DETAILED ACTION
This Office action is in response to the Applicant’s filing dated June 30th, 2026.
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 .
Priority
This application is a 371 of PCT/US2022/049478 filed on November 10th, 2022; and has a PRO of 63/278,143 filed on November 11th, 2021.
Status of Claims
Claims 1-3, 6-9, 11, 13, 17-19, 21, 23-25, 28-30, 49-56, 60-62, 64 and 66-70 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on June 30th, 2026 is acknowledged.
Claims 23-25, 28-30, 49-56, 60-62, 64 and 66-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 30th, 2026.
Applicant’s election of species without traverse of viloxazine as the Norepinephrine Selective Reuptake Inhibitor (herein referred to as NSRI) and acetazolamide as the Carbonic Anhydrase Inhibitor (herein referred to as CAI) in the reply filed on June 30th, 2026 is acknowledged.
Claims 6 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 30th, 2026.
Claims 1-3, 7-8, 11, 13, 17-19 and 21 read on the elected species and will be examined herein.
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 1-3, 7-8, 11, 13, 17-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al (WO 2021/091902 A1); in view of Taranto-Montemurro et al (American Journal of Respiratory and Critical Care Medicine, (2019), 199(10), 1267-1276).
Regarding claims 1-3, 7-8, 11, 13, 17-19 and 21, Miller teaches a method of treating a condition associated with pharyngeal airway collapse, including Obstructive Sleep Apnea (herein referred to as OSA), by administering an effective amount of an NSRI, a muscarinic receptor antagonist, and a CAI (page 1, paragraph [0004]; pages 7-8, paragraph [0027]; page 21, claim 1). Miller expressly identifies viloxazine as a suitable NSRI and acetazolamide as a suitable CAI (page 9, paragraph [0035]; page 10, paragraph [0039]; page 21, claims 2-3 and 6-7). Miller teaches that acetazolamide is administered at a dosage between 250-750mg (page 11, paragraph [0041]; page 22, claim 12). Miller further teaches that OSA is a multifactorial disorder involving at least four physiological traits, namely i) pharyngeal anatomy and its propensity towards collapse, ii) the ability of the upper airway dilator muscles to activate and reopen the airway during sleep (neuromuscular compensation), iii) the arousal threshold from sleep (the propensity for hypopneas/apneas to lead to arousal and fragmented sleep), and iv) stability of the ventilated feedback loop (loop gain); and teaches that a pharmaceutical approach targeting two or more of those traits is expected to provide effective treatment (pages 6-7, paragraph [0022]). Miller further teaches that acetazolamide independently reduces loop gain by nearly 50% and increases muscle responsiveness, stating that simultaneously lowering loop gain and increasing muscle responsiveness can resolve OSA (page 7, paragraph [0024]).
MPEP § 2144.05 states:
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Miller does not expressly disclose a method of treating a condition associated with pharyngeal airway collapse comprising administering an effective amount of an NSRI and a CAI in the absence of anti-muscarinic therapy.
Taranto-Montemurro teaches a physiological basis for employing NSRIs in OSA therapy, explaining that increasing norepinephrine concentration during sleep can stimulate upper airway motoneurons toward levels observed during wakefulness and teaches that in vitro testing of atomoxetine, an NSRI, inhibited potassium channels involved in pharyngeal hypotonia that reduce hypoglossal motoneuron excitability (page 1272, right column, first paragraph). Taranto-Montemurro further teaches that sleep-related withdrawal of endogenous noradrenergic drive is a major cause of genioglossus hypotonia, particularly during non-REM sleep; and reports that administration of desipramine, a Norepinephrine Reuptake Inhibitor (herein referred to as NRI), has been shown to improve genioglossus activity and upper airway collapsibility and reduced OSA in a subgroup of patients (page 1268, middle column, second paragraph). Thus, Taranto-Montemurro establishes that NSRIs were known to provide a physiological means of augmenting upper airway neuromuscular activity relevant to pharyngeal airway collapse. Furthermore, Taranto-Montemurro teaches that there are known disadvantages associated with the antimuscarinic therapy when treating OSA; particularly, that oxybutynin can cause severe, dose dependent anticholinergic side effects (page 1275, right column, second paragraph); further disclosing that patients diagnosed with benign prostatic hyperplasia or urinary retention were excluded from studies because the conditions could be exacerbated by antimuscarinic medications (page 1268, right column, second paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art to omit the antimuscarinic component from the regimen taught by Miller to avoid the known severe, dose dependent anticholinergic adverse effects associated with antimuscarinic therapy, while retaining the NSRI and CAI components for their respective physiological effects relevant to OSA. A person of ordinary skill in the art would have reason to retain the NSRI component because Taranto-Montemurro teaches that increasing noradrenergic activity counteracts sleep-related loss of noradrenergic drive to the upper airway musculature and thereby addresses the impaired upper airway neuromuscular compensation associated with OSA; and Miller teaches that acetazolamide addresses the distinct OSA mechanism of elevated loop gain, further teaching that pharmacological treatment directed toward two or more physiological traits is desirable. Thus, one of ordinary skill in the art would have had reason to omit the additional antimuscarinic mechanism provided by oxybutynin to avoid its known anticholinergic adverse effects, while retaining the pharmacological treatment directed to multiple OSA associated physiological traits through the NSRI and CAI. The omission of a component and its corresponding function is an obvious expedient where the advantages associated with omission would have been recognized in the art. See MPEP § 2144.04(II)(A); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). The resulting administration of viloxazine and acetazolamide in the absence of antimuscarinic therapy would have represented the predictable use of prior art elements according to their established function, with a reasonable expectation of successfully treating OSA.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Taken together, all of this would result in the method of instant claims 1-3, 7-8, 11, 13, 17-19 and 21 with a reasonable expectation of success.
Conclusion
Claims 1-3, 7-8, 11, 13, 17-19 and 21 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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