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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The current office action is made responsive to claims filed 10/05/2023.
Claims 1-24 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “the outside” in claims 8 and 17 is a term which renders the claim indefinite. The term “the outside” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this situation it is unclear what “the outside” is referring to and as the specification indicates multiple points at which there is an outside, such as the outside of the electrode housing or the outside of the blood vessel it is unclear at what point of reference this outside relates to, in an attempt to forward prosecution, the broadest interpretation is being applied which is from a point outside of the electrode housing as this encompasses multiple outsides which may be the intended limitation described in the specification. This claim limitation therefore requires further correction, clarification, and the addition of a proper antecedent basis.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, and 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Govari (US 20210059743 A1).
Regarding claim 1, Govari teaches a renal denervation catheter (Fig. 1-2; balloon catheter 40), comprising:
a catheter housing (Fig. 1-2; balloon membrane 46);
an electrode part, which is provided in the housing, emits a contact detection RF signal for contact with an inner wall of a renal vessel according to a contact detection mode, and emits a denervation RF signal for renal denervation according to a denervation mode ([0046]- [0047], [0049]); and
a control unit for allowing entry into the denervation mode when a contact detection feedback signal value generated by the contact detection mode satisfies a defined condition ([0041]- [0042], [0046]- [0047]).
Regarding claim 6, Govari teaches a renal denervation catheter (Fig. 1-2; balloon catheter 40), comprising:
a catheter housing (Fig. 1-2; balloon membrane 46);
an electrode part provided in the housing and emitting a nerve stimulation signal so as to detect reaction of a nerve to a target nerve area of a kidney ([0046]- [0047], [0049]); and
a control unit for generating a scan/detection control signal to scan and detect whether the nerve responds to the nerve stimulation signal ([0041]- [0042], [0046]- [0047]).
Regarding claim 11, Govari teaches a renal denervation catheter (Fig. 1-2; balloon catheter 40), comprising:
a catheter housing (Fig. 1-2; balloon membrane 46);
ring-shaped electrode parts, which are arranged in a ring type at preset intervals within a predetermined width in the circumferential direction of the housing and include heating electrodes for emitting a denervation RF signal so as to excise a target nerve of a kidney ([0046]- [0047], [0049] the electrode members are shown as surrounding the circumference of the balloon portion of the catheter, therefore providing a shape of a ring, additionally the electrodes for the purpose of measuring are ring shaped as in the form of a hollow ring and in a ring defined shape, therefore teaching the ring-shaped limitation as broadly as is currently claimed),
a frequency generating unit for generating the denervation RF signal and transmits the denervation RF signal to the ring-shaped electrode parts ([0033]); and
a control unit for generating a control signal so as to enable generation of the denervation RF signal ([0041]- [0042], [0046]- [0047]).
Regarding claim 12, Govari teaches the catheter according to claim 11, wherein the ring-shaped electrode part is divided into at least three sectors, and each of the sectors has a heating electrode disposed so as to excise the target nerve of the kidney ([0031] discussed a plurality of electrodes which encompass at least three sectors as broadly as is currently claimed).
Regarding claim 13, Govari teaches the catheter according to claim 12, wherein a plurality of ring-shaped electrode parts are arranged at predetermined intervals in the longitudinal direction of the catheter housing ([0030]- [0032]).
Regarding claim 14, Govari teaches the catheter according to claim 13, wherein the plurality of ring-shaped electrode parts are arranged so that positions of the heating electrodes disposed on each of the ring-shaped electrode parts are not the same as each other ([0030]- [0032]).
