Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Receipt of amendment and response dated 9/2/25 is acknowledged.
Claims 6 and 7 have been canceled.
Claims 1-5 and 8-55 are pending.
Claims 27-55 have been withdrawn as being non-elected.
Claims 1-5 and 8-26 drawn have been considered for examination.
The following rejections have been maintained:
Claim Rejections - 35 USC § 103
Claims 1-5, 8-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US 11602507 to Guditi, in view of WO 91/13612 to Grattan (cited on IDS dated 8/21/23), Singh et al (FABAD J. Pharm. Sci., 32, 91-100), US 6193962 to Metcalf et al., and US 5296228 to Chang.
Guditi teaches an oral extended release composition, comprising memantine or its pharmaceutically acceptable salt as an active ingredient, resin complexation ingredient, release retardant, extended release coating system and the composition further comprising diluents, viscosity increasing agents, glidants, sweeteners, stabilizing agents, preservatives and other pharmaceutically acceptable excipients, wherein the drug-resin complex and drug-resin complex matrix particulates and coated drug-resin
complex particulates have the specific particle size range (abstract).
Guditi recognizes that flocculation/agglomeration problem with the use of polymethacrylic acid polymers in the extended-release coating, and states that employing optimizing the resonates in the matrix composition (col. 4, l 19-25).
For the claimed dispersing agent of claim 2, Guditi teaches stabilizing agents (col. 6-7) and further specifically mentions mixing polyvinylpyrrolidone (col. 9, l 18-26) of instant claim 3. While Guditi does not teach PVP as dispersing agent, a compound and its property are inseparable. Accordingly, one of an ordinary skill in the art would have expected the composition of modified by including PVP of Guditi, would result in the instant dispersible composition.
Instant claim 4, Guditi teaches an oral suspension, see col. 17, l 10-43.
For the claimed ion exchange resins, Guditi teaches anionic and cationic exchange resins (col. 11, l 38-41) and cholestyramine (Duolite), AMBERLITE IRP-169 etc., and meet instant claims 11-15.
For the ratios of active to resin in claims 9-10 (5:1 to 1:100 or 2:1 to 1:20 respectively), Guditi teaches 1:0.5 to 1:3.5 and most preferably 1:1 to 1:3 (col. 12, l 4-10). While Guditi does not teach the exact claimed amounts, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to optimize the amounts of resin and active agents in preparing the pharmaceutical composition because Guditi suggests 5% to 15% of the active agent and 5 to 25% resin complexation ingredient (see the described embodiments in col. 6-7) for providing extended release of the active agents, and the amounts taught by Guditi overlap with the ranges of concentrations of instant claims 5 and 16.
For the claimed particle sizes of claims 1 and 7-8, Guditi teaches a particle size range of 40-250 microns, preferably 40-150 microns (col. 10, l 41-44).
Instant claims require “micronized ion-exchange resin particles as well as resin-therapeutic complex having particle sizes from 1 micron to 30 micron”.
Grattan teaches a controlled release composition comprising a drug-resin complex formed from an ion-exchange resin and a pharmaceutically active drug, with at least 20% by weight of the resinate particles have a particle size below 35 microns (abstract), at least 50% by weight or at least 60% by weight of the composition having a particle size below 50 microns (page 5, l 6-10). Grattan teaches that controlled and sustained release can be achieved from using smaller resin particles (page 4, l 25-30), whereas the targeted release may not be achievable with particles having a size greater than 50 microns (page 3, l 11-17).
Metcalfe teaches formulations comprising a medicament and an ion-exchange resin, and teaches resins such as Amberlite IRP 64, IRP 69 and IRP 88 (col. 1, l 50-67) with a particle size of 18 microns (col. 3, l 40-44) in preparing the formulation. The composition further includes viscosity agents such as xanthan gum, microcrystalline cellulose, polyvinylpyrrolidone (col. 2, l 5-50).
