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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 04/27/2026 has been entered.
Claim Rejections - 35 USC § 112
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.
Claims 1, 6, 8, 10, 14, 18, 21, 22, 28, 29, 31, 33, 39, 43, 45, 46, 55-58, 64-67, 69, and 71 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 recites the limitation "the component" in line 7. There is insufficient antecedent basis for this limitation in the claim. Claims 6, 8, 10, 14, 18, 21, 22, 28, 29, 31, 33, 39, 43, 45, 46, 55-58, 64-67, 69, and 71 are rejected due to their dependency on claim 1.
Response to Arguments
Applicant’s amendments submitted 04/27/2026 have been accepted and entered.
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Applicant argues that Le (US 20170251785 A1) in view of O’Sullivan (US 20200254478 A1) does not teach amended claim 1, specifically that the limitation of a sleeve extending past the neck and along the majority of the length of the reservoir and allowing a portion of the reservoir to be visible beneath the body. Applicant argues that Le’s sleeve (base fitment 120 and ball 121, Fig 1) does not read on the sleeve limitation. However, the combination of Le/O’Sullivan does read on the claims as written, as set forth in the rejection below.
Applicant further argues that the Board and Examiner have overlooked the alleged separation of O’Sullivan’s push button 15 and reservoir portion of cartridge 50, arguing that the pushbutton 15 walls are not part of the reservoir 52 because they are only “touching”. The Examiner respectfully disagrees, as all depictions of the cartridge 50 show the outer walls 51 of cartridge 50 encompass the push button region 15. The presence of seal 58 does not preclude cartridge 50 from reading on the claims as written. Thus the combination of Le/O’Sullivan teaches all of the limitations of claim 1 as set forth below.
Applicant did not specifically argue any other dependent claims.
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, 6, 8, 10, 14, 18, 33, 39, and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Le (US 20170251785 A1) in view of O’Sullivan (US 20200254478 A1).
Regarding Claim 1, Le discloses an applicator (rollerball assembly 100, Fig 1) for topical administration of an anticholinergic compound, or a pharmaceutically acceptable salt or composition thereof to a subject in need thereof (The rollerball assembly 100 contains essential oils ¶[0006], the ball is capable of rolling freely and transferring liquid from the inside of the bottle to the outside surface of the ball ¶[0005] Thus the rollerball assembly 100 is fully capable of containing and administering a different liquid or medication, including an anticholinergic compound, or a pharmaceutically acceptable salt or composition thereof.), the applicator (100, Fig 1) comprising: a. a bottle (200, Fig 1) comprising a neck containing bottle connector structure (threaded neck portion 210, Fig 1) at an upper portion thereof (210 is at the upper portion of 200, Fig 1), and a reservoir extending beneath the neck to hold the compound (bottle 200 comprises a cavity therein, which is fully capable of holding any liquid, and extends beneath the threaded neck portion 210, Fig 1); and b. a sleeve (base fitment 120 and ball 121, Fig 1) comprising an applicator member (ball 121, Fig 1), at a top portion of the sleeve (121 is disposed at the top portion of 120, Fig 1), for administering the compound (ball rolls freely and transfers liquid from the inside of the bottle to the outside surface of the ball ¶[0005]) , and sleeve connector structure (120 is configured to be mated with threaded neck portion 210 of bottle 200, Fig 1) to mate with the bottle connector structure (210, Fig 1) to provide communication between the bottle (200, Fig 1) and the applicator member (121, Fig 1) to enable administration of the compound (ball 121 transfers liquid from inside the bottle to the outside surface of the ball 121 ¶[0005]), wherein the bottle connector structure (threaded neck portion 210, Fig 1) and the sleeve connector structure (120 mates with the threaded neck portion 210, and thus comprises threads, Fig 1) comprise structure selected from the group consisting of respective screw threads (120 mates with the threaded neck portion 210, and thus both 120 and 210 comprise threads, Fig 1), respective snap fit structures, and respective press fit structures to mate the bottle (200, Fig 1) and the sleeve (120 and 121, Fig 1) when the bottle (200, Fig 1) is screwed into the sleeve (120 and 121, Fig 1).
Le is silent regarding the reservoir comprising translucent material near a bottom thereof to make visible an amount of the component present; a body containing the reservoir, the sleeve extending past the neck and along a majority of the length of the reservoir and allowing a portion of the reservoir to be visible beneath the body.
However, O’Sullivan teaches a dispenser with a reservoir, thus from the same field of endeavor, wherein the reservoir comprises translucent material near a bottom thereof to make visible an amount of the component present (Fig 8A, ¶[0022] cartridge 50 and/or outer container 40 may be transparent); wherein the reservoir (cartridge 50, Fig 8A) is contained within a body (reservoir 50 is contained within outer container 40, Fig 8A ¶[0088]), the sleeve extending past the neck and along a majority of the length of the reservoir (Fig 8A, outer container 40 extends past the dispensing nozzle 17 and along a majority of cartridge 50) and allowing a portion of the reservoir to be visible beneath the body (Fig 8A-B, a portion of cartridge 50 is visible beneath outer container 40) in order to hold the cartridge in place and prevent rotation of the cartridge (¶[0089][0096]) and so the user can see the composition within the reservoir to know how much is used and how much is left (¶[0111]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve of Le so that the reservoir is contained within a body of the sleeve, and wherein a portion of the reservoir is visible beneath the sleeve body, as taught by O’Sullivan in order to hold the cartridge in place and prevent rotation of the cartridge (as motivated by O’Sullivan ¶[0089][0096]) and so the user can see the composition within the reservoir to know how much is used and how much is left (as motivated by O’Sullivan ¶[0111]).
Regarding Claim 6, Le discloses that mating of the bottle connector structure (210, Fig 1) and the sleeve connector structure (120 mates with threaded neck portion 210, Fig 1) provides a seal to reduce leakage and/or evaporation (mating of 120 and 210 includes a base gasket 127, creating an effective seal between 200 and 120, Fig 1 ¶[0017]) of a medium for the anticholinergic compound, or the pharmaceutically acceptable salt or composition thereof (the seal created by the mating of 120 and 210 prevents leakage and/or evaporation of the liquid essential oil contained therein, and thus is fully capable of preventing leakage and/or evaporation of any liquid compound contained therein).
Regarding Claim 8, Le discloses that the applicator (100, Fig 1) comprises one or a plurality of rollers (121, Fig 1) disposed at the top portion of the sleeve (120, Fig 1), the roller or rollers (121, Fig 1) selected from the group consisting of spheroids and ellipsoids each rotatable about a major axis (121 is a ball, and is capable of rolling freely about any axis ¶[0005]), the roller or rollers sized to administer a desired amount of the compound (ball 121 transfers liquid from inside of the bottle to the outside surface of the ball ¶[0005]).
Regarding Claim 10, Le discloses that one or more of the bottle (200, Fig 1), the sleeve (120 and 121, Fig 1), or the roller or rollers (121, Fig 1) comprises material selected from the group consisting of polypropylene (including high-density polypropylene), polyethylene (including high-density polyethylene), polytetrafluoroethylene (PTFE), cyclic co-polymer, nylon, and polyethylene terephthalate (PET) (base fitment 120 is made of PTFE ¶[0009]).
Regarding Claim 14, Le discloses that the neck is sized to fit within the sleeve (210 is sized to fit within 120 when threadably mated, Fig 1 ¶[0017]).
Regarding Claim 18, Le discloses that the bottle (200, Fig 1) is press fit or snap fit into the sleeve (120 may mate with neck portion 210 via press fit ¶[0009]).
Regarding Claim 33, Le discloses that the sleeve (120 and 121, Fig 1) has one or more of a textured surface, finger grips, or variable diameter to facilitate gripping of the or more of the sleeve (120 has a variable diameter and a textured surface created by guide ramps 125 and capture areas 126 which are fully capable of facilitating gripping of the sleeve, Fig 1)
Regarding Claim 39, Le discloses that weight loss of the anticholinergic compound is in a range of about 0.0 to 0.35% by weight after two weeks at ambient temperature (the seals created by compression disk 111 mating with retaining lip 123 and base fitment 120 mating with gasket 127 and bottle 200 create liquid tight seals sufficient to prevent loss of the compound therein ¶[0008]).
In the alternative, if one of ordinary skill in the art would not find it inherent that weight loss of the anticholinergic compound composition is in a range of about 0.0 to 0.35% by weight after two weeks at ambient temperature, it would have been obvious to one of ordinary skill in the art to cause the device of Le to have weight loss of the anticholinergic compound composition be in a range of about 0.0 to 0.35% by weight after two weeks at ambient temperature because sealing a device to prevent loss or spillage is well known in the art and it is preferable to prevent weight loss of a compound that is intended to be delivered to a subject.
Regarding Claim 69, Le discloses a method of treating a condition in a subject in need thereof (¶[0006]), comprising the step of administering to the subject an amount of a compound, or a pharmaceutically acceptable salt or a pharmaceutical composition thereof, with an applicator of claim 1 (¶[0006] discloses precisely placing a compound to a subject with an applicator (rollerball assembly 100, Fig 1) for topical administration of an anticholinergic compound, or a pharmaceutically acceptable salt or composition thereof to a subject in need thereof (The rollerball assembly 100 contains essential oils ¶[0006], the ball is capable of rolling freely and transferring liquid from the inside of the bottle to the outside surface of the ball ¶[0005] Thus the rollerball assembly 100 is fully capable of containing and administering a different liquid or medication, including an anticholinergic compound, or a pharmaceutically acceptable salt or composition thereof.), the applicator (100, Fig 1) comprising: a. a bottle (200, Fig 1) comprising a neck containing bottle connector structure (threaded neck portion 210, Fig 1) at an upper portion thereof (210 is at the upper portion of 200, Fig 1), and a reservoir extending beneath the neck to hold the compound (bottle 200 comprises a cavity therein, which is fully capable of holding any liquid, and extends beneath the threaded neck portion 210, Fig 1); and b. a sleeve (base fitment 120 and ball 121, Fig 1) comprising an applicator member (ball 121, Fig 1), at a top portion of the sleeve (121 is disposed at the top portion of 120, Fig 1), for administering the compound (ball rolls freely and transfers liquid from the inside of the bottle to the outside surface of the ball ¶[0005]) , and sleeve connector structure (120 is configured to be mated with threaded neck portion 210 of bottle 200, Fig 1) to mate with the bottle connector structure (210, Fig 1) to provide communication between the bottle (200, Fig 1) and the applicator member (121, Fig 1) to enable administration of the compound (ball 121 transfers liquid from inside the bottle to the outside surface of the ball 121 ¶[0005]), wherein the bottle connector structure (threaded neck portion 210, Fig 1) and the sleeve connector structure (120 mates with the threaded neck portion 210, and thus comprises threads, Fig 1) comprise structure selected from the group consisting of respective screw threads (120 mates with the threaded neck portion 210, and thus both 120 and 210 comprise threads, Fig 1), respective snap fit structures, and respective press fit structures to mate the bottle (200, Fig 1) and the sleeve (120 and 121, Fig 1) when the bottle (200, Fig 1) is screwed into the sleeve (120 and 121, Fig 1).
Le is silent regarding the reservoir comprising translucent material near a bottom thereof to make visible an amount of the component present; a body containing the reservoir, the sleeve extending past the neck and along a majority of the length of the reservoir and allowing a portion of the reservoir to be visible beneath the body.
However, O’Sullivan teaches a dispenser with a reservoir, thus from the same field of endeavor, wherein the reservoir comprises translucent material near a bottom thereof to make visible an amount of the component present (Fig 8A, ¶[0022] cartridge 50 and/or outer container 40 may be transparent); wherein the reservoir (cartridge 50, Fig 8A) is contained within a body (reservoir 50 is contained within outer container 40, Fig 8A ¶[0088]), the sleeve extending past the neck and along a majority of the length of the reservoir (Fig 8A, outer container 40 extends past the dispensing nozzle 17 and along a majority of cartridge 50) and allowing a portion of the reservoir to be visible beneath the body (Fig 8A-B, a portion of cartridge 50 is visible beneath outer container 40) in order to hold the cartridge in place and prevent rotation of the cartridge (¶[0089][0096]) and so the user can see the composition within the reservoir to know how much is used and how much is left (¶[0111]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve of Le so that the reservoir is contained within a body of the sleeve, and wherein a portion of the reservoir is visible beneath the sleeve body, as taught by O’Sullivan in order to hold the cartridge in place and prevent rotation of the cartridge (as motivated by O’Sullivan ¶[0089][0096]) and so the user can see the composition within the reservoir to know how much is used and how much is left (as motivated by O’Sullivan ¶[0111]).
Claims 21-22, 28-29, 31, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Le (US 20170251785 A1) in view of O’Sullivan (US 20200254478 A1), and further in view of Crawford (US 10531721 B2).
Regarding Claims 21 and 22, Le/O’Sullivan is silent whether the bottle comprises a bottle cap that attaches to the bottle via the bottle connector structure, wherein removal of the bottle cap enables the sleeve connector structure to mate with the bottle connector structure to reduce leakage and/or evaporation, wherein the bottle cap attaches to the bottle via an attachment structure respectively in the bottle cap and the bottle connector structure, the attachment structure selected from the group consisting of respective screw threads, respective snap fit structures, and respective press fit structures.
However, Crawford teaches a deodorant dispenser with a refill cartridge, thus from the same field of endeavor, wherein the bottle (container 12, Fig 4) comprises a bottle cap (closure cap 14, Fig 4) that attaches to the bottle (12, Fig 4) via the bottle connector structure (screw threads 17, Fig 4), wherein removal of the bottle cap (14, Fig 4) enables the sleeve connector structure (body 22 of the applicator assembly 20, Fig 4) to mate with the bottle connector structure (the closure cap 14 is detached from the container 12 by rotating the closure cap 14 relative to the container 12 to disengage the cooperating respective screw threads 17 of the closure cap 14 and the container 12. Once the closure cap 14 has been removed, the chamber 16 and the fluid deodorant composition therein is fluidly connected with the exterior of the container 12. Next, the container 12 is detachably secured to the body 22 of the applicator assembly 20 by rotating the container 12 relative to the body 22 while mating the male screw thread 17 of the container 12 with the female screw thread (not shown) of the body 22. Fig 4-6 Col 9 ln 2-14) to reduce leakage and/or evaporation (the closure cap 14 prevents leakage and evaporation of the contents of container 12 prior to assembly, Fig 4), wherein the bottle cap (attaches to the bottle (12, Fig 4) via an attachment structure (The male screw thread 17 of the container 12 is also for cooperating with a female screw thread (not shown) of the closure cap 14 to detachably secure the closure cap 14 to the container 12, Fig 4 col 8 ln 60-63) respectively in the bottle cap (14, Fig 4) and the bottle connector structure (threads 17, Fig 4), the attachment structure selected from the group consisting of respective screw threads, respective snap fit structures, and respective press fit structures (screw threads 17, Fig 4) in order to preserve the contents of the container prior to use and to prevent unwanted dispensing or spillage of the contents (col 4 ln 46-48).
Therefore, it would have been obvious to modify the apparatus of Le/O’Sullivan so that the bottle comprises a bottle cap that attaches to the bottle via the bottle connector structure, wherein removal of the bottle cap enables the sleeve connector structure to mate with the bottle connector structure to reduce leakage and/or evaporation, wherein the bottle cap attaches to the bottle via an attachment structure respectively in the bottle cap and the bottle connector structure, the attachment structure selected from the group consisting of respective screw threads, respective snap fit structures, and respective press fit structures, as taught by Crawford, in order to preserve the contents of the container prior to use and to prevent unwanted dispensing or spillage of the contents (as motivated by Crawford col 4 ln 46-48).
Regarding Claim 28, Le further discloses that the sleeve (120 and 121, Fig 1) further comprises a sleeve cap connector structure (capture areas 126 of base fitment 120 mate with locking pins 115 of cap 110, Fig 1 ¶[0017])) at the top portion of the sleeve (120 and 121, Fig 1) below the roller (121, Fig 1), and a sleeve cap (cap 110, Fig 1) comprising a cap ring (110 includes a ring around its inner circumference at upper portion shown in Fig 3) extending downwardly from inside the sleeve cap (110, Fig 1) to contact the roller (121, Fig 1) and compress the roller (cap ring of 110 , the sleeve (120, Fig 1) further comprising a ring structure (retaining lip 123 secures the ball 121 in place within the sleeve 120. Retaining lip 123 creates a seal with compression gasket 111, Fig 1) which contacts the roller to urge the roller downwardly from the cap (110, Fig 1), so as to reduce leakage and/or evaporation (seal created by retaining lip 123 and compression gasket 111 prevents leakage and evaporation ¶[0017]).
Regarding Claim 29, Le further discloses a compressible structure (compression gasket 111, Fig 1 and 3) attached to the ring structure (Fig 3 shows compression gasket held in place by ring structure of cap 110), the compressible structure (111, Fig 1 and 3) compressing when contacting the roller (Fig 3 shows 111 pressed onto 121) to urge the roller (121, Fig 1) downwardly from the cap (110, Fig 1 and 3) so as to reduce leakage and/or evaporation (seal created by retaining lip 123 and compression gasket 111 prevents leakage and evaporation ¶[0017]).
Regarding Claim 31, Le further discloses that the sleeve cap (110, Fig 1) comprises a covering portion (textured portion of 110, Fig 1) extending downwardly from a top of the sleeve cap (110, Fig 1) to cover or compress the roller (121, Fig 1) to reduce leakage and/or evaporation (textured portion of 110 covers the sides of 120 as shown in Figs 2A and 3).
Regarding Claim 45, Le further discloses structure selected from the group consisting of respective screw threads, snap fit structures, and press fit structures in the sleeve cap (110 has locking pins 115 to mate with capture areas 126 of 120, Fig 2B) and the sleeve cap connector structure (120 has capture areas 126 to mate with locking pins 115 of cap 110, Fig 1 and 2B) to attach the sleeve cap (110, Fig 1) to the sleeve (120 and 121, Fig 1).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Le (US 20170251785 A1) in view of O’Sullivan (US 20200254478 A1), further in view of Crawford (US 10531721 B2), and further in view of Tapocik (US 20180228269 A1).
Regarding Claim 46, Le discloses that the sleeve cap (110, Fig 1) is attached to the sleeve (120 and 121, Fig 1),
Le/O’Sullivan/Crawford is silent whether the respective screw threads in the sleeve cap or the bottle cap engages respectively with the sleeve or bottle sufficiently tightly to constitute a child resistant structure.
However, Tapocik teaches a personal use dispensing container with a roller applicator, thus from the same field of endeavor, wherein the respective screw threads (central collar 20-IC comprises threads 20-TIC to mate with threads 315T of the container, Fig 1) in the sleeve cap or the bottle cap (cap 20, Fig 1) engages respectively with the sleeve or bottle (container 300, Fig 1) sufficiently tightly to constitute a child resistant structure (cap 20 comprises a child resistant locking assembly between the cap and container [abstract]) to prevent a child from removing the cap and gaining access to a harmful material within the container (¶[0010]).
Therefore, it would have been obvious to modify the apparatus of Le/O’Sullivan/Crawford so that the respective screw threads in the sleeve cap or the bottle cap engages respectively with the sleeve or bottle sufficiently tightly to constitute a child resistant structure, as taught by Tapocik, to prevent a child from removing the cap and gaining access to a harmful material within the container (as motivated by Tapocik ¶[0010]).
Claims 43, 55-58, 65-67, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Le (US 20170251785 A1) in view of O’Sullivan (US 20200254478 A1), and further in view of Brinkman (US 20210178135 A1).
Regarding Claim 43, Le/O’Sullivan is silent whether the compound comprises at least 48% ethanol.
However, Brinkman teaches an applicator and pharmaceutical compound for personal use, thus from the same field of endeavor, wherein the compound comprises at least 48% ethanol (ethanol concentration is preferably 50% or more ¶[0125]).
Therefore, it would have been obvious to simply substitute the fluid medicament of Le/O’Sullivan/Bhandari for the anticholinergic compound of Brinkman. The dispenser of Le is fully capable of containing and dispensing a liquid medicament, and one of ordinary skill in the art would find it obvious to simply substitute the liquid medicament of Le with the specific anticholinergic compound having a 50% or more ethanol concentration as taught by Brinkman.
Regarding Claims 55-57, Le/O’Sullivan is silent whether the anticholinergic compound is a compound of Formula (I):wherein: R1 and R2 are each, independently in each instance, selected from alkyl and alkyl substituted with alkoxycarbonyl; X- is an anion; or a pharmaceutically acceptable salt or solvate thereof, wherein the stereochemical configuration about the carbon atom is a racemic threo mixture of 2/3' R/S and 2/3' S/R, wherein the stereochemical configuration about the carbon atom indicated by 2 is R and the stereochemical configuration about carbon atom indicated by 3' is R.
However, Brinkman teaches that the anticholinergic compound is a compound of Formula (I) (Formula shown in ¶[0117]):wherein: R1 and R2 are each, independently in each instance, selected from alkyl and alkyl substituted with alkoxycarbonyl (formula shown in ¶[0117] contains an alkyl and an alkoxycarbonyl group located at the same positioned as the claimed compound); X- is an anion (Formula shown in ¶[0117] shows a bromide anion); or a pharmaceutically acceptable salt or solvate thereof, wherein the stereochemical configuration about the carbon atom is a racemic threo mixture of 2/3' R/S and 2/3' S/R (¶[0117]), wherein the stereochemical configuration about the carbon atom indicated by 2 is R and the stereochemical configuration about carbon atom indicated by 3' is R (¶[0117]).
Therefore, it would have been obvious to simply substitute the fluid medicament of Le/O’Sullivan for the anticholinergic composition of Brinkman. The dispenser of Le is fully capable of containing and dispensing a liquid medicament, and one of ordinary skill in the art would find it obvious to simply substitute the liquid medicament of Le with the specific anticholinergic composition containing a compound of Formula (I):wherein: R1 and R2 are each, independently in each instance, selected from alkyl and alkyl substituted with alkoxycarbonyl; X- is an anion; or a pharmaceutically acceptable salt or solvate thereof, wherein the stereochemical configuration about the carbon atom is a racemic threo mixture of 2/3' R/S and 2/3' S/R, wherein the stereochemical configuration about the carbon atom indicated by 2 is R and the stereochemical configuration about carbon atom indicated by 3' is R as taught by Brinkman.
Regarding Claim 58, Le/O’Sullivan is silent whether the anticholinergic compound is a compound selected from the group consisting of a glycopyrronium compound, threo glycopyrronium bromide, threo glycopyrronium tosylate, threo glycopyrronium tosylate monohydrate, a sofpironium compound, sofpironium bromide, propantheline, oxybutynin, methantheline, and benztropine.
However, Brinkman teaches that the anticholinergic compound is a compound selected from the group consisting of a glycopyrronium compound, threo glycopyrronium bromide, threo glycopyrronium tosylate, threo glycopyrronium tosylate monohydrate, a sofpironium compound, sofpironium bromide, propantheline, oxybutynin, methantheline, and benztropine (formula shown in ¶[0117] is sofpironium bromide).
Therefore, it would have been obvious to simply substitute the fluid medicament of Le/O’Sullivan for the anticholinergic composition of Brinkman. The dispenser of Le is fully capable of containing and dispensing a liquid medicament, and one of ordinary skill in the art would find it obvious to simply substitute the liquid medicament of Le with the specific anticholinergic composition containing a sofpironium bromide as taught by Brinkman.
Regarding Claims 65 and 66, Le/O’Sullivan is silent whether the anticholinergic compound includes a pharmaceutically acceptable carrier, excipient, or diluent and is formulated as a topical composition.
However, Brinkman teaches that the anticholinergic compound (formula shown in ¶[0117]) includes a pharmaceutically acceptable carrier, excipient, or diluent and is formulated as a topical composition (the formula shown in ¶[0117] is a topical pharmaceutically acceptable preparation ¶[0116-0117]).
Therefore, it would have been obvious to simply substitute the fluid medicament of Le/O’Sullivan for the anticholinergic composition of Brinkman. The dispenser of Le is fully capable of containing and dispensing a liquid medicament, and one of ordinary skill in the art would find it obvious to simply substitute the liquid medicament of Le with the specific anticholinergic compound including a pharmaceutically acceptable carrier, excipient, or diluent and which is formulated as a pharmaceutically acceptable topical composition as taught by Brinkman.
Regarding Claim 67, Le/O’Sullivan is silent whether a dose of the compound is from about 0.1 to about 0.8 mg.
However, Brinkman teaches that a dose of the compound is from about 0.1 to about 0.8 mg (dose can be in the range of 0.01 mL to 3.0 mL of a 0-15 w/w% preparation of sofpironium bromide. A dose of 0.01 mL with a concentration of 7% sofpironium bromide would contain a 0.7 mg dose of sofpironium bromide ¶[0126][0132]).
Therefore, it would have been obvious to simply substitute the fluid medicament of Le/O’Sullivan/Bhandari for the anticholinergic composition of Brinkman. The dispenser of Le is fully capable of containing and dispensing a liquid medicament, and one of ordinary skill in the art would find it obvious to simply substitute the liquid medicament of Le with the specific anticholinergic composition having a dose from about 0.1 to about 0.8 mg as taught by Brinkman.
Regarding Claim 71, Le/O’Sullivan is silent whether the subject is a mammal and the condition is selected from the group consisting of hyperhidrosis and axillary hyperhidrosis.
However, Brinkman teaches that the subject is a mammal (patient is a human ¶[0002]) and the condition is selected from the group consisting of hyperhidrosis and axillary hyperhidrosis (the condition being treated is hyperhidrosis ¶[0024]) to promote efficient application and transfer of the pharmaceutical preparation to an axilla of a human to treat or ameliorate excessive sweating, (¶[0024]) thereby improving the comfort of the patient.
Therefore, it would have been obvious to modify the method of Le/O’Sullivan/Bhandari so that the subject is a mammal and the condition is selected from the group consisting of hyperhidrosis and axillary hyperhidrosis, as taught by Brinkman to promote efficient application and transfer of the pharmaceutical preparation to an axilla of a human to treat or ameliorate excessive sweating, (as motivated by Brinkman ¶[0024]) thereby improving the comfort of the patient.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Le (US 20170251785 A1) in view of O’Sullivan (US 20200254478 A1), and further in view of Hofland (WO 2021113260 A1).
Regarding Claim 64, Le/O’Sullivan is silent whether the anticholinergic compound is a compound selected from the group consisting of: II III IV V or VI.
However, Hofland teaches compounds for treating hyperhidrosis, thus from the same field of endeavor, wherein the anticholinergic compound is a compound selected from the group consisting of:II III IV V or VI (¶[0065] shows formulas (Ij) and (Ik) which correspond to compounds II and V of the claimed invention).
Therefore, it would have been obvious to simply substitute the fluid medicament of Le/O’Sullivan for the anticholinergic composition of Hofland. The dispenser of Le is fully capable of containing and dispensing a liquid medicament, and one of ordinary skill in the art would find it obvious to simply substitute the liquid medicament of Le with the specific anticholinergic compound selected from the group consisting of: II III IV V or VI as taught by Hofland.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY LEE FLYNN whose telephone number is (571)272-8255. The examiner can normally be reached Monday-Friday 7:30-5 ET.
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/TIMOTHY L FLYNN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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