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 .
Applicant’s arguments, filed 05/20/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-3, 5-10, 21-25, and 27-35, are pending and under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-3, 5-10, 21-25 and 27-35, are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al (CA 3046296 A1), in view of Maleki et al (Res in Pharm Sci, 2015, 10(2), pp 95-108), and Eswariah (WO 2017/025981) and Oikawa et al (US 20160346199 A1, hereinafter “Oikawa”).
Baek et al teach an orally disintegrating tablet, the tablet containing an active compound of formula 2 (abs, end of pg 1, tables 1 and 2). The tablets comprise the active formula 2 at 5.0 and 10.0 wt%, crospovidone (disintegrant) at 6.35 wt%, magnesium stearate (lubricant) at 0.9 wt%, mannitol (hydrophilic excipient and diluent) at 69.75 and 67.25 wt%, pregelatinized starch (diluent) at 12.5 and 10 wt% (table 1, pg 6, pg 18). The tablets of example 2, following disintegration in saliva, have a particle size of several microns where comparative example 2 had a particle size of 100 microns or more (pg 26 last ¶). In examples 1 and 2, the carbamate compound of formula 2 was sieved through a 30 mesh sieve, resulting in a particle size of at least less than 595 microns (pg 21). The immediate release tablets comprising the active of formula 2 comprises a dose of 200 mg (ex 1 and 2). The therapeutically effective amount of the compounds (i.e., the carbamate compound) is 50-400 mg based on once daily administration (pg 19). The usage and dosage of the orally disintegrating tablets depend on the patients gender, age, and other conditions, the disease state, and the like (pg 19). The tablets were formulated with a tablet press (pg 21). The tablets of example 2, following disintegration in saliva, have a particle size of several microns where comparative example 2 had a particle size of 100 microns or more (pg 26 last ¶). The dissolution of example 1 is shown in figure 1 (fig 1). The particle sizes indicate there will be almost no foreign body sensation and residual feeling (pg 26). The reference further teaches the tablets may further comprise hydroxypropyl cellulose (a suitable surfactant as evidenced by ¶ 49 of the instant specification) (claim 1, pg 16 1st ¶). The content of the disintegrant is 1-10 wt%, and preferably 2-5 wt%, and the carbamate compound is 2.5-25 wt% (pg 7). Baek et al note that other formulations in the prior art were disadvantageous in that dissolution rate in the oral cavity was low, and it was necessary to formulate a tablet with the carbamate compound of formula 2 that that were fast disintegrating for patients who are afraid to swallow the tablets or try to avoid ingestion of the tablets (pp 3-4). The hydrophilic excipients include microcrystalline cellulose, lactose, etc. (pg 16). The disintegrant may be one or more of sodium starch glycolate, crospovidone, etc. (pg 17). The orally disintegrating tablet may be used for the treatment of anxiety, depression, convulsion, epilepsy, migraine, bipolar disorder, drug abuse, smoking, attention deficit hyperactivity disorder (ADHD), obesity, sleep disorders, neuropathic pain, stroke, cognitive disorders, and neurodegeneration or muscle spasm (pg 19).
Baek et al do not appear to specifically teach the particle size as instantly claimed, nor wherein the tablets are film coated.
Maleki et al teach that it was known that particle size and shape are important in every stage of solid oral dosage form (tablets are mentioned) and fabrication; in the body, dissolution rate is a function of solubility and particle size; the simplest way to increase the dissolution rate is particle size modification (micronization and nanosizing) of both actives and excipients (pg 96 2nd col last ¶). When particle size is reduced, the total effective surface area is increased and thereby dissolution rate is enhanced (pg 96 2nd col last ¶). Solubility, bioavailability and dissolution rate of drugs are important for achieving in vivo efficacy (abs). A mean particle size of 2-5 microns are exemplified (pg 97 1st col 1st ¶).
Maleki et al do not specifically teach the particle size distribution as instantly claimed nor wherein the tablets are film coated.
Eswariah teaches carbamate compounds may undergo conventional size reduction techniques in order to provide the desired solubility profile based on different forms of pharmaceutical composition requirements. In an exemplary embodiment, D(0.5) was measured at 23.5µm and D(0.9) at 46.3µm.
Eswariah does not appear to teach the tablets are film coated.
