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.
Status of the Claims
The current office action is made responsive to claims filed 10/09/2025
Acknowledgement is made to the cancellation of claims 1-81 and 98-99.
Acknowledgement is made to the withdrawal of claims 86-89 and 97.
Acknowledgement is made to the newly added claims 105-106.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 82-85, 90-96, and 100-106 are pending as rejected below. A complete action on the merits appears below.
Claim Objections
Claim 105 is objected to because of the following informalities: “the interventional is configured” is grammatically incorrect and should be –the interventional element is configured-- . Appropriate correction is required.
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.
Claims 82-85, 91-96, 100, and 102-105 are rejected under 35 U.S.C. 103 as being unpatentable over Taff (US 20190262069 A1) in view of Johnson (US 20050060885 A1), Tu ’576 (US 6217576 B1) and Tu ’725 (US 6129725 A).
Regarding claim 82, Taff teaches a system for removing a thrombus (Abstract) comprising:
a medical device (Fig. 1A-B; apparatus 20) having a core assembly configured to be advanced within a corporeal lumen ([0122]), the core assembly comprising:
a first conductor (Fig. 1A-B; proximal portion 24b) having a proximal end portion and a distal end portion, the first conductor forming a lumen (Fig. 1B; lumen 56);
a second conductor (Fig. 1A-B; inner electrode 28) at least partially disposed within the lumen of the first conductor ([0090]), the second conductor comprising a first conductive material ([0099], [0108]) and having a proximal end portion and a distal end portion extending distal to the distal end portion of the first conductor ([0090], [0097]);
an insulative material disposed over at least a portion of the second conductor ([0099] teaches most of wire 28 as being coated with an insulating material, with only the distal portion of the wire being uncoated), the insulative material defining one or more uninsulated portions of the second conductor ([0099], [0108]);
an interventional element (Fig. 1A-B; distal portion 24a) configured to engage and retrieve the thrombus within a blood vessel ([0090], [0097], [0116]), wherein the interventional element is coupled to the distal end portion of the first conductor ([0093]), wherein the interventional element is electrically coupled to the first conductor ([0093]), wherein the interventional element comprises a body formed of a third conductive material ([0091; and
a current generator (Fig. 1A-B; voltage source 32), wherein the first conductor of the core assembly is in electrical communication with a first terminal of the current generator (Fig. 1A-B; first wire 40), wherein the second conductive material of the core assembly is in electrical communication with a second terminal of the current generator (Fig. 1A-B; second wire 41), and wherein the current generator is configured to deliver an electrical signal to the interventional element via the first conductor to promote electrostatic attraction of the thrombus to the interventional element ([0090]).
However, Taff fails to teach a second conductive material surrounding the second conductor along at least part of the one or more uninsulated portions, the second conductive material having a higher electrical conductivity than the first conductive material; and
a fourth conductive material disposed over at least a portion of the third conductive material of the interventional element, the fourth conductive material having a higher electrical conductivity than the third conductive material.
Johnson teaches known electrodes which are attached to a catheter to treat patient tissue as being formed generally of either a single or multiple layers of metal or any other suitable electrically conductive material (Abstract, [0121], [0141]).
Johnson further teaches that when the electrodes are formed of multiple metals, the inner metal of an electrode is typically selected for its adhesion to the nonconductive substrate and the outer metal layer is selected for biocompatibility, such as gold which is a known biocompatible metal ([0121]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted an electrode comprising both an inner metal layer and an outer metal layer, such as the above discussed biocompatible outer layer being gold, as is taught by Johnson, for the electrodes which are only taught to have one layer of metal, as is taught by Taff, as both electrodes, having either a single or multiple layers of metal, the multiple layers consisting of a base metal and an additional outer metal, perform the same function of transmitting current between target tissue and an electrical source, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II)(B)
Taff further fails to teach the interventional element as comprising a mesh structure, instead teaching the interventional element as comprising a coil ([0094]).
Tu ’576 teaches a catheter for ablating tissue (Abstract) having an electrode located proximal to and surrounding the distal-most tip of the catheter (Fig. 2; electrode 12).
Tu ’576 further teaches the electrode as being formed from a variety of known electrode shapes such as a metal coil electrode or a metal mesh (Col. 2, Lines 20-30 & Col. 7, Lines 20-25).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the coil electrode as is taught by Taff with the mesh electrode as is taught by Tu ’576 as both electrode shapes perform the same function of delivering electrosurgical energy to patient tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Taff further fails to teach the interventional element as comprising a self-expanding structure. Taff instead teaches the apparatus and method as being for the removal of any material, such as plaque, that at least partially occludes a passageway by the use of a coil electrode to remove this material ([0081]).
Tu ’725 teaches an expandable electrode which is utilized to treat the buildup of plaque in blood vessels (Col. 3, Lines 18-22).
Tu ’725 further teaches the expandable electrode as being expanded when the electrode is deployed due to its resilience and semi-compressibility, this expandability of the electrode is provided so as to provide contact to the target tissue through the stent (Col. 4, Lines 10-30).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of the electrode which is utilized to treat the buildup of plaque as being an expandable electrode as is taught by Tu ’725 into the electrode for treating plaque as is taught by the modified device of Taff, to produce the predictable result of providing contact to the target tissue during plaque removal, as is taught by Tu ’725, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 83, Taff teaches the system of Claim 82, wherein the second conductive material is positioned radially adjacent to or distal of the interventional element ([0099], [0108]).
Regarding claim 84, in accordance with the above rejection of claim 82, Johnson teaches the system of Claim 82, wherein the second conductive material and the fourth conductive material each comprises a metallic material ([0121]).
Regarding claim 85, in accordance with the above rejection of claim 82, Johnson teaches the system of Claim 82, wherein the second conductive material and the fourth conductive material each comprises gold ([0121]).
Regarding claim 91, Taff teaches a system for removing a thrombus (Abstract) comprising:
an elongated shaft (Fig. 1A-B; inner electrode 28) having a proximal portion configured to be electrically coupled to a terminal of a current generator ([0090]), an intermediate portion at least partially covered with an insulative material, and a distal portion, the elongated shaft comprising a first conductive material ([0091], [0099]);
an elongated tubular member (Fig. 1A-B; proximal portion 24b) having a proximal portion that is electrically coupled to a first terminal of the current generator (Fig. 1A-B; first wire 40), a distal portion, and a lumen (Fig. 1B; lumen 56) receiving the elongated shaft therethrough such that the distal portion of the elongated shaft extends distal to the distal portion of the elongated tubular member ([0090], [0097]);
an interventional element (Fig. 1A-B; distal portion 24a) configured to engage and retrieve the thrombus within a blood vessel ([0090], [0097], [0116]), wherein the interventional element is coupled to the distal portion of the elongated tubular member ([0093]), wherein the interventional element at least partially surrounds the distal portion of the elongated shaft ([0093]), and wherein the interventional element comprises a second conductive material ([0091] teaches the outer electrode as having a higher electronegativity than that of the inner electrode and being made of a variety of materials, such as platinum or an alloy such as an allow of platinum and iridium);
an insulative material disposed over at least a portion of the elongated shaft ([0099] teaches most of wire 28 as being coated with an insulating material, with only the distal portion of the wire being uncoated), the insulative material defining one or more uninsulated portions of the elongated shaft ([0099], [0108]).
However, Taff fails to teach a third conductive material surrounding the distal portion of the elongated shaft along at least a part of its length, wherein the third conductive material is in electrical communication with a second terminal of the current generator, and wherein the third conductive material is configured to increase the electrical conductivity of the distal portion of the elongated shaft; and
a fourth conductive material surrounding the interventional element along at least a part of its length, the fourth conductive material being configured to increase the electrical conductivity of the interventional element.
Johnson teaches known electrodes which are attached to a catheter to treat patient tissue as being formed generally of either a single or multiple layers of metal or any other suitable electrically conductive material (Abstract, [0121], [0141]).
