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 March 2026 are acknowledged and have been fully considered. Claims 10-26, 29, 31, 33, 35-36, and 38 are pending. Claims 10-26, 29, 31, 33, and 35 are under consideration in the instant office action. Claims 36 and 38 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claims. Claims 1-9, 27-28, 30, 32, 34, 37, and 39-41 are canceled.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04 March 2026 is noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. A signed copy is attached herein.
Withdrawn Objection/Rejection
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
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 10-26, 29, 31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Abdelmonem et al. (Drug Design, Development and Therapy 2021:15 4383–4402, cited in IDS of 10/17/24) in view of the Fuji Brochure (published on September 2015, pages 1-19), Toksoz et al. (EP 2308464), Fujiwara (US 2012/0165413), and Lorrai et al. (Frontiers in Psychiatry, volume 7, article 68, 2016, pages 1-7).
Applicant Claims
Applicant claims an orally disintegrating composition comprising R-baclofen, F-MELT, crospovidone, sucralose, sodium stearyl fumarate, a flavoring agent, and a masking agent. Dependent claims thereof recite further limiting different features of the base claim.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Abdelmonem et al. teach direct compression method was used to prepare ODTs using three types of co-processed excipients (Prosolv ODT G2®, F-melt®, and Pharmaburst®500). ODTs were evaluated according to weight variation, thickness, friability, hardness, drug content, wetting time, in-vitro disintegration time, in-vitro dissolution test, and palatability. To enhance the in-vitro dissolution of meloxicam and palatability of ODT, a six sigma methodology was used, and an improvement phase was established where ODTs were prepared using lyophilization and levigation techniques. Finally, a pharmacokinetic study of the improved ODT was accomplished in comparison to the conventional oral tablet (page 4383 under methods). Abdelmonem et al. teach the following formulations in Table 1 and Table 2:
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252
1186
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456
584
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F-melt Type C (contained mannitol, xylitol, MCC, crospovidone, dibasic calcium phosphate anhydrous) (see materials section, page 4385). Abdelmonem et al. teach an orally disintegrating tablet (ODT) composition comprising baclofen (racemic mixture ) as the active ingredient at approximately 14% w/w in a 70 mg tablet, combined with F-MELT (a co-processed excipient for ODTs) at 49-71% w/w, crospovidone (as a disintegrant both existing in F-MELT and also added separately), and sucralose (a sweetener) at approximately 2% w/w in improved formulations (see page 4385, table 1). Abdelmonem et al. further teach the use of flavoring agents (e.g., implied through palatability testing and common ODT practices) and masking agents (e.g., sucralose and dextrose acting to improve taste), the inclusion of mannitol and xylitol in the F-MELT type c also covers sweetening agents and taste masting agents, with the composition optimized for rapid disintegration (under 30 seconds ) and enhanced pharmacokinetics via oral mucosa absorption.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Abdelmonem et al. do not specifically teach R-baclofen as the baclofen type, lower concentrations of the active ingredient, higher amounts of F-MELT levels as recited in claims 11-26, the addition of sodium stearyl fumarate as a lubricant and its amounts, and the precise narrow ranges for flavoring and masking agents as recited in claims 11-26. These deficiencies are cured by the teachings of the Fuji Brochure, Toksoz et al., Fujiwara et al., and Lorrai et al.
The Fuji Brochure teaches typical ODT compositions using F-MELT as the primary excipient with additions of crospovidone, sodium stearyl fumarate, sucralose, flavoring and masking agents. Specific teachings include F-MELT at 80-98% w/w in low active load examples (see page 16, vitamin B12 formulation with F-MELT type c at 96.37% w/w); section “Nutraceutical application-F-MELT type c and F1, Formulation Examples-Direct Compression,” formulation table. Regarding crospovidone (see page 12, formulation 3 with crospovidone at 5% w/w and example 1). The Fuji Brochure teaches sodium stearyl fumarate at 1% in formulations 3 and 4. Sucralose was added at 0.45 w/w on page 14 in the preparation of famotidine composition. The Fuji Brochure teaches on page 16 the inclusion of strawberry flavor at 2% w/w in vitamin B12 and on page 14 the inclusion of menthol at 0.05% w/w. Regarding masking agents the Fuji Brochure teaches inclusion of aspartame at 0.3% w/w in vitamin B12 as bitterness masker and acesulfame potassium at 0.4% w/w for masking in famotidine (see pages 14 and 16).
Toksoz et al. teach an orally disintegrating composition comprising pramipexole or a pharmaceutically acceptable salt, solvate and hydrate thereof and at least one pharmaceutically acceptable excipient, wherein at least one pharmaceutical excipient is a dispersing agent which is present in an amount of 1 to 90% by weight of total composition (see claim 1). Toksoz et al. teach to minimize the disintegration time and maximize the mechanical resistance of the tablets of this invention, this orally disintegrating tablet composition has been designed, made up of the following:
a. 0.01 to 5.0% by weight of pramipexole dihydrochloride monohydrate,
b. 5.0 to 90% by weight of mannitol (see below mannitol is taught as diluent or filler with F-MELT)
c. 1.0 to 90% by weight of calcium silicate,
d. 0.1 to 25% by weight of polivinylpyrrolidone
e. 1.0 to 30 % by weight of crospovidone
f. 0.1 to 2% by weight of sucralose
g. 0.1 to 5% by weight of orange flavour
h. 0.1 to 10 % by weight of sodium stearyl fumarate.