Oikawa teaches it was known to coat orally disintegrating tablets with rapidly dissolving films, where the film protects and stabilizes an active agent from environmental factors such as humidity and light (abs, ¶ 5). The films can also be applied for purposes of giving moisture resistance to a tablet to maintain tablet hardness, as well as mask the bitterness and odor of a pharmaceutical drug (¶ 5). The films provide the orally disintegrating tablets with good taste mouth feel (¶¶ 23, 38). The film coated orally disintegrating tablets maintain their disintegration properties (¶ 54). The improved tablet hardness provided by the film allows convenience in handling of the tablet to be improved (¶ 54).
Regarding the composition of claim 1, it would have been obvious to formulate the pharmaceutical compositions of examples 1 and 2 of Baek et al, which comprises the active agent of instant formula 2 and a pharmaceutically acceptable carrier (i.e., disintegrant, lubricant, and diluent).
Regarding the amount of active ingredient of claim 1, it would have been obvious to formulate the tablet of Baek et al with the active agent in an amount ranging from 50-400 mg, which is taught by Baek et al as the therapeutically effective amount of the active, for effective treatment depending on a patients gender, age, and other conditions, the disease state, and the like, as taught by Baek et al, and were the therapeutically effective amounts are taught to be based on once daily administration.
Additionally, the skilled artisan could also look to the examples where even assuming the tablets have a total weight of 200 mg, as argued by Applicants below, Baek et al teaches particular embodiments where the tablets may comprise 25 wt% of the active agent, and accordingly, it would have been obvious for the skilled artisan to modify the amount of active in the tablets to 25 wt%, thereby resulting in a tablet comprising 50 mg (25% of 200 mg = 50 mg) of instantly claimed formula 2. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding the particle size of claims 1, 2, and 3, where Baek et al teach that formulations with low oral dissolution were disadvantageous and that it was necessary to formulate a tablet with fast disintegration with immediate release for patients afraid to swallow or try to avoid ingestion of tablets, it would have been obvious for a skilled artisan to optimize the dissolution rate of the active agent in order to minimize the time it takes for the active to dissolve in the mouth of a patient that cannot or is trying to avoid taking the medication. As such, it would have been obvious to turn to known methods of improving dissolution rate, such as particle size reduction, as taught by Maleki et al, to sizes that were known to be suitable for other carbamate compounds, such as a d(0.5) at 23.5 microns and a d(0.9) at 46.3 microns, falling within the claimed ranges.
In addition to the above, a skilled artisan would also have motivation to optimize particle size where Baek et al teach it is desirable to formulate compositions without limited residual mouth feel and foreign body sensation. A skilled artisan would recognize from the teachings of Baek et al that smaller particle sizes would result in less residual mouth feel and foreign body sensation, improving the patient experience when taking the orally disintegrating tablet.
Regarding the limitation of a film-coated tablet, it would have been obvious to coat the orally disintegrating tablets with a rapidly dissolving film that maintains tablet dissolution properties in order to improve tablet hardness for improved handling, protect active agents from moisture and light, mask bitterness and odor of the tablets, and provide the tablet with good taste and mouth feel, as taught by Oikawa.
Regarding the dissolution of claims 1, 27, 28, and 29, example 1 and comparative example 1 both had about 100% dissolution within 10 minutes. Further, where the composition of Baek et al comprises the same components instantly claimed, and in the claimed amounts, and has a dissolution profile that falls within those instantly claimed, the particle size of the actives would be expected to be the same as instantly claimed, where Applicants appear to assert that the particle size is critical to achieving this dissolution profile.
Regarding claim 5, the examples of Baek comprise a diluent, a disintegrant, and a lubricant.
Regarding claim 6, it would have been obvious to further include hydroxypropyl cellulose, a suitable surfactant as evidenced by the instant specification, as taught by Baek et al.
Regarding claim 7, the dilutant in the composition made obvious above is pre-gelatinized starch.
Regarding claim 8, the composition made obvious above comprises crospovidone.
Regarding claims 9 and 32, the composition made obvious above comprises magnesium stearate.
Regarding claims 10 and 21, it would have been obvious to modify the amount of components in the composition of Baek et al, such as the amount of disintegrant from 1-10 wt%, as taught by Baek et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claims 22-25, it would have been obvious for a skilled artisan to adjust the average particle size within those ranges taught to be suitable in order to achieve desired body sensation, mouth feel, dissolution, etc.
Regarding claim 30, it would have been obvious to substitute the diluent in the examples Baek et al with other suitable diluents, including microcrystalline cellulose and lactose monohydrate, as taught by Baek et al.
Regarding claim 31, it would have been obvious to substitute the disintegrant in the examples of Baek et al with other suitable disintegrants, including sodium starch glycolate, as taught by Baek et al.
Regarding claim 33, it would have been obvious to substitute the diluent in the examples of Baek et al with microcrystalline cellulose, with those of claim 33, for the same reasons discussed above by Baek et al.
It would have been obvious to substitute the disintegrant in the examples of Baek et al with sodium starch glycolate, for the same reasons discussed above by Baek et al.
Regarding claim 34, it would have been obvious to administer to a subject in need thereof the pharmaceutical composition made obvious above for the method of treating a disease selected from anxiety, depression, convulsion, epilepsy, migraine, bipolar disorder, drug abuse, smoking, attention deficit hyperactivity disorder (ADHD), obesity, sleep disorders, neuropathic pain, stroke, cognitive disorders, and neurodegeneration or muscle spasm, as taught by Baek et al.
Regarding claim 35, it would have been obvious to administer to a subject in need thereof the pharmaceutical composition made obvious above for the method of treating epilepsy, as taught by Baek et al.
Response to Arguments
First, Applicants assert the recitation in Baek et al of a dose of 200 mg is based on a mistranslation of Baek et al. Applicants assert Baek et al is a Canadian national phase application of PCT/KR2017/0147731 (WO 2018/111002), where the Korean text was mistranslated as “200 mg dose per tablet,” and the more accurate translation is “orally disintegrating tablets having a weight of 200 mg per tablet.”
Second, Applicants assert that Baek et al’s disclosure of 2.5 to 25% by weight of the carbamate compound of Formula 1 or 2 amounts to a genus disclosure, where the range broadly describes the portion of said component in a composition, but does not indicate any specific milligram amount. Applicants assert there is no embodiment or teaching in Baek et al towards a 25 wt% carbamate compound. Applicants assert Baek et al do not describe the recited range of 50-400 mg of active ingredient as Baek et al’s express disclosure and examples do not overlap with the recited range. Applicants assert the additional references do not cure the above mentioned deficiencies.
Third, Applicants assert Baek et al is directed to a orally disintegrating tablet (ODT) and is silent regarding film-coatings. Applicants asset there is no motivation to coat Baek et al’s tablets as that would defeat the purpose of Baek et al’s rapid orally disintegrating tablets. Applicants assert the additional references do not cure the above mentioned deficiencies.
Fourth, Applicants assert the instant specification describes that the dissolution rate of carbamate compounds is variable despite its high solubility, and a general teaching regarding particle size reduction is irrelevant because the solubility level of carbamate compound of Formula 1 does not limit the absorption of a formulation. Applicants assert the skilled artisan would have reasonably understood the drawbacks of micronization, which Applicants assert tend to form unpredictable aggregates, is often used for poorly soluble compounds, and asserts when micronized, aggregation occurs which may actually delay dissolution. Applicants assert there is no indication in Baek et al that the ODTs are poorly soluble.
Fifth, Applicants assert Baek et al is silent as to the particle diameter of the active, and merely describes the mixture of active is sieved resulting in a particle size of less than 595 microns. Applicants assert Baek et al show that tablets break down into smaller particles however, the size of the disintegrated tablet has no bearing on the particle size of the active ingredient prior to disintegration.
Sixth, Applicants assert the compound of Eswariah is structurally distinct from the carbamate compound of Formula 2, and asserts the teachings of Eswariah are not applicable to Beak et al. Applicants assert Maleki describes nanosization of drugs to improve dissolution rate, however, Applicants assert Maleki is not directed to carbamate compounds.
Seventh, Applicants assert that active ingredients having a d(0.9) of 300 microns or more exhibit slower dissolution rates compared to less than 300 microns, and asserts these results are unexpected in view of the cited references and conventional understanding of the compounds of Formula 2.
First, even assuming the English publication of Baek et al were mistranslated and the exemplified tablets have a total weight of 200 mg, Baek et al teaches embodiments comprising 25 wt% of the carbamate compound of formula 2, which when applied to the 200 mg tablet, would result 50 mg of the active agent. Further, as discussed above, it would have been obvious to formulate the tablet of Baek et al with the active agent in an amount ranging from 50-400 mg, which is taught by Baek et al as the therapeutically effective amount of the active, for effective treatment depending on a patients gender, age, and other conditions, the disease state, and the like, as taught by Baek et al above.
