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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the arrangement of the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group alternately in sequence must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5-8, 11, 12 and 21-24 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.
Claims 5-8 and 21-23 recite “the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternately in sequence.” This is unclear as “arranged spatially in sequence” can be understood in spatial or temporal terms.
Claim 11 recites the limitation "the preset power range" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 is necessarily rejected as being dependent on rejected claim 11.
Claim 24 recites the limitation “the preset power range” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the language "preferably" which renders the claim indefinite because it is unclear whether the limitation(s) following the language are part of the claimed invention. See MPEP § 2173.05(d).
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, 4-8, 13-17 and 20-23 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipate by CN 112043375 A to Lei et al. (Lei, see machine translation).
Regarding claim 1, Lei teaches a radio frequency array control device (title “Radio Frequency Micro-Needle Array Control Method, Device and Radio Frequency Micro-Needle Therapeutic Apparatus”), applied to an RF therapy instrument (abstract) comprising an electrode group determination module (controller 400), configured to determine at least one target electrode group from a plurality of candidate electrodes (step S200 which states in part “determining at least one set of target coordinates from the plurality of microneedle electrodes corresponding to the coordinate”) in an RF electrode array (micro-needle array 200) according to a target output mode, a control module (switching circuit 300), configured to control an RF power supply (power supply 100) to output RF energy to the target electrode group according to a preset treatment duration (step S300 which states in part “controlling the switch switching circuit to connect the target micro-needle electrode corresponding to the at least one set of target coordinates with the power supply in the first preset time…”), so that the target electrode group transmits the RF energy to tissue, wherein the control module is also configured to return to perform a step of determining at least one target electrode group from the plurality of candidate electrodes in the RF electrode array according to the target output mode until there is no candidate electrode (pg. 10 which states in part “Specifically, the remaining selectable coordinate is the micro-needle array in removing the latest one or several times of selection or the target coordinate used in the treatment period, then removing the last selection or several times or the coordinate after the peripheral coordinate of the target coordinate selected in the treatment period is used. worth one, the number of remaining selectable coordinate can be 0, that is, all coordinate in the micro-needle array in the new target coordinate determining step cannot be used, so that the treatment period is finished, need to reload the micro-needle array of all micro-needle electrode corresponding to the coordinate to start the next period or the treatment process is finished.”), and an electrode group update module, configured to delete the target electrode group from the plurality of candidate electrodes and obtain the updated plurality of candidate electrode groups (S500 which states “obtaining all history target coordinates of the current record, S600 which states “removing the history target coordinate of the current record from the coordinate corresponding to the plurality of micro-needle electrodes, obtaining the remaining effective coordinate.” S700 which states “obtaining the peripheral coordinate of all history target coordinate, S800 which states “removing the peripheral coordinate from the residual effective coordinate, obtaining the remaining selectable coordinate), wherein the RF therapy instrument comprises the RF power supply (100), configured to output the RF energy and the RF electrode array (200), configured to be connected to the RF power supply.
Regarding claim 4, Lei teaches the RF array control device of claim 1 as well as wherein the target out mode comprises a bipolar mode (pg. 7 which states in part “wherein the polarity of the first electric polarity and the second electrode polarity are opposite”), the electrode group determination module comprises a second electrode group determination unit configured to determine two target electrode groups from the plurality of candidate electrodes of the RF electrode array according to the bipolar mode (pg. 7 which states in part “the switch switching circuit 300 based on the control signal 400, the positive and negative electrodes of the power supply 100 connected to all micro-needle electrode micro-needle array 200 in the micro-needle electrode except the target micro-needle electrode is not connected with the power supply 100; namely in the non-working state. and the power supply 100 for each group of 2 target micro-needle electrode in any one of providing positive polarity or negative polarity, and the other one for opposite negative polarity or positive polarity. namely each group of 2 target micro needle electrode of any one of the power supply 100 of the positive connection, and the other one is connected with the negative electrode of the power supply 100.”), and a first connection control nit configured to control one of the two target electrode groups to be connected to a first output end of the RF power supply, and the other to be connected to a second output end of the RF power supply (pg. 7 which states “the power supply 10 has two ports A and B, the micro-needle electrode is connected with the port A or port B, and the port A is connected with the anode, when connected with the port B is cathode. any one of the group of target micro-needle electrode in the micro-needle array 200 is connected with the port A, and the other one is connected with the port B. the other micro-needle electrode is not connected with the power supply 100 or disconnected with the power supply 100 of the connection.”).
