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 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 (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 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 1-4, 8-15, and 19 rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 20160324502 A1, hereinafter “Lu”) and Sadaka (US 20120253197 A1).
Regarding claim 1, Lu teaches an imaging medical device, comprising:
an elongate shaft (elongated member 202 [0028], [fig 2]) having a distal end region (a distal end 208 [0208]) and a proximal end region (proximal end 206 [0208]), [fig. 2]);
a hub (catheter hub 204 [0208]) coupled to the proximal end region (hub 204 is near proximal end 206 as shown in fig. 2),
a tip member (316) coupled to the distal end region (316 is on distal end region as shown in fig. 3);
an imaging assembly (one or more transducers (312 in FIG. 3) [0026]) disposed within the elongate shaft (disposed within elongate shaft as shown in fig.3), the imaging assembly including a drive cable (driveshaft 310 [0039]; [fig. 3]), a housing (306 [0029]) coupled to the drive cable (driveshaft 310 [0039]; [fig. 3]), and a transducer coupled to the housing (The imaging core 306 includes an imaging device 308 coupled to a distal end of a driveshaft 310 [0029]).
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Fig. 3 reproduced above
The first embodiment of Lu, however, does not teach:
the hub including a flush port;
a vent hole adjacent to the housing, such that fluid may be infused at the flush port on the hub and exit the vent hole to flush the shaft; and
a bubble-reducing member adjacent to the drive cable designed so that when the shaft is flushed, the bubble-reducing member blocks or reduces bubbles from traveling along the shaft towards the housing and the transducer.
Lu, in a second embodiment teaches:
the hub including a flush port (flush port 434 [0044]);
a vent hole (434 [0044]) adjacent to the housing (adjacent to housing as shown in figs. 5A and 5B); and
a bubble-reducing member (430) adjacent to the drive cable (bubble reducing member is adjacent to the drive cable 410 as shown in [0045]) designed so that when the shaft is flushed, the bubble-reducing member blocks or reduces bubbles from traveling along the shaft towards the housing and the transducer (When exposed to fluid, such as water or saline, during, for example, preparation of the catheter for the imaging procedure, the swellable material swells to fill the space between the transducer and the sheath. This can provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles [0043]; the fluid enters the catheter 402 during a flushing or other procedure. Alternatively or additionally, a fluid, such as blood, can enter the catheter 402 through flush port 434 or other port to swell the swellable material 430. ….As the swellable material 430 swells, the material displaces air bubbles within the lumen 406 of the catheter 402. Preferably, when the swellable material 430 is swollen, the material contacts the inner wall of the sheath 404. In other embodiments, the swellable material 430 fills at least 50%, 66%, 75%, 80%, 90%, 95%, or 99% of the space between the sheath 404 and the acoustically active surface 432 of the one or more transducer 412 [0047]-[0048]).
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Figs. 5A and 5B reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the first embodiment of Lu to include the hub including a flush port, a vent hole adjacent to the housing, and a bubble-reducing member adjacent to the drive cable designed so that when the shaft is flushed, the bubble-reducing member blocks or reduces bubbles from traveling along the shaft towards the housing and the transducer, as taught in the second embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
Lu, however, is silent regarding:
[a vent hole adjacent to the housing] such that fluid may be infused at the flush port on the hub and exit the vent hole to flush the shaft
Sadaka is considered analogous to the instant application as “Systems and methods for flushing bubbles from a catheter of an intravascular ultrasound imaging system” is disclosed (title).
Sadaka, first also teaches:the hub including a flush port (The flush port 210 may be defined in the hub 204 [0028]);
Sadaka further teaches:
a vent hole (316) adjacent to the housing (308) such that fluid may be infused at the flush port on the hub and exit the vent hole to flush the shaft (Pumping acoustically-favorable medium into the lumen 304 of the catheter 102 may cause displacement of air bubbles disposed within the lumen 304…. the displaced air bubbles can be pushed out the output port 316 defined in a distal end of the catheter 102 [0049]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lu to include a vent hole adjacent to the housing such that fluid may be infused at the flush port on the hub and exit the vent hole to flush the shaft, as taught by Sadaka. Doing so would facilitate removal of air bubbles. Sadaka also suggests that “air is not a desirable transmission medium and image quality may, consequently, be reduced when acoustic signals or echo signals are required by catheter design to propagate through air. In the MHz range, acoustic signals may not propagate at all through air. Accordingly, it is typically advantageous, and in some cases necessary, to purge air bubbles from the lumen 304 surrounding the one or more transducers 312 prior to the performance of an imaging procedure [0042]-[0043]).
