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 Arguments
Applicant’s arguments, see pp. 6-7, filed 04/22/2026, with respect to the rejection of claims 25, 29-30, 32, 34, 36, 39 and 42 under 35 U.S.C. 102 have been fully considered and are persuasive. Amendments moot the rejection. The rejection of 04/22/2026 has been withdrawn.
Applicant's arguments filed 04/22/2026 with respect to the rejection of claims 25-44 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that the Office fails to articulate why arriving at the recited parameters regarding tapping and shaking are the result of routine optimization. Kaneko cites tapping and shaking in numerous instances regarding the injectable preparations taught. See for example p. 16, lines 30-31 “the composition being in the form of a gel when allowed to stand, and changing to a sol when subjected to an impact” and p. 16, Items A1 to A-7 which disclose “the suspension having a high viscosity upon standing and a low viscosity upon shaking or ejection through a syringe needle” (Item A-1) and varying degrees of viscosity before and after shaking (Items A-1 to A-7). Attention is also drawn to the Exemplary compositions, for example Test Example 2 reciting “These injectable preparations returned to a sol state when gently shaken by hand, even after they had gelled” (pp. 59-60).
Kaneko generally teaches shaking, tapping or otherwise subjecting aripiprazole compositions to an impact. It is clear that the goal of said impact is returning the gelled composition to a sol state. Accordingly, any specific amount that achieves said goal, i.e. tapping at least 10 times subsequently shaking for at least 10 seconds as claimed, is the result of routine optimization of the prior art conditions of tapping and shaking aripiprazole injectable compositions to modify their viscosity.
Additionally, see Tables 6-8, Production Examples B – D on p. 60-61 showing tapping and shaking as capable of modifying viscosity for aripiprazole preparations of varying quantities. Accordingly, while the claims are drawn to different quantities, a PHOSITA can reasonably expect subjecting the compositions to light impact as taught by Kaneko et al. to be capable of modifying viscosity.
Specifics regarding tapping order can similarly be considered routine optimization in view of these teachings. Absent a teaching away from said amount of taps or time to shake or unexpected results regarding tapping or shaking the claimed amount, it is unclear how specifying specific quantities of tapping or shaking or an order thereof can render the claims nonobvious. Arguments on p. 8 appear to suggest unexpected results. However, said results are insufficient to support a conclusion of nonobvious in view of the preponderance of the evidence. Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). In the instant case, it is unclear what practical significance there is to the results discussed, i.e. how the difference in gliding force impacts clinical practice and whether said difference is significant to a degree to support a conclusion of nonobviousness. [A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Applicant presents data but it is not readily apparent how it meets the criteria for unexpected results to a degree to shift the preponderance of evidence toward a conclusion of nonobvious in view of the above. Lastly, applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02.
Applicant's arguments filed 04/22/2026 with respect to the double patenting rejections have been fully considered but they are not persuasive. Applicant requests the rejections be held in abeyance and asserts the arguments regarding the obviousness rejection as applying to the double patenting rejections. Accordingly, the arguments herein above are considered to apply in equal greater force to the double patenting rejections.
Modified rejections are presented below in order to address amendments.
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, 28-30, 32-36, 38-40, and 42-44 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 the specifics of tapping and shaking, amounts, or properties of the instant claims.
With respect to the specifics of tapping and shaking claimed, the prior art teaches tapping and shaking. To arrive at the instantly claimed order, amounts of taps, and duration of shaking amounts to routine optimization of the teachings of the prior art. Kaneko et al. generally teaches light impact to modify viscosity and therefore any form of light impact would be expected to modify viscosity. With respect to the sliding resistance limitations of claims 28 and 38, said properties would naturally flow from the teachings of the prior art. With respect to claim limitations drawn to specific quantities of aripiprazole and additional components of claims 33 and 43, the prior art compositions differ in that they are drawn primarily to lesser amounts of aripiprazole. Additional components (i.e. carboxymethylcellulose) are identical to those claimed. Modifying amounts of an API such as aripiprazole amounts to routine optimization as a PHOSITA considering that various doses of different amounts are taught by the prior art. 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 in the art to minimize patient discomfort. With respect to gluteal administration of claim 40, said administration is at once encompassed by intramuscular administration taught by the prior art.
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 25, 28-30, 32-36, 38-40, and 42-44 are 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, 28-30, 32-36, 38-40, and 42-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 36-37 of Application No. 18662049; claims 1-24 of Application No. 18249975; and claims 25-48 of Application No. 19133348 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. With respect to claims 21-24 of Application No. 18249975 and claims 45-48 of Application No. 19133348, 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).
Conclusion
Claims 25, 28-30, 32-36, 38-40, and 42-44 are rejected.
Claims 45-48 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
/VALERIE RODRIGUEZ-GARCIA/ Primary Examiner, Art Unit 1621
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