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, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/09/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 66-67,72,74,76,79-80,84,90 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner thank applicant for the affidavit, and in view of the affidavit recognizes that the applicant is owned by Brickell in, where Brickell was the subject of NPL used to read to the sofpironium bromide limitation. As there is the disclose of Brickell would have been obtained from the same inventor and/or the disclosure is commonly owned, and the NPL falls within the grace period, the previous NPL prior art is no longer applicable. The examiner notes that a new prior art reference is used to teach the limitation of sofpironium bromide, as detailed under the updated rejection of claim 66 below. As such arguments directed to the previous prior art and sofpironium bromide are moot.
Further, applicant argues that the height of .1 to 1.5mm does provide a specific function in that the dimensions allow for providing a specific dose range by holding a specific amount of dosage, and thus the design choice is not applicable. The examiner agrees. The examiner however, disagrees that “the Dandiker reference is not suitable for accurately or completely delivering sofpironium bromide with minimal spillage and minimal residual drug remaining.” Applicant argues that as the applicator of Dandiker is flexible and has “controlled adaptation zones”, one would have to modify Dandiker to reduce the height of the ridge, make it a smaller percent of the face, make it rigid, and without any controlled adaptation zone. The examiner notes that in view of Wilson US 2014/0216490 (Detailed further below), one having ordinary skill in the art would have found it obvious to modify the height of the ridge of Dandiker to be within the claimed dimension. Further, Dandiker does not disclose solely a flexible wall. Rather, side wall (114) of the applicator can be constructed of a rigid or flexible material (para. 0028). Thus the wall of Dandiker would be, or at least would be obvious to make out of a rigid material. Further, the controlled-adaptation zone of Dandiker is not an inherent feature required by the device. Rather “some embodiments…can include…at least one controlled-adaptation zone” (para. 0029). Said zone is designated as reference 118. Figures 1B,1C,2A, all depict applicators without said reference number 118. Further the examiner notes that the percentage of the face occupying the combined space of the ridge and face was found obvious in the previous rejection in view of MPEP section 2144.04 IV A. Said rejection is upheld. Thus applicant’s arguments regarding the percentage of the face, the flexibility, and the adaptation zone of Dandiker are found to be non-persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 66-67,72, 74, 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dandiker in view of Katzman, Bayly, and Opel, and further in view of Koleng US 2015/0259283 and Wilson et al. US 2014/0216490, hereafter Koleng and Wilson, respectively.
Regarding claim 66, Dandiker teaches, an applicator in the form of a cap (composition holder (100), and hold portion (126); may be integral [0011]) for applying a pharmaceutical preparation, to a skin surface of a patient (para. 0029) said applicator comprising:
one or more substantially rigid side walls ((100) and (126) may be integrally formed [0011] and (100) may be rigid [0028]) which is open at a bottom end and closed at a top end by a top wall (at least (108) when (100) is made integrally with (126)) substantially perpendicular to said one or more substantially rigid side walls to form a cap which fits over and encloses a top portion of a container or dispenser for the pharmaceutical preparation (Fig. 1A),
the substantially rigid side walls (para. 0028) being configured to detachably and matingly engage with the a-top portion of the container or dispenser [0024],
said closed top end of the applicator in the form of a cap having an outer surface comprising a central flat, rigid, and continuous face which is solid and non-porous such that liquid cannot pass through said central flat, rigid, and continuous face (Figs. 1C-1D; (108)),
the central flat, rigid, and continuous face being useful for receiving one or more doses of the pharmaceutical preparation dispensed thereon from the container or dispenser [0025], and
a rigid [0028] peripheral ridge (114) extending up from the outer surface of said closed top end (figure 1C, where closed top end is formed by central flat face (108) as detailed in the same rejection), the rigid peripheral edge bounding the central flat, rigid, and continuous face (1c, where flat face is (108)) and forming a reservoir area (104) for retaining the pharmaceutical preparation within said reservoir area when the pharmaceutical preparation is dispensed thereon from the container or dispenser [0025],
wherein the one or more substantially rigid side walls comprise indentations to facilitate gripping and handling or attaching or detaching the applicator in the form of a cap (Figs. 3A-3H).
Additionally, per the claim amendments form 01/23/2025, as seen in figure 1D of Dandiker, the top edge (best indicated by reference number 116), it can be seen that the ridge is rounded. See also figure 3I/J and 8A.
As detailed above under the same rejection of claim 66, Dandiker discloses that the device is applicable to the skin of a user, namely the armpit of a user (para. 0029). Dandiker however further fails to specifically disclose that the composition comprises an active agent for treating excessive sweating or hyperhidrosis.
Bayly teaches providing a container (18) having a contents comprising a pharmaceutical preparation effective for treating or ameliorating excessive sweating or hyperhidrosis (a container 18 is provided having the liquid composition, wherein the liquid composition comprises an antiperspirant agent to reduce or inhibit the production of sweat and is applied to the armpit; abstract; figure 8; paragraphs [0031), [0161]). Bayly further teaches wherein a preparation comprises an active pharmaceutical ingredient useful to treat or ameliorate excessive sweating or hyperhidrosis (the composition comprises an antiperspirant agent that reduces or inhibits the production of sweat, and so is capable of treating or ameliorating excessive sweating or hyperhidrosis; paragraph [0161]). Therefore as Dandiker teaches an applicator for an armpit for treating a patient and Bayly teaches an applicator for use in the armpit of a user for treating excess sweating, it would have been obvious to provide the pharmaceutical agent and method of using such pharmaceutical to treat sweating as suggested by Bayly using the device of Dandiker in order to prevent excessive sweating. One of ordinary skill would have had a reasonable expectation that the combined method as suggested would provide a device and method for properly treating hyperhidrosis.
While Dandiker discloses that the applicator is configured to releasably and sealingly couple to a composition holder (See claim 14, 15,17, where said seal is fluid tight (para. 0039)), said seal is not specifically an airtight seal. The examiner notes that while fluid-tight may be interpreted to be air-tight as air is a fluid, and the seal is configured to prevent said fluid from leaking from the device, the examiner provides Katzman, as previously applied to teach the air-tight limitation.
Katzman teaches an applicator and is therefore considered analogous to the claimed invention. Katzman further teaches wherein the substantially rigid side walls (cap (28) figure 4,5) comprise a ridge or protrusion formed thereon (annular groove (32)) matingly engage the top portion of the container or the dispenser to form a substantially airtight seal (Column 2, lines 54-61, see figure 5)). Therefore, it would have been obvious to make the simple substitution of known elements to include the seal of Katzman in the device of Dandiker in order to prevent leakage.
The examiner notes that with regard to the limitation of the pharmaceutical preparation has a moderate viscosity, Dandiker discloses this information as per paragraph 0007, Dandiker discloses that various forms of compositions are used including fluids, solutions, lotion, cream, foam and gel, it is interpreted that Dandiker is capable of holding medium-viscous substances. Should applicant disagree, Opel evidences that topical liquids may have a viscosity of at least 300 centipoise at 25 degrees Celsius, and as it would therefore be obvious to one of ordinary skill in the art to use a liquid with Dandiker with said viscosity as, the substances of Dandiker would be capable of being at least 300 centipoise and therefore considered moderately viscous. Therefore the prior art range is within the claimed range of 300-2000 centipoise at 25 degrees Celsius.
With regard to the amendments filed 08/08/2025, claim 66 now requires the continuous face being useful for receiving .1mL to 1.5mL of preparation. While the examiner notes that as previously disclosed, Dandiker teaches a dose being contained within, where “being useful for receiving” is interpreted to be functional language, in an effort to achieve compact prosecution, the examiner points of Bayley, found obvious to combine. Per Bayley, a dose of the preparation ranges from 150µg to 300µg, which converted to mL is approximately .15-.3 mL. Therefore the dose used within the combination of Dandiker and Bayley is within the claimed range and thus reads to the claimed limitation.
The amendments filed 08/08/2025 also require “the central flat, rigid, continuous face occupies 60% or more of the area of the combined area of the central flat, rigid, and continuous face and the rigid peripheral ridge, wherein the width of the top edge of the rigid peripheral ridge is twice or more of the difference in height between an uppermost portion of the ridged peripheral ridge and the central flat, rigid, and continuous face.
Regarding the limitation of the face occupying 60% or more of the surface area, Dandiker teaches the face occupying at least a percentage of the surface area but fails to specifically teach 60% of the surface area is occupied. However, Dandiker discloses variation configurations where the face takes up different percentages of the surface area (see figure 1d-2g). Further, per MPEP section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that in the response the arguments Dandiker and the prior art perform the same function. Further, per para. 0087 of the instant specification, the limitation require 60% lacks criticality in that the “flat portion occupies 5% or more of the whole area” where “…more preferable…flat portion occupies 60% or more of the whole area”. Therefore based on the specification the device is capable of functioning with 5% of the surface area made up of the flat face, therefore lacking criticality to the claimed 60% or more. As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dandiker to cover at least 60% of the surface are of the therapeutic surface as an obviousness change is size rationale.
Regarding the limitation of the width of the top edge of the ridge being twice or more the difference in height between an uppermost portion of the ridge and the central face, examiner interprets the drawings of Dandiker to teach this limitation. As seen in figure 1C the width across the device is greater than the height between the edge and face. However, there is no clear disclose that the width is twice the height. Further, per MPEP section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that in the response the arguments Dandiker and the prior art perform the same function, and Dandiker, per the same rejection clearly depicts the width being greater than the height. As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dandiker to have the width across the ridge at least twice the height between the ridge and flat face as an obviousness change is size rationale, absent persuasive that Dandiker would not function properly if the difference in size between the width of the ridge and height between the ridge and face (seen in the figures to be some degree larger) is modified to be at least two times larger.
Dandiker further fails to teach wherein the difference in height between an uppermost portion of the rigid peripheral ridge and the central flat, rigid and continuous face ranges from 0.1 mm to 1.5 mm.
Wilson teaches an applicator device and is thus considered analogous to the claimed invention. Wilson teaches that the applicator may comprise various sizes, so long as it remains compact and suitable for use by typical human fingers, while still being large enough to facilitate easy application (para. 0037). Wilson teaches that various sizes, with specific note to the thickness, may be .5 to 5mm (para. 0039). The thickness is understood to be the height of the device of Wilson. Wilson also teaches that the composition applied may include viscous compositions (para. 0063). The examiner notes that therefore, as Wilson teaches that an applicator may have a suitable height of .5 to 5mm while still maintaining a composition for application, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a height within said range as the height of the device of Dandiker. See MPEP 2144.04 IV A. The examiner notes that therefore, choosing a height within said range (for example 1mm) would thus require the difference in height between the face and ridge to be within the claimed range as the difference must be at least less than 1mm (since this is the overall height of the applicator). Said combination would still allow the device to function as intended, where the applicator holds a composition and interfaces with the skin to apply said composition, and thus in view of Wilson and MPEP 2144.04 IV A, a prima facie case of obviousness exists.
With regard to the amendments filed 03/09/2026, the examiner notes that the limitation of the air-tight seal is detailed above under the same rejection, in view of Katzman. Further, applicant amended to specifically require sofpironium bromide as the active agent being dispensed. Although, as detailed above, Dandiker does teach various compositions being able to be applied by the device, including “solution, liquid, fluid, free-flowing fluid, gel, cream, foam, or viscous solution form” (para. 0007), sofpironium bromide is not specifically disclosed.
Koleng teaches a topical formation and is thus considered analogous to the claimed invention. Koleng teaches that the topical treatment disclosed is to be used for hyperhidrosis (para. 0008), where said compound can be seen in the first image on page 1. Koleng further teaches that compounds in use for the invention may include variations where one such variation is 3'(R)-[2(R)-cyclopentylphenylhydroxyacetoxy]-1'-methyl-1'-ethoxycarbonylm- ethyl-pyrrolidinium bromide per para. 0064. Upon review of the instant specification (para. 0054), this compound is sofpironium bromide. Per paragraph 0012 of Koleng the compound taught may be formulated as a “solid or semi-solid, powder, gel, cream, lotion, foam, solution, suspension, aerosol, patch, wipes or emulsion, or the like”. Therefore, as Dandiker teaches a topical treatment (including fluids, gels, foams, and more), and Koleng teaches that gel cream, foam, or more, of sofpironium bromide is a known topical composition, it would have been obvious to one having ordinary skill in the art to use sofpironium (in a gel or otherwise form) as the composition applied by Dandiker, as Dandiker is disclosed to apply topical gels.
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Regarding claim 67, Dandiker, Katzman, Bayly, Koleng, Opel, and Wilson teach the device of claim 66, where Katzman further teaches wherein the ridges or protrusions on the inner surface (ridge formed by groove (32) on the inner surface of the cap) matingly engage with the top portion of the container (Fig. 4, column 2, lines 50-55) to detachably affix to the top portion of the dispensing tube 12 via a flexible restraining strap 20, figures 1-4; column 2, lines 54-56). Therefore, it would have been obvious to modify the device of Dandiker, Katzman and Bayly to include the flexible engagement to detachably affix the cap to the container in order to allow for secure fitment and repeat usage.
Regarding claim 72, Dandiker, Katzman, Bayly, Koleng, Opel, and Wilson teach the applicator of claim 66, where Dandiker further discloses the applicator comprising an overcap (10) which engages with the cap and covers at least the central flat surface of the applicator.
Regarding claim 74, Dandiker discloses a method for applying a liquid composition to the skin surface of a subject [0007], wherein the composition comprises a medication said method comprising the steps of:
providing a container (200) having a contents comprising a pharmaceutical preparation, and a dispenser (pump head (202)) engaged with said container for dispensing the pharmaceutical preparation from said container, said container including a detachable applicator ((100) and (126)) fitting over a top portion of said container and dispenser fitting over the top portion of the container and dispenser, (See Fig. 1A), said applicator in the form of a cap comprising
one or more substantially rigid side walls ((100) and (126) may be integrally formed [0011] and (100) may be rigid [0028]) bounding a cavity which is open at a bottom end and closed at a top end by a top wall (at least (108) when (100) is made integrally with (126)) perpendicular to said one or more substantially rigid side walls (See Fig. 1A and annotated Figures) to form a cap which fits over and encloses a top portion of a container or dispenser for the pharmaceutical preparation (Fig. 1A), the substantially rigid side walls being configured to detachably and matingly engage with the top portion of the container or dispenser [0024],
said closed top end of the applicator in the form of a cap having an outer surface comprising a central flat, rigid and continuous face (108); which is solid and non-porous such that liquid cannot pass through said central flat, rigid and continuous face [0031], the central flat, rigid and continuous flat outer face being useful for receiving one or more doses of the pharmaceutical preparation dispensed thereon from the pharmaceutical preparation container or dispenser, a rigid [0028] peripheral ridge (114) extending up from the outer surface of said closed top end (figure 1C, where closed top end is formed by central flat face (108) as detailed in the same rejection), the rigid peripheral edge bounding the central flat, rigid, and continuous face (1c, where flat face is (108)) and forming a reservoir area (104) for retaining the pharmaceutical preparation within said reservoir area when the pharmaceutical preparation is dispensed thereon from the container or dispenser [0025]. Additionally, per the claim amendments form 01/23/2025, as seen in figure 1D of Dandiker, the top edge (best indicated by reference number 116), it can be seen that the ridge is rounded. See also figure 3I/J and 8A.
wherein the one or more substantially rigid side walls comprise indentations to facilitate gripping and handling or attaching or detaching the applicator in the form of a cap (Figs. 3A-3H, unlabeled. See annotated figure.)
b) removing the cap from the [0025] and, if present, removing the overcap (10) from the applicator (not given patentable weight due to optional language);
c) dispensing one or more doses of the pharmaceutical preparation into the reservoir area on the outer flat face of the applicator [0024-0025]
d) applying the dispensed dose or doses onto the skin surface of the patient [0025].
Dandiker further teaches that the composition may be provided to the armpit [0029] but fails to teach that the method is treating or ameliorating sweating, or the pharmaceutical preparation as claimed. Bayly teaches a method for treating or ameliorating excessive sweating or hyperhidrosis in a patient in need thereof (a method of applying a liquid composition to the skin surface of a subject [0007], wherein the composition comprises a medication an antiperspirant agent to reduce or inhibit the production of sweat; abstract; paragraph [01611), said method comprising the steps of:
providing a container (18) having a contents comprising a pharmaceutical preparation effective for treating or ameliorating excessive sweating or hyperhidrosis (a container 18 is provided having the liquid composition, wherein the liquid composition comprises an antiperspirant agent to reduce or inhibit the production of sweat; abstract; figure 8; paragraphs [0031), [01611),
Therefor it would have been obvious to provide the pharmaceutical agent and method of using such pharmaceutical to treat sweating as suggested by Bayly using the device of Dandiker in order to prevent excessive sweating. One of ordinary skill would have had a reasonable expectation that the combined method as suggested would provide a device and method for properly treating hyperhidrosis found it obvious to combine the methods of Dandiker and Bayly.
While Dandiker discloses that the applicator is rigid (para. 0028) and is configured to releasably and sealingly couple to a composition holder (See claim 14, 15,17, where said seal is fluid tight (para. 0039)), said seal is not specifically an airtight seal. The examiner notes that while fluid-tight may be interpreted to be air-tight as air is a fluid, and the seal is configured to prevent said fluid from leaking from the device, the examiner provides Katzman, as previously applied to teach the air-tight limitation.
Katzman teaches an applicator and is therefore considered analogous to the claimed invention. Katzman further teaches wherein the substantially rigid side walls (cap (28) figure 4,5) comprise a ridge or protrusion formed thereon (annular groove (32)) matingly engage the top portion of the container or the dispenser to form a substantially airtight seal (Column 2, lines 54-61, see figure 5)). Therefore, it would have been obvious to make the simple substitution of known elements to include the seal of Katzman in the device of Dandiker in order to prevent leakage.
The examiner notes that with regard to the limitation of the pharmaceutical preparation has a moderate viscosity, Dandiker discloses this information as per paragraph 0007, Dandiker discloses that various forms of compositions are used including fluids, solutions, lotion, cream, foam and gel, it is interpreted that Dandiker is capable of holding medium-viscous substances. Should applicant disagree, Opel evidences that topical liquids may have a viscosity of at least 300 centipoise at 25 degrees Celsius, and as it would therefore be obvious to one of ordinary skill in the art to use a liquid with Dandiker with said viscosity as, the substances of Dandiker would be capable of being at least 300 centipoise and therefore considered moderately viscous. Therefore the prior art range is within the claimed range of 300-2000 centipoise at 25 degrees Celsius.
With regard to the amendments filed 08/08/2025, claim 66 now requires the continuous face being useful for receiving .1mL to 1.5mL of preparation. While the examiner notes that as previously disclosed, Dandiker teaches a dose being contained within, where “being useful for receiving” is interpreted to be functional language, in an effort to achieve compact prosecution, the examiner points of Bayley, found obvious to combine. Per Bayley, a dose of the preparation ranges from 150µg to 300µg, which converted to mL is approximately .15-.3 mL. Therefore the dose used within the combination of Dandiker and Bayley is within the claimed range and thus reads to the claimed limitation.
The amendments filed 08/08/2025 also require “the central flat, rigid, continuous face occupies 60% or more of the area of the combined area of the central flat, rigid, and continuous face and the rigid peripheral ridge, wherein the width of the top edge of the rigid peripheral ridge is twice or more of the difference in height between an uppermost portion of the ridged peripheral ridge and the central flat, rigid, and continuous face.
Regarding the limitation of the face occupying 60% or more of the surface area, Dandiker teaches the face occupying at least a percentage of the surface area but fails to specifically teach 60% of the surface area is occupied. However, Dandiker discloses variation configurations where the face takes up different percentages of the surface area (see figure 1d-2g). Further, per MPEP section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that in the response the arguments Dandiker and the prior art perform the same function. Further, per para. 0087 of the instant specification, the limitation require 60% lacks criticality in that the “flat portion occupies 5% or more of the whole area” where “…more preferable…flat portion occupies 60% or more of the whole area”. Therefore based on the specification the device is capable of functioning with 5% of the surface area made up of the flat face, therefore lacking criticality to the claimed 60% or more. As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dandiker to cover at least 60% of the surface are of the therapeutic surface as an obviousness change is size rationale.
Regarding the limitation of the width of the top edge of the ridge being twice or more the difference in height between an uppermost portion of the ridge and the central face, examiner interprets the drawings of Dandiker to teach this limitation. As seen in figure 1C the width across the device is greater than the height between the edge and face. However, there is no clear disclose that the width is twice the height. Further, per MPEP section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that in the response the arguments Dandiker and the prior art perform the same function, and Dandiker, per the same rejection clearly depicts the width being greater than the height. As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dandiker to have the width across the ridge at least twice the height between the ridge and flat face as an obviousness change is size rationale, absent persuasive that Dandiker would not function properly if the difference in size between the width of the ridge and height between the ridge and face (seen in the figures to be some degree larger) is modified to be at least two times larger.
Dandiker further fails to teach wherein the difference in height between an uppermost portion of the rigid peripheral ridge and the central flat, rigid and continuous face ranges from 0.1 mm to 1.5 mm.
Wilson teaches an applicator device and is thus considered analogous to the claimed invention. Wilson teaches that the applicator may comprise various sizes, so long as it remains compact and suitable for use by typical human fingers, while still being large enough to facilitate easy application (para. 0037). Wilson teaches that various sizes, with specific note to the thickness, may be .5 to 5mm (para. 0039). The thickness is understood to be the height of the device of Wilson. Wilson also teaches that the composition applied may include viscous compositions (para. 0063). The examiner notes that therefore, as Wilson teaches that an applicator may have a suitable height of .5 to 5mm while still maintaining a composition for application, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a height within said range as the height of the device of Dandiker. See MPEP 2144.04 IV A. The examiner notes that therefore, choosing a height within said range (for example 1mm) would thus require the difference in height between the face and ridge to be within the claimed range as the difference must be at least less than 1mm (since this is the overall height of the applicator). Said combination would still allow the device to function as intended, where the applicator holds a composition and interfaces with the skin to apply said composition, and thus in view of Wilson and MPEP 2144.04 IV A, a prima facie case of obviousness exists.
With regard to the amendments filed 03/09/2026, the examiner notes that the limitation of the air-tight seal is detailed above under the same rejection, in view of Katzman. Further, applicant amended to specifically require sofpironium bromide as the active agent being dispensed. Although, as detailed above, Dandiker does teach various compositions being able to be applied by the device, including “solution, liquid, fluid, free-flowing fluid, gel, cream, foam, or viscous solution form” (para. 0007), sofpironium bromide is not specifically disclosed.
Koleng teaches a topical formation and is thus considered analogous to the claimed invention. Koleng teaches that the topical treatment disclosed is to be used for hyperhidrosis (para. 0008), where said compound can be seen in the first image on page 1. Koleng further teaches that compounds in use for the invention may include variations where one such variation is 3'(R)-[2(R)-cyclopentylphenylhydroxyacetoxy]-1'-methyl-1'-ethoxycarbonylm- ethyl-pyrrolidinium bromide per para. 0064. Upon review of the instant specification (para. 0054), this compound is sofpironium bromide. Per paragraph 0012 of Koleng the compound taught may be formulated as a “solid or semi-solid, powder, gel, cream, lotion, foam, solution, suspension, aerosol, patch, wipes or emulsion, or the like”. Therefore, as Dandiker teaches a topical treatment (including fluids, gels, foams, and more), and Koleng teaches that gel cream, foam, or more, of sofpironium bromide is a known topical composition, it would have been obvious to one having ordinary skill in the art to use sofpironium (in a gel or otherwise form) as the composition applied by Dandiker, as Dandiker is disclosed to apply topical gels.
Regarding claim 80, Dandiker discloses a system for applying a pharmaceutically acceptable preparation to a skin surface of a patient in need thereof [0007], said system comprising
a container for housing and storing a plurality of doses of the pharmaceutical preparation (200), the container having an opening at a top end for receiving and engaging a dispenser for dispensing a metered dose of the pharmaceutical preparation (the container stores a volume of the liquid and comprises a dispensing means at the top of the container, and thus inherently comprises an opening at a top end for receiving and engaging the dispensing means (unlabeled), and
an applicator ((100) and (126)) in the form of a cap covering the dispenser and detachably engaging the top portion of the container or a portion of the dispenser [0024] covers the dispenser and detachably connects to the container (See Figs. 1A) said cap comprising
one or more substantially rigid side walls (114) ((100) and (126) may be integrally formed [0011] and (100) may be rigid [0028]) bounding a cavity which is open at a bottom end and closed at a top end by a top wall (at least (108) when (100) is made integrally with (126)) perpendicular to said one or more substantially rigid side walls (See Fig. 1A and annotated Figures) to form a cap which fits over and encloses a top portion of a container or dispenser for the pharmaceutical preparation (Fig. 1A), the substantially rigid side walls being configured to detachably and matingly engage with the top portion of the container or dispenser [0024],
said closed top end of the applicator in the form of a cap having an outer surface comprising a central flat, rigid and continuous face (108); which is solid and non-porous such that liquid cannot pass through said central flat, rigid and continuous face [0031], the central flat, rigid and continuous flat outer face being useful for receiving one or more doses of the pharmaceutical preparation dispensed thereon from the pharmaceutical preparation container or dispenser, a rigid [0028] peripheral ridge (114) extending up from the outer surface of said closed top end (figure 1C, where closed top end is formed by central flat face (108) as detailed in the same rejection), the rigid peripheral edge bounding the central flat, rigid, and continuous face (1c, where flat face is (108)) and forming a reservoir area (104) for retaining the pharmaceutical preparation within said reservoir area when the pharmaceutical preparation is dispensed thereon from the container or dispenser [0025]. Additionally, per the claim amendments form 01/23/2025, as seen in figure 1D of Dandiker, the top edge (best indicated by reference number 116), it can be seen that the ridge is rounded. See also figure 3I/J and 8A.
wherein the one or more substantially rigid side walls comprise indentations to facilitate gripping and handling or attaching or detaching the applicator in the form of a cap (Figs. 3A-3H, unlabeled. See annotated figure.)
As detailed above under the same rejection of claim 80, Dandiker discloses that the device is applicable to the skin of a user, namely the armpit of a user (para. 0029). Dandiker however further fails to specifically disclose that the composition comprises an active agent for treating excessive sweating or hyperhidrosis.
Bayly teaches providing a container (18) having a contents comprising a pharmaceutical preparation effective for treating or ameliorating excessive sweating or hyperhidrosis (a container 18 is provided having the liquid composition, wherein the liquid composition comprises an antiperspirant agent to reduce or inhibit the production of sweat and is applied to the armpit; abstract; figure 8; paragraphs [0031), [01611). Bayly further teaches wherein a preparation comprises an active pharmaceutical ingredient useful to treat or ameliorate excessive sweating or hyperhidrosis (the composition comprises an antiperspirant agent that reduces or inhibits the production of sweat, and so is capable of treating or ameliorating excessive sweating or hyperhidrosis; paragraph [0161]). Therefore as Dandiker teaches an applicator for an armpit for treating a patient and Bayly teaches an applicator for use in the armpit of a user for treating excess sweating, it would have been obvious to provide the pharmaceutical agent and method of using such pharmaceutical to treat sweating as suggested by Bayly using the device of Dandiker in order to prevent excessive sweating. One of ordinary skill would have had a reasonable expectation that the combined method as suggested would provide a device and method for properly treating hyperhidrosis.
While Dandiker discloses that the applicator is rigid (para. 0028) and is configured to releasably and sealingly couple to a composition holder (See claim 14, 15,17, where said seal is fluid tight (para. 0039)), said seal is not specifically an airtight seal. The examiner notes that while fluid-tight may be interpreted to be air-tight as air is a fluid, and the seal is configured to prevent said fluid from leaking from the device, the examiner provides Katzman, as previously applied to teach the air-tight limitation.
Katzman teaches an applicator and is therefore considered analogous to the claimed invention. Katzman further teaches wherein the substantially rigid side walls (cap (28) figure 4,5) comprise a ridge or protrusion formed thereon (annular groove (32)) matingly engage the top portion of the container or the dispenser to form a substantially airtight seal (Column 2, lines 54-61, see figure 5)). Therefore, it would have been obvious to make the simple substitution of known elements to include the seal of Katzman in the device of Dandiker in order to prevent leakage.
The examiner notes that with regard to the limitation of the pharmaceutical preparation has a moderate viscosity, Dandiker discloses this information as per paragraph 0007, Dandiker discloses that various forms of compositions are used including fluids, solutions, lotion, cream, foam and gel, it is interpreted that Dandiker is capable of holding medium-viscous substances. Should applicant disagree, Opel evidences that topical liquids may have a viscosity of at least 300 centipoise at 25 degrees Celsius, and as it would therefore be obvious to one of ordinary skill in the art to use a liquid with Dandiker with said viscosity as, the substances of Dandiker would be capable of being at least 300 centipoise and therefore considered moderately viscous.
With regard to the amendments filed 08/08/2025, claim 66 now requires the continuous face being useful for receiving .1mL to 1.5mL of preparation. While the examiner notes that as previously disclosed, Dandiker teaches a dose being contained within, where “being useful for receiving” is interpreted to be functional language, in an effort to achieve compact prosecution, the examiner points of Bayley, found obvious to combine. Per Bayley, a dose of the preparation ranges from 150µg to 300µg, which converted to mL is approximately .15-.3 mL. Therefore the dose used within the combination of Dandiker and Bayley is within the claimed range and thus reads to the claimed limitation.
The amendments filed 08/08/2025 also require “the central flat, rigid, continuous face occupies 60% or more of the area of the combined area of the central flat, rigid, and continuous face and the rigid peripheral ridge, wherein the width of the top edge of the rigid peripheral ridge is twice or more of the difference in height between an uppermost portion of the ridged peripheral ridge and the central flat, rigid, and continuous face.
Regarding the limitation of the face occupying 60% or more of the surface area, Dandiker teaches the face occupying at least a percentage of the surface area but fails to specifically teach 60% of the surface area is occupied. However, Dandiker discloses variation configurations where the face takes up different percentages of the surface area (see figure 1d-2g). Further, per MPEP section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that in the response the arguments Dandiker and the prior art perform the same function. Further, per para. 0087 of the instant specification, the limitation require 60% lacks criticality in that the “flat portion occupies 5% or more of the whole area” where “…more preferable…flat portion occupies 60% or more of the whole area”. Therefore based on the specification the device is capable of functioning with 5% of the surface area made up of the flat face, therefore lacking criticality to the claimed 60% or more. As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dandiker to cover at least 60% of the surface are of the therapeutic surface as an obviousness change is size rationale.
Regarding the limitation of the width of the top edge of the ridge being twice or more the difference in height between an uppermost portion of the ridge and the central face, examiner interprets the drawings of Dandiker to teach this limitation. As seen in figure 1C the width across the device is greater than the height between the edge and face. However, there is no clear disclose that the width is twice the height. Further, per MPEP section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The examiner notes that in the response the arguments Dandiker and the prior art perform the same function, and Dandiker, per the same rejection clearly depicts the width being greater than the height. As such, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Dandiker to have the width across the ridge at least twice the height between the ridge and flat face as an obviousness change is size rationale, absent persuasive that Dandiker would not function properly if the difference in size between the width of the ridge and height between the ridge and face (seen in the figures to be some degree larger) is modified to be at least two times larger.
Dandiker further fails to teach wherein the difference in height between an uppermost portion of the rigid peripheral ridge and the central flat, rigid and continuous face ranges from 0.1 mm to 1.5 mm.
Wilson teaches an applicator device and is thus considered analogous to the claimed invention. Wilson teaches that the applicator may comprise various sizes, so long as it remains compact and suitable for use by typical human fingers, while still being large enough to facilitate easy application (para. 0037). Wilson teaches that various sizes, with specific note to the thickness, may be .5 to 5mm (para. 0039). The thickness is understood to be the height of the device of Wilson. Wilson also teaches that the composition applied may include viscous compositions (para. 0063). The examiner notes that therefore, as Wilson teaches that an applicator may have a suitable height of .5 to 5mm while still maintaining a composition for application, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use a height within said range as the height of the device of Dandiker. See MPEP 2144.04 IV A. The examiner notes that therefore, choosing a height within said range (for example 1mm) would thus require the difference in height between the face and ridge to be within the claimed range as the difference must be at least less than 1mm (since this is the overall height of the applicator). Said combination would still allow the device to function as intended, where the applicator holds a composition and interfaces with the skin to apply said composition, and thus in view of Wilson and MPEP 2144.04 IV A, a prima facie case of obviousness exists.
With regard to the amendments filed 03/09/2026, the examiner notes that the limitation of the air-tight seal is detailed above under the same rejection, in view of Katzman. Further, applicant amended to specifically require sofpironium bromide as the active agent being dispensed. Although, as detailed above, Dandiker does teach various compositions being able to be applied by the device, including “solution, liquid, fluid, free-flowing fluid, gel, cream, foam, or viscous solution form” (para. 0007), sofpironium bromide is not specifically disclosed.
Koleng teaches a topical formation and is thus considered analogous to the claimed invention. Koleng teaches that the topical treatment disclosed is to be used for hyperhidrosis (para. 0008), where said compound can be seen in the first image on page 1. Koleng further teaches that compounds in use for the invention may include variations where one such variation is 3'(R)-[2(R)-cyclopentylphenylhydroxyacetoxy]-1'-methyl-1'-ethoxycarbonylm- ethyl-pyrrolidinium bromide per para. 0064. Upon review of the instant specification (para. 0054), this compound is sofpironium bromide. Per paragraph 0012 of Koleng the compound taught may be formulated as a “solid or semi-solid, powder, gel, cream, lotion, foam, solution, suspension, aerosol, patch, wipes or emulsion, or the like”. Therefore, as Dandiker teaches a topical treatment (including fluids, gels, foams, and more), and Koleng teaches that gel cream, foam, or more, of sofpironium bromide is a known topical composition, it would have been obvious to one having ordinary skill in the art to use sofpironium (in a gel or otherwise form) as the composition applied by Dandiker, as Dandiker is disclosed to apply topical gels.
Claim(s) 76, 79, 84, 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dandiker in view of Bayly, Katzman, Opel, Koleng, and Wilson and further in view of Carrara et al. (US Pre-Grant Publication 2014/0221943).
Regarding claim 76, Dandiker, Katzman, Bayly, Opel, Koleng, and Wilson teach the method of claim 74. However the combination of prior arts fails to teach wherein the pharmaceutical preparation is dispensed from the container by a metered dose dispenser as a single dose.
Carrara discloses wherein the pharmaceutical preparation is dispensed from the container by a metered dose dispenser as a single dose (a dose of gel be metered onto the application surface, and the dose be applied onto the skin; paragraph [00561). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the method of Dandiker in view of Katzman, Bayly and Opel, wherein the pharmaceutical preparation is dispensed from the container by a metered dose dispenser as a single dose, as taught by Carrara, for the advantage of applying proper amount of pharmaceutical composition to the skin surface.
Regarding claim 79, Dandiker, Katzman, Bayly, Opel, Koleg, Wilson, and Carrara teach the method of claim 76. Carrara further teaches that the metered dose has a volume in the range of 0.1mL to 1mL (Carrara [0015] teaches that the metered amount pre dispense may be between 0.5mL to 2.5mL).
Regarding claim 84, Dandiker, Katzman, Bayly, Opel, Koleng, and Wilson teach the system of claim 80. Dandiker does not disclose wherein the pump dispenser is a metered-dose pump dispenser.
Carrara discloses wherein the pump dispenser is a metered-dose pump dispenser (a dose of gel be metered onto the application surface, and the dose be applied onto the skin using a pump 5; abstract; paragraph [0056]). It would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the device of Dandiker, wherein the pump dispenser is a metered-dose pump dispenser, as taught by Carrara, for the advantage of applying proper amount of pharmaceutical composition to the skin surface.
Regarding claim 90, Dandiker, Katzman, Bayly, Opel, Koleng, Wilson, and Carrara teach the applicator of claim 84. Carrara further teaches that the metered dose has a volume in the range of 0.1mL to 1mL (Carrara [0015] teaches that the metered amount pre dispense may be between 0.5mL to 2.5mL).
Conclusion
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/MATTHEW WRUBLESKI/ Examiner, Art Unit 3781 /ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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