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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, 27-31, 34-42 and 49 of U.S. Patent No. 11,660,449. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require:
1. A system, comprising:
a plurality of electrodes;
one or more radiofrequency (RF) generators; and
a controller, configured to:
using one or more decision rules, treat skin of a user responsively to multiple ascertained values of at least one parameter, by iteratively:
ascertaining at least one respective value of the ascertained values,
by applying at least one of the decision rules to the ascertained value, identifying a treatment setting from among multiple treatment settings, and
causing the RF generators to cause one or more RF currents to pass, through the skin, between at least some of the electrodes in accordance with the identified treatment setting, and
modify at least one of the decision rules in response to the ascertained values (claim 1).
2. The system according to claim 1, wherein a different respective one of the RF generators is connected to each one of the electrodes (claim 2).
3. The system according to claim 1,
wherein the electrodes comprise at least three electrodes, at least one pair of the electrodes being spaced farther apart from one another than is another pair of the electrodes,
wherein the treatment settings specify respective groups of the electrodes for activation, and
wherein the controller is configured to cause the RF generators to cause the RF currents to pass between the group of the electrodes specified, for activation, by the identified treatment setting (claim 3).
4. The system according to claim 3, wherein at least some of the treatment settings specify, for activation, different respective ones of the groups (claim 4).
5. The system according to claim 3,
wherein the treatment settings further specify respective sets of phases, at least some of the treatment settings specifying different respective ones of the sets for the same one of the groups, and
wherein the controller is configured to cause the RF generators to cause the RF currents to pass between the group of the electrodes by causing the RF generators to apply respective RF signals to the group of the electrodes, the RF signals having, respectively, the set of phases specified by the identified treatment setting (claim 5).
6. The system according to claim 1, further comprising a surface shaped to define a track,
wherein at least one of the electrodes is moveable along the track,
wherein at least some of the treatment settings specify different respective inter-electrode separations, and
wherein the controller is configured to cause the RF generators to cause the RF currents to pass between the at least some of the electrodes in accordance with the identified treatment setting by:
moving the moveable electrode along the track such that the moveable electrode and another one of the electrodes are spaced apart from one another by the inter-electrode separation specified by the identified treatment setting, and
subsequently to moving the moveable electrode, causing the RF generators to cause the RF currents to pass between the moveable electrode and the other one of the electrodes (claim 6).
7. The system according to claim 1,
wherein the decision rules are represented by a mapping from multiple domains of the parameter to the treatment settings, respectively,
wherein the controller is configured to identify the treatment setting by identifying the domain to which the ascertained value belongs, and
wherein the controller is configured to modify the at least one of the decision rules by modifying at least one boundary of at least one of the domains (claim 7).
8. The system according to claim 7,
wherein the ascertained values are first ascertained values, and
wherein the domains include multiple skin-area domains corresponding to respective skin areas, each of the skin-area domains corresponding to a respective one of the skin areas by virtue of having been defined based on second ascertained values of the parameter associated with the skin area (claim 9).
9. The system according to claim 1, further comprising a temperature sensor configured to measure a temperature of the skin and to generate a temperature-sensor output responsively thereto, wherein the ascertained values include temperature-values of the temperature, and wherein the controller is configured to ascertain the temperature-values responsively to the temperature-sensor output (claim 10).
10. The system according to claim 1, further comprising an electric-current sensor configured to measure at least some of the RF currents and to generate an output responsively thereto, wherein the controller is configured to ascertain the ascertained values responsively to the output (claim 11).
11. The system according to claim 10, wherein the ascertained values include electric-current-property-values of a property of the at least some of the RF currents (claim 12).
12. The system according to claim 1, further comprising a voltage sensor configured to measure a voltage associated with at least some of the RF currents and to generate a voltage-sensor output responsively thereto, wherein the controller is configured to ascertain the ascertained values responsively to the voltage-sensor output (claim 13).
13. The system according to claim 12, wherein the ascertained values include voltage-property-values of a property of the voltage (claim 14).
14. The system according to claim 1, wherein the ascertained values include impedance-values of an impedance of the skin (claim 15).
15. The system according to claim 1, wherein the controller is further configured to cause the RF generators, prior to treating the skin, to cause a pre-treatment electric current to pass, through the skin, between any pair of the electrodes, and
wherein the controller is configured to ascertain an initial one of the ascertained values based on the pre-treatment electric current (claim 16).
