DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
Response to Arguments
Applicant's arguments filed 17 July 2026 have been fully considered but they are not persuasive.
Applicant argues that Eckhouse does not teach an antenna above that nail as cited parts 504 are off to the sides of the nail. This is not found to be persuasive as Eckhouse teaches in Fig. 5 that the parts 504 are located in a position on the device that is above the nail bed.
Applicant’s arguments with respect to Eckhouse not teaching use of a dielectric layer directly contacting the nail 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 17, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0015549 A1 to Eckhouse et al. (Eckhouse) in view of US 2010/0114086 A1 to Deem et al. (Deem).
Regarding claim 17, Eckhouse discloses a method of treating an appendage having nail fungus (title: “A method and apparatus for treating a diseased nail” and para [0006]), comprising: a) attaching an electrical energy device (hand piece or applicator 124; para [0033]) to said appendage having a nail with fungus (Fig. 5), wherein said energy delivery device is attached to an energy source (para [0007] the applicator may also include a source, or be connected to a source) and wherein said energy delivery device comprises an antenna (antenna comprising pair of RF electrodes 504) electrically coupled to said energy source and positioned above said nail ([0044]- "Hand piece or applicator 500 includes one or more RF electrodes 504 connected by energy delivery cable 120 to controller 104 (FIG. 1) and source of energy 108. The distance between the electrodes may be automatically adjustable so that when a digit 506 is inserted into applicator 500 electrodes 504 come to rest on opposite sides of the digit 506 nail plate 508 or, in the lack thereof, on opposite sides of nail bed tissue 512, normally covered by a nail plate 508.), and delivering radio-frequency energy to a nail bed of said appendage (paras [0033, 0044]) via said energy delivery device such that said nail with said fungus is heated (para [0006, 0007]).
However, Eckhouse does not disclose a dielectric layer positioned below said antenna and above said nail such that the dielectric layer makes contact with said nail.
Deem teaches an analogous method (title “Methods, Devices and Systems for Non-Invasive Delivery of Microwave Therapy”) including that the delivery of energy to the target can be facilitated by antenna designs that incorporate a low-loss dielectric element that can take the form of a stand-off between the antenna and the tissue ([0110]). Deem teaches that a properly configured dielectric element will not impede the energy from radiating to adjacent tissue and can be utilized as a design tool to help optimize the energy delivery to the target tissue over the course of the treatment ([0110]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the dielectric layer of Deem since the dielectric properties (permittivity and conductivity) of skin and underlying tissue can change over the course of a treatment (e.g., as temperature rises) due to loss of moisture, a dielectric element that removes the antenna from direct contact with the skin can help maintain consistent energy delivery to the target tissue by ensuring a consistent load ([0110]).
Regarding claim 20, the combination discloses the method of claim 17 as well as Eckhouse disclosing wherein said energy kills nail fungus causing organisms without harming tissue of the appendage ([0006] “The RF energy induced electric current flows through the nail bed tissue heating a segment of the tissue to a temperature level sufficient to substantially deactivate the organism without causing unwanted injury to either the nail bed tissue and/or nail plate.”).
Regarding claim 21, the combination teaches the method of claim 17 as well as Eckhouse teaching wherein said energy delivery device further comprises one or more thermal sensors (abstract “A temperature monitor can be employed to monitor changes or temperature levels and then adjust the energy application accordingly.”)
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eckhouse in view of US 2009/0012515 A1 to Hoenig et al. (Hoenig).
Regarding claim 19, Eckhouse discloses the method of claim 17, but does not disclose wherein the radio-frequency energy comprises microwave energy. Hoenig in the related art of nail fungus treating system discloses the radio-frequency generator is a microwave generator for generating microwave energy to be delivered to the infected nail (para (0059)- "In accordance with certain examples, an illustrative apparatus for providing electromagnetic energy to a tissue is shown in FIG. 1. The apparatus 100 includes an electromagnetic energy source 110 energetically coupled to an applicator 120. As used herein energetically coupled refers to the configuration where energy generated or provided by the electromagnetic energy source 110 can be transmitted to the applicator 120 and on to a tissue"; para (0060)- "In examples where the applicator is configured to deliver microwave radiation or radio waves to the tissue, the applicator may be a coaxial cable, waveguide or the like that permits passage of microwaves or radio waves from a source to the tissue"; para [0073)- "In accordance with certain examples, the applicator may be configured for delivery of electromagnetic energy to one or more nails of a human or non-human mammal. As discussed herein, treatment of keratinized tissue, such as that found in human nails or in the nails of non-human mammals such as sheep and horses, can be difficult. The devices, systems and methods disclosed herein may be used to provide electromagnetic energy to the nails and/or nail beds to improve the overall appearance of the nails. Such treatment may be performed, for example, to deactivate or kill pathogens infecting the nail and/or nail bed or to improve the overall appearance of the nail by preventing pathogens from infecting the nail or the nail bed".). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Eckhouse with the teaching of the microwave energy generator as disclosed by Hoenig as this would have provided the advantage for generating microwave energy to be delivered to the infected nail to deactivate or kill pathogens infecting the nails (para [0073]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794