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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/11/2026 has been entered.
Response to Amendment
This action is in response to the remarks filed on 7/28/2026. The amendments filed on 7/28/2026 are entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 6-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim recites the limitation “wherein, in a flat configuration” is stated in lines 9-10 and it is unclear as to the support for this limitation within the applicant’s originally filed specification as there is no recitation of particularly “a flat configuration” within the disclosure. While the exact terminology is not present in the specification, one of ordinary skill in the art would look to the various embodiments to determine whether other recited portions provide sufficient written description disclosure to support the limitation. This analysis is presented as follows.
As provided in the 112(b) rejection below, it is also unclear as to how the scope of the term “flat configuration” should be interpreted and whether it is referring to particular portions of the device, a state during manufacture, a schematic diagram presentation, or whether it is referring to an operable configuration of the device during use.
On pages 9-10 and 11 of the specification and associated figures 3-4 and 6 of the drawings, the disclosure appears to provide the carrier 20 schematically depicted in a substantially flat layout, but it is not clear as to whether this is only showing the device elements in a temporary state during manufacture, or whether the device can be reasonably separated after construction into a flat configuration as well as an attached configuration to an insertable medical device. This renders any provided flat shape observed in figures 3-4 and 6 of the drawings insufficient in supporting the language of “flat configuration” in light of the 112(b) rejection below and it is unclear as to whether the figures are a symbolic reproduction of the elements during manufacture or an actual operable state of the device during use. The claim further includes the limitation “such that the annular ultrasound transducer arrangement is positioned around an exit port” in lines 12-13 which appears to contradict a flat configuration of the element because being positioned around an exit port would necessarily wrap around the device in a cylindrically shaped manner and change the flat shape.
Furthermore, page 12 and figure 8 further include a carrier 30 which is shaped in a substantially flat manner which one of ordinary skill in the art could also interpret as a “flat configuration” of the device in light of the support from the applicant’s specification. This segment also does not particularly disclose the term “flat” and therefore it is unclear as to whether it would be sufficient to support the claim limitation in light of the 112(b) rejection below.
In either interpretation, the subject matter of the specification does not provide sufficient support to the broad and indefinite recitation of the limitation “flat configuration” as currently provided in the claims. If the applicant intends to claim any of the interpretations based upon support in the originally filed specification, it should particularly point out the structural element without broadening the written description supported subject matter.
For these reasons, the claim is rejected as failing to comply with the written description requirement.
Claims dependent upon rejected claims are also rejected. Therefore, dependent claims 2-4 and 6-16 are also rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 6-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the limitation “wherein, in a flat configuration” is stated in lines 9-10 and it is unclear as to how the scope of the term “flat configuration” should be interpreted and whether it is referring to particular portions of the device or whether it is referring to an operable configuration of the device during use. As provided in the 112(a) written description above, the specification does not provide an exact disclosure of “flat configuration” and it does not provide any clear interpretation of whether it is referring to a section of the device in a fully assembled state, a section of the device in a flat state during manufacture, or whether it is referring to a temporary operable configuration of the device during use. These varying interpretations of the device, including in light of relevant portions of the specification including pages 9-10, 11, and 12 and figures 3-4, 6, and 8, render the scope of the claim limitation indefinite as one of ordinary skill in the art would not understand how the second portion structural configuration should be interpreted within the claim.
Furthermore, the claim also recites the limitation “such that the annular ultrasound transducer arrangement is positioned around an exit port” in lines 12-13 which appears to contradict a flat configuration of the element because being positioned around an exit port would necessarily wrap around the device in a cylindrically shaped manner which further renders it unclear as to whether the second portion is extended in a flat shape or it is positioned around an exit port in a curved, cylindrical manner.
For these reasons, the scope of the claim is unclear and is rejected for indefiniteness.
Claim 16 recites the limitation "the system of claim 13" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims dependent upon rejected claims are also rejected for indefiniteness. Therefore, dependent claims 2-4 and 6-15 are also rejected.
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.
Claims 1-3 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Corl (U.S. Pub. No. 20160029999) hereinafter Corl, in view of Wang, Y., (“Optimizing the Beam Pattern of a Forward-Viewing Ring-Annular Ultrasound Array for Intravascular Imaging,” IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control. Vol 49(12), 2002. P. 1652-1664) hereinafter Wang (see attached NPL reference of the office action of 12/23/2025 for citations), in view of Dekker et al. (U.S. Pub. No. 20170008030) hereinafter Dekker, in further view of Whiseant et al. (U.S. Pub. No. 20140180124) hereinafter Whiseant ‘124.
