DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 2, 4-5, 8, 10-11, and 18-22 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Goldfarb et al. (US 2007/0118155, hereinafter “Goldfarb”).
Regarding claim 1, Goldfarb discloses a system for use with a heart of a subject (Fig 1), the system comprising:
a stand (1440), comprising a track (1450/1452) (Figs 78-80; para [0289]); and a catheter system, comprising:
a first handle (1056), mountable on the stand such that the stand supports the first handle; a first catheter (outer guide catheter 1000): shaped to define a first lumen (1018) therealong, having a first-catheter proximal portion (1014) that is coupled to the first handle, and having a first-catheter distal portion (1016) that is transluminally advanceable to the heart (para [0226]) and is steerable by operating the first handle (para [0228-0229]);
a second handle (1057), mountable on the stand proximally from the first-catheter proximal portion in a manner in which the stand supports the second handle (para [0229]); a second catheter (inner guide catheter 1020): shaped to define a second lumen (1028) therealong, having a second-catheter proximal portion (1024) that is coupled to the second handle, having a second-catheter distal portion (1026) that is steerable by operating the second handle (para [0228-0229]), and extendable through the first lumen, such that: the second-catheter proximal portion extends proximally out from the first-catheter proximal portion, and the second-catheter distal portion extends distally out from the first-catheter distal portion (Figs 60, 68, 80; para [0226]);
a third handle (304), slidably mountable on the track proximally from the second-catheter proximal portion (1024) in a manner in which (i) the stand supports the third handle, and (ii) the third handle is slidable along the track axially with respect to the second handle (para [0289]; Fig 80); and a third catheter (delivery catheter 300): shaped to define a third lumen therealong, having a third-catheter proximal portion (322) that is coupled to the third handle (304), and having a third-catheter distal portion (324), slidable through the second lumen while the third-catheter proximal portion extends proximally out from the second-catheter proximal portion (para [0284]).
Regarding claim 2, further comprising a mount (hook 1454) via which the third handle (304) is mountable to the track (Figs 78-80; para [0289]).
Regarding claim 4, wherein the third handle (304) is slidable along the track such that the third-catheter distal portion (324) slides axially with respect to the second-catheter distal portion (1026) (para [0284, 0289]; Figs 78-80).
Regarding claim 5, wherein the second handle (1057) is slidably mountable on the track such that the second handle is slidable along the track axially with respect to the third handle (304) (para [0289]; Figs 78-80).
Regarding claim 8, wherein the second handle (1057) is slidable along the track such that the second-catheter distal portion (1026) slides axially with respect to the first-catheter distal portion (1016) (para [0226, 0281, 0289]; Figs 78-80).
Regarding claim 10, wherein the system further comprises an implant (14) coupled to the third catheter (300), the implant deliverable to the heart using the catheter system (para [0122, 0185, 0282]; Figs 47, 76]).
Regarding claim 11, wherein the implant (14) is coupled to the third-catheter distal portion (324) (para [0122, 0185, 0282]; Figs 47, 76).
Regarding claim 18, wherein: the first handle (1056) comprises a first-catheter steering knob (1300a or 1300b), the first catheter comprises a plurality of first-catheter pull wires (1120) that operatively couple the first-catheter steering knob to the first-catheter distal portion, and the first-catheter steering knob is configured to steer the first-catheter distal portion via the plurality of first-catheter pull wires (para [0264-0267]; Figs 68-71).
Regarding claim 19, wherein: the second handle (1057) comprises a second-catheter steering knob (1300a or 1300b), the second catheter comprises a plurality of second-catheter pull wires (1120) that operatively couple the second-catheter steering knob to the second-catheter distal portion, and the second-catheter steering knob is configured to steer the second-catheter distal portion via the plurality of second-catheter pull wires (para [0264-0267]; Figs 68-71).
Regarding claim 20, wherein: the first-catheter proximal portion (1014) and the second-catheter proximal portion (1024) are coaxial on a longitudinal axis; and the first handle (1056) comprises a tubular portion disposed along the longitudinal axis, the second-catheter proximal portion (1014) extending through and proximally out from the tubular portion (Figs 68-69; para [0226, 0263]).
Regarding claim 21, further comprising a pair of couplings, wherein: in a first state of the catheter system, the second-catheter distal portion is rotatable within the first lumen; and the catheter system is transitionable into a second state in which the pair of couplings lock to each other in a manner that inhibits rotation of the second catheter within the first lumen (para [0230]).
Regarding claim 22, Goldfarb discloses a system for facilitating transluminal access to a heart of a subject (Fig 1), the system comprising:
a first catheter (outer guide catheter 1000) shaped to define a first lumen (1018) therealong, the first catheter comprising: a first-catheter proximal portion (1014), and a steerable first-catheter distal portion (1016) that is transluminally advanceable to the heart (para [0226-0229]);
a second catheter (inner guide catheter 1020) shaped to define a second lumen (1028), the second catheter comprising: a second-catheter proximal portion (1024), a steerable second-catheter distal portion (1026) (para [0228-0229]), and the second catheter is extendable through the first lumen, such that: the second-catheter proximal portion extends proximally out from the first-catheter proximal portion, and the second-catheter distal portion extends distally out from the first-catheter distal portion (Figs 60, 68, 80; para [0226]);
a third catheter (delivery catheter 300) shaped to define a third lumen, the third catheter comprising: a third-catheter proximal portion (322), a third-catheter distal portion (324), advanceable through the second lumen while the third-catheter proximal portion extends proximally out from the second-catheter proximal portion (para [0284]);
a stand (1140), comprising a track (1450/1452) (Figs 78-80; para [0289]);
a first handle (1056), coupled to the first-catheter proximal portion (1016), and mountable on the stand such that the stand supports the first handle (Figs 79-80; para [0289]);
a second handle (1057), coupled to the second-catheter proximal portion (1024), and mountable on the stand such that the stand supports the second handle proximally from the first-catheter proximal portion (Fig 80; para [0289]); and
a third handle (304), coupled to the third-catheter proximal portion (322), and slidably mountable on the track proximally from the second handle, the slidable mounting being such that the third handle is slidable along the track axially with respect to the second handle (para [0289]; Fig 80).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 3, 6-7, and 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldfarb (US 2007/0118155), as applied to claim 1 above, in view of Foley et al. (US 2012/0078080, hereinafter “Foley”). Goldfarb discloses the invention substantially as claimed, as shown above. However, Goldfarb fails to teach the claimed mounts on the stand such that a control knob is actuatable to control sliding of the third handle axially along the track and a control knob that is actuatable to control sliding of the second handle axially along the track. Foley discloses a similar catheter insertion and teaches a catheter stand for remotely controlling the movement of inner and outer catheters. The insertion system comprises a stand (402) comprising a track (404), wherein the catheter is mounted to the track via a sled member (178) which moves along a sled base (400) such that a control knob is actuatable to control sliding of a catheter handle along the track (Fig 23; para [para [0323, 0346-0353]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Goldfarb such that the stand comprised couplings and a control knob for each handle, similar to that taught by Foley, wherein each control knob is actuatable to control sliding of each handle axially along the track for the purpose of providing a user with more precise control when advancing and retracting the first, second, and third catheters during use.
Claims 12-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldfarb (US 2007/0118155), as applied to claim 10 above, in view of Hammer et al. (US 2012/0330410, hereinafter “Hammer”).
Goldfarb discloses the invention substantially as claimed, as shown above, but fails to disclose the implant comprises the annuloplasty structure as claimed. However, Goldfarb does teach “Also, the delivery catheter 300 may be used to deliver other types of devices to a target location within the body, including endoscopic staplers, devices for electrophysiology mapping or ablation, septal defect repair devices, heart valves, annuloplasty rings and others.” (para [0287], emphasis added), wherein the delivery catheter 300 is introduced through other introducers or guiding systems, including the second catheter.
Hammer discloses a similar apparatus for facilitating transluminal access to a heart of fa subject (delivery sheath 104; para [0371-0377]; Fig 8A) and teaches the sheath is used to deliver an annuloplasty structure for the purpose of treating mitral valve regurgitation (Figs 8A- C; para [0381-0384]). Hammer teaches the annuloplasty structure comprises an annuloplasty structure comprising a flexible elongated contracting member (26); a plurality of tissue anchors (38); and an anchor driver (68), configured to anchor the annuloplasty structure by, for each of the tissue anchors sequentially, engaging the tissue anchor, advancing the tissue anchor through the second lumen, and driving the tissue anchor into tissue of the heart (para [0382]); wherein the anchor driver is configured to screw each of the tissue anchors into the tissue (para [0318, 0382]); and further comprising a tool (contracting mechanism 40) that is advanceable through the catheter to the annuloplasty structure in the heart, and to draw the plurality of tissue anchors closer together by tensioning the contracting member (para [0333-0334, 0385, 0418]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Goldfarb such that the delivery catheter 300 was used to deliver the annuloplasty structure taught by Hammer, including a plurality of tissue anchors, anchor driver, and annuloplasty ring as claimed, for the purpose of treating mitral valve regurgitation and since Goldfarb teaches the delivery catheter may be used to deliver annuloplasty rings (para [0287]).
Claims 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goldfarb (US 2007/0118155), as applied to claim 1 above, in view of Rothe et al. (US 2011/0144576, hereinafter “Rothe”).
Goldfarb discloses the invention substantially as claimed, as shown above, including the first-catheter proximal portion (1014) and the second-catheter proximal portion (1024) are coaxial on a longitudinal axis. However, Goldfarb fails to disclose the first handle extends obliquely away from the first-catheter proximal portion at a nonzero angle with respect to the longitudinal axis. Rothe discloses a similar apparatus for facilitating transluminal access to a heart of a subject using steerable catheter system (abstract, para [0009, 0085]). Rothe teaches a handle assembly (50) for controlling articulation of a distal tip (12), distal steerable section (70) and proximal steerable section (68) includes a first handle portion or distal steering control (60) and a second handle portion or proximal steerable control (54) (Figs 6A-C; para[0077-0078]). Rothe teaches the first handle portion is oriented obliquely away from catheter steerable sections at a nonzero angle with respect to the longitudinal axis (Figs 6A-C). Rothe teaches “the design of the catheter handle assembly 50 allows the operator to easily grasp the assembly 50 with a single hand 80, left or right hand, and articulate either or both the proximal steering control 54 and/or the distal steering control 60 with a single finger, e.g., the operator's thumb 82 (although any of the operator's fingers may be utilized alone or in combination as desirable)” (para [0079]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Goldfarb such that the first handle was oriented obliquely away from the first-catheter proximal portion at a nonzero angle with respect to the longitudinal axis, as taught by Rothe, for the purpose of improving the ergonomics of the handle and allowing a user to articulate both steering controls with a single finger.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771