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 § 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(s) 47-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hauser et al. (US 7,686,825) in view of Parmentier (US 2018/0280005).
Regarding claim 47, Hauser discloses
A method for treating a patient with a thromboembolism (see fig. 20 and col. 11 lines 34-57), the method comprising:
positioning an ultrasound catheter (catheter shown in fig. 20) in a first position (position shown in fig. 20), wherein in the first position (see fig. 20):
a distal end of the ultrasound catheter is positioned proximal to a treatment site having a clot in a vessel (see fig. 20 for distal end of 980 being proximal to a thrombus/clot), and
a delivery component (982) of the ultrasound catheter faces the treatment site (see fig. 20);
delivering, with the ultrasound catheter in the first position (see fig. 20), targeted ultrasound energy from the delivery component to the treatment site for an initial treatment period (see fig. 20 and col. 11 lines 34-57).
Hauser is silent about after the initial treatment period, advancing the ultrasound catheter to a second position in which the distal end of the ultrasound catheter is positioned in the treatment site; articulating, with the ultrasound catheter in the second position, the distal end of the ultrasound catheter such that the delivery component of the ultrasound catheter faces a residual clot; and delivering, after articulating the distal end of the ultrasound catheter, targeted ultrasound energy from the delivery component to the residual clot.
However, Parmentier teaches a method of treating a patient with a thromboembolism (see figs. 1-10 and pars. 0021-0041), the method comprising advancing the ultrasound catheter (158/140) to a second position (position where 156/154 is in the thrombus) in which the distal end of the ultrasound catheter is positioned in the treatment site (see fig. 10 for distal end of 140 is positioned in the treatment site such that 154/156 is in thrombus B1); articulating (expanding 154/156), with the ultrasound catheter in the second position (see fig. 10), the distal end of the ultrasound catheter (distal end of 140 with element 154/156) such that the delivery component (154/156) of the ultrasound catheter faces a residual clot (thrombus B1 in fig. 10. See also par. 0035 for the distal end/the tip 140a is initially advanced into a blockage/thrombus, and then 154 is deployed/expanded to aid in clearing the remainder of the blockage/clot surrounding the pilot path as 140 is advanced); and delivering, after articulating the distal end of the ultrasound catheter, targeted ultrasound energy from the delivery component to the residual clot (see fig. 10 and par. 0038).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Hauser by adding an expandable portion to the ultrasound catheter and adding the steps of advancing the ultrasound catheter such that the modified expandable portion is positioned within the clot, articulating the ultrasound catheter such that the modified expandable portion is expanded and treating the clot with ultrasound energy, as taught by Parmentier, for the purpose of aiding in clearing a blockage or obstruction in a vessel (par. 0032 of Parmentier) so that the blockage is substantially cleared in a single pass, and without the need for prolonging the procedure (par. 0035 of Parmentier).
Regarding claim 48, Hauser in view of Parmentier discloses
The method of Claim 47, further comprising advancing an introducer sheath into a patient's vascular system before advancing the ultrasound catheter, and advancing the ultrasound catheter through the introducer sheath and into the treatment site (see col. 3 lines 52-62).
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Regarding claim 49, Hauser in view of Parmentier discloses the method of Claim 48, as set forth above, except for wherein the introducer sheath comprises an aspiration catheter.
However, an embodiment of Hauser teaches an aspiration catheter for asoirating fluid and particles from the vessel before, during or after maceration of an embolus (col. 10 lines 3-12).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Hauser embodiment in fig. 20 by adding an aspiration catheter, as taught by Hauser embodiment in fig. 14, for the purpose of creating a fluid flow to aid in removing the blockage/clot (col. 10 lines 3-12 of Hauser).
Regarding claim 50, Hauser in view of Parmentier discloses the method of Claim 49,
Hauser embodiment in fig. 14 teaches wherein the aspiration catheter includes an expandable funnel (802) at a distal end of the aspiration catheter (see fig. 14).
Regarding claim 51, Hauser in view of Parmentier discloses the method of claim 47,
Hauser further discloses delivering a therapeutic compound from the ultrasound catheter to the treatment site (col. 6 lines 64-67, col. 7 lines 13-28, and col. 11 lines 49-52).
Regarding claim 52, Hauser in view of Parmentier discloses the method of claim 51,
Hauser further discloses delivering the therapeutic compound through a lumen of the ultrasound catheter, and wherein the therapeutic compound comprises at least one of a lytic, microbubbles or a nanodroplets (see col. 11 lines 49-52 for the delivery of ultrasonic vibration being accompanied by the delivery of thrombolytic drugs).
Regarding claim 53, Hauser in view of Parmentier discloses the method of claim 47,
Hauser further discloses wherein the delivery component comprises an ultrasound element (982, fig. 20 and col. 11 lines 34-50) at the distal end of the ultrasound catheter (see fig. 20).
Regarding claim 54, Hauser in view of Parmentier discloses the method of claim 47, as set forth above, except for further comprising rotating the ultrasound catheter.
