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
Claim 23 is objected to because of the following informalities: Line 2 recites “composed of plurality of electronic switches” and should recite --composed of a plurality of electronic switches--. 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.
Claim 17 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 17 recites the limitation "the first preset temperature" in line 6 and “the second preset temperature” in line 9. There is insufficient antecedent basis for this limitation in the claim.
Additionally claim 17 is unclear as the recitation of an “electrode sheet” appears only in the preamble of claim 1 which states “A control circuit for controlling a treatment device to output an electrical signal to an electrode sheet”. In claim 1, the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations and is therefore not considered a limitation. Therefore, it is unclear if the electrode sheet is meant to be a part of the control circuit which is contrary to the preamble of claim 1 or is another element of a larger system.
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) 11-17, 19-22 and 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 111135458 A to Liang et al. (Liang, see attached machine translation) in view of US 11,266,852 B2 to Schwarz et al. (Schwarz).
Regarding claim 11, Liang teaches a control circuit (Fig. 1) for controlling a treatment device (title “Pelvic Floor Rehabilitation Device and System”) to output an electrical signal to an electrode sheet (electrode sheet 31), comprising a radio frequency (RF) generating module (power output module 30), wherein an output end of the RF generating module is connected to the electrode sheet (Fig. 1), a low-frequency generating module (power output module 30 and pg. 5, paragraph 3 “It should be understood that the power output module 30 can output the direct current power supply, a low frequency power supply, an intermediate power supply and/or the high frequency power supply.”), wherein an output end of the low-frequency generating module is connected to the electrode sheet (Fig. 1), and a control assembly (controller 20), wherein the control assembly is respectively connected to a controlled end of the RF generating module and a controlled end of the low-frequency generating module, and the control assembly is configured to control the RF generating module and the low-frequency generating module to output a RF signal and a low-frequency signal to the electrode sheet (Fig. 1).
However, Liang does not teach a separate radio frequency generating module and a low frequency generating module.
Schwarz teaches an analogous device (Fig. 36) to that of Liang including a connection to a power supply, a power source (3601), a high frequency generator (3602), a low frequency generator (3603), a control unit (3604) and an energy delivery element (3608) and that according to an alternative embodiment only one generator providing low and high frequency may be used (Col. 29, lines 33-41). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have two generating modules, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
Regarding claim 12, the combination teaches the control circuit of claim 11 as well Liang teaching wherein the control assembly comprises a switch module (pg. 5, paragraph 2 which states in part “In the embodiment, the power output module 30 can be configured to output different power by controlling the switch so as to adjust the power output to the electrode sheet 31.”), wherein an input end of the switched module is respectively connected to the output end of the RF and low-frequency generating module, and an output end of the switch module is connected to the electrode sheet (pg. 5, paragraph 2), and a first main controller (implicit in pg. 6, last paragraph), wherein the first main controller is connected to a controlled end of the switch module, and the first main controller is configured to control the switch module to be on/off switchable, so as to control the RF generating module and the low-frequency generating module to alternately or simultaneously output signals to the electrode sheet (pg. 6, last paragraph which states in part “the power supply circuit 10 is output to the controller 20 of the power source is a direct current power supply for controller 10, temperature detection circuit 40, a pressure detection circuit 50, the impedance detection circuit 60 output power supply such as the power supply circuit 10 to the power output module 30 of the power supply can be direct current power supply or alternating current power supply and direct current power supply to the power supply output module 30 outputs, low frequency power supply, an intermediate frequency power supply and/or the high-frequency power supply to the electrode sheet 31.”).
