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 .
Status of the Application
Claims 1-38 are pending in the application as of the response filed 01/08/2026. Claims 1-38 are examined herein.
The objection to the acronyms in the abstract of previous record is withdrawn in consideration of Applicant’s arguments on pages 10-11 (OA Item #1) of the remarks dated 01/08/2026 that was found to be persuasive.
The objection to the specification of previous record is withdrawn in consideration of amendments to the specification.
The claim objections of previous record are withdrawn in consideration of Applicant’s arguments on pages 12-13 (OA Item #3) of the remarks dated 01/08/2026.
The duplicate claims warning of previous record is maintained, since the claim amendments do not overcome the warning.
The 35 U.S.C. 112(b) rejection of previous record is partially withdrawn as is reflected in the rejections below.
The 35 U.S.C. 112(d) rejection of previous record is withdrawn in consideration of the claim amendments.
The 35 U.S.C. 102 and 35 U.S.C. 103 rejections of previous record are maintained and modified to address the claim amendments.
The nonstatutory double patenting rejections of previous record are maintained and updated to reflect claim amendments to the instant and co-pending application.
New rejections are made, necessitated by amendments.
Applicant’s submission of exhibits A-E, F1-F5 and G-H is acknowledged and fully considered. Applicant’s arguments have been fully considered and are addressed below.
Claim Rejections - 35 USC § 112 - New
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 12 and 22, the claims recite “regardless of an allopregnanolone-sulfate level of said subject”. The recitation of “regardless of an allopregnanolone-sulfate level of said subject” is not supported by the original disclosure.
According to MPEP § 2163.06, the introduction of new matter into claims is not allowed. Claims 2-11, 13-21 and 23-38 depend directly or indirectly from the rejected base claims and are similarly rejected.
This is a new matter rejection.
Duplicate Claims, Warning - Maintained
Applicant is advised that should claim 2 be found allowable, claim 12 and claim 23 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In the instant case, claims 2, 12 and 23 overall have identical claim scopes.
Response to Arguments
Applicants argue on page 13 of the response dated 01/08/2026 that “applicant has amended claim 2 such that none of claims 2, 12, and 23 have an identical scope”.
Applicant's arguments have been fully considered but they are not persuasive.
Although Applicant’s have amended claim 2 to recite “regardless of at least one of a fed state of said subject and a fasted state of said subject”, it is not meaningfully different from “regardless of a fed or fasted state of said subject” recited in claims 12 and 22. Thus, the examiner maintains that claims 2, 12 and 23 overall have identical claim scopes.
Claim Rejections - 35 USC § 112 – Partially maintained
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 4, 6, 8-9, 14, 16, 18-19, 25, 27 and 29-30 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.
Regarding claims 4, 14 and 25, the claims recite “wherein said 3α-OH-5β-pregnan-20-one comprises or is prepared from at least one of a partially crystalline 3α-OH-5β-pregnan-20-one and a non-crystalline 3α-OH-5β-pregnan-20-one”. The recitation of the open-ended phrase “comprises” renders the claim indefinite. It is unclear as to what else is included within the scope of the compound “3α-OH-5β-pregnan-20-one”.
For the purpose of applying prior art, claims 4, 14 and 25 have been interpreted as ““wherein said 3α-OH-5β-pregnan-20-one composition is prepared from at least one of a partially crystalline 3α-OH-5β-pregnan-20-one and a non-crystalline 3α-OH-5β-pregnan-20-one”.
Regarding claims 6, 16 and 27, the claims recite “wherein said 3α-OH-5β-pregnan-20-one comprises a solubilized 3α-OH-5β-pregnan-20-one”. The recitation of the open-ended phrase “comprises” renders the claim indefinite. It is unclear as to what else is included within the scope of the compound “3α-OH-5β-pregnan-20-one”.
For the purpose of applying prior art, claims 6, 16 and 27 have been interpreted as “wherein said 3α-OH-5β-pregnan-20-one is a solubilized 3α-OH-5β-pregnan-20-one”.
Regarding claims 8, 18 and 29, the claims recite “wherein said epilepsy comprises focal onset epilepsy (FOE), and wherein said seizure comprises ARS”. The recitation of the open-ended phrase “comprises” renders the claim indefinite. It is unclear as to what other conditions are included within the scope of the recitation of epilepsy and seizure within the claims.
For the purpose of applying prior art, claims 8, 18 and 29 have been interpreted as “wherein said epilepsy is focal onset epilepsy (FOE), and wherein said seizure is ARS”.
Regarding claims 9, 19 and 30, the claims recite “wherein said ARS comprises at least one of cluster seizures, serial seizures, crescendo seizures, seizure flurries, recurrent seizures, and cyclical seizures”. The recitation of the open-ended phrase “comprises” renders the claim indefinite. It is unclear as to what other types of seizures are included within the scope of the recitation of ARS within the claims.
For the purpose of applying prior art, claims 9, 19 and 30 have been interpreted as “wherein said ARS is at least one of cluster seizures, serial seizures, crescendo seizures, seizure flurries, recurrent seizures, and cyclical seizures”.
