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 .
Election/Restrictions
Claims 6 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01 December 2025.
Claim Objections
Claims 3-4 are objected to because of the following informalities:
Claim 3, line 2: “0.003 inch” should read –0.003 inches–;
Claim 4, line 2: “0.007 inch” should read –0.007 inches–;
Claim 12, line 2: “.05 inch to .07 inch” should read –.05 inches to .07 inches–;
Claim 12, line 3: “0.00055 square inch” should read –0.00055 square inches–;
Claim 15, line 2: “0.003 inch” should read –0.003 inches–;
Claim 16, line 2: “0.007 inch” should read –0.007 inches–;
Claim 25, line 2: “0.003 inch” should read –0.003 inches–; and
Claim 26, line 2: “0.007 inch” should read –0.007 inches–.
Appropriate correction is required.
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 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.
Claims 1-5, 7, 10, and 23-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuimaono et al., US 20040019349, herein referred to as “Fuimaono”.
Regarding claim 1, Fuimaono discloses a tissue treatment catheter (Figure 1), comprising: a catheter shaft (Figure 1: catheter body 12) having an outer wall sized and shaped for delivery through a radial artery to a blood vessel of a patient ([0083] and [0001]), the catheter shaft having a plurality of lumens extending longitudinally through the catheter shaft between a distal end and a proximal end (Figure 2: second lumen 21, third lumen 22, fourth lumen 23, first lumen 31, second lumen 32, and third lumen 33), wherein the plurality of lumens includes a guidewire lumen within a guidewire lumen wall (Figure 2: first lumen 31 and [0040]: “The first lumen 31 of the inner support member 30 is used to carry a guidewire and is open at its distal end, as shown in FIG. 11. ”) and a cable lumen (Figure 2: second lumen 21 and [0048]: “a coaxial cable 40 is provided in the second lumen 21 of the catheter body”), wherein the catheter shaft includes a stiffening web extending from the guidewire lumen wall (Figure 2: interior part of catheter body 12), and wherein the plurality of lumens include a first fluid lumen (Figure 2: fourth lumen 23 and [0037]: “The fourth lumen 23, which serves as an inflation lumen, is an open lumen to permit fluid to enter and exit the catheter for inflation and deflation of a balloon 26 that is part of the ablation assembly 14.”) defined between the outer wall, the guidewire lumen wall, and the stiffening web (Figure 2: fourth lumen 23 is between the outer wall of catheter body 12, first lumen 31, and the interior portion of catheter body 12), and wherein an outer wall thickness of the outer wall is less than a stiffening wall thickness of the stiffening web (Figure 2: thickness of the interior portion of catheter body 12 between the lumens is larger than the thickness of the outer wall, which is the edge of the catheter body and [0037]); an ultrasound transducer distally positioned relative to the distal end of the catheter shaft (Figure 1: transducer 28), the ultrasound transducer including a piezoelectric transducer body ([0043]); a balloon surrounding the ultrasound transducer (Figure 1: expandable balloon 26), wherein the first fluid lumen is configured to provide a fluid to the balloon ([0037]: “The fourth lumen 23, which serves as an inflation lumen, is an open lumen to permit fluid to enter and exit the catheter for inflation and deflation of a balloon 26 that is part of the ablation assembly 14.”) at a pressure and a flow rate sufficient to protect the ultrasound transducer and non-target tissue of the blood vessel from thermal injury ([0095]); and a single electrical cable extending through the cable lumen (Figure 2: coaxial cable 40), the single electrical cable electrically connected to the ultrasound transducer ([0037]: “The second lumen 21, which is the next largest in size, carries a coaxial cable 40 that is connected to a transducer 28 in the ablation assembly 14.”), wherein the single electrical cable is configured to deliver sufficient electrical energy during sonication to the transducer such that the transducer thermally induces modulation of neural fibers surrounding the blood vessel sufficient to improve a measurable physiological parameter corresponding to a diagnosed condition of the patient ([0040] and [0051]).
