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 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 17 and 18 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 17 recites the limitation "the second high frequency power generation unit" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is suggested that this limitation be changed to --a second high frequency power generation unit--
Claim 18 recites the limitation " the NE pad" in line 5 and “the second high frequency power generation unit” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. It is suggested that these limitations be amended to --a NE pad-- and --a second high frequency power generation unit--.
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) 1-7, 9-11 and 14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2007/0088413 A1 to Weber et al. (Weber).
Regarding claim 1, Weber teaches a high frequency output device (see for example Fig. 1) comprising an electrode unit (electrode assembly 14) including one or more first electrodes and one or more second electrodes (electrode array 18 and abstract which states “The electrode structure includes at least first and second electrodes that are electrically isolated from each other.”), a first high frequency generation unit (high frequency energy source 16), a switching circuit (switch 78), and a control unit (controller 25) configured to control switching operation of the switching circuit ([0034] which states in part “The switch may be electrically coupled with the controller 25 so that, for example, one of the controls 26, 27 may be used to open and close the switch 69.”) so as to output based on power generated from the first high frequency power generation unit, a monopolar-type current, in which the same polarity is applied to the first electrodes and the second electrodes, or a bipolar-type current, in which currents of different polarities are applied ([0025] which states in part “A controller 25 has user input devices in the form of controls 26, 27 that may be used, for example, to adjust the applied voltage level to the electrode array 18 and to switch the electrode array 18 between different modes of operation, including but not limited to monopolar, bipolar, and tripolar modes of operation.”).
Regarding claim 2, Weber teaches the device of claim 1 as well as wherein the control unit allows the monopolar-type current and the bipolar-type current to be output in an output setting pattern ([0057] which states in part “the active electrodes 80 and return electrode 70 may be operated in a duty cycle in which the electrode array operated in monopolar mode (Fig. 6) for a fraction of the total treatment tip and operates in bipolar mode (Fig. 5) for the remainder of the total treatment time.”), which is selected by a user or automatically set ([0058] which states in part “The circuit or circuitry in the controller 25 is configured to cause the high frequency power supply 16 to energize electrodes 70, 80 in either a monopolar, bipolar, or tripolar mode, contingent upon a depth of energy delivery desired by a clinician. The controller may include clinician mode setting control 26…”), wherein the monopolar-type current generally increases a temperature of a current supply area (Fig. 6) and the bipolar-type current locally increases a temperature of a local area by supply energy to the local area (Fig. 5), and wherein the output setting pattern is set by a combination of high frequency characteristics as the bipolar-type current and the monopolar-type current are applied simultaneously ([0057-0058]).
Regarding claim 3, Weber teaches the device of claim 1 as well as wherein the control unit allows pulse duration and energy output intensity of each of the monopolar-type current and the bipolar-type current to be adjusted depending on a current output option selected by a user through a user interface ([0057-0058]).
Regarding claim 4, Weber teaches the device of claim 1 as well as wherein a pattern output in the output pattern setting includes at least one of a first pattern in which only the monopolar-type current is output (abstract which states in part “The electrodes may be concurrently energized with high frequency energy of the same polarity in a monopolar mode to deliver energy at a relatively deep depth into a patient’s tissue…”), a second pattern in which only the bipolar-type current is output (abstract which states in part “The electrodes may be concurrently energized with high frequency energy of the same polarity in a monopolar mode to deliver energy at a relatively deep depth into a patient’s tissue or with a high frequency energy of a different polarity in a bipolar mode to provide a shallower penetration depth.”), a third pattern in which the monopolar-type current is output and then the bipolar-type current is output ([0057] which states in part “the active electrodes 80 and return electrode 70 may be operated in a duty cycle mode in which the electrode array 18a operates in a monopolar mode (FIG. 6) for a fraction of the total treatment time and operates in bipolar mode (FIG. 5) for the remainder of the total time.”), a fourth pattern in which the bipolar-type current is output and then the monopolar-type current is output, a fifth pattern in which the bipolar-type current is output after the mono-polar type current is output, and then the monopolar-type current is output again, and a sixth pattern in which the monopolar-type current is output after the bipolar-type current is output, and then the bipolar-type current is output again.
Regarding claim 5, Weber teaches the device of claim 1 as well as wherein the first electrodes and the second electrodes are disposed in a zigzag shape (Fig. 3) to supply a current to skin, and are connected to different layers insulated from each other to supply a current (abstract which states “The electrode structure includes at least first and second electrodes that are electrically isolated from each other.”).