Regarding claim 1, primary reference Corl teaches:
A medical device for insertion into a patient (abstract; [0003]), the medical device comprising:
a lumen body delimiting a lumen, and having a distal portion ([0050]-[0057], figures 4-6, include the lumen region 408 with a distal portion (transducer region 304, figure 6) being the end portion comprising a carrier mounting the ultrasound transducers) and
further comprising a carrier (figure 3, [0044]-[0047], flex circuit 314 forms a carrier in which the ultrasound transducers 312 are mounted; see also [0050]-[0057]),
wherein the carrier comprises a carrier body mounted on the lumen body ([0057], figure 3, 4-6, transition region 310 connects the transducer region 304 to the control region 308 and rest of the lumen body of the device; [0044]-[0056]) and
carrying an ultrasound transducer arrangement where the ultrasound transducer arrangement is forward-facing and mounted on a distal forward facing edge of said lumen body at said distal portion such that the ultrasound transducer arrangement is positioned around an exit port of the lumen ([0050]-[0057], figures 3 and 4-6, include the lumen region 408 with a distal portion (transducer region 304, figure 6) being the end portion comprising a carrier mounting the ultrasound transducers on a forward facing edge of the lumen body at the distal portion of the device as in figure 6. This forms a “forward-facing” transducer arrangement at the distal end of the device and directed forward out of the distal region. Examiner notes that this limitation is not considered to be required to limit to forward directionality of the transmission and reception of ultrasound signals. As shown in figures 3 and 5, ultrasound transducers are positioned around the lumen region 408 and are forward facing edge of the cylinder; [0051] and [0064], lumen region 408 of figure 5 provides for an exit port of the lumen configured to receive a guidewire; see also [0034]-[0040] and [0044]-[0047]).
Primary reference Corl is silent upon teaching:
An annular ultrasound transducer
And configured such that all the ultrasound transducers of the annular ultrasound transducer arrangement are configured to transmit and/or receive ultrasound in a forward direction relative to a central axis of the lumen body.
However, the analogous art of Wang of an ultrasound array for interventional intravascular imaging (abstract) teaches:
An annular ultrasound transducer (page 1654, col 1, paragraph 2 and figure 3, “ring-annular array” forms an annular ultrasound transducer; pages 1654-1656, and figure 5, ring annular transducer; figure 1)
And configured such that all the ultrasound transducers of the annular ultrasound transducer arrangement are configured to transmit and/or receive ultrasound in a forward direction relative to a central axis of the lumen body (page 1653 through page 1654, col 1, paragraph 2 and figures 2-3, “ring-annular array” forms an annular ultrasound transducer in which all of the transducers include elements that simultaneously provide ultrasound transmission and reception in both forward and side facing directions. Since each element provides forward direction imaging, this teaches to the “all transducers” limitation as claimed; pages 1654-1656, and figure 5, ring annular transducer; figure 1).
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 lumen body medical device with an ultrasound transducer of Corl to incorporate the annular ultrasound transducer as taught by Wang because the use of a forward viewing annular transducer enables higher image quality of an imaged object, such as a lesion, without having to cross or disturb it (Wang, page 1652, col 2, paragraphs 2-3). This leads to more efficient procedures, with a reduced chance of side effects and greater flexibility with traversing spaces with sever stenosis or total occlusion.
Primary reference Corl further fails to teach:
a plurality of flexible portions incorporating a silicon island extending from said carrier body, wherein each silicon island extends for a first portion and a second portion
However, the analogous art of Dekker of a CMUT ultrasound transducer array for use in medical imaging (abstract) teaches:
a plurality of flexible portions incorporating a silicon island extending from said carrier body, wherein each silicon island extends for a first portion and a second portion ([0045], silicon islands connected via flexible connection layer 20 to each of the transducer elements 14. Each silicon island can include a proximal and distal first and second portion of the element; figure 2)
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 lumen body medical device with an ultrasound transducer of Corl and Wang to incorporate the silicon islands as taught by Dekker because it enables the rigid silicon elements to be wrapped around a cylindrically shaped submount structure (Dekker, [0004]). This provides for positioning of a transducer array for use in catheter devices, and provides for compact and efficient packaging.
