DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 3/23/2026 with regards to the rejection of claim 1 have been fully considered but they are not persuasive.
Firstly, Applicant contends that one of ordinary skill in the art would have had no motivation to combine and incorporate the teachings of Tsukashima and Michaeli, who provide disclosure of wherein a conductivity range of normal bran is defined between 0.25 S/m to 0.3 S/m, into the device of Eggers to provide/supply a known conductivity range for brain tissue as the “acceptable conductivity range” disclosed but not expanded upon by Eggers (per Eggers Col. 8, Lines 57-67 through Col. 9, Lines 1-17). Specifically since Eggers discloses wherein energy delivered to the distal electrodes may be selectively switched on and off based on “acceptable conductivity range”, but does not provide an express disclosure of what the “acceptable conductivity range” is defined by, the teachings of Tsukashima and Michaeli were relied upon to fill in the omitted range by providing a known conductivity range for normal brain tissue. Applicant contends that Tsukashima and Michaeli only provide the disclosed range as the range of “normal tissue”, rather than in regards to what may be an acceptable range for “abnormal tissue” undergoing ablatio or other procedures. Therefore, Applicant contends that no motivation is provided in the references in providing threshold values for starting and stopping ablation for the device of Eggers. The Examiner respectfully disagrees with the interpretation of the combined references. Eggers discloses wherein the direct feedback control for selectively turning on and off the first and second electrodes (see Col. 9, Lines 1-19) is configured to selectively supply to the electrode terminals if and when the tissue encountered at the working tip of the probe is “normal” based on the measured electrical properties (see Col. 9, Lines 1-19). The Examiner contends that the device of Eggers is configured to supply power to the electrodes only when tissue at a target site is determined to be “normal”, which the combined teachings of Tsukashima and Michaeli are directed to. Eggers is not expressly configured to be limited so as to only supply power to “abnormal tissue” as suggested by Applicant, but rather the opposite appears to be true in which the presence and defection of abnormal tissue would cause the direct feedback control to limit power supplied to the electrode terminals.
Secondly, Applicant contends that the proposed combination of incorporating the teachings of Tsukashima and Michaeli into the device of Eggers would render the device of Eggers unworkable on the grounds that Eggers utilizes highly conductive fluid (isotonic saline) near the probe tip (Eggers Col. 12, Lines 2-4). None of either Eggers or the combined references of Tsukashima and Michaeli disclosure any reason to shut off the power supplied to tissue while applying highly conductive fluid. Applicant further contends that since Eggers is operating in a saline-rich environment, one of ordinary skill in the art would never apply cauterizing energy in such an environment. Thus, should the device of Eggers be modified to comprise the teachings of Tsukashima and Michaeli, the device of Eggers would become unworkable. The Examiner respectfully disagrees. Firstly, the recitation of saline as the highly conductive material is only noted to be exemplary as Eggers only mentions saline in the context of “a liquid electrically conductive fluid (e.g., isotonic saline) nay be used to concurrently “bathe” the target tissue surface to provide an additional means for removing any tissue, and to cool the region of the target tissue ablated in the previous manner” (see Eggers Col. 12, Lines 1-6). The arguments specifically pertaining to the conductivity of saline in regards to limiting the power suppled to the electrodes are therefore not persuasive as the device of Eggers is not limited to only using isotonic saline, but rather other highly conductive fluids. Additionally, the device of Eggers is already expressly disclosed to only supply power to the electrodes to perform tissue ablation when “normal tissue” is detected by the direct feedback control (see Eggers Col. 9, Lines 1-19) and thus Eggers already provides a teaching that power be limited to only be supplied to “normal tissue” while being limited or turned off when the tissue detected is abnormal. The Examiner therefore contends that the teachings of Tsukashima and Michaeli, in providing known “normal tissue” conductivity range for brain tissue are fully useable with the device of Eggers in supplying known values for “normal” brain tissue to which the device of Eggers is configured to apply ablation energy to.
