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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10-12, 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al. (US 20060282150 A1).
Regarding claim 10, Olson discloses a handle for a medical device (stent delivery catheter 20, Fig 1), the handle (handle 28, Fig 1) comprising: a rotatable knob assembly (actuator knob 52, Fig 2) and a slide assembly (paving nut 192+ first lead screw 70, Fig 12B), wherein the knob assembly (52) is couplable to the slide assembly (192+70) to drive movement of the slide assembly (192+70) by rotation of the knob assembly (52); a slip clutch assembly (clutch mechanism; [0095], Fig 12A) between the knob assembly (52) and the slide assembly (192+70), the slip clutch assembly (clutch plates 210, 212) comprising a first disc (first clutch plate 210, Fig 12A) and a second disc (second clutch plate 212, Fig 12A), wherein the first disc (210) has a first engagement face (proximal face 1001 of disc 210, Annotated Fig 1) and is rotatable with the knob assembly ([0052]: a first clutch plate 210 is fixed to the interior surface of the actuator knob 52), wherein the second disc (212) has a second engagement face (distal face 1002 of disc 212, Annotated Fig 1) and is configured to transmit rotation to the slide assembly (192+70)([0095]), wherein the first engagement face (1001, Annotated Fig 1) and the second engagement face (1002, Annotated Fig 1) are engageable to couple the rotatable knob (52) to the slide assembly (192+70) to drive movement of the slide assembly (192+70) by rotation of the knob assembly (52) ([0095]; [0093]; the teeth on the first clutch plate 210 and second clutch plate 212 fully engage translating rotation of the actuator knob 52 into rotation of the drive shaft 88, causing rotation of 70 and advancement of the paving nut 192), and are disengageable to decouple the rotatable knob (52) and the slide assembly (192+70) to prevent movement of the slide assembly (192+70) by rotation of the knob assembly (52) ([0095]; an excessive amount of torque is created, the clutch plates 210, 212 will slip due to displacement of the second clutch plate 212 against the biasing force of the compression spring 214)
Regarding claim 11, Olson discloses the handle of claim 10, wherein at least one of the first disc and the second disc (212) is translatable with respect to the slide assembly (192+70) between a first position (fully engagement position (FEP) of plates 210, and 212, Fig 12A) and a second position (displaced position (DP), Fig 12B) of the second clutch plate 212 against the biasing force of the compression spring 214), wherein in the first position (FEP, Fig 12A) the first engagement face (1001, Annotated Fig 1) and the second engagement face (1002, Annotated Fig 1) are engaged to couple the rotatable knob (52) to the slide assembly (192+70), and in the second position (DP, Fig 12B) the first engagement face (1001, Annotated Fig 1) and the second engagement face (1002, Annotated Fig 1) are disengaged to decouple the rotatable knob (52) from the slide assembly (192+70) ([0095]).
Regarding claim 12, Olson discloses the handle of claim 11, wherein the first disc (210) is fixed to the knob assembly (52), and the second disc (212) is coupled to the slide assembly (192+70) and is translatable between the first position (FEP) and the second position (DP) ([0095]).
Regarding claim 15, Olson discloses the handle of claim 11, wherein the first engagement face (1001, Annotated Fig 1) has a first set of teeth (set of teeth of face 1001, Annotated Fig 1) and the second engagement face (1002, Annotated Fig 1) has a second set of teeth (set of teeth of face 1002, Annotated Fig 1), and wherein the first set of teeth and the second set of teeth each have inclined side surfaces (1003 and 1004, Annotated Fig 1) to facilitate translation from the first position (FEP, Fig 12A) to the second position (DP, Fig 12B) by rotation of the first disc (210, Fig 12B).
Regarding claim 16, Olson discloses the handle of claim 10, wherein the second disc (212) is longitudinally fixed with respect to the first disc (210) (First disc 210 and second disc 212 are longitudinally fixed in the first position FEP as long as the torque does not exceed the determined threshold; [0095]).
Regarding claim 17, Olson discloses the handle of claim 10, wherein the first engagement face (1002, Annotated Fig 1) and second engagement face (1002, Annotated Fig 1) are engageable by magnetic forces or frictional forces (Friction force of teeth engagement between first disc 210 and second disc 212; [0095]).
