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 .
PROSECUTION REOPENED
In view of the appeal brief filed on 09/25/2025, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/TAN-UYEN T HO/ Supervisory Patent Examiner, Art Unit 3771
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.
Claim(s) 1, 3-5, 10, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPUB No. 20150150587 A1), in view of Bruneau (US Patent No. 6503261 B1).
Regarding claim 1, Smith discloses, an atherectomy device for the treatment of occluded body lumens. Smith teaches, an atherectomy device (Figure 1A, intravascular atherectomy apparatus (102); Paragraph [0027]), comprising:
a handle (Figure 1A, handle (108)) configured to be manipulated by a user (Paragraph [0027]);
a catheter (Figure 1A, catheter (106)) coupled to the handle (handle (108)) (Paragraph [0027]), the catheter (catheter (106)) comprising an outer sheath (Figure 2; Where catheter (238) is equivalent to catheter (106)) and a drive shaft (Figure 2, torque shaft (222); Paragraph [0074]), wherein the drive shaft (torque shaft (222)) is disposed within and rotatable relative to the outer sheath (Figure 2; Paragraph [0074]); and
a cutter assembly (Figures 1A-1B, cutter assembly (110); Paragraph [0027]) comprising:
a housing (Figure 1B, housing (114)) coupled to and extending distally from the outer sheath (Figures 1A-1B; Paragraph [0027]);
a proximal cutting element (Figure 2, proximal cutter (214)) rotatably carried by the housing (Figure 2, housing (210) which is equivalent to housing (114); Paragraph [0073]), the proximal cutting element (proximal cutter (214)) being coupled to and extending distally from the drive shaft (torque shaft (222); Paragraphs [0072]-[0074]), the proximal cutting element (proximal cutter (214)) comprising at least one proximal cutting blade (Figure 6, cutting flutes (602) where proximal cutter (614) is equivalent to proximal cutter (214); Paragraph [0096]);
a distal cutting element (Figure 2, distal cutter (212); Paragraph [0073]) being rotatable with the proximal cutting element (proximal cutter (214)) relative to the housing (housing (210)) (Paragraph [0074]), the distal cutting element (distal cutter (212)) comprising:
a first distal cutting blade (Figure 3A, left helical cutting flute (314) where distal cutter (312) is equivalent to distal cutter (212); Paragraph [0078]) having a first cutting edge (Figure 3A, left cutting edge (328); Paragraph [0078]), the first cutting edge (left cutting edge (328)) having a first shape (See annotated Figure 3A below, (First shape)); and
a second distal cutting blade (Figure 3A, right helical cutting flute (314); Paragraph [0078]) having a second cutting edge (Figure 3A, right cutting edge (328); Paragraph [0078]), the second cutting edge (right cutting edge (328)) having a second shape (See annotated Figure 3A below, (Second shape)).
Smith does not explicitly teach, the second shape being different than the first shape.
Bruneau discloses, atherectomy devices for removing deposits from a vessel. Bruneau teaches, a rotatable distal cutting element (Figure 1, atherectomy burr (10); Col. 2, line 15-27) comprising:
a first distal cutting blade (Figures 1-2, one of the number of cutting blades (20); Col. 2, line 28-31) having a first cutting edge (Figure 2, first edge (22); Col. 2, line 31-33), the first cutting edge (first edge (22)) having a first shape (Col. 2, line 28-45, discloses, first edge (22) as being “…generally tangential to the outer surface of the ablation burr.” and “The first edges 22 are preferably covered with an abrasive material such as diamond chips, etc., that constitute a relatively less aggressive cutting surface.” That constitute the shape of first edge (22)); and
a second distal cutting blade (Figures 1-2, another one of the number of cutting blades (20); Col. 2, line 28-31) having a second cutting edge (Figure 2, second edge (24); Col. 2, line 33-35), the second cutting edge (second edge (24)) having a second shape (Col. 2, line 28-45, discloses, second edge (24) as being “…substantially perpendicular to the outer surface of the ablation burr.” and “The transition between the first edge 22 and the second edge 24 forms a more aggressive cutting surface.” That constitute the shape of second edge (24)), the second shape being different than the first shape (As has been cited by Col. 2, line 28-45 and Figure 2, the shapes of the respective cutting edges (22 & 24) are clearly different).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s distal cutting blades to each include differently shaped edges as taught by Bruneau, as both references and the claimed invention are directed to atherectomy devices for removing deposits from a vessel. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s distal cutting blades to each include differently shaped edges as taught by Bruneau, as such a modification would have been predictable, namely, cutting characteristics of the burr can be selected by the physician in order to use a single burr to ablate a greater number of tissue types (Col. 3, line 31-34 of Bruneau).