Suitable diluents and/or fillers may comprise but not limited to mannitol, spray-dried mannitol; polysaccharides such as microcrystalline cellulose; dibasic calcium phosphate dihydrate, lactose, sugars, sorbitol; mixture of microcrystalline cellulose and guar gum (Avicel CE-15); mixture of mannitol, polyplasdone and syolid (Pharmaburst); mixture of mannitol, crospovidone and polyvinyl acetate (Ludiflash); isomalt, Panexcea, F-Melt, sucrose, inorganic salts such as calcium salts; magnesium carbonate heavy and the like and mixtures thereof; preferably the diluent and/or filler is mannitol and/or microcrystalline cellulose (see paragraph 0034). The orally disintegrating compositions of this invention also comprise sweeteners and flavouring agents to improve patient compliance (paragraph 0039). Suitable sweeteners may comprise but not limited to sucralose, acesulfame-K, aspartame, saccharin or its sodium and calcium salts, sodium cyclamate, sucrose, fructose, glucose, sorbitol and the like and mixtures thereof; preferably the sweetener is sucralose (paragraph 0040). Suitable flavouring agents may comprise but not limited to fruit flavours such as orange, cherry, strawberry, banana, wild cherry, lemon; cardamom, anise, peppermint, menthol, vanillin and ethyl vanillin and the like and mixtures thereof; preferably the flavouring agent is fruit flavour such as orange (paragraph 0041).
Fujiwara et al. teach an orally rapidly disintegrating tablet which has a good texture and taste in the oral cavity, such a sufficient hardness as not giving any worry of being chipped or dusted during production or transportation and good disintegrating properties in the oral cavity. The orally rapidly disintegrating tablet, which has a good texture and taste, an appropriate hardness, and good disintegrating properties, can be produced by using a composition, which is prepared by dispersing, by spray-drying, an inorganic excipient and starch(es) in complex particles composed of mannitol and xylitol, in an orally rapidly disintegrating tablet (see abstract). The active ingredient includes central nervous system agents, peripheral nervous system agents, agents affecting sensory organs, agents affecting circulatory organs, agents affecting respiratory organs, agents affecting digestive organs, hormonal agents, agents affecting genitourinary apparatus, medicaments affecting other organs, vitamin preparations, revitalizers, agents for blood or body fluid, other metabolized drugs, cellular stimulants, antineoplastic agents, radioactive agents, anti-allergic agents, other medicaments for tissue cellular functions, natural medicine, Chinese medicine, other natural medicine and medicine based on Chinese medicine prescription, antibiotic agents, chemotherapeutic agents, biological preparations, agents against parasitic animals, other medicine against pathogenic organism, dispensing agents, diagnostic agents, agents for public health, extracorporeal diagnostic agents, other agents not mainly intended for treatment, alkaloidal narcotics (natural narcotics), and non-alkaloidal narcotics (Drugs in Japan 2008, Jihou, Inc.), but is not limited thereto (paragraph 0057). Spasmolytic agents include afloqualone, eperisone hydrochloride, piperidolate hydrochloride, tizanidine hydrochloride, timepidium bromide hydrate, tolperisone hydrochloride, baclofen, etc., (paragraph 0066). The orally rapidly disintegrating tablet of the present invention may comprise an active ingredient, a disintegrant and other ingredients to be blended without impairing disintegrating properties, if needed. The blending ratio of each ingredient is 0.01 to 200 parts by weight of an active ingredient, 10 to 100 parts by weight of a disintegrant and 0.1 to 100 parts by weight of other ingredients to be blended without impairing disintegrating properties per 100 parts by weight of the disintegrating particle composition, preferably 0.1 to 100 parts by weight of an active ingredient, 10 to 50 parts by weight of a disintegrant and 0.1 to 50 parts by weight of other ingredients to be blended without impairing disintegrating properties per 100 parts by weight of the total amount of mannitol, xylitol, inorganic excipient(s) and starch(es) (paragraph 0054).