Regarding claim 5, Lei teaches the RF array control device of claim 4 as well as wherein the plurality of candidate electrodes of the RF electrode array comprises at least one candidate first polarity electrode group and at least one candidate second polarity electrode group, and the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternatively in sequency (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), the second electrode group determination unit is further configured to determine a first polarity target electrode group from the at least one candidate first polarity electrode group in the RF electrode array and determine a second polarity target electrode group from the at least one candidate second polarity electrode group, according to the bipolar mode, and the first polarity target electrode group and the second polarity target electrode group are adjacent to each other (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), and the first connection unit is further configured to control the first polarity target electrode group to be connected to the first output end of the RF power supply, and control the second polarity target electrode group to be connected to the second output end of the RF power supply (pg. 8 which states “the first control signal is further used for controlling the switch switching circuit so that each group of target coordinate corresponding to the two micro-needle electrode of the electrode switching at least one time. for example, the first half of the first preset time, wherein one target micro-needle electrode is connected with the A port of the power supply 100 is a positive electrode, and the other one is connected with the B port of the power supply 100 is a cathode. the second half of the first preset time, the target micro-needle electrode connected with the A port is switched to connect with the B port, namely the cathode, the other target micro-needle electrode originally connected with the B port of the power supply 100 is connected with the cathode of the target micro-needle electrode is connected with the A port, becomes the anode. namely the micro-needles connected at two ends of the radio frequency power supply; the corresponding heat dispersion area will generate different, mainly caused by the power supply characteristic, thereby causing uneven heat dispersion area so as to affect the treatment effect; by switching the power supply end, it can eliminate the influence.”).
Regarding claim 6, Lei teaches the RF array control device of claim 4 as well as wherein the plurality of candidate electrodes of the RF electrode array comprises at least one candidate first polarity electrode group and at least one candidate second polarity electrode group, and the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternatively in sequency (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), the second electrode group determination unit is further configured to determine a first polarity target group from the at least one candidate first polarity electrode group in the RF electrode array and determine a second polarity electrode group from the at least one candidate second polarity electrode group, according to the bipolar mode (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), and the first connection unit is further configured to control the first polarity target electrode group to be connected to the first output end of the RF power supply, and control the second polarity target electrode group to be connected to the second output end of the RF power supply (pg. 8 which states “the first control signal is further used for controlling the switch switching circuit so that each group of target coordinate corresponding to the two micro-needle electrode of the electrode switching at least one time. for example, the first half of the first preset time, wherein one target micro-needle electrode is connected with the A port of the power supply 100 is a positive electrode, and the other one is connected with the B port of the power supply 100 is a cathode. the second half of the first preset time, the target micro-needle electrode connected with the A port is switched to connect with the B port, namely the cathode, the other target micro-needle electrode originally connected with the B port of the power supply 100 is connected with the cathode of the target micro-needle electrode is connected with the A port, becomes the anode. namely the micro-needles connected at two ends of the radio frequency power supply; the corresponding heat dispersion area will generate different, mainly caused by the power supply characteristic, thereby causing uneven heat dispersion area so as to affect the treatment effect; by switching the power supply end, it can eliminate the influence.”).
