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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/11/2025 (“11/11/25 Amendment”) has been entered, and fully considered (by the filing of the RCE on 11/17/2025).
Response to Amendment
3. In the 11/11/25 Amendment, claims 1, 15, 16, & 20 were amended. No claims were cancelled, or newly added. Accordingly, claims 1-20 remain pending in the application.
4. The 11/11/25 Amendment has overcome the rejections under §§ 112(a) & 103 previously set forth in the Final Office Action mailed 09/16/2025 (“09/16/25 Action”).
5. New claim objections, and new rejections under §§ 112(b) & 103 are set forth herein.
Claim Objections
6. Claims 1 & 16 are objected to because of the following informalities:
a. In claim 1, lines 4-5, the recitation of “configured to administer non-therapeutic radio frequency (RF) signal” should instead recite --configured to administer a non-therapeutic radio frequency (RF) signal--.
b. In claim 16, line 14, the recitation of “(c) determine” should instead recite --(c) determining--.
c. In claim 16, line 16, the recitation of “(d) determine” should instead recite --(d) determining--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-19 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.
9. Claim 1 recites the limitation “the therapeutic RF signal” in lines 31-32. There is insufficient antecedent basis for this recitation in the claim.
10. Claims 2-15 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
11. Claim 16 recites the limitation “(b) controlling, using a processor, delivery and measurement of a non-therapeutic radio frequency (RF) signal to a plurality of electrodes, wherein the plurality of electrodes are in contact with the tissue of a patient” in lines 6-9. This recitation renders the claim indefinite, as it is not clear whether the recited “a plurality of electrodes” are intended to include/comprise the “first electrode surface” and “second electrode surface” previously recited in the claim, or whether they are provided in addition to the “first electrode surface” and “second electrode surface.” Stated another way, the relationship, if any, between the “first electrode surface” and “second electrode surface,” and the “plurality of electrodes” is not clear. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
12. Claims 17-19 are rejected as ultimately depending from a claim (claim 16) rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103
13. 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.
14. 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.
I. INDEPENDENT CLAIM 1 (& DEPENDENT CLAIMS 2-15)
15. Claims 1-4, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0235691 to Voegele et al. (“Voegele”) in view of U.S. Patent Application Publication No. 2010/0036379 to Prakash et al. ("Prakash"), and further in view of U.S. Patent Application Publication No. 2022/0071685 to (“Zhang”).
16. Regarding claim 1, Voegele teaches an apparatus for detecting and sealing tissue, the apparatus comprising:
(a) a processor [processor (1004) - ¶[0046]; FIG. 9];
(b) a non-therapeutic waveform generator [generator (102) - ¶[0033]; FIG. 1] configured to administer non-therapeutic radio frequency (RF) signal [e.g., ¶[0041] (“The generator 102 may provide a signal (e.g., a non-therapeutic signal) to the electrodes 177 and 179”)];
(c) a therapeutic waveform generator [generator (102) - ¶[0033]; FIG. 1] configured to administer therapeutic RF energy [e.g., ¶[0038] (“The generator 102 may provide a drive signal to the electrodes 177, 179 to bring about a therapeutic effect to tissue present within the jaw members 167, 169”); & ¶[0064] (“Referring Primarily to FIGS. 3, 4, and 9A, a tissue treatment cycle may comprise one or more therapeutic drive signals which can be generated by the generator 102, for example, and delivered to the tissue using the ultrasonic device 104 or the RF surgical device 106”)],…; and
(d) an end effector at a distal end of a surgical instrument [end effector (132) - ¶[0037]; FIG. 4], the end effector [(132)] configured to interact with a tissue of a patient [e.g., ¶[0038]], the end effector [(132)] comprising:
(i) a first jaw [first jaw member (167) - ¶’s [0037], [0038]; FIG. 4] comprising a first electrode surface [surface of first electrode (177) - ¶[0038]; FIG. 4] secured relative to the first jaw [¶[0038]; FIG. 4], and
(ii) a second jaw [second jaw member (169) - ¶’s [0037], [0038]; FIG. 4] pivotably coupled [¶[0039]; FIG. 4] with the first jaw and comprising a second electrode surface [surface of second electrode (179) - ¶[0038]; FIG. 4] secured relative to the second jaw [¶[0038]; FIG. 4], wherein the first and second electrode surfaces together define a plurality of electrodes [¶[0038]];
wherein the processor [(1004)] is configured to:
(i) control the non-therapeutic waveform generator [(102)] to thereby perform delivery and measurement of the non-therapeutic radio frequency (RF) signal to the plurality of electrodes, wherein the plurality of electrodes are configured to contact the tissue of a patient [¶[0041] (“The electrodes 177 and 179 may be used, for example, to measure impedance of a tissue bite present between the jaw members 167 and 169. The generator 102 may provide a signal (e.g., a non-therapeutic signal) to the electrodes 177 and 179. The impedance of the tissue bite may be found, for example, by monitoring the current, voltage, etc. of the signal”)];
(ii) determine, based on the non-therapeutic RF signal, at least one characteristic of the tissue of the patient [impedance - ¶[0041]];
***
(iv) …control the therapeutic waveform generator [(102)] to thereby perform a delivery of the therapeutic RF signal to the plurality of electrodes [e.g., ¶[0038] (“The generator 102 may provide a drive signal to the electrodes 177, 179 to bring about a therapeutic effect to tissue present within the jaw members 167, 169”)].
