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 § 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 1-21 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.
Claim 1 is indefinite for failing to include a transitional phrase. It is at most unclear to the Examiner what is being claimed as the body of the claim. See MPEP 2111.03 (“The transitional phrases “comprising”, “consisting essentially of” and “consisting of” define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. The determination of what is or is not excluded by a transitional phrase must be made on a case-by-case basis in light of the facts of each case.”).
Claim 1 recites the limitation:
“the heart” in line 2
“the other end of the conduit” in line 3
“the fact” in line 4
“the core” in line 4 and “this core” in line 6
“the main sleeve conduit” in line 5
“the diameter” in lines 9, 10 and 12
“the length” in line 11
“these electrodes” in line 11
“the catheter spiral” in line 14
There is insufficient antecedent basis for all of these limitations in the claim. Similar and consistent corrections should be made throughout claims 2-21 where these terms are present.
Claim 5 recites the limitation "the two terminal coils" and “the central coil” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 6 recites the limitation "characterized in that three-part sheath is slidably placed on the sleeve main conduit, the two terminal parts of which are conductive sheaths, and the third sheath placed between them is made of insulating material" in lines 2-4. There is insufficient antecedent basis for this limitation in the claim.
Claims 8-9 recite the limitation "the stabilizing rod". There is insufficient antecedent basis for this limitation in the claims.
Claim 9 recites the limitation "the opening" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "it" in line 2. There is insufficient antecedent basis for this limitation in the claim and it is at most unclear to the Examiner what “it” refers to.
Claim 13 recites the limitation "the rear end of the sleeve main conduit" in line 2. Further, claim 13 recites “the electrically connected connector” in line 3. It is unclear if this connector is the same connector as “an electrical connector” in claim 1. There is insufficient antecedent basis for the limitations in the claim.
Claim 19 recites the limitations “the electrically non-conductive material" and “the electrically non-conductive material". There is insufficient antecedent basis for these limitations in the claim.
Appropriate correction is required.
Claims 2-21 are rejected due to their dependance on claim 1.
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 1-5, 11-13, 15, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al., (hereinafter ‘Stewart,’ U.S. Pat. 9,554,848) in view of North (hereinafter ‘North,’ U.S. PGPub. No. 2013/0110210) and Viswanathan et al., (hereinafter ‘Viswanathan,’ U.S. PGPub. No. 2019/0069950).
Regarding claim 1, Stewart (Figs. 2A-C and 3A-3B) discloses a spring-loaded catheter (catheter assembly 20, 60) for electrophysiology studies and irreversible electroporation within the heart (as broadly claimed, the catheter assembly 20, 60 is capable of use for electrophysiology studies and irreversible electroporation within the heart) has a plastic main conduit (proximal portion 28, intermediate portion 30 of catheter body 22; see col. 7, ll. 4-8, for “intermediate 30 and the distal portion 32 are integrally formed from a biocompatible material having requisite strength and flexibility for deployment within a heart. Appropriate materials are well known in the art and include polyamide” which is a plastic) connected at one end to an electrical connector (electrical connector 44), from which electrodes (26, 64) located at the other end of the conduit are supplied via electric wires (col. 8, ll. 21-26, “The electrical connector provides electrical connections to the electrodes 26 carried by the distal portion 32. To this end, wire(s) (not shown) may extend within the central lumen (not shown) from the distal portion 32 to the handle 24.”), characterized by the fact that the core (loop 34, 70) protruding from the main sleeve conduit (30) is made of a metal alloy that retains shape memory and is bent in the shape of a conical spiral with a different number of coils (see col. 8, ll. 5-7, for “loop 34 may be formed in a variety of ways, such as by incorporating a preformed section of super elastic, shape memory material, such as Nitinol, with a loop configuration.”), at least one of which is equipped with overlapping on this core (as broadly claimed, the loop(s) overlap as best illustrated in Figs 3A-3D), sleeve electrodes (26, 64) fed through insulated electric wires (col. 8, ll. 21-26, wires (not shown)), where the diameter O1 of the first coil of the spiral ranges from 5 nm to 30 mm, and the diameter O2 of the last coil of the spiral amounts to 10 mm to 31 mm (see loop segments 72A-72C; col. 8, ll. 2-4, “the loop 34 has a diameter in the range of approximately 10-20 mm, more preferably 15 mm, although other sizes, either greater or smaller, are acceptable.” Also see col. 10, ll. 49-52, “It should be understood that one or more of the loop segments 72A-72C may define a diameter (or area) that is less than a diameter (or area) of the pulmonary vein ostium PVO in question.”), while the length of each of these electrodes is from 2 mm to 4 mm (see col. 8, l. 42, for preferable length of each of the electrodes 26 is about 4-12 mm), and the number of electrodes located on the catheter spiral is from 10 - 65 pieces (see Fig. 3A depicting more than 10 electrodes 64).
