DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s Amendment filed May 26, 2026 (hereinafter “05/26/26 Amendment") has been entered, and fully considered. In the 05/26/26 Amendment, claims 1, 8, & 13 were amended. No claims were cancelled, or newly added. Accordingly, claims 1-15 remain pending in the application.
3. The 05/26/26 Amendment has overcome the claim rejections under § 103 previously set forth in the Non-Final Office Action mailed 02/25/26 (“02/25/26 Action”).
4. A new claim objection is set forth herein, along with new grounds of rejection under § 103, necessitated by Applicant’s Amendment.
Claim Objections
5. Claims 14 & 15 are objected to because of the following informalities:
In claims 14 & 15, the recitation of “The coupler” in the preamble should instead recite --The single-piece coupler-- to be consistent with the preamble of amended independent claim 13.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
6. 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.
7. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
8. Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2024/0197389 to Van Niekerk et al. ("Van Niekerk") in view of U.S. 2018/0289356 to Buesseler et al. ("Buesseler"), and further in view of U.S. 2022/0304550 to Romo et al. (“Romo”) & U.S. 2018/0280079 to Bazilian (“Bazilian”).
9. Regarding claim 1, Van Niekerk teaches a catheter comprising:
a catheter shaft [e.g., ¶[0005] (“A catheter can include an elongated shaft that extends along a longitudinal axis, an electrode assembly that is disposed distal of the elongated shaft…”); see also exemplary catheter (100) having elongated shaft (109) - ¶[0047]; FIG. 7];
a tip electrode [e.g., ¶[0018] (“The electrode assembly can include an array of electrodes that can be arranged in a planar grid, in a sphere, and/or in a helical or circular shape. The electrode assembly can include a plurality of radial spines. Alternatively, the electrode assembly can include a single irrigated tip electrode and a contact force sensor”); & ¶[0064]];
a… coupler [coupler tube] joining the tip electrode to the catheter shaft [e.g., ¶[0005] (“A catheter can include an elongated shaft that extends along a longitudinal axis, an electrode assembly that is disposed distal of the elongated shaft, a coupler tube that is disposed between the elongated shaft and the electrode assembly…”); see also coupler tube (146) - ¶’s [0054]-[0056]; FIG. 5], wherein the coupler [(146)] comprises:
a cylindrical body [coupler tube] having an annular wall that defines a central cavity [see ¶[0056] (“The coupler tube 146 preferably includes a single central lumen 118 to allow for greater flexibility of the coupler tube 146. Alternatively, the coupler tube 146 can include multiple lumens”); FIG. 5];
a pull wire [either of puller wires (124, 126) - ¶[0057]] having a distal end connected to the coupler (146) [see ¶[0057] (“A distal portion of a puller wire 124 can extend through the coupler tube 146. A distal end of the puller wire can be coupled to a sidewall of the coupler tube 146 with an anchor 125. The anchor 125 can include a weld, glue, or other suitable structure as understood by a person skilled in the pertinent art. A distal portion of a second puller wire 126 (FIG. 6) can extend through the coupler tube 146 and a distal end of the second puller wire 126 can be coupled to a sidewall of the coupler tube by a second anchor 128”)]…; and
a sensor [e.g., electromagnetic position sensor (142) - ¶[0056]; FIG. 5].
A. SENSOR RECEPTACLE(S)
Van Niekerk teaches that “the coupler tube 146 can be shaped to house various components such as an electromagnetic position sensor 142, ring electrodes 138D, lead wires 140S to electrodes of the end effector, a cable 136 for the electromagnetic position sensor 142, etc.,” [see ¶[0056]] but does not explicitly teach “receptacles.”
As such, Van Niekerk fails to teach the following emphasized claim limitations:
wherein the coupler [(146)] comprises:
a sensor receptacle; [and]
a sensor secured within the sensor receptacle.
Buesseler, in a similar field of endeavor, teaches a coupler used to facilitate coupling of a catheter shaft to various components at the distal tip of the catheter [e.g., ¶[0038]]. While Buesseler teaches that the coupler body facilitates coupling of an ultrasonic transducer array to the catheter shaft [e.g., ¶[0042]], Buesseler further teaches that the disclosed embodiments may also be readily applied to electrophysiology and ablation catheters, as a few examples [see ¶[0080]].