Lorrai et al. teach racemic baclofen [(±)-baclofen] has repeatedly been reported to suppress several -alcohol-motivated behaviors, including alcohol drinking and alcohol -self-administration, in rats and mice. Recent data suggested that baclofen may have bidirectional, stereospecific effects, with the more active enantiomer, R(+)-baclofen, suppressing alcohol intake and the less active enantiomer, S(−)-baclofen, stimulating alcohol intake in mice. The present study was designed to investigate whether this enantioselectivity of baclofen effects may also extend to the reinforcing properties of alcohol in rats. To this end, selectively bred Sardinian alcohol-preferring (sP) rats were initially trained to lever respond on a fixed ratio 4 (FR4) schedule of reinforcement for alcohol (15%, v/v) in daily 30-min sessions. Once responding had stabilized, rats were tested with vehicle, (±)-baclofen (3 mg/kg), R(+)-baclofen (0.75, 1.5, and 3 mg/kg), and S(−)-baclofen (6, 12, and 24 mg/kg) under the FR4 schedule of reinforcement. Treatment with 3 mg/kg (±)-baclofen reduced the number of lever responses for alcohol and estimated amount of self-administered alcohol by approximately 60% in comparison to vehicle treatment. R(+)-baclofen was approximately twice as active as (±)-baclofen: treatment with 1.5 mg/kg R(+)-baclofen decreased both variables to an extent similar to that of the decreasing effect of 3 mg/kg (±)-baclofen. Conversely, treatment with all doses of S(−)-baclofen failed to affect alcohol self-administration. These results (a) confirm that non-sedative doses of (±)-baclofen effectively suppressed the reinforcing properties of alcohol in sP rats and (b) apparently do not extend to operant alcohol self-administration in sP rats the capability of S(−)-baclofen to stimulate alcohol drinking in mice (see abstract). Racemic baclofen [(±)-baclofen] is composed of a 1:1 mixture of R- and S-configurations, with the R-enantiomer being 100–1000 times more potent, both in vitro and in vivo, than the S-enantiomer. Therefore, R-baclofen is the enantiomer on which the pharmacological activity of (±)-baclofen is based. Accordingly, in the present study, R(+)-baclofen appeared to be twice as active as (±)-baclofen: administration of 1.5 mg/kg R(+)-baclofen reduced both the number of lever responses for alcohol and estimated amount of self-administered alcohol to an extent similar to that produced by administration of 3 mg/kg (±)-baclofen. Additionally, reductions produced by 0.75 mg/kg R(+)-baclofen [corresponding to 1.5 mg/kg (±)-baclofen] and 3 mg/kg R(+)-baclofen [corresponding to 6 mg/kg (±)-baclofen] were proportionally smaller and larger, respectively, than that produced by 3 mg/kg (±)-baclofen. Conversely, none of the three tested doses of S(−)-baclofen (6, 12, and 24 mg/kg) altered the number of lever responses for alcohol and estimated amount of self-administered alcohol, confirming its inactivity even at relatively high doses. A tendency toward a higher frequency of responding on the alcohol lever, in the rat group treated with 24 mg/kg S(−)-baclofen and during the 5–15 min time period of the self-administration session, was the only possible effect of S(−)-baclofen that could be detected (Figure 2) (see page 4).
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 modify the teachings of Abdelmonem et al. by utilizing higher amounts of F-MELT levels as recited in claims 11-26, the addition of sodium stearyl fumarate as a lubricant, and the precise narrow ranges for flavoring and masking agents as recited in claims 11-26 because first the Fuji Brochure teaches typical ODT compositions using F-MELT as the primary excipient with additions of crospovidone, sodium stearyl fumarate, sucralose, flavoring and masking agents. Specific teachings include F-MELT at 80-98% w/w in low active load examples (see page 16, vitamin B12 formulation with F-MELT type c at 96.37% w/w); section “Nutraceutical application-F-MELT type c and F1, Formulation Examples-Direct Compression,” formulation table. Regarding crospovidone (see page 12, formulation 3 with crospovidone at 5% w/w and example 1). The Fuji Brochure teaches sodium stearyl fumarate at 1% in formulations 3 and 4. Sucralose was added at 0.45 w/w on page 14 in the preparation of famotidine composition. The Fuji Brochure teaches on page 16 the inclusion of strawberry flavor at 2% w/w in vitamin B12 and on page 14 the inclusion of menthol at 0.05% w/w. Regarding masking agents the Fuji Brochure teaches inclusion of aspartame at 0.3% w/w in vitamin B12 as bitterness masker and acesulfame potassium at 0.4% w/w for masking in famotidine (see pages 14 and 16). Even furthermore, Toksoz et al. teach an orally disintegrating composition comprising pramipexole or a pharmaceutically acceptable salt, solvate and hydrate thereof and at least one pharmaceutically acceptable excipient, wherein at least one pharmaceutical excipient is a dispersing agent which is present in an amount of 1 to 90% by weight of total composition (see claim 1). Toksoz et al. teach to minimize the disintegration time and maximize the mechanical resistance of the tablets of this invention, this orally disintegrating tablet composition has been designed, made up of the following:
a. 0.01 to 5.0% by weight of pramipexole dihydrochloride monohydrate,
b. 5.0 to 90% by weight of mannitol (see below mannitol is taught as diluent or filler with F-MELT)
c. 1.0 to 90% by weight of calcium silicate,
d. 0.1 to 25% by weight of polivinylpyrrolidone
e. 1.0 to 30 % by weight of crospovidone
f. 0.1 to 2% by weight of sucralose
g. 0.1 to 5% by weight of orange flavour
h. 0.1 to 10 % by weight of sodium stearyl fumarate.
