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 Amendment
This office action is in response to the remarks filed on 11/06/2025.
The amendment filed 11/06/2025 has been entered. Claims 1-13, 15-16 and 18-21 remain pending in the application, and claims 14 and 17 are canceled.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: depth adjustment mechanism in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Depth adjustment mechanism: para. [0034] discloses that the corresponding structure is an anchor on the distal end of the depth adjust member, and other structures may include a flexible material and/or a cushion, configured to control the interaction of the anchor with the heart features.
If applicant wishes to provide further explanation or dispute the examiner's interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 20090182360 A1) in view of Griffin (US 20200163767 A1), hereinafter "Griffin", and Bishop et al (US 20230380969 A1, hereinafter "Bishop").
Regarding claim 1, Makower teaches
a visualization catheter (a tissue penetrating catheter device [0011]; providing an image of the surrounding tissue [0050]) comprising a proximal end (proximal end annotated in fig. 2 below), a distal end (distal end annotated in fig. 2 below), and a wall defining an elongate tubular body extending along a longitudinal axis and between the proximal end and the distal end of the visualization catheter (wall extending along the elongate tubular device that longs along the a longitudinal axis depicted below), the visualization catheter further comprising an imaging device (23 [fig. 2]; the active orientation means 23 may be a simple piezoelectric, … could be an array of receivers in relationship to a transmitter for the purposes of providing an image of the surrounding tissue [0050]) coupled to a distal portion of the visualization catheter proximal to the distal most end of the visualization catheter (imaging device 23 is near the distalmost end of the visualization catheter, depicted below);
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Fig. 2 of Makower with annotations
Although Makower discloses an anchor (27 [fig 2]; TVIS sheath 26 may be a sharp tipped or semi-rigid cannula capable of being inserted into the tissue alone [0050]), Makower, however, is silent regarding:
an anchor lumen extending from the proximal end of the visualization catheter, longitudinally through the interior of the visualization catheter, and through an anchor port defined in the wall of the visualization catheter at a location proximal to the distalmost end of the visualization catheter and opening in a radial direction with respect to the longitudinal axis and proximate to the imaging device, and a depth adjustment mechanism translatably disposed within the visualization catheter and configured to align the anchor port with a tissue target based on feedback provided by the imaging device.
Griffin is considered analogous to the instant application as a catheter device is disclosed (abstract). Griffin teaches:
an anchor lumen (lumen 127, with anchor 122 [fig. 11]; [0072]- [0073]) extending from the proximal end of the visualization catheter (proximal end shown in fig. 1 below; para. [0061] discloses the catheter that permits imaging/visualization), longitudinally through the interior of the visualization catheter (lumen 127 extends longitudinally through the interior of the catheter as shown in fig. 1 below), and through an anchor port (at least one side port 115 [0063]) defined in the wall of the visualization catheter at a location proximal to the distal most end of the visualization catheter (anchor port 115 is formed on the wall of catheter, on the proximal end, as shown in fig. 1 below) and opening in a radial direction (Side port 115 has an angle α that is defined as the angle formed between (i) a transverse axis of the catheter, L2, that is orthogonal to the central longitudinal axis of the catheter, L1, and (ii) a central axis of the at least one side port, L3. Each of the above mentioned axes (i.e., L1, L2, and L3) share a common intersection point, P1. [0063]; fig. 1 shows the angle of the side port in a radial direction with respect to the longitudinal axis A1) with respect to the longitudinal axis (longitudinal axis of the catheter, L1 [0063], fig.1) and proximate to the imaging device (anchor is proximate to the imaging device 140, as shown in fig. 1 below) ; and
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Fig. 1 of Griffin reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to include an anchor lumen extending from the proximal end of the visualization catheter, longitudinally through the interior of the visualization catheter, and through an anchor port defined in the wall of the visualization catheter at a location proximal to the distalmost end of the visualization catheter and opening in a radial direction with respect to the longitudinal axis and proximate to the imaging device, as taught by Griffin. Doing so would allow to orient the device in a desired manner within the vein of a subject, as suggested by Griffin ([0055]).
The combined invention still does not teach a depth adjustment mechanism translatably disposed within the visualization catheter and configured align the anchor port with a tissue target based on feedback provided by the imaging device.
Bishop is considered analogous to the instant application as a catheter is disclosed (title). Bishop teaches:
a depth adjustment mechanism (helical tissue anchor [0010], figs. 2F and 2G) translatably disposed (and at least one radially extending first engagement element on the side wall and exposed to the cavity, for engaging the helical tissue anchor; wherein rotation of the helical tissue anchor relative to the tubular body advances the helical tissue anchor distally out of the cavity [0010]; deploying a ventricular anchor from the catheter and into a wall of the left ventricle by rotating a helical tissue anchor into the wall of left ventricle [0045]; helical anchor is translatably disposed in the catheter as it can move back and forth and rotating the helical anchor/depth adjustment mechanism) within the visualization catheter ([0412] discloses that the catheter can be used in imaging systems to confirm location) and configured align the anchor port (the tine guides 124, 128 [0213]; the tine guides 124, 128 can direct the tines 112, 126 … The fabric may be provided with an aperture aligned with the path of the tine [0213]; the tines are additional anchors that go through the anchor ports/tine guides 124 and 128 ) with a tissue target (a helical tissue anchor; and at least one radially extending first engagement element on the side wall and exposed to the cavity, for engaging the helical tissue anchor; wherein rotation of the helical tissue anchor relative to the tubular body advances the helical tissue anchor distally out of the cavity [0010]; deploying a ventricular anchor from the catheter and into a wall of the left ventricle by rotating a helical tissue anchor into the wall of left ventricle [0045]; rotating the helical anchor/depth adjustment mechanism adjust the depth in which the device is in the heart) based on feedback provided by the imaging device ([0412] discloses that the catheter can be used in imaging systems to confirm location).
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Figs. 2F and 2G of Bishop reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower to include a depth adjustment mechanism translatably disposed within the visualization catheter and configured to align the anchor port with a tissue target based on feedback provided by the imaging device, as taught by Bishop. Doing so reduce movement of the device within the heart chamber.