More particularly, Buesseler teaches exemplary embodiments of couplers that include sensor grooves (receptacles) for accommodating sensors [see, e.g., ¶[0040] (“The coupler is configured to hold a six degrees of freedom (DOF) sensor assembly, which includes a pair of magnetic position sensors. Each of the magnetic position sensors may include a coil wound around a longitudinal axis. In some embodiments, the magnetic position sensors may be elongated. The coupler may include sensor grooves formed in an outer portion of the coupler, in which the six degrees of freedom sensor assembly can be placed”)].
Buesseler explicitly teaches that securing sensors on a coupler provides benefits/advantages relating to both size and steering of the catheter [e.g., ¶[0045] (“To alleviate size constraints of a catheter, condensing the number of components at a distal tip of the catheter is desirable. In some embodiments, a coupler is disclosed that secures one or more magnetic positioning sensors at precise locations within the distal tip… This integration of various components on to the coupler allows for a reduction in the total length of the catheter distal to the pull-ring; more importantly, this may allow for desirable sweep characteristics in response to a clinician's steering input”)].
Given that Van Niekerk teaches that the coupler tube (146) can be shaped to house various components [¶[0056]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Van Niekerk such that the coupler tube include known, art-recognized features for housing/securing/retaining coupler components such as, e.g., sensor grooves (receptacles) for accommodating sensors, as taught by Buesseler, since all the claimed elements were known in the prior art, and one skilled in the art could have easily combined the elements as claimed by known methods with no change in their respective functions, and the combination would yielded nothing more than predictable results [a coupler with sensor grooves for securing sensors] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. “SINGLE-PIECE COUPLER” & PULL WIRE RECEPTACLES
Buesseler further teaches that it was known in the art to co-locate a coupler and a pull-ring. More particularly, Buesseler teaches that a coupler may include a pull-ring groove to accommodate securing a pull-ring (part of a steering system assembly for the catheter) to the coupler [e.g., ¶’s [0046], [0060]]. The pull-ring (which forms part of the coupler) also includes pathways (receptacles) for securing steering guidewires that couple to, and extend proximally from, the pull-ring [see, e.g., ¶’s [0067], [0073], [0074]; FIGS. 7, 8, 9B].
Buesseler explicitly teaches that securing both sensors and a pull-ring on a coupler provides benefits/advantages relating to both size and steering of the catheter [e.g., ¶[0045]].
In Buesseler, however, the pull-ring comprises a separate component that it is mounted to the coupler [e.g., ¶’s [0038], [0045], [0046]].
As such, the combination of Van Niekerk & Buesseler does not teach the following emphasized claim limitations:
a single-piece* coupler… [comprising]:
a pull wire receptacle; and
a pull wire having a distal end connected to the coupler within the pull wire receptacle; and
*NOTE: the recitation of “single-piece” is being interpreted herein as consisting of or made in a single, undivided piece (rather than from multiple separate parts), as would be appreciated by one having ordinary skill in the art.
Romo, in a similar field of endeavor, relates to a flexible endoscope or steerable catheter assembly [see ¶[0041] (“The endoscope 100 may also be referred to as steerable catheter assembly as described elsewhere herein”)], and teaches that it was known to attach one or more pull wires to integrally-formed grooves in a catheter structure.
For example, with reference to FIG. 14 (reproduced below) and ¶’s [0086]-[0089], Romo compares a conventional configuration of pull wires (1413 ) attached to a control ring structure (1411), and a “novel” configuration wherein pull wires are attached to integrally formed grooves [see ¶[0086] (“FIG. 14 shows an example of a conventional configuration of pull wires 1413 attached to a control ring structure 1411 and a novel configuration 1420 of the present disclosure. The control ring may be attached to the distal end of the catheter 1415. Usually the tip of the pull wires is welded or soldered to the control ring 1411 and the control ring may also be attached to the distal tip by welding. The welding process can be costly, cumbersome and complex. Moreover, when one pull wire is broken or malfunctions, the entire steering control functionality may be affected”) and ¶[0087] (“As shown in the example 1420, the one or more pull wires 1423 may be attached to an integrally formed structure 1421 of the distal portion. For example, the integrally formed structure 1421 may be grooves that are molded with the distal tip. The grooves may have a dimension or size that match the dimension of the distal end 1421 of the pull wire such that the pull wire can be conveniently crimped at distal end. This may advantageously improve the assembly efficiency”)].
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In addition to the benefit of improving assembly efficiency, Romo teaches additional benefits associated with the use of integrally formed grooves (1421) [see ¶[0088] (“The pull wire configuration may also provide improved reliability in steering the distal portion”) and ¶[0089] (“The convenient assembly of pull wires to the distal portion may also allow for flexibility in designing pull wire configurations”)].
