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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 – 3, 10 – 19, and 22) drawn to a pharmaceutical composition comprising: A) an SV2A inhibitor, or a pharmaceutically acceptable salt, hydrate, solvate, isomer, or polymorph thereof; B) a GABAA α5 receptor agonist, or a pharmaceutically acceptable salt, hydrate, solvate, isomer, or polymorph thereof; and C) a pharmaceutically acceptable carrier and the species election of
PNG
media_image1.png
200
400
media_image1.png
Greyscale
in the reply filed on February 9th, 2026 is acknowledged.
Claims 57, 63, 65 – 67, and 70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a method of treating cognitive impairment associated with a central nervous system (CNS) disorder), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 9th, 2026.
Claims 1 – 3, 10 – 19, 22, 57, 63, 65 – 67, and 70 are currently pending in the application. However, due to a restriction requirement, claims 57, 63, 65 – 67, and 70 are withdrawn from further consideration and claims 1 – 3, 10 – 19, and 22, are being examined on the merits herein.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 12 – 16 are objected to because of the following informalities: period marks included within the body of the claim. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: still contains the strike through of which was already presented in the claim set dated July 24th, 2023. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: appears to contain a hyphen in between the words “Form E” and “exhibiting” in line 3. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: missing the word “claim” before the number “11” in line 1. 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 – 3, 10 – 11, and 17 – 22 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) in view of US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Regarding claims 1 – 3, 10 – 11, and 17 – 22, Mekonnen’268 teach compounds, compositions, and methods for the treating cognitive impairment associated with central nervous system, (CNS) disorders cognitive impairment associated with brain cancers, and brain cancers in a subject in need thereof (page 1 paragraph 0003). Additionally, Mekonnen’268 teach pharmaceutical compositions comprising a compound of formula I:
PNG
media_image2.png
158
192
media_image2.png
Greyscale
(page 1 paragraph 0011) a pharmaceutically acceptable salt, hydrate, solvate, polymorph, isomer, or combination thereof (page 17 paragraph 0418) as GABAA α5 receptor positive allosteric modulators (page 17 paragraph 0419). More specifically, Mekonnen’268 teach compound 606 5-((3-chloro-7-(methoxymethyl)-9Hbenzo[f]imidazo[ 1,5-a] [1,2,4]triazolo[ 4,3-d] [1,4]diazepin-1 0-yl)ethynyl)-2-methoxythiazole of the structure
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(claims 2, 10 – 11, and 17) (page 240 paragraph 2094). Moreover, Mekonnen’268 teach embodiments wherein the dose of compounds of the disclosure, which include compound 606, is between 0.007 and 7000 mg/day (page 134 paragraph 1362). While instant claim 18 recite doses between 5 mg and 1000 mg (claim 18) instant claim doses fall within the range taught by the prior art of Mekonnen’268. Thus 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)(MPEP 2144.05(I)). Furthermore, Mekonnen’268 teach that the compounds and compositions of the disclosure, which includes compound 606, may be administered for slow, controlled or extended release form (claim 22) (page 133 paragraph 1359). Additionally, Mekonnen’268 teach embodiments wherein the compositions of the disclosure which includes compounds of the disclosure, which further includes compound 66, can also include other therapeutically useful agents (page 134 paragraph 1366).
While the prior art of Mekonnen’268 does teach pharmaceutical compositions comprising GABAA α5 receptor agonist, other therapeutically useful agents, and a pharmaceutically acceptable carrier; Mekonnen’268 does explicitly state an SV2A inhibitor (claim 1) wherein the SV2A inhibitor is levetiracetam (claim 3). Moreover, Mekonnen’268 fails to teach the administration of the SV2A inhibitor in an amount between 0.07 mg to 350 mg (claim 19).
Nevertheless, Gallagher’075 teach a method for treating age-related cognitive impairment in a subject in need or at risk thereof, the method comprising the step of administering to said subject a therapeutically effective amount of a synaptic vesicle protein 2A (SV2A) inhibitor or a pharmaceutically acceptable salt thereof (column 1 lines 20 – 25). Moreover, Gallagher’075 teach embodiments wherein the SV2A inhibitor is administered 7 to 350 mg/day (column 61 lines 4 – 6). While instant claim 19 recite doses between 0.07 mg to 350 mg (claim 19) instant claim doses fall within the range taught by the prior art of Gallagher’075. Thus 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)(MPEP 2144.05(I)).
Moreover, Gallagher’075 teach in example 2 the administration of the SV2A inhibitor levetiracetam (claim 3) at 5 m/kg/day and 10 mg/kg/day in 6 Age-Impaired (AI) Long-Evans rats through intraperitoneal (i.p.) injection (column 67 lines 1 – 6 and 12 – 24). Furthermore, Gallagher’075 teach that for the AI rats that received the 10 mg/kg/day dose demonstrated significantly improved memory as compared to vehicle-treated controls (column 68 lines 3 – 6).
