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 .
Claim Rejections - 35 USC § 102
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.
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 1-9, 13-15, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley, US 20200405383, herein referred to as “Townley”.
Regarding claim 1, Townley discloses an apparatus (Figure 2), comprising: a shaft assembly (Figure 2: shaft 116) having a distal end (Figure 2: end near end effector 114a), the shaft assembly being configured to fit in a nasal cavity of a patient ([0045]: “a surgeon or other medical professional performing a procedure can utilize the handle 118 to manipulate and advance the shaft 116 within the nasal cavity”), the shaft assembly defining a longitudinal axis (Figure 2: shaft 116); a first electrode assembly at the distal end of the shaft assembly (Figure 6: each opposing pair of branches 246 is considered an electrode assembly); a second electrode assembly at the distal end of the shaft assembly (Figure 6: each opposing pair of branches 246 is considered an electrode assembly), the second electrode assembly including: a stimulus electrode (Figure 6: electrodes 244), and a sensing electrode (Figure 6: sensors 252), the stimulus and sensing electrodes being positioned on opposing lateral sides in relation to the longitudinal axis of the shaft assembly (Figure 6: the stimulus electrode, electrode 244, is on one branch 246 of an opposing pair and the sensing electrode, sensor 252, is on the other branch 246 of an opposing pair, thus they are on opposing lateral sides in relation to the longitudinal axis of the shaft assembly); and a controller (Figure 12: controller 107), the controller being operable to: generate an electrical signal to perform one or both of tissue ablation or denervation of a targeted nerve via the first electrode assembly ([0127]), generate an electrical stimulus signal to stimulate the targeted nerve via the stimulus electrode of the second electrode assembly ([0151]: “This allows each electrode (244, 336) to be independently activated for stimulation or neuromodulation to provide precise ablation patterns and/or individually detected via the console 104 to provide information specific to each electrode (244, 336) for neural or anatomical detection and mapping.”), and process a response signal received from the targeted nerve via the sensing electrode of the second electrode assembly ([0074]).
Regarding claim 2, Townley discloses the apparatus of claim 1, the shaft assembly having a rigid portion ([0101]: “In other embodiments, the introducer sheath may be made from a rigid material”) and a flexible portion ([0090]: “In particular the outer sheath 138 may generally include an encapsulated braid along a length of the shaft 116 to provide flexibility while retaining kink resistance and further retaining column and/or tensile strength.”), the flexible portion including the distal end (Figure 11).
Regarding claim 3, Townley discloses the apparatus of claim 2, further comprising an actuator (Figure 2: handle 118), the actuator being operable to deflect the flexible portion and thereby drive the distal end laterally relative to the longitudinal axis ([0045]: “For example, a surgeon or other medical professional performing a procedure can utilize the handle 118 to manipulate and advance the shaft 116 within the nasal cavity” and [0095]).
Regarding claim 4, Townley discloses the apparatus of claim 1, further comprising a camera assembly at the distal end ([0103]: “Yet still, in some embodiments, image guidance components may be integrated with the neuromodulation device 102 to provide image guidance during positioning of the end effector 214.”).
Regarding claim 5, Townley discloses the apparatus of claim 1, further comprising a position sensor, the position sensor being operable to generate a signal indicating a position of the distal end in three-dimensional space ([0160]: “In other embodiments, the three-dimensional visualization of the regions of influence can be used to illustrate the regions from which the electrodes (244, 336) detect data when measuring bioelectrical properties for anatomical mapping.” And [0167]: “The anatomical locations can be provided to a user (e.g., on the display 112) as a two-dimensional map (e.g., illustrating relative intensities, illustrating specific sites of potential target structures) and/or as a three-dimensional image.” And [0176]).
Regarding claim 6, Townley discloses the apparatus of claim 1, further comprising a cuff at the distal end, the first electrode assembly being secured to the distal end via the cuff (Figure 6: support member 248 secures branches 246 to the distal end).
Regarding claim 7, Townley discloses the apparatus of claim 6, the second electrode assembly being secured to the distal end via the cuff (Figure 6: support member 248 secures branches 246 to the distal end).