Regarding claim 18, Olson discloses a method for operating a medical device (stent delivery catheter 20, Fig 1), comprising:
a. with a knob assembly (actuator knob 52, Fig 2) of the medical device coupled to a slide assembly (paving nut 192+ first lead screw 70, Fig 12B) of the medical device via a slip clutch assembly (clutch mechanism; [0095], Fig 12A), applying torque to the knob assembly (52) to rotate the knob assembly (52), wherein the slip clutch assembly (clutch mechanism; [0095], Fig 12A), comprises a first disc (first clutch plate 210, Fig 12B) having a first engagement face (proximal face 1001 of disc 210, Annotated Fig 1) and a second disc (second clutch plate 212, Fig 12A) having a second engagement face (distal face 1002 of disc 212, Annotated Fig 1) engageable with the first engagement face (1001, Annotated Fig 1), wherein the first disc (210) is rotatable with the knob assembly (52), and the second disc (212) is configured to transmit rotation to the slide assembly (192+70); and
b. transmitting rotation of the knob assembly (52) to the slide assembly (192+70) via the slip clutch assembly (clutch mechanism; [0095], Fig 12A), including transmitting rotation of the knob assembly (52) to the first disc (210), transmitting rotation of the first disc (210) to the second disc (212), and transmitting rotation of the second disc (212) to the slide assembly (192+70).
Regarding claim 19, Olson discloses the method of claim 18, wherein in step b., the second engagement face (distal face 1002 of disc 212, Annotated Fig 1) is maintained in engagement with the first engagement face (proximal face 1001 of disc 210, Annotated Fig 1) by a spring (compression spring 214, Fig 12B) ([0095]).
Regarding claim 20, Olson discloses 20. The method of claim 18, further comprising:
c. increasing the torque applied to the knob assembly (52) to exceed a threshold value ([0095]); and
d. as a result of step c., decoupling the knob assembly (52) from the slide assembly (192+70) via the slip clutch assembly (clutch mechanism; [0095], Fig 12A) ([0095]: if an excessive amount of torque is created, the clutch plates 210, 212 will slip due to displacement of the second clutch plate 212 against the biasing force of the compression spring 214. The amount of torque needed to cause the clutch plates to slip may be adjusted)
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 20150231366 A1) in view of Olson et al. (US 20060282150 A1).
Regarding claim 1, Davies discloses a steerable medical device (steerable control system, Fig 1) comprising: a handle (handle 100, Fig 1) having a rotatable knob assembly (knob 10, Fig 2A) and housing (Housing 20, Fig 2A) a slide assembly (carriage 34, Fig 2C), wherein the knob assembly (10) is couplable to the slide assembly (34) to drive movement of the slide assembly (34) by rotation of the knob assembly (10)([0092]); an elongate tool (sheath 90, Fig 2C) extending from the handle (100) (Fig 1); at least one control wire (control wires 40, 42, Fig 2A) coupled between the slide assembly (34) and the tool (90)([0092]), whereby movement of the slide assembly (34) causes tensioning of the control wire (40,42), and tensioning of the control wire (40,42) causes deflection of the tool (90)([0092]);
Davies is silent regarding a slip clutch assembly between the knob assembly and the slide assembly, whereby when torque applied to the knob assembly is below a threshold value, the slip clutch assembly couples the knob assembly to the slide assembly to drive movement of the slide assembly by rotation of the knob assembly, and whereby when torque applied to the knob assembly is above the threshold value, the slip clutch assembly decouples the knob assembly from the slide assembly to prevent movement of the slide assembly by rotation of the knob assembly.