In this regard, Chang teaches a sustained release pharmaceutical compound delivery compositions wherein ion exchange resin particles are loaded with releasably bound pharmaceutical compounds and incorporated in an aqueous reversibly gelling polymeric solution. The pores of the ion exchange resin are sufficiently small to lock in the pharmaceutical compound without exposure to the large polymer molecules. The pharmaceutical compound remains bound within the pores of the ion exchange resin particles until after administration to a target tissue site where small ions migrate into the pores and initiate an exchange reaction (abstract). Chang teaches delivery compounds of the present invention are aqueous compositions, which are well suited for administration through injection or as drop instillable liquids or liquid sprays (col. 5, l 45-56). Chang teaches that the sustained release pharmaceutical compound delivery composition includes a plurality of porous ion exchange resin particles incorporated in an aqueous solution of a reversible viscosity modifying effective concentration of reversibly gelling polymer, and a pharmaceutical compound or compounds are ionically and reversibly bound within the pores of the porous ion exchange resin particles with the pores being sufficiently small in size to prevent the reversibly gelling polymer from diffusing into the pores. Because of this configuration, the polymer or polymers in the polymeric solution will not interact with the ionically bound pharmaceutical compound and prematurely cause the pharmaceutical compound to release into the aqueous polymeric solution (col. 6, l 10-25). The gelling agent can include polymers such as polycarboxylates, for instance, polyacrylic acid, polymethacrylic acid etc (col. 8, l 1-7). For the active agents, see col. 8, l 54-3) or alkyl celluloses, hydroxyalkyl celluloses, cellulosic ethers (col. 8, l 16-34). For the particle sizes, Chang teaches the ion exchange resin particles have a particle size of 1-100 microns (col. 7, l 4-12), more preferably 1-50 micron (col. 9, l 56-68). Chang teaches that the particle sizes in the enable easily passing through lacrimal glands and readily disperse in fluids (col. 7, l 4-12).
Hence, it would have been obvious for one of an ordinary skill in the art to prepare drug-resinate complexes of Guditi, by employing smaller particle size of the ion exchange resin particles as well as the resin-drug complex i.e., smaller than 50 microns, 1-50 microns, for instance as small as18 microns, because Grattan teaches that drug-resin complexes with a large particle size (greater than about 50 micron) are known to impart a gritty texture rendering the product unpalatable for oral consumption, even in liquid suspension (p 5, l 25-35), Metcalf teaches ion-exchange resin with a particle that falls within the claimed size and for providing a complex that not only imparts pleasant taste, mouth feel and also good bioavailability. Further, Grattan teaches that small particle of resin offer a more complete release of drug from the resin and increased bioavailability (p 6, l 5-9) and Chang teaches that the particle sizes in the range of 1-50 microns enable easily passing through lacrimal glands and readily disperse in fluids (col. 7, l 4-12). Grattan further teaches that a particle size greater than 50 microns is not preferable because the greater size impart a gritty texture rendering the product. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Hence, one of an of ordinary skill in the art would have been motivated to reduce the size of ion-exchange resin particles as also the major amount of drug-ion exchange resin (25-75% or 50-100%) particles to lower than 50 or 1-30 microns, with an expectation to provide taste masking as well as improved the bioavailability of the active in the complex and easy dispersibility for providing sustained release of the active agent.
Guditi, Metcalfe and Grattan references do not explicitly teach the claimed limitations- less than 1 wt% resin microparticles in the form of aggregates, taste masking and reduced gritty feeling.
Singh teaches ion exchange resins in drug delivery and therapeutic applications and include both resins such as cross-linked divinyl benzene and styrene polymers (p 92, col. 2). Singh teaches that excessive bitterness of the active principal ingredients (API) in oral formulations is the major taste problem faced by the pharmaceutical industry and that among the numerous available taste-making methods, ion resin exchange resins are inexpensive, simple, rapid and a cost-effective method of taste masking. Table 1 of Singh teaches taste masking of different types of bitter drugs. Singh further teaches that the drugs adsorbed on to ion exchange resin have reduced agglomeration and reduced hygroscopicity and provide a uniform and excellent flowability to the formulation (p 95).
Thus, it would have been obvious, from the teachings of Singh et al, for one of an ordinary skill in the art before the effective filing date of the instant invention that the ion exchange resins of Guditi (modified by Metcalfe, Grattan and Chang) provides the claimed properties i.e., effective taste masking of bitter drugs that are absorbed on the ion-exchange resins (of Guditi), provide uniformity of dispersion with very little aggregation. One of an ordinary skill in the art would have expected the claimed properties because Singh also teaches the different (cationic and anionic exchange resins) and drugs that are within the scope of the instant claimed invention.
Instant claim 5 recites 15% to 80% w/w of the liquid suspension composition comprises water. While Guditi does not explicitly state the amount of water, Guditi teaches preparation of drug-resin composition in the form of oral suspension by including water in the composition. Hence, it would have been obvious for one of an ordinary skill in the art to choose the appropriate amount of water to prepare drug-resinate complex as a suitable aqueous suspension for effective delivery of the active agent.
For the active agent of claim 25, Guditi teaches memantine or its pharmaceutically acceptable salts and further donepezil or its salts (col. 4, l 35-46), which meet the instant acidic and basic drugs, respectively.
Additionally, for claims 17-18 and 20 Grattan teaches that all ionizable drugs are administrable employing ion-exchange resin particles and suggests cationic exchange resins for drugs with basic character and anionic exchange resins for acidic drugs, and that the drugs from either resin are released upon encountering the ionic environment of the GI tract (pages 6-7). Grattan exemplifies phenylpropylamine, dextromethorphan, chlorpheniramine etc., that meet the instant claims 20-22. Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to choose a suitable drug and ion-exchange resin i.e., acidic or a basic drug to incorporate in the anionic or cationic exchange resins, respectively, of Guditi and still provide an effective release of the active agent.
Claims 1-5 and 8-26 are rejected under 35 U.S.C. 103 as being unpatentable over US 20130034503 to Howard et al (Howard) in view of US 11602507 to Guditi, WO 91/13612 to Grattan, Singh et al (FABAD J. Pharm. Sci., 32, 91-100), US 6193962 to Metcalf et al., and US 5296228 to Chang.
Howard teaches a method of treating a patient for reducing drug abuse and overdose events (abstract, 0059-0060), by administering a composition comprising ion exchange resin technology [0024], wherein the resin includes an anionic or cationic resin and at least one drug is bound to the resin [0025 & 0040]. Howard teaches the same ion-exchange resin as that of instant claims.
Howard teaches incorporating a variety of active agents in the composition and include instant claimed compounds [0102-0103] such as ibuprofen, naproxen etc (claims 17-19), morphine (of instant claims 23-24) and antimicrobial agents (instant claims 23-26). The composition can be in the form of a tablet, capsule or a suspension [0098 &0136]. Additionally, Howard exemplifies ion exchange resin composition comprising hydrocodone and pseudoephedrine (claims 20-22). The exemplified compositions of Howard include hydroxypropyl methyl cellulose, which read on the instant dispersion (claims 2 and 3). Example 1 of Howard teaches a drug to resin ratio of 12:1
Howard fails to explicitly teach the instant claim particle size, compositions comprising the claimed amounts of water, and the specific ratios of drug to resin.
The teachings of Guditi, Metcalfe, Chang and Grattan references, discussed above, have been incorporated herewith. Hence, it would have been obvious for one of an ordinary skill in the art to prepare drug-resinate complexes of Howard, by employing smaller particle size of the ion exchange resin particles as well as the resin-drug complex i.e., smaller than 50 microns, 1-50 microns, for instance as small as18 microns, because Grattan teaches that drug-resin complexes with a particle size greater than about 50 micron are known to impart a gritty texture rendering the product unpalatable for oral consumption, even in liquid suspension (p 5, l 25-35), Metcalf teaches ion-exchange resin with a particle that falls within the claimed size and for providing a complex that not only imparts pleasant taste, mouth feel and also good bioavailability. Grattan teaches that small particle of resin offer a more complete release of drug from the resin and increased bioavailability (p 6, l 5-9) and Chang teaches that the particle sizes in the range of 1-50 microns enable easily passing through lacrimal glands and readily disperse in fluids (col. 7, l 4-12). Hence, one of an of ordinary skill in the art would have been motivated to reduce the size of ion-exchange resin particles as also the major amount of drug-ion exchange resin (25-75% or 50-100%) particles to lower than 50 or less than 20 microns with an expectation to provide taste masking as well as improved the bioavailability of the active in the complex. Grattan further teaches that a particle size greater than 50 microns is not preferable because the greater size impart a gritty texture rendering the product. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Guditi, Metcalfe, Chang and Grattan references do not explicitly teach the claimed limitations- less than 1 wt% resin microparticles in the form of aggregates, taste masking and reduced gritty feeling.