Response to Arguments
Applicants argue on pages 14-17 of the response dated 01/08/2026 that the use of the open-ended transitional word “comprising” does not render the instant claims indefinite and conclude as follows.
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Applicant's arguments have been fully considered but they are not fully persuasive. The examiner has withdrawn the 35 U.S.C. 112 (b) rejection over claims 5, 15, and 26 to include the broader recitation of 0.5% of the surfactant.
However, the examiner maintains that the use of the transitional phrase “comprises” introduces indefiniteness in the context of said rejected claims. Regarding claims 4, 14, 25 and 6, 16, 27, the use of the transitional phrase “comprises” causes ambiguity regarding the scope of “3α-OH-5β-pregnan-20-one”. It is unclear if the “3α-OH-5β-pregnan-20-one” may include salts or esters thereof. Regarding claims 8, 18, 29 and 9, 19, 30, the use of the transitional phrase “comprises” causes ambiguity regarding the scope of the condition being treated.
The examiner acknowledges and appreciates Applicant’s submission of exhibits C, D, and E in this regard. The examiner does not contest that the open-ended transitional phrase “comprises” is part of many granted patents and is a common transitional phrase used to define the scope of a claim. This is clearly evident from the fact that the examiner has not rejected all the claims having the transitional phrase “comprising” or “comprises”. See, for instance, claim 1, claim 3, claim 7, etc., that recite “comprising” or “comprises” have not been rejected for indefiniteness. Thus, the claims rejected for indefiniteness have been interpreted as set forth above.
Claim Rejections - 35 USC § 102
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 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 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.
Claims 1-10, 12-20, 21-31 and 33-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masuoka et al. (US 2019/0160078 A1, publication date 30 May 2019, hereinafter Masuoka).
Regarding instant claims 1, 7, 10 and 33-34, Masuoka teaches a method of treating an encephalopathy in a human comprising orally administering a pharmaceutically acceptable pregnenolone neurosteroid to the human, wherein the human has experienced a seizure and wherein the administration results in a 35%, or better (e.g., about a 40%, about 45%, about 50%, about 55%) reduction in mean seizure frequency per 28 days, as compared to the seizure frequency during a time period of 28 days before the first administration (Para. [0049]). Masuoka teaches a patient as a subject in need of treatment (that satisfies the requirement as in instant claim 10) (Para. [0081]). Masuoka teaches providing oral liquid and oral solid neurosteroid formulations for the treatment of said epileptic conditions (Para. [0016]; Para. [0019]). Masuoka teaches nanoparticle formulations of the pregnenolone neurosteroids that are bioavailable orally (Para. [0292]). Masuoka teaches additional neurosteroids that may be used in the nanoparticle neurosteroid formulations and methods to include pregnanolone (CAS Reg. No.128-20-1) (Para. [0395]; Claim 6; Claim 15). Pregnanolone is 3α-OH-5β-pregnan-20-one as evidenced by Wikipedia definition and paragraph [0005], Fig. 1 of the instant specification (both shown below for comparison).
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According to MPEP 2131.02(III), “A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE DISCLOSURE”. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
In the instant case, a method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy comprising orally administering a composition of pregnanolone (i.e., 3α-OH-5β-pregnan-20-one) to a human subject having or being predisposed to said condition can be clearly envisaged by a person of ordinary skill in the art, given the teachings of Masuoka. The cited embodiment of Masuoka is silent on allopregnanolone-sulfate levels in the subject and thus satisfies the limitation “regardless of an allopregnanolone-sulfate level of said subject”.
Although Masuoka do not explicitly teach wherein in response to said administration, at least one of the following results/plurality (as in claim 34) of said results is achieved comprising: a subject Cmax minimum threshold of 4.25 ng mL-1, a subject Tmax within no more than about 2.5 hours, a subject Tmax within no more than about 2.0 hours, a subject Tmax within no more than about 1.5 hours, and a subject AUC0-t minimum threshold of 22.9 ng h mL-1; wherein in response to said administration, a subject PPR decrease of at least 2 points is achieved (instant claim 33), these limitations are classical pharmacokinetic parameters used to assess bioavailability and determine optimal dosing and treatment regimen.
Therefore, orally administering the same composition (i.e., a composition of pregnanolone, also known as 3α-OH-5β-pregnan-20-one) to the same patient population (a human subject having or being predisposed to a condition associated with a seizure, convulsion or epilepsy) would necessarily result in the same pharmacokinetic parameters, in the absence of evidence to the contrary.
Therefore, the disclosure of Masuoka anticipates the method as in instant claim 1.
Regarding instant claim 2, the teachings of Masuoka anticipates the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy as in instant claim 1. Masuoka teaches the methods of treatment encompass administration of the neurosteroid with or without food (Para. [0429]). Masuoka teaches the magnitude of the fed/fasted effect of the current formulations was reduced by approximately 3-fold for Cmax and 7- to 8- fold for AUC (0-∞) when compared to historical ganaxolone formulations (Para. [0553]). This implies that the pregnenolone neurosteroid formulation, say, a formulation of pregnanolone also known as 3α-OH-5β-pregnan-20-one, formulated according to Masuoka, exhibits minimal difference in its intended therapeutic benefit irrespective of the fed/fasted status of the subject. Thus, Masuoka meets the limitations of instant claim 2.