Regarding claim 2, Fuimaono discloses the tissue treatment catheter of claim 1, wherein the stiffening wall thickness is at least twice the outer wall thickness ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” Wherein the stiffening wall thickness is about the diameter of the first lumen, while the outer wall thickness is at most less than half the diameter of the second lumen; thus the stiffening wall thickness is at least twice the outer wall thickness).
Regarding claim 3, Fuimaono discloses the tissue treatment catheter of claim 2, wherein the outer wall thickness is in a range of 0.002 to 0.003 inch ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” And Figure 2: what is considered the outer wall of catheter body 12 has thickness in a range of 0.002 to 0.003 inch).
Regarding claim 4, Fuimaono discloses the tissue treatment catheter of claim 2, wherein the stiffening wall thickness is in a range of 0.003 to 0.007 inch ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” Wherein the stiffening wall thickness is about the diameter of the first lumen).
Regarding claim 5, Fuimaono discloses the tissue treatment catheter of claim 1, wherein the cable lumen is within a cable lumen wall (Figure 2: second lumen 21 has a wall), and wherein the stiffening web extends between the guidewire lumen wall and the cable lumen wall (Figure 2: the interior part of catheter body 12, the stiffening web, extends between the wall of first lumen 31 and the wall of second lumen 21).
Regarding claim 7, Fuimaono discloses the tissue treatment catheter of claim 1, wherein the plurality of lumens includes a second fluid lumen defined between the outer wall, the guidewire lumen wall, and the stiffening web ([0052]: “In a further mode, the catheter body 12 can include additional lumens (not shown) that lie either next to or coaxial with the first (guidewire) lumen 20 and that terminate at ports located within the space between the inner member 30 and the transducer 28. A cooling medium can circulate through the space defined by the stand-off 44 between the inner support member 30 and the transducer 28 via these additional lumens. ”).
Regarding claim 10, Fuimaono discloses the tissue treatment catheter of claim 1, wherein an outer diameter of the catheter shaft has a French gauge of 5 or less ([0036]: “The outer diameter of the catheter body 12 is not critical, but preferably ranges from about 5 french to about 10 french,”).
Regarding claim 23, Fuimaono discloses a method (Abstract), comprising: advancing a treatment catheter (Figure 1) through a radial artery to a blood vessel of a patient ([0083] and [0001]), the treatment catheter including a catheter shaft having an outer wall (Figure 1: catheter body 12), and a plurality of lumens extending longitudinally through the catheter shaft between a distal end and a proximal end (Figure 2: second lumen 21, third lumen 22, fourth lumen 23, first lumen 31, second lumen 32, and third lumen 33), wherein the plurality of lumens includes a guidewire lumen within a guidewire lumen wall (Figure 2: first lumen 31 and [0040]: “The first lumen 31 of the inner support member 30 is used to carry a guidewire and is open at its distal end, as shown in FIG. 11. ”) and a cable lumen (Figure 2: second lumen 21 and [0048]: “a coaxial cable 40 is provided in the second lumen 21 of the catheter body”), wherein the catheter shaft includes a stiffening web extending from the guidewire lumen wall (Figure 2: interior part of catheter body 12), and wherein the plurality of lumens includes a first fluid lumen (Figure 2: fourth lumen 23 and [0037]: “The fourth lumen 23, which serves as an inflation lumen, is an open lumen to permit fluid to enter and exit the catheter for inflation and deflation of a balloon 26 that is part of the ablation assembly 14.”) defined between the outer wall, the guidewire lumen wall, and the stiffening web (Figure 2: fourth lumen 23 is between the outer wall of catheter body 12, first lumen 31, and the interior portion of catheter body 12), and wherein an outer wall thickness of the outer wall is less than a stiffening wall thickness of the stiffening web (Figure 2: thickness of the interior portion of catheter body 12 between the lumens is larger than the thickness of the outer wall, which is the edge of the catheter body and [0037]), an ultrasound transducer distally positioned relative to the distal end of the catheter shaft (Figure 1: transducer 28), the ultrasound transducer including a piezoelectric transducer body ([0043]); a balloon surrounding the ultrasound transducer (Figure 1: expandable balloon 26), wherein the first fluid lumen is configured to provide a cooling fluid to the balloon ([0037]: “The fourth lumen 23, which serves as an inflation lumen, is an open lumen to permit fluid to enter and exit the catheter for inflation and deflation of a balloon 26 that is part of the ablation assembly 14.”) at a pressure and flow rate sufficient to protect the ultrasound transducer and non-target tissue of the blood vessel from thermal injury ([0095]), and a single electrical cable extending through the cable lumen (Figure 2: coaxial cable 40), the single electrical cable electrically connected to the ultrasound transducer ([0037]: “The second lumen 21, which is the next largest in size, carries a coaxial cable 40 that is connected to a transducer 28 in the ablation assembly 14.”), wherein the single electrical cable is configured to deliver sufficient electrical energy during sonication to the transducer such that the transducer thermally induces modulation of neural fibers surrounding the blood vessel sufficient to improve a measurable physiological parameter corresponding to a diagnosed condition of the patient ([0040] and [0051]); and applying a voltage to the ultrasound transducer, using the single electrical cable, to cause the piezoelectric transducer body to generate ultrasonic waves ([0049]).
