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 .
DETAILED ACTION
Status of claims
The amendment filed on March 12, 2026 is acknowledged. New claims 3-6 have been added. Claims 1-6 are under examination in the instant office action.
Applicants' arguments, filed on March 12, 2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 in view of the amendments (new claims). They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention
New matter Rejection
Claims 3-6 are rejected 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claims 3 and 5 recite “chronic circadian rhythm or chronic sleep disorder” and claims 4 and 6 recite “shift-work disorder and delayed sleep phase disorder” as “chronic circadian rhythm or chronic sleep disorder”. However, the original application provides no support for “chronic circadian rhythm or chronic sleep disorder” and “shift-work disorder and delayed sleep phase disorder” as “chronic circadian rhythm or chronic sleep disorder”. Therefore, it is considered as new matter.
While the subject matter of the claim need not be described literally, to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. In this case, “chronic circadian rhythm and chronic sleep disorder” are a subgenus of circadian rhythm disorders and sleep disorders. While there is generic disclosure about circadian rhythm disorders and sleep disorders in the specification, there is nowhere “chronic circadian rhythm and chronic sleep disorder” as one of sleep disorder to be treated with the claimed compound. It should be noted that a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads. The written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads). Due to lack of sufficient disclosure as stated above, the claims do not meet the written description requirement.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 (a) to § 608.04(c).
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Rajaratnam et al. (The Lancet, 373 (9662): 7–13 February 2009, pages 482-491, cited in the IDS filed on 3/22/2024) in view of eBook, “Drug Treatment of Sleep Disorders (edited by Antonio Guglietta, 2015, Springer; hereafter “Guglietta”; cited in the IDS filed on 3/22/2024).
Rajaratnam et al. disclose two randomized controlled multicenter trials regarding efficacy of the melatonin agonist, tasimelteon (VEC-162) for treatment of transient insomnia associated with shifted sleep and wake time wherein 10, 20, 50, or 100 mg of tasimelteon capsule is orally administered once 30 min before bedtime (summary, p483, col 2, para 3-4, and p488, Table 3). Rajaratnam et al. specifically disclose tasimelteon improved sleep latency, sleep efficiency, and wake after sleep onset (i.e., sleep maintenance) (Summary, p486, Results, Table 2, and Fig. 2). Rajaratnam et al. further disclose that outside the sleep episodes, wakefulness was confirmed by continuous observation (p487, Fig. 2 legend).
Rajaratnam et al. also disclose that to assess the possibility that a sleep-promoting treatment might affect wake in the day after treatment, performance was assessed the next morning relative to baseline for each individual with the psychomotor vigilance test in the phase II study and the digit symbol substitution test in the phase III study and neither study showed any difference between treatment groups and placebo (p488, col 2, para 1).
In addition, Rajaratnam et al. teach that daytime effects should be investigated, especially because some studies have shown increased sleepiness and impaired neurobehavioural performance immediately after administration of melatonin or a melatonin agonist (p489, col 2, para 1). Rajaratnam et al. further teach daytime performance and alertness should be tested to detect both carryover sedative effect as an adverse side-effect and improved daytime performance secondary to improved sleep (p489, col 2, para 1). Rajaratnam et al. disclose that in both our protocols, we measured performance to examine possible carryover effect, but none was present (p489, col 2, para 1).
As to the post-sleep period, it was known in the art that the regular sleep schedule is 8-9 hr-sleep schedule and Rajaratnam et al. teach that participants maintained a regular 8-h sleep schedule for at least 1 week followed by a 9-h sleep schedule for 1 week before inpatient study (p487, col 2, para 4 and p484, col 1, para 2). Thus, the skilled artisan would have known that the post-sleep period would begin after the regular sleep schedule such as approximately nine hours after administering the hypnotic medicine such as tasimelteon.