Regarding instant claims 3-4, the teachings of Masuoka anticipates the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy as in instant claim 1. Masuoka teaches the pregnenolone neurosteroid is administered as an oral tablet or capsule (Para. [0019]; Para. [0062]; [0434]). Masuoka teaches the compounds that serve as the active agent may be present in crystalline and non-crystalline forms (Para. [0071]). Thus, Masuoka meets the limitations of instant claims 3-4.
Regarding instant claim 5, the teachings of Masuoka anticipates the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy as in instant claim 1. Masuoka teaches the neurosteroid formulations comprise dispersing agents/wetting agents (that act as surfactants) (Paras. [0443]-[0444]). Masuoka teaches embodiments in which the surfactants are present in at least 0.5 wt% of the formulation (Para. [0481], TABLE 4, PEG3350 and PEG400 present in at least 0.5 wt%). Thus, Masuoka meets the limitations of instant claim 5.
Regarding instant claim 6, the teachings of Masuoka anticipates the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy as in instant claim 1. Masuoka teaches the neurosteroid formulations comprise solubilizing agents (Para. [0448]) and are formulated as self emulsifying drug delivery systems (SEDDS) (Para. [0449]) indicating a solubilized form. Thus, Masuoka meets the limitations of instant claim 6.
Regarding instant claims 8-9, the teachings of Masuoka anticipates the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy as in instant claim 1. Masuoka teaches wherein the conditions include uncontrolled cluster seizures, focal dyscognitive, focal convulsive seizures (Para. [0049]). Thus, Masuoka meets the limitations of instant claims 8-9.
Further, the teachings of Masuoka read on the limitations of the alternate embodiment as in instant claims 12-20 and 35-36 drawn to a method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy comprising orally administering a 3α-OH-5β-pregnan-20-one composition to a human subject having or being predisposed to said condition, wherein in response to said administration, regardless of a fed or fasted state of said subject, at least one of the following results is achieved, as in instant claim 12. Claim 12 has identical claim scope to claim 2 (see rejection of claim 2 above). Additionally, the limitations as in instant claims 13-20 and 36 are clearly envisaged based on the disclosure of Masuoka per MPEP 2131.02(III) (see above). Moreover, the cited embodiment of Masuoka is silent on allopregnanolone-sulfate levels in the subject and thus satisfies the limitation “regardless of an allopregnanolone-sulfate level of said subject”.
Further, the teachings of Masuoka read on the limitations of the alternate embodiment as in instant claims 22-31 and 37-38 drawn to a method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy comprising orally administering a 3α-OH-5β-pregnan-20-one composition to a human subject having or being predisposed to said condition, wherein in response to said administration, regardless of a fed or fasted state of said subject, said condition is treated, ameliorated, or managed. Claim 23 has identical claim scope to claim 2 (see rejection of claim 2 above). Additionally, the limitations as in instant claims 24-31 and 38 are clearly envisaged based on the disclosure of Masuoka per MPEP 2131.02(III) (see above). Moreover, the cited embodiment of Masuoka is silent on allopregnanolone-sulfate levels in the subject and thus satisfies the limitation “regardless of an allopregnanolone-sulfate level of said subject”.
Response to Arguments
Applicants argue on pages 18-21 of the response dated 01/08/2026 that “Masuoka is largely directed to the administration of pregnenolone, in distinct contrast, applicant's instant application is largely directed to the administration of pregnanolone. Moreover, applicant points out that pregnanolone and pregnenolone are not the same thing - see for instance Exhibit F1 of this response”. Applicants argue “while "pregnanolone is a well-established positive allosteric modulator (PAM) of GABAA receptors" and "binds to sites on the GABAA receptor" (see Exhibit F4 of this response), in distinct contrast, applicant notes that "pregnenolone itself isn't a direct positive modulator" and in its sulfated form acts, "as a negative modulator" (see Exhibit F5 of this response). Applicants argue “Applicant points out that the functional limitations of for instance … (as those of instant claims as in claim 1, claim 12 and claim 23) are not classical parameters, but rather are the product of R&D and unexpected results”. Applicants argue “Masuoka teaches refraining from administering pregnanolone if the intended recipient has "a level of allopregnanolone-sulfate of 2500 pg mL-1 or less" whereas applicant claims administering pregnanolone "regardless of an allopregnanolone-sulfate level of said subject, applicant urges that the instant rejection is improper”.
Applicant's arguments have been fully considered but they are not persuasive.
Applicant’s exhibits F1-F5 have been fully considered. Contrary to Applicant’s assertion, the examiner notes that Masuoka teaches an embodiment wherein the species of neurosteroid used in the methods is pregnanolone (CAS Reg. No.128-20-1) (Para. [0395]; Claim 6; Claim 15). As evidenced by the Wikipedia insert in the Office action (which is the same as exhibit F2 submitted by Applicant), pregnanolone (CAS Reg. No.128-20-1) is 3α-OH-5β-pregnan-20-one of the instant claims. Therefore, as discussed in the rejection above, a person of ordinary skill in the art would have clearly envisaged use of pregnanolone in a method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy, from the disclosure of Masuoka.
