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.
Claim Objections
Claim7 objected to because of the following informalities: Line 2 recites “adjusting cooling quantity” and should recite --adjusting a cooling quantity--. 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 8 and 9 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 8 recites the limitation "the cooling quantity" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is believed that this claim should be dependent from claim 7 which recites “adjusting cooling quantity” and has been interpreted as such for the purpose of the application of prior art.
Claim 9 is necessarily rejected as being dependent on rejected claim 8.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2021/0228899 A1 to Nebrigic et al. (Nebrigic).
Regarding claim 1, Nebrigic teaches a body contouring method (title “Tissue Treatment Apparatus and Systems with Pain Mitigation and Methods for Mitigating Pain During Tissue Treatments”) using radio frequency energy ([0027] which states in part “the treatment apparatus 10 is adapted to non-invasively and non-ablatively deliver electromagnetic energy in a high frequency band of the electromagnetic spectrum, such as the radiofrequency (RF) band, to a region of a patient's tissue. The delivered energy heats the tissue to a targeted temperature range. The elevation in temperature may produce for example, changes in collagen fibers that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”) comprising attaching an electrode pad (treatment electrode 20) comprising a plurality of electrodes (active electrodes 24, 26, 28, 30) to skin ([0028] which states in part “The treatment electrode 20, which has a portion that directly contacts the skin surface, may assume the representative form of an electrically-insulating substrate 22 and a plurality of active electrodes 24, 26, 28, 30 carried on the electrically-insulating substrate 22. Each of the active electrodes 24, 26, 28, 30 can be individually powered to deliver electromagnetic energy to the tissue.”), heating tissue by transferring the RF energy through the electrode pad ([0027] which states in part “The delivered energy heats the tissue to a targeted temperature range. The elevation in temperature may produce for example, changes in collagen fibers that achieve a desired treatment result, such as removing or reducing wrinkles and otherwise tightening the skin to thereby improve the appearance of a patient receiving the treatment.”), and cooling skin being in close-contact with the plurality of electrodes and overheated differently according to areas ([0047] which states in part “The cooling creates a reverse thermal gradient in the tissue such that the temperature of the tissue at and near the skin surface is cooler than the temperature of the tissue deeper within the epidermis or dermis. As a result, the high frequency energy delivered to the tissue fails to heat all or a portion of the patient's epidermis to a temperature sufficient to cause significant epidermal thermal damage. Depths of tissue that are not significantly cooled by pre-cooling will warm up to therapeutic temperatures, which cause a desired therapeutic effect. The amount and/or duration of pre-cooling may be used to select the protected depth of untreated tissue. The cryogen delivered by the control valve in the treatment tip 14 may also be used to cool portions of the tissue during and/or after heating by the high frequency energy transferred from the treatment electrode 20. Post-cooling may prevent or reduce heat delivered deeper into the tissue from conducting upward and heating shallower tissue regions, such as the epidermis, to temperatures which could thermally damage shallower tissue regions even though external energy delivery to the targeted tissue has ceased.”).
Regarding claim 2, Nebrigic teaches the method of claim 1 as well as wherein the cooling the overheated skin is selectively performed while and and/or after the heating the tissue ([0047] see excerpt cited in claim 1).
Regarding claim 3, Nebrigic teaches the method of claim 2 as well as wherein the cooling the overheated skin is performed by indirectly cooling some among the plurality of electrodes ([0047] which states in part “A control valve (not shown) in either the treatment tip 14 or handpiece 12 is used to deliver a cryogen spray to the back side of the treatment electrode 20 for controlling the temperature of the treatment electrode 20.”).
Regarding claim 4, Nebrigic teaches the method of claim 3 as well as wherein the cooling the overheated skin is performed by spraying a refrigerant toward the electrode targeted for cooling ([0047] see excerpt cited in claim 3).
Regarding claim 12, Nebrigic teaches the method of claim 2 as well as wherein the cooling the overheated skin is performed based on temperature values of the skin, which are calculated using values measured by temperature sensors (38) provided in the electrode pad ([0061] which states “The system controller 18 monitors a combination of inputs, such as temperatures, power levels and delivery duration, to precisely and safely control the high frequency energy and cooling delivery to each treatment site in the grid. During treatment using the energized active electrode 24, the handpiece 12 and system controller 18 cooperate to process information received from the treatment tip 14 about skin temperature, skin contact, treatment force, and/or pressure against the skin; cooling system function,; and other types of relevant data in order to generate the proper high frequency signal at the generator 42 and appropriate cooling.”).
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.
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) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nebrigic in view of US 2018/0000533 A1 to Boll et al. (Boll).
Regarding claim 5, Nebrigic teaches the method of claim 4, as well as Nebrigic teaching treating different heating areas ([0058 which states in part “the physician marks the intended treatment area on the patient with a grid of removable markings that are easily wiped away post-procedure. Each discrete square in the grid corresponds approximately to the size of the portion of the treatment electrode 20 that is placed in direct contact with the skin surface. The markings operate as a placement guide on the patient's skin surface for the treatment procedure…” and [0059] which states in part “each square within the grid is sequentially treated with high frequency energy delivered from the treatment electrode 20…”) but not wherein the heating the tissue is performed with the RF energy selected between a first frequency for a first heating area and a second frequency for a second heating area.
