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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/18/2026 has been entered.
Response to Amendment
Currently claims 1-16 and 18-20 are pending.
Claim Objections
Claim 20 is objected to because of the following informalities: line 15 recites “imagine core” and should be changed to “imaging core”. Appropriate correction is required.
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.
Claims 1, 3, 4, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Miyamoto et al., (US20080287961A1) in view of Morimoto (US20180235574A1) .
Regarding claim 1, Miyamoto teaches an intravascular imaging catheter (fig. 67 is the distal end of a catheter and includes image catheter 2 [0258), comprising: an elongate catheter shaft having a distal end region and a proximal region (see annotated fig. 67); wherein the distal end region includes a side port (fig. 67 groove 32a is a side port for the guide catheter 40 [0251]); an imaging core disposed within the elongate catheter shaft (see annotated fig. 67 imaging core comprises the distal end surface 11, elongated scope insertion portion 12 of image catheter 2); wherein the imaging core includes an imaging device (fig. 67 image catheter 2 is a part of the guide catheter 40 [0258]) configured to be slidable within the elongate catheter shaft and through the side port (fig. 68 and 69, the holding portion 46 that holds the image catheter 2 can be seen sliding out of the side port of the distal end of the catheter).
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However, Miyamoto is silent regarding the endoscope of Miyamoto as an elongate intravascular catheter shaft, wherein the imaging device being configured for imaging a coronary blood vessel.
In the same ultrasound field of endeavor, Morimoto teaches of an endoscope as an elongate intravascular catheter shaft, wherein the imaging device being configured for imaging a coronary vessel ([0119] the endoscope is an intravascular ultrasonic endoscope that is used for observation of vascular walls of coronary blood vessels); and wherein the imaging device includes an intravascular ultrasound imaging device ([0119] the endoscope is an intravascular ultrasonic endoscope used for imaging)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application apply the technique of an intravascular ultrasound endoscope as taught by Morimoto to the endoscope of modified Miyamoto, as both inventions relate the ultrasound imaging devices, and would yield the predictable result of an ultrasound device that is an intravascular ultrasound device to one of ordinary skill in the art. One of ordinary skill would be able to perform such an application, and the results of the endoscope of modified Miyamoto being an intravascular endoscope are reasonably predictable. The benefit would be that it would allow the endoscope to image the more narrow and tortuous vasculature of the body.
Regarding claim 3, modified Miyamoto teaches the device of claim 1, wherein Miyamoto further teaches the distal end region includes a tip and wherein the side port is formed in the tip (see annotated fig. 67, the side port is in the tip).
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Regarding claim 4, modified Miyamoto teaches the device of claim 1, but fails to explicitly disclose wherein the imaging device includes an ultrasound transducer.
In the same ultrasound field of endeavor, Morimoto teaches wherein the imaging device includes an ultrasound transducer (fig. 3 Ultrasonic oscillator 130 includes piezoelectric layer 131, electrode layer 132 and backing layer 133 [0070])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application apply the technique of an intravascular ultrasound endoscope as taught by Morimoto to the endoscope of modified Miyamoto, as both inventions relate the ultrasound imaging devices, and would yield the predictable result of an ultrasound device that is an intravascular ultrasound device to one of ordinary skill in the art. One of ordinary skill would be able to perform such an application, and the results of the endoscope of modified Miyamoto being an intravascular endoscope are reasonably predictable. The benefit would be that it would allow the endoscope to image the more narrow and tortuous vasculature of the body.
Regarding claim 8, modified Miyamoto teaches the device of claim 1, wherein Miyamoto further teaches wherein the imaging device is configured to shift between a first orientation and a second orientation (fig. 68 and 69 are two different orientations).
Claims 2, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Miyamoto in view of Morimoto as applied to claim 1, and further in view of Pathania et al., (US20180177488A1)
Regarding claim 2, modified Miyamoto teaches the catheter of claim 1, wherein Miyamoto does teach a lumen at the tip of the device, but fails to explicitly disclose wherein the distal end region includes a tip having a guidewire lumen formed therein.