The examiner emphasizes that Masuoka teaches pregnanolone (CAS Reg. No.128-20-1) (Para. [0395]; Claim 6; Claim 15), as a species of neurosteroid used in the methods of treating an encephalopathy in a human comprising orally administering a pharmaceutically acceptable of the neurosteroid to the human, wherein the human has experienced a seizure. Pregnanolone, also known as 3α-OH-5β-pregnan-20-one, by virtue of its inherent property is a positive allosteric modulator (PAM) of GABAA receptors and binds to sites on the GABAA receptor.
According to MPEP 2112.01(II), “Products of identical chemical composition can not have mutually exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). In the instant case, there is no confusion regarding the activity of pregnanolone, i.e., 3α-OH-5β-pregnan-20-one, taught by Masuoka, as a positive allosteric modulator (PAM) at the GABAA receptors for use in a method of treating a condition associated with a seizure, convulsion or epilepsy.
Regarding Applicant’s contention that the functional limitations are a result of R&D and unexpected results, the examiner notes that Applicants have not discussed any unexpected results regarding the recited functional limitations. The instant claims recite the active step of orally administering a composition of 3α-OH-5β-pregnan-20-one to a human subject having a condition associated with a seizure, convulsion or epilepsy to achieve said functional limitations. The instant claims neither limit the composition of 3α-OH-5β-pregnan-20-one to a specific formulation, nor recite specific dosages of the active agent, 3α-OH-5β-pregnan-20-one.
According to MPEP 2112.02 (II): “The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 154, 163 {(CCPA 1957}. However, when the claim recites using an old composition or structure and the “use’” is directed to a result or property of that composition or structure, then the claim is anticipated”. In re May, S74 F.2d 1082, 1090, 197 USPO 601, 607 (CCPA 1978).” Masuoka teaches oral dosages of the neurosteroid (about 200 mg/day to about 1800 mg/day) (Para. [0049]) which overlaps the therapeutically effective daily dose of about 50 mg to about 1350 mg (Para. [0139]; Para. [00147] of instant specification). Therefore, administering the same composition (i.e., a composition of pregnanolone, also known as 3α-OH-5β-pregnan-20-one) to the same patient population (a human subject having or being predisposed to a condition associated with a seizure, convulsion or epilepsy) via the same route (oral) would necessarily result in the same pharmacokinetic parameters, in the absence of evidence to the contrary.
Regarding Applicant’s assertion that Masuoka teaches refraining from administering pregnanolone in certain instances based on the level of allopregnanolone-sulfate in the subject, the examiner notes that not all embodiments of Masuoka are drawn to treatments based on the level of allopregnanolone-sulfate in the subject.
According to MPEP 2123 (II), “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). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”. In the instant case, the embodiment of Masuoka cited in the rejection (Para. [0049]) does not teach administering the neurosteroid based on allopregnanolone-sulfate levels in the subject. Thus the rejection of record reads on the limitation of “regardless of an allopregnanolone-sulfate level of said subject”. Therefore, the rejection of record is maintained.
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 11, 21 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Masuoka et al. (US 2019/0160078 A1, publication date 30 May 2019, hereinafter Masuoka) as applied to claims 1-10, 12-20, 21-31 and 33-38 above, in view of Voinescu et al. (Pregnant women with more seizures have lower allopregnanolone concentrations, 25 September 2021, hereinafter Voinescu).
The teachings of Masuoka are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claims 11, 21 and 32, the teachings of Masuoka anticipate the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy as in instant claims 1, 12 and 22 respectively. Masuoka do not teach wherein said subject is a WWE of childbearing age.
Voinescu teaches a study that assess the concentration of neuroactive steroids in relation to seizure control and frequency of seizures in women with epilepsy of childbearing age (Abstract). Voinescu teaches lower allopregnanolone concentrations associated with increased seizure frequency during pregnancy (Abstract; Pg. 3, first column, last paragraph – second column, continued paragraph, Table 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the teachings of Masuoka and Voinescu, to have applied the method of Masuoka in the treatment of women with epilepsy (WWE) of childbearing age, to arrive at the methods of the instant invention with a reasonable expectation of success. Masuoka anticipates the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy comprising orally administering a composition of pregnanolone (also known as 3α-OH-5β-pregnan-20-one) to a human subject having or being predisposed to said condition, as in instant claims 1, 12 and 22. Voinescu teaches lower concentrations of neuroactive steroids associated with increased seizure frequency during pregnancy in women with epilepsy of childbearing age.
Therefore, one of ordinary skill in the art would have been motivated to treat women with epilepsy of childbearing age with the method of Masuoka comprising orally administering a composition of pregnanolone (also known as 3α-OH-5β-pregnan-20-one) to a human subject having or being predisposed to said condition, with a reasonable and predictable expectation of success. The motivation being to reduce pregnancy related complications and improve the clinical care of pregnant women with epilepsy (Voinescu, Pg. 4, first column, last paragraph).
