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 May 8, 2026 (hereinafter “05/8/26 Amendment") has been entered, and fully considered. In the 05/08/26 Amendment, claims 1, 16, & 20 were amended. No claims were cancelled, or newly added. Therefore, claims 1-20 remain pending in the application.
3. The 05/08/26 Amendment has overcome the claim objections, and the rejections under §§ 112(b) & 103 previously set forth in the Non-Final Office Action mailed 02/18/2026 (“02/18/26 Action”).
4. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 103
5. 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.
6. 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)
7. Claims 1-4, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2018/0235691 to Voegele et al. (“Voegele”) in view of U.S. 2010/0036379 to Prakash et al. ("Prakash"), and further in view of U.S. 5,817,093 to Williamson, IV et al. (“Williamson”).
8. 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 a 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 a therapeutic RF signal [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) cease delivery of the non-therapeutic signal [NOTE: Voegele teaches that monitoring may occur at the onset of each treatment cycle (e.g., ¶’s [0056] & [0058]); as such, it is the Examiner’s position that Voegele is not limited to a continuous delivery of the non-therapeutic signal throughout a treatment cycle; regardless, and assuming arguendo that Voegele is interpreted as teaching continuous application of the non-therapeutic signal throughout an entire treatment cycle (i.e., simultaneously with the therapeutic signal), Williamson (addressed in detail below) teaches sequential application of non-therapeutic and therapeutic signals]; and
(v)… after ceasing delivery of the non-therapeutic RF signal [see NOTE immediately above in the discussion of step (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”)], such that the non-therapeutic RF signal and the therapeutic RF signal are provided separately in a sequence [e.g., provision of the non-therapeutic RF signal at the onset of a treatment cycle, followed by the provision of the therapeutic RF signal during the remainder of the treatment cycle].
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;
***
(v) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal, 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 (v) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal, 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 WAVEFORM GENERATORS & SEQUENCE
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 limitations:
…the non-therapeutic and the therapeutic waveform generators being separate from one another; [and]
wherein the processor [(1004)] is configured to:
(v) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal, control the therapeutic waveform generator to thereby perform a delivery of the therapeutic RF signal to the plurality of electrodes, such that the non-therapeutic RF signal and the therapeutic RF signal are provided separately in a sequence by the non-therapeutic waveform generator and the therapeutic waveform generator, respectively.
Williamson, in a similar field of endeavor, is directed to an electrosurgical device which includes query electrodes for measuring one or more electrical parameters of tissue prior to, during, or after treating the tissue with therapeutic electrodes. The measured tissue parameters may be used to determine various tissue characteristics, such as, for example, tissue type, tissue impedance characteristics, status of tissue treatment, completion of tissue coagulation, etc. [col. 1, ll. 60-67].
More particularly, Williamson teaches an end effector comprising first and second jaws, which together include query electrodes and therapeutic electrodes [e.g., col. 2, ll. 12-22].
Williamson further teaches that the query electrodes may be used to determine the impedance of tissue at a given time prior to, during, or after tissue treatment [e.g., col. 7, ll. 8-12; see also claim 19, claim 22 (“wherein the step of delivering sensing electrosurgical energy occurs at the same time as the step of delivering therapeutic electrosurgical energy”); claim 23 (“wherein the step of delivering sensing electrosurgical energy occurs prior to the step of delivering therapeutic electrosurgical energy”); and claim 24 (“wherein the step of delivering sensing electrosurgical energy occurs after the step of delivering therapeutic electrosurgical energy”)].
Additionally, Williamson teaches the use of separate generators for the delivery of non-therapeutic and therapeutic energy or signals [see, e.g., col. 11, ll. 54-63 (“A first generator 70 supplies RF energy to the tissue engaged by the end effector 15 of the instrument 10 through therapeutic electrodes 39, 18… A second generator 90 supplies electrical energy to the query electrodes 51, 52 at a different fundamental frequency…)].
Examiner notes that the delivery of sensing electrosurgical energy from one generator followed by the delivery of therapeutic electrosurgical energy from another, separate generator reads on the limitation of the non-therapeutic RF signal and the therapeutic RF signal being provided separately in a sequence by the non-therapeutic waveform generator and the therapeutic waveform generator, respectively.
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, with the non-therapeutic RF signal and the therapeutic RF signal being provided separately in a sequence by the non-therapeutic waveform generator and the therapeutic waveform generator, respectively, since such a particular generator configuration and signal delivery technique was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Williamson, 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 sequential provision of non-therapeutic and therapeutic RF waveforms by separate, dedicated generators) 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).