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Regarding claim 3, Smith teaches, the first cutting edge (left cutting edge (328)) having a first shape (First shape) that is a smooth curve (Figures 3A-3B and 11A-11D; Paragraphs [0080]-[0090]; Helical cutting edges on distal flutes are smooth curves without sharp points).
Smith does not explicitly teach, the second shape being different than the first shape of claim 1 (See above rejection of claim 1).
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
A person of ordinary skill in the art would have found it obvious to modify Smith’s distal cutting edges with Bruneau’s differing shapes while retaining Smith’s smooth curved helical profiles, as this predictably enhances versatility on mixed plaque without compromising efficient slicing.
Regarding claim 4, Smith teaches, the first shape (First shape) and the second shape (Second shape) are smooth curves (Figures 3A-3B; Opposing helical cutting edges on distal flutes are both smooth curves).
Smith does not explicitly teach, the second shape being different than the first shape of claim 1 (See above rejection of claim 1).
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
A person of ordinary skill in the art would have found it obvious to modify Smith’s distal cutting edges with Bruneau’s differing shapes while retaining Smith’s smooth curved helical profiles, as this predictably enhances versatility on mixed plaque without compromising efficient slicing.
Regarding claim 5, Smith further teaches, wherein the distal cutting element (distal cutter (312)) further comprises a third distal cutting blade having a third cutting edge (Paragraph [0078], discloses in part, “Similarly, while the distal cutter (312) is shown has having two cutting flutes (314), it should be appreciated that in other variations, the distal cutter may comprise any suitable number of cutting flutes (e.g., one, two, three, four, or more cutting flutes).”).
Regarding claim 10, Smith further teaches, wherein the distal cutting element (distal cutter (312)) includes a first number of distal cutting blades (helical cutting flutes (314); Paragraph [0078], discloses in part, “Similarly, while the distal cutter (312) is shown has having two cutting flutes (314), it should be appreciated that in other variations, the distal cutter may comprise any suitable number of cutting flutes (e.g., one, two, three, four, or more cutting flutes).”), the proximal cutting element (proximal cutter (614)) includes a second number of proximal cutting blades (cutting flutes (602); Paragraph [0096], discloses in part, “While the variation of FIG. 6 is shown having four cutting flutes (602), it should be appreciated that the proximal cutter may comprise any suitable number of cutting flutes (e.g., one, two, three, four, five, six, or more).”), and the second number is two times the first number (The 4 cutting flutes (602) seen in Figure 6 are clearly two times the 2 helical cutting flutes (314) seen in Figure 3A).
Regarding claim 18, Smith teaches, an atherectomy device (Figure 1A, intravascular atherectomy apparatus (102); Paragraph [0027]), comprising:
a handle (Figure 1A, handle (108)) configured to be manipulated by a user (Paragraph [0027]);
a catheter (Figure 1A, catheter (106)) coupled to the handle (handle (108)) (Paragraph [0027]), the catheter (catheter (106)) comprising an outer sheath (Figure 2; Where catheter (238) is equivalent to catheter (106)) and a drive shaft (Figure 2, torque shaft (222); Paragraph [0074]), wherein the drive shaft (torque shaft (222)) is disposed within and rotatable relative to the outer sheath (Figure 2; Paragraph [0074]); and
a cutter assembly (Figures 1A-1B, cutter assembly (110); Paragraph [0027]) comprising:
a housing (Figure 1B, housing (114)) coupled to and extending distally from the outer sheath (Figures 1A-1B; Paragraph [0027]);
a proximal cutting element (Figure 2, proximal cutter (214)) rotatably carried by the housing (Figure 2, housing (210) which is equivalent to housing (114); Paragraph [0073]), the proximal cutting element (proximal cutter (214)) being coupled to and extending distally from the drive shaft (torque shaft (222); Paragraphs [0072]-[0074]), the proximal cutting element (proximal cutter (214)) comprising at least one proximal cutting blade (Figure 6, cutting flutes (602) where proximal cutter (614) is equivalent to proximal cutter (214); Paragraph [0096]);
a distal cutting element (Figure 2, distal cutter (212); Paragraph [0073]) being rotatable with the proximal cutting element (proximal cutter (214)) relative to the housing (housing (210)) (Paragraph [0074]), the distal cutting element (distal cutter (212)) comprising:
a first distal cutting blade (Figure 3A, left helical cutting flute (314) where distal cutter (312) is equivalent to distal cutter (212); Paragraph [0078]) configured to cut a first profile shape into occlusive material (Annotated Figure 3A above shows the edge (328) of the left cutting flute (314) as having a (First shape) which is capable of cutting a first profile shape into occlusive material); and
a second distal cutting blade (Figure 3A, right helical cutting flute (314); Paragraph [0078]) configured to cut a second profile shape into occlusive material (Annotated Figure 3A above shows the edge (328) of the right cutting flute (314) as having a (Second shape) which is capable of cutting a second profile shape into occlusive material).