Claims 1-6 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 11,337,987 B1, date of patent, 24 May 2022, hereinafter Patel).
Regarding instant claim 1, Patel teaches a method of treating a CNS disorder comprising orally administering to the subject, a therapeutically effective amount of a pharmaceutical composition that provides an amount of 3α-OH-5α-pregnan-20-one, 3α-OH-5β-pregnan-20-one, or both that is sufficient to treat the CNS disorder (Abstract; Col. 32, Lns. 55-60). Patel teaches an embodiment in which the subject is a human (Col. 5, Lns. 17-18). Patel is silent on allopregnanolone-sulfate levels in the subject and thus satisfies the limitation “regardless of an allopregnanolone-sulfate level of said subject”.
Patel do not explicitly teach treating a condition associated with at least one of a seizure, a convulsion, and epilepsy, wherein in response to administration of the composition, at least one of the results as in claim 1 is achieved. However, Patel teaches the CNS disorder can be an episodic CNS disorder (Col. 33, Lns. 61-62). Patel teaches examples of CNS disorders in the background section to include epilepsy (Col. 1, Lns. 19-22). Patel teaches 3α-OH-5α-pregnan-20-one and/or 3α-OH-5β-pregnan-20-one exhibits anticonvulsant effects in experimental animals as well as cell and tissue cultures (Col. 12, Lns. 48-53). Patel teaches an exemplary pharmaceutical composition, composition 6-1, that results in mean Cmax of >6 ng/ml (Col. 78, Table 9; Claim 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the teachings of Patel to have utilized the pharmaceutical composition of Patel in a method of treating a subject suffering from a condition associated with at least one of a seizure, a convulsion, and epilepsy, with a reasonable expectation of success in treating such a condition and wherein in response to administration of the composition a desired Cmax is achieved. Thus, the limitations of instant claim 1 are rendered prima facie obvious.
Regarding instant claim 2, the teachings of Patel render the method of claim 1 prima facie obvious. Patel teaches the oral pharmaceutical compositions or dosage forms can be administered with or without food and administration without food can be during a fasting period of subject (Col. 32, Lns. 17-21).
Regarding instant claim 3, the teachings of Patel render the method of claim 1 prima facie obvious. Patel teaches the oral dosage form can be a capsule or a tablet (Col. 15, Lns. 22-25).
Regarding instant claims 4 and 6, the teachings of Patel render the method of claim 1 prima facie obvious. Patel teaches the compositions and methods comprise at least one of a substantially non-crystalline and/or a substantially solubilized pregn-4-ene-3,20-dione form (Col. 16, Lns. 55-58). Patel teaches these compositions provide pharmaceutically effective levels of the metabolites, say, 3α-OH-5β-pregnan-20-one, for treatment of the CNS disorders (Col. 68, Lns. 55-65). The 3α-OH-5β-pregnan-20-one metabolite provided by the pregn-4-ene-3,20-dione composition, is implicitly of non-crystalline form. Therefore, a person of ordinary skill in the art would have been motivated to formulate a non-crystalline/solubilized composition rendering the limitations of instant claims 4 and 6, prima facie obvious.
Regarding instant claim 5, the teachings of Patel render the method of claim 1 prima facie obvious. The exemplary composition of Patel, composition 6-1, comprises a surfactant in at least about 0.5 wt% of said composition (Col. 78, Table 9). PEG-35 castor oil is listed as a hydrophilic surfactant (Col. 20, Lns. 17-21) present in 4.9 wt% of the composition.
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Regarding instant claims 33-34, the teachings of Patel render the method of claim 1 prima facie obvious. Patel teaches methods in which the composition provides a Tmax for 3α-OH-5β-pregnan-20-one in at least one of less than about 1.5 hours, less than about 2 hours, less than about 3 hours post-administration (claim 6). Patel do not teach wherein in response to said administration, a subject PPR decrease of at least 2 points is achieved.
It is made of note that the exemplary composition of Patel, composition 6-1, comprises almost similar excipients as that of formulation I2 that results in the recited pharmacokinetic properties of the instant claims (Para. [00339]; Para. [00354], Table K of the instant specification).
According to MPEP 2144.05(II)(A), "[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). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have formulated a composition to arrive at the desired pharmacokinetic properties, as instantly claimed.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 11,337,987 B1, date of patent, 24 May 2022, hereinafter Patel) as applied to claims 1-6 and 33-34 above, in view of Masuoka et al. (US 2019/0160078 A1, publication date 30 May 2019, hereinafter Masuoka).
The teachings of Patel are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claims 7-10, the teachings of Patel render the method of claim 1 prima facie obvious. Patel do not teach wherein said treating, ameliorating, or managing comprises at least one of: an absence of a recurrence of a seizure after said administration for at least one of about 2 hours, about 4 hours, about 6 hours, and about 8 hours, and during a post-administration period of about 28 days, a reduction of a seizure rate of said subject relative to a baseline seizure rate of said subject of at least one of about 10%, about 20%, about 30%, about 40%, and about 50%; wherein said epilepsy comprises focal onset epilepsy (FOE), and wherein said seizure comprises ARS; wherein said ARS comprises at least one of cluster seizures, serial seizures, crescendo seizures, seizure flurries, recurrent seizures, and cyclical seizures; wherein said subject has at least one of the conditions listed in claim 10.