Given that the combination of Van Niekerk & Buesseler already teaches the co-location of a coupler and a pull-ring (i.e., placing/securing the distal ends of pull wires/guidewires at a coupler), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Van Niekerk & Buesseler to instead use the pull-wire receptacles (or grooves) integrally formed in the body of the coupler of Van Niekerk, such that the coupler comprises a single-piece coupler, with the pull wire(s) then having distal end(s) connected to the coupler within the pull wire receptacle(s), since such a modification would provide the benefits/advantages of improving assembly efficiency, as well as providing improved reliability in steering, and also allowing for flexibility in designing pull wire configurations, all as explicitly taught by Romo.
C. VIAS
Finally, while Van Niekerk teaches that coupler tube (146) can accommodate ring electrodes (138D), the combination of Van Niekerk, Buesseler, & Romo does not explicitly teach:
a plurality of vias extending through the annular wall into the central cavity.
However, the use of vias (openings) in the wall of a connector section of a catheter to allow for lead wires to reach respective ring electrodes mounted on an outer surface of the connector section was well known in the art, before the effective filing date of the claimed invention.
As one example, Bazilian, in a similar field of endeavor, teaches a connector section (35) that extends between an intermediate pre-curved section (33) of a catheter and a distal tip electrode (36) [¶’s [0042], [0059]; FIG. 9]. The lumen of the connector section (35) allows components extending from the lumens of the pre-curved section (33) to reorient themselves as needed to reach connected components in the distal assembly (34).
Bazilian further teaches that the connector section (35) may include one or more ring electrodes (44) with corresponding lead wires (43) that extend through through-holes (vias) (45) formed in the side wall of the connector section (35) [see ¶[0059] (“the one or more lead wires 43 reach one or more respective ring electrodes 44 carried on the outer surface of the connector section 35 via through-holes 74 formed in the side wall of the connector section 35”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Van Niekerk, Buesseler, & Romo such that the coupler tube include a plurality of vias extending through the annular wall into the central cavity, since such a particular, known wire-routing technique (for connecting wire leads to externally-mounted ring electrodes) was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Bazilian, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Van Niekerk, Buesseler, & Romo, and the results (facilitating wired connections to externally-mounted ring electrodes) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
10. Regarding claim 2, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk further teaches wherein the sensor comprises a localization sensor [position sensor (142)].
11. Regarding claim 3, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk further teaches wherein the localization sensor comprises a plurality of magnetic coils [¶’s [0070]-[0071]].
12. Regarding claim 4, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk was modified above (in the rejection of claim 1) to include the sensor receptacle(s) of Buesseler.
Buesseler further teaches wherein the sensor receptacle comprises a slot that extends both along a longitudinal axis of the cylindrical body and around a circumference of the cylindrical body [e.g., either of trenches (501, 502) in FIG. 5A; see ¶[0061] (“At a proximal portion 510 of the coupler 500, trenches 501 and 502 extend along a length of a circumferentially extending outer surface”)].
13. Regarding claim 5, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk was modified above (in the rejection of claim 1) to include the pull wire receptacle (for securing a distal end of the pull wire) of Romo.
Romo further teaches wherein the pull wire receptacle comprises a slot beginning at a proximal end of the cylindrical body and having a length extending along a longitudinal axis of the cylindrical body [clearly shown in FIG. 14 of Romo].
14. Regarding claim 6, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk further teaches:
a ring electrode [ring electrodes (138D) - ¶[0056]; FIG. 5] positioned around the coupler [(146)].
Van Niekerk, as modified above (in the rejection of claim 1) to include the plurality of vias of Bazilian (for routing for connecting wire leads to externally-mounted ring electrodes) further teaches a conductor attached to the ring electrode and routed through a via of the plurality of vias into the central cavity [note the rejection of claim 1 above, as well as ¶[0059] & FIG. 9 of Bazilian].
15. Regarding claim 7, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk was modified above (in the rejection of claim 1) to include the pull wire receptacle (for securing a distal end of the pull wire) of Romo.
Van Niekerk (as modified) further teaches a handle secured to a proximal end of the catheter shaft, the handle including an actuator, and wherein a proximal end of the pull wire is secured to the actuator such that movement of the actuator applies a tensile force to the pull wire and the tensile force is transmitted to the catheter shaft through the connection between the pull wire and the coupler [see ¶[0047]; note also Buesseler, at ¶[0067]].
