DETAILED ACTION
This office action is in response to applicant’s filing dated August 20, 2026.
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 Claims
Claims 1-15, 18, 19, 32, 33, and 42-46 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed August 20, 2026. Claims 16, 17, 20-31, and 34-41 were previously canceled.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a pharmaceutically acceptable composition formulated for oral administration of a compound of Formula I comprising: about 0.5% by weight to about 15% by weight of the compound of Formula I based on the total weight of the composition; at least one filler; a disintegrant; a binder; and a surfactant in the reply filed on August 20, 2026 is acknowledged.
Claims 42-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 20, 2026.
Applicant’s election without traverse of (i) the crystalline form of instant claim 5 as the elected crystalline form species (hereinafter referred to as Crystalline Form A), (ii) mannitol and microcrystalline cellulose as the elected filler species; (iii) microcrystalline cellulose as the elected disintegrant species; (iv) povidone as the elected binder species; and (v) polysorbate as the elected surfactant species in the reply filed on August 20, 2026 is acknowledged.
Claims 1-15, 18, 19, 32, and 33 are presently under examination as they relate to the elected species: Crystalline Form A, mannitol, microcrystalline cellulose, povidone, and polysorbate.
Priority
The present application is a 371 of PCT/US2022/039543 filed on August 5, 2022, which claims benefit of US Provisional Application No. 63/230,331 filed on August 6, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 5, 2024 and August 20, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on February 5, 2024.
The drawings are objected to because:
In Figure 1, the text in the boxes is pixelated, blurry, and difficult to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case, the abstract contains language that can be implied “The present disclosure provides…”
Claim Objections
Claim 33 is objected to because of the following informalities:
Claim 33 recites the phrase “wherein the aqueous medium comprising a starch-based suspension.” This phrase is grammatically incorrect. The Examiner suggests amending to:
“wherein the aqueous medium comprises a starch-based suspension.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15, 18, 19, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Demeter et al (WO 2010/100512 A1, cited in the IDS filed February 5, 2024) in view of Domany et al (WO 03/010159 A1, cited in the IDS filed February 5, 2024.
Regarding claims 1, 4, and 5, Demeter teaches a pharmaceutical composition comprising a crystalline anhydrate Form A of 2-[4-(4-Fluorobenzyl)-piperidin-1-yl]-2-oxo-N-(2-oxo-2,3-dihydro-benzoxazol-6-yl)-acetamide characterized in having characteristic X-ray diffraction reflections at about 7.8, 22.0, 23.7, 27.0, and 27.6 ± 0.2° 2θ (claims 1, 22, and 23). Demeter teaches the polymorphs of the invention can be combined with various pharmaceutically acceptable carriers, diluents (such as sucrose, mannitol, lactose, starches), and excipients known in the art including binders, disintegrants, and the like (page 16, 2nd paragraph); as well as agents for emulsifying (page 16, 3rd paragraph). Mannitol reads on a filler as evidenced by instant claim 7. An emulsifying agent reads on a surfactant. Demeter teaches 2-[4-(4-Fluorobenzyl)-piperidin-1-yl]-2-oxo-N-(2-oxo-2,3-dihydro-benzoxazol-6-yl)-acetamide has the structure (page 2, lines 1-4):
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Moreover, Demeter teaches radiprodil (anhydrate Form A) may be beneficially used for treatment of traumatic injury of the brain (page 18, Thus, Demeter teaches a pharmaceutical composition comprising the elected Crystalline Form A, a filler, a disintegrant, a binder, and a surfactant.
