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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/11/2026 has been entered.
Response to Arguments
The rejection of claims 20, 32, 34-47 and 57 under 35 U.S.C. 103 as being obvious over Frantzen et al. (US 5,514,115) in view of Stine et al. (US 6,027,514) has been withdrawn in light of applicant’s amendment made 6/11/2026. Specifically, Stine does not teach wherein an entirety of the distally-facing edge portion faces at least partially in a distal direction, wherein an entirety of the proximally-facing edge portion faces at least partially in a proximal direction opposite to the distal direction, wherein the first end portion and the second end portion are located on opposite sides of a central portion of the curved slot, wherein the first end portion connects the distally-facing edge portion and the proximally-facing edge portion on a first side of the central portion of the curved slot, wherein the second end portion connects the distally-facing edge portion and the proximally-facing edge portion on a second side of the central portion of the curved slot opposite to the first side, as recited in claim 20.
The rejection of claims 38-42, 44-45, 47, 50, 52, 56 and 59-60 under 35 U.S.C. 103 as being obvious over Frantzen et al. (US 5,514,115) in view of Clement (US 5,409,013) has been withdrawn in light of applicant’s amendment made 6/11/2026. Specifically Clement does not disclose wherein the cutting edge defines a non- planar curved path between the first edge region and the second edge region, as recited in claim 38.
Applicant’s arguments with respect to claims 20 and 38 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added references Cannon et al. (US 2018/0228476 A1) and Peterson (US 2019/0038460 A1) teach said limitations.
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.
Claim(s) 20, 32, 34-37 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frantzen et al. (US 5,514,115) in view of Cannon et al. (US 2018/0228476 A1).
Regarding claim 20, Frantzen discloses a cutting tool (atherectomy catheter 10; Figs. 1-2) capable of modifying a valvular structure (as atherectomy catheters are sized to fit within arteries and blood vessels), comprising: an outer shaft (including at least cable 28 and cutter head assembly 12) having a circumferential wall (circumferential wall of 12) with a curved slot (side opening or window 18; Fig. 2) therein; an inner shaft (flexible cable drive shaft 21) disposed within and movable with respect to the outer shaft (as the cutting blade 19 is moved both longitudinally and rotationally via the flexible cable drive shaft 21; column 6, lines 1-9), the inner shaft having a blade member (cutting blade 19) with a cutting edge (edge of 19); and a nosecone (nose cone 30) having a proximal end that abuts a distal end of the outer shaft (as the proximal end of 30 abuts the distal end of 12; Fig. 2), wherein the curved slot (18) is constructed to receive therein a portion of a leaflet of the valvular structure (as the device is sized to fit within an artery wall; therefore, capable of receiving a leaflet), and the blade member (19) is constructed to cut the leaflet in the curved slot by moving with respect to the outer shaft (as the cutting blade 19 may cut a leaflet similar to stenotic material; column 6, lines 13-16). Frantzen discloses wherein the curved slot (18) is at least partially defined by a slot perimeter comprising a distally-facing edge portion (edge at proximal end of 18) and a proximally-facing edge portion (edge at distal end of 18) that faces the distally-facing edge portion (Fig. 2), a first end portion (one lateral side of 18), a second end portion (opposing lateral side of 18), and a central portion between the first end portion and the second end portion (Fig. 2), wherein the proximally-facing edge portion (edge at distal end of 18) extends distally from the first end portion to a distal-most location on a central portion of the proximally-facing edge bounding the central portion of the curved slot and further extends proximally from the distal-most location of the proximally-facing edge portion to the second end portion (due to the distal taper of the edge at the distal end of 18; Fig. 2), wherein the distal-most location on the central portion of the proximally-facing edge portion is distal to a distal-most location on the central portion of the distally-facing edge portion (Fig. 2).
