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 claim amendments and arguments in the reply filed on 04 December 2025 are acknowledged and have been fully considered. Claims 35-46 are pending. Claims 35-46 are under consideration in the instant office action. Claims 1-34 are canceled. Claims 35-42 are amended. Applicant’s claim amendments and arguments necessitated a new ground of rejections as set forth below. Accordingly, this office action is made final.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
New Claim Objections
Claims 35 and 43-46 are objected to because of the following informalities: Claims 35 and 43-46 are indicated as “New” claims in the claim status indicator. Claim 35 is clearly amended and is different from the claim set provided on 09 January 2024. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered). The claim status indicator of claims 35 and 43-46 should be “Previously presented”. Appropriate correction is required.
Claims 36-39 are objected to because of the following informalities: Claims 36-39 recite “the orally disintegrating table”. The term “table” should read as “tablet”. Appropriate correction is required.
New Rejections Necessitated by amendments
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 35 and 40 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.
Claims 35 and 40 contains the trademark/trade name “pearlitol flash”. 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 co-processed mannitol starch excipient which provides functional properties of filler/binder as well as some disintegrant benefit to orally dispersible tablet, 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.
Claims 35-39 are rejected under 35 U.S.C. 103 as being unpatentable over HANAZAWA et al. (WO2007/072146, previously cited) in view of Kashid et al. (WO2007/074472, newly cited) and Reiner et al. (US2014/0341988, newly cited).
Applicant Claims
Applicant claims an orally disintegrating tablet containing the benzimidazole recited and other ingredients.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
HANAZAWA et al. teach in one embodiment of the invention provides a compound selected from the group consisting of: 4-[(5,7-difluoro-3,4-dihydro-2H-chromen-4-yl)oxy]-N,N,2-trimethyl-1/-/-benzimidazole-6-carboxamide; 4-[(5,7-difluoro-3,4-dihydro-2H-chromen-4-yl)oxy]-2-methyl-6-(pyrrolidin-1-ylcarbonyl)-1H-benzimidazole; 4-[(5-fluoro-3,4-dihydro-2H-chromen--4-yl)oxy]-N,N,2-trimethyl-1H-benzimidazoIe-6-carboxamide; or a pharmaceutical acceptable salt thereof (see page 6, lines 38-40 and page 7, lines 1-2). Another embodiment of the invention provides a compound selected from the group consisting of: (-)-4-[((4S)-5,7-difluoro-3,4-dihydro-2H-chromen-4-yl)oxy]-N,N,2-trimethyl-1/-/-benzimidazole-6-carboxamide; (-)-4-[(5,7-difluoro-3,4-dihydro-2H-chromen-4-yl)oxy]-2-methyl-6-(pyrroIidin-1-ylcarbonyl)-1H-benzimidazole; (-)-4-[(5-fluoro-3,4-dihydro-2H-chromen-4-yl)oxy]-N, N,2-trimethyl-1-H-benzimidazole-6-carboxamide; or a pharmaceutical acceptable salt thereof (see page 7, lines 3-10).
HANAZAWA et al. disclose for tablet dosage forms, depending on dose, the drug may make up from about 1 wt% to about 80 wt% of the dosage form, more typically from about 5 wt% to about 60 wt% of the dosage form. In addition to the drug, tablets generally contain a disintegrant. Examples of disintegrants include sodium starch glycolate, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, croscarmellose sodium, crospovidone, polyvinylpyrrolidone, methyl cellulose, microcrystalline cellulose, lower alkyl-substituted hydroxypropyl cellulose, starch, pregelatinized starch and sodium alginate. Generally, the disintegrant will comprise from about 1 wt% to about 25 wt%, preferably from about 5 wt% to about 20 wt% of the dosage form. Binders are generally used to impart cohesive qualities to a tablet formulation. Suitable binders include microcrystalline cellulose, gelatin, sugars, polyethylene glycol, natural and synthetic gums, polyvinylpyrrolidone, pregelatinized starch, hydroxypropyl cellulose and hydroxypropyl methylcellulose. Tablets may also contain diluents, such as lactose (monohydrate, spray-dried monohydrate, anhydrous and the like), mannitol, xylitol, dextrose, sucrose, sorbitol, microcrystalline cellulose, starch and dibasic calcium phosphate dihydrate. Tablets may also optionally comprise surface-active agents, such as sodium lauryl sulfate and polysorbate 80, and glidants such as silicon dioxide and talc. When present, surface active agents may comprise from about 0.2 wt% to about 5 wt% of the tablet, and glidants may comprise from about 0.2 wt% to about 1 wt% of the tablet. Tablets also generally contain lubricants such as magnesium stearate, calcium stearate, zinc stearate, sodium stearyl fumarate, and mixtures of magnesium stearate with sodium lauryl sulphate. Lubricants generally comprise from about 0.25 wt% to about 10 wt%, preferably from about 0.5 wt% to about 3 wt% of the tablet. Other possible ingredients include anti-oxidants, colourants, flavouring agents, preservatives and taste-masking agents. Exemplary tablets contain up to about 80% drug, from about 10 wt% to about 90 