DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claim(s) 24, 26, 27 and 46-55 have been considered but are moot because the new ground of rejection over Starksen et al. US 2005/0065550 in view of Houser US 6936024 and new ground of rejection over Nguyen et al. US 8790367 in view of Houser US 6936024.
Houser teaches a catheter assembly for insertion into the heart, the catheter having a steering mechanism to help deflect the distal tip (column 15, lines 1-27) or alternatively, may provide a feature wherein the catheter is a preformed shape in the distal section for positioning and biasing the catheter within the appropriate heart location and maximize tissue contact (column 15, lines 28-32), and an inflection point distal to the preformed curve (for example, column 6, lines 37-64; figure 2b, distal end of catheter comprises a pigtail 28 or inflection point to facilitate inserting the catheter without damaging surrounding structures or help stabilize the catheter within the heart, alternatively, the curve may consist of a single arc or non-linear geometry, such as a “S” shape, Examiner notes an “S” shape would comprise a first curve and an additional inflection point forming the distal portion of the “S” shape).
Claim Rejections - 35 USC § 103
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.
Claims 24, 26-27, 46 and 50-55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Starksen et al. US 2005/0065550 in view of Houser US 6936024.
Regarding claim 24, 26, 27 and 50-53, Starksen et al. discloses a method for deploying an anchor into tissue of a subject comprising: positioning a guide tunnel within a subvalvular space 552 of a heart of the subject (figure 11, paragraph 0076), the guide tunnel comprising an outer catheter 550, and an inner catheter 556 located within a lumen of the outer catheter (figure 12D; paragraph 0078, within outer catheter 550); positioning a primary anchor deployment catheter 558 within the lumen of the inner catheter (figure 12E, paragraph 0078, advanced through sheath 556), wherein the primary anchor deployment catheter comprises a tubular elongated member having a distal portion comprising a first region defining a first plane, a second region defining a second plane, and a curve between the first and second regions (guide 550 is configured to be placed in the subvalvular space as shown in figure 11, and having a generally flexible distal end having one or more curves or bends toward its distal end to facilitate placement; and subsequently catheters such as the delivery catheter are passed therethrough into the space 552; paragraph 0076, the anchor deployment catheter 558 will curve within and along the outer catheter as shown being advanced within figures 12A, 12E, therefore, the proximal end will have a curve having a first plane, and a second more distal region will have a second plane, each as guided by the outer catheter, a curve extending therebetween, see annotated figure 12D below); and advancing the first region through the guide tunnel and into the tissue (figure 12E, advanced into the tissue through 550, paragraph 0078, 0079); and deploying the anchor disposed within a lumen of the primary anchor deployment catheter into the tissue (anchor delivery device within the tissue space for performing a treatment (paragraph 0079).
Starksen et al. fails to explicitly disclose the first and second planes having a preformed curve between the first and second regions configured to form an angle of about 10 degrees to 90 degrees, of about 20 degrees to 80 degrees, or about 50 degrees to 70 degrees, the preformed curve comprises a first curved region and a second curved region distal to the first curved region, the first curved region forming an arc having a central angle from about 15 degrees to about 270 degrees, or about 45 degrees to about 180 degrees, or about 50 degrees to about 120 degrees, and an inflection point distal to the preformed curve.
Examiner notes that the placement for the anchors within the heart space would require similar flexibility of the outer catheter (paragraph 0077, 0078) and therefore would result in similar angles and curvature of the devices (for example, annotated 12D below shows an acute angle around 45-60 degrees between the first and second planes, placed around the mitral valve leaflets MVL of the heart).
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Houser teaches a catheter assembly for insertion into the heart, the catheter having a steering mechanism to help deflect the distal tip (column 15, lines 1-27) or alternatively, may provide a feature wherein the catheter is a preformed shape in the distal section for positioning and biasing the catheter within the appropriate heart location and maximize tissue contact (column 15, lines 28-32), and teaches an inflection point distal to the preformed curve (for example, column 6, lines 37-64; figure 2b, distal end of catheter comprises a pigtail 28 or inflection point to facilitate inserting the catheter without damaging surrounding structures or help stabilize the catheter within the heart, alternatively, the curve may consist of a single arc or non-linear geometry, such as a “S” shape, Examiner notes an “S” shape would comprise a first curve and an additional inflection point forming the distal portion of the “S” shape).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a preformed curve, as taught by Houser, as a known alternative to a steering mechanism for placement within the appropriate heart location, and having an angle between the first and second planes as claimed since it would have been ‘obvious to try’ to result in the claimed ranges to be placed around the desired location in the heart at the claimed angles of about 10 degrees to 90 degrees, of about 20 degrees to 80 degrees, or about 50 degrees to 70 degrees, the first curved region forming an arc having a central angle from about 15 degrees to about 270 degrees, and having inflection point distal to the preformed curve to optimize the angle positioning choosing from a finite number of identified, predictable solutions or angles, with a reasonable expectations of success and biasing the catheter within the appropriate heart location and maximize tissue contact, and to provide additional stability for the catheter and prevent damaging surrounding tissues during insertion.