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Mekonnen’268 comprising GABAA α5 receptor agonist, other therapeutically useful agents, and a pharmaceutically acceptable carrier in view of Gallagher’075, that is for a composition further comprising an SV2A inhibitor wherein the SV2A inhibitor is levetiracetam. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10159648 B2 to Gallagher et. al. (herein after Gallagher’648; cited on the IDS dated September 12th, 2023) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) and US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Gallagher’648 recite an extended release pharmaceutical composition comprising levetiracetam (instant claim 3), wherein the composition provides a steady state plasma concentration of levetiracetam in a subject of between 1.9 μg/ml and 4.4 μg/ml within 3 hours after administration and extending for at least 8 hours of a 24-hour period after said administration (reference claim 1).
However, Gallagher’648 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist (instant claim 1).
The teachings of Mekonnen’268 and Gallagher’075 as they relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Gallagher’648 comprising levetiracetam in view of Mekonnen’268, that is to further include a GABAA α5 receptor agonist, and in further view of Gallagher’075 to administer the levetiracetam between 0.07 mg to 350 mg. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 8604075 B2 to Gallagher et. al. (herein after Gallagher’075; cited on the IDS dated September 12th, 2023) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023).
Gallagher’075 recite a method for treating age-related cognitive impairment in a human subject in need thereof, the method comprising the step of administering to said human subject levetiracetam (instant claim 1) or a pharmaceutically acceptable salt thereof at a daily dose of 125-250 mg (reference claims 1, 7, and 13; instant claim 19).
However, Gallagher’075 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist (instant claim 1).
The teachings of Mekonnen’268 as it relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Gallagher’075 comprising levetiracetam in view of Mekonnen’268, that is to further include a GABAA α5 receptor agonist. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 4 of U.S. Patent No. US 10925834 B2 to Gallagher et. al. (herein after Gallagher’834; cited on the IDS dated September 12th, 2023) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) and US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Gallagher’834 recite an extended release pharmaceutical composition comprising levetiracetam (instant claim 3), wherein the composition provides a steady state plasma concentration of levetiracetam in a subject of between 1.9 μg/ml and 4.4 μg/ml within 3 hours after administration and extending for at least 8 hours of a 24-hour period after said administration (reference claim 1).
However, Gallagher’834 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist (instant claim 1).
The teachings of Mekonnen’268 and Gallagher’075 as they relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Gallagher’834 comprising levetiracetam in view of Mekonnen’268, that is to further include a GABAA α5 receptor agonist, and in further view of Gallagher’075 to administer the levetiracetam between 0.07 mg to 350 mg. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3, and 7 – 8, and 22 of U.S. Patent No. US 11414425 to Mekonnen et. al. (herein after Mekonnen’425) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) and US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Mekonnen’425 recite a compound of formula XI:
PNG
media_image3.png
154
198
media_image3.png
Greyscale
(reference claim 1 – 3, and 6). More specifically, Mekonnen’425 recite the compound of (reference) claim 1 which is
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(reference claim 8 and 26; instant claims 1 – 2, and 10 – 11). Additionally, Mekonnen’425 recite a pharmaceutical composition (reference claim 27) comprising a compound according to any one of (reference) claims 1, 2, 7 or 8, or a pharmaceutically acceptable salt, hydrate, isomer, or combination thereof, in a therapeutically effective amount; and an acceptable carrier, adjuvant or vehicle (reference claim 9; instant claim 1).
However, Gallagher’834 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist (instant claim 1).
The teachings of Mekonnen’268 and Gallagher’075 as they relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Gallagher’834 comprising levetiracetam in view of Mekonnen’268, that is to further include a GABAA α5 receptor agonist, and in further view of Gallagher’075 to administer the levetiracetam between 0.07 mg to 350 mg. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6, and 8 – 9, and 26 of U.S. Patent No. US 12291535 to Mekonnen et. al. (herein after Mekonnen’535) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) and US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Mekonnen’268 recite a compound of formula X:
PNG
media_image4.png
160
214
media_image4.png
Greyscale
(reference claim 1 - 6). More specifically, Mekonnen’268 recite the compound of (reference) claim 1 which is
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(reference claim 8 and 26; instant claims 1 – 2, and 10 – 11). Additionally, Mekonnen’425 recite a pharmaceutical composition (reference) claim 1 comprising a compound according to (reference) claim 1, or a pharmaceutically acceptable salt, hydrate, isomer, or combination thereof, in a therapeutically effective amount; and an acceptable carrier, adjuvant or vehicle (reference claim 9; instant claim 1).
However, Mekonnen’425 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist (instant claim 1).