Thirdly, Applicant contends that the device of Eggers interrupts power when there is insufficient conductive fluid around the electrode terminal, which is the opposite of the claimed invention which would permit application of energy when measured conductivity is low, to minimize tissue damage. Applicant therefore contends that one of ordinary skill in the art would have had no motivation to cut off power on low conductivity. The Examiner notes that no specific claim language is being referenced in this argument and the Examiner cannot determine which limitations Applicant is referring to. Additionally, the disclosure of wherein Eggers interrupts power when there is insufficient conductive fluid around the electrode terminal is noted to be an optional system, as the portion of Eggers reciting this feature states “The power supply may include a fluid interlock for interrupting power to the electrode terminal(s) when there is insufficient conductive fluid around the electrode terminal(s). This ensures that the instrument will not be activated when conductive fluid is not present, minimizing the tissue damage that may otherwise occur” (see Col. 12, Lines 7-16).
Applicant's arguments filed 3/23/2026 with regards to the rejection of claims 2-4 have been fully considered but they are not persuasive.
Regarding claims 2-4, Applicant contends that Govari, relied upon to disclose pressure sensors disposed on the proximal end of the probe that are operable to provide signals to the control system corresponding to pressure against the probe to selectively limit application of cauterizing energy to target tissue when the measured pressure is outside a range of 2.3 to 7 N/cm2, does not expressly disclose the claimed range of 2.3 to 7 N/cm2 as “normal” for brain tissue. The Examiner’s position that 2.7 to 7 N/cm2 is an inherent pressure property of “normal brain tissue” is not applicable to the device of Eggers on the grounds that the device of Eggers is configured to ablate tumors or AVM’s and nothing in the references suggest a lower level of sensed pressure which might be appropriate for cut-off of power. As the references do not provide a disclosure that the claimed range might constitute an energy cut-off range, the combination does not adequately read on the claimed limitations. The Examiner respectfully disagrees. Firstly, Applicant’s own specification expressly mentions wherein the claimed range constitutes normal, healthy brain tissue (see Specification Para. [0019]) so the claimed range is understood to be an inherent properly of normal brain tissue, even without an express disclosure from the combined references. Additionally, while Govari may not expressly disclose a pressure range, Govari is merely relied upon to incorporate pressure sensors into the device of Eggers in providing additional data to analyze target brain tissue, expanding upon the measured “electrical parameters” utilized to determine whether energy should be applied to the target tissue. Since Eggers is disclosed to only supply power to the electrodes in the presence of “normal tissue” (see Col. 9, Lines 1-19), the range of 2.7 to 7 N/cm2 would thus constitute a pressure threshold for “normal tissue” to which the direct feedback control system would utilize in determining the target tissue is indeed “normal tissue” before supplying power thereto.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eggers (US 6322549 B1)(previously of record) in view of Tsukashima (US 2017/0332912 A1)(previously of record), further in view of Michaeli (US 2017/0296825 A1)(previously of record).
Regarding claim 1, Eggers discloses:
A cautery device (see Fig. 1 and Col. 3, Lines 1-10) comprising:
an elongate probe (probe 10/90, see Figs. 1-2) with a distal end and a proximal end (see Fig. 1), said distal end configured for insertion into a surgical space in a patient (see Col. 3, Lines 1-10 and Col. 16, Lines 49-55; the probe is configured to be inserted into and treat tissue in the brain and spinal cord);
a first electrode and a second electrode (plurality of electrode terminals 58, see Fig. 1) disposed proximate the distal end of the probe (see Fig. 1);
means for testing conductivity between the first electrode and the second electrode, through body tissue (see Col. 8, Lines 57-67 through Col. 9, Lines 1-19 mentioning wherein “the system of the present invention measures the electrical properties of the tissue at the tip of the probe with one or more electrode terminal(s)”; conductivity is specifically mentioned as one of the desired measured electrical properties to ensure the probe is targeting the correct desired tissue); and
a control system operable to control application of cauterizing energy through the first and second electrodes in response to electrical conductivity measured by the means for testing (see Col. 9, Lines 1-19 mentioning wherein “direct feedback control can be provided to only supply power to the electrode terminal(s) either individually or to the complete array of electrodes, if and when the tissue encountered at the tip or working end of the probe is normal tissue based on the measured electrical properties”);
said control system further operable to selectively apply cauterizing energy in response to operator input when electrical conductivity, as determined by the means for testing, measures within an acceptable range, and prevent or discontinue application of cauterizing energy if conductivity, as determined by the means for testing, measures greater than an acceptable range (see Col. 9, Lines 1-19 mentioning wherein “direct feedback control can be provided to only supply power to the electrode terminal(s) either individually or to the complete array of electrodes, if and when the tissue encountered at the tip or working end of the probe is normal tissue based on the measured electrical properties” (i.e., conductivity as one of the mentioned measured properties)).