Regarding claim 7, Lei teaches the RF array control device of claim 4 as well as wherein the plurality of candidate electrodes of the RF electrode array comprises at least one candidate first polarity electrode group and at least one candidate second polarity electrode group, and the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternatively in sequency (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), the second electrode group determination unit is further configured to determine a first polarity target electrode group from the at least one candidate first polarity electrode and determine a second polarity target group from the at least one candidate second polarity electrode, according to the bipolar mode, and the first polarity target electrode group and the second polarity target electrode group are adjacent to each other (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), and the first connection control unit is further configured to control the first polarity target electrode group to be connected to the first output end of the RF power supply, and control the second polarity target electrode group to be connected to the second output end of the RF power supply (pg. 8 which states “the first control signal is further used for controlling the switch switching circuit so that each group of target coordinate corresponding to the two micro-needle electrode of the electrode switching at least one time. for example, the first half of the first preset time, wherein one target micro-needle electrode is connected with the A port of the power supply 100 is a positive electrode, and the other one is connected with the B port of the power supply 100 is a cathode. the second half of the first preset time, the target micro-needle electrode connected with the A port is switched to connect with the B port, namely the cathode, the other target micro-needle electrode originally connected with the B port of the power supply 100 is connected with the cathode of the target micro-needle electrode is connected with the A port, becomes the anode. namely the micro-needles connected at two ends of the radio frequency power supply; the corresponding heat dispersion area will generate different, mainly caused by the power supply characteristic, thereby causing uneven heat dispersion area so as to affect the treatment effect; by switching the power supply end, it can eliminate the influence.”).
Regarding claim 8, Lei teaches the RF array control device of claim 4 as well as wherein the plurality of candidate electrodes of the RF electrode array comprises at least one candidate first polarity electrode group and at least one candidate second polarity electrode group, and the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternatively in sequency (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), the second electrode determination unit is further configured to determing a first polarity target electrode group from the at least one candidate first polarity electrode and determine a second polarity electrode group from the at least one candidate second polarity electrode, according to the bipolar mode (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), and the first connection control unit is further configured to control the first polarity target electrode group to be connected to the first output end of the RF power supply, and control the second polarity target electrode group to be connected to the second output end of the RF power supply (pg. 8 which states “the first control signal is further used for controlling the switch switching circuit so that each group of target coordinate corresponding to the two micro-needle electrode of the electrode switching at least one time. for example, the first half of the first preset time, wherein one target micro-needle electrode is connected with the A port of the power supply 100 is a positive electrode, and the other one is connected with the B port of the power supply 100 is a cathode. the second half of the first preset time, the target micro-needle electrode connected with the A port is switched to connect with the B port, namely the cathode, the other target micro-needle electrode originally connected with the B port of the power supply 100 is connected with the cathode of the target micro-needle electrode is connected with the A port, becomes the anode. namely the micro-needles connected at two ends of the radio frequency power supply; the corresponding heat dispersion area will generate different, mainly caused by the power supply characteristic, thereby causing uneven heat dispersion area so as to affect the treatment effect; by switching the power supply end, it can eliminate the influence.”).
Regarding claims 13 and 14, Lei teaches the RF array control device of claim 1 as well as wherein the number of candidate electrodes in each candidate electrode group is N, wherein N is between 1 and 25 (see for example pg. 7 starting at “for example, for 7*7 micro-needle array…”), the number of electrodes in each candidate electrode group is the same (see for example pg. 9 which states in part “if a group of target micro-needle electrode is (0, 0) and (0, 6), and the other group is (0, 2) and (3, 5).”).
Regarding claim 15, Lei teaches a radio frequency therapy instrument (pg. 5 which states in part “The radio frequency micro-needle therapeutic apparatus…”) comprising an RF power supply (100), configured to output RF energy, an RF electrode array (200), connected to the RF power supply, and the RF array control device according to claim 1 (see rejection of claim 1 above).
Regarding claim 16, Lei teaches a method for delivering radio frequency energy into tissue (title “Radio Frequency Micro-Needle Array Control Method, Device and Radio Frequency Micro-Needle Therapeutic Apparatus”), the energy being delivered by the radio frequency therapy instrument of claim 15 (see rejection of claim 15 above), the treatment method comprising using the RF therapy instrument to deliver RF energy from each electrode group from an entire electrode array into the tissue at one or more times (pg. 7 from “step 300” through pg. 9 “process is finished.”), wherein the entire electrode array is divided into multiple electrode groups, each electrode group comprises one or multiple electrodes (pg. 7 from “step 300” through pg. 9 “process is finished.”).
