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 action is in response to the amendment filed on 4/10/2025. In the amendment, claims 5, 6, 8, 10-17, 19, & 20 have been amended and claims 21-22 have been cancelled.
Claim Objections
Claim 6 is objected to because of the following informalities: line 2 – examiner suggests amending ‘control wire’ to --control wires-- for proper grammar. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-9, 11, 12, 17, 18, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bhatia et al. (US Pub. No. 2022/0096110 A1) in view of Merlini (WO 2018/130978 A1).
Regarding claim 1, Bhatia et al. disclose a rotational atherectomy device (Figs. 1-3) for abrading or cutting tissue, the atherectomy device comprising: a flexible outer shaft 102, 310 (outer shaft has a flexing region where 102 and 310 meet – shown in Fig. 5); a rotatable inner drive shaft 304 (paragraph [0108]-[0111]), disposed within the outer shaft 102; an abrasive head 308 (Figs. 1-3) connected to the distal end of the rotatable inner drive shaft 304 through a mechanical joint (ball and socket 502 – shown in Figs. 9 & 10) such that the abrasive head 308 can tilt relative to the rotatable inner drive shaft 304; two control wires 302, 316 (Figs. 3 & 9-10) connected to the distal end 310 of the flexible outer shaft 102 (Figs. 9 & 10). Bhatia et al. fail to further disclose wherein there are at least three control wires. However, Merlini teaches a catheter having a steering assembly that comprises four cables 20 (Fig. 12; paragraph [0034]) fixed to the distal end in order to control movement of the catheter in four different directions, thereby providing more access for the distal end without the need for rotating the catheter to achieve bending in more than one plane. It is considered that one of ordinary skill in the art before the effective filing date of the claimed invention would have found it beneficial and obvious in view of Merlini’s teachings to add two more control wires to Bhatia et al.’s device, in order to allow for bending in a different plane without the need for rotational manipulation of the outer shaft.
Regarding claim 2, Bhatia et al.’s device is disclosed to prefer the use of a ball and socket joint as it is less complicated to manufacture when compared to the various types of mechanical joints that exist, however, Bhatia et al. disclose that universal joints are a common example of a joint used to articulate cutting heads (paragraph [0005]). It is considered that one of ordinary skill in the art would have known of this type of joint to choose from when designing the tool and would have found the choice obvious as an option before the effective filing date of the claimed invention. Such a joint is not considered novel in the art of articulating cutting heads/tools in view of the disclosure of paragraph [0005]..
Regarding claim 3, Bhatia et al. further disclose wherein the mechanical joint is a ball and socket joint 502 (Figs. 9 & 10).
Regarding claim 5, Bhatia et al. further disclose wherein the control wires 302, 316 are connected to the distal end 310 of the flexible outer shaft at regular circumferential intervals (Figs. 9 & 10).
Regarding claim 6, Merlini further teaches at least four control wires 20 connected to the distal end of the flexible outer shaft (Fig. 12; paragraph [0034]).
Regarding claim 7, Merlini further teaches wherein the distal ends of the control wires 20 are connected to the distal end of the flexible outer shaft at regular circumferential intervals (Fig. 12; paragraph [0034]).
Regarding claim 8, Bhatia et al. further disclose wherein each of the control wires 302, 316 is disposed within a respective control wire lumen of the flexible outer shaft (in distal connector portion of the shaft shown in Fig. 3 – paragraph [0114]). When Bhatia et al. is modified to include the four control wires suggested and taught by Merlini, these would also have a similar accommodating lumen in 312 by virtue of duplication of the parts to achieve the suggested number of control wires.
Regarding claim 9, Bhatia et al. further disclose wherein each of the control wire lumens terminates in a distal opening disposed proximally of the mechanical joint (312 is located proximally of the mechanical joint 502 (Figs. 9 & 10).
Regarding claim 11, Bhatia et al. further disclose wherein the abrasive head 308 comprises one or more cutting edges (seen best in Fig. 3).