Regarding claim 2, modified Lu teaches the imaging medical device of claim 1, as discussed above. Lu further teaches wherein the bubble-reducing member (430, fig. 5A) is adjacent to the drive cable (cable 410 [fig.5a]; the bubble reducing member is adjacent to the drive cable as shown in 5A).
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Fig. 5A of Lu reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include, wherein the bubble-reducing member is adjacent to the drive cable, as taught in the additional embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
Regarding claim 3, modified Lu teaches the imaging medical device of claim 1, as discussed above. Lu further teaches wherein the bubble-reducing member is coupled to the drive cable (The imaging core includes an elongated, rotatable driveshaft having a proximal end and a distal end and an imaging device coupled to the distal end of the driveshaft with rotation of the driveshaft causing a corresponding rotation of the imaging device. [0006]; 430 is disposed over a portion of the imaging core 408 including the one or more transducers 412 and extending around the entire circumference of the core and may even extend over the distal end of the imaging core [0045]; the bubble-reducing member 430 is attached/coupled to the drive cable 410, as shown in fig. 5A and described in [0006]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include, wherein the bubble-reducing member is coupled to the drive cable, as taught in the additional embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
Regarding claim 4, modified Lu teaches the imaging medical device of claim 1, as discussed above. Lu further teaches wherein bubble-reducing member (430) extends between the drive cable (410) and an inner surface of the elongate shaft (430 is disposed over at least the acoustically active surface 432 of the one or more transducer 412 and may extend over more of the imaging core 408 and further along the lumen 406 of the sheath 404 [0045]; the surface of the sheath 404 forms the inner surface of the elongate shaft, the bubble reducing member 406 extends between the drive cable 410 and the inner surface of the elongate shaft 404 as shown in figs 5A and 5B).
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Fig. 5A of Lu reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include wherein the bubble-reducing member extends between the drive cable and an inner surface of the catheter shaft, as taught in the additional embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
Regarding claim 8, modified Lu teaches the imaging medical device of claim 1, as discussed above. Lu further teaches wherein the transducer includes an ultrasound transducer (The imaging device includes at least one transducer configured and arranged for transforming applied electrical signals to acoustic signals and also for transforming received echo signals to electrical signals [0006]).
Regarding claim 9, modified Lu teaches the imaging medical device of claim 1, as discussed above. Lu further teaches wherein the imaging assembly is rotatable within the elongate shaft (at least one transducer and configured and arranged to rotate with rotation of the driveshaft [0006]).
Regarding claim 10, modified Lu teaches the imaging medical device of claim 1, as discussed above. Lu further teaches wherein the imaging assembly is translatable within the elongate shaft (the imaging core 306 may also move longitudinally (i.e., translate) along the blood vessel within which the catheter 102 is inserted so that a plurality of composite cross-sectional images may be formed into one or more larger composite images that include an axial length of the blood vessel [0037])
Regarding claim 11, Lu teaches an imaging medical device, comprising:
a catheter shaft (elongated member 202 [0028], [fig 2]) having a proximal end region (proximal end 206 [0208]);
a hub (catheter hub 204 [0208]) coupled to the proximal end region, (hub 204 is near proximal end 206 as shown in fig. 2);
an imaging assembly (one or more transducers (312 in FIG. 3) [0026]) slidably disposed within the catheter shaft (the imaging core 306 may also move longitudinally (i.e., translate) along the blood vessel within which the catheter 102 is inserted so that a plurality of composite cross-sectional images may be formed into one or more larger composite images that include an axial length of the blood vessel [0037]), the imaging assembly including a drive cable (driveshaft 310 [0039]; [fig. 3]), a housing (306 [0029]) coupled to the drive cable (driveshaft 310 [0039]; [fig. 3]), and an imaging device coupled to the housing (The imaging core 306 includes an imaging device 308 coupled to a distal end of a driveshaft 310 [0029]);
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Fig. 3 reproduced above
The first embodiment of Lu, however, does not teach:
hub including a flush port;
a vent hole disposed adjacent the housing, such that fluid may be infused into the flush port and exit the vent hole to flush the catheter shaft; and
a bubble-reducing member disposed adjacent to the drive cable, the bubble-reducing member being configured to block or reduce bubbles from traveling along the catheter shaft towards the housing and the imaging device when flushing the catheter shaft.
