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 .
Application Status
The amendment filed on 8/11/2026 is acknowledged. Claims 1, 3-5 and 7-20 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 8/11/2026 is acknowledged and has been considered except where lined through.
Rejections Maintained:
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.
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.
Claim(s) 1, 3-5 and 7-20 remain rejected under 35 U.S.C. 103 as being unpatentable over Cavion (WO2020/072773A1, 2020-04-09, IDS).
Cavion teaches methods and materials for treating mammals having or at risk of developing, one or more movement disorders (e.g. essential tremor, epilepsy, and/or Parkinson’s disease), as well as, compositions including one or more T-type calcium channel antagonist (e.g. one or more Cav3 antagonist such as CX-8998) for use in methods of administering such compositions to mammals having, or at risk of developing one or more movement disorders (e.g. essential tremor, epilepsy, and/or Parkinson’s disease) to treat the mammal (Abstract). With regards to the mammals, Cavion teaches that the mammal is in a fasting state and a human such as an adult (page 55, lines 7-10, 15-20 and 28-29). With regards to the administration timing, Cavion teaches that the composition is administered within about 4 hours of waking and can range in duration from several days to several years (page 57, lines 17-19 and page 62, lines 4-30). With regards to the compositions, Cavion teaches compositions comprises a unit dosage of the Cav3 antagonist which can be administered once a day or more than once a day and includes amounts including, but not limited to, 3mg to 30 mg or 5 mg to 25mg (page 32, lines 19-20). In particular, Cavion teaches the dose can be increased over time, wherein a dose can be titrated up to a final dose over a period of time (e.g. 1 week, 2 weeks, 3 weeks or 4 weeks) (page 60, lines 25-27). Cavion further provides the outcome of what appears to be a Clinical trial referred to as T-CALM in patients having ET (essential tremor) including both moderate and severe ET patients (Example 14). Specifically, Cavion teaches T-CALM employed the following dose titration scheme of CX-8998: Week 1 at 4 mg BID (8 mg/day), Week 2 at 8 mg BID (16mg/day) and weeks 3 and 4 at 10 mg BID (20 mg/day), wherein adverse event reports decrease after the first week of dosing despite the fact that dose was being increased at the beginning of weeks 2 and 3 showing that patients tolerate quickly to CX-8998 releated CNS and psychiatric adverse events (page 102, lines 4-8). Regarding the adverse events, Cavion teaches that adverse events include, but are not limited to, headache, dizziness, somnolence and insomnia (see Table 14 for a full listing of adverse events). Lastly, Cavion provides numerous clinical trials which have been completed, are ongoing and planned, many of which involve dose-titration or rising doses (Table 17).
Thus, while the prior art teaches treating patients having ET (essential tremor), comprising administering the following dose titration scheme of CX-8998: Week 1 at 4 mg BID (8 mg/day), Week 2 at 8 mg BID (16mg/day) and weeks 3 and 4 at 10 mg BID (20 mg/day), the prior art does not specifically teach a dose titration scheme of CX-8998: Week 1 at 5 mg QD/day, Week 2 at 10 mg QD/day, optionally, week 3 at 20 mg QD/day and optionally, week 4 at 30 mg QD/day.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the titration protocol taught by Cavion to encompass the protocol as claimed. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Cavion appears to indicate that this is a routine practice in the art since many of the clinical trials provided by Cavion contains either rising-dosing or dose titration studies.
Moreover, Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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 Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8-10 and 19-20, the limitations recited in the instant claims appear to be outcomes upon administration of the dosing-titration. Accordingly, since the obviousness rejection is based on the optimization of the dosing-titrations of the prior art it would appear that these outcomes would be achieved upon.
Note: The instant specification provides a phase 2b study to assess the safety and efficacy of CX-8998 in the treatment of adults with moderate to severe essential tremor using the instantly claimed dosing-titration protocol (Example 1). While the study provides the protocol, patient population and exclusion criteria, the study does not appear to provide any results. As such, it is unclear whether there are any unexpected/superior results with the claimed method vs. the dosing titration protocols of the prior art.
In response to this rejection, Applicant’s notes that Example 1 of the present application as filed is a protocol for a phase 2b study to assess the safety and efficacy of CX-8998 in the treatment of adults with moderate to severe essential tremor, wherein the primary endpoint for the study was the change from baseline to week 12 in the TETRAS Composite Outcome Score for JZP385 (which is a synonym for CX-8998) versus placebo. Applicants further provide results for the phase 2b study, wherein the “20 mg JZP385” and “30 mg JZP385” arms correspond to the claimed dosage regimen and were shown to numerically improve compared to placebo arm a number of key secondary endpoints. Thus, Applicants contend that the phase 2b study confirm that the claimed dosage is safe and effective in treating movement disorders which addresses the Examiners comment that it is “unclear whether there are any unexpected/superior results with the claimed method vs. the dosing titration protocols of the prior art”. Moreover, Applicants contend that the claimed dosing regimen is not merely the result of optimizing a parameter with a disclosed prior art range, but rather involves arriving at the claimed regiment requires multiple independent modification, including: (1) modifying each of the doses for weeks 1, 2 and 3 and (2) modifying the administration frequency for each of Weeks 1, 2 and 3 from twice-daily to once-daily. Accordingly, Applicants contend that since Cavion provides a twice-daily regimen, there is no reason why a person of ordinary skill in the art would have had a reasonable expectation that the once-daily regimen would possess the properties necessary or desirable for the claimed method of treatment.
