DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Formal Matters
Applicant’s response in the reply filed on 06 April 2026 are acknowledged and have been fully considered. Claims 1-20 are pending. Claims 1-9 are under consideration in the instant office action. Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05 December 2023, 01 August 2024, and 12 January 2026 are noted and the submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the references. Signed copies are attached herein.
Election/Restrictions
Applicant's election without traverse of Group I (claims 1-9) in the reply filed on 06 April 2026 is acknowledged. Additionally, Applicant’s election of AKST4290 as the API type; carnauba wax as the wax type; OPADRY moisture barrier film coating as the second coating; and ACRYL-EZE enteric coating as the third coating in the reply filed on 06 April 2026 is also acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Objection to the title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the instant application is “PROTECTIVE COATING FOR MOISTURE SENSITIVE PHARMACEUTICAL COMPOSITIONS”. The title should be brief but technically accurate and descriptive and should contain fewer than 500 characters. The title does not describe the main ingredients and perhaps the targeted active agent. Inasmuch as the words "new," "improved," "improvement of," and "improvement in" are not considered as part of the title of an invention, these words should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Similarly, the articles "a," "an," and "the" should not be included as the first words of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 7 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.
Claim 5 contains the trademark/trade name OPADRY®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “an industry-standard, fully formulated film-coating system for pharmaceutical tablets and nutritional supplements produced by Colorcon, it combines polymers, plasticizers, and pigments into a dry concentrate. When mixed with water or solvents, it creates a liquid that easily sprays onto capsules and tablets”. The types of ingredients vary with the specific type of OPADRY. Accordingly, the identification/description is indefinite.
Claim 7 contains the trademark/trade name “ACRYL-EZE®”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe aqueous acrylic enteric systems with a range of fully formulated coatings that provide pH-targeted resistance. The ingredients vary with the specific type of “ACRYL-EZE®”. Accordingly, the identification/description is indefinite.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Note: The claims are examined with respect to the elected species wherein s AKST4290 as the API type; carnauba wax as the wax type; OPADRY moisture barrier film coating as the second coating; and ACRYL-EZE enteric coating as the third coating.
Claims 1-2 and 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. (US 2014/0328912) in view of Powell et al. (Poster Presented on Neurology, April 14, 2020 issue) and Farrell et al. (US 2010/0291183).
Applicants’ claims
Applicants claim “A pharmaceutical composition comprising: a tablet comprising an active pharmaceutical ingredient (API); a first coating on a surface of the tablet comprising wax; and a second coating on a surface of the first coating, wherein the second coating comprises polyvinyl alcohol.” Dependent claims thereof recite additional features.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Vergnault et al. teach a tablet comprising a core containing an active agent, and a coating, the core being disposed within the coating such that the coating has a thickness about a longitudinal axis (X-Y) of about 4.85 to 4.95 mm. The position of the core within the coating dictating that the active agent is released rapidly after a lag time during which time no active agent is released (see abstract). The coating employed in a tablet according to the present invention is preferably formed of insoluble or poorly water soluble hydrophobic material. In use, the coating optimally acts merely as a barrier to the ingress of aqueous physiological media thereby providing a drug release lag time. For the reasons set forth above, optimally the tablet should have the minimum thickness possible consistent with the desired lag time. Accordingly, employing water insoluble or poorly, soluble hydrophobic coating materials, one is able to produce a coating that is relative recalcitrant to the ingress of moisture and so long lag times can be achieved with relatively thin coatings (paragraph 0025). Further, in order to achieve the rapid release of drug substance after the lag time has expired, it is desirable that the coating contains no, or substantially no, ingredients that swell and gel agents to such an extent that the coating acts as a diffusion barrier to the release of drug substance. In this