DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 29, 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 10-11, 13-15, and 27-30 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, applicant uses the phrase “at least one measuring components”. This language choice creates uncertainty because it is not clear if only one measuring component (singular) needs to be present or if measuring components (plural) need to be present. For purposes of examination, the examiner presumed that applicant intended to write “at least one measuring component” instead of “at least one measuring components”.
In claim 11, applicant uses the phrase “at least one measuring components”. This language choice creates uncertainty because it is not clear if only one measuring component (singular) needs to be present or if measuring components (plural) need to be present. For purposes of examination, the examiner presumed that applicant intended to write “at least one measuring component” instead of “at least one measuring components”.
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.
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 1, 2, 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over EP1450890 by Kraft in view of U.S. 4,721,123 to Cosentino in view of JP2012040159 by Komatsu.
With regard to claim 1, Kraft teaches an apparatus for cleaning a catheter (illustrated in Figure 2), wherein the catheter comprises a balloon (item 38 in Figure 2; reads on inflatable component; Abstract; pages 5-12 of translation). Kraft’s catheter comprises both a first lumen (item 42 in Figures 1 and 2) and a second lumen (item 40 in Figures 1-2), wherein the first lumen is used to inflate the balloon (page 5 of translation). Kraft’s apparatus is configured to clean (with cleaning solution) outer surfaces of the catheter using a spray nozzle assembly (item 9 in Figure 3) and an inner receptable (item 5 in Figure 3), and Kraft’s apparatus is configured to use the same cleaning solution to flush inner surfaces of the first lumen, the second lumen, and the balloon (pages 5-12 of translation). Kraft’s apparatus comprises a cleaning solution tank (item 117 in Figure 11) in which the cleaning solution is formed (by mixing a concentrate and water; pages 10-12 of translation), and this cleaning solution tank corresponds to applicant’s cleaning solution source. Kraft’s apparatus comprises a balloon-filling attaching port comprising a “receiving part” (illustrated as bottommost item 76 in Figure 4 and item 76 in Figure 6), a “connection element” (item 93 in Figure 6), and a “supply line” (bottommost item 78 in Figure 4 and item 78 in Figure 6; pages 8-11 of translation), and this balloon-filling attaching port corresponds to applicant’s medical device attachment port. Kraft’s apparatus comprises a pump (item 131 in Figure 11; reads on applicant’s pressure source) operable to move the cleaning solution from the cleaning solution tank 117 to the balloon-filling attaching port (pages 10-12 of translation), and this moving from the tank to the attaching port occurs using supply line 24 (in Figure 3), as explained on page 11 of the Kraft translation. Applicant’s limitation specifying that the fluid includes one or more of micro-pellets, microbeads, microparticles, abrasive particles, and/or microbubbles operable to provide abrasive cleaning to the inflatable component specifies intended use (see MPEP 2114 and 2115) of applicant’s apparatus and is thus not given patentable weight, as applicant’s claim 1 specifies that the cleaning solution source merely has to be operable to contain that fluid and that the at least one pressure source has to be operable to move the fluid from the cleaning solution source to the at least one medical device attachment port. In the apparatus of Kraft, the cleaning solution tank (item 117 in Figure 11; reads on cleaning solution source) is structurally capable of containing (and thus operable to contain) cleaning liquid that comprises microparticles, and the pump (item 131 in Figure 11; reads on applicant’s pressure source) of Kraft is structurally capable of pumping such cleaning liquid from the cleaning solution tank to the balloon-filling attaching port.
Kraft teaches that the apparatus senses the balloon pressure (page 11 in Kraft), but this pressure-sensing teaching is brief and doesn’t explicitly recite that the pressure sensor is structurally capable of detecting that an entirety of an inner surface of the balloon is contacted with fluid.
Cosentino teaches that when supplying cleaning solution into a catheter balloon in order to clean the interior of the catheter balloon, the balloon can be advantageously filled to a maximum operating pressure with cleaning liquid while a pressure transducer monitors the pressure inside the balloon, as this pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly (Col. 7, lines 3-37).
