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 .
Election/Restrictions
Applicant’s election without traverse of Species B (Figures 20-36) in the reply filed on 04/09/2026 is acknowledged.
Claims 16, 19, 35-37, 103, 119 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. It is noted that claims 16, 19, 35-37, 103, 119 recite electrodes for a first cutter 50, second cutter 60, and piercing element of surgical system 10, which are only drawn to nonelected Species A and not to elements in surgical system 110 of elected Species B (see [0095], [0096], [0101], [0103], [0107], [0125], [0127], [0128] of present application publication). Election was made without traverse in the reply filed on 04/09/26.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 34 and 120 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 34, line 2 recites the limitations "the first cutting element" and “the second cutting element”. There is insufficient antecedent basis for these limitations in the claim.
Claim 120, line 2 recites the limitations "the first cutting element" and “the second cutting element”. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2, 11, 13-15, 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer et al., hereinafter “Fischer” (U.S. Pub. No. 2008/0188880).
Regarding claim 2, Fischer discloses a surgical system comprising:
a shaft 33 (Figures 1, 3) having a proximal end, a distal end spaced from the proximal end along a central (longitudinal) axis, and an outer perimeter that extends around the central axis;
a cutting element 14 (Id.) carried by the shaft, the cutting element having a curved cutting edge that extends around a portion of the outer perimeter of the distal end of the shaft (Id.), the curved cutting edge configured to create a curved opening in a leaflet of a valve ([0036]).
Regarding claim 11, Fischer discloses the shaft 33 includes an inner channel that extends from the distal end toward the proximal end (Figure 9; [0039]).
Regarding claim 13, Fischer discloses the curved cutting edge of the cutting element 14 has a C-shape (either half of cutting ring 14 has a C-shape cutting edge; Figure 3).
Regarding claim 14, Fischer discloses the curved cutting edge of the cutting element 14 is further angled along a plane that intersects the central axis (see top cutting edge portion of cutting ring 14 that angles downwards towards hinge 25).
Regarding claim 15, Fischer discloses the curved cutting edge of the cutting element 14 is a sharp element ([0036]).
Regarding claim 41, Fischer discloses the shaft 33 is a first shaft, and further comprising a second shaft 10 or 32 (Figure 3) separate from the first shaft.
Claims 3, 17-18, 21, and 106 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford, III et al., hereinafter “Gifford” (U.S. Patent No. 4,926,858).
Regarding claim 3, Gifford discloses a surgical system, comprising:
a shaft 12/6 (Figures 1-2) having a proximal end and a distal end spaced from the proximal end along a central axis;
a piercing element 4 (col. 4, line 21) configured to puncture a leaflet of a valve; and
a capture element having one or more expandable portions 20 (Figures 2, 4; col. 4, lines 52-61) positioned along the central axis, the one or more expandable portions being configured to expand in order to seize a portion of a leaflet of the valve (20 is capable of seizing a valve leaflet on its proximal side when expanded, just as it is able to engage artery walls or atheroma; Id.).
Regarding claim 17, Gifford discloses the shaft 12/6 has an inner channel (Figure 2), wherein the piercing element 4 is movable between a retracted configuration (col. 4, lines 36-43) where a distal tip of piercing element is located in the inner channel, and a deployed configuration (col. 6, lines 10-13) where the distal tip of the piercing element is located outside of the inner channel.
Regarding claim 18, Gifford discloses a distal tip 5 of piercing element 4 is sharp tip (col. 4, line 21).
Regarding claim 21, Gifford discloses the capture element includes: a. an insertion configuration (Figure 2) where the one or more expandable portions 20 are collapsed toward the central axis, b. an expanded configuration (Figure 4) where the one or more expandable portions 20 are expanded outwardly away from the central axis, and c. a captured configuration where at least a portion of the one or more expandable portions 20 are positioned to seize a portion of the leaflet while in the expanded configuration (when 20 is fully expanded, it is capable of seizing a valve leaflet on its proximal side, just as it is able to engage artery walls or atheroma; Id.).
Regarding claim 106, Gifford discloses the shaft 12/6 is a first shaft, and further comprising a second shaft 10 (Figure 2) separate from the first shaft.
Claims 6, 107, 111, and 118 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford (U.S. Patent No. 4,926,858).
