DETAILED ACTION
This office action is in response to applicant’s filing dated March 21, 2024.
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 Claims
Claims 1-10 are pending in the instant application.
Priority
The present application is a CON of US Application No. 16/977,801 filed on September 2, 2020, which is a 371 of PCT/US2019/020491 filed on March 4, 2019, which claims benefit of US Provisional Application Nos. 62/638,212 and 62/675,687 filed on March 4, 2018 and May 23, 2018, respectively.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 21, 2024 and June 21, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except where marked with a strikethrough.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hetlioz® (Hetlioz® (tasimelteon) Highlights of Prescribing Information, Revised 12/2014, cited in the IDS filed March 21, 2024).
Hetlioz® teaches HETLIOZ (tasimelteon) is a melatonin receptor agonist, chemically designated as (1R, 2R)-N-[2-(2,3-dihydrobenzofuran-4-yl)cyclopropylmethyl]propanamide (page 5, 11 DESCRIPTION):
PNG
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166
400
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Hetlioz® teaches HETLIOZ 20 mg capsules are available as size 1, dark blue opaque, hard gelatin capsules containing 20 mg of tasimelteon per capsule; bottles of 30 (page 10, 16 HOW SUPPLIED/STORAGE AND HANDLING). A gelatin capsule reads on a dispensing unit. Bottles of 30 reads on pre-packaged dispensing unit.
Regarding the limitation directed immediate release, Hetlioz® teaches pharmacokinetics of HETLIOZ is linear; and peak concentration (Tmax) of tasimelteon occurred approximately 0.5 to 3 hours after fasted oral administration. This reads on immediate release.
Regarding the limitation “to provide a course of treatment for an individual to be treated for a jet lag disorder,” such limitation is directed to an intended use of the composition. Such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e., an intent to use the disclosed tasimelteon to provide a course of treatment for an individual to be treated for a jet lag disorder), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art.
Thus, Hetlioz® anticipates the composition of claim 9.
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 1-5, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rajaratnam et al (Lancet, 2009; 373:482-91, cited in the IDS filed March 21, 2024).
Regarding claims 1, Rajaratnam teaches circadian rhythm sleep disorders are common causes of insomnia for millions of individuals; a phase II study was done to establish efficacy and physiological mechanism, and a phase III study to confirm efficacy of the melatonin agonist tasimelteon (VEC-162) for treatment of transient insomnia associated with shifted sleep and wake time (Summary). Rajaratnam teaches in a phase III study, 411 healthy individuals from 19 US sites, who had transient insomnia induced in a sleep clinic by a 5-h advance of the sleep–wake schedule and a first-night effect in a sleep clinic, were given tasimelteon; prespecified primary efficacy outcomes were polysomnographic sleep efficiency (phase II study), latency to persistent sleep (phase III study), and circadian phase shifting (phase II study) (Summary). Rajaratnam teaches tasimelteon reduced sleep latency and increased sleep efficiency compared with placebo and tasimelteon improved sleep latency, sleep efficiency, and wake after sleep onset (i.e., sleep maintenance) (Summary). Thus, Rajaratnam teaches a method of treating an individual experiencing a sleep-wake-cycle-disrupting advance in the individual’s established bedtime comprising administering an amount of tasimelteon.
Rajaratnam does not explicitly teach the advance in established bedtime is eight hours or that the advance is caused by eastward jet aircraft travel.
However, Rajaratnam teaches transient insomnia refers to impaired sleep initiation, sleep maintenance, or both, assessed in this study by latency to sleep onset and sleep efficiency in the middle of the sleep episode, respectively; this model is appropriate both for jet lag and early-riser shift workers (page 483, left, 2nd paragraph). Rajaratnam teaches a phase-shifting drug such as tasimelteon has therapeutic potential for circadian rhythm sleep disorders, especially the jet-lag and shift-work types; in 2007, about 94 million passengers boarded aircraft in the USA to travel internationally; because many of these people probably cross time zones, and based on the estimate that about two-thirds of individuals have jet-lag symptoms, the worldwide frequency of jet-lag disorder is likely to be substantial (page 489, right, 3rd paragraph); 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 (page 489, right, last paragraph). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Rajaratnam to treat a subject with an advance in established bedtime caused by eastward jet aircraft travel with a reasonable expectation of success, since the prior art teaches a phase-shifting drug such as tasimelteon is useful for treating a sleep-wake-cycle-disrupting advance in the individual’s established bedtime and would be useful for treating jet-lag.
With regard to the limitation regarding the advance in bedtime of 8 hours (instant claim 1), Rajaratnam teaches tasimelteon treatment improves sleep latency, sleep efficiency, and wake after sleep onset in subjects who have a 5-h advance of the sleep–wake schedule.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Rajaratnam to treat a subject with an advance in established bedtime to treat a subject with an advance in established bedtime of eight hours or 6-8 hours with a reasonable expectation of success, since the prior art teaches tasimelteon is a phase-shifting drug useful for treating a sleep-wake-cycle-disrupting advance in the individual’s established bedtime. Moreover, treatment regimen is result-effective variables, i.e., a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding the limitation wherein the amount of tasimelteon administered is 20 mg per day administered for at least 3 consecutive days, Rajaratnam teaches subjects were randomized to 3-day treatment and 8 subjects received 20 mg tasimelteon (Figure 1).
Regarding claims 2-5, 7, and 8, Rajaratnam teaches tasimelteon improved sleep latency, sleep efficiency, and wake after sleep onset (Abstract). Moreover, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). In the instant case, the wherein clause is directed to the intended result (i.e., improving sleep parameter of total sleep time, latency to persistent sleep and wake after sleep onset (instant claims 2-4 and 7); improve next day alertness (instant claim 5); and increase in total REM sleep and/or reduction in time to accumulation of 30 minutes of REM sleep (instant claim 8) of the process step positively recited (i.e. administration of tasimelteon to treat an individual experiencing a sleep-wake-cycle-disrupting advance in the individual’s established bedtime).