In the same intraluminal field of endeavor Pathania teaches wherein the distal end region includes a tip having a guidewire lumen formed therein (fig. 4A guidewire sleeve 250 [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the lumen of modified Miyamoto to be a guidewire sleeve as taught by Pathania, as this would facilitated reception of the guidewire (see Pathania [0034]).
Regarding claim 5, modified Miyamoto teaches the device of claim 1, but fails to explicitly disclose wherein the imaging device is configured to image at an angle that is normal to the imaging core.
In the same intraluminal field of endeavor, Pathania teaches wherein the imaging device is configured to image at an angle that is normal to the imaging core (fig. 2 the imaging device can generate data at different, including an angle that is perpendicular to the imaging core [0026])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the imaging device of modified Miyamoto to be with the imaging device of Pathania, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of an imaging catheter having an imaging device that can image perpendicular to the imaging core to one of ordinary skill in the art. One of ordinary skill would be able to make such a substitution, and the results of the imaging device of modified Miyamoto having an imager that images perpendicular to the imaging core are reasonably predictable.
Regarding claim 15, modified Miyamoto teaches the device of claim 1, but fails to explicitly disclose wherein the elongate catheter shaft includes a torque-transmitting reinforcing member.
However in the same intraluminal field of endeavor, Pathania teaches wherein the elongate catheter shaft includes a torque-transmitting reinforcing member (fig. 4B drive cable 270 is used to change the rotational and/or longitudinal position of the transducer [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the imaging device of modified Miyamoto with the transducer system of Pathania, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of an imaging catheter having an imaging device that can change its rotational position to one of ordinary skill in the art. One of ordinary skill would be able to make such a substitution, and the results of the imaging device of modified Miyamoto having an imager that can change its rotational position are reasonably predictable.
Claims 6, 7, 9 , 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Miyamoto in view of Morimoto as applied to claim 1, and further in view of Kinomoto et al., (US20220071476A1).
Regarding claim 6, modified Miyamoto teaches the device of claim 1, but is silent regarding wherein the imaging device is configured to image in a distal direction at an angle less than about 90 degrees relative to the imaging core.
In the same intraluminal field of endeavor, Kinomoto teaches wherein the imaging device is configured to image in a distal direction at an angle less than about 90 degrees relative to the imaging core (fig. 9 the ultrasound device 40 can be bent as seen in fig. 9, and would image at an angle less than 90 degrees relative to the image core 40+42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Miyamoto to include the bending capability of Kinomoto, as this would improve a degree of freedom of the wirings (see Kinomoto [0008]).
Regarding claim 7, modified Miyamoto teaches the device of claim 1, but is silent regarding wherein the imaging device includes one or more distally-angled transducers.
In the same intraluminal field of endeavor, Kinomoto teaches wherein the imaging device includes one or more distally-angled transducers (fig. 3 ultrasound transducers 48 are distally angled [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the imaging device of modified Miyamoto to be the imaging device of Kinomoto, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of an imaging catheter having an imaging device that can image with distally angled transducers to one of ordinary skill in the art. One of ordinary skill would be able to make such a substitution, and the results of the imaging device of modified Miyamoto having an imager that images with distally angled transducers are reasonably predictable.
Regarding claim 9, modified Miyamoto teaches the device of claim 8, but is silent regarding wherein the imaging device is configured to image at an angle that is normal to the imaging core when the imaging device is in the first orientation.
However in the same intraluminal field of endeavor, Kinomoto teaches wherein the imaging device is configured to image at an angle that is normal to the imaging core when the imaging device is in the first orientation (fig. 9 the orientation along the Ax axis would allow the device to image at a normal angle ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the imaging device of modified Miyamoto to be the imaging device of Kinomoto, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of an imaging catheter having an imaging device that can image normal to its imaging core to one of ordinary skill in the art. One of ordinary skill would be able to make such a substitution, and the results of the imaging device of modified Miyamoto having an imager that images with normal to its imaging core are reasonably predictable.
