DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s Amendment filed January 28, 2026 (hereinafter “01/28/26 Amendment") has been entered, and fully considered. In the 01/28/26 Amendment, claims 1, 7-14, 19, & 22-25 were amended. No claims were cancelled, or newly added. Therefore, claims 1-36 remain pending in the application (with claims 26-36 withdrawn from further consideration).
3. The 01/28/26 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the Non-Final Office Action mailed 10/27/25 (“10/27/25 Action”).
4. A new claim objection, and new rejections under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
5. The prior rejection of independent claim 1 under § 102 based on U.S. Patent Application Publication No. 2006/0224152 to Behnke et al. (“Behnke”) has been updated to address the new claim limitations, and maintained.
6. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Objections
7. Claim 5 is objected to because of the following informalities:
In claim 5, line 2, the recitation of “the amount of energy” should instead recite --the actual amount of energy-- to be consistent with the recitations of amended independent claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
10. Claim 1 recites the limitation “the actual amount” in line 9. There is insufficient antecedent basis for this recitation in the claim.
11. Claims 2-25 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
12. Claim 5 recites the limitation “the patient tissue” in line 2. There is insufficient antecedent basis for this recitation in the claim.
13. Claim 6 is rejected as ultimately depending from a claim (claim 5) rejected under 35 U.S.C. 112(b).
14. Claim 7 recites the limitation “the patient tissue” in line 2. There is insufficient antecedent basis for this recitation in the claim.
15. Claims 10-16 & 19 are rejected as ultimately depending from a claim (claim 7) rejected under 35 U.S.C. 112(b).
16. Claim 10 recites the limitation “the patient tissue” in line 4. There is insufficient antecedent basis for this recitation in the claim.
17. Claim 20 recites the limitation “the patient tissue” in line 3. There is insufficient antecedent basis for this recitation in the claim.
18. Claim 20 recites the limitation “the patient” in line 5. There is insufficient antecedent basis for this recitation in the claim.
19. Claim 21 is rejected as ultimately depending from a claim (claim 20) rejected under 35 U.S.C. 112(b).
20. Claim 22 recites the limitation “the patient tissue” in line 4. There is insufficient antecedent basis for this recitation in the claim.
21. Claims 23-25 are rejected as ultimately depending from a claim (claim 23) rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
22. 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.
23. Claims 1-4, 8, 9, 17, & 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2006/0224152 to Behnke et al. (“Behnke”).
24. Regarding claim 1, Behnke discloses an electrosurgical generator comprising:
a power supply that supplies electrosurgical energy to an applicator [electrodes (16, 48) of the electrosurgical instrument - ¶[0030]] via a radio frequency (RF) output stage [see ¶[0031] (“The electrosurgical generator 10 may include a power supply (not explicitly shown) for generating energy and an output stage (not explicitly shown) for modulating the energy, such as via a waveform generator. The power supply generates energy, such as RF, microwave, ultrasound, infrared, ultraviolet, laser or thermal energy”)];
a memory [memory - ¶[0034]] that stores at least one energy quantification function [algorithm - e.g., ¶’s [0008], [0009], [0013], [0048], [0060], [0102]], the at least one energy quantification function associates actual energy delivered to tissue at a distal end of the applicator to at least one parameter of the RF output stage [e.g., voltage, current, and/or impedance - ¶’s [0036], [0037], [0047], [0048], [0060], [0102]]; and
a controller [control system (12) including control module (22) - ¶’s [0032]-[0034]] that determines the actual amount of energy delivered to a tissue surface at the distal end of the applicator based on the energy quantification function and the at least one parameter of the RF output stage [NOTE: as broadly as currently claimed, Behnke discloses determining the amount of energy to be delivered to tissue to compensate for RF energy lost in the energy-carrying components; for example, Behnke discloses that the software algorithm is used to determine phase information describing a phase difference between current and voltage waveforms output by electrosurgical generator (10), which is then used to determine the output of the electrosurgical generator and compensate for energy delivery to the operating site – see, e.g., ¶’s [0035]-[0037], [0060], and ¶[0102] (“Advantageously, the use of the phase difference information and/or the complex impedance information for the cable and/or the other components maximizes accuracy for determining characteristics related to energy delivered to the patient because the present disclosure compensates for the radiofrequency energy lost in the energy-carrying component, and delivers another amount of accurate radiofrequency energy to the patient to attribute for the energy loss. Accurate determination of characteristics related to delivered energy may be used, for example, to track energy delivery and/or tissue effect, compensate for energy losses for providing energy having desired characteristics (current, voltage, power, etc.) to the patient, etc. Furthermore, the use of the phase difference information and/or the complex impedance information advantageously contributes to obtaining an accurate measurement of the patient impedance (Zload, which is substantially equivalent to Rload), which may be altered due to factors, such as impedance of the cable and/or the other components”)], the actual amount of energy being distinct from energy measured at the RF output stage [broadly, the actual amount of energy that will ultimately be delivered to tissue differs from that initially measured at the RF output stage to compensate for the energy loss - ¶’s [0035]-[0037], [0060], and ¶[0102]].