Regarding claim 17, Lei teaches the treatment method of claim 16 as well as determining at least one target electrode group from a plurality of candidate electrodes in an RF electrode array according to a target output mode (step S200 which states in part “determining at least one set of target coordinates from the plurality of microneedle electrodes corresponding to the coordinate”), controlling an RF power supply (100) to output RF energy to the target electrode group according to a preset treatment duration (step S300 which states in part “controlling the switch switching circuit to connect the target micro-needle electrode corresponding to the at least one set of target coordinates with the power supply in the first preset time…”), so that the target electrode group transmits the RF energy to the tissue of a patient, deleting the target electrode group from the plurality of candidate electrodes and obtaining the updated plurality of candidate electrode groups (S600 which states “removing the history target coordinate of the current record from the coordinate corresponding to the plurality of micro-needle electrodes, obtaining the remaining effective coordinate.”), and returning to perform a step of determining at least one target electrode group from the plurality of electrodes in the Rf electrode array according to the target output mode until there is no candidate electrode (pg. 7 from “step 300” through pg. 9 “Step S200: the adaptive transformation is as follows: step S200’, determining at least one set of target coordinates from the remaining effective coordinates”)
Regarding claim 20, Lei teaches the treatment method of claim 17 as well as wherein when the target mode is a bipolar mode pg. 7 which states in part “wherein the polarity of the first electric polarity and the second electrode polarity are opposite”), wherein determining at least one target electrode group from the candidate electrodes in the RF electrode array according to the target output mode comprises determining two target electrode groups from the plurality of candidate electrodes of the RF electrode array (pg. 7 which states in part “the switch switching circuit 300 based on the control signal 400, the positive and negative electrodes of the power supply 100 connected to all micro-needle electrode micro-needle array 200 in the micro-needle electrode except the target micro-needle electrode is not connected with the power supply 100; namely in the non-working state. and the power supply 100 for each group of 2 target micro-needle electrode in any one of providing positive polarity or negative polarity, and the other one for opposite negative polarity or positive polarity. namely each group of 2 target micro needle electrode of any one of the power supply 100 of the positive connection, and the other one is connected with the negative electrode of the power supply 100.”) and controlling one of the two target electrode groups to be connected to a first output end of the RF power supply, and controlling the other to be connected to a second output end of the RF power supply (pg. 7 which states “the power supply 10 has two ports A and B, the micro-needle electrode is connected with the port A or port B, and the port A is connected with the anode, when connected with the port B is cathode. any one of the group of target micro-needle electrode in the micro-needle array 200 is connected with the port A, and the other one is connected with the port B. the other micro-needle electrode is not connected with the power supply 100 or disconnected with the power supply 100 of the connection.”).
Regarding claim 21, Lei teaches the treatment method of claim 20 as well as wherein the plurality of candidate electrodes of the RF electrode array comprises at least one candidate first polarity electrode group and at least one candidate second polarity electrode group, and the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternatively in sequency (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), wherein determining two target electrode groups from the plurality of candidate electrodes of the RF electrode array comprises determining a first polarity target electrode group from the at least one candidate first polarity electrode group in the RF electrode array and determining a second polarity target electrode group from the at least one candidate second polarity electrode group, and the first polarity target electrode group and the second polarity target group are adjacent to each other pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), and wherein connecting one of the two target electrode groups to a first output end of the RF power supply, and connecting the other to a second output end of the RF power supply comprises controlling the first polarity target electrode group to be connected to the first output end of the RF power supply, and controlling the second polarity target electrode group to be connected to the second output end of the RF power supply (pg. 8 which states “the first control signal is further used for controlling the switch switching circuit so that each group of target coordinate corresponding to the two micro-needle electrode of the electrode switching at least one time. for example, the first half of the first preset time, wherein one target micro-needle electrode is connected with the A port of the power supply 100 is a positive electrode, and the other one is connected with the B port of the power supply 100 is a cathode. the second half of the first preset time, the target micro-needle electrode connected with the A port is switched to connect with the B port, namely the cathode, the other target micro-needle electrode originally connected with the B port of the power supply 100 is connected with the cathode of the target micro-needle electrode is connected with the A port, becomes the anode. namely the micro-needles connected at two ends of the radio frequency power supply; the corresponding heat dispersion area will generate different, mainly caused by the power supply characteristic, thereby causing uneven heat dispersion area so as to affect the treatment effect; by switching the power supply end, it can eliminate the influence.”).
