DETAILED ACTION
This office action is responsive to the amendment filed 3/2/2026. Claims 16-20, 22-29, and 31-36 remain pending and under prosecution.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112 sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 16, 20, 22-24, and 26-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thrope et al (US Pub No. 20060200219) in view of Taimisto et al (US Pat No. 7197349) and Bessette et al (US Pat No. 6920883), and evidenced by Bartic et al (US Pub No. 20060265039).
In regard to Claims 16 and 27, Thrope et al disclose an electrical stimulator comprising:
a body 16, best seen in Figure 2B;
an electrical stimulation circuitry 28 at least partially disposed within the body, the electrical stimulation circuity configured to provide an electrical stimulation, best seen in Figure 2B (0008, 0031-0033);
a longitudinal probe body 18 coupled to and extending away from the body, best seen in Figure 2B;
a first electrode 54, wherein the first electrode is a solid cylinder comprising an electrically conductive surface defining/forming a distal end/tip of the probe – Figure 3C shows inner contact 54 is a solid cylinder with a thickness that necessarily extends a longitudinal length toward a proximal end of the probe, best seen in Figure 3C (0028),
wherein the first electrode is in electrical communication with the electrical stimulation circuitry, best seen in Figure 3C;
an insulated portion (space forming distal face 56), best seen in Figure 3C; and
a second electrode 52 disposed on the probe at a location spaced from the first electrode and electrically insulated from the first electrode by the insulated portion (space forming distal face 56) extending an entirety of a gap between the first and second electrodes and
wherein the second electrode is formed from a tubular member, best seen in Figure 3C – “FIG. 3C shows a ring electrode assembly having an outer contact 52 and an inner contact 54 exposed on the distal face 56 of the probe 18. The outer contact 52 may also extend proximally along the probe” (0028),
wherein the second electrode is in electrical communication with the electrical stimulation circuitry, best seen in Figure 3C,
the first and second electrodes are disposed coaxially with each other, best seen in Figure 3C,
wherein the first and second electrodes generate a monopolar stimulation field (0030) and
are sized to prevent tissue damage during the electrical stimulation –
applicant’s disclosure cites a size range of about 1 mm2 to 20 mm2 to prevent said tissue damage (0018 publication of specification). Thrope et al disclose the first and second electrodes can have diameters in range of 1 mm to 3 mm diameter (0027). If one assumes the diameter is 2 mm, a calculation of the circular area of the electrodes (shown in Figure 3A) results in 3.14 mm2. Thus, Thrope et al disclose the first 22 and second 24 electrodes are sized to prevent tissue damage during the electrical stimulation in the same manner taught by applicant,
wherein the first electrode is configured for delivering electrical stimulation to a target bodily tissue in an animal body; and the second electrode is configured for receiving at least a portion of the electrical stimulation that has been conducted at least partially through the target bodily tissue – for a bipolar electrode configuration to operate (0016) as shown in Figures 3A-C, the electrical stimulation current must be applied such that it exits one electrode, i.e. the cathode, thus delivering electrical stimulation to a target bodily tissue in an animal body,
and after passing through the target bodily tissue, enters back into the probe through the other electrode, i.e. the anode. The second anode electrode thus necessarily receives at least a portion of the electrical stimulation that has been conducted at least partially through the target bodily tissue, as this is the required manner of operation of typical bipolar electrode configurations.
Thrope et al provides a device enabled to for use in a conductive fluid surgical environment to elicit a desired neurological response, such would occur during access to nerves in the heart – “one aspect of the invention provides devices, systems, and methods that make possible the differentiation and identification of the epicardial fat pads on the surface of the heart, which are innervated by parasympathetic vagal nerve fibers. The devices, systems, and methods thereby make it possible to access the parasympathetic nervous system of the heart for therapeutic benefits, such as to control the ventricular rate or to provide physiologic control of the AV nodal rate” (0010, 0022).
However, Thrope et al do not expressly disclose the second electrode is at a location proximal to the first electrode, the second electrode electrically insulated from the first electrode by the insulated portion extending an entirety of the gap between the first and second electrodes/positioned longitudinally between the first and second electrodes, with the insulated portion positioned on the probe proximal to the first electrode, and
the first electrode in electrical communication/operably connected with the electrical stimulation circuitry via an electrically conductive filament or wire.
It is noted that Thrope et al disclose that multiple configurations of electrodes is possible as seen in Figure 3A-C.
