Prosecution Insights
Last updated: April 19, 2026
Application No. 18/157,953

ORAL PHARMACEUTICAL COMPOSITION COMPRISING CARBAMATE COMPOUND AND PREPARATION METHOD THEREFOR

Non-Final OA §103§DP
Filed
Jan 23, 2023
Examiner
ATKINSON, JOSHUA ALEXANDER
Art Unit
1612
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
SK Biopharmaceuticals Co. Ltd.
OA Round
8 (Non-Final)
59%
Grant Probability
Moderate
8-9
OA Rounds
3y 2m
To Grant
91%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
40 granted / 68 resolved
-1.2% vs TC avg
Strong +32% interview lift
Without
With
+32.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
52 currently pending
Career history
120
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
38.8%
-1.2% vs TC avg
§102
10.0%
-30.0% vs TC avg
§112
24.1%
-15.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 68 resolved cases

Office Action

§103 §DP
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 . A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/12/2026 has been entered. Applicants' arguments, filed 02/12/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 12, 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, 12, 21-25 and 27-35, stand 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), as evidenced by Merriam-Webster (dose, retrieved 2026). 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). As evidenced by Merriam-Webster, dose is a defined by the measured quantity of a therapeutic agent to be taken at one time. The dosage of the carbamate compound can vary depending on the severity of disease, body weight, and the metabolic status of the subject (pg 19). The therapeutically effective amount of the compounds (i.e., the carbamate compound) is 50-400 mg, etc. (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). 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. 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. 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, where the tablets of examples 1 and 2 of Baek et al comprise a dosage of 200 mg, and a dose is defined by Merriam-Webster as the amount of therapeutic agent, it appears that the 200 mg dose refers to the amount of the active ingredient, rather than the total weight of the tablet. The skilled artisan would reasonably recognize that when a dose of a composition comprising an active agent is disclosed, the dosage refers to the amount of the active agent, rather than the total tablet weight. This is further supported by Baek et al were “the dosage” is used in the context of the amount of carbamate compound, which can vary, rather than the total tablet weight. Purely arguendo, even if the 200 mg dose is the total weight of the tablet, Baek et al teaches 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 up to 25 wt%, thereby resulting in a tablet comprising 50 mg (25% of 200 mg = 50 mg) of instantly claimed formula 2, falling within the claimed range. 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 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 claim 12, the tablets were formulated with a tablet press (i.e., compressed tablet). 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 cited references fail to describe at least the range of the amount of active ingredient as recited in claim 1. Applicants assert Baek merely describes that the tablets of Examples 1 and 2 weigh 200 mg, rather than that the tablets comprise 200 mg of the active ingredient. Further, Applicants assert Baek expressly describes that the active ingredient is comprised between 2.5-25 wt% per tablet, and in another embodiment the tablet may comprise active ingredient in an amount from 1-30 mg or 10-20 mg. Applicants assert the Office’s interpretation of 200 mg of the active ingredient would result in a tablet weighing 2,000 mg or 4,000 mg, which is inconsistent with Baek. Second, Applicants assert that Baek’s description regarding a therapeutically effective amount is irrelevant to the tablet size of the actual amount of active ingredient in the tablets because a therapeutically effective amount merely corresponds to how much of a compound is needed for efficacy, and multiple tablets can be taken to achieve this amount. Third, Applicants assert modifying the tablet size of Baek without explicit technical guidance would defeat the purpose of Baek as the reference describes a specific method of preparation with specific amounts of components to arrive at orally disintegrating tablets. Applicants assert there is no indication that changing tablet size or amounts of components outside of Baek’s disclosure would result in a tablet with similar properties. Applicants assert neither Maleki nor Eswariah provides any teaching or suggestion that modifying Baek’s method of preparation and component concentrations can still lead to tablets with rapid disintegration in the oral cavity, and asserts the skilled artisan would not have had a reasonable expectation of success. First, respectfully, this argument is not persuasive. Applicants assert the 200 mg disclosed in examples 1 and 2 of Baek et al are the total weight of the tablet, however, dosages are typically used to describe the amount of active agent to be administered, rather than the total tablet weight. As evidenced by Merriam Webster, dose is defined as the measured quantity of a therapeutic agent to be taken at one time. Accordingly, where Baek et al teaches “an immediate-release tablet of 200 mg dose per tablet,” it appears that the dose is referring to the amount of the active ingredient per tablet, rather than the total tablet weight. This is further supported by Baek et al, as discussed above, which recites “the dosage of the carbamate compound of Formula 1 or 2… may typically vary…” (see pg 19 last ¶). Here, the term “dosage” explicitly refers to the amount of the active carbamate compound, rather than the total formulation weight. The examiner recognizes that Baek et al teaches from 1-30 mg of the active agent, however, this appears to simply be a preferred embodiment. Even so, purely arguendo, if the 200 mg is the total tablet weight, Baek et al teaches the active may also be up to 25 wt%, and 25 wt% of 200 mg is 50 mg of active, falling within the claimed range. 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). Applicants assert a tablet weighing 2,000 mg or 4,000 mg is inconsistent with Baek et al, but Baek et al does not appear to limit the total weight of the tablet. Second, respectfully, this argument is not persuasive. The examiner disagrees that the teachings of a therapeutically effective amount are irrelevant to the amount of active in the tablets. The skilled artisan would reasonably look to the known therapeutically effective amounts of the active agent when formulating an oral tablet comprising the active for therapeutic uses. While the examiner agrees that multiple tablets can be taken to achieve a therapeutically effective amount, by knowing the therapeutically effective amounts of the active, the skilled artisan could reasonably adjust the amount of active for a single tablet to meet the therapeutically effective dose. Nevertheless, as discussed above, even applying Applicants’ own interpretation where 200 mg is the total tablet weight, 25% of 200 mg is 50 mg, falling within the therapeutically effective amounts with a single tablet. Third, respectfully, this argument is not persuasive. Applicants assert that modifying the tablet size of Baek et al would defeat the purpose of the reference where the preparation of the tablets require specific amounts, however, it appears that a tablet comprising 200 mg of the active agent is disclosed, for the same reasons discussed above, and therefore does not require tablet size modification. Purely arguendo, applying Applicants’ interpretation of 200 mg as the total tablet weight, Baek et al explicitly teaches the active may be 25 wt% of the tablet, and 25 wt% of 200 mg results in 50 mg of active agent, falling within the claimed range. The skilled artisan would have a reasonable expectation of success in including 25 wt% (or 50 mg) of active agent in the tablets of the disclosed examples, where Baek et al explicitly teaches these amounts are suitable for fast disintegrating oral tablets. The examiner notes that Maleki et al and Eswariah where not cited for adjusting the preparation method and component concentrations. Claim 6 stands 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), and Eswariah (WO 2017/025981), as applied to claims 1-3, 5-10, 12, 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, 12, 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. 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, 12, 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. 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), and Eswariah (WO 2017/025981). 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, 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 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, 12, 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. ‘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 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOSHUA A ATKINSON/Examiner, Art Unit 1612 /SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Read full office action

