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 Objections
Claims 6 and 13 are objected to because of the following informalities:
In claim 6, line 4, the phrase “of cutting chamber” should read “of the cutting chamber”.
In claim 13, line 4, the phrase “each side wall” should read “each of the pair of side walls” or similar language.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-2, 6-7, 11, 14-15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Willard (US 5085662).
Regarding claim 1, Willard discloses (see abstract; col. 4 line 22-col. 9 line 50; figs. 1-12b) a catheter for removing material in a body lumen (abstract, fig. 9), comprising:
a catheter tube (12, col. 4 lines 22-27; fig. 1);
a flexible drive shaft (70, described as being formed of flexible materials, col. 5 lines 25-32 and col. 8 lines 39-51; figs. 1c-2) disposed within the catheter tube (figs. 1c-2) and configured to be moved by a drive (connected to oscillating means 100, col. 6 lines 19-34);
an infusion lumen (22) disposed within the catheter tube (fig. 2) and configured to receive and transport a fluid therethrough (col. 6 lines 1-18);
an extraction lumen (18) disposed within the catheter tube (fig. 2); and
a head (depicted in fig. 2) configured to remove the material in the body lumen and comprising:
a housing (30, col. 5 lines 30-44) connected to the catheter tube (fig. 2) and comprising an infusion aperture (considered to be aperture transitioning lumen 22 into balloon 40, fig. 2) fluidly coupled to the infusion lumen (fig. 2), an extraction aperture (considered to be aperture transitioning lumen 18 into housing, fig. 2) fluidly coupled to the extraction lumen (figs. 1a-2), and a cutting chamber (chamber of housing, fig. 2) having a cutout (24, col. 6 line 52-col. 7 line 3) therein;
a balloon (40) connected to the housing opposite the cutout of the cutting chamber (fig. 2) and fluidly coupled to the infusion lumen (col. 6 lines 1-18), the balloon configured to inflate and expand upon receiving the fluid therein (col. 6 lines 1-18); and
a probe (60) connected to and driven by the flexible drive shaft (col. 5 lines 25-32), the probe disposed within the cutting chamber (fig. 2), and the probe configured to remove the material from the body lumen, at the cutout, and pulverize the material within the cutting chamber (col. 6 line 52-col. 7 line 3).
Regarding claim 2, Willard discloses the catheter of claim 1. Willard further discloses wherein the probe is configured to linearly translate back and forth within the cutting chamber of the housing such that the probe is configured to collectively cut material from the body lumen, pulsate at a resonant frequency to break up the material, pulverize the material by crushing the material against the cutting chamber, and extract the now pulverized material out through the extraction aperture of the housing (oscillating means 100 pulls cutter element 60 linearly across cutting window to sever material and redirect it into upper lumen 18, col. 6 line 19-col. 7 line 42).
Regarding claim 6, Willard discloses the catheter of claim 1. Willard further discloses wherein: the cutting chamber of the housing comprises a bottom wall (at 26a, col. 4 line 62-col. 5 line 7); the probe comprises an end wall (at distal end of cutter element 60, fig. 5) which is parallel to and faces the bottom wall of cutting chamber when the probe is seated within the cutting chamber (see figs. 2-3, end wall considered to face bottom wall and include a component along cutter element that is parallel to bottom wall, figs. 2-5); and the probe is configured to linearly translate within the cutting chamber (cutter element 60 moves axially) such that the end wall of the probe forcibly contacts the bottom wall of the cutting chamber (considered to be capable of contacting the bottom wall during linear translation) to dually crush the material therebetween and generate pulsations to further pulverize the material within the cutting chamber (considered to be capable of crushing material located between the end wall and the bottom wall since cutter element 60 is rotated at a specific frequency; further note the claim language is recited functionally and does not require the cutter element 60 to actively crush material located distal of the cutter element, col. 7 lines 19-42).
Regarding claim 7, Willard discloses the catheter of claim 1. Willard further discloses wherein the balloon is configured to expand upon inflation such that the balloon contacts the body lumen and moves the housing, causing the material to enter the cutting chamber for subsequent removal thereof by the probe, within the cutting chamber (balloon inflated to press a portion of the atheroma A through cutting window 24, col. 7 lines 4-18; fig. 9).