25. Regarding claim 2, Behnke discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Behnke further discloses wherein the at least one parameter is a selected generator power setting [¶’s [0035], [0047]].
26. Regarding claim 3, Behnke discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Behnke further discloses where the at least one parameter is output power of the RF output stage, the output power determined from sampling output voltage and current of the RF output stage [e.g., ¶’s [0036], [0037]].
27. Regarding claim 4, Behnke discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Behnke further discloses an input/output interface [¶[0035] - one or more user interfaces] that receives an input for selecting the generator power setting [e.g., ¶’s [0035], [0037], [0047]].
28. Regarding claim 8, Behnke discloses all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Behnke further discloses at least one sensor [one of sensors (18)] coupled to an output of the RF output stage, the at least one sensor configured to sample voltage and/or current of the RF output of stage and provide the sampled voltage and/or current to the controller [e.g., ¶’s [0020], [0035], [0036]].
29. Regarding claim 9, Behnke discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Behnke further discloses at least one sensor [one of sensors (18)] coupled to an output of the RF output stage, the at least one sensor configured to sample voltage and/or current of the RF output stage and provide the sampled voltage and/or current to the controller [e.g., ¶’s [0020], [0035], [0036]], wherein the selected generator power setting is determined from the sampled voltage and/or current of the RF output stage [¶[0035]].
30. Regarding claim 17, Behnke discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Behnke further discloses wherein the at least one energy quantification function is selected based on a type of applicator [¶[0047]].
31. Regarding claim 18, Behnke discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Behnke further discloses wherein the at least one energy quantification function is received from the applicator upon coupling the applicator to at least one receptacle [¶[0047]].
Claim Rejections - 35 USC § 103
32. 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.
33. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
34. Claims 1-5 & 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0239024 to Ladtkow et al. (“Ladtkow”) in view of Behnke.
35. Regarding claim 1, Ladtkow teaches an electrosurgical generator comprising:
a power supply [generator (20)- ¶[0026]] that supplies electrosurgical energy to an applicator [e.g., instrument (2), or forceps (10) - ¶’s [0025], [0028], [0032]] via a radio frequency (RF) output stage [RF output stage (28) - ¶’s [0030], [0031]];
a memory [memory (26) - ¶[0033]] that stores at least one energy quantification function [algorithm - ¶’s [0009], [0035], [0043]], the at least one energy quantification function [algorithm] associates actual energy delivered to tissue at a distal end of the applicator [¶’s [0009], [0035], [0043], claim 1, - calculate energy delivered to tissue] to at least one parameter of the RF output stage [e.g., ¶’s [0034] (“output current and/or voltage”); [0043]]; and
a controller [controller (24) - ¶’s [0030], [0033]] that determines the actual amount of energy delivered to a tissue surface at the distal end of the applicator based on the energy quantification function [algorithm] and the at least one parameter of the RF output stage [e.g., ¶’s [0009], [0034],[0035], [0043]]….