Regarding claim 2, modified Makower teaches the delivery system of claim 1, as discussed above. Makower further teaches wherein the imaging device comprises an ultrasound transducer (23 [fig. 2]; the active orientation means 23 may be a simple piezoelectric, … could be an array of receivers in relationship to a transmitter for the purposes of providing an image of the surrounding tissue [0050]; piezoelectric transmitters are a part of ultrasound transducers as known in the art, also disclosed in [0063]).
Regarding claim 3, modified Makower teaches the delivery system of claim 1, as discussed above. Makower, however, does not teach an elongate member translatably disposed within a lumen of the visualization catheter and configured to align the anchor port with a tissue target based on feedback provided by the imaging device wherein the elongate member includes an anchor at a distal end of the elongate member.
Griffin, however, teaches:
an elongate member translatably disposed within a lumen of the visualization catheter (when retractable and extendable member 120 [0065] figs. 1 and 2) and configured to align the anchor port (a distal end 125 [0072]) with a tissue target (to apply at least one anchor 122 to a portion of a leaflet 202 a, 202 b of a venous valve of a subject so as to anchor at least a portion of the leaflet 202 a, 202 b to a portion of vein wall 201 of the subject. [0064]) based on feedback provided by the imaging device (device 100 may further comprise an imaging system 140 to aid in the positioning of distal end 111 of catheter 110 and/or distal end 125 of retractable and extendable member 120 in sufficient proximity to leaflet 202 a, 202 b of the venous valve of the vein of the subject so as to permit deployment of anchor 122 to at least a portion of leaflet 202 a, 202 b of the venous valve) wherein the elongate member includes an anchor (122 [0064]; fig. 1) at a distal end of the elongate member (distal end shown in fig. 1 below with anchor 122)
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Fig. 1 of Griffin reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to include an elongate member translatably disposed within a lumen of the visualization catheter and configured to align the anchor port with a tissue target based on feedback provided by the imaging device wherein the elongate member includes an anchor at a distal end of the elongate member, as taught by Griffin. Doing so would allow to orient the device in a desired manner within the vein of a subject, as suggested by Griffin ([0055]).
Claims 4-5, 8-13, 15-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 20090182360 A1) in view of Griffin (US 20200163767 A1, hereinafter "Griffin"), Bishop et al (US 20230380969 A1, hereinafter "Bishop"), and Saadat et al. (US 20130023731 A1, of record, hereinafter "Saadat").
Regarding claim 4, modified Makower teaches the delivery system of claim 1, as discussed above. Makower further teaches an expandable member (21) disposed about the visualization catheter (A balloon 21 is provided on TVIS guide catheter 5 for the purpose … stabilizing the catheter within the lumen [0021]; fig. 2 shows the expandable member 21 on surrounding the visualization catheter).
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Fig. 3 of Makower reproduced above
Makower, however does not teach the expandable member comprising a linear configuration wherein the expandable member is flush with the visualization catheter and an expanded configuration wherein the expandable member extends radially from the visualization catheter towards cardiac tissue.
Saadat is considered analogous to the instant application as “Tissue visualization device and method variations” is disclosed (title). Saadat teaches:
the expandable member (78) comprising a linear configuration wherein the expandable member is flush with the visualization catheter (fig. 6a reproduced below shows the expandable member 78 in a flush configuration) and an expanded configuration (figs. 6b and 6c shows the balloons/expandable member in an expanded configuration) wherein the expandable member extends radially from the visualization catheter towards cardiac tissue (To facilitate stabilization of the deployment catheter 16 during a procedure, one or more inflatable balloons or anchors 76 may be positioned along the length of catheter 16, as shown in FIG. 6A. For example, when utilizing a transseptal approach across the atrial septum AS into the left atrium LA, the inflatable balloons 76 may be inflated from a low-profile into their expanded configuration to temporarily anchor or stabilize the catheter 16 position relative to the heart [0105]).
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Figs. 6A-6C of Saadat reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower to include the expandable member comprising a linear configuration wherein the expandable member is flush with the visualization catheter and an expanded configuration wherein the expandable member extends radially from the visualization catheter towards cardiac tissue, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 5, modified Makower teaches the delivery system of claim 4, as discussed above. Makower further teaches wherein the expandable member (21) comprises a balloon (A balloon 21 is provided on TVIS guide catheter 5 for the purpose … stabilizing the catheter within the lumen [0021]; fig. 2 shows the expandable member 21 on surrounding the visualization catheter).
Makower, however, is silent regarding the balloon is coupled to an inflation lumen of the visualization catheter.
Saadat, however, teaches the balloon is coupled to an inflation lumen of the visualization catheter (To facilitate stabilization of the deployment catheter 16 during a procedure, one or more inflatable balloons or anchors 76 may be positioned along the length of catheter 16, as shown in FIG. 6A. For example, when utilizing a transseptal approach across the atrial septum AS into the left atrium LA, the inflatable balloons 76 may be inflated from a low-profile into their expanded configuration to temporarily anchor or stabilize the catheter 16 position relative to the heart [0105]; the balloon is inherently attached to an inflation lumen as it can expand/collapse during the procedure, as shown in figs. 6A-6C).
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Figs. 6A-6C of Saadat reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include the balloon is coupled to an inflation lumen of the visualization catheter, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 8, modified Makower teaches the delivery system of claim 1, as discussed above. Makower further teaches wherein the expandable member is disposed about at least a portion of the imaging device (A balloon 21 is provided on TVIS guide catheter 5 for the purpose … stabilizing the catheter within the lumen [0021]; fig. 2 shows the expandable member 21 on surrounding the visualization catheter/disposed about at least a portion of the imaging device).
Regarding claim 9, modified Makower teaches the delivery system of claim 1, as discussed above. Makower, however, is silent regarding a needle translatably disposed within the anchor lumen and comprising a sharpened distal tip and having a needle lumen extending therethrough; an anchor delivery catheter translatably disposed within the needle lumen; an anchor disposed within the anchor lumen; and a push rod translatably disposed within the anchor delivery catheter proximally of the anchor and configured to advance the anchor through the distal end of the anchor delivery catheter into the tissue target.
