DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s preliminary amendments received December 13, 2024 are acknowledged.
Claims 1-71 are canceled.
Claims 72-90 are newly presented.
Claims 72-90 are pending in the instant application.
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:
The instant application was filed 5/3/2024 as the latest in a line of continuations reaching back to international application PCT/IB2017/058312 filed 12/21/2017 (see the filing receipt of 12/17/2024) and as such applicant has correctly submitted a sequence listing under ST.26. As applicant is undoubtedly aware, under ST.26 amino acid sequences less than 4 residues cannot be identified via SEQ ID number, and indeed sequences shorter than 4 residues appear as "blank" data in the sequence listing (i.e. "skipped sequences") which is 100% correct. However, the claims still recite sequences shorter than 4 residues by reference to SEQ ID numbers. Specifically, in independent claim 72, the VL CDR2 sequence is referred to as “SEQ ID NO:20” which as per Table 1 stands for the polypeptide sequence “KNY”. Given that under ST.26 sequences shorter than 4 residues cannot be given SEQ ID numbers, the recitation of SEQ ID:20 in the claims for such a sequence is improper. It is suggested that the SEQ ID number in question be deleted as only the tripeptide sequence in single letter code is appropriate nomenclature in a specification that conforms to the convention of ST.26. More explicitly, the preferred language based upon claim 72 as presently constructed is " … the LCDR2 comprises the amino acid sequence KNY …” and note that SEQ ID NO:20 appears multiple times in claim 72 and all occurrences must be corrected. Obviously alternative recitations and phrasings are possible which still meet the requirements of ST.26 concerning the identification of short polypeptide sequences. Technically, in addition to the claims, the specification also should not refer to such short sequences via SEQ ID number as is done in, for example, Tables 1 and 2 beginning on page 45 of the instant specification. In other words, anywhere “SEQ ID NO:20” appears in the specification it should be replaced with “KNY” unless both already appear together (such as in a table) and in such circumstances the SEQ ID number should be deleted while leaving the tripeptide in single letter code unaltered. See proposed mockup below
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Applicant’s assistance in finding and correcting any additional sequence issues arising from the transition from ST.25 to ST.26 in child cases is earnestly solicited.
Information Disclosure Statement
The IDS forms received 5/3/2024 and 12/13/2024 are acknowledged and the references cited therein have been considered.
Claim Rejections - 35 USC § 112
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.
Claims 80 and 81 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, both claims depend from independent claim 72, and claim 72 recites that the administered anti-FXI antibody must have six CDR sequences from either the AM2 or AM1 clones that can be identified using various art-recognized techniques (Kabat, Chothia, etc., see in particular Table 2). Notably AM1 and AM2 are disclosed as affinity matured variants of a starting antibody named NOV1401 (which has a VH of SEQ ID NO:12 and a VL of SEQ ID NO:23), and these affinity matured variants comprise CDR mutations relative to the starting parental antibody (see most particularly working example 1). As such, the recitation “and wherein the VH does not comprise the amino acid sequence of SEQ ID NO: 12 and the VL does not comprise the amino acid sequence of SEQ ID NO: 23.” is problematic as its interpretation is uncertain. Specifically, since the CDRs necessarily comprise mutations relative to the starting NOV1401 sequences (this is true no matter what definition (Kabat, etc.) is used) it appears impossible to ever meet the limitations of being 100% identical to SEQ ID NOs:12 and 23. However, it that were true, why would applicant negatively disclaim something which already is excluded from the scope of the claims? Does independent claim 72 actually read upon the NOV1401 clone since applicant feels a need to negatively exclude it in dependent claims 80 and 81 even though initial (and subsequent) readings of the independent claim seem to exclude NOV1401?? It should be readily apparent that the claimed administration methods can be practiced with either the starting parental antibody sequences or the affinity matured variants and that the specification supports the administration of all such antibodies and thus is of no help in identifying the true metes and bounds of the claimed inventions. Appropriate correction is required.
