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 .
Status of the Application
Claims 32-38 are pending in the application as of the response filed 07/02/2026. Claims 1-31 are cancelled. Claims 32-38 are examined herein.
Applicants have properly invoked the 35 U.S.C. 102(b)(2)(C) exception over the prior art, Durrant et al. (WO 2021/113627 A1, filing date of 04 December 2020, hereinafter Durrant, in the IDS), by providing a statement that “the claimed invention and International Publication No. WO 2021/113627 ("Durrant") were, as of the effective filing date of the claimed invention, owned by the same person and/or subject to an obligation of assignment to the same person” as stated in the statement of common ownership submitted on 07/02/2026. Therefore, Durrant is no longer available as prior art.
The 35 U.S.C. § 102 rejection of record over Durrant is hereby withdrawn.
The provisional nonstatutory double patenting rejections of record over co-pending applications 18/959,822 and 18/972,540 in view of Durrant are hereby withdrawn.
The nonstatutory double patenting rejections of record over U.S. Patent No. 11,834,441 B2 is maintained. Applicant’s arguments have been carefully considered but were not found to be persuasive. Applicant’s arguments are addressed below.
Information Disclosure Statement
The information disclosure statements submitted on 07/02/2026 and 09/15/2026 have been considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Double Patenting - Maintained
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 32-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-11, 19-21, 35, 37-38, 47 of U.S. Patent No. 11,834,441 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a pharmaceutical composition comprising Compound 1 in Form A and/or Form B characterized by the XRPD pattern as in instant claim 32, a method of use thereof.
Claims 1, 7-11, 19-21 and 35 of the reference ‘441 patent render obvious the pharmaceutical composition/composition of instant claims 32-34 and 38 (the recitation of the transitional phrase “comprising in claim 35 of the reference patent allows for additional components in the composition). Claims 37-38 and 9-11 of the reference ‘441 patent render obvious the method of instant claims 35-37.
PNG
media_image1.png
549
320
media_image1.png
Greyscale
PNG
media_image2.png
160
287
media_image2.png
Greyscale
PNG
media_image3.png
478
300
media_image3.png
Greyscale
PNG
media_image4.png
233
306
media_image4.png
Greyscale
The instant claims 32-38 and claims 1, 7-11, 19-21, 35, 37-38, 47 of the ‘441 patent are therefore not patentably distinct.
This is a nonstatutory double patenting rejection.
Response to Arguments
Applicant argues on pages 1-2 of the response dated 07/02/2026, that “However, reference patent claims 1, 7-11, and 19-21 are directed to compounds, not pharmaceutical compositions. Reference patent claim 35 is directed to a pharmaceutical composition comprising Compound 1, but it is silent as to the form of Compound 1”. Applicant argues “The Office contends that reference patent claims 37-38 and 9-11 render obvious the claimed method … However, reference patent claims 9-11 are directed to compounds, not methods. Reference patent claims 37 and 38 are directed the methods of treating various types of pain by administering Compound 1, but they are silent as to the form of Compound 1”. Applicant concludes the reference patent claims 1, 7-11, 19-21, and 35 do not anticipate or render obvious the claimed pharmaceutical composition.
Applicant's arguments have been fully considered but they are not persuasive.
According to MPEP 2144.05(II)(A), "It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In the instant case, the claims of the reference ‘441 patent teaches the instant compound (Compound 1), including the specific crystalline forms, Form A and Form B in claims 8-11. The claims of the reference ‘441 patent teaches an embodiment of a pharmaceutical composition (reference claim 35) for the instant compound. A PHOSITA would have been naturally motivated to formulate the specific crystalline form into a composition, given that the reference patent already explicitly suggests making compositions out of that active compound. A PHOSITA would have had a reasonable expectation of success in substituting the crystalline form into that standard formulation, to arrive at the formulation of the instant claims. The claims of the reference ‘441 patent teaches an embodiment drawn to a method of treating or lessening the severity in a subject of pain (reference claim 37) comprising administering the instant compound (Compound 1). Because the reference ‘441 patent already explicitly establishes that the compound is useful for administration and that the compound can exist in that specific crystalline form, a PHOSITA would have had a reasonable expectation of success that administering a composition of that specific crystalline form would yield the stated therapeutic effect. Doing so would have been well within the skill of one of ordinary skill in the pharmaceutical arts, through routine experimentation.
In the absence of any evidence of unexpected results for the pharmaceutical composition comprising the crystalline form, combining two embodiments taught in the reference patent to arrive at the instant composition is considered routine experimentation. Therefore, the claims of the reference ‘441 patent render the instant claims drawn to a pharmaceutical composition comprising the crystalline forms of Compound 1 and their methods of use, prima facie obvious. The nonstatutory double patenting rejection of record is maintained.
Allowable Subject Matter
A pharmaceutical composition comprising Compound I in Form A and/or Form B is free of prior art. Except for the nonstatutory double patenting rejection above, all claims would be allowable.
The closest art of record is Durrant et al. (WO 2021/113627 A1, filing date 04 December 2020, hereinafter Durrant, in the IDS). However, Durrant is excepted as prior art under the 35 U.S.C. 102(b)(2)(C) exception. Therefore, the prior art of record does not teach or fairly suggest the instantly claimed pharmaceutical composition as in instant claim 1, and methods of use thereof.
Conclusion
Claims 32-38 are rejected.
No claims are allowed.
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 PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30 pm EDT.
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, Kortney L Klinkel can be reached on (571) 270-5239. 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.
/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