Ladtkow does not, however, teach the following emphasized claim limitation:
a controller that determines the actual amount of energy delivered to a tissue surface at the distal end of the applicator based on the energy quantification function and the at least one parameter of the RF output stage, the actual amount of energy being distinct from energy measured at the RF output stage.
Behnke, in a similar field of endeavor, teaches an electrosurgical generator comprising:
a power supply that supplies electrosurgical energy to an applicator [electrodes (16, 48) of the electrosurgical instrument - ¶[0030]] via a radio frequency (RF) output stage [see ¶[0031]];
a memory [memory - ¶[0034]] that stores at least one energy quantification function [algorithm - e.g., ¶’s [0008], [0009], [0013], [0048], [0060], [0102]], the at least one energy quantification function associates actual energy delivered to tissue at a distal end of the applicator to at least one parameter of the RF output stage [e.g., voltage, current, and/or impedance - ¶’s [0036], [0037], [0047], [0048], [0060], [0102]]; and
a controller [control system (12) including control module (22) - ¶’s [0032]-[0034]] that determines the actual amount of energy delivered to a tissue surface at the distal end of the applicator based on the energy quantification function and the at least one parameter of the RF output stage [NOTE: Behnke teaches determining the amount of energy to be delivered to tissue to compensate for RF energy lost in the energy-carrying components; for example, Behnke teaches that the software algorithm is used to determine phase information describing a phase difference between current and voltage waveforms output by electrosurgical generator (10), which is then used to determine the output of the electrosurgical generator and compensate for energy delivery to the operating site – see, e.g., ¶’s [0035]-[0037], [0060], and ¶[0102], the actual amount of energy being distinct from energy measured at the RF output stage [broadly, the actual amount of energy that will ultimately be delivered to tissue differs from that initially measured at the RF output stage to compensate for the energy loss - ¶’s [0035]-[0037], [0060], and ¶[0102]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ladtkow to additionally implement the energy quantification function of Behnke, and more particularly to have the controller determine the actual amount of energy delivered to a tissue surface at the distal end of the applicator based on the energy quantification function and the at least one parameter of the RF output stage, the actual amount of energy being distinct from energy measured at the RF output stage, since such a modification provides the benefit/advantage of compensating for RF energy lost in energy-carrying system components by delivering another amount of accurate RF energy to the patient to attribute for the energy loss, thereby ensuring that energy having desired characteristics (current, voltage, power, etc.) is provided to the patient, etc., as explicitly taught by Behnke.
36. Regarding claim 2, the combination of Ladtkow and Behnke teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches wherein the at least one parameter is a selected generator power setting [¶’s [0029], [0031], [0034]].
37. Regarding claim 3, the combination of Ladtkow and Behnke teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches where the at least one parameter is output power of the RF output stage, the output power determined from sampling output voltage and current of the RF output stage [e.g., ¶[0034] (“output current and/or voltage”); [0043]].
38. Regarding claim 4, the combination of Ladtkow and Behnke teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches an input/output interface that receives an input for selecting the generator power setting [e.g., ¶[0029]].
39. Regarding claim 5, the combination of Ladtkow and Behnke teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ladtkow teaches display screens for providing a user with a variety of output information [see ¶[0029] (“The generator 20 includes suitable input controls (e.g., buttons, activators, switches, touch screen, etc.) for controlling the generator 20. In addition, the generator 20 may include one or more display screens for providing the user with variety of output information (e.g., intensity settings, "treatment complete" indicators, etc.). The controls allow the user to adjust power of the RF energy, waveform parameters (e.g., crest factor, duty cycle, etc.), and other parameters to achieve the desired waveform suitable for a particular task (e.g., coagulating, tissue sealing, intensity setting, etc.)”)].
Ladtkow does not, however, explicitly teach:
an input/output interface that displays the amount of energy delivered to the patient tissue.