Demeter does not teach Crystalline Form A is present in the amounts in instant claims 1-3. However, Domany teaches new carboxylic acid amide derivatives of Formula (I) (Abstract) including 2-[4-(4-FIuoro-benzyl-piperidin-1-yI]-2-oxo-N-(2-oxo-2,3-dihydro-benzoxazoI-6-yl-acetamide (page 21, lines 12-14), compounds of formula (I) are useful for treating traumatic brain injury (claim 19). Moreover, Domany teaches preparation of pharmaceutical composition: a) Tablets: 0.01-50 % of active ingredient of formula (I),15-50 % of lactose, 15-50 % of potato starch, 5-15 % of polyvinyl pyrrolidone, 1-5 % of talc, 0.01-3 % of magnesium stearate, 1-3 % of colloid silicon dioxide and 2-7 % of ultra amylopectin are mixed, then are granulated by wet granulation and pressed to tablets (Example 251, page 94, bottom-95, line 4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to utilize the amounts of active compound taught by Domany as a starting point for optimizing the amount of Crystalline Form A for producing composition comprising Crystalline Form A since the prior art teaches radiprodil compositions and that radiprodil including Crystalline Form A is useful for treating traumatic brain injury. MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claims 18 and 19, the cited references do not teach the composition comprises not more than 0.1% of an impurity, 6-amino-2-benzoxazolone, with respect to the quantity of the compound as measured by HPLC. However, the above stability parameters depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the formulations of Crystalline Form A, a filler, a disintegrant, a binder, and a surfactant that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 32, various liquid oral dosage forms can also be used for administering the polymorphs and solvates of the inventions, including aqueous suspensions (page 16, lines 15-17).
Taken together, all this would result in the composition of claims 1-5, 18, 19, and 32 with a reasonable expectation of success.
Regarding claims 6, 9, and 11, Demeter does not teach the filler, binder, and disintegrant are present the amounts in instant claims 6, 9, and 11. However, Domany teaches new carboxylic acid amide derivatives of Formula (I) (Abstract) including 2-[4-(4-FIuoro-benzyl-piperidin-1-yI]-2-oxo-N-(2-oxo-2,3-dihydro-benzoxazoI-6-yl-acetamide (page 21, lines 12-14), compounds of formula (I) are useful for treating traumatic brain injury (claim 19). Moreover, Domany teaches preparation of pharmaceutical composition: a) Tablets: 0.01-50 % of active ingredient of formula (I),15-50 % of lactose, 15-50 % of potato starch, 5-15 % of polyvinyl pyrrolidone, 1-5 % of talc, 0.01-3 % of magnesium stearate, 1-3 % of colloid silicon dioxide and 2-7 % of ultra amylopectin are mixed, then are granulated by wet granulation and pressed to tablets (Example 251, page 94, bottom-95, line 4). Lactose reads on a binder as evidenced by instant claim 7. Polyvinyl pyrrolidone is an alternative name for povidone and thus is a binder as evidenced by instant claim 12. Moreover, Domany teaches potato starch is a disintegration agent (page 18, lines 18-19). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to utilize the amounts of filler, disintegrant, and binder taught by Domany as a starting point for optimizing the amount of filler, disintegrant, and binder for producing a composition comprising Crystalline Form A, a filler, a disintegrant, and a binder, since the prior art teaches these amounts are suitable for formulating compositions with structurally similar compounds including radiprodil. Moreover, amounts of ingredients is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts 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 amounts 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 this would result in the composition of claims 6, 9, and 11 with a reasonable expectation of success.
Regarding claim 7, Demeter teaches various solid oral dosage forms can be used for administering the polymorphs and solvates of the invention including such solid forms as tablets, gelcaps, capsules, caplets, granules, lozenges and bulk powders; the polymorphs and solvates of the present invention can be administered alone or combined with various pharmaceutically acceptable carriers, diluents (such as sucrose, mannitol, lactose, starches). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate the composition comprising Crystalline Form A, a filler, a disintegrant, a binder, and a surfactant to comprise mannitol with a reasonable expectation of success since the prior art teaches the use of mannitol as a pharmaceutically acceptable excipient.
Similarly, regarding claim 8, Demeter teaches mannitol and lactose are suitable excipients. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate the composition comprising Crystalline Form A, a filler, a disintegrant, a binder, and a surfactant to comprise mannitol and lactose with a reasonable expectation of success since the prior art teaches the use of mannitol and lactose as a pharmaceutically acceptable excipients.
Taken together, all this would result in the composition of claims 7 and 8 with a reasonable expectation of success.