The teachings of Mekonnen’268 and Gallagher’075 as they relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Mekonnen’425 comprising a GABAA α5 receptor agonist in view of Mekonnen’268, at the dose recited, and in further view of Gallagher’075 to administer the levetiracetam between 0.07 mg to 350 mg. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 57, 63, 67, and 70 of copending Application No. App. 17/372405 to Gallagher et. al. (herein after Gallagher’405).
Gallagher’405 recite a method of treating cognitive impairment associated with a central nervous system (CNS) disorder in a subject in need or at risk thereof, the method comprising administering to the subject a combination comprising: Component A: levetiracetam (instant claim 3), or a pharmaceutically acceptable salt, hydrate, solvate, isomer, or polymorph thereof, or a first pharmaceutical composition comprising the levetiracetam, or a pharmaceutically acceptable salt, hydrate, solvate, polymorph or isomer thereof, the levetiracetam being present in Component A in an amount between 0.07 mg to 350 mg (instant claim 19); Component B: a GAB AA a5 receptor agonist having the formula
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(instant claim 1 – 2, 10 – 11, and 17) or a pharmaceutically acceptable salt, hydrate, solvate, isomer, or polymorph thereof, or a second pharmaceutical composition comprising the GABAA a5 receptor agonist, or a pharmaceutically acceptable salt, hydrate, solvate, polymorph or isomer thereof, the GABAA a5 receptor agonist being present in Component B in the amount between 5 mg to 1000 mg (instant claim 18) ; and wherein one or both of the first pharmaceutical composition or the second pharmaceutical composition further comprise a pharmaceutically acceptable carrier (reference claim 57; instant claim 1).
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 10 – 12, 17 – 19, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 44 – 45 of copending Application No. 18/015445 to Gandla et. al. (herein after Gandla’445) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) and US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Gandla’445 recite a crystalline form of a compound having the structure
PNG
media_image1.png
200
400
media_image1.png
Greyscale
wherein the crystalline form is Form A (reference claim 1; instant claims 1 – 2, 10 – 12). Moreover, Gandla’445 recite the crystalline form according to (reference claim 1) wherein the crystalline form is anhydrous Form A, wherein said Perm A is anhydrous and is characterized by one or more of: (a) an X-ray diffraction pattern (XRPD) comprising at least one peak selected from 3.0 and 21.0 degrees 2θ ± 0.2 degrees 2θ (instant claim 12); (b) a C2/c single crystal x-ray diffraction space group;(c) a single crystal x-ray diffraction unit cell having the parameters: a= 58.1415(14) A, b = 4.03974(8) A, c = 17.1204(3) A, α= 90°, β= 90.261(2)0, γ = 90°, V = 4021.15(14) Å3 ; and (d) a differential scanning calorimetry (DSC) curve having an exotherm with an onset at about 207°C (reference claim 2). Furthermore, Gandla’445 recite a pharmaceutical composition comprising the crystalline Form A of the compound according to (reference) claim 1, and a pharmaceutically acceptable carrier (reference claim 44; instant claim 1) and further comprising one or more additional pharmaceutical compositions comprising one or more therapeutic agents selected from the group consisting of an antipsychotic, memantine, an SV2A inhibitor (instant claims 1 and 3), and an AChEI, or a pharmaceutically acceptable salt, hydrate, solvate, polymorph or prodrug of any of the foregoing (reference claim 45).
However, Gandla’445 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist and a SV2A inhibitor wherein the SV2inhibitor is levetiracetam (instant claim 3).
The teachings of Mekonnen’268 and Gallagher’075 as they relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Gandla’445 comprising a GABAA α5 receptor agonist in view of Mekonnen’268, at the dose recited, and in further view of Gallagher’075 to administer the levetiracetam between 0.07 mg to 350 mg. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/411753 to Mohs (herein after Mohs’753) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) and US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Mohs’753 a method of preventing or slowing the progression of cognitive impairment or preventing the development or reducing the rate of cognitive decline in an APOE4 non-carrier subject, the method comprising administering to the subject one or more of levetiracetam (instant claim 3), brivaracetam or seletracetam, or a pharmaceutically acceptable salt thereof, wherein the levetiracetam, brivaracetam or seletracetam are administered at a daily dose of 0.7-350 mg (instant claim 19), or comprising administering to the subject a pharmaceutical composition comprising the daily dose of the levetiracetam, brivaracetam or seletracetam, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier (reference claim 1).
However, Mohs’753 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist (instant claim 1).
The teachings of Mekonnen’268 and Gallagher’075 as they relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of Mohs’753 comprising levetiracetam in view of Mekonnen’268, that is to further include a GABAA α5 receptor agonist, and in further view of Gallagher’075 to administer the levetiracetam between 0.07 mg to 350 mg. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 10 – 11, 17 – 19, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 – 9 of U.S. Patent No. US 10624875 B2 to Gallagher et. al. (herein after Gallagher’875) in view of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) and US Patent No. US 8604075 B2 to Gallagher et. al. (here in after Gallagher’075; cited on the IDS submitted September 12th, 2023).