Rajaratnam et al. is silent about the step of determining whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment as recited in claim 1. However, Rajaratnam et al. already teach and suggest the need of testing daytime performance and alertness for detecting both carryover sedative effect as an adverse side-effect because some studies have shown increased sleepiness and impaired neurobehavioural performance immediately after administration of melatonin or a melatonin agonist and discloses that no carryover effects were found in tasimelteon-treatment groups when performance was assessed the next morning relative to baseline for each individual with the psychomotor vigilance test and digit symbol substitution test.
Also, Guglietta teaches that specific adverse events particularly relevant in hypnotics drugs should be monitored throughout the entire development phase in both short-term and long-term studies and particular attention should be given to the development of CNS adverse effects such as cognition, reaction time, and driving (p100, last para -p101, 1st para). Guglietta further discloses that the use of a hypnotic should not be associated with any residual undesirable effects such as memory impairment and performance deficits the day after drug administration and the individual should be able to carry out daily tasks such as driving normally (p94-95, 3.3.3 Next-day effects). Guglietta further discloses that the next-day effects constitute an important part of the clinical evaluation of a hypnotic which should also be studied during the nonclinical development phase (p95, 3.3.3 Next-day effects). In addition, it discloses that a highway driving performance study have been done after administering other hypnotics such as zolpidem (p147, abstract) eszopiclone (p182, last para), and Modafinil (p217, last para-p218, 1st para).
Also, Guglietta discloses that tasimelteon (VEC-162) is an orally bioavailable melatonin receptor agonist of the melatonin MT1 and MT2 receptors and (p261, abstract and p262, 1 Introduction) and tasimelteon helps to synchronize the circadian system and consequently improve nighttime sleep and daytime wakefulness through action at these melatonin receptor subtypes (p264, 3.2 Pharmacodynamics). Guglietta further discloses tasimelteon is presently available as a capsule with a single 20 mg dose and 20 mg of tasimelteon is administered 1 hr prior to their preferred bedtimes (p262, 1 Introduction and p265, 4 Clinical Studies).
A phase III study (n¼322) of primary insomnia subjects measuring both subjective and objective (polysomnographic) outcomes showed significant improvements in latency to persistent sleep with tasimelteon 20 and 50 mg compared with placebo (p266, 4 Clinical Studies). Also, Clinical trials disclose tasimelteon was safe and well tolerated and there were no significant next-day residual effects evident in the clinical trials (p266, 5 Safety). Guglietta further mentions about “next-day residual effects”, which are assessed in terms of vigilance, psychomotor performance, and morning sedation, throughout his book (p155, para 2, p161, para 2 and p195, para 1).
The FDA approved prescribing information recommends that tasimelteon 20 mg be taken at the same time every night without food (p267, 7 Prescribing Guidelines). Guglietta states that this compound should be beneficial for related conditions, such as insomnia disorder with sleep onset difficulty and selected circadian rhythm sleep–wake disorders (p268, Conclusion).
In view of the above teachings, one of ordinary skill in the art would have recognized that the use of medicines known to improve sleep (hypnotics) could cause residual undesirable effects such as memory impairment and performance deficits for carrying our daily tasks such as driving normally. Thus, the skilled artisan would have been motivated to determine whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment before choosing suitable sleep treatment and to select appropriate medicine based on such determination. Since tasimelteon improves daytime wakefulness as evidenced by Guglietta and the clinical studies of Rajaratnam et al. and there were no significant carryover effects on performances including psychomotor vigilance in the next morning relative to baseline, the skilled artisan would have been motivated to use tasimelteon for those individuals who are in need of operating a motor vehicle or machinery during a post-sleep period following administration of sleep treatment on the reasonable expectation that tasimelteon would not impair performance in driving or operating machinery due to lack of the carryover effects on performances while improving sleep and daytime wakefulness.
Response to Applicant’s arguments
Applicant again argued that the cited references do not disclose that patients treated with tasimelteon did not suffer from impairment during a post-sleep period, which have been already addressed in the previous rejection and reiterated rejection as stated above. Applicant argued that while the cited references would suggest to one skilled in the art no more than that it should be determined whether tasimelteon induces next-day impairment in patients, this cannot render the claimed invention obvious, since there was no way to know what the outcome of such a determination would be.
