DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/2025 has been entered.
Status of Application
The response filed 11/20/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 13 have been amended.
Claim 6, 8, 18, 20, 25 has been cancelled.
Claims 27-29 are added.
A declaration by Taylor Salinardi has been submitted on 11/20/2025.
A declaration by Gerold Mosher has been submitted on 11/20/2025.
Applicant had previously elected Group I in response to restriction requirement and for the examination.
Claims 1, 5, 7, 11-15, 17, 19, 23-24, 26-29 are pending in the case.
Claims 1, 5, 7, 11-12, 27-29 are present for examination.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn or moot as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 7, 11-12, 27-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The independent claim is directed to a liquid oral pharmaceutical suspension comprising 20mg/ml zonisamide as the only active pharmaceutic ingredient, xanthan gum, water, a preservative comprising sodium benzoate, sucralose, a buffer, a pH of 3.5-5.0, wherein the suspension has 0.10% or less ot total impurities when stored at 40oC and 25% relative humidity for at least 1 month and is not a sustained-release pharmaceutical formulation. However, the instant specification does not provide written description for what components would be in a sustained release formulation in order to be excluded from the instant suspension to not be a sustained release formulation. Sustained release formulations contain polymers like xanthan gum which is recited in the instant claims wherein there is an indefinite issue addressed below. There is no written description as to what components would be excluded from the instant suspension so as not to be a sustained release formulation, and does not describe what components constitute a sustained release formulation to be precluded.
This is a new matter rejection.
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, 5, 7, 11-12, 27-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The independent claim and its dependent claims are directed to a liquid oral pharmaceutical suspension comprising 20mg/ml zonisamide as the only active pharmaceutic ingredient, xanthan gum, water, a preservative comprising sodium benzoate, sucralose, a buffer, a pH of 3.5-5.0, wherein the suspension has 0.10% or less ot total impurities when stored at 40oC and 25% relative humidity for at least 1 month and is not a sustained-release pharmaceutical formulation. However, it is unclear what should not be in the suspension to preclude it from being a sustained release suspension as sustained release formulations contain polymers like xanthan gum which is recited in the instant claims wherein there it is indefinite as xanthan gum is a sustained release polymer (and a thickener/suspending agent) but the claim recites that it is ano a sustain release formulation. It does not allow one to ascertain the metes and bounds the claimed invention. For purposes of examination, it is treated as a formulation with coatings with these polymers around the drug particles.
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim recites “wherein the xanthan gum is present in the liquid oral pharmaceutical suspension in an amount configured to prevent sedimentation of the suspension” but it is unclear what amount would be “configured to prevent sedimentation of the suspension” as xanthan gum by its nature is a thickener/suspending agent (prevents sedimentation) where its presence would perform the function. It does not allow one to ascertain the metes and bounds of the claim as written. For purposes of examination, any amount would apply.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5, 7, 11-12, 27, 29 are rejected under 35 U.S.C. 103 as being unpatentable over Heller et al. (US. Pat. Pub. 2017/0172961) in view of Dainippon Sumitomo Pharma (Notice of launching of a new Parkinson's disease drug "TRERIEF”) and Gandhi et al. (WO 2011/107855).
Rejection:
Heller et al. teaches a pharmaceutical suspension for oral delivery containing drug particles, water, surfactant, thickeners, and physically stable (abstract, [12, 14-15, 20, 26, 30, 75]. The drug particle formulations include levodopa (L-DOPA) and a preferred pH of about 3.5-7.5 like about 4.5 and buffers like a citrate buffer solution and phosphate buffers, and one or more drugs for treating Parkinson’s disease with the levodopa and can be at concentrations including 0.1mg/ml-20mg/ml (claim 1, [26, 30, 191, 497-506, 562, 568, 594-595, 651-652, 1150, 1239]). The drugs can be co-administered where the actives can be formulated together or separately (when separately zonisamide is the only active [101, 195]). The thickeners include celluloses like microcrystalline cellulose (MCC) and carboxymethylcellulose and its salts ([35, 71, 75,504], also suspending agents). The suspensions include preservatives like sodium benzoate from 0.1-1.0%wt. [25, 423, 506], sweeteners like sucralose and saccharine sodium, and flavorings ([423, 1251] Table 24). It can also include glycerol, ethanol, propylene glycol, and polyethylene glycol (wetting agents [71], see full document specifically areas cited).
Heller et al. does not expressly teach the inclusion of zonisamide or xanthan gum but does teach the inclusion of additional drugs for treating Parkinson’s disease with the levodopa [502] that can be formulated separately and co-administered [101], and viscosity agents including carboxymethylcellulose and microcrystalline cellulose. Heller et al. also does not specify the type of flavoring but does teach the inclusion of flavorings.