9. Regarding claim 2, the combination of Voegele, Prakash, and Williamson 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]].
10. Regarding claim 3, the combination of Voegele, Prakash, and Williamson 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]].
11. Regarding claim 4, the combination of Voegele, Prakash, and Williamson 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]].
12. Regarding claim 15, the combination of Voegele, Prakash, and Williamson 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]].
13. Claims 5-7, & 11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Williamson, as applied to claim 1 above, and further in view of U.S. 2022/0039855 to Batchelor et al. ("Batchelor").
14. Regarding claims 5-7, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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).
15. Regarding claim 11, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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).
16. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Williamson, as applied to claim 1 above, and further in view of U.S. 2020/0107877 to Koblish et al. ("Koblish").
17. Regarding claim 8, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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).
18. Claims 9 & 12 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Williamson, as applied to claim 1 above, and further in view of U.S. 5,280,429 to Withers ("Withers").
19. Regarding claim 9, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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).
20. Regarding claim 12, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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).
21. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Williamson, as applied to claim 1 above, and further in view of U.S. 2018/0067154 to Cherkassky et al. ("Cherkassky").
22. Regarding claim 10, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Williamson, as applied to claim 1 above, and further in view of U.S. 2019/0274752 to Denzinger et al. ("Denzinger").
24. Regarding claim 13, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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).
25. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Prakash, and Williamson, as applied to claim 1 above, and further in view of U.S. 2017/0100092 to Kruse et al. ("Kruse").
26. Regarding claim 14, the combination of Voegele, Prakash, and Williamson 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 Williamson 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 Williamson 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 Williamson), 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)
27. 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, U.S. 2014/0135804 to Weisenburgh, II et al. (“Weisenburgh”), & Williamson.
28. 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], wherein the first and second electrode surfaces together form a plurality of electrodes [¶[0038]];
(b) controlling, using a processor [processor (1004) - ¶[0046]; FIG. 9], delivery and measurement of a non-therapeutic radio frequency (RF) signal to the plurality of electrodes from a non-therapeutic waveform generator [generator (102) - ¶[0033]; FIG. 1] [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) determining, based on the non-therapeutic RF signal, at least one characteristic of the tissue of the patient [impedance - ¶[0041]];
***
(e) ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes [NOTE: Voegele teaches that monitoring may occur at the onset of each treatment cycle (e.g., ¶’s [0056] & [0058]); as such, it is the Examiner’s position that Voegele is not limited to a continuous delivery of the non-therapeutic signal throughout a treatment cycle; regardless, and assuming arguendo that Voegele is interpreted as teaching continuous application of the non-therapeutic signal throughout an entire treatment cycle (i.e., simultaneously with the therapeutic signal), Williamson (addressed in detail below) teaches sequential application of non-therapeutic and therapeutic signals]; and
(f) … after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes [see NOTE immediately above in the discussion of step (e)],… initiate delivery of 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”)] from a therapeutic waveform generator [generator (102) - ¶[0033]; FIG. 1; NOTE: the claim does not currently require that the non-therapeutic waveform generator and the therapeutic waveform generator be separate waveform generators], such that the non-therapeutic RF signal and the therapeutic RF signal are provided separately in a sequence [e.g., provision of the non-therapeutic RF signal at the onset of a treatment cycle, followed by the provision of the therapeutic RF signal during the remainder of the treatment cycle].
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) determining, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; and
***
(f) responsive to determining that the plurality of electrodes are in contact with the intended tissue type… initiat[ing] delivery of 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) determining, based on the at least one characteristic, that the plurality of electrodes are in contact with an intended tissue type; and (f) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, initiat[ing] delivery of 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
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:
(b) … wherein delivery of the non-therapeutic radio frequency (RF) signal is through a dual position dual throw switch in a first position; [and]
(f) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, automatically transitioning the dual position dual throw switch from the first position to a second position to thereby initiate delivery of 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, and after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, automatically transitioning the dual position dual throw switch from the first position to a second position to thereby initiate delivery of 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).
D. GENERATOR(S) & SEQUENCE
As noted above, it is the Examiner’s position that the claim does not currently require that the non-therapeutic waveform generator and the therapeutic waveform generator be separate waveform generators. Further, Voegele appears to teach ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, such that the non-therapeutic RF signal and the therapeutic RF signal can be provided separately in a sequence.