Boll teaches an analogous method (title “Non-Invasive, Uniform and Non-Uniform RF Methods and Systems Related Applications”) including at least two individually addressable electrodes to which different treatment RF signals can be applied, the RF signals exhibiting one or more of a power, duty cycle, pulse duration, phase, and RF frequency ([0011]) where the various parameters of the RF energy can be selected depending on the desired treatment and the treatment area ([0066]). 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 between different frequencies for different areas as so as to allow for the desired treatment at that treatment area as taught by Boll ([0066]).
Regarding claim 6, the combination teaches the method of claim 5 as well as wherein the heating the tissue comprises transferring the RF energy while switching over between the first frequency and the second frequency as Nebrigic teaches transferring RF energy ([0062]) and Boll teaches individually addressable electrodes to which different treatment RF signals can be applied ([0011]) and switching between a first frequency and a second frequency based on a desired treatment at a treatment area ([0066]).
Regarding claim 7, the combination teaches the method of claim 6 as well as Boll teaching wherein the cooling the overheated skin is performed by adjusting cooling quantity differently according to the RF energy ([0097]). 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 Nebrigic to include adjusting the cooling based on the RF energy to allow for the selection of a target treatment zone as taught by Boll ([0097] which states in part “The ratio of heating can regulate the skin’s surface temperature and can be sued to adjust the distribution of heat in the skin so as to enable selection of a target treatment zone (e.g., depth).”). While Boll does not specifically discuss this adjustment with respect to RF frequency, it would have been obvious to one having ordinary skill in the art to select an appropriate amount of cooling based on frequency as an obvious matter of engineering design choice. This is especially true as Boll teaches that varying the parameters of the RF energy results in different treatment areas which necessitate different cooling to allow for the appropriate treatment area to be treated.
Regarding claim 8, the combination teaches the method of claim 7, but not wherein the cooling quantity is adjusted based on a cooling time period. 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 adjusted a cooling time period as an obvious matter of engineering design choice to provide a desired level of cooling. This is especially true as Boll teaches adjusting the cooling applied based on the RF energy supplied, and one having ordinary skill in the art would have been reasonably apprised of the ways in which such an adjustment could be achieved.
Regarding claim 9, the combination teaches the method of claim 8 as well as Nebrigic teaching wherein the cooling the overheated skin comprises selectively cooling an area, in which the edge effect is concentrated, of skin tissue when the RF energy is transferred to the skin tissue through the electrode ([0009] which states in part “an edge effect has been observed at the outer peripheral edge that causes the energy density of the high frequency energy delivered to the tissue to be non-uniform across the surface area of the treatment electrode. Specifically, the energy density is highest near the peripheral edge of the electrode. As a result, tissue proximate to the outer peripheral edge of the electrode is heated to a higher temperature than tissue proximate to the interior surface area of the electrode. The higher temperatures near the peripheral edge form hot spot thermal zones that are a highly likely source of heat-related pain perceived by the patient.” and [0060-0061]).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nebrigic and Boll as applied to claim 6 above, and further in view of US 2013/0268031 A1 to Ko et al. (KO).
Regarding claim 10, Nebrigic in view of Boll teaches the method of claim 6, but not wherein the heating the tissue comprises initial heating of transferring the Rf energy having a pre-heating frequency for pre-heating the tissue. Ko teaches an analogous method (title “ Optical Apparatus for Skin Treatment, Method for Controlling the Optical Apparatus, and Method for Skin Treatment” including an initial pre-heating of the tissue ([0050] which states in part “there was a problem in that some lesions is temporarily disappeared when the skin is cooled, for example, a capillary vessel is contracted and disappeared from the skin surface when the skin is cooled. However, according to the present invention, since the cooling is achieved on the skin surface in a state where the skin is pre-heated, the internal tissue of the skin can be maintained at a temperature higher than the normal body so that some lesions temporarily disappeared due to the cooling of the skin may be minimized.”). 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 Nebrigic to include the pre-heating step of Ko to allow for retained visualization of areas of to which treatment is desirably provided as taught by Ko ([0050]).
Regarding claim 11, the combination teaches the method of claim 10 as well as Ko teaching treating of heating the tissue up to a treatment temperature by transferring energy having a high-heating frequency after the initial heating ([0057] which states in part “the skin tissue is pre-heated without damaging the skin surface during radiating the first light, and the sufficient thermal energy is provided to the cooled skin during radiating the second light.” And [0058] which states in part “the internal tissue of the skin is mainly pre-heated by the first light, rather than the treatment for the skin directly.”). 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 Nebrigic to include the pre-heating step before the treatment heating of Ko to allow for retained visualization of areas of to which treatment is desirably provided as taught by Ko ([0050]) without damaging the skin surface ([0057-0058]).
Conclusion
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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