A. Intended Tissue Type
As noted above, Voegele teaches determining, based on the non-therapeutic RF signal, at least one characteristic of the tissue of the patient [impedance - ¶[0041]].
Voegele does not, however, teach the following emphasized claim limitations concerning use of the determined impedance:
wherein the processor [(1004)] is configured to:
(iii) determine, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; and
(iv) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, control the therapeutic waveform generator to thereby perform a delivery of the therapeutic RF signal to the plurality of electrodes.
However, the use of determined/measured impedance (based on the delivery of non-therapeutic RF signals) to determine whether electrodes are in contact with an intended tissue type, as well as the resulting/responsive control and delivery of therapeutic RF energy, were well known in the art, before the effective filing date of the claimed invention.
As one example, Prakash, in a similar field of endeavor, teaches various apparatus, systems, and methods of identifying and treating tissue [Abstract]. More particularly, Prakash teaches that it was known for a processing unit to compare impedance measurements of tissue grasped between first and second jaw members of an end effector assembly to known tissue impedance measurements to identify tissue type [e.g., ¶’s [0043], [0044], [0046]-[0050]]. Once it is determined that the tissue type is an intended tissue type [e.g., a specific tissue type specified by a user - see ¶[0048]], Prakash teaches that the therapeutic delivery of RF energy is adjusted appropriately [see, e.g., ¶[0056] (“Once the tissue type and condition of the tissue have been identified, bipolar forceps 100 may operate as a conventional bipolar vessel sealer. The energy delivery configuration of generator 10 may be adjusted in accordance with the identified tissue type being sealed. The closure pressure of first and second jaw members 212, 214 may also be adjusted in view of the type of tissue being sealed and/or the condition of the tissue being sealed”)].
Accordingly, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Voegele such that the processor [(1004)] be configured to further: (iii) determine, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; and (iv) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, control the therapeutic waveform generator to thereby perform a delivery of the therapeutic RF signal to the plurality of electrodes, since such a modification would provide the benefit/advantage of ensuring that an energy delivery configuration is adequate for an intended tissue to be treated, so as to effect proper treatment, and avoid unintended damage [see, e.g., ¶[0009] of Prakash].
B. Separate Non-Therapeutic and Therapeutic Waveform Generators
Finally, while Voegele teaches that generator (102) is capable of generating both non-therapeutic and therapeutic waveforms, Voegele does not teach separate generators, and therefore fails to teach the following emphasized claim limitation:
…the non-therapeutic and the therapeutic waveform generators being separate from one another.
Zhang, in a similar field of endeavor, is directed to electrosurgical systems and methods, including electrosurgical methods that may include performing an electrosurgical activity (e.g., ablation, coagulation) with energy at a first frequency, and simultaneously measuring an electrosurgical parameter by way of energy at a second frequency [e.g., ¶[0024]].
More particularly, Zhang teaches the use of separate generators for ablation, coagulation, and measurement [see, e.g., ¶[0048] (“As the names imply, the example generators are designed and constructed to provide RF energy for a particular purpose. The example ablation generator 518 is configured to produce the ablation energy at the ablation frequency”); ¶[0049] (“The example coagulation generator 520 is configured to produce the coagulation energy at the coagulation frequency”); and ¶[0050] (“The example measurement generator 522 is configured to produce the measurement energy at the measurement frequency”)].