Nonetheless, in the interest of compact prosecution, and assuming arguendo that the foregoing interpretations are deemed improper, Williamson clearly teaches the following emphasized claim limitations:
(f) responsive to determining that the plurality of electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, automatically transitioning the dual position dual throw switch from the first position to a second position to thereby initiate delivery of a therapeutic RF signal to the plurality of electrodes from a therapeutic waveform generator, such that the non-therapeutic RF signal and the therapeutic RF signal are provided separately in a sequence.
Williamson, in a similar field of endeavor, is directed to an electrosurgical device which includes query electrodes for measuring one or more electrical parameters of tissue prior to, during, or after treating the tissue with therapeutic electrodes. The measured tissue parameters may be used to determine various tissue characteristics, such as, for example, tissue type, tissue impedance characteristics, status of tissue treatment, completion of tissue coagulation, etc. [col. 1, ll. 60-67].
More particularly, Williamson teaches an end effector comprising first and second jaws, which together include query electrodes and therapeutic electrodes [e.g., col. 2, ll. 12-22].
Williamson further teaches that the query electrodes may be used to determine the impedance of tissue at a given time prior to, during, or after tissue treatment [e.g., col. 7, ll. 8-12; see also claim 19, claim 22 (“wherein the step of delivering sensing electrosurgical energy occurs at the same time as the step of delivering therapeutic electrosurgical energy”); claim 23 (“wherein the step of delivering sensing electrosurgical energy occurs prior to the step of delivering therapeutic electrosurgical energy”); and claim 24 (“wherein the step of delivering sensing electrosurgical energy occurs after the step of delivering therapeutic electrosurgical energy”)].
Additionally, Williamson teaches the use of separate generators for the delivery of non-therapeutic and therapeutic energy or signals [see, e.g., col. 11, ll. 54-63 (“A first generator 70 supplies RF energy to the tissue engaged by the end effector 15 of the instrument 10 through therapeutic electrodes 39, 18… A second generator 90 supplies electrical energy to the query electrodes 51, 52 at a different fundamental frequency…)].
Examiner notes that the delivery of sensing electrosurgical energy from one generator followed by the delivery of therapeutic electrosurgical energy from another, separate generator reads on the limitation of the non-therapeutic RF signal and the therapeutic RF signal being provided separately in a sequence by the non-therapeutic waveform generator and the therapeutic waveform generator.
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, and Weisenburgh such that the non-therapeutic and the therapeutic waveform generators comprise separate waveform generators, with the non-therapeutic RF signal and the therapeutic RF signal being provided separately in a sequence by the non-therapeutic waveform generator and the therapeutic waveform generator, since such a particular generator configuration and signal delivery technique was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Williamson, and one of ordinary skill in the art would have been capable of applying this known configuration to the known method of Voegele, Koblish, Prakash, & Weisenburgh, and the results (the sequential provision of non-therapeutic and therapeutic RF waveforms by separate, dedicated generators) 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. Claims 17 & 19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Koblish, Prakash, Weisenburgh, & Williamson, as applied to claim 16 above, and further in view of Batchelor.
30. Regarding claim 17, the combination of Voegele, Koblish, Prakash, Weisenburgh, & Williamson 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, & Williamson 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, & Williamson 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, & Williamson), 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. Regarding claim 19, the combination of Voegele, Koblish, Prakash, Weisenburgh, & Williamson 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, & Williamson 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, & Williamson 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, & Williamson), 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).
32. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Voegele, Koblish, Prakash, Weisenburgh, & Williamson, as applied to claim 16 above, and further in view of Cherkassky.
33. Regarding claim 18, the combination of Voegele, Koblish, Prakash, Weisenburgh, & Williamson 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, & Williamson 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, & Williamson 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, & Williamson), 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
34. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Voegele in view of Prakash, and further in view of Williamson.
35. Regarding claim 20, Voegele teaches a system comprising:
(a) a non-therapeutic waveform generator [generator (102) - ¶[0033]; FIG. 1] [e.g., ¶[0041] (“The generator 102 may provide a signal (e.g., a non-therapeutic signal) to the electrodes 177 and 179”)]; and
(b) a therapeutic waveform generator [generator (102) - ¶[0033]; FIG. 1] [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]; NOTE: the claim does not currently require that the non-therapeutic waveform generator and the therapeutic waveform generator be separate waveform generators];
(c) 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 non-therapeutic 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) cease delivery of the non-therapeutic RF signal to the plurality of electrodes [NOTE: Voegele teaches that monitoring may occur at the onset of each treatment cycle (e.g., ¶’s [0056] & [0058]); as such, it is the Examiner’s position that Voegele is not limited to a continuous delivery of the non-therapeutic signal throughout a treatment cycle; regardless, and assuming arguendo that Voegele is interpreted as teaching continuous application of the non-therapeutic signal throughout an entire treatment cycle (i.e., simultaneously with the therapeutic signal), Williamson (addressed in detail below) teaches sequential application of non-therapeutic and therapeutic signals], and
(E) … after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes [see NOTE immediately above in the discussion of step (D)], initiate delivery of a therapeutic RF signal to tissue via the first and second electrodes and the therapeutic waveform generator [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”)], such that the non-therapeutic RF signal and the therapeutic RF signal are provided separately in a sequence [e.g., provision of the non-therapeutic RF signal at the onset of a treatment cycle, followed by the provision of the therapeutic RF signal during the remainder of the treatment cycle].