Regarding claim 6, Gifford discloses a surgical system, comprising:
a shaft 12 (Figures 1-2) having a proximal end, a distal end spaced from the proximal end along a central axis, and an outer perimeter the extends around the central axis;
a capture element having one or more expandable portions 20 (Figures 2, 4; col. 4, lines 52-61) positioned along the central axis, the one or more expandable portions being configured to expand in order to seize a portion of a leaflet of the valve (20 is capable of seizing a valve leaflet on its proximal side when expanded, just as it is able to engage artery walls or atheroma; Id.); and
a cutting element 4 (col. 4, line 21) moveable relative to the shaft (col. 4, lines 36-43, col. 6, lines 10-13), the cutting element having a curved cutting edge (cutter 4 has annular cutting edge 5; col. 4, line 21) that extends around a portion of the outer perimeter of the distal end of the shaft, the curved cutting edge configured to create a curved opening in a leaflet of a valve (Id.).
Regarding claim 107, Gifford discloses the shaft 12 is a first shaft, and further comprising a second shaft 10 (Figure 2) separate from the first shaft.
Regarding claim 111, Gifford discloses the capture element includes: a. an insertion configuration (Figure 2) where the one or more expandable portions 20 are collapsed toward the central axis, b. an expanded configuration (Figure 4) where the one or more expandable portions 20 are expanded outwardly away from the central axis, and c. a captured configuration where at least a portion of the one or more expandable portions 20 are positioned to seize a portion of the leaflet while in the expanded configuration (when 20 is fully expanded, it is capable of seizing a valve leaflet on its proximal side, just as it is able to engage artery walls or atheroma; Id.).
Regarding claim 118, Gifford discloses the curved cutting edge 5 of the cutting element 4 is a sharp element (col. 4, line 21).
Claims 7, 30-33, 108, 112, 114, and 120 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paul et al., hereinafter “Paul” (U.S. Pub. No. 2010/0286719)
Regarding claim 7, Paul discloses a surgical system, comprising:
a shaft 1304 (Figure 21, [0119]) having a proximal end and a distal end spaced from the proximal end along a central axis;
a capture element (Figure 12, [0112]) having one or more expandable portions 1274, 1276 ([0119]) positioned along the central axis, the one or more expandable portions being configured to expand in order to seize a portion of a leaflet of the valve (Id.); and
a cutting element having a first cutter 1244 and a second cutter 1246 (Figure 16, [0107]) carried at least partly by the shaft 1304, the first cutter and the second cutter being configured to separate outward away from each other while moving in a proximal direction (and while expanded from a radially compressed configuration) to cut away a portion of the leaflet while the capture element seizes the leaflet of the valve ([0119]).
Regarding claim 30, Paul discloses the shaft 1304 has an inner channel (1304 (Figure 21, [0119]), wherein the first cutter and the second cutter have: a. an insertion configuration, where terminal ends of the first cutter and the second cutter are located inside the inner channel (radially compressed within 1304; Id.), b. a deployed configuration, where terminal ends of the first cutter and the second cutter is located outside of the inner channel (as in Figure 21), and c. a cutting configuration, where the terminal ends of the first cutter and the second cutter are splayed apart with respect to each other (Id. and Figure 16).
Regarding claim 31, Paul discloses the cutting element has at least one actuator 1302 ([0116], [0119]; Figure 21) configured to cause the first cutter 1244 and the second cutter 1246 to transition through the insertion configuration, the deployed configuration, and the cutting configuration (Id.; via advancing/retracting 1302).
Regarding claim 32, Paul discloses the first cutter 1244 and the second cutter 1246 each include a) an elongate shaft (proximal length of valvulotome arms) and b) a cutting hook (such as distal angled surface 1256) that extends from the elongate shaft (Figures 13-14, 17).
Regarding claim 33, Paul discloses the cutting hook 1256 has a curved body and at least one cutting edge (Id.).
Regarding claim 108, Paul discloses the shaft 1304 is a first shaft, and further comprising a second shaft 1302 separate from the first shaft (Figure 21).
Regarding claim 112, Paul discloses the capture element includes: a. an insertion configuration where the one or more expandable portions 1274, 1276 are collapsed toward the central axis (Figure 21; [0119]) b. an expanded configuration (Figure 12) where the one or more expandable portions are expanded outwardly away from the central axis, and c. a captured configuration where at least a portion of the one or more expandable portions are positioned to seize a portion of the leaflet while in the expanded configuration (Id.).
Regarding claim 114, Paul discloses a positioning element 1276 (Figure 12) carried by the shaft 1304 (1274 can be considered as the “one or more expandable portions”, and 1276 can be considered as the “positioning element”; Figure 12, [0112], [0119]) wherein the positioning element is sized and shaped to stabilize the position of a distal end of the shaft relative to tissue (Id.).
