DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-8 and 18-20) in the reply filed on 6/10/2026 is acknowledged.
Group II (Claims 9-17) is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected atherectomy device comprising an expansion mechanism without electromagnetic elements, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/10/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1-6, 8, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houser (US 6936024 B1) in view of Anderson (US 2014/0100585 A1).
Regarding claim 1, Houser discloses:
An atherectomy device (see Fig. 6A) comprising:
a catheter (catheter 20, see Fig. 6A) having a proximal end and a distal end (see Fig. 6A);
at least one cutting element (cutting elements 14, see Fig. 6A) movably coupled to the catheter at the distal end (see Col. 8, Lines 28-45 mentioning wherein cutting elements are configured to be actuated along the length of the catheter to cut/incise tissue) the at least one cutting element comprising an abrasive surface for performing an atherectomy procedure (see Col. 8, Lines 3-8 and Lines 29-40 mentioning wherein cutting elements are configured to incise/cut tissue, indicating the surfaces are abrasive).
However, Houser does not expressly disclose (i) wherein the cutting elements are magnetically actuated beads, (ii) a first electromagnet coupled to the distal end of the catheter at a position proximal to the at least one magnetically actuated bead, a second electromagnet coupled to the distal end of the catheter at a position distal to the at least one magnetically actuated bead, (iii) wherein the first electromagnet and the second electromagnet are configured to move the at least one magnetically actuated bead along a length of the catheter.
As to the above, in the same field of endeavor, namely atherectomy devices, Anderson teaches:
An atherectomy device (see Figs. 2-3 and 7A-8) comprising:
a catheter (shaft 110, see Fig. 2 and 7A) having a proximal end and a distal end (see Fig. 2 and 7A);
at least one magnetically actuated bead (second bulbous element 213, see Figs. 7A-8; see also Para. [0068] mentioning wherein the bulbous elements are magnetic) movably coupled to the catheter at the distal end (see Para. [0067], [0069] and [0071]), the at least one magnetically actuated bead comprising an abrasive surface for performing an atherectomy procedure (see Para. [0078]);
a first electromagnet coupled to the distal end of the catheter at a position proximal to the at least one magnetically actuated bead (proximal-most electromagnetic coil 218, see Fig. 8); and
a second electromagnet coupled to the distal end of the catheter at a position distal to the at least one magnetically actuated bead (distal-most electromagnetic coil 218, see Fig. 8);
wherein the first electromagnet and the second electromagnet are configured to move the at least one magnetically actuated bead along a length of the catheter (see Para. [0057], [0062], [0067]-[0071] and [0075]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known atherectomy cutting mechanism for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of substituting the linearly/rotationally actuatable cutting/incising mechanism of House with the magnetically-driven cutting/incising mechanism of Anderson. The resulting configuration would replace cutting elements 14 with magnetic bulbous elements of Anderson, driven by magnetic coils on opposing sides of each bulbous element which oscillate the magnetic bulbous elements axially to cut/incise a target thrombus. As both Houser and Anderson disclose known incising mechanisms within the art, one of ordinary skill in the art would have expected the device of Houser to function equally well with the magnetically-driven incision/cutting mechanism disclosed by Anderson.
Regarding claim 2, the combination of Houser and Anderson disclose the invention of claim 1, Houser, as modified by Anderson, further discloses wherein: a first current applied to the first electromagnet moves the at least one magnetically actuated bead toward the first electromagnet, and a second current applied to the second electromagnet moves the at least one magnetically actuated bead toward the second electromagnet (see Anderson Para. [0067]-[0071]; magnetic field generated by electromagnetic coils causes axial translation and vibration/rotation of the bulbous elements, as incorporated into the device of Houser).
Regarding claim 3, the combination of Houser and Anderson discloses the invention of claim 2, Houser, as modified by Anderson, further discloses a current source coupled to the first electromagnet and the second electromagnet (AC source, see Anderson Para. [0052] and [0056]) and configured to alternate delivery of current between the first electromagnet and the second electromagnet to oscillate the at least one magnetically actuated bead between the first electromagnet and the second electromagnet (see Anderson Para. [0056]-[0057] and [0071]-[0073] mentioning current supplied to electromagnetic coils may be varied to achieve a desired oscillating waveform, as incorporated into the device of Houser).
