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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in PCT/IB2022/058864 on September 20, 2022. It is noted, however, that applicant has not filed a certified copy of the foreign application as required by 37 CFR 1.55.
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.
The factual inquiries 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.
Claim(s) 1-11, and 16-17 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence et al. US 20060069429 A1, herein referred to as Spence, in view of Machold et al. US 20080091264 A1
Regarding claim 1, Spence discloses: a method, comprising: transluminally advancing a vessel-protection device (Fig 3A-C, system of magnetic catheters 64 and 66; [0112]) into a blood vessel ([0112]: "CS catheter 64 can be translated to a different position within the CS 46''); and using a delivery tool (Figs 3A-B, catheter 66).
But does not explicitly discloses the steps of driving an anchor into tissue adjacent the blood vessel while temporarily distancing the blood vessel from the anchor using the vessel-protection device disposed within the blood vessel.
Machold teaches driving an anchor ([0166]: “deployment catheter 24 via the LA catheter 60 is used to position a posterior bridge stop 18 (anchor) and a preferably preattached and predetermined length of bridging element 12 within the great cardiac vein”) into tissue adjacent the blood vessel while temporarily distancing the blood vessel from the anchor (18) using the vessel-protection device (Fig 27, deployment catheter 24) disposed within the blood vessel ([0166]; teaches housed inside delivery catheter).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Spence to incorporate the steps of driving an anchor into tissue adjacent the blood vessel while temporarily distancing the blood vessel from the anchor using the vessel-protection device disposed within the blood vessel, taught and suggested by Machold in order to allow accessibility from outside the body for future positioning (Machold [0166]).
Regarding claim 2, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches further comprising, subsequently to driving the anchor into the tissue (Machold [0166]), removing the vessel-protection device from the blood vessel (Machold [0177]).
Regarding claim 3, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the tissue is tissue of an atrium of a heart (Machold [0178]), and wherein driving the anchor into the tissue comprises using a delivery tool disposed within the atrium to drive the anchor into the tissue (Spence [0113]).
Regarding claim 4, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the tissue is tissue of a ventricle of a heart (Machold [0184]), and wherein driving the anchor into the tissue comprises using a delivery tool disposed within the ventricle to drive the anchor into the tissue (Machold [0184]; needle puncture as taught, also anchors into ventricle).
Regarding claim 5, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein: the anchor is a first anchor of an implant (Spence [0111]; Fig 1A and 1B anchor 60),
and driving the anchor into the tissue comprises driving the first anchor of the implant into the tissue at a first site while distancing the blood vessel from the first anchor using the vessel-protection device disposed within the blood vessel in proximity to the first site (Machold [0166]),
and the method further comprises: subsequently to driving the first anchor into the tissue at the first site (Machold [0166]), moving the vessel-protection device within the blood vessel from being in proximity to the first site to being in proximity to a second site ([0111] Spence teaches a second anchor away from the first site, see Fig 4, anchors 76),
and driving a second anchor of the implant into the tissue at the second site while distancing the blood vessel from the second anchor using the vessel-protection device disposed within the blood vessel in proximity to the second site (Spence [0117] using magnets to distance such those used in the instant application see [0140]).
Regarding claim 6, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the implant is an adjustable implant including a tether (Fig 1A, flexible tensile member 54) coupled to the anchor (Spence Fig 1A), and wherein the method further comprises adjusting the implant by tensioning the tether subsequently to driving the anchor into the tissue (Spence teaches adjusting cable length for positioning and traction of implant into tissue [0021]; Fig 1A-B).
Regarding claim 7, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the tissue is tissue of a annulus of a heart valve (Spence Fig 1a, atrium 12 annulus; [0024]), and the blood vessel is a coronary blood vessel (Spence [0027]) in proximity to the annulus ([0033]), and wherein driving the anchor into the tissue comprises driving the anchor into the annulus (Spence Fig 1A; [0025]).
Regarding claim 8, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 7 teaches wherein the anchor (Spence Fig 5, anchor 76) is an anchor of an annuloplasty implant (Spence Fig 5, tensile member 80, forms a ring around annulus; [0113]), and wherein driving the anchor into the annulus comprises driving the anchor of the annuloplasty implant into the annulus (Spence [0113]).
Regarding claim 9, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein driving the anchor into the tissue comprises driving the anchor into the tissue using a delivery tool while distancing the blood vessel from the anchor by applying a mechanical force using the vessel-protection device disposed within the blood vessel (Spence [0113]).
Regarding claim 10, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 9 teaches protection device includes a deflector (Spence Fig 34G proximal end of 344; [0142]), and wherein applying the mechanical force using the vessel-protection device comprises temporarily pushing a part of the blood vessel away from the tissue using the deflector (Spence [0142]).
Regarding claim 11, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 10 teaches wherein pushing the part of the blood vessel away from the tissue using the deflector comprises pushing the part of the blood vessel away from the tissue by temporarily transitioning the deflector into a deflecting state in which the deflector bulges away from the tissue ([0142] Fig 34G show bulging away of tissue (40 atrial tissue) from deflecting element).
Regarding claim 16, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein: the blood vessel is of a heart (Machold [0178]), the heart has a valve adjacent a chamber (Fig 1a, atrium 12 annulus; [0024]), the valve having a annulus (Fig 1a, atrium 12 annulus; [0024]), the tissue being tissue of a annulus of the valve (Fig 1a, atrium 12 annulus; Spence [0024]), the blood vessel being in proximity to the annulus (Spence[0033]), and driving the anchor into the tissue comprises driving the anchor into the tissue using a delivery tool while distancing the blood vessel via magnetic repulsion using the vessel-protection device disposed within the blood vessel ([0026]).
Regarding claim 17, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 16 teaches wherein distancing the blood vessel via magnetic repulsion comprises distancing the blood vessel via magnetic repulsion between the vessel-protection device disposed within the blood vessel and the anchor disposed within the chamber (Spence [0028]).
Regarding claim 18, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 16 teaches wherein distancing the blood vessel via magnetic repulsion comprises distancing the blood vessel via magnetic repulsion between the vessel-protection device disposed within the blood vessel and the delivery tool disposed within the chamber (Spence [0028-0029]).
Regarding claim 20, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches a method comprising: transluminally advancing a vessel-protection device into a simulated blood vessel (Spence [0112]: “"CS catheter 64 can be translated to a different position within the CS 46'; simulated vessels are used in the form of cadavers or virtual trainings for routine evaluations. Therefore, not posing a patentable distinction in method of use); and using a delivery tool (Machold [0166]: “deployment catheter 24 via the LA catheter 60 is used to position a posterior bridge stop 18 (anchor) and a preferably preattached and predetermined length of bridging element 12 within the great cardiac vein”), driving an anchor into simulated tissue adjacent the simulated blood vessel while temporarily distancing the simulated blood vessel from the anchor using the vessel-protection device disposed within the simulated blood vessel (Machold [0166]; teaches housed inside delivery catheter).
Regarding claim 22, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches a method, for treating a heart of a subject (Spence [0112]), the heart having a chamber and a coronary blood vessel in adjacent the chamber (Spence [0027]), the method comprising: transluminally advancing an anchor driver into the chamber (Machold [0166]: “deployment catheter 24 via the LA catheter 60 is used to position a posterior bridge stop 18 (anchor) and a preferably preattached and predetermined length of bridging element 12 within the great cardiac vein”),
the anchor driver (Machold [0166] driver is catheter 24) including:
a flexible tube (Machold Fig 27, catheter 24), having a distal portion that: has a tube axis (Machold Fig 27), is transluminally advanceable into the chamber (Machold Fig 27), and has a distal opening (Machold Fig 27);
a first magnet (Spence Fig 4, 64a), disposed at the distal portion of the tube (Spence Fig 4),
and having a first magnetic axis that is substantially parallel with the tube axis (Spence Fig 4);
and a rod (Spence Fig 4, 64), disposed within the tube (Spence Fig 4);
transluminally advancing a vessel-protection device into the coronary blood vessel (Spence [0027]),
the vessel-protection device including: a longitudinal member (Spence Fig 4, 46), having a distal portion that has a longitudinal axis and that is transluminally advanceable into the coronary blood vessel (Spence Fig 4; [0027]);
and a second magnet (Spence Fig 4, 66a), disposed at the distal portion of the longitudinal member (Spence Fig 4), and having a second magnetic axis that is substantially orthogonal to the longitudinal axis (in the process of fastening, axes become orthogonal momentarily); bringing the distal portion of the tube, within the chamber (Spence Fig 4), into proximity with the vessel-protection device within the coronary blood vessel (Spence [0027]), such that a magnetic force between the first magnet and the second magnet biases the tube axis toward being parallel with the second magnetic axis (Spence Fig 8c; [0117]); and while the magnetic force continues to bias the tube axis toward being parallel with the second magnetic axis (Spence Fig 8c, parallel with a magnetic axis of the second magnet), driving an anchor out of the distal opening and into tissue of the heart (Spence [0018]; Fig 9).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Machold, and in further view of Saadat et al. US 6051008 A, herein referred to as Saadat.
Regarding claim 12, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 11, but does not disclose wherein: the deflector is biased toward assuming the deflecting state, transluminally advancing the vessel-protection device into the blood vessel comprises transluminally advancing the deflector into the blood vessel while the deflector is constrained in a non-deflecting state, and transitioning the deflector into the deflecting state comprises eliminating the constraint such that the deflector automatically responsively transitions toward the deflecting state.
But Saadat teaches wherein: the deflector is biased toward assuming the deflecting state (bias toward holding shape; Col 15, lines 7-17; Fig 20a, wire or band 186), transluminally advancing the vessel-protection device into the blood vessel comprises transluminally advancing the deflector into the blood vessel while the deflector is constrained in a non-deflecting state (Col 15, lines 7-17), and transitioning the deflector into the deflecting state comprises eliminating the constraint such that the deflector automatically responsively transitions toward the deflecting state (Col 15, lines 7-17).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Spence/Machold to incorporate the steps of wherein: the deflector is biased toward assuming the deflecting state, transluminally advancing the vessel-protection device into the blood vessel comprises transluminally advancing the deflector into the blood vessel while the deflector is constrained in a non-deflecting state, and transitioning the deflector into the deflecting state comprises eliminating the constraint such that the deflector automatically responsively transitions toward the deflecting state, as taught and suggested by Saadat in order to provide stabilization to the distal end of the catheter (Saadat Col 15).
Regarding claim 13, Spence/Machold/Sadaat discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches wherein: the vessel-protection device includes a tether (Saadat Fig 20b 177) that extends proximally from the deflector (Saadat Col 14 lines 52- 67 and Col 15,lines 7-17), and transitioning the deflector into the deflecting state comprises transitioning the deflector into the deflecting state by tensioning the tether (Saadat Col 14 lines 52- 67 and Col 15,lines 7-17).
Regarding claim 14, Spence/Machold/Sadaat discloses the invention substantially as claimed and as discussed above with respect to claim 13 teaches wherein transitioning the deflector into the deflecting state comprises transitioning the deflector into the deflecting state by tensioning the tether such that the deflector curves (Sadaat Col 12 lines 31-41).
Regarding claim 15, Spence/Machold/Sadaat discloses the invention substantially as claimed and as discussed above with respect to claim 13 teaches wherein transitioning the deflector into the deflecting state comprises transitioning the deflector into the deflecting state by tensioning the tether such that the deflector articulates (Col 15, lines 7-17).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Machold, and in further view of taking Official Notice.
Regarding claim 19, Spence/Machold discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose further comprising sterilizing the vessel-protection device, the anchor or the delivery tool.
Examiner takes Official Notice that the limitation sterilization of surgical tools is well known in the art. The advantages of sterilization is limiting risk of infection in patients. Therefore, it would have been obvious at the time of effective filing to have modified Jones in view of Official Notice to have included limitation sterilization in order to lower risk of infection in patients.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
