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 1-31 were originally filed July 20, 2023.
The amendment received October 17, 2023 amended claims 3-6, 8-10, 12, 14, 18, 20, 25-29, and 31 and cancelled claims 16, 17, 21-24, and 30.
Claims 1-15, 18-20, 25-29, and 31 are currently pending.
Claims 1-8, 10, and 18-20 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15 and 18-20) in the reply filed on September 22, 2025 is acknowledged.
Claims 25-29 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 22, 2025.
Applicant’s election without traverse of SEQ ID NO: 34 wherein W is Ala, X1 is Pro, U is Tyr, X2 is Hyp, Y is Thr-DOPA-Hyp-Lys, and G is absent and a gel as the formulation type as the species in the reply filed on September 22, 2025 is acknowledged.
Please note: applicants neglected to elect an adjuvant, diluent, or carrier of present claims 18 and 19 from which claim 20 depends (i.e. species of gel). In order to advance prosecution, the species election has been accepted and claims 18-20 are examined. However, this does not preclude withdrawal of new claims or a requirement for an additional species.
Claims 9 and 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.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 September 22, 2025.
Please note: regarding applicants’ attorney’s assertation that the present claims are not drawn to Mytilus edulis foot protein (mefp) which is a type of mussel adhesive protein (MAP), this is clearly disputed by the prior art of record and applicants’ own specification.
Priority
The present application is a 371 (National Stage) of PCT/CN2020/133436 filed December 2, 2020 which is a CIP of PCT/CN2019/122391.
PCT/CN2019/122391 can not be both a CIP and a foreign priority document.
There is not a one-to-one correlation between the sequences in the present application and in PCT/CN2019/122391. Applicants must supply a one-to-one correspondence between the sequences in the present claims and the sequences in PCT/CN2019/122391 to be provided the benefit of the later date.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 1, 2022; December 29, 2022; May 11, 2023; November 6, 2023; July 12, 2024; October 11, 2024; April 9, 2025; June 6, 2025; and October 24, 2025 are being considered by the examiner. Please note: only the English language portions of the references were considered.
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 deficiencies and the required response to this Office Action 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 page 5.
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 abstract of the disclosure is objected to because all variable residues should be indicated by X or Xaa (the variable residues may also be numbered – e.g. X1, X2, Xaa1, Xaa2). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). See MPEP § 2412.03(a); § 2412.05(d); and § 2422.
The disclosure is objected to because of the following informalities: all variable residues should be indicated by X or Xaa (the variable residues may also be numbered – e.g. X1, X2, Xaa1, Xaa2). See MPEP § 2412.03(a); § 2412.05(d); and § 2422.
Appropriate correction is required.
The disclosure is objected to because of the following informalities: a “Brief Description of the Drawings” section is not present. See MPEP § 608.01(f).
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 1 is objected to because of the following informalities: each recitation of “represents” should be “is”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: each recitation of “selected” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “as well as” should be removed. Appropriate correction is required. The following is suggested: “regioisomers, stereoisomers, pharmaceutically acceptable salts, or cosmetically acceptable salts thereof”.
Claim 1 is objected to because of the following informalities: “G is absent or represents DOPA or dopamine” should read “G is absent, DOPA, or dopamine”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: “represents” should be “is”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “represents” should be “is”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “selected from the group” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “represents” should be “is”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “selected from the group” should read “selected from the group consisting of” or “in which each amino acid is independently selected from the group consisting of”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: “selected from the group” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “wherein the amino acid sequence defined by Y” should be “wherein Y is”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “selected from the group” should read “selected from the group consisting of”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “SEQ ID No:” should read “SEQ ID NO:”. 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.
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 1-8, 10, and 18-20 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 presently claimed peptide. For example, applicants are incorrectly defining G/Gly/glycine, W/Trp/tryptophan, and Y/Tyr/tyrosine. In addition, applicants are incorrectly identifying variables in an amino acid sequence as G, W, U, and Y (i.e. X or Xaa should be utilized wherein numbering is permitted – e.g. X1, X2, Xaa1, Xaa2). While G, W, U, and Y are defined in the claim, the variable sequence should still conform with the requirements for sequences (see MPEP § 2412).
Claims 1-8, 10, and 18-20 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 presently claimed peptide. For example, applicants are attempting to “define” Hyp and diHyp in the specification to be broader than art recognized (see pages 9 and 10 of the specification). Please note: pages 9 and 10 are not considered a definition of the terms as required (see MPRP § 2173.01). In addition, it appears that applicants are utilizing Hyp and diHyp to encompass more than one species. For clarity in the claims and since the specification should not be incorporated into the claims (see MPEP § 2111.01 II), applicants should utilize single species in the Markush group (i.e. 3Hyp, 4Hyp, etc. – see MPEP § 2412.03(c)).
