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 .
Claim Rejections - 35 USC § 112
Claim 6 is 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 6 recites the limitation “Wherein the first switch switching circuit and the second switch switching circuit are one same switch switching circuit….. and switchably connect the therapeutic electrode and/or the return electrode to the first interface and the second interface respectively.” The sentence “Wherein the first switch switching circuit and the second switch switching circuit are one same switch switching circuit” lacks definitiveness, making the scope of the claim indefinite. It is unclear as to whether both the first and second circuits are required components of the system or if the system only requires one circuit to switch between the unipolar and bipolar mode, since the claim states that the first switching circuit and the second switch switching circuit are one same switch switching circuit. See MPEP 2173.05(a)(II).
Claim 11 recites the limitation “…a heat quantity generated by connecting any one of the plurality of electrode slices of the therapeutic electrodes to the first interface is W1, and a heat quantity generated by connecting any one of the plurality of electrode slices of the therapeutic electrodes to the second interface is W2, wherein W1/W2 is not less than 0.5 and not greater than 2.0” and Claim 13 recites the limitation “……in the combined mode, during one therapeutic process, a heat quantity generated in the unipolar mode is W3, and a heat quantity generated in the bipolar mode is W4, wherein W3/W4 is not less than 0.5 and not greater than 2.0.” The sentences above lack definitiveness, making the scope of the claim indefinite. It is unclear as to what W1-W4 is, since the heat quantity discussed in the specification is unitless. Paragraphs [0039]-[0042] and [0100]-[0102] discuss obtaining temperature readings of the electrode slice, but do not specifically reference the temperature readings when discussing the heat quantity (as presented in paragraphs [0033] and [0037]). Ultimately, it is unclear what unit of measure applicant is defining with the term “heat quantity.”
For examination purposes, the examiner is interpreting the heat quantity as the ratio between temperature readings being no less than 0.5 and no greater than 2.0.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 4-6, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 111529056 A to Lei *It is noted that while the CN is being used for the actual rejection, the application US 2023/0293221 A1 is being used for translation/citations purposes in the explanation of the rejection of all claims below.
Regarding claims 1 and 15, Lei teaches:
An RF therapeutic apparatus comprising a multi-pole radio frequency (RF) device (see abstract (emphasis on lines 1-3), para [0005] , and para [0012]-[0013]), comprising:
an RF power supply provided with a first interface and a second interface, wherein an electric polarity of the first interface is opposite to an electric polarity of the second interface (see abstract, annotated fig. 1, para [0015]-[0016], para [0018]-[0025], and para [0052]);
a return electrode (see fig. 1, 20);
a therapeutic electrode/microneedle electrode provided with a plurality of electrode slices/needles (see annotated fig. 1 below, para [0046], and para [0049]);
a first switch switching circuit provided with a first input terminal electrically connected to the first interface and a second input terminal electrically connected to the second interface (see annotated fig. 1 below),
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wherein a first output terminal of the first switch switching circuit is electrically connected to the therapeutic electrode/microneedle electrode(s),
a second output terminal of the first switch switching circuit is switchably and electrically connected to the return electrode or part of the plurality of the electrode slices (see the second version of annotated fig. 1 below and the first version of annotated fig. 1 above),
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and
the first output terminal and the second output terminal are respectively connected to the first input terminal and the second input terminal (see second version of annotated fig. 1 above);
and/or:
a second switch switching circuit, wherein a third input terminal of the second switch switching circuit is connected to the first interface, a fourth input terminal of the second switch switching circuit is connected to the second interface, and the second switch switching circuit is provided with a third output terminal and a fourth output terminal;
and a controller (see annotated fig. 1, 50);
wherein in response to that the multi-pole RF device comprises the first switch switching circuit, the controller comprises a unipolar mode and a bipolar mode (see abstract, para 0006-0013);
in the unipolar mode, the controller is configured to control the first output terminal to be electrically connected to the therapeutic electrode/microneedle electrode, and control the second output terminal to be electrically connected to the return electrode, and in the bipolar mode, the controller is configured to control the first output terminal and the second output terminal to be connected to at least one of the plurality of electrode slices respectively (see para [0018]-[0026]).
and in response to that the multi-pole RF device comprises the second switch switching circuit, the controller is configured to control the third input terminal to be switchably connected to the third output terminal, and control the fourth input terminal to be switchably connected to the fourth output terminal (does not apply – limitations satisfied using the first switch switching circuit).