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 Voegele and Prakash such that the non-therapeutic and the therapeutic waveform generators comprise separate waveform generators, since such a particular generator configuration was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Zhang, and one of ordinary skill in the art would have been capable of applying this known configuration to the known device of Voegele and Prakash, and the results (the provision of non-therapeutic and therapeutic RF waveforms) 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). Still further, such a modification would provide better control of an on-going electrosurgical procedure by facilitating measurement of electrosurgical parameters at frequencies different than frequencies being simultaneously applied to create tissue altering effects [Zhang, ¶[0024]].
17. Regarding claim 2, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Voegele further teaches the first jaw further comprising a first knife pathway, the second jaw further comprising a second knife pathway, the first and second knife pathways together being configured to accommodate translation of a knife member through a portion of the end effector [e.g., ¶[0038] (“A reciprocating blade 175 is illustrated between the jaw members 167, 169”); & [0039]].
18. Regarding claim 3, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Voegele further teaches wherein the plurality of electrodes are in a bifurcation configuration where the plurality of electrodes are movable relative to a central axis and opposite to one another [¶[0039]].
19. Regarding claim 4, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Voegele further teaches a switching system configured to switch between the non-therapeutic RF signal and the therapeutic RF signal [broadly, the processor (1004) performs this function by employing the generator (102) to apply either a non-therapeutic RF signal, or a therapeutic RF signal - e.g., ¶’s [0046], [0054], [0064], [0069]-[0071]].
20. Regarding claim 15, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Prakash further teaches, wherein the processor is further configured to, responsive to determining that the plurality of electrodes are not in contact with the intended tissue type, perform an action selected from the group consisting of:
(i) disable delivery of a therapeutic RF signal to the plurality of electrodes,
(ii) provide a notification to an operator, and
(iii) modify a surgical plan [broadly, Prakash teaches implementing alternative approaches to determining tissue type when electrical property measurements from known tissue types are not available for comparison - see, e.g., ¶’s [0049], [0050]].
21. Claims 5-7, & 11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Zhang, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2022/0039855 to Batchelor et al. ("Batchelor").
22. Regarding claims 5-7, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claims 5-7 further recite limitations directed to a send voltage, return voltage, send current, and return current upon which the at least one characteristic [impedance] is based, as well as determination of a capacitive reactance and inductive reactance to determine impedance:
5. The apparatus of claim 1, further comprising:
(a) a voltage sensor device; and
(b) a current sensor device; wherein the processor is further configured to:
(i) obtain, from the voltage sensor device, a send voltage, and a return voltage for the non-therapeutic RF signal, and
(ii) obtain, from the current sensor device, a send current and a return current for the non-therapeutic RF signal,
wherein the at least one characteristic is based on the send voltage, the return voltage, the send current, and the return current.
6. The apparatus of claim 5, wherein the processor is further configured to:
(i) determine, based on the send voltage and the return voltage, a capacitive reactance of a circuit, and
(ii) determine, based on the send voltage and the return voltage, an inductive reactance of the circuit,
wherein the at least one characteristic is based on the send voltage, the return voltage, the send current, and the return current.
7. The apparatus of claim 6, wherein the processor is further configured to:
determine, based on the capacitive reactance and the inductive reactance, an impedance of the circuit, wherein the at least one characteristic is based on the send voltage, the return voltage, the send current, and the return current.
While Voegle teaches calculating the impedance (Z) of tissue based on measured values of current and voltage, as well as a current sense circuit and a voltage sense circuit [Voegle, ¶[0054]], the combination of Voegele, Prakash, and Zhang does not teach the foregoing limitations concerning the send voltage, return voltage, send current, return current, capacitive reactance, and inductive reactance.
However, use of such parameters when determining impedance of a tissue was well known in the art, before the effective filing date of the claimed invention.
As one example, Batchelor, in a similar field of endeavor, teaches that it was known to determine at least one characteristic of tissue [impedance] based on obtaining (from a voltage sensor device) a send voltage, and a return voltage for the RF signal, and (from a current sensor device) a send current and a return current for the RF signal, as well as determining a capacitive reactance and an inductive reactance (based on the send voltage and the return voltage) used to determine impedance [Batchelor, e.g., ¶’s [0074]-[0077]].
