DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions. The amendment filed on 02/11/2026 has been entered. Claims 1-41 are pending in this application. Claims 16, 17, 19, and 21-41 are withdrawn. Claims 1-15, 18, and 20 are currently under examination.
Priority
This application is a CON of 17/384,616 filed on 07/23/2021, now PAT 11969470, which is a CON of 15/254,195 filed on 09/01/2016, now PAT 11071787, which is a DIV of 12/407,734 filed on 03/19/2009, now ABN, which is a CIP of 11/855,642 filed on 09/14/2007, now ABN, and claims benefit of US PRO 60/844,875 filed on 09/15/2006.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application Nos. 60/844,875, 11/855,642, 12/407,734, 15/254,195, and/or 17/384,616 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-15, 18, and 20 recite “Dravet's syndrome… hypoxic-ischemic encephalopathy, subdural hematoma, periventricular leukomalacia, mental retardation, grey matter injury, white matter injury, an infection, ischemic stroke… simple partial seizures, complex partial seizures, secondarily generalized seizures, generalized seizures, typical absence seizures, atypical absence seizures, myoclonic seizures, tonic seizures, clonic seizures, generalized tonic-clonic seizures, atonic seizures, and seizures associated with juvenile myoclonic epilepsy”, “a pH adjusting agent”, “about 0.2 mg/kg/day to about 50 mg/kg/day”, “greater than or equal to about 1.4: 1”, “about 1.4: 1 to about 5: 1”, “about 1.4: 1”, “administered daily”, and/or “intraarterial, nasal, or rectal”, which are not disclosed or supported by the prior-filed Application Nos. 60/844,875 and 11/855,642. Also, claim 4 recites “the alkanolamine is ethanolamine, methanolamine, 2-aminio-2-methyl-1-propanol, valinol, or N-methyl-(2,3,4,5,6-pentahydroxyhexyl)- amine”, which is not disclosed or supported by the prior-filed Application Nos. 12/407,734, 15/254,195, and/or 17/384,616. Thus, the priority date of claims 1-3, 5-15, 18, and 20 is 03/19/2009, and the priority date of claim 4 is 04/05/2024.
Election/Restrictions
Applicant's election without traverse of Group I invention (claims 1-21) and species (a. in Formula I, n = 5, R1, R2, R3, R4, R5, R6, R7, R8 and R9 are each, independently, -O- or a -O-(butyl)-SO3- group, wherein at least one of R1 and R2 is independently a -O-(butyl)-SO3-, and S1, S2, S3, S4, S5, S6, S7, S8 and S9 are each, independently, H or a pharmaceutically acceptable cation group; b. N-methyl-(2,3,4,5,6-
pentahydroxy-hexyl)-amine; c. intravenous administration; and d. epilepsy) in the reply filed on 02/11/2026 is acknowledged. Claims 16, 17, 19, and 21-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1-15, 18, and 20 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/06/2025 has been considered.
Claim Objections
Claims 1, 7, and 9-12 are objected to because of the following informalities: In claim 1, spell out the abbreviated “POS” (line 6) to “partial onset seizures”. In claim 7, change the incorrect recitation “at least one of R1 and R2 is independently a -O-(C2-C6 alkylene)SO3- group that is” (line 1 to 2) to “the -O-(C2-C6 alkylene)SO3- group of the at least one of R1 and R2 is” as a proper dependent claim. In claim 9, change the incorrect recitation “effective amount comprises” (line 1), which is open-ended, to “effective amount is” because the effective amount is a range. In claims 10-12, insert the missing word “molar” immediately before the recitation “ratio” (line 2 of claims 10-12). Appropriate correction is required.
Claim 1 is objected to because they include reference characters which are not enclosed within parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m). Applicant is advised to change the symbol “I”, immediately underneath the Formula I structure in claim 1, to “(I)”.
Claim Rejections - 35 USC § 112
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 1-15, 18, and 20 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 pre-AIA the applicant regards as the invention. Claims 2-15, 18, and 20 depend from claim 1.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: Claim 1 recites “treating a subject who has or is at risk for developing a condition” (lines 1 to 2), and also recite “administering to a subject in need thereof” (line 16), in which the “a subject” in two locations of the same claim does not have the same scope and thus there is a gap between the necessary structural connections. Also, claim 1 recites “a composition comprising topiramate or a salt thereof”, which is open-ended and allows additional agent(a), whereas the claim further recites “wherein the sole active ingredient in the composition is topiramate or a salt thereof”, in which “active ingredient” is not specifically defined and would encompass compound of Formula I and a pH adjusting agent, and the “sole active ingredient” amounts to a gap between the necessary structural connections. Applicant is advised to change the recitation “a subject in need thereof” (line 16) to “the subject”; and delete the recitation “, wherein the sole active ingredient in the composition is topiramate or a salt thereof” (last line).