In response, the issue is not whether the prior art demonstrates that tasimelteon has no daytime effects but claimed determining step would have been obvious to one of ordinary skill in the art. In this case, Rajaratnam et al. already teaches administering the same compound for improving sleep. While it is silent about determining step, it is common practice to check if the individual intends to or may operate a motor vehicle or machinery during a post-sleep period when the individual is using a hypnotic including tasimelteon due to potential next-day effects of hypnotics as evidenced by Guglietti. The general guidance of Guglietti evidences that it is common practice to check if the individual intends to or may operate a motor vehicle or machinery during a post-sleep period when the individual is using a hypnotic including tasimelteon. It is Examiner’s position that such determining would have been obvious to the skilled artisan who has known the general guidance of Guglietti and in the absence of evidence to the contrary. The skilled artisan would have been motived to do so for patient’s safety. This is what a person of ordinary skill in the corresponding art does.
Also, it should be noted that the claim 1 does not limit administering tasimelteon to an individual who has been determined to have an intention to operate a motor vehicle or machinery during a post-sleep period, but any individual for improving sleep. While the claim recites determining step, the administering step does not depend on the outcome of such determination. In other words, the claim encompasses administering tasimelteon to an individual who has been determined not to operate a motor vehicle or machinery during a post-sleep period because the claim simply requires determining step but does recite selecting an individual for administering step based on the outcome of such determination.
In response to Applicant’s argument that Rajaratnam suggests further study about daytime effect, one of ordinary skill in the art would have reasonably expected that tasimelteon does not have the next day residual effects based on Rajaratnam’s clinical studies showing that tasimelteon did not have carryover effects and outside the sleep episodes, wakefulness was confirmed by continuous observation. Especially, there is no evidence to the contrary. It should be noted that obviousness does not require absolute predictability of success. Also, the prior art teaches administering the same compound in the same amount to the same patient, thus improving sleep without impairing post-sleep performance necessarily occurs regardless of determining step. It is noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable.
In addition, the instant claim recites the post-sleep period includes a period beginning approximately nine hours after administration of tasimelteon. Thus, what Rajaratnam showed there was no carryover effects the next day after administration provides evidence that patients treated with tasimelteon did not suffer from impairment during the post-sleep period as the instant claims require.
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 v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. “[A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal-and even common-sensical-we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references.” Id. at 1368, 80 USPQ2d at 1651. In this case, the ordinary artisan possesses knowledge and skills to combine the prior art references. Also, when considering obviousness of a combination of known elements, the operative question is thus “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. In this regard, there is no evidence that the claimed invention is more than the predictable use of prior art elements according to the established functions of tasimelteon.
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Rajaratnam et al. (The Lancet, 373 (9662): 7–13 February 2009, Pages 482-491, cited in the IDS filed on 3/1/2021) in view of eBook, “Drug Treatment of Sleep Disorders (Antonio Guglietta (ed.), 2015, Springer; hereafter “Guglietta”) in further view of WO 2016/109359.
Rajaratnam et al. and Guglietta as applied supra are herein applied for the same teachings in their entirety.
As to new claims 3-6, Rajaratnam et al. teach and suggest that a phase-shifting drug such as tasimelteon has therapeutic potential for circadian rhythm sleep disorders, especially the jet-lag and shift-work types (shift-work disorder) (p489, col 2, para 3). Rajaratnam et al. further teach that tasimelteon may be used not only to treat jet-lag disorder, but also to alleviate sleep complaints in individuals who start work at early hours (p489, col 2, para 3). Rajaratnam et al. disclose that most of work force people probably experience chronic sleep restriction because they are unable to initiate and maintain sleep when they attempt to sleep in the early or late evening hours and tasimelteon might alleviate this problem by advancing the sleep–wake cycle, by providing a direct sleep-promoting effect, or both (p489, col 2, para 3). Also, Rajaratnam et al. disclose that by simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms, tasimelteon has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders, including people affected by jet lag, or those who work at night, and early-riser workers (shift-work disorder) (p489, col 2, last para).
