DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 4/29/2026 is acknowledged.
4. Claim filed on 4/29/2026 is acknowledged.
5. Claims 7-9 and 15-17 have been cancelled.
6. Claims 1-6, 10-14 and 18-26 are pending in this application.
7. Claims 10-14 and 18 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 4 and 21-25 are withdrawn from consideration as being drawn to non-elected species.
8. Claims 1-3, 5, 6, 19, 20 and 26 are under examination.
Election/Restrictions
9. Applicant’s election without traverse of Group 1 (claims 1-6 and 19-26) and election without traverse of
PNG
media_image1.png
226
800
media_image1.png
Greyscale
as species of compound of formula (I) or a pharmaceutically acceptable salt thereof in the reply filed on 4/29/2026 is acknowledged. The requirement is made FINAL in this office action.
Group 1 is drawn to a compound of formula (I)
PNG
media_image2.png
242
342
media_image2.png
Greyscale
or a pharmaceutically acceptable salt thereof. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claim 1; and prior art was found. Claims 4 and 21-25 are withdrawn from consideration as being drawn to non-elected species. Claims 1-3, 5, 6, 19, 20 and 26 are examined on the merits in this office action.
Sequence Non-Compliance
10. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims.
In the instant case, instant specification and figures disclose various peptides, for example, cyclic Arg on page 23 of instant specification; and many others in instant specification and instant figures. However, these various peptides are not in the filed sequence listing.
All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.
Objections
11. The specification is objected to for containing/referring to sequences without also identifying them by the sequence identifier assigned to them in the sequence listing as required by 37 CFR 1.821(d). The specification discloses various peptides, for example, cyclic Arg on page 23 of instant specification; and many others in instant specification. However, these various peptides are not in the filed sequence listing, and they are missing the sequence identifier.
Furthermore, many peptides disclosed in the instant specification are missing the sequence identifier.
Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d).
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
12. The drawings are objected to for the following minor informality:
Figures 1-19, 21-40 and 42-45: These figures recite various peptides. However, some of the recited peptides are not in the filed sequence listing, and all these peptides are missing the sequence identifier.
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.
13. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A compound of formula (I):
PNG
media_image2.png
242
342
media_image2.png
Greyscale
, wherein:…each m is independently an integer…Z is…a peptide that is 2 to 10 amino acids in length, and…”.
Furthermore, Applicant is suggested to amend the recited “(C1-C6)alkyl” as “C1-6 alkyl”.
14. Claim 3 is objected to for the following minor informality: Applicant is suggested to amend claim 3 as “…Z is…a peptide that is 2 to 10 amino acids in length”.
15. Claim 5 is objected to for the following minor informality: Applicant is suggested to amend claim 5 as “…wherein the compound is a compound of formula (2)…and wherein A, L…”.
16. Claim 6 is objected to for the following minor informality: Applicant is suggested to amend claim 6 as “…and wherein B1 and B2 are independently selected from the group consisting of CH2, NH and O; h is an integer…”.
17. Claim 19 is objected to for the following minor informality: Applicant is suggested to amend claim 19 as “…and wherein # indicates the point of attachment to the L…”.
18. Claim 20 is objected to for the following minor informality: Applicant is suggested to amend claim 20 as “…wherein the EWG is selected from…and wherein
PNG
media_image3.png
38
18
media_image3.png
Greyscale
indicates the point of attachment to the S”.
19. Claim 26 is objected to for the following minor informality: Applicant is suggested to amend claim 26 as “…wherein the compound is a compound of formula (2b)…and wherein A…”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
20. 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.
21. Claims 1, 2, 5, 6, 19, 20 and 26 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 pre-AIA the applicant regards as the invention.
22. Claim 1 recite the limitation “Z is…a hydrophobic moiety”. With regards to the term “hydrophobic moiety”, the instant specification fails to define it. Therefore, it is unclear what is the cutoff between “a hydrophobic moiety” and “a hydrophilic moiety”. Using hydrophobic amino acid as an example, the list of hydrophobic amino acid varies, as disclosed in the Amino Acid Physical Properties document (from ThermoFisher Scientific, 2026, enclosed pages 1-3, see for example, the list on page 2) and the Amino Acids Reference Chart document (from Millipore Sigma, 2026, enclosed pages 1-9, see for example, pages 4-5). Therefore, it is unclear what is encompassed within the recited “Z is…a hydrophobic moiety”. Thus, the metes and bounds of instant claim 1 is vague and indefinite. Because claims 2, 5, 6, 19, 20 and 26 depend from indefinite claim 1; and none of these claims clarifies the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
Claim Rejections - 35 U.S.C. § 112 paragraph (a)
Written Description
23. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
24. Claims 1, 3, 5, 6 and 26 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” (MPEP § 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure (MPEP § 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
In the instant case, claims 1, 3, 5, 6 and 26 are drawn a compound of formula (I)
PNG
media_image2.png
242
342
media_image2.png
Greyscale
or a pharmaceutically acceptable salt thereof, wherein A is a moiety capable of binding to a cell surface.