However, given that a stated purpose of the algorithm of Ladtkow is for the calculation of energy delivered to tissue [e.g., Abstract; ¶’s [0009], [0043]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow and Behnke such that the amount of energy delivered to the patient tissue, which is already calculated by Ladtkow, also be displayed, since such a modification would enable a surgeon to visually monitor/confirm the amount of energy delivered in real-time, thereby enabling the surgeon to react more quickly to any abnormal/unexpected operating conditions, which would help increase safety for a patient.
40. Regarding claim 7, the combination of Ladtkow and Behnke teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches wherein the controller is configured to count the energy delivered to the patient tissue based on the selected power setting and a duration of activation time of the applicator at the selected power setting [increment feature - ¶’s [0036], [0037], [0042]-[0045]].
41. Regarding claim 8, the combination of Ladtkow and Behnke teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches at least one sensor [sensor circuitry - ¶[0034]; FIG. 2] coupled to an output of the RF output stage [FIG. 2], the at least one sensor configured to sample voltage and/or current of the RF output of stage and provide the sampled voltage and/or current to the controller [¶[0034] (“output current and/or voltage”)].
42. Regarding claim 9, the combination of Ladtkow and Behnke teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches at least one sensor [sensor circuitry - ¶[0034]; FIG. 2] coupled to an output of the RF output stage [FIG. 2], the at least one sensor configured to sample voltage and/or current of the RF output stage and provide the sampled voltage and/or current to the controller [¶[0034] (“output current and/or voltage”)], wherein the selected generator power setting is determined from the sampled voltage and/or current of the RF output stage [¶[0034]].
43. Claims 6 & 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ladtkow and Behnke, and further in view of U.S. Patent Application Publication No. 2015/0230861 to Woloszko et al. ("Woloszko").
44. Regarding claim 6, the combination of Ladtkow and Behnke teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
The combination of Ladtkow and Behnke does not, however, teach:
wherein the amount of energy delivered to the patient tissue is displayed in Joules.
Woloszko, in a similar field of endeavor, teaches exemplary electrosurgical methods that measure the flow of energy delivered to an applicator (active electrode of a wand) during a procedure in Joules [e.g., ¶’s [0023], [0025]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow and Behnke such that the amount of energy delivered to the patient tissue, as displayed by Ladtkow, be displayed in Joules, since it is well-known that the “Joule” is the standard unit of energy in the International System of Units, and displaying a value in its known, conventional unit of measure would have been entirely routine for the skilled artisan.
45. Regarding claim 22, the combination of Ladtkow and Behnke teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
While Ladtkow discloses accommodation of various types of surgical instruments [e.g., ¶[0032]], the combination of Ladtkow and Behnke does not teach:
a flow controller that provides at least one gas to the applicator, wherein the applicator is configured to generate plasma from the electrosurgical energy and the at least one gas, the plasma to be delivered to the patient tissue.
Woloszko, in a similar field of endeavor, teaches exemplary electrosurgical methods and systems for ablation using plasma delivered via an electrosurgical wand [¶’s [0017], [0018], [0025], [0026], 0030], [0031]].
More particularly, Woloszko teaches a flow controller [¶[0051]] that provides at least one gas to the applicator, wherein the applicator generates plasma from the electrosurgical energy and the at least one gas, the plasma to be delivered to the patient tissue [¶’s [0017], [0018], [0025], [0026], 0030], [0031]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow and Behnke to implement ablation which employs Coblation® technology, including a flow controller that provides at least one gas to the applicator, wherein the applicator is configured to generate plasma from the electrosurgical energy and the at least one gas, the plasma to be delivered to the patient tissue, all as taught by Woloszko, since such a particular known ablation technique was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Woloszko, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Ladtkow & Behnke, and the results (ablation) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
46. Regarding claim 23, the combination of Ladtkow, Behnke, and Woloszko teaches all of the limitations of claim 22 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches wherein the controller is configured to count the energy delivered to the patient tissue based on at least one of a type of the at least one gas, a flow rate of the at least one gas and/or a power setting of the electrosurgical generator [¶’s [0036], [0037], [0042]-[0045]].
