DETAILED ACTION
Claims 21 and 23-39 are currently pending in the instant application.
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 .
Response to Amendment
Applicant’s amendments and arguments in a response filed 07/09/2025 have been fully considered and entered into the application. Applicant has overcome
The statutory double patenting rejection of claims 1 and 21 in view of Applicant’s amendment to claim 21 and cancellation of claim 1. The double patenting rejection has been modified as discussed below.
Applicant argues that the instant claims are not obvious over US Pat. No. 9,745,310 (hereafter referred to as US ‘310) since US ‘310 does not recite the pharmaceutically acceptable salts of amended claim 21. However, instant claim 21 does not require that the compound is in its pharmaceutically acceptable salt form. Rather, claim 21 is drawn to a pharmaceutical composition comprising a therapeutically effective amount of a compound of Chemical Formula (1) or pharmaceutically acceptable salt thereof. Thus, amended claim 21 is still drawn to a pharmaceutical composition comprising the compounds themselves. Thus, the double patenting rejections have been maintained.
Applicant further argues that limitations of the instant claims 21-29 are not obvious over US ‘310 in view of WO 2012/083,224 (hereafter referred to as WO ‘224) since WO ‘224 is directed towards different structural compounds than those of the instant application. However, WO ‘224 is relied upon to show general teaching that when formulating pharmaceutical compositions comprising compounds having the same activity as those of the instant application, the different pharmaceutically acceptable carriers and pharmaceutically acceptable salts of compounds may be used in said formulations. MPEP 2144.06 states that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In reKerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Thus, since both WO ‘224 and US ‘310 are directed towards compositions having the same purpose, it would follow that utilizing the composition resulting from combining the prior art compositions in the same manner taught by the prior art would be obvious.
Additionally, within the instant specification, specific salts corresponding to those of the instant application are taught (see col. 18) in addition to how the pharmaceutical compositions may be formulated (see col. 19) and within other diluents, etc. (see col. 19).
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 § 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 21 and 30-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 18-19 of U.S. Patent No. 9,745,310 (hereafter referred to as ‘310). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 21 and 30-39 are drawn to a pharmaceutical composition comprising compounds of the same formula as compounds that are in claims 1-15 and 18-19 of ‘310. However the instant claims also have a pharmaceutically acceptable carrier or excipient in addition to the compound. However, it would be obvious to add a carrier to an obvious compound – see Ex parte Douros, 163 USPQ 667 (P.T.O. Bd. App. 1968) in order to allow for administration of the compound in the treatment of disease related modulation of metabotropic glutamate receptor subtype 4 (mGluR5).
Claims 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 18-19 of U.S. Patent No. 9,745,310 (hereafter referred to as ‘310) in view of WO 2012/083224 (hereafter referred to as ‘224). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of claim 21 are taught as discussed above. Regarding claims 22-29, WO ‘224 teaches compounds useful as positive allosteric modulators of the metabotropic glutamate receptor subtype 5 (mGluR5) in pharmaceutical compositions. The pharmaceutical compositions can include a pharmaceutically acceptable carrier and a compound or a pharmaceutically acceptable salt of the compounds of the invention. The compounds of the invention, or pharmaceutically acceptable salts thereof, can also be included in pharmaceutical compositions in combination with one or more other therapeutically active compounds (see paragraph [0424]). Further, WO ‘224 teaches that the pharmaceutically acceptable salts of the compounds, including those derived from ammonium (see paragraph [0421]) and can be hydrobromic, benzenesulfonic acid, etc (see paragraph [0422]). These compositions may in be in the form of capsules, tables, etc (see paragraph [0422] and [0426]) that may also comprise diluents, including lactose (see paragraph [0425]), agents such as starch, cellulose (see paragraph [0426]). Further the composition may be administered parenteral (see paragraph [0432]) with a buffer (see paragraph [0433]) in an amount of 0.1 to 500 mg/kg (see paragraph [0434]). Thus it would be obvious to one of ordinary skill in the art to formulate the compounds of ‘310 as taught by WO ‘224 to arrives at the instantly claimed compositions.
