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 1-59 were originally filed November 6, 2023.
The amendment received June 5, 2024 amended claims 1, 6, 19, 24, 43, 49, 50, and 52 and canceled claims 3-5, 7-18, 21-23, 25-36, 39-42, 45-48, 51, and 53-59.
Please note: claim 19 should have a status identifier of “currently amended”.
Claims 1, 2, 6, 19, 20, 24, 37, 38, 43, 44, 49, 50, and 52 are currently pending.
Claims 1, 2, 6, 49, 50, and 52 are currently under consideration.
Election/Restrictions
Applicant’s election of COPD, human, SEQ ID NO: 4, and inhalation as the species in the reply filed on May 26, 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Claims 19, 20, 24, 37, 38, 43, and 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.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 26, 2026.
Priority
The present application is a 371 (National Stage) of PCT/AU2022/050427 filed May 6, 2022 which claims foreign priority to Australia 2021901369 filed May 7, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 12, 2024 and May 26, 2026 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:
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 paragraphs 10, 12-16, 21-23, 33, 39, 52, 114, 117, 119, 122, 127, and 128.
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 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.
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.
Please note: “formula” language will be interpreted as closed (i.e. only containing the residues/structure recited in the formula).
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, 2, 6, 49, 50, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kenley WO 2013/082667 published June 13, 2023.
For present claims 1, 2, 6, 49, 50, and 52, Kenley teaches methods of treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering SEQ ID NO: 1 (Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 45, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 2 – 100% identity and the same length) via inhalation (please refer to the entire specification particularly the abstract; pages 1-9, 12, 13, 18, 19, 22-25; claims). Kenley also teaches SEQ ID NO: 21 (Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 46, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 3 – 100% identity and the same length) (see page 22).
Therefore, the teachings of Kenley anticipate the presently claimed method.
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, 2, 6, 49, 50, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Kenley WO 2013/082667 published June 13, 2023 and Gearing et al. WO 2019/136528 published July 18, 2019.
For present claims 1, 2, 6, 49, 50, and 52, Kenley teaches methods of treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering SEQ ID NO: 1 (Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 45, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 2 – 100% identity and the same length) via inhalation (please refer to the entire specification particularly the abstract; pages 1-9, 12, 13, 18, 19, 22-25; claims). Kenley also teaches SEQ ID NO: 21 (Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 46, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 3 – 100% identity and the same length) (see page 22).
For present claims 1, 2, 6, 49, 50, and 52, Gearing et al. teach methods of administering SEQ ID NO: 6 (100% identity and the same length as present SEQ ID NO: 1), SEQ ID NO: 2 (100% identity and the same length as present SEQ ID NO: 2), SEQ ID NO: 3 (100% identity and the same length as present SEQ ID NO: 3), SEQ ID NO: 4 (100% identity and the same length as present SEQ ID NO: 4), or SEQ ID NO: 5 (100% identity and the same length as present SEQ ID NO: 5) to humans via inhalation or insufflation (please refer to the entire specification particularly the abstract; paragraphs 7, 9, 12-28, 54-60, 76-80, 83, 88-91, 115, 121-137, 144-157, 177, 179; claims). Gearing et al. also teach present SEQ ID NOs: 6-10, 48-50, (see pages 5-7, 13, 14, 36, 37, 40, 41; claims).
All the claimed elements were known in the prior art (i.e. functional fragments of the peptides taught by Kenley) 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 the substitution of one known element (i.e. slightly longer peptides of Kenley comprising the common core of Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly) for another (i.e. fragment consisting of the common core of Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly taught by Gearing et al.) 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. treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering a peptide comprising a common core of Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly) 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 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 14, 16-20, 22, 24, 26, 27, 29, 31, 34, 35, 37, 38, 40, 47, and 48 of copending Application No. 18/291,004 (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. 18/291,004 (reference application) are drawn to method of administering CRSVEGSCG (SEQ ID NO: 7; present SEQ ID NO: 4) to treat inflammatory airway disease.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6, 49, 50, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 14, 16-20, 22, 24, 26, 27, 29, 31, 34, 35, 37, 38, 40, 47, and 48 of copending Application No. 18/291,004 in view of Kenley WO 2013/082667 published June 13, 2023.
Copending Application No. 18/291,004 (reference application) are drawn to method of administering CRSVEGSCG (SEQ ID NO: 7; present SEQ ID NO: 4) to treat inflammatory airway disease.
Kenley teaches methods of treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering SEQ ID NO: 1 (Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 45, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 2 – 100% identity and the same length) via inhalation (please refer to the entire specification particularly the abstract; pages 1-9, 12, 13, 18, 19, 22-25; claims). Kenley also teaches SEQ ID NO: 21 (Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 46, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 3 – 100% identity and the same length) (see page 22).