Dainippon Sumitomo Pharma teaches that zonisamide is useful for Parkinson’s disease and should be combined with levodopa (Page 1, Page 2 –Indications, and Dosage and Administration).
Gandhi et al. teaches that known thickening/viscosity agents (also called suspension stabilizers) include xanthan gum, carboxymethylcellulose or its alkali metal salt like sodium carboxymethylcellulose, microcrystalline cellulose and mixtures thereof; and are known to be present from 1-25% preferably about 1-about 15%wt.; and that known flavor agents include peppermint flavor (Page 9 line 11-18, Page 10 line 13-Page 11 line 2, Page 12 line 19-21).
Wherein it would be obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate zonisamide in the composition and xanthan gum as suggested by Dainippon Sumitomo Pharma and Gandhi et al. and produce the claimed invention; as it is prima facie obvious to include zonisamide as Heller teaches the inclusion of additional drugs for treating Parkinson’s disease with the levodopa which can be formulated separately and co-administered, and Dainippon Sumitomo Pharma expressly teaches the two drugs to be in combination for Parkinson’s disease, and optimize the amount of the drug within the taught range (i.e. 0.1-20mg/ml) with a reasonable expectation of success absent evidence of criticality for the claimed value. It is also obvious to incorporate known viscosity/thickening/suspending agents as disclosed by Gandhi, as Heller teaches their inclusion and the incorporation of another known viscosity agent (mixture) like xanthan gum with MCC and sodium CMC (carboxymethylcellulose alkali salt) for its known purpose and additive effect in their known range is prima facie obvious with a reasonable expectation of success; as it is obvious to optimize within the taught range for the mixture of viscosity agents (i.e. xanthan gum/MCC/CMC) and arrive at the claimed range (i.e. about 1% MCC/CMC and about 2-about 3.5mg/ml xanthan) as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
While the prior art does not teach the exact claimed dependent values for the sodium benzoate, they are embraced by the taught range of Heller wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. As the suspension contains the recited structural components claimed (i.e. zonisamide, xanthan gum, water, sucralose, buffers, sodium benzoate, and pH), the composition would be expected to have the same impurity profile at the recited conditions as Heller establishes and expectation of long term stability and the instant disclosure addresses that the zonisamide suspension with these structural components would have the recited impurity profile at the recited conditions.
Response to Arguments:
Applicant arguments are centered on the assertion that Heller does not teach or suggest a formulation of a second drug to be co-administered separately with levodopa nor a separate formulation of the second drug to be physically stable or with the recited components, that Dainippon is to a tablet, that Gandhi is to a sustained release suspension with pellets where it does not cure the deficiencies of Heller and Dainippon, that the reference do not provide an example of the oral formulation of zonisamide, that the references do not teach the recited xanthan gum and other components, assertion for secondary considerations, that the references do not teach a stable zonisamide suspension with the recited impurity profile at the recited conditions which is unexpected, that there is no context/disclosure to combine them with a reasonable success.
This is fully considered but not persuasive as Applicant's arguments to Heller and Dainippon and Gandhi are against the references individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Dainippon is presented merely to show that zonisamide is known to be useful for Parkinson’s disease and should be combined with levodopa, Gandhi is presented merely to show known thickening/suspending agents. The assertion that Heller does not teach/suggest a formulation of a second drug to be co-administered separately is not persuasive as contrary to Applicant’s assertion, Heller expressly teaches the drug suspension comprising levodopa with the various components and expressly teaches/defines co-administration with additional actives which can be together or separately wherein it expressly teaches/suggests formulation to contain additional actives (together in the formulation) or separately (separate drugs in the formulation). With regards to the assertion that the references do not have an example of the claimed suspension is again to the references individually as addressed above, and Applicant’s argument is an assertion for anticipation of the reference which is not the basis for obviousness rejection as presented above.
