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 the Claims
Claims 17 and 24 – 42 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 01/09/2024, 01/30/2024, 05/06/2024, and 02/06/2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered.
The second information disclosure statement filed on 01/09/2024 does not fully comply with the requirements of 37 CFR 1.98(b) because: non-patent literature number 46 does not include a valid publication date. A valid publication date is the date the literature became available to the public. Applicant must indicate the date of publication of each reference.
Drawings
The drawings are objected to because Figs. 1 and 14 include text and symbols that are illegible and must be modified so that they are clear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 - Sequences appearing in the claims are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). See claim objections below.
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 sequence identifiers, 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.
Claim Objections
Claims 25, 31, 35 and 37 – 42 are objected to because of the following informalities:
Claims 25 and 35 include sequences having more than four amino acids without sequence identifiers (see Nucleotide and/or Amino Acid Sequence Disclosures above). Although the sequences of claim 35 refer to short sequences within larger sequences that have sequence identifiers, because the shorter sequences within the longer sequences each have four or more amino acids, the shorter sequences must have SEQ ID NOs of their own. Each sequence having four or more amino acids must have its own sequence identifier.
Claim 31 seems to be missing the article “a” between “of’ and “measured”.
Claims 37 – 42 depend from claim 35 and thus inherit the objections of claim 35.
Appropriate correction is required.
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.
Claim 29 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites “including, but not limited to” in parentheses, but it is not clear what else is included in addition to the example in the parentheses.
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.
Claim 17 and 24 – 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 9 of U.S. Patent No. 12,460,006 in view of PRAKASH (US 20180312567 A1, published 11/01/2018; see PTO-892: Notice of References Cited).
Patented claim 1 recites an anti-integrin alpha 11 beta 1 (α11β1) antibody, or antigen-binding fragment thereof, wherein the antibody or antigen-binding fragment thereof comprises: (1) a heavy chain comprising a heavy chain complementarity determining region 1 (CDRH1), a heavy chain complementarity determining region 2 (CDRH2), and a heavy chain complementarity determining region 3 (CDRH3) and (2) a light chain comprising a light chain complementarity determining region 1 (CDRL1), a light chain complementarity determining region 2 (CDRL2), and a light chain complementarity determining region 3 (CDRL3), and wherein
the CDRH1 comprises the sequence GYTFTSYG (SEQ ID NO: 439),
the CDRH2 comprises the sequence ISAYNGNT (SEQ ID NO: 265),
the CDRH3 comprises the sequence VTGITGTTIDP (SEQ ID NO: 267),
the CDRL1 comprises the sequence QSISSY (SEQ ID NO: 216),
the CDRL2 comprises the sequence DAS (SEQ ID NO: 269), and
the CDRL3 comprises the sequence QQYNNWPQT (SEQ ID NO: 271).
Patented claim 9 recites that the heavy chain further comprises: a heavy chain framework region 1 (FRH1), a heavy chain framework region 2 (FRH2), a heavy chain framework region 3 (FRH3), and a heavy chain framework region 4 (FRH4); wherein the light chain further comprises a light chain framework region 1 (FRL1), a light chain framework region 2 (FRL2), a light chain framework region 3 (FRL3), and a light chain framework region 4 (FRL4); and wherein the FRH1 comprises the sequence QVQLVQSGAEVKKPGASVKVSCKAS (SEQ ID NO: 263), the FRH2 comprises the sequence ISWVRQAPGQGLEWMGW (SEQ ID NO: 264), the FRH3 comprises the sequence NYAQKLQGRVTMTTDTSTSTAYMELRSLRSDDTAAYYCAR (SEQ ID NO: 266), the FRH4 comprises the sequence WGQGTMVTVSS (SEQ ID NO: 268), the FRL1 comprises the sequence DIQMTQSPSSLSASVGDRVTITCRAS (SEQ ID NO: 227), the FRL2 comprises the sequence LNWYQQKPGKAPKLLIY (SEQ ID NO: 217), the FRL3 comprises the sequence SLESGVPSRFSGSGSGTEFTLTISSLQPDDFAVYYC (SEQ ID NO: 270), and the FRL4 comprises the sequence FGQGTKVEIK (SEQ ID NO: 272).
The patented SEQ ID NOs are identical to corresponding SEQ ID NOs of the same number of present claim 1.
The main difference between the present claims and the patented claims is that the present claims recite the anti-integrin alpha 11 beta 1 (α11β1) antibody, or antigen-binding fragment thereof in a method of treating a subject having or at risk of chronic kidney disease. However, PRAKASH teaches this difference.
According to the present specification, ITGA11 is the gene encoding integrin alpha-11 in humans (paragraph 0042 of the pre-grant publication (PG Pub)) and “a fibrotic disorder is or comprises idiopathic pulmonary fibrosis (IPF), chronic kidney disease, . . .” (paragraph 0041 of the PG Pub). Thus “ITGA11” is suggested to be another name for α11β1 and that chronic kidney disease is or comprises fibrosis.
PRAKASH is directed to an isolated or recombinant integrin alpha 11 (“ITGA11”) binding peptide. See claim 42. PRAKASH also teaches a method for the treatment of a subject that has fibrosis or a fibrosis related disorder, an inflammatory disease or cancer comprising administering to the subject a therapeutically effective amount of the peptide. See claim 39. PRAKASH teaches that fibrosis refers to a condition characterized by a deposition of extracellular matrix components in the skin or organs, including kidneys. See paragraph 0195.
Because the patented claims recite an anti-integrin alpha 11 beta 1 (α11β1) antibody, or antigen-binding fragment thereof having the same CDRs as the present claims, and PRAKASH teaches that the antibody may be used in a method to treat kidney disease, it would have been obvious to one having ordinary skill in the art to use the patented claims’ antibody in PRAKASH’s method to arrive to the present claims. There would have been a reasonable expectation of success considering that targeting integrins, such as integrin alpha 11 beta 1 (α11β1), is known to successfully treat kidney diseases, as evidenced by the applied prior art.
Regarding claims 30-34, it is noted that a wherein clause in a method claim is not given patentable weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESTELLA M. GUSTILO whose telephone number is (703)756-1706. The examiner can normally be reached Monday - Friday 9:00 AM - 5:00 PM.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/PETER J REDDIG/Primary Examiner, Art Unit 1646