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 1-53 were originally filed July 20, 2023.
The amendment received July 12, 2024 amended claims 1-5, 7-9, 12, 15, 17, 18, 20-26, 34-40, and 42 and cancelled claims 10, 11, 13, 14, 16, 19, 27-33, 41, and 43-53.
The amendment received March 27, 2026 amended claims 2, 22-26, 34, 36, 37, 39, 40, and 42; cancelled claims 21, 35, and 38; and added new claims 54-58.
Claims 1-9, 12, 15, 17, 18, 20, 22-26, 34, 36, 37, 39, 40, 42, and 54-58 are currently pending.
Claims 1-3, 7, 15, 17, 18, 19, and 54 are currently under consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-9, 12, 15, 17, 18, and 20) in the reply filed on March 27, 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Claims 22-26, 34, 36, 37, 39, 40, and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 27, 2026.
Applicant’s election of IIH; octreotide in a liquid formulation and at a dose of 70 mg wherein the area-under-the-curve is equal to or less than about 10% of the dose administered by a non-nasal route; subcutaneous as the non-nasal route; 3 doses per day; and reduces an acute, ongoing episode of IIH in the reply filed on March 27, 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)).
Please note: applicants’ representative states on page 9 of the response received March 27, 2026 that he believes that species F and G are for the product claims of Group II and not to the elected method claims of Group I. It is unclear why applicants’ representative believes that reagents utilized in a method and method steps of a method are species for a product. The response to the species of F and G is being treated as an election of nothing for each.
Claims 4-6, 8, 9, 12, and 55-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species , there being no allowable generic or linking claim.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 March 27, 2026.
Priority
The present application is a 371 (National Stage) of PCT/US2022/013144 filed January 20, 2022 which claims the benefit of 63/139,893 filed January 21, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 5, 2023 is being considered by the examiner, in part (see the crossed-out citations – no copies were provided).
The information disclosure statements (IDS) submitted on September 9, 2024; October 21, 2024; February 3, 2025; and August 26, 2025 are being considered by the examiner.
Drawings
No drawings are present.
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 - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because sequences are present in paragraphs 68, 69, 80, and 101.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o 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.
Claim Objections
Claim 17 is objected to because of the following informalities: “selected from” should read “selected from the group consisting of” and the conjunction should be changed from “or” to “and”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 7, 15, 17, 18, 20, and 54 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 claim. For example, it is unclear what formulation is required for “direct nose-to-brain administration”. Will any intranasal formulation work? Are specific reagents in the formulation necessary to provide the function of “direct nose-to-brain administration”? Is a specific apparatus required to provide “direct nose-to-brain administration”?
Claims 3 and 7 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 claim. For example, it is unclear if method steps for determining the effective amount are required by the claim or not (e.g. method step of intranasal administration, method step of non-intranasal administration, and a comparison method step; adjustment method step for the actual final dose administered).
Claims 3 and 7 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 claim. For example, it is unclear what the effective intranasal amount is.
Claim 17 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 claim. For example, it is unclear how a “somatostatin mimetic” can be “somatostatin”.
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 1-3, 7, 15, 17, 18, 20, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Haviv U.S. Patent 10,682,387 issued June 16, 2020 and Weeke et al., 1992, A Randomized Comparison of Intranasal and Injectable Octreotide Administration in Patients with Acromegaly, Journal of Clinical Endocrinology and Metabolism, 75(1): 163-169.
For present claims 1-3, 7, 15, 17, 18, 20, and 54, Haviv teaches methods of administering octreotide, lanreotide, pasireotide, and/or somatostatin to a subject to treat headaches or IIH at a dosage of about 5 mg to about 120 mg given daily, 2, or 3 times a day in liquid form (please refer to the entire specification particularly the abstract; Deftereos et al.; Panagopoulos et al.; columns 1-7; Examples).
While Haviv teaches oral or injectable administration, intranasal administration is not taught.
For present claims 1-3, 7, 15, 17, 18, 20, and 54, Weeke et al. teach methods of administering octreotide intranasally (please refer to the entire specification particularly the abstract; Study design, Dose selection and blinding; Figures 1-5).
