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 .
Status of the Claims
Claims 1-21 were originally filed September 6, 2023.
Claims 1-21 are currently pending.
Claims 1-8 and 12-19 are currently under consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-20) in the reply filed on May 12, 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)). Simply stating “with traverse” without distinctly and specifically point out the supposed errors in the restriction requirement is interpreted as an election without traverse.
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 12, 2026.
Applicant’s election of K1 is acetyl; P1/B is V/Val/valine; P2 is cyclohexylglycine (Chg); P3 is R/Arg/arginine; P4 is tetrahydroisoquinoline-3-carboxylate (Tic); P5/ArAA is F/Phe/phenylalanine; K2 is NHCH2CH2OCH3; and salt trifluoroacetate/acetate/HCl as the species in the reply filed on May 12, 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)).
Claims 9-11 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 12, 2026.
Please note: claim 20 is withdrawn because claim 20 requires both a pharmaceutically acceptable salt and a pharmaceutically acceptable carrier which was not elected. See page 28 and the examples regarding trifluoroacetate, acetate, and HCl being pharmaceutically acceptable salts only.
Priority
The present application is a 371 (National Stage) of PCT/US2022/019445 filed March 9, 2022 which claims the benefit of 63/263,172 filed March 19, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 20, 2023 and June 30, 2025 are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
B. Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See Tables 2-6 and both Tables 8 (pages 55 and 58).
See pages 9, 54, 56, 57, and 59.
See claims 7-11.
Please note: the amendment to the specification received May 12, 2026 was not entered.
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.
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834.
See Tables 2-6 and both Tables 8 (pages 55 and 58).
See pages 9, 54, 56, 57, and 59.
See claims 7-11.
Please note: the amendment to the specification received May 12, 2026 was not entered.
Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because of the following informalities: two tables are labeled Table 8 (see pages 55 and 58).
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 5 is objected to because of the following informalities: the claim should be dependent on claim 4 instead of claim 3 (i.e. claim 4 refers to K1). Appropriate correction is required.
Claims 7 and 8 are objected to because of the following informalities: the sequences require SEQ ID NOs:. Appropriate correction is required. Also see withdrawn claims 9-11.
Claim 8 is objected to because of the following informalities: the claim should depend on claim 1 instead of claim 2. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: the conjunction should be “and” to correlate with “selected from the group consisting of”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-5, 17, and 19 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what “when present” means. Does the compound have to be formula (I)? Does the compound require any amino acids? In addition, the combination of “when present” and “are each independently amino acyl groups of a natural amino acid or a non-natural amino acid” is unclear. Is each of P1-P5 required or not? Furthermore, it is unclear how K1 can be an N-capping group if an N-terminus of an amino acid or peptide is not present and how K2 can be a C-terminus substituent if a C-terminus of an amino acid or peptide is not present.
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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what from Table 6 is required. See MPEP § 2173.05(s) regarding Tables in the claims.
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." See Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim 18 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what from Table 6 is required. See MPEP § 2173.05(s) regarding Tables in the claims.
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." See Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim 18 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what “above” is referring to (see line 3).
Claim 18 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation at least one of P1-P5 is a nonnatural amino acid or peptide mimetic, and the claim also recites P1 and P5 are each independently amino acyl groups of a natural amino acid or a non-natural amino acid including those set forth in Table 6 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 18 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation at least one of P1-P5 is a nonnatural amino acid or peptide mimetic, and the claim also recites “at least two of P1-P5 is a nonnatural amino acid or peptide mimetic” and “at least three of P1-P5 is a nonnatural amino acid or peptide mimetic” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 7 is rejected, in part, 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. Claim 7 depends on independent claim 1. Independent claim 1 requires that K2 is a substituent in which the C-terminus is an oligoalkoxyalkyl amide group. Dependent claim 7 allows for n to be 0, thus an oligoalkoxyalkyl amide group is not present. Therefore, the recitation of n is 0 fails to further limit independent claim 1. 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 § 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.
Claims 1-8 and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al. U.S. Patent 7,439,231 published October 21, 2008.
For present claims 1-8 and 12-19, Olson et al. teach SEQ ID NO: 97 (ValChgArgTicPhe) with N-terminal acetylation and C-terminal oligoalkoxyalkyl amide group (please refer to the entire specification particularly columns 4-8, 10-14, 19-24, 26, 42-48; Tables 2, 3).
Therefore, the teachings of Olson et al. anticipate the presently claimed compound.
Claims 1-8 and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al. WO 2004/073625 published September 2, 2004.
For present claims 1-8 and 12-19, Olson et al. teach SEQ ID NO: 97 (ValChgArgTicPhe) with N-terminal acetylation and C-terminal oligoalkoxyalkyl amide group (please refer to the entire specification particularly pages 5-11, 14-19, 23-30, 34, 51-61; Tables 2, 3).
Therefore, the teachings of Olson et al. anticipate the presently claimed compound.
Claim Rejections - 35 USC § 103
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.
Claims 1-8 and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. U.S. Patent 7,439,231 published October 21, 2008 and Nachman et al., 1995, Diuretic Activity of C-terminal Group Analogues of the Insect Kinins in Acheta domesticus, Peptides, 16(5): 809-813.
For present claims 1-8 and 12-19, Olson et al. teach SEQ ID NO: 97 (ValChgArgTicPhe) with N-terminal acetylation and C-terminal oligoalkoxyalkyl amide group (please refer to the entire specification particularly columns 4-8, 10-14, 19-24, 26, 42-48; Tables 2, 3).
For present claims 1-8 and 12-19, Nachman et al. teach utilizing C-terminal NHCH2CH2OCH3 as an alternative to amidation (i.e. NH2) (please refer to the entire reference particularly the abstract; Table 1; Figure 1).
All the claimed elements were known in the prior art (i.e. C-terminal NHCH2CH2OCH3) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (e.g. blocking of the C-terminus to increase stability, etc.) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of C-terminal blocking group) for another (i.e. C-terminal NHCH2CH2OCH3) would have yielded predictable results (i.e. increased stability of the peptide) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. adding a C-terminal NHCH2CH2OCH3 to a peptide) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-8 and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. WO 2004/073625 published September 2, 2004 and Nachman et al., 1995, Diuretic Activity of C-terminal Group Analogues of the Insect Kinins in Acheta domesticus, Peptides, 16(5): 809-813.
For present claims 1-8 and 12-19, Olson et al. teach SEQ ID NO: 97 (ValChgArgTicPhe) with N-terminal acetylation and C-terminal oligoalkoxyalkyl amide group (please refer to the entire specification particularly pages 5-11, 14-19, 23-30, 34, 51-61; Tables 2, 3).
For present claims 1-8 and 12-19, Nachman et al. teach utilizing C-terminal NHCH2CH2OCH3 as an alternative to amidation (i.e. NH2) (please refer to the entire reference particularly the abstract; Table 1; Figure 1).
All the claimed elements were known in the prior art (i.e. C-terminal NHCH2CH2OCH3) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (e.g. blocking of the C-terminus to increase stability, etc.) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of C-terminal blocking group) for another (i.e. C-terminal NHCH2CH2OCH3) would have yielded predictable results (i.e. increased stability of the peptide) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. adding a C-terminal NHCH2CH2OCH3 to a peptide) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent 8,222,215
U.S. Patent 8,598,312
U.S. Patent Application Publication 20040162242
Masterson, Unlocking the Structure and Flexibility in a Four Residue Peptide Using 1H NMR Spectroscopy, 381-389, retrieved June 9, 2026.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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