DETAILED ACTION
This Office action is in response to amendments filed June 30, 2026. Claims 24 and 26-46 are pending. Claims 1-23 and 25 are cancelled.
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 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.
Withdrawn Rejections
The rejection of claim 44 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of applicant’s amendments.
The rejection of claims 24, 28-44 and 46 under 35 U.S.C. 102(a)(1) as being anticipated by Strollo et al (SLEEP, Vol. 43, Abstract Supplement, 2020; cited in IDS filed 2/29/24) is withdrawn in light of applicant’s amendments.
The rejection of claim 25 under 35 U.S.C. 103 as being unpatentable over Strollo et al (SLEEP, Vol. 43, Abstract Supplement, 2020; cited in IDS filed 2/29/24) in view of Carter et al (US 2020/0163927; cited in IDS filed 2/29/24) is withdrawn in light of applicant’s amendments.
Modified Rejections Necessitated by Applicant’s Amendments
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, 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.
Claims 24 and 26-46 are rejected under 35 U.S.C. 103 as being unpatentable over Strollo et al (SLEEP, Vol. 43, Abstract Supplement, 2020; cited in IDS filed 2/29/24) in view of Carter et al (US 2020/0163927; cited in IDS filed 2/29/24).
Regarding claim 24, Strollo et al discuss results from a 1-year open label extension study that showed ≥ 5% weight loss in 4.5%, 17.3% and 32.4% of participants with narcolepsy or obstructive sleep apnea receiving solriamfetol ((R)-2-amino-3-phenylpropylcarbamate) 75, 150 or 300 mg/day (Introduction). The study was conducted because of increased prevalence of obesity reported in patients with narcolepsy and obstructive sleep apnea (Introduction). Thus, Strollo et al teach the administration of (R)-2-amino-3-phenylpropylcarbamate to patients with at least one biomarker of cardiovascular risk due to body weight.
However, Strollo et al do not explicitly teach the administration of (R)-2-amino-3-phenylpropylcarbamate to patients with a BMI of 25 kg/m2 or greater.
Carter et al teach the administration of (R)-2-amino-3-phenylpropylcarbamate to subjects with excessive daytime sleepiness (paragraph 0097; abstract; whole document). Carter et al disclose a study in which (R)-2-amino-3-phenylpropylcarbamate is administered to treat excessive daytime sleepiness with obstructive sleep apnea (paragraph 0100). Baseline demographics for the study were predominantly male with a BMI > 30 kg/m2 (paragraph 0107, Table 1).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to administer (R)-2-amino-3-phenylpropylcarbamate to patients with a BMI of 30 kg/m2 or greater in the teachings of Strollo et al. A skilled artisan would have been motivated to do so since patients in the study of Strollo et al have obstructive sleep apnea and Carter et al teach the baseline demographic of patients with obstructive sleep apnea have BMIs of 30 kg/m2 or greater. Further, it would have been obvious to administer (R)-2-amino-3-phenylpropylcarbamate to patients with higher-than-average BMIs that include 30 kg/m2 or greater since Strollo et al teach (R)-2-amino-3-phenylpropylcarbamate has favorable long-term effects on weight loss in patients with obstructive sleep apnea.
Regarding claims 26-27; it would have been obvious to an artisan of ordinary skill before the effective filing date to administer (R)-2-amino-3-phenylpropylcarbamate to patients with a BMI in the range of 25 kg/m2 to less than 30 kg/m2 or with a BMI of 30 kg/m2 or greater in the teachings of Strollo et al. A skilled artisan would have been motivated to do so since patients in the study of Strollo et al have obstructive sleep apnea and Carter et al teach the baseline demographic of patients with obstructive sleep apnea have BMIs of 30 kg/m2 or greater. Further, it would have been obvious to administer (R)-2-amino-3-phenylpropylcarbamate to patients with higher-than-average BMIs that include 30 kg/m2 or greater since Strollo et al teach (R)-2-amino-3-phenylpropylcarbamate has favorable effects on weight loss in patients with obstructive sleep apnea.
