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
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.
Claims 1-7, 11-14, 18-21 and 23-24 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by PIKUS (US 20150105715).
Regarding claim 1, PIKUS discloses a medical device for ablation of tissue adjacent an anatomical lumen wall of a patient (fig.5) comprising: an inner catheter (fig.5; second tubular member 524); an outer jacket (fig.5; first tubular member 522); an expandable section (fig.5; expandable basket 512) including a first portion secured to the inner catheter and a second portion secured to the outer jacket (fig.5, see also [0104]); an energy emitting element (fig.5; one or more ablation transducers 510 attached to the inner catheter [0097], wherein the energy emitting element is configured to emit microwave energy [0099]; and an actuator configured to cause relative translational movement between the inner catheter and the outer jacket to cause the expandable section to radially expand or contract [0108], wherein the expandable section is configured to define a displacement between the energy emitting element and a radially outer surface of the expandable section when the expandable section radially expands to contact the anatomical lumen wall (fig.5, see also [0108]). The actuation mechanism, pull/push wire, maybe attached to the distal end of 515 of the expandable basket 512 that is secured to the second tubular member 524. The wire being pushed distally causes the relative translation movement between the first tubular member 522 and second tubular member 524. As a result, the basket 512 expands to expandable state (fig.5, see also [0108]).
Regarding claim 2, PIKUS discloses the medical device of claim 1, wherein the inner catheter defines a longitudinal axis, and wherein the expandable section is configured to radially expand in a direction substantially perpendicular to the longitudinal axis, when the actuator causes relative translational movement between the inner catheter and the outer jacket (fig.5, see also [0108]).
Regarding claim 3, PIKUS discloses the medical device of claim 1, wherein the outer jacket defines a lumen (fig.5, lumen 528), and wherein the inner catheter is configured to slidably translate within the lumen when the actuator causes relative translational movement between the inner catheter and the outer jacket [0108].
Regarding claim 4, PIKUS discloses the medical device of claim 1, wherein the inner catheter defines a longitudinal axis, and wherein the actuator is configured to cause the expandable section to define a radial displacement from the longitudinal axis (fig.5).
Regarding claim 5, PIKUS discloses the medical device of claim 1 any of claims 14, wherein the expandable section is configured to define a plurality of passages establishing fluid communication through the expandable section at least when the expandable section is radially expanded. The expandable basket 512 includes struts 514 defining a plurality of passages establishing fluid communication through the expandable section at least when the expandable section is radially expanded (fig.5, see also [0106]).
Regarding claim 6, PIKUS discloses the medical device of claim 1, wherein the radial expansion and contraction of the expandable section is proportional to a distance the inner catheter translates relative to the outer jacket, and wherein the actuator is configured to control the translated distance [0108].
Regarding Claim 7, PIKUS discloses the medical device of claim 1, wherein the inner catheter is configured to at least one of position the energy emitting element between the distal end of the expanding member and the proximal end of the expanding member, or position the energy emitting element distal to the distal end of the expanding member (one or more ablation transducers 510 is position between the distal end of basket 512 and proximal end of basket 512).
Regarding claim 11, PIKUS discloses the medical device of claim 1, wherein the inner catheter defines a longitudinal axis, and wherein the energy emitting element is configured to emit the microwave energy in a substantially radial direction from the longitudinal axis and circumferentially around the axis when the expandable section is radially expanded (fig.5).
Regarding claim 12, PIKUS discloses a method, comprising: radially expanding an expandable section (fig.5; expandable basket 512) using an actuator [0108], wherein the actuator is configured to produce relative translational movement between an inner catheter (second tubular member 524) and an outer jacket (fig.5; first tubular member 522, see also [0108]), wherein the expandable section includes a first portion secured to the inner catheter (fig.5, see also [0104]) and a second portion secured to the outer jacket (fig.5, see also [0104]); and emitting microwave energy from an energy emitting element attached to the inner catheter [0034], wherein the expandable section defines a displacement between the energy emitting element and a radially outer surface of the expandable section when the expandable section radially expands to contact an anatomical lumen wall (fig.5, see also [0104]).