wt% binder, from about 0 wt% to about 85 wt% diluent, from about 2 wt% to about 10 wt% disintegrant, and from about 0.25 wt% to about 10 wt% lubricant. Tablet blends may be compressed directly or by roller to form tablets. Tablet blends or portions of blends may alternatively be wet-, dry-, or melt-granulated, melt congealed, or extruded before tabletting. The final formulation may comprise one or more layers and may be coated or uncoated; it may even be encapsulated (see entire pages 36-37). The compounds of the invention may also be used in fast-dissolving, fast-disintegrating dosage forms such as those described in Expert Opinion in Therapeutic Patents, 11. (6), 981-986 by Liang and Chen (2001) (see page 36, lines 14-16). For administration to human patients, the total daily dose of the compounds of the invention is typically in the range of about 0.5 mg to about 300 mg depending, of course, on the mode of administration, preferred in the range of about 1 mg to about 100 mg and more preferred in the range of about 1 mg to about 20 mg. For example, oral administration may require a total daily dose of from about 1 mg to about 20 mg, while an intravenous dose may only require from about 0.5 mg to about 10 mg. The total daily dose may be administered in single or divided doses (see page 40).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
HANAZAWA et al. do not specifically teach the incorporation of about 50 mg of mannitol or xylitol, about 3.5 mg of sucralose, maltitol, or aspartame, ethanol, and pearlitol flash and the tablet hardness. These deficiencies are cured by the teachings of Kashid et al. and Reiner et al.
Kashid et al. teach a orally disintegrating and/or dissolving oral pharmaceutical composition, comprising one or more active pharmaceutical ingredients, one or more fillers having particle size of 100 microns or above, a high and desirable amount of silicon dioxide, one or more disintegrating agents, optionally effervescent couple, wherein said composition has good organoleptic properties like desired mouth feel and fast oral disintegration time (see abstract). An orally disintegrating and/or dissolving pharmaceutical composition comprising of: (a) one or more active pharmaceutical agents, (b) one or more fillers having average particle size of 150 microns or above, (c) high and desirable amount of silicon dioxide ranging from about 5 to 30% by weight, and optionally an effervescent couple (see claim 1). The pharmaceutical composition according to claim 1, wherein said filler is selected from the group comprising mannitol, dextrates, sorbitol, xylitol, sucrose, fructose, lactitol, erythritol or maltitol (see claim 5). The pharmaceutical composition according to claim 5, wherein said filler is preferably mannitol (see claim 6). The pharmaceutical composition according to claim 1, wherein the silicon dioxide is preferably used in an amount of about 5 to 15% by weight (see claim 7). The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition dissolves in mouth in 60 seconds or less (see claim 10). The pharmaceutical composition according to claim 1, wherein said composition further comprises disintegrant, surfactant, lubricant, anti-adherent, glidant, sweetener or flavoring agent (see claim 11). The pharmaceutical composition according to claim 11, wherein said disintegrant is selected from the group comprising polacrilin potassium, microcrystalline cellulose, low substituted hydroxypropyl cellulose, carboxymethyl cellulose, croscarmellose sodium, sodium starch glycolate or crospovidone (crosslinked polyvinylpyrrolidone) (see claim 12). The pharmaceutical composition according to claim 12, wherein said disintegrant is preferably selected from crosslinked polyvinylpyrrolidone or polacrilin potassium or a combination thereof (see claim 13). The pharmaceutical composition according to claim 11, wherein said lubricant is selected from the group comprising sodium stearyl fumarate, glyceryl behenate, calcium stearate, magnesium stearate or stearic acid (see claim 18). The pharmaceutical composition according to claim 11 , wherein said sweetening agent is selected from the group comprising aspartame, saccharin and salts thereof, acesulfame potassium, sucralose, sucrose or fructose (see claim 21). The pharmaceutical composition according to claim 21, wherein said sweetener is preferably aspartame (see claim 22). The pharmaceutical composition according to claim 21, wherein said sweetener is used in an amount of about 1 to 5% by weight (see claim 23). The pharmaceutical composition according to claim 11, wherein said flavoring agent is selected from the group comprising grape fruit, cream vanilla, black currant, orange flavor, strawberry, cherry, peppermint or caramel (see claim 24). The pharmaceutical composition according to claim 11, wherein said glidant or ant adherent is selected from the group comprising talc, magnesium silicate, colloidal silicon dioxide, amorphous silicon dioxide or calcium silicate (see claim 27). Kashid et al. teach for instance in Example 4 as follows: Hydrochlorothiazide rapidly/orally disintegrating/dissolving tablet composition as follows:
