DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/23/2023 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 1/23/2026.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6-9, 24-26, 29-30, 32-33 & 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (2009/0171274, previously cited) in view of Mullis et al. (5,967,977, previously cited), as evidenced by Clancy Outdoors (previously cited), Viswanathan et al. (2020/0205892, previously cited) and Ditter et al. (2013/0006238, previously cited).
Concerning claim 1, as illustrated in at least Figs. 1-2C, 8A-D & 12, Harlev et al. disclose a medical system comprising a catheter configured to be inserted into a body part of a living subject (system comprising catheter 10; [0048]), and including:
a deflectable element extending along a longitudinal axis from a proximal portion to a distal end (deflection segment 34 couples to distal array segment 36; [0050]);
an expandable distal end assembly disposed distal to the distal end of the deflectable element (deflection segment 34 couples to distal array segment 36; [0050]), and comprising a plurality of splines, a plurality of electrodes disposed on the plurality of splines about the longitudinal axis (splines 50 carry electrodes; [0054]), and configured to expand from a collapsed form to an expanded deployed form (distal array segment 36 can move between a closed and open or deployed state; [0051]), each spline of the plurality of splines comprising flexible strips that are substantially flat across a width (splines 50 are substantially flat across their width) and comprise a portion having a reduced thickness defining a hinge (splines 50 have areas of stiffening layers 120 forming stiffer zones 124 and areas have of reduced thickness at hinged areas 126 that have a thinner cross-sectional area and are formed from less stiffener material than stiffer zones 124; [0085-0092]), and a portion being connected to a distal connector and extending radially between the distal connector and a nose cap (distal end portions of splines 50 form bonding band 70 that is connected to and located radially between plug 74, taken to be the nose cap, and tip electrode 54, taken to be the distal connector; [0069-0070]);
a second irrigation tube disposed in the deflectable element and extending distally from the deflectable element and into the expandable distal end assembly to deliver the irrigation fluid into a region surrounded by the expandable distal end assembly (porous sheath 200 allows introduced fluid from proximal end of catheter 10 into distal array segment 36; [0097]).
Harlev et al. fail to disclose the portion being connected to the distal connector and extending radially between the distal connector and the nose cap to be the hinged portion. However, Harlev et al. teach stiffening layers (120) along the splines (50) creates a non-uniform shape characteristic that results in control of the final deployed shape of the electrode array ([0088], [0093]) and teach an alternative embodiment in Fig. 9A-E, where a portion with reduced thickness (126) forming a curved portion as an alternative to a hinged portion that is directly connected to the distal connector (54) and extending radially between the distal connector (54) and the nose cap (74). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the spline, including the hinge, of Harlev et al. to further comprise the portion being connected to the distal connector and extending radially between the distal connector and the nose cap to be the hinged portion in order to provide the benefit of a creating a desired deployed shape as taught by Harlev et al. ([0088-0093]; Fig. 8A-9D)
Harlev et al. fail to disclose each spline comprising yarn configured to reinforce the hinge. However, Mullis et al. disclose an expandable distal end assembly (60) comprising a plurality of splines (30) each comprising yarn (spider ice line wire formed of the ultra-high molecular weight polyethylene Spectra yarn, as evidenced by Clancy Outdoors), reinforcing the spine along its length except for locations of electrodes (35). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the spline, including the hinge, of Harlev et al. to further comprise yarn configured to reinforce the spline along its length, and thus also along the hinge, in order to provide the benefit of imparting additional strength to the splines as taught by Mullis et al. (Col. 5, ll. 48-57 & Col. 8, ll. 21-31; Fig. 2(a) & 2(c))