In addition, tasimeltion has shown promise in treating circadian rhythm-related disorders, jet-lag, work-shift syndrome (shift-work disorder), sleep disorders, delayed sleep phase disorder as evidenced by WO 2016/109359 ([0003]). The work-shift syndrome (shift-work disorder) and delayed sleep phase disorder are recited as chronic circadian rhythm disorder or chronic sleep disorders in the instant claims 4 and 6.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use tasimelteon in the treatment of chronic circadian rhythm disorder or chronic sleep disorder such as shift-work disorder and delayed sleep phase disorder as well as transient insomnia on the reasonable expectation that tasimelteon would be similarly effective for treating such sleep disorders without causing memory impairment and performance deficits in driving and operating machinery due to lack of the next day effects while simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of copending application 18/611987 in view of eBook, “Drug Treatment of Sleep Disorders (edited by Antonio Guglietta, 2015, Springer; hereafter “Guglietta”) and Rajaratnam et al. (The Lancet, 373 (9662): 7–13 February 2009, Pages 482-491.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘987 application are drawn to a method of treating a sleep-wake cycle disrupting advance or jet lag by administering 20 mg tasimelteon which improves sleep parameter such as total sleep time and next day alertness (an improvement on the Karolinska Sleepiness Scale, an improvement on the Visual Analog Scale, or both).
The claims of the patent are silent about the step of determining whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment.
However, it was well known in the case of hypnotics that specific adverse events particularly relevant in this class of drugs should be monitored throughout the entire development phase in both short-term and long-term studies and particular attention should be given to the develop of CNS adverse effects such as cognition, reaction time, and driving as evidenced by Guglietta (p100, last para -p101, 1st para). Guglietta further discloses that the use of a hypnotic should not be associated with any residual undesirable effects such as memory impairment and performance deficits the day after drug administration and the individual should be able to carry out daily tasks such as driving normally as evidenced by Guglietta (p94-95, 3.3.3 Next-day effects). Guglietta further discloses that the next-day effects constitute an important part of the clinical evaluation of a hypnotic which however should also be studied during the nonclinical development phase (p95, 3.3.3 Next-day effects). Also, it discloses that a highway driving performance study have been done after administering other hypnotics such as zolpidem (p147, abstract) eszopiclone (p182, last para), and Modafinil (p217, last para-p218, 1st para). In addition, Guglietta discloses that tasimelteon helps to synchronize the circadian system and consequently improve nighttime sleep and daytime wakefulness through action at these melatonin receptor subtypes (p264, 3.2 Pharmacodynamics) and clinical trials disclose tasimelteon was safe and well tolerated and there were no significant next-day residual effects evident in the clinical trials (p266, 5 Safety). Furthermore, Guglietta states that tasimelteon should be beneficial for related conditions, such as insomnia disorder with sleep onset difficulty and selected circadian rhythm sleep–wake disorders (p268, Conclusion). Also, it was known in the art that the circadian sleep-wake disorder includes jet lag disorder as evidenced by Guglietta (p263, para 1).
Also, Rajaratnam et al. already teach and suggest the need of testing daytime performance and alertness for detecting both carryover sedative effect as an adverse side-effect because some studies have shown increased sleepiness and impaired neurobehavioural performance immediately after administration of melatonin or a melatonin agonist and discloses that no carryover effects were found in tasimelteon treatment groups when performance was assessed the next morning relative to baseline for each individual with the psychomotor vigilance test and digit symbol substitution test (see details as stated in 103 rejection).