Regarding claim 4, the combination of Houser and Anderson discloses the invention of claim 3, Houser, as modified by Anderson, further discloses an electronic control unit communicatively coupled to the current source (see Anderson Para. [0054]; control system to regulate the amount of current supplied into the system by the AC source), the electronic control unit being configured to control an amount of the current from the current source to selectively provide the current from the current source to the first electromagnet and the second electromagnet, wherein controlling the amount of the current controls a speed of the at least one magnetically actuated bead (see Anderson Para. [0056]-[0057] and [0071]-[0073]; selective supply of current achieves a desired oscillating waveform).
Regarding claim 5, the combination of Houser and Anderson disclose the invention of claim 1, Houser, as modified by Anderson, further discloses an expansion mechanism movably coupled to the catheter and configured to move in a longitudinal direction along the length of the catheter between a retracted position and an extended position, wherein moving the expansion mechanism to the retracted position radially displaces the at least one magnetically bead from a centerline of the catheter (see Houser Col. 7, Lines 58-67 and Col. 8, L:ines 1-10; stylet 10 moves cutting elements along the longitudinal axis to transition between a retracted position and an extended position in which the cutting elements are displaced from the centerline of the catheter).
Regarding claim 6, the combination of Houser and Anderson disclose the invention of claim 5, Houser, as modified by Anderson, further discloses wherein: the catheter comprises a catheter body defining a lumen (see Houser Fig. 6A showing a lumen within catheter 20 within which styler 22 and cutting elements 14 are disposed) and an opening extending through a sidewall of the catheter body to the lumen; (windows 16, see Houser Fig. 6C) the expansion mechanism is positioned within the lumen (see Fig. 6A showing styler 22 within the lumen of catheter 20), in the retracted position, the at least one magnetically actuated bead is at least partially positioned within the lumen (see Houser Col. 7, Lines 58-67 and Col. 8, Lines 1-10 mentioning wherein in the retracted position, the cutting elements are disposed within the lumen of the catheter), and in the extended position, the at least one magnetically actuated bead extends out of the opening in the catheter, and is spaced apart from an outer surface of the catheter body (Houser Col. 7, Lines 58-67 and Col. 8, Lines 1-10 mentioning wherein in the extended position, cutting elements extend through windows 16 and away from the centerline of the catheter, as shown in Fig. 6A).
Regarding claim 8, the combination of Houser and Anderson disclose the invention of claim 1, Houser, as modified by Anderson, further discloses wherein the at least one magnetically actuated bead comprises one of a magnetic and a ferromagnetic material (see Anderson Para. [0050] mentioning wherein the bulbous elements, as incorporated into the device of Houser, may be magnetized via ferromagnetic material).
Regarding claim 18, Houser discloses:
A method of operating an atherectomy device, the method comprising:
providing the atherectomy device (see Fig. 6A), the atherectomy device comprising:
a catheter (catheter 20, see Fig. 6A) having a proximal end and a distal end (see Fig. 6A);
at least one cutting element (cutting elements 14, see Fig. 6A) movably coupled to the catheter at the distal end (see Col. 8, Lines 28-45 mentioning wherein cutting elements are configured to be actuated along the length of the catheter to cut/incise tissue), the at least one cutting element comprising an abrasive surface for performing an atherectomy procedure (see Col. 8, Lines 3-8 and Lines 29-40 mentioning wherein cutting elements are configured to incise/cut tissue, indicating the surfaces are abrasive).
However, Houser does not expressly disclose (i) wherein the cutting elements are magnetically actuated beads, (ii) a first electromagnet coupled to the distal end of the catheter at a position proximate the at least one magnetically actuated bead and a second electromagnet coupled to the distal end of the catheter at a position distal to the at least one magnetically actuated bead, wherein the first electromagnet and the second electromagnet are configured to move the at least one magnetically actuated bead along a length of the catheter, (iii) supplying a current to the first electromagnet and the second electromagnet to move the at least one magnetically actuated bead along the length of the catheter.
