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 in response to the amendments filed on 7/6/2026. Claims 21 and 36 are amended. Claims 21-40 are pending and addressed below.
Response to Arguments
Applicant’s arguments, filed on 7/6/2026, with respect to claim 21 have been fully considered but they are not persuasive.
Regarding arguments on page 7, the applicant states that “Combining Newhauser's lower-speed motor that alternates directions with Robinson's high-speed (20,000-160,000 rpm) unidirectional atherectomy device changes the principle of operation of both devices. Specifically, an alternating, lower-speed motor cannot generate the centrifugal force that urges the burrs into the claimed "orbital path having an orbit diameter greater than a maximum diameter" of the burrs. Additionally, applying an alternating, low-speed motor to a high-speed atherectomy device would be counter to Robinson's design, which ablates tissues using high-speed orbital paths, rendering the device inoperable”. The examiner disagrees with the applicant because the motor of Robinson is still being used to rotate the drive shaft at 20,000-160,000 rpms (Robinson, Paragraph 0049) and Newhauser is only being used as a teaching reference to modify the current motor of Robinson to be able to rotate the drive shaft in an opposite or reverse direction. Since the motor of Robinson is still being used for high degree of rotation and modifying the motor of Robinson to be able to rotate in an opposite or reversed direction as taught by Newhauser would not render the device inoperable since the motor of Robinson is still able to rotate the drive shaft at 20,000-160,000 rpms. The examiner wants to clearly note that the motor of Robinson is not being replaced by the low-speed motor of Newhauser but only being modified to be able to rotate in an opposite or reverse direction. Therefore, the rejection is proper.
Regarding arguments on page 8, the applicant states that “Operating the drive shaft in a rotational direction that is opposite from the helical array spiral direction, in the manner claimed, would be contrary to Cambronne's augering effect. Plas-Pak, 600 Fed. Appx. at 759. ("Such a change in a reference's 'principle of operation' is unlikely to motivate a person of ordinary skill to pursue a combination with that reference"). The Office Action provides no explanation as to why a person of skill would have abandoned Cambronne's stated purpose of inducing an augering effect merely to use the "option" of a reverse rotation, including a reverse rotation at much lower speeds”. The examiner disagrees with the applicant because the drive shaft of Robinson modified by Newhauser and Cambronne would not only being moving in a reversed direction but also in a forward direction which would be able to achieve the augering effect of Cambronne. Also, the examiner wants to note that Cambronne is just a teaching reference and not the main reference where it is being modified so a change of Cambronne’s principle of operation is irrelevant in this situation. The only reference that is important regarding change of principle of operation would be Robinson, and Robinson modified by Newhauser and Cambronne would not make the device inoperable. Lastly, the examiner wants to clearly note that the motor of Robinson is not being replaced by the low-speed motor of Newhauser but is only being modified to be able to rotate in an opposite or reverse direction Therefore, the rejection is proper.
Claim Rejections - 35 USC § 103
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 of this title, 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 21-33, 35, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson (US Pub No. 2015/0196320) in view of Newhauser (US Pub No. 2015/0272615) and Cambronne (US Pub No. 2014/0081298).
Regarding claim 21, Robinson discloses (Figures 1A-6) a rotational atherectomy device (600) (Figure 6), comprising: an elongate flexible drive shaft (610) defining a longitudinal axis and comprising a torque- transmitting coil helically wound around the longitudinal axis in a coil spiral direction [Clockwise direction as shown in Figure 1C] extending toward a distal end of the elongate flexible drive shaft (Figure 1C); a motor (Paragraph 0036) to drive rotation of the drive shaft at 20,000-160,000 rpms in a shaft rotation direction (Paragraph 0049) and five abrasive burrs (Paragraph 0061 discloses it can have five abrasive burrs) fixedly mounted to the torque- transmitting coil (Figure 6) (Paragraph 0061) such that each of the abrasive spheres has a center of mass offset from the longitudinal axis of the drive shaft (Paragraph 0061), wherein the motor is configured to rotate of the drive shaft at 20,000-160,000 rpms in the shaft rotation direction while the five abrasive burrs are fixedly mounted to the torque-transmitting coil such that one or more the abrasive burrs is urged in an orbital path having an orbit diameter greater than a maximum diameter of the five abrasive burrs (clearly shown in Figure 2D where the orbital diameter is greater than the maximum diameter of the abrasive burrs) (Paragraphs 0049-0050 and 0052).
Robinson fails to disclose an actuator handle assembly connected to the drive shaft and the motor driving rotation of the drive shaft in the shaft rotation direction that is the same as the coil spiral direction extending toward a distal end of the elongate flexible drive shaft.
Newhauser, in the same field of endeavor, teaches (Figures 1-5E) a cutting device (Figures 3A-3B) that includes an actuator handle assembly (303) (Figure 5A) connected a drive shaft (301) and a motor (503) (Figure 5B) to drive rotation of the drive shaft in a clockwise direction or a counterclockwise direction (Paragraphs 0088 and 0090). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the motor of Robinson to be able to drive rotation of the drive shaft in both a clockwise direction and a counterclockwise direction as taught by Newhauser, in order to facilitate the process of removing plaque by having the drive shaft to rotate in two different directions instead of a single direction (Newhauser, Paragraphs 0088 and 0090).
[Since Robinson modified by Newhauser has a drive shaft with a coil helically wound around the longitudinal axis in a coil spiral direction or a clockwise direction and the motor is configured to drive rotation of the drive shaft about the longitudinal axis in a shaft rotation direction or the clockwise direction since it has the option to rotate either in a clockwise direction or a counterclockwise direction, then this would result in Robinson modified by Newhauser as a whole to disclose the limitation of the motor driving rotation of the drive shaft in a shaft rotation direction that is the same as the coil spiral direction extending toward a distal end of the elongate flexible drive shaft]
Robinson also fails to disclose the abrasive burrs fixedly mounted to the torque-transmitting coil in a helical array such that each of the abrasive burr has a center of mass offset from the longitudinal axis of the drive shaft at a radial angle of 20 degrees to 50 degrees different from each adjacent abrasive burr, said radial angle of 20 degrees to 50 degrees between each adjacent abrasive burr defining a helical array spiral direction for the five abrasive burrs that extend toward the distal end spiraling opposite from both the coil spiral direction and the shaft rotation direction.
Cambronne, in the same field of endeavor, teaches (Figures 1-4B) a rotational atherectomy device (Figure 1) that includes abrasive elements (clearly shown in Figure 4B) attached to a distal end portion of a drive shaft (20) (Figure 2) and each having a center of mass offset from the longitudinal axis (A) (clearly shown Figure 3B) (Paragraphs 0034-0035) at a radial angle of 20 degrees to 50 degrees (Figure 4A) (Paragraphs 0034 and 0038) different from each adjacent abrasive sphere (clearly shown in Figures 4A-4B) (Paragraph 0038), said radial angle of 20 degrees to 50 degrees between each adjacent abrasive sphere defining a helical array spiral direction [As shown in Figure 4B, going from the center of mass of the first abrasive element 28 to the center of mass of the second abrasive element 29 in a counterclockwise direction will define a helical array spiral direction] for the abrasive spheres that extends toward the distal end (Paragraph 0038) [The examiner wants to note that the helical array spiral direction as shown in Figure 4B starting at the center of mass of the first abrasive element 28 and moving towards to the 4th eccentric abrading head is in a counterclockwise direction].
Since Robinson discloses five abrasive burrs that each have a center of mass offset from the longitudinal axis of the drive shaft but does not disclose the exact radial angle and also, the five abrasive burrs fixedly mounted to the torque-transmitting coil in a helical array, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Robinson so that each of the abrasive spheres has a center of mass offset from the longitudinal axis of the drive shaft at a radial angle of 20 degrees to 50 degrees different from each adjacent abrasive sphere to thereby define a helical array spiral direction extending toward the distal end and spiraling in a counterclockwise direction as taught by Cambronne, in order to facilitate the ability of the system of eccentric abrasive elements to work together to open the stenotic lesion and also to provide a system having unbalanced centers of mass to not only stimulate greater rotational diameters but also arranged in a matter whereby a debris-removing augering effect occurs that channels away debris from the occlusive along the spiral channel of the system in a controlled fashion (Cambronne, Paragraphs 0011, 0035 and 0037-0038).
[Robinson modified by Newhauser and Cambronne would result in the helical array spiral direction (counterclockwise) to be opposite from both the coil spiral direction and shaft rotation direction (clockwise). Also, Robinson modified by Newhauser and Cambronne would result in the motor to be configured to rotate the drive shaft at 20,000-160,000 rpms in the shaft rotation direction while the five abrasive burrs in the helical array are fixedly mounted to the torque-transmitting coil such that one or more the abrasive burrs is urged in an orbital path having an orbit diameter greater than a maximum diameter of the five abrasive burrs in the helical array]
Regarding claim 22, Robinson modified by Newhauser and Cambronne discloses each abrasive burr being an abrasive metallic sphere (Robinson, Paragraphs 0043 and 0061).
