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 Arguments
The previous objection of claim 35 due to minor informalities has been withdrawn in light of applicant’s amendments made 1/27/2026.
The rejection of claims 20, 32, 34-42, 44-45, 47, 50, 52 and 56 under 35 U.S.C. 102(a)(1) as being anticipated by Frantzen et al. (US 5,514,115) has been withdrawn in light of applicant’s amendment made 1/27/2026. Specifically, Frantzen does not teach wherein the distally-facing edge extends distally from the first end to a distal-most location on a central portion of the distally-facing edge bounding the central portion of the curved slot and further extends proximally from the distal-most location of the distally-facing edge to the second end, as recited in claim 20 and/or 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, 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 reference Stine et al. (US 6,027,514) teaches said limitation.
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 Stine et al. (US 6,027,514).
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 distally-facing edge (edge at proximal end of 18) and a proximally-facing edge (edge at distal end of 18) that faces the distally-facing edge (Fig. 2), wherein the curved slot has a first end (one lateral side of 18), a second end (opposing lateral side of 18), and a central portion between the first end and the second end (Fig. 2), wherein the proximally-facing edge (edge at distal end of 18) extends distally from the first end 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 to the second end (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 is distal to a distal-most location on the central portion of the distally-facing edge (Fig. 2).
Frantzen fails to disclose wherein the distally-facing edge extends distally from the first end to a distal-most location on a central portion of the distally-facing edge bounding the central portion of the curved slot and further extends proximally from the distal-most location of the distally-facing edge to the second end.
However, Stine teaches a cutting tool (catheter 10) comprising: an outer shaft (catheter body 12) having a circumferential wall (Fig. 1) with a curved slot (at outer cutting blade 20) therein (Fig. 1), wherein the curved slot is at least partially defined by a distally-facing edge and a proximally-facing edge that faces the distally-facing edge (see annotated Fig. 5A below), wherein the curved slot has a first end (end on one lateral side of slot as shown as a line in annotated Fig. 5A), a second end (end on opposing lateral side of slot), and a central portion between the first end and the second end (Fig. 5A), wherein the distally-facing edge extends distally from the first end to a distal-most location on a central portion of the distally-facing edge bounding the central portion of the curved slot and further extends proximally from the distal-most location of the distally-facing edge to the second end (Fig. 5A), wherein the proximally-facing edge extends distally from the first end 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 to the second end (Fig. 5A), wherein the distal-most location on the central portion of the proximally-facing edge is distal to the distal-most location on the central portion of the distally-facing edge (Fig. 5A).
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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 curved slot of Frantzen to be the shape taught by Stine, 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 (Fig. 5A of Stine).
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).
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, as measured in a direction parallel to an axial direction of the outer shaft from the proximally-facing edge to the distally-facing edge, increases from the first end of the curved slot to the central portion of the curved slot and narrows from the central portion of the cured slot to the second end of the curved slot (as both the distally and proximally facing edges taper distally; Fig. 5A of Stine).
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 Clement (US 5,409,013).
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.
However, Clement teaches a cutting tool (tissue removal assembly 10) comprising: an outer shaft (cannula 20) defining an outer shaft opening (notch 30); and an inner shaft (cutter 50) disposed within and movable relative to the outer shaft along an axial direction (Figs. 1-4) and comprising a distally-facing cutting edge (sharpened edge 52) wherein the cutting edge comprises a first edge region (bottom of first lateral side), a second edge region (bottom of opposing lateral side), and a central edge region (central portion) located between the first edge region and the second edge region (Fig. 1), 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 (due to the tapered distal face of 52; Fig. 1), and wherein the cutting edge defines a curved path between the first edge region and the second edge region (Fig. 1).
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 Clement, 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 (sharpened edge 52 of Clement) of the inner shaft (cutter 50 of Clement), a serrated edge of the inner shaft, or a blade disposed at a circumferential edge of the inner shaft (Fig. 1).
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 50 of Clement 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) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frantzen et al. (US 5,514,115) in view of Stine et al. (US 6,027,514), 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 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) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frantzen et al. (US 5,514,115) in view of Clement (US 5,409,013), 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 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 Stine et al. (US 6,027,514), 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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