DETAILED ACTION
This action is pursuant to claims filed on 1/24/202. Claims 1-20 are pending. A first action on the -merits of claims 1-20 is as follows.
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 Objections
Claim 13 objected to because it is dependent upon itself. Appropriate correction is required. For the purposes of compact prosecution, it will be interpreted as dependent upon claim 12.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-11, 14, 17, and 19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Schepsis et al. (hereinafter ‘Schepsis’, US 20200179697 A1).
Regarding independent claim 1, Schepsis discloses a probe for radiofrequency (RF) tissue ablation (Fig. 3G), the probe comprising:
an elongated shaft (shaft 124 of “electrode” 120 in Fig. 3G – while Schepsis refers to probe 120 as the “electrode”, the probe is not functioning as an electrode. The probe 120 has both an active and return contact as well as a temperature sensor and multiple different circuitry inside of it as discussed in paragraph [0228]. Therefore, the examiner will refer to 120 as the probe since it is not functioning as a single electrode, but rather as a probe containing multiple conductive contacts, which themselves function as electrodes, and sensors) that extends from a proximal end to a distal end (proximal end is nearest the wire and distal end is furthest from the wire in Fig. 3G), the elongated shaft comprising a bent portion at the distal end (bent portion shown in Figs. 3G and bend at position D in Fig. 4A); and
a tip positioned on the distal end of the elongated shaft after the bent portion (tip 122 after bend on distal portion in Fig. 3G), the tip comprising an active side (active side at 150a in Figs. 3G and 4A) and an inactive side (side opposite portion 150a that is covered with insulation in Figs. 3G and 4A), the inactive side opposite the active side and comprising an insulating material ([0050]: the conductive regions of each of the electrical contacts are on the same side of the elongated body and do not deliver electrical energy circumferentially to a portion of a circumference of the elongated body without electrical contacts; [0206]: the electrode 150a is positioned on one side of the elongated body and do not deliver energy circumferentially; as highlighted in Figs. 3G and 4A, insulation is present on the inactive side opposite the active contact 150a – Fig. 3G states that the dark portion is insulation; also can be seen in Fig. 5 portion D and described in paragraph [0224] – while the Fig. 5 appears to incorrectly number the proximal and distal contact, the corresponding paragraph [0224] clearly states that 150b is the proximal contact and 150a is the distal contact), the active side comprising one or more electrodes extending therefrom (electrical contact 150a in Figs. 3G and 4A) for delivering RF energy to a target nerve ([0212]: 150a serves as an active contact near the target neural structure; [0178]: the electrical signal delivered can be within the frequency range of 100kHz to 1MHz – this band is in the RF frequency range).
PNG
media_image1.png
693
495
media_image1.png
Greyscale
PNG
media_image2.png
415
508
media_image2.png
Greyscale
Regarding claim 2, Schepsis discloses the probe of claim 1, wherein the bent portion is defined by an arc or curve in the elongated shaft (curve in shaft seen in Figs. 3G and 4A).
Regarding claim 3, Schepsis discloses the probe of claim 1, wherein the proximal end of the elongated shaft defines a first shaft section (section of shaft before the bend in Figs. 3G and 4A) and the distal end of the elongated shaft defines a second shaft section (section of shaft after the bend in Figs. 3G and 4A).
Regarding claim 4, Schepsis discloses the probe of claim 3, wherein the bent portion of the elongated shaft is defined by the connection between the first shaft section and the second shaft section (the bend is located where the two sections of the shaft meet as seen in Figs. 3G and 4A).
Regarding claim 5, Schepsis discloses the probe of claim 4, wherein an angle of the bent portion of the elongated shaft is fixed ([0044]: the elongate shaft can have a bend wherein the angle of the distal tip portion with respect to the longitudinal axis of the elongated body is preferably between 5 and 15 degrees – thus the bent portion is set at a fixed angle).
Regarding claim 6, Schepsis discloses the probe of claim 5, wherein the angle is 15° ([0044]: the bend has an angle between 0 and 50 degrees, and preferably between 5 and 15 degrees – a 15 degree bend is clearly disclosed by Schepsis).