Regarding claim 15, Govari teaches a renal denervation catheter (Fig. 1-2; balloon catheter 40), comprising:
a catheter housing (Fig. 1-2; balloon membrane 46);
ring-shaped electrode parts, which are arranged in a ring type at preset intervals within a predetermined width in the circumferential direction of the housing, and include detection electrodes for emitting a nerve stimulation signal so as to detect reaction of a nerve in a target nerve area of a kidney and heating electrodes for emitting a denervation RF signal so as to excise a target nerve of a kidney ([0046]- [0047], [0049] the electrode members are shown as surrounding the circumference of the balloon portion of the catheter, therefore providing a shape of a ring, additionally the electrodes for the purpose of measuring are ring shaped as in the form of a hollow ring and in a ring defined shape, therefore teaching the ring-shaped limitation as broadly as is currently claimed); and
a control unit for generating a control signal so as to enable generation of the nerve stimulation signal and the denervation RF signal ([0041]- [0042], [0046]- [0047]).
Regarding claim 16, Govari teaches the catheter according to claim 15, wherein the ring-shaped electrode parts are arranged, so that the detection electrodes and the heating electrodes are alternately repeated, and are divided into at least three sectors, respectively ([0030]- [0032] teaches the positioning of the electrodes which measure and which provided electrode as being on either side of one another).
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 20210059743 A1) in view of Ryan (US 6066139 A).
Regarding claim 2, Govari teaches the catheter according to claim 1, further comprising a detection unit for detecting a feedback value generated by the contact detection RF signal ([0034]).
However, Govari fails to teach the feedback value as being a current.
Govari instead teaches the value which determines contact as being impedance (Abstract, [0034]).
Ryan teaches an apparatus which determines electrode contact be received values measured by a sensor (Abstract).
Ryan further teaches determining tissue impedance based on a sensed current based on the known relationship between current and impedance (Col. 3, Lines 40-65).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of sensing a current so as to determine tissue impedance, as is taught by Ryan, into the system for measuring impedance to determine tissue contact as is taught by Govari, to produce the predictable result of utilizing a produced impedance value from measured tissue values to determine tissue contact, as is taught by Ryan, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 3, Govari as modified teaches the catheter according to claim 2, wherein
the control unit includes:
a blood vessel inner wall contact check unit, which compares the feedback current value transmitted from the current detection unit with the pre-defined condition, and determines whether the electrode part is in contact with the inner wall of the renal vessel ([0019], [0042]- [0043] [0047]); and
a mode switching unit ([0008], [0024]- [0025], [0034), which switches and changes the contact detection mode and the denervation mode, and switches the contact detection mode to the denervation mode according to a control signal of the blood vessel inner wall contact check unit ([0019], [0046]- [0047], [0049]).
Regarding claim 4, Govari teaches the catheter according to claim 3, further comprising a frequency generating unit for generating an RF frequency corresponding to the mode switched by the mode switching unit and transmitting the RF frequency to the electrode part ([0033]).
Regarding claim 5, Govari teaches the catheter according to claim 4, wherein
the frequency generating unit includes:
a frequency generating unit for generating a blood vessel inner wall contact detection RF frequency according to the contact detection mode and transmitting the blood vessel inner wall contact detection RF frequency to the electrode part ([0046]- [0047], [0049]); and
a frequency generating unit for generating a denervation RF frequency according to the denervation mode and transmitting the denervation RF frequency to the electrode part ([0041]- [0042], [0046]- [0047]).
However, while Govari does not specifically teach the frequency generating unit which performs these actions as being two separate elements as is recited by the claim in the language of “a blood vessel inner wall contact detection frequency generating unit” and “a denervation frequency generating unit” Govari teaches a unit which performs these elements and Applicant has not disclosed that these components being separable produces an unexpected result and it has been held that separation of parts is an obvious modification (MPEP 2144.04(V)(B)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the frequency generating unit which performs these actions as being two separate elements as is recited by the claim in the language of “a blood vessel inner wall contact detection frequency generating unit” and “a denervation frequency generating unit” as long as each functional element retains its ability to function in a desired and predictable manner.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 20210059743 A1) in view of Long (US 20160310211 A1) and Schmidt (US 20190117969 A1).