Smith does not explicitly teach, the second profile shape being different than the first profile shape.
Bruneau teaches, a rotatable distal cutting element (Figure 1, atherectomy burr (10); Col. 2, line 15-27) comprising:
a first distal cutting blade (Figures 1-2, one of the number of cutting blades (20); Col. 2, line 28-31) configured to cut a first profile shape into occlusive material (Col. 1, line 56-63 and Col. 2, line 46-60 disclose first edge (22) of blade (20) as cutting a “first profile shape into occlusive material”); and
a second distal cutting blade (Figures 1-2, another one of the number of cutting blades (20); Col. 2, line 28-31) configured to cut a second profile shape into occlusive material, the second profile shape being different than the first profile shape (Col. 1, line 56-63 and Col. 2, line 46-60 disclose second edge (24) of blade (20) as cutting a “second profile shape into occlusive material,” where clearly the second profile shape being different than the first profile shape).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s distal cutting blades to each include differently shaped edges as taught by Bruneau, such that each distal cutting blade cuts a profile shape into the occlusive material that is different than the other, as both references and the claimed invention are directed to atherectomy devices for removing deposits from a vessel. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s distal cutting blades to each include differently shaped edges as taught by Bruneau, such that each distal cutting blade cuts a profile shape into the occlusive material that is different than the other, as such a modification would have been predictable, namely, cutting characteristics of the burr can be selected by the physician in order to use a single burr to ablate a greater number of tissue types (Col. 3, line 31-34 of Bruneau).
Regarding claim 19, Smith further teaches, wherein the distal cutting element (distal cutter (312)) further comprises a third distal cutting blade (Paragraph [0078], discloses in part, “Similarly, while the distal cutter (312) is shown has having two cutting flutes (314), it should be appreciated that in other variations, the distal cutter may comprise any suitable number of cutting flutes (e.g., one, two, three, four, or more cutting flutes).”) configured to cut a third profile shape into occlusive material (Given that the third distal cutting blade is similar in structure and design to the other two distal cutting blades seen in Figure 3A, then it will also have the cutting edge (328), which will also have a shape, that is capable of cutting a third profile shape into occlusive material).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith, in view of Bruneau, and further in view of O’Sullivan (US PGPUB No. 20120158028 A1).
Regarding claim 2, Smith teaches, wherein the first cutting edge (For ease of understanding, Examiner will be referring to the distal cutter (1100) variation depicted in Figures 11A-11D and disclosed in Paragraph [0083]-[0091], where the cutting blade of the distal cutting element (distal cutter (1100) correspond to the helical flutes (1102) which comprises cutting blades (1103) that comprise radially distant edges (1104)) comprises a first proximal portion and a first distal portion (See annotated Figure 11B below, (first proximal portion) & (first distal portion)), the second cutting edge comprises a second proximal portion and a second distal portion (Figures 11A-11D and paragraph [0083] disclose/illustrate, the helical flutes (1102) as being one, two, three, four, or more helical flutes, as such another one of the helical flutes comprises cutting blade (1103) that comprise radially distant edge (1104), as such it would also comprise (second proximal portion) & (second distal portion) similar to that seen in annotated Figure 11B below).