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The above example includes mannitol (50.50 mg), colloidal silicon dioxide, sodium stearyl fumarate (functionally equivalent lubricant as magnesium stearate), crospovidone, aspartame (2 mg), strawberry flavor (flavoring agent), and purified water. Example 4 for instance tablet hardness of about 7 to 9 N and the friability was 1.30%. The average in vitro disintegration time was 10-12 seconds.
HANAZAWA et al. and Kashid et al. do not specifically teach the incorporation of ethanol and pearlitol flash. These deficiencies are cured by the teachings of Reiner et al.
Reiner et al. teach pharmaceutical dosage forms, particularly dosage forms in granular form having good palatability and capable of rapidly and completely dispersed in the mouth when orally administered (see abstract). An orally dispersible granular mixture comprising a plurality of granules wherein each of said granules comprises an active ingredient, a disintegrating agent, a coating agent, and optionally other excipients (e.g. buffering agents, flavors, flavor enhancers), each uniformly distributed throughout said granules, wherein said granular mixture optionally substantially completely disperses within 5 minutes in the mouth when orally administered (see claim 10). The final formulation can be composed of the first granular mixture optionally along with extragranular agents such as sweeteners and flavorings to improve the quality of the finished product. In addition, the granular mixture can be compressed into tablets and administered as an orally disintegrating tablet. Additionally, the solvent used in the granulating solution can be ethanol, water, acetone, or another suitable solvent or combination thereof (paragraph 0019). In still another embodiment the invention provides an orally dispersible granular mixture comprising a plurality of granules wherein each of said granules comprises an active ingredient, a diluent, a disintegrating agent, a coating agent, and optionally other excipients (e.g. buffering agents, flavors, flavor enhancers), each uniformly distributed throughout said granules, wherein said granular mixture optionally substantially completely dissolves or disperses within seconds to minutes in the mouth when orally administered. In yet another embodiment the granular mixture completely dissolves or disperses in the mouth, but the active ingredient does not dissolve completely into solution (paragraph 0020). Reiner et al. teach that the formulation also preferably includes at least one disintegrating agent, preferably a super disintegrant, as well as diluent. One example of a diluent is a bulking agent such as a polyalcohol. A preferred combination of bulking agent and disintegrant is marketed as PEARLITOL FLASH®, is a ready to use mixture of mannitol and maize starch (mannitol/maize starch). In general, any polyalcohol bulking agent can be used when coupled with a disintegrant or a super disintegrant agent such as maize starch. Additional disintegrating agents include, but are not limited to, agar, calcium carbonate, maize, potato or tapioca starch, alginic acid, alginates, certain silicates, and sodium carbonate. A list of suitable super disintegrating agents include, but are not limited to crospovidone, croscarmellose sodium, AMBERLITE (Rohm and Haas, Philadelphia, Pa.), and sodium starch glycolate (paragraph 0047). Reiner et al. teach in example 2 that the granule components were separately weighed. The granulating solution was then prepared by dissolving the coating agent and any sweeteners and flavoring agents in a prescribed volume of ethanol. The active ingredient (passed through an appropriate sieve if aggregates were present) was introduced to a high share mixer (Diosna). The mixer was turned on, and the granulating solution was slowly added; when all the granulating solution was added, the mixer speed was increased, the chopper on the high shear mixer turned on, and the PEARLITOL FLASH® slowly added. The granulation continued for about 5 minutes and the resulting granulate was then passed through a 630μ stainless steel sieve. Examples 2a and 2c were prepared in this manner. The granular formulation dissolves or disperses in the mouth within about 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 seconds or about 1, 2, 3, 4, or 5 minutes. In another embodiment the granular formulation dissolves or disperses in the mouth between 1 to 10 seconds, 1 to 30 seconds, 1 to 45 seconds, 1 to 60 seconds, 1 to 2 minutes, or 1 to 5 minutes (paragraph 0053). The use of 200mg of pearlitol flash is demonstrated in paragraph 0124.