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 .
In order to make a correction for the inadvertent errors present in the previous Non-Final Rejection, the examiner has decided to rewrite another Non-Final Rejection in the followings:
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 12/18/2025 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 Rajaratnam et al art is that the applied Rajaratnam 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 Rajaratnam 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 Rajaratnam 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 Rajaratnam et al 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 should 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 the Wikipedia’ package insert of 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 Rajaratnam et al 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 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.
Also, Rajaratnam et al does mention the application of tasimelteon capsules including a dose of 20 mg as indicated in the Fig 1 ((see page 484,) and the kit number identified the capsule-containing bottle given to the individual in the phrase III study(see page 483, a section of methods and participants, the right col. , the second paragraph). Also, it is known in the art that the meaning of the kit number in the clinical trial is that the kit number in a clinical study is a unique identifier printed on the packaging of an investigational product (drug).
From the above disclosure, the Rajaratnam et al does the use of the kit containing tasimelteon capsules directly during the clinal trial, whereas Wikipedia describes generally that package inserts include a section called Highlights which summarizes the most important information about benefits and risks (see Page 2 , January 2006 revision).
Both prior art are related to each other with respect to a pharmaceutical composition comprising: a pharmaceutically-acceptable carrier; and a quantity of tasimelteon capsules in a form of the kit and the package insert for 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 in the form of a kit safely, 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 in order to inform the benefits and adverse events of tasimelteon for the patient. 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:
A. Claims 1-9 are rejected under 35 USC 103 as allegedly unpatentable over
Rajaratnam in view of Wikipedia.3 This rejection is respectfully traversed.
It is unclear how this is relevant to the pending claims. The Examiner has previously attempted to describe this as something that "could imply the presence of the plurality of tasimelteon capsules with the instruction in the bottle."What this could imply, however, is at least two steps removed from what it teaches. Further, the Examiner provides no explanation for how this passage in the Office Action may be reconciled with the passage immediately thereafter, in which the Examiner concedes that the claimed invention "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 the tasimelteon should be taken without food for at least one hour to 3 hours prior to administration is unexemplified in the prior art."
In view of this concession, it would seem impossible for the Examiner to set forth any valid prior art rejection. The Wikipedia article cited by the Examiner certainly doesn't cure these deficiencies. It merely describes, at a very high level of generality and without respect to any particular drug or class of drugs, the kinds of information that may be included in the prescribing information for a drug.
But the rejection becomes even more confused, to the point that it is defective on its face. The Examiner goes on to state:
• "The difference between the current application and the applied Dressman et al art is that the applied Dressman et al art do [sic] 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."7
• "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."8
"The deficiencies of Wikipedia are partially cured by the Dressman et al."
The Dressman reference was previously withdrawn by the Examiner in response to Applicant's arguments that it does not constitute valid prior art. "Regarding applicant's argument [that Dressman is not valid prior art, the examiner has noted applicants' [sic] arguments. They are considered as convincing arguments."
Has the Examiner nevertheless decided to reapply Dressman? Does the Examiner no longer agree that the reference is not valid prior art? Upon what combination of references is the Examiner relying in rejecting the pending claims? It is impossible to answer these questions. And the jumbling of cited and withdrawn references makes it impossible for Applicant to provide a meaningful response. The rejection is defective on its face for this reason.
B. The rejection is also defective on its face for an additional reason. Even if one could resolve the question of whether the Examiner is relying on Rajaratnam, Dressman, or a combination thereof, and even if Wikipedia taught what is alleged, the Examiner's allegation that Wikipedia partially cures the conceded deficiencies is not sufficient to establish a prima facie case of obviousness. A partially cured defect is a defect nonetheless.
As with the Examiner's conclusion in the rejection over Rajaratnam alone, Applicant asserts that the Examiner's conclusion is an admission of the use of impermissible hindsight reasoning. What the Examiner states, in essence, is: "If one skilled in the art wanted to develop and market a packaged pharmaceutical composition comprising a plurality of tasimelteon capsules and instructions not to take them with food, as Applicant claims, it would have been obvious for them to do so."
Yet, at the same time, the Examiner has conceded that what Applicant claims is
"unexemplified" not just by Rajaratnam or Wikipedia, but in the prior art as a whole. From where but Applicant's own disclosure, then, could any perceived obviousness derive?
