DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. Claims included in the prosecution are claims 1, 3, 4 and 8-13.
Applicants' arguments, filed 06/12/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
1. Claims 1, 3, 4, 8, 9 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duffield et al. (US 2010/0055133, Mar. 4, 2010) (hereinafter Duffield) in view of Gant et al. (US 2010/0130480, May 27, 2010) (hereinafter Gant).
Duffield discloses a pharmaceutical composition that includes tetrabenazine and a release-retarding agent (abstract). The composition may be in an oral unit dosage form (claim 2). The composition may be in the form of a modified release dosage form (¶ [0095]). The terms modified-release, controlled-release and extended release are used interchangeably (¶ [0097[). The in-vitro release profile of tetrabenazine is such that after about 4 hours about 40% to about 75% tetrabenazine is released (¶ [0426]). In certain embodiments there is provided a modified-release tablet having a core including tetrabenazine and conventional excipients (¶ [0148]). The tablet core can be coated (¶ [0162]). Suitable excipients include hydrophobic polymers and hydrophilic polymers (¶ [0191]). In at least one embodiment the controlled release matrix dosage form includes a polyethylene oxide. Examples of poly(ethylene oxide)s include commercially available POLYOX® grade WSR N-60K (molecular weight 2 million) (¶ [0198]). The poly(ethylene oxide)s have a viscosity range of about 50 to about 2,000,000 centipoise (¶ [0231]). Polyethylene oxide may be included in the tablet from about 15% (¶ [0283]). Tetrabenazine may be included in the composition from about 5% to about 20% (claim 17). The composition may contain from about 5 mg to about 50 mg of tetrabenazine (¶ [0133]). There may be at least one pharmaceutically acceptable excipient including diluents, binders, lubricants, solubility enhancers, and fillers (¶ [0287]). Suitable diluents include mannitol (i.e., filler of the instant claims) (¶ [0204]). The diluent is included in an amount of about 15% to about 60% of the composition (¶ [0049]). Suitable fillers include microcrystalline cellulose (i.e., absorbent of the instant claims) (¶ [0332]). Microcrystalline cellulose may be included in the composition from about 19% (¶ [0282]). Suitable binders include polyvinyl pyrrolidone (i.e., dispersant of the instant claims). The binder is included in an amount from about 0.5% to about 15% (¶ [0153]). Suitable lubricants include magnesium stearate (claim 15). The lubricant is included in the composition in an amount from about 0.1 to about 2% (claim 16). The solubility enhancer is present in an amount from about 0.1% to about 99% (¶ [0321]). Suitable solubility enhancers include TWEEN20® (i.e., polysorbate) (¶ [0205]). The composition may be used to treat a hyperkinetic movement disorder (e.g., Huntington’s disease) (abstract).
Duffield differs from the instant claims insofar as not disclosing wherein the composition comprises deutetrabenazine.
However, Gant discloses pharmaceutical compositions comprising new benzoquinoline compounds (abstract). Example 2 discloses wherein the new benzoquinoline compound is d6-tetrabenazine. The compound may be used to treat a chronic hyperkinetic movement disorder such as Huntington’s disease (claim 18). Tetrabenazine is commonly prescribed for the treatment of Huntington’s disease (¶ [0003]). Adverse effects associated with the administration of tetrabenazine include neuroleptic malignant syndrome, drowsiness, fatigue, nervousness, anxiety and depression (¶ [0004]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated d6-tetrabenazine into the composition of Duffield as the active compound since tetrabenazine has adverse effects and d6-tetrabenazine, like tetrabenazine, treats Huntington’s disease but without the adverse effects as taught by Gant.
2. Claims 10-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Duffield et al. (US 2010/0055133, Mar. 4, 2010) (hereinafter Duffield) in view of Gant et al. (US 2010/0130480, May 27, 2010) (hereinafter Gant) and further in view of Nangia et al. (US 2008/0299204, Dec. 4, 2008) (hereinafter Nangia).
The teachings of Duffield and Gant are discussed above. Duffield and Gant do not teach wherein the composition comprises an antioxidant.
However, Nangia discloses a pharmaceutical composition for the treatment of a patient suffering from Parkinson's disease and/or or another movement disorder (claim 1). Another movement disorder includes Huntington's chorea (¶ [0002]). It is advisable to incorporate antioxidants to inhibit any impurity-related degradation of drugs. Suitable antioxidants include butylated hydroxyanisole and butylated hydroxytoluene (¶ [0755]). The composition comprises typically about 0.1% to about 20% antioxidants (¶ [0765]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated about 0.1% to about 20% butylated hydroxyanisole and/or butylated hydroxytoluene into the pharmaceutical composition of Duffield since these compounds are antioxidants and antioxidants inhibit any impurity-related degradation of drugs as taught by Nangia.