Johnson further teaches that when the electrodes are formed of multiple metals, the inner metal of an electrode is typically selected for its adhesion to the nonconductive substrate and the outer metal layer is selected for biocompatibility, such as gold which is a known biocompatible metal ([0121]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted an electrode comprising both an inner metal layer and an outer metal layer, such as the above discussed biocompatible outer layer being gold, as is taught by Johnson, for the electrodes which are only taught to have one layer of metal, as is taught by Taff, as both electrodes, having either a single or multiple layers of metal, the multiple layers consisting of a base metal and an additional outer metal, perform the same function of transmitting current between target tissue and an electrical source, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II)(B)
Taff further fails to teach the interventional element as comprising a mesh structure, instead teaching the interventional element as comprising a coil ([0094]).
Tu ’576 teaches a catheter for ablating tissue (Abstract) having an electrode located proximal to and surrounding the distal-most tip of the catheter (Fig. 2; electrode 12).
Tu ’576 further teaches the electrode as being formed from a variety of known electrode shapes such as a metal coil electrode or a metal mesh (Col. 2, Lines 20-30 & Col. 7, Lines 20-25).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the coil electrode as is taught by Taff with the mesh electrode as is taught by Tu ’576 as both electrode shapes perform the same function of delivering electrosurgical energy to patient tissue and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Taff further fails to teach the interventional element as comprising a self-expanding structure. Taff instead teaches the apparatus and method as being for the removal of any material, such as plaque, that at least partially occludes a passageway by the use of a coil electrode to remove this material ([0081]).
Tu ’725 teaches an expandable electrode which is utilized to treat the buildup of plaque in blood vessels (Col. 3, Lines 18-22).
Tu ’725 further teaches the expandable electrode as being expanded when the electrode is deployed due to its resilience and semi-compressibility, this expandability of the electrode is provided so as to provide contact to the target tissue through the stent (Col. 4, Lines 10-30).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teaching of the electrode which is utilized to treat the buildup of plaque as being an expandable electrode as is taught by Tu ’725 into the electrode for treating plaque as is taught by the modified device of Taff, to produce the predictable result of providing contact to the target tissue during plaque removal, as is taught by Tu ’725, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 92, in accordance with the above rejection of claim 91, Taff in view of Johnson teach the system of Claim 91, wherein the third conductive material (Johnson, [0121] teaches the incorporated third conductive material as being gold) has a higher electrical conductivity than the first conductive material (Taff, [0091] teaches the inner electrode as being made of stainless steel, nitinol, or titanium).
Regarding claim 93, in accordance with the above rejection of claim 91, Taff in view of Johnson teach the system of Claim 91, wherein the fourth conductive material (Johnson, [0121] teaches the incorporated third conductive material as being gold) has a higher electrical conductivity than the second conductive material (Taff, [0091] teaches the outer electrode as having a higher electronegativity than that of the inner electrode and being made of a variety of materials, such as platinum or an alloy such as an allow of platinum and iridium).
Regarding claim 94, in accordance with the above rejection of claim 91, Taff teaches the system of Claim 91, wherein the distal portion of the inner electrode as being positioned radially adjacent to or distal of the interventional element ([0099], [0108]).
Johnson further teaches the distal portion of the inner electrode as being comprised of the third conductive material ([0121]).
Regarding claim 95, Johnson further teaches the system of Claim 91, wherein the third conductive material and the fourth conductive material each comprises a metallic material ([0121]).
Regarding claim 96, Johnson further teaches the system of Claim 91, wherein the third conductive material and the fourth conductive material each comprises gold ([0121]).
Regarding claim 100, Taff teaches the system of Claim 91, wherein the one or more uninsulated portions comprises a distal tip ([0099]).
Regarding claim 102, Taff teaches the system of Claim 82, wherein the second conductive material surrounds the second conductor along a distal tip of the second conductor, and wherein the current generator is configured to produce an electrical signal configured to flow distally through the interventional element to reach the distal tip ([0090], [0127]).