Suitable diluents and/or fillers may comprise but not limited to mannitol, spray-dried mannitol; polysaccharides such as microcrystalline cellulose; dibasic calcium phosphate dihydrate, lactose, sugars, sorbitol; mixture of microcrystalline cellulose and guar gum (Avicel CE-15); mixture of mannitol, polyplasdone and syolid (Pharmaburst); mixture of mannitol, crospovidone and polyvinyl acetate (Ludiflash); isomalt, Panexcea, F-Melt, sucrose, inorganic salts such as calcium salts; magnesium carbonate heavy and the like and mixtures thereof; preferably the diluent and/or filler is mannitol and/or microcrystalline cellulose (see paragraph 0034). The orally disintegrating compositions of this invention also comprise sweeteners and flavouring agents to improve patient compliance (paragraph 0039). Suitable sweeteners may comprise but not limited to sucralose, acesulfame-K, aspartame, saccharin or its sodium and calcium salts, sodium cyclamate, sucrose, fructose, glucose, sorbitol and the like and mixtures thereof; preferably the sweetener is sucralose (paragraph 0040). Suitable flavouring agents may comprise but not limited to fruit flavours such as orange, cherry, strawberry, banana, wild cherry, lemon; cardamom, anise, peppermint, menthol, vanillin and ethyl vanillin and the like and mixtures thereof; preferably the flavouring agent is fruit flavour such as orange (paragraph 0041). One of ordinary skill in the art would have been motivated to utilize each of the ingredients in amounts as recited because both the Fuji Brochure and Toksoz et al. teach an orally disintegrating composition comprising the recited ingredients in amounts that overlaps with the instantly claimed amounts in claims 11-26 as effective and workable ranges to prepare e.g., ODT tablets. 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 modify the teachings of Abdelmonem et al. by incorporating baclofen in amounts as recited in claims 11-26 because Fujiwara et al. teach an orally rapidly disintegrating tablet which has a good texture and taste in the oral cavity, such a sufficient hardness as not giving any worry of being chipped or dusted during production or transportation and good disintegrating properties in the oral cavity. The orally rapidly disintegrating tablet, which has a good texture and taste, an appropriate hardness, and good disintegrating properties, can be produced by using a composition, which is prepared by dispersing, by spray-drying, an inorganic excipient and starch(es) in complex particles composed of mannitol and xylitol, in an orally rapidly disintegrating tablet (see abstract). The active ingredient includes central nervous system agents, peripheral nervous system agents, agents affecting sensory organs, agents affecting circulatory organs, agents affecting respiratory organs, agents affecting digestive organs, hormonal agents, agents affecting genitourinary apparatus, medicaments affecting other organs, vitamin preparations, revitalizers, agents for blood or body fluid, other metabolized drugs, cellular stimulants, antineoplastic agents, radioactive agents, anti-allergic agents, other medicaments for tissue cellular functions, natural medicine, Chinese medicine, other natural medicine and medicine based on Chinese medicine prescription, antibiotic agents, chemotherapeutic agents, biological preparations, agents against parasitic animals, other medicine against pathogenic organism, dispensing agents, diagnostic agents, agents for public health, extracorporeal diagnostic agents, other agents not mainly intended for treatment, alkaloidal narcotics (natural narcotics), and non-alkaloidal narcotics (Drugs in Japan 2008, Jihou, Inc.), but is not limited thereto (paragraph 0057). Spasmolytic agents include afloqualone, eperisone hydrochloride, piperidolate hydrochloride, tizanidine hydrochloride, timepidium bromide hydrate, tolperisone hydrochloride, baclofen, etc., (paragraph 0066). One of ordinary skill in the art would have been motivated to do so because Fujiwara et al. teach that the orally rapidly disintegrating tablet of the present invention may comprise an active ingredient, a disintegrant and other ingredients to be blended without impairing disintegrating properties, if needed. The blending ratio of each ingredient is 0.01 to 200 parts by weight of an active ingredient, 10 to 100 parts by weight of a disintegrant and 0.1 to 100 parts by weight of other ingredients to be blended without impairing disintegrating properties per 100 parts by weight of the disintegrating particle composition, preferably 0.1 to 100 parts by weight of an active ingredient, 10 to 50 parts by weight of a disintegrant and 0.1 to 50 parts by weight of other ingredients to be blended without impairing disintegrating properties per 100 parts by weight of the total amount of mannitol, xylitol, inorganic excipient(s) and starch(es) (paragraph 0054). In the case where the claimed amounts of ingredients and actives "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 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 modify the teachings of Abdelmonem et al. by utilizing R-baclofen as the active type because Lorrai et al. teach racemic baclofen [(±)-baclofen] has repeatedly been reported to suppress several -alcohol-motivated behaviors, including alcohol drinking and alcohol -self-administration, in rats and mice. Recent data suggested that baclofen may have bidirectional, stereospecific