DETAILED ACTION
Applicant's amendments and remarks, filed 4/30/26, are fully acknowledged by the Examiner. Currently, claims 1-21 are pending with claims 1, 9, and 17 amended. The following is a complete response to the 4/30/26 communication.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
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.
Claim(s) 1-4, 17, 19 and 21 is/are rejected under 35 U.S.C. 103 as being un patentable over Kelly (US 2015/0305807) in view of Hixon (US 2007/0173814), in view of Beeckler (US 2017/0311893), in view of Lopes (US 2013/0172883), in further view of Shelton (US 2019/0201029).
Regarding claim 1, Kelly teaches a catheter comprising: a catheter shaft including a proximal end
and a distal end having at least one electrode or sensor (shaft 2136 as in Fig. 36a with a proximal end near 2300 and a distal end with sensors as in par. [0096]); an electrical conductor coupled to the catheter shaft (2318 as in par. [(0096]), the electrical conductor communicatively coupled to the
electrode or the sensor at the distal end of the catheter shaft (analogous to 210, 212 as noted in par. [0096], 210 and 212 as thermocouple wires as in par. [0064]); a catheter handle including a proximal end, a distal end (handle with a distal end closer to the shaft 2136 and a proximal end further from the shaft), and a housing (2300), the catheter handle coupled to the proximal end of the catheter shaft (2300 at the proximal end of the shaft 2316); a circuit conformed and disposed along the inner surface of one of the top portion and the bottom portion and extending between the proximal end and the distal end of the catheter shaft (par. [0096] PCB printed on the handle and extending via connectors to the end effector through the catheter shaft), and wherein the circuit includes: a first connection interface located at a distal end of the circuit and at the distal end of the catheter handle (interface of the connection of the PCB to the routing lines 2318 as in Fig. 36a at the distal end of the PCB and distal end of the handle 2300), wherein the first connection interface is located within one of the non-planar surfaces (located within the non-planar housing), wherein the first connection interface is configured for electrical communication with an electrode or a sensor of the catheter shaft (routing lines analogous to the wires 210-212 for connection to electrodes), and a second connection interface located at a proximal end of the circuit and a proximal end of the catheter handle (proximal end connecting to the connector 2330 as in par. [0096]), wherein the second connection interface is located within the same non-planar surface as the first connection interface (located within the non-planar housing 2300), wherein the second connection interface is configured for electrical communication with an electronic control unit (connection to energy generator 132), wherein the circuit is electrically coupled to the electrode or the sensor through the electrical conductor and configured for communication with an electronic control unit (connected with the routing lines 2318 and energy generator 132).
The Fig. 36a embodiment of Kelly is not explicit regarding the housing having a top portion and a
bottom portion, and while teaching a non-planar surface defining an internal volume sized and shaped to a profile of the handle (2300 with a non-planar inner surface with a conical shape reflecting the profile of 2300, further shown by the PCB plugging into 2330 with a cylindrical connection), is not explicit regarding the housing having an inner surface comprising a planar surface.
However, Fig. 35a-b of Kelly teaches a housing having a top portion and a bottom portion
(2200a-b as top and bottom of a housing). Kelly further teaches in Fig. 35a an alternate housing shape, having planar and non-planar inner surfaces (Fig. 35a with housing 2202 having non planar inner surfaces and planar surfaces such as surfaces with 2232a).
It would have been obvious to one of ordinary skill in the art to modify Fig. 36 of Kelly with the multiple pieces of housing as in Fig. 35 of Kelly, as a known manner of construction of a housing,
allowing for easier assembly of the device. It would have further been obvious to one of ordinary skill in the art to modify Kelly such that the housing is shaped as in the Fig. 35 embodiment of Kelly, especially given that Fig. 36 embodiment refers to Figs 35a-b as in par. [0096], as a known handle shape to be used according to ergonomic utility.
Kelly is further not explicit regarding the circuit being compliant.
However, Hixon teaches flexible circuits that conform to tightly spaced areas (par. [0128]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the flex circuit of Hixon rather than the printed-on PCB of Kelly, allowing for facilitating manufacturing (par. [0128]).
Kelly is not explicit regarding at least one dielectric layer; at least one conductive layer.
However, Beeckler teaches flexible circuits that have a conductive layer of a conductive polymer
and a dielectric layer (par. [0008)]).
Lopes teaches spring back properties of conductors of flexible circuits that affect strain and are a
factor in preventing failure (par. [0369] and Fig. 7j).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive
polymer and dielectric layer, as in Beeckler, as known layers of a flexible circuit. It would have further been obvious to one of ordinary skill in the art that conductive layers would have a strain relief feature as shown by Lopes, to prevent failure of the circuit.Kelly is not explicit regarding the circuit disposed along the inner surface comprising the planar and non-planar surface. However, Shelton teaches circuits that are on the inner surface of a handle having both nonplanar and planar surfaces (Fig. 86-87 with circuits along the nonplanar handle and a planar portion, including the proximal end and 215120 as in at least par. [0501]).It would have been obvious to one of ordinary skill in the art that the circuit would be along a planar and non-planar surface depending on the shape of the handle, as taught by Shelton.
