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 .
Election/Restrictions
Applicant’s response to the restriction/ election requirement from 1/5/2026 is acknowledged. Applicant has elected without traverse the invention of Group I, claims 19, 21-28, 30 and 32.
Applicant’s response pertaining to the election of species requirement is completely non-responsive. Applicant was required to elect a single species of a therapeutically active component comprising a CGRP inhibitor. In response, Applicant did not elect a single species, but rather a whole genus—small molecule CGRP receptor antagonist, which more or less simply restates the request for election. An election of a single species would have been e.g. zavegepant. Applicant was further required to elect a single species of a pain disorder. Applicant did elect one at all, but rather stated: “Regarding the pain disorder, the Applicant respectfully submits that a search for the treatment of a pain disorder does not present an undue burden and that the second species rejection should be withdrawn.” It is noted that Applicant cannot simply not elect. Applicant is required to elect. Applicant may traverse, but Applicant may not just not elect. The traversal does not even have a legal basis, because undue search burden pertains solely to US restriction practice, while the standard for restriction used herein was unity of invention. Even so, even if the standard were undue search burden, which it is not, it is noted that what is covered under a pain disorder, in e.g. Applicant’s claim 32, is a really broad and highly diverse group of disorders of vastly different pathology and completely different search strings.
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While in the interest of compact prosecution the Examiner decided to not issue a miscellaneous communication requesting that Applicant comply with the election of species requirement, and proceeds with examination on the merits, she expressly reserves the right to request an election of species again in the course of prosecution, should the need arise.
Claims 19, 21-28, 30 and 32 are pending, and have been examined herewith.
Claim Objections
Claim 19 is objected to because of the following informalities: it recites CGRP, which is not a commonly known abbreviation. Appropriate correction with the full name “calcitonin gene-related peptide (CGRP)” is required.
Claim 32 is objected to because of an extra comma in “carcinomatous, neuropathy”. Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19, 21-28, 30 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treatment or prevention of pain in a pain disorder associated with aberrant levels of CGRP in a subject in need thereof comprising intranasally administering to the subject a therapeutically effective composition comprising a small molecule CGRP receptor antagonist, does not reasonably provide enablement for a method for treatment or prevention of a pain disorder associated with aberrant levels of CGRP in a subject in need thereof comprising intranasally administering to the subject a therapeutically effective composition comprising a small molecule CGRP receptor antagonist. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The instant specification fails to provide information that would allow the skilled artisan to practice the instant invention without undue experimentation. Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art, the relative skill of those in the art, and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The instant invention pertains to a method for treatment or prevention of a pain disorder associated with aberrant levels of CGRP in a subject in need thereof, the method comprising intranasally administering to the subject a composition comprising a therapeutically active component comprising a CGRP inhibitor wherein the CGRP inhibitor is a small molecule CGRP receptor antagonist.
Breadth of the claims: The instant claims are deemed very broad since these claims read on treating or preventing any and every pain disorder. They are not, however, limited to treatment of pain. Rather, they recite treatment or prevention of a very loose and broad category of so-called pain disorders, which in fact have a vastly different pathology and many more symptoms than merely pain, many of which there is still no cure fore, e.g. various neurodegenerative disorders, AIDS-associated neuropathy, etc. See, e.g., claim 32:
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Guidance of the Specification/Working Examples: Applicant shows in examples solely data pertaining to a single CGRP inhibitor- zavegepant, given to patients with migraine, who were shown to get pain relief.
The state of the prior art: At the time of the instant invention multiple disorders are still not known to have a cure. They include various neurodegenerative disorders, AIDS, etc. Yet, Applicant’s specification broadly claims treatment of such, e.g., alcoholic polyneuropathy, HIV- or AIDS-associated neuropathy, chronic inflammatory demyelinating polyradiculoneuropathy, etc.
Predictability/Unpredictability in the Art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation encompasses any CGRP inhibitor, which includes a great number compounds with different structures, potencies, effects, etc., for the treatment of a vast array of disorders of multiple symptoms, many of which are not known to yet have a cure. One of skill in the art would recognize that it is highly unpredictable in regard to therapeutic effects, side effects and toxicity generated by any CGRP inhibitor, and with unlikely success for diseases with no known cure to date.
