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
Election of Species and Status of the Claims
Applicant’s election without traverse of “80 mg atomoxetine and 50 mg spironolactone,” as the single specific pharmaceutical composition and “a patient with obstructive sleep apnea and hypertension,” as the single patient population in the response filed on February 13th 2026 is acknowledged. Claims 1-10, 15, 17-20, 29-44, 49, 51-54, 62, 70, and 74-75 are pending. Claims 4, 31, 32, and 38 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1-3, 5-10 15, 17-20, 29, 30, 33-37, 39-44, 49, 51-54, 62, 70, 74, and 75 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on February 13th 2026 and September 21st 2023 in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and its dependent claims 2-3, 5-10 15, 17-20, 33-34, and 74 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and its dependent claims 2-3, 5-10 15, 17-20, 33-34, and 74 are indefinite for the phrase “a condition associated with pharyngeal airway collapse,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the conditions described by the phrase. Specifically, the term “associated with,” is a relative term, is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, the term ‘associated with pharyngeal airway collapse,’ will be interpreted as ‘caused by pharyngeal airway collapse,’ which necessitates that the patient receiving treatment has/has had pharyngeal airway collapse
Regarding claim 33, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-10, 15, 17-19, 29-30, 33, 35-37, 39-44, 49, 51-52, 62, 70, and 74-75 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Miller (US 2023/0135373 A1 effectively filed on April 2nd 2020).
Claims 1-3, 5-10, 29-30, 33, 35-37, 39-44, and 74-75 are directed towards the treatment of obstructive sleep apnea via administration of a pharmaceutical composition comprising:
A norepinephrine reuptake inhibitor, such as atomoxetine
A mineralocorticoid antagonist, such as spironolactone
A muscarinic receptor antagonist
Miller teaches the treatment of obstructive sleep apnea with a pharmaceutical composition comprising atomoxetine, spironolactone and oxybutynin (a muscarinic receptor antagonist):
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[Miller, pg. 6, paragraph [0056]].
Miller thereby anticipates claims 1-3, 5-10, 29-30, 33, 35-37, 39-44, and 74-75.
Claims 15 and 49 additionally require administration of a diuretic. As spironolactone is a known diuretic, Miller anticipates claims 15 and 49.
Claims 17, 18, 51, and 52 limit the dose of atomoxetine to 25-100 mg. Miller teaches the same dosage (Miller, pg. 3, paragraph [0019]), anticipating claims 17, 18, 51, and 52.
Claim 62 requires that the composition administered is a syrup, pill, tablet, troche, or capsule. Miller teaches tablets, pills, troches, and capsules (Miller, pg. 5, paragraph [0050]), anticipating claim 62.
Claim 70 is directed towards a kit comprising a norepinephrine reuptake inhibitor and a mineralocorticoid antagonist. Miller teaches such a composition (Miller, pg. 6, paragraph [0056]) and a kit form of pharmaceutical compositions (Miller, pg. 6, paragraph [0055]). Miller thereby anticipates claim 70.
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.
Claims 1-3, 5-10 15, 17-20, 29, 30, 33-37, 39-44, 49, 51-54, 62, 70, 74, and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Messineo (Messineo et al., The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial. Am J Respir Crit Care Med. 2019 May 15;199(10):1267-1276) in view of Gaddam (Gaddam et al., Spironolactone reduces severity of obstructive sleep apnea in patients with resistant hypertension: a preliminary report. J Hum Hypertens. 2010 Aug;24(8):532-7).
Claim 1 is directed towards the treatment of a subject with a condition caused by pharyngeal airway collapse, such as obstructive sleep apnea, via administration of a combination of a norepinephrine reuptake inhibitor, such as the norepinephrine selective reuptake inhibitor, atomoxetine, and a mineralocorticoid antagonist, such as spironolactone.
Messineo teaches administration of a combination of 80 mg atomoxetine and 5 mg oxybutyrin to subjects with obstructive sleep apnea, including subjects with hypertension (Messineo, pg. 1268, Methods), and that such a combination was effective in reducing obstructive sleep apnea (Messineo, pg. 1272, Discussion).
Gaddam teaches administration of 50 mg spironolactone to subjects with hypertension and obstructive sleep apnea (Gaddam, pg. 1, Methods; Gaddam, pg. 2, Treatment and Follow up). Gaddam demonstrates that such a method is effective in reducing obstructive sleep apnea (Gaddam, pg. 1, Conclusion).
As both treatments are known in the art as being effective for the treatment of obstructive sleep apnea in hypertensive subjects, one of ordinary skill in the art would have a reasonable expectation of success in combining the treatments and treating obstructive sleep apnea in a hypertensive subject with a combination of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone. See MPEP § 2144.06(I):
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
The treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is thereby prima facie obvious, and consequently, claim 1 prima facie obvious.
Claim 2-3 and 5-6 limit the norepinephrine reuptake inhibitor of claim 1 to atomoxetine. Claims 2-3 and 5-6 are prima facie obvious for the same reasons as claim 1.
Claims 7-9 limit the mineralocorticoid antagonist of claim 1 to spironolactone. Claim 7-9 are prima facie obvious for the same reasons as claim 1.
Claim 10 limits the method of claim 1 to further require administration of a muscarinic receptor antagonist. One such antagonist is oxybutyrin. As the treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is prima facie obvious (see the above 103 rejection for claim 1, claim 10 is prima facie obvious.
Claim 15 limits claim 1 to further require administration of a diuretic. As spironolactone is a diuretic, claim 15 is prima facie obvious for the same reasons as claim 1.
Claims 17-18 further limit the method of claim 6 to require that the atomoxetine is administered in a dose of about 25 to about 100 mg. As the treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is prima facie obvious (see the above 103 rejection for claim 1), claims 17-18 are prima facie obvious.
Claims 19-20 further limit the method of claim 8 to require that the spironolactone is administered in a dose of about 20 to about 80 mg. As the treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is prima facie obvious (see the above 103 rejection for claim 1), claims 19-20 are prima facie obvious.
Claims 29-30 further limit the method of claim 1 to require that the condition associated with pharyngeal airway collapse is obstructive sleep apnea. As the treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is prima facie obvious (see the above 103 rejection for claim 1), claims 29-30 are prima facie obvious.
Claim 33 requires that, in the method of claim 1, the subject is asleep. As obstructive sleep apnea necessarily requires that the subject is asleep, claim 33 is prima facie obvious for the same reasons as claim 1.
Claims 34 requires that, in the method of claim 1, the subject has hypertension. As the treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is prima facie obvious (see the above 103 rejection for claim 1), claims 33 is prima facie obvious.
Claims 35-44 are directed to a pharmaceutical composition comprising amotoxetine, spironolactone, and a muscarinic receptor antagonist. As the treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is prima facie obvious (see the above 103 rejection for claim 1), one of ordinary skill in the art would have a reasonable expectation of success in administering the drugs together, and claims 35-44 are prima facie obvious.
Claim 49 requires that the composition of claim 35 comprises a diuretic. As spironolactone is a diuretic, claim 49 is prima facie obvious for the same reasons as claim 35.
Claims 51-52 further limit the composition of claim 35 to require that the atomoxetine is in a dose of about 25 to about 100 mg. As a composition comprising a dose of 80 mg atomoxetine is prima facie obvious (see the above 103 rejection for claim 35), claims 51-52 are prima facie obvious.
Claims 53-54 further limit the composition of claim 35 to require that the atomoxetine is in a dose of about 20 to about 80 mg. As a composition comprising a dose of 50 mg spironolactone is prima facie obvious (see the above 103 rejection for claim 35), claims 53-54 are prima facie obvious.
Claim 62 requires that the composition of claim 35 is in an oral form, such as a pill or capsule. Messineo teaches a capsule form of atomoxetine/oxybutyrin (Messineo, pg. 1269). Spironolactone is universally known as being administered in an oral form1, one of ordinary skill in the art would have a reasonable expectation of success in administering the drugs together in such a form, and claim 62 is prima facie obvious.
Claim 70 is directed towards a kit comprising a norepinephrine reuptake inhibitor and a mineralocorticoid antagonist. As a composition comprising such components is prima facie obvious (see the above 103 rejection for claim 35), a kit comprising said components is prima facie obvious. See MPEP § 2112.01(III):
Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product."). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ( "Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability….[T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." ); In re Miller, 418 F.2d 1392, 1396 (CCPA 1969) (finding a new and nonobvious relationship between a measuring cup and writing showing how to "half" a recipe); In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art); In re Xiao, 462 Fed. App'x 947, 950-51 (Fed. Cir. 2011) (non-precedential) (affirming an obviousness rejection of claims directed to a tumbler lock that used letters instead of numbers and had a wild-card label instead of one of the letters); In re Bryan, 323 Fed. App'x 898, 901 (Fed. Cir. 2009) (non-precedential) (printed matter on game cards bears no new and nonobvious functional relationship to game board).
Claim 74 requires that, in the method of claim 1, the norepinephrine reuptake inhibitor is atomoxetine and the mineralocorticoid antagonist is spironolactone. As the treatment of obstructive sleep apnea in a subject with hypertension via administration of 80 mg atomoxetine, 5 mg oxybutyrin, and 50 mg spironolactone is thereby prima facie obvious (see the above 103 rejection for claim 1), claim 74 is prima facie obvious.
Claim 75 requires that, in the composition of claim 35, the norepinephrine receptor inhibitor is atomoxetine, and the mineralocorticoid antagonist is spironolactone. As a composition comprising both of these components is prima facie obvious (see the above 103 rejection for claim 35), claim 75 is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 For evidentiary support see Medline Plus (https://medlineplus.gov/druginfo/meds/a682627.html, 2018, accessed 05/19/2026)
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