Regarding claim 7, Govari teaches the catheter according to claim 6.
Govari further teaches the renal denervation as occurring by RF signals for measuring and ablating tissue ([0033]- [0034, [0049]).
However, Govari is silent on the teaching of the catheter wherein the nerve stimulation signal is a current pulse signal, in which positive and negative currents alternately repeat during one cycle, so that in a current pulse signal of a first cycle, positive current is generated first, followed by negative current, and in a current pulse signal of a second cycle, negative current is generated first, followed by positive current, and the current pulse signals of the first cycle and second cycle are periodically repeated.
Long teaches a catheter device for renal denervation ablation (Abstract). Wherein the ablation of nerves for denervation can be from either an ablation energy in the form of RF energy that generates thermal energy or in the form of pulses that generate electroporation of cells ([0002]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the RF ablation of tissue, as is taught by Govari with the delivery of pulses to generate the electroporation of cells, as is taught by Long as both manners of delivering energy perform the same function of providing renal denervation to patient tissue, as is taught by Long and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Long further teaches the sequence of pulses which generate electric fields to electroporate tissue as being in a variety of forms such as monophasic, biphasic, or multiphasic forms which may be balanced or unbalanced, as a wide variety of variations to the distribution of pulses during the electroporation of tissue are known to those skilled in the art ([0009], [0062]- [0063]).
Schmidt teaches a variety of known sequences of pulses which are utilized to generate electric fields so as to treat patient tissue (Abstract, [0154], [0164]).
Schmidt further teaches a sequence of pulses which is utilized to treat patient tissue as being in a form of a positive then a negative pulse followed by a negative then a positive pulse ([0186]- [0187], [0201]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known sequence of pulses for producing electric fields to treat patient tissue, as is taught by Schmidt, into the pulses for generating an electric field to treat patient tissue as is taught by Long to produce the predictable result of producing an electric field which treats patient tissue, as is taught by Schmidt, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 20210059743 A1) in view of Long (US 20160310211 A1) and Schmidt (US 20190117969 A1) further in view of Dunning (US 20080281309 A1).
Regarding claim 8, Govari as modified teaches the catheter according to claim 7, wherein
the control unit includes:
a target scan mode unit ([0033]- [0034]), which generates the scan/detection control signal; and
a denervation determination unit for determining whether to treat the target nerve by receiving a detection signal from the outside for reaction of the nerve in response to the nerve stimulation signal emitted by the electrode part ([0033], [0045]- [0047]).
Govari further teaches the use of controlling and changing the position of the catheter and frequency of the nerve stimulation signal according to the reaction sensitivity of a target nerve ([0047] teaches that based on the received signal the sensing signal will be stopped to ablate or will be repositioned).
However, Govari does not teach this as occurring by the target scan mode unit but instead teaches this adjustment as occurring based on the physician ([0047]), so while Govari does not specifically teach this as occurring by the use of a unit Applicant has not disclosed that these automations of manual activities produces an unexpected result and it has been held that integration of parts is an obvious modification (MPEP 2144.04(III)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any mechanical elements which are functional to perform this disclosed function of adjusting the positioning and provided signal as is taught by Govari to occur by the use of a machine as long as each functional element retains its ability to function in a desired and predictable manner.
Govari further fails to teach the electrosurgery energy being applied as being for excising the tissue.
Govari instead teaches treating the tissue by ablating the tissue ([0046]- [0047]).
Dunning teaches a device for providing electrosurgical energy to modify biological tissue ([0004]- [0005], [0061]).