Regarding claim 23, Robinson modified by Newhauser and Cambronne discloses the invention above, Cambronne further teaches wherein the actuator handle assembly further includes a carriage assembly (11) that is movable in relation to other portions of the actuator handle assembly to longitudinally translate the drive shaft (Paragraphs 0029-0030). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Robinson to have included a carriage assembly that is movable in relation to other portions of the actuator handle assembly to longitudinally translate the drive shaft as taught by Cambronne, in order facilitate the surgical procedure by having the user to easily manipulate the rotational atherectomy device (Cambronne, Paragraphs 0029-0030).
Regarding claim 24, Robinson modified by Newhauser and Cambronne further discloses a sheath (Cambronne, Figure 1) (13) extending distally from the actuator handle assembly with the torque-transmitting coil slidably positioned within the sheath such that the torque-transmitting coil is rotatable within a lumen defined by the sheath and longitudinally movable relative to the sheath (Cambronne, Figure 2) (Paragraphs 0029-0030).
Regarding claim 25, Robinson modified by Newhauser and Cambronne further discloses wherein the sheath is connected to the actuator handle assembly and configured to deliver a flush fluid through the lumen of the sheath (Cambronne, Figure 1) (Paragraphs 0029-0030) [Deliver fluid through fluid supply line 17 as shown in Figure 1].
Regarding claim 26, Robinson modified by Newhauser and Cambronne further discloses wherein the helical array of five abrasive burrs comprises a first abrasive sphere, a second abrasive sphere, a third abrasive sphere, a fourth abrasive sphere, and a fifth abrasive sphere that are all fixedly mounted to the torque-transmitting coil at a distal end portion of the drive shaft (Robinson, Paragraph 0061) but fails to disclose wherein the overall radial angle of the helical array of the five abrasive burrs is less than 180 degrees along the distal end portion of the drive shaft.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Robinson modified by Newhauser and Cambronne to have the body region to have the overall radial angle of the spiral path to be always less than 180 degrees along the distal end portion of the drive shaft since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Regarding claim 27, Robinson modified by Newhauser and Cambronne further discloses wherein the first abrasive sphere is a proximal-most abrasive burr in the helical array of five abrasive burrs, the second, third, and fourth abrasive spheres are intermediate abrasive burrs in the helical array of five abrasive burrs, and the fifth abrasive sphere is a distal-most abrasive burr in the helical array of five abrasive burrs (Robinson, Paragraph 0061), the proximal-most abrasive burr having a smaller diameter than the intermediate abrasive burrs in the helical array of five abrasive burrs (similar to what is shown in Figure 6 of Robinson) [The proximal-most abrasive burr will have a smaller diameter than the intermediate abrasive burrs since Paragraph 0061 of Robinson discloses that together, the abrasive elements has a tapered outer profile shape].
Regarding claim 28, Robinson modified by Newhauser and Cambronne further discloses wherein the distal-most abrasive burr has a smaller diameter than the intermediate abrasive burrs in the helical array of five abrasive burrs (similar to what is shown in Figure 6 of Robinson) [The distal-most abrasive burr will have a smaller diameter than the intermediate abrasive burrs since Paragraph 0061 of Robinson discloses that together, the abrasive elements has a tapered outer profile shape].
Regarding claim 29, Robinson modified by Newhauser and Cambronne further discloses wherein the center of mass of the second abrasive sphere is offset from the longitudinal axis of the drive shaft at a radial angle of about 37.5 degrees from first abrasive sphere (Cambronne, Paragraph 0038) [Between 0 degree to 45 degree which 37.5 falls within that range], the center of mass of the third abrasive sphere is offset from the longitudinal axis of the drive shaft at a radial angle of about 37.5 degrees from second abrasive sphere (Cambronne, Paragraph 0038) [Between 0 degree to 45 degree which 37.5 falls within that range], the center of mass of the fourth abrasive sphere is offset from the longitudinal axis of the drive shaft at a radial angle of about 37.5 degrees from third abrasive sphere (Cambronne, Paragraph 0038) [Between 0 degree to 45 degree which 37.5 falls within that range], and the center of mass of the fifth abrasive sphere is offset from the longitudinal axis of the drive shaft at a radial angle of about 37.5 degrees from fourth abrasive sphere (Cambronne, Paragraph 0038) [Between 0 degree to 45 degree which 37.5 falls within that range].
Regarding claim 30, Robinson modified by Newhauser and Cambronne further discloses a distal metallic cylindrical element (Robinson, 630) (Paragraph 0043) fixedly mounted to the torque-transmitting coil distally of the helical array of the five abrasive burrs and having a center of mass aligned with the longitudinal axis (Robinson, Paragraph 0042).