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 apparatus of Kraft such that a pressure transducer is arranged to sense the interior pressure of the balloon as the balloon is filled to a maximum operating pressure with cleaning solution, as this sensed pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly. The motivation for performing the modification was provided by Cosentino, who teaches that when supplying cleaning solution into a catheter balloon in order to clean the interior of the catheter balloon, the balloon can be advantageously filled to a maximum operating pressure with cleaning liquid while a pressure transducer monitors the pressure inside the balloon, as this pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly. In this combination of Kraft in view of Cosentino, since the pressure transducer can sense the interior pressure of the balloon, it is structurally capable of sensing that an entirety of an inner surface of the balloon has been contacted with the cleaning solution.
In the combination of Kraft in view of Cosentino, a pressure sensor is used to determine if the balloon is leaking or otherwise functioning improperly. The combination of Kraft in view of Cosentino does not teach that the apparatus comprises a diameter-measuring component and/or a weight-measuring component.
Cosentino teaches that one potential problem with a catheter balloon is that its volume can become outside the range of the manufacturer’s specifications (Col. 7, lines 23-37).
Komatsu teaches that when testing a medical balloon, a camera and image-processing of imagery therefrom can successfully be used to determine the dimensions (including diameter and length) of the ballon (Abstract; pages 8 and 10-12 of translation).
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 apparatus of Kraft in view of Cosentino such that the apparatus also comprises a camera and a computer capable of image processing imagery from said camera such that the camera and computer can successfully be used to evaluate the dimensions of the balloon as the balloon is filled with cleaning liquid. Cosentino teaches that one potential problem with a catheter balloon is that its volume can become outside the range of the manufacturer’s specifications, and motivation for performing the modification was provided by Komatsu, who teaches that when testing a medical balloon, a camera and image-processing of imagery therefrom can successfully be used to determine the dimensions (including diameter and length) of the ballon. In this combination of Kraft in view of Cosentino in view of Komatsu, if the dimensions of the balloon are abnormal (according to image-processing) during the filling of the balloon with cleaning liquid, a user can be alerted to further inspect the balloon to see if the balloon is still suitable for medical use, as Cosentino teaches that a balloon having a wrong volume is a known potential problem for such balloons. In this combination of Kraft in view of Cosentino in view of Komatsu, the combination of the pressure transducer and the camera-and-computer-based-image-processing tool is considered to correspond to structure that applicant calls at least one fill sensor, and this combination is structurally capable of being used to determine that a catheter balloon is fully expanded.
With regard to claim 2, in the apparatus of Kraft in view of Cosentino in view of Komatsu, the supply line 24 (in Figure 3 of Kraft) and its valve (item 143 in Figure 3 of Kraft) can also be considered part of the balloon-filling attaching port because valve 143 and line 24 are what deliver the cleaning solution to “supply line” (bottommost item 78 in Figure 4 and item 78 in Figure 6; pages 11 and 12 of Kraft translation).
With regard to claim 5, the apparatus of Kraft in view of Cosentino in view of Komatsu comprises a balloon-cleaning fluidic path (through supply line 78 in Figure 6 of Kraft), a lumen-cleaning fluidic path (through hose 62 in Figure 8 of Kraft), and an exterior-cleaning fluidic path (through spray nozzle assembly 9 in Figure 3; pages 5-12 of Kraft translation).
With regard to claim 6, in the apparatus of Kraft in view of Cosentino in view of Komatsu, the balloon-cleaning fluidic path is operable to provide the cleaning solution to the balloon, the lumen-cleaning fluidic path is operable to provide the cleaning solution to a lumen of the catheter, and the exterior-cleaning fluidic path is operable to supply the cleaning solution to an exterior surface of the catheter (pages 5-12 of Kraft translation).
With regard to claim 7, in the apparatus of Kraft in view of Cosentino in view of Komatsu, multiple balloon-comprising catheters can be arranged for cleaning in a sieve insert (item 7 in Figure 4 of Kraft) and the balloon-filling attaching port is one of a plurality of medical device attachment ports, wherein said plurality of medical device attachment ports includes a second balloon-filling attaching port (comprising uppermost item 76 in Figure 4 and uppermost 78 in Figure 4 of Kraft), and wherein each of the balloon-filling attaching ports is in fluid communication with a corresponding balloon (pages 5-8 and 11 of Kraft translation).