Claims 1-8, 10, and 18-20 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 presently claimed peptide. For example, it is unclear what the “as well as” phrase at line 13 requires. As presently claimed, it appears that the phrase encompasses the combination of the variable sequence and regioisomers, stereoisomers, pharmaceutically acceptable salts, and cosmetically acceptable salts instead of as alternatives.
Claim 10 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 presently claimed peptide. For example, it is unclear what “has” encompasses (e.g. open, closed, etc.).
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 presently claimed peptide. For example, it is unclear what “defined in” encompasses (e.g. open, closed, etc.).
Claim 19 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 presently claimed peptide. For example, it is unclear what “suitable for, adapted for, and/or packaged and presented for” encompasses. Are additional elements required? In addition, it is unclear what the metes and bounds of “that is” are (e.g. open, closed, etc.). Utilization of “topical adjuvant, topical diluent, or topical carrier” only is suggested.
Please note: due to the myriad of objections and 35 USC 112 issues, applicants are respectfully requested to carefully review the claims for any addition issues.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8, 10, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a fragment of mussel polyphenolic protein (i.e. Mytilus edulis foot protein (Mefp) or mussel adhesive protein (mfp or mefp)) without significantly more (see Figure 4 of Waite, 1987, Nature’s underwater adhesive specialist, Int J Adhesion and Adhesives, 7(1): 9-14 – provided by applicants in the IDS filed on December 29, 2022; Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys). Mefp1 is also known by the sequence Ala-Lys-Pro-Ser-Tyr-Pro-Pro-Thr-Tyr-Lys wherein residues 3, 6, and 7 can be Hyp (bold and underlined) and residues 5 and 9 can be DOPA (bold and italics) (see the abstract and Table 1 of Burzio et al., 2000, Cross-Linking in Adhesive Quinoproteins: Studies with Model Decapeptides, Biochemistry, 39: 11147-11153 – provided by applicants in the IDS filed May 11, 2023). The claims recite the peptide only. This judicial exception is not integrated into a practical application because the claims are drawn to a product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because dependent claims 18-20 are drawn to adjuvants, diluents, or carriers for topical administration in the form of a gel, spray, cream, ointment, or dry powder which are well-understood, routine, and conventional in the art. In addition, the claims do not require the adjuvants, diluents, or carriers to be covalently bound to the peptide.
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.
(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.
Claims 1-5 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yen U.S. Patent 5,616,311 issued April 1, 1997 (provided by applicants in the IDS filed December 29, 2022).
For present claims 1-5 and 18-20, Yen teaches aqueous suspensions or dry powders with carriers comprising Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-Tyr-Lys (W = Ala, X1 = Pro, U = Tyr, X2 = Hyp, Y = HypThrTyr, G is absent) (please refer to the entire specification particularly the abstract; columns 1, 28, 31).
Therefore, the teachings of Yen anticipate the presently claimed compound.
Claims 1-5 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yen WO 96/39128 (provided by applicants in an IDS filed December 29, 2022).
For present claims 1-5 and 18-20, Yen teaches aqueous suspensions or dry powders with carriers for topical use comprising Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-Tyr-Lys (W = Ala, X1 = Pro, U = Tyr, X2 = Hyp, Y = HypThrTyr, G is absent) (please refer to the entire specification particularly the abstract; pages 1, 36, 38, 42).
Therefore, the teachings of Yen anticipate the presently claimed compound.
Claims 1-8, 10, and 18-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Samuelsson et al. U.S. Patent Application Publication 2021/0309696 filed September 14, 2019 (effective filing date of September 14, 2018).
The applied reference has a common 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.
For present claims 1-8, 10, and 18-20, Samuelsson et al. teach SEQ ID NO: 22 (100% identity and the same length as present SEQ ID NO: 1) and additional sequences which read on present claims 1-8 and 18-20 including SEQ ID NO: 4 wherein adjuvants, diluents, and carriers for topical use are utilized and formulations as gels, sprays, creams, ointments, or dry powders (please refer to the entire specification particularly the abstract; ).
Therefore, the teachings of Samuelsson et al. anticipate the presently claimed peptides.
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 1-5, 10, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yen U.S. Patent 5,616,311 issued April 1, 1997 and Fang et al., 2007, Functional Group Approaches to Prodrugs: Functional Groups in Peptides, Chapter 3.7, pages 965-988, Prodrugs: Challenges and Rewards Part 1, Eds Stella, Borchardt, Hageman, Oliyai, Maag, and Tilley.
