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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 May 2026 has been entered. Claims 1, 7, 16-18, and 20 are currently amended. Claims 1-20 are pending in the application. Applicant’s amendments to the claims have overcome the objections previously set forth in the Final Office Action mailed 23 February 2026.
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.
Claims 1, 7-8, and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al. (US PGPub No. 2007/0083194), hereinafter Kunis, in view of Taimisto et al. (US PGPub No. 2005/0273095), hereinafter Taimisto.
Regarding claim 1, Kunis teaches a medical apparatus comprising:
a tubular member extending from a proximal portion to a distal portion along a longitudinal axis (Fig. 3: outer shaft 36);
an actuator shaft extending from inside the tubular member to an actuator shaft distal end (Fig. 3: second control shaft 57 with tip 62);
a first expandable member comprising a first expandable distal portion coupled to the actuator shaft distal end and a first expandable proximal portion coupled to a slidable coupler so that there is no movement between the first expandable proximal portion and the slidable coupler (Fig. 3: second carrier assembly 55 with arms 54,56 coupled to ring 52 and distal tip 62; pars. 0076-77: “Second control shaft 57 includes tip 62 on its distal end that fixedly attaches one end of each distal carrier arm segment 56 to second control shaft 57 […] The opposite end of each proximal arm segment 54 is fixedly attached to the distal end of first control shaft 48 via ring 52”);
a second expandable member comprising a second expandable proximal portion coupled to the tubular member and a second expandable distal portion coupled to a slidable coupler so that there is no movement between the second expandable distal portion and the slidable coupler (Fig. 3: first carrier assembly 45 with arms 42,44 coupled to ring 52 and outer shaft 36; par. 0074: “First control shaft 48 includes ring 52 on its distal end that fixedly attaches one end of each distal carrier arm segment 44 to first control shaft 48. Each distal carrier arm segment 44 is pivotally attached on its opposite end to one end of a proximal carrier arm segment 42. The opposite end of each proximal arm segment 42 is fixedly attached to the distal end of outer shaft 36 via ring 38”);
in which the slidable coupler comprises: a coupler body comprising an opening extending along the longitudinal axis through the coupler body (Fig. 3: ring 52 having an opening through which second control shaft 57 extends),
the opening slidingly engaged to the actuator shaft to allow movement of the coupler body relative to the actuator shaft and to provide a sealing fit between the coupler body with the actuator shaft (Fig. 3: second control shaft 57 slidably disposed inside ring 52 and distal end of first control shaft 48; par. 0076: “First control shaft 48 slidingly receives second control shaft 57”),
the slidable coupler being spaced apart from the tubular member, as broadly as claimed (Fig. 3: ring 52 longitudinally spaced apart from outer shaft 36).
Kunis does not explicitly teach wherein the expandable members are balloons. However, in a related art, Taimisto teaches a medical apparatus for ablation of a pulmonary vein ostium with an anchoring balloon and an ablation balloon that correspond to Kunis’s second carrier assembly and first carrier assembly, respectively (Fig. 9D: anchoring device 110, ablation assembly 108; par. 0030: “the anchoring device 110 includes an expandable-collapsible member 170, such as a balloon;” par. 0032: “The ablation assembly 108 includes an expandable-collapsible member 180, such as a balloon”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one known expandable-collapsible element (balloons as taught in Taimisto) for another (carrier assembly with arms as taught in Kunis), since one of ordinary skill in the art could have performed such a substitution, and the results were predictable, namely, that the system would be capable of controlling the shape of the expandable members using inflation as well as shaft actuation.
