(a) a heavy chain variable region comprising a CDR1 of SEQ ID NO:1, CDR2 of SEQ ID NO:2, and CDR3 of SEQ ID NO:3, as well as a light chain variable region comprising a CDR1 of SEQ ID NO:4, CDR2 of SEQ ID NO:5, and CDR3 of SEQ ID NO:6;
(b) a heavy chain variable region comprising a CDR1 of SEQ ID NO:1, CDR2 of SEQ ID NO:2, and CDR3 of SEQ ID NO:59, as well as a light chain variable region comprising a CDR1 of SEQ ID NO:4, CDR2 of SEQ ID NO:5, and CDR3 of SEQ ID NO:6;
(c) a heavy chain variable region comprising a CDR1 of SEQ ID NO:9, CDR2 of SEQ ID NO:10, and CDR3 of SEQ ID NO:11, as well as a light chain variable region comprising a CDR1 of SEQ ID NO:12, CDR2 of SEQ ID NO:14, and CDR3 of SEQ ID NO:15;
(d) a heavy chain variable region comprising a CDR1 of SEQ ID NO:9, CDR2 of SEQ ID NO:10, and CDR3 of SEQ ID NO:11, as well as a light chain variable region comprising a CDR1 of SEQ ID NO:12, CDR2 of SEQ ID NO:14, and CDR3 of SEQ ID NO:16;
(e) a heavy chain variable region comprising a CDR1 of SEQ ID NO:9, CDR2 of SEQ ID NO:10, and CDR3 of SEQ ID NO:11, as well as a light chain variable region comprising a CDR1 of SEQ ID NO:12, CDR2 of SEQ ID NO:14, and CDR3 of SEQ ID NO:17; or
(f) a heavy chain variable region comprising a CDR1 of SEQ ID NO:9, CDR2 of SEQ ID NO:10, and CDR3 of SEQ ID NO:11, as well as a light chain variable region comprising a CDR1 of SEQ ID NO:13, CDR2 of SEQ ID NO:14, and CDR3 of SEQ ID NO:18.
Claim Objections
Claim 1 is objected to because of the following informalities: instant claim uses the preamble phrase directed to an immunoresponsive cell that “binding” to human CD56, which is grammatically incorrect.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 8 recites the limitation "the scFv, Fab, or F(ab)2" in regard to Claims 7 and 1. There is insufficient antecedent basis for this limitation in the claim because Claims 7 and 1 are silent to Fab, or F(ab)2, thereby rendering Claim 8 incomplete. Appropriate correction is required.
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 obviousness-type 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-8, 10-28 are rejected on the grounds of nonstatutory double patenting over claim 1-25, 29 and 32-35 of U.S. Patent No. 10,730,941 (Sadelain et al., Patented 8/04/2020).
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the method for producing an immunoresponsive cell comprising an anti-CD56 CAR anticipates the method of instant application. It is clear that elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent method of producing claim is dependent on a CAR composition claimed used in the instantly claimed method..
Since the instant application claims are anticipated cited patent claims, said claims are not patentably distinct.
Claims 9 is rejected on the grounds of nonstatutory double patenting over claim 1-25, 29 and 32-35 of U.S. Patent No. 10,730,941 (Sadelain et al., Patented 8/04/2020), in view of Huston et al., 1988 (Proc. Natl. Acad. Sci. 85:5879-5883, see IDS filed 6/04/2025).
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the method for producing an immunoresponsive cell comprising an anti-CD56 CAR makes obvious the method of instant application. It is clear that elements of the cited patent claims are to be found in instant claim. The difference between the cited patent claims and the instant claim lies in the fact that the instant claim is more specific with respect to the linker being (GlyGlyGlyGlySer)3.
For example, instant SEQ ID NO: 39 corresponds to the patented heavy chain of SEQ ID NO: 7 linked by a GGGGS3 linker to the patented light chain of SEQ ID NO: 8.
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Nevertheless, Houston teaches the GGGGS3 linker was well known in the prior art for connecting the heavy chain and light chain of an scFv type antigen recognition domain (Abstract, p. 5880, Fig. 2). obvious an
Accordingly, it would have been obvious to practice a method of producing an immunoresponsive cell that binds to human CD56 comprising the heavy chains and light chains separated by a linker as claimed in cited patent, and choose the GGGGS3 linker as taught by Houston with a reasonable expectation of success. One of ordinary skill would have been motivated to do so as taught by Houston because this 15 amino acid linker was shown not exhibit an inhibitory secondary structure or any tendency to interfere with the heavy and light chain folding (p. 5879, Protein design).
Since the instant application claims are obvious over cited patent claims in view of Houston, said claims are not patentably distinct.
Examiner’s Comment
The Examiner notes that the restriction requirement in cited patent’s original application of 15/884,608 was withdrawn in the notice of allowance mailed 3/27/2020, and instant claims are not directed solely to the subject to subject matter described and claimed in the 15/884,608 application as filed.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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