Primary reference Corl further fails to teach:
A tapered flexible portion, wherein, in a flat configuration, the second portion tapers as the second portion extends distally from the first portion to enable the second portion to fold over said distal forward facing edge of the lumen body upon positioning the first portion around the lumen body
and wherein at least the second portion comprises at least one ultrasound transducer
However, the analogous art of Whiseant ‘124 of a steerable catheter delivery system with diagnostic imaging (abstract) teaches:
A tapered flexible portion, wherein, in a flat configuration, the second portion tapers as the second portion extends distally from the first portion to enable the second portion to fold over said distal forward facing edge of the lumen body upon positioning the first portion around the lumen body ([0070], figure 4A, tapered portion 412 includes the circumferentially positioned transducers which are connected to a forward facing edge of the distal portion 404, and tapered/folded over and inward to the center of the device and lumen opening 408. The distal portion forms the tapered second portion and the proximal first portion is positioned around the lumen body at the device; In combination with the teachings of Dekker to the plurality of silicon islands for mounting individual transducer elements, the tapered flexible portion would include a plurality, and the plurality of flexible islands being folded over the tip towards the center of the lumen as taught by Whiseant ‘124. As the tapered portion includes a substantially flat angle, this is sufficient to teach to the limitation in light of the 112(a) and 112(b) rejections above)
and wherein at least the second portion comprises at least one ultrasound transducer ([0070], figure 4A, tapered portion 412 includes the circumferentially positioned transducers which are connected to a forward facing edge of the distal portion 404, and tapered/folded over and inward to the center of the device and lumen opening 408; In combination with the teachings of Dekker to the plurality of silicon islands for mounting individual transducer elements, the tapered flexible portion of the second portion would include a plurality, and the plurality of flexible islands being folded over the tip towards the center of the lumen as taught by Whiseant ‘124)
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 lumen body medical device with an ultrasound transducer of Corl, Wang, and Dekker to incorporate the tapered flexible portion folded over the forward facing edge as taught by Whiseant ‘124 because it provides a positioning of the transducers to face an angle that adds side-viewing functionality to the direction of the transducer elements (Whiseant ‘124, [0070]). This expands the viewing field of viewing, leading to a better diagnostic imaging picture to a user.
Regarding claim 2, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further teaches:
wherein the ultrasound transducers are spatially distributed around the lumen ([0050]-[0057], figures 3 and 4-6, include the lumen region 408 with a distal portion (transducer region 304, figure 6) being the end portion comprising a carrier mounting the ultrasound transducers 312 spatially distributed around the lumen (figure 5). See also [0034]-[0040] and [0044]-[0047]).
Regarding claim 3, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 2. Primary reference Corl further teaches:
wherein the ultrasound transducers are individually addressable ([0044]-[0047], ultrasound transducers 312 of the ultrasound array are PMUTs in which drive signals can select one or more of the transducers individually to emit ultrasound and receive the reflected echo; see also figures 3 and 4-6 and [0056]).
Regarding claim 6, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further fails to teach:
further comprising a plurality of wires extending in a length direction of the medical device over said lumen body, each of said wires being connected to one of said silicon islands
However, the analogous art of Dekker of a CMUT ultrasound transducer array for use in medical imaging (abstract) teaches:
further comprising a plurality of wires extending in a length direction of the medical device over said lumen body, each of said wires being connected to one of said silicon islands ([0048]-[0050], ultrasound transducer elements connected to the catheter core wire via connection pads 40 and connection wire 70, as in [0070], which forms the plurality of wires connecting between each of the silicon islands and transducer assemblies; [0081]-[0082]; see also [0065]; In combination with teachings of Corl, the silicon island connections would be combined with the transducer array of figure 3 of Corl and associated wiring in the combined invention).
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, and Whiseant ‘124 to incorporate the wires connecting to the silicon islands across a length direction of the device as taught by Dekker because it provides electrical connection to the transducer elements positioned on the silicon islands. This enables emission and detection of ultrasound signals at the transducer elements by the signal processing system (Dekker, [0045]; [0050]).
