Detailed Action
The present office action is in response to the reply filed on 10 Aug 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 .
Status
Claims 1-3, 6, 10-11, 16, and 76 of the pending application have been examined on the merits. Claims 7-9, 18-19, 36-38, 41-45, 65, 72, and 78 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 10 Aug 2026. Acknowledgement is made of the cancellation of claims 4-5, 12-15, 17, 20-35, 39-40, 46-64, 66-71, 73-75, and 77.
Priority
The instant application retains the priority date of 16 Apr 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10 Aug 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Arguments
Acknowledgement is made of the remarks filed 10 Aug 2026.
The rejection of claims 24, 31-33, and 77 under 35 U.S.C. § 103 is rendered moot following the cancellation of the claims.
Regarding the rejection of claims 1-3, 6, 10-11, 16, and 76 under 35 U.S.C. § 103 over Carley et al. (Sleep, 2018, 41:zsx184; provided in the office action mailed 09 Apr 2026), hereinafter Carley, further in view of Taranto-Montemurro et al. (Am J Respir Crit Care Med, 2019, 199:1267-1276; provided in the office action mailed 09 Apr 2026), hereinafter Taranto-Montemurro, and Stadelmann et al. (PLoS One, 2014, 9:e93931; provided in the office action mailed 09 Apr 2026), hereinafter Stadelmann, applicant arguments have been fully considered and are persuasive in part.
Applicant argues on pg. 8 of the remarks that the claims directed to the treatment of obstructive sleep apnea by administering a carbonic anhydrase inhibitor have been cancelled and so Stadelmann is irrelevant. This is persuasive and the rejection has been amended to remove the Stadelmann reference. This is necessitated by applicant amendment.
Applicant argues on pgs. 7-8 of the remarks that Carley does not teach the combination of a NRI and cannabinoid, and instead teaches treatment of obstructive sleep apnea with dronabinol without providing a suggestion or motivation to combine dronabinol with another active agent. Further, applicant argues that Taranto-Montemurro teaches a treatment for obstructive sleep apnea with a combination of oxybutynin + atomoxetine, without a further suggestion of combining or substituting the active ingredients with a cannabinoid. Applicant argues that the previous office action mailed 09 Apr 2026 did not provide a rationale for why the claimed combination would be used.
This is not persuasive. As discussed on pgs. 5-6 of the office action mailed 09 Apr 2026, it is prima facie obvious to combine two compositions which are taught by the prior art to be useful for the same purpose to form a third composition to be used for the same purpose. See MPEP § 2144.06(I). Carley teaches treatment of obstructive sleep apnea using dronabinol. Taranto-Montemurro teaches treatment of obstructive sleep apnea using a combination of oxybutynin + atomoxetine. Therefore, it is prima facie obvious to combine the treatments to treat obstructive sleep apnea.
Applicant argues on pg. 8 of the remarks that the person of ordinary skill in the art would prefer a single agent therapy due to greater predictability, such as reduced possibility of adverse side effects from a combination therapy.
This is not persuasive. Applicant arguments cannot take the place of evidence when evidence is necessary. See MPEP § 2145(I).
Applicant argues on pgs. 9-10 of the remarks that the data as found in the instant specification and published as Messineo et al. (J Clin Sleep Med, 2023, 19:1183-1190; provided in IDS 08/10/26), hereinafter Messineo, show the combination of atomoxetine and dronabinol results in improvements in multiple OSA severity metrics compared to atomoxetine alone.
This is not persuasive for two reasons. First, the limitations argued are not the limitations of the claims. The data of the specification and Messineo are limited to combinations of 40 mg or 80 mg of atomoxetine and 2.5 mg, 5 mg, or 10 mg of dronabinol and not all cannabinoids or all NRIs, and so the limitations argued are narrower than the instant claims. See MPEP § 2145(VI). Second, it is not clear that the conclusions of synergy may be taken from the data. Messineo teaches that “the absence of blinding, randomization, and a control group are evident limitations of this study. Therefore, the findings of this trial can only be considered preliminary and not conclusive.” (pg. 1188, column 2) The data further do not include controls of treatment with just dronabinol to show evidence of synergy. It is therefore not persuasive that the data indicate synergy for the full scope of the instant claims.
In light of the discussion above, the rejection of claims 1-3, 6, 10-11, 16, and 76 under 35 U.S.C. § 103, as obvious over Carley and Taranto-Montemurro is amended for the reasons of record and restated below.
