DETAILED ACTION
Status of Application
The response filed 05/05/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1, 13 have been amended.
Claim 7, 19, 26-27 has been cancelled.
A terminal disclaimer was submitted for U.S. Pat. Application 17975789, U.S. Pat. Application 18/114469, U.S. Pat. 11529333, and U.S. Pat. 12491179 on 05/05/2026 and approved on 05/05/2026; wherein the double patenting rejection to these items are withdrawn.
Applicant had previously elected Group I in response to restriction requirement and for the examination.
Claims 1, 5, 11-15, 17, 23-24, 28-29 are pending in the case.
Claims 1, 5, 11-12, 28-29 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All grounds not addressed in the action are withdrawn or moot as a result of amendment or terminal disclaimer.
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 § 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, 11-12, 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 and the exemplified strawberry flavor in Example 2 (Page 9 line 11-18, Page 10 line 13-Page 11 line 2, Page 12 line 19-21, Example 2 Page 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 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. It is also prima facie obvious to incorporate known flavorings like strawberry as Heller teaches the inclusion of flavorings with a reasonable expectation of success absent evidence of criticality for the claimed flavor.
While the prior art does not teach the exact claimed dependent values for the sodium benzoate (1-2mg/ml=0.1-0.2%wt.), they are embraced by the taught range of Heller (0.1-1.0%wt.) 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 separate 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 been 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, 11-12, 29 above, further in view of www.mystrica.com (0.1M Citric acid-Sodium citrate buffer buffer - pH range 3.0-6.2).
Rejection:
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.
Response to Arguments:
Applicant arguments are those presented with regards to Heller et al. in view of Dainippon Sumitomo Pharma and Gandhi et al. which are addressed above.
Applicant’s remaining argument to www.mystrica.com that it does not have an example of an oral formulation of zonisamide is to the reference individually which is not persuasive as 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).
Accordingly, the rejection stands.
Claims 1, 5, 11-12, 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) and Medisca (Suggested Flavoring Reference Chart).
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].
Medisca teaches that flavorings are known for taste masking and masking drug classes which include raspberry, tutti frutti, peppermint oil, and strawberry.
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 and strawberry flavoring as suggested by Dainippon Sumitomo Pharma and Namburi et al. and Medisca 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. It is also prima facie obvious to incorporate a known flavoring for its known purpose with a reasonable expectation of success absent evidence of criticality for the claimed flavor.
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 Namburi is cited for viscosity/suspending/thickening agents with exemplification of ibuprofen/acetaminophen/guaifenesin, that the references 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 Namburi 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, Namburi is presented merely to show known thickening/suspending agents are present from about 0.05-about 5%. 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 separate 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 Namburi 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 been 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 Namburi et al. (U.S. Pat. Pub. 2008/0260837) and Medisca (Suggested Flavoring Reference Chart).as applied to claims 1, 5, 11-12, 29 above, further in view of www.mystrica.com (0.1M Citric acid-Sodium citrate buffer buffer - pH range 3.0-6.2).
Rejection:
The teaching of Heller et al. in view of Dainippon Sumitomo Pharma and Namburi et al. and Medisca are addressed above.
Heller et al. in view of Dainippon Sumitomo Pharma and Namburi et al. and Medisca 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.
Response to Arguments:
Applicant arguments are those presented with regards to Heller et al. in view of Dainippon Sumitomo Pharma and Namburi et al. and Medisca which are addressed above.
Applicant’s remaining argument to www.mystrica.com that it does not have an example of an oral formulation of zonisamide is to the reference individually which is not persuasive as 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).
Accordingly, the rejection stands.
Claims 1, 5, 11-12, 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gandhi et al. (WO 2011/107855) in view of Ohno et al. (WO 2017/057562) and www.mystrica.com (0.1M Citric acid-Sodium citrate buffer buffer — pH range 3.0-6.2).
CA 2999414 is the national stage entry of WO 2017/057562 and will be used as the translation. All references will be to the translation.