Saadat is considered analogous to the instant application as “Tissue visualization device and method variations” is disclosed (title). Saadat teaches:
a needle translatably disposed within the anchor lumen and comprising a sharpened distal tip and having a needle lumen extending therethrough (a therapeutic tool such as needle 328 may be delivered through fluid delivery lumen 324 or in another working lumen and advanced through open area 332 for treating the tissue which is visualized [0145-0146])
an anchor delivery catheter translatably disposed within the needle lumen (FIG. 7C shows an imaging hood 12 having one or more tubular support members 86, e.g., four support members 86 as shown, integrated with the imaging hood 12. The tubular support members 86 may define lumens therethrough each having helical tissue engaging devices 88 positioned within [0109]);
an anchor disposed within the anchor lumen (FIG. 7C shows an imaging hood 12 having one or more tubular support members 86, e.g., four support members 86 as shown, integrated with the imaging hood 12. The tubular support members 86 may define lumens therethrough each having helical tissue engaging devices 88 positioned within [0109]); and
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Fig. 7C of Saadat reproduced above
a push rod translatably disposed within the anchor delivery catheter proximally of the anchor and configured to advance the anchor through the distal end of the anchor delivery catheter into the tissue target (the distal end of the deployment catheter or separate manipulatable catheters may be articulated through various controlling mechanisms such as push-pull wires manually or via computer control [0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower, to include a needle translatably disposed within the anchor lumen and comprising a sharpened distal tip and having a needle lumen extending therethrough; an anchor delivery catheter translatably disposed within the needle lumen; an anchor disposed within the anchor lumen; and a push rod translatably disposed within the anchor delivery catheter proximally of the anchor and configured to advance the anchor through the distal end of the anchor delivery catheter into the tissue target, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 10, modified Makower teaches the delivery system of claim 9, as discussed above. Makower, however, is silent regarding the anchor is one of a plurality of anchors disposed within the anchor lumen, wherein each anchor is coupled to a distal end of one of a plurality of sutures, the proximal end of the sutures extending proximally through the anchor lumen, wherein the visualization catheter is rotatable about the longitudinal axis to direct the anchor port towards a plurality of different tissue targets to embed the plurality of anchors within the different tissue targets, and wherein the delivery system comprises a clamp translatably disposed within a working channel of the visualization catheter and configured to join at least two of the plurality of sutures.
Griffin, however, teaches:
the anchor (122) is one of a plurality of anchors disposed within the anchor lumen (multiple anchors 122 within the anchor lumen 127 as shown in fig. 1 below)
wherein the visualization catheter is rotatable about the longitudinal to direct the anchor port (rotating catheter 110 so as to position distal end 125 of retractable and extendable member 120 in sufficient proximity to the venous valve of vein 200 of the subject so as to permit deployment of at least one anchor 122 to at least a portion of a second leaflet 202 b of the venous valve… the body of catheter 110 may be rotated within the vein by an amount of rotation which is greater than 0 degrees but less than 360 degrees. [0095]) towards a plurality of different tissue targets to embed the plurality of anchors within the different tissue targets (Fig. 2e shows the anchors 122 in different tissue targets; [0091]).
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Fig. 2D of Griffin reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to include the anchor is one of a plurality of anchors disposed within the anchor lumen, and wherein the visualization catheter is rotatable about the longitudinal to direct the anchor port towards a plurality of different tissue targets to embed the plurality of anchors within the different tissue targets, as taught by Griffin. Doing so would allow to orient the device in a desired manner within the vein of a subject, as suggested by Griffin ([0055]).
The combined invention, however, is still silent regarding
wherein each anchor is coupled to a distal end of one of a plurality of sutures, the proximal end of the sutures extending proximally through the anchor lumen, and wherein the delivery system comprises a clamp translatably disposed within a working channel of the visualization catheter and configured to join at least two of the plurality of sutures.
Saadat, first also teaches:
wherein the anchor is one of a plurality of anchors disposed within the anchor lumen, wherein each anchor is coupled to a distal end of one of a plurality of sutures (an imaging hood having a deployable anchor assembly attached to the tissue contact edge and an assembly view of the anchors and the suture or wire connected to the anchors, respectively [0068]).
