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 .
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) 1, 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 8409558 B2) in view of Davis et al. (US 20190201335 A1).
Regarding Claim 1, Nguyen discloses a method of treating a fungal nail infection ("treatment of nail fungi" col. 1 ln. 14-15), comprising the steps of:
debriding a nail plate of a fungal infected nail to remove nail plate debris and an encapsulated fungus ("debridement of the infected nail surface" col. 3 ln. 10-11);
applying a dispersion layer impregnated with a first anti-fungal agent on the debrided nail to inhibit a growth and spread of the fungal infection and to create a fungistatic environment ("application of an effective amount of a liquid composition containing a cyanoacrylate ester or cyanoacrylate ethyl (alkyl cyanoacrylate) to form a substantially impermeable barrier to prevent further supply of moisture and air to the fungus necessary for continued growth" col. 3 ln. 5-10);
cosmetically treating the fungal infected nail by trimming and shaping the mesh dispersion layer and UV adhesive layer ("by first mechanically grinding away the infected nail down to the level of the normal nail" col. 5 ln. 66-67).
Nguyen does not explicitly disclose the remaining claim limitations.
However, Davis teaches a nail “treatment composition comprising a polymerisable and/or curable composition” ([0013]) applying a UV adhesive layer on the dispersion layer to cover the dispersion layer and the debrided nail to seal the dispersion layer and to add depth and rigidity ("flowable components can be mixed and placed on the nail surface" [0022]);
curing the UV adhesive layer with UV light ("polymerisation initiated when a UV source is introduced to the mixed composition" [0022]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Nguyen to incorporate the teachings of Davis to provide “controlled, sustained delivery of topical” treatment to infected nails ([0043]).
Regarding Claim 9, Nguyen discloses the UV adhesive is an acrylate (“alkyl cyanoacrylate such as cyanoacrylate esters or cyanoacrylate ethyl” col. 2 ln. 18-19)
Regarding Claim 10, Nguyen discloses applying a nail polish on the cosmetically treated nail (“preferred for nail polish to be applied over the cured layer of cyanoacrylate” col. 6 ln. 17-18).
Claim(s) 2-3 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, and further in view of Selner (US 20100035939 A1).
Regarding Claims 2-3 & 7, Selner teaches an “antifungal liquid composition for topical administration” (see Abstract) wherein the UV adhesive layer is impregnated with a second anti-fungal agent, and wherein the second anti-fungal agent is the same or different than the first anti-fungal agent ("one or more members selected from the group consisting of ciclopirox olamine, terbinafine, tolnaftate, microconazole, itraconazole, ketoconazole, econazole, and fluconazole" [0022]); wherein the first anti-fungal agent and the second anti-fungal agent is one of terbinafine 1%, tolnaftate 1%, ciclopirox 8%, efinaconazole 10%, and tavaborole 5% ([0022]; "antifungal medications are each present in an amount of from 0.1% to 10%" [0037]); wherein the dispersion layer is a layer of an alcohol-based terbinafine 1% ("carrier or delivery system comprises a combination of turpentine (pine oil) and at least one of peppermint oil or mineral oil or one or more essential oil alcohols" [0034]). Therefore, it would have been obvious to modify the device of Nguyen/Davis to incorporate the teachings of Selner “to provide a carrier for topical medicaments that can penetrate and transport a broad spectrum of antifungal compounds through keratinous tissues, such as nail bed and nail plate” ([0011]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, and further in view of Pope et al. (US 20130173279 A1).
Regarding Claim 4, Pope teaches a “Method for providing dermatologic treatment wherein an electronic request for treatment is received by a physician” (see Abstract) wherein a patient seeks medical diagnosis and treatment for the fungal nail infection on an on-line telehealth service website ([0013]-[0022]; FIG. 1). Therefore, it would have been obvious to modify the device of Nguyen/Davis to incorporate the teachings of Pope to suitably provide diagnostic/treatment services wherever needed ([0002]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, and further in view of Pillai et al. (US 20150148378 A1).
Regarding Claim 5, Pillai teaches “methods for treating onychomycosis” (see Abstract) wherein the debridement step further includes: scrubbing at least one of 40% urea, baking soda, an abrasive material, sodium percarbonate, and citric acid on the fungal infected nail (“citric acid anhydrous” [0013]); and cleaning the fungal infected nail with isopropyl alcohol ([0045]). Therefore, it would have been obvious to modify the device of Nguyen/Davis to incorporate the teachings of Pillai to suitably treat “onychomycosis and/or killing or inhibiting microorganisms through administration of efinaconazole formulations” ([0005]).
Claim(s) 6 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, and further in view of Deckner et al. (US 20030113356 A1).
Regarding Claims 6 & 8, Deckner teaches the dispersion layer is a transdermal drug delivery system (TDDS) layer, and wherein the TDDS layer is at least one of a mesh, a transdermal patch, microsponages, liposomes, and fiberglass (“substrate” [0124]-[0128]); wherein supplies for the dispersion layer and the UV adhesive layer are provided in a treatment kit (“may be sold as kits” [0008]). Therefore, it would have been obvious to modify the device of Nguyen/Davis to incorporate the teachings of Deckner to allow “more efficient delivery of benefit agents to the skin than previously known devices and affords greater formulation flexibility” ([0013]).
Claim(s) 11 & 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis and Pillai et al., and further in view of Deckner et al.
Regarding Claim 11, Nguyen discloses a method of treating a fungal nail infection ("treatment of nail fungi" col. 1 ln. 14-15), comprising the steps of:
debriding a nail plate of a fungal infected nail to remove nail plate debris and an encapsulated fungus ("debridement of the infected nail surface" col. 3 ln. 10-11), applying a dispersion layer impregnated with a first anti-fungal agent on the debrided nail to inhibit the growth and spread of the fungal infection and to create a fungistatic environment ("alkyl cyanoacrylate such as cyanoacrylate ester or ethyl is combined with an effective amount of an antifungal agent" col. 3 ln. 18-20; "application of an effective amount of a liquid composition containing a cyanoacrylate ester or cyanoacrylate ethyl (alkyl cyanoacrylate) to form a substantially impermeable barrier to prevent further supply of moisture and air to the fungus necessary for continued growth" col. 3 ln. 5-10);
cosmetically treating the fungal infected nail by trimming and shaping the mesh dispersion layer and UV adhesive layer ("by first mechanically grinding away the infected nail down to the level of the normal nail" col. 5 ln. 66-67).
Nguyen does not explicitly disclose the remaining claim limitations.
However, Davis teaches a nail “treatment composition comprising a polymerisable and/or curable composition” ([0013]) applying a UV adhesive layer on the dispersion layer to cover the dispersion layer and the debrided nail to seal the dispersion layer and to add depth and rigidity ("flowable components can be mixed and placed on the nail surface" [0022]);
curing the UV adhesive layer with UV light ("polymerisation initiated when a UV source is introduced to the mixed composition" [0022]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Nguyen to incorporate the teachings of Davis to provide “controlled, sustained delivery of topical” treatment to infected nails ([0043]).
Deckner teaches the dispersion layer is one of a mesh (“substrate” & “woven” [0124]-[0128]). Therefore, it would have been obvious to modify the device of Nguyen/Davis to incorporate the teachings of Deckner to allow “more efficient delivery of benefit agents to the skin than previously known devices and affords greater formulation flexibility” ([0013]).
Pillai teaches “methods for treating onychomycosis” (see Abstract) wherein the debridement step further includes: scrubbing at least one of baking soda, an abrasive material, sodium percarbonate, and citric acid on the fungal infected nail (“citric acid anhydrous” [0013]); and cleaning the fungal infected nail with isopropyl alcohol ([0045]). Therefore, it would have been obvious to modify the device of Nguyen/Davis/Deckner to incorporate the teachings of Pillai to suitably treat “onychomycosis and/or killing or inhibiting microorganisms through administration of efinaconazole formulations” ([0005]).
Regarding Claims 15-16, Nguyen discloses applying a nail polish on the cosmetically treated nail (“preferred for nail polish to be applied over the cured layer of cyanoacrylate” col. 6 ln. 17-18) & the UV adhesive is an epoxy resin or acrylate (“Alkyl cyanoacrylate such as cyanoacrylate esters or cyanoacrylate ethyl” col. 3 ln. 24-25).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, Pillai et al., and Deckner et al., and further in view of Selner.
Regarding Claims 12-13, Selner teaches the UV adhesive layer is impregnated with a second anti-fungal agent, wherein the second anti-fungal agent is the same or different than the first anti-fungal agent ("one or more members selected from the group consisting of ciclopirox olamine, terbinafine, tolnaftate, microconazole, itraconazole, ketoconazole, econazole, and fluconazole" [0022]); wherein the first anti-fungal agent and the second anti-fungal agent is one of terbinafine 1%, tolnaftate 1%, ciclopirox 8%, efinaconazole 10%, and tavaborole 5% ([0022]; "antifungal medications are each present in an amount of from 0.1% to 10%" [0037]). Therefore, it would have been obvious to incorporate the teachings of Selner “to provide a carrier for topical medicaments that can penetrate and transport a broad spectrum of antifungal compounds through keratinous tissues, such as nail bed and nail plate” ([0011]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, Pillai et al., and Deckner et al., and further in view of Glassman (US 6281239 B1).
Regarding Claim 14, Glassman teaches a method of treating onychomycosis (see Abstract) wherein the debridement step is a chemical debridement step using 40% urea (“administering to the nail area of a human in need of such treatment or prevention, a safe and effective amount of an antifungal composition and a safe and effective amount of a potent tissue softening composition containing an effective amount of urea, for example, from about 30 to 60 wt-%, preferably about 40-50 wt-%, and particularly about 40 wt-%” col. 2 ln. 21-28). Therefore, it would have been obvious to modify the device of Nguyen/Davis/Pillai/Deckner to incorporate the teachings of Glassman to “improve drug penetration and effects a chemical debridement of the hypertrophic nail” col. 1 ln. 59-60).
Claim(s) 17-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, Pillai et al., and Selner.
Regarding Claim 17, Nguyen discloses a method of treating a fungal nail infection ("treatment of nail fungi" col. 1 ln. 14-15), comprising the steps of:
debriding a nail plate of a fungal infected nail to remove nail plate debris and an encapsulated fungus ("debridement of the infected nail surface" col. 3 ln. 10-11), applying a UV adhesive layer impregnated with an anti-fungal agent on the alcohol-based anti-fungal agent topical solution layer to cover the alcohol-based anti-fungal agent topical solution layer and the debrided nail to seal and to add depth and rigidity ("alkyl cyanoacrylate such as cyanoacrylate ester or ethyl is combined with an effective amount of an antifungal agent" col. 3 ln. 18-20; "application of an effective amount of a liquid composition containing a cyanoacrylate ester or cyanoacrylate ethyl (alkyl cyanoacrylate) to form a substantially impermeable barrier to prevent further supply of moisture and air to the fungus necessary for continued growth" col. 3 ln. 5-10);
cosmetically treating the fungal infected nail by trimming and shaping the mesh dispersion layer and UV adhesive layer ("by first mechanically grinding away the infected nail down to the level of the normal nail" col. 5 ln. 66-67).
Nguyen does not explicitly disclose the remaining claim limitations.
However, Davis teaches a nail “treatment composition comprising a polymerisable and/or curable composition” ([0013]) applying a UV adhesive layer on the dispersion layer to cover the dispersion layer and the debrided nail to seal the dispersion layer and to add depth and rigidity ("flowable components can be mixed and placed on the nail surface" [0022]);
curing the UV adhesive layer with UV light ("polymerisation initiated when a UV source is introduced to the mixed composition" [0022]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Nguyen to incorporate the teachings of Davis to provide “controlled, sustained delivery of topical” treatment to infected nails ([0043]).
Pillai teaches “methods for treating onychomycosis” (see Abstract) wherein the debridement step further includes scrubbing at least one of baking soda, an abrasive material, sodium percarbonate, and citric acid on the fungal infected nail (“citric acid anhydrous” [0013]); and cleaning the fungal infected nail with isopropyl alcohol ([0045]). Therefore, it would have been obvious to modify the device of Nguyen/Davis to incorporate the teachings of Pillai to suitably treat “onychomycosis and/or killing or inhibiting microorganisms through administration of efinaconazole formulations” ([0005]).
Selner teaches applying an alcohol-based anti-fungal agent topical layer ("essential oil alcohols" [0020]) with on the debrided nail to inhibit the growth and spread of the fungal infection to create a fungistatic environment ([0027]-[0028]); wherein the anti-fungal agent is the same or different than an anti-fungal agent of the alcohol-based anti-fungal agent topical solution layer ("one or more members selected from the group consisting of ciclopirox olamine, terbinafine, tolnaftate, microconazole, itraconazole, ketoconazole, econazole, and fluconazole" [0022]);. Therefore, it would have been obvious to incorporate the teachings of Selner “to provide a carrier for topical medicaments that can penetrate and transport a broad spectrum of antifungal compounds through keratinous tissues, such as nail bed and nail plate” ([0011]).
Regarding Claims 18 & 20, Selner teaches an “antifungal liquid composition for topical administration” (see Abstract) wherein the anti-fungal agent of the alcohol-based topical layer and the anti-fungal agent of the UV adhesive layer is one of terbinafine 1%, tolnaftate 1%, ciclopirox 8%, efinaconazole 10%, and tavaborole 5% ("one or more members selected from the group consisting of ciclopirox olamine, terbinafine, tolnaftate, microconazole, itraconazole, ketoconazole, econazole, and fluconazole" [0022]); wherein the first anti-fungal agent and the second anti-fungal agent is one of terbinafine 1%, tolnaftate 1%, ciclopirox 8%, efinaconazole 10%, and tavaborole 5% ([0022]; "antifungal medications are each present in an amount of from 0.1% to 10%" [0037]); wherein the alcohol-based anti-fungal topical solution layer is a layer of an alcohol-based terbinafine 1% ("carrier or delivery system comprises a combination of turpentine (pine oil) and at least one of peppermint oil or mineral oil or one or more essential oil alcohols" [0022]-[0034]). Therefore, it would have been obvious to incorporate the teachings of Selner “to provide a carrier for topical medicaments that can penetrate and transport a broad spectrum of antifungal compounds through keratinous tissues, such as nail bed and nail plate” ([0011]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen in view of Davis, Pillai et al., Selner, and further in view of Glassman.
Regarding Claim 19, Glassman teaches a method of treating onychomycosis (see Abstract) wherein the debridement step is a chemical debridement step using 40% urea. (“administering to the nail area of a human in need of such treatment or prevention, a safe and effective amount of an antifungal composition and a safe and effective amount of a potent tissue softening composition containing an effective amount of urea, for example, from about 30 to 60 wt-%, preferably about 40-50 wt-%, and particularly about 40 wt-%” col. 2 ln. 21-28). Therefore, it would have been obvious to incorporate the teachings of Glassman to “improve drug penetration and effects a chemical debridement of the hypertrophic nail” col. 1 ln. 59-60).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781