However, while Eggers discloses wherein energy delivered to the distal electrodes may be selectively switched on and off based on acceptable conductivity ranges/values (see Col. 8, Lines 57-67 through Col. 9, Lines 1-17), Eggers does not provide an express conductivity range and thus does not expressly disclose wherein said control system is configured to selectively apply cauterizing energy in response to operator input when electrical conductivity as determined by the means for testing, measures within a range of between 0.02 to .3 S/m and prevent or discontinue application of cauterizing energy if conductivity, as determined by the means for testing, measures greater than 0.3 S/m.
In the same field of endeavor, namely surgical instruments for providing electrical stimulus to a brain, Tsukashima teaches wherein brain tissue typically has normal conductivity of between 0.25 S/m to about 0.28 S/m (see Para. [0021]).
Additionally, in the field of endeavor of surgical instruments for providing electrical stimulus to a brain, Michaeli teaches wherein conductivity of brain tissue can reach a value of 0.3 S/m (see Para. [0034]).
With the express disclosure from Tsukashima and Michaeli pertaining to standard normal conductivity values for brain tissue, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the feedback control system of Eggers to define an acceptable conductivity range for brain tissue to be between 0.25 S/m and 0.3 S/m and to only supply power to the electrode terminals, when working within the brain, when a measured conductivity is between 0.25 S/m and 0.3 S/m and to stop and prevent further power from being delivered to the electrodes when the measured conductivity measures greater than 0.3 S/m as this would indicate a non-standard brain tissue in contact with the electrode(s).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eggers (US 6322549 B1)(previously of record) in view of Tsukashima (US 2017/0332912 A1)(previously of record), further in view of Michaeli (US 2017/0296825 A1)(previously of record), further in view of Govari (US 2016/0143696 A1)(previously of record).
Regarding claim 2, the combination of Eggers, Tsukashima and Michaeli disclose all of the limitations of the invention of claim 1.
However, while Eggers provides a disclosure of wherein “electrical properties” of a target site are measured by the one or more electrode terminals to detect what type of tissue is present at the distal tip of the device (see Col. 8, Lines 57-67 through Col. 9, Lines 1-17), Eggers does not expressly mention wherein pressure is one of the measured “electrical parameters” and thus does not expressly disclose:
a pressure sensor disposed on the distal end of the probe, said pressure sensor operable to provide signals to the control system corresponding to the pressure against the probe due to contact with body tissue;
wherein the control system is further operable to selectively apply cauterizing energy in response to operator input when, in addition to the conditions of claim 1, pressure on the distal end of the probe, as determined by the pressure sensor, measures in the range of 2.3 to 7 N/cm2, (23 kPa to 70 kPa), and prevent or discontinue application of cauterizing energy if resistance, as determined by the pressure sensor, measures less than about 2.3 N/cm2.