Lu , in a second embodiment, teaches:
the hub including a flush port (flush port 434 [0044]);
a vent hole (434 [0044]) disposed adjacent the housing (adjacent to housing as shown in figs. 5A and 5B), and
a bubble-reducing member (430) disposed adjacent to the drive cable (bubble reducing member is adjacent to the drive cable 410 as shown in [0045]), the bubble- reducing member being configured to block or reduce bubbles from traveling along the catheter shaft towards the housing and the imaging device when flushing the catheter shaft (When exposed to fluid, such as water or saline, during, for example, preparation of the catheter for the imaging procedure, the swellable material swells to fill the space between the transducer and the sheath. This can provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles [0043]; the fluid enters the catheter 402 during a flushing or other procedure. Alternatively or additionally, a fluid, such as blood, can enter the catheter 402 through flush port 434 or other port to swell the swellable material 430. ….As the swellable material 430 swells, the material displaces air bubbles within the lumen 406 of the catheter 402. Preferably, when the swellable material 430 is swollen, the material contacts the inner wall of the sheath 404. In other embodiments, the swellable material 430 fills at least 50%, 66%, 75%, 80%, 90%, 95%, or 99% of the space between the sheath 404 and the acoustically active surface 432 of the one or more transducer 412 [0047]-[0048]).
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Figs. 5A and 5B reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the first embodiment of Lu to include the hub including a flush port, a vent hole adjacent to the housing, and a bubble-reducing member disposed adjacent to the drive cable, the bubble- reducing member being configured to block or reduce bubbles from traveling along the catheter shaft towards the housing and the imaging device when flushing the catheter shaft, as taught in the second embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
The combined invention of Lu, however, is silent regarding:
[a vent hole disposed adjacent the housing], such that fluid may be infused into the flush port and exit the vent hole to flush the catheter shaft.
Sadaka is considered analogous to the instant application as “Systems and methods for flushing bubbles from a catheter of an intravascular ultrasound imaging system” is disclosed (title).
Sadaka first also teaches the hub including a flush port (The flush port 210 may be defined in the hub 204 [0028]).
Sadaka further teaches:
a vent hole (316) disposed adjacent the housing (308), such that fluid may be infused into the flush port and exit the vent hole to flush the catheter shaft (Pumping acoustically-favorable medium into the lumen 304 of the catheter 102 may cause displacement of air bubbles disposed within the lumen 304…. the displaced air bubbles can be pushed out the output port 316 defined in a distal end of the catheter 102 [0049]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lu to include a vent hole adjacent to the housing such that fluid may be infused at the flush port on the hub and exit the vent hole to flush the shaft, as taught by Sadaka. Doing so would facilitate removal of air bubbles. Sadaka also suggests that “air is not a desirable transmission medium and image quality may, consequently, be reduced when acoustic signals or echo signals are required by catheter design to propagate through air. In the MHz range, acoustic signals may not propagate at all through air. Accordingly, it is typically advantageous, and in some cases necessary, to purge air bubbles from the lumen 304 surrounding the one or more transducers 312 prior to the performance of an imaging procedure ([0042]-[0043]).
Regarding claim 12, modified Lu teaches the imaging medical device of claim 11, as discussed above. Lu further teaches herein the catheter shaft includes a distal end region (a distal end 208 [0208]) and wherein a tip member (316) is coupled to the distal end region (316 is on distal end region as shown in fig. 3).
Regarding claim 13 modified Lu teaches the imaging medical device of claim 11, as discussed above. Lu further teaches wherein the bubble-reducing member (430, fig. 5A) is adjacent to the drive cable (cable 410 [fig.5a]; the bubble reducing member is adjacent to the drive cable as shown in 5A).
