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 (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.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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) 1, 4, 5 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8,702,691 B2 to Weber et al. (Weber) in view of US 7,229,436 B2 to Stern et al. (Stern) and US 5,810,801 to Anderson et al. (Anderson).
Regarding claim 1, Weber teaches a skin treatment system (see for example Fig. 1) using a radio frequency, comprising a skin treatment device (10, Fig. 1), the skin treatment device comprising an insulator layer comprising a pair of electrodes (electrode array 18a), wherein the pair of electrodes comprises a first electrode and a second electrode (set of active electrodes 80) and forms a bipolar electrode structure (abstract which states in part “The electrodes may be energized with high frequency energy of different phase relationships to deliver energy concurrently in both monopolar and bipolar modes with the phase difference determining a depth of energy delivery.” and Figs. 5 and 7-8), a RF generator (high frequency energy source or power supply 16) configured to supply a radiofrequency current to the pair of electrodes to cause a discharge therebetween (see for example Fig. 5 and Col. 3, lines 60-67), a dielectric sheet (a skin-contacting dielectric layer or substrate 82) configured to cover a to-be-treated skin portion to be treated (see for example Fig. 5), wherein the dielectric sheet has an inner surface and an outer surface opposite the inner surface which contacts the to-be-treated skin portion (Figs. 5 and 7-8), wherein the dielectric sheet is located between the pair of electrodes and the to-be-treated skin portion (Figs. 5 and 7-8) and a cooling apparatus (fluid delivery member 32) including a nozzle (nozzle 34) for spraying a cooling fluid so as to cool the dielectric sheet (Col. 4, lines 18-20), wherein the nozzle is configured to spray the inner surface of the dielectric sheet (Col. 4, lines 18-20), wherein the dielectric sheet is replaceably attached to (Col. 3 lines 16-26 which state in part “Although the electrode assembly 14 is constituted by multiple components, the assembled components are understood to comprise a structure that is releasably coupled as a unit with the housing 12…an electrode assembly 18 is exposed and visible when the electrode assembly 14 is coupled mechanically with the housing 12.” It is understood that the dielectric sheet is part of the electrode assembly) the skin treatment device such that discharge between the pair of electrodes transverses the dielectric sheet in addition to the skin portion to the treated (see for example Figs. 5 and 7-8).
Weber does not specifically teach wherein the dielectric sheet itself is replaceably attached to the insulator layer. Stern teaches an analogous device to that of Weber including a dielectric member coupled to an RF electrode where the dielectric member is separate from the electrode (Col. 4, lines 24-32). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Weber with the separate dielectric member of Stern, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. This is especially true as Stern teaches providing the dielectric layer as a separate member.
While Weber teaches the RF generator is configured to have an output power and produces a radiofrequency current of several hundred kHz to about 20MHz (Col. 3, lines 60-63) and that the specific depths of the high frequency energy delivery is contingent on multiple factors, such as the frequency and power of the high frequency power delivered (Col. 7, lines 24-28), the reference is silent with respect to the output power specifically being 100-500 W and the radio frequency current specifically being 4-15MHz. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used an output power and radio frequency current as claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
While Weber teaches that the specific depths of the high frequency energy delivery is contingent on multiple factors, such as the frequency and power of the high frequency power delivered (Col. 7, lines 24-28), the reference is silent with respect to wherein a combination of the power range and the frequency range causes the radiofrequency current to penetrate about 0.5 mm of skin depth into a to-be-treated skin portion. Anderson teaches an analogous device (title “Method and Apparatus for Treating Wrinkles in Skin Using Radiation”) to that of Weber including wherein the induced zone of thermal injury is centered at a depths in the range from about 0.5 to 1.0 mm beneath the surface of the skin (Col. 6, line 61Col. 7, line 3) and that wrinkles are best treated at a target region between 100 microns and 1.3 millimeters below a wrinkle in the skin (abstract). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a power range and frequency range to penetrate about 0.5 mm of skin depth in a to-be-treated skin portion, to achieve the desired treatment of the wrinkles in the skin which is a stated purpose of Weber since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
Regarding claim 4, the combination teaches the skin treatment system of claim 1, as well as Weber teaching that the active electrodes (80) may have different geometries and arrangements than depicted (Col. 9, lines 1-3) and that the electrodes (80) are arranged on the dielectric layer (Col. 8, lines 56-58), but not specifically wherein the first electrode and the second electrode have a plate shape.
With respect to the shape of the first and second electrode, it would have been obvious to ne having ordinary skill in the art before the effective filing date of the claimed invention to make the electrodes of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Regarding claim 5, the combination teaches the skin treatment device of claim 1 as well as Weber teaching wherein the pair of electrodes is plural (see for example Fig. 5).
Regarding claim 10, Weber the combination the skin treatment system of claim 1, as well as Weber teaching that the active electrodes (80) may have different geometries and arrangements than depicted (Col. 9, lines 1-3) and that the electrodes (80) are arranged on the dielectric layer (Col. 8, lines 56-58), but not specifically wherein the first electrode and the second electrode are rod-shaped, wherein the first electrode has a pointed end at an end of the first electrode facing the dielectric sheet, and wherein the second electrode has a pointed end at an end of the second electrode facing the dielectric sheet.
With respect to the shape of the first and second electrode, it would have been obvious to ne having ordinary skill in the art before the effective filing date of the claimed invention to make the electrodes of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results.
Claim(s) 2, 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber, Stern and Anderson as applied to claim 1 above, and further in view of US 2020/0360070 A1 to Niedbala et al. (Niedbala).
Regarding claims 2 and 3, Weber in view of Stern teaches the skin treatment system of claim 1, but not the skin treatment device comprising a counter configured to count the number of times the cooling fluid is sprayed through the nozzle or wherein the skin treatment device is configured to determine a remaining number of times the cooling fluid can be sprayed. Niedbala teaches a cooling device (title) where a counter tracks the number of treatments and duration of each treatment and the amount of cooling fluid used in the treatments based on the number and duration is calculated and subtracted from the full level to allow for an indication of the amount of cooling fluid remaining ([0040]). It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Weber to include the counter of Niedbala to allow for the indication of the amount of cooling fluid remaining as taught by Niedbala ([0040]).
Regarding claim 9, the combination teaches the skin treatment system of claim 2 as well as Niedbala teaching a valve (solenoid valve 866), and wherein the counting is based on a number of times of operation of the valve ([0040] which states “The input PCB 1010 calculates the amount of cryogenic material used in those treatments based on number and duration and subtracts it from the “full” level.” and [0042] which states “Input PCB 1010 provides power and logic to energize solenoid coil 1070 to open and close solenoid valve 866.”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber, Stern and Anderson as applied to claim 1 as applied above, and further in view of US 6,413,255 B1 to Stern (255 Stern).
Regarding claim 6, Weber in view of Stern teaches the skin treatment system of claim 1, but not wherein the dielectric sheet is formed of a flexible material. 255 Stern teaches an analogous skin treatment device to that of Weber including electrode (16) coated with a dielectric material (32) to form a dielectric layer (32’) which can be made of a conformable material that conforms to the surface of the skin (Col. 8, line 27-Col. 9, line 63). It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the flexible dielectric layer of 255 Stern to allow for conformance to the skin as well as other safety advantages taught by Stern (Col. 8, lines 27-Col. 9, line 63).
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
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