The Quantitation of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to conduct an exhaustive amount of experiments. Applicant would need to provide reasonable data showing that any CGRP inhibitor can treat any disorder, which has a pain component to it, but comprehensively, and not just for the pain aspects. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome.
Genentech states that "patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable." Genentech v. Novo Nordisk, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
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 24 and 26 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.
Claims 24 and 26 recite:
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The claims are vague and ambiguous because it is unclear what this relative means “most bothersome symptom”. Moreover, it is even unclear what this is in reference to overall. The two claims ultimately depend from claim 19, which recites a pain disorder. Various pain disorders have various symptoms, and the symptoms listed above do not appear to apply to all at all. It seems that they may potentially be only relevant to migraine, which is not even a recited pain disorder in claims from which claims 24 and 26 depend.
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 19, 21-28, 30 and 32 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by WO 2020/150703 A1 to Coric et al. (“Coric”).
Regarding claims 19 and 32, Coric discloses a pharmaceutical composition for treatment or prevention of a pain disorder associated with aberrant levels of CGRP in a subject in need thereof, the method comprising intranasally administering to the subject a composition comprises a therapeutically active component comprising a CGRP inhibitor, wherein the CGRP inhibitor is a small molecule CGRP receptor antagonist. (p. 3, para 5: "In an aspect of the invention, there is provided a method of treating breakthrough migraine in a patient undergoing underlying treatment with a migraine medication who has experienced a breakthrough resulting in a migraine headache, symptom or episode, said method including administering to the patient a pharmaceutical composition including a therapeutically effective amount of a breakthrough CGRP antagonist, or a pharmaceutically acceptable salt thereof."; p. 5, para 12: "In another aspect, the CGRP antagonist may be administered intranasally."; p. 2, para 2: "For example, research and clinical studies have shown: serum levels of CGRP are elevated during migraine attacks,").
Regarding claim 21, Coric discloses wherein the small molecule CGRP receptor antagonist is zavegepant, a solvate thereof, or a pharmaceutically acceptable salt thereof (p. 4, para 15: " the breakthrough CGRP antagonist may be vazegepant.").1
Regarding Applicant’s claims 22-28 and 30, Coric discloses that the dose of the CGRP antagonist can be e.g. 5 mg, 10 mg, 20 mg, etc., to include intranasally. (p. 5). Coric discloses administering as a single daily dose. (p. 67). Since Coric discloses administering the same drug in the same pharmaceutically effective amounts as claimed by Applicant, this will result in the same pain from freedom in %, reduction in symptoms, and at the same times after dosing, as per Applicant’s claims.
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 19, 21-28, 30 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-70 and 98 of copending Application No. 18/700,075 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter.
Specifically, the claims of the instant application are directed to a method for treatment or prevention of a pain disorder associated with aberrant levels of CGRP in a subject in need thereof, the method comprising intranasally administering to the subject a composition comprising a therapeutically active component comprising a CGRP inhibitor wherein the CGRP inhibitor is a small molecule CGRP receptor antagonist. A specifically claimed CGRP antagonist is zavegepant. Claimed pain disorders include trigeminal neuralgia.
The claims of the co-pending application are directed to treating or prevention of trigeminal neuralgia with a CGRP antagonist, which is:
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This structure is zavegepant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19, 21-28, 30 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 32, 33 and 35 of copending Application No. 17/269,227 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter.
Specifically, the claims of the instant application are directed to a method for treatment or prevention of a pain disorder associated with aberrant levels of CGRP in a subject in need thereof, the method comprising intranasally administering to the subject a composition comprising a therapeutically active component comprising a CGRP inhibitor wherein the CGRP inhibitor is a small molecule CGRP receptor antagonist. A specifically claimed CGRP antagonist is zavegepant. Disclosed pain disorders in the specification include migraine.
The claims of the co-pending application are directed to treating breakthrough migraine in a patient undergoing underlying treatment with a migraine medication who has experienced a breakthrough resulting in a migraine headache, symptom or episode, said method comprising administering to the patient a pharmaceutical composition comprising a therapeutically effective amount of zavegepant, or a pharmaceutically acceptable salt thereof.
Applicant’s transitional phrase “comprising” is open ended, and does not preclude treatment with another migraine medication.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
1 For the record, zavegepant and vazegepant are different names of the same compound. See, cf. Applicant’s specification at p. 18.
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