DETAILED ACTION
This office action is in response to the Applicant’s filing dated July 26th, 2024.
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
This application has a PRO of 63/516,212 filed on July 28th, 2023.
Status of Claims
Claims 1-15 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on July 26th, 2024. Acknowledgment is made of Applicant’s amendment of claims 3-4, 7-10, 12-13 and 15.
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.
Claims 1-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al (Epilepsy & Behavior Reports, (2022), 20100567); in view of NCT03350035 (https://cdn.clinicaltrials.gov/large-docs/35/NCT03350035/Prot_002.pdf).
Regarding claims 1-8 and 10-12, Singh teaches a method of treating Super-Refractory Status Epilepticus (herein referred to as SRSE) in pediatric patients by administering intravenous ganaxolone (herein referred to as GNX) as an initial intravenous bolus followed by continuous intravenous infusion before a transition to enteric maintenance GNX. Singh expressly reports that the subjects were receiving intravenous anesthetic therapy and that administration of GNX safely permitted the intravenous anesthetics to be weaned.
In Patient 1, GNX was administered by intravenous bolus followed by continuous intravenous infusion over four days followed by a taper on day 5 and transition to oral enteric maintenance GNX at the maximal adult dose of 1800 mg/day divided into three doses, with pentobarbital discontinued on day 1 of GNX treatment; by day 3 of GNX treatment, clinical and electrographic seizures stopped (page 2, left column, third paragraph; page 3, Figure 1a). In Patient 2, GNX was administered via intravenous bolus followed by continuous intravenous infusion over 4.5 days, followed by a taper on day 5 and transition to oral enteric maintenance GNX at a dose of 63 mg/kg/day divided into three doses; midazolam was discontinued on day 2 and ketamine was discontinued on day 8 of IV GNX protocol; seizures stopped by day 8 (page 3, left column, first paragraph; page 3, right column, first paragraph; page 4, Figure 1b).
Singh does not expressly teach the instantly claimed weight-based dosing regimens, continuous infusion rates, or tapering in successive four-hour increments.
NCT03350035 protocol teaches dosing for GNX administered via intravenous bolus and continuous intravenous treatment regimen. NCT03350035 expressly discloses that patients weighing ≥40kg receive a 30mg bolus dose over ~3 minutes with a continuous intravenous infusion rate of 80mg/hour for 2 hours, followed by a rate of 40mg/hour for 10 hours, followed by a rate of 20mg/hour until the drug is tapered (page 54, first and second bullet points; page 55, Table 2); whereas patients weighing ≤40kg receive a 0.43mg/kg bolus dose over ~3 minutes with a continuous intravenous infusion rate of 1.14mg/kg/hour for 2 hours, followed by a rate of 0.57mg/kg/hour for 10 hours, followed by a rate of 0.29mg/kg/hour until the drug is tapered (page 55, first and second bullet points; page 56, Table 3). NCT03350035 further teaches that when intravenous GNX is tapered, the dose is reduced by 33.3% every 4 hours; stopping when dosage reaches 5.93-13.35 mg/hour for patients weighing ≥40kg and 0.08-0.19 mg/kg/hour for patients weighing ≤40kg (page 54, third bullet point; page 55, Table 2; page 56, Table 3). NCT03350035 states that subject GNX dosing can be optimized and infusion parameters adjusted to maximize safety and efficacy (page 57, Dose Optimization).
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of GNX taught by NCT03350035 and Singh as a starting point for optimizing the amount and treatment regimen of amantadine GNX utilized to treat SRSE, since Singh teaches GNX is useful for treating SRSE and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP § 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all of this would result in the method of instant claims 1-8 and 10-12 with a reasonable expectation of success.
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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-10, 15-18, 20, 22 and 24-31 of copending Application No. 19/044,894 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘894 application are drawn to a method of treating Status Epilepticus (herein referred to as SE) with GNX via the same administration routes, and SE is an epileptic disorder that encompasses subtypes including the instantly claimed disorder treated SRSE. Moreover, the dosage and regimen are very similar; and which are obvious to optimize because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP § 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19-21 of copending Application No. 18/625,718 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘718 application are drawn to a method of treating Established Status Epilepticus (herein referred to as ESE) with GNX via the same administration routes; ESE is a subtype of SE, and SE is an epileptic disorder that encompasses subtypes including the instantly claimed disorder treated SRSE. Moreover, the dosage and regimen are very similar; and which are obvious to optimize because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP § 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9-10 and 14-25 of copending Application No. 18/321,374 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘374 application are drawn to a method of treating SRSE with GNX via the same administration routes with a very similar dosage and regimen; of which are obvious to optimize because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP § 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented (no patent number has yet been issued), although the Examiner notes a Notice of Allowance was sent on June 10th, 2026 in the reference ‘374 application.
Conclusion
Claims 1-15 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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