47. Regarding claims 24 & 25, the combination of Ladtkow, Behnke, and Woloszko teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches:
[claims 24 & 25] an input/output interface [Ladtkow teaches display screens for providing a user with a variety of output information [see ¶[0029] (“The generator 20 includes suitable input controls (e.g., buttons, activators, switches, touch screen, etc.) for controlling the generator 20. In addition, the generator 20 may include one or more display screens for providing the user with variety of output information (e.g., intensity settings, "treatment complete" indicators, etc.). The controls allow the user to adjust power of the RF energy, waveform parameters (e.g., crest factor, duty cycle, etc.), and other parameters to achieve the desired waveform suitable for a particular task (e.g., coagulating, tissue sealing, intensity setting, etc.)”)].
The combination of Ladtkow, Behnke, and Woloszko does not, however, teach:
[claims 24 & 25] an input/output interface that displays the counted energy delivered to the patient tissue.
However, given that a stated purpose of the algorithm of Ladtkow is for the calculation of energy delivered to tissue [e.g., Abstract; ¶’s [0009], [0043]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow, Behnke, and Woloszko such that the energy delivered to the patient tissue, which is already calculated by Ladtkow, also be displayed, since such a modification would enable a surgeon to visually monitor/confirm the amount of energy delivered in real-time, thereby enabling the surgeon to react more quickly to any abnormal/unexpected operating conditions, which would help increase safety for a patient.
Woloszko further teaches that it was known to measure the flow of energy delivered to an applicator (active electrode of a wand) during a procedure in Joules [claim 24] and Joules per second [claim 25] [e.g., ¶’s [0023], [0025]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow, Behnke, and Woloszko such that the amount of energy delivered to the patient tissue, as displayed by Ladtkow, be displayed in Joules, or Joules per second, since it is well-known that the “Joule” is the standard unit of energy in the International System of Units, and displaying a value in its known, conventional unit of measure would have been entirely routine for the skilled artisan.
48. Claims 10-16, & 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ladtkow and Behnke, and further in view of U.S. Patent Application Publication No. 2017/0196617 to Denis et al. ("Denis").
49. Regarding claim 10, the combination of Ladtkow and Behnke teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches at least one sensor that measures impedance at the RF output stage and provides the measured impedance to the controller [see ¶[0034]].
While Ladtkow further teaches monitoring "tissue-to-patient" contact [see ¶[0027]], the combination of Ladtkow and Behnke does not teach:
wherein the controller is configured to determine if the applicator is applying energy to the patient tissue or to ambient air based on the measured impedance.
Denis, in a similar field of endeavor, teaches that it was known to monitor impedance for the purpose of determining the environment in which the working end of an RF instrument is currently positioned (e.g., coupled to tissue, positioned in the air), in order to control the power delivered to the working end [e.g., ¶[0105]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow and Behnke such that the controller is configured to determine if the applicator is applying energy to the patient tissue or to ambient air based on the measured impedance, since such a modification would provide the benefit/advantage of limiting power when the applicator is not coupled to (or contacting) tissue, so as to prevent any unintended thermal damage to surrounding (or non-target) tissue due to overheating (or unintended heating) of the applicator.
As modified, it would have further been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the controller of Ladtkow/Behnke add the delivered energy to the count only when the applicator is applying energy to the patient tissue, since the goal of the algorithm of Ladtkow is to calculate/determine energy delivered to tissue.
50. Regarding claim 11, the combination of Ladtkow and Behnke teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches wherein the controller is configured to cause the power supply to stop supplying electrosurgical energy to the applicator when the count exceeds the energy endpoint [¶’s [0036]-[0038], [0042]-[0045]].
