Prosecution Insights
Last updated: April 19, 2026
Application No. 18/283,376

PEPTIDE AND PEPTIDE-CONTAINING COMPOSITION

Non-Final OA §102§112
Filed
Sep 21, 2023
Examiner
COFFA, SERGIO
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Japan AS Represented By The Director-General Of National Institute Of Infectious Diseases
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
2y 11m
To Grant
94%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
436 granted / 719 resolved
+0.6% vs TC avg
Strong +34% interview lift
Without
With
+33.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
61 currently pending
Career history
780
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
32.1%
-7.9% vs TC avg
§102
20.5%
-19.5% vs TC avg
§112
27.0%
-13.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 719 resolved cases

Office Action

§102 §112
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. DETAILED ACTION Status of the Claims Claims 1-16, 19, 24-25 and 30-35 are pending in this application. Claims 1-16, 19, 24-25 and 30-35 are presently under consideration. Duplicate claims Applicant is advised that should claims 15 and 31 be found allowable, claims 30 and 32 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k). Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 19 and 24-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 19 and 25 have been interpreted as being drawn to “A method for prevention of preventing or treating coronavirus infection”. See rejection under 35 U.S.C 112(b) below. The claims are drawn to methods for preventing, treating or diagnosing coronavirus infection by administering the peptide of claim 1. When referring to the peptide, the specification and claim 1 teach that the peptide comprises SEQ ID NO: 2, or an amino acid sequence having a substitution, addition, deletion, or insertion in 1 to 10 amino acid residues selected from the group consisting of amino acids residues at positions 1-10. However, the specification does not provide any structural attributes associated with the claimed peptide. Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).” Here, the specification fails to describe what part of the sequence correlates with the required activity (i.e. to prevent, treat or diagnose coronavirus infection). The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad. Based on the teachings of the specification, the peptide can be any peptide of SEQ ID NO: 2, wherein the first 10 amino acids can be deleted, or substituted, or wherein the peptide can have amino acid insertions. However, the specification fails to provide a representative number of examples for the claimed peptide. The specification does not provide any teaching of what modifications can be made within the claimed sequence to allow for the claimed function. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description. 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 appl icant regards as his invention. Claim s 19, 24-25 and 34-35 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. Claims 19, 25 and 34 are drawn to methods for prevention of preventing or treating coronavirus infection. From the instant specification it is clear that the claimed peptides prevent or treat coronavirus infection. However, the claims as written are directed to the prevention of the prevention, or to the prevention of treatment, which renders the claims indefinite. In other words, if the prevention (or treatment) is prevented, what is the method for? With respect t claim 25, one of ordinary skill in the art would not know what is encompassed by the claimed “additional agent for prevention or treatment of coronavirus infection”. Claims 24 and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: diagnosing coronavirus infection. To diagnose coronavirus infection , the peptide must be detectably labeled with an enzyme, a radioactive substance, a fluorescent material, or an antibody (see para [0287]). The claims should be amended to include the detectable label, and the step of detecting said label . Claim Rejections - 35 USC § 102 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 – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim s 1 , 16 and 19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by DeMarco et al. (US 2009/0054345) . With respect to claim 1, DeMarco et al. teach a peptide comprising Cha-C ( claims 26 and 46). With respect to claim 1 6 , DeMarco et al. teach that the peptide is cyclic (claims 60-61). Claim 19 ha s been interpreted as being drawn to “A method for prevention of preventing or treating coronavirus infection”. See rejection under 35 U.S.C 112(b) above . With respect to this claim , DeMarco et al. teach administering the peptide (claim 53), which would inherently prevent coronavirus infection. Claim 1 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Brust et al. ( J. Med. Chem. 2016, 59, 2381 - 2395 ) . Brust et al. teach various peptides comprising Cha-C (se e Table 1), which corresponds to instantly claimed SEQ ID NO: 2 wherein amino acids 1-10 have been substituted with other amino acids. Allowable Subject Matter Claim s 2 -14 and 33 are allowed. Claims 15 and 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Note that claims 30 and 32 have not been included here as they are duplicates of claims 15 and 31 (see above). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SERGIO COFFA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3022 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 6AM-4PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT MELISSA FISHER can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. FILLIN "Examiner Stamp" \* MERGEFORMAT /SERGIO COFFA Ph.D./ Primary Examiner Art Unit 1658 /SERGIO COFFA/ Primary Examiner, Art Unit 1658
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Prosecution Timeline

Sep 21, 2023
Application Filed
Feb 21, 2026
Non-Final Rejection — §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
61%
Grant Probability
94%
With Interview (+33.6%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 719 resolved cases by this examiner. Grant probability derived from career allow rate.

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