However, an embodiment of Hauser teaches a step of rotating the catheter (col. 6 lines 48-63).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Hauser method by adding a step of rotating the catheter, as taught by an embodiment of Hauser, for the purpose of providing mechanical forces on the embolus/clot, thereby causing it to compress and eventually dissolve into harmless smaller particles so that the body’s own lytic capabilities are able to quickly dissolve the remaining pieces over time (col. 6 lines 48-63 of Hauser).
Regarding claim 55, Hauser in view of Parmentier discloses the method of claim 47,
Parmentier further teaches wherein articulating the distal end of the ultrasound catheter comprises articulating the distal end of the ultrasound catheter to an angle greater than - 180 degrees and less than 180 degrees with respect to a longitudinal axis of the ultrasound catheter (see figs. 6-7 for element 154/156 at the distal end of 140 being articulated from its retracted position to its expanded position, the angle is between -180 and +180 degrees).
Regarding claim 56, Hauser in view of Parmentier discloses the method of claim 47,
Parmentier further teaches wherein articulating the distal end of the ultrasound catheter comprises articulating the distal end of the ultrasound catheter (articulating 154/156 at the distal end of 140) such that the delivery component (154/156) of the ultrasound catheter (140) faces the residual clot and a wall of the vessel (see fig. 10, par. 0035 for 154/156 facing the residual clot and a wall of the vessel after the tip 140a is advanced into the clot/blockage).
Regarding claim 57, Hauser discloses
A method for treating a patient with a thromboembolism (see fig. 20 and col. 11 lines 34-57), the method comprising:
positioning an ultrasound catheter (catheter shown in fig. 20) in a first position (position shown in fig. 20 ), wherein, in the first position (see fig. 20), a delivery component (982) of the ultrasound catheter faces a clot in a vessel (see fig. 20);
delivering, with the ultrasound catheter in the first position (see fig. 20), targeted ultrasound energy from the delivery component (see fig. 20 and col. 11 lines 34-57) and a therapeutic compound from a lumen of the ultrasound catheter to the clot for an initial treatment period (see col. 11 lines 49-52 for the delivery of ultrasonic vibration to the clot be accompanied by the delivery of thrombolytic drugs);
Hauser is silent about after the initial treatment period, positioning the ultrasound catheter in a second position; articulating, with the ultrasound catheter in the second position, a distal end of the ultrasound catheter with respect to a longitudinal axis of the ultrasound catheter; and delivering, after articulating the distal end of the ultrasound catheter, targeted ultrasound energy from the delivery component and the therapeutic compound from the lumen of the ultrasound catheter to a residual clot.
However, Parmentier teaches a method of treating a patient with a thromboembolism (see figs. 1-10 and pars. 0021-0041), the method comprising positioning the ultrasound catheter (158/140) in a second position (position where 156/154 is in the thrombus); articulating (expanding 154/156), with the ultrasound catheter in the second position (see fig. 10), a distal end of the ultrasound catheter (distal end of 140 with element 154/156) with respect to a longitudinal axis of the ultrasound catheter (see fig. 10); and delivering, after articulating the distal end of the ultrasound catheter, targeted ultrasound energy from the delivery component and the therapeutic compound from the lumen of the ultrasound catheter to a residual clot (see fig. 10 and par. 0038. See also par. 0035 for the distal end/the tip 140a is initially advanced into a blockage/thrombus, and then 154 is deployed/expanded to aid in clearing the remainder of the blockage/clot surrounding the pilot path as 140 is advanced).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Hauser by adding an expandable portion to the ultrasound catheter and adding the steps of advancing the ultrasound catheter such that the modified expandable portion is positioned within the clot, articulating the ultrasound catheter such that the modified expandable portion is expanded and treating the clot with ultrasound energy, as taught by Parmentier, for the purpose of aiding in clearing a blockage or obstruction in a vessel (par. 0032 of Parmentier) so that the blockage is substantially cleared in a single pass, and without the need for prolonging the procedure (par. 0035 of Parmentier).
Regarding claim 58, see the rejection of claim 48.
Regarding claim 59, see the rejection of claim 49.
Regarding claim 60, see the rejection of claim 50.
Regarding claim 61, Hauser in view of Parmentier discloses the method of claim 57,
Hauser further discloses wherein the delivery component (982) is positioned on the distal end of the ultrasound catheter (see fig. 20).
Regarding claim 62, Hauser in view of Parmentier discloses the method of claim 57,
Hauser further discloses wherein the therapeutic compound comprises at least one of a lytic, microbubbles or a nanodroplets (see col. 11 lines 49-52 for the delivery of ultrasonic vibration being accompanied by the delivery of thrombolytic drugs).
Regarding claim 63, Hauser in view of Parmentier discloses the method of claim 57,
Hauser further discloses wherein the delivery component comprises an ultrasound element (982, fig. 20 and col. 11 lines 34-50).
Regarding claim 64, see the rejection of claim 54.
Regarding claim 65, see the rejection of claim 55.
Regarding claim 66, see the rejection of claim 56.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
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