Saadat further teaches:
wherein each anchor is coupled to a distal end of one of a plurality of sutures, the proximal end of the sutures extending proximally through the anchor lumen (The anchor assembly 450 may be seen as having a plurality of discrete tissue anchors 456, e.g., barbs, hooks, projections, etc., each having a suture retaining end, e.g., an eyelet or opening 458 in a proximal end of the anchors 456. A suture member or wire 452 may be slidingly connected to each anchor 456 through the openings 458 and through a cinching element 454, which may be configured to slide uni-directionally over the suture or wire 452 to approximate each of the anchors 456 towards one another [0164]), and wherein the delivery system comprises a clamp (cinching element 454 [0164]), translatably disposed within a working channel of the visualization catheter and configured to join at least two of the plurality of sutures (A suture member or wire 452 may be slidingly connected to each anchor 456 through the openings 458 and through a cinching element 454, which may be configured to slide uni-directionally over the suture or wire 452 to approximate each of the anchors 456 towards one another [0164]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include wherein each anchor is coupled to a distal end of one of a plurality of sutures, the proximal end of the sutures extending proximally through the anchor lumen, and wherein the delivery system comprises a clamp translatably disposed within a working channel of the visualization catheter and configured to join at least two of the plurality of sutures as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 11, Makower teaches a system for delivering repair components to a cardiac cavity (A device, system and method are provided for utilizing the vascular system as a conduit through which an intervention can be rendered within and beyond the vascular wall [0009]), the system including:
a visualization catheter (providing an image of the surrounding tissue [0050]) comprising:
a proximal end (proximal end annotated in fig. 2 below);
a distal end (distal end annotated in fig. 2 below);
a radially-directed imaging device (orientation detection means 23 permits the proper 360 degree orientation of the distal portion on the TVIS guide catheter S within the lumen of the vessel, in this case cardiac vein 3. This active orientation means 23 can utilize any one but is not limited to one of the following technological schemes: the active orientation means 23 may be a simple piezoelectric…for the purposes of providing an image of the surrounding tissue [0050])… and
a wall defining an elongate tubular body extending along a longitudinal axis and between the proximal end and the distal end of the visualization catheter (wall extending along the elongate tubular device that longs along the a longitudinal axis depicted below)
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Fig. 2 of Makower with annotations
Although Makower discloses and anchor (27 [fig 2]; TVIS sheath 26 may be a sharp tipped or semi-rigid cannula capable of being inserted into the tissue alone [0050]), Makower, however, is silent regarding: [a wall defining an elongate tubular body extending along a longitudinal axis and between the proximal end and the distal end of the visualization catheter] and defining an anchor lumen extending from the proximal end of the visualization catheter longitudinally through the interior of the catheter and toward the distal end of the visualization catheter and transversely to an anchor port opening radially with respect to the longitudinal axis through the wall of the visualization catheter at a location proximal to the distalmost end of the visualization catheter and proximate the radially-directed imaging device; a depth adjustment mechanism translatably disposed within the visualization catheter and configured to align the anchor port with a tissue target based on feedback provided by the imaging device; and an anchor delivery system disposed within the anchor lumen of the visualization catheter and comprising: a hollow needle translatably disposed within the anchor lumen; an anchor delivery catheter translatably disposed within hollow needle; an anchor translatably disposed within the anchor delivery catheter; and an actuator configured to expel the anchor from the anchor delivery catheter through the anchor port at a location proximal to the distal end of the visualization catheter to embed the anchor into tissue.
Griffin is considered analogous to the instant application as a catheter device is disclosed (abstract). Griffin teaches:
a wall … defining an anchor lumen (lumen 127, with anchor 122 [fig. 11]; [0072]- [0073]) extending from the proximal end of the visualization catheter (proximal end shown in fig. 1 below; para. [0061] discloses the catheter that permits imaging/visualization) longitudinally through the interior of the catheter and toward the distal end of the visualization catheter (lumen 127 extends longitudinally through the interior of the catheter as shown in fig. 1 below) and transversely to an anchor port (anchor port 115 is formed on the wall of catheter, on the proximal end, as shown in fig. 1 below) opening radially (Side port 115 has an angle α that is defined as the angle formed between (i) a transverse axis of the catheter, L2, that is orthogonal to the central longitudinal axis of the catheter, L1, and (ii) a central axis of the at least one side port, L3. Each of the above mentioned axes (i.e., L1, L2, and L3) share a common intersection point, P1. [0063]; fig. 1 shows the angle of the side port in a radial direction with respect to the longitudinal axis A1) with respect to the longitudinal axis through the wall of the visualization catheter (longitudinal axis of the catheter, L1 [0063], fig.1) at a location proximal to the distalmost end of the visualization catheter and proximate the radially-directed imaging device (anchor is proximate to the imaging device 140, as shown in fig. 1 below).
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Fig. 1 of Griffin reproduced above
an actuator configured to expel the anchor (lumen 127, with anchor 122 [fig. 11]; [0072]- [0073]) from the anchor delivery catheter through the anchor port at a location proximal to the distal end of the visualization catheter to embed the anchor into tissue (Retractable and extendable member 120 may be actuated (e.g., extended and/or retracted) via an actuating device, such as a thumb slider operatively connected to retractable and extendable member 120 [0073]; allow application anchor deployment mechanism 123 to apply at least one anchor 122 to a portion of a leaflet 202 a, 202 b of a venous valve of a subject [0074]; anchor 122 is actuated in an out of distal end of device to valve/tissue, fig. 1 above depicts the actuating mechanism as shown in fig. 1 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to include a wall defining an anchor lumen extending from the proximal end of the visualization catheter longitudinally through the interior of the catheter and toward the distal end of the visualization catheter and transversely to an anchor port opening radially with respect to the longitudinal axis through the wall of the visualization catheter at a location proximal to the distalmost end of the visualization catheter and proximate the radially-directed imaging device; and an actuator configured to expel the anchor from the anchor delivery catheter through the anchor port at a location proximal to the distal end of the visualization catheter to embed the anchor into tissue, as taught by Griffin. Doing so would allow to orient the device in a desired manner within the vein of a subject, as suggested by Griffin ([0055]).
The combined invention still does not teach: a depth adjustment mechanism translatably disposed within the visualization catheter and configured to align the anchor port with a tissue target based on feedback provided by the imaging device, and an anchor delivery system disposed within the anchor lumen of the visualization catheter and comprising: a hollow needle translatably disposed within the anchor lumen, an anchor delivery catheter translatably disposed within hollow needle, an anchor translatably disposed within the anchor delivery catheter.
Bishop is considered analogous to the instant application as a catheter is disclosed (title). Bishop teaches:
a depth adjustment mechanism (helical tissue anchor [0010], figs. 2F and 2G) translatably disposed (and at least one radially extending first engagement element on the side wall and exposed to the cavity, for engaging the helical tissue anchor; wherein rotation of the helical tissue anchor relative to the tubular body advances the helical tissue anchor distally out of the cavity [0010]; deploying a ventricular anchor from the catheter and into a wall of the left ventricle by rotating a helical tissue anchor into the wall of left ventricle [0045]; helical anchor is translatably disposed in the catheter as it can move back and forth and rotating the helical anchor/depth adjustment mechanism) within the visualization catheter ([0412] discloses that the catheter can be used in imaging systems to confirm location) and configured to align the anchor port (the tine guides 124, 128 [0213]; the tine guides 124, 128 can direct the tines 112, 126 … The fabric may be provided with an aperture aligned with the path of the tine [0213]; the tines are additional anchors that go through the anchor ports/tine guides 124 and 128) with a tissue target (a helical tissue anchor; and at least one radially extending first engagement element on the side wall and exposed to the cavity, for engaging the helical tissue anchor; wherein rotation of the helical tissue anchor relative to the tubular body advances the helical tissue anchor distally out of the cavity [0010]; deploying a ventricular anchor from the catheter and into a wall of the left ventricle by rotating a helical tissue anchor into the wall of left ventricle [0045]; rotating the helical anchor/depth adjustment mechanism adjust the depth in which the device is in the heart) based on feedback provided by the imaging device ([0412] discloses that the catheter can be used in imaging systems to confirm location).