In the field of endeavor of control systems for selectively controlling the delivery of electrical energy to electrodes at the distal end of a surgical probe, Govari teaches a surgical probe (see Fig. 2) comprising electrodes at the distal end thereof (see Para. [0026]) configured to deliver electrical energy to target tissue (see Para. [0025]-[0026]); wherein the probe comprises a control system (console 24 and power generator 25, see Fig. 1 and Para. [0046]) configured to, through pressure sensors located at the distal end of the probe (see Para. [0007] and [0046] mentioning wherein a sensor is disposed on the distal end of the probe to be able to detect an applied pressure), selectively deliver energy to the probe tip in contact with the tissue when the pressure applied to the probe tip by the target tissue is within a desired, acceptable range (see Para. [0046]) while not providing any power to the electrode when the pressure applied to the probe tip is outside (i.e., either above or below) of said desired range (see Para. [0046]) which ensures proper contact between the probe tip and target tissue.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of using a known technique to improve similar devices in the same way (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of providing a pressure sensor at the distal end of the probe of Eggers to measure pressure applied thereto by the target tissue, as taught and suggested by Govari, to further expand on the “electrical parameters” measurable by the device of Eggers to include pressure to indicate the presence of desired tissue and/or to ensure sufficient contact between said tissue and the distal electrodes. The incorporation of the pressure sensor into the feedback system of Eggers allows for selectively providing electrical energy to the distal electrodes when the pressure applied to the target tissue is within an acceptable range (i.e., ensuring proper contact with the desired tissue) while limiting or preventing electrical energy from being applied to the distal electrodes when the applied pressure is outside of said desired range (see Govari Para. [0046]). Regarding the claimed parameters of “2.3 to 7 N/cm2”, the examiner notes that this range appears to be an inherent pressure applied to surgical instruments operating within the brain. This can be seen in Para. [0019] of the Specification mentioning wherein this pressure is a property of normal, healthy brain tissue. Since the device of Eggers is also configured to be used within the brain, the “acceptable range” of pressure would be the same as the claimed range under normal operational conditions.
Regarding claim 3, Eggers discloses:
A method of applying cauterizing energy to a target tissue within the body of a patient, said method comprising:
providing a cautery system (see Fig. 1 and Col. 3, Lines 1-10) comprising:
an elongate probe (probe 10/90, see Figs. 1-2) with a distal end and a proximal end (see Fig. 1), said distal end configured for insertion into a surgical space in a patient (see Col. 3, Lines 1-10 and Col. 16, Lines 49-55; the probe is configured to be inserted into and treat tissue in the brain and spinal cord);
a first electrode and a second electrode disposed proximate the distal end of the probe (plurality of electrode terminals 58, see Fig. 1);
means for testing conductivity between the first electrode and the second electrode, through body tissue (see Col. 8, Lines 57-67 through Col. 9, Lines 1-19 mentioning wherein “the system of the present invention measures the electrical properties of the tissue at the tip of the probe with one or more electrode terminal(s)”; conductivity is specifically mentioned as one of the desired measured electrical properties to ensure the probe is targeting the correct desired tissue);
a control system operable to control application of cauterizing energy through the first and second electrodes in response to operator input inserting the distal end of the probe into the body of the patient and into contact with the target tissue (see Col. 9, Lines 1-19 mentioning wherein “direct feedback control can be provided to only supply power to the electrode terminal(s) either individually or to the complete array of electrodes, if and when the tissue encountered at the tip or working end of the probe is normal tissue based on the measured electrical properties”);
applying cauterizing energy to the target tissue when electrical conductivity, as determined by the means for testing, measures within an acceptable range, and avoiding or discontinuing application of cauterizing energy if conductivity, as determined by the means for testing, measures greater than the acceptable range (see Col. 9, Lines 1-19 mentioning wherein “direct feedback control can be provided to only supply power to the electrode terminal(s) either individually or to the complete array of electrodes, if and when the tissue encountered at the tip or working end of the probe is normal tissue based on the measured electrical properties” (i.e., conductivity as one of the mentioned measured properties).
However, while Eggers discloses wherein energy delivered to the distal electrodes may be selectively switched on and off based on acceptable conductivity ranges/values (see Col. 8, Lines 57-67 through Col. 9, Lines 1-17), Eggers does not provide an express conductivity range and thus does not expressly disclose wherein said control system is configured to selectively apply cauterizing energy in response to operator input when electrical conductivity as determined by the means for testing, measures within a range of between 0.02 to .3 S/m and prevent or discontinue application of cauterizing energy if conductivity, as determined by the means for testing, measures greater than 0.3 S/m.
