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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/31/25 has been entered.
Non-Final Rejection
The Status of Claims:
Claims 1-9 are pending.
Claims 1-9 are rejected.
DETAILED ACTION
1. Claims 1-9 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation of 18322290 05/23/2023ABN, which is a continuation of 17407921 08/20/2021 (PAT 11786502), which is a continuation of 16800611 02/25/2020 (PAT 11141400), which is a continuation of 6517111 07/19/2019 (PAT 10610511), which is a continuation of 14511669 10/10/2014 (PAT10376487), which has a priority of 61927465 01/14/2014, which has a priority of 61903354 11/12/2013.
Drawings
The drawing filed on 6/24/24 are accepted by the examiner.
IDS
4 The IDS filed on 11/21/2025 were reviewed by the examiner.
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 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.
Claim Rejections - 35 USC § 103
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 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 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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rajaratnam et al (Lancet (2009), 373(9662), 482-491) in view of Wikipedia ( Medication package insert, March 2013, pages 1-3)..
Applicant claims the followings:
1. (original) A packaged pharmaceutical composition comprising:a plurality of tasimelteon capsules; andprinted information including an instruction that tasimelteon should be taken without food.
2. (original) The packaged pharmaceutical composition of claim 1, wherein each of the plurality of tasimelteon capsules includes a dose of 20 mg of tasimelteon.
3. (currently amended) The packaged pharmaceutical composition of The packaged pharmaceutical composition of wherein the printed information includes an instruction that tasimelteon should be taken with no food for at least one-half hour prior to administration.
4. (currently amended) The packaged pharmaceutical composition of The packaged pharmaceutical composition of wherein the printed information includes an instruction that tasimelteon should be taken with no food for at least one hour prior to administration.
5. (currently amended) The packaged pharmaceutical composition of The packaged pharmaceutical composition of wherein the printed information includes an instruction that tasimelteon should be taken with no food for at least one-and-one-half hours prior to administration.
6. (currently amended) The packaged pharmaceutical composition of The packaged pharmaceutical composition of wherein the printed information includes an instruction that tasimelteon should be taken with no food for at least two hours prior to administration.
7. (currently amended) The packaged pharmaceutical composition of The packaged pharmaceutical composition of wherein the printed information includes an instruction that tasimelteon should be taken with no food for at least two-and-one-half hours prior to administration.
8. (currently amended) The packaged pharmaceutical composition of The packaged pharmaceutical composition of wherein the printed information includes an instruction that tasimelteon should be taken with no food for at least three hours prior to administration.
9. (original) The packaged pharmaceutical composition of claim 1, further comprising:a container within which each of the plurality of tasimelteon capsules is contained.
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Determination of the scope and content of the prior art
Rajaratnam et al teaches phase II and phase III randomized, double-blind, placebo-controlled, parallel-group studies. In a phase II study, 39 healthy individuals from two US sites were randomly assigned to tasimelteon (10 [n=9], 20 [n=8], 50 [n=7], or 100 mg [n=7]) or placebo (n=8). They monitored individuals for 7 nights: 3 at baseline, 3 after a 5-h advance of sleep–wake schedule with treatment before sleep, and 1 after treatment; we measured plasma melatonin concentration for circadian phase assessment. 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 (20 [n=100], 50 [n=102], or 100 mg [n=106]) or placebo (n=103) 30 min before bedtime. 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). Analysis was by intention to treat. Safety was assessed in both studies.(see page 482, summary)
When each individual started the study, the investigator or designee contacted the interactive voice response system to assign a randomization and kit number. The kit number identified the capsule-containing bottle given to the individual. In this study, individuals who had previously slept in a sleep clinic were excluded to increase the first-night effect. (see page 483, a section of methods and participants, the right col. , the second paragraph)
The current invention, however, differs from the prior art in that the claimed packaged pharmaceutical composition comprising a plurality of tasimelteon capsules in a container with an instruction that tasimelteon should be taken without food for at least one hour to 3 hours prior to administration is unexemplified in the prior art.
Wikipedia describes that package inserts follow a standard format for every medication and include the same types of information. Different manufacturers may have different titles for their sections, however, to make them easier for the average person to read and comprehend-for example, instead of "Contraindications" the section may be headed, "Who should not take this medication?"
■ Dosage and administration - gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children) (see pages 1-2 , sections of a package insert)
Ascertainment of the difference between the prior art and the claims
The difference between the current application and the applied Dressman et al art is that the applied Dressman et al art do not expressly teach the claimed
packaged pharmaceutical composition comprising a plurality of tasimelteon capsules in a container with an instruction that tasimelteon should be taken without food for at least one-half hour to 3 hours prior to administration. The deficiency of Dressman et al is partially cured by the Wikipedia.
The difference between the current application and the applied Wikipedia art is that the applied Wikipedia art does not expressly teach the claimed
packaged pharmaceutical composition comprising a plurality of tasimelteon capsules in a container that tasimelteon should be taken without food for at least one-half hour to 3 hours prior to administration.
The deficiencies of Wikipedia are partially cured by the Dressman et al.
Resolving the level of ordinary skill in the pertinent art.