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Figs. 2F and 2G of Bishop reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower to include a depth adjustment mechanism translatably disposed within the visualization catheter and configured align the anchor port with a tissue target based on feedback provided by the imaging device, as taught by Bishop. Doing so reduce movement of the device within the heart chamber.
The combined invention still does not teach: an anchor delivery system disposed within the anchor lumen of the visualization catheter and comprising: a hollow needle translatably disposed within the anchor lumen, an anchor delivery catheter translatably disposed within hollow needle, an anchor translatably disposed within the anchor delivery catheter. Saadat is considered analogous to the instant application as “Tissue visualization device and method variations” is disclosed (title).
Saadat teaches:
an anchor delivery system disposed within the an anchor lumen of the visualization catheter (A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in FIG. 7A, and into imaging hood 12. [0106]) and comprising:
a hollow needle translatably disposed within the anchor lumen (a therapeutic tool such as needle 328 may be delivered through fluid delivery lumen 324 or in another working lumen and advanced through open area 332 for treating the tissue which is visualized [0145-0146]);
an anchor delivery catheter translatably disposed within hollow needle (shows an imaging hood 12 having one or more tubular support members 86, e.g., four support members 86 as shown, integrated with the imaging hood 12. The tubular support members 86 may define lumens therethrough each having helical tissue engaging devices 88 positioned within [0109]);
an anchor translatably disposed within the anchor delivery catheter (an imaging hood having a deployable anchor assembly attached to the tissue contact edge and an assembly view of the anchors and the suture or wire connected to the anchors, respectively [0068]); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include an anchor delivery system disposed within the anchor lumen of the visualization catheter and comprising: a hollow needle translatably disposed within the anchor lumen, an anchor delivery catheter translatably disposed within hollow needle, an anchor translatably disposed within the anchor delivery catheter, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 12, modified Makower teaches the system of claim 11. Makower, however does not teach wherein the visualization catheter further includes a working channel and a clamp tool disposed within the working channel.
Saadat, however teaches the visualization catheter further includes a working channel and a clamp tool disposed within the working channel (The positioning of the tissue engaging device 84 may be locked temporarily relative to the deployment catheter 16 to ensure secure positioning of the imaging hood 12 during a diagnostic or therapeutic procedure within the imaging hood 12 [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include the visualization catheter further includes a working channel and a clamp tool disposed within the working channel, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 13, modified Makower teaches system of claim 12, as discussed above. Although Makower teaches an expandable member comprising a balloon (A balloon 21 is provided on TVIS guide catheter 5 for the purpose … stabilizing the catheter within the lumen [0021]). Makower does not teach [an expandable member comprising a balloon, a spline, a stent, or a combination thereof], having a linear configuration wherein the expandable member lies flush against an external surface of the visualization catheter, and an expanded configuration wherein at least a portion of the expandable member extends radially from the external surface of the visualization catheter.
Saadat, however, teaches an expandable member comprising a balloon (46) having a linear configuration wherein the expandable member lies flush against an external surface of the visualization catheter (one or more inflatable balloons or anchors 76 may be positioned along the length of catheter 16, as shown in FIG. 6A [0105]), and an expanded configuration wherein at least a portion of the expandable member extends radially from the external surface of the visualization catheter (To facilitate stabilization of the deployment catheter 16 during a procedure, one or more inflatable balloons or anchors 76 may be positioned along the length of catheter 16, as shown in FIG. 6A. For example, when utilizing a transseptal approach across the atrial septum AS into the left atrium LA, the inflatable balloons 76 may be inflated from a low-profile into their expanded configuration to temporarily anchor or stabilize the catheter 16 position relative to the heart [0105]).
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Figs. 6A-6C of Saadat reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include an expandable member comprising a balloon having a linear configuration wherein the expandable member lies flush against an external surface of the visualization catheter, and an expanded configuration wherein at least a portion of the expandable member extends radially from the external surface of the visualization catheter, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 15, modified Makower teaches system of claim 11, as discussed above. Makower, however, does not teach wherein the anchor lumen is one of a plurality of anchor lumens, each anchor lumen of the plurality of anchor lumens extending from one of a plurality of ports defined in the wall of the visualization catheter to the proximal end of the visualization catheter.
Saadat, however teaches the anchor lumen is one of a plurality of anchor lumens (86), each anchor lumen of the plurality of anchor lumens extending from one of a plurality of ports defined in the wall (lumens 86 extend from wall of catheter 16) of the visualization catheter to the proximal end of the visualization catheter (Handle assembly 112 may also define one or more instrument ports 130 through which a number of intravascular tools may be passed for tissue manipulation and treatment within imaging hood 12 [0014]; FIG. 7C shows an imaging hood 12 having one or more tubular support members 86, e.g., four support members 86 as shown, integrated with the imaging hood 12. The tubular support members 86 may define lumens therethrough each having helical tissue engaging devices 88 positioned within. When an expanded imaging hood 12 is to be temporarily anchored to the tissue, the helical tissue engaging devices 88 may be urged distally to extend from imaging hood 12 and each may be torqued from its proximal end to engage the underlying tissue [0109]).
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Fig. 7C of Saadat reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to include wherein the anchor lumen is one of a plurality of anchor lumens, each anchor lumen of the plurality of anchor lumens extending from one of a plurality of ports defined in the wall of the visualization catheter to the proximal end of the visualization catheter. Doing so would enhance navigation of the device through a patient body.
