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
This office action is in response to applicant’s reply filed on May 22, 2026.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 1-2, 4, 6-8 and 12-16) in the reply filed on May 22, 2026, is acknowledged.
Status of Claims
Claims 1-2, 4, 6-8, 12-16, 19-20, 22-26, 29, 31-35 and 37-42 are currently pending and are the subject of this office action.
Claim 19-20, 22-26, 29, 31-35 and 37-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 22, 2026.
Claims 1-2, 4, 6-8 and 12-16 are presently under examination.
Priority
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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.
1) Claim(s) 1, 6 and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rzepka-Migut et. al. (Brain Sciences (2020) 10:1-21)), Wheeler et. al. (Sleep (2005) 28:1609-1610), Laje et. al. (American Journal of Medical genetics Part C (2010) 154C:456-462), Rajaratnam et. al. (The Lancet (2009) 373:482-491), Hull et. al. (Sleep Medicine (2017) e139), Lavedan et. al. (US 2019/0105297), and Dressman et. al. (US 2015/0148419).
For claims 1 and 6, Rzepka-Migut teaches a method of treating sleep disorders in patients suffering from autism spectrum disorder (ASD) comprising the administration of a dose of melatonin (see title, see section 3 on page 5 and section 4 on page 7).
Wheeler teaches that melatonin is also effective in treating sleep disorders in Smith Magenis Syndrome (SMS) patients (see title and right column, last paragraph).
Laje teaches that Smith-Magenis Syndrome (SMS) and autism spectrum disorders (ASD) are interrelated and that therapeutic interventions for autism are likely to benefit individuals with SMS (see abstract). In fact, melatonin is effective in treating sleep disorders in both: SMS and ASD patients (see page 462, right column) which coincides with the teachings disclosed by Rzepka-Migut and Wheeler above.
Rzepka-Migut. Wheeler and Laje do not teach the treatment of sleep disorders in ASD patients comprising the administration of a dose of tasimelteon. However. Rajaratnam teaches that tasimelteon, like melatonin, is a melatonin agonist that exhibits affinities for MT1 and MT2 melatonin receptors (see page 482, right column, last sentence and page 483, left column, second paragraph, first sentence) and both are effective in treating sleep disorders.
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Hull further teaches that tasimelteon (like melatonin) is also effective in treating sleep disorders in Smith Magenis Syndrome (SMS) patients (see title). Lavedan, like Hull, also teaches that tasimelteon is effective in treating sleep disorders in SMS patients (see abstract). Further, Lavedan teaches that tasimelteon metabolites are also effective in treating sleep disorders in SMS patients (see [0028]
Finally, Dressman teaches that the metabolites of tasimelteon are also effective in treating autism, among other diseases (see [0012]-[0016], [0029] and claim 6.
Since the prior art teaches a method of treating sleep disorders in ASD patients comprising de administration of the melatonin receptor agonist melatonin (with MT1 and MT2 affinities) which is also effective in treating sleep disorders in SMS patients, and since the prior art teaches that tasimelteon is (like melatonin) a melatonin receptor agonist (with MT1 and MT2 affinities) and it’s (like melatonin) effective in treating sleep disorders in SMS patients, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any MT1/MT2 melatonin agonist that it is effective in treating sleep disorders in SMS patients, like melatonin) for another (tasimelteon, which is also a MT1/MT2 melatonin agonist that it is effective in treating sleep disorders in SMS patients) with an expectation of success, since the prior art establishes that both function in similar manner. The skilled in the art will also be motivated to treat sleep disorders in ASD patients comprising the administration of tasimelteon, since the prior art also teaches that tasimelteon metabolites are effective in treating ASD, thus resulting in the practice of claims 1 and 6, with a reasonable expectation of success.
For claim 12, Rajaratnam teaches that the administration of tasimelteon improved the sleep latency (see page 486, right column, last paragraph), so before the effective filing date of the invention it would have been prima facie obvious to treat sleep disturbance the includes any latency including 45 minutes, thus resulting in the practice of claim 12 with a reasonable expectation of success.
For claim 13, Rajaratnam teaches several effective dosages of tasimelteon like 20 mg (see page 483, right column, last paragraph), thus resulting in the practice of claim 13 with a reasonable expectation of success.
For claim 14, Rajaratnam teaches the administration of tasimelteon 30 minutes before bedtime (see page 483, right column, last paragraph), thus resulting in the practice of claim 14 with a reasonable expectation of success.
For claim 15, Rajaratnam teaches the administration of capsules (i.e. orally) and there is no mention of food, thus resulting in the practice of claim 15 with a reasonable expectation of success.
For claim 16 Rajaratnam teaches several effective dosages of tasimelteon like 50 mg (see page 483, right column, last paragraph), For an 80 kg person, this translates into 0.62 mg/kg which is very close to 0.7 mg/kg.
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 16 with a reasonable expectation of success.
2) Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rzepka-Migut et. al. (Brain Sciences (2020) 10:1-21)), Wheeler et. al. (Sleep (2005) 28:1609-1610), Laje et. al. (American Journal of Medical genetics Part C (2010) 154C:456-462), Rajaratnam et. al. (The Lancet (2009) 373:482-491), Hull et. al. (Sleep Medicine (2017) e139), Lavedan et. al. (US 2019/0105297), and Dressman et. al. (US 2015/0148419) as applied to claims 1, 6 and 12-16 above, further in view of During et. al. (US 2019/0374492).
The prior art teaches all the limitations of claims 2 and 4, except for the improvement of specific ASD symptoms. However, During teaches that repetitive behaviors and facial expressions are normal ASD symptoms (see [0049]),
As such: “improving repetitive behaviors and/or facial expressions” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (tasimelteon) is being administered to the same subjects (ASD patients). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “improving repetitive behaviors and/or facial expressions”, by practicing the method made obvious by the prior art: “the administration of tasimelteon to ASD patients", one will also be “improving repetitive behaviors and/or facial expressions”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("improving repetitive behaviors and/or facial expressions”) of the method made obvious by the prior art (“the administration of tasimelteon to ASD patients ").
MPEP 2145 II states: “The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious”. Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
All this will result in the practice of claims 2 and 4 with a reasonable expectation of success.
3) Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rzepka-Migut et. al. (Brain Sciences (2020) 10:1-21)), Wheeler et. al. (Sleep (2005) 28:1609-1610), Laje et. al. (American Journal of Medical genetics Part C (2010) 154C:456-462), Rajaratnam et. al. (The Lancet (2009) 373:482-491), Hull et. al. (Sleep Medicine (2017) e139), Lavedan et. al. (US 2019/0105297), and Dressman et. al. (US 2015/0148419) as applied to claims 1, 6 and 12-16 above, further in view of Hoffman (US 2016/0193169).
The prior art teaches all the limitations of claims 7-8, except for the specific methods of measuring improvements like: Clinical Global Impressions (CGI) scale. However, Hoffman teaches that assessment of autism symptoms can be performed by measuring Clinical Global Impressions (CGI) scale based on changes in various psychometric tests (see [0017] and [0067]).
As such: “improvement of a symptom in at least a CGI-scale” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (tasimelteon) is being administered to the same subjects (ASD patients). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “improvement of a symptom in at least a CGI-scale”, by practicing the method made obvious by the prior art: “the administration of tasimelteon to ASD patients", one will also be “improving of a symptom in at least a CGI-scale”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("improvement of a symptom in at least a CGI-scale”) of the method made obvious by the prior art (“the administration of tasimelteon to ASD patients ").
MPEP 2145 II states: “The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious”. Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
All this will result in the practice of claims 7 and 8 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
June 3, 2026.
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