Regarding claims 7-8 and 14-15, the combination teaches the device of claim 1 as described previously. Kunis further teaches in which the actuator shaft includes a first passage to allow insertion of a guide wire into the first passage (Fig. 3, par. 0076: “Distal tip 62 includes guidewire lumen 63”), but does not explicitly teach a second passage generally parallel with the first passage to allow fluid to flow through the second passage and exit through at least one peripheral port, or a second/primary irrigation passage to provide fluid flow to enter the second balloon via a fluid port and a third passage to allow fluid flow to the first balloon independent of delivery of fluid to the second balloon. However, Taimisto further teaches a second and third passage for fluid flow into separate balloons, respectively, that are generally parallel with a first passage for a guide wire (Fig. 7: guide wire lumen 402, channel 162 with port 166, channel 160 with port 164; par. 0033: “the pump 130 has two reservoirs of fluid and two outlets for connecting to the channels 160, 162, and is configured to independently deliver fluid from the reservoirs to the anchoring device 110 and the ablation assembly 108 via the channels 160, 162, respectively”). To provide the device of the combined reference with fluid passages in fluid communication with the first and second balloons, as suggested by Taimisto, would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention, i.e., one skilled in the art would have recognized that the individual fluid passages of Taimisto would provide a means for inflation and deflation of the balloons.
Regarding claims 11-13, the combination teaches the device of claim 1 as described previously. Kunis further teaches wherein the first and second expandable members each include a plurality of electrodes disposed on their outer surfaces (Fig. 3: electrodes 58, 64).
Regarding claim 16, Kunis teaches a method of operating an expandable end effector, the method comprising the steps of:
providing an end effector including a tubular member extending from a proximal portion to a distal portion along a longitudinal axis (Fig. 3: outer shaft 36);
with an actuator shaft extending from inside the tubular member to an actuator shaft distal end (Fig. 3: second control shaft 57 with tip 62);
a first expandable member comprising a first expandable distal portion coupled to the actuator shaft distal end and a first expandable proximal portion coupled to a slidable coupler so that there is no movement between the first expandable proximal portion and the slidable coupler (Fig. 3: second carrier assembly 55 with arms 54,56 coupled to ring 52 and distal tip 62; pars. 0076-77: “Second control shaft 57 includes tip 62 on its distal end that fixedly attaches one end of each distal carrier arm segment 56 to second control shaft 57 […] The opposite end of each proximal arm segment 54 is fixedly attached to the distal end of first control shaft 48 via ring 52”);
the slidable coupler slidingly engaged to the actuator shaft to allow movement of the slidable coupler relative to the actuator shaft (Fig. 3: second control shaft 57 slidably disposed inside ring 52 and distal end of first control shaft 48; par. 0076: “First control shaft 48 slidingly receives second control shaft 57”),
the slidable coupler being spaced apart from the tubular member, as broadly as claimed (Fig. 3: ring 52 longitudinally spaced apart from outer shaft 36);
a second expandable member comprising a second expandable proximal portion coupled to the tubular member and a second expandable distal portion coupled to a slidable coupler so that there is no movement between the second expandable distal portion and the slidable coupler (Fig. 3: first carrier assembly 45 with arms 42,44 coupled to ring 52 and outer shaft 36; par. 0074: “First control shaft 48 includes ring 52 on its distal end that fixedly attaches one end of each distal carrier arm segment 44 to first control shaft 48. Each distal carrier arm segment 44 is pivotally attached on its opposite end to one end of a proximal carrier arm segment 42. The opposite end of each proximal arm segment 42 is fixedly attached to the distal end of outer shaft 36 via ring 38”);
extending the actuator shaft in a distal direction to a maximum length of the actuator shaft relative to the tubular member (par. 0077: “Advancement and retraction of second control shaft 57 changes the diameter of carrier assembly 55, including a fully compacted (minimum diameter) radial state when second control shaft 57 is fully advanced”);
and expanding the first and second expandable members (par. 0079: “Carrier assembly 55 is sized such that it can engage the luminal wall of a pulmonary vein, and carrier assembly 45 is sized and of sufficient flexibility such that it can engage the ostium of a pulmonary vein”).