With regard to claim 8, in the apparatus of Kraft in view of Cosentino in view of Komatsu, a supply line downstream of valve 143 (in Figure 3 of Kraft) splits such that some cleaning solution is directed to spray nozzle assembly 9 (in Figure 3 of Kraft) and some cleaning solution is directed to line 24 and from line 24 to the first and second lumens of cleaned catheters (pages 11-12 of Kraft translation). The splitting point is a manifold, and this manifold directs cleaning solution to the balloon-filling attaching ports.
With regard to claim 10, in the combination of Kraft in view of Cosentino in view of Komatsu, the camera-and-computer-based-image-processing tool is considered to correspond to applicant’s machine vision system.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over EP1450890 by Kraft in view of U.S. 4,721,123 to Cosentino in view of JP2012040159 by Komatsu as applied to claim 2 above, and further in view of U.S. 2018/0304315 by Connelly.
With regard to claim 3, the combination of Kraft in view of Cosentino in view of Komatsu teaches filling the balloon with the cleaning solution and the sucking the cleaning solution out of the balloon in a cyclic fashion, wherein the cleaning solution is supplied through supply line 78 (in Figure 6 of Kraft), wherein the sucking occurs through discharge line 80 (in Figure 6 of Kraft), and wherein the sucking is performed by a vacuum source that is not illustrated in Kraft’s Figures (pages 11-12 of Kraft translation). When cyclically filling and emptying the balloon, cleaning solution is supplied from supply line 78 into balloon connector 44 (in Figure 6 of Kraft), and suction is applied from discharge line 80 to balloon connector 44 (pages 11-12 of Kraft translation).
The combination of Kraft in view of Cosentino in view of Komatsu does not recite using a single valve to achieve this cyclic supply and suction of cleaning solution.
However, in the art of supplying cleaning liquid, it is well known that a three-way valve can be successfully used to open a first fluid path while a second fluid path is closed, close the first fluid path while the second fluid path is open, or be in an “off” mode where both fluid paths are closed. Connelly teaches such a three-way valve as item 42 in Figure 1, wherein the three-way valve can open a first fluid path while a second fluid path is closed, close the first fluid path while the second fluid path is open, or be in an “off” mode where both fluid paths are closed (Par. 0022). 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 apparatus of Kraft in view of Cosentino in view of Komatsu such that the receiving part (item 76 in Kraft’s Figure 6) comprises a three-way valve configured to permit three situations: the first situation being that the supply line 78 is open communication with balloon connector 44 (such that the balloon can be supplied with cleaning solution) while the discharge line 80 is closed to the balloon connector, the second situation being that the discharge line 80 is in open communication with the balloon connector 44 (such that suction of cleaning liquid from the balloon occurs) while the supply line 78 is closed to the balloon connector, and the third situation simply being an “off” situation where the supply and suction paths are both closed. The motivation for performing the modification is that such a three-way valve allows for the cyclic supply and suction of cleaning solution taught by Kraft in view of Cosentino in view of Komatsu. Kraft doesn’t bother to illustrate his taught vacuum source or valves that might be used to achieve the cyclic supply and suction he teaches. In the art of supplying cleaning liquid, it is well known that a three-way valve can be successfully used to open a first fluid path while a second fluid path is closed, close the first fluid path while the second fluid path is open, or be in an “off” mode where both fluid paths are closed, Connelly being an example of prior art teaching such a well-known valve.
With regard to claim 4, in the combination of Kraft in view of Cosentino in view of Komatsu in view of Connelly, a pressure sensor is used to measure the pressure inside the balloon to determine if the balloon is leaking or otherwise functioning improperly.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over EP1450890 by Kraft in view of U.S. 4,721,123 to Cosentino in view of JP2012040159 by Komatsu as applied to claim 1 above, and further in view of U.S. 2023/0270904 by Simonovsky as evidenced by U.S. 2007/0197963 by Griffiths.
With regard to claim 27, the combination of Kraft in view of Cosentino in view of Komatsu does not teach that the apparatus comprises a sensor operable to detect that the balloon (of the balloon-comprising catheter) has an amount of contrast below a predetermined threshold.
Simonovsky teaches that, in a medical environment, a cleaning apparatus can comprise a conductivity sensor such that sensed conductivity data can be used to sense a level of contaminants in used washing liquid, wherein the sensed level of contaminants in used washing liquid can advantageously be used to determine if washing is successfully completed or not (Abstract; Par. 0006, 0028, 0029, and 0042).