Regarding claim 11, Willard discloses the catheter of claim 1. Willard further discloses wherein the head is configured to generate a flow of fluid within the cutting chamber that creates a lower pressure within the cutting chamber in comparison to a higher pressure of a surrounding fluid flow of the body lumen, which aspirates the material into the cutting chamber (via vacuum port 97, col. 6 lines 1-18).
Regarding claim 14, Willard discloses the catheter of claim 1. Willard further discloses wherein the head further comprises a nose connected to a distal end of the housing (at 16, figs. 1-2).
Regarding claim 15, Willard discloses the catheter of claim 14. Willard further discloses wherein the nose comprises: a proximal end configured to mate against the distal end of the housing (see figs. 2-3); a perimeter wall extending outwardly from the proximal end and configured to surround the distal end of the housing (tapered portion of 16); a distal end opposite the proximal end and defining a distal apex of the nose (distal end, depicted in figs. 2-3); and a wire aperture (20) extending through the nose (figs. 2-3), from the proximal end to the distal end of the nose, and configured to receive a guide wire (50, figs. 3 and 9) therethrough.
Regarding claim 18, Willard discloses the catheter of claim 1. Willard further discloses further comprising a guide wire (50) extending through the catheter tube and the head (extends through central lumen 20, fig. 3), and the guide wire is configured to guide the head within the body lumen (col. 5 lines 45-55).
Regarding claim 19, Willard discloses (see abstract; col. 4 line 22-col. 9 line 50; figs. 1-12b) a head (depicted in fig. 2) for an atherectomy catheter configured to remove material from a body lumen (abstract, fig. 9), comprising:
a housing (30, col. 5 lines 30-44) configured to be connected to a catheter tube (connected to 12, fig. 2), the housing comprising an infusion aperture (considered to be aperture transitioning lumen 22 into balloon 40, fig. 2) configured to receive a fluid (col. 6 lines 1-18), an extraction aperture (considered to be aperture transitioning lumen 18 into housing, fig. 2), and a cutting chamber (chamber of housing, fig. 2) having a cutout (24, col. 6 line 52-col. 7 line 3) therein;
a balloon (40) connected to the housing opposite the cutout of the cutting chamber (fig. 2), and the balloon configured to inflate and expand upon receiving the fluid therein (col. 6 lines 1-18); and
a probe (60) disposed within the cutting chamber (fig. 2), and the probe configured to remove the material from the body lumen, at the cutout, and pulverize the material within the cutting chamber (col. 6 line 52-col. 7 line 3).
Regarding claim 20, Willard discloses (see abstract; col. 4 line 22-col. 9 line 50; figs. 1-12b) a catheter for removing material in a body lumen (abstract; fig. 9), comprising:
a catheter tube (12, col. 4 lines 22-27; fig. 1) including an infusion lumen (22) and an extraction lumen (18);
a flexible drive shaft (70, described as being formed of flexible materials, col. 5 lines 25-32 and col. 8 lines 39-51; figs. 1c-2) disposed within the extraction lumen of the catheter tube (see fig. 1c); and
a head (depicted in fig. 2) configured to remove the material in the body lumen and comprising:
a housing (30, col. 5 lines 30-44) connected to the catheter tube (fig. 2) and comprising an infusion aperture (considered to be aperture transitioning lumen 22 into balloon 40, fig. 2) fluidly coupled to the infusion lumen (fig. 2), an extraction aperture (considered to be aperture transitioning lumen 18 into housing, fig. 2) fluidly coupled to the extraction lumen (figs. 1a-2), and a probe compartment (chamber of housing, fig. 2) having a cutout (24, col. 6 line 52-col. 7 line 3) therein;
a balloon (40) connected to the housing opposite the probe compartment (fig. 2) and fluidly coupled to the infusion lumen (col. 6 lines 1-18), the balloon configured to inflate and expand upon receiving the fluid therein (col. 6 lines 1-18); and
a probe (60) connected to and driven by the flexible drive shaft (col. 5 lines 25-32), the probe disposed within the probe compartment (fig. 2), and the probe configured to oscillate within the probe compartment to pulverize the material within the probe compartment (col. 6 line 52-col. 7 line 3).
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(s) 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of MacDonald Stuart G. (US 4846192).
Regarding claim 3, Willard discloses the catheter of claim 1.