16. Regarding claim 8, Van Niekerk teaches a method of manufacturing a catheter, comprising:
providing a catheter shaft [e.g., ¶[0005] (“A catheter can include an elongated shaft that extends along a longitudinal axis, an electrode assembly that is disposed distal of the elongated shaft…”); see also exemplary catheter (100) having elongated shaft (109) - ¶[0047]; FIG. 7], a tip electrode [e.g., ¶[0018] (“The electrode assembly can include an array of electrodes that can be arranged in a planar grid, in a sphere, and/or in a helical or circular shape. The electrode assembly can include a plurality of radial spines. Alternatively, the electrode assembly can include a single irrigated tip electrode and a contact force sensor”); & ¶[0064]], a pull wire [either of puller wires (124, 126) - ¶[0057]], a sensor [e.g., electromagnetic position sensor (142) - ¶[0056]; FIG. 5], and a… coupler [coupler tube] [[e.g., ¶[0005] (“A catheter can include an elongated shaft that extends along a longitudinal axis, an electrode assembly that is disposed distal of the elongated shaft, a coupler tube that is disposed between the elongated shaft and the electrode assembly…”); see also coupler tube (146) - ¶’s [0054]-[0056]; FIG. 5]], wherein the coupler [(146)] comprises:
a cylindrical body [coupler tube] having an annular wall that defines a central cavity [see ¶[0056] (“The coupler tube 146 preferably includes a single central lumen 118 to allow for greater flexibility of the coupler tube 146. Alternatively, the coupler tube 146 can include multiple lumens”); FIG. 5];
joining the catheter shaft [(109)], the tip electrode [¶’s [0018], [0064]], and the coupler [(146)] [e.g., ¶’s [0027]-[0029]];
connecting the pull wire to the coupler by securing a distal end of the pull wire [see ¶[0057] (“A distal portion of a puller wire 124 can extend through the coupler tube 146. A distal end of the puller wire can be coupled to a sidewall of the coupler tube 146 with an anchor 125. The anchor 125 can include a weld, glue, or other suitable structure as understood by a person skilled in the pertinent art. A distal portion of a second puller wire 126 (FIG. 6) can extend through the coupler tube 146 and a distal end of the second puller wire 126 can be coupled to a sidewall of the coupler tube by a second anchor 128”)]…; and
securing the sensor [¶[0056]; FIG. 5].
A. SENSOR RECEPTACLE(S)
Van Niekerk teaches that “the coupler tube 146 can be shaped to house various components such as an electromagnetic position sensor 142, ring electrodes 138D, lead wires 140S to electrodes of the end effector, a cable 136 for the electromagnetic position sensor 142, etc.,” [see ¶[0056]] but does not explicitly teach “receptacles.”
As such, Van Niekerk fails to teach the following emphasized claim limitations:
wherein the coupler [(146)] comprises:
a sensor receptacle; [and]
securing the sensor within the sensor receptacle.
Buesseler, in a similar field of endeavor, teaches a coupler used to facilitate coupling of a catheter shaft to various components at the distal tip of the catheter [e.g., ¶[0038]]. While Buesseler teaches that the coupler body facilitates coupling of an ultrasonic transducer array to the catheter shaft [e.g., ¶[0042]], Buesseler further teaches that the disclosed embodiments may also be readily applied to electrophysiology and ablation catheters, as a few examples [see ¶[0080]].
More particularly, Buesseler teaches exemplary embodiments of couplers that include sensor grooves (receptacles) for accommodating sensors [see, e.g., ¶[0040] (“The coupler is configured to hold a six degrees of freedom (DOF) sensor assembly, which includes a pair of magnetic position sensors. Each of the magnetic position sensors may include a coil wound around a longitudinal axis. In some embodiments, the magnetic position sensors may be elongated. The coupler may include sensor grooves formed in an outer portion of the coupler, in which the six degrees of freedom sensor assembly can be placed”)].
Buesseler explicitly teaches that securing sensors on a coupler provides benefits/advantages relating to both size and steering of the catheter [e.g., ¶[0045] (“To alleviate size constraints of a catheter, condensing the number of components at a distal tip of the catheter is desirable. In some embodiments, a coupler is disclosed that secures one or more magnetic positioning sensors at precise locations within the distal tip… This integration of various components on to the coupler allows for a reduction in the total length of the catheter distal to the pull-ring; more importantly, this may allow for desirable sweep characteristics in response to a clinician's steering input”)].