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 Voegele, Prakash, and Zhang to include a voltage sensor device, a current sensor device, and wherein the processor is further configured to: obtain, from the voltage sensor device, a send voltage, and a return voltage for the non-therapeutic RF signal, obtain, from the current sensor device, a send current and a return current for the non-therapeutic RF signal, determine, based on the send voltage and the return voltage, a capacitive reactance of a circuit, determine, based on the send voltage and the return voltage, an inductive reactance of the circuit, and determine, based on the capacitive reactance and the inductive reactance, an impedance of the circuit, wherein the at least one characteristic is based on the send voltage, the return voltage, the send current, and the return current, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Batchelor), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results (determining impedance) 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).
23. Regarding claim 11, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Prakash, and Zhang does not, however, teach:
wherein the processor is further configured to perform a fast Fourier transform (FFT) on the non-therapeutic RF signal, and wherein the at least one characteristic is based on the FFT.
Batchelor, in a similar field of endeavor, teaches that it was known to utilize a Discrete Fourier Transform (DFT) signal-processing technique when determining tissue impedance [the at least one characteristic] [see ¶’s [0077]-[0078]; those skilled in the art will appreciate that the fast Fourier transform (FFT) is an algorithm that efficiently computes the DFT].
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 Voegele, Prakash, and Zhang such that the processor is further configured to perform a fast Fourier transform (FFT) on the RF signal, and wherein the at least one characteristic [impedance] is based on the FFT, since such a particular known signal-processing technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Batchelor), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results (determining impedance) 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).
24. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Zhang, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2020/0107877 to Koblish et al. ("Koblish").
25. Regarding claim 8, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Prakash, and Zhang does not, however, teach:
wherein the non-therapeutic RF signal comprises a plurality of waveforms summed into a multi-waveform, wherein each of the plurality of waveforms has a unique frequency.
Koblish, in a similar field of endeavor, teaches that it was known in the art to determine impedance by applying a signal comprising a multi-tone waveform having a first frequency and a second frequency to a pair of electrodes, and processing the resulting waveform to obtain impedance measurements at the first frequency and the second frequency [e.g., ¶[0228]].
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 Voegele, Prakash, and Zhang such that the non-therapeutic RF signal comprises a plurality of waveforms summed into a multi-waveform, wherein each of the plurality of waveforms has a unique frequency, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Koblish), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results (determining impedance) 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).
26. Claims 9 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Zhang, as applied to claim 1 above, and further in view of U.S. Patent No. 5,280,429 to Withers ("Withers").
27. Regarding claim 9, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Prakash, and Zhang does not, however, teach:
wherein the non-therapeutic RF signal comprises a multi-burst waveform with single or multiple different periods, amplitudes, or wave shapes.
Withers, in a similar field of endeavor, teaches that it was known to utilize a multi-burst waveform with a sinusoidal wave shape [FIG. 1B] when determining impedance [col. 6, ll. 26-41; col. 9, ll. 24-41].
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 Voegele, Prakash, and Zhang such that the non-therapeutic RF signal comprises a multi-burst waveform with a single wave shape, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Withers), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results (determining impedance) 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).
28. Regarding claim 12, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Prakash, and Zhang does not, however, teach:
wherein the processor is further configured to perform a cross-correlation analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the cross-correlation analysis.
Withers, in a similar field of endeavor, teaches that it was known to utilize a cross-correlation statistical technique when determining impedance [Abstract; col. 6, ll. 26-64].
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 Voegele, Prakash, and Zhang such that the processor is further configured to perform a cross-correlation analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the cross-correlation analysis, since such a particular known statistical technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Withers), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results (determining impedance) 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).
29. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Zhang, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2018/0067154 to Cherkassky et al. ("Cherkassky").
30. Regarding claim 10, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Prakash, and Zhang does not, however, teach:
wherein the non-therapeutic RF signal comprises at least one of:
(A) an amplitude modulated signal,
(B) a frequency modulated signal,
(C) a phase modulated signal,
(D) a frequency-shift keying modulation signal, or
(E) a chirp waveform.
Cherkassky, in a similar field of endeavor, teaches that it was known when measuring impedance that an injected current signal (also referred to as an excitation signal or carrier signal) is modulated in amplitude and phase by the impedance of the biological tissue under test [¶[0003]].
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 Voegele, Prakash, and Zhang such that the non-therapeutic RF signal comprises at least one of an amplitude modulated signal or a frequency modulated signal, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Cherkassky), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results (determining impedance) 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).
31. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Zhang, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2019/0274752 to Denzinger et al. ("Denzinger").
