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
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/28/2026.
Applicant's election with traverse of group I, claims 1-14, in the reply filed on 01/28/2026 is acknowledged. The traversal is on the ground(s) that the claims can be examined without a serious search burden. This is not found persuasive because the search for group I requires a separate search including text searching for method steps of bringing the cutter close to a lesion within the blood vessel and starting rotation of the cutter and continuing rotation of the cutter during a first operation at a first rotation speed through rotation of the drive shaft while the lesion is located distal of the cutter so that the cutter does not cut the lesion not required for the search of group II. Furthermore, group II requires the separate search for a stop condition of main rotation at the second rotation speed is an elapsed time longer than a time of rotating the cutter at the first rotation speed not required by group I.
The requirement is still deemed proper and is therefore made FINAL.
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, 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 1-4, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Neuharth et al. (US 20210077143 A1) in view of Zeroni et al. (US 20120109171 A1) and Moberg et al. (US 20100312263 A1).
Regarding claim 1, Neuharth discloses (fig. 1, 3, 5-6) a method including cutting an object in the blood vessel (see [0043]) a medical device including a drive shaft (drive cable 24, see [0055]) that is rotatable (see [0054]-[0055]), a cutter disposed (burr) on a distal side of the drive shaft (see [0045]), a drive unit (drive mechanism) that rotates the drive shaft (see [0054] and [0044]), the method comprising:
rotating the cutter at a first rotation speed that is set in advance (initial rotation of the burr; see [0044] and [0053]);
determining whether or not a stop condition of a prior operation at the first rotation speed is satisfied (see [0053], the device is adapted to stop if “if the estimated torque meets or exceeds a predetermined torque threshold”); and
rotating the cutter (burr) at a second rotation speed that is set in advance after it is determined that the stop condition of the prior operation is satisfied (reverse rotation, see [0053]).
Neuharth is silent regarding positioning the medical device in a blood vessel; bringing the cutter close to a lesion within the blood vessel, and then, rotating; an outer tubular shaft that rotatably accommodates the drive shaft.
However Zeroni, in the same filed of endeavor, teaches (fig. 1-3 and 19A-19C) positioning a medical device in a blood vessel (see fig. 19A and [0054]); bringing the cutter close to a lesion within the blood vessel (see fig. 19A and [0054]), and then, rotating (see [0054]); an outer tubular shaft 5 that rotatably accommodates the drive shaft (see [0030] and fig. 1-2).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Neuharth to have the method include positioning the medical device in a blood vessel and bringing the cutter close to a lesion within the blood vessel, and then, rotating and to have the device include an outer tubular shaft that rotatably accommodates the drive shaft as taught by Zeroni, for the purpose of being able to bring the cutter in position with the lesion to treat the vessel (see Zeroni [0054]) and be able to introduce the device to the correct location without causing unnecessary damage to healthy tissue (see Zeroni [0030]).
Neuharth as modified is silent regarding the second rotation speed being 10,000 rpm or more and 150,000 rpm or less.
Moberg, in the same filed of endeavor, teaches the cutting element can be rotated about 1 to 160,000 rpm but may be rotated at any other suitable speed depending upon the particular application (see [0033]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Neuharth to have the second rotation speed be 1 to 160,000 rpm as taught by Moberg, for the purpose of being able cut tissue as required for the particular application (see Moberg [0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to adjust the speed of Neuharth as modified from between 1 to 160,000 rpm to between 10,000 and 150,000 rpm as applicant appears to have placed no criticality on the claimed range (see specification [0062] indicating the speed “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, Neuharth as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Neuharth further discloses (fig. 1, 3, 5-6) reducing or stopping the rotation of the cutter after it is determined that the stop condition is satisfied and before the cutter is rotated at the second rotation speed (see [0053], the speed will slow as it transitions to the reverse direction).
Regarding claim 3, Neuharth as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Neuharth as modified fails to disclose the first rotation speed is 400 rpm or more and 10,000 rpm or less.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to the first rotation speed is 400 rpm or more and 10,000 rpm or less because Applicant has placed criticality on the first rotation speed simply indicating that it “may” be within the claimed range (see [0010]). One of ordinary skill in the art, furthermore, would have expected Neuharth as modified’s device, and applicant’s invention, to perform equally well with either the speed taught by Neuharth as modified or the claimed 400 to 10000rpm because both speeds would perform the same function of cutting a lesion.