The genus of instant claimed A is extremely broad, including any moiety that can bind to a cell surface under any condition.
The instant specification discloses various examples of A on pages 39-48 of instant specification.
The issue at question is whether a person of ordinary skilled in the art would be able to determine what structural feature is required for a moiety to have the functional characteristics of being capable of binding to a cell surface or not.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
In the instant case, the instant specification discloses various examples of A on pages 39-48 of instant specification.
Furthermore, maleimide, 5(6)-carboxytetramethylrhodamine (TAMRA), Cys, or thionitrobenzoic acid (TNB) as A are tested in the working examples in instant specification.
Taken all these together, other than the limited examples, the instant specification fails to disclose what structural feature is required for a moiety to have the functional characteristics of being capable of binding to a cell surface.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure:
As discussed above, in the instant case, based on the disclosure of instant specification, other than the limited examples, a person of ordinary skilled in the art would not be able to determine what structural feature is required for a moiety to have the functional characteristics of being capable of binding to a cell surface.
With regards to a moiety capable of binding to a cell surface, the art is unpredictable, as discussed in Lowe (2022, pages 1-6, from https://www.science.org/content/blog-post/not-alphafold-s-fault) and many others. Lowe explicitly states that “the number of strong binding interactions predicted is basically the same between the active compounds and the inactive ones” (see page 2, the 2nd paragraph).
Therefore, based on the state of art, a person of ordinary skilled in the art would not be able to determine what structural feature is required for a moiety to have the functional characteristics of being capable of binding to a cell surface.
(d) representative number of samples:
In the instant case, the genus of instant claimed A is extremely broad, including any moiety that can bind to a cell surface under any condition.
And, as discussed in (a) and (b) above, the instant specification discloses various examples of A on pages 39-48 of instant specification.
Furthermore, maleimide, 5(6)-carboxytetramethylrhodamine (TAMRA), Cys, or thionitrobenzoic acid (TNB) as A are tested in the working examples in instant specification.
Considering the broadness of the genus of instant claimed moiety capable of binding to a cell surface, the instant specification fails to provide sufficient examples to describe the entire genus of a moiety capable of binding to a cell surface claimed.
Taken all these together, considering the state of the art and the disclosure in instant specification, it is deemed that the instant specification fails to provide adequate written description for the claimed genus of a moiety capable of binding to a cell surface; and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 U.S.C. § 102(a)(1)
25. 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.
26. Claims 1-3, 5, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parang et al (US 2015/0038671 A1).
The instant claims 1-3, 5, 19 and 20 are drawn to a compound of formula (I)
PNG
media_image2.png
242
342
media_image2.png
Greyscale
or a pharmaceutically acceptable salt thereof.
Parang et al teach compound R7C with the structure
PNG
media_image4.png
238
446
media_image4.png
Greyscale
, for example, Figure 19. The compound R7C in Parang et al is a compound of instant formula (2) with A being
PNG
media_image5.png
152
72
media_image5.png
Greyscale
, L being a bond, n being 6 and Z being NH2. It meets the limitations of instant claims 1-3, 5, 19 and 20.
Furthermore, the MPEP states the following: “A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990)” (see MPEP § 2131.02).
Since the reference teaches all the limitations of instant claims 1-3, 5, 19 and 20; the reference anticipates instant claims 1-3, 5, 19 and 20.
27. Claims 1, 3, 5, 6 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tartaglia et al (US 2014/0329743 A1), and as evidenced by Granell et al (PNAS, 2013, 18, pages E4733-E4742).
The instant claims 1, 3, 5, 6 and 26 are drawn to a compound of formula (I)
PNG
media_image2.png
242
342
media_image2.png
Greyscale
or a pharmaceutically acceptable salt thereof.
Tartaglia et al teach peptide of SEQ ID NO: 263 consisting of the amino acid sequence Ac-Nle-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys)-Doc-(Arg)5-Gln-(Arg)3-NH2, for example, page 19, SEQ ID NO: SEQ ID NO: 263. The peptide of SEQ ID NO: 263 in Tartaglia et al is a compound of instant formula (2b) with A being Ac-Nle-c(Cys-D-Ala-His-D-Phe-Arg-Trp-Cys) (a moiety that binds to MC4R, see SEQ ID NO: 107 on page 10), L being
PNG
media_image6.png
50
148
media_image6.png
Greyscale
, n being 4, and Z being a peptide comprising 4 amino acids (Gln-(Arg)3-NH2). And as evidenced by Granell et al, MC4R is a cell surface hormone receptor (see page E4733, Section “Significance”). Therefore, the peptide of SEQ ID NO: 263 in Tartaglia et al meets the limitations of instant claims 1, 3, 5, 6 and 26.
Furthermore, the MPEP states the following: “A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990)” (see MPEP § 2131.02).
Since the reference teaches all the limitations of instant claims 1, 3, 5, 6 and 26; the reference anticipates instant claims 1, 3, 5, 6 and 26.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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 on 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.
/LI N KOMATSU/Primary Examiner, Art Unit 1658
Prosecution Insights