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 apparatus of Kraft in view of Cosentino in view of Komatsu such that a conductivity sensor is arranged to sense a level of contaminants in used cleaning solution that was used to clean the balloon of the catheter, wherein such sensing is used to detect when the cleaning of the balloon has been successfully completed. The motivation for performing the modification was provided by Simonovsky, who teaches that, in a medical environment, a cleaning apparatus can comprise a conductivity sensor such that sensed conductivity data can be used to sense a level of contaminants in used washing liquid, wherein the sensed level of contaminants in used washing liquid can advantageously be used to determine if washing is successfully completed or not.
In the combination of Kraft in view of Cosentino in view of Komatsu in view of Simonovsky, the conductivity sensor is capable of sensing a level of contaminants in used cleaning solution in order to determine if cleaning is completed or not, and the conductivity sensor is thus considered to be structurally capable of determining if the level of contaminants is below a predetermined threshold. The combination of Kraft in view of Cosentino in view of Komatsu in view of Simonovsky does not explicitly recite that the conductivity sensor is structurally capable of detecting a level of contrast medium. However, in the medical art, it is well-known that contrast medium can be ionic (MPEP 2144.03, Official Notice). An example of this is Griffiths, who teaches that contrast medium in the medical field can be ionic (Par. 0060, 0084, and 0097). The conductivity sensor in the apparatus of Kraft in view of Simonovsky is thus considered to be structurally capable of being used to determine if a level of ionic contrast medium is below a predetermined threshold or not.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over EP1450890 by Kraft in view of U.S. 4,721,123 to Cosentino in view of JP2012040159 by Komatsu as applied to claim 1 above, and further in view of U.S. 2013/0186428 by Lutz.
With regard to claim 28, in the apparatus of Kraft in view of Cosentino in view of Komatsu, multiple balloon-comprising catheters are arranged for cleaning on a sieve tray (item 7 in Figure 4 of Kraft) during the cleaning of internal and external surfaces of the catheters (pages 5-8 and 11 of Kraft translation).
The combination of Kraft in view of Cosentino in view of Komatsu does not teach that the apparatus comprises a moving component to cause the cleaning solution inside the balloon to move.
Lutz teaches that when cleaning medical equipment with cleaning liquid while the equipment is arranged on a tray, an actuator can be configured to advantageously agitate the tray in order to enhance the liquid-based cleaning of the medical equipment thereon (Par. 0014 and 0048).
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 apparatus of Kraft in view of Cosentino in view of Komatsu such that an actuator (reads on moving component) is arranged to agitate the tray during the liquid-base cleaning of the catheter and its balloon’s interior. The motivation for performing the modification was provided by Lutz, who teaches that when cleaning medical equipment with cleaning liquid while the equipment is arranged on a tray, an actuator can be configured to advantageously agitate the tray in order to enhance the liquid-based cleaning of the medical equipment thereon. In this combination of Kraft in view of Cosentino in view of Komatsu in view of Lutz, the actuator-driven agitation of the tray is considered to be structurally capable of causing movement of cleaning liquid inside the catheter’s balloon such that fresh cleaning liquid contacts an interior of the balloon (due to said caused movement of the cleaning liquid) because the catheter is on the agitated tray.
Claims 11, 13, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP1450890 by Kraft in view of U.S. 4,721,123 to Cosentino in view of JP2012040159 by Komatsu.
