Examiner note: This action supersedes prior office action sent on 08/10/2026. There was a typographical error on the PTO-326 which stated that the shortened statutory period for reply was 2 months, rather than the correct 3 months.
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 .
Election/Restrictions
In response to the restriction requirement dated 27 March, 2026, Applicant elects, without
traverse, Group I, claims 1-8, drawn to a method of producing a peptide. In response to the species election, Applicant elects the protective group forming reagent (I). Applicant’s election in the reply filed on 20 May 2026 is acknowledged. Claims 1-8 are hereby examined on the merits. Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Priority
This application, filed 09/18/2023, is a Continuation of PCT/JP2022/012551 , filed 03/18/2022
claims foreign priority to 2021-045625, filed 03/19/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/04/2026, 12/19/2025, 08/18/2025, 04/14/2025, 12/30/2024, 10/31/2024, 12/13/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
The examiner also acknowledges Applicants response to election of species and providing a single species for the claimed variables. Following an extensive search and examination, the originally elected species has been deemed free of the prior art. Per MPEP § 803.02, “If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended”. Accordingly, the search has been extended to the full scope of claimed method. The broadest genus has been rejected under 35 USC 112(a) as explained below.
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 1-8 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.
Claim 1 is drawn to a method for producing a peptide, comprising a peptide chain extending step in which a side chain amino group is protected with a protective group represented by Formula (I).
In the above claim, all are variables, such as peptide, amino acid, process conditions, reagents to protect functional groups or deprotect the protecting groups, reagents for cleaving the peptide from the resin etc.
The dependent claim further limits the protecting group to recited subgenus and guanidino group as a protecting group for amino acid arginine (see claim 8). Although peptide synthesis is a well-established process, a skilled person can expect unpredictability, because of divergency in the claimed variables - R11, n, R21, R22, substituents, linking portion (*), a peptide, C-terminal protecting step, C-terminal protective agent, N-terminal protective group, N-terminal deprotecting step and first amino acid. There are no limitations on any variable. There are no limitations on conditions, such as pH, solvent or other reagents, in the claimed method. The above claimed process reads as “a method for producing a peptide, with the recited method steps, with all possible protecting groups, to create all possible peptides, and deprotecting all protected groups”.
Thus, there is no limit to the nature or number of substituents which are encompassed by the instantly claimed subject matter, or to the protection and deprotection of a specific group and amino acid. So, the issue is in the scope of the broadly recited subject matter. In other words, the structure/function relationship for the claimed subject matter for making the recited peptide is not described.
Applicants can claim as broadly as possible for the claimed invention. However, if there is a divergency in the genus in the broadly claimed subject matter, and if it expects unpredictability for the claimed method, then the specification must describe the genus with divergent species, so that a skilled person in the art can understand the claimed invention and can reproduce Applicants’ claimed method. In this case, peptide synthesis is probably one of the most unpredictable areas of biotechnology since it is very sensitive to reaction conditions and reagents etc., and consequently, its effects on the desired peptide cannot be predicted. So, the absence of description with divergent species makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
To support the above broadly claimed subject matter, the specification discloses data shown in Table 1 [0063] (see page 27) which is limited to Example compound 1 as protecting agent for Arginine. The data disclosed in Table 1, is limited to compound 1 as the protective group, in the synthesis of the 5-residue peptide: Fmoc-MeNle-MeNle-Arg(X)-Cys(Mmt)-Gly-NH2. Accordingly, Applicants failed to describe actual reduction to practice, the breadth of the claimed invention.
Embodiments of the specification disclose a single protecting agent, for single amino acid Arginine, in the synthesis of a 5-residue peptide. However, there is variability in the broadly claimed subject matter, and that variability results in unpredictability or uncertainties for the claimed subject matter. As noted, Isidro-Llobet et al., teach that choice of protecting group differs with amino acid and the group that is protected; for example, protecting group of Cys is particularly complex because most of the protecting groups used can be removed either by oxidation to the disulfide bridge or by other mechanisms (see page 2483, section 9.3).
So, there is an unpredictability in the protecting group used, deprotection of protecting group, etc. 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. Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure single species to make and possibly use of the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed subject matter and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Elected species of protective group-forming reagent (I) shown below, is allowable.
PNG
media_image1.png
142
287
media_image1.png
Greyscale
PNG
media_image2.png
123
139
media_image2.png
Greyscale
The closest prior art US8808964B2 teaches the structure as shown (see Col 5 formula (I)). The compound is used to formulate a chemically amplified positive resist composition capable of forming a pattern with advantages including high resolution, rectangular profile and minimized dark-bright difference (see Col 4, lines 15-25). The reference does not teach or provide motivation to combine formula (I) for use as a protective group-forming reagent in producing a peptide.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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, Melissa Fisher can be reached at 5712707430. 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.
/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights