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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the spring brace describe in claims 11-12 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities: the use of the term “it” in line 2 of the claim should be replaced with the structure to which Applicant is seeking patent protection. Appropriate correction is required.
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 1-22 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 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. Claim 1 recites: “A method of nail correction for a human or animal fingernail or toenail, comprising the steps of:”. The omitted elements are: the steps for performing the method as set forth in the preamble of claim 1. For the purpose of examination, the Office has relied on the claims submitted in the Auxiliary PDF of Application filed on 10/14/2025.
Claim 6 recites the limitation "the range" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
As to claim 7, the use of the term "sheet-like manner" does not positively recite the application of the primer and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting sheet-shaped manner in order to overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim 7 recites the limitation "the entire nail surface" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the opposite end" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the range" in line 16 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 1-5, 8-11, 13-15 and 17-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite since they depend directly or indirectly on rejected base claim 1 and therefore, contain the same deficiencies.
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.
Claim(s) 1, 3, 5-10 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hillebrand U.S. Publication No. (2012/0191033 A1) in view of Vironda (US 3981298 A).
With respect to claim 1, Hillebrand substantially discloses a method of nail correction for a human or animal fingernail or toenail, comprising the steps of:
- applying a light-curable primer to the nail, the primer being configured to be polymerized by irradiation with light [0018, In the first step a) at least one layer (3,4) of at least one compound will be applied to the fingernail or toenail]-[0019, the layer comprises at least one compound, which is preferably a polymer or a polymer composition, meaning a composition that comprises at least one type of polymer. The composition may generally be any compound(s) selected, so long as they are suitable for application to a fingernail or toenail, and the curvature of a fingernail or toenail can be corrected with their assistance. The composition is preferably a polymerized or polymerizable organic compound completely or partially dissolved in an aqueous or organic solvent. It is particularly preferred if the composition contains a co-polymerizable or graft-polymerizable oligomere or polymer compound. The compound may preferably contain at least one photo-polymerizable compound based upon acrylic acid esters. Any polymer may be used as the polymer, so long as they permit being hardened on the nail bed];
- polymerizing the primer by irradiation with light [0027, the compound may contain one or more photo initiators, which by irradiation with UV or visible light may trigger the polymerization reaction. The polymeric compound intended for polymerization may for example contain as photo initiators individual suitable photo initiators];
- holding the nail in a desired position during and after the application of the light-curing composition [0035, Alternatively, a phase change in the at least one layer may also be evoked by the light or thermal treatment, which is accompanied by an expansion or contraction of the at least one layer. If for example the at least one applied layer (3,4) is an amorphous thermoplastic, then a phase change can occur by heating above the glass transition temperature T.sub.G, whereby the layer converts to a phase with reduced or increased spatial volume. Here the nail will be bent in the direction of reduced convexity and thereby corrected], which implies that the nail is being held in a desired position in order for the nail to be bent in a direction of reduced convexity for it to become corrected;
- polymerizing the light-curing composition by irradiation with light while maintaining the nail in the desired position [0034] and [0035, Alternatively, a phase change in the at least one layer may also be evoked by the light or thermal treatment, which is accompanied by an expansion or contraction of the at least one layer. If for example the at least one applied layer (3,4) is an amorphous thermoplastic, then a phase change can occur by heating above the glass transition temperature T.sub.G, whereby the layer converts to a phase with reduced or increased spatial volume. Here the nail will be bent in the direction of reduced convexity and thereby corrected], which implies that the nail is being held in a desired position in order for the nail to be bent in a direction of reduced convexity for it to become corrected.
Hillebrand substantially discloses substantially discloses the invention as claimed except - applying a light-curing composition onto the nail in one or more line-shaped applications having a line width of 2 to 6 millimeters. Hillebrand however, discloses in [0017, the method is to correct nail preferably has an undesirably high convex curvature, which should be corrected. Alternately the disclosure may also concern a therapeutic method, if a pathological change in the nail should be treated, such as for example a pathological ingrown nail, which has already led to frequent inflammation of the nail tissue or of the nail bed in the patient. In the sense of this application, under "correction" any method step shall be understood that can correct the undesirable curvature of the fingernail or toenail. For example, the reduction of the convexity of an ingrown nail shall be understood under correction, so that after correction the nail is primarily planar or at least exhibits minimal convexity]; in [0018, Hillebrand discloses, the application itself can occur through existing mechanical application processes, for example by layered brushing of the compound.
Furthermore, Vironda teaches a method of treating a toenail or fingernail for correcting an ingrown condition which comprises applying a material in flowing or liquid form across the nail at the base or proximal portion in a limited area having a normal radius of curvature, causing the material to harden and to become adhered to the nail and to serve as a form-retaining support, permitting the support to remain adhered to the nail as the nail grows over a period of time until the coated and supported portion extends beyond the end of the toe, and removing the portion of the nail having the coated material thereon, the nail remaining being partially or totally cured of the ingrown condition (abstract); wherein the nail (17, figs.1-10) is an analogous liquid cured brace 17 [(Col. 2 line 48 and Col. 3 line 11)], wherein this analogous brace 17 is applied in the form of lines or strips (Figs. 4-5, 7, 9) having a line width of 1/8 inch to 3/16 inch [(Col. 3 lines 15-17, 3.18 mm to 4.76 mm when converting to from inch to millimeter)], wherein Vironda provides that this width is not critical and is the minimal width required in order to effect nail therapy with the brace [(Col. 3], lines 12-20).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method Hillebrand such that the light-curing brace is applied in the form of lines having a line width of 3.18 mm to 4.76 mm (which finds obvious to range of 2-6 mm; furthermore, applicant appears to have placed no criticality on the claimed range simply stating in para [23] of the specification “The application is made in the form of lines (see Figure 1) with a line width of 2-6 mm”, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. See MPEP § 2144.05), in order to provide sufficient nail therapy with the nail brace in order to correct an undesirably high convex curvature.
With respect to claim 3, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the polymerization starter comprises camphorquinone and an amino starter [0027, Representatives of such photo initiators are for example benzoic alkyl ether, benzil ketals, acylphosphine oxide, or aliphatic and aromatic 1,2-diketone compounds, for example camphor quinone, whereby the light polymerization can be accelerated in a manner that is known by the addition of activators, such as tertiary amines or organic phosphites].
With respect to claim 5, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the fillers comprise at least one filler selected from silicate-based fillers and polymeric particles [0068, To achieve a natural shading, the layer may also contain pigments, such as for example titanium oxide, as well as any coloration pigment materials permitted for use in decorative cosmetics, as well as pigments produced with metal oxide coated reflective plates that are reflective when viewed. The layer may also contain other solid material, so long as their presence does not disturb the contraction or expansion of the layer. For example, the layer may contain highly dispersed free silica for adjusting the viscosity].
With respect to claim 6, the combination of Hillebrand/Vironda substantially discloses the invention as claimed except the pigments and fillers have particle sizes in the range of 0.1 to 10 micrometers, however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the pigments and fillers have particle sizes in the range of 0.1 to 10 micrometers through routine experimentation in order to suit the material properties to the task at hand.
With respect to claim 7, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the primer is applied in a sheet-like manner over the entire nail surface [0031] and [0049].
With respect to claim 8, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Vironda further teaches the light-curing composition is applied in multiple line-shaped applications ([Col.3], lines 12-29).
With respect to claim 9, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand discloses the light-curing composition is applied in a thickness sufficient to deform a thickened nail [0035, Alternatively, a phase change in the at least one layer may also be evoked by the light or thermal treatment, which is accompanied by an expansion or contraction of the at least one layer. If for example the at least one applied layer (3,4) is an amorphous thermoplastic, then a phase change can occur by heating above the glass transition temperature T.sub.G, whereby the layer converts to a phase with reduced or increased spatial volume. Here the nail will be bent in the direction of reduced convexity and thereby corrected].
With respect to claim 10, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Vironda further teaches the light-curing composition is re-ground after curing to remove any sharp edges ([Col.2], lines 48-51).
With respect to claim 15, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the polymerization of the primer is initiated using a light source having a wavelength of approximately 450 nanometers [0034].
With respect to claim 16, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the light source has an intensity in the range of 100 to 1500 milliwatts per square centimeter [0074, The layers were hardened by irradiation with short wave UV light (lambda=254 nm, radiation dose W=4 J cm-2) with use of a photo-mask to protect the skin components].
With respect to claim 17, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the primer is polymerized by irradiating with light for a duration of 5 to 60 seconds [0073, the compound is then hardened, in that the applied layer is radiated by a UV lamp (60 Watt, wavelength 380 nm to 450 nm) for a time period of 1 minute, whereby the layer hardens].
With respect to claim 18, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the primer is polymerized by irradiating with light for approximately 10 seconds [0073, the compound is then hardened, in that the applied layer is radiated by a UV lamp (60 Watt, wavelength 380 nm to 450 nm) for a time period of 1 minute, whereby the layer hardens].
With respect to claim 19, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the polymerization of the light-curing composition is initiated immediately after application [0073, the compound is then hardened, in that the applied layer is radiated by a UV lamp (60 Watt, wavelength 380 nm to 450 nm) for a time period of 1 minute, whereby the layer hardens].
With respect to claim 20, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the light-curing composition is polymerized by irradiating with light for a duration of 5 to 60 seconds seconds [0073, the compound is then hardened, in that the applied layer is radiated by a UV lamp (60 Watt, wavelength 380 nm to 450 nm) for a time period of 1 minute, whereby the layer hardens].
With respect to claim 21, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the light-curing composition is polymerized while manually holding the nail in a corrected shape during the irradiation step [0035].
With respect to claim 22, the combination of Hillebrand/Vironda substantially discloses the invention as claimed. Hillebrand further discloses the light source is an LED light source [0034].
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hillebrand/Vironda as applied to claim 1 above, and further in view of Sutor et al. (EP 2829255 A1).
With respect to claim 11, the combination of Hillebrand/Vironda substantially discloses the invention as claimed except applying a spring brace to the nail using the light-curing composition.
Sutor et al. however, teaches a device for nail correction is described, which comprises an adhesive element (2) to be adhesively bonded to the surface of a human nail (4) and at least one spring element (1), preferably consisting of spring-hard wire. The device is characterized in that the spring element (1) by means of firmly attached to the adhesive element (2) receiving means (3) can be positively connected thereto and by, resulting from its elastic deformation during attachment, restoring forces transmits a bending moment on the nail plate. Significant advantages of the device consist in its particularly simple and rapid application due to the one-piece nature of the initially tension-free adhesive adhesive element. The exercise of a continuous spring force on the nail without invasive engagement under the nail edges proves to be particularly effective in terms of the desired cure success (abstract) and (fig.1).
In view of the teachings of Sutor et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Hillebrand/Vironda by incorporating a spring brace to the nail using the light-curing composition as the exercise of a continuous spring force on the nail without invasive engagement under the nail edges proves to be particularly effective in terms of the desired cure success.
With respect to claim 12, the combination of Hillebrand/Vironda/Sutor et al. substantially discloses the invention as claimed. Sutor et al. further teaches the spring brace is fixed by pressing it into a first portion of the light-curing composition, curing said first portion, spanning the spring brace over the nail, and fixing the opposite end using a second portion of the light-curing composition (abstract) and (fig.1).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hillebrand/Vironda as applied to claim 1 above, and further in view of Horrigan U.S. Publication No. (2008/0287912 A1).
With respect to claim 13, the combination of Hillebrand/Vironda substantially discloses the invention as claimed except the primer further comprises 0.1 to 2 percent by weight of one or more antimycotic agents.
Horrigan however, teaches an improved method, device and formulation for the treatment of nail disorders characterized by de-lamination, thickening or crumbling of the nails (abstract) comprising applying a biocide deep under the nail to kill fungus and treat infections hidden deep within a nail cavity [0024] and [0080].
In view of the teachings of Horrigan, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Hillebrand/Vironda by incorporating one or more antimycotic agents for treating infections hidden deep within a nail cavity. The combination of Hillebrand/Vironda/Horrigan substantially discloses the invention as claimed except the primer further comprises 0.1 to 2 percent by weight of one or more antimycotic agents, however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the primer further comprises 0.1 to 2 percent by weight of one or more antimycotic agents through routine experimentation in order to suit the material properties to the task at hand which is to kill fungus and bacteria within the nail cavity.
With respect to claim 14, the combination of Hillebrand/Vironda/Horrigan substantially discloses the invention as claimed. Hillebrand further discloses the primer further comprises one or more penetration amplifiers based on substituted 1,3-dioxolanes [0028, acetone].
Allowable Subject Matter
Claims 2 and 4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record fails to show or make obvious the claimed combinations of elements particularly the limitations as set forth in dependent claims 2, 4 and 14 which recite features not taught or suggested by the prior art of record, in combination with the other elements (or steps) of the apparatus and method recited in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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