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 .
Response to Amendments
Applicant’s amendments to the claims of April 1, 2026, in response to the Office Action of January 8, 2026, are acknowledged.
Response to Arguments
Applicant’s claim objections and rejections under § 112 are withdrawn in view of the amendments to the claims.
With respect to the §103 rejection, Applicant argues that trigeminal neuralgia (TGN) is different than neuropathic pain and it is hard to treat. Further, Applicant notes that carbamazepine is the first line treatment for TGN.
The examiner notes that the prior art teaches the claimed compound to treat neuropathic pain and that TGN is neuropathic pain. However, the prior art teaches more than this. For example, the Nielson reference teaches the claimed agent to work as a GABAA receptor ligand, receptors of which are present throughout the CNS. The claimed compound is taught as a novel GABAA positive allosteric modulator for the treatment and prevention of neuropathic pain.
Further, we would expected the claimed compound to treat TGN for the following reasons. Carbamazepine is a GABAA agonist. Thus, the first line treatment of TNG works to treat neuropathic pain through a same mechanism by which the first line treatment of TNG works. See Harkin et al., “Carbamazepine,” Pract Diab Int June 2010 Vol. 27 No. 5.
Further, Chaudhry, “Management of Trigeminal Neuralgia” Journal of Pharmaceutical and Biological Sciences 2020;8(2):60-64, teaches baclofen as useful for treating TGN as a GABAA agonist. See p62, 1st par. CBZ, OXC, pregabalin, gabapentin, and topiramate are or baclofen can be used to treat TGN. See p63. Similarly to the claimed compound, many of these agents works as positive allosteric modulators (PAM) of GABA.
As such, a prima facie showing is established because the claimed agent is known to treat neuropathic pain as a PAM of GABA. While Applicant argues that TGN would not be expected to be treated with a GABAA agonist, the examiner notes that agents including carbamazepine are acknowledged to do so through this same mechanism of action. While a guarantee is not set forth, there is a reasonable and predictable expectation of success that an agent that acts as a GABAA agonist that is taught to treat neuropathic pain will treat TGN. As such, this argument is not persuasive.
Status of the Claims
Claims 1, 2, 4-10, 12, 13, 17, and 19 are pending.
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, 4-10, 12, 13, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al., (WO2020/053377 A1) (cited in ISR), in view of Xie et al., (US2016/0347810), in view of Piomelli et al., (US2009/0082435), in view of Vickers et al., “Neuropathic Orofacial Pain Part 1- Prevalence and Pathophysiology,” Australian Endodontic Journal February 11, 2010 (Abstract).
Nielson teaches treatment of neuropathic pain with the claimed compound. See Abstract. The compound can treat pain, neuropathic pain, and/or itch. See p1, lines 7-8. The compound can be used to prevent, treat, and alleviate neuropathic pain. See p3, lines 12-13. Compositions may be administered orally as well as buccally and sublingually, and by inhalation, e.g. See p7-8, bridging par. An oral dose can range from 1 microgram or .001 mg to 100 mg/kg/day orally. See p9, lines 28-29. Symptoms of neuropathic pain including burning, tingling, electricity, pins and needles, hyperalgesia, and many other characterizations. See p10, lines 23-28. Administration of an API is taught after surgery. Further, chronic administration of was shown to maintain effects indicating a lack of tolerance. See Figure 3, e.g. It is not apparent that the type of surgery would impact the ability to mitigate and/or treat pain and itch resulting therefrom.
With regard to claims directed to administration for a number of days prior to an operation, the examiner notes that Nielson teaches after 7 days of chronic treatment, a significant analgesic effect of all doses tested was maintained. As such, when prevention is intended, a starting point for dosage regimen optimization would be considered to be 7 days prior to surgery, e.g. Chronic and acute administration are both effective. See Example 4, among others.
Nielson does not teach facial pain in particular.
Xie teaches neuropathic pain to include: trigeminal neuralgia (par. 92), postoperative pain (prior claim 16); and migraine or tension headache (par. 189).
Piomelli teaches neuropathic pain to include: trigeminal neuralgia, post-surgical pain, atypical facial neuralgia after tooth extraction, mononeuropathy, and others. See par.’s 19 and 48.
Vickers teaches orofacial pain is neuropathic pain and those predisposed may include those suffering from cluster or migraine headaches. See Abstract. This is common at the dentist and is common after endodontic treatments.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of Nielson, Xie, Piomelli, and Vickers. One would be motivated to do so because the claimed API is taught to treat neuropathic pain at claimed dosages and through a same route of administration. Moreover, Xie, Piomelli, and Vickers collectively teach that trigeminal neuralgia, postoperative pain, atypical facial neuralgia, orofacial pain, migraines, and tension headaches are forms of neuropathic pain. As such, a POSA would have a reasonable and predictable expectation of success in treating the forms of facial pain and neuropathic pain by administering an agent known to treat neuropathic pain at dosages taught to prevent and treat neuropathic pain when administered by a claimed route of administration at a claimed dosage.
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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