Regarding claim 13, PIKUS discloses the method of claim 12, wherein radially expanding the expandable section comprises radially expanding the expandable member section in a direction substantially perpendicular to a longitudinal axis defined by the inner catheter, and using the actuator to produce relative translational movement between the inner catheter and the outer jacket and translate the energy emitting element relative to the outer jacket (fig.5; see also [0108]).
Regarding claim 14, PIKUS discloses the method of claim 12, wherein the expandable member defines a plurality of passages that establish fluid communication through the expandable section when the expandable section is radially expanded [0108].
Regarding claim 18, PIKUS discloses the method of claim 12, further comprising: causing, using a fluid intake defined by the inner catheter, the outer jacket, or the actuator, the fluid intake to receive a cooling fluid; transferring heat from the energy emitting element to the cooling fluid; and discharging the heated cooling fluid from a fluid discharge defined by the inner catheter, the outer jacket, or the actuator ([0096] and [0110]).
Regarding claim 19, PIKUS discloses the method of claim 12, wherein the expandable section defines a maximum radial displacement when the inner catheter and the outer catheter define a minimum axial displacement, and the method further comprising contracting the expandable section by establishing a medial axial displacement using the relative translational movement, wherein the medial axial displacement is greater than the minimum axial displacement (fig.5).
Regarding claim 20, PIKUS discloses the medical device of claim 1, wherein the energy emitting element is configured to remain substantially radially stationary with respect to the inner catheter when the actuator causes relative translational movement between the inner catheter and the outer jacket (fig.5).
Regarding claim 21, PIKUS discloses the medical device of claim 1, wherein the inner catheter defines a fluid intake and a fluid discharge, wherein the inner catheter is configured to receive a cooling fluid through the fluid intake, and cause a heat transfer from the energy emitting element to the cooling fluid to generate a heated cooling fluid, and discharge the heated cooling fluid from the fluid discharge ([0096] and [0110]).
Regarding claim 23, PIKUS discloses the medical device of claim 8, wherein the radial expansion and contraction of the expandable section is proportional to the motion of the positioning member relative to the actuator body (fig.5, see also [0108]).
Regarding claim 24, PIKUS discloses a medical device comprising: an inner catheter (fig.5; second tubular member 524); an outer jacket (first tubular member 522); an expandable section (fig.5; basket 512) basket including a first portion secured to the inner catheter ([0104]: “the distal end 515 of the basket 512 may be secured to the second tubular member 524”) and a second portion secured to the outer jacket ([0104]: “the proximal end 513 of the basket 512 may be secured to the first tubular member 522”); an energy emitting element (fig.5; one or more ablation transducers 510 ) attached to the inner catheter [0097]; and an actuator configured to cause relative translational movement between the inner catheter and the outer jacket to cause the expandable section to radially expand or contract, wherein the expandable section is configured to define a displacement between the energy emitting element and a radially outer surface of the expandable section when the expandable section radially expands to contact the anatomical lumen wall (fig.5, see also [0108], and wherein the expandable section is configured to define a plurality of passages establishing fluid communication through the expandable section at least when the expandable section radially expands. The actuation mechanism, pull/push wire, maybe attached to the distal end of 515 of the expandable basket 512 that is secured to the second tubular member 524. The wire being pushed distally causes the relative translation movement between the first tubular member 522 and second tubular member 524. As a result, the basket 512 expands to expandable state (fig.5, see also [0108]).
Claims 1-13, 15-17, 19-20 and 23 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Yamazak (US 2005/0203597).