regard, it is preferable that the coating contains no, or substantially no, materials such as natural or synthetic gums that modulate release of the drug substance through an intact swollen coating. Drug substance is released from the core as a result of the physical rupturing of the coating and not as a result of the drug substance diffusing through a swollen coating material. That the mechanism of drug release is substantially dependent on the physical splitting of the coating, and not on a diffusion process through a swellable and gellable coating, means that a wide range of drug substances can be delivered from tablets according to the invention in a reliable and reproducible manner paragraph 0026). The tablet coating may contain one or more water insoluble or poorly soluble hydrophobic excipients. Such excipients may be selected from any of the known hydrophobic cellulosic derivatives and polymers including alkylcellulose, ethylcellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, and derivatives thereof; polymethacrylic polymers, polyvinyl acetate and cellulose acetate polymers; fatty acids or their esters or salts; long chain fatty alcohols; polyoxyethylene alkyl ethers; polyoxyethylene stearates; sugar esters; lauroyl macrogol-32 glyceryl, stearoyl macrogol-32 glyceryl, and the like. Hydroxypropylmethyl cellulose materials are preferably selected from those low Mw and low viscosity materials such as E-Type methocel, and 29-10 types as defined in the USP (paragraph 0027). Other agents or excipients that provide hydrophobic quality to coatings may be selected from any waxy substance known for use as tablet excipients. Preferably they have a HLB value of less than 5, and more preferably about 2. Suitable hydrophobic agents include waxy substances such as carnauba wax, paraffin, microcrystalline wax, beeswax, cetyl ester wax and the like; or non-fatty hydrophobic substances such as calcium phosphate salts, e.g. dibasic calcium phosphate (paragraph 0028). The tablets described above are press-coated tablets comprising a core and a coating covering said core. However, variants of this basic construction are within the ambit of the present invention. Thus, the press-coating may be further coated with an outer coating that may be functional and/or aesthetic in its design. For example, functional coatings may include the addition an immediate release coating containing a drug substances that may be the same or different to the drug substance contained in the core (paragraph 0095). Functional coatings also include enteric coatings covering the press-coating. Enteric coated forms may be of use in treating local conditions in the bowel such as Crohn's disease, ulcerative colitis, IBS and IBD. In this embodiment, the enteric coating would prevent release of any drug before the tablet enters the bowel (paragraph 0097). Aesthetic coatings include taste, masking coatings and coloured coatings as a generally well known in the art (paragraph 0098). As stated above a wide variety of drug substances may be employed in the present invention. Drugs for treating conditions the symptoms of which result from nocturnal circadian rhythms are particularly suitable. Accordingly, drugs for treating incontinence, sleep disorders, apnoea, asthma, epilepsy, bronchitis, parkinsonism, rheumatoid arthritis, allergic rhinitis and ischaemic heart diseases, cluster and migraine headache, congestive heart failure, and depression are particularly suitable for use in tablets according to the present invention (paragraph 0047). The amount of drug substance employed in tablets of the present invention will depend on the particular drug substance used, the condition of the patient and the nature and severity of the condition to be treated. A typical drug loading might be from 1 to 50% by weight of the core (paragraph 0046).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Vergnault et al. do not specifically teach the elected active agent AKST4290. These deficiencies are cured by the teachings of Powell et al.
Powell et al. teach assessment of motor function in the practically defined off-medication state (≥12 hours off levodopa) in subjects with Parkinson’s disease (PD) following treatment for 12 weeks with placebo or AKST4290, a highly specific and potent small molecule antagonist of CCR3 (objective). Robust preclinical evidence in rodent models of PD provides the foundation for development of this novel therapeutic approach in humans. In this Phase 2 study, the efficacy and safety of 12 weeks of AKST4290 in subjects with PD will be assessed (see conclusion).
Vergnault et al. and Powell et al. do not specifically teach OPADRY moisture barrier film coating as the second coating with polyvinyl alcohol; ACRYL-EZE enteric coating; and the inclusion of sodium bicarbonate in the tablet composition. These deficiencies are cured by the teachings of Farrell et al.