16. The system according to claim 1, further comprising a server configured to communicate with the controller over a computer network, wherein the server and the controller are configured to cooperatively carry out a process that includes:
comparing a quantity derived from the ascertained values to a baseline quantity, and
responsively to the comparing, generating an output to the user (claim 17).
17. A method, comprising:
using one or more decision rules, treating skin of a user responsively to multiple ascertained values of at least one parameter, by iteratively:
ascertaining at least one respective value of the ascertained values,
by applying at least one of the decision rules to the ascertained value, identifying a treatment setting from among multiple treatment settings, and
causing one or more radiofrequency (RF) currents to pass, through the skin, between at least some of a plurality of electrodes in accordance with the identified treatment setting; and
modifying at least one of the decision rules in response to the ascertained values (claim 27).
18. The method according to claim 17, wherein the electrodes comprise at least three electrodes, at least one pair of the electrodes being spaced farther apart from one another than is another pair of the electrodes, wherein the treatment settings specify respective groups of the electrodes for activation, and wherein causing the RF currents to pass between the at least some of the electrodes comprises causing the RF currents to pass between the group of the electrodes specified, for activation, by the identified treatment setting (claim 28).
19. The method according to claim 18, wherein at least some of the treatment settings specify, for activation, different respective ones of the groups (claim 29).
20. The method according to claim 18, wherein the treatment settings further specify respective sets of phases, at least some of the treatment settings specifying different respective ones of the sets for the same one of the groups, and wherein causing the RF currents to pass between the group of the electrodes comprises causing the RF currents to pass between the group of the electrodes by causing one or more RF generators to apply respective RF signals to the group of the electrodes, the RF signals having, respectively, the set of phases specified by the identified treatment setting (claim 30).
21. The method according to claim 17, wherein at least one of the electrodes is moveable along a track, wherein at least some of the treatment settings specify different respective inter-electrode separations, and wherein causing the RF currents to pass between the at least some of the electrodes in accordance with the identified treatment setting comprises: moving the moveable electrode along the track such that the moveable electrode and another one of the electrodes are spaced apart from one another by the inter-electrode separation specified by the identified treatment setting; and subsequently to moving the moveable electrode, causing the RF currents to pass between the moveable electrode and the other one of the electrodes (claim 31).
22. The method according to claim 17, wherein the decision rules are represented by a mapping from multiple domains of the parameter to the treatment settings, respectively,
wherein identifying the treatment setting comprises identifying the treatment setting by identifying the domain to which the ascertained value belongs, and
wherein modifying the at least one of the decision rules comprises modifying the at least one of the decision rules by modifying at least one boundary of at least one of the domains (claim 49).
23. The method according to claim 22, wherein the ascertained values are first ascertained values, and wherein the domains include multiple skin-area domains corresponding to respective skin areas, each of the skin-area domains corresponding to a respective one of the skin areas by virtue of having been defined based on second ascertained values of the parameter associated with the skin area (claim 34).
24. The method according to claim 17, wherein the ascertained values include temperature-values of a temperature of the skin (claim 35).
25. The method according to claim 17, further comprising measuring at least some of the RF currents and generating an output responsively thereto, wherein the method comprises ascertaining the ascertained values responsively to the output (claim 36).
26. The method according to claim 25, wherein the ascertained values include electric-current-property-values of a property of the at least some of the RF currents (claim 37).
27. The method according to claim 17, further comprising measuring a voltage associated with at least some of the RF currents and generating a voltage-indicating output responsively thereto, wherein the method comprises ascertaining the ascertained values responsively to the voltage-indicating output (claim 38).
28. The method according to claim 27, wherein the ascertained values include voltage-property-values of a property of the voltage (claim 39).
29. The method according to claim 17, wherein the ascertained values include impedance-values of an impedance of the skin (claim 40).
30. The method according to claim 17, further comprising, prior to treating the skin, causing a pre-treatment electric current to pass, through the skin, between any pair of the electrodes,
wherein the method comprises ascertaining an initial one of the ascertained values based on the pre-treatment electric current (claim 41).
31. The method according to claim 17, further comprising:
comparing a quantity derived from the ascertained values to a baseline quantity; and responsively to the comparing, generating an output to the user (claim 42).
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 1-16 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.
In claim 1, the antecedent basis for the limitation of “the RF generators” in line 10 seems indefinite. Claim 1 recites “one or more radiofrequency (RF) generators” in line 3. Therefore, more than one RF generator is made optional by the term “one or more” in line 3, which is inconsistent with line 10 of claim 1 that requires a plurality of RF generators. Similarly, claim 2 recites the limitation of “a different respective one of the RF generators” in line 1, which would require having a plurality of RF generators. Examiner suggests positively reciting ”a plurality of RF generators” in line 3 of claim 1. For the purpose of examination, the claims have been interpreted as having “a plurality of RF generators.”