Taimisto et al teach that it is well known in the art to provide an analogous electrical stimulation probe comprising a first electrode 22, 24 disposed at a distal end of the probe and a second electrode 30 disposed at a location proximal to the first electrode and electrically insulated from the first electrode by insulated portion 26 extending an entirety of the gap between the first and second electrodes/positioned longitudinally between the first and second electrodes, with the insulated portion positioned on the probe proximal to the first electrode, best seen in Figure 6-12, as an effective configuration for at least two electrodes to emit stimulation as well as measure electrical signals in the body as desired (Col.1: 52-58; Col.6: 51-Col.7:41).
Taimisto et al also disclose second electrode 30 is formed from a tubular member – “electrode 30 shown in FIGS. 7A 7C is preferably cylindrical in shape, and is coaxially secured about the circumference of the catheter body 12,” best seen in Figure 7D (Col.6; 66-Col.7: 1). This tubular shape for the second electrode provides for the longitudinally spaced first and second electrode configuration of Taimisto et al, best seen in Figures 6-12.
Taimisto et al also disclose first electrode 22, 24 in electrical communication with electrical stimulation circuitry via an electrically conductive filament or wire 32, best seen in Figure 7A-B – “the first electrode in electrical communication with the electrical stimulation circuitry via an electrically conductive filament or wire” (Col.6: 59-65).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the electrodes of Thrope et al arranged such that the second electrode is at a location proximal to the first electrode with the insulated portion positioned longitudinally in between the first and second electrodes an entirety of the insulative gap, as taught by Taimisto et al in the manner above as an equally as effective configuration for at least two electrodes for stimulating and/or measuring of electrical signals in the body as desired and as taught by Thrope et al, such that in combination, the second electrode is formed from a tubular member as taught by Thrope et al and Taimisto et al above.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al such that the first electrode is in electrical communication/operably connected with the electrical stimulation circuitry via an electrically conductive filament or wire as taught by Taimisto et al to effectively connect the first electrode to the electrical stimulation circuitry already in Thrope et al.
However, Thrope et al in combination with Taimisto et al do not expressly disclose the first electrode has an exposed axial length extending proximally from the distal end of the probe, the exposed axial length selected to achieve during delivery of the electrical stimulation, a cathodic charge density of about 0.5 uC/mm2 to about 2.0 uC/mm2. It is noted that the specification discloses the charge density selected so that tissue damage is prevented (0018 of publication).
Bessette et al teach that it is well-known in the art to provide known configurations of an analogous stimulation probe 1600 comprising various configurations of a distal electrode 1610, including having the electrode with an exposed axial length extending proximally from the distal end of the probe, best seen in Figure 44A, and that “Thus, other numbers, shapes, configurations, and arrangements of active electrode terminals, electrode supports, and return electrodes are also contemplated under the invention” (Col.35: 24-50). It is noted that Thrope et al already disclose multiple configurations of electrodes is possible as seen in Figure 3A-C.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al as modified by Taimisto et al such that the first electrode extends from the distal end of the probe a length as taught by Bessette et al to effectively provide a configuration of the first electrode as desired, wherein by doing so a skilled artisan would be able to achieve a cathodic charge density of about 0.5 uC/mm2 to about 2.0 uC/mm2 as based on the desired effect of the stimulation, since it is well-known in the art that charge density is a measure of current that is delivered and a skilled artisan would be motivated to adjust the charge density such that tissue isn’t damaged from the stimulation, as evidenced by Bartic et al and as desired by the invention – “the smaller the surface area of the stimulation electrode, the higher the charge density will become (.mu.Coul/cm.sup.2). The charge density determines the amount of current that can be delivered, and this should happen without damaging the tissue where the probe device 20 is positioned” (0083). This would thus occur in a conductive fluid surgical environment to elicit a desired neurological response, as already taught by Thrope et al.
20. Thrope et al disclose the electrical stimulator of claim 16, wherein the first 54 and second 52 electrodes are cylindrical in shape, seen in Figure 3C (0028). Taimisto et al also disclose the same in Figure 6.
22. Thrope et al disclose the electrical stimulator of claim 16, wherein the second electrode 52 is cylindrical in shape and the second electrode is displaced from the distal end of the probe, best seen in Figure 3C (0028 – “The outer contact 52 may also extend proximally along the probe”). However, Thrope et al do not expressly disclose the second electrode has an aperture formed therethrough.