Given that Van Niekerk teaches that the coupler tube (146) can be shaped to house various components [¶[0056]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Van Niekerk such that the coupler tube include known, art-recognized features for housing/securing/retaining coupler components such as, e.g., sensor grooves (receptacles) for accommodating sensors, as taught by Buesseler, since all the claimed elements were known in the prior art, and one skilled in the art could have easily combined the elements as claimed by known methods with no change in their respective functions, and the combination would yielded nothing more than predictable results [a coupler with sensor grooves for securing sensors] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. “SINGLE-PIECE COUPLER” & PULL WIRE RECEPTACLES
Buesseler further teaches that it was known in the art to co-locate a coupler and a pull-ring. More particularly, Buesseler teaches that a coupler may include a pull-ring groove to accommodate securing a pull-ring (part of a steering system assembly for the catheter) to the coupler [e.g., ¶’s [0046], [0060]]. The pull-ring (which forms part of the coupler) also includes pathways (receptacles) for securing steering guidewires that couple to, and extend proximally from, the pull-ring [see, e.g., ¶’s [0067], [0073], [0074]; FIGS. 7, 8, 9B].
Buesseler explicitly teaches that securing both sensors and a pull-ring on a coupler provides benefits/advantages relating to both size and steering of the catheter [e.g., ¶[0045]].
In Buesseler, however, the pull-ring comprises a separate component that it is mounted to the coupler [e.g., ¶’s [0038], [0045], [0046]].
As such, the combination of Van Niekerk & Buesseler does not teach the following emphasized claim limitations:
a single-piece* coupler… [comprising]:
a pull wire receptacle; and
connecting the pull wire to the coupler by securing a distal end of the pull wire within the
the pull wire receptacle; and
*NOTE: the recitation of “single-piece” is being interpreted herein as consisting of or made in a single, undivided piece (rather than from multiple separate parts), as would be appreciated by one having ordinary skill in the art.
Romo, in a similar field of endeavor, relates to a flexible endoscope or steerable catheter assembly [see ¶[0041] (“The endoscope 100 may also be referred to as steerable catheter assembly as described elsewhere herein”)], and teaches that it was known to attach one or more pull wires to integrally-formed grooves in a catheter structure.
For example, with reference to FIG. 14 (reproduced below) and ¶’s [0086]-[0089], Romo compares a conventional configuration of pull wires (1413 ) attached to a control ring structure (1411), and a “novel” configuration wherein pull wires are attached to integrally formed grooves [see ¶[0086] (“FIG. 14 shows an example of a conventional configuration of pull wires 1413 attached to a control ring structure 1411 and a novel configuration 1420 of the present disclosure. The control ring may be attached to the distal end of the catheter 1415. Usually the tip of the pull wires is welded or soldered to the control ring 1411 and the control ring may also be attached to the distal tip by welding. The welding process can be costly, cumbersome and complex. Moreover, when one pull wire is broken or malfunctions, the entire steering control functionality may be affected”) and ¶[0087] (“As shown in the example 1420, the one or more pull wires 1423 may be attached to an integrally formed structure 1421 of the distal portion. For example, the integrally formed structure 1421 may be grooves that are molded with the distal tip. The grooves may have a dimension or size that match the dimension of the distal end 1421 of the pull wire such that the pull wire can be conveniently crimped at distal end. This may advantageously improve the assembly efficiency”)].
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In addition to the benefit of improving assembly efficiency, Romo teaches additional benefits associated with the use of integrally formed grooves (1421) [see ¶[0088] (“The pull wire configuration may also provide improved reliability in steering the distal portion”) and ¶[0089] (“The convenient assembly of pull wires to the distal portion may also allow for flexibility in designing pull wire configurations”)].
Given that the combination of Van Niekerk & Buesseler already teaches the co-location of a coupler and a pull-ring (i.e., placing/securing the distal ends of pull wires/guidewires at a coupler), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Van Niekerk & Buesseler to instead use the pull-wire receptacles (or grooves) integrally formed in the body of the coupler of Van Niekerk, such that the coupler comprises a single-piece coupler, with the pull wire(s) then having distal end(s) connected to the coupler within the pull wire receptacle(s), since such a modification would provide the benefits/advantages of improving assembly efficiency, as well as providing improved reliability in steering, and also allowing for flexibility in designing pull wire configurations, all as explicitly taught by Romo.
C. VIAS
Finally, while Van Niekerk teaches that coupler tube (146) can accommodate ring electrodes (138D), the combination of Van Niekerk, Buesseler, & Romo does not explicitly teach:
a plurality of vias extending through the annular wall into the central cavity.
However, the use of vias (openings) in the wall of a connector section of a catheter to allow for lead wires to reach respective ring electrodes mounted on an outer surface of the connector section was well known in the art, before the effective filing date of the claimed invention.