Regarding claim 1 and 12, Yamazak discloses a medical device for ablation of tissue adjacent an anatomical lumen wall of a patient (fig.1) comprising: an inner catheter (fig.1; inner shaft 3); an outer jacket (fig.1; outer shaft 4); an expandable section (fig.1; balloon 2) including a first portion secured to the inner catheter (the distal end of the balloon 2) and a second portion secured to the outer jacket (fig.1, at the proximal end of the balloon 2); an energy emitting element (fig.1; high frequency current-carrying electrode 5), wherein the energy emitting element is configured to emit microwave energy [0052]; and an actuator (fig.3; operation handle 12) configured to cause relative translational movement between the inner catheter and the outer jacket to cause the expandable section to radially expand or contract [0045], wherein the expandable section is configured to define a displacement between the energy emitting element and a radially outer surface of the expandable section when the expandable section radially expands to contact the anatomical lumen wall (fig.1, see also [0045]).
Regarding claim 2 and 13, Yamazak discloses the medical device, wherein the inner catheter defines a longitudinal axis, and wherein the expandable section is configured to radially expand in a direction substantially perpendicular to the longitudinal axis, when the actuator causes relative translational movement between the inner catheter and the outer jacket (fig.1-3).
Regarding claim 3, Yamazak discloses the medical device of claim 1, wherein the outer jacket defines a lumen (fig.1; lumen defined by outer shaft 4), and wherein the inner catheter is configured to slidably translate within the lumen when the actuator causes relative translational movement between the inner catheter and the outer jacket [0045].
Regarding claim 4, Yamazak discloses the medical device of claim 1, wherein the inner catheter defines a longitudinal axis, and wherein the actuator is configured to cause the expandable section to define a radial displacement from the longitudinal axis (fig.1, see also [0045]).
Regarding claim 5, Yamazak discloses the medical device of claim 1 any of claims 14, wherein the expandable section is configured to define a plurality of passages establishing fluid communication through the expandable section at least when the expandable section is radially expanded. The expandable basket 512 includes struts 514 defining a plurality of passages establishing fluid communication through the expandable section at least when the expandable section is radially expanded (fig.5, see also [0106]).
Regarding claim 6, Yamazak discloses the medical device of claim 1, wherein the radial expansion and contraction of the expandable section is proportional to a distance the inner catheter translates relative to the outer jacket, and wherein the actuator is configured to control the translated distance [0108].
Regarding Claim 7, Yamazak discloses the medical device of claim 1, wherein the inner catheter is configured to at least one of position the energy emitting element between the distal end of the expanding member and the proximal end of the expanding member, or position the energy emitting element distal to the distal end of the expanding member (fig.1; see also [0045]).
Regarding claim 8 and 15, Yamazak discloses the medical device, wherein the actuator mechanically engages a proximal end of the inner catheter (fig.3, see also [0045]) and a proximal end of the outer jacket to cause the relative translational movement between the inner catheter and the outer jacket (fig.3; see also [0045]: the four way connector 11 that is secured to outer shaft 4 engages mechanically when operation handle 12 inserts the inner shaft 3 through the proximal end (fig.3; 11a) of outer shaft 4), wherein the actuator defines an actuator body (central branch pipe 11a) and a positioning member (scale 20) configured to move relative to the actuator body, and wherein the actuator is configured to cause the relative translational movement between the inner catheter and the outer jacket when the positioning member moves relative to the actuator body (fig.3, see also [0045]).
Regarding claim 9 and 17, Yamazak discloses the medical device, wherein the actuator is configured to indicate one or more positions of the positioning member relative to the actuator body [0045], and wherein each of the one or more positions correspond to a specific displacement between the expandable section and a longitudinal axis defined by the inner catheter [0045].
Regarding claim 10, Yamazak discloses the medical device of claim 1, wherein the actuator includes a release mechanism, wherein the expandable section is configured to exert a force on the release mechanism when the expandable section contacts the anatomical lumen wall of the vasculature (any pressure applied to the balloon will affect the movement of the inner shat that is coupled to the balloon at the distal end), and wherein the release mechanism is configured to decrease the radial expansion of the expandable section when the force exerted exceeds a threshold (fig.1, see also [0040] and [0045]).
