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 .
Priority
On page 5, per Applicant’s request, the examiner confirms that there is not currently any dispute as to the priority date afforded the instant claims.
Status of the Claims
Pursuant to the amendment dated 01/05/2026, claims 2 and 8 have been cancelled. Claims 1, 3-7, and 9-20 are pending. Claim 18 stands withdrawn with traverse. Claims 1, 3-7, 9-17, 19, and 20 are under current examination.
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.
Claims 19 and 20 are 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 19 recites Markush groups for the suspending agent, the buffering agent and the tonicity agent; however the Markush groups are not in the proper format. The claim currently recites the phrase “comprising”. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. and MPEP 2173.05(h). Please refer to MPEP 2173.05(h) for examples of proper Markush language: When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper. Amending the claims to recite “the group consisting of” in each instance would obviate the rejection. Although the claim could be interpreted to read on a composition comprising each of the listed substances, the examiner considers interpreting the language as a Markush group to be the most reasonable interpretation in view of the specification in which no such combination is described or exemplified.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive. On page 4, Applicant comments that the claims have been amended to address the rejections under 35 USC 112(b); however, the relevant sections of the claim reciting improper Markush language have not been addressed. The issue remains in lines 6, 7, and 9, where each Markush group begins with the word “comprises” rather than the phrase “is selected from the group consisting of”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 3-7, 9-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bhadauria et al. (US 2024/0165107; publication date: 05/23/2024; available as prior art under 35 USC 102(a)(2); effectively filed date of Foreign Priority Application No. IN202121011063: 03/16/2021) in view of Johnson et al. (US20070032509; publication date: 02/08/2007), and further in view of Pollinger et al. (US5023257; issue date: 06/11/1991).
With regard to claims 1, 19, and 20, Bhadauria discloses a composition comprising cariprazine (base or salt) in a pharmaceutically acceptable carrier (example A1, table following para 0102). The composition is injectable (title). The composition is a suspension (0109 – 0110) in water and has a D90 between about 1 micron and 200 microns (0099).
As noted above, Bhadauria discloses that the cariprazine may be in salt or free base form, and as there are only two general choices, either would have been obvious to try (see MPEP 2142(I)(E)). Although Bhadauria does not provide reasoning as to why one or the other might provide benefits, such was known in the art:
Johnson discloses that the free base form of a compound is generally less soluble in aqueous solutions than the salt and therefore free bases are employed to provide more sustained release of active agent. An active agent in particulate form which has not dissolved into solution is not available to induce a physiological response, but serves as a depot of bioavailable drug which gradually dissolves into solution (0192).
It would have been prima facie obvious to use the free base form of cariprazine, as proposed by Bhadauria as a means to extend the release of the active agent, cariprazine. The skilled artisan would have had reasonable expectation of success because this was a well-known means to achieve this goal as of the instant effective filing date.
With regard to claims 1, 19, and 20, as noted above, Bhadauria discloses a range in particle size that overlaps with the range recited in the instant claims, therefore this limitation of claim 1 is obvious over Bhadauria (see MPEP 2144.05(I)). Although Bhadauria does not disclose a reason to experiment with the particle size, such would have been routine optimization for one of ordinary skill as of the instant effective filing date: Pollinger discloses that varying particle size is a means to control release rate of active agents (col 1, lines 43-45; see MPEP 2144.05(II)(A)).
With regard to claims 1, 4, 9, and 19, in example A3 in the table following para 0135, the composition comprises 7.5 mg/mL (i.e. 0.75% by weight) citric acid monohydrate and 6 mg/mL (i.e. 0.6% by weight) sodium dihydrogen phosphate monohydrate.
With regard to claim 3, in example A3 in the table following para 0135, the cariprazine is present at 180 mg/mL (i.e. 18% by weight).
With regard to claims 4-6, and 19, in example A3 in the table following para 0135, the composition contains the suspending agent PEG (i.e. polyethylene glycol) at 75 mg/mL (i.e. 7.5 % by weight).
With regard to claim 7, alternatively, the diluent may contain sodium carboxymethyl cellulose (0083).