Harlev et al. in view of Mullis et al. fail to disclose a proximal electrode disposed on the deflectable element proximate the distal end of the deflectable element adjacent to the expandable distal end assembly, and extending circumferentially around the deflectable element. However, Viswanathan et al. disclose a system comprising a catheter (110/1110) comprising an expandable distal end assembly (1140) on the distal end of a deflectable element (1110) and a proximal electrode (1120) disposed on the deflectable element (1110) proximate the distal end of the deflectable element (1110) adjacent to the expandable distal end assembly (1140), and extending circumferentially around the deflectable element (1110). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Mullis et al. to further comprise a proximal electrode disposed on the deflectable element proximate the distal end of the deflectable element adjacent to the expandable distal end assembly, and extending circumferentially around the deflectable element in order to provide the benefit of delivering a pulse waveform between the proximal electrode and the distal end assembly to ablate tissue and also to have an electrode configured for sensing and/or recording electrophysiology data in place of a mapping catheter as taught by Viswanathan et al. ([0104-0106], [0108-0109]; Fig. 11)
Harlev et al. in view of Mullis et al. and Viswanathan et al. fail to disclose irrigation holes disposed radially about the proximal electrode and longitudinally along the longitudinal axis through which irrigation fluid is configured to be provided thereto; a first irrigation tube disposed in the deflectable element and configured to be in fluid communication with the irrigation holes of the proximal electrode. However, Ditter et al. disclose a medical system (Fig. 1) comprising a catheter (10) having a deflectable element (12) and an electrode (19/AR), the electrode (19/AR) including irrigation holes (69) disposed radially about the electrode (19/AR) and longitudinally along a longitudinal axis of deflectable element (12) (when in a generally straightened position through guiding sheath) through which irrigation fluid is provided thereto and an irrigation tube (59) disposed in the deflectable element (12) and configured to be in fluid communication with the irrigation holes (69) of the proximal electrode (19/AR). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Mullis et al. and Viswanathan et al. such that the proximal electrode includes irrigation holes disposed radially about the proximal electrode and longitudinally along the longitudinal axis through which irrigation fluid is provided thereto and a first irrigation tube disposed in the deflectable element and configured to be in fluid communication with the irrigation holes of the proximal electrode in order to provide the benefit of minimizing charring as taught by Ditter et al. ([0011], [0049-0052], [0076- 0080]; Fig. 2-3 & 13-14)
Concerning claim 6, Ditter et al. further disclose the electrode (19/AR) and the deflectable element (12) define an annular hollow (G) therebetween, the first irrigation tube (59) being coupled to transfer irrigation fluid into the annular hollow (G), the first irrigation tube (59) being in fluid communication with the irrigation holes (69) via the annular hollow (G) ([0077]; Fig. 13-14).
Concerning claim 7, Harlev et al. disclose an ablation power generator configured to be connected to the catheter ([0048]), but fail to disclose the ablation power generator configured to apply an electrical signal between at least one of the plurality of electrodes and the proximal electrode. Viswanathan et al. further disclose an ablation power generator (120) configured to be connected to the catheter (110/1110), and apply an electrical signal between at least one of the plurality of electrodes (1132) and the proximal electrode (1120) ([0105]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. such that the ablation power generator is configured to apply an electrical signal between at least one of the plurality of electrodes and the proximal electrode in order to provide the benefit of delivering a pulse waveform between the proximal electrode and the distal end assembly to ablate tissue as taught by Viswanathan et al. ([0104-0106], [0108-0109]; Fig. 11). Ditter et al. further disclose an irrigation reservoir (inherent) configured to store the irrigation fluid; and a pump (not shown) configured to be connected to the irrigation reservoir and the catheter (10), and to pump the irrigation fluid from the irrigation reservoir through the irrigation holes (100) via the first irrigation tube (59) ([0049], [0076-0080]; Fig. 2 & 13-14).
Concerning claim 8, Viswanathan et al. disclose the ablation power generator is configured to apply the electrical signal between at least one of the plurality of electrodes (1132) and the proximal electrode (1120) to perform electroporation of tissue of the body part ([0058], [0105]; Fig. 1).
