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
Applicant’s election of Group I and the species C1-74-2,
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in the reply filed on 06/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In response to the restriction requirement dated 10 April, 2026, Applicant elects, without
traverse: Group I, claims 22-35 drawn to a bicyclic peptide composition and elected species disclosed in the application as C1-74-2. Claims 22, 23, 25-28, 34 and 36-40 read on the elected species. Claims 36-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 12/15/2023 is a Continuation of 17136578 , filed 12/29/2020 ,now U.S. Patent # 11859019; 17136578 is a Continuation of 16462914 , filed 05/21/2019 ,now U.S. Patent # 10913773; 16462914 is a National Stage entry of PCT/US2017/062945 , International Filing Date: 11/22/2017 PCT/US2017/062945 Claims Priority from Provisional Application 62425471 , filed 11/22/2016.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/07/2026, 04/10/2026, 03/26/2025, complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
The specification filed on 01/24/2024 does not recite appropriate sequence identifiers in the form of
SEQ ID numbers. For example, please see: page 56, line 23 and line1. The sequences recited in the specification must include SEQ ID numbers to properly identify the sequences. Appropriate correction is required.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The use of the term Accutane, Adrucil, Argyrin, etc., and several other trademarks disclosed e.g., in pages 37-38 which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 25, R3 is a peptide having from 2 to 8 natural and / or unnatural amino acid residues. The instant claim is dependent on claim 22, which recites that R3 is a tripeptide.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 22-35 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.
The claimed invention is directed to bicyclic peptide compositions comprising specific
substitutions within the composition.
Regarding claim 22, the claim recites limitations specifying variables for R1-R3, R5-R9, R11-R12.
Applicant reduced to practice, for R2, benzyl substituted with -OH (e.g. see elected species). Applicant does not disclose the rest of the recited variables that correspond to R2. For R3, Applicant discloses tripeptide in the structures for C1-74-1 to C1-74-6 (see page 73 and 74 of the specification). Applicant does not disclose broadly, all tripeptides as claimed for R3. Choice of amino acids in a tripeptide can generate an array of compositions that vary in characteristic and property.
Regarding claims 25 and 26, Applicant reduces to practice R3, disclosed in compounds C1-74-1 to C1-74-6 (see page 73 and 74 of the specification). Applicant does not disclose broadly all combinations of amino acids for R3 as claimed.
Consequently, one of ordinary skill in the art would not conclude Applicant was in possession of
the claimed genus of bicyclic peptide composition. Claims 22, 25 and 26 lacks written description because the instant application does not provide sufficient guidance to one of ordinary skill in the art to
determine the sequences for R3 or variables for R2 falling within the scope of the genus of bicyclic peptides. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. A “representative number of species” means that the species are adequately described are representative of the entire genus. See MPEP §2163.
Claims 23, 24, 27-35 which depend from claims 22 are rejected under 35 U.S.C. 112(a) or 35
U.S.C. 112(pre-AIA ), first paragraph, as these claims incorporate by dependency the lack of adequate
written description of claim 22.
Claim Rejections - 35 USC § 102
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 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.
(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.
Claim(s) 22, 23, 27 and 28 are rejected under 35 U.S.C. 102(a)(2) and 102(a)(1) as being anticipated by US 9,868,767B2 hereinafter ‘797 (PCT filed May 23, 2014).
The applied reference has a common Applicant and Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicant’s election of species is noted. However, in the interest of compact prosecution, search has been expanded to include the genus.
Regarding claim 22, ‘797 teaches the structure represented by Formula I-A-1 (see page 65, represented below on the right) (i.e. Formula II, see below) which meets the limitations of the claim. Specifically, in ‘797, wherein, R1 is a benzyl ring; R2 is benzyl substituted with one or more -OH; R3 is neutral or selected from H; R5 is benzyl substituted with one or more -OH; R6 is benzyl; R7 is H; R8 is C1-6 alkyl substituted with one or more -NH2; R9 is CH2imidazole; R11 is NH2.
