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 application is a 371 application, filed 07/27/2023, of PCT application PCT/US22/14242, filed 01/28/2022, which claims priority benefits from
Provisional No. 63262838, filed 10/21/2021,
Provisional No. 63220194, filed 07/09/2021,
Provisional No. 63159323, filed 03/10/2021, and
Provisional No. 63142748, filed 01/28/2021.
The effective filing date of this application is 01/28/2021, the filing date of Provisional No. 63142748.
Restriction/Election
Applicant's election with traverse of elected combination of CDR sequences (for what the Specification calls antibody "MAb3/4") in the reply filed on 04/28/2026 is acknowledged. The traversal is on the grounds that election requirements were between antibodies species differing only by different CDR numbering conventions, such as Kabat, Chothia, IMGT, and AbM, and therefore should be considered the same species of antibody. This is not found persuasive because the claimsThe requirement is still deemed proper and is therefore made final.
However, the applicant’s amendments to the claims, distinctly claiming the exact combination of CDR sequences, which is directed to the elected antibody Mab3/4, though by different CDR numbering convention, are accordingly regarded as falling within the elected species.
Claims Status
Amendments filed 04/28/2026 are entered. Claims 82-136 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/14/2024, 09/24/2025, and 04/28/2026 are being considered by the examiner.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of in Figures 1, 5, 13, 15, 18-19. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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.
Specific deficiencies and the required response to this Office Action are as follows:
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.
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.
Closest Prior Art
Nixon et al (WO 2014152232 A2; filed 03/14/2014)
Nixon et al teaches anti-plasma kallikrein antibodies (Abstract) and that genetically engineered antibodies can be produced by, for example, conventional recombinant technology (p. 20, para 1). Specifically, Nixon et al teaches DNA encoding the monoclonal antibody can be placed into expression vector(s), which are transfected into host cells to obtain the synthesis of the monoclonal antibody in the recombinant host cell (p. 20, para 1). Nixon et al further teaches that the anti-plasma kallikrein antibodies can be formulated into pharmaceutical compositions with a pharmaceutically acceptable carrier or excipient (p. 23, section Pharmaceutical Compositions, paragraph 1). Nixon et al teaches the antibody’s Kd and binding buffer (p. 10), which is similar to the binding buffer instantly claimed. Nixon et al teaches the antibody could bind to residues T596 or S597 on plasma kallikrein (p.2, lines 7-14).
Nixon et al does not explicitly teach the exact amino acid sequence that encodes the HC, LC, VH, VL, or CDRs of the instantly claimed antibody. Nixon et al does not explicitly teach the mutations to the heavy chain constant region, nor how to make the antibody humanized and IgG1 isotype.
Danos et al (WO 2020219868 A1; filed 04/24/2020)
Danos et al teaches the mutations to the heavy chain constant region in claim 92 and 97 is to enhance antibody affinity to human FcRn (para 0128). Danos et al teaches the sequences to make antibody humanized (Abstract) and IgG1 isotype (e.g. p. 12, number 4). Danos et al teaches anti-kallikrein antibodies (para 0039).
Danos et al does not explicitly the exact amino acid sequence that encodes the HC, LC, VH, VL, or CDRs of the instantly claimed antibody.
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.
Copending App. No. 18615934
Claims 82-99 and 135-136 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18615934 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 of App. ‘934 recites an anti-plasma kallikrein antibody that comprises of heavy chain comprising of amino acid sequence of SEQ ID NO: 9 and light chain comprising of amino acid sequence of SEQ ID NO: 10.
Instant SEQ ID NO: 10, encoding Mab3/4 heavy chain has a 100% sequence match with SEQ ID NO: 9 of copending App. No. 18615934.
Instant SEQ ID NO: 8, encoding Mab3/4 light chain has a 100% sequence match with SEQ ID NO: 10 of copending App. No. 18615934.
These matching heavy and light chains comprise of instantly claimed SEQ ID NO: 5, encoding Mab3/4 VH, and SEQ ID NO: 6, encoding Mab3/4 VL.
These VH and VL sequences comprise of the combination of 6 CDR sequences, as presented in instant specification Tables 2-5, for Mab3/4.