Regarding claim 120, Paul discloses in a first mode of operation, the first cutting element (interpreted as referring to first cutter 1244) and the second cutting element (interpreted as referring to second cutter 1246) are configured to advance in tandem (when radially compressed within shaft 1304), and in a second mode of operation, the second cutting element is configured to advance relative to the first cutting element and the shaft (when second cutter 1246 radially expands from a compressed configuration, it advances radially relative to the first cutter 1244 and the shaft 1304).
Claims 10, 109, and 113 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford (U.S. Patent No. 4,926,858).
Regarding claim 10, Gifford discloses a surgical system, comprising:
a shaft 12 (Figures 1-2) having a proximal end and a distal end spaced from the proximal end along a central axis;
a piercing element 4 (col. 4, line 21) configured to puncture a leaflet of a valve; and
a capture element carried by the shaft, the capture element having a distally located expandable portion 20 (Figures 2, 4; col. 4, lines 52-61) and a proximally located fixed collar 6 spaced relative to the expandable portion along the central axis in a proximal direction, wherein the expandable portion is configured to expand in order to seize a portion of a leaflet of the valve with the collar (20 and 6 are capable of seizing a valve leaflet when 20 is expanded and 6 abuts the leaflet, as they are capable of engaging artery walls or atheroma; Id.).
Regarding claim 109, Gifford discloses the shaft 12 is a first shaft, and further comprising a second shaft 10 separate from the first shaft (Figure 2).
Regarding claim 113, Gifford discloses the capture element includes: a. an insertion configuration (Figure 2) where the one or more expandable portions 20 are collapsed toward the central axis, b. an expanded configuration (Figure 4) where the one or more expandable portions 20 are expanded outwardly away from the central axis, and c. a captured configuration where at least a portion of the one or more expandable portions 20 are positioned to seize a portion of the leaflet while in the expanded configuration (when 20 is fully expanded, it is capable of seizing a valve leaflet on its proximal side, just as it is able to engage artery walls or atheroma; Id.).
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.
Claims 6 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Huber (U.S. Pub. No. 2006/0074484) in view of Fischer (U.S. Pub. No. 2008/0188880).
Regarding claim 6, Huber discloses a surgical system, comprising:
a shaft 111 (Figures 11-13; [0095]) having a proximal end, a distal end spaced from the proximal end along a central axis, and an outer perimeter the extends around the central axis;
a capture element having one or more expandable portions 113 ([0096]) positioned along the central axis, the one or more expandable portions being configured to expand in order to seize a portion of a leaflet of the valve; and
a cutting element 116 ([0095]-[0096]).
However, Huber does not disclose the cutter element moveable relative to the shaft, the cutting element having a curved cutting edge that extends around a portion of the outer perimeter of the distal end of the shaft, the curved cutting edge configured to create a curved opening in a leaflet of a valve.
Fischer teaches in Figure 3 and [0036] a cutter element 13 moveable relative to shaft 33, the cutting element having a curved cutting edge that extends around a portion of the outer perimeter of the distal end of the shaft, the curved cutting edge configured to create a curved opening in a leaflet of a valve (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to mofiy Huber with the cutter element being moveable relative to the shaft and having a curved cutting edge as claimed, as taught by Fischer, in order to facilitate cutting a defective heart valve (Id.).
Regarding claim 34, Huber as modified teaches a first mode of operation, the first cutting element and the second cutting element are configured to advance in tandem (Huber, [0095]; first and second cutting elements 115, 116 can be advanced over a guidewire), and in a second mode of operation, the second cutting element is configured to advance relative to the first cutting element and the shaft (Fischer, Figures 3-4, [0010], [0027], [0026]; first and second cutting elements 14, 13 are moveable relative to one another to cut tissue).
Claims 104 and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer (U.S. Pub. No. 2008/0188880), as applied to claim 3 above, in view of Cohen et al., hereinafter “Cohen” (U.S. Pub. No. 2014/0228871).
Regarding claim 104, Fischer discloses the claimed invention, as discussed above, except for further comprising a steering element configured to guide the distal end of the shaft toward a target location of a valve.
Cohen teaches in Figures 12A-14 and [0065], [0072] a steering element (including “steerable joint”) configured to guide a distal end of a shaft toward a target location of a valve.
It would have been obvious to one of ordinary skill before the effective filing date to modify Fischer with a steering element as claimed, as taught by Cohen, since the ability to steer a surgical system in the area of a heart valve enables accurate positioning and guidance as well as minimizes risk of cardiac or vascular injury/perforation during manipulation (Cohen; [0009], [0079]).