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Fig. 5A of Lu reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include, wherein the bubble-reducing member is adjacent to the drive cable, as taught in the additional embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
Regarding claim 14, modified Lu teaches the imaging medical device of claim 11, as discussed above. Lu further teaches wherein the bubble-reducing member is coupled to the drive cable (The imaging core includes an elongated, rotatable driveshaft having a proximal end and a distal end and an imaging device coupled to the distal end of the driveshaft with rotation of the driveshaft causing a corresponding rotation of the imaging device. [0006]; 430 is disposed over a portion of the imaging core 408 including the one or more transducers 412 and extending around the entire circumference of the core and may even extend over the distal end of the imaging core [0045]; the bubble-reducing member 430 is attached/coupled to the drive cable 410, as shown in fig. 5A and described in [0006]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include, wherein the bubble-reducing member is coupled to the drive cable, as taught in the additional embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
Regarding claim 15, modified Lu teaches the imaging medical device of claim 11, as discussed above. Lu further teaches wherein bubble-reducing member (430) extends between the drive cable (410) and an inner surface of the elongate shaft (430 is disposed over at least the acoustically active surface 432 of the one or more transducer 412 and may extend over more of the imaging core 408 and further along the lumen 406 of the sheath 404 [0045]; the surface of the sheath 404 forms the inner surface of the elongate shaft, the bubble reducing member 406 extends between the drive cable 410 and the inner surface of the elongate shaft 404 as shown in figs 5A and 5B).
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Fig. 5A of Lu reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include wherein the bubble-reducing member extends between the drive cable and an inner surface of the catheter shaft, as taught in the additional embodiment of Lu. Doing so would provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles, as suggested by Lu ([0043]).
Regarding claim 19, modified Lu teaches the imaging medical device of claim 11, as discussed above. Lu further teaches wherein the transducer includes an ultrasound transducer (The imaging device includes at least one transducer configured and arranged for transforming applied electrical signals to acoustic signals and also for transforming received echo signals to electrical signals [0006]).
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 20160324502 A1, hereinafter “Lu”) and Sadaka (US 20120253197 A1) and Lee et al. (US 20070167825 A1, of record, hereinafter "Lee").
Regarding claim 5, modified Lu teaches the imaging medical device of claim 1, as discussed above. Lu, however, does not teach wherein the bubble-reducing member includes a barrier disk with a plurality of openings formed therein.
Lee discloses “Apparatus For Catheter Tips, Including Mechanically Scanning Ultrasound Probe Catheter Tip” (title). Lee teaches the imaging medical device, wherein the bubble-reducing member (eliminate air bubbles that may interfere with ultrasonic imaging [0051]) includes a barrier disk with a plurality of openings formed therein (Distal aperture 58 is depicted as a screen mesh with a plurality of openings, and may alternatively comprise one or a smaller number of more discrete openings [0058]; additional fluid can be added from the syringe 89 at proximal end 94 to purge such bubble [0059]).
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Fig. 3A of Lee reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lu by substituting the bubble reducing member with a barrier disk with a plurality of openings formed therein, as taught by Lee, in order to eliminate bubbles that may interfere with the image quality ([0059]).
Regarding claim 16, modified Lu teaches the imaging medical device of claim 11, as discussed above. Lu, however, does not teach wherein the bubble-reducing member includes a barrier disk with a plurality of openings formed therein.
Lee discloses “Apparatus For Catheter Tips, Including Mechanically Scanning Ultrasound Probe Catheter Tip” (title). Lee teaches the imaging medical device, wherein the bubble-reducing member (eliminate air bubbles that may interfere with ultrasonic imaging [0051]) includes a barrier disk with a plurality of openings formed therein (Distal aperture 58 is depicted as a screen mesh with a plurality of openings, and may alternatively comprise one or a smaller number of more discrete openings [0058]; additional fluid can be added from the syringe 89 at proximal end 94 to purge such bubble [0059]).
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Fig. 3A of Lee reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lu by substituting the bubble reducing member with a barrier disk with a plurality of openings formed therein, as taught by Lee, in order to eliminate bubbles that may interfere with the image quality ([0059]).
