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 1-11 were originally filed March 9, 2023.
The preliminary amendment received March 9, 2023 amended claims 3-5, 7, 8, and 11 and canceled claim 10.
The amendment received May 6, 2026 amended claims 1 and 5-9 and canceled claims 2-4.
Claims 1, 5-9, and 11 are currently pending.
Claims 1 and 5-9 are currently under consideration.
Election/Restrictions
Applicant elected, without traverse, Group I (claims 1-9) in the reply filed on December 3, 2025.
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicant elected, without traverse, SEQ ID NO: 1, intramolecular disulfide bond connecting X and Y, SEQ ID NO: 5, acylation, amidation, and SEQ ID NO: 10 as the species in the reply filed on December 3, 2025.
Please note: the election of SEQ ID NO: 10 (Ac-(D-Cys)(D-Ala)(D-Arg)(D-Arg)(D-Arg)(D-Ala)(D-Arg)-NH2) wherein Cys is linked to SEQ ID NO: 5 via a disulfide bond does not correlate with the election of SEQ ID NO: 1 (Ac-CysAlaArgArgArg(D-Ala)Arg). The election of SEQ ID NO: 1 is considered controlling.
Claim 9 was previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Please note: claim 9 was previously withdrawn because each amino acid in Y (top sequence) is in the D form. Elected SEQ ID NO: 1 is (Ac-CysAlaArgArgArg(D-Ala)Arg). Claim 9 has been rejoined in view of the amendment received May 6, 2026 and due to issues with the claim.
Regarding applicants arguments about SEQ ID NO: 1, applicant elected “Y as set forth in SEQ ID NO: 1” in the response received December 3, 2025 (see page 2; i.e. SEQ ID NO: 1 of the originally filed sequence listing). The examiner of record is not responsible for applicant’s representative’s mistakes. Nor should the examiner of record be expected to go through the entire specification and ensure that the sequence listing matches every recitation of the SEQ ID NO:, that falls within applicant’s representative’s responsibility.
SEQ ID NO: 1 in the sequence listing filed on March 9, 2023 is Acetylated-CysAlaArgArgArg(D-Ala)Arg-Amidated.
Paragraph 34 of the originally filed specification refers to SEQ ID NO: 1 as Ac-(D-Cys)(D-Ala)(D-Arg)(D-Arg)(D-Arg)Ala(D-Arg)-NH2.
Paragraph 182 of the originally filed specification refers to SEQ ID NO: 1 as Ac-(D-Cys)(D-Ala)(D-Arg)(D-Arg)(D-Arg)(D-Ala)(D-Arg)-NH2.
Therefore, three different sequences are associated with SEQ ID NO: 1 in the originally filed sequence listing and the originally filed specification.
Therefore, applicant’s representative’s assertations that what is found in the sequence listing is “mere error” and that SEQ ID NO: 1 is “always” recorded as Ac-(D-Cys)(D-Ala)(D-Arg)(D-Arg)(D-Arg)(D-Ala)(D-Arg)-NH2 is false (see page 11 of the response received May 6, 2026).
It is not the examiner of record’s responsibility to ensure consistency between all recitations of the same sequence. That responsibility lies with applicant and the applicant’s representative.
If a specific SEQ ID NO: is elected, the sequence listing is controlling.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/CN2021/088266 filed April 20, 2021 which claims foreign priority to China 202010946404.5 filed September 10, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 6, 2026 is being considered by the examiner.
Please note: only the sections of the references provided were considered (e.g. abstract only).
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:
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).
See paragraphs 154 and 202.
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.
Specific deficiency - This application contains sequence disclosures in accordance with 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 - 1.825.
The sequence disclosures are located at paragraph 154 (i.e. (GlySer)2, (GlySer)3, SGGSGGS). See n = 2 or 3.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
The “Sequence Listing XML” part of the disclosure filed with this application in accordance with 37 CFR 1.831-1.834 has been found to contain an error or errors as indicated on the document “Computer Readable Form (CRF) for Sequence Listing - Defective”. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above submitted in accordance with either item 1. or 2., together with
o A statement that identifies the location of all additions, deletions, or replacements of sequence information in the replacement “Sequence Listing XML” as required by 1.835(b)(3);
o A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
o A statement that the replacement “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(b)(5); and
o 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:
• 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.