Stewart is silent regarding sleeve electrodes separated from each other by plastic ring elements.
However, in the same field of endeavor, North teaches a similar catheter comprising plastic spacer portions (13) (see [0055], for plastic spacer portions, thereby meeting the limitation of plastic ring elements). The spacer portions (13) are provided between electrodes (12), thereby separating the electrodes from one another. The flexible spacer portions (13) may be configured such that the spacer portions (13) align with bends (22), thereby facilitating bending of the catheter and overall flexibility between electrodes (12). North teaches “common to all, and a benefit of the instant invention, is the ability to vary the bend in a flexible lead 10 (in particular at or near the tip, within or near the electrode contacts 12) by moving the stylet 20 within the lead 10, without changing its bend, removing it, or replacing it, resulting in significant convenience for the operator.” ([0037]), thereby improving flexibility, control and accuracy of placement. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the catheter as taught by Stewart to include sleeve electrodes separated from each other by plastic ring elements, as taught by North, in order to provide the benefit and ability to vary the bend in the catheter, “without changing its bend, removing it, or replacing it, resulting in significant convenience for the operator.” ([0037]), thereby improving flexibility, control and accuracy of placement
Further, Stewart in view of North are silent regarding the diameter O is from 1 mm to 3 mm, where the electrodes which send a pulse with an amplitude of 100-3000V in time and from 5 microseconds to 6 milliseconds.
However, in the same field of endeavor, Viswanathan teaches a similar catheter for electrophysiology studies and irreversible electroporation comprising electrodes having a diameter O is from 1 mm to 3 mm ([0089], “electrodes of the ablation device (900″′) may have a length from about 0.5 mm to about 5.0 mm and a cross-sectional dimension (e.g., a diameter) from about 0.5 mm to about 2.5 mm, including all values and subranges in between.”). The ablation device is configured to send a pulse with an amplitude of 100-3000V in time and from 5 microseconds to 6 milliseconds ([0212], “In some embodiments, such as for irreversible electroporation applications, the height of each pulse (2100) or the voltage amplitude of the pulse (2100) can be in the range from about 400 volts, about 1,000 volts, about 5,000 volts, about 10,000 volts, about 15,000 volts, including all values and sub ranges in between. As illustrated in FIG. 21, the pulse (2100) is separated from a neighboring pulse by a time interval (2102), also sometimes referred to as a first time interval. The first time interval can be about 10 microseconds . . . about 1 millisecond including all values and sub ranges in between, in order to generate irreversible electroporation.”). This configuration is advantageous because it provides irreversible electroporation to a targeted tissue such that it permits “exchange of biomolecular material across the membrane [of a targeted tissue] leading to necrosis and/or apoptosis (cell death). Subsequently, the surrounding tissue may heal naturally.” ([0002]), thereby increasing control, accuracy of treatment and overall safety. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the catheter as taught by Stewart in view of North to include the diameter O (of the electrode(s)) is from 1 mm to 3 mm, where the electrodes which send a pulse with an amplitude of 100-3000V in time and from 5 microseconds to 6 milliseconds, as taught by Viswanathan, in order to provide irreversible electroporation to a targeted tissue such that it permits “exchange of biomolecular material across the membrane [of a targeted tissue] leading to necrosis and/or apoptosis (cell death). Subsequently, the surrounding tissue may heal naturally.” ([0002]), thereby increasing control, accuracy of treatment and overall safety.
Regarding claim 2, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart discloses characterized in that the conical spiral is a tapering spiral (Fig. 3A; see col. 10, ll. 17-31, for loop segments 72A-72C preferably defines a different diameter).
Regarding claim 3, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart discloses characterized in that the conical spiral is a divergent spiral (Fig. 3A; see col. 10, ll. 17-31).