The claims would have been obvious because the substitution of one known element (i.e. oral or intravenous administration of octreotide) for another (i.e. intranasal administration of octreotide) would have yielded predictable results (i.e. treatment with octreotide) 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. intranasal administration of octreotide) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-3, 7, 15, 17, 18, 20, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Mamluk et al. U.S. Patent Application Publication 2019/0298792 published October 3, 2019 and Lerner et al., 2004, Enhanced Delivery of Octreotide to the Brain via Transnasal Iontophoretic Administration, Journal of Drug Targeting, 12(5): 273-280.
For present claims 1-3, 7, 15, 17, 18, 20, and 54, Mamluk et al. teach methods of administering octreotide, somatostatin, lanreotide, or pasireotide to subjects with IIH or cluster headaches wherein administration is oral or intravenous at dosages of about 5 mg to about 35 mg, 20 mg, 40 mg, 60 mg, 80 mg, 90 mg, or 120 mg daily, every 8-16 hours, twice daily, or three or more times daily in liquid form (please refer to the entire specification particularly the abstract; paragraphs 5-10, 24-26, 29, 33-35, 37-39, 48, 49, 53, 54, 58-63, 79-82, 84-91).
While Mamluk et al. teach oral or intravenous administration, intranasal administration is not taught.
For present claims 1-3, 7, 15, 17, 18, 20, and 54, Lerner et al. teach methods of transnasal administration of octreotide in a liquid formulation (please refer to the entire specification particularly the abstract; Drug Formulation; Figures 1 and 3).
The claims would have been obvious because the substitution of one known element (i.e. oral or intravenous administration of octreotide) for another (i.e. intranasal administration of octreotide) would have yielded predictable results (i.e. treatment with octreotide) 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. intranasal administration of octreotide) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-3, 7, 15, 17, 18, 20, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Mamluk U.S. Patent Application Publication 2016/0220628 published August 4, 2016 and Tomono et al., 2020, Nasal absorption enhancement of protein drugs independent to their chemical properties in the presence of hyaluronic acid modified with tetraglycine-L-octaarginine, European Journal of Pharmaceutics and Biopharmaceutics, 154: 186-194.
For present claims 1-3, 7, 15, 17, 18, 20, and 54, Mamluk et al. teach methods of administering octreotide, somatostatin, lanreotide, or pasireotide to subjects with IIH or cluster headaches wherein administration is oral or intravenous at dosages of about 5 mg to about 35 mg, 20 mg, 40 mg, 60 mg, 80 mg, 90 mg, or 120 mg daily, every 8-16 hours, twice daily, or three or more times daily in liquid form (please refer to the entire specification particularly the abstract; paragraphs 4-10, 19, 23-25, 28, 34, 36-38, 46-52, 57-96).
While Mamluk et al. teach oral or intravenous administration, intranasal administration is not taught.
For present claims 1-3, 7, 15, 17, 18, 20, and 54, Tomono et al. teach methods of intranasal administration of octreotide in a liquid formulation (i.e. diluted in PBS or saline) (please refer to the entire specification particularly the abstract; section 2.4; Tables 1 and 4).
The claims would have been obvious because the substitution of one known element (i.e. oral or intravenous administration of octreotide) for another (i.e. intranasal administration of octreotide) would have yielded predictable results (i.e. treatment with octreotide) 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. intranasal administration of octreotide) was recognized as part of the ordinary capabilities of one skilled in the art. 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 1-3, 7, 15, 17, 18, 20, and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 12,15-18, 20-27, 30, 33, 35, 37, 38, 48, 51, 52, 54, 55, 57, 58, 61, 69, 74, 77, and 82 of copending Application No. 18/276,724 (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. 18/276,724 (reference application) are drawn to methods of treating IIH or cluster headache via intranasal administration of a somatostatin mimetic including somatostatin, octreotide, loanreotide, pasireotide, or penetreotide at a dose of equal to or less than about 100 mg daily and administered daily or in 2, 3, or 4 divided doses in a powder, liquid, or gel formulation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Deftereos et al., 2011, Treatment of idiopathic intracranial hypertension: Is there a place for octreotide?, Cephalalgia, 31(16): 1679-1680.
Matharu et all., 2004, Subcutaneous Octreotide in Cluster Headache: Randomized Placebo-Controlled Double-Blind Crossover Study, Ann Neurol, 56: 488-494.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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