Olson teaches a slip clutch assembly (clutch mechanism; [0095], Fig 12A) between the knob assembly (actuator knob 52, Fig 2) and the slide assembly (paving nut 192+ first lead screw 70, Fig 12B), whereby when torque applied to the knob assembly (52) is below a threshold value, the slip clutch assembly (192+70) couples the knob assembly (50) to the slide assembly (192+70) to drive movement of the slide assembly (192+70) by rotation of the knob assembly (50), and whereby when torque applied to the knob assembly (50) is above the threshold value, the slip clutch assembly (192+70) decouples the knob assembly (50) from the slide assembly to prevent movement of the slide assembly (192+70) by rotation of the knob assembly (50) ([0095]; [0093]; the teeth on the first clutch plate 210 and second clutch plate 212 fully engage translating rotation of the actuator knob 52 into rotation of the drive shaft 88, causing rotation of 70 and advancement of the paving nut 192; an excessive amount of torque is applied, the clutch plates 210, 212 will slip due to displacement of the second clutch plate 212 against the biasing force of the compression spring 214).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Davies with similar clutch mechanism including clutch plates (210,212), spring (214), driveshaft (88) and flange (1006, annotated Fig 1) and modify the slide assembly to be coupled via (first lead screw 70) as taught by Olson for the purpose for the purpose of disengaging the knob from the slide assembly when a torque exceeds the threshold ([0022];[0095]).
Regarding claim 2, Davies/Olson discloses the steerable medical device of claim 1. As combined Olson teaches wherein the slip clutch assembly (clutch mechanism; [0095], Fig 12A) comprises: a first disc (first clutch plate 210, Fig 12A) rotatable with the knob assembly (actuator knob 52, Fig 2) and having a first engagement face (proximal face 1001 of disc 210, Annotated Fig 1); and a second disc (second clutch plate 212, Fig 12A) configured to transmit rotation to the slide assembly (34, from Davies + 70, from Olson) and having a second engagement face (distal face 1002 of disc 212, Annotated Fig 1,).
Regarding claim 3, Davies/Olson discloses the steerable medical device of claim 2. As combined, Olson teaches wherein at least one of the first disc and the second disc (212) is translatable between a first position (fully engagement position (FEP) of plates 210, and 212, Fig 12A) and a second position (displaced position (DP), Fig 12B), wherein in the first position (FEP, Fig 12A) the first engagement face (1001, Annotated Fig 1) and the second engagement face (1002, Annotated Fig 1) are engaged to couple the rotatable knob (52) to the slide assembly (34, from Davies + 70, from Olson), and in the second position (DP, Fig 12B) the first engagement face (1001, Annotated Fig 1) and the second engagement face (1002, Annotated Fig 1) are disengaged to decouple the rotatable knob (52) from the slide assembly (192) ([0095]).
Regarding claim 4, Davies/Olson discloses the steerable medical device of claim 3. As combined, Olson teaches wherein the first disc (210) is fixed to the knob assembly (52), and the second disc (212) is coupled to the slide assembly (34, from Davies + 70, from Olson) and is translatable between the first position (FEP) and the second position (DP) ([0095]).
Regarding claim 5, Davies/Olson discloses the steerable medical device of claim 4. As combined, Olson teaches wherein: the slip clutch assembly (clutch mechanism; [0095], Fig 12A) further comprises a driveshaft (drive shaft 88, Fig 12B) fixed to the slide assembly (34, from Davies + 70, from Olson) (drive shaft 88 is translationally fixed relative to the first lead screw 70 of the slide assembly; [0090]) and extending towards the rotatable knob (54) and a spring (compression spring 214, Fig 12B) biasing the second disc (212, Fig 12A) towards the first position (FEP, Fig 12A); the driveshaft (88) comprises a spline (1005, Annotated Fig 4); the second disc (212, Fig 12A) is annular (Fig 12A) and comprises an inner surface having a longitudinal groove (inner surface of disc 212 have at least a groove where the key of shaft 88 is inserted); and the second disc (212) is received on the drive shaft (88) with the spline engaged with the groove (Fig 12A-B) ([0095]; The second clutch plate 212 is keyed to the drive shaft 88 such that it is able to slide proximally along the drive shaft 88 but cannot rotate on the shaft.)
Davies/Olson are silent regarding the plurality of splines and the plurality of grooves.