effects, with the more active enantiomer, R(+)-baclofen, suppressing alcohol intake and the less active enantiomer, S(−)-baclofen, stimulating alcohol intake in mice. The present study was designed to investigate whether this enantioselectivity of baclofen effects may also extend to the reinforcing properties of alcohol in rats. To this end, selectively bred Sardinian alcohol-preferring (sP) rats were initially trained to lever respond on a fixed ratio 4 (FR4) schedule of reinforcement for alcohol (15%, v/v) in daily 30-min sessions. Once responding had stabilized, rats were tested with vehicle, (±)-baclofen (3 mg/kg), R(+)-baclofen (0.75, 1.5, and 3 mg/kg), and S(−)-baclofen (6, 12, and 24 mg/kg) under the FR4 schedule of reinforcement. Treatment with 3 mg/kg (±)-baclofen reduced the number of lever responses for alcohol and estimated amount of self-administered alcohol by approximately 60% in comparison to vehicle treatment. R(+)-baclofen was approximately twice as active as (±)-baclofen: treatment with 1.5 mg/kg R(+)-baclofen decreased both variables to an extent similar to that of the decreasing effect of 3 mg/kg (±)-baclofen. Conversely, treatment with all doses of S(−)-baclofen failed to affect alcohol self-administration. These results (a) confirm that non-sedative doses of (±)-baclofen effectively suppressed the reinforcing properties of alcohol in sP rats and (b) apparently do not extend to operant alcohol self-administration in sP rats the capability of S(−)-baclofen to stimulate alcohol drinking in mice (see abstract). One of ordinary skill in the art would have been motivated to do so because Lorrai et al. teach that racemic baclofen [(±)-baclofen] is composed of a 1:1 mixture of R- and S-configurations, with the R-enantiomer being 100–1000 times more potent, both in vitro and in vivo, than the S-enantiomer. Therefore, R-baclofen is the enantiomer on which the pharmacological activity of (±)-baclofen is based. Accordingly, in the present study, R(+)-baclofen appeared to be twice as active as (±)-baclofen: administration of 1.5 mg/kg R(+)-baclofen reduced both the number of lever responses for alcohol and estimated amount of self-administered alcohol to an extent similar to that produced by administration of 3 mg/kg (±)-baclofen. Additionally, reductions produced by 0.75 mg/kg R(+)-baclofen [corresponding to 1.5 mg/kg (±)-baclofen] and 3 mg/kg R(+)-baclofen [corresponding to 6 mg/kg (±)-baclofen] were proportionally smaller and larger, respectively, than that produced by 3 mg/kg (±)-baclofen. Conversely, none of the three tested doses of S(−)-baclofen (6, 12, and 24 mg/kg) altered the number of lever responses for alcohol and estimated amount of self-administered alcohol, confirming its inactivity even at relatively high doses. A tendency toward a higher frequency of responding on the alcohol lever, in the rat group treated with 24 mg/kg S(−)-baclofen and during the 5–15 min time period of the self-administration session, was the only possible effect of S(−)-baclofen that could be detected (Figure 2) (see page 4). One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Abdelmonem et al., Fuji Brochure, Toksoz et al., Fujiwara et al., and Lorrai et al. because Abdelmonem et al. and Fujiwara et al. teach orally disintegrating composition containing baclofen as an active agent using common ingredients used in ODT preparation. Similarly, Fuji Brochure and Toksoz et al. are drawn to orally disintegrating compositions mainly tablets comprising active agents and similar inactive ingredients commonly used in ODT preparations. Lorrai et al. is mainly supporting Abdelmonem et al. why one of ordinary skill in the art would have been motivated to pick the R-baclofen as an active agent.
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.
Response to Arguments
Applicant's arguments filed 04 March 2026 have been fully considered but they are not persuasive.
Applicants argue first, Lorrai is not in the same field of endeavor as the claimed invention. Lorrai is directed to studying the effects of baclofen enantiomers on alcohol self-administration in rats. Importantly, Lorrai administered baclofen into the rats intraperitoneally, not orally ("(±)-Baclofen, R(+)-baclofen and S(-)-baclofen were dissolved in saline and administered intraperitoneally (injection volume: 2 ml/kg) 30 min before the start of the test session." Lorrai at p.3, right col, "Test Phase"). Lorrai does not relate at all to orally disintegrating tablet formulations and excipient selection. Applicants further explain that how Applicants’ invention is drawn to orally disintegrating composition. Applicant also argues second, Lorrai is not reasonably pertinent to the problem faced by the inventors. In determining if a reference is reasonably pertinent, "the examiner should consider the problem faced by the inventor, as reflected-either explicitly or implicitly-in the specification." M.P.E.P. § 2141.01(a)(I). Here, the Application explicitly makes clear that the problem to be solved is the development of an orally disintegrating baclofen composition with superior disintegration and stability (see quotations above) and agreeable flavor ("A R-baclofen ODT formulation with excellent disintegration time and taste masking profiles was successfully developed." Application at p. 59, lines 1-11). Lorrai provides no teaching or suggests a solution to orally disintegrating formulation development.