Concerning claim 9, Ditter et al. further disclose the electrode (19/AR) and the deflectable element (23) define an annular hollow (G) therebetween, the first irrigation tube (59) being coupled to transfer irrigation fluid into the hollow (G), the first irrigation tube (59) being in fluid communication with the irrigation holes (69) via the hollow (G), the pump (not shown) being configured to pump the irrigation fluid from the irrigation reservoir (inherent) via the first irrigation tube (59) into the annular hollow (G) and out of the irrigation holes (69) ([0049], [0076-0080]; Fig. 2 & 13-14).
Concerning claim 24, Viswanathan et al. fail to disclose the proximal electrode comprises a maximum thickness measured perpendicular to the axis of the deflectable element of at least approximately 0.20 mm to 0.25 mm and an inner diameter in the range of approximately 2 mm to approximately 6 mm. However, Ditter et al. further disclose the electrode (19/AR) comprises a maximum thickness measured perpendicular to the axis of the deflectable element is less than 0.47 mm (outer diameter is about 2.8 mm and inner diameter is about 2.33 mm) and an inner diameter of about 2.33 mm ([0075]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the maximum thickness of the proximal element measured perpendicular to the axis of the deflectable element of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. from approximately between 0 to 0.47 mm to between approximately 0.2 mm to 0.25 mm as Applicant appears to have placed no criticality on the claimed range (“The wall thickness “t” of the proximal electrode 106-1 may have any suitable value, for example, in the range of 0.01 mm to 0.25 mm… The proximal electrode 106-1 or 106-2 may have any suitable wall thickness “t””) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner diameter of the proximal element measured perpendicular to the axis of the deflectable element of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. to an inner diameter in the range of approximately 2 mm to approximately 6 mm as taught by Ditter et al. as Applicant appears to have placed no criticality on the claimed range (“In some embodiments, the proximal electrode 106-1 or 106-2 may have … an inner diameter D in the range of 2 mm to 6 mm.”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 25, while Harlev et al. disclose a position sensor (55) disposed on the distal end assembly ([0055]; Fig. 3A-B), Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. fail to disclose a magnetic position sensor within the deflectable element. However, Ditter et al. further disclose magnetic position sensors within the deflectable distal element (12). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. to further comprise a magnetic position sensor within the deflectable element in order to provide the benefit of determining the position (location and/or orientation) coordinates of the catheter distal end and also possibly the deformation of the distal assembly as taught by Ditter et al. ([0109]). Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. fail to disclose the position sensor at least partially surrounded by the proximal electrode. However, Viswanathan et al. teach the use of a radiopaque marker position sensor at least partially surrounded by the inflatable member to aid an operator in locating and positioning the ablation device, and specifically the expandable distal end assembly ([0087]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. such that the position sensor is at least partially surrounded by the proximal electrode in order to provide benefit of aiding an operator in locating and positioning the ablation device as taught by Viswanathan et al. and specifically in locating and positioning the proximal electrode.
Concerning claim 26, Ditter et al. further disclose the magnetic position sensor is configured to generate signals indicative of a position of the magnetic position sensor in response to one or more magnetic field generator coils positioned external to the living subjection ([0109]).
Concerning claim 29, Mullis et al. further disclose the yarn comprises an ultra-high molecular weight polyethylene yarn, a yarn spun from a liquid-crystal polymer, or both (Col. 8, ll. 21-31).
Concerning claim 30, Mullis et al., as evidenced by Clancy’s Outdoors, further disclose the yarn to be Spectra® an ultra-high molecular weight polyethylene yarn (Col. 8, ll. 21-31). Spectra® is produced with varying linear densities, but Mullis et al., as evidenced by Clancy’s Outdoors, fail to specifically disclose the yarn having a linear density in a range of between 25 denier and 250 denier. Further, Applicant appears to have placed no criticality on the claimed range , indicating simply that “[t]he yarn may be any suitable linear density, for example, in a range between 25 denier and 250 denier.” It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. such that the yarn has a linear density in a range of between 25 denier and 250 denier, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Concerning claim 32, Harlev et al. disclose the hinges (126) are positioned on a distal portion of the distal end assembly (Fig. 8C-E).