Willard further discloses wherein the probe comprises: at least one cutting blade (at cutting edge 62, fig. 4) configured to cut the material only within the cutting chamber upon rotating the probe (cuts material which has entered the cutting window, col. 6 line 52-col. 7 line 3).
However, Willard fails to disclose the probe comprising an extraction aperture which is fluidly coupled to the extraction aperture of the housing such that the material exits internally through the probe, the housing, and the extraction lumen.
MacDonald Stuart G. teaches (col. 2 line 34-col. 4 line 30; figs. 1-3), in the same field of endeavor, a catheter for removing material in a body lumen (abstract) comprising a probe (40) comprising an extraction aperture (includes aperture of tube 48 and openings 49 within 40, fig. 2) which is fluidly coupled to an extraction aperture of a housing (fluidly coupled to body portion 23, col. 3 lines 10-30) such that material exits internally through the probe, the housing and an extraction lumen (wash liquid pumped through tube to exit at apertures 49 to aid in removal of material via suction through body portion 23), for the purpose of aiding in removing cut material by pulling liquid and the cut debris down towards the incision through the device (col. 2 line 63-col. 3 line 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cutter element of Willard to further comprise an extraction aperture extending within the cutter element, in order to provide the capability of delivering fluid through the cutter element to aid in removing cut material by pulling liquid and cut debris towards the vacuum port, based on the teachings of MacDonald Stuart G. (col. 2 line 63-col. 3 line 30).
Regarding claim 13, Willard discloses the catheter of claim 1.
However, Willard fails to disclose wherein: the cutting chamber is configured to shear cut the material in conjunction with the probe; and the cutting chamber comprises a pair of side walls, each side wall comprising a taper defining a sharp cutting edge that is configured to shear cut the material in conjunction with the probe upon rotating the probe within the cutting chamber.
MacDonald Stuart G. teaches (col. 2 line 34-col. 4 line 30; figs. 1-3), in the same field of endeavor, a catheter for removing material in a body lumen (abstract), wherein a cutting chamber (formed by 28) is configured to shear cut material in conjunction with a probe (via cutting edge 30, col. 3 lines 10-30), the cutting chamber comprising a pair of side walls (includes walls 30 and 32), each side wall comprising a taper defining a sharp cutting edge (each wall may define a sharp cutting edge, 32 considered to be tapered similarly to 30 when defining a sharp cutting edge, col. 2 lines 49-62) that is configured to shear cut the material in conjunction with the probe upon rotating the probe within the cutting chamber (cutting edge 56 cooperates with cutting edge 30 to shear off fatty deposits, sharp edges 30 and 32 considered to be capable of both working in conjunction with the internal cutting component of the device when sharp, col. 3 lines 10-30), for the purpose of shearing off fatty deposits that get caught in the aperture when directed rearwardly (col. 3 lines 10-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the longitudinal side walls of the cutting window of Willard to further include tapered sharp cutting edges as claimed, in order to provide the ability to shear off fatty deposits that get caught in the aperture during proximal movement of the cutter element, based on the suggestions and teachings of MacDonald Stuart G. (col. 3 lines 10-30).
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of MacDonald Stuart G as applied to claim 3 above, and further in view of Yamanouchi (US 2019/0008550 A1).
Regarding claim 4, Willard (as modified) teaches the catheter of claim 3.
However, Willard (as modified) fails to teach wherein the at least one blade of the probe comprises a pair of cutting blades.
Yamanouchi teaches (paras. [0091]-[0097]; figs. 5a-6), in the same field of endeavor, a catheter for removing material in a body lumen (para. [0002]) comprising a probe (13) comprising a pair of cutting blades (at least 2 propellers 62), for the purpose of reliably sucking a large foreign substance out through the device by reliably cutting and nodulizing the foreign substance using a plurality of blades (para. [0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cutter element of Willard (as modified) to include an additional cutting edge such that the cutter element comprises at least a pair of cutting blades, in order to reliably suck a large foreign substance out through the device by reliably cutting and nodulizing the foreign substance using a plurality of blades, providing a larger amount of surface area of the cutter element contacting the material, based on the teachings of Yamanouchi (para. [0097]).
Regarding claim 5, Willard (as modified) teaches the catheter of claim 3.