The above assertions are not found persuasive because first in response to applicant's argument that Lorrai et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, it should be noticed that the orally disintegrating composition limitation is taught by Abdelmonem et al. and the other references as described in detail above and which are incorporated herein by reference. It should be also notice that Abdelmonem et al. clearly also teach baclofen as active type to be incorporated in the orally disintegrating tablet (ODT) composition. Lorrai et al. is incorporated in the rejection to provide the underlying motivation why one of ordinary skill in the art would have been motivated to use R-baclofen. The examiner contends that one of ordinary skill in the art reading Lorrai et al. would reasonably conclude Lorrai et al.’s findings are applicable to the general knowledge of formulation. 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 modify the teachings of Abdelmonem et al. by utilizing R-baclofen as the active type because Lorrai et al. teach racemic baclofen [(±)-baclofen] has repeatedly been reported to suppress several -alcohol-motivated behaviors, including alcohol drinking and alcohol -self-administration, in rats and mice. Recent data suggested that baclofen may have bidirectional, stereospecific effects, with the more active enantiomer, R(+)-baclofen, suppressing alcohol intake and the less active enantiomer, S(−)-baclofen, stimulating alcohol intake in mice. The present study was designed to investigate whether this enantioselectivity of baclofen effects may also extend to the reinforcing properties of alcohol in rats. To this end, selectively bred Sardinian alcohol-preferring (sP) rats were initially trained to lever respond on a fixed ratio 4 (FR4) schedule of reinforcement for alcohol (15%, v/v) in daily 30-min sessions. Once responding had stabilized, rats were tested with vehicle, (±)-baclofen (3 mg/kg), R(+)-baclofen (0.75, 1.5, and 3 mg/kg), and S(−)-baclofen (6, 12, and 24 mg/kg) under the FR4 schedule of reinforcement. Treatment with 3 mg/kg (±)-baclofen reduced the number of lever responses for alcohol and estimated amount of self-administered alcohol by approximately 60% in comparison to vehicle treatment. R(+)-baclofen was approximately twice as active as (±)-baclofen: treatment with 1.5 mg/kg R(+)-baclofen decreased both variables to an extent similar to that of the decreasing effect of 3 mg/kg (±)-baclofen. Conversely, treatment with all doses of S(−)-baclofen failed to affect alcohol self-administration. These results (a) confirm that non-sedative doses of (±)-baclofen effectively suppressed the reinforcing properties of alcohol in sP rats and (b) apparently do not extend to operant alcohol self-administration in sP rats the capability of S(−)-baclofen to stimulate alcohol drinking in mice (see abstract). One of ordinary skill in the art would have been motivated to do so because Lorrai et al. teach that racemic baclofen [(±)-baclofen] is composed of a 1:1 mixture of R- and S-configurations, with the R-enantiomer being 100–1000 times more potent, both in vitro and in vivo, than the S-enantiomer. Therefore, R-baclofen is the enantiomer on which the pharmacological activity of (±)-baclofen is based. Accordingly, in the present study, R(+)-baclofen appeared to be twice as active as (±)-baclofen: administration of 1.5 mg/kg R(+)-baclofen reduced both the number of lever responses for alcohol and estimated amount of self-administered alcohol to an extent similar to that produced by administration of 3 mg/kg (±)-baclofen. Additionally, reductions produced by 0.75 mg/kg R(+)-baclofen [corresponding to 1.5 mg/kg (±)-baclofen] and 3 mg/kg R(+)-baclofen [corresponding to 6 mg/kg (±)-baclofen] were proportionally smaller and larger, respectively, than that produced by 3 mg/kg (±)-baclofen. Conversely, none of the three tested doses of S(−)-baclofen (6, 12, and 24 mg/kg) altered the number of lever responses for alcohol and estimated amount of self-administered alcohol, confirming its inactivity even at relatively high doses. A tendency toward a higher frequency of responding on the alcohol lever, in the rat group treated with 24 mg/kg S(−)-baclofen and during the 5–15 min time period of the self-administration session, was the only possible effect of S(−)-baclofen that could be detected (Figure 2) (see page 4). Lorrai et al. is reasonably pertinent to the particular problem with which the inventor was concerned (the active agent baclofen), in order to be relied upon as a basis for rejection of the claimed invention. Knowing the fact that R-baclofen is the effective enantiomer for treatment is a valuable knowledge that is applicable to Abdelmonem et al. when preparing the ODT formulations.
Applicants further argue the primary reference Abdelmonem teaches a different composition because it includes a poorly soluble drug meloxicam in the composition.
The above assertions are not found persuasive because Applicants use the transitional phrase “comprising” in claim recitations. The inclusion of other actives is not excluded by the claim language. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004).