Regarding claim 2, Kelly is not explicit regarding the compliant circuit includes material configured to stretch and comply with the non-planar surface.
However, Hixon teaches flexible circuits that conform to tightly spaced areas (par. [0128]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the flex circuit of Hixon rather than the printed on PCB of Kelly, allowing for facilitating manufacturing (par. [0128)).
Regarding claim 3, Kelly is not explicit regarding wherein at least one of the dielectric layers and
at least one of the conductive layers each includes a respective material configured to stretch and comply with the non- planar surface.
However, Beeckler teaches flexible circuits that have a conductive layer of a conductive polymer and a dielectric layer (par. [0008)]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive polymer and dielectric layer, as in Beeckler, as known layers of a flexible circuit. In the combination, the layers would fit on the non-planar surface of Keller.
Regarding claim 4, Kelly teaches wherein the conductive layer includes a printable conductive polymer.
However, Beeckler teaches a conductive polymer used in circuitry, as well as printable circuit boards (par. [0008)).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive layer of a conductive polymer as in Beeckler, as a known material that works in medical circuitry that are also flexible.
Regarding claim 17, Kelly teaches a method comprising: disposing a compliant circuit along a non-planar surface of an interior surface of a catheter handle (PCB along a nonplanar surface of catheter handle 2300 as in Figs. 36a-d and par. [0096]), a first connection interface electrically coupled to at least one of the conductive layers (a first connection to 2316), wherein the first connection interface is located within the non-planar surfaces (located within the non-planar housing 2300), and a second connection interface electrically coupled to at least one of the conductive layers (a second connection connecting to 132 as in par. [0096]), wherein the first connection interface is located within the non-planar surface (located within the non-planar housing 2300) and the compliant circuit extends from the proximal end and the distal end of the catheter handle (circuit connecting a proximal end to a distal end of the catheter as in Fig. 36b).
Kelly is silent regarding a planar inner surface.
However, Fig. 35a-b of Kelly teaches a housing having a top portion and a bottom portion (2200a-b as top and bottom of a housing). Kelly further teaches in Fig. 35a an alternate housing shape, having planar and non-planar inner surfaces (Fig. 35a with housing 2202 having non planar inner surfaces and planar surfaces such as surfaces with 2232a).
It would have further been obvious to one of ordinary skill in the art to modify Kelly such that the housing is shaped as in the Fig. 35 embodiment of Kelly, especially given that Fig. 36 embodiment refers to Figs 35a-b as in par. [0096], as a known handle shape to be used according to ergonomic utility.
Kelly is silent regarding wherein the compliant circuit includes: a dielectric layer having a dielectric material configured to stretch and comply with the non-planar surface, a plurality of conductive layers, each having a conductive material configured to stretch and comply with the non-planar surface.However, Beeckler teaches flexible circuits that have conductive layers of a conductive polymer and a dielectric layer (par. [0008)]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive polymer and dielectric layers, as in Beeckler, as known layers of a flexible circuit to receive and deliver energy.
Kelly is further silent regarding conforming at least a portion of the compliant circuit to the non-planar surface.
However, Hixon teaches flexible circuits that conform to tightly spaced areas (par. [0128]).It would have been obvious to one of ordinary skill in the art to modify Kelly with the flex circuit of Hixon rather than the printed on PCB of Kelly, allowing for facilitating manufacturing (par. [0128)).
Kelly is not explicit regarding at least one dielectric layer; at least one conductive layer, wherein the conductive layer comprises a strain relief feature.
However, Beeckler teaches flexible circuits that have a conductive layer of a conductive polymer and a dielectric layer (par. [0008)]).
Lopes teaches spring back properties of conductors of flexible circuits that affect strain and are a factor in preventing failure (par. [0369] and Fig. 7j).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive polymer and dielectric layer, as in Beeckler, as known layers of a flexible circuit. It would have further been obvious to one of ordinary skill in the art that conductive layers would have a strain relief feature as shown by Lopes, to prevent failure of the circuit.Kelly is not explicit regarding the circuit disposed along the inner surface comprising the planar and non-planar surface. However, Shelton teaches circuits that are on the inner surface of a handle having both nonplanar and planar surfaces (Fig. 86-87 with circuits along the nonplanar handle and a planar portion, including the proximal end and 215120 as in at least par. [0501]).It would have been obvious to one of ordinary skill in the art that the circuit would be along a planar and non-planar surface depending on the shape of the handle, as taught by Shelton.