Regarding claim 12, Bhatia et al. further disclose the abrasive head 308 is substantially spherical shaped (Fig. 3).
Regarding claim 17, Bhatia et al. further disclose a control unit 802 connected to the proximal end of the rotatable inner drive shaft 304 (paragraph [0108]).
Regarding claim 18, Bhatia et al. further disclose wherein the control unit comprising a motor 802 (paragraphs [0108] & [0155]) for providing rotation to the rotatable inner drive shaft 304.
Regarding claim 20, Bhatia et al. further disclose wherein the control unit comprises a tilt control mechanism 110 for controlling the angle and direction of tilt of the abrasive head 308 (paragraph [0110]).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over in view of Bhatia et al. (US Pub. No. 2022/0096110 A1) in view of Merlini (WO 2018/130978 A1) further in view of Moutafis et al. (WO 03/024340).
Regarding claim 10, Bhatia et al. and Merlini fail to further disclose wherein the abrasive head comprises an abrasive surface. However, Moutafis et al. teach a similar surgical rotary cutter/burr wherein it is taught that the burr can be selected from a variety of contacting elements to include a standard burr with cutting edges or one with an abrasive surface (page 10, line 30 to page 11, line 6), in order to provide options that are tailored to the specific target site for cutting/abrading with the cutting head. It is considered that one of ordinary skill in the art would have found it obvious in view of the suggestion/teachings of Moutafis et al. that modifying a cutting head to have an abrasive surface would provide a more controlled cutting for finishing off a cutting procedure/more precision cutting during a procedure.
Claims 13 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Bhatia et al. (US Pub. No. 2022/0096110 A1) in view of Merlini (WO 2018/130978 A1) further in view of Salahi (WO 2016/149217).
Regarding claims 13 & 14, Bhatia et al. and Merlini fail to further disclose, teach, or suggest wherein the abrasive head is substantially cone shaped [claim 13]/ellipsoid shaped [claim 14]. However, Salahi teaches a similar rotational burr tool wherein multiple options of burr shape are suggested and taught in Fig. 4B, to include a cone-shape and an ellipsoid-shape as an alternative to the standard spherical shape. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the suggestion and teachings of Salahi to incorporate other configurations/shapes for the cutting head since providing such a change in shape can provide a more specific and accurate cutting based on the target cutting site.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over in view of Bhatia et al. (US Pub. No. 2022/0096110 A1) in view of Merlini (WO 2018/130978 A1) further in view of Efremkin (US Pub. No. 2019/0142453 A1).
Regarding claim 19, Bhatia et al. and Merlini fail to further disclose, teach, or suggest wherein the control unit comprises a rotation control mechanism for controlling the speed of rotation of motor.
However, Efremkin teaches a control unit for a rotational burr/cutter wherein the control unit is used to control the rotational speed of the burr/cutter (via the motor) (paragraph [0054]) in order to optimize the cutting effect based on the targeted cutting site parameters. It would have been beneficial and obvious for one of oridinary skill in the art to utilize the suggestion/teachings of Efremkin to have the control unit control the rotational speed of the cutter for the added benefit of modifying the speed based on the parameters of the target site being cut. Such an added benefit can ensure safe and efficient cutting.
Allowable Subject Matter
Claims 4, 15, & 16 are 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to further disclose, teach, or suggest: wherein the ball and socket joint comprises a first ball positioned within a first socket and a second ball positioned within a second socket, and wherein the first ball and socket are configured to move in a plane orthogonal to the second ball and socket [claim 4]; wherein the rotatable inner drive shaft is flexible [claim 15]; and wherein the rotatable inner drive shaft has a guidewire lumen for accommodating a guidewire [claim 16].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pub. No. 2005/0149084 A1 discloses a rotational abrasive burr for atherectomy, wherein the abrasive burr is steerable via steering wires 72,74 (Fig. 2), however, the steering wires are not connected to a distal end of the outer shaft, they are connected directly to the burr, therefore, they do not meet the limitations of the claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 September 3, 2026