With regard to claim 11, Kraft teaches an apparatus for cleaning a catheter (illustrated in Figure 2), wherein the catheter comprises a balloon (item 38 in Figure 2; reads on inflatable component; Abstract; pages 5-12 of translation). Kraft’s catheter comprises both a first lumen (item 42 in Figures 1 and 2) and a second lumen (item 40 in Figures 1-2), wherein the first lumen is used to inflate the balloon (page 5 of translation). Kraft’s apparatus is configured to clean (with cleaning solution) outer surfaces of the catheter using a spray nozzle assembly (item 9 in Figure 3) and an inner receptable (item 5 in Figure 3), and Kraft’s apparatus is configured to use the same cleaning solution to flush inner surfaces of the first lumen, the second lumen, and the balloon (pages 5-12 of translation). Kraft’s apparatus comprises a cleaning solution tank (item 117 in Figure 11) in which the cleaning solution is formed (by mixing a concentrate and water; pages 10-12 of translation), and this cleaning solution tank corresponds to applicant’s cleaning solution source. Kraft’s apparatus comprises a balloon-filling attaching port comprising a “receiving part” (illustrated as bottommost item 76 in Figure 4 and item 76 in Figure 6), a “connection element” (item 93 in Figure 6), and a “supply line” (bottommost item 78 in Figure 4 and item 78 in Figure 6; pages 8-11 of translation), and this balloon-filling attaching port corresponds to applicant’s medical device attachment port. Kraft’s apparatus comprises a pump (item 131 in Figure 11; reads on applicant’s pressure source) operable to move the cleaning solution from the cleaning solution tank 117 to the balloon-filling attaching port (pages 10-12 of translation), and this moving from the tank to the attaching port occurs using supply line 24 (in Figure 3), as explained on page 11 of the Kraft translation. The apparatus of Kraft comprises a balloon-cleaning fluidic path (through supply line 78 in Figure 6), a lumen-cleaning fluidic path (through hose 62 in Figure 8), and an exterior-cleaning fluidic path (through spray nozzle assembly 9 in Figure 3; pages 5-12 of translation). The apparatus of Kraft comprises a valve (item 143 in Figure 3) in fluid communication with the three fluidic paths (the three paths being the balloon-cleaning fluidic path, the lumen-cleaning fluidic path, and the exterior-cleaning fluidic path) such that the valve directs cleaning solution to the three fluidic paths (pages 11-12 of translation). Applicant’s limitation specifying that the fluid includes one or more of micro-pellets, microbeads, microparticles, abrasive particles, and/or microbubbles operable to provide abrasive cleaning to the inflatable component specifies intended use (see MPEP 2114 and 2115) of applicant’s apparatus and is thus not given patentable weight, as applicant’s claim 11 specifies that the cleaning solution source merely has to be operable to contain that fluid and that the at least one pressure source has to be operable to move the fluid to the fluidic paths. In the apparatus of Kraft, the cleaning solution tank (item 117 in Figure 11; reads on cleaning solution source) is structurally capable of containing (and thus operable to contain) cleaning liquid that comprises microparticles, and the pump (item 131 in Figure 11; reads on applicant’s pressure source) is structurally capable of moving such cleaning liquid from the cleaning solution tank into the balloon-cleaning fluidic path, the lumen-cleaning fluidic path, and the exterior-cleaning fluidic path.
Kraft teaches that the apparatus senses the balloon pressure (page 11 in Kraft), but this pressure-sensing teaching is brief and doesn’t explicitly recite that the pressure sensor is structurally capable of detecting that an entirety of an inner surface of the balloon is contacted with fluid.
Cosentino teaches that when supplying cleaning solution into a catheter balloon in order to clean the interior of the catheter balloon, the balloon can be advantageously filled to a maximum operating pressure with cleaning liquid while a pressure transducer monitors the pressure inside the balloon, as this pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly (Col. 7, lines 3-37).
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 apparatus of Kraft such that a pressure transducer is arranged to sense the interior pressure of the balloon as the balloon is filled to a maximum operating pressure with cleaning solution, as this sensed pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly. The motivation for performing the modification was provided by Cosentino, who teaches that when supplying cleaning solution into a catheter balloon in order to clean the interior of the catheter balloon, the balloon can be advantageously filled to a maximum operating pressure with cleaning liquid while a pressure transducer monitors the pressure inside the balloon, as this pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly. In this combination of Kraft in view of Cosentino, since the pressure transducer can sense the interior pressure of the balloon, it is structurally capable of sensing that an entirety of an inner surface of the balloon has been contacted with the cleaning solution.
In the combination of Kraft in view of Cosentino, a pressure sensor is used to determine if the balloon is leaking or otherwise functioning improperly. The combination of Kraft in view of Cosentino does not teach that the apparatus comprises a diameter-measuring component and/or a weight-measuring component.
Cosentino teaches that one potential problem with a catheter balloon is that its volume can become outside the range of the manufacturer’s specifications (Col. 7, lines 23-37).
