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 1-12.
Claim Objections
Claim 8 is objected to because of the following informalities: “and” in the last line should be recited as --- or ---. Appropriate correction is required.
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 5 is 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.
Claim 5 contains the trademark/trade name POLYOX®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe poly(ethylene oxide) polymer and, accordingly, the identification/description is indefinite.
1. Claims 1-9 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 (¶ [0198]). 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). 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., polysorbates) (¶ [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 disclose 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.
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 1-12 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 1-12 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 1-12 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 1-12 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 1-12 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.
Conclusion
Claims 1-12 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1612