Masuoka teaches a method of treating an encephalopathy in a human comprising orally administering a pharmaceutically acceptable pregnenolone neurosteroid to the human, wherein the human has experienced a seizure and wherein the administration results in a 35%, or better (e.g., about a 40%, about 45%, about 50%, about 55%) reduction in mean seizure frequency per 28 days, as compared to the seizure frequency during a time period of 28 days before the first administration (Para. [0049]). Masuoka teaches wherein the conditions include uncontrolled cluster seizures, focal dyscognitive, focal convulsive seizures (Para. [0049]). Masuoka teaches a patient as a subject in need of treatment (Para. [0081]). Masuoka teaches additional neurosteroids that may be used in the nanoparticle neurosteroid formulations and methods to include pregnanolone (CAS Reg. No.128-20-1) (Para. [0395]; Claim 6; Claim 15). Pregnanolone is 3α-OH-5β-pregnan-20-one as evidenced by Wikipedia definition and paragraph [0005], Fig. 1 of the instant specification (see discussion in the 35 U.S.C. 102 rejection over Masuoka above).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the teachings of Patel and Masuoka to have utilized the pharmaceutical composition of Patel in a method of treating a subject suffering from a condition associated with at least one of a seizure, a convulsion, and epilepsy, wherein said epilepsy comprises focal onset epilepsy (FOE), and wherein said seizure comprises ARS, to arrive at the instant methods with a reasonable expectation of success. Additionally, it would have been prima facie obvious to arrive at the instant method claims wherein in response to administration the seizure rate is reduced as instantly claimed, with a reasonable expectation of success in view of the teachings of Patel and Masuoka.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 11,337,987 B1, date of patent, 24 May 2022, hereinafter Patel) as applied to claims 1-6 and 33-34 above, in view of Voinescu et al. (Pregnant women with more seizures have lower allopregnanolone concentrations, 25 September 2021, hereinafter Voinescu).
The teachings of Patel are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 11, the teachings of Patel render the method of claim 1 prima facie obvious. Patel teaches the subject could be a female of childbearing age or pregnant (Col. 5, Lns. 18-19; Col. 34, Lns. 11-14). Patel do not teach wherein said subject is a women with epilepsy (WWE) of childbearing age.
Voinescu teaches a study that assess the concentration of neuroactive steroids in relation to seizure control and frequency of seizures in women with epilepsy of childbearing age (Abstract). Voinescu teaches lower allopregnanolone concentrations associated with increased seizure frequency during pregnancy (Abstract; Pg. 3, first column, last paragraph – second column, continued paragraph, Table 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the teachings of Patel and Voinescu, to have applied the method of Patel in the treatment women with epilepsy (WWE) of childbearing age, to arrive at the methods of the instant invention with a reasonable expectation of success. Patel renders obvious the method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy comprising orally administering a composition that provides 3α-OH-5β-pregnan-20-one to a human subject having or being predisposed to said condition, as in instant claim 1. Voinescu teaches lower concentrations of neuroactive steroids associated with increased seizure frequency during pregnancy in women with epilepsy of childbearing age.
Therefore, one of ordinary skill in the art would have been motivated to treat women with epilepsy of childbearing age with the method of Patel comprising orally administering a composition of pregnanolone (also known as 3α-OH-5β-pregnan-20-one) to a human subject having or being predisposed to said condition, with a reasonable and predictable expectation of success. The motivation being to reduce pregnancy related complications and improve the clinical care of pregnant women with epilepsy (Voinescu, Pg. 4, first column, last paragraph).
Patel teaches the described features, structures, or characteristics can be combined in any suitable manner in one or more embodiments (Col. 3, Ln. 66 – Col. 4, Ln. 8).
According to MPEP 2144.05(II)(A), "[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). Therefore, given the teachings of Patel (as applied to claims 1-6 and 33-34 above), Masuoka (as applied to claims 7-10 above, Patel in view of Masuoka) and Voinescu (as applied to claim 11 above, Patel in view of Voinescu), it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived the alternate embodiments of claims 12-21, 35-36 AND claims 22-32, 37-38, with a reasonable expectation of success in the absence of evidence to the contrary.
Response to Arguments
Applicants argue on pages 21-23 of the response dated 01/08/2026 that “Applicant respectfully urges that applicant has established above that none of claims 11, 21 and 32 are anticipated by Masuoka. Further, Voinescu fails to bridge the teaching gap of Masuoka”. Applicants argue “However, Patel teaches the CNS disorder can be an episodic CNS disorder … Applicant points out that inherency in an obviousness rejection carries with it the burden of the examiner to shown that the missing element - in this case the "at least one of a seizure, a convulsion, and epilepsy".
Applicant's arguments have been fully considered but they are not persuasive.