Smith does not explicitly teach, the second proximal portion being disposed radially inwardly relative to the first proximal portion, and the second distal portion being disposed radially outwardly relative to the first distal portion.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
O'Sullivan discloses, a surgical bur. O'Sullivan teaches, wherein the first cutting edge comprises a first proximal portion and a first distal portion, the second cutting edge comprises a second proximal portion and a second distal portion, the second proximal portion being disposed radially inwardly relative to the first proximal portion, and the second distal portion being disposed radially outwardly relative to the first distal portion (Figures 12-15; Paragraph [0053], discloses, “Thus, the cutting edges 138 of flutes 116, 120, 124, 128 and 132 are spaced inwardly of the cutting edges of flutes 114, 118, 122, 126 and 130.” Paragraph [0054], discloses, “As seen by FIGS. 12 and 15, at the position along the length of the bur head 112 where the head is of largest diameter, flutes 116, 120, 124, 128 and 132 are fully emerged from the head core. All flutes 114-132 are of equal height relative to the perimeter of the bur head core. Thus the cutting edges 138 all contact, and therefore cut, the tissue against which this section of the bur is placed.” And Paragraph [0080], discloses, “…in the disclosed version of the invention, the flutes with the short length cutting edges are alternate with the flutes having the longer length cutting edges.” These disclosures describe a second set of cutting edges (flutes 116, etc.) being radially inwardly relative to a first set (flutes 114, etc.) at a specific location along the axis. The reference also describes that at the point of the burr's largest diameter (a distal location in the spherical head embodiment), all flutes are fully emerged and are of "equal height relative to the perimeter of the bur head core," meaning their cutting edges are all at the maximum radial position at that point. The reference explicitly states that flutes with short cutting edges alternate with flutes having longer cutting edges. This combination of teachings—alternating flutes that are inwardly spaced at one point and uniformly outwardly spaced at another point—teaches the spatial relationship claimed).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith's atherectomy device to include cutting blades with varying radial positions along the length as taught by O'Sullivan, as all the references and the claimed invention are directed to surgical cutting tools (atherectomy devices/surgical burs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith's atherectomy device to include cutting blades with varying radial positions along the length as taught by O'Sullivan, as such a modification would have been predictable, namely, reducing chatter vibration (Paragraphs [0002] and [0008] of O'Sullivan).
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Claim(s) 6, 9, 11, 15-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith, in view of Bruneau, and further in view of Wulfman (US Patent No. 6156048 A).
Regarding claim 6, Smith teaches, a third cutting blade with a third cutting edge which has a third shape (Paragraphs [0078] and [0096], distal cutter variations with three or more helical flutes/blades).
Smith does not explicitly teach, the third shape being different than the first shape and the second shape.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman discloses, an atherectomy device that may reduce the risk of damage to a vessel wall. Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s distal cutting blades to each include differently shaped edges as taught by Bruneau and Wulfman, as all the references and the claimed invention are directed to atherectomy devices for removing deposits from a vessel. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to distal cutting blades to each include differently shaped edges as taught by Bruneau and Wulfman, as such a modification would have been predictable, namely, cutting characteristics of the burr can be selected by the physician in order to use a single burr to ablate a greater number of tissue types (Col. 3, line 31-34 of Bruneau).
Regarding claim 9, Smith teaches, smooth curved helical shapes (Figures 3A-3B and 11A-11D; Paragraphs [0080]-[0090]; Helical cutting edges on distal flutes are smooth curves without sharp points).
Smith does not explicitly teach, the third shape being different than the first shape and the second shape of claim 6 (See above rejection of claim 6).
Bruneau teaches, two (first and second) differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
A person of ordinary skill in the art would have found it obvious to modify Smith’s distal cutting edges with Bruneau’s and Wulfman’s differing shapes while retaining Smith’s smooth curved helical profiles, as this predictably enhances versatility on mixed plaque without compromising efficient slicing.