As such, the antibody claimed in App. ‘934 is the same as the instantly claimed antibody, and contains the instantly claimed combinations of HC, LC, and VH, VL, HCDRs, and HCDRs sequences of instant claims 82-87, 98-99, and contain the mutations in the heavy chain constant region in instant claims 92 and 97. Inherently, the antibody of App ‘ 934, having the same sequence as the variable and constant sequences of the instantly claimed antibody will also meet the limitations dictated by sequence in instant claims 88-91 and 93-96, and have the same functions and properties as those in instant claims 135 and 136.
Claims 100-134 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18615934 (reference application), as applied to claims 82-99 and 135-136 above, in view of Nixon et al (Nixon et al, WO 2014152232 A2; published 09/25/2014). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The teachings of the references regarding the parent claims are incorporated in their entirety for their dependent claims and discussed further below, as is relevant for each claim.
Regarding claims 100-134, App. ‘934 does not explicitly claim the nucleic acid and expression vector encoding the instantly claimed antibody sequences, the host cell expressing an expression vector encoding the antibody and a method of making the antibody from the host cell, nor a pharmaceutical composition comprising of the antibody.
However, Nixon et al teaches anti-plasma kallikrein antibodies (Abstract) and that genetically engineered antibodies can be produced by, for example, conventional recombinant technology (p. 20, para 1). Specifically, Nixon et al teaches DNA encoding the monoclonal antibody can be placed into expression vector(s), which are transfected into host cells to obtain the synthesis of the monoclonal antibody in the recombinant host cell (p. 20, para 1). Nixon et al further teaches that the anti-plasma kallikrein antibodies can be formulated into pharmaceutical compositions with a pharmaceutically acceptable carrier or excipient (p. 23, section Pharmaceutical Compositions, paragraph 1).
It would be obvious to substitute the anti-plasma kallikrein antibody claimed in App. ‘934 with the anti-plasma kallikrein antibody and related inventions of Nixon et al to arrive at the instantly claimed inventions related to the antibody. Regarding instant claims 100-106 and 107-113, it would be obvious to one skilled in the art that the amino acid sequence of the antibody claimed in App. ‘934 teaches the nucleic acid and expression vector, respectively, encoding itself. Regarding instant claims 114-120 and 121-127, it would be obvious to one skilled in the art that the antibody can be made from a host cell expressing an expression vector encoding the antibody. Regarding instant claims 128-134, it would be obvious to one skilled in the art that the antibody can be formulated into a pharmaceutical composition.
One skilled in the art would be motivated to adapt the conventional methods of making antibodies taught by Nixon et al to produce the anti-plasma kallikrein antibody taught in App ‘934 in light of its potential therapeutic utility. To use the antibody, one skilled in the art would be further motivated to formulate the antibody into a pharmaceutical composition. One skilled in the art would have reasonable expectation of success that the antibody from App ‘934 could be adapted for conventional antibody expression and formulation methods that are highly generalizable to antibodies.
Copending App. No. 19134598
Claims 82-99 and 135-136 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19134598 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 82-136, claim 1 of App. ‘598 recites an anti-plasma kallikrein antibody that comprises of heavy chain comprising of amino acid sequence of SEQ ID NO: 9 and light chain comprising of amino acid sequence of SEQ ID NO: 10. Instant SEQ ID NO: 10, encoding Mab3/4 heavy chain has a 100% sequence match with SEQ ID NO: 9 of copending App. No. 19134598. Instant SEQ ID NO: 8, encoding Mab3/4 light chain has a 100% sequence match with SEQ ID NO: 10 of copending App. No. 19134598.
As explained for the previous double patenting rejection, as such, the antibody claimed in App. ‘598 is the same as the instantly claimed antibody.
Claims 100-134 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19134598 (reference application), as applied to claims 82-99 and 135-136 above, in view of Nixon et al (Nixon et al, WO 2014152232 A2; published 09/25/2014). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Similarly starting from an identical antibody to the instantly claimed antibody, for the same reasons explained for the previous double patenting rejection, the instant claims are anticipated by copending App. No. 19134598 or obvious over App. No. 19134598 in view of the prior art references.
Conclusion
The Specification is objected to. Claims 82-136 are free of the prior art but are subject to provisional double patenting rejections. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIRATH CHHAY whose telephone number is (571)272-0682. The examiner can normally be reached Mon-Thu 8AM-5PM EST.
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/BONIRATH CHHAY/Examiner, Art Unit 1645 May 20, 2026
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 May 21, 2026
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