With regard to claims 4, 10, 11, and 19, the composition comprises about 1 mg/ml to about 6 mg/ml sodium chloride (0097).
With regard to claims 12-14, in example A3 in the table following para 0135, the composition comprises 1 mg/mL (i.e. 0.1% by weight) sorbitan monolaurate.
With regard to claims 15-17, the composition contains sodium hydroxide/HCL q.s. to desired pH. The examiner considers it a matter of routine to determine the required amount of pH adjusting agent to achieve a particular desired pH.
Claims 1, 3-7, 9-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ying et al. (WO2022042642; publication date: 03/03/2022; available as prior art under 35 USC 102(a)(1) and 102(a)(2); effective filing date 08/26/2021; cited in the IDS filed 12/29/2023; citing the US National Stage as an English translation: US 20230414504) in view of Johnson et al. (US20070032509; publication date: 02/08/2007).
With regard to claims 1, 19, and 20, Ying discloses a cariprazine pharmaceutical comprising cariprazine solid particles of Dv(50) less than or equal to 50 microns in an aqueous suspension (i.e. a pharmaceutically acceptable carrier; abstract). The range in particle size overlaps with the range required by the instant claims (see MPEP 2144.05). In an embodiment, the solid particles of cariprazine may be selected from solid particles of cariprazine or a salt or solvate thereof (0008). The suspension is for injection (0093).
As noted above, Ying discloses that the cariprazine may be in salt or free base form, and as there are only two general choices, either would have been obvious to try (see MPEP 2142(I)(E)). Although Ying does not provide reasoning as to why one or the other might provide benefits, such was known in the art:
Johnson discloses that the free base form of a compound is generally less soluble in aqueous solutions than the salt and therefore free bases are employed to provide more sustained release of active agent. An active agent in particulate form which has not dissolved into solution is not available to induce a physiological response, but serves as a depot of bioavailable drug which gradually dissolves into solution (0192).
It would have been prima facie obvious to use the free base form of cariprazine, as proposed by Ying as a means to extend the release of the active agent, cariprazine. The skilled artisan would have had reasonable expectation of success because this was a well-known means to achieve this goal as of the instant effective filing date.
With regard to claims 1, 4, 9, and 19, in the table following para 0188, the compositions contain 45 mg/10mL (0.45 % by weight) disodium phosphate and 9 mg/10 (0.09 % by weight) mL monosodium phosphate.
With regard to claim 3, in example compositions disclosed in the table following para 0188, the cariprazine salt is present at 573 mg/10mL (i.e. 5.73 % by weight). This would have given the artisan of ordinary skill a starting point for routine optimization of cariprazine dose (see MPEP 2144.5(II)(A)).
With regard to claims 4-7, and 19, in the table following para 0188, example 25 contains 100 mg/10 mL (i.e. 1% by weight) sodium carboxymethyl cellulose.
With regard to claims 4, 10, 11, and 19, in the table following para 0188, the example compositions contain 247 mg/mL (i.e. 2.47 % by weight) mannitol.
With regard to claims 12-14, in the table following para 0188, the example compositions contain 100mg/10mL (i.e. 1 % by weight) Tween 20, i.e. polysorbate.
With regard to claims 15-17, in the table following para 0188, the example compositions contain sodium hydroxide and hydrochloric acid. The examiner considers it a matter of routine for one of ordinary skill to determine the quantity of these pH adjusters to achieve a desired pH for the composition.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
On page 6, Applicant points to the benefits of the instant invention (controlled sustained release with reduced dosing frequency for cariprazine), and cites data presented in the specification. Applicant argues that Bhadauria does not specifically teach the elements recited in instant claim 1 or that the claimed features can lead to the controlled, sustained in vivo release profile demonstrated in the present application.
Please see the discussion below regarding the burden on Applicant to overcome an obviousness rejection with a persuasive showing of unexpected results.
On pages 6-7, Applicant argues that Johnson is not directed to the same active substance or route of administration as Bhadauria or the instant application, and does not address injectable depot formulations, particle sizes of antipsychotic compounds such as cariprazine, or buffering agents.