Regarding claim 11, Yamazak discloses the medical device of claim 1, wherein the inner catheter defines a longitudinal axis, and wherein the energy emitting element is configured to emit the microwave energy in a substantially radial direction from the longitudinal axis and circumferentially around the axis when the expandable section is radially expanded (fig.1, see also [0043]).
Regarding claim 16, Yamazak discloses the method of claim 15, further comprising imparting a force to at least one of the inner catheter or the outer jacket to cause the relative translational movement between the inner catheter and the outer jacket when the positioning member moves relative to the actuator body [0045].
Regarding claim 17, Yamazak discloses the method of claim 15, further comprising controlling the radial expansion and contraction of the expandable section using the motion of the positioning member relative to the actuator body [0045].
Regarding claim 19, Yamazak discloses the method of claim 12, wherein the expandable section defines a maximum radial displacement when the inner catheter and the outer catheter define a minimum axial displacement, and the method further comprising contracting the expandable section by establishing a medial axial displacement using the relative translational movement, wherein the medial axial displacement is greater than the minimum axial displacement (fig.1, see also [0045]).
Regarding claim 20, Yamazak discloses the medical device of claim 1, wherein the energy emitting element is configured to remain substantially radially stationary with respect to the inner catheter when the actuator causes relative translational movement between the inner catheter and the outer jacket (fig.1).
Regarding claim 23, Yamazak discloses the medical device of claim 8, wherein the radial expansion and contraction of the expandable section is proportional to the motion of the positioning member relative to the actuator body (fig.1, see also [0045]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over PIKUS (US 2015/0105715) in view of Salahieh (US 2020/0069364).
Regarding claim 22, PIKUS does not disclose wherein the expandable section comprises a plurality of braided members, wherein each braided member is in slidable contact with and weaved through at least two other braided members, and wherein each braided member is configured to separate from the at least two other braided members to define the plurality of passages when the expandable section is radially expanded.
Salahieh teaches an ablation catheter with expandable member disposed at the distal region of an elongate member. Salahieh teaches the structure of the membrane 34 can vary including, but not limited to a membrane sheet, cylinder, tube, inflatable, expandable, or fillable structure, such as a balloon, or braided mesh and the like. Salahieh further teaches an expandable structure that is open, such as a woven, braided or weaved through some or all the loops of the expandable structure (fig.17A-D, see also [0146]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by PIKUS with the expandable section comprises a plurality of braided members, wherein each braided member is in slidable contact with and weaved through at least two other braided members, and wherein each braided member is configured to separate from the at least two other braided members to define the plurality of passages when the expandable section is radially expanded as taught by Salahieh since these modification may provide flexibility to the variety of anatomical shapes.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over PIKUS (US 2015/0105715) in view of Yamazak (US 2005/0203597).
Regarding Claim 25, PIKUS does not disclose wherein the actuator includes a release mechanism, wherein the expandable section is configured to exert a force on the release mechanism when the expandable section contacts the anatomical lumen wall of the vasculature, and wherein the release mechanism is configured to decrease the radial expansion of the expandable section when the force exerted exceeds a threshold.
Yamazak teaches operation handle 12 configured to cause relative translational movement between the inner catheter and the outer jacket to cause the expandable section to radially expand or contract [0045]. The actuator includes a release mechanism (distal end of operation handle) , wherein the expandable section is configured to exert a force on the release mechanism when the expandable section contacts the anatomical lumen wall of the vasculature (any pressure applied to the balloon will affect the movement of the inner shat that is coupled to the balloon at the distal end), and wherein the release mechanism is configured to decrease the radial expansion of the expandable section when the force exerted exceeds a threshold ([0040] and [0045]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by PIKUS with actuator with a release mechanism configured to inflate and deflate when force is exerted as taught by Yamazak for the purpose of controlled treatment.
Conclusion
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794