While Ladtkow additionally teaches input controls for enabling a user to adjust power of the RF energy along with other parameters to achieve a desired waveform suitable for a particular task [e.g., ¶[0029]], the combination of Ladtkow and Behnke does not explicitly teach:
an input/output interface that enables selection of an energy endpoint for a procedure.
Denis, in a similar field of endeavor, teaches that it was known to store configuration parameters used to determine operational characteristics (including, e.g., power limits) for different types of applicator tips coupled to the handpiece [e.g., ¶’s [0019], [0073], [0092], [0120]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow and Behnke to enable a user to select power limits and start/end duration segments (among other operational characteristics) for a particular desired surgical procedure from among saved parameters, since such a modification would provide the benefit/advantage of facilitating a given procedure by enabling the user to select from an already-known energy endpoint specified for the procedure.
51. Regarding claim 12, the combination of Ladtkow, Behnke, and Denis teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches wherein the controller is configured to trigger a notification via the input/output interface when the count exceeds the energy endpoint [e.g., ¶’s [0029], [0038]].
52. Regarding claim 13, the combination of Ladtkow, Behnke, and Denis teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Ladtkow further teaches wherein the controller is configured to trigger a notification when the count exceeds the energy endpoint [e.g., ¶’s [0029], [0038]].
Denis further teaches transmitting data on a substantially continuous basis to, e.g., a remotely located unit [see ¶[0076]; while not explicitly taught, it is the Examiner’s position that Denis implicitly teaches a “communication module” to effectuate the remote transmissions].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow, Behnke, and Denis to further transmit the notification to an external device via a communication module, since such a modification would provide the benefit/advantage of allowing for later analysis to help refine/update stored configuration parameters and operational characteristics for different procedures.
53. Regarding claim 14, the combination of Ladtkow, Behnke, and Denis teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Denis further teaches wherein the memory is configured to store a predetermined energy endpoint for each of a plurality of procedures [Denis teaches that it was known to store configuration parameters used to determine operational characteristics (including, e.g., power limits) for different types of applicator tips coupled to the handpiece [e.g., ¶’s [0019], [0073], [0092], [0120]] for different procedures [¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow, Behnke, and Denis such that the memory is configured to store a predetermined energy endpoint for each of a plurality of procedures, since such a modification would provide the benefit/advantage of facilitating a given procedure by enabling the user to select from an already-known energy endpoint specified for the procedure.
54. Regarding claim 15, the combination of Ladtkow, Behnke, and Denis teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Denis further teaches wherein the input/output interface enables selection of at least one of the plurality of procedures, wherein upon selection of at least one procedure, the controller retrieves a corresponding energy endpoint from the memory [e.g., ¶’s [0019], [0073], [0092], [0120]].
55. Regarding claim 16, the combination of Ladtkow, Behnke, and Denis teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Denis further teaches a communication module that receives the predetermined energy endpoint for each of the plurality of procedures from an external device [see ¶[0120] (“It will be appreciated that the configuration parameters may be stored in alternate locations such as a computer or device which is separate from the power supply”); while not explicitly taught, it is the Examiner’s position that Denis implicitly teaches a “communication module” to effectuate receipt of the remote transmissions].
56. Regarding claim 19, the combination of Ladtkow and Behnke teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
The combination of Ladtkow and Behnke does not, however, teach:
an input/output interface that enables storing in the memory a total count of energy delivered to a first treatment area of a patient as an energy endpoint, wherein upon selection of a procedure for a contralateral treatment area of the patient, the controller retrieves a stored energy endpoint from the memory.
Denis, in a similar field of endeavor, teaches that it was known to store configuration parameters used to determine operational characteristics (including, e.g., power limits) for different types of applicator tips coupled to the handpiece [e.g., ¶’s [0019], [0073], [0092], [0120]] for different procedures [¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow and Behnke such that an input/output interface enable storing in the memory a total count of energy delivered to a first treatment area of a patient as an energy endpoint, since such a modification would provide the benefit/advantage of allowing for later analysis to help refine/update stored configuration parameters and operational characteristics for different procedures [Denis, ¶[0120]].