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to include about 50 mg of mannitol or xylitol, about 3.5 mg of sucralose, maltitol, or aspartame in the composition of HANAZAWA et al. because Kashid et al. teach a orally disintegrating and/or dissolving oral pharmaceutical composition, comprising one or more active pharmaceutical ingredients, one or more fillers having particle size of 100 microns or above, a high and desirable amount of silicon dioxide, one or more disintegrating agents, optionally effervescent couple, wherein said composition has good organoleptic properties like desired mouth feel and fast oral disintegration time (see abstract). An orally disintegrating and/or dissolving pharmaceutical composition comprising of: (a) one or more active pharmaceutical agents, (b) one or more fillers having average particle size of 150 microns or above, (c) high and desirable amount of silicon dioxide ranging from about 5 to 30% by weight, and optionally an effervescent couple (see claim 1). The pharmaceutical composition according to claim 1, wherein said filler is selected from the group comprising mannitol, dextrates, sorbitol, xylitol, sucrose, fructose, lactitol, erythritol or maltitol (see claim 5). The pharmaceutical composition according to claim 5, wherein said filler is preferably mannitol (see claim 6). The pharmaceutical composition according to claim 1, wherein the silicon dioxide is preferably used in an amount of about 5 to 15% by weight (see claim 7). The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition dissolves in mouth in 60 seconds or less (see claim 10). The pharmaceutical composition according to claim 1, wherein said composition further comprises disintegrant, surfactant, lubricant, anti-adherent, glidant, sweetener or flavoring agent (see claim 11). The pharmaceutical composition according to claim 11, wherein said disintegrant is selected from the group comprising polacrilin potassium, microcrystalline cellulose, low substituted hydroxypropyl cellulose, carboxymethyl cellulose, croscarmellose sodium, sodium starch glycolate or crospovidone (crosslinked polyvinylpyrrolidone) (see claim 12). The pharmaceutical composition according to claim 12, wherein said disintegrant is preferably selected from crosslinked polyvinylpyrrolidone or polacrilin potassium or a combination thereof (see claim 13). The pharmaceutical composition according to claim 11, wherein said lubricant is selected from the group comprising sodium stearyl fumarate, glyceryl behenate, calcium stearate, magnesium stearate or stearic acid (see claim 18). The pharmaceutical composition according to claim 11 , wherein said sweetening agent is selected from the group comprising aspartame, saccharin and salts thereof, acesulfame potassium, sucralose, sucrose or fructose (see claim 21). The pharmaceutical composition according to claim 21, wherein said sweetener is preferably aspartame (see claim 22). The pharmaceutical composition according to claim 21, wherein said sweetener is used in an amount of about 1 to 5% by weight (see claim 23). The pharmaceutical composition according to claim 11, wherein said flavoring agent is selected from the group comprising grape fruit, cream vanilla, black currant, orange flavor, strawberry, cherry, peppermint or caramel (see claim 24). The pharmaceutical composition according to claim 11, wherein said glidant or ant adherent is selected from the group comprising talc, magnesium silicate, colloidal silicon dioxide, amorphous silicon dioxide or calcium silicate (see claim 27). Kashid et al. teach for instance in Example 4 as follows: Hydrochlorothiazide rapidly/orally disintegrating/dissolving tablet composition as follows:
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The above example includes mannitol (50.50 mg), colloidal silicon dioxide, sodium stearyl fumarate (functionally equivalent lubricant as magnesium stearate), crospovidone, aspartame (2 mg), strawberry flavor (flavoring agent), and purified water. Example 4 for instance tablet hardness of about 7 to 9 N and the friability was 1.30%. The average in vitro disintegration time was 10-12 seconds. One of ordinary skill in the art would have been motivated to do so because Kashid et al. clearly demonstrates the use of mannitol as a diluent or filler and aspartame as sweetener in amounts overlapping with the claimed amounts in the preparation of a fast orally disintegrating tablet. The diluents or fillers and the sweeteners are functionally equivalent with the diluents/fillers and sweeteners of HANAZAWA et al.. Second, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). Third, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) In the case where the claimed amounts or concentrations of 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). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration or amount 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). It is within the purview of one of ordinary skill in the art to optimize amount or concentrations of ingredients as amount or concentrations of ingredients are result effective parameters absent a showing of criticality. One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of HANAZAWA et al. and Kashid et al. because both references teach fast disintegrating tablets containing diluents/fillers and sweeteners.