Claim Rejections - 35 USC § 103
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 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 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.
Claims 1-14, 16-29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Azar et al. (Publication No. US 2008/0183251 A1, hereinafter “Azar”, cited by Applicant) in view of Friedrichs et al. (Publication No. EP 2469699 A2, hereinafter “Friedrichs”, cited by Applicant).
Regarding claims 1 and 17 , Azar discloses a system and method, comprising:
a plurality of electrodes (par. [0014]: …a plurality of electrodes…);
one or more radiofrequency (RF) generators (Figs. 1 and 2, (4) and par. [0014]: …a plurality of electrodes electrically connectable to the RF electromagnetic energy generating unit for applying RF electromagnetic energy to the skin); and
a controller (Figs. 1 and 2, (8) and par. [0014]: …and at least one controller unit operatively connected to the at least one RF electromagnetic energy generating unit for controlling the application of electromagnetic energy by the at least one RF electromagnetic energy generating unit…)
causing the RF generators to cause one or more RF currents to pass, through the skin, between at least some of the electrodes in accordance with the identified treatment setting (par. [0024]: …the at least one controller is configured for processing signals received by the at least one sensor to obtain processed data and for performing based on the data one or more actions selected from, terminating the application of RF electromagnetic energy to the skin through one or more groups of the electrodes, initiating the application of RF electromagnetic energy to the skin through one or more groups of the electrodes, terminating the application of RF electromagnetic energy to the skin through at least a first group of the electrodes and initiating the application of RF electromagnetic energy to the skin through at least a second group of electrodes different than the first group of electrodes), and
While Azar discloses a controller (Fig. 1 and 2) that allows selection of treatment parameters based on skin condition (pars. [0021]-[0023], [0098], and [0111]) it fails to disclose
a controller, configured to:
using one or more decision rules, treat skin of a user responsively to multiple ascertained values of at least one parameter, by iteratively: ascertaining at least one respective value of the ascertained values,
by applying at least one of the decision rules to the ascertained value, identifying a treatment setting from among multiple treatment settings, and
modify at least one of the decision rules in response to the ascertained values
However Friedrichs, in the same field of endeavor: electrosurgical generator controller for regulation of output power, discloses a controller (Fig. 1 (110), (111), (112)), configured to:
using one or more decision rules (pars. [0022]: an electrosurgical generator controller operates with near-deadbeat control to maintain a desired AC output of an electrosurgical generator, which operates in at least one of a constant voltage mode, a constant current mode, and a constant power mode., treat skin of a user responsively to multiple ascertained values of at least one parameter (par. [0022]: …an electrosurgical generator controller operates with near-deadbeat control to maintain a desired AC output of an electrosurgical generator, which operates in at least one of a constant voltage mode, a constant current mode, and a constant power mode. The mode selection is generally based on the impedance associated with the tissue being cut), by iteratively:
ascertaining at least one respective value of the ascertained values (par. [0023]: ...the load Z changes because tissue impedances vary),
by applying at least one of the decision rules to the ascertained value, identifying a treatment setting from among multiple treatment settings (Fig. 2 and par. [0025]: …mode selector 113 compares the output voltage V.sub.out(t) and the inductor current i.sub.L(t) to "predetermined limits" (discussed in further detail herein) in order to determine the desired mode of operation of electrosurgical generator 100. …as the load impedance increases and causes the voltage to increase, the corresponding increasing output voltage triggers the transitioning of the operating mode from constant current (A) to constant power (B) to constant voltage (C). Similarly…as the load impedance decreases and causes the current to increase, the corresponding decreasing output voltage triggers the opposite transitioning from constant voltage (C) to constant power (B) to constant current (A) operating modes), and
modify at least one of the decision rules in response to the ascertained values (par. [0024]: ESG control system 110 is configured to measure power characteristics of electrosurgical generator 100, and control electrosurgical generator 100 based at least in part on the measured power characteristics. Examples of the measured power characteristics include the current through inductor 103 and the voltage at the output of DC-AC boost inverter 102) to provide the benefit of facilitating precision control of desired tissue effects during a medical procedure (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system and method of skin treatment using RF as taught by Azar, to include ascertaining tissue impedance to modify a mode of operation based on impedance, as taught by Friedrichs, in order to facilitate precision control of desired tissue effects during a medical procedure.