The assertion that the references do not recite the xanthan gum and other components are not persuasive as addressed by the obviousness rejection above, as Heller teaches the inclusion of thickening/suspension agents like MCC and CMC, and Gandhi teaches that mixtures of thickeners like xanthan gum, sodium CMC, and MCC are known for suspensions from about 1-15% wherein the incorporation of another known viscosity agent (mixture) like xanthan gum with MCC and sodium CMC (carboxymethylcellulose alkali salt) for its known purpose in the known range is prima facie obvious with a reasonable expectation of success; and it is also obvious to optimize within the taught range for the mixture of viscosity agents and arrive at the claimed range as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values which has not been presented. As for the assertion for secondary considerations, the Salinardi declaration and Mosher declaration are directed to the specific formulation of the ZONISADE formulation which has be patented in the grandchild application and not commensurate in scope with the instant claims which is significantly broader. Applicant’s remaining arguments that the prior art does not provide a reasonable expectation of success for arriving at the claimed formulation with the recited stability is fully considered but not persuasive. Formulation of a known oral suspension of levodopa in combination with zonisamide for its additive effect for Parkinson’s as separate formulations as addressed by Heller (wherein zonisamide is the only active in separate formulations) is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed amount of zonisamide or specific excipients. As the prior art rejection is directed to the formulation of the suspension and as the suspension contains the recited structural components claimed – the composition would be expected to have the same impurity profile at the recited conditions absent evidence to the contrary as Heller establishes and expectation of long term stability and the instant disclosure addresses that the zonisamide suspension with these structural components would have the recited impurity profile at the recited conditions.
Accordingly, the rejection stands.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Heller et al. (US. Pat. Pub. 2017/0172961) in view of Dainippon Sumitomo Pharma (Notice of launching of a new Parkinson's disease drug "TRERIEF”) and Gandhi et al. (WO 2011/107855) as applied to claims 1, 5, 7, 11-12, 27, 29 above, further in view of www.mystrica.com (0.1M Citric acid-Sodium citrate buffer buffer - pH range 3.0-6.2).
The teaching of Heller et al. in view of Dainippon Sumitomo Pharma and Gandhi et al. are addressed above.
Heller et al. in view of Dainippon Sumitomo Pharma and Gandhi et al. do not recite the components of the citrate buffer but does teach the inclusion of citrate buffer.
www.mystrica.com teaches that a citrate buffer contains citric acid monohydrate and trisodium citrate dihydrate and water.
Wherein it would be obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate the components of a citrate buffer (citric acid monohydrate and trisodium citrate dihydrate) in the composition as suggested by www.mystrica.com and produce the claimed invention; as it is prima facie obvious to include incorporate the known components of a citrate buffer when a citrate buffer is taught to be included in the composition with a reasonable expectation of success.
Claims 1, 5, 7, 11-12, 27, 29 are rejected under 35 U.S.C. 103 as being unpatentable over Heller et al. (US. Pat. Pub. 2017/0172961) in view of Dainippon Sumitomo Pharma (Notice of launching of a new Parkinson's disease drug "TRERIEF”) and Namburi et al. (U.S. Pat. Pub. 2008/0260837).
Rejection:
Heller et al. teaches a pharmaceutical suspension for oral delivery containing drug particles, water, surfactant, thickeners, and physically stable (abstract, [12, 14-15, 20, 26, 30, 75]. The drug particle formulations include levodopa (L-DOPA) and a preferred pH of about 3.5-7.5 like about 4.5 and buffers like a citrate buffer solution and phosphate buffers, and one or more drugs for treating Parkinson’s disease with the levodopa and can be at concentrations including 0.1mg/ml-20mg/ml (claim 1, [26, 30, 191, 497-506, 562, 568, 594-595, 651-652, 1150, 1239]). The drugs can be co-administered where the actives can be formulated together or separately (when separately zonisamide is the only active [101, 195]). The thickeners include celluloses like microcrystalline cellulose (MCC) and carboxymethylcellulose ([35, 71, 75,504], also suspending agents). The suspensions include preservatives like sodium benzoate from 0.1-1.0%wt. [25, 423, 506], sweeteners like sucralose and saccharine sodium, and flavorings [423, 1251 Table 24]. It can also include glycerol, ethanol, propylene glycol, and polyethylene glycol (wetting agents [71], see full document specifically areas cited).
Heller et al. does not expressly teach the inclusion of zonisamide or xanthan gum but does teach the inclusion of additional drugs for treating Parkinson’s disease with the levodopa [502] that can be formulated separately and co-administered [101], and viscosity agents including carboxymethylcellulose and microcrystalline cellulose. Heller et al. also does not specify the type of flavoring but does teach the inclusion of flavorings.
Dainippon Sumitomo Pharma teaches that zonisamide is useful for Parkinson’s disease and should be combined with levodopa (Page 1, Page 2 –Indications, and Dosage and Administration).
Namburi et al. teaches that known viscosity/suspending/thickening agents include xanthan gum, carboxymethylcellulose sodium, microcrystalline cellulose and mixtures thereof; and are known to be present from about 0.05-about 5% [20].