Regarding claim 22, Lei teaches the treatment method of claim 20 as well as wherein the plurality of candidate electrodes of the RF electrode array comprises at least one candidate first polarity electrode group and at least one candidate second polarity electrode group, and the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternatively in sequency (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), wherein determining two target electrode groups from the plurality of candidate electrodes of the RF electrode array comprises determining a first polarity target electrode group from the at least one candidate first polarity electrode group in the RF electrode array and determining a second polarity target electrode group from the at least one candidate second polarity electrode group (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), and controlling the first polarity target electrode group to be connected to the first output end of the RF power supply, and controlling the second polarity target electrode group to be connected to the second output end of the RF power supply (pg. 8 which states “the first control signal is further used for controlling the switch switching circuit so that each group of target coordinate corresponding to the two micro-needle electrode of the electrode switching at least one time. for example, the first half of the first preset time, wherein one target micro-needle electrode is connected with the A port of the power supply 100 is a positive electrode, and the other one is connected with the B port of the power supply 100 is a cathode. the second half of the first preset time, the target micro-needle electrode connected with the A port is switched to connect with the B port, namely the cathode, the other target micro-needle electrode originally connected with the B port of the power supply 100 is connected with the cathode of the target micro-needle electrode is connected with the A port, becomes the anode. namely the micro-needles connected at two ends of the radio frequency power supply; the corresponding heat dispersion area will generate different, mainly caused by the power supply characteristic, thereby causing uneven heat dispersion area so as to affect the treatment effect; by switching the power supply end, it can eliminate the influence.”).
Regarding claim 23, Lei teaches the treatment method of claim 20 as well as wherein the plurality of candidate electrodes of the RF electrode array comprises at least one candidate first polarity electrode group and at least one candidate second polarity electrode group, and the at least one candidate first polarity electrode group and the at least one candidate second polarity electrode group are arranged alternatively in sequency (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), wherein determining two target electrode groups from the plurality of candidate electrodes of the RF electrode array comprises determining a first polarity target electrode group from the at least one candidate first polarity electrode and determining a second polarity target electrode group from the at least one candidate second polarity electrode, according to the bipolar mode (pg. 7 from “step 300” through pg. 9 “corresponding to the coordinate is (3, 0) and (3, 1).”), and controlling the first polarity target electrode group to be connected to the first output end of the RF power supply, and controlling the second polarity target electrode group to be connected to the second output end of the RF power supply (pg. 8 which states “the first control signal is further used for controlling the switch switching circuit so that each group of target coordinate corresponding to the two micro-needle electrode of the electrode switching at least one time. for example, the first half of the first preset time, wherein one target micro-needle electrode is connected with the A port of the power supply 100 is a positive electrode, and the other one is connected with the B port of the power supply 100 is a cathode. the second half of the first preset time, the target micro-needle electrode connected with the A port is switched to connect with the B port, namely the cathode, the other target micro-needle electrode originally connected with the B port of the power supply 100 is connected with the cathode of the target micro-needle electrode is connected with the A port, becomes the anode. namely the micro-needles connected at two ends of the radio frequency power supply; the corresponding heat dispersion area will generate different, mainly caused by the power supply characteristic, thereby causing uneven heat dispersion area so as to affect the treatment effect; by switching the power supply end, it can eliminate the influence.”).
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) 2, 3, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lei in view of EP 2 366 352 A1 to EP 2366352 A1 to Mulier et al. (Mulier).