Regarding claim 2, the Azar and Friedrichs combination discloses the system according to claim 1, wherein a different respective one of the RF generators is connected to each one of the electrodes (Azar, Fig. 14 (280) and par. [0243]: …device 280 also includes …two RF energy generating units 270 and 272. The RF energy generating unit 270 is suitably connected to RF electrodes 258A-258D to provide RF energy to the electrodes 258A-258D and the RF energy generating unit 272 is suitably connected to RF electrodes 260A-260D to provide RF energy to the electrodes 260A-260D).
Regarding claims 3 and 18, the Azar and Friedrichs combination discloses the system according to claim 1 and the method according to claim 17, wherein the electrodes comprise at least three electrodes, at least one pair of the electrodes being spaced farther apart from one another than is another pair of the electrodes,
wherein the treatment settings specify respective groups of the electrodes for activation, and wherein the controller is configured to cause the RF generators to cause the RF currents to pass between the group of the electrodes specified, for activation, by the identified treatment setting (Azar, Fig. 13 and pars. [0014], [0252]: …the RF electrode assembly 256….may be controllably moved laterally within such slots as described hereinabove to change the distance between some or all of the RF electrodes 258A-258D).
Regarding claims 4 and 19, the Azar and Friedrichs combination discloses the system according to claim 4 and the method according to claim 18, wherein at least some of the treatment settings specify, for activation, different respective ones of the groups (pars. [0033], [0052]: … The method includes the steps of providing a plurality of electrodes for applying RF electromagnetic energy to the skin, applying RF electromagnetic energy to the skin through at least a first group of electrodes selected from the plurality of electrodes, [0248]: The application of RF energy to the skin through each of the electrode groups 258A-258D and 260A-260D may be implemented using any method of RF electrode switching described hereinabove, including but not limited to electrode pair switching, bipolar and/or tripolar electrode configurations, as disclosed hereinabove).
Regarding claim 5 and 20, the Azar and Friedrichs combination discloses the system according to claim 3 and the method according to claim 18,
wherein the treatment settings further specify respective sets of phases, at least some of the treatment settings specifying different respective ones of the sets for the same one of the groups, and
wherein the controller is configured to cause the RF generators to cause the RF currents to pass between the group of the electrodes by causing the RF generators to apply respective RF signals to the group of the electrodes, the RF signals having, respectively, the set of phases specified by the identified treatment setting (Azar, Fig. 15 (305) and pars. [0041], [0043] … the device also includes a phase shifting unit connected to at least one RF electrode and to the RF energy generating unit for shifting the phase of the RF electromagnetic waves applied to the skin through the at least a first RF electrode relative to the phase of an RF electromagnetic wave applied to the skin through at least a second RF electrode different than the first RF electrode).
Regarding claim 6 and 21, the Azar and Friedrichs combination discloses the system according to claim 1 and the method according to claim 17, further comprising a surface shaped to define a track,
wherein at least one of the electrodes is moveable along the track (Azar, Fig. 4 (68A,B), (70A,B)),
wherein at least some of the treatment settings specify different respective inter-electrode separations, and
wherein the controller is configured to cause the RF generators to cause the RF currents to pass between the at least some of the electrodes in accordance with the identified treatment setting by:
moving the moveable electrode along the track such that the moveable electrode and another one of the electrodes are spaced apart from one another by the inter-electrode separation specified by the identified treatment setting, and
subsequently to moving the moveable electrode, causing the RF generators to cause the RF currents to pass between the moveable electrode and the other one of the electrodes (Azar, Fig. 9A-C and par. [0194]: …housing 180 has three elongated (slot-like) openings 182A, 182B and 182C formed therein. Three movable RF electrodes 188A, 188B and 188C are movably disposed in the openings 182A, 182B and 182C, respectively…Each of the electrodes 188A, 188B and 188C may be and controllably moved laterally along the length of the respective opening in which the electrode is disposed. For Example, the RF electrode 188A may be controllably moved to any desired position along the opening 182A. The other RF electrodes 188B and 188C may each be similarly controllably moved within their respective openings 182B and 182C).
Regarding claims 7 and 22, Azar discloses the system according to claim 1 and the method according to claim 17, except wherein the decision rules are represented by a mapping from multiple domains of the parameter to the treatment settings, respectively,
wherein the controller is configured to identify the treatment setting by identifying the domain to which the ascertained value belongs, and
wherein the controller is configured to modify the at least one of the decision rules by modifying at least one boundary of at least one of the domains.