In the same field of endeavor, namely surgical instruments for providing electrical stimulus to a brain, Tsukashima teaches wherein brain tissue typically has normal conductivity of between 0.25 S/m to about 0.28 S/m (see Para. [0021]).
Additionally, in the field of endeavor of surgical instruments for providing electrical stimulus to a brain, Michaeli teaches wherein conductivity of brain tissue can reach a value of 0.3 S/m (see Para. [0034]).
With the express disclosure from Tsukashima and Michaeli pertaining to standard normal conductivity values for brain tissue, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the feedback control system of Eggers to define an acceptable conductivity range for brain tissue to be between 0.25 S/m and 0.3 S/m and to only supply power to the electrode terminals, when working within the brain, when a measured conductivity is between 0.25 S/m and 0.3 S/m and to stop and prevent further power from being delivered to the electrodes when the measured conductivity measures greater than 0.3 S/m as this would indicate a non-standard brain tissue in contact with the electrode(s).
However, while Eggers provides a disclosure of wherein “electrical properties” of a target site are measured by the one or more electrode terminals to detect what type of tissue is present at the distal tip of the device (see Col. 8, Lines 57-67 through Col. 9, Lines 1-17), Eggers does not expressly mention wherein pressure is one of the measured “electrical parameters” and thus does not expressly disclose:
a pressure sensor disposed on the distal end of the probe, said pressure sensor operable to provide signals to the control system corresponding to the pressure against the probe due to contact with body tissue; and
applying cauterizing energy to the target tissue when pressure on the distal end of the probe, as determined by the pressure sensor, measures in the range of 2.3 to 7 N/cm2, (23 kPa to 70 kPa), and avoiding or discontinuing application of cauterizing energy if pressure on the distal end of the probe, as determined by the pressure sensor, measures less than about 2.3 N/cm2.
In the field of endeavor of control systems for selectively controlling the delivery of electrical energy to electrodes at the distal end of a surgical probe, Govari teaches a surgical probe (see Fig. 2) comprising electrodes at the distal end thereof (see Para. [0026]) configured to deliver electrical energy to target tissue (see Para. [0025]-[0026]); wherein the probe comprises a control system (console 24 and power generator 25, see Fig. 1 and Para. [0046]) configured to, through pressure sensors located at the distal end of the probe (see Para. [0046] mentioning wherein a sensor is disposed on the distal end of the probe to be able to detect an applied pressure), selectively deliver energy to the probe tip in contact with the tissue when the pressure applied to the probe tip by the target tissue is within a desired, acceptable range (see Para. [0046]) while not providing any power to the electrode when the pressure applied to the probe tip is outside (i.e., either above or below) of said desired range (see Para. [0046]) which ensures proper contact between the probe tip and target tissue.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of using a known technique to improve similar devices in the same way (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of providing a pressure sensor at the distal end of the probe of Eggers to measure pressure applied thereto by the target tissue, as taught and suggested by Govari, to further expand on the “electrical parameters” measurable by the device of Eggers to include pressure to indicate the presence of desired tissue and/or to ensure sufficient contact between said tissue and the distal electrodes. The incorporation of the pressure sensor into the feedback system of Eggers allows for selectively providing electrical energy to the distal electrodes when the pressure applied to the target tissue is within an acceptable range (i.e., ensuring proper contact with the desired tissue) while limiting or preventing electrical energy from being applied to the distal electrodes when the applied pressure is outside of said desired range (see Govari Para. [0046]). Regarding the claimed parameters of “2.3 to 7 N/cm2”, the examiner notes that this range appears to be an inherent pressure applied to surgical instruments operating within the brain. This can be seen in Para. [0019] of the Specification mentioning wherein this pressure is a property of normal, healthy brain tissue. Since the device of Eggers is also configured to be used within the brain, the “acceptable range” of pressure would be the same as the claimed range under normal operational conditions.