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
(I) Claims 1, 5, 7-15, 18, and 20 are rejected under pre-AIA 35 U.S.C. 102(a) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Duettmann et al. (US 2003/0235576, published on December 25, 2003, hereinafter referred to as Duettmann ‘576, also listed in IDS filed on 03/06/2025).
With regard to structural limitations “a method consisting essentially of (interpreted as “comprising” due to absent a clear indication in the specification according to MPEP 2111.03 [III]; or consists of) administering (or daily; or parenteral or intravenous administration) to a subject who has ischemic stroke an effective amount of a composition comprising topiramate, and a compound of Formula I:
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wherein at least one of R1 and R2 is independently a -O-(C2-C6 alkylene)-SO3- group (or n = 5, R1, R2, R3, R4, R5, R6, R7, R8 and R9 are each, independently, -O- or a -O-(butyl)-SO3- group, wherein at least one of R1 and R2 is independently a -O-(butyl)-SO3-, and S1, S2, S3, S4, S5, S6, S7, S8 and S9 are each, independently, H, which is elected and equivalent to sulfobutylether-beta-cyclodextrin; or further comprising a pH adjusting agent)” (claims 1, 5, 7, 8, and 13-15), “the effective amount comprises about 0.2 mg/kg/day to about 50 mg/kg/day topiramate” (claim 9), and “a molar ratio of Formula I to topiramate is greater than or equal to about 1.4:1 (or about 1.4:1 to about 5:1; or about 1.4:1” (claims 10-12):
Duettmann ‘576 disclosed a method of treating cardiac or cerebral ischaemias, most preferably stroke, more preferably ischaemic stroke. Preferably one sodium channel blocker 1 and preferably one fibrinolytic 2 are administered simultaneously or sequentially in one single or two separate preparations. Within the scope of the present drug combination, preferred sodium channel blockers 1 are those selected from the group consisting of pirmenol, sipatrigine, irampanel, pilsicainide, oxcarbazepine, topiramate, fosphenytoin, flunarizin, ropivacaine, levobupivacaine, zonisamide, mexiletine, bipridil, bisaramil, milacainide, safinamide, bupivacaine, tetrodotoxin, NS 7, the compounds of general formula la. A particularly preferred compound of formula la is crobenetine (pages 5/10 to 6/10, [0096]; pages 2/10 to 3/10, [0004 and 0068]). These formulations contain at least one compound of formula la or lb or one of the pharmaceutically acceptable salts thereof and a cyclodextrin derivative, particularly gamma-cyclodextrin (y-CD), hydroxypropyl-gamma-cyclodextrin (HP-y-CD), hydroxypropyl-beta-cyclodextrin (HP-ß-CD) or sulphobutylether-beta-cyclodextrin (SBE-ß-CD). The pharmaceutical compositions intended for parenteral use may contain isotonic agents glucose, mannitol or sodium chloride or sodium acetate or sodium acetate trihydrate as buffer combined with acetic acid or a citric acid/phosphate buffer. The molar ratio of the compound of formula la or lb to cyclodextrin is between 1:1 and 1:5 in these formulations. A molar ratio of 1:2.5 to 1:3.5 is preferred. FORMULATION EXAMPLE 4:
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(pages 6/10 to 7/10, [0106-0108, and 0116]). The compounds 1 may be administered orally, transdermally, by inhalation or parenterally. An effective dose of the compounds 1 is, preferably between 0.1 and 70 mg/dose, for intravenous or intramuscular administration. It is particularly possible to use the component 1 as a solution for infusion, preferably in a physiological saline or nutrient saline solution. In an infusion, for example 10-100 mg/h, preferably 25-60 mg/h of the compound 1 may be used (page 6/10, [0102 and 0103]).
Thus, these teachings of Duettmann ‘576 anticipate Applicant’s claims 1, 5, 7-15, 18, and 20 because both topiramate and crobenetine are preferred sodium channel blocker as component 1, and the 25-60 mg sodium channel blocker is calculated to be 0.42 to 1.0 mg/kg for a 60-kg human subject. Or, one of skilled artisan would substitute crobenetine with topiramate because both topiramate and crobenetine are preferred sodium channel blocker for treating ischemic stroke. The method of Duettmann ‘576 meets all structural limitation of claimed method and would achieve the same intended results, including “subject is a neonate” and “condition is seizures”, required by claims 18 and 20.