Singh teaches ion exchange resins in drug delivery and therapeutic applications and include both resins such as cross-linked divinyl benzene and styrene polymers (p 92, col. 2). Singh teaches that excessive bitterness of the active principal ingredients (API) in oral formulations is the major taste problem faced by the pharmaceutical industry and that among the numerous available taste-making methods, ion resin exchange resins are inexpensive, simple, rapid and a cost-effective method of taste masking. Table 1 of Singh teaches taste masking of different types of bitter drugs. Singh further teaches that the drugs adsorbed on to ion exchange resin have reduced agglomeration and reduced hygroscopicity and provide a uniform and excellent flowability to the formulation (p 95).
Thus, it would have been obvious, from the teachings of Singh et al, for one of an ordinary skill in the art before the effective filing date of the instant invention that the ion exchange resins of Howard (modified by Guditi, Metcalfe, Chang and Grattan) provides the claimed properties i.e., effective taste masking of bitter drugs that are absorbed on the ion-exchange resins (of Guditi), provide uniformity of dispersion with very little aggregation. One of an ordinary skill in the art would have expected the claimed properties because Singh also teaches the different (cationic and anionic exchange resins) and drugs that are within the scope of the instant claimed invention.
Instant claim 5 recites 15% to 80% w/w of the liquid suspension composition comprises water. While Guditi does not explicitly state the amount of water, Guditi teaches preparation of drug-resin composition in the form of oral suspension by including water in the composition. Further, with respect to the ratios of drug to resin particles, Guditi suggests 5% to 15% of the active agent and 5 to 25% resin complexation ingredient (see the described embodiments in col. 6-7) for providing extended release of the active agents, and the amounts taught by Guditi overlap with the ranges of concentrations of instant claims 5 and 16. Hence, it would have been obvious for one of an ordinary skill in the art to prepare the composition of Howard in the form of a suspension by choosing the appropriate amount of water in relation to the ratio or the amounts of drug-ion exchange resin, so as to prepare a suspension for effective delivery of the active agent.
Double Patenting
Claims 1-5, 8-23 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of copending Application No. 17/618033 (US 20220257469) in view of US 11602507 to Guditi, WO 91/13612 to Grattan, Singh et al (FABAD J. Pharm. Sci., 32, 91-100), US 6193962 to Metcalf et al., and US 5296228 to Chang.
Copending claims 1-37 are directed to a unit dose system comprising a self-dispersible dry pharmaceutical composition that comprises at least one active agent, a taste-masking agent, a matrix forming agent and further include an ion exchange resin that is micronized to a size of less than 50 microns (copending claim 13). Claim 14 of the copending claims recite the instant claimed resins (see instant claim 15).
The copending claims recite self-dispersible composition, copending claims recite employing a taste masking agent and a matrix forming agent. The above copending claims lack the instant particle size of 1-30 microns, dispersion agent, and the amounts or ratio of active to ion exchange resins.
In this regard, Guditi teaches an oral extended release composition, comprising memantine or its pharmaceutically acceptable salt as an active ingredient, anionic and cationic exchange resins (col. 11, l 38-41) and in particular, cholestyramine (Duolite), AMBERLITE IRP-169 etc; release retardant, extended release coating system and the composition further comprising diluents, viscosity increasing agents, glidants, sweeteners, stabilizing agents, preservatives and other pharmaceutically acceptable excipients, wherein the drug-resin complex and drug-resin complex matrix particulates and coated drug-resin complex particulates have the specific particle size range (abstract). For the ratios of active to resin in claims 9-10 (5:1 to 1:100 or 2:1 to 1:20 respectively), Guditi teaches 1:0.5 to 1:3.5 and most preferably 1:1 to 1:3 (col. 12, l 4-10). For the claimed dispersing agent of claim 2, Guditi teaches stabilizing agents (col. 6-7) and further specifically mentions mixing polyvinylpyrrolidone (col. 9, l 18-26) of instant claim 3. For Instant claim 4, Guditi teaches an oral suspension, see col. 17, l 10-43).
Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to modify the claims of the copending claims and include the stabilizing agents (also read on matrix forming agents) so as to provide a dispersion as well as stabilization of the copending composition because Guditi suggests including PVP for preparing the drug-resin complexes, which meet the instant matrix forming agent. While Guditi does not teach PVP as dispersing agent, a compound and its property are inseparable. Accordingly, one of an ordinary skill in the art would have expected the composition of copending claims modified by including PVP of Guditi, would result in the instant dispersible composition.
