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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 19th, 2026 has been entered.
Response to Amendment
Claims filed on March 19th, 2026 have been entered. Claims 1-7, 10, 12- 22, 25, and 27- 34 are pending in the application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 7, 10, 15- 16, 18-20, 22, 25, and 30- 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin, JR. et al (US 2001/0037121) in view of Barry (US 2002/0151917).
Regarding claims 1 and 16, McGuckin, JR. teaches an orbital atherectomy system (abstract)(Figs. 2A- 14F), comprising: a handheld driver (drive unit 5, air tank 1, air lines 3)(The drive unit, as seen in Fig. 2A is a device able to be held.) having a motor (For purposes of examination, the air tank 1 and air lines 3 are considered the motor as they cause the rotation of the driveshaft (Paragraph 0064).); an elongated flexible driveshaft (22)(Paragraph 0064) having a proximal end portion and a distal end portion defining a distal end (see annotated Fig. 2A and Fig. 4 below), the proximal end portion being drivably coupled to the motor (Paragraph 0064), the distal end portion defining a rotational axis (see annotated Fig. 4 below); and an abrasive element (atherectomy tip 30) fixedly disposed on the distal end portion of the elongate flexible driveshaft (Paragraph 0075), wherein the abrasive element includes a first flat side (flat or linear sidewall 52a), a second flat side (flat or linear sidewall 52b), a leading tapered end portion having a leading end, and a trailing tapered end portion having a trailing end (see annotated Fig. 11 below), wherein the first flat side and the second flat side are on opposite sides of the rotational axis and a maximum width of the abrasive element is defined between the first flat side and the second flat side (see annotated Fig. 14F below)(Paragraph 0069).
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McGuckin, JR. does not teach wherein the distal end of the elongate flexible driveshaft terminates at or proximally to a leading proximal end of the leading tapered end portion of the abrasive element.
Barry teaches a similar atherectomy system (22)(abstract)(Figs. 1-6), comprising: a motor (Paragraph 0028); an elongated flexible driveshaft (26) having a proximal end portion and a distal end portion defining a distal end (see annotated Fig. 1 and 2 below), the proximal end portion being drivably coupled to the motor (Paragraph 0028), the distal end portion defining a rotational axis (see annotated Fig. 2 below); and an abrasive element (ablation burr 28) fixedly disposed on the distal end portion of the elongate flexible driveshaft (Paragraphs 0028 and 0030), wherein the abrasive element includes a leading tapered end portion having a leading end and a trailing tapered end portion having a trailing end, and wherein the distal end of the elongate flexible driveshaft terminates proximally to a leading proximal end of the leading tapered end portion of the abrasive element (see annotated Fig. 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the configuration of the driveshaft and the leading tapered end portion of the abrasive element as taught by McGuckin, JR. to have the configuration of the distal end of the elongate flexible driveshaft terminating proximally to a leading proximal end of the leading tapered end portion of the abrasive element as taught by Barry for the purpose of performing an atherectomy. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one configuration for another because both configurations are disclosed as equivalent structures for performing an atherectomy and cutting debris within a vessel (McGuckin, JR., abstract; Barry, abstract and Paragraph 0028) and substitution of one for the other would have resulted in the predictable result of cutting debris within a vessel. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claims 3 and 18, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. further teaches wherein the first flat side and the second flat side are substantially parallel (see annotated Fig. 14F below)(Paragraph 0069).
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Regarding claims 4 and 19, McGuckin, JR. and Barry make obvious teaches the orbital atherectomy system as discussed above.
McGuckin, JR. further teaches wherein a longitudinal length of each of the first flat side and the second flat side is less than an overall longitudinal length of the abrasive element (see annotated Fig. 11 below).
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Regarding claim 5 and 20, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. further teaches wherein the leading tapered end portion and the trailing tapered end portion of the abrasive element taper in opposite directions along the rotational axis (see annotated Fig. 11 below).
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Regarding claim 7 and 22, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. further teaches wherein the abrasive element is configured: to be symmetrical around the rotational axis (see annotated Fig. 11 below).
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Regarding wherein the abrasive element is configured to have a non-uniform mass distribution around the rotational axis, as McGuckin teaches that the proximal end of the abrasive element has a wider diameter and therefore more mass that the distal end of the abrasive element, it would be obvious to one of ordinary skill in the art that the abrasive element has a non-uniform mass distribution around the rotational axis. Furthermore, as McGuckin teaches the same structure, the structure would be expected to have the same mechanical properties as the claimed element.