Kunis does not explicitly teach wherein the expandable members are balloons, wherein the actuator shaft has a plurality of fluid ports. However, in a related art, Taimisto teaches a method for ablation of a pulmonary vein ostium with an anchoring balloon and an ablation balloon that correspond to Kunis’s second carrier assembly and first carrier assembly, respectively (Fig. 9D: anchoring device 110, ablation assembly 108; par. 0030: “the anchoring device 110 includes an expandable-collapsible member 170, such as a balloon;” par. 0032: “The ablation assembly 108 includes an expandable-collapsible member 180, such as a balloon”), and a plurality of fluid ports in an actuator shaft for inflating the balloons (Fig. 7: channel 162 with port 166, channel 160 with port 164; par. 0033: “fluid is conveyed under positive pressure by the pump 130, through the second port 166 and into the lumen 186. The fluid fills the interior lumen 186 of the expandable-collapsible member 180, thereby exerting interior pressure that urges the expandable-collapsible member 180 from its collapsed geometry to its enlarged geometry;” par. 0031: “fluid is conveyed under positive pressure by the pump 130, through the port 164 and into the lumen 176. The fluid fills the interior lumen 176 of the expandable-collapsible member 170, thereby exerting interior pressure that urges the expandable-collapsible member 170 from its collapsed geometry to its enlarged geometry”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one known expandable-collapsible element (balloons as taught in Taimisto) for another (carrier assembly with arms as taught in Kunis), since one of ordinary skill in the art could have performed such a substitution, and the results were predictable, namely, that the method would be capable of controlling the shape of the expandable members using inflation as well as shaft actuation. It would further have been obvious to provide a plurality of fluid ports in the actuator shaft, as taught by Taimisto, for inflating the balloons, as taught by Taimisto.
Kunis further does not teach inflating the first balloon without inflating the second balloon; and inflating the second balloon. However, Taimisto further teaches inflating the first balloon without inflating the second balloon (Fig. 9C: anchoring device 110 inflated without inflating ablation assembly 108), and inflating the second balloon (Fig. 9D: ablation assembly 108 inflated), in order to anchor the ablation device to maintain contact with the ostium (par. 0058: “Because the ablation assembly 108 is secured relative to the ostium 610 by the anchoring device 110, the ablation assembly 108 is maintained contact with the ostium 610, which is constantly moving due to the beating heart”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of the combined reference by inflating the first balloon without inflating the second balloon, and inflating the second balloon, as taught by Taimisto, in order to anchor the ablation device to maintain contact with the ostium, as taught by Taimisto.
Regarding claims 17-18, the combination teaches the method of claim 16 as described previously. Kunis further teaches further comprising the step of increasing a second balloon outer diameter of the second balloon to a maximum outer diameter and decreasing a first balloon outer diameter of the first balloon by retraction of a coupler body relative to the tubular member, and increasing a first balloon outer diameter to a maximum outer diameter by retraction, relative to the tubular member, of the actuator shaft along the longitudinal axis towards the proximal portion of the tubular member (par. 0074: “Advancement and retraction of first control shaft 48 changes the diameter of carrier assembly 45, including a fully compacted (minimal diameter) radial state when first control shaft 48 is fully advanced, and a maximum diameter state when first control shaft 48 is fully retracted;” par. 0077: “Advancement and retraction of second control shaft 57 changes the diameter of carrier assembly 55, including a fully compacted (minimum diameter) radial state when second control shaft 57 is fully advanced, and a maximum diameter state when second control shaft 57 is fully retracted”).
Regarding claim 19, the combination teaches the method of claim 16 as described previously. Kunis teaches the limitations of this claim for the same reasons set forth previously in the rejection of claim 11.
Regarding claim 20, the combination teaches the method of claim 19 as described previously. Kunis further teaches further comprising ablating tissue with the plurality of electrodes (par. 0081: “to initiate energy delivery, such as when first carrier assembly 45 is positioned against a pulmonary vein ostium and ablation catheter 40 is electrically connected to an energy delivery unit”).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kunis in view of Taimisto and further in view of Coughlin et al. (US PGPub No. 2005/0131446), hereinafter Coughlin.
Kunis in view of Taimisto teaches the device of claim 1 as described previously. The combination is silent with respect to the specific method of attaching the balloons to the catheter and does not explicitly teach the use of a nose piece or coupling ring to capture an end of either balloon between the coupling ring and another part of the catheter. However, in an analogous art, Coughlin teaches that using clamp rings is a known mounting method in the balloon catheter art (par. 0019: “balloon 20 can be mounted to catheter 15 with adhesive, and with or without clamp rings, as will be understood to those of skill in the field of balloon catheters”). In light of Coughlin’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use clamp rings (that is, a nose piece or coupling ring, as broadly as claimed) to mount the first and second balloons to the various parts of the catheter of the combined reference, since Coughlin teaches that clamp rings are well known in the balloon catheter art as a mounting mechanism for balloons.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kunis in view of Taimisto and further in view of Laske et al. (US PGPub No. 2013/0197498), hereinafter Laske.