Regarding the current Claims 1-9, with respect to the lack of teaching the packaged pharmaceutical composition comprising a plurality of tasimelteon capsules with an instruction that tasimelteon should be taken without food for at least one hour to 3 hours prior to administration, the prior art does mention at least the use of the kit number identified the capsule-containing bottle given to the individual (see page 483, a section of methods and participants, the right col. , the second paragraph), and they were given tasimelteon (20 mg [n=100]) 30 min before bedtime (see page 482, a summary),
Furthermore, the lack of teaching the use of the package with the instruction for the composition, the Wikipedia does mention that the medication of package insert is used for the patient’s benefits and specific risks about the drug information which is stored inside a container.
From the above information, it could imply the presence of the plurality of tasimelteon capsules with the instruction in the bottle. Also, this could also contemplate administration of tasimelteon at earlier times in the day, e.g., not only 30 min, but also, about 1 or 2 hours, or about 3 hours prior to target sleep time.
So, If the skilled artisan in the art had desired to design a new study with the packaged pharmaceutical composition comprising a plurality of tasimelteon capsules with an instruction that tasimelteon to be taken without food for at least one hour to 3 hours prior to administration, it would have been obvious for the skilled artisan in the art to do so in the absence of an unexpected result. Thus, the prior art is relevant to the claimed invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Rajaratnam et al does teach the phase II and phase III randomized, double-blind, placebo-controlled, parallel-group studies by using tasimelteon capsules including a dose of 20 mg with the instruction in the kit.
Furthermore, Rajaratnam does specify that tasimelteon with the dose of 20 mg can be administered 30 min before bedtime. Also, it is reasonable for the skilled artisan in the art to contemplate administration of tasimelteon at earlier times in the day, e.g., not only 30 min, but also, about 1 or 2 hours, or about 3 hours prior to target sleep time.
Whereas Wikipedia describes that package inserts follow a standard format for every medication and include the same types of information. Both prior art are related to each other with respect to a pharmaceutical composition comprising: a pharmaceutically-acceptable carrier; and a quantity of tasimelteon in a form of capsules and the instruction for the drug information.
So, if the skilled artisan in the art had desired to develop and market a packaged pharmaceutical composition comprising a plurality of tasimelteon capsules with the drug instruction in a container, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate Wikipedia’s medication of package insert (instruction) into Rajaratnam’s packaged pharmaceutical composition comprising a plurality of tasimelteon capsules in the container in order to promote a successful selling product to the public.
This is because the skilled artisan in the art would expect such modifications for the application of the pharmaceutical composition product to be acceptable and feasible; it is within the purview of the skilled artisan in the art.
Applicants’ Argument
I. Applicants argue the following issues:
1 Claims 1-9 are rejected under 35 USC 103 as allegedly unpatentable over Dressman.' This rejection is respectfully traversed.
Without conceding the correctness of the Examiner's position with respect to the alleged teachings of Dressman, Applicant asserts that the reference is not valid prior art against the claimed invention.
Dressman was published on 1 August 2013. Both provisional patent applications to which the instant application claims priority were filed within one year of the publication date of Dressman. US Provisional Patent Application Serial No. 61/903,354 was filed on 12 November 2013 and US Provisional Patent Application Serial No. 61/927,465 was filed on 13 January 2014.
Inventors Dressman and Polymeropoulos of the Dressman reference are also named inventors in the instant application and in the '354 and '465 provisional applications. In addition, as of the effective filing date of the claimed invention, the subject matter of Dressman and that of the claimed invention were subject to an obligation of assignment and/or assigned to Applicant.
For the reasons above, the Dressman reference is excluded as prior art under 35 USC 102(b)(1)(A), 35 USC 102(b)(2)(A), and/or 35 USC 102(b)(2)(C), rendering the rejection defective.
2 The Examiner concedes that Rajaratnam "does not expressly teach the claimed packaged pharmaceutical composition comprising a plurality of tasimelteon capsules in a container with an instruction that tasimelteon should be taken without food for at least one hour to 3 hours prior to administration."6 Applicant agrees, but notes that the conceded deficiencies constitute all of the elements of claims 1, 4, 8, and 9. It is difficult to see, therefore, how a rejection of these claims over Rajaratnam is not, by definition, defective.
In short, Rajaratnam teaches nothing with respect to the effect of food on the efficacy of treatment with tasimelteon. And it provides absolutely no basis for instructing a patient as to whether tasimelteon should be taken with food, without food, or without regard to such. Everything the Examiner alleges in this regard could equally be alleged as to the administration of tasimelteon with food because, where it is not based on hindsight, everything the Examiner alleges is based on mere speculation.
For the reasons above, Applicant asserts that Rajaratnam fails to teach or suggest the features of the pending claims.
Regarding the first argument, the examiner has noted applicants’ arguments. They are considered as convincing arguments.
Regarding the second argument, the examiner has noted applicants’ arguments.
However, as indicated in the above, in view of finding a new prior art, another 103 rejection seems necessary at this time; due to the new rejection based on the combined prior art, the examiner will respond to applicants’ second arguments in the next communication.
Conclusion
Claims 1-9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 11/29/2025
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