While copending claims do not teach the exact claimed amounts, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to optimize the amounts of resin and active agents in preparing the pharmaceutical composition because Guditi suggests 5% to 15% of the active agent and 5 to 25% resin complexation ingredient (see the described embodiments in col. 6-7) for providing extended release of the active agents, and the amounts taught by Guditi overlap with the ranges of concentrations of instant claims 5 and 16.
Guditi does not explicitly teach the claimed limitations- less than 1 wt% resin microparticles in the form of aggregates, taste masking and reduced gritty feeling.
Singh teaches ion exchange resins in drug delivery and therapeutic applications and include both resins such as cross-linked divinyl benzene and styrene polymers (p 92, col. 2). Singh teaches that excessive bitterness of the active principal ingredients (API) in oral formulations is the major taste problem faced by the pharmaceutical industry and that among the numerous available taste-making methods, ion resin exchange resins are inexpensive, simple, rapid and a cost-effective method of taste masking. Table 1 of Singh teaches taste masking of different types of bitter drugs. Singh further teaches that the drugs adsorbed on to ion exchange resin have reduced agglomeration and reduced hygroscopicity and provide a uniform and excellent flowability to the formulation (p 95).
Thus, it would have been obvious, from the teachings of Singh et al, for one of an ordinary skill in the art before the effective filing date of the instant invention that the ion exchange resins of copending claims (modified by Guditi) provide the claimed properties i.e., effective taste masking of bitter drugs that are absorbed on the ion-exchange resins (of Guditi), provide uniformity of dispersion with very little aggregation. One of an ordinary skill in the art would have expected the claimed properties because Singh also teaches the different (cationic and anionic exchange resins) and drugs that are within the scope of the instant claimed invention.
Instant claims have been amended and now requires “micronized ion-exchange resin particles having particle sizes from 1 micron to 30 micron”. It is noted that the previous particle sizes claims refer to the drug-resin complex and not ion-exchange resin particles alone.
In this regard, the teachings of Guditi, Metcalfe, Grattan and Chang references, discussed above, have been incorporated herewith. Hence, it would have been obvious for one of an ordinary skill in the art to prepare drug-resinate complexes of copending claims, by employing smaller particle size of the ion exchange resin particles as well as the resin-drug complex i.e., smaller than 50 microns, 1-30 microns, for instance as small as18 microns, because Grattan teaches that drug-resin complexes with a particle size greater than about 50 micron are known to impart a gritty texture rendering the product unpalatable for oral consumption, even in liquid suspension (p 5, l 25-35), Metcalf teaches ion-exchange resin with a particle that falls within the claimed size and for providing a complex that not only imparts pleasant taste, mouth feel and also good bioavailability. Grattan teaches that small particle of resin offer a more complete release of drug from the resin and increased bioavailability (p 6, l 5-9) and Chang teaches that the particle sizes in the range of 1-50 microns enable easily passing through lacrimal glands and readily disperse in fluids (col. 7, l 4-12). Hence, one of an of ordinary skill in the art would have been motivated to reduce the size of ion-exchange resin particles as also the major amount of drug-ion exchange resin (25-75% or 50-100%) particles to lower than 50 or less than 20 microns with an expectation to provide taste masking as well as improved the bioavailability of the active in the complex. Grattan further teaches that a particle size greater than 50 microns is not preferable because the greater size impart a gritty texture rendering the product. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
This is a provisional nonstatutory double patenting rejection.
Claims 1-5 and 8-26 are provisionally rejected on the ground of 8nonstatutory double patenting as being unpatentable over claims 1-37 of copending Application No. 17/618033 (US 20220257469) in view of US 11602507 to Guditi, and US 6193962 to Metcalf et al., WO 91/13612 to Grattan, US 5296228 to Chang and Singh et al (FABAD J. Pharm. Sci., 32, 91-100), as applied to claims 1-5, 7-18, 20-22 and 25, and further in view of US 20130034503 to Howard et al (Howard).
The copending claims mentioned above fails to teach the specific therapeutic agents of claim 24.