Regarding claims 46, 54 and 55, Starksen et al. discloses wherein the guide tunnel is positioned within the subvalvular space of a mitral valve (abstract, paragraph 0076-0077, figure 11), the target tissue being tissue of a mitral valve (figure 1, catheter inserted into the left ventricular against the mitral valve to facilitate anchor delivery, paragraph 0014, 0077) or the left ventricular tissue (paragraph 0010, 0015, devices within a left ventricle, or at intersection of the left ventricle and one or more mitral valve leaflets of the heart).
Claims 24, 26-27 and 46-55 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Nguyen et al. US 8790367 in view of Houser US 6936024.
The applied reference has a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the pre-AIA 35 U.S.C. 102(e) date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
Regarding claim 24, 26, 27, 46 and 50-55, Nguyen et al. discloses a method for deploying an anchor into tissue of a subject comprising: positioning a guide tunnel within a subvalvular space of a heart of the subject (for example, figures 1, 16, 17), the guide tunnel comprising an outer catheter, and an inner catheter located within a lumen of the outer catheter (figure 2, column 5, lines 55-57; tunnel comprises an outer catheter and an inner catheter slidably therein); positioning a primary anchor deployment catheter within the lumen of the inner catheter (figure 2, column 5, lines 58-60; delivery catheter advanced through lumen of tunnel catheter), wherein the primary anchor deployment catheter comprises a tubular elongated member having a distal portion and comprising, a first region defining a first plane (for example, see annotated figure 3C below), a second region defining a second plane (for example, see annotated figure 3C below), and a preformed curve (for example, see annotated figure 3C below) between the first and second regions (column 7, lines 46-50; any of the catheters or guidewires may be pre-formed to provide any suitable number of curves, angles or configurations); wherein the inflection point and preformed curve are configured to orient the anchor for deployment into a target tissue of the heart (placed around mitral valve, figure 3C) advancing the first region through the guide tunnel and into the tissue (figure 2, 3A-3C, column 7, lines 20-35); and deploying the anchor disposed within a lumen of the primary anchor deployment catheter into the tissue (column 7, lines 51-63),wherein the guide tunnel is positioned within the subvalvular space of a mitral valve 106, the target tissue being a mitral valve (for example, figure 1) or left ventricular tissue (figure 1, placed into left ventricle surrounding the mitral valve leaflets).
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Nguyen et al. discloses providing one or more curves or bends toward the distal end for placing the catheter around the mitral valve or in the heart, but fails to explicitly disclose the preformed curve extending between the first and second regions is configured to form an angle of about 10 degrees to 90 degrees, of about 20 degrees to 80 degrees, or about 50 degrees to 70 degrees, the preformed curve comprises a first curved region and a second curved region distal to the first curved region, the first curved region forming an arc having a central angle from about 15 degrees to about 270 degrees, or about 45 degrees to about 180 degrees, or about 50 degrees to about 120 degrees, or an inflection point distal to the preformed curve.
Houser teaches a catheter assembly for insertion into the heart, the catheter having a steering mechanism to help deflect the distal tip (column 15, lines 1-27) or alternatively, may provide a feature wherein the catheter is a preformed shape in the distal section for positioning and biasing the catheter within the appropriate heart location and maximize tissue contact (column 15, lines 28-32), and teaches an inflection point distal to the preformed curve (for example, column 6, lines 37-64; figure 2b, distal end of catheter comprises a pigtail 28 or inflection point to facilitate inserting the catheter without damaging surrounding structures or help stabilize the catheter within the heart, alternatively, the curve may consist of a single arc or non-linear geometry, such as a “S” shape, Examiner notes an “S” shape would comprise a first curve and an additional inflection point forming the distal portion of the “S” shape).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a preformed curve, as taught by Houser, as a known alternative to a steering mechanism for placement within the appropriate heart location to provide additional stability for the catheter and prevent damaging surrounding tissues during insertion, and having an angle between the first and second planes as claimed since it would have been ‘obvious to try’ to result in the claimed ranges to be placed around the desired location in the heart at the claimed angles of about 10 degrees to 90 degrees, of about 20 degrees to 80 degrees, or about 50 degrees to 70 degrees, the first curved region forming an arc having a central angle from about 15 degrees to about 270 degrees, and having inflection point distal to the preformed curve to optimize the angle positioning choosing from a finite number of identified, predictable solutions or angles, with a reasonable expectations of success and biasing the catheter within the appropriate heart location and maximize tissue contact, and to provide additional stability for the catheter and prevent damaging surrounding tissues during insertion.
Regarding claims 47-49, Nguyen et al. discloses a method for deploying an anchor into tissue of a subject comprising: positioning a guide tunnel 148 the outer catheter of the guide tunnel comprises a window, the inner catheter of the guide tunnel comprises a window, and the anchor is deployed through a window of the guide tunnel (column 7, lines 51-63, anchors deployed from openings along the tunnel catheter 148; the tunnel catheter comprising an inner and outer catheter).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
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