Response to Arguments
Applicant argues that the effects of exchanging an amount of tetrabenazine for an amount of d6-tetrabenazine in a dosage form would have been unpredictable.
The Examiner does not find Applicant’s argument to be persuasive. Gant does not disclose a % amount of d6-tetrabenazine. Therefore, one of ordinary skill in the art would have tried to use the amount of tetrabenazine disclosed by Duffield for d6-tetrabenazine since d6-tetrabenazine and tetrabenazine are substantially similar. Tetrabenazine and d6-tetrabenazine both have the same base structure and both have the same property of treating Huntington’s disease. Applicant has not shown with objective evidence that the amount of tetrabenazine disclosed by Duffield would be unsuitable for d6-tetrabenazine. Additionally, Gant discloses in paragraph [0067] wherein tablets may contain 5 mg to 500 mg of the compounds disclosed. Duffield discloses wherein the composition may contain from about 5 mg to about 50 mg of tetrabenazine. Therefore, since there is overlap in dosage, one of ordinary skill in the art would have had a reasonable expectation of success in trying the amount of tetrabenazine for d6-tetrabenazine. As such, Applicant’s argument is unpersuasive.
Applicant argues that those skilled in the art would not have arrived at a d6-tetrabenazine formulation having about 5% to about 20% of a recited polymer.
The Examiner does not find Applicant’s argument to be persuasive. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success supports a conclusion of obviousness. See MPEP 2143(I). Thus, since poly(ethylene oxide) is an exemplary polymer as disclosed by Duffield, it would have been obvious to one of ordinary skill in the art to have chosen poly(ethylene oxide) from Duffield’s list of polymers. Also, a reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). With regards to the amount of poly(ethylene oxide), Duffield specifically discloses wherein polyethylene oxide may be included in the tablet from about 15%. Therefore, a composition comprising about 15% poly(ethylene oxide) would have been obvious and Applicant’s argument is unpersuasive.
Applicant argues that the claimed dosage forms produce surprising and unexpected pharmacokinetic effects. The claimed d6-tetrabenazine dosage forms do not exhibit a significant food effect.
The Examiner does not find Applicant’s argument to be persuasive. Applicant’s showing compares Formulation A (15 mg d6-tetrabenazine in a round tablet, 350 mg), Formulation B (15 mg d6-tetrabenazine in an oval tablet, 700 mg), and tetrabenazine (25 mg in an immediate release tablet) and found that the Cmax achieved with Formulations A and B are irrespective of whether they are dosed in the fed or fasted state, while the tetrabenazine formulation has a food effect. Applicant’s showing is unpersuasive since Applicant’s unexpected result appears to be from using d6-tetrabenazine and there’s already motivation in the prior art to use d6-tetrabenazine. As discussed in the rejection, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated d6-tetrabenazine into the composition of Duffield as the active compound since tetrabenazine has adverse effects and d6-tetrabenazine, like tetrabenazine, treats Huntington’s disease but without the adverse effects as taught by Gant. Thus, since there is motivation to use d6-tetrabenazine, Applicant finding another reason to use d6-tetrabenazine does not make use of d6-tetrabenazine unexpected. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144(IV). As such, Applicant’s argument is unpersuasive.
Applicant argues that Nangia does not remedy the deficiencies of Duffield and Gant.
The Examiner submits that arguments regarding Duffield and Gant are addressed above and are unpersuasive. Therefore, the rejection with Nangia is maintained.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1, 3, 4 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 9,346,800. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite AUC and half-life properties) and thus read on the instant claims.
Claims 1, 3, 4 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,296,739. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite weight of solid dosage form) and thus read on the instant claims.
Claims 1, 3, 4 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,814,708. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite AUC property) and thus read on the instant claims.
Claims 1, 3, 4 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 U.S. Patent No. 9,233,959. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite weight of dosage form) and thus read on the instant claims.
Claims 1, 3, 4 and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,166,183 in view of Gant et al. (US 2010/0130480, May 27, 2010). The pending claims differ from the conflicting claims insofar as reciting d6-tetrabenazine. However, Gant et al. disclose pharmaceutical compositions comprising new benzoquinoline compounds (abstract). Example 2 discloses wherein the new benzoquinoline compound is d6-tetrabenazine. The compound may be used to treat a chronic hyperkinetic movement disorder such as Huntington’s disease (claim 18). Tetrabenazine is commonly prescribed for the treatment of Huntington’s disease (¶ [0003]). Adverse effects associated with the administration of tetrabenazine include neuroleptic malignant syndrome, drowsiness, fatigue, nervousness, anxiety and depression (¶ [0004]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated d6-tetrabenazine as the active compound since tetrabenazine has adverse effects and d6-tetrabenazine functions like tetrabenazine but without the adverse effects as taught by Gant et al.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1, 3, 4 and 8-13 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 TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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