(II) Claims 1-15, 18, and 20 are rejected under pre-AIA 35 U.S.C. 102(a) or 102(b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Lee et al. (WO2009/018326, published on February 5, 2009, filed on July 30, 2008, and benefitted by PRO No. 60/953,186, filed on July 31, 2007 and 61/076,612, filed on June 27, 2008; hereinafter referred to as Lee ‘326).
With regard to structural limitations “a method consisting essentially of (interpreted as “comprising” due to absent a clear indication in the specification according to MPEP 2111.03 [III]; or consists of) administering (or daily; or parenteral or intravenous administration) to a subject who has epilepsy, which is elected, an effective amount of a composition comprising topiramate, and a compound of Formula I:
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wherein at least one of R1 and R2 is independently a -O-(C2-C6 alkylene)-SO3- group (or n = 5, R1, R2, R3, R4, R5, R6, R7, R8 and R9 are each, independently, -O- or a -O-(butyl)-SO3- group, wherein at least one of R1 and R2 is independently a -O-(butyl)-SO3-, and S1, S2, S3, S4, S5, S6, S7, S8 and S9 are each, independently, H, which is elected and equivalent to sulfobutylether-beta-cyclodextrin, or a pharmaceutically acceptable cation, wherein the pharmaceutically acceptable cation is an ammonium ion or an amine cation or a (C1-C6)-alkanolarnine, or N-methyl-(2,3,4,5,6-pentahydroxyhexyl)-amine, which is elected and equivalent to Meglumine; or further comprising a pH adjusting agent or N-methyl-(2,3,4,5,6-pentahydroxyhexyl)-amine)” (claims 1-8, 13-15, and 20), “the effective amount comprises about 0.2 mg/kg/day to about 50 mg/kg/day topiramate” (claim 9), and “a molar ratio of Formula I to topiramate is greater than or equal to about 1.4:1 (or about 1.4:1 to about 5:1; or about 1.4:1” (claims 10-12):
Lee ‘400 disclosed a method of treating a condition by administering to an animal suffering from the condition an effective amount of a therapeutic agent and an amount of a pyrone analog sulfoalkyl cyclodextrin such as flavonoid-sulfoalkyl cyclodextrin, e.g. flavonoid-sulfobutylether-7-ß-cyclodextrin that is a BTB transport protein activator sufficient to reduce or eliminate a side effect of the therapeutic agent. In some embodiments, the methods encompass the use of an anticonvulsant in combination with a pyrone analog-sulfobutylether-7-ß-cyclodextrin such as flavonoid-sulfobutylether-7-ß-cyclodextrin composition that reduces a side effect of the anticonvulsant (= antiepileptic or antiseizure). In some embodiments, the anticonvulsant is topiramate. Reversible, non-covalent, complexation of flavonoids with the sulfobutylether-7-ß-cyclodextrin (under the trade name Captisol™ from CyDex, Inc.) can provide for increased solubility and stability in aqueous solutions (page 70/137, [00399]; page 79/137, [00448]; page 58/137, [00347]). In another aspect, an aqueous solution of a pyrone analog such as a flavonoid comprising mixing a pyrone analog such as a flavonoid, a cyclodextrin, and a basic amino acid or sugar-amine at a pH of about 8.5 or greater. In some cases, the sugar-amine is meglumine (N-Methyl-d-glucamine). While not being bound by theory, these compounds may provide solvation of the pyrone analogs such as flavonoids, e.g. quercetin in the presence of cyclodextrins e.g. sulfobutylether-ß-cyclodextrin by having both a basic functional group which can assist in removing a proton from an acidic group on the pyrone analog such as a flavonoid, e.g. quercetin, and by having a hydrophilic portion (the polyhydroxy functionality) to assist in solvation with water. In some cases, the composition comprises an aqueous solution comprising quercetin or a quercetin derivative at about 4 mg/mL to about 12 mg/mL, sulfobutylether-{J-cyclodextrin at about 15% w/v to about 30% w/v, and meglumine at about 20 mM to about 60 mM (page 16/137, [0096]; pages 62/137 to 63/137, [00361 and 00364]). An effective amount of the transport protein modulator and an effective amount of the therapeutic agent may be administered in either single or multiple doses by any of the accepted modes of administration of agents having similar utilities, including rectal, buccal, intranasal and transdermal routes, by intraarterial injection, intravenously, intraperitoneally, parenterally (page 113/137, [00606]). In some embodiments, a concentration of the therapeutic agents is in the range of 0.0001-10 g, 0.0005-9 g, 0.001-8 g, 0.005-7 g, 0.01-6 g, 0.05-5 g, 0.1-4 g, 0.5-4 g, or 1-3 g. In some embodiments, a molar ratio of the therapeutic agent to the pyrone analog such as flavonoid-sulfobutylether-7-ß-cyclodextrin can be 0.0001: 1 to 1:1, or about 0.5:1 to about 2:1, or about 0.1:1 to about 1:1. Typically, the daily dosage of the pyrone analog sulfoalkyl cyclodextrin such as flavonoid-sulfobutylether-7-ß-cyclodextrin will be about 0.5-100 mg/kg (pages 92/137 to 93/137, [00510- 00512]; page 109/137, [00590]).