32. Regarding claim 13, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Prakash, and Zhang does not, however, teach:
wherein the processor is further configured to perform a zero-crossing analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the zero-crossing analysis.
Denzinger, in a similar field of endeavor, teaches that it was known to utilize voltage and current feedback data to determine impedance phase, e.g., the phase difference between the voltage and current signals, and that a known technique for determining the phase difference is the zero-crossing method which produces highly accurate results [¶’s [0270]-[0273]].
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 Voegele, Prakash, and Zhang such that the processor is further configured to perform a zero-crossing analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the zero-crossing analysis, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Denzinger), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results (determining impedance) 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).
33. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Zhang, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2017/0100092 to Kruse et al. ("Kruse").
34. Regarding claim 14, the combination of Voegele, Prakash, and Zhang teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Prakash, and Zhang does not, however, teach:
wherein the processor is further configured to perform a Pseudo Inverse Matrix Fourier (PIMF) analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the PIMF analysis.
Kruse, in a similar field of endeavor, teaches the use of pseudoinverse (e.g., generalized inverse, Moore-Penrose inverse, etc.) algorithms as exemplary signal processing algorithms applied to amplitude and phase information [¶[0145]].
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 Voegele, Prakash, and Zhang such that the processor is further configured to perform a Pseudo Inverse Matrix Fourier (PIMF) analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the PIMF analysis, since such a particular known signal-processing technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Kruse), and one of ordinary skill in the art would have been capable of applying this known technique to the known device (of Voegele, Prakash, and Zhang), and the results 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).
II. INDEPENDENT CLAIM 16 (& DEPENDENT CLAIMS 17-19)
35. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Voegele in view of Koblish, and further in view of Prakash and U.S. Patent Application Publication No. 2014/0135804 to Weisenburgh, II et al. (“Weisenburgh”).
36. Regarding claim 16, Voegele teaches a method for detecting and sealing tissue, the method comprising:
(a) clamping, between a first jaw [first jaw member (167) - ¶’s [0037], [0038]; FIG. 4] and a second jaw [second jaw member (169) - ¶’s [0037], [0038]; FIG. 4] of an end effector [end effector (132) - ¶[0037]; FIG. 4], a tissue of a patient [e.g., ¶[0038]], wherein the first jaw comprises a first electrode surface [surface of first electrode (177) - ¶[0038]; FIG. 4] and the second jaw comprises a second electrode surface [surface of second electrode (179) - ¶[0038]; FIG. 4];
(b) controlling, using a processor [processor (1004) - ¶[0046]; FIG. 9], delivery and measurement of a non-therapeutic radio frequency (RF) signal to a plurality of electrodes [e.g., ¶[0041] (“The generator 102 may provide a signal (e.g., a non-therapeutic signal) to the electrodes 177 and 179”)], wherein the plurality of electrodes are in contact with the tissue of a patient [¶[0038]]…,
(c) determine, based on the non-therapeutic RF signal, at least one characteristic of the tissue of the patient [impedance - ¶[0041]];
***
(e) … deliver a therapeutic RF signal to the plurality of electrodes [e.g., ¶[0038] (“The generator 102 may provide a drive signal to the electrodes 177, 179 to bring about a therapeutic effect to tissue present within the jaw members 167, 169”)].
A. Multi-Waveform
Vogele does not, however, teach:
wherein the non-therapeutic RF signal comprises a plurality of waveforms summed into a multi-waveform.
Koblish, in a similar field of endeavor, teaches that it was known in the art to determine impedance by applying a signal comprising a multi-tone waveform having a first frequency and a second frequency to a pair of electrodes, and processing the resulting waveform to obtain impedance measurements at the first frequency and the second frequency [e.g., ¶[0228]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Voegele such that the non-therapeutic RF signal comprises a plurality of waveforms summed into a multi-waveform, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Koblish), and one of ordinary skill in the art would have been capable of applying this known technique to the known method (of Voegele), and the results (determining impedance) 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).
B. Intended Tissue Type
As noted above, Voegele teaches determining, based on the non-therapeutic RF signal, at least one characteristic of the tissue of the patient [impedance - ¶[0041]].
Voegele does not, however, teach the following emphasized claim limitations concerning use of the determined impedance:
(d) determine, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; and
(e) responsive to determining that the plurality of electrodes are in contact with the intended tissue type… deliver[ing] a therapeutic RF signal to the plurality of electrodes
However, the use of determined/measured impedance (based on the delivery of non-therapeutic RF signals) to determine whether electrodes are in contact with an intended tissue type, as well as the resulting/responsive control and delivery of therapeutic RF energy, were well known in the art, before the effective filing date of the claimed invention.