Applicants argue the primary reference Abdelmonem teaches away from the use of F-MELT because Abdelmonem states "F-melt showed longer [disintegration time (DT)] than Pharmaburst; this may be due to the lower specific surface area of F-melt than Pharmaburst 500, which was the reason for the delay of DT in F-melt based formula (F2) than Pharamaburst [sic] formula (F1)." Abdelmonem at p. 4389, left col. 1st paragraph).
The above assertions are not found persuasive because the above statement is basically comparing F-melt with Pharmaburst 500. The F-2 formulation that contains F-melt clearly also disintegrates. Abdelmonem et al. teach that F-melt-based formula (F2) showed (83.13 ± 0.056% for meloxicam) at 15 min and (89.54 ±0.029% for baclofen) at 4 min. It should be noticed that claim 10 does not require a specific disintegrating or dissolving time.
Applicants then argue that the rejection relies on impermissible hindsight. Regarding the Fuji Brochure, the Examiner alleges that this reference teaches ODT compositions using F-MELT as the primary excipient with additions of crospovidone, sodium stearyl fumarate, sucralose, flavoring and masking agents. Office Action at p. 14. To do so, the Examiner picks and chooses the formulation components from different formulations and asserts that these components can be combined without providing any rationale for doing so. For example, the Examiner points to the famotidine formulations on pages 11 and 14 of the Fuji Brochure for
sucralose; acetaminophen, ascorbic acid, and CoQ10 formulations on pages 12, 13, and 17 for sodium stearyl fumarate; and the ascorbic acid and a different acetaminophen formulation on pages 12 and 13 for crospovidone. The Examiner provides no teaching or suggestion that a person of skill in the art would have been motivated to combine these excipients that are used for different active ingredient formulations with a reasonable expectation of success to arrive at the claimed baclofen formulation. Similar arguments are presented regarding Toksoz et al., and Fujiwara et al.
The above assertions are not found persuasive because first in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, the examiner reminds Applicants that 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). Selection of such ingredients and their workable ranges based on their known intended use is prima facie obvious even if the list is long. The examiner reminds Applicants that let alone under 35 USC 103, the Board found that A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in [pre-AIA ] 35 U.S.C. 102(a), in that publication."). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.). When a claimed compound is not specifically named in a reference, but instead it is necessary to select portions of teachings within the reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be "at once envisaged." One may look to the preferred embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962). In a similar analogy selecting a known agent from a list of agents performing the same purpose and its working amounts is prima facie obvious. The examiner also brings applicant’s attention to the concept of picking known agents and their respective working amount ranges from a prior art disclosed generic teachings. The specific ingredients claimed are disclosed by the references as described above in detail. If applicants resort to argue the reference does not provide any motivation to select the specific ingredients, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Furthermore, in the case where the claimed concentration or amount 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 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).
Applicant then argues the Examiner's reliance on overlapping ranges to establish prima facie obviousness is misplaced. The cited range of Fujiwara is so extraordinarily broad that it would encompass virtually any conceivable formulation ranging from trace amounts to 100% of the active ingredient. Such a disclosure does not present typical overlapping ranges for the purposes of obviousness.
The above assertions are not found persuasive because indeed in the case where the claimed concentration or amount 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 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). Applicant should provide objective data showing the criticality of the claimed amounts. Absent evidence such a showing it is within one of ordinary skill in the art to optimize the amounts or concentrations of actives and other ingredients.
Applicants then argue as described in the Examples, Applicant tested many different excipient mixtures to arrive at a desirable formulation. The tablets needed to be hard enough to be physically stable in packaging while also maintaining a quick disintegration time. "The main criterion for a successful ODT was an in vivo disintegration time of approximately 15 seconds or less. This time was identified as necessary for patient compliance in a pediatric cohort." Application at p. 47, lines 24-25. "Tablet hardness was monitored and adjusted to provide tablets with enough physical strength to minimize friability and withstand typical handling conditions during manufacturing and packaging, but also to allow tablets to disintegrate quickly when in contact with moisture." Application at p. 47, lines 26-28. Numerous combinations of excipients were tested to achieve a good balance between hardness and disintegration time, ultimately arriving at the claimed formulation for having "superior physical attributes (quick disintegration, low friability, and good taste and mouth feel)." Application at p. 55, lines 4-5; see also Tables 4-10. Because the tablets were intended to be given to pediatric patients, including those with atypical neurocognitive function, different flavoring and taste masking agents were also optimized: "It was determined that strawberry flavor with sucralose produced a better combination of taste and sweetness." Application at p. 54, lines 11-12. Through their testing, Applicant was able to develop an ODT formulation that addressed the competing needs of disintegration and storage while also being agreeable to a particular subset of pediatric patients.
