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 responsive to the preliminary amendment filed 06/05/2024. Claims 21-105 have been cancelled. Claims 1-20 are currently pending in the application and under examination.
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.
Claims 1, 5, 9-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 2019/0209206) in view of Doud et al. (US 2014/0107679).
Regarding claim 1, Patel discloses multiple arrangements of an atherectomy device (see Fig. 1A) comprising: a catheter (100) including a distal nosecone (105) coupled to an elongate body (101), the catheter including a cutter window (107) between the nosecone and the elongate body, wherein the elongate body includes a shapeable section (133) including a first portion, a second portion, and a third portion each configured to bend upon activation (curved portion 133 can be divided into three portions, see Fig. 1A); and a driveshaft configured to rotate and translate within the catheter (there is a drive shaft, see [0038]), the driveshaft including a distal cutter (103) configured to extend through the cutting window (see Fig. 1A), wherein a force applied to the driveshaft in a proximal direction causes the shapeable section to on a shape (the curve can be user-activated by pushing and pulling on the driveshaft, see [0038]).
Patel fails to teach the shape is a U-shape. However, Patel discloses there can be other numbers and arrangements of the stiffening members resulting in other shapes (see [0038]).
Doud, in the same field of art, teaches a related atherectomy catheter (see Fig. 4B) comprising a catheter 56 including a shapeable section having a U-shape defined by a first curve, a second curve, and a third curve (see annotated Fig. 4B below).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the shapeable section of Patel to take on a U-shape, as taught by Doud, since a U-shape was a known configuration of a shapeable section of an atherectomy catheter and doing so would have yielded only predictable results, namely, the U-shape of Doud in the device of Patel would similarly have pushed the cutter against the vessel wall.
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Regarding claim 5, Patel further teaches wherein an extent of curvature of the shapeable section is adjustable based on an amount of force applied to the rotatable driveshaft in the proximal direction (the curve can be user-activated by pushing and pulling on the driveshaft therefore it is understood the amount of tension of applied in the proximal direction will affect the amount of bending, see [0038]).
Regarding claim 9, Patel further teaches wherein the shapeable section is configured to revert back to a straight configuration upon distal movement of the driveshaft (the curve can be user-activated by pushing and pulling on the driveshaft, see [0038]).
Regarding claim 10, Patel further teaches wherein the shapeable section includes a frame configured to limit an extent to which the shapeable section bends (Patel teaches the shapeable section can include a frame, see Fig. 5A, which includes slits 550 which control the extent of bending, see [0045]).
Regarding claim 11, the combination of Patel and Doud teaches the atherectomy device of claim 1, wherein the shapeable section includes a first axial portion, a second axial portion, and a third axial portion, wherein the first and third axial portions are configured to bend in a first direction, wherein the second axial portion is configured to bend in a second direction opposite the first direction (the first, second and third curves of Doud correspond to first, second and third axial positions and the first and third curves bend in the same direction while the second curve bends in the opposite direction, see annotated Fig. 4B of Doud above).
Regarding claim 12, the combination of Patel and Doud teaches the atherectomy device of claim 11, wherein each of the first, second and third axial portions includes a longitudinal backbone, wherein activation of the shapeable section causes each of the first, second and third axial portions to bend away from its corresponding backbone (Doud teaches first, second and third axial positions as discussed above with respect to claim 11 and Patel teaches the shapeable section can include a back bone where activation of the shapeable section cause the bending portions to bend away from a corresponding back bone, see Patel [0046] and Fig. 6A).
Regarding claim 13, Patel further teaches the shapeable section includes a tubular frame (see Fig. 5A) having a plurality of slits (550), wherein activation of the shapeable section causes compression of the tubular frame such that spaces between the plurality of slits become closer together (when actuated during bending the slit compress and/or overlap, see [0041]).
Regarding claim 14, Patel further teaches the slits are slanted with respect to a transverse axis of the tubular frame (the slits an have any geometrical arrangement including slanted with respect to the transverse axis of the frame, see [0045] and Fig. 8A).
Regarding claim 15, Patel further teaches wherein the shapeable section includes a tubular frame having bend control features configured to limit an extent to which the shapeable section bends (the shapeable section can include a frame which includes control features in the form of slits which control the extent of bending, see Fig. 5A and [0045]).
Regarding claim 16, the combination of Patel and Doud teaches the atherectomy device of claim 1, wherein the first, second and third curves are arranged along a plane (the curves are all arranged along a plane, see annotated Fig. 4B of Doud above).
Regarding claim 17, the combination of Patel and Doud teaches the atherectomy device of claim 1, wherein the shapeable section includes portions that are configured to bend in at least two different lateral directions (see annotated Fig. 4B of Doud above showing the first and second curves curve in two different directions and [0011] of Patel which sections of the curved section can curve in opposite directions).
Regarding claim 19, Patel discloses a method of using an atherectomy device (see Fig. 1A), the atherectomy device including a cutter (103) coupled to a rotatable driveshaft within a catheter, the catheter having a distal nosecone (105) coupled to an elongate body (101) and a cutter window (107) between the distal nosecone and the elongate body, the method comprising: applying an axial force in a proximal direction on the driveshaft within the catheter to cause a shapeable section (133) of the elongate body to form a shape (the pre-formed curve of the catheter can be user-activated by pushing and pulling on the driveshaft, see [0038]).
Patel fails to teach the shape is a U-shape. However, Patel discloses there can be other numbers and arrangements of the stiffening members resulting in other shapes (see [0038]).
Doud, in the same field of art, teaches a related method of using an atherectomy catheter (56, see Fig. 4B) including a shapeable section having a U-shape defined by a first curve, a second curve, and a third curve (see annotated Fig. 4B above).
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 method of Patel by causing the shapeable section of Patel to take on a U-shape, as taught by Doud, since a U-shape was a known configuration of a shapeable section of an atherectomy catheter and doing so would have yielded only predictable results, namely, the U-shape of Doud in the device of Patel would similarly have pushed the cutter against the vessel wall.
Claims 2-4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Patel and Doud, as applied to claim 1 above, and further in view of Gupta et al. (US 2015/0141816).
Regarding claims 2, 3, and 4, the combination of Patel and Doud teaches the atherectomy device of claim 1, but fails to teach the nosecone is fixedly coupled to the elongate body at a fixed bend of the catheter, wherein the cutter window is on a convex side of the fixed bend and wherein the cutter window is distally located along the catheter with respect to the fixed bend.
Gupta, in the same field of art, teaches a related atherectomy device, having a nosecone (205, see Fig. 3D) which is fixed coupled to an elongated body (201) at a fixed bend (the nose cone can be biased to the bent position, see [0052]). The device further includes a cutting window (207) on a convex side of the fixed bend (the cutter window 207 is on the convex side of the bend, see Fig. 3D) and distally located along the catheter with respect to the fixed bend (the cutting window 207 has a portion extending distally from the curve, see Fig. 3D).
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 device of Patel and Doud so that the nosecone is fixedly coupled to the elongated body at fixed bend, as taught by Gupta, since doing so would provide control over exposure of the cutter to tissue (see [0052] of Gupta).
Regarding claim 18, the combination of Patel and Doud teaches the atherectomy device of claim 1, but fails to teach the cutter includes an imaging sensor configured to collect images outside of the catheter while the cutter rotates.
Gupta, in the same field of art, teaches a related atherectomy device including a cutter having an imaging sensor (see [0016]).
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 device of Patel and Doud to include an imaging sensor on the cutter, as taught by Gupta, since doing would facilitate visualization of the treatment site during use of the device.
Claims 6-8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Patel and Doud, as applied to claims 1 and 19 above, and further in view of Zhang et al. (US 2011/0130777).
Regarding claims 6, 7 and 8, the combination of Patel and Doud teaches the atherectomy device of claim 1, but fails to teach wherein the cutter is configured to tilt in a first direction and extend though the cutter window upon proximal movement of the driveshaft with respect to the catheter, wherein the cutter is configured to tilt in a second direction opposite the first direction and retract within the cutter window upon distal movement of the driveshaft with respect to the catheter, and wherein the cutter is configured to extend distally within the nosecone upon further distal movement of the driveshaft with respect to the catheter.
Zhang, in the same field of art, teaches a related atherectomy device (see Fig. 1-3) having a configured to tilt in a first direction and extend though the cutter window upon proximal movement of the driveshaft with respect to the catheter, and configured to tilt in a second direction opposite the first direction and retract within the cutter window upon distal movement of the driveshaft with respect to the catheter and configured to extend distally within the nosecone upon further distal movement of the driveshaft with respect to the catheter (movement of the cutter 4 in the proximal direction cause the cutter to tilt and extend through the cutting window 6 and movement in the distal direction causes the cutter to tilt in the opposite direction and it is further understood the cutter can be moved distally within the nosecone 12 since it is capable of being moved proximally, see [0041] and Fig. 1-3).
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 cutter of Patel and Doud so that it is configured to tilt, as taught by Zhang, since doing so would cause the cutter to extend towards the tissue to be cut.
Regarding claim 20, the combination of Patel and Doud teaches the method of claim 19, but fails to teach moving the driveshaft in a proximal direction to cause the cutter to tilt in a first direction and extend through the cutter window.
Zhang, in the same field of art, teaches a related method including moving a driveshaft in a proximal direction to cause the cutter to tilt in a first direction and extend through the cutter window to extend the cutter towards tissue to be cut (see [0044] and Fig. 1-3).
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 method of Patel and Doud by causing the cutter to tilt, as taught by Zhang, since doing so would cause the cutter to extend towards the tissue to be cut.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related atherectomy devices and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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