Regarding claims 10 and 12, Demeter does not teach including the elected excipients, microcrystalline cellulose and povidone. However, Domany teaches the pharmaceutical compositions for oral administration can contain polyvinyl pyrrolidine as binders or granulating agents and microcrystalline cellulose is added as disintegration agents (page 18, lines 16-19). Polyvinyl pyrrolidine is an alternative name for povidone. Thus, polyvinyl pyrrolidine reads on the elected, povidone. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate the composition comprising Crystalline Form A, a filler, a disintegrant, a binder, and a surfactant taught by Demeter to comprise polyvinyl pyrrolidine as a binder and microcrystalline cellulose as a disintegrant with a reasonable expectation of success since the prior art teaches formulating structurally similar compounds including radiprodil in pharmaceutical compositions and polyvinyl pyrrolidine as a binder and microcrystalline cellulose as a disintegrant are suitable for formulating such compositions.
Taken together, all this would result in the composition of claims 10 and 12 with a reasonable expectation of success.
Regarding claims 13 and 14, Demeter does not teach including the elected excipient, polysorbate. However, Domany teaches the test substances were suspended in 5% tween-80 (page 16, line 2) and the test substances include radiprodil (Table 2, 45-70001620, and Example 3, page 21, lines 12-14). Tween-80 reads on polysorbate. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate the composition comprising Crystalline Form A, a filler, a disintegrant, a binder, and a surfactant taught by Demeter to comprise polysorbate/Tween-80 with a reasonable expectation of success since the prior art teaches Tween-80 as a suitable excipient for formulating suspensions comprising radiprodil. Moreover, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to utilize the amounts Tween-80 taught by Domany as a starting point for optimizing the amount of polysorbate for producing a composition comprising Crystalline Form A, a filler, a disintegrant, a binder, and surfactant, polysorbate, since the prior art teaches these amounts are suitable for formulating compositions with structurally similar compounds including radiprodil.
Taken together, all this would result in the composition of claims 13 and 14 with a reasonable expectation of success.
Regarding claim 15, the cited references do not teach the composition is a granule for an oral solution. However, Demeter does teach the polymorphic forms of the drug substance can undergo phase conversion when exposed to a range of manufacturing processes, including wet granulation (page 8, lines 8-10) and that the polymorphs can be formed into granules (page 16, lines 6-8). Moreover, Domany does teach a method of preparing a pharmaceutical composition where the composition is granulated (Example 251, page 94, bottom-95, line 4). Domany further teaches pharmaceutical compositions for oral administration can contain granulating agents (page 18, lines 16-18). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate the disclosed composition into a granule since the prior art teaches the disclosed formulations can be granulated.
Taken together, all this would result in the composition of claim 15 with a reasonable expectation of success.
Regarding claim 33, the cited references do not teach the aqueous medium comprises a starch-based suspension. However, Domany teaches the pharmaceutical compositions for oral administration may contain starch as excipients (page 18, lines 16-17). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate the disclosed composition into an aqueous suspension comprising starch since the prior art teaches starch is a suitable excipient for structurally similar compounds including radiprodil.
Taken together, all this would result in the composition of claim 33 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 1-15, 18, 19, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12 of U.S. Patent No. 12,419,881. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a pharmaceutical composition comprising a compound of Formula (I) comprising about 0.5% by weight to about 15% by weight of the compound of formula (I) based on the total weight of the composition; at least one filler; a disintegrant; a binder; and a surfactant.
The previously allowed claims are directed to a method of treating a neurodevelopmental disorder comprising orally administering a composition comprising a compound of formula (I) wherein the composition comprises 30% by weight of the crystalline compound, wherein the crystalline form has the same crystalline peaks (claim 10), comprises mannitol, microcrystalline cellulose, crospovidone, povidone, and polysorbate. Moreover, the previously allowed claims teach administering to the subject an amount sufficient to provide to the subject 0.125 mg/kg to 0.75 mg/kg of the compound. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to utilize the amount of compound of formula (I) of the previously allowed claims as a starting point to optimize the amount of the compound to administer the desired dose with a reasonable expectation of success. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at a composition of the instant claims from the composition of the previously allowed claims.
Claims 1-15, 18, 19, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/695,552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a pharmaceutical composition comprising a compound of Formula (I) comprising about 0.5% by weight to about 15% by weight of the compound of formula (I) based on the total weight of the composition; at least one filler; a disintegrant; a binder; and a surfactant.