Regarding claim 7, Schepsis discloses the probe of claim 4, wherein the connection between the bent portion of the elongated shaft is articulable such that the tip is movable with respect to the elongated shaft and such that an angle of the bent portion of the elongated shaft is variable ([0223]: a flexible electrode probe 120 can be used and any of the configurations mentioned, individually or in combination, can be used with any electrode probe 120 discussed herein – therefore, the shaft 124 of electrode 120 in Figs. 3G and 4A can be flexible and thus capable of being articulable such that the tip is movable with respect to the shaft; as written, this is a functional limitation that Schepsis is fully capable of performing based on the disclosed flexibility).
Regarding claim 9, Schepsis discloses the probe of claim 1, further comprising at least one sensor at the tip (sensor 210 on the tip of the probe as seen in Fig. 3G – the “tip” is defined as the distal portion after the bend as consistent with claim 1, and the sensor 124 is on the distal portion of the bend).
Regarding claim 10, Schepsis discloses the probe of claim 9, wherein the sensor is one of a temperature sensor, an impedance sensor, a pressure sensor, a current sensor, a position sensor, or a movement sensor ([0189]: sensor 210 is a temperature sensor; [0247]: multiple different types of sensors like temperature, impedance, blood flow, skin conductance, heart rate monitor, and muscle activity can be used).
Regarding claim 11, Schepsis discloses the probe of claim 1, wherein the one or more electrodes comprise oval or circular contacts ([0054]: the electrical contacts can be oval shaped).
Regarding claim 14, Schepsis discloses the probe of claim 1, wherein the tip is at least partially hollow ([0224]: a lumen may be incorporated in all designs).
Regarding claim 17, Schepsis discloses the probe of claim 1, further comprising a handle positioned on the proximal end of the elongated shaft (handle as seen in Fig. 9B which is on the proximal portion of the shaft; electrode holder 126 and the portion above the skin in Fig. 4A can also be interpreted as the handle as a user can hold that portion with their hand, meeting the definition of a handle).
PNG
media_image3.png
380
391
media_image3.png
Greyscale
Regarding independent claim 19, Schepsis discloses a kit comprising:
a probe (Fig. 3G) comprising:
an elongated shaft (shaft 124 of “electrode” 120 in Fig. 3G – while Schepsis refers to probe 120 as the “electrode”, the probe is not functioning as an electrode. The probe 120 has both an active and return contact as well as a temperature sensor and multiple different circuitry inside of it as discussed in paragraph [0228]. Therefore, the examiner will refer to 120 as the probe since it is not functioning as a single electrode, but rather as a probe containing multiple conductive contacts, which themselves function as electrodes, and sensors) that extends from a proximal end to a distal end (proximal end is nearest the wire and distal end is furthest from the wire in Fig. 3G), the elongated shaft comprising a bent portion at the distal end (bent portion shown in Figs. 3G and bend at position D in Fig. 4A); and
a tip positioned on the distal end of the elongated shaft after the bent portion (tip 122 after bend on distal portion in Fig. 3G), the tip comprising an active side (active side at 150a in Figs. 3G and 4A) and an inactive side (side opposite portion 150a that is covered with insulation in Figs. 3G and 4A), the inactive side opposite the active side and comprising an insulating material ([0050]: the conductive regions of each of the electrical contacts are on the same side of the elongated body and do not deliver electrical energy circumferentially to a portion of a circumference of the elongated body without electrical contacts; [0206]: the electrode 150a is positioned on one side of the elongated body and do not deliver energy circumferentially; as highlighted in Figs. 3G and 4A, insulation is present on the inactive side opposite the active contact 150a – Fig. 3G states that the dark portion is insulation; also can be seen in Fig. 5 portion D and described in paragraph [0224] – while the Fig. 5 appears to incorrectly number the proximal and distal contact, the corresponding paragraph [0224] clearly states that 150b is the proximal contact and 150a is the distal contact), the active side comprising one or more electrodes extending therefrom (electrical contact 150a in Figs. 3G and 4A) for delivering RF energy to a target nerve ([0212]: 150a serves as an active contact near the target neural structure; [0178]: the electrical signal delivered can be within the frequency range of 100kHz to 1MHz – this band is in the RF frequency range); and
a cannula through which the elongated shaft and the tip of the probe extend to facilitate insertion of the probe into a patient ([0211]: the probe may be placed with the help of introducer tools such as cannulas; cannula 230 in Fig. 5).
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.
Claim(s) 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Schepsis as applied to claims 1 and 14/1, respectively, and described above, in view of Cosman (US 7077842 B1).