It would have additionally been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow, Behnke, and Denis such that, upon selection of a procedure for a contralateral treatment area of the patient, the controller retrieves a stored energy endpoint from the memory, given that, as modified above, the system would already have a stored energy endpoint for a similar procedure, performed at a similar location on the body (albeit contralateral to the first treatment area), and likely using the same applicator tip given the similar nature of the intended procedure.
57. Regarding claim 20, the combination of Ladtkow and Behnke teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Ladtkow and Behnke does not, however, teach:
wherein upon completion of a procedure to a first treatment area of a patient, the controller determines a total amount of energy delivered to the patient tissue and stores the determined total amount of energy in the memory as an energy endpoint for a procedure to a contralateral treatment area of the patient.
Denis, in a similar field of endeavor, teaches that it was known to store configuration parameters used to determine operational characteristics (including, e.g., power limits) for different types of applicator tips coupled to the handpiece [e.g., ¶’s [0019], [0073], [0092], [0120]] for different procedures [¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow and Behnke such that, upon completion of a procedure to a first treatment area of a patient, the controller determines a total amount of energy delivered to the patient tissue and stores the determined total amount of energy in the memory as an energy endpoint for a procedure, since such a modification would provide the benefit/advantage of allowing for later analysis to help refine/update stored configuration parameters and operational characteristics for different procedures [Denis, ¶[0120]].
It would have additionally been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Ladtkow, Behnke, and Denis such that the determined total amount of energy in the memory as an energy endpoint for a procedure to a contralateral treatment area of the patient, particularly given that the procedure to the contralateral treatment area would be performed at a similar location on the body (albeit to a contralateral treatment area), and likely using the same applicator tip given the similar nature of the intended procedure. Further, such a modification would provide the benefit/advantage of facilitating the procedure to the contralateral treatment area by enabling the user to select from an already-known energy endpoint specified for a procedure at a similar body location.
58. Regarding claim 21, the combination of Ladtkow, Behnke, and Denis teaches all of the limitations of claim 20 for the reasons set forth in detail (above) in the Office Action.
As modified, Ladtkow/Behnke/Denis further teaches enabling selection of a procedure for the contralateral treatment area, wherein upon selection of the procedure, the controller retrieves the stored energy endpoint from the memory [Denis, ¶[0120]].
Response to Arguments
59. As noted above, the 01/28/26 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the 10/27/25 Action.
60. A new claim objection, and new rejections under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
61. Behnke
62. The rejection of independent claim 1 under § 102 based on Behnke has been updated to address the new claim limitations, and maintained.
63. In the Remarks, Applicant argues that the rejection under § 102 based on Behnke is improper:
Behnke determines generator-side energy, not tissue-delivered energy. Behnke discloses monitoring and controlling RF energy based on generator-side electrical conditions, such as impedance and output characteristics, in order to regulate energy delivery. However, Behnke does not determine an actual amount of energy delivered to a tissue surface at a distal end of an applicator, as now required by amended claim 1. Behnke does not disclose or suggest storing or using an energy quantification function that maps RF output-stage parameters to energy delivered at the tissue interface. Instead, Behnke relies on generator-side measurements to regulate output, not to compute or determine tissue-surface energy.
01/28/26 Amendment, pg. 12, emphasis added.
64. This argument is not persuasive. As indicated above in the body of the rejection of amended claim 1, and as broadly as currently claimed, Behnke discloses determining the overall, actual amount of energy to be delivered to tissue, which includes the additional energy delivered to compensate for RF energy lost in the energy-carrying components. The actual amount of energy ultimately delivered to tissue differs from that initially measured at the RF output stage - to compensate for the energy loss.
65. Ladtkow
66. Applicant’s arguments concerning the alleged deficiencies of Ladtkow [01/28/26 Amendment, pg. 12] are moot in view of the new rejections under § 103 set forth in detail above, necessitated by Applicant’s Amendment.
Conclusion
67. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
68. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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