Regarding claim 5, Kunis in view of Taimisto teaches the device of claim 1 as described previously. The combination is silent with respect to the means by which the moving cuff (that is, the coupler body) may be translated along the longitudinal axis and thus does not explicitly teach in which at least one puller wire is connected to the coupler body so that when the at least one puller wire is retracted towards the proximal portion of the tubular member, the slidable coupler translates relative to the actuator shaft. However, in an analogous art, Laske teaches an ablation catheter that uses a puller wire connected to a retractable element so that when the at least one puller wire is retracted towards the proximal portion of the catheter, the retractable element translates relative to the other elements of the catheter (Figs. 2-3: sheath 28 translating relative to fluid injection tube 16 and distal tip 30; par. 0029: “the sheath 28 may be retracted and advanced using pull wires”). To provide the coupling body of the combined reference with a puller wire for retraction and advancement, as suggested by Laske, would have been obvious to one of ordinary skill in the art for the following reasons:
Kunis in view of Taimisto teaches a prior art balloon catheter upon which the claimed invention (having a puller wire connected to the coupler body) can be seen as an “improvement” (the combination is silent with respect to the means of moving the coupler body). Laske teaches a prior art ablation catheter using a known technique that is applicable to the catheter of the combined reference, namely, the technique of using a pull wire for retraction and advancement of a retractable element relative to other elements of the catheter. Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Laske to the catheter of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system where the coupler body is movable during use of the catheter via retraction and advancement with a puller wire.
Regarding claim 6, the combination teaches the device of claim 5 as described previously. It would further have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a second puller wire disposed diametrically to the first puller wire, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kunis in view of Taimisto and further in view of Lenker et al. (US PGPub No. 2018/0289388), hereinafter Lenker.
Kunis in view of Taimisto teaches the device of claim 1 as described previously. The combination does not explicitly teach in which the sealing fit comprises a solid lubricant coating disposed on an outer surface of the actuator shaft or on an inside surface of the coupler body having a thickness greater than a difference of an outside diameter of the actuator shaft and an inside diameter of the coupler body. However, in an analogous art, Lenker teaches a catheter with two elements that slide relative to one another (Fig. 8: outer tube 710, inner tube 720) wherein a solid lubricant coating is disposed on the outer surface of the inner element or the inner surface of the outer element, which facilitates longitudinal movement between the two elements (par. 0142: “Lubricants such as, but not limited to, silicone oil, hydrophilic hydrogels, hydrophilic polyurethane materials, PFA, FEP, or polytetrafluoroethylene (PTFE) coatings can be applied to the inner diameter of the outer tube 710, the outer diameter of the inner tube 720, or both, to decrease sliding friction to facilitate longitudinal relative travel”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a solid lubricant coating on an outer surface of the actuator shaft or an inside surface of the coupler body, as suggested by Lenker, in order to decrease sliding friction and facilitate longitudinal movement between the two elements, as taught by Lenker.
Response to Arguments
Applicant’s arguments, filed 28 May 2026, with respect to the rejection(s) of claim(s) 1 and 16 under 35 U.S.C. 103 have been fully considered. In light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kunis, which teaches wherein the slidable coupler is slidingly engaged to the actuator shaft and is spaced apart from the tubular member.
Applicant's arguments regarding the Kunis reference have been fully considered but they are not persuasive. In response to applicant's argument that the reference fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., wherein the slidable coupler is not attached to a secondary actuator shaft and is not independently actuatable) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the combination of Kunis and Taimisto changes the principle of operation of the primary reference because the combination requires the ring of Kunis to be redesigned for use with balloons, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this instance, since the skilled artisan would have been motivated in light of Taimisto to replace Kunis’s basket structure with balloons, one of ordinary skill in the art would also have been capable of making the necessary modifications for the device of the combined reference to function.
Conclusion
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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