Rejection II
Claims 21 and 30-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,046,702 (hereafter referred to as ‘702). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘702 is drawn to method of modulating metabotropic glutamate receptor subtype 5 (mGluR5) comprising administering to subject a compound of Formula (I)
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. Regarding claims 21 and 30-39, the compositions comprising the compounds of these claims also comprise the same compound used in the same methods as recited in ‘702. Although, instant claims 21 and 30-39 also have a pharmaceutically acceptable carrier or excipient in addition to the compound, it would be obvious to add a carrier to an obvious compound – see Ex parte Douros, 163 USPQ 667 (P.T.O. Bd. App. 1968) in order to allow for administration of the compound in the treatment of disease related modulation of metabotropic glutamate receptor subtype 4 (mGluR5).
Claims 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,046,702 (hereafter referred to as ‘702) in view of WO 2012/083224 (hereafter referred to as ‘224), pub. 06/21/2012. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of claim 21 are taught as discussed above. Regarding claims 23-29, WO ‘224 teaches compounds useful as positive allosteric modulators of the metabotropic glutamate receptor subtype 5 (mGluR5) in pharmaceutical compositions. The pharmaceutical compositions can include a pharmaceutically acceptable carrier and a compound or a pharmaceutically acceptable salt of the compounds of the invention. The compounds of the invention, or pharmaceutically acceptable salts thereof, can also be included in pharmaceutical compositions in combination with one or more other therapeutically active compounds (see paragraph [0424]). Further, WO ‘224 teaches that the pharmaceutically acceptable salts of the compounds, including those derived from ammonium (see paragraph [0421]) and can be hydrobromic, benzenesulfonic acid, etc (see paragraph [0422]). These compositions may in be in the form of capsules, tables, etc (see paragraph [0422] and [0426]) that may also comprise diluents, including lactose (see paragraph [0425]), agents such as starch, cellulose (see paragraph [0426]). Further the composition may be administered parenteral (see paragraph [0432]) with a buffer (see paragraph [0433]) in an amount of 0.1 to 500 mg/kg (see paragraph [0434]). Thus it would be obvious to one of ordinary skill in the art to formulate the compounds of ‘702 as taught by WO ‘224 to arrives at the instantly claimed compositions.
Rejection III
Claims 21 and 30-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,100,057 (hereafter referred to as ‘057). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘057 is drawn to method for treating schizophrenia mediated by glutamate dysfunction and metabotropic glutamate receptor subtype 5 (mGluR5) comprising administering to subject a compound of Formula (I)
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. Regarding instant claims 21 and 30-39, the compositions comprising the compounds of these claims also comprise the same compound used in the same methods as recited in ‘057. Although, instant claims 21 and 30-39 also have a pharmaceutically acceptable carrier or excipient in addition to the compound, it would be obvious to add a carrier to an obvious compound – see Ex parte Douros, 163 USPQ 667 (P.T.O. Bd. App. 1968) in order to allow for administration of the compound in the treatment of disease modulated by metabotropic glutamate receptor subtype 4 (mGluR5).
Claims 23-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,100,057 (hereafter referred to as ‘057) in view of WO 2012/083224 (hereafter referred to as ‘224), pub. 06/21/2012. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of claim 21 are taught as discussed above. Regarding claims 23-29, WO ‘224 teaches compounds useful as positive allosteric modulators of the metabotropic glutamate receptor subtype 5 (mGluR5) in pharmaceutical compositions. The pharmaceutical compositions can include a pharmaceutically acceptable carrier and a compound or a pharmaceutically acceptable salt of the compounds of the invention. The compounds of the invention, or pharmaceutically acceptable salts thereof, can also be included in pharmaceutical compositions in combination with one or more other therapeutically active compounds (see paragraph [0424]). Further, WO ‘224 teaches that the pharmaceutically acceptable salts of the compounds, including those derived from ammonium (see paragraph [0421]) and can be hydrobromic, benzenesulfonic acid, etc (see paragraph [0422]). These compositions may in be in the form of capsules, tables, etc (see paragraph [0422] and [0426]) that may also comprise diluents, including lactose (see paragraph [0425]), agents such as starch, cellulose (see paragraph [0426]). Further the composition may be administered parenteral (see paragraph [0432]) with a buffer (see paragraph [0433]) in an amount of 0.1 to 500 mg/kg (see paragraph [0434]). Thus it would be obvious to one of ordinary skill in the art to formulate the compounds of ‘057 as taught by WO ‘224 to arrives at the instantly claimed compositions.
Conclusion
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 KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623