Regarding claim 4, Eggers discloses:
A method of applying cauterizing energy to a target tissue within the body of a patient, said method comprising:
providing a cautery system (see Fig. 1 and Col. 3, Lines 1-10) comprising:
an elongate probe (probe 10/90, see Figs. 1-2) with a distal end and a proximal end (see Fig. 1), said distal end configured for insertion into a surgical space in a patient (see Col. 3, Lines 1-10 and Col. 16, Lines 49-55; the probe is configured to be inserted into and treat tissue in the brain and spinal cord);
a first electrode and a second electrode disposed proximate the distal end of the probe (plurality of electrode terminals 58, see Fig. 1);
means for testing conductivity between the first electrode and the second electrode, through body tissue (see Col. 8, Lines 57-67 through Col. 9, Lines 1-19 mentioning wherein “the system of the present invention measures the electrical properties of the tissue at the tip of the probe with one or more electrode terminal(s)”; conductivity is specifically mentioned as one of the desired measured electrical properties to ensure the probe is targeting the correct desired tissue);
a control system operable to control application of cauterizing energy through the first and second electrodes in response to electrical conductivity measured by the means for testing (see Col. 9, Lines 1-19 mentioning wherein “direct feedback control can be provided to only supply power to the electrode terminal(s) either individually or to the complete array of electrodes, if and when the tissue encountered at the tip or working end of the probe is normal tissue based on the measured electrical properties”),;
said control system further operable to selectively apply cauterizing energy in response to operator input when electrical conductivity, as determined by the means for testing, measures in an acceptable range, and prevent or discontinue application of cauterizing energy if conductivity, as determined by the means for testing, measures greater than the acceptable range (see Col. 9, Lines 1-19 mentioning wherein “direct feedback control can be provided to only supply power to the electrode terminal(s) either individually or to the complete array of electrodes, if and when the tissue encountered at the tip or working end of the probe is normal tissue based on the measured electrical properties” (i.e., conductivity as one of the mentioned measured properties);
inserting the distal end of the probe into the body of the patient and into contact with the target tissue (see Figs. 7A-9 and Fig. 15); and
providing input to the control system to apply cauterizing energy to the target tissue while operating the control system to prevent application of cauterizing energy if conductivity, as determined by the means for testing, measures greater than the acceptable range (see Col. 9, Lines 1-19 mentioning wherein “direct feedback control can be provided to only supply power to the electrode terminal(s) either individually or to the complete array of electrodes, if and when the tissue encountered at the tip or working end of the probe is normal tissue based on the measured electrical properties”)
However, while Eggers discloses wherein energy delivered to the distal electrodes may be selectively switched on and off based on acceptable conductivity ranges/values (see Col. 8, Lines 57-67 through Col. 9, Lines 1-17), Eggers does not provide an express conductivity range and thus does not expressly disclose:
wherein said control system is configured to selectively apply cauterizing energy in response to operator input when electrical conductivity as determined by the means for testing, measures within a range of between 0.02 to .3 S/m and prevent or discontinue application of cauterizing energy if conductivity, as determined by the means for testing, measures greater than 0.3 S/m;
a pressure sensor disposed on the distal end of the probe, said pressure sensor operable to provide signals to the control system corresponding to the pressure against the probe due to contact with body tissue; and
wherein the control system is further operable to selectively apply cauterizing energy in response to operator input when pressure on the distal end of the probe, as determined by the pressure sensor, measures in the range of 2.3 to 7 N/cm2, (23 kPa to 70 kPa), and prevent or discontinue application of cauterizing energy if pressure on the distal end of the probe, as determined by the pressure sensor, measures less than about 2.3 N/cm2.
In the same field of endeavor, namely surgical instruments for providing electrical stimulus to a brain, Tsukashima teaches wherein brain tissue typically has normal conductivity of between 0.25 S/m to about 0.28 S/m (see Para. [0021]).