As one example, Bazilian, in a similar field of endeavor, teaches a connector section (35) that extends between an intermediate pre-curved section (33) of a catheter and a distal tip electrode (36) [¶’s [0042], [0059]; FIG. 9]. The lumen of the connector section (35) allows components extending from the lumens of the pre-curved section (33) to reorient themselves as needed to reach connected components in the distal assembly (34).
Bazilian further teaches that the connector section (35) may include one or more ring electrodes (44) with corresponding lead wires (43) that extend through through-holes (vias) (45) formed in the side wall of the connector section (35) [see ¶[0059] (“the one or more lead wires 43 reach one or more respective ring electrodes 44 carried on the outer surface of the connector section 35 via through-holes 74 formed in the side wall of the connector section 35”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Van Niekerk, Buesseler, & Romo such that the coupler tube include a plurality of vias extending through the annular wall into the central cavity, since such a particular, known wire-routing technique (for connecting wire leads to externally-mounted ring electrodes) was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Bazilian, and one of ordinary skill in the art would have been capable of applying this known technique to the known device/method of Van Niekerk, Buesseler, & Romo, and the results (facilitating wired connections to externally-mounted ring electrodes) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
17. Regarding claim 9, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk further teaches wherein the sensor comprises a localization sensor [position sensor (142)].
18. Regarding claim 10, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk further teaches wherein the localization sensor comprises a plurality of magnetic coils [¶’s [0070]-[0071]].
19. Regarding claim 11, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk further teaches:
placing a ring electrode [ring electrodes (138D) - ¶[0056]; FIG. 5] around the coupler [(146)].
Van Niekerk, as modified above (in the rejection of claim 1) to include the plurality of vias of Bazilian (for routing for connecting wire leads to externally-mounted ring electrodes) further teaches attaching a conductor to the ring electrode, and routing the conductor through a via of the plurality of vias and into the central cavity [note the rejection of claim 8 above, as well as ¶[0059] & FIG. 9 of Bazilian].
20. Regarding claim 12, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk was modified above (in the rejection of claim 8) to include the pull wire receptacle (for securing a distal end of the pull wire) of Romo.
Van Niekerk (as modified) further teaches securing a handle to a proximal end of the catheter shaft, the handle including an actuator; and connecting the pull wire to the handle by securing a proximal end of the pull wire to the actuator such that movement of the actuator applies a tensile force to the pull wire and the tensile force is transmitted to the catheter shaft through the connection between the pull wire and the coupler [see ¶[0047]; note also Buesseler, at ¶[0067]].
21. Regarding claim 13, Van Niekerk teaches a… coupler [coupler tube] [e.g., ¶[0005] (“A catheter can include an elongated shaft that extends along a longitudinal axis, an electrode assembly that is disposed distal of the elongated shaft, a coupler tube that is disposed between the elongated shaft and the electrode assembly…”); see also coupler tube (146) - ¶’s [0054]-[0056]; FIG. 5] for securing a tip electrode [e.g., ¶[0018] (“The electrode assembly can include an array of electrodes that can be arranged in a planar grid, in a sphere, and/or in a helical or circular shape. The electrode assembly can include a plurality of radial spines. Alternatively, the electrode assembly can include a single irrigated tip electrode and a contact force sensor”); & ¶[0064]], a sensor [e.g., electromagnetic position sensor (142) - ¶[0056]; FIG. 5], and a pull wire [either of puller wires (124, 126) - ¶[0057]] to a catheter shaft [e.g., ¶[0005] (“A catheter can include an elongated shaft that extends along a longitudinal axis, an electrode assembly that is disposed distal of the elongated shaft…”); see also exemplary catheter (100) having elongated shaft (109) - ¶[0047]; FIG. 7], comprising:
a cylindrical body [coupler tube] having an annular wall that defines a central cavity [see ¶[0056] (“The coupler tube 146 preferably includes a single central lumen 118 to allow for greater flexibility of the coupler tube 146. Alternatively, the coupler tube 146 can include multiple lumens”); FIG. 5].
A. SENSOR RECEPTACLE(S)
Van Niekerk teaches that “the coupler tube 146 can be shaped to house various components such as an electromagnetic position sensor 142, ring electrodes 138D, lead wires 140S to electrodes of the end effector, a cable 136 for the electromagnetic position sensor 142, etc.,” [see ¶[0056]] but does not explicitly teach “receptacles.”
As such, Van Niekerk fails to teach the following emphasized claim limitations:
a sensor receptacle.