The examiner notes that claims 11, 21, and 32 are rejected using an obviousness rationale and not anticipation. Further, the rejection of record clearly articulates the rationale behind combining said references to arrive at the instant method claims.
With due respect, the examiner asserts that an inherency rationale was not used in the rejection of claims 1-6 and 33-34 over the Patel reference. As discussed in the 103 rejection over Patel, Patel teaches a method of treating a CNS disorder comprising orally administering to the subject, a therapeutically effective amount of a pharmaceutical composition that provides an amount of 3α-OH-5α-pregnan-20-one, 3α-OH-5β-pregnan-20-one, or both that is sufficient to treat the CNS disorder, wherein the subject is a human. Patel teaches the CNS disorder can be an episodic CNS disorder and further mentions epilepsy as an example of a CNS disorder (Col. 1, Lns. 19-22). Therefore, Patel provides enough motivation to treat a CNS disorder – epilepsy, using the compounds of the invention. Moreover, exhibit H provided by Applicant also teaches epilepsy as an example of episodic CNS disorders, portions of which are reproduced below.
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Therefore, the rejection of record over Masouka and Voinescu, and Patel, Masouka and Voinescu are maintained.
Double Patenting – Maintained and updated
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-17, 22-25 and 30 of co-pending Application No 17/706,210 in view of Masuoka et al. (US 2019/0160078 A1, publication date 30 May 2019, hereinafter Masuoka).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to an oral composition of 3α-OH-5β-pregnan-20-one for use in a method of treating a CNS condition.
The instant claims are drawn to a method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy comprising orally administering a 3α-OH-5β-pregnan-20-one composition to a human subject having or being predisposed to said condition, regardless of an allopregnanolone-sulfate level of said subject.
The claims of co-pending Application No 17/706,210 are drawn to an oral dosage form pharmaceutical composition for use in treating a CNS disorder, said composition comprising a predetermined quantity of treated 3α-OH-5β-pregnan-20-one and a plurality of additives.
The claims of the reference ‘210 application anticipates a composition of 3α-OH-5β-pregnan-20-one composition comprising a surfactant in an amount of at least 0.5% (instant claim 5) for use in treating a CNS disorder. The claims of the reference ‘210 application do not teach ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy; or the limitations of the other dependent claims.
Masuoka teaches a method of treating an encephalopathy in a human comprising orally administering a pharmaceutically acceptable pregnenolone neurosteroid to the human, wherein the human has experienced a seizure and wherein the administration results in a 35%, or better (e.g., about a 40%, about 45%, about 50%, about 55%) reduction in mean seizure frequency per 28 days, as compared to the seizure frequency during a time period of 28 days before the first administration (Para. [0049]) (instant claims 1 and 7). Masuoka teaches an embodiment of nanoparticle neurosteroid formulations pregnanolone (CAS Reg. No.128-20-1) (Para. [0395]; Claim 6; Claim 15) for use in the methods. Pregnanolone is 3α-OH-5β-pregnan-20-one as evidenced by Wikipedia definition, as discussed in the anticipation rejection above. Masuoka teaches the methods of treatment encompass administration of the neurosteroid with or without food (Para. [0429]) (instant claim 2). Masuoka teaches the magnitude of the fed/fasted effect of the current formulations was reduced by approximately 3-fold for Cmax and 7- to 8- fold for AUC (0-∞) when compared to historical ganaxolone formulations (Para. [0553]). This implies that the pregnenolone neurosteroid formulation, say, a formulation of pregnanolone also known as 3α-OH-5β-pregnan-20-one, formulated according to Masuoka, exhibits minimal difference in its intended therapeutic benefit irrespective of the fed/fasted status of the subject. Masuoka teaches the pregnenolone neurosteroid is administered as an oral tablet or capsule (Para. [0019]; Para. [0062]; [0434]) (instant claim 3). Masuoka teaches the compounds that serve as the active agent may be present in crystalline and non-crystalline forms (Para. [0071]) (instant claim 4). Masuoka teaches the neurosteroid formulations comprise solubilizing agents (Para. [0448]) and are formulated as self emulsifying drug delivery systems (SEDDS) (Para. [0449]) indicating a solubilized form (instant claim 6). Masuoka teaches wherein the conditions include uncontrolled cluster seizures, focal dyscognitive, focal convulsive seizures (Para. [0049]) (instant claims 8-9).
According to MPEP 2144.05(II)(A), "[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). Therefore, in light of the teachings of the reference ‘210 application and Masuoka, it would have been prima facie obvious to have treated a female subject with epilepsy of childbearing age. Moreover, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived the alternate embodiments of claims 12-21, 35-36 AND claims 22-32, 37-38, with a reasonable expectation of success in the absence of evidence to the contrary.
Thus, claims 11-17, 22-25 and 30 of co-pending application 17/706,210 and instant claims 1-38 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of US Patent No 11,337,987 B1 in view of Masuoka et al. (US 2019/0160078 A1, publication date 30 May 2019, hereinafter Masuoka).
Although the claims at issue are not identical, both sets of claims are drawn a method of treating a condition comprising orally administering a composition of 3α-OH-5β-pregnan-20-one composition to a human subject.