Friedrichs discloses the decision rules are represented by a mapping from multiple domains of the parameter to the treatment settings, respectively,
wherein the controller is configured to identify the treatment setting by identifying the domain to which the ascertained value belongs (par. [0022]: The mode selection is generally based on the impedance associated with the tissue being cut. Different types of tissue, such as muscle and fat, have different impedances; the types of tissue and /or tissue layers present different domains , for which impedance is measure to determine operating mode) , and
wherein the controller is configured to modify the at least one of the decision rules by modifying at least one boundary of at least one of the domains (Fig. 2 and par. [0025]: …as the load impedance increases and causes the voltage to increase, the corresponding increasing output voltage triggers the transitioning of the operating mode from constant current (A) to constant power (B) to constant voltage (C)) to provide the benefit of facilitating precision control of desired tissue effects during a medical procedure (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system and method of skin treatment using RF as taught by Azar, to include modifying settings to maintain constant power, as taught by Friedrichs, in order to facilitate precision control of desired tissue effects (e.g. the amount of surface homeostasis versus thermal spread) during a medical procedure.
Regarding claims 8 and 23, Azar discloses the system according to claims 7 and the method according to claim 22 , wherein the ascertained values are first ascertained values, and wherein the domains include multiple skin-area domains corresponding to respective skin areas,
each of the skin-area domains corresponding to a respective one of the skin areas by virtue of having been defined based on second ascertained values of the parameter associated with the skin area (par. [0022]: The mode selection is generally based on the impedance associated with the tissue being cut. Different types of tissue, such as muscle and fat, have different impedances; the characteristic value of power requires constant current for the lymphatic tissue domain and more voltage for the surface tissue domain ) to provide the benefit of facilitating precision control of desired tissue effects during a medical procedure (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system and method of skin treatment using RF as taught by Azar, to include ascertaining multiple skin-area domains (i.e. impedance) to correspond to different skin areas, as taught by Friedrichs, in order to facilitate precision control of desired tissue effects (e.g. the amount of surface homeostasis versus thermal spread) during a medical procedure.
Regarding claims 9 and 24, the Azar and Friedrichs combination disclose the system according to claim 1 and the method according to claim 17, further comprising a temperature sensor configured to measure a temperature of the skin and to generate a temperature-sensor output responsively thereto, wherein the ascertained values include temperature-values of the temperature, and wherein the controller is configured to ascertain the temperature-values responsively to the temperature-sensor output (Azar, Figs. 12A and 12B (225A), (225B) and (225C) and pars. [0061]: …the method also includes the step of terminating the application of RF energy to the skin through any electrode group selected from the at least first group of electrodes and the at least second group of electrodes if the temperature of the skin …exceeds a threshold value, [0098], [0103]: …the controller unit used in the devices may process signals received from temperature sensors (such as, but not limited to, the temperature sensors 225A, 225B and 225C of FIG. 12A-12B) to determine the temperature of the skin and to stop the application of RF energy to the skin through one or more electrode pair or electrode group when the determined skin temperature exceeds a threshold value).
Regarding claims 10, 11, 25 and 26, Azar discloses the system according to claim 1 and the method according to claim 17 , except further comprising an electric-current sensor configured to measure at least some of the RF currents and to generate an output responsively thereto, wherein the controller is configured to ascertain the ascertained values responsively to the output; and
wherein the ascertained values include electric-current-property-values of a property of the at least some of the RF currents.
Friedrichs discloses comprising an electric-current sensor configured to measure at least some of the RF currents and to generate an output responsively thereto, wherein the controller is configured to ascertain the ascertained values responsively to the output (Fig. 1 and par. [0024]: ESG control system 110 is configured to measure power characteristics of electrosurgical generator 100, and control electrosurgical generator 100 based at least in part on the measured power characteristics. Examples of the measured power characteristics include the current through inductor 103…); and
wherein the ascertained values include electric-current-property-values of a property of the at least some of the RF currents (pars. [0024]: …the measured power characteristics include the current through inductor 103…, [0035]: i.sub.L(t) is measured with a sensor and not an estimated value) for providing the benefit of operating using constant power output and/or return to using constant power output as quickly as possible if there is deviation (par. [0024]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system and method of skin treatment using RF as taught by Azar, to include measuring power characteristics including voltage and current, as taught by Friedrichs, in order to operate using constant power output and/or return to using constant power output as quickly as possible if there is deviation.