Regarding the obviousness-type nonstatutory double patenting rejections of claims 1-3, 6, 10-11, 16, and 76 over U.S. Patent No. 11,911,351 and co-pending App Nos. 18/271,716, 18/548,604, 18/283,303, 18/573,673, 18/687,660, 18/708,616, and 18/865,115, applicant arguments have been fully considered but are not persuasive.
Applicant argues on pg. 11 that each patent or application relates to the use of atomoxetine or other norepinephrine reuptake inhibitors and that for the same reasons as provided above regarding the rejection under 35 U.S.C. § 103 it would not have been obvious to combine the inventions of the reference claims with Carley to arrive at the instant claims.
This is not persuasive. For the reasons stated above regarding the rejection under 35 U.S.C. § 103 it would be obvious for the artisan to combine the reference inventions with Carely to arrive at the invention of the instant claims. Therefore, the rejections are maintained for the reasons of record and restated below.
Claim Rejections - 35 U.S.C. § 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.
Claim(s) 1-3, 6, 10-11, 16, and 76 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Carley et al. (Sleep, 2018, 41:zsx184; provided in the office action mailed 09 Apr 2026), hereinafter Carley, further in view of Taranto-Montemurro et al. (Am J Respir Crit Care Med, 2019, 199:1267-1276; provided in the office action mailed 09 Apr 2026), hereinafter Taranto-Montemurro.
The instant claims are drawn to a method of treating obstructive sleep apnea by administering a cannabinoid and a norepinephrine reuptake inhibitor (claims 1-3, 6, 10, 16, and 76). Applicant elected dronabinol as the species of cannabinoid and atomoxetine as the species of norepinephrine reuptake inhibitor in the response filed 19 Feb 2026. The claims further limit the dose of atomoxetine to between 20 mg and 200 mg (claim 16). Additionally, the disclosure claims administering a muscarinic receptor antagonist (claim 11) in addition to the cannabinoid and the norepinephrine reuptake inhibitor.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring. However, Carley does not teach the treatment of obstructive sleep apnea by administering a norepinephrine reuptake inhibitor, a muscarinic receptor antagonist, or a carbonic anhydrase inhibitor.
Taranto-Montemurro teaches treatment of obstructive sleep apnea by a combination of the norepinephrine reuptake inhibitor atomoxetine and oxybutynin, a muscarinic receptor antagonist (pg. 1267, Abstract). Atomoxetine was administered at 80 mg and oxybutynin was administered at 5 mg (pg. 1267, Abstract). Taranto-Montemurro teaches that the combination greatly reduced obstructive sleep apnea severity (pg. 1267, Abstract).
Based on the teachings of Carley and Taranto-Montemurro, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of 10 mg/day of dronabinol with the composition of 80 mg of atomoxetine and 5 mg of oxybutynin to create a third composition for the treatment of obstructive sleep apnea and snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6, 10-11, 31-33, and 76-77 rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,911,351, hereinafter ‘351, in view of Carley.
‘351 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering a combination of atomoxetine and pure (R)-oxybutynin (claim 1). The reference further claims administering atomoxetine at a dosage of 20-100 mg (claim 2) and claims obstructive sleep apnea (claim 5) or simple snoring (claim 4) as the condition associated with pharyngeal airway collapse. However, ‘351 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘351 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of atomoxetine and pure (R)-oxybutynin with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 1-3, 6, 10-11, 16, 31-33, and 76-77 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-3, 6, 8-12, 15, 18, and 28-29 of copending Application No. 18/271,716, hereinafter ‘716, in view of Carley.
‘716 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering a combination of atomoxetine and Lemborexant (claim 1). The reference further claims administering atomoxetine at a dosage of 25-150 mg (claim 2) and claims obstructive sleep apnea (claim 29) or simple snoring (claim 28) as the condition associated with pharyngeal airway collapse. ‘716 claims further administering a muscarinic receptor antagonist (claims 15 and 18). However, ‘716 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘716 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of atomoxetine, Lemborexant, and a muscarinic receptor antagonist with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 10-11, and 31-33 provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-5, 8, 10-19, and 21 of copending Application No. 18/548,604, hereinafter ‘604, in view of Carley.