As one example, Prakash, in a similar field of endeavor, teaches various apparatus, systems, and methods of identifying and treating tissue [Abstract]. More particularly, Prakash teaches that it was known for a processing unit to compare impedance measurements of tissue grasped between first and second jaw members of an end effector assembly to known tissue impedance measurements to identify tissue type [e.g., ¶’s [0043], [0044], [0046]-[0050]].
Once it is determined that the tissue type is an intended tissue type [e.g., a specific tissue type specified by a user - see ¶[0048]], Prakash teaches that the therapeutic delivery of RF energy is adjusted appropriately [see, e.g., ¶[0056] (“Once the tissue type and condition of the tissue have been identified, bipolar forceps 100 may operate as a conventional bipolar vessel sealer. The energy delivery configuration of generator 10 may be adjusted in accordance with the identified tissue type being sealed. The closure pressure of first and second jaw members 212, 214 may also be adjusted in view of the type of tissue being sealed and/or the condition of the tissue being sealed”)].
Accordingly, 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 Voegele and Koblish to include (d) determin[ing], based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; and (e) responsive to determining that the plurality of electrodes are in contact with the intended tissue type deliver[ing] a therapeutic RF signal to the plurality of electrodes, since such a modification would provide the benefit/advantage of ensuring that an energy delivery configuration is adequate for an intended tissue to be treated, so as to effect proper treatment, and avoid unintended damage [see, e.g., ¶[0009] of Prakash].
C. DPDT Switch
Finally, the combination of Voegele, Koblish, and Prakash does not teach transitioning between delivery of the non-therapeutic radio frequency (RF) signal and the therapeutic RF signal via a dual position dual throw switch, and therefore fails to teach the following emphasized claim limitations:
wherein delivery of the non-therapeutic radio frequency (RF) signal is through a dual position dual throw switch in a first position; [and]
(e) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, transitioning the dual position dual throw switch from the first position to a second position to thereby deliver a therapeutic RF signal to the plurality of electrodes.
Weisenburgh, in a similar field of endeavor, teaches that it was known in the art to utilize a double pole double throw (DPDT) selector switch (in the form of a user toggle) to switch between different energy outputs [e.g., ¶[0322]].
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 Voegele, Koblish, and Prakash to implement a DPDT selector switch to switch between delivery of the non-therapeutic radio frequency (RF) signal and the therapeutic RF signal, or more particularly such that delivery of the non-therapeutic radio frequency (RF) signal is through a dual position dual throw switch in a first position, and responsive to determining that the plurality of electrodes are in contact with the intended tissue type, transitioning the dual position dual throw switch from the first position to a second position to thereby deliver a therapeutic RF signal to the plurality of electrodes, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results (i.e., using a known switch to switch between different energy outputs) to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
37. Claims 17 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Koblish, Prakash, & Weisenburgh, as applied to claim 16 above, and further in view of Batchelor.
38. Regarding claim 17, the combination of Voegele, Koblish, Prakash, & Weisenburgh teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
While Voegle teaches calculating the impedance (Z) of tissue based on measured values of current and voltage, as well as a current sense circuit and a voltage sense circuit [Voegle, ¶[0054]], the combination of Voegele, Koblish, Prakash, & Weisenburgh does not teach the following limitations concerning the send voltage, return voltage, send current, return current, capacitive reactance, and inductive reactance:
(a) obtaining, from a voltage sensor device, a send voltage, and a return voltage for the non-therapeutic RF signal;
(b) obtaining, from a current sensor device, a send current and a return current for the non-therapeutic RF signal;
(c) determining, based on the send voltage and the return voltage, a capacitive reactance of a circuit; and
(d) determining, based on the send voltage and the return voltage, an inductive reactance of the circuit;
wherein the at least one characteristic is based on the send voltage, the return voltage, the send current, and the return current.
However, use of such parameters when determining impedance of a tissue was well known in the art, before the effective filing date of the claimed invention.
