DETAILED ACTION
This action is in response to preliminary amendments received on 01/06/2025. It is acknowledged that claims 11 and 13-14 have been amended and new claims 16-20 added. A complete action on the merits of claims 1-20 follows below.
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.
Claim Objections
Claim 15 is objected to because of the following informalities: “configured to received” in line 1 should be amended to recite --configured to receive--. Appropriate correction is required.
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 1-4 and 6-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US Pub. No. 2014/0128859).
Regarding Claim 1, Lee teaches a device for treating varicose vein ([0047] teaches “Embodiments of the present invention relate to a power generating and control apparatus, often for the treatment of targeted tissue in order to achieve a therapeutic effect. In some embodiments, the target tissue is tissue containing or proximate to nerves, including renal arteries and associated renal nerves. In other embodiments the target tissue is luminal tissue, which may further comprise diseased tissue such as that found in arterial disease” therefore, although Lee does not specifically teach the use of the device in treating varicose vein, it is shaped and configured to be used in such treatment), comprising:
a catheter (Fig. 33) comprising:
an elongated shaft (the shaft shown in Fig. 33) having a proximal end and a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (Fig. 33); and
a heating element disposed near the distal end of the elongated shaft, the heating element comprising:
an inflatable balloon (“expandable balloon 20” [0063]) having a proximal end and an opposite distal end and defining a longitudinal dimension therebetween (Fig. 33); and
a plurality of electrode sets (“the expandable balloon 20 includes several longitudinally extending series of bipolar electrode pairs 34 positioned about the circumference of the balloon” [0063]) disposed circumferentially about the balloon (Fig. 33), wherein each electrode set comprises first and second elongated electrodes extending along a majority of the longitudinal dimension of the balloon (Fig. 33), wherein the electrodes of each electrode set are configured to form an anode-cathode pair for bipolar delivery of radiofrequency ablative energy to target tissue of the target blood vessels (“series of bipolar electrode pairs 34” [0063]).
Regarding Claim 2, Lee teaches wherein the inflatable balloon has a length greater than three (3) centimeters (“the expandable device may have a working length of about 10 mm to about 100 mm” [0056]).
Regarding Claim 3, Lee teaches wherein the inflatable balloon has a length smaller than ten (10) centimeters (“the expandable device may have a working length of about 10 mm to about 100 mm” [0056]).
Regarding Claim 4, Lee teaches wherein the inflatable balloon has a diameter greater than five (5) millimeters when inflated (“a balloon with a 6, 7, or 8 mm diameter” [0056]).
Regarding Claim 6, Lee teaches wherein the inflatable balloon has a diameter greater than a diameter of the target blood vessel when inflated ([0097] teaches “an expanded diameter of up to 10 mm” thereby it is configured to have a diameter greater than a diameter of the target blood vessel when inflated depending on the diameter of the blood vessel being treated such as “the systems and devices described herein may be used in renal arteries or other vessels having diameters of less than 4 mm and/or lengths of less than 20 mm” [0210]).
Regarding Claim 7, Lee teaches wherein the inflatable balloon has a length and a diameter, wherein the length is at least two times of the diameter when inflated (Fig. 33).
Regarding Claim 8, Lee teaches wherein at least one electrode in the plurality of electrode sets comprises a flexible circuit ([0097] and [0115]).
Regarding Claim 9, Lee teaches wherein a distance between an anode-cathode pair is smaller than a distance between two adjacent electrode sets (“the expandable balloon 20 includes several longitudinally extending series of bipolar electrode pairs 34 positioned about the circumference of the balloon” [0063], as seen in Fig. 33 the spacing between each longitudinally extending electrode pairs 34 is more than the electrode pairs on each strep 34 itself).
Regarding Claim 10, Lee teaches the distance between two adjacent electrode sets is at least two (2) times of the distance between the anode-cathode pair (“the expandable balloon 20 includes several longitudinally extending series of bipolar electrode pairs 34 positioned about the circumference of the balloon” [0063] and Fig. 33 shows the spacing between each longitudinally extending electrode pairs 34 being more than (at least two times) the spacing between the electrode pairs of each strep 34 itself).
