DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Current Status of 18/396,432
This Office Action is responsive to the amended claims of 13 August 2025.
Original claims 1-18 have been examined on the merits.
Priority
The effective filing date is 13 October 2011.
Response to Arguments
The Examiner acknowledges receipt of and has reviewed Applicants’ Reply of 31 March 2026.
Terminal Disclaimer (TD)
Applicants filed a TD on 31 March 2026 which was approved on 31 March 2026.
The TD terminally disclaims: US 9,567,344; US 9,566,351; and 11,897,893. This approved TD renders moot the non-statutory double patent (NSDP) rejections made within paragraphs 13-15 and 17 of the previous Office Action.
The non-statutory double patent (NSDP) rejection against 17/996,821 (paragraph 19 of previous Office Action) is withdrawn since Applicants’ abandoned 17/996,821 on 9 October 2025.
However, the NSDP rejection against U.S. 9,469,648 B2 is maintained (reproduced, below).
The Applicants’ traversal against U.S. 9,469,648 B2 (paragraph 16 of previous Office Action) centers on the following points:
The instant and reference US ‘648 will both expire on same day
Policy goals of non-statutory double patent rejections: to prevent an unjustified timewise extension of patent exclusivity beyond the life of a patent
By filing a TD, the policy goals will have been met
That the reference claims and instant claims are “distinct” under non-statutory double patent reasoning because they are “distinct” under Restriction Requirement reasoning
The Examiner finds these traversals unpersuasive and hence is maintaining this NSDP rejection (below):
Applicant’s reliance on same expiration date/effective filing date is unpersuasive because non-statutory double patenting (NSDP) turns on whether the claims are patentably distinct, not solely on whether additional term would result. Further, restriction practice does not control the NSDP analysis; absent applicability of the 35 U.S.C. § 121 safe harbor, product and method claims may still be subject to NSDP if they are not patentably distinct.
Per the MPEP:
First, NSDP is not defeated merely because the two patents share the same effective filing date or expire on the same day; the doctrine also prevents an applicant from obtaining multiple patents on patentably indistinct inventions, including the possibility of separate enforcement and harassment, not just term extension. See MPEP § 804; Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1378–79 (Fed. Cir. 2003).
Second, the fact that the Office may in some cases treat product and method claims as distinct for restriction practice does not, by itself, preclude an NSDP rejection. Restriction/election practice and NSDP are different inquiries; protection from double patenting arises only under the 35 U.S.C. § 121 safe harbor, and only when its requirements are satisfied, including consonance. See MPEP §§ 804, 804.01, 804.03, 1210; Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1362–63 (Fed. Cir. 2008).
Moreover, the NSDP rejection against U.S. 9,956,229 B2 is maintained (reproduced, below).
The Applicants’ traversal against U.S. 9,956,229 B2 (paragraph 18 of previous Office Action) centers on the following points:
The Specification of the instant application does not have any teaching or suggestion of using the claimed compound for treatment of intoxication from ingestion of cocaine, fentanyl, or methamphetamine
Thus, Applicants allege that the claims of the reference US ‘229 and the instant are indistinct from each other
The Examiner finds these traversals unpersuasive and hence is maintaining this NSDP rejection (below):
1) The Sun analysis does not apply here—as the Examiner indicated within page 13-14 of the previous Office Action: “the anticipatory NSDP is based on the underlying compound of the reference method claims anticipating the instant claims 12-18 compounds”.
2) the rejection made against reference U.S. ‘229 (see paragraph 18 of previous Office Action) did indicate a species in the reference claim (“last compound of reference claim 7”-page 14 of the previous Office Action) that anticipates the same last compound of instant claim 18. Thus, per the MPEP guidance, the Examiner cited a reference claimed species that anticipates the instant claims’ compounds. This is counter to Applicants’ arguments that the Examiner improperly applied the anticipatory analysis under MPEP 804(II)(B)(2).
Double Patenting (Maintained Rejections)
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 12-18 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,469,648 B2. The instant claims of 13 August 2025 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims, drawn to a method of use of the underlying compound:
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or a salt, partial salt, a hydrate, or a stereoisomer thereof, anticipates the instant claim 12, drawn to the same compound, since reference claims are drawn to the same underlying compound as the instant claim 12. This anticipatory non-statutory double patent rejection is based on the underlying compound of the reference claims anticipating the instant claims.
Moreover, the last compound of reference claim 7:
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anticipates the same (last) compound of instant claim 18, wherein variable “A” in reference claim 7 and instant claim 18 is identically defined.
Furthermore, reference claim 2, drawn to embodiments of ring A, anticipates instant claim 13, drawn to same.
Reference claim 3, drawn to embodiments of LG-X, anticipates instant claim 14, drawn to same.
Reference claim 4, drawn to embodiments of LG-TG, anticipates instant claim 15, drawn to same.
Reference claim 5, drawn to an embodiment in which ring A groups are the same, anticipates instant claim 16, drawn to same.
Each sub-genus and the limitations of variable Z of reference claim 6 anticipates instant claim 17, drawn to same.
Each compound of reference claim 7 anticipates the compounds of instant claim 18, and further the variable “A” in reference claim 7 and instant claim 18 are identically defined.
This is properly being made FINAL as this rejection is being maintained.
Claims 12-18 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,956,229 B2. The instant claims of 13 August 2025 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims, drawn to a method of use of the underlying compound:
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or a salt, partial salt, a hydrate, or a stereoisomer thereof, anticipates the instant claim 12, drawn to the same compound, since reference claims are drawn to the same underlying compound as the instant claim 12. This anticipatory non-statutory double patent rejection is based on the underlying compound of the reference claims anticipating the instant claimed compound(s).
Moreover, the last compound of reference claim 7:
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anticipates the same (last) compound of instant claim 18, wherein variable “A” in reference claim 7 and instant claim 18 is identically defined.
Furthermore, reference claim 2, drawn to embodiments of ring A, anticipates instant claim 13, drawn to same.
Reference claim 3, drawn to embodiments of LG-X, anticipates instant claim 14, drawn to same.
Reference claim 4, drawn to embodiments of LG-TG, anticipates instant claim 15, drawn to same.
Reference claim 5, drawn to an embodiment in which ring A groups are the same, anticipates instant claim 16, drawn to same.
Each sub-genus and the limitations of variable Z of reference claim 6 anticipates instant claim 17, drawn to same.
Each compound of reference claim 7 anticipates the compounds of instant claim 18, and further the variable “A” in reference claim 7 and instant claim 18 are identically defined.
This is properly being made FINAL as this rejection is being maintained.
Conclusion
Claims 12-18 are not presently allowable as written.
Claims 1-11 are presently allowable as written.
Claims 1 and 12 are free of the prior art for the rationale stated within paragraphs 21-26 of the Non-Final Office Action mailed 1 October 2025.
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 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 JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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