The copending claims are directed to a method of treating a GRIN-related neurodevelopmental disorder comprising orally administering a composition comprising a compound of formula (I) sufficient to provide a titration dose of about 0.05 mg/kg to about 1 mg/kg of the compound at each administration, wherein the composition comprises about 30% by weight of the compound. Compound of Formula (I) comprises the same crystalline peaks as instantly elected (claim 9). The composition of the copending claims further comprises at least one filler; a disintegrant; a binder; and a surfactant. The composition of the copending claims differs from the instantly claimed composition in the amounts of compound of formula (I) claimed. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to utilize the amount of compound of formula (I) of the copending claims as a starting point to optimize the amount of the compound to administer the desired dose with a reasonable expectation of success. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at a composition of the instant claims from the composition of the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15, 18, 19, 32, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,691,063 in view of Demeter et al (WO 2010/100512 A1, cited in the IDS filed February 5, 2024) and Domany et al (WO 03/010159 A1, cited in the IDS filed February 5, 2024).
Claims 1-15, 18, 19, 32, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-30 of copending Application No. 17/882,019;
claims 78-81, 82-88, 90, 92, 94, 96, 98, and 100-114 of copending Application No. 19/171,169;
claims 45-72 of copending Application No. 19/376,486;
claims 1-17 of copending Application No. 19/752,230; and
claims 1-30 of copending Application No. 19/833,351
in view of Demeter et al (WO 2010/100512 A1, cited in the IDS filed February 5, 2024) and Domany et al (WO 03/010159 A1, cited in the IDS filed February 5, 2024).
This is a provisional nonstatutory double patenting rejection.
The instant claims are directed to a pharmaceutical composition comprising a compound of Formula (I) comprising about 0.5% by weight to about 15% by weight of the compound of formula (I) based on the total weight of the composition; at least one filler; a disintegrant; a binder; and a surfactant.
The previously allowed claims are directed to a method of treating a GRIN-related neurodevelopmental disorder comprising orally administering a composition comprising a compound of formula (I) wherein the composition wherein the crystalline form has the same crystalline peaks (claim 1), wherein the composition comprises about 30% by weight of the anhydrous crystalline form. The previously allowed claims do not explicitly claim the instantly claimed formulation.
Similarly, copending Application No. 17/882,019 is directed to a method of identifying a safe and therapeutically effective dose of a compound of Formula (I). However, ‘019 does not explicitly claim the instantly claimed formulation or the instantly claimed crystalline form.
Copending Application No. 19/171,169 is directed to a method of treating a GRIN-related neurodevelopmental disorder comprising orally administering a composition comprising a compound of formula (I) wherein the composition wherein the crystalline form has the same crystalline peaks (claim 1), wherein the composition comprises about 30% by weight of the anhydrous crystalline form. The copending claims do not explicitly claim the instantly claimed formulation.
Copending Application No. 19/376,486 is directed to a method of treating an epileptic disorder, a brain disorder characterized by overactive glutamatergic transmission, or a brain disorder characterized by a mutation in GRN2B, GRIN2A, GRIN1, or GRIN2D comprising orally administering a composition comprising a compound of formula (I) wherein the composition wherein the crystalline form has the same crystalline peaks (claim 48), wherein the composition comprises the same stability characteristics and is in aqueous medium comprising a starch based suspension. The copending claims do not explicitly claim the instantly claimed formulation.
Copending Application No. 19/752,230 is directed to a method of identifying a safe and therapeutically effective dose of a compound of Formula (I). However, ‘019 does not explicitly claim the instantly claimed formulation or the instantly claimed crystalline form.
Copending Application No. 19/833,351 is directed to a method of treating a GRIN-related neurodevelopmental disorder comprising orally administering a composition comprising radiprodil (a compound of formula (I)). The copending claims do not explicitly claim the instantly claimed formulation or the instantly claimed crystalline form.
However, the teachings of Demeter and Domany are set forth in the 103 rejection set forth above. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at a composition comprising a compound of formula (I)/radiprodil within the instant claims from the of the previously allowed claims and copending claims in view of the teachings of Demeter and Domany with a reasonable expectation of success.
Conclusion
Claims 1-15, 18, 19, 32, and 33 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm ET, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
Prosecution Insights