Regarding Claim 11, Lee teaches a system for treating varicose vein ([0047] teaches “Embodiments of the present invention relate to a power generating and control apparatus, often for the treatment of targeted tissue in order to achieve a therapeutic effect. In some embodiments, the target tissue is tissue containing or proximate to nerves, including renal arteries and associated renal nerves. In other embodiments the target tissue is luminal tissue, which may further comprise diseased tissue such as that found in arterial disease” therefore, although Lee does not specifically teach the use of the device in treating varicose vein, it is shaped and configured to be used in such treatment), comprising:
a catheter (Fig. 33) comprising:
an elongated shaft (the shaft shown in Fig. 33) having a proximal end and a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (Fig. 33); and
a heating element disposed near the distal end of the elongated shaft, the heating element comprising:
an inflatable balloon (“expandable balloon 20” [0063]) having a proximal end and an opposite distal end and defining a longitudinal dimension therebetween (Fig. 33); and
a plurality of electrode sets (“the expandable balloon 20 includes several longitudinally extending series of bipolar electrode pairs 34 positioned about the circumference of the balloon” [0063]) disposed circumferentially about the balloon (Fig. 33), wherein each electrode set comprises first and second elongated electrodes extending along a majority of the longitudinal dimension of the balloon (each of the electrode streps 34 comprises a pair of electrodes, Fig. 33), wherein the electrodes of each electrode set are configured to form an anode-cathode pair for bipolar delivery of radiofrequency ablative energy to target tissue of the target blood vessels ([0063]);
an energy generator 110 connected to the catheter and configured to generate an electric signal (“control unit 110 can include an RF generator” [0051], [0054], Figs. 1A, 6); and a controller operatively connected to the energy generator to control the generation of the electric signal (“the control unit 110 may include a processor or otherwise be coupled to a processor to control or record treatment” [0052], also see [0125] and [0194]).
Regarding Claim 12, Lee teaches wherein the plurality of electrode sets are operatively coupled to the energy generator (Figs. 1A and 6 and [0051]-[0054] and [0194]).
Regarding Claim 13, Lee teaches wherein the inflatable balloon 20 is configured to be inflated to a first diameter at a first operating mode and the inflatable balloon is configured to be inflated to a second diameter at a second operating mode, wherein the first diameter is different from the second diameter ([0123]-[0125] where the first mode is interpreted to be the initial insertion and inflation of the balloon where based on the feedback control the amount of inflation of the balloon changes to achieve the appropriate contact with the vessel wall and the second mode is interpreted to be the final positioning and inflation of the balloon where the sensors provide feedback that the balloon is in adequate contact with the vessel wall and/or [0127] teaches moving the balloon to a second location by deflating the balloon and re-inflating it, depending on the diameter of the new location, the balloon is configured to be inflated to a less or greater diameter than the first location).
Regarding Claim 14, Lee teaches wherein the inflatable balloon 20 is configured to be inflated to a size diameter such that an expandable membrane of the inflatable balloon is pressed against a wall of the target blood vessel (Fig. 33 and [0086]).
Regarding Claim 15, Lee teaches wherein the controller is configured to received a measured impedance between the plurality of electrode sets to determine if the inflatable balloon is contacting the wall of the target blood vessel ([0125] and [0146]).
Regarding Claim 16, Lee teaches a catheter for treating varicose veins ([0047] teaches “Embodiments of the present invention relate to a power generating and control apparatus, often for the treatment of targeted tissue in order to achieve a therapeutic effect. In some embodiments, the target tissue is tissue containing or proximate to nerves, including renal arteries and associated renal nerves. In other embodiments the target tissue is luminal tissue, which may further comprise diseased tissue such as that found in arterial disease” therefore, although Lee does not specifically teach the use of the device in treating varicose vein, it is shaped and configured to be used in such treatment), the catheter comprising:
an elongated shaft (the shaft shown in Fig. 33) having a proximal end and a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (Fig. 33); and
an inflatable balloon (“expandable balloon 20” [0063]) disposed at the distal end of the shaft, the inflatable balloon having a proximal end and an opposite distal end and defining a longitudinal dimension therebetween (Fig. 33), wherein the longitudinal dimension is at least two times a diameter of the balloon when inflated (Fig. 33); and
a plurality of electrode sets (“the expandable balloon 20 includes several longitudinally extending series of bipolar electrode pairs 34 positioned about the circumference of the balloon” [0063]) disposed circumferentially about the balloon (Fig. 33), wherein each electrode set comprises first and second elongated electrodes extending along a majority of the longitudinal dimension of the balloon (each of the electrode streps 34 comprises a pair of electrodes, Fig. 33), wherein the electrodes of each electrode set 34 are configured to form an anode-cathode pair for bipolar delivery of radiofrequency ablative energy to target tissue of the target blood vessels ([0063]).
Regarding Claim 17, Lee teaches wherein at least one electrode in the plurality of electrode sets comprises a flexible circuit ([0097] and [0115]).
