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 .
DETAILED ACTION
The office acknowledges Applicants filing of the amendments on 10/25/2024. Claims 1-21 has been cancelled. Claims 22-41 are pending and are examined based on the merits herein.
Application Priority
This application filed on 07/29/2024 is a Continuation of 17446387, filed 08/30/2021,now U.S. 12048696, 17446387 is a Continuation of 16720475, filed 12/19/2019, now U.S. 11103506, 16720475 is a Divisional of 15112818, filed 07/20/2016, now U.S. 10537573, 15112818 is a National Stage entry of PCT/EP2015/051029, International Filing Date: 01/20/2015, PCT/EP2015/051029 Claims Priority from Provisional Application 61929795 , filed 01/21/2014, PCT/EP2015/051029 Claims Priority from Provisional Application 62091668, filed 12/15/2014, claims foreign priority to 14187429.7, filed 10/02/2014, 14183324.4, filed 09/03/2014, 14153880.1, filed 02/04/2014, filed 14153887.6, filed 02/04/2014.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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 22-41 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of U.S. 11369606 (‘606) or claims 1-24 of U.S. 12048696 (‘696) or claims 1-4, 7, 10, 13-16 of co-pending Application No. 18934038 (‘038).
The instant claims are directed to:
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The dependent claims are limited to specific disorder, migraine or bipolar disorder, its types and specific SV2A ligand.
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The dependent claims are limited to specific disorder, migraine or bipolar disorder, its types and specific SV2A ligand.
‘606 reference claims are directed to:
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The dependent claims are limited to specific SV2A ligand, types of epilepsy, administration regimen.
‘696 reference claims are directed to:
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The dependent claims are limited to specific SV2A ligand, the pharmaceutical composition comprising the carrier, pharmaceutical composition of the compound in combination with the SV2A ligand.
‘038 reference claims are directed to:
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The dependent claims are limited to pharmaceutical composition of the compound in combination with the SV2A ligand, process of preparation, combination or use as a medicament.
The instantly claimed pharmaceutical composition or the pharmaceutical product would have been obvious over the reference claims because both teach the same pharmaceutical composition comprising the compound and SV2A ligands. The reference claims teach the use of the composition in a method of treating epilepsy. It is noted that the intended use does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference (beyond the composition being in a form usable to treat epilepsy), thus the intended use is not further limiting over any topical composition (see, e.g., MPEP 2112). Statements of intended use do not serve to distinguish structure over the prior art. See In re Pearson, 494 F .2d 1399, 1403, 181 USPQ 641, 644 (CCPA 1974); In re Yanush, 477, F .2d 958, 959, 177 USPQ 705, 706 (CCPA 1973); In re Casey, 370 F .2d 576, 580, 152 USPQ 235, 238 (CCPA 1967). As to the amounts of the active agents, it is within the skill of an ordinary artisan to arrive at the claimed amounts and it is routine. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (citing In re Aller, 220 F.2d 454, 456 (1955)). As to the limitation of the agent (the compound and SV2A ligand) is in an amount that is not individually therapeutically effective for treating the conditions, though it is not explicitly taught in the reference claims, the reference claims all the dosage amounts including the instantly claimed amounts. Thus claims 22-31 are obvious over the reference claims. As to claims 32-41, it is noted that the intended use, which is recited on the label or package of the insert, lacks a function relationship because the insert or label does not physically or chemically affect the chemical nature within the article of manufacture, and furthermore, the old article or old composition of the kit can still be used by the skilled artisan for other purposes. Therefore the pharmaceutical product comprised with the instructions are unpatentable over the prior art, because they function equally effectively with or without the labeling, and accordingly no functional relationship exists between the instructions for use and the composition. The instructions for use included in a kit or article manufacture constitute an "intended use" for that kit or article of manufacture. Intended use does not impart patentable weight to a product. See MPEP 2111.03.
Note: As to co-pending Application No. 18934038, this is a provisional non-statutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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 Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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