Regarding claim 24, Fuimaono discloses the method of claim 23, wherein the stiffening wall thickness is at least twice the outer wall thickness ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” Wherein the stiffening wall thickness is about the diameter of the first lumen, while the outer wall thickness is at most less than half the diameter of the second lumen; thus the stiffening wall thickness is at least twice the outer wall thickness).
Regarding claim 25, Fuimaono discloses the method of claim 24, wherein the outer wall thickness is in a range of 0.002 to 0.003 inch ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” And Figure 2: what is considered the outer wall of catheter body 12 has thickness in a range of 0.002 to 0.003 inch).
Regarding claim 26, Fuimaono discloses the method of claim 24, wherein the stiffening wall thickness is in a range of 0.003 to 0.007 inch ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” Wherein the stiffening wall thickness is about the diameter of the first lumen).
Regarding claim 27, Fuimaono discloses the method of claim 23, further comprising transferring cooling fluid between a reservoir and the balloon using the first fluid lumen to cool the ultrasound transducer and at least a portion of the single electrical cable that extends through the cable lumen ([0052] and [0095]).
Regarding claim 28, Fuimaono discloses the method of claim 23, further comprising ablating tissue of the blood vessel into which the ultrasound transducer is inserted ([0012]: “ The circumferential ablation element preferably comprises an ultrasound ablation element secured to the catheter at a fixed position within the inflatable balloon, wherein the ultrasound ablation element is adapted to emit a substantially circumferential pattern of ultrasound energy and to ablatively couple to a substantial portion of a circumferential region of tissue engaged by the inflatable balloon in the radially expanded position when the ultrasound ablation element is coupled to and actuated by an ultrasound ablation actuator.”), using the ultrasonic waves that are generated by the piezoelectric transducer body ([0051]: “The piezoelectric crystal that forms central layer 36 of the ultrasound transducer is adapted to radially contract and expand (or radially "vibrate") when an alternating current is applied from a current source and across the outer and inner tubular layers 35 and 37 via the electrical transducer leads 38. This controlled vibration emits the ultrasonic energy that is adapted to ablate tissue and form a circumferential conduction block according to the present embodiment.”).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fuimaono in view of Yock, US 5000185, herein referred to as “Yock”.
Regarding claim 8, Fuimaono discloses the tissue treatment catheter of claim 7, but does not explicitly disclose a catheter wherein the first fluid lumen and the second fluid lumen are symmetric about a vertical plane extending through the stiffening web.
However, Yock teaches a catheter (Figure 1) wherein the first fluid lumen and the second fluid lumen are symmetric about a vertical plane extending through the stiffening web (Figure 4: lumens 17 and 18 are symmetric about a vertical plane extending through flexible tubular element 13 and Col. 3, lines 60-62).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Fuimaono so that the first fluid lumen and the second fluid lumen are symmetric about a vertical plane extending through the stiffening web as taught by Yock so that the device can conveniently be formed as a single extrusion which provides the lumens (Yock Col. 3, line 62 – Col. 4, line 2).