As one example, Batchelor, in a similar field of endeavor, teaches that it was known to determine at least one characteristic of tissue [impedance] based on obtaining (from a voltage sensor device) a send voltage, and a return voltage for the RF signal, and (from a current sensor device) a send current and a return current for the RF signal, as well as determining a capacitive reactance and an inductive reactance (based on the send voltage and the return voltage), wherein the at least one characteristic [impedance] is based on the send voltage, the return voltage, the send current, and the return current [Batchelor, e.g., ¶’s [0074]-[0077]].
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 Voegele, Koblish, Prakash, & Weisenburgh to include (a) obtaining, from a voltage sensor device, a send voltage, and a return voltage for the non-therapeutic RF signal, (b) obtaining, from a current sensor device, a send current and a return current for the non-therapeutic RF signal, (c) determining, based on the send voltage and the return voltage, a capacitive reactance of a circuit, and (d) determining, based on the send voltage and the return voltage, an inductive reactance of the circuit, wherein the at least one characteristic is based on the send voltage, the return voltage, the send current, and the return current, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Batchelor), and one of ordinary skill in the art would have been capable of applying this known technique to the known method (of Voegele, Koblish, Prakash, & Weisenburgh), and the results (determining impedance) 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).
39. Regarding claim 19, the combination of Voegele, Koblish, Prakash, & Weisenburgh teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Koblish, Prakash, & Weisenburgh does not, however, teach:
wherein the processor further performs at least one of:
(i) a fast Fourier transform (FFT) on the non-therapeutic RF signal, wherein the at least one characteristic is based on the FFT,
(ii) cross-correlation analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the cross- correlation analysis, or
(iii) a zero-crossing analysis on the non-therapeutic RF signal, wherein the at least one characteristic is based on the zero-crossing analysis.
Batchelor, in a similar field of endeavor, teaches that it was known to utilize a Discrete Fourier Transform (DFT) signal-processing technique when determining tissue impedance [the at least one characteristic] [¶’s [0077]-[0078]; those skilled in the art will appreciate that the fast Fourier transform (FFT) is an algorithm that efficiently computes the DFT].
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 Voegele, Koblish, Prakash, & Weisenburgh such that the processor further performs (i) a fast Fourier transform (FFT) on the RF signal, wherein the at least one characteristic [impedance] is based on the FFT, since such a particular known signal-processing technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Batchelor), and one of ordinary skill in the art would have been capable of applying this known technique to the known method (of Voegele, Koblish, Prakash, & Weisenburgh), and the results (determining impedance) 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).
40. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Koblish, Prakash, & Weisenburgh, as applied to claim 16 above, and further in view of Cherkassky.
41. Regarding claim 18, the combination of Voegele, Koblish, Prakash, & Weisenburgh teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
The combination of Voegele, Koblish, Prakash, & Weisenburgh does not, however, teach:
wherein the non-therapeutic RF signal comprises at least one of:
(i) an amplitude modulated signal,
(ii) a frequency modulated signal,
(iii) a phase modulated signal, or
(iv) a frequency-shift keying modulation signal.
Cherkassky, in a similar field of endeavor, teaches that it was known when measuring impedance that an injected current signal (also referred to as an excitation signal or carrier signal) is modulated in amplitude and phase by the impedance of the biological tissue under test [¶[0003]].
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 Voegele, Koblish, Prakash, & Weisenburgh such that the non-therapeutic RF signal comprises at least one of an amplitude modulated signal or a frequency modulated signal, since such a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Cherkassky), and one of ordinary skill in the art would have been capable of applying this known technique to the known method (of Voegele, Koblish, Prakash, & Weisenburgh), and the results (determining impedance) 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).
III. INDEPENDENT CLAIM 20
42. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Voegele in view of Prakash.