Buesseler, in a similar field of endeavor, teaches a coupler used to facilitate coupling of a catheter shaft to various components at the distal tip of the catheter [e.g., ¶[0038]]. While Buesseler teaches that the coupler body facilitates coupling of an ultrasonic transducer array to the catheter shaft [e.g., ¶[0042]], Buesseler further teaches that the disclosed embodiments may also be readily applied to electrophysiology and ablation catheters, as a few examples [see ¶[0080]].
More particularly, Buesseler teaches exemplary embodiments of couplers that include sensor grooves (receptacles) for accommodating sensors [see, e.g., ¶[0040] (“The coupler is configured to hold a six degrees of freedom (DOF) sensor assembly, which includes a pair of magnetic position sensors. Each of the magnetic position sensors may include a coil wound around a longitudinal axis. In some embodiments, the magnetic position sensors may be elongated. The coupler may include sensor grooves formed in an outer portion of the coupler, in which the six degrees of freedom sensor assembly can be placed”)].
Buesseler explicitly teaches that securing sensors on a coupler provides benefits/advantages relating to both size and steering of the catheter [e.g., ¶[0045] (“To alleviate size constraints of a catheter, condensing the number of components at a distal tip of the catheter is desirable. In some embodiments, a coupler is disclosed that secures one or more magnetic positioning sensors at precise locations within the distal tip… This integration of various components on to the coupler allows for a reduction in the total length of the catheter distal to the pull-ring; more importantly, this may allow for desirable sweep characteristics in response to a clinician's steering input”)].
Given that Van Niekerk teaches that the coupler tube (146) can be shaped to house various components [¶[0056]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Van Niekerk such that the coupler tube include known, art-recognized features for housing/securing/retaining coupler components such as, e.g., sensor grooves (receptacles) for accommodating sensors, as taught by Buesseler, since all the claimed elements were known in the prior art, and one skilled in the art could have easily combined the elements as claimed by known methods with no change in their respective functions, and the combination would yielded nothing more than predictable results [a coupler with sensor grooves for securing sensors] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. “SINGLE-PIECE COUPLER” & PULL WIRE RECEPTACLES
Buesseler further teaches that it was known in the art to co-locate a coupler and a pull-ring. More particularly, Buesseler teaches that a coupler may include a pull-ring groove to accommodate securing a pull-ring (part of a steering system assembly for the catheter) to the coupler [e.g., ¶’s [0046], [0060]]. The pull-ring (which forms part of the coupler) also includes pathways (receptacles) for securing steering guidewires that couple to, and extend proximally from, the pull-ring [see, e.g., ¶’s [0067], [0073], [0074]; FIGS. 7, 8, 9B].
Buesseler explicitly teaches that securing both sensors and a pull-ring on a coupler provides benefits/advantages relating to both size and steering of the catheter [e.g., ¶[0045]].
In Buesseler, however, the pull-ring comprises a separate component that it is mounted to the coupler [e.g., ¶’s [0038], [0045], [0046]].
As such, the combination of Van Niekerk & Buesseler does not teach the following emphasized claim limitations:
A single-piece* coupler… comprising:
a pull wire receptacle.
*NOTE: the recitation of “single-piece” is being interpreted herein as consisting of or made in a single, undivided piece (rather than from multiple separate parts), as would be appreciated by one having ordinary skill in the art.
Romo, in a similar field of endeavor, relates to a flexible endoscope or steerable catheter assembly [see ¶[0041] (“The endoscope 100 may also be referred to as steerable catheter assembly as described elsewhere herein”)], and teaches that it was known to attach one or more pull wires to integrally-formed grooves in a catheter structure.
For example, with reference to FIG. 14 (reproduced below) and ¶’s [0086]-[0089], Romo compares a conventional configuration of pull wires (1413 ) attached to a control ring structure (1411), and a “novel” configuration wherein pull wires are attached to integrally formed grooves [see ¶[0086] (“FIG. 14 shows an example of a conventional configuration of pull wires 1413 attached to a control ring structure 1411 and a novel configuration 1420 of the present disclosure. The control ring may be attached to the distal end of the catheter 1415. Usually the tip of the pull wires is welded or soldered to the control ring 1411 and the control ring may also be attached to the distal tip by welding. The welding process can be costly, cumbersome and complex. Moreover, when one pull wire is broken or malfunctions, the entire steering control functionality may be affected”) and ¶[0087] (“As shown in the example 1420, the one or more pull wires 1423 may be attached to an integrally formed structure 1421 of the distal portion. For example, the integrally formed structure 1421 may be grooves that are molded with the distal tip. The grooves may have a dimension or size that match the dimension of the distal end 1421 of the pull wire such that the pull wire can be conveniently crimped at distal end. This may advantageously improve the assembly efficiency”)].