Regarding claim 19, Kelly teaches wherein the compliant circuit is conformed to a shape of the
non-planar surface and then disposed and attached to the non-planar surface (PCB printed onto the surface of 2300 which is nonplanar, as in par. [0096] and Fig. 36a-b).
Regarding claim 21, Kelly is not explicit regarding further comprising fabricating the compliant circuit, wherein fabricating the compliant circuit includes disposing the conductive layer on the dielectric layer.
However, Beeckler teaches flexible circuits that have conductive layers of a conductive polymer and a dielectric layer (par. [0008)]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive polymer and dielectric layers, as in Beeckler, as known layers of a flexible circuit to receive and deliver energy.
Claim(s) 9-10, 16 is/are rejected under 35 U.S.C. 103 as being un patentable over Kelly (US 2015/0305807) in view of Hixon (US 2007/0173814), in view of Shelton.
Regarding claim 9, Kelly teaches a handle configured for use with a catheter system (handle 2300), the handle comprising:
a non-planar surface included along an interior of the handle (2300 with a nonplanar interior surface as in Fig. 36a with a conal shape, further shown by the PCB plugging into 2330 with a cylindrical connection);
a distal end configured for coupling with a catheter shaft (2300 couples to a shaft 2136 at a distal end of 2300 as in Fig. 36a);
a proximal end configured for coupling with an electrical cable for communication with an electronic control unit (proximal end of 2300 coupled to energy generator 132 via cable); and a compliant circuit disposed within one or more of the top portion and bottom portion of the housing (par. [0096] PCB in the handle), wherein the compliant circuit is conformed to the non-planar surface (par. [0096] PCB in the handle) and extends between the proximal end and distal end of the handle (par. [0096] PCB printed on the handle and extending via connectors to the end effector through the catheter shaft), and wherein the compliant circuit includes: a first connection interface located at a distal end of the compliant circuit (connection interface 2230 connecting to 2316 and the electrodes), wherein the first connection interface is located within the non-planar surfaces (located within the non-planar housing 2300), the first connection interface configured for electrical communication with an electrode or a sensor of the catheter shaft (par. [0096] with connection between the routing lines and the PCB), and a second connection interface located at a proximal end of the compliant circuit (connection from PCB to 2330 as in par. [0096]), wherein the second connection interface is located within the non-planar surfaces (located within the non-planar housing 2300), the second connection interface configured for electrical communication with the electronic control unit (connection to 2330 and energy generator 132 as in par. [0096]).
The Fig. 36a embodiment of Kelly is not explicit regarding the housing having a top portion and a bottom portion. Kelly further teaches wherein the circuit extends between along a length of the handle between the first connection interface and the second connection interface (Fig. 36b circuit extends from 2316 to the distal end to connect to 2330), but not explicit regarding the compliant circuit along the one of the non-planar surfaces of one of the top portion and the bottom portion.
However, Fig. 35 of Kelly teaches a housing having atop portion and a bottom portion (2200a-b as top and bottom of a housing), with circuitry running through the portion (circuits connecting via at least 2224). Kelly further teaches in Fig. 35a an alternate housing shape, having planar and non-planar inner surfaces (Fig. 35a with housing 2202 having non planar inner surfaces and planar surfaces such as surfaces with 2232a).
It would have been obvious to one of ordinary skill in the art to modify Fig. 36 of Kelly with the multiple pieces of housing as in Fig. 35 of Kelly, as a known manner of construction of a housing, allowing for easier assembly of the device. It would have further been obvious to one of ordinary skill in the art to modify Kelly such that the housing is shaped as in the Fig. 35 embodiment of Kelly, especially given that Fig. 36 embodiment refers to Figs 35a-b as in par. [0096], as a known handle shape to be used according to ergonomic utility.
Kelly is not explicit regarding the circuit being compliant.
However, Hixon teaches flexible circuits that conform to tightly spaced areas (par. [0128]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the flex circuit of Hixon rather than the printed on PCB of Kelly, allowing for facilitating manufacturing (par. [0128)).Kelly is not explicit regarding the circuit conformed to the interior surface comprising the planar and non-planar surface. However, Shelton teaches circuits that are on the inner surface of a handle having both nonplanar and planar surfaces (Fig. 86-87 with circuits along the nonplanar handle and a planar portion, including the proximal end and 215120 as in at least par. [0501]).It would have been obvious to one of ordinary skill in the art that the circuit would be along a planar and non-planar surface depending on the shape of the handle, as taught by Shelton.
Regarding claim 10, Kelly is not explicit regarding the compliant circuit includes material configured to stretch and comply with the non-planar surface.