Therefore, it would have been prima facie obvious to modify Neuharth as modified to obtain the invention as specified in claim 3 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Neuharth as modified.
Regarding claim 4, Neuharth as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Neuharth as modified fails to disclose the first rotation speed is 10,000 rpm or more and 60,000 or less.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to the first rotation speed is 10,000 rpm or more and 60,000 rpm or less because Applicant has placed criticality on the first rotation speed simply indicating that it “may” be within the claimed range (see [0011]). One of ordinary skill in the art, furthermore, would have expected Neuharth as modified’s device, and applicant’s invention, to perform equally well with either the speed taught by Neuharth as modified or the claimed 10,000 rpm or more and 60,000 because both speeds would perform the same function of cutting a lesion.
Therefore, it would have been prima facie obvious to modify Neuharth as modified to obtain the invention as specified in claim 4 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Neuharth as modified.
Regarding claim 7, Neuharth as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Neuharth as modified further teaches wherein, in the rotating of the cutter at the first rotation speed, the cutter is rotated at the first rotation speed after the cutter is oriented to the lesion within the blood vessel (the cutter of Neuharth is modified to be positioned in the vessel and then rotated, see claim 1 above).
Regarding claim 8, Neuharth as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Neuharth as modified further teaches wherein, in the rotating of the cutter at the first rotation speed (see Neuharth [0053]), the cutter is rotated at the first rotation speed as the cutter is oriented to the lesion within the blood vessel (the cutter is modified to rotate after positioning in the vessel).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Neuharth in view of Zeroni and Moberg as applied to claim 1 above, and further in view of Hilse et al. (US 20200397464 A1).
Regarding claim 5, Neuharth as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Neuharth as modified is silent regarding the stop condition is an elapsed time of 0.01 seconds or more. However Hilse, in the same filed of endeavor, teaches the stop condition is an elapsed time of 0.01 seconds or more (see [0057]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Neuharth to have regarding the stop condition is an elapsed time of 0.01 seconds or more as taught by Hilse, for the purpose of being able to pulse the deice to assist in getting the burr unstuck (see Hilse [0057]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Neuharth in view of Zeroni and Moberg as applied to claim 1 above, and further in view of Masubuchi et al. (US 20200289148 A1).
Regarding claim 6, Neuharth as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Neuharth as modified is silent regarding the stop condition is a number of rotations of the cutter that is five or more.
However Masubuchi, in the same field of endeavor, teaches the stop condition is a number of rotations of the cutter that is five or more (see [0059] and [0066]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Neuharth to have regarding the stop condition is a number of rotations of the cutter that is five or more as taught by Masubuchi, for the purpose of ensuring proper removal of a stenosed site within a blood vessel and reduce the hazard on biological tissues and/or blood vessels by stopping the rotation of an agitator or catheter assembly upon engagement with the biological tissues and/or blood vessels (see Masubuchi [0005]).
Allowable Subject Matter
Claims 9-14 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious (in addition to the other limitations of claim 9): a method comprising starting rotation of the cutter and continuing rotation of the cutter during a first operation at a first rotation speed through rotation of the drive shaft while the lesion is located distal of the cutter so that the cutter does not cut the lesion; determining that a stop condition of the first operation at the first rotation speed is satisfied; and rotating the cutter at a preset second rotation speed through rotation of the drive shaft while the cutter is in contact with the lesion so that the lesion is cut by rotation of the cutter at the second rotation speed, the rotating of the cutter at the preset second rotation speed occurring after determining that the stop condition of the first operation at the first rotation speed has been satisfied. The closest prior art has been citied herein and none of the references teach rotating the cutter at a first rotation speed while the lesion is located distal of the cutter so that the cutter does not cut the lesion; determining that a stop condition of the first operation at the first rotation speed is satisfied; and then rotating the cutter at a second speed while the cutter is in contact with the lesion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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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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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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