Insomuch as Applicant may be arguing that Johnson is not analogous art, the examiner points out that Johnson is directed to sustained release injectable suspensions for drug delivery, and is therefore in the same field of endeavor as the instant invention and as the primary reference cited against the instant claims. With regard to Johnson not teaching injectable depot formulations, particle sizes of antipsychotic compounds such as cariprazine, or buffering agents, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On page 7, Applicant argues that Johnson’s statement, which Applicant characterizes as “that free base forms are necessarily less soluble than salts” is not universally true, citing Ying (of record) as disclosing that certain cariprazine salts are less soluble than the free base.
As an initial matter, Johnson does not state that free base forms are necessarily less soluble than salts, Johnson provides evidence that it was known in the art that a free base is likely to be less soluble than a salt form for any drug. Thus, it was a known variable to test during optimization of release profile relying on the solubility of the active agent in aqueous solution as one factor that determines release rate. Applicant’s citation of Ying only further supports the obviousness conclusion because the water solubility of cariprazine HCl salt, other salts, and the free base were all known as of the instant effective filing date, and in fact known to be dependent upon pH of the aqueous solution. One having ordinary skill, in looking to provide an injectable composition that releases cariprazine slowly to overcome compliance issues that result from a dosing regimen requiring daily oral administration would have recognized the free base as offering pH-dependent flexibility in cariprazine solubility, in all cases much lower than the solubility of the hydrochloride salt, as a means to optimize release to achieve a target pharmacokinetic profile. The examiner also points out that Ying discloses cariprazine free base to show lower solubility than various embonate salts at pH of 9 or 7.
Applicant asserts that Johnson does not provide motivation to select cariprazine free base particles having the claimed particle sizes and buffering agent content as recited in claim 1 and also does not provide reasonable expectation of success that such formulations would achieve controlled long acting in vivo release as demonstrated in the instant specification.
In response, the examiner refers Applicant to MPEP 2145(X)(A) which states:
Applicants may also argue that the combination of two or more references is “hindsight” because “express” motivation to combine the references is lacking. However, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See MPEP § 2141 and § 2143 for guidance regarding establishment of a prima facie case of obviousness. (Emphasis added.)
With regard to Applicant’s assertion that Johnson does not provide reasonable expectation of success, the examiner points out that conclusive proof of efficacy is not required to show a reasonable expectation of success, and obviousness does not require absolute predictability, but at least some degree of predictability is required. See MPEP 2143.02(I) and (II). In the instant case, the primary reference states expressly that the free base of cariprazine can be used in the disclosed invention, provides an overlapping range in particle size, and directs the artisan of ordinary skill to seek long-lasting injectable sustained release formulations. Bhadauria alone is sufficient to establish a prima facie case of obviousness and the secondary references are merely cited to provide evidence that both selection of the free base vs. a salt as well as experimenting with particle size were well-known methods to optimize drug release from sustained release formulations. The skill level of the ordinary artisan in the art of biomedical formulations science is very high, e.g. a Ph.D. or M.D. degree, and absolute predictability is not required to establish obviousness under 35 USC §103. The examiner maintains the opinion that the instant invention carves out a subsection of the invention disclosed by Bhadauria; however, to arrive at the instant invention, as claimed, would merely have been a matter of routine experimentation within the teachings provided by the cited prior art.
On page 7, Applicant argues that Pollinger relates to intramuscular injection forms of gyrase inhibitors such as ciprofloxacin and that Pollinger teaches drug release rate to depend upon several factors and that Pollinger does not teach that particle size alone controls release and does not specify a particle size range applicable to cariprazine free base injectable depots.
Insomuch as Applicant may be arguing that Pollinger is not analogous art, the examiner points out that Pollinger is directed to sustained release injectable formulations for drug delivery, and is therefore properly in the same field of endeavor as the instant invention and as the primary reference cited against the instant claims. With regard to Applicant’s argument that Pollinger does not teach that particle size alone controls release, it is not the examiner’s position that particle size was the only variable known to the artisan of ordinary skill that could be adjusted to modify drug release profile, but rather that the particle size would have been optimized as a matter of routine as one of the variables important to achieving a particular drug release rate.