Regarding claim 10, modified Miyamoto teaches the device of claim 8, but is silent regarding wherein the imaging device is configured to image in a distal direction at an angle less than about 90 degrees relative to the imaging core when the imaging device is in the second orientation.
However, in the same intraluminal field of endeavor, Kinomoto teaches wherein the imaging device is configured to image in a distal direction at an angle less than about 90 degrees relative to the imaging core when the imaging device is in the second orientation (fig. 9 the ultrasound device 40 can be bent as seen in fig. 9, and would image at an angle less than 90 degrees relative to the image core 40+42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Miyamoto to include the bending capability of Kinomoto, as this would improve a degree of freedom of the wirings (see Kinomoto [0008]).
Regarding claim 11, modified Miyamoto teaches the device of claim 8, but is silent regarding wherein the imaging device is configured to image in a distal direction at a variable angle.
In the same intraluminal field of endeavor, Kinomoto teaches wherein the imaging device is configured to image in a distal direction at a variable angle (fig. 9 the ultrasound device 40 can be bent as seen in fig. 9, and would image at an angle less than 90 degrees relative to the image core 40+42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Miyamoto to include the bending capability of Kinomoto, as this would improve a degree of freedom of the wirings (see Kinomoto [0008]).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Miyamoto in view of Morimoto as applied to claim 1, and further in view of Gijsbers et al., (US20200383661A1).
Regarding claim 12, modified Miyamoto teaches the device of claim 1, but fails to explicitly disclose wherein the imaging device is mounted upon an inflatable member.
However in the same imaging field of endeavor, Gijsbers teaches wherein the imaging device is mounted upon an inflatable member (fig. 3 ultrasound transducer arrays are on balloon 108 [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging device of modified Miyamoto with the ballon of Gijsbers, as this would help facilitate insertion and guiding of the catheter (see Gijsbers [0044]).
Regarding claim 13, modified Miyamoto teaches the device of claim 12, but fails to explicitly disclose wherein the imaging device includes a plurality of transducers.
However in the same imaging field of endeavor, Gijsbers teaches wherein the imaging device includes a plurality of transducers. (fig. 3 ultrasound transducer arrays are on balloon 108 [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging device of modified Miyamoto with the ballon of Gijsbers, as this would help facilitate assessment of the target (see Gijsbers [0045]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Miyamoto as modified by Morimoto and Gijsbers as applied to claim 12, and further in view of Davidson et al., (US20040148006A1).
Regarding claim 14, modified Miyamoto teaches the device of claim 12, but fails to explicitly disclose wherein the inflatable member has a guidewire lumen formed therein.
In the same intraluminal field of endeavor, Davidson teaches wherein the inflatable member has a guidewire lumen formed therein (fig. 3 transducer 22 is mounted on balloon 20 and includes a lumen for guidewire 18 [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of modified Miyamoto to include a guidewire lumen as taught by Davidson, as this would help guide the device to a desired region (see Davidson [0026]).
Claims 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Miyamoto in view of Pathania and in further view of Morimoto and Kinomoto.
Regarding claim 16, Miyamoto teaches an intravascular imaging catheter (fig. 67 is the distal end of a catheter and includes image catheter 2 [0258), comprising: an elongate catheter shaft having a distal end region and a proximal region (see annotated fig. 67); wherein the distal end region includes a side port (fig. 67 groove 32a is a side port for the guide catheter 40 [0251]); an imaging core disposed within the elongate catheter shaft (see annotated fig. 67 imaging core comprises the distal end surface 11, elongated scope insertion portion 12 of image catheter 2); and wherein the imaging core includes an imaging device (fig. 67 image catheter 2 is a part of the guide catheter 40 [0258]) configured to be slidable within the elongate catheter shaft and through the side port (fig. 68 and 69, the holding portion 46 that holds the image catheter can be seen sliding out of the side port of the distal end of the catheter).