However, Willard (as modified) fails to teach wherein the at least one blade of the probe comprises four cutting blades.
Yamanouchi teaches (paras. [0091]-[0097]; figs. 5a-6), in the same field of endeavor, a catheter for removing material in a body lumen (para. [0002]) comprising a probe (13) comprising four cutting blades (propellers 62, figs. 5a-6), for the purpose of reliably sucking a large foreign substance out through the device by reliably cutting and nodulizing the foreign substance using a plurality of blades (para. [0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cutter element of Willard (as modified) to include a total of 4 cutting edges such that the cutter element comprises four cutting blades, in order to reliably suck a large foreign substance out through the device by reliably cutting and nodulizing the foreign substance using a plurality of blades, providing a larger amount of surface area of the cutter element contacting the material, based on the teachings of Yamanouchi (para. [0097]).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Malhi (US 2016/0128715 A1).
Regarding claim 8, Willard discloses the catheter of claim 1.
Willard further discloses wherein the fluid is configured to flow through the infusion lumen (22), and through the balloon to inflate the balloon (col. 6 lines 1-18).
However, Willard fails to disclose wherein the fluid is configured to flow into and through the cutting chamber to irrigate and flush the material out of the cutting chamber, and into the extraction lumen for subsequent extraction of the material.
Malhi teaches (para. [0075]; figs. 4-8), in the same field of endeavor, a catheter for removing material in a body lumen (abstract), wherein fluid is configured to flow into and through a cutting chamber (68, para. [0075]) to irrigate and flush material out of the cutting chamber (para. [0067]), and into an extraction lumen (30a) for subsequent extraction of the material (para. [0067]), for the purpose of causing entrainment of surrounding fluid and occlusive material into a jet of fluid in the proximity of the exhaust lumen (para. [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflation fluid of Willard to flow into and through the cutting chamber and then into the lower lumen 18, in order to aid in extraction of material within the cutting chamber with the fluid by causing entrainment of surrounding fluid and occlusive material into a jet of fluid in the proximity of the exhaust lumen, based on the teachings of Malhi (para. [0067]).
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Malhi as applied to claim 8 above, and further in view of Bonnette (US 2023/0201540 A1).
Regarding claim 9, Willard (as modified) teaches the catheter of claim 8.
However, Willard (as modified) fails to teach wherein the housing further comprises at least one nozzle fluidly coupled to the balloon, the at least one nozzle opens into the cutting chamber, and the at least one nozzle is configured to pressurize the fluid passing therethrough such that the fluid flushes out the cutting chamber and forces the material out through the extraction lumen.
Bonnette teaches (paras. [0065]-[0068]; figs. 8a-c), in the same field of endeavor, a catheter for removing material in a body lumen (abstract) comprising a housing (fig. 8a) further comprising at least one nozzle (see nozzles 318) fluidly coupled to a balloon (800, fig. 8a), the at least one nozzle opens into a cutting region (considered to open towards a region in which the thrombus is captured, para. [0068]), and the at least one nozzle is configured to pressurize the fluid passing therethrough (paras. [0031] and [0054]) such that the fluid flushes out the cutting region and forces the material out through an extraction lumen (removes thrombus for passage to the suction lumen 502, para. [0060]), for the purpose of facilitating the removal of thrombus (paras. [0054] and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Willard (as modified) to further include a nozzle fluidly connected to the balloon and opening into the cutting chamber as claimed, in order to facilitate the removal of thrombus without adding an additional irrigation fluid to the device, allowing the same fluid to inflate the balloon and encourage material to move towards lumen 18 connected to the vacuum port for extraction, based on the suggestions and teachings of Bonnette (paras. [0054] and [0060]).
Regarding claim 10, Willard (as modified) teaches the catheter of claim 9. Willard (as modified) further teaches wherein the housing further comprises at least one nozzle channel extending into an end wall of the housing (combination considered to further teach nozzle extending into housing via a channel, see fig. 8a of Bonnette depicting nozzles 318 fluidly connected within tubular portion of device to balloon 800), the at least one nozzle channel is fluidly coupled to the balloon (via 18) and the at least one nozzle (combination considered to further teach connection between balloon and nozzle via the nozzle channel), and the at least one nozzle channel is configured to guide the fluid from the balloon to the at least one nozzle (combination considered to further teach fluid connection between nozzle and balloon, see fig. 8a of Bonnette depicting fluid connection between balloon 800 and nozzles 318).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Schulz (US 5836957).
