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 .
Response to Amendment
Applicant’s submission filed 03/06/2026 has been entered. Currently claims 1-3,5-10 and 12-22 are pending.
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, 2, 5-8, 10, 13, 15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of figure 10A/B of Yuan (US20060276711A1) in view of the embodiment of figure 6A/B of Yuan.
Regarding claim 1, the embodiment of figure 10A/B of Yuan teaches An intraluminal imaging device (Abstract medical device with an imaging device insertable into the body), comprising:
a flexible elongate member configured to be positioned within a patient (fig. 10A sheath 104; [0049] sheath 104 can be made of the same material as membrane 402, and membrane 402 can have any level of elasticity); and
an ultrasound imaging assembly coupled to a distal portion of the flexible elongate member and comprising (fig. 10 A ultrasound elements 110 is coupled to sheath 104 as they are of the same device [0060]):
an expandable support member comprising a first and second state(fig. 10A/B base structure 702 has two states); and
a transducer array comprising a plurality of transducer elements(fig. 10A elements 110),
wherein, in the first state of the expandable member, the transducer array comprises a first shape (fig. 10A first state of the transducer array and base structure 702), and in the second state of the expandable support member, the transducer array comprises a second shape (fig. 10B second state of the transducer array and base structure 702);
wherein the transducer array configured to change between the first and second shapes in the first and second states (fig. 10A/B the transducer array changes shapes when the base structure 702 is flexed [0061]).
However, the embodiment of fig. 10A/B is silent regarding a flexible substrate coupled to the expandable member; a transducer array, comprising a plurality of transducer elements coupled to the same flexible substrate, wherein the transducer array is configured to change between the first and second shapes in response to flexing of the same flexible substrate.
In the same reference, the embodiment of fig. 6A/6B teaches a flexible substrate coupled (fig. 6A membrane 402) to the expandable support membrane (fig. 2A coupling member 150 would be coupled to the membrane 402 since they are part of the same device[0040]), a transducer array, comprising a plurality of transducer elements coupled to the same flexible substrate (fig. 6A elements 110 form a transducer array, and are coupled to the membrane 402 since they are of the same device), wherein the transducer array is configured to change between the first and second shapes in response to flexing of the same flexible substrate (fig. 6A/6B the first and second shapes of the transducer array change shape depending on if the membrane 402 is flexed or not).
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 the embodiment of fig. 10A/B of Yuan with the membrane 402 of the embodiment of fig. 6A/B, Yuan discloses that each feature of each embodiment can be mixed and matched with other features shown in other embodiments. The membrane would also isolate the imaging device to prevent damage or injury to any surround body tissue (see Yuan [0045]).
Regarding claim 2, Yuan teaches the device of claim 1, wherein Yuan further teaches wherein the expandable support member comprises a shape memory alloy ([0059] base structure 702 is composed of a shape memory material).
Regarding claim 5, Yuan teaches the device of claim 1, wherein Yuan further teaches wherein the transducer array comprises a first edge and an opposite second edge, wherein the first shape is substantially cylindrical such that the first edge or proximate to and facing substantially toward the second edge (fig. 9A the first edge is proximate to the second edge and is opposite the second edge).
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Regarding claim 6, Yuan teaches the device of claim 1, wherein Yuan further teaches wherein the transducer array comprises a first edge and an opposite second edge, wherein the second shape is an open arcuate shape such that the first edge is spaced from, and not facing toward, the second edge (see fig. 9B the transducer array is in an open arcuate shape and the edges are not facing toward each other).
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Regarding claim 7, Yuan teaches the device of claim 1, wherein Yuan further teaches wherein the plurality of transducer elements comprises a plurality of capacitive micromachined ultrasonic transducers (CMUTs) ([0032] the elements 110 may be CMUTs).
Regarding claim 8, Yuan teaches the device of claim 7, wherein Yuan further teaches wherein the first shape of the transducer array comprises an intravascular ultrasound (IVUS) configuration ([0029] the device is inserted into a blood vessel; [0005] the invention is an ultrasound imaging system).
Regarding claim 10, Yuan teaches the device of claim 1, wherein Yuan further teaches wherein the transducer array is a two- dimensional (2D) transducer array ([0031] the imaging device can be a two-dimensional array).