Frantzen fails to disclose wherein an entirety of the distally-facing edge portion faces at least partially in a distal direction, wherein an entirety of the proximally-facing edge portion faces at least partially in a proximal direction opposite to the distal direction, wherein the first end portion and the second end portion are located on opposite sides of a central portion of the curved slot, wherein the first end portion connects the distally-facing edge portion and the proximally-facing edge portion on a first side of the central portion of the curved slot, wherein the second end portion connects the distally-facing edge portion and the proximally-facing edge portion on a second side of the central portion of the curved slot opposite to the first side, wherein the distally-facing edge portion extends distally from the first end portion to a distal-most location on a central portion of the distally-facing edge portion bounding the central portion of the curved slot and further extends proximally from the distal-most location of the distally-facing edge portion to the second end portion, wherein the distal-most location on the central portion of the distally-facing edge portion is distal to each of the first end portion and the second end portion.
However, Cannon teaches a cutting tool (cannula 104) comprising: an outer shaft (body of 104) having a circumferential wall (Fig. 1) with a curved slot (side notch 120) therein (Fig. 1), wherein the curved slot (120) is at least partially defined by a slot perimeter (Fig. 1) comprising a distally-facing edge portion (surface between reference numbers 126 and 122 when viewing Fig. 1C), a proximally-facing edge portion (surface between reference numbers 126 and 124 when viewing Fig. 1C) that faces the distally-facing edge portion (Fig. 1C), a first end portion (portion connecting the distally-facing edge portion and the proximally-facing edge portion on a side of the cannula 104 i.e., where reference number 126 is when viewing Figs. 1A and 1C), and a second end portion (portion connecting the distally-facing edge portion and the proximally-facing edge portion of the opposing side of the cannula 104; Fig. 1A), wherein an entirety of the distally-facing edge portion faces at least partially in a distal direction (Fig. 1C), wherein an entirety of the proximally-facing edge portion faces at least partially in a proximal direction opposite to the distal direction (Fig. 1C), wherein the first end portion and the second end portion are located on opposite sides of a central portion of the curved slot (Fig. 1A), wherein the first end portion connects the distally-facing edge portion and the proximally-facing edge portion on a first side of the central portion of the curved slot (Figs. 1A, 1C), wherein the second end portion connects the distally-facing edge portion and the proximally-facing edge portion on a second side of the central portion of the curved slot opposite to the first side (Fig. 1A), wherein the distally-facing edge portion extends distally from the first end portion to a distal-most location (at reference number 122 when viewing Fig. 1A) on a central portion of the distally-facing edge portion bounding the central portion of the curved slot and further extends proximally from the distal-most location of the distally-facing edge portion to the second end portion (Fig. 1A), wherein the proximally-facing edge portion extends distally from the first end portion to a distal-most location (at reference number 124 when viewing Fig. 1A) on a central portion of the proximally-facing edge portion bounding the central portion of the curved slot and further extends proximally from the distal-most location of the proximally-facing edge portion to the second end portion (Fig. 1A), wherein the distal-most location on the central portion of the proximally-facing edge portion is distal to the distal-most location on the central portion of the distally-facing edge portion (Fig. 1A), wherein the distal-most location on the central portion of the distally-facing edge portion is distal to each of the first end portion and the second end portion (Figs. 1A, 1C), wherein the curved slot (120) is constructed to receive therein a portion of a leaflet of the valvular structure (as the cannula 104 and slot 120 are sized to fit within arteries and blood vessels; [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the curved slot of Frantzen to be the shape taught by Cannon, as claimed. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of having a cutting slot able to cut tissue.
Regarding claim 32, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the blade member (19) is configured to cut the leaflet by moving along an axial direction of the outer shaft, by rotating about a central axis of the blade member, or both (as the cutting blade 19 is moved both longitudinally and rotationally via the flexible cable drive shaft 21; column 6, lines 1-9).
Regarding claim 34, Frantzen modified discloses wherein the curved slot has a crescent-shaped profile (Figs. 1A, 1C of Cannon).