Regarding claim 12, Willard discloses the catheter of claim 1.
However, Willard fails to disclose wherein the housing further comprises an open balloon compartment located opposite the cutting chamber, and the open balloon compartment is configured to receive and house at least a portion of the balloon therein.
Schulz teaches (col. 6 lines 7-22; fig. 11), in the same field of endeavor, a catheter for removing material in a body lumen (abstract) comprising a housing (includes 100 and 104) comprising an open balloon compartment (compartment of 104) located opposite a cutting chamber (located opposite cutter window 102), and the open balloon compartment is configured to receive and house at least a portion of the balloon therein (fig. 11), for the purpose of pulling slack balloon material into the housing and preventing the material from rolling into the cutter window (col. 6 lines 7-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Willard to include an open balloon compartment configured to receive and house at least a portion of the balloon, in order to pull any slack balloon material and prevent the material from rolling into the cutter window upon inflation, based on the teachings of Schulz (col. 6 lines 7-22).
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Bonnette and Malhi.
Regarding claim 16, Willard discloses the catheter of claim 14.
However, Willard fails to disclose wherein the nose comprises: a fluid inlet fluidly connected to the balloon; an internal fluid chamber fluidly connected to the fluid inlet; and at least one nozzle fluidly connected to the internal fluid chamber and opening toward the cutting chamber of the housing, and the at least one nozzle is configured to pressurize the fluid passing therethrough such that the fluid flushes out the cutting chamber and forces the material out through the extraction lumen.
Bonnette teaches (paras. [0065]-[0068]; figs. 8a-c), in the same field of endeavor, a catheter for removing material in a body lumen (abstract) comprising a nose (distal end of catheter depicted in figs. 8a-c) comprising a fluid inlet (at least one nozzle 318 in communication with balloon 800, see aperture within balloon 800 in fig. 8a) fluidly connected to a balloon (800, fig. 8a); an internal fluid chamber (internal portion of catheter) fluidly connected to the fluid inlet (figs. 8a-c); and at least one nozzle (second nozzle 318 distal of balloon, fig. 8a) fluidly connected to the internal fluid chamber (figs. 8a-c), and the at least one nozzle is configured to pressurize the fluid passing therethrough (fluid is pressurized, paras. [0031] and [0054]) such that the fluid flushes out the catheter and forces material out through an extraction lumen (removes thrombus for passage to the suction lumen, para. [0060]), for the purpose of facilitating the removal of thrombus (paras. [0054] and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nose of Willard to further include an inlet fluidly connected to the balloon, an internal fluid chamber fluidly connected to the fluid inlet, and at least one nozzle fluidly connected to the internal fluid chamber, the at least one nozzle configured to pressurize the fluid passing therethrough such that the fluid flushes out the cutting chamber as claimed, in order to facilitate removal of material by providing infusion fluid within the cutting chamber, encouraging material to move towards lumen 18 for extraction, based on the suggestions and teachings of Bonnette (paras. [0054] and [0060]).
Willard (as modified) still fails to teach the at least one nozzle opening toward the cutting chamber of the housing.
Malhi teaches (para. [0064]; fig. 2), in the same field of endeavor, a catheter for removing material in a body lumen (abstract) comprising a nozzle (40a, fig. 5) opening towards a chamber of the housing (opens towards 30a along longitudinal axis), for the purpose of causing entrainment of surrounding fluid and occlusive material into the jet in proximity of the exhaust lumen 30a (para. [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nozzle of Willard (as modified) to open towards the cutting chamber of the housing, in order to direct the material along the longitudinal axis of the housing in proximity to the exhaust lumen, based on the suggestions and teachings of Malhi (para. [0067]).
Regarding claim 17, Willard (as modified) teaches the catheter of claim 16. Willard (as modified) further teaches wherein the balloon comprises a proximal end connected to the infusion lumen (see fig. 2 of Willard) and a distal end connected to the fluid inlet of the nose (combination considered to further teach fluid connection between balloon and fluid inlet of nose).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 4794931 to Yock, disclosing a catheter.
US 5100424 to Jang, disclosing a catheter comprising a balloon and an aspiration lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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