Second, respectfully, this argument is not persuasive. The examiner notes that a reference may be relied upon for all it teaches, and where Baek et al explicitly teaches the therapeutically effective amount of the active agent ranges from 50-400 mg, it would have been obvious for the skilled artisan to formulate the tablets within the known dosage range for effective treatments. In other embodiments, Baek et al also teaches the orally disintegrating tablet may comprise carbamate compound of Formula 1 or 2 in an amount of 2.5 to 25 wt% per tablet, and where using Applicants interpretation of the examples of having a 200 mg tablet, the resulting amount of the compound of Formula 2 can be 50 mg, overlapping the claimed range. Further, while this is an exemplified embodiment, as discussed above, the reference does not limit the total tablet weight.
Third, respectfully, this argument is not persuasive. It would have been obvious to modify the tablets of Baek et al by film-coating the tablets for the above mentioned benefits taught by Oikawa. Where the rapidly dissolving film-coatings are suitable for orally disintegrating tablets and maintains the tablets dissolution properties, the film coatings would not appear to defeat the purpose of Baek et al’s rapid orally disintegrating tablets.
Fourth, respectfully, this argument is not persuasive. Applicants assert that the instant specification states that the dissolution rate of carbamate compounds is variable despite its high solubility, but do not appear to have provided any evidence to support this statement. It appears that the dissolution rates from table 1 and fig 1 of the instant specification shows a predictable and stable dissolution profile where embodiments with a smaller d(0.9) resulted in faster dissolution. From the teachings of Maleki, the skilled artisan would recognize that micronization of active agents increases their surface area and thereby increase the dissolution rate as more surface area is in contact with the dissolution media. The same would appear to hold true for both soluble and slightly soluble actives alike. This general understanding is bolstered by the teaching of Eswariah that micronization of a carbamate compound results in faster disintegration. Applicants assert several potential drawbacks of micronization, and asserts it would not have been obvious to micronize the carbamate compound of formula 2 of Baek et al, however, the carbamate compound of formula 2 is already micronized where the active agent is less than 595 microns, thereby suggesting that micro size is suitable. The skilled artisan could reasonably adjust within the micro range, including those known to be suitable for carbamate compounds in orally disintegrating tablets, having a d(0.9) of 46.3, with a reasonable expectation of success. The skilled artisan would have motivation to adjust the particle size in order to increase dissolution, decrease residual mouth feel and foreign body sensation, etc., as discussed above.
Fifth, respectfully, this argument is not persuasive. Applicants assert Baek et al is silent as to active agent particle size, but the active agent is sieved resulting in a particle size of less than 595 microns, which is a teaching on particle diameter of the active (i.e., it is less than 595 microns). Applicants assert Baek et al show that tablets break down into smaller particles, however, these teachings were not relied upon for making obvious the particle size of the active agent in the orally disintegrating tablet.
Sixth, respectfully, this argument is not persuasive. The examiner again notes that claim 1 is drawn to a composition comprising particles of a carbamate compound. Applicants specification provides evidence that using smaller particles of carbamate compound provides more rapid disintegration (Figure 1). However, such a finding is predictable based on the teachings of Eswariah, where it is taught that a carbamate compound can undergo conventional size reduction techniques, and Maleki teaches size reduction, including micronization, improves dissolution rate of active agents for the same reasons discussed above. Differences in molecular structure does not change the general expectation that micronization of active agents leads to faster dissolution, as discussed above and in a prior Office Action.
Seventh, this argument is not persuasive. Applicants assert that their results showing that dissolution rates are slower at 300 microns or more compared to 300 microns or less, however, this result is consistent with the teachings of the cited prior art. As discussed above, the general understanding in the cited prior art is that decreased particle size increases surface area, exposing more of the active agent to dissolution media, and thus increasing dissolution rate. Accordingly, based on the teachings of the prior art, the skilled artisan would have reasonably expected that smaller active agent particle sizes would have a faster dissolution rate compared to larger particle sizes.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Baek et al (CA 3046296 A1), Maleki et al (Res in Pharm Sci, 2015, 10(2), pp 95-108), Eswariah (WO 2017/025981), and Oikawa et al (US 20160346199 A1, hereinafter “Oikawa”), as applied to claims 1-3, 5-10, 21-25 and 27-35 above, and in further view of Sheth (US 20170368031).
Baek et al, Maleki et al, and Eswariah are discussed above and while teaching hydroxypropyl cellulose, if it would not have been obvious to include as a surfactant, the following applies.
Sheth teaches a carbamate compound and an oral composition for administering the carbamate compound. The compositions may also include a surfactant (¶ 66). The compositions comprise diluents, disintegrants, and lubricants (¶ 65-66).
It would have been obvious to further include a surfactant to the combination of Baek et al, Maleki et al, and Eswariah, as taught by Sheth, where both are drawn to oral compositions comprising a carbamate compound, diluents, disintegrants, and lubricants.