Thus, these teachings of Lee ‘326 anticipate Applicant’s claims 1-15, 18, and 20, or in the alternative, are obvious to skilled artisan to obtain the claimed effective dosage of topiramate and molar ratio to sulfoalkyl cyclodextrin. The method of Lee ‘326 meets all structural limitation of claimed method and would achieve the same intended purpose, including “subject is a neonate”, required by claim 18.
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.
(I) Claims 1 and 7-15, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 5, 7, 10-16, 18, and 20 of U.S. Patent No. 11,071,787 (Inventor: James C. Cloyd, published on Jul. 27, 2021, also listed in IDS filed on 03/06/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat ‘787 claims “A method for treating a subject who has or is at risk for developing a condition selected from the group consisting of epilepsy, seizures, anoxia, stroke, status epilepticus, refractory status epilepticus… and an infection, the method consisting essentially of (or consists of) administering to a subject in need thereof an effective amount of a composition comprising topiramate or a salt thereof, and a compound of Formula I:
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wherein: n is 4, 5 or 6; R1, R2, R3, R4, R5, R6, R7, R8 and R9 are each, independently, -O- or a -O-(C2-C6 alkylene)-SO3- group, wherein at least one of R1 and R2 is independently a -O-(C2-C6 alkylene)-SO3- group; and S1 , S2 , S3 , S4 , S5 , S6 , S7 , S8 and S9 are each, independently, H or a pharmaceutically acceptable cation (or an alkali metal, an alkaline earth metal, an ammonium ion, or an amine cation)” (claims 4, 5, and 7), reading on or overlapping with claims 1, 7, and 8 of this Application. Claims 10, 11, 12, 13, 14, 15, 16, 18, and 20 of Pat ‘787 read on or are encompassed by claims 9, 10, 11, 12, 13, 14, 15, 18, and 20 of this Application, respectively.
(II) Claims 1 and 7-15, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 5, 7, 10-16, 18, and 20 of U.S. Patent No. 11,969,470 (Inventor: James C. Cloyd, published on Apr. 30, 2024, also listed in IDS filed on 03/06/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat ‘470 claims “A method for treating a subject who has been or is diagnosed at risk for developing a condition selected from the group consisting of ischemic stroke, neonatal anoxia, conditions caused by exposure to sarin, neonatal seizures… and seizures associated with juvenile myoclonic epilepsy, the method consisting essentially of (or consists of) administering to the subject an effective amount of a composition consisting of topiramate or a salt thereof, a compound of Formula I:
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wherein: n is 4, 5 or 6; R1, R2, R3, R4, R5, R6, R7, R8 and R9 are each, independently, -O- or a -O-(C2-C6 alkylene)-SO3- group, wherein at least one of R1 and R2 is independently a -O-(C2-C6 alkylene)-SO3- group; and S1 , S2 , S3 , S4 , S5 , S6 , S7 , S8 and S9 are each, independently, H or a pharmaceutically acceptable cation (or an alkali metal, an alkaline earth metal, an ammonium ion, or an amine cation) and an additional pharmaceutically acceptable carrier” (claims 4, 5, and 7), reading on or overlapping with claims 1, 7, and 8 of this Application. Claims 8, 9, 10, 11, 12, 13, 14, 17, and 18 of Pat ‘470 read on or are encompassed by claims 9, 10, 11, 12, 13, 14, 15, 18, and 20 of this Application, respectively.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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