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 .
Status of the Application
This Office Action is in response to Applicant's arguments filed on December 5, 2025. Claim(s) 7 and 10-15 are pending and examined herein.
Response to Arguments
Applicant’s amendments and arguments with respect to the following rejections have been considered:
Claims 7 and 10-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,096,941.
Claims 7 and 10-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8,268,848.
Claims 7 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Terauchi (US 2012/0095031).
Applicant argues:
… Applicant has amended independent claim 7 to recite a method of improving continuity of nocturnal sleep in a subject comprising administering to a subject in need thereof an effective amount in a dosage form of 2.5 mg to 15 mg of at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof, and solvates of any of the foregoing. The amended claims are not rendered obvious by Terauchi for the following reasons. Terauchi does not teach or suggest the use of lemborexant in a dosage form of 2.5 mg to 15 mg for improving continuity of nocturnal sleep. Therefore, Terauchi does not teach or suggest each and every claim feature of the rejected claims. Moreover, a person of ordinary skill in the art, based on Terauchi's teachings, would have had no reason to select lemborexant, then determine the specific dosing regimen of a dosage form of 2.5 mg to 15 mg for improving continuity of nocturnal sleep, and would have had no reasonable expectation of success in the specific claimed dosage form for improving continuity of nocturnal sleep without improperly using the present invention as a roadmap to conclude that the specific selections are obvious from the broad disclosure of Terauchi.
Applicant’s arguments are not persuasive as they are based on amended claims.
The maintained/modified rejections are made in the Final Office action below as necessitated by amendment.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 7 and 10-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,096,941. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to a method of improving continuity of nocturnal sleep in a subject comprising administering to a subject in need thereof an effective amount of at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof. The dependent claims further recite benefits experienced by subject administered said medicament, including consolidated wakefulness hours during the daytime (claim 11), increased sleep efficiency (claim 12), decreased daytime sleepiness (claim 13), increased daytime alertness (claim 14), improved circadian rhythms.
The patented claims are drawn to a method of treating irregular sleep-wake rhythm disorder in a subject (claim 1), a method of treating at least one circadian rhythm sleep disorder in a subject with dementia due to Alzheimer's disease and/or related disorders (claim 2), method of treating at least one circadian rhythm sleep disorder in a subject with mild cognitive impairment due to Alzheimer's disease (claim 3), all administering lemborexant.
Nocturnal sleep is a type of irregular sleep disorder and is embraced within the patented claims. Although the patient population of the instant claims do not suffer from Alzheimer’s disease, one of ordinary skill in the art would find it obvious to employ lemborexant to also treat the sleep disorder of said patients. The skilled artisan would expect the treatment to have a reasonable degree of success regardless of which ailments the sleep disorders arise from.
While the patented claims do not teach the specific dosage range of 2.5 mg to 15 mg, as required by the instant claims, an effective dose is taught to treat sleep irregularities. Therefore, the optimization of dose amount is a parameter within the purview of the skilled artisan to adjust.
Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Claims 7 and 10-15 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 8,268,848. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to a method of improving continuity of nocturnal sleep in a subject comprising administering to a subject in need thereof an effective amount of at least one compound chosen from lemborexant, pharmaceutically acceptable salts thereof. The dependent claims further recite benefits experienced by subject administered said medicament, including consolidated wakefulness hours during the daytime (claim 11), increased sleep efficiency (claim 12), decreased daytime sleepiness (claim 13), increased daytime alertness (claim 14), improved circadian rhythms.
The patented claims are drawn to a compound of formula A, which embrace lemborexant and pharmaceutical compositions thereof (claims 1-10) and a method of treating sleep disorder for which orexin receptor antagonist is effective (claim 11).
Nocturnal sleep is a type of sleep disorder and is embraced within the patented claims. Regarding patented claims 1-10, while said claims are product claims, they must have utility as they are utility patents. In order to understand the utility of the compounds, Examiner went to the specification for guidance. Since the scope of the composition of the instant invention is encompassed by composition of said patent and their utilities are encompassed, that is nocturnal sleep is a type of sleep disorder, then the instant application is obvious over said patent.
While the patented claims do not teach the specific dosage range of 2.5 mg to 15 mg, as required by the instant claims, an effective dose is taught to treat sleep irregularities. Therefore, the optimization of dose amount is a parameter within the purview of the skilled artisan to adjust.
Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
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.
Claims 7 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Terauchi (US 2012/0095031).
Terauchi teaches cyclopropane compounds formula (A) or a pharmaceutically acceptable salt thereof as orexin receptor antagonists, useful for the treatment of sleep disorder for which orexin receptor antagonism is effective, for example, insomnia (abstract).
Terauchi specifically teaches lemborexant (page 15, [00352], Formula 16).
Terauchi teaches orexin receptors are found in the mammalian brain and may have numerous implications in pathologies such as sleep disorders, disturbed biological and circadian rhythms; sleep disturbances associated with diseases such as neurological disorders, sleep apnea; narcolepsy; insomnia; parasomnia, among other ailments [0006].
Terauchi teaches the dose of the cyclopropane compound is different depending on the degree of symptoms, age, sex, body weight, administration route/the type of a salt, the specific type of disease, and the like. In general, in the case of oral administration, the cyclopropane compound is administered at a dose of approximately 30 μg to 10 g, preferably 100 μg to 5 g, and more preferably 100 μg to 1 g per adult per day. In the case of administration via injection, it is administered at a dose of approximately 30 μg to 1 g, preferably 100 μg to 500 mg, and more preferably 100 μg to 300 mg per adult per day [0477].
Terauchi does not explicitly teach the patient population in need of improving continuity of nocturnal sleep, wakefulness consolidation and/or sleep efficiency, thereof, as required by the limitations of the instant claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have envisioned employing an orexin receptor antagonist, namely lemborexant, for the treatment of a sleep disorders such as sleep with disturbed biological and circadian rhythms; sleep disturbances associated with diseases, sleep apnea, or insomnia as taught by Terauchi and employed said medicament to also improve the continuity of nocturnal sleep. The skilled artisan would have expected, with a reasonable degree of success, that treating the ailments above would improve the quality, continuity and efficiency of sleep, regardless of whether the patient population suffers from nocturnal sleep irregularities or other sleep irregularity etiology.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 7 and 10-15 are not allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not
mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622