Withdrawn Objections
The objection to claim 2 regarding utilization of formula (IIa) and formula (IIb) twice is unnecessary is withdrawn in view of the cancellation of the claim in the amendment received May 6, 2026.
The objection to claim 2 regarding a conjunction should be present between “formula (IIa)” and “formula (IIb)” is withdrawn in view of the cancellation of the claim in the amendment received May 6, 2026.
The objection to claim 2 regarding “set forth in formula (IIa) or formula (IIb)”; “formula (IIa)”; and “formula (IIb)” should be deleted is withdrawn in view of the cancellation of the claim in the amendment received May 6, 2026.
The objection to claim 2 regarding “peptide chain” should read “peptide sequence” is withdrawn in view of the cancellation of the claim in the amendment received May 6, 2026.
The objection to claim 5 regarding “modification” at line 3 is redundant and unnecessary is withdrawn in view of the amendment received May 6, 2026.
The objection to claim 7 regarding the repetition of “wherein ID is an intramolecular disulfide bond or a linker formed between X and Y” from claim 1 is unnecessary is withdrawn in view of the amendment received May 6, 2026.
The objection to claim 7 regarding the numbers (e.g. “(1)”, “(2)”) should be removed as the numbers are unnecessary is withdrawn in view of the amendment received May 6, 2026.
The objection to claim 8 regarding the numbers (e.g. “(1)”, “(2)”) should be removed as the numbers are unnecessary is withdrawn in view of the amendment received May 6, 2026.
The objection to claim 8 regarding the inclusion of the N- and C-terminus is unnecessary and should be removed (e.g. H2N and OH for SEQ ID NOs: 2-6, 12, and 13) is withdrawn in view of the amendment received May 6, 2026.
The objection to claim 8 regarding “L” should be removed because it could be interpreted as L/Leu/leucine is withdrawn in view of the amendment received May 6, 2026.
The objection to claim 8 regarding “D”, the amino acids in D form should be written as follows: (D-Tyr) is withdrawn in view of the amendment received May 6, 2026.
The objection to claim 8 regarding utilization of SEQ ID NO: 2-6 and 12-18 twice is redundant is withdrawn in view of the amendment received May 6, 2026.
Maintained Objection
Claim Objections
Claim 8 is objected to because of the following informalities: “peptide chain” should read “peptide sequence”. Appropriate correction is required.
Arguments and Response
Applicants’ arguments directed to the objection to claim 8 were considered but are not persuasive for the following reasons.
Applicants contend that the amendments received May 6, 2026 negate the objection.
Applicants’ arguments are not convincing since the amendment to claim 8 did not alter “peptide chain”.
New Objections Necessitated by Amendment
Specification
The amendment filed May 6, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the originally filed specification at paragraph 34 did not designate the 6th residue of SEQ ID NO: 1 in the D form (i.e. originally filed specification referred to “Ala” not “D-Ala”).
Applicant is required to cancel the new matter in the reply to this Office Action.
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 1 is objected to because of the following informalities: “Xaa4 is glycine,” should read “Xaa4 is glycine;” (i.e. change comma to semicolon) to correlate with the rest of the claim. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “or” should be between the two “when” clauses. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “and” is missing before the last wherein clause. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: “cysteine” in line 4 appears to be missing context (e.g. cysteine in X and cysteine in Y). Appropriate correction is required.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Therefore, the present claims require 100% identity and the same length as SEQ ID NO: 1 and 100% identity and the same length as present Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6 wherein Xaa1 is L-tyrosine or D-tyrosine; Xaa2 is selected from the group consisting of L-cysteine, D-cysteine, 2-aminoisobutyric acid, D-arginine, D-proline, and D-histidine; Xaa3 is selected from the group consisting of L-phenylalanine, D-phenylalanine, and D-tyrosine; Xaa4 is glycine; Xaa5 is glycine; and when Xaa2 is L-cysteine or D-cysteine, Xaa6 is absent; and when Xaa2 is selected from the group consisting of 2-aminoisobutyric acid, D-arginine, D-proline, and D-histidine, Xaa6 is L-cysteine.