These arguments have been carefully considered, but are not found persuasive.
First, the Examiner appreciates Applicants synopsis of the results for the phase 2b study. However, it is unclear how these results specifically address the Examiners previous comment that it is “unclear whether there are any unexpected/superior results with the claimed method vs. the dosing titration protocols of the prior art”. For example, the examiner acknowledges that there were three arms for JZP385, “10mg of JZP385”, “20 mg JZP385” and “30 mg JZP385”, which appears to be a dosing titration (see specification, paragraph 0070). While the Examiner notes that Applicants contend that the “20 mg JZP385” and “30 mg JZP385” is commensurate with the claims, the Examiner would like to point out that “20 mg” per day, for example, does not necessarily mean a single dose of 20 mg. Two (2) 10mg doses a day still equates to 20 mg/day. Assuming arguendo that the results are commensurate in scope with the claims, there is no comparison between once daily vs. twice daily or any evidence that the instantly claimed regimen is superior to twice daily. Applicants are reminded that “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)” and “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)” see MPEP 716.02.
As noted above, Cavion appears to indicate that this is a routine practice in the art since many of the clinical trials provided by Cavion contain either rising-dosing or dose titration studies. As such, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the titration protocol taught by Cavion to encompass the protocol as claimed. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success. Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). As noted above, Applicants have not clearly identified how the claimed regimen is critical.
Accordingly, the rejection is 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 1, 3-5 and 7-20 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 51-70 of copending Application No. 19/184847 in view of Cavion (WO2020/072773A1, 2020-04-09, IDS).
The copending application claims a method of treating a movement disorder, said method comprising administering once daily to said human an oral dosage form, wherein the oral dosage form comprises a Cav3 antagonist, wherein the Cav3 antagonist is CX-8998. Moreover, the copending application claims that the oral dosage form comprises from about 0.5 mg to about 20 mg of CX-8998 (claim 70).
The copending application differs from the instant claims in that it does not specifically claim a dose titration scheme of CX-8998: Week 1 at 5 mg QD/day, Week 2 at 10 mg QD/day, optionally, week 3 at 20 mg QD/day and optionally, week 4 at 30 mg QD/day.
Cavion teaches methods and materials for treating mammals having or at risk of developing, one or more movement disorders (e.g. essential tremor, epilepsy, and/or Parkinson’s disease), as well as, compositions including one or more T-type calcium channel antagonist (e.g. one or more Cav3 antagonist such as CX-8998) for use in methods of administering such compositions to mammals having, or at risk of developing one or more movement disorders (e.g. essential tremor, epilepsy, and/or Parkinson’s disease) to treat the mammal (Abstract). With regards to the mammals, Cavion teaches that the mammal is in a fasting state and a human such as an adult (page 55, lines 7-10, 15-20 and 28-29). With regards to the administration timing, Cavion teaches that the composition is administered within about 4 hours of waking and can range in duration from several days to several years (page 57, lines 17-19 and page 62, lines 4-30). With regards to the compositions, Cavion teaches compositions comprises a unit dosage of the Cav3 antagonist which can be administered once a day or more than once a day and includes amounts including, but not limited to, 3mg to 30 mg or 5 mg to 25mg (page 32, lines 19-20). In particular, Cavion teaches the dose can be increased over time, wherein a dose can be titrated up to a final dose over a period of time (e.g. 1 week, 2 weeks, 3 weeks or 4 weeks) (page 60, lines 25-27). Cavion further provides the outcome of what appears to be a Clinical trial referred to as T-CALM in patients having ET (essential tremor) including both moderate and severe ET patients (Example 14). Specifically, Cavion teaches T-CALM employed the following dose titration scheme of CX-8998: Week 1 at 4 mg BID (8 mg/day), Week 2 at 8 mg BID (16mg/day) and weeks 3 and 4 at 10 mg BID (20 mg/day), wherein adverse event reports decrease after the first week of dosing despite the fact that dose was being increased at the beginning of weeks 2 and 3 showing that patients tolerate quickly to CX-8998 releated CNS and psychiatric adverse events (page 102, lines 4-8). Regarding the adverse events, Cavion teaches that adverse events include, but are not limited to, headache, dizziness, somnolence and insomnia (see Table 14 for a full listing of adverse events). Lastly, Cavion provides numerous clinical trials which have been completed, are ongoing and planned, many of which involve dose-titration or rising doses (Table 17).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the method claimed by the copending application to encompass the protocol as claimed in view of the teachings of Cavion. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Cavion appears to indicate that this is a routing practice in the art since many of the clinical trials provided by Cavion contains either rising-dosing or dose titration studies.
Moreover, Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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 Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection.
In response to this rejection, Applicants request reconsideration and withdrawal of the rejection for the reasons set forth above.
These arguments have been considered above and have not been found persuasive for the reasons set forth above and incorporated herein.
Conclusion
Therefore, No claim is allowed.
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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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