Regarding claim 8, Townley discloses the apparatus of claim 6, the cuff being formed of an electrically insulative material ([0068]: “In various embodiments, the internal support member 248 can also carry an electrode (not shown) at the distal end portion 250 and/or along the length of the support member 248.”; internal support member 248 must be electrically insulative to carry an electrode while functioning properly).
Regarding claim 9, Townley discloses the apparatus of claim 1, the first electrode assembly including a first electrode and a second electrode (Figure 6: each branch 246 contains multiple electrodes 244).
Regarding claim 13, Townley discloses the apparatus of claim 9, the first electrode and the second electrode facing distally away from the distal end of the shaft assembly (Figure 6: each electrode 244 has some portion that faces distally away from the distal end of the shaft assembly).
Regarding claim 14, Townley discloses the apparatus of claim 1, the second electrode assembly further including: a first shaft (Figure 6: one branch 246 of an opposing pair of branches 246), the stimulus electrode being secured to the first shaft (Figure 6: electrode 244 is secured to the first branch 246), and a second shaft (Figure 6: other branch 246 of an opposing pair of branches 246), the sensing electrode being secured to the second shaft (Figure 6: sensor 252 is secured to the other branch 246).
Regarding claim 15, Townley discloses the apparatus of claim 1, further comprising an actuator (Figure 5: first mechanism 126), the actuator being operable to drive the second electrode assembly longitudinally relative to the shaft assembly ([0069]).
Regarding claim 18, Townley discloses the apparatus of claim 1, the controller being further operable to generate an electrical stimulus signal having a modulated waveform ([0168]: “In some embodiments, the neuromodulation energy can be applied in a pulsed manner, allowing the tissue to cool between modulation pulses to ensure appropriate modulation without undesirably affecting non-target tissue.”).
Regarding claim 19, Townley discloses an apparatus (Figure 2), comprising: a shaft assembly (Figure 2: shaft 116) having a distal end (Figure 2: end near end effector 114a), the shaft assembly being configured to fit in a nasal cavity of a patient ([0045]: “a surgeon or other medical professional performing a procedure can utilize the handle 118 to manipulate and advance the shaft 116 within the nasal cavity”), the shaft assembly defining a longitudinal axis (Figure 2: shaft 116); a first electrode assembly at the distal end of the shaft assembly (Figure 6: each opposing pair of branches 246 is considered an electrode assembly), including a distally-facing first electrode (Figure 6: electrodes 244 are distally-facing); a second electrode assembly at the distal end of the shaft assembly (Figure 6: each opposing pair of branches 246 is considered an electrode assembly), the second electrode assembly including: a stimulus electrode (Figure 6: electrodes 244), and a sensing electrode (Figure 6: sensors 252); and a controller (Figure 12: controller 107), the controller being operable to: generate an electrical signal to perform one or both of tissue ablation or denervation of a targeted nerve via the first electrode assembly ([0127]), generate an electrical stimulus signal to stimulate the targeted nerve via the stimulus electrode of the second electrode assembly ([0151]: “This allows each electrode (244, 336) to be independently activated for stimulation or neuromodulation to provide precise ablation patterns and/or individually detected via the console 104 to provide information specific to each electrode (244, 336) for neural or anatomical detection and mapping.”), and process a response signal received from the targeted nerve via the sensing electrode of the second electrode assembly ([0074]).