Regarding claims 2-3, the rejection of claim 1 above relies only on the claimed first switching circuit, and does not need to show the second switching circuit (since the two are claimed in the alternative "and/or"). Since claims 2-3 apply to the alternative second switch switching circuit, these claims are rejected under the same reasoning as previously presented above.
Regarding claim 4, Lei teaches:
The multi-pole RF device according to claim 1, wherein in response to that the multi-pole RF device comprises the first switch switching circuit, controlling, by the controller, the first output terminal and the second output terminal of the first switch switching circuit to be switched at least once between the unipolar mode and the bipolar mode ( para [0012]-[0016] and para [0018]-[0025]).
Regarding claims 5, Lei teaches:
The multi-pole RF device according to claim 4, wherein the controller is configured to control the first switch switching circuit to work, controlling the first output terminal and the second output terminal of the first switch switching circuit to be switched in a second preset period between the unipolar mode and the bipolar mode (see para [0014], para [0018]-[0026], and para [0061]-[0062]).
Regarding claim 6, Lei teaches:
The multi-pole RF device according to claim 1, wherein the first switch switching circuit and the second switch switching circuit are one same switch switching circuit/one switch switching circuit (see fig. 1, 40 and para [0061] – emphasis on lines 1-16),
and the controller is configured to switch between the unipolar mode and the bipolar mode (see para [0013]),
And,
switchably connect the therapeutic electrode/microneedle electrode(s) and/or the return electrode to the first interface and the second interface respectively (see annotated fig. 1 below).
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Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over CN 111529056 A to Lei in view of US 2020/0205875 A1 to Levin et al. (hereinafter “Levin”).
Regarding claim 7, Lei teaches the device of claim 1, but does not explicitly disclose wherein a contact area of the return electrode is larger than a contact area of the therapeutic electrode.
However, Levin teaches an ablation system containing multiple electrodes configured to contact body tissue of a patient (see abstract, lines 1-4). The system (fig. 1), teaches where a contact area of the return electrode is larger than a contact area of the therapeutic electrode (see annotated fig. 1 below and para [0032]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lei with the teachings of Levin to arrive at the claimed invention, since such modification would improve the system by ensuring the thermal effect is properly generated in the ablation electrode/therapeutic electrode, ultimately properly regulating the thermal effect needed during treatment.
Claims 8, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lei in view of US 2014/0025069 A1 to Willard et al. (hereinafter “Willard”).
Regarding claim 8, Lei teaches:
A method for controlling the multi-pole RF device, applied to the multi-pole RF device according to claim 1 (see abstract),comprising:
determining a user input signal/impedance tissue reading according to different depths of regions under a skin surface (see para [0032]-[0034]), and switching between a unipolar and bipolar mode (see para [0005]-[0012], para [0026], para [0038]- emphasis on the last sentence, para [0063], para [0067], and para [0086]-[0087]),
where, when entering the unipolar mode, the first output terminal to be electrically connected to the therapeutic electrode and the second output terminal to be electrically connected to the return electrode, so as to make electric polarities of the plurality of electrode slices of the therapeutic electrode same or identical (see abstract and para [0046]), and wherein in the bipolar mode, controlling the first output terminal and the second output terminal to be connected to at least one of the electrode slices respectively, so as to make an electric polarity of at least one electrode slice of the therapeutic electrode opposite to electrical polarities of remaining electrode slices (see abstract and para [0052]), and,
providing RF therapy once the microneedle reaches a preset depth (para [0003], [0005], [0032-0035]), and switching between unipolar and bipolar mode (see para [0062]), but does not explicitly disclose the following:
wherein in response to that the user input signal is the unipolar mode signal for a relatively shallow region to be treated, entering the unipolar mode, and,
wherein in response to that the user input signal is the bipolar mode signal for a relatively deep region to be treated, entering the bipolar mode,
and wherein in response to that the user input signal is a combined mode signal for a moderate region to be treated, controlling the first output terminal and the second output terminal to be switched at least once between the unipolar mode and the bipolar mode.