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Regarding claim 23, ‘797 teaches R2 is 4-hydroxy benzyl.
Regarding claim 27, ‘797 teaches R8 is –(CH2)4NH2.
Regarding claim 28, ‘797 teaches R9 is CH2Imidazole.
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(s) 22, 23, 25, 26, 27, 28 are rejected under 35 U.S.C. 103 as being unpatentable over by US 9,868,767B2 hereinafter ‘797 (PCT filed May 23, 2014).
The teaching in the ‘797 patent have been set forth above.
Additionally, regarding claim 25, ‘797 teaches Formula I-A.
‘797 does not disclose R3 is a peptide having 2-8 amino acid residues in a single embodiment. ‘797 discloses ‘K’ (see Col 36, page 55); and wherein Xm comprises a peptide chain of 3-7 amino acid residues (see Col 36, line 11-13) and Xn comprises a peptide chain length of 2-6 amino acids (see Col 36, line 25-26) i.e. 2-8 natural and/or unnatural amino acid residues.
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of ‘797 to comprise
a peptide chain of 2-8 amino acid residues. One motivated to do so, would have a reasonable expectation of success, as both references teach bicyclic peptide compositions targeting TNFα. Thus, one would have recognized that applying the teaching of ‘797 would have yielded predictable results, since ‘797 specifically suggests a peptide chain in the structure of the bicyclic peptide. See MPEP §2143.
Regarding claim 26, as noted above in the rejection for claim 25, ‘797 discloses amino acid residue length (i.e. tripeptide).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 22-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US10913773. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 22, reference patent ‘773 claims Formula II (see claim 1, 2).
Regarding claim 23, reference patent ‘773 teaches Formula II (see claim 4).
Regarding claim 24, reference patent ‘773 teaches Formula II (see claims 5-7).
Regarding claim 25, reference patent ‘773 teaches Formula II (see claim 8).
Regarding claim 26, reference patent ‘773 teaches Formula II (see claim 8 and 9).
Regarding claim 27, reference patent ‘773 teaches Formula II (see claim 13).
Regarding claim 28, reference patent ‘773 teaches Formula II (see claim 14).
Regarding claim 29, reference patent ‘773 teaches Formula II (see claim 15).
Regarding claims 30-35 reference patent ‘773 teaches Formula II (see claim 17).
2. Claims 22-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. US11859019. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 22, reference patent ‘019 claims Formula II (see claim 1-22).
Regarding claim 23, reference patent ‘019 teaches Formula II (see claim 1-22).
Regarding claim 24, reference patent ‘019 teaches Formula II (see claims 1-22).
Regarding claim 25, reference patent ‘019 teaches Formula II (see claim 1-22).
Regarding claim 26, reference patent ‘019 teaches Formula II (see claim 1-22).
Regarding claim 27, reference patent ‘019 teaches Formula II (see claim 1-22).
Regarding claim 28, reference patent ‘019 teaches Formula II (see claim 1-22).
Regarding claim 29, reference patent ‘019 teaches Formula II (see claim 1-22).
Regarding claims 30-35 reference patent ‘019 teaches Formula II (see claim 1-22).
3. Claims 22-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US 9,868,767B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 22, reference patent ‘767 claims Formula II (see claim 1-9).
Regarding claim 23, reference patent ‘767 teaches Formula II (see claim 1-19).
Regarding claim 24, reference patent ‘767 teaches Formula II (see claims 1-19).
Regarding claim 25, reference patent ‘767 teaches Formula II (see claim 1-19).
Regarding claim 26, reference patent ‘767 teaches Formula II (see claim 1-19).
Regarding claim 27, reference patent ‘767 teaches Formula II (see claim 1-19).
Regarding claim 28, reference patent ‘019 teaches Formula II (see claim 1-19).
Regarding claim 29, reference patent ‘019 teaches Formula II (see claim 1-19).
Regarding claims 30-35 reference patent ‘019 teaches Formula II (see claim 1-19).
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