Regarding claims 2 and 3, Lei teaches the RF array control device of claim 1, but not wherein the RF therapy instrument further comprises a negative plate detachable connected to the RF power supply, the target output mode comprising a unipolar mode, a first electrode group determination unit configured to determine one target electrode from the plurality of candidate electrodes in the RF electrode array according to the unipolar mode, and a first connection control unit configured to control the one target electrode group to be connected to one end of the RF power supply, and control the other end of the RF power supply to be connected to the negative plate, wherein the first electrode group determination unit is further configured to determine at least one candidate electrode group from the plurality of candidate electrodes of the RF electrode array and determine the one target electrode group from the at least one candidate electrode group, according to the unipolar mode. Mulier teaches an analogous RF array control module wherein the RF therapy instrument includes a ground plate ([0050]) where the operation algorithm determines output parameters of the electrodes that will be activated as a group, the electric mode by which each group of electrodes is activated, i.e. monopolar or bipolar, which electrodes will be activated as positive and which will be activated as negative electrodes in the bipolar mode, the activation mode of the electrodes, i.e. either sequential, simultaneous or switching mode, in case of switching mode, the time interval of activation of each group of electrodes and the order in which the groups are activated in a circular movement, the power output and current strength, and the duration of total ablation procedure ([0059]). 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 Lei to also work in monopolar mode to allow for a greater breath of treatment through the use of either a monopolar or bipolar modality as taught by Mulier.
Regarding claims 18 and 19, Lei teaches the treatment method of claim 17, but not wherein the RF therapy instrument further comprises a negative plate detachable connected to the RF power supply, wherein the target mode is a unipolar mode, wherein determining at least one target electrode group from the plurality of candidate electrodes in the RF electrode array according to the target output mode comprises determining one target electrode group from the plurality of candidate electrodes in the RF electrode array according to the unipolar mode, and controlling the one target electrode group to be connected to one end of the RF power supply and controlling the other end of the RF power supply to be connected to the negative plate, wherein determining one target electrode group from the plurality of candidate electrodes in the RF electrode array according to the unipolar mode comprises determining at least one candidate electrode group from the plurality of candidate electrodes of the RF electrode array and further determining the one target electrode group from the at least one candidate electrode group. Mulier teaches an analogous RF array control module wherein the RF therapy instrument includes a ground plate ([0050]) where the operation algorithm determines output parameters of the electrodes that will be activated as a group, the electric mode by which each group of electrodes is activated, i.e. monopolar or bipolar, which electrodes will be activated as positive and which will be activated as negative electrodes in the bipolar mode, the activation mode of the electrodes, i.e. either sequential, simultaneous or switching mode, in case of switching mode, the time interval of activation of each group of electrodes and the order in which the groups are activated in a circular movement, the power output and current strength, and the duration of total ablation procedure ([0059]). 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 Lei to also work in monopolar mode to allow for a greater breath of treatment through the use of either a monopolar or bipolar modality as taught by Mulier.
Claim(s) 9-12 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lei.
Regarding claims 9 and 10, Lei teaches the RF array control device of claim 1, as well as that the preset duration may be on a millisecond level (pg. 7), but not wherein the preset time duration is between 1ms and 50ms or between 1ms and 30ms. 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 time duration between 1ms and 50ms or 1ms and 30ms, 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.
Regarding claims 11 and 12, Lei teaches the RF array control device of claim 1 as well as wherein the control module is further configured to control the RF power supply to sequentially output the RF energy to the target electrode group according to the preset treatment duration (pg. 7 from “step 300” through pg. 9 “process is finished.”) and a preset RF output power range (pg. 5 which states in part “the output frequency of the power supply 100 can 0.3MHz-100MHz” which will require a certain power range to supply), but is silent with respect to the preset RF power range being between 1W and 25W or between 1W and 15W. 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 between 1W and 25W or between 1W and 15W, 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.
Regarding claim 24, Lei teaches the treatment method of claim 17 as well as controlling the RF power supply to sequentially output the RF energy to the target electrode group to the preset treatment duration pg. 7 from “step 300” through pg. 9 “process is finished.”) and a preset RF power range (pg. 5 which states in part “the output frequency of the power supply 100 can 0.3MHz-100MHz” which will require a certain power range) to supply so that the target electrode group transmits the RF energy to the target area, but not wherein the preset RF output power range is between 1W and 25W or between 1W and 15W. 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 between 1W and 25W or between 1W and 15W, 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.
Conclusion
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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