Thrope et al disclose that multiple configurations of electrodes is possible as seen in Figure 3A-C.
Taimisto et al disclose the second electrode 30 is substantially cylindrical in shape and comprises an aperture formed therethrough, wherein the second electrode is displaced from the distal end of the probe, seen in Figure 6-12, as an effective configuration for at least two electrodes to emit stimulation as well as measure electrical signals in the body as desired.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al as modified by Taimisto et al such that the second electrode has an aperture formed therethrough as taught by Taimisto et al to provide an equally as effective configuration for the least two electrodes to emit stimulation as well as measure electrical signals in the body as desired.
23. Thrope et al disclose the electrical stimulator of claim 16, wherein the probe 18 is straight along at least its entire length, best seen in Figure 2B and 3B.
24. Thrope et al disclose the electrical stimulator of claim 23, wherein the first 54 electrode has a first exposed surface area and the second 52 electrode has a second exposed surface area, and further wherein the second exposed surface area is greater than the first exposed surface area, best seen in Figure 3C.
26. Taimisto et al disclose the insulated portion 26 comprises a sleeve, best seen in Figure 7B, to provide the configuration of the first 22, 24 and second 30 electrodes separated by the insulated portion in the manner when combined with Thrope et al above.
Claims 17-19, 28-29, and 31-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thrope et al (US Pub No. 20060200219) in view of Taimisto et al (US Pat No. 7197349), Bessette et al (US Pat No. 6920883), and evidenced by Bartic et al (US Pub No. 20060265039), further in view of Solomon et al (US Pub No. 20130023910), Johnson et al (US Pub No. 20050057243), and Strother et al (US Pub No. 20070191915).
In regard to Claims 17-19 and 28, Thrope et al as modified disclose the electrical stimulator above further comprising a visual status indicator including at least one light source 38 coupled to the handle, seen in Figure 2B (0038, 0040).
However, Thrope et al as modified do not expressly disclose a shroud mounted to and extending from the handle and the at least one light source disposed within the shroud, wherein the light source confirms delivery of the electrical stimulation, at least a portion of the probe passes through an aperture of the shroud.
Solomon et al teach that it is well known in the art to provide a medical probe with a shroud having an exterior surface that is least partially translucent to enable at least one light source to shine through for indication of various conditions (0026).
Johnson et al teach that it is well known in the art to provide a probe with shroud 105 with LEDs (on PCB assembly 150) such that at least a portion of the probe passes through an aperture of the shroud as an effective configuration for the viewing of the LEDs, seen in Figure 1-2 (0027). Johnson et al also shows visual status indicator 105 as a shroud extending from handle (defined as the junction of element 130 and 135) and towards the distal end 115 of the probe, seen in Figure 1-2.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the invention of Thrope et al as modified have the status indictor of Thrope et al that comprises an at least partially translucent shroud such that at least a portion of the probe extends through an aperture of the shroud, the shroud extending from the handle, the at least one light source of the visual status indicator of Thrope et al disposed within the shroud, as taught by Solomon et al and Johnson et al in the manner above to provide a convenient and effective visual indicator for the device for advantages relating to visualization of the indicator.
Strother et al teach that it is well known in the art to provide an analogous electrical stimulation probe having an analogous visual indicator 126 with a light source configured to confirm delivery of the electrical stimulation to enable the surgeon to determine that the device is properly functioning (0064, 0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to modify Thrope et al in combination with Taimisto et al, Bessette et al, Bartic et al, Solomon et al, and Johnson et al such that the light source is configured to confirm delivery of the electrical stimulation in the manner above as taught by Strother et al to effectively enable the surgeon to determine that the device is functioning properly.
29. Taimisto et al disclose the insulated portion 26 comprises a sleeve, best seen in Figure 7B, to provide the configuration of the first 22, 24 and second 30 electrodes separated by the insulated portion in the manner when combined with Thrope et al above.
31. Thrope et al in disclose the electrical stimulation device of claim 28, wherein the light source 38 is configured to generate an indication in response to verifying that a threshold amount of stimulus current associated with the electrical stimulation has been received by the second electrode 24 (0038 – “The control circuitry 28 thereby provides reliable feedback to the clinician as to the requested delivery of stimulus current”).
32. Thrope et al in disclose the electrical stimulation device of claim 28, wherein the light source 38 is capable and thus configured to generate an indication in response to at least one of the first electrode 22 not contacting the target bodily tissue or the second electrode 24 not contacting the target bodily tissue as feedback (0038, 0040 – “Through the use of different tones, colors, different flash rates, etc., the control circuitry 28 can allow the clinician to confirm that the probe is in contact with tissue”).
Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thrope et al in view of Taimisto et al, Bessette et al, and evidenced by Bartic et al as applied to Claim 16, further in view of Katims (US Pat No. 5806522).
Thrope et al in combination with Taimisto et al, Bessette et al, and evidenced by Bartic et al disclose the invention above but do not expressly disclose the second exposed surface area is five to nine times the first exposed surface area.
Katims teaches that it is well known in the art to provide an electrode system wherein a second electrode 261 comprises a surface area at least five to nine times an exposed surface area of a first electrode 260, seen in Figure 15, to vary the sensations being felt during the procedure as desired – 10 vs. 1 square cm (Col.11: 50 – Col.12: 16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al as modified by Taimisto et al, Bessette et al, and evidenced by Bartic et al to have the second exposed surface area five to nine times the first exposed surface area as taught by Katims to effectively vary the sensations felt by the patient during the procedure.
Claims 33-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thrope et al (US Pub No. 20060200219) in view of Taimisto et al (US Pat No. 7197349), Solomon et al (US Pub No. 20130023910), Johnson et al (US Pub No. 20050057243), Bessette et al (US Pat No. 6920883), and evidenced by Bartic et al (US Pub No. 20060265039).
In regard to Claim 33, Thrope et al disclose an electrical stimulation device comprising:
a body 16 comprising electrical circuitry 28, best seen in Figure 2B;
a visual status indicator 38 extending from the body (0038, 0040), best seen in Figure 2A-B, wherein the visual status indicator comprises:
a light source 38 disposed within the shroud and in electrical communication with the electrical stimulation circuitry 28 (0038, 0040);
a probe 18 coupled to and extending away from the body, best seen in Figure 2B;
a first electrode 54 comprising s a solid cylinder comprising an electrically conductive surface forming a distal end of the probe – Figure 3C shows inner contact 54 is a solid cylinder with a thickness that necessarily extends a longitudinal length toward a proximal end of the probe, best seen in Figure 3C (0028);
an insulative portion extending from the first electrode for a distance (area 56 between electrodes 52, 54), best seen in Figure 3C; and
a second electrode 52 electrically insulated from the first electrode by the insulative portion, positioned from the first electrode by the distance, best seen in Figure 3A-C,
wherein the first electrode and the second electrode are in electrical communication with the electrical circuitry (0031),
the first and second electrodes are disposed coaxially with each other, best seen in Figure 3C, and
the first electrode and the second electrodes are sized to prevent tissue damage during electrical stimulation – applicant’s disclosure cites a size range of about 1 mm2 to 20 mm2 to prevent said tissue damage (0018 publication of specification). Thrope et al disclose the first and second electrodes can have diameters in range of 1 mm to 3 mm diameter (0027). If one assumes the diameter is 2 mm, a calculation of the circular area of the electrodes (shown in Figure 3A) results in 3.14 mm2. Thus, Thrope et al disclose the first 22 and second 24 electrodes are sized to prevent tissue damage during the electrical stimulation in the same manner taught by applicant,
the first and second electrodes generate a monopolar stimulation field during delivery of electrical stimulation (0030).
Thrope et al provides a device enabled to for use in a conductive fluid surgical environment to elicit a desired neurological response, such would occur during access to nerves in the heart – “one aspect of the invention provides devices, systems, and methods that make possible the differentiation and identification of the epicardial fat pads on the surface of the heart, which are innervated by parasympathetic vagal nerve fibers. The devices, systems, and methods thereby make it possible to access the parasympathetic nervous system of the heart for therapeutic benefits, such as to control the ventricular rate or to provide physiologic control of the AV nodal rate” (0010, 0022).
However, Thrope et al do not expressly disclose the insulative portion extending longitudinally from the first electrode or the first electrode is operably connected with the electrical circuitry via an electrically conductive filament or wire and the first electrode. It is noted that Thrope et al disclose that multiple configurations of electrodes is possible as seen in Figure 3A-C.
Taimisto et al teach that it is well known in the art to provide an analogous electrical stimulation probe comprising a first electrode 22, 24 disposed at a distal end of the probe and a second electrode 30 disposed at a location proximal to the first electrode and insulated from the first electrode by an insulated portion 26 positioned proximally longitudinally between the first and second electrodes, as an effective configuration for at least two electrodes to emit stimulation as well as measure electrical signals in the body as desired, seen in Figure 6-12 (Col.1: 52-58; Col.6: 51-Col.7:41).
Taimisto et al also disclose first electrode 22, 24 operably connected with electrical circuitry via an electrically conductive filament or wire 32, best seen in Figure 7A-B – “the first electrode in electrical communication with the electrical stimulation circuitry via an electrically conductive filament or wire” (Col.6: 59-65).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the electrodes of Thrope et al arranged such that the insulative portion is extending longitudinally from the first electrode with the second electrode electrically insulated from the first electrode by the insulative portion and disposed on the probe at a location longitudinally proximal to the electrode, as taught by Taimisto et al in the manner above as an equally as effective configuration for at least two electrodes for stimulating and/or measuring of electrical signals in the body as desired and as taught by Thrope et al.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al such that the first electrode is operably connected with the electrical circuitry via an electrically conductive filament or wire as taught by Taimisto et al to effectively connect the first electrode to the electrical circuitry already in Thrope et al.
However, Thrope et al do not expressly disclose a shroud, the light source disposed within the shroud, the probe extending from and passing at least partially through the shroud.
Solomon et al teach that it is well known in the art to provide a medical probe with a shroud having an exterior surface that is least partially translucent to enable at least one light source to shine through for indication of various conditions (0026).
Johnson et al teach that it is well known in the art to provide a probe with shroud 105 with LEDs (on PCB assembly 150) such that at least a portion of the probe passes through an aperture of the shroud as an effective configuration for the viewing of the LEDs, seen in Figure 1-2 (0027).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the invention of Thrope et al as modified by Taimisto et al have the status indictor of Thrope comprises a shroud such that at least a portion of the probe extends through an aperture of the shroud, the light source of the visual status indicator of Thrope et al disposed within the shroud, as taught by Solomon et al and Johnson et al in the manner above to provide a convenient and effective visual indicator for the device for advantages relating to visualization of the indicator.
However, Thrope et al as modified do not expressly disclose the first electrode extends from the distal end of the probe a length to achieve a cathodic charge density of about 0.5 uC/mm2 to about 2.0 uC/mm2. It is noted that the specification discloses the charge density selected so that tissue damage is prevented (0018 of publication).
Bessette et al teach that it is well-known in the art to provide known configurations of an analogous stimulation probe 1600 comprising various configurations of a distal electrode 1610, including having the electrode extend from the distal end of the probe as desired, best seen in Figure 44A, and that “Thus, other numbers, shapes, configurations, and arrangements of active electrode terminals, electrode supports, and return electrodes are also contemplated under the invention” (Col.35: 24-50). It is noted that Thrope et al already disclose multiple configurations of electrodes is possible as seen in Figure 3A-C.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al as modified by Taimisto et al, Solomon et al, and Johnson et al such that the first electrode extends from the distal end of the probe a length as taught by Bessette et al to effectively provide a configuration of the first electrode as desired, wherein by doing so a skilled artisan would be able to achieve a cathodic charge density of about 0.5 uC/mm2 to about 2.0 uC/mm2 as based on the desired effect of the stimulation, since it is well-known in the art that charge density is a measure of current that is delivered and a skilled artisan would be motivated to adjust the charge density such that tissue isn’t damaged from the stimulation, as evidenced by Bartic et al and as desired by the invention – “the smaller the surface area of the stimulation electrode, the higher the charge density will become (.mu.Coul/cm.sup.2). The charge density determines the amount of current that can be delivered, and this should happen without damaging the tissue where the probe device 20 is positioned” (0083). This would thus occur in a conductive fluid surgical environment to elicit a desired neurological response, as already taught by Thrope et al.
34. Thrope et al disclose the electrical stimulation device of claim 33, wherein the at least one light source 38 generates an indication in response to at least one of an amount of stimulus current received by the second electrode, a status of a power source, a predetermined life span, or an output of the electrical circuitry 28 (0038).
Claim 35 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thrope et al in view of Taimisto et al, Solomon et al, Johnson et al, Bessette et al, and evidenced by Bartic et al as applied to Claim 33, further in view of Katims (US Pat No. 5806522).
Thrope et al in combination with Taimisto et al, Solomon et al, Johnson et al, Bessette et al, and evidenced by Bartic et al disclose the invention above but do not expressly disclose the second electrode comprises an exposed surface area at least one to five times larger than an exposed surface area of the first electrode.