Regarding claim 9, Fuimaono discloses the tissue treatment catheter of claim 1, but does not explicitly disclose a catheter wherein a web surface of the stiffening web, a guidewire lumen surface of the guidewire lumen wall, and a cable lumen surface of a cable lumen wall containing the cable lumen face radially outward toward the first fluid lumen, and wherein an outer wall surface of the outer wall faces radially inward toward the first fluid lumen.
However, Yock teaches a catheter wherein a web surface of the stiffening web, a guidewire lumen surface of the guidewire lumen wall, and a cable lumen surface of a cable lumen wall containing the cable lumen face radially outward toward the first fluid lumen (Figure 4: the middle portion of flexible tubular element 13, the surface of lumen 14, and the surface of lumen 16 face radially outward toward lumen 18), and wherein an outer wall surface of the outer wall faces radially inward toward the first fluid lumen (Figure 4: surface of cover tube 23 faces radially inward towards lumen 18).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Fuimaono so that the web surface of the stiffening web, a guidewire lumen surface of the guidewire lumen wall, and a cable lumen surface of a cable lumen wall containing the cable lumen face radially outward toward the first fluid lumen, and wherein an outer wall surface of the outer wall faces radially inward toward the first fluid lumen as taught by Yock so that the device can conveniently be formed as a single extrusion which provides the lumens (Yock Col. 3, line 62 – Col. 4, line 2).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fuimaono in view of Zadno-Azizi, US 20060200191, herein referred to as “Zadno-Azizi”.
Regarding claim 11, Fuimaono discloses the tissue treatment catheter of claim 1, wherein an outer diameter of the catheter shaft has a French gauge of 4 to 5 ([0036]: “The outer diameter of the catheter body 12 is not critical, but preferably ranges from about 5 french to about 10 french,”), but does not explicitly disclose a catheter wherein the first fluid lumen has a length in a range of 145 to 175 cm and is configured to deliver fluid at a head pressure of 34 psi or less.
However, Zadno-Azizi teaches a catheter (Figure 2A) wherein the first fluid lumen has a length in a range of 145 to 175 cm ([0166]: “ tubular body 44 is comprised of a hollow hypotube having a length in the range from about 160 to about 320 centimeters”) and is configured to deliver fluid at a head pressure of 34 psi or less ([0300]: “ the pressure of the irrigation liquid is typically maintained under 30 psi.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Fuimaono so that the first fluid lumen has a length in a range of 145 to 175 cm as taught by Zadno-Azizi so that the catheter can be used in a conventional percutaneous transluminal coronary angioplasty procedure involving femoral artery access (Zadno-Azizi [0166]). It would also have been obvious to modify the catheter disclosed by Fuimaono so that the first fluid lumen is configured to deliver fluid at a head pressure of 34 psi or less as taught by Zadno-Azizi to prevent excessive expansion of the vessel being treated (Zadno-Azizi [0300]).
Regarding claim 12, Fuimaono discloses the tissue treatment catheter of claim 1, wherein an outer diameter of the catheter shaft is .05 inch to .07 inch ([0036]: “The outer diameter of the catheter body 12 is not critical, but preferably ranges from about 5 french to about 10 french” wherein 0.07 inches is 5.33 french), and wherein the first fluid lumen has a minimum cross-sectional area of 0.00055 square inch ([0037]: “the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch” wherein ). Fuimaono does not explicitly disclose a catheter wherein the first fluid lumen has a length of at least 145 cm.
However, Zadno-Azizi teaches a catheter (Figure 2A) wherein the first fluid lumen has a length of at least 145 cm ([0166]: “ tubular body 44 is comprised of a hollow hypotube having a length in the range from about 160 to about 320 centimeters”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Fuimaono so that the first fluid lumen has a length of at least 145 cm as taught by Zadno-Azizi so that the catheter can be used in a conventional percutaneous transluminal coronary angioplasty procedure involving femoral artery access (Zadno-Azizi [0166]).