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to include ethanol and pearlitol flash in the composition of HANAZAWA et al. and Kashid et al. because Reiner et al. teach pharmaceutical dosage forms, particularly dosage forms in granular form having good palatability and capable of rapidly and completely dispersed in the mouth when orally administered (see abstract). An orally dispersible granular mixture comprising a plurality of granules wherein each of said granules comprises an active ingredient, a disintegrating agent, a coating agent, and optionally other excipients (e.g. buffering agents, flavors, flavor enhancers), each uniformly distributed throughout said granules, wherein said granular mixture optionally substantially completely disperses within 5 minutes in the mouth when orally administered (see claim 10). In still another embodiment the invention provides an orally dispersible granular mixture comprising a plurality of granules wherein each of said granules comprises an active ingredient, a diluent, a disintegrating agent, a coating agent, and optionally other excipients (e.g. buffering agents, flavors, flavor enhancers), each uniformly distributed throughout said granules, wherein said granular mixture optionally substantially completely dissolves or disperses within seconds to minutes in the mouth when orally administered. In yet another embodiment the granular mixture completely dissolves or disperses in the mouth, but the active ingredient does not dissolve completely into solution (paragraph 0020). Reiner et al. teach that the formulation also preferably includes at least one disintegrating agent, preferably a super disintegrant, as well as diluent. One of ordinary skill in the art would have been motivated to add pearlitol flash because Reiner et al. teach that one example of a diluent is a bulking agent such as a polyalcohol. A preferred combination of bulking agent and disintegrant is marketed as PEARLITOL FLASH®, is a ready to use mixture of mannitol and maize starch (mannitol/maize starch). In general, any polyalcohol bulking agent can be used when coupled with a disintegrant or a super disintegrant agent such as maize starch. Additional disintegrating agents include, but are not limited to, agar, calcium carbonate, maize, potato or tapioca starch, alginic acid, alginates, certain silicates, and sodium carbonate. A list of suitable super disintegrating agents include, but are not limited to crospovidone, croscarmellose sodium, AMBERLITE (Rohm and Haas, Philadelphia, Pa.), and sodium starch glycolate (paragraph 0047). One of ordinary skill in the art would have been motivated to include ethanol because Reiner et al. teach the final formulation can be composed of the first granular mixture optionally along with extragranular agents such as sweeteners and flavorings to improve the quality of the finished product. In addition, the granular mixture can be compressed into tablets and administered as an orally disintegrating tablet. Additionally, the solvent used in the granulating solution can be ethanol, water, acetone, or another suitable solvent or combination thereof (paragraph 0019). Reiner et al. teach in example 2 that the granule components were separately weighed. The granulating solution was then prepared by dissolving the coating agent and any sweeteners and flavoring agents in a prescribed volume of ethanol. The active ingredient (passed through an appropriate sieve if aggregates were present) was introduced to a high share mixer (Diosna). The mixer was turned on, and the granulating solution was slowly added; when all the granulating solution was added, the mixer speed was increased, the chopper on the high shear mixer turned on, and the PEARLITOL FLASH® slowly added. The granulation continued for about 5 minutes and the resulting granulate was then passed through a 630μ stainless steel sieve. Examples 2a and 2c were prepared in this manner. The granular formulation dissolves or disperses in the mouth within about 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 seconds or about 1, 2, 3, 4, or 5 minutes. In another embodiment the granular formulation dissolves or disperses in the mouth between 1 to 10 seconds, 1 to 30 seconds, 1 to 45 seconds, 1 to 60 seconds, 1 to 2 minutes, or 1 to 5 minutes (paragraph 0053). The use of 200mg of pearlitol flash is demonstrated in paragraph 0124. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) In the case where the claimed amounts or concentrations of 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). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Furthermore, differences in concentration or amount 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). It is within the purview of one of ordinary skill in the art to optimize amount or concentrations of ingredients as amount or concentrations of ingredients are result effective parameters absent a showing of criticality. One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of HANAZAWA et al., Kashid et al., and Reiner et al. because all of the references teach fast disintegrating tablets comprising substantially similar and overlapping ingredients.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded 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) 40-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over HANAZAWA et al. (WO2007/072146, previously cited) in view of Kashid et al. (WO2007/074472, newly cited) and Reiner et al. (US2014/0341988, newly cited) as applied to claim 35-39 above, and further in view of Wittorff (US 2019/0350847, previously cited).