Regarding claim 31, Robinson modified by Newhauser and Cambronne further discloses wherein the torque-transmitting coil comprises a distal-most extension portion (see annotated figure below) that extends distally of the metallic cylindrical element (see annotated figure below).
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Regarding claim 32, Robinson modified by Newhauser and Cambronne further discloses a concentric tip member (see annotated figure above) affixed to and extending distally from a distal-most end of the torque-transmitting coil (see annotated figure above).
Regarding claim 33, Robinson modified by Newhauser and Cambronne further discloses wherein the concentric tip member (see annotated figure above) defines a central opening (opening for guidewire as disclosed in Paragraph 0037) that is coaxial with a longitudinal lumen defined by the drive shaft (Robinson, Paragraph 0037).
Regarding claim 35, Robinson modified by Newhauser and Cambronne further discloses wherein the concentric tip member has a maximum outer diameter that is equal to an outer diameter of the torque-transmitting coil of the drive shaft (clearly shown in the annotated figure above).
Regarding claim 37, Robinson modified by Newhauser and Cambronne further discloses means for increasing column strength of the drive shaft to facilitate pushing the drive shaft through stenotic lesions (Robinson, Paragraph 0040).
Regarding claim 40, Robinson modified by Newhauser and Cambronne discloses the invention above except for wherein each of the five abrasive burrs in the helical array have a diameter of 1 mm to 3 mm.
Since Robinson in Paragraph 0061 discloses that all of the abrasive burrs can have a different outer profile shape, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Robinson modified by Newhauser and Cambronne to have each of the five abrasive burrs in the helical array to have a diameter of 1mm to 3mm since the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (MPEP 2144.04 (IV)(A)).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson (US Pub No. 2015/0196320) in view of Newhauser (US Pub No. 2015/0272615) and Cambronne (US Pub No. 2014/0081298) as applied to claim 33 above, and further in view of Gurm (US Pub No. 2019/0262035).
Regarding claim 34, Robinson modified by Newhauser and Cambronne discloses the invention of claim 33 above except for an abrasive coating on an exterior of the concentric tip member.
Gurm, in the same field of endeavor, teaches (Figure 12B) an atherectomy device that includes an abrasive coating (22) (Paragraph 0097) on an exterior of the concentric tip member (14’) (Paragraph 0097). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Robinson modified by Newhauser and Cambronne to have included an abrasive coating on an exterior of the concentric tip member as taught by Gurm, in order to remove plaque in small vessels and along vessels with turns and tortuosity (Gurm, Paragraphs 0097-0098).
Claims 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson (US Pub No. 2015/0196320) in view of Newhauser (US Pub No. 2015/0272615) and Cambronne (US Pub No. 2014/0081298) as applied to claim 21 above, and further in view of Schoenle (US Pub No. 2013/0253552).
Regarding claims 38 and 39, Robinson modified by Newhauser and Cambronne discloses the invention of claim 21 above except for a controller having user-selectable interface buttons and being in communication with the motor of the actuator handle assembly and wherein the user-selectable interface buttons of the controller that correspond to a plurality of rotational speeds configured to drive rotation of the drive shaft at a selected one of the rotation speeds.
Schoenle, in the same field of endeavor, teaches (Figures 1-5) a controller (40) having user-selectable interface buttons (12) (Figure 5) and being in communication with a motor of the actuator handle assembly and wherein the user-selectable interface buttons of the controller that correspond to a plurality of rotational speeds configured to drive rotation of the drive shaft at a selected one of the rotation speeds (Paragraphs 0075, 0083 and 0085). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Robinson modified by Newhauser and Cambronne to have included a controller having user-selectable interface buttons and being in communication with the motor of the actuator handle assembly and wherein the user-selectable interface buttons of the controller that correspond to a plurality of rotational speeds configured to drive rotation of the drive shaft at a selected one of the rotation speeds as taught by Schoenle, in order to facilitate the surgical procedure by providing the device with different speeds to remove plaque (Schoenle, Paragraphs 0075, 0083 and 0085).
Allowable Subject Matter
Claim 36 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and also, if they overcome the double patenting rejection set forth in this Office Action.
The following is an examiner’s statement of reasons for indicating allowable subject matter in the dependent claims:
The prior art of record fails to disclose or render obvious the combination of features as claimed. In particular, the prior art of record fails to disclose wherein the distal metallic cylindrical element comprises an abrasive coating on an exterior of the distal metallic cylindrical element (claim 36).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
