CTNF 18/557,801 CTNF 88677 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. 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. Election/Restrictions 08-25 AIA Applicant's election with traverse of group I (cyclic peptides) and the sequence YAISYRGKTTLLC in the reply filed on 3 June, 2026 is acknowledged. The traversal is on the ground(s) that the references cited to break unity do not do so . This is not found persuasive because the reference anticipates at least one claim. Applicants state that Romano et al does not describe the sugar dehydrogenase sequence. However, it mentions the bacteria that produce it; as evidenced by the NCBI sequence. This means that the sequence is inherently present in the disclosure of Romano et al. Applicants argue that the alignment only shows 11 of the 17 residues of SEQ ID 1. However, that clearly shows at least half of the residues of SEQ ID 1, which is sufficient to anticipate claim 1. Applicants argue that the protein of the NCBI sequence is not a cyclic peptide, a claim limitation. However, with 9 Cys residues, it is unreasonable to assume that there are no disulfide bonds, and hence, no cyclic structures . The requirement is still deemed proper and is therefore made FINAL. Applicants have elected a cyclic peptide of SEQ ID 2. A search was conducted for this invention, and a reference that anticipated it was found. As a result, claims 1-7 were examined, and claims 8-20 were withdrawn from consideration. Applicants have stated that they believe claims 8 and 9 read on their election, however, the formulation they elected does not describe either a carrier or a buffer. Thus, these claims are properly withdrawn. Claims Status Claims 1-20 are pending. 08-05 AIA Claim s 8-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3 June, 2026 . Specification 07-29 AIA The disclosure is objected to because of the following informalities: the specification lists sequences without their associated SEQ ID number, not paragraph 8, for example. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03) . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim 6 is objected to because of the following informalities: the claim shows sequences without the appropriate SEQ ID numbers. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03) . Appropriate correction is required. Drawings 06-22 AIA The drawings are objected to because fig 4 requires color. Applicants are required to amend the claims to avoid color. If that is not possible without removing information important to the invention, applicants can petition for color drawings . 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. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-3 are rejected under 35 U.S.C. 101 because they read on a natural phenomenon. The Supreme Court has given a two part test for eligibility under this statute: 1) Does the claim read on a process, machine, manufacture, or composition of matter? 2a) If the first test is passed, does a judicial exception apply? 2b) If a judicial exception applies, is there anything beyond the judicial exception? Applying the test. the claims are drawn to peptides; a composition of matter. 2a) Uniprot compound MiPHX7 (2020) lists a sequence comprising the sequence YASSIRGKKTLLC (position 24-36). Note that this is 77% identity with applicant’s elected species. There are two cysteines, making it reasonable to assume a cyclic structure. 2b) As the sequence with just the polypeptide reads on the claims, there can be nothing beyond the polypeptide. Thus, these claims are not patent eligible. Claim Rejections - 35 USC § 112(b) 07-30-02 AIA 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. 07-34-01 Claim 6 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 6 describes 6 sequences, but each sequence has some sort of loop structure, and has a letter D or L in front of each sequence in a smaller font. It is not clear if the loop structure is a generic carbonyl structure (the only clearly identifiable structure on the loop) or are a thioether attached to the Tyr residue from reaction with a chloroacetyl group, or some other interpretation. Nor is it clear if the letter in front of the sequence is an additional amino acid or specifying the stereochemistry of one or more amino acids. Note that fig 1B assigns SEQ ID numbers to these structures, but the sequence listing does not mention stereochemistry, additional amino acids, or cyclization. Improper Markush 08-40 Claims 1-7 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch , 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi , 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117. The Markush grouping of the claims is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: there is no significant sequence identity between the peptides of the claims, thus, there is no single structural similarity responsible for their activity. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-12-aia AIA (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. 07-15-03-aia AIA Claim (s) 1-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dietlein et al (US 20240150810, priority date 11 March, 2021) . Dietlein et al discuss inhibitors of Usp22 (abstract). Preferred embodiments are cyclic peptides, with the most preferable SEQ ID 9, which the N-terminal amino acid can be a d-amino acid (paragraph 17). This can be cyclized by attaching a chloroacetic acid at position 1 of the sequence to forma thioether (paragraph 17). PNG media_image1.png 226 470 media_image1.png Greyscale PNG media_image2.png 35 319 media_image2.png Greyscale Note that this sequence is identical with applicant’s elected sequence. While the reference does not specify if the C-terminus is amide or carboxyl, a person of ordinary skill in the art can immediately envision an amide. Thus, the reference anticipates claims 1-6. Note that just the peptide itself reads on a composition, anticipating claim 7. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30. Examiner interviews are available via telephone 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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /FRED H REYNOLDS/Primary Examiner, Art Unit 1658 Application/Control Number: 18/557,801 Page 2 Art Unit: 1658 Application/Control Number: 18/557,801 Page 3 Art Unit: 1658 Application/Control Number: 18/557,801 Page 4 Art Unit: 1658 Application/Control Number: 18/557,801 Page 5 Art Unit: 1658 Application/Control Number: 18/557,801 Page 6 Art Unit: 1658 Application/Control Number: 18/557,801 Page 7 Art Unit: 1658
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