Regarding claim 16, modified Makower teaches system of claim 15, as discussed above. Makower, however does not teach wherein the plurality of ports includes at least two ports disposed along a common longitudinal path or along different longitudinal paths or both along the wall of the visualization catheter.
Saadat, however, teaches wherein the plurality of ports includes at least two ports disposed along a common longitudinal path (Handle assembly 112 may also define one or more instrument ports 130 through which a number of intravascular tools may be passed for tissue manipulation and treatment within imaging hood 12 [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower to include wherein the plurality of ports includes at least two ports disposed along a common longitudinal path, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 18, Makower teaches, a method of papillary approximation, the method comprising:
axially advancing a distal portion of a visualization catheter (a tissue penetrating catheter device [0011]; providing an image of the surrounding tissue [0050]) into a heart chamber in a direction along the longitudinal axis of the visualization catheter (fig. 2, reproduced below, shows the visualization catheter advancing along the heart chamber in a direction along the longitudinal axis/length of the catheter), imaging the heart chamber with an imaging device positioned to image the heart chamber laterally (a tissue penetrating catheter device [0011]; providing an image of the surrounding tissue [0050]) with respect to the longitudinal axis of the visualization catheter to identify a first tissue target (the active orientation means 23 may be a simple piezoelectric, … could be an array of receivers in relationship to a transmitter for the purposes of providing an image of the surrounding tissue [0050]);
aligning the anchor (27)… with the first tissue target (The figure shows a TVIS probe 27 being advanced through the TVIS guide catheter 5 through an opening in the cardiac vein 3 to a desired point in the coronary artery 2 [0049]),
wherein the anchor port extends transversely through a wall of the visualization catheter to open in a direction transverse to the longitudinal axis of the visualization catheter and proximal to the distalmost end of the visualization catheter and proximate to the imaging device (27 [fig 2]; TVIS sheath 26 may be a sharp tipped or semi-rigid cannula capable of being inserted into the tissue alone [0050]; anchor 27 is transverse to the longitudinal axis/length of the catheter as shown in fig. 2 below, with the imaging device 23 proximate to the anchor 27);
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Fig. 2 of Makower with annotations
Makower, however, does not teach:
positioning a depth adjustment mechanism translatably disposed within the visualization catheter to adjust a position of an anchor port within the heart chamber; [aligning the anchor port with the first tissue target] by translating the depth adjustment mechanism relative to the visualization catheter, advancing a hollow needle longitudinally through a lumen in the visualization catheter and then in a direction transverse to the longitudinal axis of the visualization catheter to extend out the anchor port and into the first tissue target, forwarding a first anchor through the hollow needle into the first tissue target, the first anchor coupled at a proximal end to a first suture, rotating the visualization catheter, imaging the heart chamber laterally with respect to the longitudinal axis of the visualization catheter to identify a second tissue target, advancing the hollow needle through the port into the second tissue target, forwarding a second anchor through the hollow needle into the second tissue target, the second anchor coupled at a proximal end to a second suture, pulling together the first suture and the second suture to pull the first anchor and first tissue target towards the second anchor and second tissue target to provide a modified heart chamber configuration, and clamping the first suture to the second suture to retain the modified heart chamber configuration.
Griffin is considered analogous to the instant application as a catheter device is disclosed (abstract). Griffin teaches:
an anchor port (distal end 125 [0072]),
aligning the anchor port with the first tissue target by translating the depth adjustment mechanism relative to the visualization catheter (Retractable and extendable member 120 may be actuated (e.g., extended and/or retracted) via an actuating device, such as a thumb slider operatively connected to retractable and extendable member 120 [0073]; allow application anchor deployment mechanism 123 to apply at least one anchor 122 to a portion of a leaflet 202 a, 202 b of a venous valve of a subject [0074]);
rotating the visualization catheter (rotating catheter 110 so as to position distal end 125 of retractable and extendable member 120 in sufficient proximity to the venous valve of vein 200 of the subject so as to permit deployment of at least one anchor 122 to at least a portion of a second leaflet 202 b of the venous valve… the body of catheter 110 may be rotated within the vein by an amount of rotation which is greater than 0 degrees but less than 360 degrees. [0095]);
imaging the heart chamber laterally with respect to the longitudinal axis of the visualization catheter to identify a second tissue target (Fig. 2e shows the anchors 122 in different tissue targets; [0091]; rotating catheter 110 so as to position distal end 125 of retractable and extendable member 120 in sufficient proximity to the venous valve of vein 200 of the subject so as to permit deployment of at least one anchor 122 to at least a portion of a second leaflet 202 b of the venous valve… the body of catheter 110 may be rotated within the vein by an amount of rotation which is greater than 0 degrees but less than 360 degrees. [0095]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to include an anchor port, aligning the anchor port with the first tissue target by translating the depth adjustment mechanism relative to the visualization catheter rotating the visualization catheter, imaging the heart chamber laterally with respect to the longitudinal axis of the visualization catheter to identify a second tissue target, as taught by Griffin. Doing so would allow to orient the device in a desired manner within the vein of a subject, as suggested by Griffin ([0055]).
The combined invention still does not teach: positioning a depth adjustment mechanism translatably disposed within the visualization catheter to adjust a position of an anchor port within the heart chamber; advancing a hollow needle longitudinally through a lumen in the visualization catheter and then in a direction transverse to the longitudinal axis of the visualization catheter to extend out the anchor port and into the first tissue target, forwarding a first anchor through the hollow needle into the first tissue target, the first anchor coupled at a proximal end to a first suture, advancing the hollow needle through the port into the second tissue target, forwarding a second anchor through the hollow needle into the second tissue target, the second anchor coupled at a proximal end to a second suture, pulling together the first suture and the second suture to pull the first anchor and first tissue target towards the second anchor and second tissue target to provide a modified heart chamber configuration, and clamping the first suture to the second suture to retain the modified heart chamber configuration.