Regarding claim 4, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart discloses characterized in that the maximum number of coils of the spiral in the catheter is 5 coils (see Fig. 3A having three loop segments 72A-72C). In view of the prior modification of Stewart in view of North and Viswanathan, Viswanathan teaches “[i]t should be understood that the examples and illustrations in this disclosure serve exemplary purposes and departures and variations such as numbers of splines, number of electrodes, and so on can be built and deployed according to the teachings herein without departing from the scope of this invention.”
Stewart in view of North and Viswanathan are silent regarding the number of sleeve electrodes arranged on the coils of the spiral is 65. However, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the number of sleeve electrodes as taught by Stewart in view of North and Viswanathan such that the number of sleeve electrodes arranged on the coils of the spiral is 65, 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.
Regarding claim 5, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart discloses the central coil of the spiral is covered with a plastic sheath protecting the core together with electric wires supplying current to the sleeve electrodes of the coil (see col. 8, ll. 14-19 for sheath, “the catheter assembly 20 may include a sheath (not shown) slidably receiving the catheter body 22. Prior to deployment, the distal portion 32 would be retracted within the sheath, rendering the loop 34 straight. Upon deployment from the sheath, the distal portion 32 would form the loop 34.” Also see col. 14, ll. 51-52, for sheath formed of a relatively soft material such as 35D or 40D Pebex, which is a plastic).
In view of the prior modification of Stewart in view of North and Viswanathan, North teaches characterized in that the two terminal coils of the conical spiral have sleeve electrodes separated by plastic ring elements (see Fig. 2 for spacer portions 13, electrodes 12).
Further, in view of the prior modification of Stewart in view of North and Viswanathan, Viswanathan teaches “[i]t should be understood that the examples and illustrations in this disclosure serve exemplary purposes and departures and variations such as numbers of splines, number of electrodes, and so on can be built and deployed according to the teachings herein without departing from the scope of this invention.” Stewart in view of North and Viswanathan are silent regarding 15 sleeve electrodes. However, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the number of sleeve electrodes as taught by Stewart in view of North and Viswanathan such that the number of sleeve electrodes is 15, 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.
Regarding claim 11, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart discloses characterized in that it ends with a sleeve electrode (see Fig. 3A illustrating a tip electrode at 72c).
Regarding claim 12, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart discloses characterized in that it terminates with a plastic annular element (see Fig. 3Aillustrating a distal end terminating with a plastic annular element and electrode; see col. 7, ll. 4-8, for “polyamide” which is a plastic).
Regarding claim 13, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart (Figs. 2A-C and 3A-3B) discloses characterized in that at the rear end of the sleeve main conduit, a driver handle (24) is provided in front of the electrically connected connector (44) for bending only the end of the catheter spiral (see col. 8, ll. 14-19 for sheath, “the catheter assembly 20 may include a sheath (not shown) slidably receiving the catheter body 22. Prior to deployment, the distal portion 32 would be retracted within the sheath, rendering the loop 34 straight. Upon deployment from the sheath, the distal portion 32 would form the loop 34.”).
Regarding claim 15, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart (Figs. 2A-C and 3A-3B) discloses characterized in that the sleeve electrodes are provided with thermocouples (col. 10, ll. 40-42, “the electrodes 64 are preferably configured to provide feedback information indicative of tissue contact, such as by including a thermocouple.”).
Regarding claim 16, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart (Figs. 2A-C and 3A-3B) discloses that the sleeve electrodes (26, 64) are entirely made of electrically conductive material (col. 8, ll. 27-54; see Figs. 2A-C and 3A-3B for unitary electrodes).
Regarding claim 20, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart (Figs. 2A-C and 3A-3B) discloses characterized in that its core is made of nitinol and is covered with a plastic sheath (see col. 8, ll. 5-7, for “loop 34 may be formed in a variety of ways, such as by incorporating a preformed section of super elastic, shape memory material, such as Nitinol, with a loop configuration.” Col. 8, ll. 14-19 for sheath, “the catheter assembly 20 may include a sheath (not shown) slidably receiving the catheter body 22. Prior to deployment, the distal portion 32 would be retracted within the sheath, rendering the loop 34 straight. Upon deployment from the sheath, the distal portion 32 would form the loop 34.” Also see col. 14, ll. 51-52, for sheath formed of a relatively soft material such as 35D or 40D Pebex, which is a plastic).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view of North and Viswanathan as applied to claim 1 above, and further in view of Stewart et al., (hereinafter ‘Stewart ‘948,’ U.S. PGPub. No. 2019/0223948).