Applicant Claims
Applicant claims an orally disintegrating tablet containing the benzimidazole recited and other ingredients.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of HANAZAWA et al., Kashid et al., and Reiner et al. are described in detail above and are herein incorporated by reference. It should be recognized that instant claim 40 is written in product-by-process format. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim"). "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983) (The claims were directed to a zeolite manufactured by mixing together various inorganic materials in solution and heating the resultant gel to form a crystalline metal silicate essentially free of alkali metal. The prior art described a process of making a zeolite which, after ion exchange to remove alkali metal, appeared to be "essentially free of alkali metal." The court upheld the rejection because the applicant had not come forward with any evidence that the prior art was not "essentially free of alkali metal" and therefore a different and nonobvious product.).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
HANAZAWA et al., Kashid et al., and Reiner et al. do not specifically teach mannitol 220SD that are recited in the process section of claim 40. These deficiencies are cured by the teachings of Wittorff.
Wittorff teach a disintegrating oral tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting in a burst of the at least one flavor ingredient upon mastication of the tablet (see claim 1). Non-DC sugar alcohol particles are typically available in a non-DC form of the relevant sugar alcohol as particles which have not been preprocessed by granulation with other sugar alcohols or binders for the purpose of obtaining so-called direct compressible particles (DC) on the basis of sugar alcohol particles which are by themselves not suitable for direct compression. Such non-DC particles of sugar alcohol may typically consist of the sugar alcohol. Therefore, non-DC sugar alcohol particles may typically be particles consisting of sugar alcohol, which is non-directly compressible in its pure form. Examples of sugar alcohols which are non-directly compressible when provided as particles consisting of the sugar alcohol in question include erythritol, xylitol, maltitol, mannitol, lactitol, isomalt, etc. (paragraph 0015). Examples of trade grades of DC sugar alcohols include sorbitol particles provided as e.g. Neosorb® P 300 DC from Roquette, mannitol particles provided as e.g. Pearlitol® 300DC or Pearlitol 200 SD from Roquette, maltitol provided as e.g. SweetPearl® P 300 DC, xylitol provided as e.g. Xylisorb® 200 DC or Xylitab 200 from Dupont (paragraph 0096). In an embodiment of the invention, the DC sugar alcohol particles comprises sugar alcohols selected from DC particles of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, isomalt, and combinations thereof. Preference may be based on sweetness and solubility (paragraph 0094). High intensity artificial sweetening agents can also be used alone or in combination with the above sweeteners. Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside (natural intensity sweetener) and the like, alone or in combination. In order to provide longer lasting sweetness and flavor perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the artificial sweeteners. Techniques such as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, conservation, encapsulation in yeast cells and fiber extrusion may be used to achieve desired release characteristics. Encapsulation of sweetening agents can also be provided using another tablet component such as a resinous compound (paragraph 0120). In an embodiment of the invention the oral tablet obtains the burst through salivation promoted by the non-DC sugar alcohol particles during mastication in combination with a resulting dissolving of sweetener. The combination of an increased salivation and a resulting dissolving of sweetener increases the user's perception of flavors, and the user perception of flavors may thus be promoted through the inventive use of non-sugar alcohols according to the provisions of the invention (paragraph 0017).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to substitute or incorporate the different types of sweeteners in the composition of HANAZAWA et al., Kashid et al., and Reiner et al. by incorporating mannitol 200SD because Wittorff teach a disintegrating oral tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting in a burst of the at least one flavor ingredient upon mastication of the tablet (see claim 1). Non-DC sugar alcohol particles are typically available in a non-DC form of the relevant sugar alcohol as particles which have not been preprocessed by granulation with other sugar alcohols or binders for the purpose of obtaining so-called direct compressible particles (DC) on the basis of sugar alcohol particles which are by themselves not suitable for direct compression. Such non-DC particles of sugar alcohol may typically consist of the sugar alcohol. Therefore, non-DC sugar alcohol particles may typically be particles consisting of sugar alcohol, which is non-directly compressible in its pure form. Examples of sugar alcohols which are non-directly compressible when provided as particles consisting of the sugar alcohol in question