DETAILED ACTION
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.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-5, 8, 10-19 and 21 and species in the reply filed on 04/17/2026 is acknowledged.
Applicant provide compliant species of muscarinic receptor antagonist (MRA): oxybutynin
Examiner found prior for applicant elected species, therefore Markush search was not extended to other species of MRA according to Markush search practices.
Claims 23-24, 28-30, 32, 34-35, and 44-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/17/2026.
The non-elected Group II composition claims can never be rejoined with elected Group I method claims. Applicants should cancel Group I claims to expedite allowance.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 1-5, 8, 10-19 and 21 are examined.
Current Status of 18/548,604
This Office Action is in response to the amended claims of 09/01/2023.
Claims 1-3,10-15, 18, 23-24,29 and 44-46 are original; and claims 4-5, 8, 16-17, 19, 21, 28, 32 and 34-35 currently amended.
Claims 1-5, 8, 10-19 and 21 are examined.
Claims 23-24, 28-30, 32, 34-35, 44-46 and 44-46 are withdrawn.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 09/01/2023 and 04/17/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 03/04/2021.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-5, 8, 10-19 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andrew et.al. (WO 2018/200775 A, publication date is 01/11/2018).
Claims 1, 8, 10-19 and 21 are directed to method of treating a subject having a condition associated with pharyngeal airway collapse, comprising of administering reboxetine or pharmaceutically acceptable salt thereof and a muscarinic receptor antagonist (MRA). Andrews et. al teaches method of treating a subject having a condition associated with pharyngeal airway collapse, comprising of administering a norepinephrine reuptake inhibitor(NRI) and a muscarinic receptor antagonist (MRA) and pharmaceutically acceptable salt (page 20-21, claims 1-3,5, 9, 23) where norepinephrine reuptake inhibitor comprises of reboxetine (page 20 claim 5)and MRA is Oxybutynin (applicant’s elected species) (page 21, claims 9, 13-16), anticipating claims 1, 8 and 10. Andrews is silent on the stereochemistry of Oxybutynin and reboxetine, examiner interpret reboxetine and Oxybutynin in Andrews as (S,S)-reboxetine and (R)-oxybutynin) respectively thus anticipating claims 16 and 11 respectively. Andrews discloses dosage of oxybutynin to in the range of 2mg to about 15 mg (page 21, claims 9, 13-16) which is within the range recited in claims 12-15, thus anticipating claims 12-15.
Andrew teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea or snoring (page 21 claims 17-8) thus anticipating claims 17-19. Andrew further teaches method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep (page 20-21 claims 1, and 19) thus anticipating claim 21.
Claim 4 drawn to daily administering reboxetine or MRA daily, Andrew discloses daily administration of norepinephrine reuptake inhibitor and a muscarinic receptor antagonist (page 10, lines 28-35), thus anticipating claim 4.
Claim 5 is drawn to single composition in oral form of MRA and reboxetine, Andrew discloses NRI there by reboxetine and MRA are administered in a single composition in oral form (page 22, claims 20 and 21) thus anticipating claim 5.
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.
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 1-5, 8, 10-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over
Andrew et.al. ( WO 2018/200775 A, publication date is 01/11/2018)
In view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Andrew et.al teaches claims 1, 4-5, 8, 10-19 and 21 as stated in 102 rejection above.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Although Andrew et.al teaches method of treating a subject having a condition associated with pharyngeal airway collapse, comprising of administering a norepinephrine reuptake inhibitor(reboxetine) and a muscarinic receptor antagonist and pharmaceutically acceptable salt thereof (claims 1, 4-5, 8, 10-19 and 21). Andrew does not teach dosage of reboxetine
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who is optimizing dosage of medicine to be administered to subject.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-3 are directed to dosage of reboxetine or pharmaceutically acceptable salt thereof. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Therefore it would be prima facia obvious to combine the teaching Andrew, which teaches a method of treating condition associated with pharyngeal airway collapse, comprising of administering reboxetine or pharmaceutically acceptable salt thereof and a muscarinic receptor antagonist (MRA)(Andrew page 20-22) with the routine optimization of dosage of pharmaceuticals (Anisel et.al. page 50) to teach all the elements of claims 1-5, 8, 10-19 and 21.
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, 4-5, 8, 10-19 and 21 rejected on the ground of anticipatory nonstatutory double patenting as being anticipated over claims 1, 4, 6, 8, 10-14 of U.S. Patent No. US-11123313-B2. Amended instant claims of 09/01/2023 was used to make this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1, 4, 6 and 14 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine(reference claim 4) and MRA is oxybutynin(referenced claims 6 and 16) anticipating claims anticipating claims 1, 8 and 10. Reference claims are silent on the stereochemistry of Oxybutynin and reboxetine, examiner interpret reboxetine and Oxybutynin in reference claims as (S,S)-reboxetine and (R)-oxybutynin) respectively thus anticipating claims 16 and 11 respectively. Reference claim 10 discloses dosage of oxybutynin to in the range of 2mg to about 15 mg which is within the range recited in instant claims 12-15, thus anticipating claims 12-15.
Reference claims 11 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea or snoring thus anticipating claims 17-19. Reference claims 1 and 12 further discloses method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep thus anticipating claim 21.
Reference claim 13 discloses the method of wherein the NRI (reboxetine) and the muscarinic receptor antagonist are administered in a single composition (examiner interpret this as oral dosage administered daily) anticipating claims 4-5.
Claims 1-5, 8, 10-19 and 21 rejected on the ground of obvious type-nonstatutory double patenting as being obvious over claims 1, 4, 6, 8, 10-14 of U.S. Patent No. US-11123313-B2 in view of
In view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
Amended instant claims of 09/01/2023 was used to make this rejections.
1. Determining the scope and contents of the prior art.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1, 4, 6 and 14 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine(reference claim 4) and MRA is oxybutynin(referenced claims 6 and 16) anticipating claims anticipating claims 1, 8 and 10. Reference claims are silent on the stereochemistry of Oxybutynin and reboxetine, examiner interpret reboxetine and Oxybutynin in reference claims as (S,S)-reboxetine and (R)-oxybutynin) respectively thus anticipating claims 16 and 11 respectively. Reference claim 10 discloses dosage of oxybutynin to in the range of 2mg to about 15 mg which is within the range recited in instant claims 12-15, thus anticipating claims 12-15.
Reference claims 11 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea or snoring thus anticipating claims 17-19. Reference claims 1 and 12 further discloses method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep thus anticipating claim 21.
Reference claim 13 discloses the method of wherein the NRI (reboxetine) and the muscarinic receptor antagonist are administered in a single composition (examiner interpret this as oral dosage administered daily) anticipating claims 4-5.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Although reference US patent teaches instant claims 1, 4-5, 8, 10-19 and 21. Reference patent does not teach dosage of reboxetine of instant claim 2-3.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who is optimizing dosage of medicine to be administered to subject.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-3 are directed to dosage of reboxetine or pharmaceutically acceptable salt thereof. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Therefore, it would be prima facia obvious to combine reference U.S. Patent No. US-11123313-B2 with the routine optimization of dosage of pharmaceuticals (Anisel et.al. page 50) to teach all the elements of instant claims 1-5, 8, 10-19 and 21.
Claims 1, 8, 10-19 and 21 provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, 10-11, 13-17, 37-39 and 41 of copending Application No. 18/687,660 (reference application). Amended instant claims of 09/01/2023 was used to make this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1-3 , 7-8 and 10 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine(reference claim 3) and MRA is oxybutynin(referenced claims 7-8, 10) anticipating claims anticipating claims 1, 8 and 10. Reference claims are silent on the stereochemistry of reboxetine, examiner interpret reboxetine in reference claims as (S,S)-reboxetine thus anticipating claims 16. Reference claims 11 discloses oxybutynin as (R)-oxybutynin, anticipating claim 11.
Reference claims 14-15 discloses dosage of oxybutynin to in the range of 1mg to about 15 mg (page 21, claims 9, 13-16) which is within the range recited in instant claims 12-13, thus anticipating claims 12-13. Reference claims 14-15 discloses dosage of oxybutynin to in the range of 1mg to about 15 mg which is within the range recited in instant claims 12-13, thus anticipating claims 12-13.
Reference claims 16-17 discloses dosage of (R)-oxybutynin to in the range of 0.5mg mg to about 10 mg (page 21, claims 9, 13-16) which is within the range recited in instant claims 14-15, thus anticipating claims 14-15.
Reference claims 37-39 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea (reference claims 37-28) or snoring (reference claims 39 thus anticipating claims 17-19. Reference claim 41 further discloses method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep thus anticipating claim 21.
Claims 1, 4-5, 8, 10-19 and 21 provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-3, 5, 9-19 of copending Application No. 19/348,331 (reference application). Amended instant claims of 09/01/2023 was used to make this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1-3, 5 and 9-13 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine(reference claim 3) and MRA is oxybutynin(referenced claims 9-13) anticipating claims anticipating claims 1, 8 and 10. Reference claims are silent on the stereochemistry of reboxetine, examiner interpret reboxetine in reference claims as (S,S)-reboxetine thus anticipating claims 16. Reference claims 11 discloses oxybutynin as (R)-oxybutynin, anticipating claim 11.
Reference claims 11-13 discloses dosage of (R)-oxybutynin to in the range of 2mg to about 15 mg which is within the range recited in instant claims 12-15, thus anticipating claims 12-15. Please note examiner is interpreting (R)-oxybutynin as oxybutynin.
Reference claims 14-15 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea (reference claim 14-15) or snoring (reference claim 14) thus anticipating claims 17-19. Reference claims 16-17 further discloses method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep thus anticipating claim 21.
Reference claims 18-19 discloses the method of wherein the NRI (reboxetine) and the muscarinic receptor antagonist are oral administered in a single composition (examiner interpret this as oral dosage administered daily) anticipating claims 4-5.
Claims 1, 8, 10-11, and 16-19 provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-3, 11 and 31-33 of copending Application No. 18/286,399 (reference application). Amended instant claims of 09/01/2023 was used to make this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1-3 and 11 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine(reference claim 3) and MRA is oxybutynin(referenced claims 10) anticipating claims anticipating claims 1, 8 and 10. Reference claims are silent on the stereochemistry of Oxybutynin and reboxetine, examiner interpret reboxetine and Oxybutynin in reference claims as (S,S)-reboxetine and (R)-oxybutynin) respectively thus anticipating claims 16 and 11 respectively.
Reference claims 31-33 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea (reference claims 31-32) or snoring (reference claims 33) thus anticipating claims 17-19.
Claims 1, 8, 10-11, 16-19 and 21 provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-3, 10 and 29-33 of copending Application No. 18/283,303 (reference application). Amended instant claims of 09/01/2023 was used to make this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1-3 and 11 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine(reference claim 3) and MRA is oxybutynin(referenced claims 10) anticipating claims anticipating claims 1, 8 and 10. Reference claims are silent on the stereochemistry of Oxybutynin and reboxetine, examiner interpret reboxetine and Oxybutynin in reference claims as (S,S)-reboxetine and (R)-oxybutynin) respectively thus anticipating claims 16 and 11 respectively.
Reference claims 29-32 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea (reference claims 31-32) or snoring (reference claims 33) thus anticipating claims 17-19. Reference claims 33 further discloses method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep thus anticipating claim 21
Claims 1, 8, 10-11, 16-19 and 21 provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-3, 15, 18 and 28-31 of copending Application No. 18/271,716 (reference application). Amended instant claims of 09/01/2023 was used to make this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1-3 and 15 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine(reference claim 3) and MRA is oxybutynin(referenced claims 15) anticipating claims anticipating claims 1, 8 and 10. Reference claims 18 are silent on the stereochemistry of reboxetine, examiner interpret reboxetine in reference claims as (S,S)-reboxetine thus anticipating claims 16. Reference claims 18 discloses oxybutynin as (R)-oxybutynin, anticipating claim 11.
Reference claims 29-32 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea (reference claims 28-29) or snoring (reference claim 28) thus anticipating claims 17-19. Reference claims 30-31 further discloses method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep thus anticipating claim 21.
Claims 1, 4-5, 8, 10-19 and 21 provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1,4, 9-11 and 16-23 of copending Application No. 19/407,061 (reference application). Amended instant claims of 09/01/2023 was used to make this rejections.
Although the claims at issue are not identical, they are not patentably distinct from each other because, reference claims 1, 4 and 9-11 discloses method of treating a subject having a condition associated with pharyngeal airway collapse the method comprising administering to a subject in need thereof an effective amount of (i) a norepinephrine reuptake inhibitor (NRI) and (ii) a muscarinic receptor antagonist (MRA)wherein NRI is reboxetine (referenced claim 4) and MRA is oxybutynin(referenced claims 9-11) anticipating claims anticipating claims 1, 8 and 10. Reference claims are silent on the stereochemistry of reboxetine, examiner interpret reboxetine in reference claims as (S,S)-reboxetine thus anticipating claims 16. Reference claims 10-11 discloses oxybutynin as (R)-oxybutynin, anticipating claim 11.
Reference claims 16-17 discloses dosage of oxybutynin in the range of 1 mg to about 15 mg which is within the range recited in instant claims 12-15, thus anticipating claims 12-15. Please note examiner is interpreting (R)-oxybutynin as oxybutynin.
Reference claims 18-19 teaches method of treating pharyngeal airway collapse is Obstructive sleep apnea (reference claim 18-19) or snoring (reference claim 18) thus anticipating claims 17-19. Reference claims 20-21 further discloses method of treating a subject associated with pharyngeal airway collapse is in a non-fully conscious state, wherein non fully conscious state is sleep thus anticipating claim 21.
Reference claims 18-19 discloses the method of wherein the NRI (reboxetine) and the muscarinic receptor antagonist are oral administered in a single composition (examiner interpret this as oral dosage administered daily) anticipating claims 4-5.
Conclusion
No claims are allowable as written.
US patent no 11,911,351 and copending application No. 18/708,616 are not double patenting because claims are directed to different combination of oxybutynin and NRI compounds.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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