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In addition to the benefit of improving assembly efficiency, Romo teaches additional benefits associated with the use of integrally formed grooves (1421) [see ¶[0088] (“The pull wire configuration may also provide improved reliability in steering the distal portion”) and ¶[0089] (“The convenient assembly of pull wires to the distal portion may also allow for flexibility in designing pull wire configurations”)].
Given that the combination of Van Niekerk & Buesseler already teaches the co-location of a coupler and a pull-ring (i.e., placing/securing the distal ends of pull wires/guidewires at a coupler), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Van Niekerk & Buesseler to instead use the pull-wire receptacles (or grooves) integrally formed in the body of the coupler of Van Niekerk, such that the coupler comprises a single-piece coupler, with the pull wire(s) then having distal end(s) connected to the coupler within the pull wire receptacle(s), since such a modification would provide the benefits/advantages of improving assembly efficiency, as well as providing improved reliability in steering, and also allowing for flexibility in designing pull wire configurations, all as explicitly taught by Romo.
C. VIAS
Finally, while Van Niekerk teaches that coupler tube (146) can accommodate ring electrodes (138D), the combination of Van Niekerk, Buesseler, & Romo does not explicitly teach:
a plurality of vias extending through the annular wall into the central cavity.
However, the use of vias (openings) in the wall of a connector section of a catheter to allow for lead wires to reach respective ring electrodes mounted on an outer surface of the connector section was well known in the art, before the effective filing date of the claimed invention.
As one example, Bazilian, in a similar field of endeavor, teaches a connector section (35) that extends between an intermediate pre-curved section (33) of a catheter and a distal tip electrode (36) [¶’s [0042], [0059]; FIG. 9]. The lumen of the connector section (35) allows components extending from the lumens of the pre-curved section (33) to reorient themselves as needed to reach connected components in the distal assembly (34).
Bazilian further teaches that the connector section (35) may include one or more ring electrodes (44) with corresponding lead wires (43) that extend through through-holes (vias) (45) formed in the side wall of the connector section (35) [see ¶[0059] (“the one or more lead wires 43 reach one or more respective ring electrodes 44 carried on the outer surface of the connector section 35 via through-holes 74 formed in the side wall of the connector section 35”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Van Niekerk, Buesseler, & Romo such that the coupler tube include a plurality of vias extending through the annular wall into the central cavity, since such a particular, known wire-routing technique (for connecting wire leads to externally-mounted ring electrodes) was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Bazilian, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Van Niekerk, Buesseler, Romo, & Bazilian, and the results (facilitating wired connections to externally-mounted ring electrodes) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
22. Regarding claim 14, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk was modified above (in the rejection of claim 13) to include the sensor receptacle(s) of Buesseler.
Buesseler further teaches wherein the sensor receptacle comprises a slot that extends both along a longitudinal axis of the cylindrical body and around a circumference of the cylindrical body [e.g., either of trenches (501, 502) in FIG. 5A; see ¶[0061] (“At a proximal portion 510 of the coupler 500, trenches 501 and 502 extend along a length of a circumferentially extending outer surface”)].
23. Regarding claim 15, the combination of Van Niekerk, Buesseler, Romo, & Bazilian teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Van Niekerk was modified above (in the rejection of claim 13) to include the pull wire receptacle (for securing a distal end of the pull wire) of Romo.
Romo further teaches wherein the pull wire receptacle comprises a slot that begins at a proximal end of the cylindrical body and has a length extending along a longitudinal axis of the cylindrical body [clearly shown in FIG. 14].
Response to Arguments
24. As noted above, the 05/26/26 Amendment has overcome the claim rejections under § 103 previously set forth in the 02/25/26 Action.
25. A new claim objection is set forth herein, along with new grounds of rejection under § 103, necessitated by Applicant’s Amendment. More particularly, Applicant's arguments concerning the prior rejections under § 103 have been fully considered and are persuasive (in view of the current Amendment). Therefore, these rejections have been withdrawn. However, upon further consideration, new grounds of rejection under § 103 are set forth in detail above, necessitated by Applicant’s Amendment.
Conclusion
26. 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 extension fee 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 date of this final action.
27. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Bradford C. Blaise whose telephone number is (571) 272-5617. The Examiner can normally be reached on Monday - Friday, 8:30 AM - 4:30 PM MST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 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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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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