Regarding wherein the abrasive element is configured to have a center of mass that lies on the rotational axis, as McGuckin teaches that the abrasive element is symmetrical around the rotational axis (see annotated Fig. 11 above) and has the same structure as claimed, the abrasive element of McGuckin would have a center of mass that lies on the rotational axis. Furthermore, as McGuckin does not teach that the center of mass has changed, the center of mass of the object would remain in the center, where the rotational axis runs through, due to the structure of the abrasive element.
Regarding claims 10 and 25, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. further teaches wherein the abrasive element includes an intermediate section (44) interposed between the leading tapered end portion and the trailing tapered end portion (Paragraph 0068), the intermediate section having diametrically opposed convex side surfaces (54a, 54b) that are circumferentially interposed between the oppositely facing first flat side and the second flat side (see annotated Fig. 14F below)(Paragraph 0069).
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Regarding claims 15 and 30, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. further teaches the system further comprising a guidewire (60) and wherein the elongate flexible driveshaft has an elongate guidewire lumen that is configured to slidably receive the guidewire, the elongate flexible driveshaft configured to be axially advanced over and rotated around the guidewire (Paragraph 0075).
Regarding claim 31, McGuckin, JR. teaches an abrasive element (atherectomy tip 30)(Figs. 2A- 14F) for use in an orbital atherectomy system (abstract and Paragraph 0064), comprising a first flat side (flat or linear sidewall 52a), a second flat side (flat or linear sidewall 52b), a leading tapered end portion having a leading end at a distal end of the abrasive element, a trailing end portion having a trailing end at a proximal end of the abrasive element, and an elongate opening for receiving an elongate flexible driveshaft (22)(Paragraph 0064)(see annotated Fig. 4 and 11 below), wherein the first flat side and the second flat side are on opposite sides of a rotational axis or the abrasive element and a maximum width of the abrasive element is defined between the first flat side and the second flat side (see annotated Fig. 14F below)(Paragraph 0069).
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McGuckin, JR. does not teach wherein the elongate opening distally terminates at or proximally to a leading proximal end of the leading tapered end portion of the abrasive element.
Barry teaches a similar atherectomy system (22)(abstract)(Figs. 1-6), comprising: a motor (Paragraph 0028); an elongated flexible driveshaft (26), the proximal end portion being drivably coupled to the motor (Paragraph 0028); and an abrasive element (ablation burr 28) fixedly disposed on the distal end portion of the elongate flexible driveshaft (Paragraphs 0028 and 0030) and defining a rotational axis, wherein the abrasive element includes a leading tapered end portion having a leading end, a trailing tapered end portion having a trailing end, and an elongate opening (axial socket 52) for receiving the driveshaft (Paragraph 0030), and wherein the elongate opening terminates proximally to a leading proximal end of the leading tapered end portion of the abrasive element (see annotated Fig. 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the configuration of the elongate opening and the leading tapered end portion of the abrasive element as taught by McGuckin, JR. to have the configuration of the elongate opening distally terminating at or proximally to a leading proximal end of the leading tapered end portion of the abrasive element as taught by Barry for the purpose of performing an atherectomy. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one configuration for another because both configurations are disclosed as equivalent structures for performing an atherectomy and cutting debris within a vessel (McGuckin, JR., abstract; Barry, abstract and Paragraph 0028) and substitution of one for the other would have resulted in the predictable result of cutting debris within a vessel. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 32, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. teaches wherein the leading end portion and the trailing end portion are rounded (see annotated Fig. 11 below).
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Regarding claim 33, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. teaches wherein the abrasive element is longitudinally symmetrical (see annotated Fig. 11 below).
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Claim(s) 2, 14, 17, 29, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin, JR et al. (US 2001/0037121) in view of Barry (US 2002/0151917), as applied to claims 1, 16, and 31 above, in further view of Chanduszko (WO 2016/108860).
Regarding claims 2 and 17, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
The combination does not teach wherein the abrasive element has an exterior surface that encompasses the first flat side, the second flat side, the leading tapered end portion, and the trailing tapered end portion, wherein at least a portion of the exterior surface includes abrasive particles.
Chanduszko teaches an orbital atherectomy system (1)(abstract)(Figs. 1- 8J), comprising: a driver (drive system 3) having a motor (Paragraph 0088); an elongated flexible driveshaft (5) having a proximal end portion and a distal end portion (see annotated Fig. 1 below), the proximal end portion being drivably coupled to the motor (Paragraph 0088), the distal end portion defining a rotational axis (see annotated Fig. 1A below); and an abrasive element (200) fixedly disposed on the distal end portion of the elongate flexible driveshaft (Paragraph 0092), wherein the abrasive element includes a leading tapered end portion having a leading end and a trailing tapered end portion having a trailing end (see annotated Fig. 8C below). Chanduszko further teaches wherein the abrasive element has an exterior surface (207) wherein at least a portion of the exterior surface includes abrasive particles (Paragraph 0093).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the exterior surface of the abrasive element as taught by the combination of McGuckin, JR. and Barry to include abrasive particles as taught by Chanduszko, since Chanduszko teaches that the abrasive particles “may increase the ability of the abrasive element 200 to ablate lesions: (Paragraph 0093).