Response to Arguments
Applicants assert Sheth fails to cure the above mentioned deficiencies.
This argument is not persuasive. The claims stand rejected for the same reasons above and of record.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-3, 5-10, 21-25 and 27-35, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/778,450 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite a method for preparing pharmaceutical composition comprising the active of instant formula 2 in an amount from 5 mg to 400 mg, further comprises a carrier, and has a particle diameter d(0.9) of less than 300 microns. The tablets may be film-coated tablets. A person having ordinary skill in the art following the claims of the reference applications would have found it prima facie obvious to choose from among the suitable components to arrive at the instant claims. MPEP 2143.
It would have been obvious to formulate the compositions of ‘450 with an amount of active from 50-400 mg, as disclosed by the claims of ‘450. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants request the double patenting request be held in abeyance until allowable subject matter is indicated.
Examiner acknowledges applicants assertion. The claims stand rejected for the same reasons above and of record.
Claims 1-3, 5-10, 21-25 and 27-35, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 16/469,268 (reference application), hereinafter referred to as ‘268, in view of Baek et al (CA 3046296 A1), Maleki et al (Res in Pharm Sci, 2015, 10(2), pp 95-108), Eswariah (WO 2017/025981), and Oikawa et al (US 20160346199 A1, hereinafter “Oikawa”). Although the claims are not identical they are not patentably distinct from each other because ‘268 discloses a tablet comprising a carbamate compound of formula 2, and a hydrophilic excipient selected from starch, microcrystalline cellulose, lactose, etc., a disintegrant selected from crospovidone, etc. The carbamate compound is 2.5-25 wt%, the hydrophilic excipient is 65-90 wt%, and the disintegrant is 1-10 wt% of the tablet. The tablet can be used for the treatment of epilepsy, etc.
‘268 does not disclose the amount in milligrams of the active, the particle diameter of the compound of formula 2, wherein the tablets are film-coated tablets, a lubricant and its amounts, the inclusion of a surfactant, nor the method of treating the diseases of claims 34 and 35.
It would have been obvious to modify ‘268 based on the teachings above.
It would have been obvious to include known amounts of active, such as those amounts taught by Baek et al.
It would have been obvious to adjust the particle size, for the same reasons discussed above and of record by Baek et al, Maleki et al, and Eswariah.
It would have been obvious to include a film-coating, as taught by Oikawa for the same reasons discussed above.
It would have been obvious to include a lubricant and a surfactant in known amounts suitable for tablets comprising a carbamate compound, as taught by Baek et al and for the same reasons discussed above and of record.
It would have been obvious to use the composition to treat epilepsy, as motivated by ‘268.
Response to Arguments
Applicants request the double patenting request be held in abeyance until allowable subject matter is indicated.
Examiner acknowledges applicants assertion. The claims stand rejected for the same reasons above and of record.
Claims 1-3, 5-10, 21-25 and 27-35, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/019,856 (reference application), hereinafter referred to as ‘856, in view of Baek et al (CA 3046296 A1). Although the claims are not identical they are not patentably distinct from each other because ‘856 discloses an oral solid dosage form comprising a carbamate compound of formula 2 (same as instantly claimed) from 25-65 wt%, a diluent (carrier) from 5-50 wt%, a lubricant from 0.1-2 wt%, and a disintegrant from 0.5-10 wt%, wherein the particle diameter of the active ingredient is 300 microns or less. The tablets may be film-coated tablets.
‘856 does not disclose the amount in milligrams of the active, the composition in the form of a tablet, the weight percent of the diluent as instantly claimed, nor a method for treating a disease from those recited in claims 34 and 35.
Baek et al are discussed above and in the prior Office Action.
It would have been obvious to modify ‘856 based on the teachings above and in the prior Office Action.
It would have been obvious to include known amounts of active, such as those amounts taught by Baek et al.
It would have been obvious to formulate ‘856 in the form of a tablet, as taught by Baek et al.
It would have been obvious to adjust the amount of diluent of ‘856 to those known to be suitable oral compositions comprising a carbamate compound, such as those taught by the Baek et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
It would have been obvious to use the composition of ‘856 for the method of treating epilepsy, etc., as taught by Baek et al, where both comprise the same active.
Response to Arguments
Applicants request the double patenting request be held in abeyance until allowable subject matter is indicated.
Examiner acknowledges applicants’ assertion. The claims stand rejected for the same reasons above and of record.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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