Regrading claim 35, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the cutting edge of the blade member (19) has a profile that matches the profile of the curved slot (as the circular profile of 19 slides and fits within the circular profile of 12; Fig. 2; similar to the circular profile of cannula 104 of Cannon).
Regarding claim 36, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the outer shaft (18, 12) comprises a capsule portion (12) with a diameter that is larger than a portion of the outer shaft proximal to the capsule portion (28; Fig. 2), wherein the blade member (19) has a diameter that is larger than a portion of the inner shaft proximal to the blade member (21; Fig. 2), and wherein the blade member (19) is configured to translate axially within the capsule portion to cut the leaflet (as the cutting blade 19 is moved both longitudinally and rotationally via the flexible cable drive shaft 21; column 6, lines 1-9).
Regarding claim 37, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the cutting tool (10) is configured to retain a severed portion of the leaflet within the capsule portion (12) after the leaflet is cut (as tissue may be retained between the cutting blade 19 and the distal portion of the cutter head assembly 12 within the inner chamber 20; Fig. 2).
Regarding claim 57, Frantzen modified discloses wherein a width of the curved slot (120 of Cannon), as measured in a direction parallel to an axial direction of the outer shaft from the proximally-facing edge portion to the distally-facing edge portion, increases from a portion of the curved slot bounded by the first end portion of the slot perimeter to the central portion of the curved slot and narrows from the central portion of the curved slot bounded by to the second end portion of the slot perimeter (Figs. 1A, 1C of Cannon).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frantzen et al. (US 5,514,115) in view of Cannon et al. (US 2018/0228476 A1), as applied to claim 20 above, and further in view of Styrc Mikolaj Witold (FR 2,903,292).
Regarding claim 33, Frantzen modified fails to disclose wherein the blade member has a sidewall disposed so as to block the curved slot after the blade member is displaced distal of the curved slot to perform the cutting of the leaflet.
However, Witold teaches a cutting tool (tool 10; Fig. 1) for cutting valve leaflets (leaflets 80A-80C; Fig. 5), comprising an outer shaft (cylindrical body 32) having a circumferential wall with a curved slot (transverse notch 34) therein; an inner shaft (internal linkage 72) disposed within and movable with respect to the outer shaft (page 4, paragraph 1 of the translation), the inner shaft having a blade member (blade 36; Fig. 5), wherein the blade member (36) has a sidewall (outer edge 62) disposed so as to block the curved slot (34) after the blade member is displaced distal of the curved slot to perform the cutting of the leaflet (when blade 36 reaches passage slot 54; Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blade member and/or curved slot of modified Frantzen such that the blade member has a sidewall disposed so as to block the curved slot after the blade member is displaced distal of the curved slot to perform the cutting of the leaflet as taught by Witold in order to prevent additional tissue from entering the window after the blade member has moved to the distal cutting position.
Claim(s) 38-42, 44-45, 47, 50, 52, 56 and 59-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frantzen et al. (US 5,514,115) in view of Peterson (US 2019/0038460 A1).
Regarding claim 38, Frantzen discloses a cutting tool (atherectomy catheter 10; Figs. 1-2) capable of modifying a valvular structure (as atherectomy catheters are sized to fit within arteries and blood vessels), comprising: an outer shaft (including at least cable 28 and cutter head assembly 12) defining an outer shaft opening (window 18); and an inner shaft (flexible cable drive shaft 21) disposed within and movable relative to the outer shaft along an axial direction (as the cutting blade 19 is moved both longitudinally and rotationally via the flexible cable drive shaft 21; column 6, lines 1-9) and comprising a distally-facing cutting edge (cutting blade 19), wherein the outer shaft opening (18) is configured to receive therein a portion of a leaflet of the valvular structure (as the device is sized to fit within an artery wall; therefore, capable of receiving a leaflet), and wherein the cutting tool (10) is configured to modify the leaflet by moving the inner shaft (21) relative to the outer shaft (28, 12) to cut the leaflet with the cutting edge while the leaflet extends within the outer shaft opening (as the cutting blade 19 may cut a leaflet similar to stenotic material; column 6, lines 13-16), wherein the cutting edge comprises a first edge region (one lateral side of slot), a second edge region (opposing lateral side of slot), and a central edge region located between the first edge region and the second edge region (mid-point between lateral sides of slot), and wherein the cutting edge defines a curved path between the first edge region and the second edge region (Fig. 2).