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 20160324502 A1, hereinafter “Lu”) and Sadaka (US 20120253197 A1) and Lee et al. (US 20070167825 A1, of record, hereinafter "Lee") and Geva et al (US 20180104455 A1, hereinafter “Geva”).
Regarding claim 6, modified Lu teaches imaging medical device of claim 1, as discussed above. Lu, however, does not teach wherein the bubble-reducing member includes a tapered mesh.
Lee, however, teaches the imaging medical device, wherein the bubble-reducing member (eliminate air bubbles that may interfere with ultrasonic imaging [0051]) includes a mesh (Distal aperture 58 is depicted as a screen mesh with a plurality of openings, and may alternatively comprise one or a smaller number of more discrete openings [0058]; additional fluid can be added from the syringe 89 at proximal end 94 to purge such bubble [0059]; [fig. 3a] reproduced below).
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Fig. 3A of Lee reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include a mesh, as taught by Lee, in order to eliminate bubbles that may interfere with the image quality.
The combined invention still does not teach [wherein the bubble-reducing member includes a] tapered [mesh].
Geva is considered analogous to the instant application as an ultrasonic system is disclosed (abstract).
Geva teaches:
wherein the bubble-reducing member (openings 438 in the net or mesh are big enough to allow passage of fluid through such openings….diameters of openings 438 may vary between different portions/areas of the net or mesh. For a non-limiting example, specific areas of the net or mesh may include openings 438 in the net or mesh that allow portions of the bladder wall to collapse into the openings and contact the surface of the balloon, thereby preventing cavitation bubbles from forming in these portions of the bladder wall. [0143]); includes a tapered mesh (structure 434 may expand upon expansion of balloon 430… Structure 434 may be in a form of a net or a mesh of wires 436 [0142]; mesh tapers out as shown in fig. 4).
It would have also been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu, to combine the mesh with a tapered surface, as taught by Geva. One with ordinary skill in the art would recognize that Geva’s use of a mesh that is tapered as it is able to prevent the formation of bubbles as noted in paragraph 0143. This utilization of a tapering of the mesh can be integrated on the combination of Lu as it operates for the same purpose of bubble reduction. This modification allows lower acoustic output thus reducing the risk of adverse effects, as suggested by Geva ([0142]). Furthermore, the mesh is able to allow passage of fluids and prevent the formation of cavitation bubbles ([0143]).
Regarding claim 17, modified Lu teaches imaging medical device of claim 11, as discussed above. Lu, however, does not teach wherein the bubble-reducing member includes a tapered mesh.
Lee, however, teaches the imaging medical device, wherein the bubble-reducing member (eliminate air bubbles that may interfere with ultrasonic imaging [0051]) includes a mesh (Distal aperture 58 is depicted as a screen mesh with a plurality of openings, and may alternatively comprise one or a smaller number of more discrete openings [0058]; additional fluid can be added from the syringe 89 at proximal end 94 to purge such bubble [0059]; [fig. 3a] reproduced below).
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Fig. 3A of Lee reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu to include a mesh, as taught by Lee, in order to eliminate bubbles that may interfere with the image quality.
The combined invention still does not teach [wherein the bubble-reducing member includes a] tapered [mesh].
Geva is considered analogous to the instant application as an ultrasonic system is disclosed (abstract).
Geva teaches:
wherein the bubble-reducing member (openings 438 in the net or mesh are big enough to allow passage of fluid through such openings….diameters of openings 438 may vary between different portions/areas of the net or mesh. For a non-limiting example, specific areas of the net or mesh may include openings 438 in the net or mesh that allow portions of the bladder wall to collapse into the openings and contact the surface of the balloon, thereby preventing cavitation bubbles from forming in these portions of the bladder wall. [0143]); includes a tapered mesh (structure 434 may expand upon expansion of balloon 430… Structure 434 may be in a form of a net or a mesh of wires 436 [0142]; mesh tapers out as shown in fig. 4).