The instant claims are drawn to a method of treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy comprising orally administering a 3α-OH-5β-pregnan-20-one composition to a human subject having or being predisposed to said condition regardless of an allopregnanolone-sulfate level of said subject, wherein in response to said administration, at least one of the following results is achieved comprising: a subject Cmax minimum threshold of 4.25 ng mL-1, a subject Tmax within no more than about 2.5 hours, a subject Tmax within no more than about 2.0 hours, a subject Tmax within no more than about 1.5 hours, and a subject AUC0-t minimum threshold of 22.9 ng h mL-1; wherein said results are achieved regardless of a fed or fasted state of said subject.
The claims of the reference ‘987 patent are drawn to
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Claim 1 of the reference ‘987 patent anticipates a 3α-OH-5β-pregnan-20-one composition that when orally administered to a human subject results in a Cmax greater than 6 ng/ml that anticipates the Cmax as recited in the instant claim 1. Claim 1 of the reference ‘987 patent anticipates a partially solubilized or non-crystalline form of 3α-OH-5β-pregnan-20-one (as in instant claims 4 and 6). Claim 7 of the reference ‘987 patent anticipates wherein said composition comprises at least one of a tablet, a capsule (as in instant claim 3). Claim 6 of the reference ‘987 patent anticipates a Tmax for 3α-OH-5β-pregnan-20-one of less than about 1.5 hours, less than about 2 hours, less than about 3 hours (instant claims 1 and 34).
The reference ‘987 patent does not teach treating, ameliorating, or managing a condition associated with at least one of a seizure, a convulsion, and epilepsy AND wherein said results are achieved regardless of at least one of a fed state of said subject and a fasted state of said subject.
Masuoka teaches a method of treating an encephalopathy in a human comprising orally administering a pharmaceutically acceptable pregnenolone neurosteroid to the human, wherein the human has experienced a seizure and wherein the administration results in a 35%, or better (e.g., about a 40%, about 45%, about 50%, about 55%) reduction in mean seizure frequency per 28 days, as compared to the seizure frequency during a time period of 28 days before the first administration (Para. [0049]). Masuoka teaches wherein the conditions include uncontrolled cluster seizures, focal dyscognitive, focal convulsive seizures (Para. [0049]). Masuoka teaches a patient as a subject in need of treatment (Para. [0081]). Masuoka teaches additional neurosteroids that may be used in the nanoparticle neurosteroid formulations and methods to include pregnanolone (CAS Reg. No.128-20-1) (Para. [0395]; Claim 6; Claim 15). Pregnanolone is 3α-OH-5β-pregnan-20-one as evidenced by Wikipedia definition and paragraph [0005], Fig. 1 of the instant specification (see discussion in the 35 U.S.C. 102 rejection over Masuoka above). Masuoka teaches the methods of treatment encompass administration of the neurosteroid with or without food (Para. [0429]). Masuoka teaches the magnitude of the fed/fasted effect of the current formulations was reduced by approximately 3-fold for Cmax and 7- to 8- fold for AUC (0-∞) when compared to historical ganaxolone formulations (Para. [0553]). This implies that the pregnenolone neurosteroid formulation exhibits minimal difference in its intended therapeutic benefit irrespective of the fed/fasted status of the subject.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the teachings of the reference ‘987 patent and Masuoka to have utilized the pharmaceutical composition the ‘987 patent in a method of treating a subject suffering from a condition associated with at least one of a seizure, a convulsion, and epilepsy, wherein said epilepsy comprises focal onset epilepsy (FOE), and wherein said seizure comprises ARS, to arrive at the instant methods with a reasonable expectation of success. Further, it would have been prima facie obvious to have treated a female subject with epilepsy of childbearing age. Additionally, it would have been prima facie obvious to arrive at the instant method claims wherein said results are achieved regardless of a fed or fasted state of said subject.
According to MPEP 2144.05(II)(A), "[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). Therefore, in light of the teachings of the reference ‘987 patent and Masuoka, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived the alternate embodiments of claims 12-21, 35-36 AND claims 22-32, 37-38, with a reasonable expectation of success in the absence of evidence to the contrary.
The claims of the reference ‘987 patent render the instant claims prima facie obvious, in view of Masuoka.
The instant claims 1-38 and claims 1-26 of the ‘987 patent are therefore not patentably distinct.
This is a nonstatutory double patenting rejection.
Response to Arguments
Applicants argue on pages 23-25 of the response dated 01/08/2026 that “In light of the facts presented above which demonstrate that not only is the NSDP rejection improper, but that none of instant claims 1-38 are coextensive with any of the Reference Claims, applicant respectfully requests that the examiner withdraw the NSDP rejection of instant claims 1-38 over the Reference Claims".
Applicant's arguments have been fully considered but they are not persuasive.
As discussed in the nonstatutory double patenting rejections above, the instant claims are rendered prima facie obvious in view of the claims of the reference application/patent and cited prior art. Therefore, the nonstatutory double patenting rejections are maintained.
Conclusion
Claims 1-38 are rejected.
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 PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627