Regarding claim 110, Fischer discloses the claimed invention, as discussed above, except for a positioning element carried by the shaft, wherein the positioning element is sized and shaped to stabilize the position of a distal end of the shaft relative to tissue.
Cohen further teaches a positioning element (“stabilizing element” in Figures 12A-14, [0067]) carried by a shaft ([0073]) wherein the positioning element is sized and shaped to stabilize the position of a distal end of the shaft relative to tissue ([0067]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Fischer with a positioning element as claimed, as taught by Cohen, in order to stabilize the distal end of the shaft within the heart to prevent undesired movement for accurate cutting.
Claims 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford (U.S. Patent No. 4,926,858), as applied to claim 6 above, in view of Cohen (U.S. Pub. No. 2014/0228871).
Regarding claims 44-47, Gifford discloses the claimed invention, as discussed above, except for a positioning element carried by the shaft, wherein the positioning element is sized and shaped to stabilize the position of a distal end of the shaft relative to tissue, wherein the positioning element is a slidable tube that extends around the distal end of the shaft, or wherein the positioning element is a hood carried by the distal end of the shaft, or wherein the positioning element is an adjustable loop carried by the distal end of the shaft.
In Figures 12A-14 and [0067] Cohen teaches a positioning element (“stabilizing element”, such as a retractable cage) carried by a shaft ([0073]) wherein the positioning element is sized and shaped to stabilize the position of a distal end of the shaft relative to tissue ([0067]), wherein the positioning element is a slidable tube (the cage is retractable and has a lumen, and therefore can be considered as a slidable tube) that extends around the distal end of the shaft, or wherein the positioning element is a hood (the cage can be considered as a hood) carried by the distal end of the shaft, or wherein the positioning element is an adjustable loop (the circular distal edge of the cage can be considered as a loop, which is adjustable or retracts/expands) carried by the distal end of the shaft.
It would have been obvious to one of ordinary skill before the effective filing date to modify Fischer with a positioning element as claimed, as taught by Cohen, in order to stabilize the distal end of the shaft within the heart to prevent undesired movement for accurate cutting.
Claims 116-117 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford (U.S. Patent No. 4,926,858), as applied to claim 6 above, in view of Fischer (U.S. Pub. No. 2008/0188880).
Regarding claims 116-117, Gifford discloses the claimed invention, as discussed above, except for the curved cutting edge of the cutting element has a C-shape, or wherein the curved cutting edge of the cutting element is further angled along a plane that intersects the central axis.
In Figure 3, Fischer teaches a curved cutting edge of a cutting element 14 has a C-shape (either half of cutting ring 14 has a C-shape cutting edge; Figure 3), and wherein the curved cutting edge of the cutting element 14 is further angled along a plane that intersects the central axis (see top cutting edge portion of cutting ring 14 that angles downwards towards hinge 25).
It would have been obvious to one of ordinary skill before the effective filing date to modify the cutting edge with a C-shape or to be angled as claimed, as taught by Fischer, since doing so would be substitution of one known cutting element for another, which would yield predictable results, namely removing undesired tissue from the body. See MPEP 2143.
Claims 105 and 115 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford (U.S. Patent No. 4,926,858), as applied to claim 10 above, in view of Cohen (U.S. Pub. No. 2014/0228871).
Regarding claim 105, Gifford discloses the claimed invention, as discussed above, except for further comprising a steering element configured to guide the distal end of the shaft toward a target location of a valve.
Cohen teaches in Figures 12A-14 and [0065], [0072] a steering element (including “steerable joint”) configured to guide a distal end of a shaft toward a target location of a valve.
It would have been obvious to one of ordinary skill before the effective filing date to modify Gifford with a steering element as claimed, as taught by Cohen, since the ability to steer a surgical system in the area of a heart valve enables accurate positioning and guidance as well as minimizes risk of cardiac or vascular injury/perforation during manipulation (Cohen; [0009], [0079]).
Regarding claim 115, Gifford discloses the claimed invention, as discussed above, except for a positioning element carried by the shaft, wherein the positioning element is sized and shaped to stabilize the position of a distal end of the shaft relative to tissue.
Cohen further teaches a positioning element (“stabilizing element” in Figures 12A-14, [0067]) carried by a shaft ([0073]) wherein the positioning element is sized and shaped to stabilize the position of a distal end of the shaft relative to tissue ([0067]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Gifford with a positioning element as claimed, as taught by Cohen, in order to stabilize the distal end of the shaft within the heart to prevent undesired movement and for accurate cutting.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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