Gallagher’875 recite a pharmaceutical composition comprising an SV2A inhibitor (instant claim 1) and an antipsychotic or their pharmaceutically acceptable salts, hydrates, solvates, polymorphs or prodrugs, wherein the SV2A inhibitor in the composition is present: a) in an amount of 0.07-350 mg (instant claim 19); b) in an amount of 50-250 mg; c) in an amount of 3-50 mg; or d) in an amount less than 350 mg, less than 250 mg, less than 200 mg, less than 150 mg, less than 100 mg, less than 50 mg, less than 10 mg, less than 5 mg, less than 1 mg, less than 0.5 mg, less than 0.1 mg, or less than 0.07 mg (reference claim 6); wherein the Moreover, both the invention of Gallagher’875 and the instant application direct to a pharmaceutical composition wherein the composition is in a solid form, a liquid form, a suspension form, a sustained release form, a delayed release form, or an extended release form (reference claim 8; instant claim 22); and wherein the SV2A inhibitor is selected from the group consisting of levetiracetam, brivaracetam and seletracetam (instant claims 3) and derivatives analogs pharmaceutically acceptable salts, hydrates, solvates, polymorphs and prodrugs thereof (reference claim 9).
However, Gallagher’875 fails to recite a pharmaceutical composition further comprising a GABAA α5 receptor agonist (instant claim 1).
The teachings of Mekonnen’268 and Gallagher’075 as they relate to the prior art rejections of instant claims 1 – 3, 10 – 11, 17 – 19, and 22, are given previously in this office action and are fully incorporated here.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition of Gallagher’875 comprising levetiracetam in view of Mekonnen’268, that is to further include a GABAA α5 receptor agonist, and in further view of Gallagher’075 to administer the levetiracetam between 0.07 mg to 350 mg. One of ordinary skill in the art would have been motivated to make this motivation because the prior art of Mekonnen’268 and Gallagher’075 taught that both the GABAA α5 receptor agonist and levetiracetam separately were useful in method of treating cognitive impairment associated. Thus one of ordinary skill in the art would have a reasonable expectation that a composition comprising both the GABAA α5 receptor agonist and levetiracetam would at least be as effective as a separate compositions.
Discussion of the Prior art
The closet prior art of US Patent Application Publication Number US 2020/0048268 A1 to Mekonnen et.al. (herein after Mekonnen’268; cited on the IDS submitted September 12th, 2023) teach compounds, compositions, and methods for the treating cognitive impairment associated with central nervous system, (CNS) disorders cognitive impairment associated with brain cancers, and brain cancers in a subject in need thereof (page 1 paragraph 0003). Additionally, Mekonnen’268 teach pharmaceutical compositions comprising a compound of formula I:
PNG
media_image2.png
158
192
media_image2.png
Greyscale
(page 1 paragraph 0011) a pharmaceutically acceptable salt, hydrate, solvate, polymorph, isomer, or combination thereof (page 17 paragraph 0418) as GABAA α5 receptor positive allosteric modulators (page 17 paragraph 0419). More specifically, Mekonnen’268 teach compound 606 5-((3-chloro-7-(methoxymethyl)-9Hbenzo[f]imidazo[ 1,5-a] [1,2,4]triazolo[ 4,3-d] [1,4]diazepin-1 0-yl)ethynyl)-2-methoxythiazole of the structure
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(page 240 paragraph 2094). Moreover, Mekonnen’268 teach embodiments wherein the dose of compounds of the disclosure, which include compound 606, is between 0.007 and 7000 mg/day (page 134 paragraph 1362). Furthermore, Mekonnen’268 teach that the compounds and compositions of the disclosure, which includes compound 606, may be administered for slow, controlled or extended release form (page 133 paragraph 1359). Additionally, Mekonnen’268 teach embodiments wherein the compositions of the disclosure which includes compounds of the disclosure, which further includes compound 66, can also include other therapeutically useful agents (page 134 paragraph 1366).
However, Mekonnen’268 fails to teach a pharmaceutical composition comprising a polymorph crystalline Form A as recited in claim 12, Form B as recited in claim 13, Form C as recited in claim 14, Form E as recited in claim 15, and Form F as recited in claim 16. Moreover, the prior art fails to provide motivation obvious the polymorphs as recited in claims 12 – 16. Thus given that the closet prior art fails to anticipate or render obvious the crystal forms of claims 12 – 16; the crystal forms are free of the prior art.
Conclusion
Claims 1 – 3, 10 – 12, 17 – 19, and 22 are rejected. Claims 13 – 16 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627