include erythritol, xylitol, maltitol, mannitol, lactitol, isomalt, etc. (paragraph 0015). Examples of trade grades of DC sugar alcohols include sorbitol particles provided as e.g. Neosorb® P 300 DC from Roquette, mannitol particles provided as e.g. Pearlitol® 300DC or Pearlitol 200 SD from Roquette, maltitol provided as e.g. SweetPearl® P 300 DC, xylitol provided as e.g. Xylisorb® 200 DC or Xylitab 200 from Dupont (paragraph 0096). In an embodiment of the invention, the DC sugar alcohol particles comprises sugar alcohols selected from DC particles of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, isomalt, and combinations thereof. Preference may be based on sweetness and solubility (paragraph 0094). High intensity artificial sweetening agents can also be used alone or in combination with the above sweeteners. Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside (natural intensity sweetener) and the like, alone or in combination. In order to provide longer lasting sweetness and flavor perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the artificial sweeteners. Techniques such as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, conservation, encapsulation in yeast cells and fiber extrusion may be used to achieve desired release characteristics. Encapsulation of sweetening agents can also be provided using another tablet component such as a resinous compound (paragraph 0120). In an embodiment of the invention the oral tablet obtains the burst through salivation promoted by the non-DC sugar alcohol particles during mastication in combination with a resulting dissolving of sweetener. The combination of an increased salivation and a resulting dissolving of sweetener increases the user's perception of flavors, and the user perception of flavors may thus be promoted through the inventive use of non-sugar alcohols according to the provisions of the invention (paragraph 0017). One of ordinary skill in the art would have been motivated to do so because first the sweeteners and diluents/fillers are functionally equivalent. Second, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). Third, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) Furthermore, Wittorrof teaches that in an embodiment of the invention the oral tablet obtains the burst through salivation promoted by the non-DC sugar alcohol particles during mastication in combination with a resulting dissolving of sweetener. The combination of an increased salivation and a resulting dissolving of sweetener increases the user's perception of flavors, and the user perception of flavors may thus be promoted through the inventive use of non-sugar alcohols according to the provisions of the invention (paragraph 0017). One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of HANAZAWA et al., Kashid et al., Reiner et al. and Wittorrof because all of the references teach fast disintegrating tablets containing substantially similar ingredients.
With regard to the property limitations of instant claims 41-44 since the combination teachings of HANAZAWA et al., Kashid et al., Reiner et al. and Wittorrof meet the claimed product, the property limitations recited in claims 41-44 would necessarily be there. "[I]nherency may supply a missing claim limitation in an obviousness analysis." PAR, 773 F.3d at 1194-1195 ; see also Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374 , 1381 , 127 U.S.P.Q.2D (BNA) 1409 (Fed. Cir. 2018) ("An inherent characteristic of a formulation can be part of the prior art in an obviousness analysis even if the inherent characteristic was unrecognized or unappreciated by a skilled artisan."). It is long settled that in the context of obviousness, the "mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art." In re Oelrich, 666 F.2d 578 , 581 (C.C.P.A. 1981). The Supreme Court explained long ago that "[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242 , 249 , 66 S. Ct. 81 , 90 L. Ed. 43 , 1946 Dec. Comm'r Pat. 611 (1945).
We too have previously explained that "an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations," because "[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property." Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 , 1354 (Fed. Cir. 2012). In In re Kao, we found that the claimed controlled-release oxymorphone formulation was obvious because an inherent pharmacokinetic property of oxymorphone that was present in controlled-release oxymorphone "add[ed] nothing of patentable consequence." In re Huai-Hung Kao, 639 F.3d 1057 , 1070 , 98 U.S.P.Q.2D (BNA) 1799 (Fed. Cir. 2011). In In re Kubin, we found an inherent property obvious, explaining that "[e]ven if no prior art of record explicitly discusses the [limitation], the . . . application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the [claimed protein], but rather a property necessarily present in [the claimed protein]." In re Kubin, 561 F.3d 1351 , 1357 , 90 U.S.P.Q.2D (BNA) 1417 (Fed. Cir. 2009). Our predecessor court similarly concluded that it "is not the law" that "a structure suggested by the prior art, and, hence, potentially in the possession of the public, is patentable . . . because it also possesses an [i]nherent, but hitherto unknown, function which [the patentees] claim to have discovered." In re [*1191] Wiseman, 596 F.2d 1019 , 1023 (C.C.P.A. 1979).
Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195 . Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531 , 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511 -96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 , 1369 (Fed. Cir. 2012) (relying on inherency where the claims recited "a property that is necessarily present" in the prior art). "If . . . the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient" to render the function inherent. Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939)).
On appeal, Persion contends that the district court erred in applying the inherency doctrine in its obviousness analysis because Devane does not teach administering its hydrocodone-only formulation to patients with mild or moderate hepatic impairment. Thus, Persion asserts, "'the natural result flowing from the operation as taught' in Devane cannot be the claimed [pharmacokinetic] values for [hepatically impaired] patients." Appellant's Br. 37 (quoting Oelrich, 666 F.2d at 581 ); Reply Br. 19.
To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that "inherency may supply a missing claim limitation in an obviousness analysis" where the limitation at issue is "the natural result of the combination of prior art elements." PAR, 773 F.3d at 1194-1195 (emphasis added, internal quotations omitted). Here, the district court specifically found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions. Pernix, 323 F. Supp. 3d at 607 , 610 . In this context, the district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded 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) 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over HANAZAWA et al. (WO2007/072146, previously cited) in view of Kashid et al. (WO2007/074472, newly cited), Reiner et al. (US2014/0341988, newly cited), and Wittorff (US 2019/0350847, previously cited) as applied to claim 35-44 above, and further in view of Kim et al. (US 2019/0281873, previously cited).
Applicant Claims
Applicant claims an orally disintegrating tablet containing the benzimidazole recited and other ingredients. Claim 45 recites the use of enzymatically modified stevia.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of HANAZAWA et al., Kashid et al., Reiner et al. and Wittorrof are described in detail above which are incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
HANAZAWA et al., Kashid et al., Reiner et al. and Wittorrof do not specifically teach enzymatically modified stevia. This deficiency is cured by the teachings of Kim et al.
Kim et al. teach a sweetener containing an enzymatically modified stevia composition having improved sweetness quality, including 90 wt % or more of steviol glycoside, wherein only glycosylation is carried out using cyclodextrin as a glycosylation material of a stevia extract (steviol glycoside), without a purification process using an existing porous adsorbent resin (aromatic, styrene type), to thus produce enzymatically modified stevia, which can be utilized as an ingredient and a reagent for sweeteners, flavor enhancers and flavor modifiers for a variety of confections, drinks (including alcoholic beverages), foods and food products, thereby providing an enzymatically modified stevia sweetener and products thereof (see abstract). Kim et al. teach accordingly, with the goal of solving such problems, thorough research into improvements in the sweetness quality of enzymatically modified stevia has been carried out, and the present inventors have thus ascertained a method of easily preparing an enzymatically modified stevia composition, which is superior in sweetness quality compared to existing methods, thus culminating in the present invention (see paragraph 0006).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to utilize or incorporate enzymatically modified stevia as a sweetener because Kim et al. teach a sweetener containing an enzymatically modified stevia composition having improved sweetness quality, including 90 wt % or more of steviol glycoside, wherein only glycosylation is carried out using cyclodextrin as a glycosylation material of a stevia extract (steviol glycoside), without a purification process using an existing porous adsorbent resin (aromatic, styrene type), to thus produce enzymatically modified stevia, which can be utilized as an ingredient and a reagent for sweeteners, flavor enhancers and flavor modifiers for a variety of confections, drinks (including alcoholic beverages), foods and food products, thereby providing an enzymatically modified stevia sweetener and products thereof (see abstract). One of ordinary skill in the art would have been motivated to do so because Kim et al. teach accordingly, with the goal of solving such problems, thorough research into improvements in the sweetness quality of enzymatically modified stevia has been carried out, and the present inventors have thus ascertained a method of easily preparing an enzymatically modified stevia composition, which is superior in sweetness quality compared to existing methods, thus culminating in the present invention (see paragraph 0006). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of HANAZAWA et al., Kashid et al., Reiner et al., Wittorrof and Kim et al. because all of the references teach compositions containing sweeteners.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded 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.
Conclusions
No claims are allowed.
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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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
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