It would have also been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu, to combine the mesh with a tapered surface, as taught by Geva. One with ordinary skill in the art would recognize that Geva’s use of a mesh that is tapered as it is able to prevent the formation of bubbles as noted in paragraph 0143. This utilization of a tapering of the mesh can be integrated on the combination of Lu as it operates for the same purpose of bubble reduction. This modification allows lower acoustic output thus reducing the risk of adverse effects, as suggested by Geva ([0142]). Furthermore, the mesh is able to allow passage of fluids and prevent the formation of cavitation bubbles ([0143]).
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 20160324502 A1, hereinafter “Lu”) and Sadaka (US 20120253197 A1) and Lee et al. (US 20070167825 A1, of record, hereinafter "Lee") and Garben et al. (US 20190142546 A1, hereinafter "Garben").
Regarding claim 7, modified Lu teaches imaging medical device of claim 1, as discussed above. Lu, however, does not teach, wherein the bubble-reducing member includes a plurality of axially-extending fingers.
Garben is considered analogous to the instant application as “Medical device flushing systems and methods”. Garben teaches: wherein the bubble-reducing member (the flushing apparatus 600 [0163]; fig. 4c) includes a plurality of axially-extending fingers (the fluid-providing channels of the plurality of fluid-providing channels may be circumferentially arranged about the centroid of the flushing cavity [0010]; in FIG. 4I (three rings 606 a, 606 b, and 606 c shown in FIG. 4I for illustration purposes only), instead of the one ring 606 … Such multiple rings may be a repetition of the structure shown in FIG. 4C in series in a stacked arrangement. [0134]; areas between the channels 604a-h that span the radius of the device are the “axial fingers” as claimed, as shown in fig. 4C, fig. 4I depict a stacked formation along the length of the device, therefore it is “axially extends”)
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Fig. 4C of Garben annotated
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Fig. 4I of Garben annotated
It would have also been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu, to include a plurality of axially-extending fingers, as taught by Garben, as arrangement may allow for the supplying of flushing fluid to generate, at least in part, the fluid vortex whose centrifugal action allows for the relatively less denser undesired fluid (e.g., air or other gas bubbles) to gather primarily proximate the axis where the undesired fluid is removed, as suggested by Garben ([0161])
Regarding claim 18, modified Lu teaches imaging medical device of claim 11, as discussed above. Lu, however, does not teach, wherein the bubble-reducing member includes a plurality of axially-extending fingers.
Garben is considered analogous to the instant application as “Medical device flushing systems and methods”. Garben teaches: wherein the bubble-reducing member (the flushing apparatus 600 [0163]; fig. 4c) includes a plurality of axially-extending fingers (the fluid-providing channels of the plurality of fluid-providing channels may be circumferentially arranged about the centroid of the flushing cavity [0010]; in FIG. 4I (three rings 606 a, 606 b, and 606 c shown in FIG. 4I for illustration purposes only), instead of the one ring 606 … Such multiple rings may be a repetition of the structure shown in FIG. 4C in series in a stacked arrangement. [0134]; areas between the channels 604a-h that span the radius of the device are the “axial fingers” as claimed, as shown in fig. 4C, fig. 4I depict a stacked formation along the length of the device, therefore it is “axially extends”)
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Fig. 4C of Garben annotated
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Fig. 4I of Garben annotated
It would have also been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Lu, to include a plurality of axially-extending fingers, as taught by Garben, as arrangement may allow for the supplying of flushing fluid to generate, at least in part, the fluid vortex whose centrifugal action allows for the relatively less denser undesired fluid (e.g., air or other gas bubbles) to gather primarily proximate the axis where the undesired fluid is removed, as suggested by Garben ([0161])
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US 20160324502 A1, hereinafter “Lu”) and Sadaka (US 20120253197 A1) and Tierney (US 20130123634 A1)
Regarding claim 20, Lu teaches an imaging medical device, comprising:
a catheter shaft (elongated member 202 [0028], [fig 2]) having a proximal end region (proximal end 206 [0208]);
a hub (catheter hub 204 [0208]) coupled to the proximal end region, (hub 204 is near proximal end 206 as shown in fig. 2);