Regarding claim 6, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1, but are silent regarding characterized in that three-part sheath is slidably placed on the sleeve main conduit, the two terminal parts of which are conductive sheaths, and the third sheath placed between them is made of insulating material, the conductive sheaths are made entirely of electrically conductive material or are in half made of electrically conductive material and in half of insulating material or ¼ of these sheaths are made of electrically conductive material, and 3/4 of insulating material.
However, in the same field of endeavor, Stewart ‘948 teaches a similar multipart sheath (44) comprised of non-conductive material and conductive material (see Figs. 4 and 5). Stewart ‘948 teaches, “[i]n either embodiment the sheath 44 is composed of a non-conductive material, and the configurations of electrically conductive energy return electrodes 14 shown in FIGS. 4 and 5 each causes a concentration of the return energy vector on the side of the sheath 44 on which the energy return electrodes 14, or the conductive portions 48 of the energy return electrodes 14, are located. When the sheath 44 is positioned such that the energy return electrodes 14 are proximate or in contact with the target tissue, delivery of the electric current from the energy delivery device 16 and flow of the electric current to the conductive portions 48 of the energy return electrodes 14 will cause the formation of a lesion in the target tissue, while minimizing or avoiding heating of the blood and potentially the formation of gas bubbles and/or char.” ([0087]). Therefore, it would have obvious to one having ordinary skill in the art at the time of filing to have modified the sheath as taught by Stewart in view of North and Viswanathan to incorporate a three-part sheath is slidably placed on the sleeve main conduit, the two terminal parts of which are conductive sheaths, and the third sheath placed between them is made of insulating material, the conductive sheaths are made entirely of electrically conductive material or are in half made of electrically conductive material and in half of insulating material or ¼ of these sheaths are made of electrically conductive material, and 3/4 of insulating material, as taught by Stewart ‘948, in order to direct the flow of electric current from the catheter and cause the formation of a lesion in the target tissue, while minimizing or avoiding heating of the blood and potentially the formation of gas bubbles and/or char ([0087]), thereby increasing control, accuracy and safety.
Regarding claim 7, Stewart in view of North and further in view of Viswanathan and Stewart ‘948 teach all of the limitations of the spring-loaded catheter according to claim 6, but are silent regarding characterized in that the electrically conductive material is copper or a copper alloy. However, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the electrically conductive material as taught by Stewart in view of North and further in view of Viswanathan and Stewart ‘948 to include copper or a copper alloy since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view of North and Viswanathan as applied to claim 1 above, and further in view of Stewart.
Regarding claim 8, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. In an alternate embodiment, Stewart further teaches “[t]o facilitate guiding of the distal portion 32 into a heart (not shown), the catheter assembly 20 may include a stylet (not shown) internally disposed within the catheter body 22” (thereby meeting the limitation of a stabilizing rod). The stabilizing rod (stylet 226 in Figs.9A-9B) is inserted into the sleeve main conduit (col. 15, ll. 59-61,“[e]ach of the stylets 226 are relatively rigid shafts sized to be slidably received within lumens (not shown) formed by the catheter body 222.”). This configuration is utilized to deploy and retract the distal end of the catheter, and provides an alternative and interchangeable method to form the desired loop configuration, thereby improving control. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the catheter as taught by Stewart in view of North and Viswanathan to include the stabilizing rod is inserted into the sleeve main conduit, as taught by Stewart in order to deploy and retract the distal end of the catheter, and provide an alternative and interchangeable method to form the desired loop configuration, thereby improving control. This would have merely comprised a simple substitution of one well known means for deployment for another in order to produce a predictable result. MEPE 2143(I)(B).
Stewart in view of North and Viswanathan are silent regarding characterized in that the stabilizing rod made of PTFE-coated stainless steel, however, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the stabilizing rod as taught by Stewart in view of North and Viswanathan to include PTFE-coated stainless steel since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Stewart in view of North and further in view of Viswanathan and Stewart teach all of the limitations of the spring-loaded catheter according to claim 8. Stewart (Figs. 9A-9B) further teaches characterized in that the stabilizing rod (stylet 226) exits the main conduit (222) through the opening in front of the conical spiral (234) so that the spiral is wound around the main conduit (as broadly claimed, the loop 234 is wound around the circumference of the catheter body 222).