Farrell et al. teach immediate release film coating systems for use on oral dosage forms such as compressed tablets and other orally-ingestible substrates which have improved moisture barrier properties. The film coating systems can be applied either directly to a substrate or after the substrate has been coated with a subcoat. In preferred aspects, the moisture barrier film coating is prepared as a dry powder mixture containing polyvinyl alcohol, a polymer with pH dependent solubility, a plasticizer, a glidant, and, optionally, a detackifier, an alkalizing agent and a pigment. Film coating compositions containing an aqueous suspension of the powder mixtures, methods of applying the coatings to substrates and the coated substrates are also disclosed (see abstract). The coated orally-ingestible substrates described above can also be made to include a subcoat film coating between the orally-ingestible substrate and the enhanced barrier film coating. The subcoat selected is preferably based on an edible film coating composition that is compatible with and adheres to both the orally-ingestible substrate and the enhanced barrier coating. Thus, the artisan may choose from a wide variety of pharmaceutical or food-acceptable coatings for use as subcoats such as Opadry® brand products available from Colorcon, Inc. or others containing freely soluble cellulosic or PVA polymers in the present invention. The subcoat is also applied to the substrate to provide from about a 0.25 to about a 5% weight gain to the orally-ingestible substrate (paragraph 0035). A non-limiting list of suitable substrates that can be coated with the inventive coating system include compressed tablets, caplets, cores including pharmaceuticals, nutraceuticals and dietary supplements as well as any other art-recognized orally ingestible core (paragraph 0037). A first aspect of the invention includes powder mixtures which are useful in preparing immediate release film coatings. The film coatings have excellent moisture barrier properties and are typically applied as aqueous suspensions to orally ingestible substrates such as compressed tablets and the like using pan coating or spraying techniques well known to those of ordinary skill. The inventive powder mixtures preferably include polyvinyl alcohol, a polymer with pH-dependent solubility, a plasticizer, a glidant, and optionally additional additives including alkalizing agents, detackifiers and pigments (paragraph 0018). The alkalizing agent may be sodium bicarbonate or other components such as known other bicarbonates, a carbonate, a phosphate, or a hydroxide of sodium or potassium, magnesium carbonate, magnesium hydroxide, ammonium carbonate, ammonium bicarbonate, calcium hydroxide, or mixtures thereof which can neutralize acidic moieties on the backbone of a polymer with pH-dependent solubility. Sodium or potassium salts are preferred in some aspects of the invention. Sodium bicarbonate is a preferred alkalizing agent. The alkalizing agent is used principally to maintain a fully soluble formulation, and to ensure the film coating solution/suspension does not require sieving before use. (paragraph 0025). Another category of useful polymers are those that are substantially insoluble above pH of about 5 but soluble at lower pH. These polymers are generally referred to as reverse enteric polymers. One particularly suitable reverse enteric polymer is poly(butyl methacrylate, 2-dimethylaminoethyl methacrylate, methyl methacrylate) 1:2:1 sold, for example, under the Eudragit E trade name (paragraph 0021). Combinations of the previously mentioned pH dependent polymers as well as fully-formulated systems comprising one or more of the polymers may be utilized. Fully-formulated film coatings comprising polymers with pH-dependent solubility include Acryl-EZE (comprising Eudragit L100-55), Sureteric (comprising PVAP) and Chromateric (comprising Kollicoat MAE-100P) tradenames. The polymers with pH-dependent solubility or formulated coatings comprising them may be used such that the pH dependent polymers are in the range of 1-15%, preferably between 2-10%, and more preferably between 4 and 8% of the final dry film coating composition (paragraph 0022).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of Vergnault et al. by including AKST4290 as an active agent because Powell et al. teach assessment of motor function in the practically defined off-medication state (≥12 hours off levodopa) in subjects with Parkinson’s disease (PD) following treatment for 12 weeks with placebo or AKST4290, a highly specific and potent small molecule antagonist of CCR3 (objective). One of ordinary skill in the art would have been motivated to do so because Robust preclinical evidence in rodent models of PD provides the foundation for development of this novel therapeutic approach in humans. In this Phase 2 study, the efficacy and safety of 12 weeks of AKST4290 in subjects with PD will be assessed (see conclusion). It should be noticed that Vergnault et al. teach that as stated above a wide variety of drug substances may be employed in the present invention. Drugs for treating conditions the symptoms of which result from nocturnal circadian rhythms are particularly suitable. Accordingly, drugs for treating incontinence, sleep disorders, apnoea, asthma, epilepsy, bronchitis, parkinsonism, rheumatoid arthritis, allergic rhinitis and ischaemic heart diseases, cluster and migraine headache, congestive heart failure, and depression are particularly suitable for use in tablets according to the present invention (paragraph 0047). One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Vergnault et al. and Powell et al. because both references are drawn to an oral pharmaceutical composition that are applicable for treatment of Parkinson’s disease.
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of Vergnault et al. and Powell et al. to include a second coating layer comprising OPADRY and PVA because Farrell et al. teach immediate release film coating systems for use on oral dosage forms such as compressed tablets and other orally-ingestible substrates which have improved moisture barrier properties. The film coating systems can be applied either directly to a substrate or after the substrate has been coated with a subcoat. In preferred aspects, the moisture barrier film coating is prepared as a dry powder mixture containing polyvinyl alcohol, a polymer with pH dependent solubility, a plasticizer, a glidant, and, optionally, a detackifier, an alkalizing agent and a pigment. Film coating compositions containing an aqueous suspension of the powder mixtures, methods of applying the coatings to substrates and the coated substrates are also disclosed (see abstract). One of ordinary skill in the art would have been motivated to do so because Farrell et al. teach that the coated orally-ingestible substrates described above can also be made to include a subcoat film coating between the orally-ingestible substrate and the enhanced barrier film coating. The subcoat selected is preferably based on an edible film coating composition that is compatible with and adheres to both the orally-ingestible substrate and the enhanced barrier coating. Thus, the artisan may choose from a wide variety of pharmaceutical or food-acceptable coatings for use as subcoats such as Opadry® brand products available from Colorcon, Inc. or others containing freely soluble cellulosic or PVA polymers in the present invention. The subcoat is also applied to the substrate to provide from about a 0.25 to about a 5% weight gain to the orally-ingestible substrate. The examiner notes that the subcoat provides aesthetic as well as protecting the core from oxidative and other external effects (paragraph 0035). A non-limiting list of suitable substrates that can be coated with the inventive coating system include compressed tablets, caplets, cores including pharmaceuticals, nutraceuticals and dietary supplements as well as any other art-recognized orally ingestible core (paragraph 0037). A first aspect of the invention includes powder mixtures which are useful in preparing immediate release film coatings. The film coatings have excellent moisture barrier properties and are typically applied as aqueous suspensions to orally ingestible substrates such as compressed tablets and the like using pan coating or spraying techniques well known to those of ordinary skill. The inventive powder mixtures preferably include polyvinyl alcohol, a polymer with pH-dependent solubility, a plasticizer, a glidant, and optionally additional additives including alkalizing agents, detackifiers and pigments (paragraph 0018). One of ordinary skill in the art would have been motivated to include sodium bicarbonate in the tablet composition because Farrell et al. teach that the alkalizing agent may be sodium bicarbonate or other components such as known other bicarbonates, a carbonate, a phosphate, or a hydroxide of sodium or potassium, magnesium carbonate, magnesium hydroxide, ammonium carbonate, ammonium bicarbonate, calcium hydroxide, or mixtures thereof which can neutralize acidic moieties on the backbone of a polymer with pH-dependent solubility. Sodium or potassium salts are preferred in some aspects of the invention. Sodium bicarbonate is a preferred alkalizing agent. The alkalizing agent is used principally to maintain a fully soluble formulation, and to ensure the film coating solution/suspension does not require sieving before use (paragraph 0025). One of ordinary skill in the art would have been motivated to use Acryl-EZE as an enteric coating polymer because Farrell et al. teach combinations of the previously mentioned pH dependent polymers as well as fully-formulated systems comprising one or more of the polymers may be utilized. Fully-formulated film coatings comprising polymers with pH-dependent solubility include Acryl-EZE (comprising Eudragit L100-55), Sureteric (comprising PVAP) and Chromateric (comprising Kollicoat MAE-100P) tradenames. The polymers with pH-dependent solubility or formulated coatings comprising them may be used such that the pH dependent polymers are in the range of 1-15%, preferably between 2-10%, and more preferably between 4 and 8% of the final dry film coating composition (paragraph 0022). The Acryl-EZE enteric polymer layer will help protect the active from degradation under the gastric acid environment. Furthermore, in the case where the claimed amounts of active and other ingredients "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, differences in concentration or any measurable parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Vergnault et al., Powell et al., and Farrell et al. because all of the references are drawn to pharmaceutical compositions for the delivery of active agents.