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 .
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 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.
Response to Amendment
The Response filed March 26, 2026 has been entered. Claims 1-20 are pending in the application.
Election/Restriction
Applicant’s election without traverse of Invention I (Claims 1-8 and 18-20) in the reply filed on March 26, 2026 is acknowledged.
Claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 26, 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
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 are rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. (U.S. Patent Application Publication No. 20180055535;’ hereinafter “Tada”) in view of Smith et al. (U.S. Patent Application Publication No. 20130096587; hereinafter “Smith”).
Regarding claim 1, Tada discloses a medical device (10; Fig. 3) for cutting substances inside a body lumen, the medical device comprising:
a flexible and elongated drive shaft (21) including a distal portion (Figs. 4A-4B) and a proximal portion (Fig. 3);
an outer shaft (30) that surrounds the drive shaft (Fig. 3);
a cutting member (40) connected to the distal portion to be rotatable with the drive shaft (Figs. 4A-4B); and
a hub (60) by which the proximal portion is supported (Fig. 3), the hub including:
a plurality of bearings (63, 64) on the drive shaft (para. [0065]), and
wherein the drive shaft includes a lumen through which the substances cut by the cutting member are transported from the distal portion side thereof to the proximal portion side thereof and discharged at a location of the drive shaft that is between the bearings (paras. [0067]-[0069], [0075]-[0093]).
The device of Tada is not explicitly disclosed with a knob connected to the outer shaft.
Smith, a reference in the medical device field of endeavor, teaches providing a medical device with a knob (2056) connected to an outer shaft (2026) and independently rotatable with respect to a drive shaft (2020; Figs. 20A-22D; paras. [0207]-[0208]) to allow a cutter assembly to cut more occlusive material (para. [0208]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the device of Tada with a knob connected to the outer shaft and independently rotatable with respect to the drive shaft, in view of Smith, in order to facilitate cutting more occlusive material to improve blood flow within a treated vessel.
Regarding claim 2, the modified device is not explicitly disclosed with one of the bearings being at a location corresponding to a distal portion of the knob. However, Tada discloses seal (63) being located adjacent a distal portion of operation unit (60; Fig. 3) to maintain a seal of the operation unit during use. Smith teaches knob (2056) being located adjacent a distal portion of a handle (2002; Fig. 20B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to position one of the bearings at a location corresponding to a distal portion of the knob, in view of Tada and Smith, in order to maintain a proper seal of the operation unit during movement of the knob during use.
Regarding claim 3, Tada discloses wherein the proximal portion of the drive shaft (21) includes a pipe (21) and an aspiration drill (which includes connecting shaft (23) and conveying body (22); Figs. 3 and 7) by which the substances are discharged, and the bearings include a first bearing (63) on the pipe and a second bearing (64) on the aspiration drill (Fig. 3).
Regarding claim 4, Tada discloses wherein the aspiration drill is located on a proximal side of the pipe (Fig. 3).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tada in view of Smith, as applied to claims 1 and 3 above, and further in view of Isobe et al. (U.S. Patent No. 8939345; hereinafter “Isobe”).
Regarding claim 5, Tada discloses the invention substantially as claimed, except for the seal portions (63, 64) being an O-ring to rotatably support the drive shaft (21; para. [0066]) instead of an elastic O-ring contacting a first bearing.
Isobe, a reference in the medical device field of endeavor, teaches configuring a seal portion as an elastic O-ring (52a) contacting a first bearing (26) to rotatably support a drive shaft (Fig. 7; col. 16, ll. 13-28).
Thus, a person having ordinary skill in the art would recognize an O-ring and an O-ring contacting a first bearing were equivalent structures known in the art to rotatably support a drive shaft.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute an O-ring contacting a bearing, as taught by Isobe, for each of the O-rings (63, 64) in Tada to achieve the predictable result of rotatably supporting the drive shaft since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Regarding claim 6, the modified device discloses wherein an outer diameter of the first elastic O-ring (e.g., diameter of an inner surface of O-ring (52a); Isobe Fig. 7) is smaller than an outer diameter of the first bearing (Isobe Fig. 7).
Regarding claim 7, the modified device discloses wherein the hub includes a second elastic O-ring (52a) on a proximal side of the second bearing (26; Isobe Fig. 7).
Regarding claim 8, Tada discloses the invention substantially as claimed, except for the seal portions (63, 64) being an O-ring to rotatably support the drive shaft (21; para. [0066]) instead of a ball bearing including an inner ring, an outer ring, and a plurality of balls therebetween.
Isobe, a reference in the medical device field of endeavor, teaches configuring a seal portion as a ball bearing (26) that includes an inner ring (26a), an outer ring (26b), and a plurality of balls therebetween (Fig. 7) to rotatably support a drive shaft (col. 16, ll. 13-28).
Thus, a person having ordinary skill in the art would recognize an O-ring and a ball bearing were equivalent structures known in the art to rotatably support a drive shaft.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a ball bearing that includes an inner ring, an outer ring, and a plurality of balls therebetween, as taught by Isobe, for each of the O-rings (63, 64) in Tada to achieve the predictable result of rotatably supporting the drive shaft since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tada in view of Smith.
Regarding claim 18, Tada discloses a medical device (10; Fig. 3)for cutting substances inside a body lumen, the medical device comprising:
a flexible and elongated drive shaft (21) including a distal portion (Figs. 4A-4B) and a proximal portion (Fig. 3);
an outer shaft (30) that surrounds the drive shaft (Fig. 3);
a cutting member (40) connected to the distal portion to be rotatable with the drive shaft (Figs. 4A-4B);
a hub (60) by which the proximal portion is supported (Fig. 3), the hub including:
a plurality of bearings (63, 64) on the drive shaft (para. [0065]), and
a handle (90) connectable to a proximal end of the hub and including a motor (91) by which the drive shaft is rotated (Fig. 1; para. [0070]), wherein
the drive shaft includes a lumen through which the substances cut by the cutting member are transported from the distal portion side thereof to the proximal portion side thereof and discharged at a location of the drive shaft that is between the bearings (paras. [0067]-[0069], [0075]-[0093]).
The device of Tada is not explicitly disclosed with a knob connected to the outer shaft or a handle.
Smith, a reference in the atherectomy device field of endeavor, teaches providing a medical device with a knob (2056) connected to an outer shaft (2026) and independently rotatable with respect to a drive shaft (2020; Figs. 20A-22D; paras. [0207]-[0208]) to allow a cutter assembly to cut more occlusive material (para. [0208]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the device of Tada with a knob connected to the outer shaft and independently rotatable with respect to the drive shaft, in view of Smith, in order to facilitate cutting more occlusive material to improve blood flow within a treated vessel.
Regarding claim 19, Tada discloses wherein the proximal portion of the drive shaft (21) includes a pipe (21) and an aspiration drill (which includes connecting shaft (23) and conveying body (22); Figs. 3 and 7) by which the substances are discharged, and the bearings include a first bearing (63) on the pipe and a second bearing (64) on the aspiration drill (Fig. 3).
Regarding claim 20, Tada discloses wherein the aspiration drill is located on a proximal side of the pipe (Fig. 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Escudero et al. (U.S. Patent Application Publication No. 20090234378) disclosing an atherectomy device with a knob and propellor (Figs. 13A-13D).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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