Dunning further teaches a variety of desired tissue effects being produced by the application of current from an electrosurgical generator through a source electrode to a return electrode, such as ablation and cutting which are well-known ([0004]- [0005], [0061]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the delivery of electrosurgical energy from an electrode to produce ablation as is taught by Govari with the electrosurgical energy from an electrode to produce cutting as is taught by Dunning as both items use electrosurgical energy applied through an electrode to modify biological tissue and perform the same function of treating tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 20210059743 A1) in view of Long (US 20160310211 A1) and Schmidt (US 20190117969 A1) further in view of Dunning (US 20080281309 A1) and Bonfils-Rasmussen (US 20170150923 A1)
Regarding claim 9, Govari as modified teaches the catheter according to claim 8, wherein
the control unit further includes:
a denervation mode unit ([0033]- [0034], [0046]- [0047]) for generating a denervation control signal according to the target nerve excision determination of the denervation determination unit.
However, Govari fails to teach the control using further including an excision position marking unit for marking an excision position of the target nerve according to target nerve excision determination of the denervation determination unit.
Dunning teaches a device for providing electrosurgical energy to modify biological tissue ([0004]- [0005], [0061]).
Dunning further teaches a variety of desired tissue effects being produced by the application of current from an electrosurgical generator through a source electrode to a return electrode, such as ablation and cutting which are well-known ([0004]- [0005], [0061]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the delivery of electrosurgical energy from an electrode to produce ablation as is taught by Govari with the electrosurgical energy from an electrode to produce cutting as is taught by Dunning as both items use electrosurgical energy applied through an electrode to modify biological tissue and perform the same function of treating tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Bonfils-Rasmussen teaches a system for nerve identification, monitoring and location and treatment tracking (Abstract, [0016]).
Bonfils-Rasmussen further teaches the desire to position a surgical instrument at a location for treatment based on marking of the desired nerves for tracking and reference as necessary ([0006]- [0007]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated marking the desired location for treatment during a surgical procedure, as is taught by Bonfils-Rasmussen, into the processor as is taught by Govari as modified, to produce the predictable result of providing location tracking and references relative to a surgical instrument during a procedure, as is taught by Bonfils-Rasmussen, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 10, Govari teaches the catheter according to claim 9, comprising:
a frequency generating unit for generating the current pulse signal according to the control signal of the target scan mode unit and transmitting the control signal to the electrode part so as to enable detection of reaction of the target nerve ([0046]- [0047], [0049]); and
a frequency generating unit for generating the denervation RF frequency according to the control signal of the denervation mode unit and transmitting the denervation RF frequency to the electrode part so as to enable excision of the target nerve ([0041]- [0042], [0046]- [0047]).
However, while Govari does not specifically teach the frequency generating unit which performs these actions as being two separate elements as is recited by the claim in the language of “a nerve stimulation frequency generating unit” and “a denervation frequency generating unit” Govari teaches a unit which performs these elements and Applicant has not disclosed that these components being separable produces an unexpected result and it has been held that separation of parts is an obvious modification (MPEP 2144.04(V)(B)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the frequency generating unit which performs these actions as being two separate elements as is recited by the claim in the language of “a nerve stimulation frequency generating unit” and “a denervation frequency generating unit” as long as each functional element retains its ability to function in a desired and predictable manner.
Claims 17- 18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 20210059743 A1) in view of Dunning (US 20080281309 A1).
Regarding claim 17, Govari teaches the catheter according to claim 16, wherein
the control unit includes:
a target scan mode unit ([0033]- [0034]), which generates a scan/detection control;
a target area determination unit ([0043]) for determining a treatment area of the target nerve by receiving a detection signal from the outside for reaction of the nerve in response to the nerve stimulation signal emitted by the detection electrode;
a denervation mode unit ([0033, [0045]- [0047]) for generating a denervation control signal according to treatment area determination of the target area determination unit; and
a mode setting unit ([0034]) for controlling mode switching of the target scan mode unit and the denervation mode unit.
Govari further teaches the use of controlling and changing the position of the catheter and frequency of the nerve stimulation signal according to the reaction sensitivity of a target nerve ([0047] teaches that based on the received signal the sensing signal will be stopped to ablate or will be repositioned).