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. (US 2014/0328912) in view of Powell et al. (Poster Presented on Neurology, April 14, 2020 issue) and Farrell et al. (US 2010/0291183) as applied to claims 1-2 and 4-9 above, and further in view of Jerry Allen Biddle Sr (US Patent No. 3,438,797).
Applicants’ claims
Applicants claim “A pharmaceutical composition comprising: a tablet comprising an active pharmaceutical ingredient (API); a first coating on a surface of the tablet comprising wax; and a second coating on a surface of the first coating, wherein the second coating comprises polyvinyl alcohol.” Dependent claims thereof recite additional features.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
The teachings of Vergnault et al., Powell et al., and Farrell et al. are described in detail above and are incorporated herein by reference.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Vergnault et al., Powell et al., and Farrell et al. do not specifically teach the amount of carnauba wax as recited in claim 2. These deficiencies are cured by the teachings of Jerry Allen Biddle Sr.
Jerry Allen Biddle Sr teaches the present invention resides in a method of preparing imprinted tablets which comprises the steps of tumbling sugar-coated tablets in contact with a wax emulsion for a period of time only sufficient to completely cover the tablets with a thin, uniform, unpolished coating of wax, drying the unpolished wax coating, imprinting ink indicia on a portion of the dry unpolished coating, drying the imprinted indicia, and then applying a protective transparent outer coating of a suitable material over the imprinted wax coating (column 2, lines 29-38). The wax emulsions of the present invention are oil-inwater emulsions of waxes such as parafiin wax or carnauba wax, which are obtained by emulsification of the wax in distilled water with a suitable surfactant or a mixture or blend of surfactants. Although the preferred waxes are parafiin wax and carnauba wax, any of the commercially available, pharmaceutically acceptable waxes, such as for example beeswax, may be used in the practice of this invention (column 2, lines 39-47). To attain the desired unpolished coating of wax on the tablets, those skilled in the art will appreciate that the amount of coating solution to be used, the concentration of wax in the coating solution and the time the tablets are allowed to tumble will vary according to such factors as the number of tablets to be coated in a single operation, the size of the tablets, and the like. According to the practice of this invention sugar-coated tablets measuring approximately 0.235 inch thick by 0.360 inch in diameter were wax coated in batches of about 160,000 tablets. For coating a batch of tablets of this size it was found that an operable concentration of wax in the coating solution is from about 0.5 to about 4.6 weight percent. More specifically, in the case of paraffin wax, an operable concentration is from about 0.5 to 4.6 weight percent and preferably, about 1.0 weight percent. For a carnauba wax coating the concentration of wax in the coating solution should be from about 1.0 to about 4.0 weight percent, with the preferred concentration being about 1.0 weight percent. As noted hereinabove, the time the tablets are allowed to tumble in the coating solution, that is, the coating time, is not narrowly critical; it will vary according to such factors as the number of tablets to be coated in a single operation, size of the tablets, etc. In the practice of this invention best results are obtained by allowing the tablets to tumble in the coating solution for from about 2 minutes to about 3 minutes. After application of the wax coating the tablets are removed from the coating pan and placed on drying racks where they are allowed to remain until the wax coating is dry. Once the coating is thoroughly dry the wax-coated tablets may be imprinted with ink indicia in any conventional manner, it being necessary simply to cause the tablets to bear against a printing mechanism such as a roller or stamp having the desired indicia engraved therein or embossed thereon and supplied with an edible ink. For imprinting of the ink indicia on the tablets, it is preferred to use any of the various commercially available shellac based edible ink compositions (column 3, lines 56-75 and column 4, lines 1-19).