Additionally, in the field of endeavor of surgical instruments for providing electrical stimulus to a brain, Michaeli teaches wherein conductivity of brain tissue can reach a value of 0.3 S/m (see Para. [0034]).
With the express disclosure from Tsukashima and Michaeli pertaining to standard normal conductivity values for brain tissue, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the feedback control system of Eggers to define an acceptable conductivity range for brain tissue to be between 0.25 S/m and 0.3 S/m and to only supply power to the electrode terminals, when working within the brain, when a measured conductivity is between 0.25 S/m and 0.3 S/m and to stop and prevent further power from being delivered to the electrodes when the measured conductivity measures greater than 0.3 S/m as this would indicate a non-standard brain tissue in contact with the electrode(s).
However, while Eggers provides a disclosure of wherein “electrical properties” of a target site are measured by the one or more electrode terminals to detect what type of tissue is present at the distal tip of the device (see Col. 8, Lines 57-67 through Col. 9, Lines 1-17), Eggers does not expressly mention wherein pressure is one of the measured “electrical parameters” and thus does not expressly disclose:
a pressure sensor disposed on the proximal end of the probe, said pressure sensor operable to provide signals to the control system corresponding to the pressure against the probe due to contact with body tissue;
wherein the control system is further operable to selectively apply cauterizing energy in response to operator input when, in addition to the conditions of claim 1, pressure on the distal end of the probe, as determined by the pressure sensor, measures in the range of 2.3 to 7 N/cm2, (23 kPa to 70 kPa), and prevent or discontinue application of cauterizing energy if resistance, as determined by the means for testing, measures less than about 2.3 N/cm2.
In the field of endeavor of control systems for selectively controlling the delivery of electrical energy to electrodes at the distal end of a surgical probe, Govari teaches a surgical probe (see Fig. 2) comprising electrodes at the distal end thereof (see Para. [0026]) configured to deliver electrical energy to target tissue (see Para. [0025]-[0026]); wherein the probe comprises a control system (console 24 and power generator 25, see Fig. 1 and Para. [0046]) configured to, through pressure sensors located at the distal end of the probe (see Para. [0046] mentioning wherein a sensor is disposed on the distal end of the probe to be able to detect an applied pressure), selectively deliver energy to the probe tip in contact with the tissue when the pressure applied to the probe tip by the target tissue is within a desired, acceptable range (see Para. [0046]) while not providing any power to the electrode when the pressure applied to the probe tip is outside (i.e., either above or below) of said desired range (see Para. [0046]) which ensures proper contact between the probe tip and target tissue.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of using a known technique to improve similar devices in the same way (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of providing a pressure sensor at the distal end of the probe of Eggers to measure pressure applied thereto by the target tissue, as taught and suggested by Govari, to further expand on the “electrical parameters” measurable by the device of Eggers to include pressure to indicate the presence of desired tissue and/or to ensure sufficient contact between said tissue and the distal electrodes. The incorporation of the pressure sensor into the feedback system of Eggers allows for selectively providing electrical energy to the distal electrodes when the pressure applied to the target tissue is within an acceptable range (i.e., ensuring proper contact with the desired tissue) while limiting or preventing electrical energy from being applied to the distal electrodes when the applied pressure is outside of said desired range (see Govari Para. [0046]). Regarding the claimed parameters of “2.3 to 7 N/cm2”, the examiner notes that this range appears to be an inherent pressure applied to surgical instruments operating within the brain. This can be seen in Para. [0019] of the Specification mentioning wherein this pressure is a property of normal, healthy brain tissue. Since the device of Eggers is also configured to be used within the brain, the “acceptable range” of pressure would be the same as the claimed range under normal operational conditions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 10828082 B2 to Colquhoun, US 9033974 B2 to Zada, US 2015/0094712 A1 to Murdeshwar, US 7445619 B2 to Auge, US 2006/0084965 A1 to Young, and US 12121286 B2 to Sartor disclose surgical probes configured for use within the brain comprising either a pressure sensor or conductivity sensor at the probe tip to measure the given electrical parameter(s) during a procedure.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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