Regarding claim 10, Stewart in view of North and further in view of Viswanathan and Stewart teach all of the limitations of the spring-loaded catheter according to claim 8. In view of the prior modification of Stewart in view of North and further in view of Viswanathan and Stewart, North teaches the plastic ring elements of the conical spiral of the catheter (see above). Further, Stewart (Figs. 9A-9B) teaches characterized in that the stabilizing rod (stylet 226), placed in the sleeve main conduit (222), passes through the holes of the sleeve electrodes and the holes of the plastic ring elements of the conical spiral of the catheter (col. 15, ll. 59-61,“[e]ach of the stylets 226 are relatively rigid shafts sized to be slidably received within lumens (not shown) formed by the catheter body 222,” thereby passing through the center of the sleeve electrodes 224 and the center of the plastic ring elements of the conical spiral of the catheter).
Claims 14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view of North and Viswanathan as applied to claim 1 above, and further in view of Fang et al., (hereinafter ‘Fang’ U.S. PGPub. No. 2013/0253504).
Regarding claim 14, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1, but are silent regarding characterized in that the sleeve electrodes are provided with thermistors.
However, in the same field of endeavor, Fang teaches a similar catheter wherein “[e]ach spine 14 can also include at least one temperature sensor, e.g., a thermocouple or thermistor, for the tip electrode 20 or any of the ring electrodes.” ([0044]-[0045]). It is well known in the art (as can be seen in Fang) to provide sleeve electrodes (i.e., ring electrodes) with thermistors in order to provide temperature sensing and monitoring at a targeted site, thereby improving control and safety. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the catheter as taught by Stewart in view of North and Viswanathan to include characterized in that the sleeve electrodes are provided with thermistors, as taught by Fang, in order to provide temperature sensing and monitoring at a targeted site, thereby improving control and safety.
Regarding claim 21, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1. Stewart (Figs. 2A-C and 3A-3B) discloses characterized in that the number of pins placed in the connector corresponds to the number of electric wires supplying the sleeve electrodes (“The handle 24 is preferably sized to be grasped by a user and includes an electrical connector 44. The electrical connector provides electrical connections [(i.e., pins)] to the electrodes 26 carried by the distal portion 32. To this end, wire(s) (not shown) may extend within the central lumen (not shown) from the distal portion 32 to the handle 24.”).
Stewart in view of North and Viswanathan are silent regarding the number of pins placed in the connector corresponds to the number of sensors placed in these electrodes.
However, in the same field of endeavor, Fang teaches a similar catheter wherein “[e]ach spine 14 can also include at least one temperature sensor, e.g., a thermocouple or thermistor, for the tip electrode 20 or any of the ring electrodes.” ([0044]-[0045]). It is well known in the art (as can be seen in Fang) to provide sleeve electrodes (i.e., ring electrodes) with thermistors in order to provide temperature sensing and monitoring at a targeted site, thereby improving control and safety. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the catheter as taught by Stewart in view of North and Viswanathan to incorporate sensors placed in the electrodes and the number of pins placed in the connector corresponds to the number of sensors placed in these electrodes, as taught by Fang, in order to provide temperature sensing and monitoring at a targeted site, thereby improving control and safety.
Claims 17 - 19 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view of North and Viswanathan as applied to claim 1 above, and further in view of Housley et al., (‘Housley,’ U.S. PGPub. No. 2016/0129246).
Regarding claim 17, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1, but are silent regarding characterized in that half of the diameter of the sleeve electrodes are made of electrically conductive material and half of electrically non-conducting material.
However, in the same field of endeavor, Housley teaches a similar electroporation device wherein “the cathode, or electrodes in the cathode array, and the anode, or electrodes in the anode array, may comprise electrically conductive, non-toxic or bio-inert metal, for instance platinum, gold, tungsten, or stainless steel. The electroporation electrode may be electrically conductive over or along its entire surface. Alternatively, the electroporation electrode may be electrically conductive at its surface along one or more portions of the entire length of the electrode, and electrically non-conductive at its surface along another portion or portions of its length. The non-conductive portions may be insulated at the surface of the electrode with a coating, such as a resin or plastic coating. The non-conductive portions may be made of a non-conducting material, such as a resin or plastic. Conductive and non-conductive polymer materials and hydrogel materials may also be used.” ([0064]). Housley teaches that electrically conductive electroporation electrodes and partially electrically non-conductive electroporation electrodes are considered well known and widely considered interchangeable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the sleeve electrodes as taught by Stewart in view of North and Viswanathan to include characterized in that half of the diameter of the sleeve electrodes are made of electrically conductive material and half of electrically non-conducting material, as taught by Housley, since electrodes entirely made of electrically conductive material and electrodes characterized in that half of the diameter of the sleeve electrodes are made of electrically conductive material and half of electrically non-conducting material are well known and widely considered interchangeable. This would have merely comprised a simple substitution of one well known electrode for another in order to produce a predictable result. MEPE 2143(I)(B).