Regarding claim 11, Smith teaches, an atherectomy device (Figure 1A, intravascular atherectomy apparatus (102); Paragraph [0027]), comprising:
a handle (Figure 1A, handle (108)) configured to be manipulated by a user (Paragraph [0027]);
a catheter (Figure 1A, catheter (106)) coupled to the handle (handle (108)) (Paragraph [0027]), the catheter (catheter (106)) comprising an outer sheath (Figure 2; Where catheter (238) is equivalent to catheter (106)) and a drive shaft (Figure 2, torque shaft (222); Paragraph [0074]), wherein the drive shaft (torque shaft (222)) is disposed within and rotatable relative to the outer sheath (Figure 2; Paragraph [0074]); and
a cutter assembly (Figures 1A-1B, cutter assembly (110); Paragraph [0027]) comprising:
a housing (Figure 1B, housing (114)) coupled to and extending distally from the outer sheath (Figures 1A-1B; Paragraph [0027]);
a first cutting blade (Figure 3A, left helical cutting flute (314); Paragraph [0078]) being rotatable relative to the housing (left helical cutting flute (314) is part of distal cutter (312) seen in Figure 3A and distal cutter (312) is equivalent to distal cutter (212) seen in Figure 2 which is housed within housing (210) and rotates relative to it; Paragraphs [0073]-[0074]), the first cutting blade having a first cutting edge (Figure 3A, left cutting edge (328); Paragraph [0078]), the first cutting edge having a first shape (See annotated Figure 3A above, (First shape));
a second cutting blade (Figure 3A, right helical cutting flute (314); Paragraph [0078]) being rotatable with the first cutting blade (left helical cutting flute (314)) relative to the housing (left and right helical cutting flutes (314) are part of distal cutter (312) seen in Figure 3A and distal cutter (312) is equivalent to distal cutter (212) seen in Figure 2 which is housed within housing (210) and rotates relative to it; Paragraphs [0073]-[0074]), the second cutting blade having a second cutting edge (Figure 3A, right cutting edge (328); Paragraph [0078]), the second cutting edge having a second shape (See annotated Figure 3A above, (Second shape)); and
a third cutting blade being rotatable with the first cutting blade and the second cutting blade relative to the housing, the third cutting blade having a third cutting edge, the third cutting edge having a third shape (Paragraph [0078], discloses in part, “Similarly, while the distal cutter (312) is shown has having two cutting flutes (314), it should be appreciated that in other variations, the distal cutter may comprise any suitable number of cutting flutes (e.g., one, two, three, four, or more cutting flutes).” Indicating that similar to the left and right cutting flutes (314), a third cutting flute (314) will have a third cutting edge similar to cutting edges (328), which has a third shape and which is rotatable with the left and right helical cutting flutes (314) relative to the housing).
Smith does not explicitly teach, the second shape being different than the first shape; and the third shape being different than the first shape and the second shape.
Bruneau teaches, a rotatable distal cutting element (Figure 1, atherectomy burr (10); Col. 2, line 15-27) comprising:
a first cutting blade (Figures 1-2, one of the number of cutting blades (20); Col. 2, line 28-31) having a first cutting edge (Figure 2, first edge (22); Col. 2, line 31-33), the first cutting edge (first edge (22)) having a first shape (Col. 2, line 28-45, discloses, first edge (22) as being “…generally tangential to the outer surface of the ablation burr.” and “The first edges 22 are preferably covered with an abrasive material such as diamond chips, etc., that constitute a relatively less aggressive cutting surface.” That constitute the shape of first edge (22)); and
a second cutting blade (Figures 1-2, another one of the number of cutting blades (20); Col. 2, line 28-31) having a second cutting edge (Figure 2, second edge (24); Col. 2, line 33-35), the second cutting edge (second edge (24)) having a second shape (Col. 2, line 28-45, discloses, second edge (24) as being “…substantially perpendicular to the outer surface of the ablation burr.” and “The transition between the first edge 22 and the second edge 24 forms a more aggressive cutting surface.” That constitute the shape of second edge (24)), the second shape being different than the first shape (As has been cited by Col. 2, line 28-45 and Figure 2, the shapes of the respective cutting edges (22 & 24) are clearly different).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s cutting blades to each include differently shaped edges as taught by Bruneau and Wulfman, as all the references and the claimed invention are directed to atherectomy devices for removing deposits from a vessel. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s cutting blades to each include differently shaped edges as taught by Bruneau and Wulfman, as such a modification would have been predictable, namely, cutting characteristics of the burr can be selected by the physician in order to use a single burr to ablate a greater number of tissue types (Col. 3, line 31-34 of Bruneau).
Regarding claim 15, Smith teaches, the first cutting edge (left cutting edge (328)) having a first shape (First shape) that is a smooth curve (Figures 3A-3B and 11A-11D; Paragraphs [0080]-[0090]; Helical cutting edges on distal flutes are smooth curves without sharp points).