Oath/Declaration
The Declaration under 37 CFR 1.132 filed May 6, 2026 was unnecessary to overcome the rejection of record as set forth in the last Office action because the claim amendments received May 6, 2026 negated the written description rejection of record.
Withdrawn Rejections
The rejection of claims 1, 2, and 5-8 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claims 1, 2, and 5-8 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claim 2 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 is withdrawn in view of the cancelation of the claim in the amendment received May 6, 2026.
The rejection of claim 2 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 is withdrawn in view of the cancelation of the claim in the amendment received May 6, 2026.
The rejection of claim 5 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claim 7 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claim 7 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claim 7 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claim 7 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claim 8 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 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claims 1, 2, and 5-7 under 35 U.S.C. 102(a)(1) as being anticipated by Karim et al. WO 2011/014707 published February 3, 2011 (provided with the Restriction Requirement mailed on October 8, 2025) is withdrawn in view of the amendment received May 6, 2026.
The rejection of claims 1, 2, and 5-8 under 35 U.S.C. 103 as being unpatentable over Karim et al. WO 2011/014707 published February 3, 2011 (provided with the Restriction Requirement mailed on October 8, 2025) and Newcomb et al. U.S. Patent 6,653,460 issued November 25, 2003 is withdrawn in view of the amendment received May 6, 2026.
The rejection of claims 1, 2, and 5-8 under 35 U.S.C. 103 as being unpatentable over Karim et al. WO 2011/014707 published February 3, 2011 (provided with the Restriction Requirement mailed on October 8, 2025); Newcomb et al. U.S. Patent 6,653,460 issued November 25, 2003; and Tran et al., 2006, Designing amino acid residues with single-conformations, Protein Engineering, Design & Selection, 19(9): 401-408 is withdrawn in view of the amendment received May 6, 2026.
New Rejections Necessitated by Amendment
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 and 5-9 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 which SEQ ID NO: is meant in the present claim.
SEQ ID NO: 1 in the sequence listing filed on March 9, 2023 is Acetylated-CysAlaArgArgArg(D-Ala)Arg-Amidated.
Paragraph 34 of the originally filed specification refers to SEQ ID NO: 1 as Ac-(D-Cys)(D-Ala)(D-Arg)(D-Arg)(D-Arg)Ala(D-Arg)-NH2.
Paragraph 182 of the originally filed specification refers to SEQ ID NO: 1 as Ac-(D-Cys)(D-Ala)(D-Arg)(D-Arg)(D-Arg)(D-Ala)(D-Arg)-NH2.
Therefore, three different sequences are associated with SEQ ID NO: 1 in the originally filed sequence listing and the originally filed specification.
Claims 1 and 5-8 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.
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 1 recites the broad recitation “Y is a calcium-sensing receptor agonist”, and the claim also recites “Y is a peptide sequence consisting of the amino acid sequence of SEQ ID NO: 1” 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.
Claims 1, 5-7, and 9 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.
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 1 recites the broad recitation “X is an osteogenic growth peptide-like peptide or a stimulator of bone marrow mesenchymal stem cells”, and the claim also recites “X is a peptide sequence consisting of the amino acid sequence of “Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6 wherein Xaa1 is L-tyrosine or D-tyrosine; Xaa2 is selected from the group consisting of L-cysteine, D-cysteine, 2-aminoisobutyric acid, D-arginine, D-proline, and D-histidine; Xaa3 is selected from the group consisting of L-phenylalanine, D-phenylalanine, and D-tyrosine; Xaa4 is glycine; Xaa5 is glycine; and when Xaa2 is L-cysteine or D-cysteine, Xaa6 is absent; when Xaa2 is selected from the group consisting of 2-aminoisobutyric acid, D-arginine, D-proline, and D-histidine, Xaa6 is L-cysteine” 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 5 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.