Regarding claim 8, Schepsis discloses the probe of claim 1, further comprising electrical circuitry that extends through the elongated shaft and the tip and connects to the one or more electrodes ([0220]: the lead can include electrical cables and connectors to the probe 120 which may be used to provide electrical connection to the distal electrical contact 150a, proximal contact 150b, and to a temperature sensing element; these cables can be seen in Fig. 4A; [0228]: concentric surfaces connect to unique components of the electrode probe 120 and the needle gauge may be selected to provide for passage of a lumen in addition to routing the active, return, and temperature sensing electrical traces/circuitry).
However, Schepsis is silent to this connection circuitry being wiring inside of the probe.
Cosman teaches a device for the ablation of target tissue which comprises a cooling channel for circulating cooling fluid to the electrodes, similar to the device of Schepsis ([Abstract]). The device comprises an elongate shaft which houses the connection wires for connection to the exposed electrodes ([Col 12, lines 52-67]). Switching the electrical traces of Schepsis for wiring is a simple substitution of one known element for another. This substitution would maintain operability of Schepsis as it would maintain the operability of the electrodes as well as the ability to circulate cooling fluid, which is also taught by Cosman. Therefore, the substitution of one known element (the wires taught by Cosman) for another (the traces/circuitry of Schepsis) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the wires shown in Cosman would have yielded predictable results, namely, proving an electrical connection to the electrical contacts while preserving the ability to circulate cooling fluid through the probe.
Regarding claim 15, Schepsis discloses the probe of claim 14, further comprising one or more fluid circulation channels that extend internally to and through the elongated shaft to the distal end of the elongate shaft, wherein the one or more fluid circulation channels are configured to circulate a fluid through the tip for transferring heat generated by application of the RF energy by the one or more electrodes ([0224]: a lumen may be incorporated in all designs to allow for injection of fluid through the probe 120; [0190]: cooling circulation mechanism includes conduits 160 for transmitting fluid through the probe 120 to cool the probe).
However, Schepsis is silent to the conduits/lumen inside of the probe having outlets at the distal end of the probe.
Cosman teaches a device for the ablation of target tissue which comprises a cooling channel for circulating cooling fluid to the electrodes, similar to the device of Schepsis ([Abstract]). As seen in Fig. 4, the coolant is sent through delivery conduit 707 to the distal tip, where it leaves the conduit to circulate in the distal tip, and then returns through return conduit to exit the probe ([Col 13, line 45] – [Col 14, line 9]). Allowing the fluid to circulate inside of the tip in this manner allows for the tip to be effectively cooled by the internal fluid, thus reducing the tissue temperature next to the tip such that more power can be delivered to the electrodes before any steam begins to form ([Col 13, line 45] – [Col 14, line 9]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the outlets of Cosman with the cooling system of Schepsis such that the coolant can exit the delivery conduit and circulate through the tip of the device to allow for more effective cooling of the tip and surrounding tissue, resulting in more effective energy delivery.
Claim(s) 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Schepsis as applied to claims 1 and described above, in view of Taimisto (US 20080140068 A1).
Regarding claim 12, Schepsis discloses the probe of claim 1 as discussed above.
However, Schepsis is silent to the contact 150a comprising a first circular contact and a second circular contact, the second circular contact surrounding the first circular contact.
Taimisto teaches an apparatus for delivering energy to tissue including an elongate flexible member ([Abstract]). The device comprises an electrode operably connected to the elongate flexible shaft ([0014]). Taimisto further teaches that the energy transmission means can be a center disc surrounded by a single ring or multiple rings as seen in Fig. 3B ([0068]). The rings can operate as separate electrodes or all be connected to the same channel of the generator, thus operating as a single electrode ([0068]). Taimisto further teaches that utilizing a single large electrode can make it difficult to maintain uniform heating and utilizing multiple rings and controlling the relative shapes and sizes of the rings aids in the control of the density of energy delivered to tissue ([0069]). Furthermore, modifying the ovular electrode of Schepsis to a ring formation as taught by Taimisto is simply a change in the shape of the electrode, which is recognized as being within the ordinary level of skill in art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode of Schepsis to the concentric rings as taught by Taimisto such that the energy density delivered to the tissue can be better controlled.
Regarding claim 13, the Schepsis/Taimisto combination discloses the probe of claim 12 as described above. Taimisto further states that the widths of these electrodes can be selected in order to deliver the appropriate energy density in order to achieve the desired tissue effect without causing deleterious effects to the tissue ([0069]). Modifying the sizes of the electrodes/contacts would inherently alter the size of the gap between them since the gap would increase if the electrodes were shrunk and the gap would decrease if the electrodes were widened.