43. Regarding claim 20, Voegele teaches a system comprising:
(a) a waveform generator [generator (102) - ¶[0033]; FIG. 1]; and
(b) an electrosurgical device comprising:
(i) a processor [processor (1004) - ¶[0046]; FIG. 9],
(ii) a surgical instrument [electrosurgical or RF surgical device (106) - ¶’s [0033], [0037]; FIG. 4] having a distal end with an end effector [end effector (132) - ¶[0037]; FIG. 4], the end effector [(132)] being configured to interact with a tissue of a patient [e.g., ¶[0038]], the end effector [(132)] comprising:
(A) a first jaw [first jaw member (167) - ¶’s [0037], [0038]; FIG. 4] comprising a first electrode [first electrode (177) - ¶[0038]; FIG. 4], and
(B) a second jaw [second jaw member (169) - ¶’s [0037], [0038]; FIG. 4] pivotably coupled [¶[0039]; FIG. 4] with the first jaw, the second jaw comprising a second electrode [second electrode (179) - ¶[0038]; FIG. 4];
wherein the processor [(1004)] is configured to:
(A) control delivery, determine a voltage measurement across the tissue of the patient, and determine a current measurement through the tissue of the patient of a non-therapeutic radio frequency (RF) signal to the first and second electrodes, wherein the non-therapeutic RF signal is generated by the waveform generator [see ¶[0054] (“For example, the processor 1004 can be configured to employ the generator 102 to apply a non-therapeutic radio frequency (RF) signal to tissue grasped by the end effector 132 between the jaw members 167 and 169. In certain instances, a current sense circuit 1014 can be employed to sense current flowing between electrodes 177 and 179 through the tissue. Furthermore, a voltage sense circuit 1016 can be employed to sense an output voltage applied to the electrodes 177 and 179 by the generator 102… The processor 1004 may be configured to… calculate the impedance Z of the tissue based on the measured values of current and voltage. It is worthwhile noting that the RF energy applied to the tissue for purposes of measuring the tissue impedance Z can be a low level non-therapeutic signal that may not contribute in a significant manner, or at all, to the treatment of the tissue”)],
(B) determine, based on the determined voltage measurement and the determined current measurement of the non-therapeutic RF signal, at least one characteristic of the tissue of the patient [impedance - ¶[0041]],
***
(D) …control delivery of a therapeutic RF signal to tissue via the first and second electrodes [e.g., ¶[0038] (“The generator 102 may provide a drive signal to the electrodes 177, 179 to bring about a therapeutic effect to tissue present within the jaw members 167, 169”)].
Intended Tissue Type
As noted above, Voegele teaches determining, based on the non-therapeutic RF signal, at least one characteristic of the tissue of the patient [impedance - ¶[0041]].
Voegele does not, however, teach the following emphasized claim limitations concerning use of the determined impedance:
wherein the processor [(1004)] is configured to:
(C) determine, based on the at least one characteristic, that the first and second electrodes are in contact with an intended tissue type, and
(D) responsive to determining that the first and second electrodes are in contact with the intended tissue type, control delivery of a therapeutic RF signal to tissue via the first and second electrodes.
However, the use of determined/measured impedance (based on the delivery of non-therapeutic RF signals) to determine whether electrodes are in contact with an intended tissue type, as well as the resulting/responsive control and delivery of therapeutic RF energy, were well known in the art, before the effective filing date of the claimed invention.
As one example, Prakash, in a similar field of endeavor, teaches various apparatus, systems, and methods of identifying and treating tissue [Abstract]. More particularly, Prakash teaches that it was known for a processing unit to compare impedance measurements of tissue grasped between first and second jaw members of an end effector assembly to known tissue impedance measurements to identify tissue type [e.g., ¶’s [0043], [0044], [0046]-[0050], [0052]].
Once it is determined that the tissue type is an intended tissue type [e.g., a specific tissue type specified by a user - see ¶[0048]], Prakash teaches that the therapeutic delivery of RF energy is adjusted appropriately [see, e.g., ¶[0056] (“Once the tissue type and condition of the tissue have been identified, bipolar forceps 100 may operate as a conventional bipolar vessel sealer. The energy delivery configuration of generator 10 may be adjusted in accordance with the identified tissue type being sealed. The closure pressure of first and second jaw members 212, 214 may also be adjusted in view of the type of tissue being sealed and/or the condition of the tissue being sealed”)].
Accordingly, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Voegele such that the processor [(1004)] be configured to further (C) determine, based on the at least one characteristic, that the first and second electrodes are in contact with an intended tissue type, and (D) responsive to determining that the first and second electrodes are in contact with the intended tissue type, control delivery of a therapeutic RF signal to tissue via the first and second electrodes, since such a modification would provide the benefit/advantage of ensuring that an energy delivery configuration is adequate for an intended tissue to be treated, so as to effect proper treatment, and avoid unintended damage [see, e.g., ¶[0009] of Prakash].
Response to Arguments
44. As noted above, the 11/11/25 Amendment has overcome the rejections under §§ 112(a) & 103 previously set forth in the 09/16/25 Action.
45. New claim objections, and new rejections under §§ 112(b) & 103 are set forth herein.
Conclusion
46. 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.
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/Bradford C. Blaise/Examiner, Art Unit 3794