For present claims 1-5, 10, and 18-20, Yen teaches aqueous suspensions or dry powders with carriers comprising Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-Tyr-Lys (W = Ala, X1 = Pro, U = Tyr, X2 = Hyp, Y = HypThrTyr, G is absent; SEQ ID NO: 20 without the N-terminal HCA) (please refer to the entire specification particularly the abstract; columns 1, 28, 31).
For present claims 1-5, 10, and 18-20, Fang et al. teach utilizing phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability (please refer to the entre reference particularly “Phenylpropionic acid and acyloxyalkoxy systems”; Table 1).
All the claimed elements were known in the prior art 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 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 phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability) 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 1-5, 10, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yen WO 96/39128 (provided by applicants in an IDS) and Fang et al., 2007, Functional Group Approaches to Prodrugs: Functional Groups in Peptides, Chapter 3.7, pages 965-988, Prodrugs: Challenges and Rewards Part 1, Eds Stella, Borchardt, Hageman, Oliyai, Maag, and Tilley.
For present claims 1-5, 10, and 18-20, Yen teaches aqueous suspensions or dry powders with carriers for topical use comprising Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-Tyr-Lys (W = Ala, X1 = Pro, U = Tyr, X2 = Hyp, Y = HypThrTyr, G is absent; SEQ ID NO: 20 without the N-terminal HCA) (please refer to the entire specification particularly the abstract; pages 1, 36, 38, 42).
For present claims 1-5, 10, and 18-20, Fang et al. teach utilizing phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability (please refer to the entre reference particularly “Phenylpropionic acid and acyloxyalkoxy systems”; Table 1).
All the claimed elements were known in the prior art 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 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 phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability) 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).
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.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28, 31-37, and 41-48 of copending Application No. 18/316,496 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/316,496 (reference application) are drawn to topical dry powders or sprays comprising SEQ ID NO: 22 (i.e. present SEQ ID NO: 34).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-53 of copending Application No. 18/612,989 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/612,989 (reference application) are drawn to gels, liquid aerosol (i.e. spray), cream, ointment, and powder aerosol (i.e. dry powder) comprising AlaLysProSerTyr4Hyp4HypThrTyrLys.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-53 of copending Application No. 18/612,989 in view of Fang et al., 2007, Functional Group Approaches to Prodrugs: Functional Groups in Peptides, Chapter 3.7, pages 965-988, Prodrugs: Challenges and Rewards Part 1, Eds Stella, Borchardt, Hageman, Oliyai, Maag, and Tilley.
Copending Application No. 18/612,989 (reference application) claims gels, liquid aerosol (i.e. spray), cream, ointment, and powder aerosol (i.e. dry powder) comprising AlaLysProSerTyr4Hyp4HypThrTyrLys.
Fang et al. teach utilizing phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability (please refer to the entre reference particularly “Phenylpropionic acid and acyloxyalkoxy systems”; Table 1).
All the claimed elements were known in the prior art 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 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 phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability) 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).
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-40, 43, 44, 47, 50, and 53 of copending Application No. 18/282,362 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/282,362 (reference application) are drawn to at least SEQ ID NO: 30 (i.e. present SEQ ID NO: 34) and carriers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 45-84 of copending Application No. 18/281,859 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/281,859 (reference application) are drawn to at least SEQ ID NO: 13 (i.e. present SEQ ID NO: 34) and carriers for topical administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, 8, 11, 12, 14, 15, 17, 18, 21-23, 26, 27, 31-35, 38-46, 49-52, and 54-56 of copending Application No. 17/642,764 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 17/642,764 (reference application) are drawn to at least SEQ ID NO: 14 (i.e. present SEQ ID NO: 34) and adjuvants, diluents, or carriers for topical administration via gels, sprays, creams, ointments, or dry powders.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-14, 16-47, 50-53, 55-58, 61-68, and 70 of copending Application No. 17/781,543 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 17/781,543 (reference application) are drawn to at least SEQ ID NO: 16 (i.e. present SEQ ID NO: 34) and carriers for topical administration via gels, sprays, creams, ointments, or dry powders.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16, 18, 20-24, 26, 28, 31-38, 41-47, and 49 of copending Application No. 17/781,438 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 17/781,438 (reference application) are drawn to at least SEQ ID NO: 5 (i.e. present SEQ ID NO: 34) and carriers for topical administration via gels, sprays, creams, ointments, or dry powders.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of copending Application No. 19/155,785 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 19/155,785 (reference application) are drawn to peptides of at least SEQ ID NO: 83 (i.e. present SEQ ID NO: 34) and adjuvants, diluents, or carriers for topical administration in the form of a gel, spray, cream, ointment, or dry powder.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,568,938. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 10,568,938 are drawn to MAP/mefp-1 (see the references in the 35 USC 101 rejection regarding the sequences) formulated in gels or lotions/creams.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,090,360. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,090,360 are drawn to MAP/mefp-1 (see the references in the 35 USC 101 rejection regarding the sequences) formulated in cosmetics.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,675,327. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 10,675,327 are drawn to MAP/mefp-1 (see the references in the 35 USC 101 rejection regarding the sequences) formulated in cosmetics and spraying onto the skin.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,458,190. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,458,190 are drawn to MAP/mefp-1 (see the references in the 35 USC 101 rejection regarding the sequences) formulated in gels.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,485,848. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 10,485,848 are drawn to MAP/mefp-1 (see the references in the 35 USC 101 rejection regarding the sequences) formulated in gels.