Smith does not explicitly teach, the second shape being different than the first shape; and the third shape being different than the first shape and the second shape of claim 11 (See above rejection of claim 11).
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
A person of ordinary skill in the art would have found it obvious to modify Smith’s distal cutting edges with Bruneau’s and Wulfman’s differing shapes while retaining Smith’s smooth curved helical profiles, as this predictably enhances versatility on mixed plaque without compromising efficient slicing.
Regarding claim 16, Smith teaches, the first shape (First shape) and the second shape (Second shape) are smooth curves (Figures 3A-3B; Opposing helical cutting edges on distal flutes are both smooth curves).
Smith does not explicitly teach, the second shape being different than the first shape of claim 1 (See above rejection of claim 1).
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
A person of ordinary skill in the art would have found it obvious to modify Smith’s distal cutting edges with Bruneau’s and Wulfman’s differing shapes while retaining Smith’s smooth curved helical profiles, as this predictably enhances versatility on mixed plaque without compromising efficient slicing.
Regarding claim 17, Smith teaches, smooth curved helical shapes (Figures 3A-3B and 11A-11D; Paragraphs [0080]-[0090]; Helical cutting edges on distal flutes are smooth curves without sharp points).
Smith does not explicitly teach, the third shape being different than the first shape and the second shape of claim 6 (See above rejection of claim 6).
Bruneau teaches, two (first and second) differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
A person of ordinary skill in the art would have found it obvious to modify Smith’s distal cutting edges with Bruneau’s and Wulfman’s differing shapes while retaining Smith’s smooth curved helical profiles, as this predictably enhances versatility on mixed plaque without compromising efficient slicing.
Regarding claim 20, Smith teaches, a third distal cutting blade configured to cut a third profile shape into occlusive material (Paragraphs [0078] and [0096], distal cutter variations with three or more helical flutes/blades).
Smith does not explicitly teach, wherein the third profile shape is different than the first profile shape and the second profile shape.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes and cutting profile shapes into occlusive material (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s distal cutting blades to each include differently shaped edges as taught by Bruneau and Wulfman, such that each distal cutting blade cuts a profile shape into the occlusive material that is different than the other, as all the references and the claimed invention are directed to atherectomy devices for removing deposits from a vessel. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s distal cutting blades to each include differently shaped edges as taught by Bruneau and Wulfman, such that each distal cutting blade cuts a profile shape into the occlusive material that is different than the other, as such a modification would have been predictable, namely, cutting characteristics of the burr can be selected by the physician in order to use a single burr to ablate a greater number of tissue types (Col. 3, line 31-34 of Bruneau).
Claim(s) 7-8 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith, in view of Bruneau, further in view of Wulfman, and even further in view of O’Sullivan.
Regarding claim 7, Smith teaches, wherein the first cutting edge (For ease of understanding, Examiner will be referring to the distal cutter (1100) variation depicted in Figures 11A-11D and disclosed in Paragraph [0083]-[0091], where the cutting blade of the distal cutting element (distal cutter (1100) correspond to the helical flutes (1102) which comprises cutting blades (1103) that comprise radially distant edges (1104)) comprises a first proximal portion and a first distal portion (See annotated Figure 11B above, (first proximal portion) & (first distal portion)), the second cutting edge comprises a second proximal portion and a second distal portion (Figures 11A-11D and paragraph [0083] disclose/illustrate, the helical flutes (1102) as being one, two, three, four, or more helical flutes, as such another one of the helical flutes comprises cutting blade (1103) that comprise radially distant edge (1104), as such it would also comprise (second proximal portion) & (second distal portion) similar to that seen in annotated Figure 11B above), the third cutting edge comprises a third proximal portion and a third distal portion (The same logic of the second cutting edge applies to the third cutting edge such that it comprises a (third proximal portion) & (third distal portion)).
Smith does not explicitly teach, the first proximal portion being disposed radially outwardly relative to the second proximal portion and the third proximal portion, and the second distal portion being disposed radially outwardly relative to the first distal portion and the third distal portion.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
O'Sullivan teaches, cutting edges with varying radial positions along the length to reduce chatter vibration (Figures 12-15; Paragraphs [0002], [0008], [0053]-[0054], and [0080]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as all the references and the claimed invention are directed to surgical cutting tools (atherectomy devices/surgical burs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as such a modification would have been predictable, namely, to select cutting characteristics or reduce vibration for treating various tissue types.
