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 .
Response to Arguments
Applicant’s remarks concerning the previous prior art rejections have been fully considered. Although the Examiner respectfully disagrees for the reasons outlined below, the rejections have been updated to incorporate a newly discovered reference which provides a more direct teaching of a helical curve-shaped distal end in a similar delivery catheter, to address the newly amended claim limitations.
Applicant first argues that Goode fails to teach a helical shape because Goode’s curved portion is shown as only lying within a plane, and thus it does not have a component along a helix axis. The Examiner respectfully disagrees. In both FIGS. 3A and 4A of Goode, the straight proximal segment 41 in one plane eventually transitions into a distal curved shape in one or more other planes; at the very least, the transition regions between these segments has both a curvature around an (unlabeled) axis, as well as a component along that axis, i.e. the position along that axis changes with the curve. This is best seen in FIG. 4A, although there is a transition area in 3A as well (as evidenced by the smooth, curved transition between segments, as opposed to an immediate and sharp 90-degree turn). There is thus a helical shape at least in the transition away from the proximal segment 41, since the shape begins to curve around an axis while also continuing to translate along that axis. The shape in these transition area(s) meets the newly added limitations since the helical shape is “continuous” within the boundaries of those areas/regions.
Similarly concerning Williams ‘555, as noted in the rejection, the disclosure at Paras. 29 and 31 that the tip may be “out of plane by as much as approximately 30 degrees” effectively teaches a helical structure since it includes a curvature around an axis while translating along that axis.
Nevertheless, as noted in the first paragraph above, in the interest of more directly addressing the new limitations and avoiding a disagreement over interpretation, the rejections have been updated to incorporate an additional reference which more specifically discusses and shows a helical shape in a similar delivery catheter. Additionally, although not relied upon in any rejections at this time, another newly discovered reference, Lederman, is also cited in this action and explicitly teaches a helical distal portion for a similar delivery catheter (see, e.g., the abstract and FIG. 4).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2020/0298009 A1 to Williams (hereinafter “Williams ‘009”).
Regarding Claim 1, Williams ‘009 teaches a sheath for implanting an electrode in the septum of a human heart (see e.g. abstract, Paras. 2-6, 16), comprising; an elongated sheath shaft (20) which delimits a lumen (26), wherein the sheath shaft has a flexible distal end portion (22), wherein the distal end portion is preshaped into a helical curve such that the distal end potion forms a three-dimensional curve which winds continuously around about a helix axis and thereby also has a component along the helix axis (see e.g. FIGS. 5-6; distal region 22 is helix shaped, with radius 40 extending to the helix axis, and including a component 47 along the axis; see e.g. “helix” in the abstract, Para. 25 and claim 17).
Regarding Claim 5, see e.g. FIGS. 5-6 (angle is less than 340 degrees).
Regarding Claims 9-11, see generally Paras. 2-6, 16, 19, 31.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0010469 A1 to Goode et al. (hereinafter “Goode”) in view of Williams ‘009.
Regarding Claim 1, Goode teaches a sheath for implanting an electrode in the septum of a human heart (see e.g. abstract, Para. 3; the exact location of the implantation is considered a statement of intended use in this apparatus claim, and is thus met by Goode which teaches a sheath that could be used to deliver to a variety of locations in or around the heart), comprising; an elongated sheath shaft (e.g. 300 in FIG. 1C,3A and/or 400 in FIG. 1C,4A) which delimits a lumen (see e.g. FIG. 1C), wherein the sheath shaft has a flexible distal end portion (see Para. 24), wherein the distal end portion is preshaped into a helical curve such that the distal end potion forms a three-dimensional curve which winds continuously around about a helix axis and thereby also has a component along the helix axis (see e.g. FIGS. 3A, 4A: the straight proximal segment 41 in one plane eventually transitions into a distal curved shape in one or more other planes; at the very least, the transition regions between these segments has both a curvature around an (unlabeled) axis, as well as a component along that axis, i.e. the position along that axis changes with the curve. This is best seen in FIG. 4A, although there is a transition area in 3A as well (as evidenced by the smooth, curved transition between segments, as opposed to an immediate and sharp 90-degree turn). There is thus a helical shape at least in the transition away from the proximal segment 41, since the shape begins to curve around an axis while also continuing to translate along that axis).
Further concerning the helix curve/shape, although Goode is considered to teach this limitation as discussed above, attention is further directed to Williams ‘009 who teaches an analogous cardiac delivery catheter including the same claimed helical distal curve shape (see e.g. FIGS. 5-6; distal region 22 is helix shaped, with radius 40 extending to the helix axis, and including a component 47 along the axis; see e.g. “helix” in the abstract, Para. 25 and claim 17). Williams ‘009 teaches that this is advantageous for His bundle stimulation (see e.g. the abstract: “The unique shape of the distal region allows the distal tip be perpendicularly aligned with the septal wall of the right atrium at the His bundle location when the catheter is advanced therein”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Goode to include a helical curve throughout the distal portion, as seen in Williams ‘009, because it would predictably enhance Goode’s ability to treat certain types of conditions.
Regarding Claim 2, Goode further teaches wherein a local radius of the helical curve increases along the sheath shaft from distal to proximal (see e.g. FIGS. 3A-C, 4A-C). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 3, Goode further teaches wherein the local radius increases exponentially from distal to proximal (see e.g. Para. 28: “for example, as illustrated in FIG. 2; according to the exemplary embodiment described above, second curve 432 is compound and has a first radius r41 between approximately 9.4 cm (3.7'') and approximately 10.4 cm (4.1''), a second radius r42 between approximately 5 cm (2'') and approximately 6.1 cm (2.4''), and a third radius r43 between approximately 2.3 cm (0.9'') and approximately 3.3 cm (1.3'')”). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 4, Goode further teaches wherein a local gradient of the helical curve increases from proximal to distal (see e.g. FIGS. 3A, 4A). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 5, Goode further teaches wherein the helical curve winds about a helix axis and thereby passes through an angle of a maximum 340 degrees (see e.g. FIGS. 3A-C, 4A-C). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 6, Goode further teaches wherein the helical curve winds about a helix axis and thereby passes through an angle in the range of 4 rad to 20 rad (see e.g. FIGS. 3A-C, 4A-C). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 7, Goode further teaches wherein the sheath shaft has a soft tip at a distal end (see e.g. Para. 24: “According to some preferred embodiments of the present invention, a stiffness of catheters 300, 400, 500 may vary along a length thereof, such that catheters 300, 400, 500 have an increased flexibility in proximity to tips 350, 450, 550”).
Regarding Claim 8, Goode further teaches wherein the sheath shaft has a stiffness decreasing from proximal to distal (see e.g. Para. 24: “According to some preferred embodiments of the present invention, a stiffness of catheters 300, 400, 500 may vary along a length thereof, such that catheters 300, 400, 500 have an increased flexibility in proximity to tips 350, 450, 550”).
Regarding Claims 9 and 11, Goode teaches the delivery of a pacing electrode to the heart for implantation (see e.g. Paras. 3-6 of Goode), but fails to specify an endocardial introduction via a heart vein to a septum of the heart, and/or His bundle stimulation. Another reference, Williams ‘009, teaches an extremely similar delivery catheter which can be used to deliver a pacing electrode to a septum of the heart via a cardiac vein for His bundle stimulation (see e.g. abstract, Paras. 2-6). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Goode to utilize the delivery route and stimulation target taught by Williams ‘009 because it would predictably provide the advantage of being able to treat those conditions which are best treated by His bundle stimulation.
Regarding Claim 10, Goode further teaches wherein a dilator is initially inserted into the lumen for inserting the sheath, by which means a curvature of the distal end portion is reduced (see e.g. Paras. 21, 23 of Goode). The Examiner further notes that this practice is extraordinarily common for cardiac catheters.
Claims 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0203555 A1 to Williams (hereinafter “Williams ‘555”) (minor note: the publication lists the name as “Williaims” which appears to be a typographical error, as other publications by that same inventor use “Williams” – see the other references by that inventor cited in this and past actions) in view of Williams ‘009.
Regarding Claim 1, Williams ‘555 teaches a sheath for implanting an electrode in the septum of a human heart (see e.g. abstract, Paras. 3-6, 34-35), comprising; an elongated sheath shaft (“delivery catheter” which is referenced as 300, 400) which delimits a lumen (see e.g. FIG. 3, Para. 26), wherein the sheath shaft has a flexible distal end portion (see e.g. FIGS. 4-5, Para. 27: “It should be understood that catheter distal portion 20 has a flexibility allowing deformation”), wherein the distal end portion is preshaped into a helical curve such that the distal end potion forms a three-dimensional curve which winds continuously around about a helix axis and thereby also has a component along the helix axis (see e.g. FIGS. 4-5; see also e.g. Paras. 29,31: the tip may be “out of plane by as much as approximately 30 degrees” effectively teaches a helical structure since it includes a curvature around an axis while translating along that axis).
Further concerning the helix curve/shape, although Williams ‘555 is considered to teach this limitation as discussed above, attention is further directed to Williams ‘009 who teaches an analogous cardiac delivery catheter including the same claimed helical distal curve shape (see e.g. FIGS. 5-6; distal region 22 is helix shaped, with radius 40 extending to the helix axis, and including a component 47 along the axis; see e.g. “helix” in the abstract, Para. 25 and claim 17). Williams ‘009 teaches that this is advantageous for His bundle stimulation (see e.g. the abstract: “The unique shape of the distal region allows the distal tip be perpendicularly aligned with the septal wall of the right atrium at the His bundle location when the catheter is advanced therein”), which is the same desired stimulation target in Williams ‘555. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Williams ‘555 to include a helical curve throughout the distal portion, as seen in Williams ‘009, because it would predictably enhance Williams ‘555’s ability to treat certain types of conditions.
Regarding Claim 2, Williams ‘555 further teaches wherein a local radius of the helical curve increases along the sheath shaft from distal to proximal (see e.g. FIGS. 4-5). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 3, Williams ‘555 further teaches wherein the local radius increases exponentially from distal to proximal (see e.g. FIGS. 4-5). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 4, Williams ‘555 further teaches wherein a local gradient of the helical curve increases from proximal to distal (Paras. 29,31: tip “may be out of plane”). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 5, Williams ‘555 further teaches wherein the helical curve winds about a helix axis and thereby passes through an angle of a maximum 340 degrees (see e.g. FIGS. 4-5). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 6, Williams ‘555 further teaches wherein the helical curve winds about a helix axis and thereby passes through an angle in the range of 4 rad to 20 rad (see e.g. FIGS. 4-5). Furthermore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and shape values for the helix depending on the exact target tissue and pathway to the target. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding Claim 7, Williams ‘555 further teaches wherein the sheath shaft has a soft tip at a distal end (see e.g. Para. 27 and FIGS. 6-14 depicting a reducing stiffness towards the distal end).
Regarding Claim 8, Williams ‘555 further teaches wherein the sheath shaft has a stiffness decreasing from proximal to distal (see e.g. Para. 27 and FIGS. 6-14 depicting a reducing stiffness towards the distal end).
Regarding Claims 9 and 11, Williams ‘555 further teaches using the sheath of claim 1 for delivering a pacing electrode to a septum of the heart via a cardiac vein (see e.g. FIGS. 1-2, Paras. 34-35, 54) for His bundle stimulation (see e.g. abstract, Paras. 2, 5-7)
Claim 10 is also rejected under 35 U.S.C. 103 as being unpatentable over Williams ‘555 in view of Williams ‘009 as applied to claim 9 above, and further in view of Goode.
Regarding Claim 10, Williams ‘555 as modified teaches claim 9 as discussed above, but fails to specifically teach wherein a dilator is initially inserted into the lumen for inserting the sheath, by which means a curvature of the distal end portion is reduced. However, as noted above, Goode teaches this limitation (see e.g. Paras. 21, 23 of Goode). The Examiner further notes that this practice is extraordinarily common for cardiac catheters. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Williams ‘555 such that a dilator is initially inserted into the lumen for inserting the sheath, by which means a curvature of the distal end portion is reduced, as taught in Goode, since this would merely involve adapting a common practice for helping to achieve different shapes of the device during delivery to help navigate body passageways.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2010/0305579 A1 to Williams has many of the same teachings as the Williams ‘555 reference used in the rejections above, and is thus considered relevant for at least the same reasons.
US 2021/0138203 A1 to Lederman explicitly teaches a helical distal portion for a similar delivery catheter (see, e.g., the abstract and FIG. 4).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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