Regarding claim 13, Yuan teaches the device of claim 1, wherein Yuan further teaches wherein a diameter of the transducer is larger in the second shape of the transducer array than in the first shape of the transducer array (the diameter if the transducer array in fig. 10B is larger than the diameter of the transducer array in fig. 10A)
Regarding claim 15, the embodiment of figure 10A/B of Yuan teaches An intraluminal imaging device (Abstract medical device with an imaging device insertable into the body), comprising:
a flexible elongate (fig. 10A sheath 104; [0049] sheath 104 can be made of the same material as membrane 402, and membrane 402 can have any level of elasticity); and
an ultrasound imaging assembly coupled to a distal portion of the flexible elongate member and comprising (fig. 10 A ultrasound elements 110 is coupled to sheath 104 as they are of the same device [0060]):
an expandable support member comprising a first and second state(fig. 10A/B base structure 702 has two states); and
a transducer array comprising a plurality of transducer elements(fig. 10A elements 110) such that, in the first state of the expandable support member, the transducer comprises a first shape for imaging while positioned within a first body lumen of the patient ([0006] the imaging device can be adapted to image in the undeployed layout, therefore the transducer array in fig. 10A can image while in a blood vessel ([0029])),
and transitioning the expandable support member to a second state such that the transducer array comprises a second shape for imaging while positioned within a second body lumen of the patient (fig. 10A-10B the base structure 702 changes, and would be able image in a second body lumen of the patient once deployed [0061]), wherein the transducer array changes between the first and second shapes in response to flexing of the same flexible substrate in the first and second states of the expandable support member (fig. 10A-10B when the base structure 702 is flexed the shape changes [0061]).
However, the embodiment of fig. 10A/B is silent regarding a flexible substrate coupled to the expandable member; a transducer array, comprising a plurality of transducer elements coupled to the same flexible substrate, wherein the transducer array is configured to change between the first and second shapes in response to flexing of the same flexible substrate.
In the same reference, the embodiment of fig. 6A/6B teaches a flexible substrate coupled (fig. 6A membrane 402) to the expandable support membrane (fig. 2A coupling member 150 would be coupled to the membrane 402 since they are part of the same device[0040]), a transducer array, comprising a plurality of transducer elements coupled to the same flexible substrate (fig. 6A elements 110 form a transducer array, and are coupled to the membrane 402 since they are of the same device), wherein the transducer array is configured to change between the first and second shapes in response to flexing of the same flexible substrate (fig. 6A/6B the first and second shapes of the transducer array change shape depending on if the membrane 402 is flexed or not).
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 the embodiment of fig. 10A/B of Yuan with the membrane 402 of the embodiment of fig. 6A/B, Yuan discloses that each feature of each embodiment can be mixed and matched with other features shown in other embodiments. The membrane would also isolate the imaging device to prevent damage or injury to any surround body tissue (see Yuan [0045]).
Regarding claim 22, Yuan teaches the device of claim 1, wherein Yuan further teaches wherein the transducer array is configured to perform ultrasound imaging in the first shape and in the second shape ([0006] the imaging device can image in the undeployed as well as the deployed state)
Claims 3 and 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 1 above, and further in view of Sliwa et al., (US 20100168569 A1).
Regarding claim 3, Yuan teaches the device of claim 1, but is silent regarding wherein changing a tension of the tension wire causes the expandable support member to change from the first state to the second state.
In the same intraluminal field of endeavor, Sliwa teaches wherein changing a tension of the tension wire causes the expandable support member to change from the first state to the second state (fig. 8a -8b the pull wire 60, when pulled, causes the transducer assembly to change from a first and second state).
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 Yuan to include pull wires such as Sliwa, as this would allow for an improved view of target sites (see Sliwa [0045]).
Regarding claim 16, Yuan teaches the device of claim 1, but is silent regarding wherein changing a tension of the tension wire causes the expandable support member to change from the first state to the second state.
In the same intraluminal field of endeavor, Sliwa teaches wherein changing a tension of the tension wire causes the expandable support member to change from the first state to the second state (fig. 8a -8b the pull wire 60, when pulled, causes the transducer assembly to change from a first and second state).
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 Yuan to include pull wires such as Sliwa, as this would allow for an improved view of target sites (see Sliwa [0045]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 1 above, and further in view of Graveley et al., (US20220409170A1).
Regarding claim 9, Yuan teaches the device of claim 1, but is silent regarding wherein the second shape of the transducer array comprises an intracardiac echography (ICE) configuration.