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However, Miyamoto fails to explicitly disclose wherein the proximal region includes a torque-transmitting reinforcing member, and wherein the imaging core includes on or more ultrasound transducers.
However in the same intraluminal field of endeavor, Pathania teaches wherein the proximal region includes a torque-transmitting reinforcing member, and wherein the imaging core includes one or more ultrasound transducers (fig. 4B drive cable 270 is on the proximal side and is used to change the rotational and/or longitudinal position of the ultrasound transducer [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the imaging device of Miyamoto with the transducer system of Pathania, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of an imaging catheter having an imaging device that can change its rotational position to one of ordinary skill in the art. One of ordinary skill would be able to make such a substitution, and the results of the imaging device of Miyamoto having an imager that can change its rotational position are reasonably predictable.
However, the combination of references are silent regarding the endoscope of modified Miyamoto as an elongate intravascular catheter shaft, wherein the imaging device being configured for imaging a coronary blood vessel.
In the same ultrasound field of endeavor, Morimoto teaches of an endoscope as an elongate intravascular catheter shaft, wherein the imaging device being configured for imaging a coronary vessel ([0119] the endoscope is an intravascular ultrasonic endoscope that is used for observation of vascular walls of coronary blood vessels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application apply the technique of an intravascular ultrasound endoscope as taught by Morimoto to the endoscope of modified Miyamoto, as both inventions relate the ultrasound imaging devices, and would yield the predictable result of an ultrasound device that is an intravascular ultrasound device to one of ordinary skill in the art. One of ordinary skill would be able to perform such an application, and the results of the endoscope of modified Miyamoto being an intravascular endoscope are reasonably predictable. The benefit would be that it would allow the endoscope to image the more narrow and tortuous vasculature of the body.
However, the combination of references are silent regarding wherein the one or more ultrasound transducers include one or more distally-angled transducers that are angled so that at least one of the one or more ultrasound transducers is oriented toward a wall of the coronary blood vessel when advancing the imaging core through the side port.
In the same intraluminal field of endeavor, Kinomoto teaches wherein the one or more ultrasound transducers include one or more distally-angled transducers that are angled (fig. 3 ultrasound transducers 48 are distally angled [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the imaging device of modified Miyamoto to be the imaging device of Kinomoto, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of an imaging catheter having an imaging device that can image with distally angled transducers to one of ordinary skill in the art. One of ordinary skill would be able to make such a substitution, and the results of the imaging device of Miyamoto having an imager that images with distally angled transducers are reasonably predictable. One of ordinary skill would understand that this substitution would result in the IVUS endoscope of modified Miyamoto reading upon the limitation of “so that at least one of the one or more ultrasound transducers is oriented toward a wall of the coronary blood vessel when advancing the imaging core through the side port.”
Regarding claim 18, modified Miyamoto teaches the device of claim 16, wherein Miyamoto further teaches wherein the imaging device is configured to shift between a first orientation and a second orientation (fig. 68 and 69 are two different orientations).
Regarding claim 19, modified Miyamoto teaches the device of claim 18, but is silent regarding wherein the one or more ultrasound transducers are configured to image at a first angle that is normal to the imaging core when the one or more ultrasound transducers are in the first orientation, wherein the imaging device is configured to image in a distal direction at an angle less than about 90 degrees relative to the imaging core when the imaging device is in the second orientation.
However in the same intraluminal field of endeavor, Kinomoto teaches wherein the one or more ultrasound transducers are configured to image at a first angle that is normal to the imaging core when the one or more ultrasound transducers are in the first orientation (fig. 9 the orientation along the Ax axis would allow the device to image at a normal angle ), wherein the imaging device is configured to image in a distal direction at an angle less than about 90 degrees relative to the imaging core when the imaging device is in the second orientation (fig. 9 the ultrasound device 40 can be bent as seen in fig. 9, and would image at an angle less than 90 degrees relative to the image core 40+42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Miyamoto to include the bending capability of Kinomoto, as this would improve a degree of freedom of the wirings (see Kinomoto [0008]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pathania in view of Miyamoto and further in view of Kinomoto.
Regarding claim 20, Pathania teaches A method for imaging a vascular region (fig. 1 system 100 for intravascular imaging [0020]), the method comprising:
advancing an intravascular imaging catheter through a blood vessel to a position adjacent to an area of interest ([0031] the intravascular imaging device 235 is advanced to the region of interest);
wherein the intravascular imaging catheter comprises:
an elongate catheter shaft having a distal end region and a proximal region (fig. 3B catheter assembly 200 includes proximal region 210 and distal region 215 [0029]),
an imaging core disposed within the elongate catheter shaft (fig. 4B transducer housing 265, transducer 235, and drive cable 270 make up the imaging core), and wherein the imaging core includes an imaging device configured to be slidable within the elongate catheter shaft ([0037] The drive cable 270 can be used to change the rotational position and/or the longitudinal position of the ultrasound transducer within the housing 205 during image data generation); and
imaging the blood vessel using the imaging device ([0021] Image items includes layers of a vessel or accumulated matter within the vessel).
However, Pathania fails to explicitly disclose wherein the distal end includes a side port, and wherein the imaging core is configured to be slidable through the slide port, and advancing the imaging core so that the imaging device advances through the side port.
In the same intraluminal field of endeavor, Miyamoto teaches wherein the distal end includes a side port (fig. 67 groove 32a is a side port for the guide catheter 40 [0251]), and wherein the imaging core is configured to be slidable through the slide port (fig. 67 groove 32a is a side port for the guide catheter 40 that includes the imaging catheter 2 [0251]); and advancing the imaging core so that the imaging device advances through the side port (fig. 1 the guide catheter 40 with the image catheter 2 is inserted through opening portion 87 [0104]; fig. 67 groove 32a is a side port for the guide catheter 40 that includes the imaging catheter 2 and is advanced through the groove 32a [0251]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Pathania with the side port of Miyamoto, as this would make it easier to identify the position and size of an abnormal rea of the body cavity by changing the view direction (see Miyamoto [0144]).
However, the combination of references are silent regarding wherein the imaging device includes an imaging transducer arranged at an angle relative to a longitudinal axis of the imaging core, wherein the angle of the imaging transducer orients the imaging transducer toward a wall of the blood vessel when advancing the imaging core.
In the same ultrasound field of endeavor, Kinomoto teaches wherein the imaging device includes an imaging transducer arranged at an angle relative to a longitudinal axis of the imaging core (fig. 3 the transducers 48 are arranged in an arc, and would be arranged at a an angle relative to the longitudinal axis [0060]), wherein the angle of the imaging transducer orients the imaging transducer toward a wall of the blood vessel when advancing the imaging core (fig. 3 the arc of transducers 48 would orient the transducers towards the wall of a blood vessel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the imaging device of modified Miyamoto to be the imaging device of Kinomoto, as both inventions relate to intraluminal imaging devices, and would yield the predictable result of an imaging catheter having an imaging device that can image with distally angled transducers to one of ordinary skill in the art. One of ordinary skill would be able to make such a substitution, and the results of the imaging device of modified Miyamoto having an imager that images with distally angled transducers are reasonably predictable.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Miyamoto in view of Morimoto has now been used to teach claim 1.
Applicant’s arguments with respect to claim 16 have been considered but are unpersuasive. Applicant has argued that Pathania, Miyamoto, and Kinomoto fails to teach amended claim 16. Examiner disagrees, as Kinomoto teaches imaging device with transducers that are arranged at an angle relative to a longitudinal axis, and when combined with Pathania and Miyamoto, would orient the transducers toward a wall of the blood vessel when advancing the imaging core through the side port.
The remaining claims are rejected for the same reasons above.
Conclusion
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798