Regarding claim 103, Taff teaches the system of Claim 91, wherein the electrode located on the elongated shaft is positioned at a distal tip of the distal portion of the elongated shaft ([0090], [0097]), and wherein an electrical signal produced by the current generator is configured to flow distally through the interventional element to reach the distal tip ([0065], [0082]- [0083]).
In accordance with the above rejection of claim 91, Johnson further teaches the electrode as comprising an outer metallic layer comprising the third conductive material which surrounds the elongated shaft ([0121], [0141]).
Regarding claim 104, Taff teaches the system of claim 82, wherein the current generator is configured to provide a voltage having a magnitude within a range from 2 volts to 28 volts ([0132]- [0134]).
Regarding claim 105, Tu ’725 further teaches the system of claim 82, wherein the interventional element has a low-profile configuration for intravascular delivery to the treatment site and an expanded configuration for engaging clot material at the treatment site, and wherein the interventional is configured to self-expand from the low-profile configuration to the expanded configuration (Col. 4, Lines 10-30).
Claims 90 and 101 are rejected under 35 U.S.C. 103 as being unpatentable over Taff (US 20190262069 A1) in view of Johnson (US 20050060885 A1), Tu ’576 (US 6217576 B1) and Tu ’725 (US 6129725 A)further in view of Pedersen (US 20160278839 A1).
Regarding claim 90, Taff as modified teaches the system of Claim 82.
However, Taff as modified fails to teach the system wherein a surface area defined by the second conductive material is at least about 15% of a surface area defined by the fourth conductive material.
Pedersen teaches an RF ablation system including a catheter, a first electrode and a second electrode (Abstract).
Pedersen further teaches the second electrode as having a surface area twice that of the first electrode so as to generate negligible heat at the second electrode and therefore have no blood clotting or other ablation material be formed over the catheter (Abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of this range, which overlaps with the range provided in the claim, as is taught by Pedersen into the device of Taff as modified to produce the predictable result of reduced blood clotting or formation of other ablation materials being formed over the catheter, as is taught by Pedersen.
Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Additionally, there does not appear to be any disclosed criticality for the recited range relative to the prior art. Pending a statement of criticality, the recited range does not patentably distinguish over that of the prior art.
Regarding claim 101, Taff as modified teaches the system of Claim 91.
However, Taff as modified fails to teach the system wherein a surface area defined by the third conductive material is at least about 15% of a surface area defined by the fourth conductive material.
Pedersen teaches an RF ablation system including a catheter, a first electrode and a second electrode (Abstract).
Pedersen further teaches the second electrode as having a surface area twice that of the first electrode so as to generate negligible heat at the second electrode and therefore have no blood clotting or other ablation material be formed over the catheter (Abstract).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of this range, which overlaps with the range provided in the claim, as is taught by Pedersen into the device of Taff as modified to produce the predictable result of reduced blood clotting or formation of other ablation materials being formed over the catheter, as is taught by Pedersen.
Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Additionally, there does not appear to be any disclosed criticality for the recited range relative to the prior art. Pending a statement of criticality, the recited range does not patentably distinguish over that of the prior art.
Claim 106 is rejected under 35 U.S.C. 103 as being unpatentable over Taff (US 20190262069 A1) in view of Johnson (US 20050060885 A1), Tu ’576 (US 6217576 B1) and Tu ’725 (US 6129725 A) further in view of Haldis (US 20180161541 A1).
Regarding claim 106, Taff as modified teaches the system of claim 82.
In accordance with the above rejection of claim 82, Tu ’725 further teaches the self-expanding electrode element as comprising a stent (Col. 4, Lines 10-30).
Haldis teaches the known use of a thrombectomy to remove a clot from the body of a patient ([0003]).
Haldis further teaches a stent retriever as being a device like a stent which is allowed to expand and embed in an embolus and then be retracted to restore blood blow ([0025]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the stent as is taught by Tu ’725 with a stent retriever as is taught by Haldis to produce the predictable result of allowing the device to be retracted to restore blood flow as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the request for continued examination has necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the modified Taff reference are moot in view of the new rejections under the newly provided incorporation of Tu ’725.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794