However, the Schepsis/Taimisto combination does not explicitly state the first circular contact and the second circular contact are separated by an interelectrode distance of 0.1 mm to 10 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the gap between the contacts to be a distance of 0.1 mm to 10 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In the present case, Taimisto clearly teaches modifying the electrode sizes to achieve the desired tissue effect and it is well within the ordinary level of skill in the art to modify the contact sizes such that the gap size falls within the claimed range.
Claim(s) 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schepsis as applied to claims 1 and 19, respectively, and described above.
Regarding claim 16, Schepsis discloses the probe of claim 1, wherein the elongated shaft is a first shaft and the tip is a first tip, the probe further comprising:
a second elongated shaft that extends from a proximal end to a distal end, the second elongated shaft comprising a bent portion at the distal end (second elongated shaft and bent portion as seen in Fig. 3B in a multi-probe arrangement); and
a second tip positioned on the distal end of the second elongated shaft after the bent portion (tip on the distal portion of the second probe),
However, the second elongated probe shown does not explicitly disclose the second tip comprising an active side and an inactive side, the inactive side opposite the active side and comprising an insulating material, the active side comprising one or more second electrodes extending therefrom for delivering RF energy to the target nerve.
Incorporating these components into a second probe is simply a duplication of essential parts. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the tip components of the first probe into the second probe, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Furthermore, the instant application does not provide any criticality to the two-probe arrangement as it is merely an alternative implementation to the single elongated shaft (Instant application [0023]).
Regarding claim 20, Schepsis discloses the kit of claim 19, wherein the probe is a first probe, the kit further comprising: a second probe comprising:
a second elongated shaft that extends from a proximal end to a distal end, the second elongated shaft comprising a bent portion at the distal end (second elongated shaft and bent portion as seen in Fig. 3B in a multi-probe arrangement); and
a second tip positioned on the distal end of the second elongated shaft after the bent portion (tip on the distal portion of the second probe);
wherein the second elongated shaft and the second tip of the second probe further extend through the cannula to facilitate insertion of the second probe into the patient ([0211]: the probes 120 are inserted through the cannula – as seen in Fig. 3B and 3E, the two probes are labelled together as 120 and not as separate probes, and paragraph [0211] states that 120 is inserted via a cannula which means that can both be inserted through the cannula).
However, the second elongated probe shown does not explicitly disclose the second tip comprising an active side and an inactive side, the inactive side opposite the active side and comprising an insulating material, the active side comprising one or more second electrodes extending therefrom for delivering RF energy to the target nerve.
Incorporating these components into a second probe is simply a duplication of essential parts. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the tip components of the first probe into the second probe, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Furthermore, the instant application does not provide any criticality to the two-probe arrangement as it is merely an alternative implementation to the single elongated shaft (Instant application [0023]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schepsis as applied to claims 17/1 and described above, in view of Taimisto et al. (hereinafter ‘Taimisto ‘793’, US 20040116793 A1).
Regarding claim 18, Schepsis discloses the probe of claim 17. Schepsis also discloses that the handle can have a circular button/mark on it as seen in Fig. 9B. The circle in 9B marks the upper side which is the inactive side and the underside of the handle is the active side as seen in Fig. 9B.
It is the examiner’s opinion that since the claim is not specific to what these orientation markings are, the circular mark on the handle can serve as a marking for the orientation of the electrodes.
However, Schepsis does not explicitly disclose the handle comprising orientation markings formed on an exterior surface, wherein the orientation markings correspond to the active side and the inactive side of the tip and in order to advance prosecution a teaching reference has been included.
Taimisto ‘793 teaches a catheter tip for mapping and ablation including ring electrodes ([Abstract]). The distal tip of the catheter can be straight, curved, or three-dimensional with an electrode secured on the end ([0006]). Taimisto ‘793 further teaches that a marker may be placed on the handle for indicating the orientation of the distal end which aid in positioning and navigating the catheter into the desired location ([0065]). Including markers that show the orientation of the distal tip (which corresponds to the active and inactive sides) would be of routine skill in the art since it merely requires having a line present on the side of the handle that has the electrode and a different mark on the side without an electrode. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the orientation markings taught by Taimisto ‘793 with the handle of Schepsis such that the active and inactive sides are marked which provides for the orientation of the distal tip and allows for better positioning and navigating of the distal tip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/W.M./ Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights