DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/11/2025 and 10/18/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 25-44 in the reply filed on 10/29/2025 is acknowledged.
Claims 45-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/29/2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 25, 29-30, 32, 34, 36, 39 and 42 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO2013162048A1 to Kaneko et al.
Kaneko et al. teaches the dispersing of aripiprazole gel preparations to form a sol or a suspension before administration (see at least pp. 26-27, Fig. 1-4). The preparations are injectable (see description of Figures) and long-acting (see at least Fig. 16). With respect to claims 29 and 39, prefilled syringes are taught (see at least Abstract). With respect to claims 30, 34 and 36 intramuscular administration and use in treating schizophrenia or bipolar I disorder is taught (see at least claim 36). With respect to claims 32 and 42, amounts of 2.0 mL or more per container are taught (p. 36). While each limitation may not necessarily be present in a single embodiment, the instantly claimed combinations of limitations are at once envisaged by a PHOSITA based upon these teachings. Accordingly, claims 25, 29-30, 32, 34, 36, 39 and 42 are anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-44 are rejected under 35 U.S.C. 103 as being unpatentable over WO2013162048A1 to Kaneko et al.
Kaneko et al. teaches the dispersing of aripiprazole gel preparations to form a sol or a suspension before administration (see at least pp. 26-27, Fig. 1-4). The preparations are injectable (see description of Figures) and long-acting (see at least Fig. 16). With respect to claims 29 and 39, prefilled syringes are taught (see at least Abstract). With respect to claims 30, 34 and 36 intramuscular administration and use in treating schizophrenia or bipolar I disorder is taught (see at least claim 36). With respect to claims 32 and 42, amounts of 2.0 mL or more per container are taught (p. 36).
Kaneko et al. does not teach various quantities, properties, and administration routes of the instant claims.
With respect to the limitations of claims 26-27 and 37, the prior art teaches tapping and shaking. To arrive at the instantly claimed amounts of taps and durations of shaking amounts to routine optimization of the teachings of the prior art. With respect to the sliding resistance limitations of claims 28 and 38, said properties are not necessarily inherent but would naturally flow from the teachings of the prior art, i.e., applicant has shown no evidence that the claimed sliding resistance is an unexpected result over the properties of the prior art compositions. Claims 31, 33, 41 and 43 are drawn to specific quantities and/or forms of aripiprazole. The prior art compositions differ in that they are drawn primarily to lesser amounts of aripiprazole and in the monohydrate form (see Examples 1 to 7, pp. 53-55, Table 1 on p. 55). Additional components are identical to those claimed. Modifying amounts of aripiprazole amounts to routine optimization and anhydrous forms of aripiprazole are taught as acceptable (p. 24). With respect to the slow administration of claims 35 and 44, slow administration of an injectable, i.e., over longer than 0.5 seconds is routine. With respect to gluteal administration of claim 40, said administration is routine in view of the teachings of intramuscular administration in the prior art.
Double Patenting
Claims 25-44 of this application is patentably indistinct from claims 1-20 of Application No. 18249975 and claims 25-44 of Application No. 19133348. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822. Note that withdrawn claims 45-48 also have identical claims in the copending applications.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 25-44 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of Application No. 18249975 and claims 25-44 of Application No. 19133348. The claims are identical and therefore coextensive in scope. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 25-44 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10517951; claims 1-24 of U.S. Patent No. 11097007; claims 1-35 of U.S. Patent No. 11638757; and claims 1-38 of U.S. Patent No. 12016927 in view of WO2013162048A1. The issued claims are drawn to injectable preparations and methods of use thereof of aripiprazole for which a PHOSITA would find the instantly claimed methods obvious in view of WO2013162048A1. See the obviousness rejection above which applies in equal or greater force to the instant nonstatutory double patenting rejection.
Claims 25-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 36-37 of Application No. 18662049 in view of WO2013162048A1. The copending claims are drawn to injectable preparations and methods of use thereof of aripiprazole for which a PHOSITA would find the instantly claimed methods obvious in view of WO2013162048A1. See the obviousness rejection above which applies in equal or greater force to the instant nonstatutory double patenting rejection.
Claims 25-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-24 of Application No. 18249975 and claims 45-48 of Application No. 19133348. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are drawn to a preparation for which the claimed utility is disclosed. In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 25-44 are rejected.
Claims 45-48 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623