Applicant asserts that release behavior is formulation specific and unpredictable. On page 8, Applicant cites a publication by Leng that has not been cited in an IDS or provided on the record (the examiner notes Applicant’s statement that a copy has been provided; however, this does not appear to be the case at this point in prosecution) and asserts that Leng provides evidence that in some cases smaller drug particle size does not lead to better in vivo performance. Applicant asserts that Leng confirms particle size optimization is not routine or predictable.
As Leng has not been provided on the record, the examiner cannot respond fully to this argument; however, please see above for a summary of the Office’s position regarding the requirement for predictability in order to achieve a reasonable expectation of success under 35 USC §103.
On page 9, Applicant argues claim 19 is distinguishable over the cited references for the same reason as claim 1.
See above for the examiner’s response to the traversal of the rejection of claim 1.
On page 9, Applicant argues that Ying teaches cariprazine embonate to be preferrable. Applicant argues that Ying’s central objective is to develop injectable preparations of very slightly soluble salts of cariprazine to address shortcomings of cariprazine hydrochloride to avoid excessive plasma concentrations and potentially toxic side effects. On page 10, Applicant describes various disclosures of Ying relating to cariprazine embonate and argues that in view of these disclosures, Ying teaches away from using cariprazine free base.
In response, Applicant is reminded that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
On page 10, Applicant replicates that traversal of the examiner’s reliance on Johnson as teaching that in general the free base of a drug is expected to be less soluble than the salt, as summarized above.
Just as for the rejection over Bhadauria, Johnson, and Pollinger, the examiner does not find these remarks persuasive. With regard to Applicant’s assertion that Johnson does not provide reasonable expectation of success, the examiner points out that conclusive proof of efficacy is not required to show a reasonable expectation of success, and obviousness does not require absolute predictability, but at least some degree of predictability is required. See MPEP 2143.02(I) and (II). In the instant case, the primary reference states expressly that the free base of cariprazine (specifically “solid particles of cariprazine may be selected from solid particles of cariprazine (the free base), a pharmaceutically acceptable salt of cariprazine, and a solvate thereof”; 0008) can be used in the disclosed invention, Ying provides an overlapping range in particle size, and directs the artisan of ordinary skill to seek long-lasting injectable sustained release formulations (see e.g. para 0004-0006, where Ying indicates that their invention is meant to overcome challenges associated with poor patient compliance for daily doses of an oral formulation containing the highly water soluble hydrochloride salt). Ying alone is sufficient to establish a prima facie case of obviousness and the secondary reference is merely cited to provide evidence that both selection of the free base vs. a salt was a well-known method to optimize drug release from sustained release formulations. The skill level of the ordinary artisan in the art of biomedical formulations science is very high, e.g. a Ph.D. or medical degree, and absolute predictability is not required to establish obviousness under 35 USC §103. The examiner maintains the opinion that the instant invention carves out a subsection of the invention disclosed by Ying; however, to arrive at the instant invention, as claimed, would merely have been a matter of routine experimentation within the teachings provided by the cited prior art.
On page 11, Applicant argues that Ying directly contradicts the generalization relied upon by the rejection as Ying demonstrates that multiple cariprazine salts are less soluble than the free base. Applicant asserts that one could not have predicted the solubility of cariprazine free base compared to its salts based upon the teaching in Johnson. Applicant asserts that Johnson therefore does not overcome Ying’s preference for very slightly soluble salts and does not provide reasonable expectation of success that selecting cariprazine free base would yield a controlled long acting injectable formulation.
The examiner respectfully disagrees with Applicant’s analysis here. As an initial matter, Ying expressly indicates that the cariprazine free base may be used in their invention (0008). With regard to the argument that one could not have predicted the solubility of cariprazine based upon Johnson, the examiner points out that Ying discloses the solubilities of cariprazine and various salts thereof in table 3 on page 9, thus, the skilled artisan has no need to predict their solubility from Johnson. The foregoing notwithstanding, determining solubility of a drug in a formulation would have been a simple test for the artisan of ordinary skill, having an advanced degree in formulation science. Johnson was merely cited as evidence that selecting the form of an active agent based upon its solubility was routine practice as of the instant effective filing date. Please also see above regarding the requirement for predictability in the art.