an imaging assembly (one or more transducers (312 in FIG. 3) [0026]) slidably disposed within the catheter shaft (the imaging core 306 may also move longitudinally (i.e., translate) along the blood vessel within which the catheter 102 is inserted so that a plurality of composite cross-sectional images may be formed into one or more larger composite images that include an axial length of the blood vessel [0037]), the imaging assembly including a drive cable (driveshaft 310 [0039]; [fig. 3]), a housing (306 [0029]) coupled to the drive cable (driveshaft 310 [0039]; [fig. 3]), and an imaging device coupled to the housing (The imaging core 306 includes an imaging device 308 coupled to a distal end of a driveshaft 310 [0029]);
a vent hole (434 [0044])
a bubble-reducing member (430) disposed adjacent to the drive cable (bubble reducing member is adjacent to the drive cable 410 as shown in [0045]), the bubble- reducing member being configured to block or reduce bubbles from traveling along the catheter shaft towards the housing and the imaging device when flushing the catheter shaft (When exposed to fluid, such as water or saline, during, for example, preparation of the catheter for the imaging procedure, the swellable material swells to fill the space between the transducer and the sheath. This can provide an acoustically favorable transmission medium between the transducer and the sheath while eliminating or reducing air bubbles [0043]; the fluid enters the catheter 402 during a flushing or other procedure. Alternatively or additionally, a fluid, such as blood, can enter the catheter 402 through flush port 434 or other port to swell the swellable material 430. ….As the swellable material 430 swells, the material displaces air bubbles within the lumen 406 of the catheter 402. Preferably, when the swellable material 430 is swollen, the material contacts the inner wall of the sheath 404. In other embodiments, the swellable material 430 fills at least 50%, 66%, 75%, 80%, 90%, 95%, or 99% of the space between the sheath 404 and the acoustically active surface 432 of the one or more transducer 412 [0047]-[0048]).
Lu, however, is silent regarding:
the hub including a flush port
a vent hole formed in the catheter shaft a position adjacent to the housing, the vent hole being configured so that fluid may be infused into the catheter shaft through the flush port and exit the vent hole.
Sadaka is considered analogous to the instant application as “Systems and methods for flushing bubbles from a catheter of an intravascular ultrasound imaging system” is disclosed (title).
Sadaka teaches:the hub including a flush port (The flush port 210 may be defined in the hub 204 [0028]);
a vent hole (316) … a position adjacent to the housing, the vent hole being configured so that fluid may be infused into the catheter shaft through the flush port and exit the vent hole (housing 308; Pumping acoustically-favorable medium into the lumen 304 of the catheter 102 may cause displacement of air bubbles disposed within the lumen 304…. the displaced air bubbles can be pushed out the output port 316 defined in a distal end of the catheter 102 [0049]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lu to include the hub including a flush port a vent hole a position adjacent to the housing, the vent hole being configured so that fluid may be infused into the catheter shaft through the flush port and exit the vent hole, as taught by Sadaka. Doing so would facilitate removal of air bubbles. Sadaka also suggests that “air is not a desirable transmission medium and image quality may, consequently, be reduced when acoustic signals or echo signals are required by catheter design to propagate through air. In the MHz range, acoustic signals may not propagate at all through air. Accordingly, it is typically advantageous, and in some cases necessary, to purge air bubbles from the lumen 304 surrounding the one or more transducers 312 prior to the performance of an imaging procedure” ([0042]-[0043]).
The combined invention still does not teach [a vent hole] formed in the catheter shaft a position adjacent to the housing.
Tierney is considered analogous to the instant application as “Systems and methods for promoting flow of an acoustically-favorable medium over a transducer of an ultrasound imaging system” is disclosed (title).
Tierney teaches a vent hole (594) formed in the catheter shaft (302) a position adjacent to the housing (housing 306; The one or more outlet ports 594 may extend through the sheath 302 at any suitable angle relative to a longitudinal length of the catheter 102 [0061]).
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Fig. 5B of Tierney reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Lu to include a vent hole formed in the catheter shaft a position adjacent to the housing, as taught by Tierney. Doing so would facilitate “to purge air from the lumen 304, 406 surrounding the one or more transducers 312, 412 prior to (or one or more times during) the performance of an imaging procedure” as suggested by Tierney ([0044]-[0045] discloses advantages of purging air from within the catheter).
Conclusion
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/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798