Regarding claim 18, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1, but are silent regarding characterized in that the sleeve electrodes in % a of their diameters are made of electrically conductive material, and in other % of non-conductive material.
However, in the same field of endeavor, Housley teaches a similar electroporation device wherein “the cathode, or electrodes in the cathode array, and the anode, or electrodes in the anode array, may comprise electrically conductive, non-toxic or bio-inert metal, for instance platinum, gold, tungsten, or stainless steel. The electroporation electrode may be electrically conductive over or along its entire surface. Alternatively, the electroporation electrode may be electrically conductive at its surface along one or more portions of the entire length of the electrode, and electrically non-conductive at its surface along another portion or portions of its length. The non-conductive portions may be insulated at the surface of the electrode with a coating, such as a resin or plastic coating. The non-conductive portions may be made of a non-conducting material, such as a resin or plastic. Conductive and non-conductive polymer materials and hydrogel materials may also be used.” ([0064]). Housley teaches that electrically conductive electroporation electrodes and partially electrically non-conductive electroporation electrodes are considered well known and widely considered interchangeable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the sleeve electrodes as taught by Stewart in view of North and Viswanathan to include characterized in that the sleeve electrodes in % a of their diameters are made of electrically conductive material, and in other % of non-conductive material, as taught by Housley, since electrodes entirely made of electrically conductive material and electrodes characterized in that the sleeve electrodes in % a of their diameters are made of electrically conductive material, and in other % of non-conductive material, are well known and widely considered interchangeable. This would have merely comprised a simple substitution of one well known electrode for another in order to produce a predictable result. MEPE 2143(I)(B).
Regarding claim 19, Stewart in view of North and Viswanathan teach all of the limitations of the spring-loaded catheter according to claim 1, but are silent regarding characterized in that the electrically conductive material of the sleeve electrodes is platinum, gold or surgical steel and the electrically non-conductive material is PVC or Teflon.
However, in the same field of endeavor, Housley teaches a similar electroporation device wherein “the cathode, or electrodes in the cathode array, and the anode, or electrodes in the anode array, may comprise electrically conductive, non-toxic or bio-inert metal, for instance platinum, gold, tungsten, or stainless steel. The electroporation electrode may be electrically conductive over or along its entire surface. Alternatively, the electroporation electrode may be electrically conductive at its surface along one or more portions of the entire length of the electrode, and electrically non-conductive at its surface along another portion or portions of its length. The non-conductive portions may be insulated at the surface of the electrode with a coating, such as a resin or plastic coating. The non-conductive portions may be made of a non-conducting material, such as a resin or plastic. Conductive and non-conductive polymer materials and hydrogel materials may also be used.” ([0064]). Housley teaches that electrically conductive electroporation electrodes and partially electrically non-conductive electroporation electrodes are considered well known and widely considered interchangeable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the sleeve electrodes as taught by Stewart in view of North and Viswanathan to include characterized in that the electrically conductive material of the sleeve electrodes is platinum, gold or surgical steel, as taught by Housley, since electrodes entirely made of electrically conductive material and electrodes made of electrically conductive material, including platinum or gold, and non-conducting material are well known and widely considered interchangeable. This would have merely comprised a simple substitution of one well known electrode for another in order to produce a predictable result. MEPE 2143(I)(B).
Although, Housley teaches the “[t]he non-conductive portions may be made of a non-conducting material, such as a resin or plastic” ([0064]), the combination is silent regarding the electrically non-conductive material is specifically PVC or Teflon. However, it would have been obvious to one having ordinary skill in the art at the time of filing to have modified the electrically non-conductive material as taught by Stewart in view of North and further in view of Viswanathan and Housley to be PVC or Teflon since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE A DEDOULIS whose telephone number is (571)272-2459. The examiner can normally be reached M-F, 8am to 5pm.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/C.A.D./Examiner, Art Unit 3794