However, Willard teaches a system for tissue modulation (see abstract, line 1 and para [0004]). The system (figs. 1 and 5) teach wherein, in response to that the user input signal is the unipolar mode signal for a relatively shallow region to be treated, entering the unipolar mode, and,
Wherein, in response to that the user input signal is the bipolar mode signal for a relatively deep region to be treated, entering the bipolar mode,
and wherein in response to that the user input signal is a combined mode signal for a moderate region to be treated, controlling the first output terminal and the second output terminal to be switched at least once between the unipolar mode and the bipolar mode (see abstract, fig. 2, and para [0038]-[0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lei with the teachings of Willard to arrive at the claimed invention. Such modification would improve the system by properly treating and targeting diseased tissue in each patient, ultimately providing more effective therapeutic treatment.
Regarding claim 12, Lei as modified teaches:
The method for the multi-pole RF device according to claim 8, wherein the controller is configured to control the first switch switching circuit to work, controlling the first output terminal and the second output terminal of the first switch switching circuit to be switched in a second preset period between the unipolar mode and the bipolar mode (see Lei, para [0014], para [0018]-[0026], and para [0061]-[0062]).
Regarding claim 14, Lei as modified teaches:
The method according to claim 8, further comprising:
Obtaining a temperature of the electrode slice of the therapeutic electrode,
determining whether the temperature of the electrode slice exceeds a preset safety temperature threshold, wherein in response to that the temperature of the electrode slice exceeds the preset safety temperature threshold/final warning threshold, controlling the RF power supply to stop outputting RF energy, and, wherein in response to that the temperature of the electrode slice does not exceed the preset safety temperature threshold, controlling the RF power supply to keep outputting effective RF energy (See Lei, para [0103-0104]). It is inherent that the RF energy device will continue to run if it does not exceed the safety threshold, due to the device only stopping when the final warning threshold is exceeded.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lei in view of Willard, and further in view of US 7,344,532 B2 to Goble et al. (hereinafter “Goble”).
Regarding claim 9, Lei teaches:
The method for controlling the multi-pole RF device according to claim 8 containing a bipolar and/or unipolar mode, but does not disclose wherein the device further comprises:
in the bipolar mode or the unipolar mode, controlling a connection of the third input terminal and the third output terminal being switched at least once by a connection of the fourth input terminal and the fourth output terminal.
However, Goble teaches a bipolar electrosurgical instrument comprising an electrosurgical generator for generating radio-frequency power for providing a cutting RF waveform and a coagulating RF waveform during a predetermined start setting and predetermined end setting (see abstract). The system (figs. 2, 4, and 6-7, and col. 4, lines 14-41) teaches wherein the device controls a connection of the third input terminal and the third output terminal being switched at least once by a connection of the fourth input terminal and the fourth output terminal (see fig. 2 and annotated figs. 3-4 and 6-7 below, col. 5, lines 64-67 through col. 6, lines 1-26 and 54-60, and col. 7, lines 13-46). The first input into the switch mode power supply is the control input (66A), and the second input to the switch mode power supply is the output of the voltage threshold detector (68A). Regarding the third and fourth input, these inputs are sent to the switch (45), which produces third and fourth outputs for the control of the RF cutting waveform and RF coagulating waveform at the respective first, second and third output connection for the electrodes (the first output connection (48) goes to the cutting electrode 2, while output connections 49 and 50 go to coagulating electrodes 3 and 40 shown in fig. 3 below)
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lei with the switching circuit(s) and output system of Goble to arrive at the claimed invention, since such modification would improve the system by providing more thorough treatment to the target tissue.
Regarding claim 10, Lei as modified teaches:
The method for controlling the multi-pole RF device according to claim 8 containing a bipolar and/or unipolar mode, but does not disclose wherein the device further comprises:
controlling the connection of the third input terminal the third output terminal being switched within a first preset period by the connection of the fourth input terminal and the fourth output terminal.
However, Goble teaches a bipolar electrosurgical instrument comprising an electrosurgical generator for generating radio-frequency power for providing a cutting RF waveform and a coagulating RF waveform during a predetermined start setting and predetermined end setting (see abstract). The system (figs. 2, 4, and 6-7, and col. 4, lines 14-41) teaches wherein the device controls a connection of the third input terminal and the third output terminal being switched at least once by a connection of the fourth input terminal and the fourth output terminal (see fig. 2 and annotated figs. 3-4 and 6-7 below, col. 5, lines 64-67 through col. 6, lines 1-26 and 54-60, and col. 7, lines 13-46), where controlling the connection of the third input terminal the third output terminal being switched within a first preset period/ predetermined progression or rate by the connection of the fourth input terminal and the fourth output terminal (see abstract - last sentence, col. 4, lines 41-46 and lines 52-56, col. 9, lines 46-67 and col. 10, lines 1-8). When controlling of the first input into the switch mode power supply is the control input (66A), and the second input to the switch mode power supply is the output of the voltage threshold detector (68A). Regarding the third and fourth input, these inputs are sent to the switch (45), which produces third and fourth outputs for the control of the RF cutting waveform and RF coagulating waveform at the respective first, second and third output connection for the electrodes (the first output connection (48) goes to the cutting electrode 2, while output connections 49 and 50 go to coagulating electrodes 3 and 40 shown in fig. 3 below). The switching between the cutting waveform and coagulating waveform is performed by the circuit with the third an fourth inputs and outputs as shown in fig. 7 (both lines of 60C) and fig. 10 (lines 80-81) at a specific time or predetermined period.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lei with the switching circuit(s), output system, and timing system of Goble to arrive at the claimed invention, since such modification would improve the system by providing more thorough treatment to the target tissue.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being anticipated by Lei in view of US 2011/0034915 A1 to Ibrahim et al. (hereinafter “Ibrahim”).
Regarding claim 11, Lei discloses all of the claimed invention except for maintaining a heat quantity ratio between W1 and W2 is not less than 0.5 and is not greater than 2.
However, in the same field of endeavor, RF ablation Ibrahim discloses controllably switching power to a plurality of active electrodes to maintain approximately equal temperatures at each electrode (see para [0033]) to provide an even heating of tissue and uniform ablation pattern (therefore making the ratio of heating equal to 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lei with the temperature regulation technique of Ibrahim to arrive at the claimed invention, since such modification would improve the system by ensuring the heat distribution at all electrodes are relatively equal, therefore allowing for even and effective therapeutic RF treatment when treating the diseased tissue of a patient.
Regarding claim 13, Lei discloses all of the claimed invention except for:
in the combined mode, during one therapeutic process, a heat quantity generated in the unipolar mode is W3, and a heat quantity generated in the bipolar mode is W4, wherein W3/W4 is not less than 0.5 and not greater than 2.0.
However, in the same field of endeavor, RF ablation Ibrahim discloses controllably switching power to a plurality of active electrodes to maintain approximately equal temperatures at each electrode (see para [0033]) to provide an even heating of tissue and uniform ablation pattern (therefore making the ratio of heating equal to 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Lei with the temperature regulation technique of Ibrahim to arrive at the claimed invention, since such modification would improve the system by ensuring the heat distribution at all electrodes are relatively equal, therefore allowing for even and effective therapeutic RF treatment when treating the diseased tissue of a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0256240 A1 to Bloom et al. teaches an electrosurgical system containing an RF frequency and a bipolar electrode configuration (see abstract and para 0044).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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