Claims 1-5 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,129,313. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 12,129,313 are drawn to Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys for topical administration to the skin.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,129,313 in view of Fang et al., 2007, Functional Group Approaches to Prodrugs: Functional Groups in Peptides, Chapter 3.7, pages 965-988, Prodrugs: Challenges and Rewards Part 1, Eds Stella, Borchardt, Hageman, Oliyai, Maag, and Tilley.
U.S. Patent No. 12,129,313 claims Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys for topical administration to the skin.
Fang et al. teach utilizing phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability (please refer to the entre reference particularly “Phenylpropionic acid and acyloxyalkoxy systems”; Table 1).
All the claimed elements were known in the prior art 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 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 phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability) 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 1-5 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,059,859. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,059,859 are drawn to Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys with carriers for topical administration to the skin.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,059,859 in view of Fang et al., 2007, Functional Group Approaches to Prodrugs: Functional Groups in Peptides, Chapter 3.7, pages 965-988, Prodrugs: Challenges and Rewards Part 1, Eds Stella, Borchardt, Hageman, Oliyai, Maag, and Tilley.
U.S. Patent No. 11,059,859 are drawn to Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys with carriers for topical administration to the skin.
Fang et al. teach utilizing phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability (please refer to the entre reference particularly “Phenylpropionic acid and acyloxyalkoxy systems”; Table 1).
All the claimed elements were known in the prior art 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 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 phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability) 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 1-5 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,672,792. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,672,792 are drawn to Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys with carriers for topical administration via gels, creams, or ointments.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,672,792 in view of Fang et al., 2007, Functional Group Approaches to Prodrugs: Functional Groups in Peptides, Chapter 3.7, pages 965-988, Prodrugs: Challenges and Rewards Part 1, Eds Stella, Borchardt, Hageman, Oliyai, Maag, and Tilley.
U.S. Patent No. 11,672,792 are drawn to Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys with carriers for topical administration via gels, creams, or ointments.
Fang et al. teach utilizing phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability (please refer to the entre reference particularly “Phenylpropionic acid and acyloxyalkoxy systems”; Table 1).
All the claimed elements were known in the prior art 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 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 phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability) 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 1-5 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 11,680,082. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,680,082 are drawn to at least Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys with carriers for topical administration via sprays or dry powder.
Claims 1-8, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 11,680,082 in view of Fang et al., 2007, Functional Group Approaches to Prodrugs: Functional Groups in Peptides, Chapter 3.7, pages 965-988, Prodrugs: Challenges and Rewards Part 1, Eds Stella, Borchardt, Hageman, Oliyai, Maag, and Tilley.
U.S. Patent No. 11,680,082 are drawn to at least Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys with carriers for topical administration via sprays or dry powder.
Fang et al. teach utilizing phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability (please refer to the entre reference particularly “Phenylpropionic acid and acyloxyalkoxy systems”; Table 1).
All the claimed elements were known in the prior art 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 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 phenylpropionic acid/3,4-dihydrocinnamic acid on the N-terminus of peptides to increase physiochemical properties and membrane permeability) 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, 10, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,260,111. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,260,111 are drawn to MAP/mefp-1 (see the references in the 35 USC 101 rejection regarding the sequences) formulated in gels.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication 2017/0190746
U.S. Patent Application Publication 2018/0228873
U.S. Patent Application Publication 2018/0221444
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/AMBER D STEELE/ Primary Examiner, Art Unit 1658