DETAILED ACTION
The amendment submitted on July 16, 2026 has been entered. Claims 8 and 11-17 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a method for treating post-operative respiratory disorders/depression or respiratory disorders/depression induced by an opioid or an anesthetic, is acknowledged. All of the pending claims correspond to the elected invention, with claims drawn to the other invention having been cancelled.
Withdrawn Rejections
The rejection of claims 8-17 under 35 U.S.C. 112(a) for lack of enablement is withdrawn because “preventing” has been deleted from the claims.
The rejection for double patenting over U.S. Patent No. 12,594,269 B2 (Application No. 17/791,302) is withdrawn because the examiner finds applicant’s arguments to be persuasive. The examiner agrees that the claims of the ‘269 Patent “are silent regarding the claimed patient population,” and they “are silent regarding opioids and anesthesia generally.” See applicant’s Remarks, submitted July 16, 2026, at p. 9.
Response to Arguments
Applicant argues that “Fujimoto is silent regarding treating postoperative respiratory disorders/depression, postoperative sedation, respiratory disorders/depression induced by an opioid, sedation induced by an opioid, and reducing recovery time from anesthesia.” At best, applicant asserts that this reference “briefly mentions anesthetic antagonist and side effects of anesthesia among a long list of conditions.” See applicant’s Remarks, submitted July 16, 2026, at p. 6. Applicant points out similar teachings that are missing from Drummond. In applicant’s view, this reference “discloses the physiological effects of opioids on patients under isoflurane anesthesia,” but does not “teach[] or suggest[] using an orexin type 2 receptor agonist, much less the claimed compound specifically, to treat any of the physiological effects of opioids disclosed therein.” Remarks at pp. 6-7. The examiner agrees that neither reference alone teaches the claimed invention. The claimed invention would nevertheless have been prima facie obvious to one of skill in the art when teachings of the references are read in light of each other. The exam-iner maintains that motivation for combining the teachings of the references comes from the observation that the effects of the orexin compounds described in Fujimoto, especially counter-acting symptoms of sedation and coma, would have been desirable in promoting arousal and wakefulness.
Applicant also asserts an unexpected result in rebuttal of the rejection, namely, that “the claimed methods unexpectedly provide beneficial effects in treating postoperative respiratory disorders/depression and sedation induced by an opioid, and reducing recovery time from anesthesia, while also not counteracting the analgesic effects provided by the opioid.” Remarks at p. 7. In general, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP1 716.02 (Allegations of Unexpected Results). The examiner appreciates the scientific merit of applicant’s clinical observations, but it is not clear how this advances the useful arts. As explained in the rejection, one of skill in the art would have been motivated to use to administer the compound of Fujimoto to someone recovering from anesthesia as taught by Drummond. The fact that applicant has recognized other advantages that would flow naturally from following this sugges-tion does not change anything. Stated another way, there are no doubt many interesting clinical observations that one could make about this treatment method, but just making those observa-tions does not change the conclusion that using an orexin 2 agonist would have been desirable in a person recovering from anesthesia.
Applicant arguments have been fully considered but are not persuasive. The rejections below are therefore maintained.
Maintained Rejections 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 differ-ences 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8 and 11-17, as amended, remain rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0226137 A1 by Fujimoto et al. in view of Drummond et al., Respir. Physiol. Neurobiol. 2013;185(2):425-34.
Fujimoto (cited in the prior action) discloses the chemical compound referred to in the instant claims. See Example 5 at para. 0323 (the instant claims do not designate any stereochem-istry; but the compound of Example 5 is nevertheless within the scope of the instant claims). This compound has “orexin type 2 receptor agonist activity” (para. 0001) and is therefore useful as “anesthetic antagonist, a prophylactic or therapeutic drug for side effects and complications due to anesthesia” (para. 0013). The reference also discloses intravenous administration and drip infusion (para. 0236), which meets the limitations of claims 11 and 17.
The difference between the prior art and the claims at issue is that Fujimoto does not specifically disclose that the side effects or complications due to the anesthesia include respira-tory depression or sedation (see instant claims 1 and 16), which may be induced by an opioid, or which drug is used to induce the anesthesia (see claims 12 and 14).
Drummond (also cited in the prior action), however, discloses (p. 425) that “[o]pioid agents are frequently administered in the course of general anaesthesia, primarily to reduce autonomic and motor responses to stimulation. Opioids have profound effects on breathing. Opioids prolong expiration and thus reduce breathing frequency.” Intravenous fentanyl is disclosed (p. 426) as an example opioid, which meets the limitations of claims 12-13. Another example drug used for general anesthesia is “inspired isoflurane” (p. 427), i.e., inhaled isoflurane, which meets the limitations of claims 13-14.
It would have been prima facie obvious to one of skill in the art as of the effective filing date to administer the compound of Fujimoto to someone recovering from anesthesia as taught by Drummond and thereby arrive at subject matter within the scope of the instant claims. Fujimoto discloses that the orexin compounds are useful for as an “anesthetic antagonist, a prophylactic or therapeutic drug for side effects and complications due to anesthesia” (para. 0013), but this reference does not specifically disclose which anesthetic drugs or which side effects they would be useful against. This omission is presumably because it would have been within the skill of the artisan to look up this information, and Drummond provides an answer to these questions. It would have been apparent to the artisan that the effects of the orexin compounds described in Fujimoto (para. 0013 and 0473), especially counteracting symptoms of sedation and coma, as well as promoting arousal and wakefulness, would have been useful in recovering from anesthesia as taught by Drummond.
The instant claims appear to represent the inventor’s discovery that the foregoing treat-ment also has an effect on respiration or respiratory depression. As explained above, it would have been prima facie obvious to one of skill in the art to use the compounds of Fujimoto in someone recovering form fentanyl or isoflurane anesthesia as taught by Drummond. The fact that applicant has evidently recognized that this treatment has a beneficial effect on respiration does not render nonobvious an otherwise known invention. Granting a patent on the discovery of such an unknown but latent property would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. The fact that applicant has “recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” See MPEP 2144(II) (prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art).
The claims have been amended to require a dosage amount of “about 5 mg to about 50 mg” (see the amendment to claims 8 and 16). This dosage amount, however, would have been prima facie obvious over the general disclosure in Fujimoto (para. 0250) that “dose is for example, about 0.01 to 100 mg/kg body weight per dose,” which for a typical human of about 75 kg is equivalent to a dosage of about 0.75-75 mg. The claimed range is therefore within the general range taught by the reference. In situations like this, where “the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” See MPEP 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions). The exam-iner therefore concludes that a dosage amount “from about 5 mg to about 50 mg” is prima facie obvious.
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 possi-ble 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 provi-sions 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 accompa-nied 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 8 and 11-17, as amended, remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,287,305 B2 in view of Drummond as applied above. Although the claims at issue are not identical, they are not patentably distinct from each other. Claims 1-2 of the ‘305 Patent (cited in the prior action) are directed to the same compound referred to in the instant claims. The ‘305 Patent (col. 2, ll. 20-25) explains that this compound is an “anesthetic antagonist, a prophylactic or therapeutic drug for side effects and complications due to anesthesia.” The disclosure of the ‘305 Patent is substantively the same as that of Fujimoto, discussed above. Although the ‘305 Patent does not specifically disclose or claim a method for treating postoperative respiratory depression or sedation, this subject matter would nevertheless have been prima facie obvious over the disclo-sure of Drummond as discussed above, mutatis mutandis.
Claims 8 and 11-17, as amended, remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,898,737 B2 in view of Drummond as applied above. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. The ‘737 Patent was cited in the prior action.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the exten-sion 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (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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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
October 3, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
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