Prosecution Timeline

Jan 23, 2023
Application Filed
May 11, 2023
Non-Final Rejection — §103, §DP
Jul 11, 2023
Response Filed
Jul 28, 2023
Final Rejection — §103, §DP
Oct 09, 2023
Request for Continued Examination
Oct 12, 2023
Response after Non-Final Action
Dec 30, 2023
Non-Final Rejection — §103, §DP
Mar 11, 2024
Response Filed
Mar 27, 2024
Final Rejection — §103, §DP
May 24, 2024
Applicant Interview (Telephonic)
May 30, 2024
Request for Continued Examination
Jun 01, 2024
Examiner Interview Summary
Jun 04, 2024
Response after Non-Final Action
Oct 31, 2024
Non-Final Rejection — §103, §DP
Jan 16, 2025
Applicant Interview (Telephonic)
Jan 21, 2025
Examiner Interview Summary
Apr 02, 2025
Response Filed
Jun 16, 2025
Non-Final Rejection — §103, §DP
Jul 24, 2025
Response Filed
Jul 24, 2025
Response after Non-Final Action
Oct 23, 2025
Final Rejection — §103, §DP
Nov 25, 2025
Examiner Interview Summary
Nov 25, 2025
Applicant Interview (Telephonic)
Feb 12, 2026
Request for Continued Examination
Feb 13, 2026
Response after Non-Final Action
Mar 06, 2026
Non-Final Rejection — §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

8-9
Expected OA Rounds
59%
Grant Probability
91%
With Interview (+32.0%)
3y 2m
Median Time to Grant
High
PTA Risk
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