In view of the above teachings, one of ordinary skill in the art would have recognized that the use of medicines known to improve sleep (hypnotics) could cause residual undesirable effects such as memory impairment and performance deficits for carrying our daily tasks such as driving normally. Thus, the skilled artisan would have been motivated to determine whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment before choosing suitable sleep treatment and to select appropriate medicine based on such determination. Since tasimelteon improves daytime wakefulness and there were no significant carryover effects on performances including psychomotor vigilance in the next morning relative to baseline as evidenced by Guglietta and Rajaratnam et al., the skilled artisan would have been motivated to use tasimelteon for those individuals who are in need of operating a motor vehicle or machinery during a post-sleep period following administration of sleep treatment on the reasonable expectation that tasimelteon would not impair performance in driving and operating machinery due to lack of the carryover effects on performances while improving sleep and daytime wakefulness.
As to new claims 3-6, Rajaratnam et al. teach and suggest that a phase-shifting drug such as tasimelteon has therapeutic potential for circadian rhythm sleep disorders, especially the jet-lag and shift-work types (shift-work disorder) (p489, col 2, para 3). Rajaratnam et al. further teach that tasimelteon may be used not only to treat jet-lag disorder, but also to alleviate sleep complaints in individuals who start work at early hours (p489, col 2, para 3). Rajaratnam et al. disclose that most of work force people probably experience chronic sleep restriction because they are unable to initiate and maintain sleep when they attempt to sleep in the early or late evening hours and tasimelteon might alleviate this problem by advancing the sleep–wake cycle, by providing a direct sleep-promoting effect, or both (p489, col 2, para 3). Also, Rajaratnam et al. disclose that by simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms, tasimelteon has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders, including people affected by jet lag, or those who work at night, and early-riser workers (shift-work disorder) (p489, col 2, last para). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use tasimelteon in the treatment of chronic circadian rhythm disorder or chronic sleep disorder such as shift-work disorder and delayed sleep phase disorder as well as transient insomnia on the reasonable expectation that tasimelteon would be similarly effective for treating such sleep disorders without causing memory impairment and performance deficits in driving and operating machinery due to lack of the next day effects while simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms.
Thus, the instant claims would have been obvious over the claims of the co-pending application.
Claims 1-6 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of US patent 11458116 in view of eBook, “Drug Treatment of Sleep Disorders (edited by Antonio Guglietta, 2015, Springer; hereafter “Guglietta”) and Rajaratnam et al. (The Lancet, 373 (9662): 7–13 February 2009, Pages 482-491.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘116 patent are drawn to a method of treating a circadian rhythm sleep disorder by administering 20 mg tasimelteon which improves sleep parameters such as total sleep time and latency to persistent sleep. As to new claim 3-6, the claims of the patent teaches that the circadian rhythm sleep disorder is delayed sleep wake phase disorder.
The claims of the patent are silent about the step of determining whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment.
However, it was well known in the case of hypnotics that specific adverse events particularly relevant in this class of drugs should be monitored throughout the entire development phase in both short-term and long-term studies and particular attention should be given to the develop of CNS adverse effects such as cognition, reaction time, and driving as evidenced by Guglietta (p100, last para -p101, 1st para). Guglietta further discloses that the use of a hypnotic should not be associated with any residual undesirable effects such as memory impairment and performance deficits the day after drug administration and the individual should be able to carry out daily tasks such as driving normally as evidenced by Guglietta (p94-95, 3.3.3 Next-day effects). Guglietta further discloses that the next-day effects constitute an important part of the clinical evaluation of a hypnotic which however should also be studied during the nonclinical development phase (p95, 3.3.3 Next-day effects). Also, it discloses that a highway driving performance study have been done after administering other hypnotics such as zolpidem (p147, abstract) eszopiclone (p182, last para), and Modafinil (p217, last para-p218, 1st para). In addition, Guglietta discloses that tasimelteon helps to synchronize the circadian system and consequently improve nighttime sleep and daytime wakefulness through action at these melatonin receptor subtypes (p264, 3.2 Pharmacodynamics) and clinical trials disclose tasimelteon was safe and well tolerated and there were no significant next-day residual effects evident in the clinical trials (p266, 5 Safety). Furthermore, Guglietta states that tasimelteon should be beneficial for related conditions, such as insomnia disorder with sleep onset difficulty and selected circadian rhythm sleep–wake disorders (p268, Conclusion). Also, it was known in the art that the circadian sleep-wake disorder includes jet lag disorder as evidenced by Guglietta (p263, para 1).