Regarding claim 13, the combination teaches the control circuit of claim 12, but not specifically wherein the switch module comprises a first electronic switch, wherein an input end of the first electronic switch is connected to the output end of the low-frequency generating module, an output end of the first electronic switch is connected to the electrode sheet, and a controlled end of the first electronic switch is connected to the first main controller or a second electronic switch, wherein an input end of the second electronic switch is connected to the output end of the RF generating module, an output end of the second electronic switch is connected to the electrode sheet, and a controlled end of the second electronic switch is connected to the first main controller. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used first and second switches, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
Regarding claim 14, the combination teaches the control circuit of claim 13 as well as Liang teaching wherein the control assembly further comprises a temperature sensor (temperature sensor 41) connected to the first main controller, and the temperature sensor is configured to detect a temperature of the target object and output the temperature (pg. 7, paragraph 2 which states in part “a temperature detecting circuit 40; the temperature detecting circuit 40 whose input terminal is connected to the temperature sensor 41, the temperature detecting circuit 40 of the output end is connected with the first input end of the controller 20; the temperature of the temperature detection circuit 40, for detecting the target tissue via the temperature sensor 41, the feedback temperature signal to the controller 20 to adjust the power output module 30 of the output power and the output power.”), but not specifically the first main controller is further configured to control the first electronic switch to be on and the second electronic switch to be off in response to the temperature of the target area rises to a first preset temperature, and the first main controller is further configured to control the first electronic switch to be off and the second electronic switch to be on in response to that the temperature of the target area drops to a second preset temperature.
Schwarz teaches the inclusion of at least one sensor, e.g. a temperature sensor that provides information to the control unit (3604), HF generator (3602) and/or to LF generator (3603) and that the temperature sensor is used to control the parameters of the treatment). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the temperature sensor to control the parameters of the device to allow for the control of the treatment as taught by Schwarz.
Regarding claim 15, the combination teaches the control circuit of claim 14 as well as wherein the control assembly further comprise a timer (implicit in for example pg. 6, paragraph 1 that states “under the control of the controller 20, the power supply output module 30 outputs direct current power supply….0-60s, rise time, fall time 0-60s, 0-30min stimulation time, rest time 0-30min, treatment time 0-3h.”) wherein in response to that the temperature of the target area rises to the first preset temperature, the first main controller is further configured to control the second electronic switch to be off, and then control the first electronic switch to be on after a first preset time lag and/or wherein in response to that the temperature of the target area drops to a second preset temperature, the first main controller is further configured to control the first electronic switch to be off, and then control the second electronic switch to be on after a second preset time lag (pgs. 6-7). It is additionally noted that the two responses are interpreted in the alternative as the claim recites and/or and therefore in an or interpretation only one is required.
Regarding claim 16, the combination teaches the control circuit of claim 5, as well as Liang teaching that the first main controller stops working after a third preset time (pg. 8, paragraph 3 which states in part “stimulation time, rest time…treatment time, stimulation time, rest time, rise time and fall time…”).
Regarding claim 17, the combination teaches the control circuit of claim 13 as well as Liang teaching wherein the electrode sheet is divided into a plurality of groups and arrayed in the target area (pg. 5, paragraph 4 which states in part “a plurality of electrode sheets…is set on the treating head of pelvic floor rehabilitation device…”), the control assembly further configured to control the RF generating module to output the RF signal to each group of he electrode sheet sequentially until the target area reaches a first preset temperature (pg. 6, paragraph 4) and/or the control assembly further configured to control the low-frequency generating module to output the low frequency signal to each group of the electrode sheet sequentially until the target area drops to a second preset temperature (It is noted that the two responses are interpreted in the alternative as the claim recites and/or and therefore in an or interpretation only one is required.).
Regarding claims 19 and 20, the combination teaches the control circuit of claim 11 as well as wherein the RF generating module is a high-frequency power supply and a low frequency power supply (power output module 30 and pg. 5, paragraph 3 “It should be understood that the power output module 30 can output the direct current power supply, a low frequency power supply, an intermediate power supply and/or the high frequency power supply.”), but not frequencies in the ranges of 200-50MHZz and 800-1200Hz. 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 used frequences in the ranges of 200-50MHZz and 800-1200Hz, 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 21 and 22, the combination teaches the device of claims 11 and 12 as well as wherein the control assembly is an integrated microcontroller or a digital signal processor (pg. 5 which states in part “the controller 20 can be a single-chip microprocessor, a DSP, a FPGA and the like…”).