The above assertions are not found persuasive because Applicant must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). Applicants may compare the claimed invention with prior art that is more closely related to the invention than the prior art relied upon by the examiner. In re Holladay, 584 F.2d 384, 199 USPQ 516 (CCPA 1978); Ex parte Humber, 217 USPQ 265 (Bd. App. 1961). Furthermore, whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). Claim 10 is drawn to an orally disintegrating composition comprising the components as claimed at any amount which is not commensurate in scope with the alleged unexpected results.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdelmonem et al. (Drug Design, Development and Therapy 2021:15 4383–4402, cited in IDS of 10/17/24) in view of the Fuji Brochure (published on September 2015, pages 1-19), Toksoz et al. (EP 2308464), Fujiwara (US 2012/0165413), and Lorrai et al. (Frontiers in Psychiatry, volume 7, article 68, 2016, pages 1-7) as applied to claims 1-2, 4, 7-29, 31, and 33 above, and further in view of Bandari et al. (Asian Journal of Pharmaceutics, pages 2-11, 2008).
Applicant Claims
Applicant claims an orally disintegrating composition, comprising: baclofen, a stereoisomer thereof, a derivative thereof, an analog thereof, a prodrug thereof, or a pharmaceutically acceptable salt thereof; an excipient; a disintegrating agent; and a lubricating agent. Claim 35 recites the unit dose of claim 31, further comprising a foil packaging encapsulating the composition.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Abdelmonem et al., Fuji Brochure, Toksoz et al., Fujiwara et al., and Lorrai et al. are described in detail above and are incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Abdelmonem et al., Fuji Brochure, Toksoz et al., Fujiwara et al., and Lorrai et al. do not specifically teach the unit dose of further comprising a foil packaging encapsulating the composition. These deficiencies are cured by the teachings of Bandari et al.
Bandari et al. teach oral drug delivery remains the preferred route for oral administration of various drugs. Recent developments in the technology have prompted scientists to develop orally disintegrating tablets (ODTs) with improved patient compliance an convenience. ODTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. ODTs provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules (see abstract). Bandari et al. teach Zydis is patented by R.P. Scherer. This technology includes physical trapping of the drug in a matrix composed of a saccharide and a polymer. Polymers generally employed are partially hydrolyzed gelatin, hydrolyzed dextran, dextrin, alginates, polyvinyl alcohol, polyvinylpyrrolidone, acacia, and these mixtures. The methodology involves solution or dispersion of components is prepared and filled in to blister cavities, which are frozen in a liquid nitrogen environment. The frozen solvent is removed or sublimed to produce porous wafers. Peelable backing foil is used to pack zydis units (see page 4). Bandari et al. teach in packaging of ODT section that packing is one of the important aspects of manufacturing ODT. The products obtained by various technologies vary in some of the parametrs especially in mechanical strength to a good extent . The products obtained lyophilization process including various technologies such as has Zydis, Lyoc, Quicksolv, and nanocrystal are porous in nature, have less physical resistance, sensitive to moisture, and may degrade at higher humidity conditions. For the above reasons products obtained require special packaging. Zydis units are general packed with peelable backing foil (see page 9).
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 modify the teachings of Abdelmonem et al., Fuji Brochure, Toksoz et al., Fujiwara et al., and Lorrai et al. by utilizing a foil packaging encapsulating the ODT unit dosage form because Bandari et al. teach oral drug delivery remains the preferred route for oral administration of various drugs. Recent developments in the technology have prompted scientists to develop orally disintegrating tablets (ODTs) with improved patient compliance an convenience. ODTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. ODTs provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules (see abstract). Bandari et al. teach Zydis is patented by R.P. Scherer. This technology includes physical trapping of the drug in a matrix composed of a saccharide and a polymer. Polymers generally employed are partially hydrolyzed gelatin, hydrolyzed dextran, dextrin, alginates, polyvinyl alcohol, polyvinylpyrrolidone, acacia, and these mixtures. The methodology involves solution or dispersion of components is prepared and filled in to blister cavities, which are frozen in a liquid nitrogen environment. The frozen solvent is removed or sublimed to produce porous wafers. Peelable backing foil is used to pack zydis units (see page 4). One of ordinary skill in the art would have been motivated to do so because Bandari et al. teach in packaging of ODT section that packing is one of the important aspects of manufacturing ODT. The products obtained by various technologies vary in some of the parametrs especially in mechanical strength to a good extent . The products obtained lyophilization process including various technologies such as has Zydis, Lyoc, Quicksolv, and nanocrystal are porous in nature, have less physical resistance, sensitive to moisture, and may degrade at higher humidity conditions. For the above reasons products obtained require special packaging. Zydis units are general packed with peelable backing foil (see page 9). 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 chance of success in combining the teachings of Abdelmonem et al., Fuji Brochure, Toksoz et al., Fujiwara et al., Lorrai et al., and Bandari et al. because all of the references are drawn to orally disintegrating compositions.
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.
Response to Arguments
Applicant's arguments filed 04 March 2026 have been fully considered but they are not persuasive.
Applicants argue for at least the reasons provided above, claim 35 is non-obvious over Abdelmonem, Fuji Brochure, Toksoz, Fujiwara, and Lorrai. Bandari fails to remedy these deficiencies.
The above assertions are not found persuasive for at least the same rebuttal arguments set forth above which are incorporated herein by reference.
Conclusions
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
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