For the remainder of this office action, the claims have been interpreted at face value of the independent claim, i.e. NOV1401 is not a valid antibody that can be administered by any of the claimed methods. If such an interpretation is incorrect, any future grounds of rejection necessitated by inclusion of the NOV1401 antibody in the claimed administration methods will be treated as necessitated by applicant’s amendments and will not preclude issuance of a final office action.
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 72-74 and 78-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,168,147. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious species encompassed by the issued claims.
Specifically, the issued claims recite antibodies that bind factor XI as well as their administration to treat thromboembolic disorders including stroke and deep vein thrombosis (see all claims , particularly 1, 15, 16, 22, and 23). Notably such antibodies are recited at various levels of structural specificity and encompass antibodies comprising all six CDRs, the complete VH and VL sequences, and the complete heavy and light chain sequences of the AM2 clone (see most particularly issued claims 6, part (b) of claim 8, part (iii) of claim 9, and part (iii) of claim 10, and note that all SEQ ID numbers are identical as the application that became the ‘147 patent is the grandparent of the instant application related via continuations). While the issued administration claims depend from product claims encompassing multiple species of anti-FXI antibodies which include, but are not limited to, AM2, given that the issued product claims explicitly call out the AM2 clone at various levels of specificity (including full length heavy and light chains) it would be exceedingly obvious that any of the recited antibody species could be administered as part of the claimed treatment methods. Administration of statins in combination with anti-FXI antibodies is explicitly claimed (see issued claim 17).
Claims 72-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,012,464 in view of claims 1-23 of U.S. Patent No. 11,168,147.
The claims of the ‘464 patent recite methods of treating thromboembolic disorders by administering anti-FXI antibodies that have the CDRs, VH and VL, or complete heavy and light chains of the AM3 clone, and AM3 is an affinity matured variants of starting antibody NOV1401 (i.e. VH and VL of SEQ ID NOs:12 and 23). Notably, such methods are recited as coadministering statins (issued claim 3), comprising administration of fresh frozen plasma and other volume expanders (issued claim 4), and administering albumin (issued claim 5). Doses for administering the anti-FXI antibody are disclosed (compare issued claim 12 to instant claim 84) as are time intervals and duration of administration (see issued claims 14-16). Treated diseases include stroke and deep vein thrombosis (see issued claim 2). Pharmaceutical compositions comprising excipients, as well as routes of intravenous and subcutaneous administration are also recited (see issued claims 17 and 18). Such claims differ from what is presently claimed in that the issued claims recite the AM3 clone whereas the instant recited sequences are those of the AM2 clone.
The ‘147 claims recite antibodies that bind factor XI as well as their administration to treat thromboembolic disorders including stroke and deep vein thrombosis (see all claims , particularly 1, 15, 16, 22, and 23). Notably such antibodies are recited at various levels of structural specificity and encompass antibodies comprising all six CDRs, the complete VH and VL sequences, and the complete heavy and light chain sequences of the AM2 clone (see most particularly issued claims 6, part (b) of claim 8, part (iii) of claim 9, and part (iii) of claim 10, and note that all SEQ ID numbers are identical as the application that became the ‘147 patent is the grandparent of the instant application related via continuations).
Therefore, it would have bene obvious to artisans that the treatment methods of the ‘464 patent could be practiced using any of the anti-FXI antibody species recited in the ‘147 patent claims. This is because the treatment methods of the ‘464 patent are more detailed than the administration methods of the ‘147 patent and because the ‘484 patent is a child application of that which became the ‘187 patent. As such artisans would readily realize that the various anti-FXI antibodies and their administration protocols could be recombined to arrive at what is presently claimed as all of the antibodies of both the ‘464 and ‘187 patents are variants of the starting NOV1401 antibody of SEQ ID NOs:14 and 23.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
Prosecution Insights