Frantzen fails to disclose wherein the cutting edge extends distally from the first edge region to a distal-most edge location in the central edge region and further extends proximally from the distal-most edge location to the second edge region, and wherein the cutting edge defines a non-planar curved path between the first edge region and the second edge region.
However, Peterson teaches a cutting tool (aspirating cutter 110; Fig. 10) comprising: an outer shaft (outer tube 118; Fig. 6) defining an outer shaft opening (port 134); and an inner shaft (inner tube 122b; Fig. 8) disposed within and movable relative to the outer shaft along an axial direction (Fig. 10) and comprising a distally-facing cutting edge (inner edge 132b) wherein the cutting edge comprises a first edge region, a second edge region, and a central edge region located between the first edge region and the second edge region, wherein the cutting edge extends distally from the first edge region to a distal-most edge location in the central edge region and further extends proximally from the distal-most edge location to the second edge region, and wherein the cutting edge defines a non- planar curved path between the first edge region and the second edge region (see annotated Fig. 8 of Peterson below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the distally-facing cutting edge of Frantzen to be the shape taught by Peterson, as claimed. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of having a cutting edge able to cut tissue.
Regarding claim 39, Frantzen modified discloses wherein the cutting edge comprises one or more of a sharp edge (including at least inner edge 132b and edge 160; Fig. 8 of Peterson) of the inner shaft (122b of Peterson), a serrated edge of the inner shaft, or a blade disposed at a circumferential edge of the inner shaft (Fig. 8 of Peterson).
Regarding claim 40, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the outer shaft (28, 12) comprises a pair of opposed edges (opposed edges of 18) that at least partially define the outer shaft opening (18) therebetween (Fig. 2), and wherein the cutting tool (10) is configured to cut the leaflet with the cutting edge while the leaflet engages one of the pair of opposed edges (as the cutting blade 19 may cut a leaflet against the distal edge of 18 similar to stenotic material; column 6, lines 13-16).
Regarding claim 41, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the cutting tool (10) is configured to retain a severed portion of the leaflet within the outer shaft (12) after the leaflet is cut (as tissue may be retained between the cutting blade 19 and the distal portion of the cutter head assembly 12 within the inner chamber 20; Fig. 2).
Regarding claim 42, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the cutting tool (10) is configured to cut the leaflet at least partially via rotation of the inner shaft relative to the outer shaft (as the cutting blade 19 is moved both longitudinally and rotationally via the flexible cable drive shaft 21; column 6, lines 1-9).
Regarding claim 44, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the outer shaft opening (18) is a curved opening (Fig. 2).
Regarding claim 45, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the outer shaft opening (18) is defined in a circumferential wall of the outer shaft (12; Figs. 1-2).
Regarding claim 47, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the inner shaft defines an inner shaft opening (as 21 and 19 are hollow; Fig. 3; it is further noted 122b of Peterson is also hollow), and wherein the cutting edge at least partially defines the inner shaft opening (Figs. 2-3).
Regarding claim 50, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein the cutting tool (10) is configured to cut the leaflet by moving the inner shaft distally relative to the outer shaft (as the cutting blade 19 is moved both longitudinally and rotationally via the flexible cable drive shaft 21; column 6, lines 1-9).
Regarding claim 52, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses wherein each of the inner shaft (21) and the outer shaft (28, 12) is cylindrical in shape (Figs. 2-3).