Regarding claim 20, Townley discloses a method (Figure 2) comprising: inserting a shaft assembly (Figure 2: shaft 116) into a nasal cavity of a patient ([0045]: “a surgeon or other medical professional performing a procedure can utilize the handle 118 to manipulate and advance the shaft 116 within the nasal cavity”), the shaft assembly defining a longitudinal axis (Figure 2: shaft 116); engaging tissue of the patient with a first electrode assembly (Figure 6: each opposing pair of branches 246 is considered an electrode assembly); applying electrical energy to the tissue via the first electrode assembly ([0151]: “This allows each electrode (244, 336) to be independently activated for stimulation or neuromodulation to provide precise ablation patterns and/or individually detected via the console 104 to provide information specific to each electrode (244, 336) for neural or anatomical detection and mapping.”); engaging the tissue with a second electrode assembly (Figure 6: each opposing pair of branches 246 is considered an electrode assembly); applying an electrical stimulus to a nerve associated with the tissue, the electrical stimulus being applied via a stimulus electrode of the second electrode assembly (Figure 6: each opposing pair of branches 246 is considered an electrode assembly), the stimulus electrode contacting the tissue at a first lateral side of the longitudinal axis (Figure 6: the stimulus electrode, electrode 244, is on one branch 246 of an opposing pair and the sensing electrode, sensor 252, is on the other branch 246 of an opposing pair, thus they are on opposing lateral sides in relation to the longitudinal axis of the shaft assembly); and determining whether a signal is received via a sensing electrode of the second electrode assembly in response to the electrical stimulus applied via the stimulus electrode ([0074]), the sensing electrode contacting the tissue at a second lateral side of the longitudinal axis (Figure 6: the stimulus electrode, electrode 244, is on one branch 246 of an opposing pair and the sensing electrode, sensor 252, is on the other branch 246 of an opposing pair, thus they are on opposing lateral sides in relation to the longitudinal axis of the shaft assembly).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Townley in view of Salazar et al., US 20190374280, herein referred to as “Salazar”.
Regarding claim 10, Townley discloses the apparatus of claim 9, but does not explicitly disclose an apparatus with the first electrode and the second electrode cooperating to define a generally circular shape encircling the longitudinal axis.
However, Salazar teaches an apparatus (Figure 4) with the first electrode and the second electrode cooperating to define a generally circular shape encircling the longitudinal axis (Figure 4: RF electrodes 222 and 224).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Townley so that the first electrode and the second electrode cooperate to define a generally circular shape encircling the longitudinal axis as taught by Salazar so that one electrode can act as an active electrode and the other electrode can act as a return electrode without shorting (Salazar [0040]).
Regarding claim 11, Townley discloses the apparatus of claim 9, but does not explicitly disclose an apparatus with the first electrode and the second electrode being angularly spaced apart from each other by a first gap and a second gap.
However, Salazar teaches an apparatus (Figure 4) with the first electrode and the second electrode being angularly spaced apart from each other by a first gap and a second gap (Figure 4: RF electrodes 222 and 224).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Townley so that the first electrode and the second electrode being angularly spaced apart from each other by a first gap and a second gap as taught by Salazar so that one electrode can act as an active electrode and the other electrode can act as a return electrode without shorting (Salazar [0040]).
Regarding claim 12, Townley discloses the apparatus of claim 9, but does not explicitly disclose an apparatus with the first electrode and the second electrode each having an arcuate shape.
However, Salazar teaches an apparatus (Figure 4) with the first electrode and the second electrode each having an arcuate shape (Figure 4: RF electrodes 222 and 224).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Townley so that the first electrode and the second electrode each having an arcuate shape as taught by Salazar so that one electrode can act as an active electrode and the other electrode can act as a return electrode without shorting (Salazar [0040]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Townley in view of Townley et al., US 20180133460, herein referred to as “Townley 2”.
Regarding claim 16, Townley discloses the apparatus of claim 1, but does not explicitly disclose an apparatus with the stimulus electrode comprising a first needle electrode, the sensing electrode comprising a second needle electrode.
However, Townley 2 teaches an apparatus with the stimulus electrode comprising a first needle electrode, the sensing electrode comprising a second needle electrode (Figure 9: needle electrodes 960).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Townley so that the stimulus electrode comprises a first needle electrode and the sensing electrode comprises a second needle electrode as taught by Townley 2 to provide high spatial resolution and high level of accuracy with a minimal level of invasiveness (Townley 2 [0111]).
Regarding claim 17, Townley discloses the apparatus of claim 1, but does not explicitly disclose an apparatus with the first electrode assembly including a first electrode and a second electrode, the stimulus electrode being angularly interposed between the first electrode and the second electrode.
However, Townley 2 teaches an apparatus with the first electrode assembly including a first electrode and a second electrode (Figure 9: electrodes 344), the stimulus electrode being angularly interposed between the first electrode and the second electrode (Figure 9: needle electrodes 960 are angularly interposed between electrodes 344).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the apparatus disclosed by Townley so that the stimulus electrode is angularly interposed between the first electrode and the second electrode as taught by Townley 2 to provide high spatial resolution and high level of accuracy with a minimal level of invasiveness (Townley 2 [0111]).
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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