On page 11, Applicant argues that the instant invention shows superior in vivo sustained release behavior compared with Ying’s cariprazine embonate formulations, particularly that Ying’s Cmax ranges from 25-90 ng/mL and Tmax is 1-3 h with no cariprazine detected by 11-15 days; vs. the claimed invention shows similar Cmax, but a Tmax of 72-120 hours post administration and cariprazine remains detectable throughout a 28 day period, still detected on the 42nd and 56th day post-administration.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, although the data have practical and statistical significance, the results appear to be optimizing known parameters for an extended release injectable formulation of cariprazine within the direction provided by either Bhadauria or Ying by adjusting parameters well-recognized in the art to affect drug release, particle size, and solubility of drug particles (see detailed discussion above). Applicant has also argued that that release behavior is formulation specific and unpredictable. Accordingly, the data are not commensurate in scope with the claims. The claims embrace any excipient, whereas specific formulations were shown in the specification to provide the release profile noted in the remarks as superior. As such, the data in the specification fails to meet the burden on Applicant to overcome an obviousness rejection with a persuasive showing of unexpected results.
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 1, 3-7, 9-17, 19, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18198488 in view of Song et al. (CN108261394; publication date: 07/10/20218; cited in the IDS filed 04/14/2023; citing the English human assisted machine translation).
Inter alia, the claims of the ‘488 application embrace a pharmaceutical composition comprising cariprazine and a polymer (i.e. suspending agent) in a solvent.
The claims of the ‘488 application do not limit the particle size of the cariprazine.
Song discloses achieving long action injection dosage forms by controlling particle size of cariprazine (page 4). Song discloses a suitable D(v)90 to be 0.5 to 20 microns (claim 2).
It would have been prima facie obvious to adjust the particle size of the cariprazine in the formulation of the ‘488 application in order to optimize the release rate of the drug. The skilled artisan would have had reasonable expectation of success because this was a well-known method to adjust drug release rate in extended release formulations.
The claims of the ‘488 patent are also silent with respect to the specific suspending agent in the composition, as well as including a pH adjusting agent, tonicity agent, or wetting agent.
Song discloses that carboxymethyl cellulose or polyvinylpyrrolidone can be used as a suspending agent, lactose or sucrose can be used as a freeze drying protectant, dihydrogen phosphate or citric acid can be used as a buffering agent, polysorbates can be used as a stabilizing agent, and sodium hydroxide can be used as a pH adjusting agent in cariprazine suspensions for injection.
It would have been prima facie obvious to include these excipients in the ‘488 injectable formulation of cariprazine because these excipients were routinely added to this type of composition as of the instant effective filing date (see MPEP 2143(I)(A)).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
On pages 13-15, Applicant argues that MPEP §804(I)(A) states that obviousness-type double patenting is determined by a claim-to-claim comparison asking whether the pending claims are merely an obvious modification of the claims of the reference or patent application and asserts that the rejection is not based on statutory prior art and prior art cannot be used to import missing limitations into the reference claims or to reconstruct a different invention than that which is actually claimed. Applicant asserts that the proper inquiry is whether the pending claims are obvious over what is recited in the claims of the ‘488 application, not over unclaimed embodiments or combinations reconstructed using Song. Applicant points out differences between the invention claimed in the instant application, and that of the ‘488 application and asserts that Song cannot be used to rewrite the claims of the ‘488 application.
In response, Applicant is directed to MPEP 804:
The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent. The public policy behind this doctrine is that:
The public should . . . be able to act on the assumption that upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants which would have been obvious to those of ordinary skill in the art at the time the invention was made, taking into account the skill in the art and prior art other than the invention claimed in the issued patent. (Emphasis added.)
Therefore, the examiner should take into account what was understood in the art at the time the instant invention was filed.
Conclusion
No claims are allowed.
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 KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617