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:
(C) determine, based on the at least one characteristic, that the first and second electrodes are in contact with an intended tissue type, and
***
(E) responsive to determining that the first and second electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, initiate 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 (E) responsive to determining that the first and second electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, initiate 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].
B. GENERATOR(S) & SEQUENCE
As noted above, it is the Examiner’s position that the claim does not currently require that the non-therapeutic waveform generator and the therapeutic waveform generator be separate waveform generators. Further, Voegele appears to teach ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, such that the non-therapeutic RF signal and the therapeutic RF signal can be provided separately in a sequence.
Nonetheless, in the interest of compact prosecution, and assuming arguendo that the foregoing interpretations are deemed improper, Williamson clearly teaches the following emphasized claim limitations:
wherein the processor [(1004)] is configured to:
(E) responsive to determining that the first and second electrodes are in contact with the intended tissue type, and after ceasing delivery of the non-therapeutic RF signal to the plurality of electrodes, initiate delivery of a therapeutic RF signal to tissue via the first and second electrodes and the therapeutic waveform generator, such that the non-therapeutic RF signal and the therapeutic RF signal are provided separately in a sequence.
Williamson, in a similar field of endeavor, is directed to an electrosurgical device which includes query electrodes for measuring one or more electrical parameters of tissue prior to, during, or after treating the tissue with therapeutic electrodes. The measured tissue parameters may be used to determine various tissue characteristics, such as, for example, tissue type, tissue impedance characteristics, status of tissue treatment, completion of tissue coagulation, etc. [col. 1, ll. 60-67].
More particularly, Williamson teaches an end effector comprising first and second jaws, which together include query electrodes and therapeutic electrodes [e.g., col. 2, ll. 12-22].
Williamson further teaches that the query electrodes may be used to determine the impedance of tissue at a given time prior to, during, or after tissue treatment [e.g., col. 7, ll. 8-12; see also claim 19, claim 22 (“wherein the step of delivering sensing electrosurgical energy occurs at the same time as the step of delivering therapeutic electrosurgical energy”); claim 23 (“wherein the step of delivering sensing electrosurgical energy occurs prior to the step of delivering therapeutic electrosurgical energy”); and claim 24 (“wherein the step of delivering sensing electrosurgical energy occurs after the step of delivering therapeutic electrosurgical energy”)].
Additionally, Williamson teaches the use of separate generators for the delivery of non-therapeutic and therapeutic energy or signals [see, e.g., col. 11, ll. 54-63 (“A first generator 70 supplies RF energy to the tissue engaged by the end effector 15 of the instrument 10 through therapeutic electrodes 39, 18… A second generator 90 supplies electrical energy to the query electrodes 51, 52 at a different fundamental frequency…)].
Examiner notes that the delivery of sensing electrosurgical energy from one generator followed by the delivery of therapeutic electrosurgical energy from another, separate generator reads on the limitation of the non-therapeutic RF signal and the therapeutic RF signal being provided separately in a sequence by the non-therapeutic waveform generator and the therapeutic waveform generator.
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 such that the non-therapeutic and the therapeutic waveform generators comprise separate waveform generators, with the non-therapeutic RF signal and the therapeutic RF signal being provided separately in a sequence by the non-therapeutic waveform generator and the therapeutic waveform generator, since such a particular generator configuration and signal delivery technique was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Williamson, and one of ordinary skill in the art would have been capable of applying this known configuration to the known system of Voegele & Prakash, and the results (the sequential provision of non-therapeutic and therapeutic RF waveforms by separate, dedicated generators) 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).
Response to Arguments
36. As noted above, the 05/08/26 Amendment has overcome the claim objections, and the rejections under §§ 112(b) & 103 previously set forth in the 02/18/26 Action.
37. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Conclusion
38. 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.
39. 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, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 303-297-4276. 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
Prosecution Insights