Guditi, Metcalf, Grattan, Chang and Singh fail to teach the claimed
Howard teaches incorporating a variety of active agents in the composition and include instant claimed compounds [0102-0103] such as ibuprofen, naproxen etc (claims 17-19), morphine (of instant claims 23-24) and antimicrobial agents (instant claims 23-26). The composition can be in the form of a tablet, capsule or a suspension [0098 &0136]. Additionally, Howard exemplifies ion exchange resin composition comprising hydrocodone and pseudoephedrine (claims 20-22). The exemplified compositions of Howard include hydroxypropyl methyl cellulose, which read on the instant dispersion (claims 2 and 3). Example 1 of Howard teaches a drug to resin ratio of 12:1.
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare ion exchange resin -drug complexes of copending claims (modified by Guditi, Metcalf, Grattan, Chang and Singh) with any type of drugs including those taught by Howard i.e., ibuprofen, naproxen or morphine, and thus arrive at the instant claims. One of an ordinary skill in the art would have been motivated to do so because Howard teaches the use of ion exchange resin technology to eliminate or to diminish the overdose hazard and adverse events if excessive quantities of the inventive product are accidently or intentionally ingested, and Singh teaches the use of ion exchange resin technology to be cost-effective and for providing effective release of the drug.
Response to Arguments
Applicant's arguments filed 9/2/25 have been fully considered but they are not persuasive.
Obviousness Rejection: Applicants argue that Guditi does not teach particle size that does not overlap with the claimed sizes; Grattan does not cure the deficiencies of Guditi because the references teach at least 20% by weight of the resinate particles below 35 microns; Singh does not cure the deficiencies of Guditi because the reference ion exchange resin can be used to mask the unpleasant taste of drugs but not the claimed particle size ranges; and Metcalf teaches a median particle size of 18 microns, but fails to teach that less than 1% of the resin particles in the form of aggregate. It is argued that Chang does not teach oral composition and does not teach the preferred size range of the resin drug complex. It is argued that the Singh reference does not provide a correlation the particle sizes and taste masking, and to the uniform dispersion of the resin-therapeutic agent complexes i.e., less than 1% resin particles form aggregates.
Applicants’ arguments are not found persuasive because firstly, each of the cited references are directed to drug delivery compositions comprising ion-exchange resin particles and constitute analogous art, and therefore it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to look the relevant teachings of Grattan, Metcalfe, Chang and Singh, for modifying the composition of Guditi, with respect to the particle sizes, in modifying the teachings of Guditi or Howard. While Guditi does not teach 1-30 microns, Grattan and Metcalfe references suggest a particle size within the claimed range. Grattan teaches that controlled and sustained release can be achieved from using smaller resin particles (page 4, l 25-30), whereas the targeted release may not be achievable with particles having a size greater than 50 microns (page 3, l 11-17), thus a result-effective variable. Further, Grattan teaches that drug-resin complexes with a large particle size (greater than about 50 micron) are known to impart a gritty texture rendering the product unpalatable for oral consumption, even in liquid suspension (p 5, l 25-35), Metcalf teaches ion-exchange resin with a particle that falls within the claimed size and for providing a complex that not only imparts pleasant taste, mouth feel and also good bioavailability. Thus, one of an ordinary skill in the art would have been able to choose a smaller size of the resin-drug particles i.e., within the claimed sizes with an expectation to provide a controlled release of the active agent in the resin-drug complex. (E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Singh further teaches that the drugs adsorbed on to ion exchange resin have reduced agglomeration and reduced hygroscopicity and provide a uniform and excellent flowability to the formulation (p 95), and therefore the argument that none of the references teach less than 1% of micronized particles in the form of aggregates when re-dispersed/constituted in a liquid medium. Thus, one of an ordinary skill in the art would have recognized the importance of preparing resin-drug particles having less than 1% aggregates. Further, with respect to “less than 1 wt% of the particles forming aggregates when re-dispersed”, none of the references state the formation of aggregation and therefore, the burden is on applicants to show that the references teach aggregation of the particles when re-dispersed.
Applicants argue that Howard does not teach the claimed particle size of 1-30 microns. However, Applicants’ arguments are not found persuasive because the rejection relies on the teachings of Grattan, Guditi, Chang and Metcalf for the teachings of particle sizes. Further, Applicants arguments regarding the particle sizes have been addressed above.
Double patenting rejection: Without agreeing with the rejection, Applicants requests holding the double patenting rejection in abeyance because no claims have been allowed in the instant case. At this time no claims have been allowed and accordingly, the rejections have been maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/LAKSHMI S CHANNAVAJJALA/Primary Examiner, Art Unit 1611