Claim 5 recites the limitation "the chemical modification of the carboxyl terminal of …Y" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
While a carboxyl terminal for Y is inherently present in formula (Ib), independent claim 1 only refers to the carboxyl terminal of X having a chemical modification.
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.
Claim 6 recites the limitation "the chemical modification of the amino terminal" in lines 1-2 and “the amino terminal” at line 3. There is insufficient antecedent basis for this limitation in the claim (i.e. claim 5 from which claim 6 depends was amended to only refer to the amino terminal of X).
Claim 9 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 SEQ ID NOs: 7-11, 21, and 22 are referring to. SEQ ID NOs: 7-11, 21, and 22 are variations of SEQ ID NO: 1. While the sequence listing also refers to what the sequences are linked to, the full polypeptide compound should be clearly and definitively claimed (e.g. Y is selected from the group consisting of SEQ ID NOs: 7-11, 21, and 22 or The polypeptide compound according to claim 1 selected from the group consisting of SEQ ID NO: 7 wherein Cys is linked to Cys of SEQ ID NO: 2 via a disulfide bond, SEQ ID NO: 8 wherein Cys is linked to Cys of SEQ ID NO: 3 via a disulfide bond, SEQ ID NO: 9 wherein Cys is linked to Cys of SEQ ID NO: 4 via a disulfide bond, SEQ ID NO: 10 wherein Cys is linked to Cys of SEQ ID NO: 5 via a disulfide bond, SEQ ID NO: 11 wherein Cys is linked to Cys of SEQ ID NO: 6 via a disulfide bond, SEQ ID NO: 21 wherein Cys is linked to Cys of SEQ ID NO: 12 via a disulfide bond, and SEQ ID NO: 22 wherein Cys is linked to Cys of SEQ ID NO: 13 via a disulfide bond).
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 9 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. Claim 9 depends on independent claim 1. Independent claim 1 requires a Y peptide and an X peptide linked via an intramolecular disulfide bond wherein Y consists of SEQ ID NO: 1 and X consists of Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6 wherein Xaa1 is L-tyrosine or D-tyrosine; Xaa2 is selected from the group consisting of L-cysteine, D-cysteine, 2-aminoisobutyric acid, D-arginine, D-proline, and D-histidine; Xaa3 is selected from the group consisting of L-phenylalanine, D-phenylalanine, and D-tyrosine; Xaa4 is glycine; Xaa5 is glycine; and when Xaa2 is L-cysteine or D-cysteine, Xaa6 is absent; when Xaa2 is selected from the group consisting of 2-aminoisobutyric acid, D-arginine, D-proline, and D-histidine, Xaa6 is L-cysteine. SEQ ID NO: 1 (i.e. Y peptide) in the present sequence listing is Acetylated-CysAlaArgArgArg(D-Ala)Arg-Amidated (i.e. a single D amino acid at the 6th residue). Dependent claim 9 requires the Y peptide of SEQ ID NOs: 7-11, 21, and 22 which are all Acetylated-(D-Cys)(D-Ala)(D-Arg)(D-Arg)(D-Arg)(D-Ala)(D-Arg)-amidated (i.e. all amino acids are D amino acids). Therefore, dependent claim 9 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 7 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. Claim 7 depends on independent claim 1. Independent claim 1 requires ID to be an intramolecular disulfide bond connecting X and Y. Dependent claim 7 requires that the intramolecular disulfide bond is formed between cysteine in X and cysteine (i.e. presumably in Y). However, the only amino acid residues in SEQ ID NO: 1 (Y peptide) and the X peptide that can form intramolecular disulfide bonds is cysteine. Therefore, dependent claim 7 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.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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.
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.
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 6 recites the broad recitation “alkylation”, and the claim also recites “C1-6 alkylation or aralkylation” 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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 6 were considered but are not persuasive for the following reasons.
Applicants contend that changing “and” to “wherein” negates the rejection.
Applicants’ arguments are not convincing since merely changing “and” to “wherein” does not negate the fact that a broad recitation and more narrow recitations are present in the same claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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