Rejection:
Gandhi et al. teaches an oral liquid suspension dosage form comprising actives including zonisamide and levetiracetam. The liquid suspension contains thickening agents (suspension agent/stabilizers) like xanthan gum and carboxymethylcellulose or its alkali metal salt (i.e. sodium carboxymethylcellulose, sodium CMC) and microcrystalline cellulose (MCC) and mixtures thereof (preferably about 1-about 15%), excipients, inert pellets with seal coating and drug layer (abstract, claims 1, 4, 6-7, 10, 12-13; Page 3 line 10-Page 4 line 14, Page 5 line 1-Page 6 line 4, Page 6 line 25-28, Page 11 line 1-4). The suspension can be aqueous and include buffers like sodium citrate and citric acid (monohydrate, example 3) and sodium phosphate and mixtures thereof - with the buffer being the preferred mixture of citric acid and sodium citrate, sweeteners like aspartame and sucrose, flavorings like peppermint and the exemplified strawberry (Example 2), preservatives like sodium benzoate from 0.01-to 5%, inert cores that are sugar spheres or other equivalents like microcrystalline cellulose), fillers like microcrystalline cellulose (about 1-about 50%), binders like sodium carboxymethylcellulose (about 0.1-about 20%), and humectants like glycerin and propylene glycol (wetting agents, Page 7 line 11-15, Page 8 line 27-Page 9 line 18, Page 10 line 13-Page 11 line 4, Page 11 line 20-26, Page 12 line 8-Page 13 line 15). The dosage form can be prepared with the therapeutic dosage of the active. Example 2 contains a coated active with HPMC (hydroxypropylmethylcellulose) in an aqueous suspension with xanthan gum, parabens (preservative), aspartame (sweetener), strawberry flavor. Example 5-6 are to pellets that utilize microcrystalline cellulose cores that are suspended in aqueous based dispersing agent with additives (see full document specifically areas cited).
While Gandhi et al. does not expressly teach an example with zonisamide, but does teach the suspension with incorporation of an active like zonisamide with various excipients and exemplifies a suspension with an active and thickener and other excipients such as Example 2; wherein the formulation of the suspension like Example 2 with another active like zonisamide with the taught excipients like the thickening agents (suspension agent/stabilizers) of xanthan gum, preservatives like sodium benzoate, with the taught buffers, are prima facie obvious with a reasonable expectation of success.
Gandhi et al. does not expressly teach the amount of zonisamide or the recited pH range, but does teach the inclusion of the therapeutic dose of the active in the suspension and teaches the inclusion of buffers including a preferred mixture of citric acid and sodium citrate.
Ohno et al. teaches that zonisamide can be formulation for oral route including suspension [124] and the effective dose is 1 mg to 2000 mg specifically ranges of 10mg to 1000mg and 20mg to 600mg [124-125], and be 0.1-70% of the formulation [126].
www.mystrica.com teaches that a citrate buffer contains citric acid monohydrate and trisodium citrate dihydrate and water, and that it produces a pH range of 3.0-6.2.
Wherein it would be obvious to one or ordinary skill in the art before the effective filing date of the claimed to invention incorporate zonisamide within the known effective range and to incorporate the known components of a citrate buffer as suggested by Ohno et al. and www.mystrica.com teaches and produce the claimed invention; as it is prima facie obvious to optimize the amount of zonisamide within the known effective range and arrive at the claimed values with a reasonable expectation of success absent evidence of criticality for the claimed amount of zonisamide. It is also prima facie obvious to incorporate the known components of a citrate buffer that is taught to be included in the composition and adjust the pH of the taught citrate buffer within its known range and arrive at the claimed values with a reasonable expectation of success absent evidence of criticality. It is also prima facie obvious to optimize around the taught pH based on the known pH range of the preferred citrate buffer and arrive at the recited values absent evidence of criticality for the claimed values. As the suspension contains the recited structural components claimed (zonisamide, suspending agent comprising xanthan gum, water, recited buffers, preservative, and sweetener, pH), the composition would be expected to have the same impurity profile at the recited conditions which is dictated by the structural components as taught by the instant disclosure.
With regards to the amount of suspending agents (i.e. xanthan gum) and preservative like sodium benzoate, it falls within the taught range wherein it would be prima facie obvious to optimize within the taught ranges and arrive at the claimed values (i.e. about 3-about 3.5mg/ml xanthan, about 1-2mg/ml sodium benzoate) as a means to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Conclusion
Claims 1, 5, 11-12, 28-29 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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