Katims teaches that it is well known in the art to provide an electrode system wherein a second electrode 261 comprises a surface area at least one to five times larger than an exposed surface area of a first electrode 260, seen in Figure 15, to vary the sensations being felt during the procedure as desired – 10 vs. 1 square cm (Col.11: 50 – Col.12: 16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al as modified by Taimisto et al, Solomon et al, Johnson et al, Bessette et al, and evidenced by Bartic et al to have the second electrode comprises an exposed surface area at least one to five times larger than an exposed surface area of the first electrode as taught by Katims to effectively vary the sensations felt by the patient during the procedure.
Claim 36 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thrope et al in view of Taimisto et al, Solomon et al, Johnson et al, Bessette et al, and evidenced by Bartic et al as applied to Claim 33, further in view of Woloszko (US Pub No. 20080167645).
Thrope et al in combination with Taimisto et al, Solomon et al, Johnson et al, Bessette et al, and evidenced by Bartic et al disclose the invention above but do not expressly disclose the probe is sized to pass through an arthroscopic cannula having an inner diameter of 5 mm. It is noted that Thrope et al disclose the diameter of about 10 mm for the probe with the first and second electrode (0026).
Woloszko teach that it is well known in the art to use an analogous electrical stimulation probe for applications such as arthroscopic surgery, wherein the probe has a diameter in the range of 1-10 mm to fit into a cannula used for the arthroscopic surgery (0053). It is noted that applicant has not expressed any criticality toward the diameter of 5 mm for the arthroscopic cannula as solving a particular problem, conferring a specific advantage, or providing a desired result other than being a typical size for such.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Thrope et al in combination with Taimisto et al, Solomon, Johnson et al, Bessette et al, and evidenced by Bartic et al to have the probe is sized to pass through an arthroscopic cannula having an inner diameter of 5 mm, as taught by Woloszko, as an effective size for the probe and the arthroscopic cannula to advantageously use the probe of Thrope et al for said desired application.
Response to Arguments
Applicant has not provided any specific arguments regarding the references or rejection above. It is submitted that Taimisto et al teach first electrode 22, 24 in electrical communication with electrical stimulation circuitry via an electrically conductive filament or wire 32, best seen in Figure 7A-B – “the first electrode in electrical communication with the electrical stimulation circuitry via an electrically conductive filament or wire” (Col.6: 59-65).
Taimisto et al also teach the configuration of the first electrode 22, 24 distal of the second electrode 30, with the insulated portion positioned longitudinally in the entirety of the gap between, the second electrode being a tubular shape, provide the configuration best seen in Figure 6 and 7D, which is the same as the instant invention. Thrope et al also already discloses a device enabled to for use in a conductive fluid surgical environment to elicit a desired neurological response, such would occur during access to nerves in the heart (0010, 0022).
Bessette et al teach that it is well-known in the art to provide known configurations of an analogous stimulation probe 1600 comprising various configurations of a distal electrode 1610, including having the electrode extend from the distal end of the probe as desired, best seen in Figure 44A, and that “Thus, other numbers, shapes, configurations, and arrangements of active electrode terminals, electrode supports, and return electrodes are also contemplated under the invention” (Col.35: 24-50). It is noted that Thrope et al already disclose multiple configurations of electrodes is possible as seen in Figure 3A-C.
When combined, Thrope et al as modified thus teach the first electrode extends from the distal end of the probe a length as taught by Bessette et al to effectively provide a configuration of the length of extension of the first electrode as desired, wherein by doing so a skilled artisan would be able to achieve a cathodic charge density of about 0.5 uC/mm2 to about 2.0 uC/mm2 as based on the desired effect of the stimulation, since it is well-known in the art that charge density is a measure of current that is delivered and a skilled artisan would be motivated to adjust the charge density such that tissue isn’t damaged from the stimulation, as evidenced by Bartic et al and as desired by the invention – “the smaller the surface area of the stimulation electrode, the higher the charge density will become (.mu.Coul/cm.sup.2). The charge density determines the amount of current that can be delivered, and this should happen without damaging the tissue where the probe device 20 is positioned” (0083). This would occur in the conductive fluid surgical environment to elicit a desired neurological response, as recited and already taught by Thrope et al.
The previous 112 rejections are overcome in light of applicant’s amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791