Regarding claims 28-33 and the reduction of blood pressure; it should be noted that the reduction of systolic and/or diastolic blood pressure at i) 1 mm Hg or greater or ii) 2 mm Hg or greater would naturally result from administering (R)-2-amino-3-phenylpropylcarbamate to patients within teachings of Strollo et al modified by Carter et al. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Further, Strollo et al teach participants in its study administered (R)-2-amino-3-phenylpropylcarbamate had reductions in systolic blood pressure of 2.6 mm ± 11 mmHg and reductions in diastolic blood pressure of 1.0 ± 9/.0 mmHg (Results).
Regarding claims 34 and 37 and the reduction of triglycerides and glucose level in the patient; such results would naturally result from administering (R)-2-amino-3-phenylpropylcarbamate to patients within the teachings of Strollo et al. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Further, Strollo et al teach participants in its study administered (R)-2-amino-3-phenylpropylcarbamate had decreases in percentages with high serum glucose (36.6% to 28.1%) or triglycerides (26.6% to 21.9%) (Results).
Regarding claims 35-36, 38-39 and 41; Strollo et al teach participants in its studies reduced body weight and more specifically, ≥ 5% weight loss over a span of 40 weeks (Introduction, Method, Results).
Regarding claim 40 and the experience of losing at least about 5% loss in BMI; such results would naturally result from administering (R)-2-amino-3-phenylpropylcarbamate to patients over a span of 40 weeks within the teachings of Strollo et al. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Regarding claim 42 and the patient’s lack of displaying an increased propensity toward a non-dipping classification over course of treatment; the lack of increased propensity would naturally result from administering (R)-2-amino-3-phenylpropylcarbamate to patients within the teachings of Strollo et al. See MPEP 2112.02. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Regarding claims 43-44, Strollo et al discuss that its participants received (R)-2-amino-3-phenylpropylcarbamate at 75, 150 or 300 mg/day over the study (Introduction).
Regarding claim 45, Carter et al further disclose that there was a titration phase in its study to achieve a maximum tolerated dose, in which patients started on a once daily dose of (R)-2-amino-3-phenylpropylcarbamate of 75 mg that was titrated up every 3 days to reach a maximum tolerated dose of 150 mg/day (paragraph 0101).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to titrate the dosage of (R)-2-amino-3-phenylpropylcarbamate within the studies of Strollo et al. One would have been motivated to do so since Carter et al teach it’s a safe and effective method to achieve the maximum tolerated dose of (R)-2-amino-3-phenylpropylcarbamate in patients.
Regarding claim 46, Strollo et al discussed its participants either have narcolepsy or obstructive sleep apnea (Introduction). Thus, Strollo et al discuss patients with obstructive sleep apnea (not narcolepsy).
Response to Arguments
Applicant's arguments filed 6/30/26 have been fully considered but they are not persuasive.
Applicant argues that the instant specification explains that previous medications including DNRIs which have been used in treating excessive daytime sleepiness associated with obstructive sleep apnea and narcolepsy have resulted in increased cardiovascular risk. Applicant argues that clinicians would have been dissuaded from prescribing these DNRIs to patients with a biomarker profile associated with increased cardiovascular risk. Thus, applicant argues that it is surprising and unexpected that the DNRI, solriamfetol, has shown improvements in various biomarkers associated with cardiovascular risk in patients after treatment.
However, the examiner respectfully disagrees that such results are unexpected. Strollo provides evidence that such results are not unexpected at the time of the invention. As noted in the prior art rejection above, Strollo discusses results from a 1-year open label extension study that showed ≥ 5% weight loss in 4.5%, 17.3% and 32.4% of participants with narcolepsy or obstructive sleep apnea receiving solriamfetol ((R)-2-amino-3-phenylpropylcarbamate) 75, 150 or 300 mg/day (Introduction). Accordingly, it would have been expected that solriamfetol improves various biomarkers associated with cardiovascular risk (i.e., body weight). Applicant is directed to MPEP 716.02c: “Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
As such, the 103 rejection above over Strollo in view of Carter is maintained for the reasons stated above.
Conclusion
Claims 24 and 26-46 are rejected. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL E BREDEFELD whose telephone number is (571)270-5237. The examiner can normally be reached 8:00-5:00 Monday-Friday.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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