‘604 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering a combination of reboxetine, a norepinephrine reuptake inhibitor, and a muscarinic receptor antagonist (claim 1). The reference further claims obstructive sleep apnea (claim 18) or simple snoring (claim 19) as the condition associated with pharyngeal airway collapse. However, ‘604 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘604 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of reboxetine and a muscarinic receptor antagonist with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 6, 10-11, 16, 31-33, and 76-77 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-3, 5-10, 17-18, 29-34, and 74 of copending Application No. 18/283,303, hereinafter ‘303, in view of Carley.
‘303 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering a combination of a norepinephrine reuptake inhibitor and a mineralocorticoid antagonist (claim 1). The reference further claims administering the norepinephrine reuptake inhibitor as atomoxetine (claim 6) at a dosage of 20-100 mg (claim 17) and claims obstructive sleep apnea (claim 30) or snoring (claim 31) as the condition associated with pharyngeal airway collapse. Additionally, ‘303 claims further administering a muscarinic receptor antagonist (claim 10). However, ‘351 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘303 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of a norepinephrine inhibitor, a mineralocorticoid antagonist, and a muscarinic receptor antagonist with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 10, and 31-33 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 8-14, and 16-19 of copending Application No. 18/570,673, hereinafter ‘673, in view of Carley.
‘673 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering a combination of a norepinephrine reuptake inhibitor selected from reboxetine, edivoxetine, and viloxazine, in the absence of antimuscarinic therapy (claim 1). The reference further claims obstructive sleep apnea (claim 17) or simple snoring (claim 19) as the condition associated with pharyngeal airway collapse. However, ‘673 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘673 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of a norepinephrine inhibitor with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 6, 10-11, 16, 31-33, and 76-77 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 10-19, and 35-39 of copending Application No. 18/687,660, hereinafter ‘660, in view of Carley.
‘660 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering a combination of a norepinephrine reuptake inhibitor and MAD therapy (claim 1). The reference further claims administering atomoxetine as the norepinephrine reuptake inhibitor at a dosage of 20-150 mg (claim 12) and claims obstructive sleep apnea (claim 38) or simple snoring (claim 39) as the condition associated with pharyngeal airway collapse. The reference further claims administering a muscarinic receptor antagonist (claim 7). However, ‘660 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘660 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of a norepinephrine reuptake inhibitor and MAD therapy with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 6, 10, 16, 24, 31-33, and 76-77 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-3, 6-9, 11, 13, 17-19, and 21 of copending Application No. 18/708,616, hereinafter ‘616, in view of Carley.
‘616 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering a combination of a norepinephrine reuptake inhibitor and a carbonic anhydrase inhibitor in the absence of antimuscarinic therapy (claim 1). The reference further claims atomoxetine as the norepinephrine reuptake inhibitor and administering atomoxetine at a dosage of 20-200 mg (claims 6 and 9) and claims obstructive sleep apnea (claim 18) or simple snoring (claim 19) as the condition associated with pharyngeal airway collapse. However, ‘616 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘616 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of a norepinephrine reuptake inhibitor and a carbonic anhydrase inhibitor with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 10-11, and 31-33 provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 1, 3-4, 8, 10-14, and 17-20 of copending Application No. 18/865,115, hereinafter ‘115 in view of Carley.
‘115 teaches a method of treating a subject having a condition associated with pharyngeal airway collapse by administering the norepinephrine reuptake inhibitor, ampreloxetine (claim 1). The reference further claims administering a muscarinic receptor antagonist (claim 3) and claims obstructive sleep apnea (claim 18) or snoring (claim 19) as the condition associated with pharyngeal airway collapse. However, ‘115 does not claim administering a cannabinoid to treat the condition associated with pharyngeal airway collapse.
Carley teaches treating obstructive sleep apnea with dronabinol (pg. 1, Methods). Carley teaches that treatment with 10 mg/day of dronabinol reduced the overall apnea-hypopnea index and that between the placebo, 2.5 mg/day of dronabinol, and 10 mg/day of dronabinol, participants reported the highest satisfaction with the 10 mg/day dose (pg. 1, Results). Carley teaches tracking snoring as part of the measurements (pg. 3, column 1). Thus, by treating obstructive sleep apnea Carley necessarily teaches treatment of snoring.
Based on the teachings of ‘115 and Carley, it would be prima facie obvious to one having ordinary skill in the art to combine the composition of ampreloxetine with the composition of 10 mg/day of dronabinol to create a third composition for the treatment of obstructive sleep apnea or snoring with a reasonable expectation of success. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed. THIS ACTION IS MADE FINAL. 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