Regarding claims 12, 13, 27 and 28, Azar discloses the system according to claims 1, and the method according to claim 17, except further comprising a voltage sensor configured to measure a voltage associated with at least some of the RF currents and to generate a voltage-sensor output responsively thereto, wherein the controller is configured to ascertain the ascertained values responsively to the voltage-sensor output; and
wherein the ascertained values include voltage-property-values of a property of the voltage.
Friedrichs discloses a voltage sensor configured to measure a voltage associated with at least some of the RF currents and to generate a voltage-sensor output responsively thereto, wherein the controller is configured to ascertain the ascertained values responsively to the voltage-sensor output (par. [0033]: …the voltage-mode control involves measuring the output voltage v.sub.out(t) of DC-AC boost circuit 102 with a sensor network, feeding the sensed output voltage .sub.Vout(t) to a control loop in voltage-mode controller 312, and adjusting the converter's duty cycle command based on the relative difference between the measured output voltage .sub.Vout(t) and the reference output voltage V.sub.max); and
wherein the ascertained values include voltage-property-values of a property of the voltage (Fig. 1 and par. [0024]: …the measured power characteristics include…the voltage at the output of DC-AC boost inverter 102) for providing the benefit of operating using constant power output and/or return to using constant power output as quickly as possible if there is deviation (par. [0024]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system and method of skin treatment using RF as taught by Azar, to include measuring power characteristics including voltage, as taught by Friedrichs, in order to operate using constant power output and/or return to using constant power output as quickly as possible if there is deviation.
Regarding claims 14 and 29, the Azar and Friedrich combination discloses the system according to claim 1 and the method according to claim 17, wherein the ascertained values include impedance-values of an impedance of the skin (Azar, par. [0331] The RF electrode assembly may (optionally) include any number and type of sensors and/or switching mechanisms… including impedance sensing based electrical sensors and the like, as is known in the art).
Regarding claims 16 and 31, Azar discloses all of the system according to claim 1, and the method of claim 17 except further comprising a server configured to communicate with the controller over a computer network, wherein the server and the controller are configured to cooperatively carry out a process that includes: comparing a quantity derived from the ascertained values to a baseline quantity, and responsively to the comparing, generating an output to the user.
Friedrichs discloses comprising a server configured to communicate with the controller over a computer network, wherein the server and the controller are configured to cooperatively carry out a process that includes: comparing a quantity derived from the ascertained values to a baseline quantity, and responsively to the comparing, generating an output to the user (par. [0033]: …the voltage-mode control involves measuring the output voltage v.sub.out(t) of DC-AC boost circuit 102 with a sensor network, feeding the sensed output voltage .sub.Vout(t) to a control loop in voltage-mode controller 312, and adjusting the converter's duty cycle command based on the relative difference between the measured output voltage .sub.Vout(t) and the reference output voltage V.sub.max) to provide the benefit of facilitating precision control of desired tissue effects during a medical procedure (par. [0006]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system and method of skin treatment using RF as taught by Azar, to include comparing ascertained values to a baseline value for responsive output, as taught by Friedrichs, in order to facilitate precision control of desired tissue effects (e.g. the amount of surface homeostasis versus thermal spread) during a medical procedure.
Claims 15 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Azar and Friedrichs as applied to claims 1-14, 16-29 and 31 above, and further in view of Palero et al. (WO 2016/162234 A1, hereinafter, "Palero", cited by Applicant).
Regarding claims 15 and 30, the Azar and Friedrichs combination discloses the system according to claim 1 and the method according to claim 28, wherein the controller is further configured to cause the RF generators, prior to treating the skin, to cause a pre-treatment electric current to pass, through the skin, between any pair of the electrodes, and wherein the controller is configured to ascertain an initial one of the ascertained values based on the pre-treatment electric current (Abstract, pg. 4, lns. 10-16: …a controller programmed such that, during operation, the controller, before activating the r.f. generator to apply the r.f. treatment signal…measure an initial skin impedance (Zo) between the r.f. treatment electrode and the return electrode, wherein the treatment settings determiner is programmed such that, during operation, the treatment settings determiner determines the treatment settings depending on the measured initial skin impedance (Zo)) for the purpose determining, in advance, i.e. before the actual treatment, the appropriate r.f. treatment settings accurately enough to avoid undesired skin damage during the treatment (pg. 5, lns. 7-11).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system and method of RF skin treatment using decision rules as taught by Azar and Friedrichs, to include artificial intelligence approaches, as taught by Palero, in order to apply patient-specific data for treatment of the patient.
Conclusion
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/AAA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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