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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 12th 2026 has been entered.
DETAILED ACTION
Status of the Claims
Claims 1, 7-17, and 22-29 are pending. Claims 9, 11-13, 15-17, and 24-25 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 7-8, 10, 14, 22-23, and 26-29 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on January 12th 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 112(b) Rejections Overcome by Amendment
Applicant’s amendment to claim 1 in the response filed on January 12th 2026 is acknowledged. Applicant has amended the claim to recite a technical aspect of the claimed method rather than a result. The associated 112(b) rejection is thereby withdrawn.
35 U.S.C. § 102 Rejections Over Wills and Blankman Overcome by Amendment
Applicant has amended claim 1 to require that the MAGL inhibitor is administered prior to the administration of the opioid. As Wills teaches administration only to rats who have already received morphine, the 102 rejections over Wills are withdrawn. As Blankman does not explicitly teach a dosage schedule, the 102 rejections over Blankman are also withdrawn.
35 U.S.C. § 102(a)(1) Rejections Over Wilkerson Maintained.
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 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.
Rejections Over Wilkerson
The rejection of claims 1, 8, 10, 23, and 27-29 under 35 U.S.C. 102(a)(1) as being anticipated by Wilkerson (Wilkerson et al., J Pharmacol Exp Ther. 2016 Apr;357(1):145-56) is maintained.
Applicant argues in the response filed on January 12th 2026 that Wilkerson does not teach the administration of the MAGL inhibitor before the opioid. However, Wilkerson does teach this order of administration:
“All experiments employed a 1-hour absorption period for MJN110, based on previous studies (Ignatowska-Jankowska et al., 2015), and a 30-minute drug absorption period for all other drugs. In studies in which MJN110 and morphine were coadministered, MJN110 was given at 0 minutes, morphine was administered at 30 minutes, and behavioral testing commenced at 60 minutes.”
[Wilkerson, pg. 146, Materials and Methods, Drugs]
The 102 rejections over Wilkerson are thereby maintained.
Rejections Over Wilkerson Reiterated
Wilkerson teaches the administration of the MAGL inhibitor, MJN110 alongside morphine for the treatment of neuropathic pain (Wilkerson, pg. 145), anticipating claims 1, 7, 8, 10, and 23.
Wilkerson further teaches that MJ110 delays tolerance to the morphine (Wilkerson, pg. 152, Figure 5), and does not decrease the analgesic properties of the opioid (Wilkerson, pg. 153, Figure 6).
Wilkerson teaches that administration of MJN110 increases 2-AG levels and decreases AA levels (Wilkerson, pg. 152).
Wilkerson administers the MJN110 in an intraperitoneal injection, in a solution with the morphine (Wilkerson, pg. 146, Materials and Methods), anticipating claims 27, and 28.
Wilkerson administers twice daily (Wilkerson, Abstract), anticipating claim 29.
Arguments From Previous Final Rejection Filed September 23rd 2025
Applicant argues, both in the response filed on August 25th 2025, and in the affidavit filed on August 25th 2025, that Wilkerson addresses the attenuation of opioid tolerance with a MAGL inhibitor, but does not disclose or suggest reduction of opioid reward, and therefore does not anticipate claim 1. However, as stated in the non-final rejection filed on March 26th 2025, the patient population recited in claim 1, as written, currently encompasses any/all subjects that are taking/ have taken/ will take an opioid. See MPEP 2111.02(II):
“The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification."
“Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.)”
As the prior art teaches the administration of MAGL inhibitors to an identical patient population as that claimed in claim 1, and any effects/results of the administration (i.e. the attenuation of the rewarding effect of an opioid/the lack of decrease of analgesic properties of the opioid) are inherent in the administration, all 102 rejections are thus maintained.
35 U.S.C. § 103 Rejections Necessitated by Amendment
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, 7-8, 10-14, 22-23, 26-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Blankman (WO 2016/183097 A1 published on November 17th 2016).
The claims are directed towards a method of attenuating the rewarding effect of an opioid in a subject via administration of the compound ABX-1431:
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wherein the compound is administered to the subject prior to administration of the opioid.
The compound is intended to reduce dependence/ delay tolerance of opioids in patients receiving them for treatment of pain, such as neuropathic pain or cancer-associated pain, while allowing the patient to receive the analgesic effect of the opioids.
Blankman teaches administration of ABX-1431 (referred to as 1,1,1,3,3,3-hexafluoropropan-2-yl 4-(2-(pyrrolidine-1-yl)-4-(trifluoromethyl)benzyl)piperazine-1-carboxylate or compound 1) orally, once daily in a patient receiving step 3 opioids (i.e. morphine, methadone, fentanyl, oxycodone, buprenorphine, hydromorphone, oxymorphone) for the treatment of moderate to severe cancer pain in adult humans (Blankman, pg. 109-111, Example 14). Blankman does not explicitly describe a dosage order. However, only three dosage orders are possible:
Daily, before the day’s opioid dose
Daily, concurrently with the day’s opioid dose
Daily, after the day’s opioid dose
The first case is equivalent to applicant’s method. In each of the other two cases, a mere re-ordering of the two steps (administration of the MAGL inhibitor; administration of the opioid) results in the dosage order described by applicant. Absent unexpected results associated with said dosage order, such a re-ordering of steps is obvious. See MPEP 2144.04(IV)(C):
“Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).”
Consequently, claims 1, 7-8, 10, 14, 22-23, 26-27, and 29, (directed towards the method of claim 1, wherein the subject is a human adult, administration is oral, daily, the MAGL inhibitor is ABX-1431, and the opioid is morphine) are prima facie obvious.
Conclusion
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/A.J.S./Examiner, Art Unit 1629