Wherein it would be obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate zonisamide in the composition and xanthan gum as suggested by Dainippon Sumitomo Pharma and Namburi et al. and produce the claimed invention; as it is prima facie obvious to include zonisamide as Heller teaches the inclusion of additional drugs for treating Parkinson’s disease with the levodopa which can be formulated separately and co-administered, and Dainippon Sumitomo Pharma expressly teaches the two drugs to be in combination for Parkinson’s disease, and optimize the amount of the drug within the taught range (i.e. 0.1-20mg/ml) with a reasonable expectation of success absent evidence of criticality for the claimed value. It is also obvious to incorporate known viscosity/thickening/suspending agents as disclosed by Namburi, as Heller teaches their inclusion and the incorporation of another known viscosity agent (mixture) like xanthan gum with MCC and sodium CMC (carboxymethylcellulose alkali salt) or simple substitution of one known viscosity agent for another for its known purpose in their known range is prima facie obvious with a reasonable expectation of success; as it is obvious to optimize within the taught range for the viscosity agents (i.e. xanthan gum, xanthan gum/MCC/CMC) and arrive at the claimed range (i.e. about 2-about 3.5mg/ml xanthan (0.2-0.35%), any value for MCC/CMC like about 1% with 0.3% xanthan gum) as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
While the prior art does not teach the exact claimed dependent values for the sodium benzoate, they are embraced by the taught range of Heller wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values. As the suspension contains the recited structural components claimed (i.e. zonisamide, xanthan gum, water, sucralose, buffers, sodium benzoate, and pH), the composition would be expected to have the same impurity profile at the recited conditions as Heller establishes and expectation of long term stability and the instant disclosure addresses that the zonisamide suspension with these structural components would have the recited impurity profile at the recited conditions.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Heller et al. (US. Pat. Pub. 2017/0172961) in view of Dainippon Sumitomo Pharma (Notice of launching of a new Parkinson's disease drug "TRERIEF”) and Namburi et al. (U.S. Pat. Pub. 2008/0260837) as applied to claims 1, 5, 7, 11-12, 27, 29 above, further in view of www.mystrica.com (0.1M Citric acid-Sodium citrate buffer buffer - pH range 3.0-6.2).
The teaching of Heller et al. in view of Dainippon Sumitomo Pharma and Namburi et al. are addressed above.
Heller et al. in view of Dainippon Sumitomo Pharma and Namburi et al. do not recite the components of the citrate buffer but does teach the inclusion of citrate buffer.
www.mystrica.com teaches that a citrate buffer contains citric acid monohydrate and trisodium citrate dihydrate and water.
Wherein it would be obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate the components of a citrate buffer (citric acid monohydrate and trisodium citrate dihydrate) in the composition as suggested by www.mystrica.com and produce the claimed invention; as it is prima facie obvious to include incorporate the known components of a citrate buffer when a citrate buffer is taught to be included in the composition 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, 5, 7, 11-12, 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11529333 in view of Namburi et al. (U.S. Pat. Pub. 2008/0260837).
The patented claim recite components that fall within the breath of the instant claims. The patented claim does not recite the specific sweetener but does teach the inclusion of a sweetener.
Namburi et al. teaches that known sweeteners for suspensions include sucralose (claim 13).
Wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate sucralose as suggested by Namburi et al. and produce the claimed invention as it is prima facie obvious to include a known sweetener with a reasonable expectation of success. As the suspension contains the recited structural components claimed (zonisamide, suspending agents, water, preservative, and sweetener, pH), the composition would be expected to have the same impurity profile at the recited conditions.
Response to Arguments:
Applicant requests reconsideration. This is fully considered but not persuasive as the patented claims recite a composition with the instantly claimed components and the inclusion of sweeteners which include sucralose as addressed by Namburi et al. wherein the inclusion of a known sweetener is prima facie obvious with a reasonable expectation of success wherein there is a case of double patenting.
Accordingly, the rejection stands.
Claims 1, 5, 7, 11-12, 27, 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11529333 in view of Namburi et al. (U.S. Pat. Pub. 2008/0260837).
The patented claims recite a liquid suspension comprising about 20mg/ml zonisamide, suspending agents of xanthan gum (about 2-about 3.5 mg/ml) and about 20mg/ml of a combination of microcrystalline cellulose and sodium CMC, buffers and excipients like a preservative, a pH of 3.5-5 with the same stability recitations instantly claimed. Dependent patented claims recite the same preservatives and buffers, and the inclusion of flavoring.
The independent patented claim do not recite a sweetener, the specific preservative, or carrier to be water.
Namburi et al. teaches that suspensions are known to be aqueous and include sweeteners like sucralose, preservatives like sodium benzoate from 0.05-about 2%, flavorings, and buffer components like citric acid monohydrate (abstract, claims 1, 13, 15, [23]).
Wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate sweeteners like sucralose, and other excipients such as specific known preservatives and flavorings as suggested by Namburi et al. and produce the claimed invention as it is prima facie obvious to include components known to be included in a suspension with a reasonable expectation of success. It is also prima facie obvious to optimize within the known range (i.e. sodium benzoate preservatives) and arrive at the claimed values as a means of attaining the desired therapeutic profile absent evidence of criticality for the claimed values. As the suspension contains the recited structural components claimed (zonisamide, suspending agents, water, preservative, and sweetener, pH), the composition would be expected to have the same impurity profile at the recited conditions.
Response to Arguments:
Applicant requests reconsideration. This is fully considered but not persuasive as the patented claims recite a composition with the instantly claimed components and the inclusion of excipients known to be included in a suspension (i.e. sweeteners like sucralose, a known preservative and carriers) as addressed by Namburi et al. is prima facie obvious with a reasonable expectation of success wherein there is a case of double patenting.
Accordingly, the rejection stands.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11529333 in view of Namburi et al. (U.S. Pat. Pub. 2008/0260837) as applied to claims 1, 5, 7, 11-12, 27, 29 above, further in view of www.mystrica.com (0.1M Citric acid-Sodium citrate buffer buffer - pH range 3.0-6.2).
The teaching of the patented claims in view of Namburi et al. are addressed above.
The patented claims in view of Namburi et al. do not recite the components of the citrate buffer but does teach the inclusion of buffer and components like citric acid monohydrate.
www.mystrica.com teaches that a citrate buffer contains citric acid monohydrate and trisodium citrate dihydrate and water.
Wherein it would be obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate the components of a citrate buffer (citric acid monohydrate and trisodium citrate dihydrate) in the composition as suggested by www.mystrica.com and produce the claimed invention; as it is prima facie obvious to include incorporate the known components of a citrate buffer when a citrate buffer is taught to be included in the composition with a reasonable expectation of success.
Claims 1, 5, 7, 11-12, 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12491179 (previously presented 18/665824).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are more specific than the instant claims and fall within the breath of the instant claims with the same recited impurity profile and therein obvious over the instant claims.
Response to Arguments:
Applicant requests reconsideration. This is fully considered but not persuasive as the patented claims fall within the breath instantly claimed.
Accordingly, the rejection stands.
Claims 1, 5, 7, 11-12, 27-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9, 13-14, 24-25, 29 -31 of copending Application No. 17/975789.
The copending claims recite a liquid suspension comprising about 20mg/ml zonisamide, about 2-about 3.5mg/ml xanthan gum, water, sodium benzoate, sucralose, buffers like citric acid monohydrate and trisodium citrate dihydrate, a pH of 3.5-5 with the same stability and impurity recitations instantly claimed.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant requests reconsideration. This is fully considered but not persuasive as the copending claims recite the same components falling within the breath instantly claimed.
Accordingly, the rejection stands.
Claims 1, 5, 7, 11-12, 27-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-9, 12-13, 27, 30-33 of copending Application No. 18/114469 in view of Namburi et al. (U.S. Pat. Pub. 2008/0260837).
The copending claims recite a liquid suspension comprising about 20mg/ml zonisamide, about 2-about 3.5mg/ml xanthan gum, water, buffers like citric acid monohydrate and trisodium citrate dihydrate, sweetener, preservatives, and a pH of 3.5-5 with the same stability and impurity recitations instantly claimed.
The copending claims do not recite the specific preservative or specific sweetener.
Namburi et al. teaches that suspensions are known to be aqueous and include sweeteners like sucralose, preservatives like sodium benzoate from 0.05-about 2% (abstract, claims 1, 13, 15, [23]).
Wherein it would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate sweeteners like sucralose and preservatives like sodium benzoate as suggested by Namburi et al. and produce the claimed invention as it is prima facie obvious to include known sweeteners and preservatives with a reasonable expectation of success. It is also prima facie obvious to optimize within the known range (i.e. sodium benzoate preservative) and arrive at the claimed values as a means of attaining the desired therapeutic profile absent evidence of criticality for the claimed values.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
Applicant requests reconsideration. This is fully considered but not persuasive as the copending claims recite the same components absent the specific preservative and sweetener which as addressed by Namburi et al are known wherein the inclusion of known preservatives and sweeteners for suspensions for their known purpose is prima facie obvious with a reasonable expectation of success.
Accordingly, the rejection stands.
Conclusion
Claims 1, 5, 7, 11-12, 27-29 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613