Regarding claim 8, Smith teaches, wherein the first cutting edge further comprises a first intermediate portion (See annotated Figure 11B above, (First intermediate portion)) disposed between the first proximal portion and the first distal portion (As seen in Figure 11B, the (First intermediate portion) is indeed between the (first proximal portion) & (first distal portion)), the second cutting edge comprises a second intermediate portion disposed between the second proximal portion and the second distal portion, the third cutting edge comprises a third intermediate portion disposed between the third proximal portion and the third distal portion (Given Figures 11A-11D and paragraph [0083] disclose/illustrate, the helical flutes (1102) as being one, two, three, four, or more helical flutes, as such other helical flutes comprise cutting blades (1103) that comprise radially distant edges (1104), as such they would also comprise (Second intermediate portion) & (Third intermediate portion)).
Smith does not explicitly teach, the third intermediate portion being disposed radially outwardly relative to the first intermediate portion and the second intermediate portion.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
O'Sullivan teaches, cutting edges with varying radial positions along the length to reduce chatter vibration (Figures 12-15; Paragraphs [0002], [0008], [0053]-[0054], and [0080]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as all the references and the claimed invention are directed to surgical cutting tools (atherectomy devices/surgical burs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as such a modification would have been predictable, namely, to select cutting characteristics or reduce vibration for treating various tissue types.
Regarding claim 12, Smith teaches, wherein the first cutting edge (For ease of understanding, Examiner will be referring to the distal cutter (1100) variation depicted in Figures 11A-11D and disclosed in Paragraph [0083]-[0091], where the cutting blade of the distal cutting element (distal cutter (1100) correspond to the helical flutes (1102) which comprises cutting blades (1103) that comprise radially distant edges (1104)) comprises a first proximal portion and a first distal portion (See annotated Figure 11B above, (first proximal portion) & (first distal portion)), the second cutting edge comprises a second proximal portion and a second distal portion (Figures 11A-11D and paragraph [0083] disclose/illustrate, the helical flutes (1102) as being one, two, three, four, or more helical flutes, as such another one of the helical flutes comprises cutting blade (1103) that comprise radially distant edge (1104), as such it would also comprise (second proximal portion) & (second distal portion) similar to that seen in annotated Figure 11B above).
Smith does not explicitly teach, the second proximal portion being disposed radially inwardly relative to the first proximal portion, and the second distal portion being disposed radially outwardly relative to the first distal portion.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
O'Sullivan teaches, wherein the first cutting edge comprises a first proximal portion and a first distal portion, the second cutting edge comprises a second proximal portion and a second distal portion, the second proximal portion being disposed radially inwardly relative to the first proximal portion, and the second distal portion being disposed radially outwardly relative to the first distal portion (Figures 12-15; Paragraph [0053], discloses, “Thus, the cutting edges 138 of flutes 116, 120, 124, 128 and 132 are spaced inwardly of the cutting edges of flutes 114, 118, 122, 126 and 130.” Paragraph [0054], discloses, “As seen by FIGS. 12 and 15, at the position along the length of the bur head 112 where the head is of largest diameter, flutes 116, 120, 124, 128 and 132 are fully emerged from the head core. All flutes 114-132 are of equal height relative to the perimeter of the bur head core. Thus the cutting edges 138 all contact, and therefore cut, the tissue against which this section of the bur is placed.” And Paragraph [0080], discloses, “…in the disclosed version of the invention, the flutes with the short length cutting edges are alternate with the flutes having the longer length cutting edges.” These disclosures describe a second set of cutting edges (flutes 116, etc.) being radially inwardly relative to a first set (flutes 114, etc.) at a specific location along the axis. The reference also describes that at the point of the burr's largest diameter (a distal location in the spherical head embodiment), all flutes are fully emerged and are of "equal height relative to the perimeter of the bur head core," meaning their cutting edges are all at the maximum radial position at that point. The reference explicitly states that flutes with short cutting edges alternate with flutes having longer cutting edges. This combination of teachings—alternating flutes that are inwardly spaced at one point and uniformly outwardly spaced at another point—teaches the spatial relationship claimed).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith's atherectomy device to include cutting blades with varying radial positions along the length as taught by O'Sullivan, as all the references and the claimed invention are directed to surgical cutting tools (atherectomy devices/surgical burs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith's atherectomy device to include cutting blades with varying radial positions along the length as taught by O'Sullivan, as such a modification would have been predictable, namely, reducing chatter vibration (Paragraphs [0002] and [0008] of O'Sullivan).