As to the above, in the same field of endeavor, namely atherectomy devices, Anderson teaches:
An atherectomy device (see Figs. 2-3 and 7A-8) comprising:
a catheter (shaft 110, see Fig. 2 and 7A) having a proximal end and a distal end (see Fig. 2 and 7A);
at least one magnetically actuated bead (second bulbous element 213, see Figs. 7A-8; see also Para. [0068] mentioning wherein the bulbous elements are magnetic) movably coupled to the catheter at the distal end (see Para. [0067], [0069] and [0071]), the at least one magnetically actuated bead comprising an abrasive surface for performing an atherectomy procedure (see Para. [0078]);
a first electromagnet coupled to the distal end of the catheter at a position proximal to the at least one magnetically actuated bead (proximal-most electromagnetic coil 218, see Fig. 8); and
a second electromagnet coupled to the distal end of the catheter at a position distal to the at least one magnetically actuated bead (distal-most electromagnetic coil 218, see Fig. 8);
wherein the first electromagnet and the second electromagnet are configured to move the at least one magnetically actuated bead along a length of the catheter (see Para. [0057], [0062], [0067]-[0071] and [0075]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known atherectomy cutting mechanism for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of substituting the linearly/rotationally actuatable cutting/incising mechanism of House with the magnetically-driven cutting/incising mechanism of Anderson. The resulting configuration would replace cutting elements 14 with magnetic bulbous elements of Anderson, driven by magnetic coils on opposing sides of each bulbous element which oscillate the magnetic bulbous elements axially to cut/incise a target thrombus. As both Houser and Anderson disclose known incising mechanisms within the art, one of ordinary skill in the art would have expected the device of Houser to function equally well with the magnetically-driven incision/cutting mechanism disclosed by Anderson.
Regarding claim 19, the combination of Houser and Anderson disclose the method of claim 18, Houser, as modified by Anderson, further disclose supplying a first current to the first electromagnet from a current source (AC source, see Houser Para. [0052] and [0056]-[0057], [0062], [0067]-[0071] and [0075]); supplying a second current to the second electromagnet from the current source (see Houser Para. [0052] and [0056]-[0057], [0062], [0067]-[0071] and [0075]); and changing an amount of either of the first current supplied to first electromagnet and the second current supplied to the second electromagnet (see Para. [0056]-[0057] and [0071]-[0073] mentioning current supplied to electromagnetic coils may be varied to achieve a desired oscillating waveform).
Regarding claim 20, the combination of Houser and Anderson disclose the method of claim 18, Houser, as modified by Anderson, further discloses adjusting an expansion mechanism slidably positioned within the catheter to move the at least one magnetically actuated bead in a direction away from or toward a centerline of the catheter (see Houser Col. 7, Lines 58-67 and Col. 8, L:ines 1-10; stylet 10 moves cutting elements along the longitudinal axis to transition between a retracted position and an extended position in which the cutting elements are displaced from the centerline of the catheter).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houser (US 6936024 B1) in view of Anderson (US 2014/0100585 A1), further in view of Buck (US 2023/0248504 A1), considered prior are due to a provisional application filed May 13, 2022.
Regarding claim 7, the combination of Houser and Anderson disclose all of the limitations of the invention of claim 6, Houser further discloses wherein the expansion mechanism comprises an elongated member slidably engaged with the at least one magnetically actuated bead (see Col. 7, Lines 57-67 through Col. 8, Lines 1-10).
However, none of either Houser or Anderson expressly disclose (i) wherein the elongated member of the expansion mechanism comprises a tapered surface in a distal to proximal direction.
As to the above, in the same field of endeavor, namely atherectomy devices, Buck teaches an atherectomy device (see Figs. 1 and 6A) comprising a cutting element (engagement tip 90, see Fig. 6A) disposed within an outer sheath body (aspiration catheter, see Para. [0095]); wherein the cutting element is axially movable within the outer sheath body via an expansion mechanism (flexible shaft 82, see Fig. 6A; see also Para. [0095]) comprising a tapered distal section which allows for increased flexibility at the distal end thereof (see Para. [0090]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stylet of Houser to comprise a tapered distal tip as taught and suggested by Buck to, in this case, provide increased flexibility at the distal end thereof during navigation to a target site (see Para. [0090]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2022/0313307 A1 to Helebert, US 11147582 B2 to Kallok, US 2008/0300636 A1 to Carli and US 8177801 B2 to Kallok all disclose atherectomy devices comprising rotatable/oscillating and/or magnetically-driven cutting elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/Andrew Restaino/Primary Examiner, Art Unit 3771
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