Komatsu teaches that when testing a medical balloon, a camera and image-processing of imagery therefrom can successfully be used to determine the dimensions (including diameter and length) of the ballon (Abstract; pages 8 and 10-12 of translation).
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 apparatus of Kraft in view of Cosentino such that the apparatus also comprises a camera and a computer capable of image processing imagery from said camera such that the camera and computer can successfully be used to evaluate the dimensions of the balloon as the balloon is filled with cleaning liquid. Cosentino teaches that one potential problem with a catheter balloon is that its volume can become outside the range of the manufacturer’s specifications, and motivation for performing the modification was provided by Komatsu, who teaches that when testing a medical balloon, a camera and image-processing of imagery therefrom can successfully be used to determine the dimensions (including diameter and length) of the ballon. In this combination of Kraft in view of Cosentino in view of Komatsu, if the dimensions of the balloon are abnormal (according to image-processing) during the filling of the balloon with cleaning liquid, a user can be alerted to further inspect the balloon to see if the balloon is still suitable for medical use, as Cosentino teaches that a balloon having a wrong volume is a known potential problem for such balloons. In this combination of Kraft in view of Cosentino in view of Komatsu, the combination of the pressure transducer and the camera-and-computer-based-image-processing tool is considered to correspond to structure that applicant calls at least one fill sensor, and this combination is structurally capable of being used to determine that a catheter balloon is fully expanded.
With regard to claim 13, in the combination of Kraft in view of Cosentino in view of Komatsu, a pressure sensor is used to measure the pressure inside the balloon to determine if the balloon is leaking or otherwise functioning improperly.
With regard to claim 14, in the apparatus of Kraft in view of Cosentino in view of Komatsu, multiple balloon-comprising catheters can be arranged for cleaning in a sieve insert (item 7 in Figure 4 of Kraft) and the balloon-filling attaching port is one of a plurality of medical device attachment ports, wherein said plurality of medical device attachment ports includes a second balloon-filling attaching port (comprising uppermost item 76 in Figure 4 and uppermost 78 in Figure 4 of Kraft), and wherein each of the balloon-filling attaching ports is in fluid communication with a corresponding balloon (pages 5-8 and 11 of Kraft translation).
With regard to claim 15, in the apparatus of Kraft in view of Cosentino in view of Komatsu, a supply line downstream of valve 143 (in Figure 3 of Kraft) splits such that some cleaning solution is directed to spray nozzle assembly 9 (in Figure 3 of Kraft) and some cleaning solution is directed to line 24 and from line 24 to the fluidic paths (that is, the balloon-cleaning fluidic paths, the lumen-cleaning fluidic paths, and the exterior-cleaning fluidic paths) of cleaned catheters (pages 11-12 of Kraft translation). The splitting point is a manifold, and this manifold directs cleaning solution to the balloon-filling attaching ports.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over EP1450890 by Kraft in view of U.S. 4,721,123 to Cosentino in view of JP2012040159 by Komatsu as applied to claim 11 above, and further in view of U.S. 2023/0270904 by Simonovsky as evidenced by U.S. 2007/0197963 by Griffiths.
With regard to claim 29, the combination of Kraft in view of Cosentino in view of Komatsu does not teach that the apparatus comprises a sensor operable to detect that the balloon (of the balloon-comprising catheter) has an amount of contrast below a predetermined threshold.
Simonovsky teaches that, in a medical environment, a cleaning apparatus can comprise a conductivity sensor such that sensed conductivity data can be used to sense a level of contaminants in used washing liquid, wherein the sensed level of contaminants in used washing liquid can advantageously be used to determine if washing is successfully completed or not (Abstract; Par. 0006, 0028, 0029, and 0042).
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 apparatus of Kraft in view of Cosentino in view of Komatsu such that a conductivity sensor is arranged to sense a level of contaminants in used cleaning solution that was used to clean the balloon of the catheter, wherein such sensing is used to detect when the cleaning of the balloon has been successfully completed. The motivation for performing the modification was provided by Simonovsky, who teaches that, in a medical environment, a cleaning apparatus can comprise a conductivity sensor such that sensed conductivity data can be used to sense a level of contaminants in used washing liquid, wherein the sensed level of contaminants in used washing liquid can advantageously be used to determine if washing is successfully completed or not.