"[I]mpermissible hindsight must be avoided and the legal conclusion must be reached on the basis of the facts gleaned from the prior art."13 "It is difficult but necessary that the decisionmaker forget what he or she has been taught ... about the claimed invention and cast the mind back to the time the invention was made ( often as here many years), to occupy the mind of one skilled in the art ... “
C. Finally, even if one were able to get past the conceded deficiencies of Rajaratnam, Wikipedia, and the prior art generally, and even if the Examiner's motivation was somehow not based on impermissible hindsight, the rejection is still fatally defective. Obviousness cannot be found where a rejection is based on an allegation or belief that features of a claimed invention could have been combined. The case law on this is entirely clear.
In Personal Web Technologies, LLC v. Apple, Inc.,15 the Federal Circuit noted that merely stating that the skilled artisan would have understood that a proposed combination would have allowed the features of one reference to be used with the features of another reference is deficient because it says "no more than that a skilled artisan, once presented with the two references, would have understood that they could be combined [emphasis original]. And that is not enough: it does not imply a motivation to pick out those two references and combine them to arrive at the claimed invention. See Belden Inc. v. BerkTek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) ('[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention [emphasis
For all of the reasons above, Applicant asserts that the pending claims are allowable over Rajaratnam and Wikipedia (and Dressman), whether considered individually or in any combination.
D. Applicant objects to the quality of the examination of the instant application to date. In the Office Action issued 24 February 2025, the Examiner rejected all claims based on a reference, Dressman, that did not qualify as prior art.
In the Final Office Action dated 31 July 2025, the Examiner withdrew the Dressman rejection but rejected the claims over Rajaratnam alone, making the rejection final despite the Dressman rejection being legally defective and claim 1 having been unamended. There was no legal basis for the finality of that rejection.
Now, the Examiner has withdrawn the rejection over Rajaratnam alone-again, based on Applicant's arguments and no amendments to claim 1-and rejected the claims over Rajaratnam in combination with Wikipedia and, perhaps, the previously withdrawn Dressman reference.
Regarding the first and fourth arguments, the examiner has noted applicants’ arguments. As indicated in the above, the examiner admitted that the examiner made , inadvertently, mistakes for using the same previous Dressman et al reference instead of Rajaratnam et al for the current Office Action. In order to correct the previous Non-Final rejection, the examiner has decided to rewrite another Non-Final Rejection based on the combined Rajaratnam et al and Wikipedia prior art.
Regardless of the quality of the examination of the instant application, the examiner has a duty to find any suitable prior art close to the current invention at any time regarding the verification of its patentability throughout the world and has to perform various searches for numerous prior arts for the given time frame for each application. The examiner has been examining the current application as best as the examiner can do although the applicant may not satisfy the examiner’s work.
Regarding the second argument, the examiner has noted applicants’ arguments.
Regarding the examiner’s impermissible hindsight based on the applicant’s invention, the examiner is disagreed with applicant’s arguments. One of the important facts disclosed by Rajaratnam et al is the presence of tasimelteon capsules in the bottle for the clinical trial as the Rajaratnam et al does teach the application of tasimelteon capsules including a dose of 20 mg as indicated in Fig. 1(see page 484) and 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). Furthermore, it is known in the art that the meaning of the kit number in the clinical trial is that the kit number in a clinical study is a unique identifier printed on the packaging of an investigational product (drug) or a biological sample collection box. Therefore, unlike applicant’s arguments, it is not the examiner’s impermissible hindsight at all.
Regarding the third argument, the examiner has noted applicants’ arguments.
Regarding the deficiencies of the motivation to combine Rajaratnam and Wikipedia,
there is a motivation to combine both prior art; the Rajaratnam et al does mention the application of tasimelteon capsules including a dose of 20 mg as indicated in the Fig 1 ((see page 484,) and the kit number identified the capsule-containing bottle given to the individual in the phrase III study(see page 483, a section of methods and participants, the right col. , the second paragraph). Also, it is known in the art that the meaning of the kit number in the clinical trial is that the kit number in a clinical study is a unique identifier printed on the packaging of an investigational product (drug). So, the Rajaratnam et al does the use of the kit containing tasimelteon capsules directly during the clinal trial, whereas Wikipedia describes generally that package inserts include a section called Highlights which summarizes the most important information about benefits and risks (see Page 2 , January 2006 revision).
Both prior art are related to each other with respect to a pharmaceutical composition comprising: a pharmaceutically-acceptable carrier; and a quantity of tasimelteon capsules in a form of the kit and the instruction for the drug information.
Thus, there is a motivation to combine both prior art in order to inform the benefits and adverse events of tasimelteon for the patient.
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 in order to inform the benefits and adverse events of tasimelteon for the patient effectively. 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. Therefore, applicant’s arguments are not persuasive.
Conclusion
Claims 1-9 are rejected.
.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 5/21/2026
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