Regarding claims 14 and 29, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. teaches wherein the abrasive element includes an elongate opening (rear opening 32) configured to receive the elongate flexible driveshaft (Paragraph 0075).
The combination does not teach wherein the abrasive element being fixedly attached at the elongate opening to the distal end portion of the elongate flexible driveshaft by a weld.
Chanduszko teaches an orbital atherectomy system (1)(abstract)(Figs. 1- 8J), comprising: a driver (drive system 3) having a motor (Paragraph 0088); an elongated flexible driveshaft (5) having a proximal end portion and a distal end portion (see annotated Fig. 1 below), the proximal end portion being drivably coupled to the motor (Paragraph 0088), the distal end portion defining a rotational axis (see annotated Fig. 1A below); and an abrasive element (200) fixedly disposed on the distal end portion of the elongate flexible driveshaft (Paragraph 0092), wherein the abrasive element includes a leading tapered end portion having a leading end and a trailing tapered end portion having a trailing end (see annotated Fig. 8C below). Chanduszko further teaches wherein the abrasive element includes an elongate opening configured to receive the elongate flexible driveshaft (see annotated Fig. 8A below), the abrasive element being fixedly attached at the elongate opening to the distal end portion of the elongate flexible driveshaft by a weld (Paragraph 0092).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the attachment of the abrasive element and the driveshaft as taught by the combination of McGuckin, JR. and Barry to be attached by a weld as taught by Chanduszko, since Chanduszko teaches that this connection allows the pieces to move unison (Paragraph 0091) and as Chanduszko teaches that this connection is one of many known in the art (Paragraphs 0092 and 0105).
Regarding claim 34, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. does not teach wherein the abrasive element is longitudinally asymmetrical.
Chanduszko teaches an orbital atherectomy system (1)(abstract)(Figs. 1- 8J), comprising: a driver (drive system 3) having a motor (Paragraph 0088); an elongated flexible driveshaft (5) having a proximal end portion and a distal end portion (see annotated Fig. 1 below), the proximal end portion being drivably coupled to the motor (Paragraph 0088), the distal end portion defining a rotational axis (see annotated Fig. 1A below); and an abrasive element (200) fixedly disposed on the distal end portion of the elongate flexible driveshaft (Paragraph 0092), wherein the abrasive element includes a leading tapered end portion having a leading end, and a trailing tapered end portion having a trailing end (see annotated Fig. 8C below). Chanduszko further teaches wherein the abrasive element is longitudinally asymmetrical (see annotated Fig. 8C below).
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It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the abrasive element as taught by the combination of McGuckin, JR. and Barry to be asymmetrical as taught by Chanduszko, since Chanduszko teaches that the shape increases the ability of the abrasive element through tight passageways and through calcified material (Paragraph 0095) and increases the effectiveness of the device (Paragraph 0099).
Claim(s) 6 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin, JR et al. (US 2001/0037121) in view of Barry (US 2002/0151917), as applied to claim 1 above, in further view of Lupton et al. (US 2012/0197276).
Regarding claims 6 and 21, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
The combination does not teach wherein an angle of taper of the leading tapered end portion of the abrasive element relative to the rotational axis is in a range of 10 degrees to 75 degrees, and an angle of taper of the trailing tapered end portion of the abrasive element relative to the rotational axis is in a range of minus 10 degrees to minus 75 degrees.
Lupton (Lupton et al.) teaches a system (Figs. 1- 10) for recanalizing a blocked vessel (abstract), the system comprising a guidewire (1) with a proximal end (3), a distal end (4), a terminal member (7) and a taper on the terminal member (see annotated Fig. 7 below). Lupton further teaches that the taper has an angle within the range of 5 degrees to 60 degrees (Paragraph 0118).
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It would have been obvious to one of ordinary skill in the art to modify the taper of the leading tapered end portion as taught by the combination to have the angle relative to the rotational axis be in the range of 5 degrees to 60 degrees as taught by Lupton, since Lupton teaches that the angle is “sufficiently acute for gradually opening” an occlusion within a blood vessel (Paragraph 0116) and therefore allows the device to interact with the occlusion without pushing it farther into the vessel.