Claims 13-17, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Fuimaono in view of Taylor et al., US 10350440, herein referred to as “Taylor”.
Regarding claim 13, Fuimaono discloses a tissue treatment system (Figure 1), comprising: a treatment catheter ([0035]) including a catheter shaft (Figure 1: catheter body 12) having an outer wall sized and shaped for delivery through a radial artery to a blood vessel of a patient ([0083] and [0001]), the catheter shaft having a plurality of lumens extending longitudinally through the catheter shaft between a distal end and a proximal end (Figure 2: second lumen 21, third lumen 22, fourth lumen 23, first lumen 31, second lumen 32, and third lumen 33), wherein the plurality of lumens includes a guidewire lumen within a guidewire lumen wall (Figure 2: first lumen 31 and [0040]: “The first lumen 31 of the inner support member 30 is used to carry a guidewire and is open at its distal end, as shown in FIG. 11. ”) and a cable lumen (Figure 2: second lumen 21 and [0048]: “a coaxial cable 40 is provided in the second lumen 21 of the catheter body”), wherein the catheter shaft includes a stiffening web extending from the guidewire lumen wall (Figure 2: interior part of catheter body 12), and wherein the plurality of lumens includes a first fluid lumen (Figure 2: fourth lumen 23 and [0037]: “The fourth lumen 23, which serves as an inflation lumen, is an open lumen to permit fluid to enter and exit the catheter for inflation and deflation of a balloon 26 that is part of the ablation assembly 14.”) defined between the outer wall, the guidewire lumen wall, and the stiffening web (Figure 2: fourth lumen 23 is between the outer wall of catheter body 12, first lumen 31, and the interior portion of catheter body 12), and wherein an outer wall thickness of the outer wall is less than a stiffening wall thickness of the stiffening web (Figure 2: thickness of the interior portion of catheter body 12 between the lumens is larger than the thickness of the outer wall, which is the edge of the catheter body and [0037]); an ultrasound transducer distally positioned relative to the distal end of the catheter shaft (Figure 1: transducer 28), the ultrasound transducer including a piezoelectric transducer body ([0043]); a balloon surrounding the ultrasound transducer (Figure 1: expandable balloon 26), wherein the first fluid lumen is configured to provide a cooling fluid to the balloon ([0037]: “The fourth lumen 23, which serves as an inflation lumen, is an open lumen to permit fluid to enter and exit the catheter for inflation and deflation of a balloon 26 that is part of the ablation assembly 14.”) at a pressure and flow rate sufficient to protect the ultrasound transducer and non-target tissue of the blood vessel from thermal injury ([0095]); and a single electrical cable extending through the cable lumen (Figure 2: coaxial cable 40), the single electrical cable electrically connecting the signal generator to the ultrasound transducer ([0037]: “The second lumen 21, which is the next largest in size, carries a coaxial cable 40 that is connected to a transducer 28 in the ablation assembly 14.”), wherein the single electrical cable is configured to deliver sufficient electrical energy during sonication to the transducer such that the transducer thermally induces modulation of neural fibers surrounding the blood vessel sufficient to improve a measurable physiological parameter corresponding to a diagnosed condition of the patient ([0040] and [0051]). Fuimaono does not explicitly disclose a tissue treatment system comprising a controller including a signal generator.
However, Taylor teaches a tissue treatment system comprising a controller including a signal generator (Col. 7, lines 53-61).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a controller in the tissue treatment system disclosed by Fuimaono, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Regarding claim 14, Fuimaono in view of Taylor discloses the tissue treatment system of claim 13, wherein the stiffening wall thickness is at least twice the outer wall thickness ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” Wherein the stiffening wall thickness is about the diameter of the first lumen, while the outer wall thickness is at most less than half the diameter of the second lumen; thus the stiffening wall thickness is at least twice the outer wall thickness).
Regarding claim 15, Fuimaono in view of Taylor discloses the tissue treatment system of claim 14, wherein the outer wall thickness is in a range of 0.002 to 0.003 inch ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” And Figure 2: what is considered the outer wall of catheter body 12 has thickness in a range of 0.002 to 0.003 inch).