In the same ultrasound field of endeavor, Graveley teaches wherein the second shape of the transducer array comprises an intracardiac echography (ICE) configuration ([0025] the ultrasound device may be an ICE device with [0029] cMUTs).
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 transducers of Yuan with the ICE device of Graveley, as both inventions relate to ultrasound imaging devices, and would yield the predictable result of an intraluminal imaging device that is an ICE device to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of the intraluminal device of Yuan having ICE capacities are reasonably predictable.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 1 above, and further in view of Steinberg et al., (US20240237967A1).
Regarding claim 12, Yuan teaches the device of claim 1, but fails to explicitly disclose wherein the flexible elongate member further comprises a pullwire coupled to and configured to deflect the distal portion of the flexible elongate member.
However, in the same intravascular ultrasound field of endeavor, Steinberg teaches wherein the flexible elongate member further comprises a pullwire coupled to and configured to deflect the distal portion of the flexible elongate member (fig. 4 tension member 30 is used to deflect the imaging head 20 [0043]).
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 Yuan with the pull wires of Steinberg, as this would facilitated manipulation of the ultrasonic device (see Steinberg [0042]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 1 above, and further in view of Cully et al., (US20110166455A1)
Regarding claim 14, Yuan teaches the device of claim 1, but fails to explicitly disclose wherein the expandable support member comprises a first plurality of arms that are attached to the transducer array and a second plurality of arms that are not attached to the transducer array.
However in the same ultrasound field of endeavor, Cully teaches wherein the expandable support member comprises a first plurality of arms that are attached to the transducer array and a second plurality of arms that are not attached to the transducer array (figs. 40A and 40B, the body of the catheter has a plurality of arms (four arms in figs. 40A/B) and at least one may have an ultrasound assembly, meaning there can be two arms that have a transducer array and two that do not; 612A and 612B show an ultrasound transducer but the other two arms do not show one [0377]).
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 arms of Werneth with the arms of Cully, as both inventions relate to ultrasound imaging devices with arms, and would yield the predictable result of some of the splines not having an ultrasound transducer array while others do to one of ordinary skill. One of ordinary skill would be able to perform such a substitution, and the results of Yuan having some ultrasound transducers on the splines and some don’t are reasonably predictable.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 1 above, and further in view of Salgaonkar et al., (US20220378399A1) and Eberle et al., (US20070239024A1).
Regarding claim 17, Yuan teaches the device of claim 1, wherein Yuan further teaches the flexible elongate member is configured to be positioned within a blood vessel of the patient and a heart chamber of the patient ([0051] medical device is navigated through the coronary artery and is then navigated into a heart chamber) but fails to explicitly disclose: wherein: the first shape of the transducer array is suitable for intravascular ultrasound (IVUS) imaging within the blood vessel, and the second shape of the transducer array is a substantially planar or hemicylindrical shape suitable for intracardiac echography (ICE) imaging within the heart chamber.
However in the same intravascular imaging field of endeavor, Salgaonkar teaches in the first shape of the transducer array is suitable for intravascular ultrasound (IVUS) imaging within the blood vessel (fig. 2 [0016] the probe is used for imaging when in the vasculature), and the second shape of the transducer array is a substantially planar or hemicylindrical shape suitable for intracardiac echography (ICE) imaging within the heart chamber (fig. 4 the transducer array 12 is part of an ICE catheter is substantially planar and is used to image inside a cardiac chamber [0017]).
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 transducers of Yuan with the transducers of Salgaonkar, as this would allow for two different aperture at different times within the patient, and allow for greater quality imaging (see Salgaonkar [0002]).
However, the combination of references are silent regarding a substantially cylindrical shape suitable for intravascular ultrasound (IVUS) imaging.
In the same intravascular imaging, Eberle teaches a substantially cylindrical shape suitable for intravascular ultrasound (IVUS) imaging (fig. 4 cylindrical ultrasound imaging assembly).
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 transducers of modified Yuan with the transducers of Eberle that image in a cylindrical configuration, as this would improve image quality provided by ultrasound imaging apparatuses (see Eberle [0014]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 1 above, and further in view of Steinberg.
Regarding claim 18, Yuan teaches the device of claim 1, but fails to explicitly disclose an actuating mechanism configured to change the expandable support member between the first state and the second state, and wherein the actuating mechanism comprises a tension wire or a pullwire.
In the same ultrasound field of endeavor, Steinberg teaches an actuating mechanism configured to change the expandable support member between the first state and the second state, and wherein the actuating mechanism comprises a tension wire or a pullwire ([0051] actuator allows operator to draw in cable to move the imaging head).
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 Yuan with the actuator of Steinberg, as this would allow to move the head into a more aligned position (see Steinberg [0051]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 15 above, and further in view of Steinberg.
Regarding claim 19, Yuan teaches the method of claim 15, wherein Yuan further teaches wherein the intraluminal imaging device further comprises an actuating mechanism, the method comprises actuating the actuating mechanism to transition the expandable support member to the second state (fig. 10A/B pusher member 710 presses against base structure 702 in order flex base structure 702 into one state or the other) but fails to explicitly disclose wherein the actuating mechanism comprises a tension wire or a pullwire.
In the same ultrasound field of endeavor, Steinberg teaches and wherein the actuating mechanism comprises a tension wire or a pullwire ([0051] actuator allows operator to draw in cable to move the imaging head).
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 Yuan with the pullwire of Steinberg, as this would allow to move the head into a more aligned position (see Steinberg [0051]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 15 above, and further in view of Salgaonkar and Eberle.
Regarding claim 20, Yuan teaches the method of claim 15, wherein Yuan the flexible elongate member is configured to be positioned within a blood vessel of the patient and a heart chamber of the patient ([0051] medical device is navigated through the coronary artery and is then navigated into a heart chamber), but fails to explicitly disclose in the first state of the expandable support member, the first shape of the transducer array for intravascular ultrasound (IVUS) imaging within the blood vessel, and in the second state of the expandable support member, the second shape of the transducer array is in a substantially planar or hemicylindrical shape for intracardiac echography (ICE) imaging within the heart chamber.
In the same ultrasound field of endeavor, Salgaonkar teaches in the first state of the expandable support member, the transducer array is suitable for intravascular ultrasound (IVUS) imaging within the blood vessel (fig. 2 [0016] the probe is used for imaging when in the vasculature), and in the second state of expansion of the expandable support member, the transducer array is in a substantially planar or hemicylindrical shape suitable for intracardiac echography (ICE) imaging within the heart chamber (fig. 4 the transducer array 12 is part of an ICE catheter is substantially planar and is used to image inside a cardiac chamber [0017]).
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 transducers of Yuan with the transducers of Salgaonkar, as this would allow for two different aperture at different times within the patient, and allow for greater quality imaging (see Salgaonkar [0002]).
However, the combination of references are silent regarding a substantially cylindrical shape suitable for intravascular ultrasound (IVUS) imaging.
In the same intravascular imaging, Eberle teaches a substantially cylindrical shape suitable for intravascular ultrasound (IVUS) imaging (fig. 4 cylindrical ultrasound imaging assembly).
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 transducers of modified Yuan with the transducers of Eberle that image in a cylindrical configuration, as this would improve image quality provided by ultrasound imaging apparatuses (see Eberle [0014]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Yuan as applied to claim 1 above, and further in view of Yamagata et al., (US 20140276079 A1).
Regarding claim 21, Yuan teaches the device of claim 1, wherein Yuan further teaches the transducer array wrapped around only a portion of the expandable support member or is not wrapped around the expandable support member, in the second shape of the transducer (fig. 10B the transducer elements 110 are wrapped around a portion of the base structure 702) but fails to explicitly disclose the transducer array wrapped entirely around the support member, in the first shape of the transducer array.
In the same ultrasound field of endeavor, Yamagata teaches the transducer array wrapped entirely around the support member, in the first shape of the transducer array (fig. 5-6 the transducers 30 wrap around the support 15 entirely in a shape [0055]).
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 wrapping entirely around a support member as taught by Yamagata to the first shape of the expandable support member as taught by Yuan, as both inventions relate to ultrasound imaging and would yield the predictable result of an intravascular ultrasound imaging device that has a first shape wherein the transducers wrap around the support member entirely to one of ordinary skill in the art. One for ordinary skill would be able to perform such an application, and the results of Yuan applying the technique of a support member entirely wrapped by a transducer array are reasonably predictable. This would be an improvement as it would provide full circumferential field of view while also providing uniform imaging geometry.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 15 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. Yuan has now been used to teach the limitations of claim 1 and 15.
The remaining claims are rejected for the same reasons as above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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