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
This application is a CIP of PCT/US2021/057804 filed 11/03/2021. PCT/US2021/057804 has PRO 63/109,374 filed 11/04/2020.
Information Disclosure Statement
The information disclosure statements submitted on 05/02/2023 has been considered by the examiner.
Election/Restrictions
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/24/2026. Applicant’s election without traverse of Group I drawn to a peptide, in the reply filed on 03/24/2026 is acknowledged.
Applicant further elects the species of SEQ ID NO: 5, as a result, claim 2 is withdrawn from consideration.
Claim Status
Claims 2, 8-10 are withdrawn from consideration. Claims 1, 3-7, and 11-14 are being examined on the merits in this office action.
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 14 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Claim 14 depends on the withdrawn claim 10 which recites a method and not a composition. Claim 10 is withdrawn and is not being examined. The claim is therefore indefinite because the metes and bounds are not known. Thus, it is unclear what claim the claim is intended to depend from. For examination purposes, claim 14 is interpreted as depending on claim 11.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Interpretation
The claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 211 l.0l(IV), describing how Applicant may act as their own lexicographer).
Independent claim 1 recites a peptide with the article “comprising”. Claim 7 depends on claim 1 which recites that the peptide comprises at least six contiguous amino acid residues from the N-terminal domain of MMP-13. Claim 11 recites similar claim language. Examiner is interpretating that the peptide of claim 7 comprises the amino acid sequences recited in claim 7 and 14.
"Comprising" is an open-ended transitional term (see, e.g., MPEP § 2111.03(1)), wherein additional amino acids residues are not excluded. However, "'[c]omprising' is a term of art used in claim language which means that the named elements are essential" (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Claims 1, 3-7, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rooney (WO 2018/187356A2 – hereinafter “Rooney”).
Rooney teaches immunotherapeutic peptides, peptide binding agents, and their use, for example, in the immunotherapy of cancer (Abstract). Rooney teaches that the peptide comprises at least 8 contiguous amino acids of the epitopes of Table 1-6 (claim 1), that the peptide is between 6 and about 25 amino acids in length, or between about 9 and about 15 amino acids in length [0007, 0106]. Rooney teaches a composition comprising the peptides from Table 1-6, and a pharmaceutically acceptable carrier, diluent, or excipient [0012, 0144, 0160, 0255]. Rooney teaches that the peptides are comprises at least 8 contiguous amino acids of the sequence including Table 3 and Table 3 teaches that MMP-13 sequence (See Table 3 at bottom of Page 76) which comprises the instant N-terminal domain of SEQ ID NO: 2, and thus comprises at least six contiguous amino acid residues from the N-terminal domain of MMP-13.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Rooney to include peptides that comprise at least six contiguous amino acid residues from the N-terminal of MMP-13 since Rooney teaches that the peptides are between 6 and about 25 amino acids in length and derived from the sequences including the MMP-13 sequence and for use as immunotherapeutic peptides. One of ordinary skill in the art would have had a reasonable expectation of success in using the teachings of Rooney to arrive to the instant invention since Rooney teaches that peptides can derived from the instant SEQ ID NO: 2, and the peptides can have a length similar to the instant length and for use in the instant way as immunosuppressive peptides. The disclosures render obvious claims 1 and 11.
Regarding claim 3, Rooney teaches the MMP-13 sequence (See Table 3 at bottom of Page 76). This sequence of Rooney comprises at least six contiguous amino acids residues of 245-256 of the instant SEQ ID NO: 4.
Regarding claims 4-6, Rooney teaches that the peptide comprises at least 8 contiguous amino acids of the epitopes of Table 1-6 (claim 1), that the peptide is between 6 and about 25 amino acids in length, or between about 9 and about 15 amino acids in length [0007, 0106]. Rooney teaches a composition comprising the peptides from Table 3, and a pharmaceutically acceptable carrier, diluent, or excipient [0012, 0144, 0160, 0255]. Rooney teaches the amino acid sequence of the MMP-13 sequence (See Table 3 at bottom of Page 76) which comprises the instant N-terminal domain of SEQ ID NO: 2. This sequence comprises 6-25, 6-20, and 6-13 contiguous amino acids on the N-terminal domain of MMP-13, rendering obvious claims 4-6.
Regarding claim 7, Rooney teaches the MMP-13 sequence (See Table 3 at bottom of Page 76), which comprises at least six contiguous amino acids residues of the instant SEQ ID NO: 4. Examiner notes that claim 7 depends on claim 1 and claim 1 recites the transitional article “comprising”. The cited reference, Rooney teaches peptides that are same length as the instant peptides teaches that the peptides are derived from the instant sequence of SEQ ID NO: 2, and the sequence comprises some of the sequences recited in claim 7 such as SEQ ID NO: 5, rendering obvious claim 7.
Regarding claims 12-13, Rooney teaches that the peptide comprises at least 8 contiguous amino acids of the epitopes of Table 1-6 (claim 1), that the peptide is between 6 and about 25 amino acids in length, or between about 9 and about 15 amino acids in length [0007, 0106]. Rooney teaches a composition comprising the peptides from Table 3, and a pharmaceutically acceptable carrier, diluent, or excipient [0012, 0144, 0160, 0255]. Rooney teaches the amino acid sequence of the MMP-13 sequence (See Table 3 at bottom of Page 76) which comprises the instant N-terminal domain of SEQ ID NO: 2, rendering obvious claims 12-13.
Regarding claim 14, Rooney teaches the MMP-13 sequence (See Table 3 at bottom of Page 76), which comprises at least six contiguous amino acids residues of the instant SEQ ID NO: 5. Rooney teaches a composition comprising the peptides from Table 3, and a pharmaceutically acceptable carrier, diluent, or excipient [0012, 0144, 0160, 0255]. Examiner notes that claims recite the transitional article “comprising”. The cited reference, Rooney teaches peptides that are same length as the instant peptides teaches that the peptides are derived from the instant sequence of SEQ ID NO: 2, and the sequence comprises some of the sequences recited in claim 14 such as SEQ ID NO: 5, rendering obvious claim 14.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
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