All the claimed elements were known in the prior art (i.e. human subjects with COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema; administration via inhalation) 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 the substitution of one known element (i.e. genus of inflammatory airway disease) for another (i.e. species of COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema) 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. treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering a peptide comprising CRSVEGSCG) 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, 2, and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 37, 38, 43, 44, 49-51, 53, and 64-71 of copending Application No. 17/911,972 (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. 17/911,972 (reference application) are drawn to methods of treating a respiratory tract infection/inflammatory airway disease in a human wherein present SEQ ID NOs: 1-5 and 11-47 are administered.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Please note: a Notice of Allowance was mailed on May 27, 2026.
Claims 1, 2, 6, 49, 50, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 37, 38, 43, 44, 49-51, 53, and 64-71 of copending Application No. 17/911,972 in view of Kenley WO 2013/082667 published June 13, 2023.
Copending Application No. 17/911,972 (reference application) are drawn to methods of treating a respiratory tract infection/inflammatory airway disease in a human wherein present SEQ ID NOs: 1-5 and 11-47 are administered.
Kenley teaches methods of treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering SEQ ID NO: 1 (Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 45, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 2 – 100% identity and the same length) via inhalation (please refer to the entire specification particularly the abstract; pages 1-9, 12, 13, 18, 19, 22-25; claims). Kenley also teaches SEQ ID NO: 21 (Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 46, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 3 – 100% identity and the same length) (see page 22).
All the claimed elements were known in the prior art (i.e. human subjects with COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema; administration via inhalation) 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 the substitution of one known element (i.e. genus of inflammatory airway disease) for another (i.e. species of COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema) 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. treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering a peptide comprising CRSVEGSCG; administration via inhalation) 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.
Please note: a Notice of Allowance was mailed on May 27, 2026.
Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10, 64, 66, 67, 70, and 71 of copending Application No. 17/788,845 (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. 17/788,845 (reference application) are drawn to methods of treating an inflammatory respiratory condition wherein present SEQ ID NO: 2 is administered.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6, 49, 50, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10, 64, 66, 67, 70, and 71 of copending Application No. 17/788,845 in view of Kenley WO 2013/082667 published June 13, 2023.
Copending Application No. 17/788,845 (reference application) are drawn to methods of treating an inflammatory respiratory condition wherein present SEQ ID NO: 2 is administered.
Kenley teaches methods of treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering SEQ ID NO: 1 (Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 45, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 2 – 100% identity and the same length) via inhalation (please refer to the entire specification particularly the abstract; pages 1-9, 12, 13, 18, 19, 22-25; claims). Kenley also teaches SEQ ID NO: 21 (Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 46, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 3 – 100% identity and the same length) (see page 22).
All the claimed elements were known in the prior art (i.e. human subjects with COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema; administration via inhalation) 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 the substitution of one known element (i.e. genus of inflammatory airway disease) for another (i.e. species of COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema) 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. treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering a peptide comprising CRSVEGSCG; administration via inhalation) 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, 2, 6, 49, 50, and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,758,593 in view of Kenley WO 2013/082667 published June 13, 2023.
U.S. Patent No. 10,758,593 claims methods of administering present SEQ ID NOs: 1-3 (see SEQ ID NOs: 1, 22-26, and 31-41).
Kenley teaches methods of treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering SEQ ID NO: 1 (Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 45, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 2 – 100% identity and the same length) via inhalation (please refer to the entire specification particularly the abstract; pages 1-9, 12, 13, 18, 19, 22-25; claims). Kenley also teaches SEQ ID NO: 21 (Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 46, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 3 – 100% identity and the same length) (see page 22).
All the claimed elements were known in the prior art (i.e. human subjects with COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema; administration via inhalation) 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. treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering a peptide comprising CRSVEGSCG; administration via inhalation) 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, 2, 6, 49, 50, and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,111,933 in view of Kenley WO 2013/082667 published June 13, 2023.
U.S. Patent No. 10,111,933 claims methods of administering present SEQ ID NOs: 1 or 2 (see SEQ ID NOs: 1, 22-26, and 34-40).
Kenley teaches methods of treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering SEQ ID NO: 1 (Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 45, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 2 – 100% identity and the same length) via inhalation (please refer to the entire specification particularly the abstract; pages 1-9, 12, 13, 18, 19, 22-25; claims). Kenley also teaches SEQ ID NO: 21 (Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe; i.e. 100% identity and the same length as present SEQ ID NO: 1; R1 is SEQ ID NO: 46, SEQ ID NO: 4, and R2 is F or present SEQ ID NO: 3 – 100% identity and the same length) (see page 22).
All the claimed elements were known in the prior art (i.e. human subjects with COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema; administration via inhalation) 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. treating COPD, cystic fibrosis, asthma, chronic bronchitis, or emphysema in humans via administering a peptide comprising CRSVEGSCG; administration via inhalation) 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 art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please note: if claims 37 and 38 are rejoined, a Double Patenting rejection will be made regarding U.S. Patent 11,566,049.
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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