Regarding claim 16, Fuimaono in view of Taylor discloses the tissue treatment system of claim 14, wherein the stiffening wall thickness is in a range of 0.003 to 0.007 inch ([0037]: “In one preferred embodiment, the first lumen 20 has a diameter of approximately 0.05 inch, the second lumen 21 has a diameter of approximately 0.03 inch, and the third lumen 22 and fourth lumen 23 each have a diameter of approximately 0.028 inch.” Wherein the stiffening wall thickness is about the diameter of the first lumen).
Regarding claim 17, Fuimaono in view of Taylor discloses the tissue treatment system of claim 13, wherein the cable lumen is within a cable lumen wall (Figure 2: second lumen 21 has a wall), and wherein the stiffening web extends between the guidewire lumen wall and the cable lumen wall (Figure 2: the interior part of catheter body 12, the stiffening web, extends between the wall of first lumen 31 and the wall of second lumen 21).
Regarding claim 19, Fuimaono in view of Taylor discloses the tissue treatment system of claim 13, wherein the plurality of lumens includes a second fluid lumen defined between the outer wall, the guidewire lumen wall, and the stiffening web ([0052]: “In a further mode, the catheter body 12 can include additional lumens (not shown) that lie either next to or coaxial with the first (guidewire) lumen 20 and that terminate at ports located within the space between the inner member 30 and the transducer 28. A cooling medium can circulate through the space defined by the stand-off 44 between the inner support member 30 and the transducer 28 via these additional lumens. ”).
Regarding claim 22, Fuimaono in view of Taylor discloses the tissue treatment system of claim 19, wherein an outer diameter of the catheter shaft has a French gauge of 5 or less ([0036]: “The outer diameter of the catheter body 12 is not critical, but preferably ranges from about 5 french to about 10 french,”).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fuimaono in view of Taylor, further in view of Yock.
Regarding claim 20, Fuimaono in view of Taylor discloses the tissue treatment system of claim 19, but does not explicitly disclose a catheter wherein the first fluid lumen and the second fluid lumen are symmetric about a vertical plane extending through the stiffening web.
However, Yock teaches a catheter (Figure 1) wherein the first fluid lumen and the second fluid lumen are symmetric about a vertical plane extending through the stiffening web (Figure 4: lumens 17 and 18 are symmetric about a vertical plane extending through flexible tubular element 13 and Col. 3, lines 60-62).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Fuimaono so that the first fluid lumen and the second fluid lumen are symmetric about a vertical plane extending through the stiffening web as taught by Yock so that the device can conveniently be formed as a single extrusion which provides the lumens (Yock Col. 3, line 62 – Col. 4, line 2).
Regarding claim 21, Fuimaono in view of Taylor discloses the tissue treatment system of claim 13, but does not explicitly disclose a catheter wherein a web surface of the stiffening web, a guidewire lumen surface of the guidewire lumen wall, and a cable lumen surface of a cable lumen wall containing the cable lumen face radially outward toward the first fluid lumen, and wherein an outer wall surface of the outer wall faces radially inward toward the first fluid lumen.
However, Yock teaches a catheter wherein a web surface of the stiffening web, a guidewire lumen surface of the guidewire lumen wall, and a cable lumen surface of a cable lumen wall containing the cable lumen face radially outward toward the first fluid lumen (Figure 4: the middle portion of flexible tubular element 13, the surface of lumen 14, and the surface of lumen 16 face radially outward toward lumen 18), and wherein an outer wall surface of the outer wall faces radially inward toward the first fluid lumen (Figure 4: surface of cover tube 23 faces radially inward towards lumen 18).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter disclosed by Fuimaono so that the web surface of the stiffening web, a guidewire lumen surface of the guidewire lumen wall, and a cable lumen surface of a cable lumen wall containing the cable lumen face radially outward toward the first fluid lumen, and wherein an outer wall surface of the outer wall faces radially inward toward the first fluid lumen as taught by Yock so that the device can conveniently be formed as a single extrusion which provides the lumens (Yock Col. 3, line 62 – Col. 4, line 2).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794