Regarding claim 6, Weber teaches the device of claim 4 as well as wherein in a case of the first pattern, an electrode of a first polarity of the first high frequency power generation unit is simultaneously connected to the first electrodes and the second electrodes, an electrode of a second polarity of the first high frequency power generation unit opposite to the first polarity is connected to a natural electrode (NE) pad (non-therapeutic passive or return electrode 70), and thus the control unit controls a switching operation of the switching circuit such that a current is applied between the NE pad and the first electrodes and the second electrodes ([0050]).
Regarding claim 7, Weber teaches the device of claim 4 as well as wherein in a case of the second pattern, an electrode of a first polarity of the first high frequency power generation unit is connected to the first electrodes, an electrode of a second polarity of the first high frequency power generation unit, which is opposite to the first polarity, is connected to the second electrodes, and thus the control unit controls a switching operation of the switching circuit such that a current is applied between the first electrodes and the second electrodes ([0051]).
Regarding claim 9, Weber teaches the device of claim 4 as well as wherein in a case of the third or fourth pattern, when the monopolar-type current is output, an electrode of a first polarity of the first high frequency power generation unit is connected to the first electrodes and the second electrodes through controlling a switching operation of the switching circuit, an electrode of a second polarity of the first high frequency generation unit, which is opposite to the first polarity of the first high frequency power generation unit, is connected to an NE pad (non-therapeutic passive or return electrode 70) through controlling a switching operation of the switching circuit, and thus the control unit allows a current to flow between the NE pad and the first electrodes and second electrodes, and when the bipolar-type current is output, the electrode of the second polarity of the first high frequency power generation unit is connected to the second electrodes through controlling the switching operation of the switching circuit, and thus the control unit allows a current to flow between the first electrodes and the second electrodes ([0048-0052 and 0057]).
Regarding claim 10, Weber teaches the device of claim 4 as well as wherein in a case of the third pattern, the control unit performs pre-heating to deliver energy to a lower dermis layer of skin by generally increasing a temperature of the skin by using an output of the monopolar-type current thus applied first ([0057-0058]), and locally supplies energy to the skin, on which the temperature is increased, such that the energy is concentrated on a skin tissue, by using an output of the bipolar-type current thus applied next ([0057-0058]).
Regarding claim 11, Weber teaches the device of claim 1 as well as wherein in a case of the third pattern or the fourth pattern, the control unit delivers electrical energy to skin in a horizontal direction by using an output of the bipolar-type current, and allows conductivity of the electrical energy delivered in the horizontal direction to be increased by using an output of the monopolar-type current (inherent in the application pattern which is disclosed in [0057] of Weber).
Regarding claim 14, Weber teaches the device of claim 1 as well as wherein the electrode unit is classified into an electrode group for outputting monopolar-type current and an electrode group for outputting bipolar-type current to simultaneously output the monopolar-type current and the bipolar type current for each group ([0053-0055]).
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) 8, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of US 4,171,700 to Farin (Farin).
Regarding claim 8, Weber teaches the device of claim 1, but not a second high frequency power generation unit connected to a separate electrodes from the first high frequency power generation unit to supple current. Farin teaches an analogous device (title “High-Frequency Surgical Apparatus”) to that of Weber as well an embodiment that has two high frequency generators (1, 17) provided independently of each other to produce a monopolar current and a bipolar current (Col. 3, lines 3-24) and alternatively an embodiment that has a single high-frequency generator (11’) that provides both monopolar and bipolar current. 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 two independent high frequency power generation units as an obvious matter of engineering design choice as one having ordinary skill in the art would have expected either two independent high frequency generation units or a single high frequency generation unit to perform equally well because both would perform the same function of providing monopolar and bipolar current the electrodes. Therefore, it would have been prima facia obvious to modify Weber to obtain the invention as specified in claim 8 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art.
Regarding claim 17, Weber teaches the device of claim 1 as well as wherein the control unit allows operations of the first high frequency power generation unit (Figs. 5-6) such that monopolar-type current and bipolar-type current are applied to the electrode unit either simultaneously or sequentially ([0057]), but not wherein the control unit allows also operation of a second high frequency power generation unit, which is connected to a separate electrode from the first high frequency power generation unit to supply a current, to be turned on or off such that the monopolar-type current and the bipolar-type current are applied to the electrode unit simultaneously or sequentially. Farin teaches an analogous device (title “High-Frequency Surgical Apparatus”) to that of Weber as well an embodiment that has two high frequency generators (1, 17) provided independently of each other to produce a monopolar current and a bipolar current (Col. 3, lines 3-24) and alternatively an embodiment that has a single high-frequency generator (11’) that provides both monopolar and bipolar current. 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 two independent high frequency power generation units as an obvious matter of engineering design choice as one having ordinary skill in the art would have expected either two independent high frequency generation units or a single high frequency generation unit to perform equally well because both would perform the same function of providing monopolar and bipolar current the electrodes. Therefore, it would have been prima facia obvious to modify Weber to obtain the invention as specified in claim 8 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art.
Regarding claim 18, Weber teaches the device of claim 1, as well as wherein the electrode unit includes a first electrode group (any of electrodes 80) composed of the one or more first electrodes (Figs. 4-6) and a second electrode group (any of another of electrodes 80) composed of the one or more second electrodes (Figs. 4-6), and wherein the first electrode group is connected to the first high frequency power generation unit to form a closed circuit in correspondence with an NE pad (non-therapeutic passive or return electrode 70) for an output of the monopolar-type current ([0050]), but not wherein the second electrode group is connected to a separate electrode from the first high frequency power generation unit to supply a current connected to a second high frequency power generation unit, and is an electrode for an output of the bipolar-type current. Farin teaches an analogous device (title “High-Frequency Surgical Apparatus”) to that of Weber as well an embodiment that has two high frequency generators (1, 17) provided independently of each other to produce a monopolar current and a bipolar current (Col. 3, lines 3-24) and alternatively an embodiment that has a single high-frequency generator (11’) that provides both monopolar and bipolar current. 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 two independent high frequency power generation units as an obvious matter of engineering design choice as one having ordinary skill in the art would have expected either two independent high frequency generation units or a single high frequency generation unit to perform equally well because both would perform the same function of providing monopolar and bipolar current the electrodes. Therefore, it would have been prima facia obvious to modify Weber to obtain the invention as specified in claim 8 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art.
Claim(s) 12 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of WO 2020/086552 A1 to Wootten et al. (Wootten).
Regarding claim 12, Weber teaches the device of claim 4, but not under control of the control unit, monopolar-type impedance and bipolar-type impedance of a tissue are measured immediately before and after a first shot, set power is delivered, and power is adjusted through monopolar-type impedance matching and bipolar-type impedance matching at a second shot. Wootten teaches an analogous device (title “Methods, Devices and Systems for Inducing Collagen Regeneration”) to that of Weber including a treatment electrode array and adjusting an energy or waveform amplitude or waveform period based off the threshold electrical impedance value, wherein the electrical impedance value is obtained by an invasive or non-invasive electrode ([0011]) 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 impedance measurement adjustment of Wootten to allow for to define the treatment area as taught by Wootten ([0011]).
Regarding claims 15 and 16, Weber teaches the device of claim 1, but not wherein the electrode unit is formed on a needle tip surface, or a plurality of needles formed on the first electrodes and the second electrodes, wherein when the electrode unit is formed in a type of a plurality of needles, a pattern in which the bipolar-type current and the monopolar type current are changed to each other is output, in a process of inserting the needle. Wootten teaches an analogous device (title “Methods, Devices and Systems for Inducing Collagen Regeneration”) to that of Weber including a microneedle array (110) including one or more microneedles (112) where the microneedles may be configured to penetrate the skin of the patient or can be adapted to rest upon the skin without piercing the epidermis ([0029]), with the monopolar/bipolar output of the microneedles changed in a process of inserting the needle ([0031-0034]). 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 microneedle arrangement of Wootten as an obvious matter of engineering design choice so as to provide the desired treatment. Additionally using the microneedle array (110) of Wootten provides for additional versatility if penetration is desired for treatment.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber.
Regarding claim 13, Weber teaches the device of claim 4 as well as that the control unit (controller 25) configured to cause the high frequency power generation unit (high frequency power supply 16) to energize electrodes (70, 80) in either a monopolar, bipolar, or tripolar mode, contingent upon a depth of energy delivery desired by a clinician ([0058]). The control unit (controller 25) may include clinician mode setting control (26) separate from a power control (27) for changing which electrodes (70, 80) are energized to change a depth of energy delivered. Clinician setting control (26), which is separate from the power control (27), varies the monopolar/bipolar mode of operation of the electrodes (70, 80) for changing the depth of energy delivery into the tissue (24). Any number of different setting levels for clinician setting control (26) can be provided using digital or analog control circuits. For example, as few as two or three levels may be set using control (26), or as many as ten, fifty, one hundred, or several hundred levels may be set using control (26). However, Weber does not specifically teach the control unit lowers a resistance value of skin by using an output of the monopolar-type current thus first applied, increases a temperature of an epidermal layer by causing a current to flow locally into the epidermal layer of skin, on which the resistance is lowered, by using an output of the bipolar-type current thus second applied, and lowers impedance of the skin such that energy penetrates dermis and a fat layer of the skin, by using an output of the monopolar-type current thus third applied. 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 with the sequence as claimed as an obvious matter of engineering design choice to achieve the desired depth of treatment. This is especially true as Weber teaches that the depth of treatment is varied by using various modes of monopolar/bipolar operation of the electrodes.
Conclusion
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794