Regarding claim 25, the combination teaches the device of claim 13, but not specifically wherein a number of the first electronic switches is equal to a number of output ends of the low-frequency generating module, and a number of the second electronic switches is equal to a number of the output ends of the RF generating module. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have an equal number of switches to output ends, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art.
Regarding claim 26, the combination teaches the device of claim 13, but not wherein the first electronic switch comprises at least one selecting from a group of a triodes, a metal-oxide-semiconductor tube, and an insulated gate bipolar transistor. 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 the switch to be one of a triodes, a metal-oxide-semiconductor tube, and an insulated gate bipolar transistor as an obvious matter of engineering design choice as one having ordinary skill in the art would be reasonably apprised of the available switching mechanisms.
Regarding claim 27, the combination teaches the device of claim 14, but not specifically wherein the first preset temperature is in a range from 46-50oC and the second preset temperature is in a range from 36-40oC. 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 used the first preset temperature is in a range from 46-50oC and the second preset temperature is in a range from 36-40oC, 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 28, the combination teaches the device of claim 15, but not wherein both the first preset time lag and the second preset time lad are in a range from 0 to 2 seconds. 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 used both the first preset time lag and the second preset time lad are in a range from 0 to 2 seconds, 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 29, Liang teaches a treatment device (Fig. 1) comprising a treatment device body (elements included within the dashed lines of Fig. 1) and a treatment tip (part of electrode sheet 31 that faces/is applied to the user), an electrode sheet (electrode sheet 31) being provided at the treatment tip, and the control circuit according to claim 11 (see rejection above which is a combination of Liang in view of Schwarz) being provided in the treatment body (see Fig. 1 of Liang).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liang and Schwarz as applied to claim 1 above, and further in view of US 2007/0299488 A1 to Carr (Carr).
Regarding claim 18, Liang in view of Schwarz teaches the device of claim 11, but not a low pass filter, wherein one end of the low-pass filter is connected to the output end of the low-frequency generating module, and the other end of the low-pass filter connected to the electrode sheet, a high pass filter, wherein one end of the high-pass filter is connected to the output end of the RF generating module, and the other end of the high-pass filter is connected to the electrode sheet, or a second main controller configured to control the RF generating module and the low-frequency generating module to work.
Carr teaches an analogous device to that of Liang including a control unit (Fig. 6) that includes various high pass and low pass filters which allows the isolation of various signals being sent to and from the treatment device (10). 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 Liang to include the high and low pass filters of Carr to allow for the isolation of various signals being sent to and from the treatment device as taught by Carr ([0048]).
With respect to a second main controller configured to control the RF generating module and the low-frequency generating module to work. 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 included a second main controller, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liang and Schwarz as applied to claim 12 above, and further in view of US 10,610,696 B1 to Peled (Peled).
Regarding claim 23, Liang in view of Schwartz teaches the circuit of claim 12, but not wherein the switch modules an electronic array composed of a plurality of electronic switches which is equal to a number of the at least two electrode sheets. Peled teaches an analogous device (title “Apparatus and Method for Treating Biological Tissue”) to that of Liang including a switch module being an electronic switch array (switching matrix Fig. 27F) composed of a plurality of switches (Col. 7, lines 4-29). 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 Liang with the switching array of Peled to allow for selective delivery of the RF energy as taught by Peled (Col. 7, lines 4-29).
Regarding claim 24, the combination teaches the circuit of claim 23, as well as each RF-electrode includes switches (Col. 7, lines 4-29) but not specifically wherein a number of the electronic switches is equal to a number of the at least two electrode sheets. 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 included an equal number of electronic switches to a number of the at least two electrode sheets, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
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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