Also, Rajaratnam et al. already teach and suggest the need of testing daytime performance and alertness for detecting both carryover sedative effect as an adverse side-effect because some studies have shown increased sleepiness and impaired neurobehavioural performance immediately after administration of melatonin or a melatonin agonist and discloses that no carryover effects were found in tasimelteon treatment groups when performance was assessed the next morning relative to baseline for each individual with the psychomotor vigilance test and digit symbol substitution test (see details as stated in 103 rejection).
In view of the above teachings, one of ordinary skill in the art would have recognized that the use of medicines known to improve sleep (hypnotics) could cause residual undesirable effects such as memory impairment and performance deficits for carrying our daily tasks such as driving normally. Thus, the skilled artisan would have been motivated to determine whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment before choosing suitable sleep treatment and to select appropriate medicine based on such determination. Since tasimelteon improves daytime wakefulness and there were no significant carryover effects on performances including psychomotor vigilance in the next morning relative to baseline as evidenced by Guglietta and Rajaratnam et al., the skilled artisan would have been motivated to use tasimelteon for those individuals who are in need of operating a motor vehicle or machinery during a post-sleep period following administration of sleep treatment on the reasonable expectation that tasimelteon would not impair performance in driving and operating machinery due to lack of the carryover effects on performances while improving sleep and daytime wakefulness.
Thus, the instant claims would have been obvious over the claims of the patents.
Claims 1-6 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US patent 10376487 in view of eBook, “Drug Treatment of Sleep Disorders (edited by Antonio Guglietta, 2015, Springer; hereafter “Guglietta”) and Rajaratnam et al. (The Lancet, 373 (9662): 7–13 February 2009, Pages 482-491.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of treating a circadian rhythm sleep disorder or a sleep disorder by orally administering 20 mg tasimelteon without food.
The claims of the patent are silent about the step of determining whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment.
However, it was well known in the case of hypnotics that specific adverse events particularly relevant in this class of drugs should be monitored throughout the entire development phase in both short-term and long-term studies and particular attention should be given to the develop of CNS adverse effects such as cognition, reaction time, and driving as evidenced by Guglietta (p100, last pa7ra -p101, 1st para). Guglietta further discloses that the use of a hypnotic should not be associated with any residual undesirable effects such as memory impairment and performance deficits the day after drug administration and the individual should be able to carry out daily tasks such as driving normally as evidenced by Guglietta (p94-95, 3.3.3 Next-day effects). Guglietta further discloses that the next-day effects constitute an important part of the clinical evaluation of a hypnotic which however should also be studied during the nonclinical development phase (p95, 3.3.3 Next-day effects). Also, it discloses that a highway driving performance study have been done after administering other hypnotics such as zolpidem (p147, abstract) eszopiclone (p182, last para), and Modafinil (p217, last para-p218, 1st para). In addition, Guglietta discloses that tasimelteon helps to synchronize the circadian system and consequently improve nighttime sleep and daytime wakefulness through action at these melatonin receptor subtypes (p264, 3.2 Pharmacodynamics) and clinical trials disclose tasimelteon was safe and well tolerated and there were no significant next-day residual effects evident in the clinical trials (p266, 5 Safety). Furthermore, Guglietta already states that tasimelteon should be beneficial for related conditions, such as insomnia disorder with sleep onset difficulty and selected circadian rhythm sleep–wake disorders (p268, Conclusion). Also, it was known in the art that the circadian sleep-wake disorder includes jet lag disorder as evidenced by Guglietta (p263, para 1).