However, the claim and the specification fail to provide indication that this configuration of the disc and driveshaft results in an unexpected technical benefit or serves a critical functional purpose. Even though Olson does not disclose more than one spline and groove, the addition and arrangement of identical splines and grooves to accomplish the same function is not considered inventive since it accomplishes the same desired function and achieves the same results. Therefore, the duplication of components is considered an obvious modification that would have been within the skill of a person of ordinary skill in the art.
Regarding claim 6, Davies/Olson discloses the steerable medical device of claim 5. As combined, Olson teaches wherein the slip clutch assembly (clutch mechanism; [0095], Fig 12A) further comprises a flange (1006, Annotated Fig 1) from which the driveshaft (88) extends, wherein the spring (214) is received on the driveshaft (88) and is compressed between the flange (1006, Annotated Fig 1) and the second disc (212).
Regarding claim 7, Davies/Olson discloses the steerable medical device of claim 3. As combined, Olson teaches wherein the first engagement face (1001, Annotated Fig 1) has a first set of teeth (set of teeth of face 1001, Annotated Fig 1), and the second engagement face (1002, Annotated Fig 1) has a second set of teeth (set of teeth of face 1002, Annotated Fig 1), and wherein the first set of teeth and the second set of teeth each have inclined side surfaces (1003 and 1004, Annotated Fig 1) to facilitate movement from the first position (FEP, Fig 12A) to the second position (DP, Fig 12B) by rotation of the first disc (210, Fig 12B).
Regarding claim 8, Davies/Olson discloses the steerable medical device of claim 2. As combined, Olson teaches wherein the second disc (212) is longitudinally fixed with respect to the first disc (210) (First disc 210 and second disc 212 are longitudinally fixed in the first position FEP under biasing action of compression spring 214 as long as the torque does not exceed the determined threshold; [0095]).
Regarding claim 9, Davies/Olson discloses the steerable medical device of claim 2. As combined, Olson teaches wherein when torque applied to the knob assembly (50) is below a threshold value (value at which discs slip; [0095]), the first disc (210) transmits rotation to the second disc (212) by magnetic forces or frictional forces between the first engagement face (1001, Annotated Fig 1) and the second engagement face (1002, Annotated Fig 1) ([0095]; [0093]; frictional).
Claim 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (US 20060282150 A1).
Regarding claim 13, Olson discloses the handle of claim 12, wherein: the slip clutch assembly further comprises a driveshaft fixed (drive shaft 88, Fig 12B) to the slide assembly (192+70) (drive shaft 88 is translationally fixed relative to the first lead screw 70 of the slide assembly; [0090]) and extending towards the knob assembly (52) (Fig 12B, shows the first lead screw extending into the direction of drive shaft 88), and a spring (compression spring 214, Fig 12B) biasing the second disc (212) toward the first position (FEP, Fig 12A); the driveshaft (88) comprises a spline (1005, Annotated Fig 4); the second disc (212, Fig 12A) is annular (Fig 12A) and comprises an inner surface having a longitudinal groove (inner surface of disc 212 have at least a groove where the key of shaft 88 is inserted); and the second disc (212) is received on the drive shaft (88) with the spline engaged with the groove (Fig 12A-B) ([0095]; The second clutch plate 212 is keyed to the drive shaft 88 such that it is able to slide proximally along the drive shaft 88 but cannot rotate on the shaft.)
Olson is silent regarding the plurality of splines and the plurality of grooves.
However, the claim and the specification fail to provide indication that this configuration of the disc and driveshaft results in an unexpected technical benefit or serves a critical functional purpose. Even though Olson does not disclose the plurality of splines and grooves, the addition and arrangement of identical splines and grooves to accomplish the same function is not considered inventive since it accomplishes the same desired function and achieves the same results. Therefore, the duplication of components is considered an obvious modification that would have been within the skill of a person of ordinary skill in the art.
Regarding claim 14, Olson discloses the handle of claim 13, wherein the slip clutch assembly (clutch mechanism; [0095], Fig 12A) further comprises a flange (1006, Annotated Fig 1) from which the driveshaft (88) extends, wherein the spring (214) is received on the driveshaft (88) and is compressed between the flange (1006, Annotated Fig 1) and the second disc (212).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