Regarding claim 13, Smith teaches, wherein the first cutting edge (For ease of understanding, Examiner will be referring to the distal cutter (1100) variation depicted in Figures 11A-11D and disclosed in Paragraph [0083]-[0091], where the cutting blade of the distal cutting element (distal cutter (1100) correspond to the helical flutes (1102) which comprises cutting blades (1103) that comprise radially distant edges (1104)) comprises a first proximal portion and a first distal portion (See annotated Figure 11B above, (first proximal portion) & (first distal portion)), the second cutting edge comprises a second proximal portion and a second distal portion (Figures 11A-11D and paragraph [0083] disclose/illustrate, the helical flutes (1102) as being one, two, three, four, or more helical flutes, as such another one of the helical flutes comprises cutting blade (1103) that comprise radially distant edge (1104), as such it would also comprise (second proximal portion) & (second distal portion) similar to that seen in annotated Figure 11B above), the third cutting edge comprises a third proximal portion and a third distal portion (The same logic of the second cutting edge applies to the third cutting edge such that it comprises a (third proximal portion) & (third distal portion)).
Smith does not explicitly teach, the first proximal portion being disposed radially outwardly relative to the second proximal portion and the third proximal portion, and the second distal portion being disposed radially outwardly relative to the first distal portion and the third distal portion.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
O'Sullivan teaches, cutting edges with varying radial positions along the length to reduce chatter vibration (Figures 12-15; Paragraphs [0002], [0008], [0053]-[0054], and [0080]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as all the references and the claimed invention are directed to surgical cutting tools (atherectomy devices/surgical burs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as such a modification would have been predictable, namely, to select cutting characteristics or reduce vibration for treating various tissue types.
Regarding claim 14, Smith teaches, wherein the first cutting edge further comprises a first intermediate portion (See annotated Figure 11B above, (First intermediate portion)) disposed between the first proximal portion and the first distal portion (As seen in Figure 11B, the (First intermediate portion) is indeed between the (first proximal portion) & (first distal portion)), the second cutting edge comprises a second intermediate portion disposed between the second proximal portion and the second distal portion, the third cutting edge comprises a third intermediate portion disposed between the third proximal portion and the third distal portion (Given Figures 11A-11D and paragraph [0083] disclose/illustrate, the helical flutes (1102) as being one, two, three, four, or more helical flutes, as such other helical flutes comprise cutting blades (1103) that comprise radially distant edges (1104), as such they would also comprise (Second intermediate portion) & (Third intermediate portion)).
Smith does not explicitly teach, the third intermediate portion being disposed radially outwardly relative to the first intermediate portion and the second intermediate portion.
Bruneau teaches, differently shaped edges (tangential vs. perpendicular) for varying aggressiveness on heterogeneous tissue (Col. 2, line 28-45).
Wulfman teaches, multiple blades with distinct edge shapes (Figures 1-3 and 7-10; Col. 6, line 15-30, Col. 7, line 47-55, and Col. 8, line 46-49; e.g., softer/ductile vs. hardened; concave/convex/recessed for varied tissue engagement).
O'Sullivan teaches, cutting edges with varying radial positions along the length to reduce chatter vibration (Figures 12-15; Paragraphs [0002], [0008], [0053]-[0054], and [0080]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as all the references and the claimed invention are directed to surgical cutting tools (atherectomy devices/surgical burs). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Smith’s device to include multiple cutting blades with different edge shapes and varying radial positions, as taught by Bruneau, Wulfman, and O'Sullivan, as such a modification would have been predictable, namely, to select cutting characteristics or reduce vibration for treating various tissue types.
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed 09/25/2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. 102 have been fully considered and are persuasive. Examiner agrees Smith fails to explicitly disclose, “cutting edges/profiles with different shapes.” Therefore, the rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made in view of Smith, Bruneau, O'Sullivan, and Wulfman.
See updated rejections above.
Further, Applicant’s arguments with respect to the rejection of claim 10 under 35 U.S.C. 112(b) has been fully considered and is persuasive. Therefore, the rejection has been withdrawn.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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