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of Vergnault et al., Powell et al. and Farrell et al. by including carnauba wax in amounts as recited in claim 2 because Jerry Allen Biddle Sr teaches the present invention resides in a method of preparing imprinted tablets which comprises the steps of tumbling sugar-coated tablets in contact with a wax emulsion for a period of time only sufficient to completely cover the tablets with a thin, uniform, unpolished coating of wax, drying the unpolished wax coating, imprinting ink indicia on a portion of the dry unpolished coating, drying the imprinted indicia, and then applying a protective transparent outer coating of a suitable material over the imprinted wax coating (column 2, lines 29-38). The wax emulsions of the present invention are oil-inwater emulsions of waxes such as parafiin wax or carnauba wax, which are obtained by emulsification of the wax in distilled water with a suitable surfactant or a mixture or blend of surfactants. Although the preferred waxes are parafiin wax and carnauba wax, any of the commercially available, pharmaceutically acceptable waxes, such as for example beeswax, may be used in the practice of this invention (column 2, lines 39-47) One of ordinary skill in the art would have been motivated to do so because Jerry Allen Biddle Sr teaches that to attain the desired unpolished coating of wax on the tablets, those skilled in the art will appreciate that the amount of coating solution to be used, the concentration of wax in the coating solution and the time the tablets are allowed to tumble will vary according to such factors as the number of tablets to be coated in a single operation, the size of the tablets, and the like. According to the practice of this invention sugar-coated tablets measuring approximately 0.235 inch thick by 0.360 inch in diameter were wax coated in batches of about 160,000 tablets. For coating a batch of tablets of this size it was found that an operable concentration of wax in the coating solution is from about 0.5 to about 4.6 weight percent. More specifically, in the case of paraffin wax, an operable concentration is from about 0.5 to 4.6 weight percent and preferably, about 1.0 weight percent. For a carnauba wax coating the concentration of wax in the coating solution should be from about 1.0 to about 4.0 weight percent, with the preferred concentration being about 1.0 weight percent. As noted hereinabove, the time the tablets are allowed to tumble in the coating solution, that is, the coating time, is not narrowly critical; it will vary according to such factors as the number of tablets to be coated in a single operation, size of the tablets, etc. In the practice of this invention best results are obtained by allowing the tablets to tumble in the coating solution for from about 2 minutes to about 3 minutes. After application of the wax coating the tablets are removed from the coating pan and placed on drying racks where they are allowed to remain until the wax coating is dry. Once the coating is thoroughly dry the wax-coated tablets may be imprinted with ink indicia in any conventional manner, it being necessary simply to cause the tablets to bear against a printing mechanism such as a roller or stamp having the desired indicia engraved therein or embossed thereon and supplied with an edible ink. For imprinting of the ink indicia on the tablets, it is preferred to use any of the various commercially available shellac based edible ink compositions (column 3, lines 56-75 and column 4, lines 1-19). Furthermore, in the case where the claimed amounts of active and other ingredients "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, differences in concentration or any measurable parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Vergnault et al., Powell et al., Farrell et al., and Jerry Allen Biddle Sr because all of references are drawn to pharmaceutical composition comprising active agents.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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