However, Govari does not teach this as occurring by the target scan mode unit but instead teaches this adjustment as occurring based on the physician ([0047]), so while Govari does not specifically teach this as occurring by the use of a unit, Applicant has not disclosed that these automations of manual activities produces an unexpected result and it has been held that integration of parts is an obvious modification (MPEP 2144.04(III)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any mechanical elements which are functional to perform this disclosed function of adjusting the positioning and provided signal as is taught by Govari to occur by the use of a machine as long as each functional element retains its ability to function in a desired and predictable manner.
Govari however fails to teach the electrosurgery energy being applied as being for excising the tissue.
Govari instead teaches treating the tissue by ablating the tissue ([0046]- [0047]).
Dunning teaches a device for providing electrosurgical energy to modify biological tissue ([0004]- [0005], [0061]).
Dunning further teaches a variety of desired tissue effects being produced by the application of current from an electrosurgical generator through a source electrode to a return electrode, such as ablation and cutting which are well-known ([0004]- [0005], [0061]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the delivery of electrosurgical energy from an electrode to produce ablation as is taught by Govari with the electrosurgical energy from an electrode to produce cutting as is taught by Dunning as both items use electrosurgical energy applied through an electrode to modify biological tissue and perform the same function of treating tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 18, Govari teaches the catheter according to claim 17, wherein
the target scan mode unit includes:
a first target scan mode unit for allowing a pair of first and second detection electrodes to emit first and second nerve stimulation signals to the target nerve and to detect reaction of a nerve adjacent to a first heating electrode disposed between the first and second detection electrodes ([0025], [0034] teaches measuring by a plurality of measuring elements such as back electrodes or connection points, the contact at a tissue, where the tissue is near or in direct contact with the balloon, therefore, teaching the claim limitation as broadly as is currently claimed);
a second target scan mode unit for allowing a pair of second and third detection electrodes to emit first and second nerve stimulation signals to a target nerve and to detect reaction of the nerve adjacent to a second heating electrode disposed between the second and third detection electrodes ([0025], [0034] teaches measuring by a plurality of measuring elements such as back electrodes or connection points, the contact at a tissue, where the tissue is near or in direct contact with the balloon, therefore, teaching the claim limitation as broadly as is currently claimed); and
a third target scan mode unit for allowing a pair of first and third detection electrodes to emit first and second nerve stimulation signals to a target nerve and to detect reaction of the nerve adjacent to a third heating electrode disposed between the first and third detection electrodes ([0025], [0034] teaches measuring by a plurality of measuring elements such as back electrodes or connection points, the contact at a tissue, where the tissue is near or in direct contact with the balloon, therefore, teaching the claim limitation as broadly as is currently claimed).
Regarding claim 24, Govari as modified teaches the catheter according to claim 17, comprising:
a frequency generating unit for generating the current pulse signal according to the control signal of the target scan mode unit and transmitting the control signal to the detection electrode so as to enable detection of reaction of the target nerve ([0046]- [0047], [0049]); and
a frequency generating unit for generating the denervation RF frequency according to the control signal of the denervation mode unit and transmitting the denervation RF frequency to the heating electrode so as to enable excision of the target nerve ([0041]- [0042], [0046]- [0047]).
However, while Govari does not specifically teach the frequency generating unit which performs these actions as being two separate elements as is recited by the claim in the language of “nerve stimulation frequency generating unit” and “a denervation frequency generating unit” Govari teaches a unit which performs these elements and Applicant has not disclosed that these components being separable produces an unexpected result and it has been held that separation of parts is an obvious modification (MPEP 2144.04(V)(B)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the frequency generating unit which performs these actions as being two separate elements as is recited by the claim in the language of “nerve stimulation frequency generating unit” and “a denervation frequency generating unit” as long as each functional element retains its ability to function in a desired and predictable manner.
Claims 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US 20210059743 A1) in view of Dunning (US 20080281309 A1) further in view of Long (US 20160310211 A1) and Schmidt (US 20190117969 A1).