Also, Rajaratnam et al. already teach and suggest the need of testing daytime performance and alertness for detecting both carryover sedative effect as an adverse side-effect because some studies have shown increased sleepiness and impaired neurobehavioural performance immediately after administration of melatonin or a melatonin agonist and discloses that no carryover effects were found in tasimelteon treatment groups when performance was assessed the next morning relative to baseline for each individual with the psychomotor vigilance test and digit symbol substitution test (see details as stated in 103 rejection).
In view of the above teachings, one of ordinary skill in the art would have recognized that the use of medicines known to improve sleep (hypnotics) could cause residual undesirable effects such as memory impairment and performance deficits for carrying our daily tasks such as driving normally. Thus, the skilled artisan would have been motivated to determine whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment before choosing suitable sleep treatment and to select appropriate medicine based on such determination. Since tasimelteon improves daytime wakefulness and there were no significant carryover effects on performances including psychomotor vigilance in the next morning relative to baseline as evidenced by Guglietta and Rajaratnam et al., the skilled artisan would have been motivated to use tasimelteon for those individuals who are in need of operating a motor vehicle or machinery during a post-sleep period following administration of sleep treatment on the reasonable expectation that tasimelteon would not impair performance in driving and operating machinery due to lack of the carryover effects on performances while improving sleep and daytime wakefulness.
As to new claims 3-6, Rajaratnam et al. teach and suggest that a phase-shifting drug such as tasimelteon has therapeutic potential for circadian rhythm sleep disorders, especially the jet-lag and shift-work types (shift-work disorder) (p489, col 2, para 3). Rajaratnam et al. further teach that tasimelteon may be used not only to treat jet-lag disorder, but also to alleviate sleep complaints in individuals who start work at early hours (p489, col 2, para 3). Rajaratnam et al. disclose that most of work force people probably experience chronic sleep restriction because they are unable to initiate and maintain sleep when they attempt to sleep in the early or late evening hours and tasimelteon might alleviate this problem by advancing the sleep–wake cycle, by providing a direct sleep-promoting effect, or both (p489, col 2, para 3). Also, Rajaratnam et al. disclose that by simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms, tasimelteon has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders, including people affected by jet lag, or those who work at night, and early-riser workers (shift-work disorder) (p489, col 2, last para). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use tasimelteon in the treatment of chronic circadian rhythm disorder or chronic sleep disorder such as shift-work disorder and delayed sleep phase disorder as well as transient insomnia on the reasonable expectation that tasimelteon would be similarly effective for treating such sleep disorders without causing memory impairment and performance deficits in driving and operating machinery due to lack of the next day effects while simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms.
Thus, the instant claims would have been obvious over the claims of the patents.
Claims 1-6 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US patent 10610511 in view of eBook, “Drug Treatment of Sleep Disorders (edited by Antonio Guglietta, 2015, Springer; hereafter “Guglietta”) and Rajaratnam et al. (The Lancet, 373 (9662): 7–13 February 2009, Pages 482-491.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to a method of treating a circadian rhythm sleep disorder or a sleep disorder by administering 20 mg tasimelteon.
The claims of the patent are silent about the step of determining whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment.