Taken together, all this would result in the practice of the method of claims 1-5, 7, and 8 with a reasonable expectation of success.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rajaratnam et al (Lancet, 2009; 373:482-91, cited in the IDS filed December 2, 2020) as applied to claims 1-5, 7, and 8 above, and further in view of Shahid et al (STOP, THAT and one hundred other sleep scales (2012): 209-210).
Rajaratnam teaches all the limitations of claim 6 (see above 103 rejection), except wherein the improvement in next day alertness includes an improvement on the Karolinska Sleepiness Scale.
However, Shahid teaches The KSS (Karolinska Sleepiness Scale) is a measure of situational sleepiness; it is sensitive to fluctuations (page 209, left, 1st paragraph); and it has been used in studies of shift work, jetlag, for driving abilities, attention and performance, and in clinical settings (page 209, left 2nd paragraph); and KSS has high validity (page 209, left, last bridge paragraph). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Rajaratnam to measure sleepiness utilizing the Karolinska Sleepiness Scale with a reasonable expectation of success, since the prior art teaches KSS (Karolinska Sleepiness Scale) is a measure of situational sleepiness; it is sensitive to fluctuations and has high validity and is used in studies of jetlag.
Taken together, all this would result in the practice of the method of claim 6 with a reasonable expectation of success.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Birznieks (WO 2007/137244 A1, cited in the IDS filed March 21, 2024) in view of Pilchik, R. (Pharmaceutical technology, 2000; 24(11):68-68).
Birznieks teaches a clinical trial was conducted to assess the safety of MA-1 as well as to determine the ability of MA-1 to shift the sleep/wake cycle following a 5 hour advance in bedtime. The study was a randomized, double-blind, parallel group, placebo-controlled study. It consisted of a 2-4 week outpatient screening period followed by an 8-day inpatient stay. After acclimating to the sleep lab, bedtime was advanced by 5 hours (page 8, last paragraph). Birznieks teaches for oral doses of MA-1 were administered including 20 mg. Birznieks teaches subjects were randomized to once daily treatment in one of the five treatment groups; subject sleep-wake routines were advanced 5 hours; treatment was administered and the time shift was maintained for 3 days (page 9, last paragraph). Birznieks teaches another primary objective of this study was to investigate the exposure-response to MA-1 on mean sleep efficiency parameters (page 12, last paragraph). Thus, Birznieks teaches a method of treating an individual experiencing a sleep-wake-cycle-disrupting advance in the individual’s established bedtime comprising administering an amount of tasimelteon wherein tasimelteon is administered once daily for 3 days. Moreover, Birznieks teaches suitable dosage forms for MA-1 pharmaceutical compositions include oral; if a solid carrier is used, the preparation may be tableted or placed in hard gelatin (page 5, 4th paragraph). Thus, Birznieks establishes that tasimelteon can be alternatively formulated as a tablet or hard gelatin capsule for use in a method of treating an individual experiencing a sleep-wake-cycle-disrupting advance in the individual’s established bedtime and that tasimelteon is administered once daily for 3 days.
Pilchik teaches the most important reason for introducing blister packaging technology was to offer patients a clearly marked individual dose, enabling them to check whether they had taken the prescribed drugs on a given day; the drugs that were not taken remained in the original package and were fully protected against adverse external conditions; and the patient could handle the blister package more easily and could store it more conveniently than conventional packages (page 70, left, 2nd paragraph). Pilchik teaches manufacturers and packagers recognized other advantages of blister packaging such as the prevention of broken glass bottles and reduced costs and higher packaging speeds relative to other packaging materials; it is easier to prove misuse with blister packaging than with conventional packaging; and blister packages effectively meet the demand for tamper-evident packaging (page 70, left, 3rd paragraph).
As such, since Birznieks teaches a method of treating an individual experiencing a sleep-wake-cycle-disrupting advance in the individual’s established bedtime comprising administering 20 mg tasimelteon wherein tasimelteon is administered once daily for 3 days and that tasimelteon can be formulated as a tablet formulation, and since Pilchik teaches that blister packaging offers advantages over conventional packaging, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to produce a blister pack containing three 20 mg tasimelteon tablets with an expectation of success, since the prior art establishes that tasimelteon was known to be used in a 3-day treatment and blister pack packaging offers advantages over conventional packaging including being tamper-evident and reduced manufacturing costs.
Taken together, all this would result in the composition of claims 9 and 10 with a reasonable expectation of success.
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.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5-8 of copending Application No. 17/655,929 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating an individual experiencing a sleep-wake-cycle- disrupting advance in the individual's established bedtime comprising administering to the individual an amount of tasimelteon effective to reduce one or more untoward consequences of the resulting disruption of said individual's established sleep-wake cycle, wherein the advance is caused by jet aircraft travel and a method of treating jet lag in an individual subjected to eastward travel from a place of origin through six to eight time zones to a place of destination during overnight travel by air, said method comprising orally administering to the individual 20 mg tasimelteon in an immediate release form following arrival at the place of destination at or prior to the individual's bedtime in the place of destination. The copending claims are directed to a method of treating a circadian rhythm disorder associated with a 5-hour circadian phase advance comprising administering 20 mg/d MA-1 in immediate release form at or within 2 hours prior to the subject’s phase-advanced bedtime. It would have been prima facie obvious to one of ordinary skill in the art to arrive at the method of the instant claims from the method of the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-10 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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