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 .
Status of Application, Amendments and/or Claims
Claims 1-13, 16-20, 23, and 24 are pending.
Election/Restrictions
Applicant’s election of Group I, claims 1-7, drawn to compositions comprising an inhibitor or B cell maturation or function, in the reply filed on 31 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8-13, 16-20, 23, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 March 2026.
Claims 1-7 are under consideration in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02 April 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. It is noted that the Banchereau et al. reference has been crossed off by the Examiner because it is incomplete (only two pages (79 and 80) are present).
Oath/Declaration
It is noted to Applicant that as stated in the Communication of 17 November 2022, a properly executed inventor’s oath or declaration has not been received for the inventors of the instant application. Although no time period for reply is set forth in the instant Office Action, Applicant must submit the inventor's oath or declaration no later than the expiration of the time period set forth in a “Notice of Allowability” to avoid abandonment (see 37 CFR 1.495(c)).
Nucleotide and/or Amino Acid Sequence Disclosures
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.
1. Specific deficiencies and the required response to this Office Action are as follows:
1a. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. Specifically, the incorporation by reference paragraph does not identify the size of the file in bytes. Rather, the paragraph indicates that the file is 14 kilobytes (KB).
1b. 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.
Specification
2. The disclosure is objected to because of the following informalities:
2a. At page 4, line 28, the specification refers to “Figure 8D” (in the phrase “Figure 8A through Figure 8D”). However, there is no Figure 8D present in the drawings filed on 28 July 2022. It is suggested that the Brief Description of the Drawings at page 4, line 28 refers to “Figure 8A through Figure 8C”.
Appropriate correction is required.
Claim Objections
3. Claim 4 is objected to because of the following informalities:
3a. In claim 4, line 2, the word “encodes” should recite “encode”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hibiya et al. (US 2021/0147523, with priority to 06 April 2018).
Hibiya et al. teach a pharmaceutical composition comprising a nucleic acid molecule encoding a SPNS2 neutralizing antibody or an expression vector comprising the nucleic acid, meeting the limitations of instant claims 1 and 5 (page 18, [0387], subparts 41, 42, 45, and 46; [0086-0087]). Hibiya et al. indicate that the SPNS2 neutralizing antibody may be monoclonal, Fab, scFv, or bispecific, meeting the limitations of instant claim 4 (page 19, [0387], subpart 51; page 40, [0793-0797]; page 44, [0827]). Hibiya et al. disclose that the pharmaceutical composition comprises a pharmaceutically acceptable diluent or carrier, meeting the limitations of instant claim 7 (page 18, [0387], subparts 46-47; page 41, [0804]). Hibiya et al. also teach that pharmaceutical composition comprising the nucleic acid molecule further comprises an active ingredient, wherein the active ingredient is interferon β 1b, interferon β 1a, natalimumab, or anti-CD20 antibody (rituximab), meeting the limitations of instant claims 1-3 (page 19, [0387], subparts 49-50; [0098]). Hibiya et al. teach that a medicament comprising the invention may contain other known drugs (active ingredients), including anti-PD-1 antibodies and anti-CTLA4 antibodies, meeting the limitations of instant claim 1-3 and 6 (page 42, [0806]).
5. Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hibiya et al. (WO 2019/194314; published 10 October 2019; herein after “Hibiya2”). Please see attached English translation provided by WIPO. The citations below refer to the English translation document.
Hibiya2 teach a pharmaceutical composition comprising a nucleic acid molecule encoding a SPNS2 neutralizing antibody or an expression vector comprising the nucleic acid, meeting the limitations of instant claims 1 and 5 ([0023], subparts 42, 45, and 46; [0086-0087]; [0118]). Hibiya2 indicate that the SPNS2 neutralizing antibody may be monoclonal, Fab, scFv, or bispecific, meeting the limitations of instant claim 4 ([0023], subpart 51; [0827]; [0085-0089]; [0118]). Hibiya2 disclose that the pharmaceutical composition comprises a pharmaceutically acceptable diluent or carrier, meeting the limitations of instant claim 7 ([0023], subparts 46-47; [0096]). Hibiya2 also teach that pharmaceutical composition comprising the nucleic acid molecule further comprises an active component/ingredient, wherein the active component/ingredient is interferon β 1b, interferon β 1a, natalimumab, or anti-CD20 antibody (rituximab), meeting the limitations of instant claims 1-3 ([0023], subpart 50; [0098]). Hibiya et al. teach that a medicament/drug comprising the invention may contain other known drugs (active ingredients), including anti-PD-1 antibodies and anti-CTLA4 antibodies, meeting the limitations of instant claim 1-3 and 6 ([0098]).
6. Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muthumani et al. (WO 2017/193094; 09 November 2017).
Muthumani et al. teach a composition comprising one or more nucleic acid molecules encoding one or more synthetic antibodies or fragments thereof, wherein the one or more antibodies or fragments target at least one immune checkpoint molecule (e.g., PD-1, PD-L1, LAG-3, GITR, CD40, OX40, CTLA-4, TIM-3, 4-1BB), meeting the limitations of instant claims 1 and 6 (page 1, lines 7-10; page 3, lines 14-20). Muthumani et al. teach that the encoded synthetic antibodies bind and neutralize their targets (page 8, lines 6-7; page 17, lines 26-30). It is noted that one of the encoded synthetic antibodies is directed to the CD40 receptor, which would therefore also inhibit CD40L (ligand), absent evidence to the contrary, meeting the inhibitor of B cell maturation/function limitations of instant claims 1 and 2. Muthumani et al. indicate that the encoded antibody can be monoclonal, chimeric, single chain, or bispecific meeting the limitations of instant claim 4 (page 34, lines 18-24; page 62, lines 6-27; Figure 1). Muthumani et al. also disclose that the one or more nucleic acid molecules are engineered to be in an expression vector, meeting the limitations of instant claim 5 (page 4, lines 6-7). Muthumani et al. state that the composition further comprises a pharmaceutically acceptable excipient, meeting the limitations of instant claim 7 (page 4, lines 10-11; page 43, lines 25-32). Muthumani et al. teach that the pharmaceutically acceptable excipient can be an adjuvant in addition to the checkpoint inhibitor antibodies of the invention (page 44, lines 16-17). Muthumani et al. disclose that the adjuvant may be interferon-β, meeting the inhibitor of B cell maturation/function limitations of instant claims 1 and 3 (page 44, lines 19-20).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIDGET E BUNNER whose telephone number is (571)272-0881. The examiner can normally be reached Monday-Friday 9:00 am-6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BEB
Art Unit 1647
02 June 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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