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 .
Priority
This Application filed on 11/16/2022 is a 371 of PCT/US2021/033716 filed on 05/21/2021 which has PRO 63/029,783 filed on 05/26/2020.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed August 25, 2025 to the restriction requirement made on July 16, 2025.
Applicant's election without traverse of Group II, claims 8-13, 14 (amended) and newly added 16-21 and the species suvorexant and morphine, in the reply filed on August 25, 2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 11/16/22 is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The rejections are as below:
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 8-13 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Roehrs et al. (Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo. J Clin Sleep Med. 2020 Mar 15;16(3):415-421. doi: 10.5664/jcsm.8220. Epub 2020 Jan 14. PMID: 31992394; PMCID: PMC7075085) in view of Auget et al. (US 20090270400 A1) .
The claims are examined to the extent that they read on: “method for treating, inhibiting, or reducing pain in a subject, which comprises administering to the subject one or more opioids in combination with one or more hypocretin/orexin receptor antagonists.”
Roehrs et al. teaches suvorexant, an orexin antagonist approved for treatment of insomnia, was effective on both sleep and the pain of fibromyalgia. The reference teaches suvorexant 20 mg in patients with fibromyalgia, improved sleep time and reduced next-day pain sensitivity on assessments of FWL to a radiant heat stimulus.
The reference does not specify the combination of suvorexant and morphine.
Auget et al. teaches a painkilling formulation comprising a dose of 0.015 mg/kg morphine. Administration of a medicament according to the invention can be carried out by topical route, oral route, parenteral route, by intramuscular injection, sub-cutaneous injection, intravenous injection, etc. or by a combination of these routes. [0109] The pain treated is pain associated with fibromyalgia. (see claim 9)
It would have been obvious to one of ordinary skill in the art at the time of filing to combine suvorexant and morphine. The motivation to administer both suvorexant and morphine in combination flows logically from the efficacy demonstrated in the prior art as compounds used in treating pain. The skilled artisan would have reasonably concluded, in light of the shared efficacy against pain, that the concomitant administration of suvorexant and morphine would have been reasonably expected to achieve, at minimum, additive, if not synergistic, effects when combined. lt is further noted that in the absence of evidence to the contrary, it is generally prima facie obvious to use in combination two or more agents that have previously been used separately for the same purpose. See In re Kerkhoven, 205 USPQ 1069 (CCPA). Therefore, a skilled artisan would have had reasonable expectation of successfully achieving similar efficacy and results. With respect to the amounts and ratios of the opioid, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(1)) With respect to the amounts and ratios of the hypocretin/orexin receptor antagonist, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(Il)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Lastly, it would have been obvious to a person of ordinary skill in the art at the time of invention to co-administer suvorexant, and morphine in a sequential or administer suvorexant before or after administration of morphine within a time limit (i.e. less than 6 hours) because it is well known in the pharmaceutical art co- administering two drugs encompassing, administering them together at the same time, sequentially, or administering one drug before or after another drug to achieve therapeutic effects. Thus, administering sequentially or administering suvorexant before or after morphine to achieve therapeutic effects is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Roehrs et al. (Sleep and pain in humans with fibromyalgia and comorbid insomnia: double-blind, crossover study of suvorexant 20 mg versus placebo. J Clin Sleep Med. 2020 Mar 15;16(3):415-421. doi: 10.5664/jcsm.8220. Epub 2020 Jan 14. PMID: 31992394; PMCID: PMC7075085) in view of Auget et al. (US 20090270400 A1), as applied to claims 8-13 and 16-21, and further in view of Thannickal et al. (Opiates increase the number of hypocretin-producing cells in human and mouse brain and reverse cataplexy in a mouse model of narcolepsy. Sci Transl Med. 2018 Jun 27;10(447):eaao4953. doi: 10.1126/scitranslmed.aao4953. PMID: 29950444; PMCID: PMC8235614).
Roehrs et al. and Auget et al. are as discussed above.
Roehrs et al. and Auget et al. do not specify the increase in hypocretin and/or an increase in the amount of hypocretin neurons caused by administration of opioids.
Thannickal et al. teaches opiates increase the number of hypocretin-producing cells in human. (abstract)
It would have been obvious to one of ordinary skill in the art at the time of filing to reduce an increase in hypocretin caused by an opioid with a hypocretin/orexin antagonist, i.e. suvorexant. The motivation to reduce an increase in hypocretin caused by an opioid with a hypocretin/orexin antagonist, i.e. suvorexant is because opiates increase the number of hypocretin and suvorexant is a hypocretin/orexin antagonist. The skilled artisan would have reasonably expectation of successfully reducing an increase in hypocretin caused by an opioid with a hypocretin/orexin antagonist.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM PST.
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, James Henry Alstrum-Acevedo, can be reached on (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622