In the combination of Kraft in view of Cosentino in view of Komatsu in view of Simonovsky, the conductivity sensor is capable of sensing a level of contaminants in used cleaning solution in order to determine if cleaning is completed or not, and the conductivity sensor is thus considered to be structurally capable of determining if the level of contaminants is below a predetermined threshold. The combination of Kraft in view of Cosentino in view of Komatsu in view of Simonovsky does not explicitly recite that the conductivity sensor is structurally capable of detecting a level of contrast medium. However, in the medical art, it is well-known that contrast medium can be ionic (MPEP 2144.03, Official Notice). An example of this is Griffiths, who teaches that contrast medium in the medical field can be ionic (Par. 0060, 0084, and 0097). The conductivity sensor in the apparatus of Kraft in view of Cosentino in view of Komatsu in view of Simonovsky is thus considered to be structurally capable of being used to determine if a level of ionic contrast agent is below a predetermined threshold or not.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over EP1450890 by Kraft in view of U.S. 4,721,123 to Cosentino in view of JP2012040159 by Komatsu as applied to claim 11 above, and further in view of U.S. 2013/0186428 by Lutz.
With regard to claim 30, in the apparatus of Kraft in view of Cosentino in view of Komatsu, multiple balloon-comprising catheters are arranged for cleaning on a sieve tray (item 7 in Figure 4 of Kraft) during the cleaning of internal and external surfaces of the catheters (pages 5-8 and 11 of Kraft translation).
The combination of Kraft in view of Cosentino in view of Komatsu does not teach that the apparatus comprises a moving component to cause the cleaning solution inside the balloon to move.
Lutz teaches that when cleaning medical equipment with cleaning liquid while the equipment is arranged on a tray, an actuator can be configured to advantageously agitate the tray in order to enhance the liquid-based cleaning of the medical equipment thereon (Par. 0014 and 0048).
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 apparatus of Kraft in view of Cosentino in view of Komatsu such that an actuator (reads on moving component) is arranged to agitate the tray during the liquid-base cleaning of the catheter and its balloon’s interior. The motivation for performing the modification was provided by Lutz, who teaches that when cleaning medical equipment with cleaning liquid while the equipment is arranged on a tray, an actuator can be configured to advantageously agitate the tray in order to enhance the liquid-based cleaning of the medical equipment thereon. In this combination of Kraft in view of Cosentino in view of Komatsu in view of Lutz, the actuator-driven agitation of the tray is considered to be structurally capable of causing movement of cleaning liquid inside the catheter’s balloon such that fresh cleaning liquid contacts an interior of the balloon (due to said caused movement of the cleaning liquid) because the catheter is on the agitated tray.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot in view of the new grounds of rejection.
On page 9 of applicant’s arguments, applicant argues that “[Cosentino] does not contemplate specifically determining that the entirety of the interior surface of the inflatable component has been contacted with the fluid”. However, as discussed above in the rejection of claim 1, for example, 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 apparatus of Kraft such that a pressure transducer is arranged to sense the interior pressure of the balloon as the balloon is filled to a maximum operating pressure with cleaning solution, as this sensed pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly. The motivation for performing the modification was provided by Cosentino, who teaches that when supplying cleaning solution into a catheter balloon in order to clean the interior of the catheter balloon, the balloon can be advantageously filled to a maximum operating pressure with cleaning liquid while a pressure transducer monitors the pressure inside the balloon, as this pressure information can advantageously be used to determine if the balloon is leaking or otherwise functioning improperly. In this combination of Kraft in view of Cosentino, since the pressure transducer can sense the interior pressure of the balloon, it is structurally capable of sensing that an entirety of an inner surface of the balloon has been contacted with the cleaning solution.
If a ballon has a maximum operating pressure, and if a pressure sensor can sense the pressure inside the ballon when filled with cleaning solution, then the pressure sensor is structurally capable of detecting when that maximum operating pressure has been reached and thus when an entirety of an inner surface of the balloon has been contacted with the cleaning solution.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN L COLEMAN whose telephone number is (571)270-7376. The examiner can normally be reached 9-5 Monday-Friday.
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/RLC/
Ryan L. Coleman
Patent Examiner, Art Unit 1714
/KAJ K OLSEN/Supervisory Patent Examiner, Art Unit 1714