Bishop is considered analogous to the instant application as a catheter is disclosed (title). Bishop teaches:
positioning a depth adjustment mechanism (helical tissue anchor [0010], figs. 2F and 2G) translatably disposed (and at least one radially extending first engagement element on the side wall and exposed to the cavity, for engaging the helical tissue anchor; wherein rotation of the helical tissue anchor relative to the tubular body advances the helical tissue anchor distally out of the cavity [0010]; deploying a ventricular anchor from the catheter and into a wall of the left ventricle by rotating a helical tissue anchor into the wall of left ventricle [0045]; helical anchor is translatably disposed in the catheter as it can move back and forth and rotating the helical anchor/depth adjustment mechanism adjust the depth in which the device is in the heart) within the visualization catheter ([0412] discloses that the catheter can be used in imaging systems to confirm location) to adjust a position of an anchor port (the tine guides 124, 128 [0213]; the tine guides 124, 128 can direct the tines 112, 126 … The fabric may be provided with an aperture aligned with the path of the tine [0213]; the tines are additional anchors that go through the anchor ports/tine guides 124 and 128 within the heart chamber (a helical tissue anchor; and at least one radially extending first engagement element on the side wall and exposed to the cavity, for engaging the helical tissue anchor; wherein rotation of the helical tissue anchor relative to the tubular body advances the helical tissue anchor distally out of the cavity [0010]; deploying a ventricular anchor from the catheter and into a wall of the left ventricle by rotating a helical tissue anchor into the wall of left ventricle [0045]; rotating the helical anchor/depth adjustment mechanism adjust the depth in which the device is in the heart).
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Figs. 2F and 2G of Bishop reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower to include positioning a depth adjustment mechanism translatably disposed within the visualization catheter to adjust a position of an anchor port within the heart chamber, as taught by Bishop. Doing so reduce movement of the device within the heart chamber.
The combined invention still does not teach: [advancing a hollow needle longitudinally through a lumen in the visualization catheter and then in a direction transverse to the longitudinal axis of the visualization catheter to extend out the anchor port and into the first tissue target, forwarding a first anchor through the hollow needle into the first tissue target, the first anchor coupled at a proximal end to a first suture, advancing the hollow needle through the port into the second tissue target, forwarding a second anchor through the hollow needle into the second tissue target, the second anchor coupled at a proximal end to a second suture, pulling together the first suture and the second suture to pull the first anchor and first tissue target towards the second anchor and second tissue target to provide a modified heart chamber configuration, and clamping the first suture to the second suture to retain the modified heart chamber configuration.
Saadat is considered analogous to the instant application as “Tissue visualization device and method variations” is disclosed (title). Saadat first also teaches:
advancing a hollow needle longitudinally through a lumen in the visualization catheter and then in a direction transverse to the longitudinal axis of the visualization catheter to extend out the anchor port and into the first tissue target (a therapeutic tool such as needle 328 may be delivered through fluid delivery lumen 324 or in another working lumen and advanced through open area 332 for treating the tissue which is visualized [0145]-[0146]; needle can moved through any open lumen);
forwarding a first anchor through the hollow needle into the first tissue target (shows an imaging hood 12 having one or more tubular support members 86, e.g., four support members 86 as shown, integrated with the imaging hood 12. The tubular support members 86 may define lumens therethrough each having helical tissue engaging devices 88 positioned within [0109]), the first anchor coupled at a proximal end to a first suture (imaging hood having a deployable anchor assembly attached to the tissue contact edge and an assembly view of the anchors and the suture or wire connected to the anchors, respectively [0068])
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Fig. 7C of Saadat reproduced above
advancing the hollow needle through the port into the second tissue target (a therapeutic tool such as needle 328 may be delivered through fluid delivery lumen 324 or in another working lumen and advanced through open area 332 for treating the tissue which is visualized [0145]-[0146]);
forwarding a second anchor through the hollow needle into the second tissue target (shows an imaging hood 12 having one or more tubular support members 86, e.g., four support members 86 as shown, integrated with the imaging hood 12. The tubular support members 86 may define lumens therethrough each having helical tissue engaging devices 88 positioned within [0109]), the second anchor coupled at a proximal end to a second suture (an imaging hood having a deployable anchor assembly attached to the tissue contact edge and an assembly view of the anchors and the suture or wire connected to the anchors, respectively [0068]);
pulling together the first suture and the second suture to pull the first anchor and first tissue target towards the second anchor and second tissue target to provide a modified heart chamber configuration (A suture member or wire 452 may be slidingly connected to each anchor 456 through the openings 458 and through a cinching element 454, which may be configured to slide uni-directionally over the suture or wire 452 to approximate each of the anchors 456 towards one another [0164]); and
clamping the first suture to the second suture to retain the modified heart chamber configuration (A suture member or wire 452 may be slidingly connected to each anchor 456 through the openings 458 and through a cinching element 454, which may be configured to slide uni-directionally over the suture or wire 452 to approximate each of the anchors 456 towards one another [0164]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include advancing a hollow needle longitudinally through a lumen in the visualization catheter and then in a direction transverse to the longitudinal axis of the visualization catheter to extend out the anchor port and into the first tissue target, forwarding a first anchor through the hollow needle into the first tissue target, the first anchor coupled at a proximal end to a first suture, advancing the hollow needle through the port into the second tissue target, forwarding a second anchor through the hollow needle into the second tissue target, the second anchor coupled at a proximal end to a second suture, pulling together the first suture and the second suture to pull the first anchor and first tissue target towards the second anchor and second tissue target to provide a modified heart chamber configuration, and clamping the first suture to the second suture to retain the modified heart chamber configuration, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 19, modified Makower teaches the method of claim 18, as discussed above. Makower, however, does not teach wherein the first anchor is one of a first pair of anchors, the second anchor is one of a second pair of anchors, and the method further includes forwarding the first pair of anchors through a pair of ports into the first tissue target, rotating the visualization catheter, and forwarding the second pair of anchors through the pair of ports into the second tissue target.