Regarding Claim 18, Lee teaches wherein a distance between an anode-cathode pair is smaller than a distance between two adjacent electrode sets (“the expandable balloon 20 includes several longitudinally extending series of bipolar electrode pairs 34 positioned about the circumference of the balloon” [0063] and Fig. 33 shows the spacing between each longitudinally extending electrode pairs 34 being more than the spacing between the electrode pairs of each strep 34 itself).
Regarding Claim 19, Lee teaches the distance between two adjacent electrode sets is at least two times of the distance between the anode-cathode pair (“the expandable balloon 20 includes several longitudinally extending series of bipolar electrode pairs 34 positioned about the circumference of the balloon” [0063] and Fig. 33 shows the spacing between each longitudinally extending electrode pairs 34 being more than (at least two times) the spacing between the electrode pairs of each strep 34 itself).
Regarding Claim 20, Lee teaches wherein the inflatable balloon is configured to be inflated to a first diameter at a first operating mode and the inflatable balloon is configured to be inflated to a second diameter at a second operating mode, wherein the first diameter is different from the second diameter ([0123]-[0125] where the first mode is interpreted to be the initial insertion and inflation of the balloon where based on the feedback control the amount of inflation of the balloon changes to achieve the appropriate contact with the vessel wall and the second mode is interpreted to be the final positioning and inflation of the balloon where the sensors provide feedback that the balloon is in adequate contact with the vessel wall and/or [0127] teaches moving the balloon to a second location by deflating the balloon and re-inflating it, depending on the diameter of the new location, the balloon is configured to be inflated to a less or greater diameter than the first location).
Claims 1, 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber (US Pub. No. 2015/0105773).
Regarding Claim 1, Weber teaches a device for treating varicose vein ([0020]), comprising:
a catheter (Fig. 1) comprising:
an elongated shaft 202/302/402 having a proximal end and a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (Fig. 1); and
a heating element disposed near the distal end of the elongated shaft, the heating element comprising:
an inflatable balloon 210/304/404 having a proximal end and an opposite distal end and defining a longitudinal dimension therebetween (Figs. 2-4); and
a plurality of electrode sets (“one or more pairs of bipolar electrodes” [0005], 212a-212b Fig. 2, 312a-312f Fig. 3, 412a-412f/ 416a-416f [0042] and Fig. 4) disposed circumferentially about the balloon (Figs. 2-4), wherein each electrode set comprises first and second elongated electrodes extending along a majority of the longitudinal dimension of the balloon (Figs. 2-4), wherein the electrodes of each electrode set are configured to form an anode-cathode pair for bipolar delivery of radiofrequency ablative energy to target tissue of the target blood vessels (“one or more pairs of bipolar electrodes” [0005]-[0006], [0030] and [0042]).
Regarding Claim 6, Weber teaches wherein the inflatable balloon has a diameter greater than a diameter of the target blood vessel when inflated (Fig. 2 and [0025], also based on the teachings of [0034] the compliant balloon of Fig. 3 is configured to have a diameter greater than a diameter of the target blood vessel when inflated).
Regarding Claim 7, Weber teaches wherein the inflatable balloon has a length and a diameter, wherein the length is at least two times of the diameter when inflated (Figs. 2-4).
Regarding Claim 8, Weber teaches wherein at least one electrode in the plurality of electrode sets comprises a flexible circuit (Figs. 2-4, [0029]-0033], [0040] and [0042]-0045]).
Regarding Claim 9, Weber teaches wherein a distance between an anode-cathode pair is smaller than a distance between two adjacent electrode sets (bipolar electrode pairs 412c/412f vs. bipolar electrode pairs 416a/416d [0042] and Fig. 4).
Regarding Claim 10, Weber teaches the distance between two adjacent electrode sets is at least two (2) times of the distance between the anode-cathode pair (bipolar electrode pairs 412c/412f vs. bipolar electrode pairs 416a/416d [0042] and Fig. 4).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied above in view of Martin (US Pub. No. 2017/0172580).
Regarding Claim 5, Lee teaches wherein the inflatable balloon has a diameter of “expanded diameter of up to 10 mm” [0097], but not greater than twelve (12) millimeters when inflated.
In the field of treating varicose veins, Martin teaches “in certain embodiments, each of the inflated distal balloon diameter and the inflated proximal balloon diameter may be from at least about any of the following: 5, 6, 7, and 8 mm and/or at most about 20, 19, 18, 17, 16, 15, 14, 13, and 12 mm (e.g., about 6-18 mm, about 5-14 mm, etc.)” in [0034].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to have the balloon diameter be flexible to reach and contact different sized vessels such as greater than twelve (12) millimeters when inflated in order to allow the use of the device in different treatment procedures such as treating varicose veins. In addition, a change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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