Regarding claim 56, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses a nosecone (nose cone 30) having a proximal end that abuts a distal end of the outer shaft (as the proximal end of 30 abuts the distal end of 12; Fig. 2), wherein the nosecone has a guidewire lumen (lumen through 30) extending proximally therefrom (Fig. 2), and wherein the inner (21) and outer shafts (28, 12) are coaxial with the guidewire lumen Fig. 2).
Regarding claim 59, Frantzen discloses the invention as claimed above, and Frantzen further discloses wherein the outer shaft opening is at least partially defined by a distally-facing opening edge (proximal edge of slot 18) and a proximally-facing opening edge (distal edge of slot 18) that faces the distally-facing opening edge (Fig. 2), wherein the outer shaft opening has a first opening end (first side), a second opening end (second side), and a central opening portion between the first opening end and the second opening end (Fig. 2), and wherein the distally-facing opening edge comprises a distal-most opening location along the central opening portion (Fig. 2).
Regarding claim 60, Frantzen discloses the invention as claimed above, and Frantzen further discloses wherein the cutting tool is configured to modify the leaflet by moving the inner shaft (21) relative to the outer shaft (28, 12) to cut the leaflet with the cutting edge while the distal-most edge location of the cutting edge is circumferentially aligned with the distal-most opening location (as 21 is translatable relative to 28, 12).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frantzen et al. (US 5,514,115) in view of Peterson (US 2019/0038460 A1), as applied to claim 38 above, and further in view of Styrc Mikolaj Witold (FR 2,903,292).
Regarding claim 43, Frantzen modified fails to disclose wherein the cutting tool is configured such that the inner shaft blocks the outer shaft opening prior to cutting the leaflet.
However, Witold teaches a cutting tool (tool 10; Fig. 1) for cutting valve leaflets (leaflets 80A-80C; Fig. 5), comprising an outer shaft (cylindrical body 32) having a circumferential wall with an outer shaft opening (transverse notch 34) therein; an inner shaft (internal linkage 72 and blade 36) disposed within and movable with respect to the outer shaft (page 4, paragraph 1 of the translation), the inner shaft having a blade member (blade 36; Fig. 5), wherein the cutting tool (10) is configured such that the inner shaft (36) blocks the outer shaft opening prior to cutting the leaflet (as the blade 36 is moveable within 34 such that the user may manipulate the device to translationally move blade 36; page 4, paragraph 1 of the translation; Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blade member of the inner shaft of modified Frantzen such that the blade member has a sidewall disposed so as to block the outer shaft opening prior the blade member cutting as taught by Witold in order to prevent inadvertent cutting of a tissue prior to proper placement of the cutting tool.
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frantzen et al. (US 5,514,115) in view of Cannon et al. (US 2018/0228476 A1), as applied to claim 20 above, and further in view Plaia et al. (US 5,084,010).
Regarding claim 58, Frantzen modified discloses the invention as claimed above, and Frantzen further discloses a guidewire lumen (lumen through 30) connected to and extending proximally from the nosecone (30) within the inner shaft (lumen through 21; Fig. 3), wherein the inner shaft (21) is movable axially toward and away from the nosecone (via translation of 21).
Frantzen modified fails to disclose wherein the outer shaft is movable axially toward or away from the nosecone.
However, Plaia teaches a cutting tool (atherectomy catheter 10; Fig. 1) with a nosecone (terminal component 36; Fig. 2) and an outer shaft (12, 30), wherein the outer shaft (12, 30) is movable axially toward or away from the nosecone (via threading 34, 44; Fig. 2) for the purpose of mounting the nosecone relative to the outer shaft.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer shaft of modified Frantzen to be movable axially toward and away from the nosecone by a threaded fitting as taught by Plaia in order to allow the nosecone to be removeable for additional uses and/or sterilization purposes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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