Concerning claim 33, Harlev et al. disclose the distal portion of the distal end assembly is covered with an insulating material (92) ([0075-0076]; Fig. 6B)
Concerning claim 36, Harlev et al. disclose the flexible strips are formed from nitinol ([0081]).
Concerning claim 37, Harlev et al. disclose the nitinol (120) comprises the portion having a recessed thickness (126) to form the hinge ([0081], [0085-0092]; Fig. 8B-E & 9B-E).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (2009/0171274, previously cited) in view of Mullis et al. (5,967,977, previously cited), as evidenced by Clancy Outdoors, Viswanathan et al. (2020/0205892, previously cited) and Ditter et al. (2013/0006238, previously cited), as applied to claim 1, in further view of Reid et al. (5,464,437, previously cited).
Concerning claim 27, Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. fail to specifically disclose the first irrigation tube is disposed closer to the outer surface of the deflectable element compared to the second irrigation tube. However, Reid et al. discloses a medical system comprising an expandable distal end assembly (51) configured to expand from a collapsed form to an expanded deployed form and a proximal assembly (63) through which fluid is configured to be provided thereto, where a first irrigation tube (83) provides fluid to the proximal assembly (63) and a second irrigation tube (72) provides fluid to the distal end assembly (51), the first irrigation tube (83) is disposed closer to the outer surface of the deflectable element (32) compared to the second irrigation tube (72) (see Fig. 5 where lumen 83 is disposed closer to right hand side of outer surface of 32 than lumen 72; Col. 4-5, ll. 39-21). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. such that the first irrigation tube is disposed closer to the outer surface of the deflectable element compared to the second irrigation tube as taught by Reid et al., since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (2009/0171274, previously cited) in view of Mullis et al. (5,967,977, previously cited), as evidenced by Clancy Outdoors, Viswanathan et al. (2020/0205892, previously cited) and Ditter et al. (2013/0006238, previously cited), as applied to claim 33, in further view of Danaek et al. (2003/0233099, previously cited).
Concerning claim 34, Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. fail to disclose the insulating material comprises thermoplastic polymer shrink wrap. However, Danaek et al. disclose an expandable distal end assembly (104) comprising a plurality of splines (106) and a plurality of electrodes, the distal portion of the distal end assembly (104) covered with an insulating material (410) that comprises a thermoplastic polymer shrink wrap. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Harlev et al. in view of Mullis et al., Viswanathan et al. and Ditter et al. such that the insulating material comprises thermoplastic polymer shrink wrap in order to provide the benefit of a suitable insulative coating as taught by Danaek et al. ([0123], [0145], [0167]; Fig. 5A, K & O) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Concerning claim 35, the hinge, the yarn, and the insulating material of the modified invention of Harlev et al. in view of Mullis et al., Viswanathan et al., Ditter et al. and Danaek et al. have a combined thickness, but Harlev et al. in view of Mullis et al., Viswanathan et al., Ditter et al. and Danaek et al. fail to disclose the thickness to be 10 to 140 microns. It appears that the device of Harlev et al. in view of Mullis et al., Viswanathan et al., Ditter et al. and Danaek et al. would operate equally well with the claimed thickness. Further, Applicant has not disclosed that the range claimed solves any stated problem or is for any particular purpose, indicating simply that the hinges (including the yarn and covering layers) “may” be within the claimed ranges (Pg. 17). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Harlev et al. in view of Mullis et al., Viswanathan et al., Ditter et al. and Danaek et al. such that the yarn has a thickness of 10 to 140 microns because it appears to be an arbitrary design consideration which fails to patentably distinguish over the modified invention of Harlev et al. in view of Mullis et al., Viswanathan et al., Ditter et al. and Danaek et al.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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