However, Hixon teaches flexible circuits that conform to tightly spaced areas (par. [0128]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the flex circuit of Hixon rather than the printed on PCB of Kelly, allowing for facilitating manufacturing (par. [0128)).
Regarding claim 16, Kelly is not explicit regarding the compliant circuit is insert molded to the non-planar surface. However, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP 2113.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being un patentable over Kelly in view of Hixon, in view of Shelton, in further view of Beeckler.
Regarding claim 11, Kelly is not explicit regarding the circuit includes at least one dielectric layer and at least one conductive layer, wherein at least one of the dielectric layers and at least one of the conductive layers each includes a respective material configured to stretch and comply with the non-planar surface.
However, Beeckler teaches flexible circuits that have a conductive layer of a conductive polymer and a dielectric layer (par. [0008)]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive polymer and dielectric layer, as in Beeckler, as known layers of a flexible circuit.
Regarding claim 12, Kelly teaches wherein the conductive layer includes a printable conductive polymer.
However, Beeckler teaches a conductive polymer used in circuitry, as well as printable circuit boards (par. [0008)).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the conductive layer of a conductive polymer as in Beeckler, as a known material that works in medical circuitry that are also flexible.
Claim(s) 5-8, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Hixon in view of Beeckler, in view of Lopes, in view of Shelton, and in further view of Ghaffari (US 2010/0298895).
Regarding claim 5, Kelly is silent regarding a logic component embedded within the compliant circuit. Ghaffari teaches a logic component (par. [0020]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the logic component of Ghaffari, allowing for controlling and conditioning the signal delivered to the patient (par. [0084] of Ghaffari).
Regarding claim 6, Kelly is silent, but Ghaffari teaches a logic component as an amplifier (par. [0084]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the logic component of Ghaffari as an amplifier, allowing for controlling and conditioning the signal delivered to the patient (par. [0084] of Ghaffari).
Regarding claim 7, Kellis is silent, but Ghaffari teaches the logic component includes a semiconductor (par. [0084]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the logic component of Ghaffari as a semiconductor, allowing for controlling and conditioning the signal delivered to the patient (par. [0084] of Ghaffari).
Regarding claim 8, Kelly teaches wherein the logic component includes a p-type material, n-type material, or both (par. [0219] n-type and p-type elements).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the logic component of Ghaffari with the n and p type materials, allowing for controlling and conditioning the signal delivered to the patient (par. [0084] of Ghaffari).
Regarding claim 18, Kelly teaches directly printing the circuit on the non-planar surface (par. [0096]), but is not explicit regarding the layers, and printing a second layer of at least one dielectric layer or at least one conductive layer on the first layer.
However, Ghaffari teaches printed circuits (at least par. [0101]) and further multiple substrate layers (par. [0097]).
It would have been obvious to one of ordinary skill in the art to modify the combination with the multiple substrate layers as taught by Ghaffari, allowing for multiple layers of construction to allow for stress and strain relief (par. [0097]).
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Hixon, in view of Shelton, and in further view of Ghaffari.
Regarding claim 13, Kelly is silent regarding a logic component embedded within the compliant circuit.
Ghaffari teaches a logic component (par. [0020)).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the logic component of Ghaffari, allowing for controlling and conditioning the signal delivered to the patient (par. [0084] of Ghaffari).
Regarding claim 14, Kelly is silent, but Ghaffari teaches a logic component as an amplifier (par. [0084]).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the logic component of Ghaffari as an amplifier, allowing for controlling and conditioning the signal delivered to the patient (par. [0084] of Ghaffari).
Regarding claim 15, Kelly is silent, but Ghaffari teaches wherein the logic component includes a p-type material, n- type material, or both (par. [0219] n-type and p-type elements).
It would have been obvious to one of ordinary skill in the art to modify Kelly with the logic component of Ghaffari with the n and p type materials, allowing for controlling and conditioning the signal delivered to the patient (par. [0084] of Ghaffari).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Hixon in view of Beeckler, in view of Lopes, in view of Shelton, in further view of Ritchie (US 2005/0113815).
Regarding claim 20, Kelly is silent wherein conforming the compliant circuit to the non-planar surface includes positioning the compliant circuit within a mold, and wherein disposing the compliant circuit along the non-planar surface includes insert molding the non-planar surface of the catheter handle to the compliant circuit. However, Ritchie teaches a PCB (66) that may be insert molded into a flange of a handle of a medical device (par. [0035] and Fig. 4). It would have been obvious to one of ordinary skill in the art to modify Kelly with the insert molding of Ritchie, as a known manufacturing method of inserting a PCB into a handle of a device.
Response to Arguments
Applicant’s arguments, see the remarks, filed 4/30/26, with respect to the rejection(s) of claim(s) 1-21 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Shelton as a secondary reference.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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