Sadaat, however, teaches:
wherein the first anchor is one of a first pair of anchors, the second anchor is one of a second pair of anchors, and the method further includes forwarding the first pair of anchors through a pair of ports into the first tissue target, rotating the visualization catheter, and forwarding the second pair of anchors through the pair of ports into the second tissue target (the imaging hood comprises more than one port where each port can include a different tools; FIG. 30A shows one variation of an angled instrument 360, such as a tissue grasper, … FIG. 30B shows another configuration for an instrument 362 being configured to reconfigure its distal portion into an off-axis configuration within imaging hood 12 [0148]).
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Fig. 30A and 30B reproduced above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include wherein the first anchor is one of a first pair of anchors, the second anchor is one of a second pair of anchors, and the method further includes forwarding the first pair of anchors through a pair of ports into the first tissue target, rotating the visualization catheter, and forwarding the second pair of anchors through the pair of ports into the second tissue target, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 20, modified Makower teaches the method of claim 19, as discussed above. Makower, however does not teach wherein the first anchor is one of a first pair of anchors, the second anchor is one of a second pair of anchors, and the method further includes forwarding the first pair of anchors through a pair of ports into the first tissue target, rotating the visualization catheter, and forwarding the second pair of anchors through the pair of ports into the second tissue target.
Saadat, however, teaches wherein the first anchor is one of a first pair of anchors, the second anchor is one of a second pair of anchors, and the method further includes forwarding the first pair of anchors through a pair of ports into the first tissue target, rotating the visualization catheter, and forwarding the second pair of anchors through the pair of ports into the second tissue target (paras. 0068 and 0176; an imaging hood having a deployable anchor assembly attached to the tissue contact edge and an assembly view of the anchors and the suture or wire connected to the anchors, respectively [0068]; “walking” the catheter along a tissue surface [0176]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combined Makower, to include wherein the first anchor is one of a first pair of anchors, the second anchor is one of a second pair of anchors, and the method further includes forwarding the first pair of anchors through a pair of ports into the first tissue target, rotating the visualization catheter, and forwarding the second pair of anchors through the pair of ports into the second tissue target, as taught by Saadat. Doing so would enhance navigation of the device through a patient body.
Regarding claim 21, modified Makower teaches system of claim 11, as discussed above. Makower, however, teaches the at least one elongate member (26) configured to position and stabilize a distal end of the visualization catheter within the cardiac cavity (fig. 2 and [0049] disclose elongate member 27 with tip 26 used to fix the distal end of the catheter: the TVIS sheath 26 may be a sharp tipped or semi-rigid cannula capable of being inserted into the tissue alone [0050]
Claims 6-7, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 20090182360 A1) in view of Griffin (US 20200163767 A1, hereinafter Griffin), Bishop et al (US 20230380969 A1, hereinafter "Bishop"), and To et al (US Pub No. 2009/0024085).
Regarding claim 6, modified Makower teaches the delivery system of claim 4, as discussed above. Makower however, does not explicitly teach wherein the retention mechanism comprises a plurality of expandable splines.
To, in the same field of endeavor of catheters, teaches retention mechanism comprises a plurality of expandable splines (The sweep member 270 can comprise a tubular structure or a spline or wire that has sufficient column strength to compress as well as rotate the sweep frame 250 [0225]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to incorporate the teachings of To to provide expandable splines. Doing so would help in improving navigation through tortuous anatomy as well as improving transmission of torque generated at the proximal end of the device as taught within To in paragraph [0226].
Regarding claim 7, modified Makower teaches the delivery system of claim 4, as discussed above. Makower, however, does not explicitly teach wherein the retention mechanism comprises an expandable stent.
To, in the same field of endeavor, teaches the retention mechanism comprises an expandable stent (a sweep frame 250 comprising a woven, coiled, braided or laser cut mesh structure similar to that of a vascular stent. The sweep frame 250 structure can comprise a wire or ribbon material having a reinforced section to function as the spine 256. For example, one side of the stent structure sweep frame 250 can be treated via a coating, fixture or any other means to increase a column strength of the section [0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to incorporate the teachings of To to provide expandable stents. Doing so would help in improving navigation through tortuous anatomy as well as improving transmission of torque generated at the proximal end of the device as taught within To in paragraph [0226].
Regarding claim 14, modified Saadat teaches system of claim 11, as discussed above. Makower, however, does not explicitly teach the system further comprising a depth adjustment mechanism translatably disposed within a lumen of the visualization catheter, and configured to extend distally of the visualization catheter to control a depth of the anchor port (paras. [0141] and [0175] discloses limiting depth through the use of a housing/collar).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Makower to incorporate the teachings of To to provide depth adjustment mechanism. Doing so would minimizing collateral tissue damage as taught within To in paragraph [0141].
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant argues on page 8, regarding the 35 U.S.C. 112(f) interpretation of the term “depth adjustment mechanism” in claim 1, that the claims recite sufficient structure, however, the examiner respectfully disagrees as the claims have not been amended to recite any particular structure. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Applicant argues, regarding the 35 USC § 103 rejection of claims 1-3, on page 8 of remarks, are premised upon the assertion that prior art does not teach the newly added limitation to claim 1 regarding “a depth adjustment mechanism translatably disposed within the visualization catheter and configured to align the anchor port with a tissue target based on feedback provided by the imaging device”. The examiner respectfully disagrees. Paragraph [0412] of Bishop discloses using the imaging device to confirm the location of the device within the heart. Paragraph [0045] further discloses adjusting the depth of the anchor within the target tissue. Accordingly, this argument is not persuasive.
Applicant argues, regarding the 35 USC § 103 rejection of claims 11 and 18, on page 9 of remarks, are premised upon the assertion that the claims are allowable for the same reasons as stated above for claim 1. The examiner respectfully disagrees for the reasons stated above.
Applicant argument’s on pages 9-10 regarding the 35 USC 103 rejection of the remaining dependent claims are premised upon the assertion that the dependent claims are allowable due to dependency on an allowable claim. The examiner respectfully disagrees for the reasons stated above.
Conclusion
THIS ACTION IS MADE FINAL. 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 NESHAT BASET whose telephone number is (571)272-5478. The examiner can normally be reached M-F 8:30-17:30 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PASCAL M. BUI-PHO can be reached on (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.B./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798