However, it was well known in the case of hypnotics that specific adverse events particularly relevant in this class of drugs should be monitored throughout the entire development phase in both short-term and long-term studies and particular attention should be given to the develop of CNS adverse effects such as cognition, reaction time, and driving as evidenced by Guglietta (p100, last para -p101, 1st para). Guglietta further discloses that the use of a hypnotic should not be associated with any residual undesirable effects such as memory impairment and performance deficits the day after drug administration and the individual should be able to carry out daily tasks such as driving normally as evidenced by Guglietta (p94-95, 3.3.3 Next-day effects). Guglietta further discloses that the next-day effects constitute an important part of the clinical evaluation of a hypnotic which however should also be studied during the nonclinical development phase (p95, 3.3.3 Next-day effects). Also, it discloses that a highway driving performance study have been done after administering other hypnotics such as zolpidem (p147, abstract) eszopiclone (p182, last para), and Modafinil (p217, last para-p218, 1st para). In addition, Guglietta discloses that tasimelteon helps to synchronize the circadian system and consequently improve nighttime sleep and daytime wakefulness through action at these melatonin receptor subtypes (p264, 3.2 Pharmacodynamics) and clinical trials disclose tasimelteon was safe and well tolerated and there were no significant next-day residual effects evident in the clinical trials (p266, 5 Safety). Furthermore, Guglietta already states that tasimelteon should be beneficial for related conditions, such as insomnia disorder with sleep onset difficulty and selected circadian rhythm sleep–wake disorders (p268, Conclusion). Also, it was known in the art that the circadian sleep-wake disorder includes jet lag disorder as evidenced by Guglietta (p263, para 1).
Also, Rajaratnam et al. already teach and suggest the need of testing daytime performance and alertness for detecting both carryover sedative effect as an adverse side-effect because some studies have shown increased sleepiness and impaired neurobehavioural performance immediately after administration of melatonin or a melatonin agonist and discloses that no carryover effects were found in tasimelteon treatment groups when performance was assessed the next morning relative to baseline for each individual with the psychomotor vigilance test and digit symbol substitution test (see details as stated in 103 rejection).
In view of the above teachings, one of ordinary skill in the art would have recognized that the use of medicines known to improve sleep (hypnotics) could cause residual undesirable effects such as memory impairment and performance deficits for carrying our daily tasks such as driving normally. Thus, the skilled artisan would have been motivated to determine whether the individual intends to or may operate a motor vehicle or machinery during a post-sleep period following treatment before choosing suitable sleep treatment and to select appropriate medicine based on such determination. Since tasimelteon improves daytime wakefulness and there were no significant carryover effects on performances including psychomotor vigilance in the next morning relative to baseline as evidenced by Guglietta and Rajaratnam et al., the skilled artisan would have been motivated to use tasimelteon for those individuals who are in need of operating a motor vehicle or machinery during a post-sleep period following administration of sleep treatment on the reasonable expectation that tasimelteon would not impair performance in driving and operating machinery due to lack of the carryover effects on performances while improving sleep and daytime wakefulness.
As to new claims 3-6, Rajaratnam et al. teach and suggest that a phase-shifting drug such as tasimelteon has therapeutic potential for circadian rhythm sleep disorders, especially the jet-lag and shift-work types (shift-work disorder) (p489, col 2, para 3). Rajaratnam et al. further teach that tasimelteon may be used not only to treat jet-lag disorder, but also to alleviate sleep complaints in individuals who start work at early hours (p489, col 2, para 3). Rajaratnam et al. disclose that most of work force people probably experience chronic sleep restriction because they are unable to initiate and maintain sleep when they attempt to sleep in the early or late evening hours and tasimelteon might alleviate this problem by advancing the sleep–wake cycle, by providing a direct sleep-promoting effect, or both (p489, col 2, para 3). Also, Rajaratnam et al. disclose that by simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms, tasimelteon has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders, including people affected by jet lag, or those who work at night, and early-riser workers (shift-work disorder) (p489, col 2, last para). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use tasimelteon in the treatment of chronic circadian rhythm disorder or chronic sleep disorder such as shift-work disorder and delayed sleep phase disorder as well as transient insomnia on the reasonable expectation that tasimelteon would be similarly effective for treating such sleep disorders without causing memory impairment and performance deficits in driving and operating machinery due to lack of the next day effects while simultaneously improving sleep latency and sleep maintenance with a shift in circadian rhythms.
Thus, the instant claims would have been obvious over the claims of the patents.
Response to Applicant’s arguments
Applicant argued that the above ODP rejections are without basis for the reasons above and those previously set forth as to the deficiencies of Rajaratnam and Guglietta. Thus, the same responses stated above are applied.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 date of this final action.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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