As the combination of McGuckin, JR., Barry, and Lupton teaches a range of 5 degrees to 60 degrees, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range to be 10 degrees to 75 degrees, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding the angle of the taper of the trailing tapered end portion of the abrasive element relative to the rotational axis is in a range of minus 10 degrees to minus 75 degrees, as McGuckin, JR. teaches that the taper of the trailing tapered end portion is the opposite of the taper of the leading tapered end portion (see annotated Fig. 11 below), and that both portions are inserted into a vessel with an occlusion (abstract), it would have been obvious to modify the angle of the trailing tapered end portion to be in the range of 5 degrees to 60 degrees as taught by Lupton, since Lupton teaches that the angle is “sufficiently acute for gradually opening” an occlusion within a blood vessel (Paragraph 0116) and therefore allows the device to interact with the occlusion without pushing it farther into the vessel and therefore, as the angles are opposite, have the range be -5 degrees to -60 degrees. Furthermore, as the combination has a range of -5 degrees to -60 degrees, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range to be -10 degrees to -75 degrees, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
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Claim(s) 12 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin, JR et al. (US 2001/0037121) in view of Barry (US 2002/0151917), as applied to claim 1 above, in further view of Takayama et al. (US 2018/0116784).
Regarding claims 12 and 27, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
The combination does not teach wherein the leading tapered end portion of the abrasive element directly transitions into the trailing tapered end portion of the abrasive element.
Takayama (Takayama et al.) teaches a system (Fig. 5B) for cutting tissue (abstract)(Paragraph 0003) comprising: a drive shaft (72) with a cutting element (74) with a leading tapered end portion of the abrasive element and a trailing tapered end portion of the abrasive element, a first flat side and a second flat side that is opposite of the first flat side of an axis (see annotated Fig. 5B below). Takayama further teaches wherein the leading tapered end portion of the abrasive element directly transitions into the trailing tapered end portion of the abrasive element (see annotated Fig. 5B below).
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It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the abrasive element as taught by the combination to be the shape of the cutting element as taught by Takayama, since a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976). Furthermore, applicant has not shown unexpected results gleaming from having the claimed shape.
Claim(s) 13 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin, JR et al. (US 2001/0037121) in view of Barry (US 2002/0151917), as applied to claim 1 above, in further view of Fleming et al. (US 2018/0317956).
Regarding claims 13 and 28, McGuckin, JR. and Barry make obvious the orbital atherectomy system as discussed above.
McGuckin, JR. teaches wherein the leading tapered end portion of the abrasive element is at least partially defined by a cone-shaped surface, wherein the cone-shaped surface adjoins and transitions to the first flat side and the second flat side (see annotated Fig. 11 below).
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McGuckin, JR. does not teach wherein the trailing tapered end portion of the abrasive element is at least partially defined by a cone- shaped surface, wherein the cone-shaped surface adjoins and transitions to the first flat side and the second flat side.
Fleming (Fleming et al.) teaches an orbital atherectomy system (catheter 10)(abstract)(Figs. 1- 9) comprising: a motor (43) and an abrasive element (tissue- removing element 20)(Paragraph 0035) with a leading tapered end portion (distal segment 84) of the abrasive element and a trailing tapered end portion (proximal segment 80) of the abrasive element, wherein the trailing tapered end portion is at least partially defined by a cone- shaped surface, and the cone- shaped surface adjoins and transitions into an intermediate portion (middle segment 82)(see annotated Fig. 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the abrasive element as taught by the combination to have the trailing tapered end portion have a cone-shaped surface as taught by Fleming, since Fleming teaches this shape wedges open the tissue passages and then removes tissue (Paragraph 0037).
Response to Arguments
Applicant's arguments filed March 19th, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see Page 10, regarding that McGuckin, JR. does not teach wherein a maximum width of the abrasive element is defined between the first flat side and the second flat side, this argument has been fully considered but is not persuasive. Under BRI, a maximum width of the abrasive element only needs to be between the first flat side and the second flat side, it is not defined as being from the first flat side to the second flat side and is not defined as the greatest width of the abrasive element. Therefore, McGuckin teaches a maximum width defined between the first flat side and the second side (see annotated Fig. 14F below).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Sullivan et al. (US 2017/0150974) teaches a similar abrasive element with flat sides (Fig. 13B)(abstract and Paragraph 0051).
Shiber (US 2020/0069328) teaches a similar abrasive element with flat sides (Fig. 3)(abstract and Paragraph 0049).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
Prosecution Insights