Regarding claim 19, Govari as modified teaches the catheter according to claim 18.
Govari further teaches the renal denervation as occurring by RF signals for measuring and ablating tissue ([0033]- [0034, [0049]).
However, Govari is silent on the teaching of the catheter wherein each of the first and second nerve stimulation signals is a current pulse signal, in which positive and negative currents alternately repeat during one cycle, so that in a current pulse signal of a first cycle, positive current is generated first, followed by negative current, and in a current pulse signal of a second cycle, negative current is generated first, followed by positive current, and the current pulse signals of the first cycle and second cycle are periodically repeated.
Long teaches a catheter device for renal denervation ablation (Abstract). Wherein the ablation of nerves for denervation can be from either an ablation energy in the form of RF energy that generates thermal energy or in the form of pulses that generate electroporation of cells ([0002]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the RF ablation of tissue, as is taught by Govari with the delivery of pulses to generate the electroporation of cells, as is taught by Long as both manners of delivering energy perform the same function of providing renal denervation to patient tissue, as is taught by Long and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Long further teaches the sequence of pulses which generate electric fields to electroporate tissue as being in a variety of forms such as monophasic, biphasic, or multiphasic forms which may be balanced or unbalanced, as a wide variety of variations to the distribution of pulses during the electroporation of tissue are known to those skilled in the art ([0009], [0062]- [0063]).
Schmidt teaches a variety of known sequences of pulses which are utilized to generate electric fields so as to treat patient tissue (Abstract, [0154], [0164]).
Schmidt further teaches a sequence of pulses which is utilized to treat patient tissue as being in a form of a positive then a negative pulse followed by a negative then a positive pulse ([0186]- [0187], [0201]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known sequence of pulses for producing electric fields to treat patient tissue, as is taught by Schmidt, into the pulses for generating an electric field to treat patient tissue as is taught by Long to produce the predictable result of producing an electric field which treats patient tissue, as is taught by Schmidt, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 20, Schmidt further teaches the catheter according to claim 19, wherein the second nerve stimulation signal is emitted to the target nerve in a discharge section of the first nerve stimulation signal ([0186]- [0187], [0201] as broadly as is currently claimed).
Regarding claim 21, Govari teaches the catheter according to claim 20, wherein a plurality of ring-shaped electrode parts are arranged at predetermined intervals in the longitudinal direction of the catheter housing ([0030]- [0032]).
Regarding claim 22, Govari teaches the catheter according to claim 21, wherein the plurality of ring-shaped electrode parts are arranged so that positions of the heating electrodes and the detection electrodes disposed on each of the ring-shaped electrode parts are not the same as each other ([0030]- [0032]).
Regarding claim 23, Govari teaches the catheter according to claim 22, wherein
the mode setting unit includes:
a mode unit for detecting and providing a treatment energy to the target nerve while fixing the ring-shaped electrode part ([0034], [0042], [0044], [0046]- [0047]); and
a mode unit for detecting and providing a treatment energy to the target nerve while moving the ring-shaped electrode part along a renal vessel, so as to disperse a nerve excision area ([0034], [0042], [0044], [0046]- [0047]).
However, while Govari does not specifically teach the unit which performs these actions as being two separate elements as is recited by the claim in the language of “detection/excision/fixation mode unit” and “detection/excision/movement mode unit” Govari teaches a unit which performs these elements and Applicant has not disclosed that these components being separable produces an unexpected result and it has been held that separation of parts is an obvious modification (MPEP 2144.04(V)(B)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the unit which performs these actions as being two separate elements as is recited by the claim in the language of “detection/excision/fixation mode unit” and “detection/excision/movement mode unit” as long as each functional element retains its ability to function in a desired and predictable manner.
In accordance with the above rejection of claim 17, Dunning teaches the electrosurgery energy being applied as being for excising the tissue ([0004]- [0005], [0061]).
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794