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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed November 20, 2025, is a reissue of U.S. Patent 11,858,941 (hereinafter the ‘941 patent), which issued from U.S. application Serial No. 17/254,660 (the ‘660 application) with claims 1-16 on January 2, 2024.
Consent of Assignee
This application is objected to under 37 CFR 1.172(a) as lacking the written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR 1.172. See MPEP § 1410.01.
The Consent of Assignee filed 11/20/2025 is defective because it does not state the assignee’s name in the box that states: “The assignee(s) owning an undivided interest in said original patent is/are and the assignee(s) consent to the accompanying application for reissue.”
A proper assent of the assignee in compliance with 37 CFR 1.172 and 3.73 is required in reply to this Office action.
Non-Compliant Amendment
The amendment filed 11/20/2025 is improper. The amendment does not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. While the improper amendment has been entered and considered, Applicant’s next response should be a compliant amendment. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
All amendment changes must be made relative to the patent to be reissued, not relative to a previous submitted amendment. Pursuant to 37 CFR 1.173(d), any such changes which are made to the specification, including the claims, must be shown by employing the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets, i.e., single brackets; and (2) The matter to be added by reissue must be underlined.
The non-compliance issues are as follows:
In the ‘941 patent, in claim 1, col. 260, line 13 (in the definition of R4) recites “C340cycloalkyl”. Reissue claim 1 has changed this term to “C3-10cycloalkyl” without using underlining and singe bracketing. See reissue claim 1 at the fifteenth line on p. 3 of the amendment. Such a change is not considered broadening since the “C340cycloalkyl” was a typo by the Office printer. Applicant’s amendment filed 07/21/2023 during prosecution of the ‘941 patent recited “C3-10cycloalkyl”. Nonetheless, single bracketing and underling must be used in the instant reissue application to make the correction.
In the ‘941 patent, in claim 1, col. 260, line 49 (in the definition of R8) recites “halo-C1˗6 alkoxy”. Reissue claim 1 has changed this term to “halo-C1-6alkoxy” without using underlining and singe bracketing. See reissue claim 1 at the eleventh line on p. 4 of the amendment.
Currently claims 2-16 are unamended, original claims. Such claims should have the status identifier “Original” rather than “Previously Presented”. With the changes to claim 1 noted above, claim 1 should have the status identifier “Amended”.
Scope of Claims
During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification. In re Reuter, 651 F.2d 751, USPQ 249 (CCPA 1981) (claims given "their broadest reasonable interpretation consistent with specification"). This reissue application contains claims 1-36 presented in the amendment filed 11/20/2025. New claim 20 is representative:
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The ’941 patent specification defines the word “form” as follows: “As used herein, the term ‘form’ means a compound of Formula (I) having a form selected from the group consisting of a free acid, free base, salt, hydrate, solvate, racemate, enantiomer, diastereomer, stereoisomer, and tautomer form thereof.” Note that the chemical formula
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is a free base compound, i.e., it is the uncharged, non-salt version of the compound.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 2, at line 7, it appears that the leading zero in the compound name “0(1R,5S)-9-azabicyclo[3.3.1]nonyl, 3-oxa-9-azabicyclo[3.3.1]nonyl” should not be present. Since the leading zero is also present in issued claim 2, single bracketing must be used to delete it.
Claim 17 is indefinite because a free base as the “form” lacks positive antecedent basis in claim 1, wherein the Markush group for the form states “a form of the compound is selected from the group consisting of a salt, hydrate, solvate, racemate, enantiomer, diastereomer, stereoisomer, and tautomer form thereof.” Since the “compound” of Formula (Ibb1) in claim 1 includes numerous species that are free base in structure (see, e.g., the compound structural formula in instant claim 20 and the compound structural formulas bridging cols. 35-100, it is suggested that claim 17 be rewritten as follows: “The compound of claim 1 or a form thereof, which is the compound of Formula (Ibb1) as a free base.”
Claim 18 and its dependent claim 19 are indefinite because a pharmaceutically acceptable salt form lacks positive antecedent basis in claim 17, which sets forth that the form is a free base. It is suggested that claim 18 be amended to depend from claim 1.
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 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 1, 2, 4-9, 12-14 and 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/871,302 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 1, 2 and 17-18, claim 1 of the reference application sets forth the following compound of Formula (I) or a form thereof:
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wherein W1, W2, RA and RB are defined in the claim. Claim 1 of the reference application also sets forth that the form of the compound is selected from the group consisting of a pharmaceutically acceptable salt (as per instant claim 18), hydrate, solvate, racemate, enantiomer, diastereomer, stereoisomer, and tautomer form thereof. Claim 5 of the reference application depends from claim 1 and sets forth, for example, the following two compound species which read on the claimed compound (free base):
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which is 6-[3-(2,2,6,6-tetramethylpiperidin-4-yl)-3H-[1,2,3]triazolo[4,5-c]pyridazin-6- yl]quinolin-7-ol; and
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which is 2-methyl-6-[3-(2,2,6,6-tetramethylpiperidin-4-yl)-3H-[1,2,3]triazolo[4,5-c]pyridazin-6-yl]-1,3-benzothiazol-5-ol.
Accordingly, instant claims 1, 2 and 17-18 are anticipated by the claims of the reference application.
With respect to instant claims 4-9 and 12-14 and 16, claims 7 and 8 of the reference application depend from claim 1 and set forth a method of treating or ameliorating Huntington’s disease in a subject in need there comprising administering to the subject an effective amount of the compound according to claim 1, wherein the effective amount of the compound is in a range of from about 0.001 mg/kg/day to about 500 mg/kg/day. Claim 15 of the reference application depends from claim 1 and sets forth a pharmaceutical composition for use in treating or ameliorating Huntington's disease comprising an effective amount of the compound of according to claim 1 and a pharmaceutically acceptable excipient.
Claims 7, 8 and 15 of the reference application do not specifically require that the compound according to claim 1 of the reference application is, for example, either of the two compound species noted above.
However, since the above two compound species are disclosed in the reference application specification as species within the scope of the compound of said Formula (I) (see compounds 2 and 27 on pp. 30, 32, 37 and 39 of the reference application specification), it would have been obvious for a person of ordinary skill in the art to have selected either of said two compound species to practice the compound genus of Formula (I) and the method and pharmaceutical composition in claims 7, 8 and 15 of the reference application.
Accordingly, instant claims 4-9 and 12-14 and 16 are rendered obvious by the claims of the reference application.
Claims 1 and 5 of the reference application render obvious the hydrochloride salt of instant claim 19 since hydrochloride is a conventional salt form in the pharmaceutical art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 20-36 are allowed.
Claims 3, 10, 11 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 3, 10, 11 and 15 require that the instant R2 is phenyl, optionally substituted optionally with one, two or three R5 substituents, and optionally with one additional R6 substituent. The compound in claims 20-36 also has a substituted phenyl for R2. Said reference application’s RB is in the same location as the instant R2, but is a fused ring system not encompassed by instant claims 3, 10, 11, 15 and 20-36.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 11,858,941 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached on 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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