Regarding claim 7, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further fails to teach:
wherein the carrier comprises an annular ring carrying the ultrasound transducer arrangement
However, the analogous art of Wang of an ultrasound array for interventional intravascular imaging (abstract) teaches:
wherein the carrier comprises an annular ring carrying the ultrasound transducer arrangement (page 1654, col 1, paragraph 2 and figure 3, “ring-annular array” forms an annular ultrasound transducer; pages 1654-1656, and figure 5, ring annular transducer)
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, and Whiseant ‘124 to incorporate the annular ultrasound transducer as an annular ring carrier array as taught by Wang because the use of a forward viewing annular transducer enables higher image quality of an imaged object, such as a lesion, without having to cross or disturb it (Wang, page 1652, col 2, paragraphs 2-3). This leads to more efficient procedures, with a reduced chance of side effects and greater flexibility with traversing spaces with sever stenosis or total occlusion.
Regarding claim 8, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further teaches:
wherein the carrier further comprises:
at least one contact in between the lumen body and an outer surface of the medical device and a flexible connection between the at least one contact and the ultrasound transducer arrangement ([0050], figure 5, outer membrane 404 forms the outer surface of the medical device, with ground layer 402 as a conductive ground layer contact between the lumen body of flex circuit 314 and the lumen body. The flexible flex circuit 314 forms the flexible connection between the contact portion and the ultrasound transducers 312; see also [0047]-[0054]); and
a wire connected to the at least one contact and extending in a length direction of the medical device over the lumen body ([0036], [0042], [0045]-[0048], includes the cable 114 of figure 3 which provides a wire that connects in the length direction from the transducers 312 and is connected to the conductive film layer of flex circuit 314 in turn connected with the ground layer 402 as in [0050] and [0047]-[0054]).
Regarding claim 9, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 7. Primary reference Corl further teaches:
wherein the carrier comprises a double-walled housing in which the annular ring is housed, said housing including an outer wall fitted around the lumen body ([0050], outer membrane 404 and ground layer 402 bounded to the flex circuit 314, forms a outer membrane as the outer wall of the double-walled housing in which the annular ring transducers are housed; see also [0047]-[0057]).
Regarding claim 10, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 9. Primary reference Corl further teaches:
wherein the ultrasound transducer arrangement comprises one or more PZT elements ([0035], PZT transducers; [0044], PZT ceramic; [0070]).
Regarding claim 11, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further teaches:
wherein the ultrasound transducer arrangement comprises one or more CMUT elements, PMUT elements or single crystal ultrasound transducer elements ([0035], CMUTs; [0044], CMUTs; [0058]; [0065]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Corl, in view of Wang, in view of Dekker, in further view of Whiseant ‘124 as applied to claim 2 above, and further in view of Whiseant (U.S. Pub. No. 20140276015) hereinafter Whiseant ‘015.
Regarding claim 4, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 2. Primary reference Corl further teaches:
wherein the ultrasound transducers are slanted relative to a central axis of the medical device such that said ultrasound transducers are aiming away from said central axis
However, the analogous art of Whiseant ‘015 of a ultrasound device for imaging a vessel with a forward-looking imaging element (abstract) teaches:
wherein the ultrasound transducers are slanted relative to a central axis of the medical device such that said ultrasound transducers are aiming away from said central axis ([0029], as shown in figure 5, the slanting angle of the imaging element provides for aiming of the transducers away from the central axis of the device).
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, and Whiseant ‘124 to incorporate the slanting angle of the imaging element transducers as taught by Whiseant ‘015 because it provides a manipulation of the forward imaging plane to acquire the desired viewing range of the intravascular region (Whiseant ‘015, [0029]). This provides for a more complete image, leading to better visualization of the target regions of interest.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Corl, in view of Wang, in view of Dekker, in further view of Whiseant ‘124 as applied to claim 1 above, and further in view of Johnson et al. (WO2014145469) hereinafter Johnson (see attached WO Publication of the office action of 12/23/2025 for citations).
Regarding claim 12, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further fails to teach:
further comprising at least one pressure sensor and/or at least one imaging element on an outer surface of the distal portion of the medical device proximal to the ultrasound transducer arrangement
However, the analogous art of Johnson of a body lumen imaging and treatment device (abstract) teaches:
further comprising at least one pressure sensor and/or at least one imaging element on an outer surface of the distal portion of the medical device proximal to the ultrasound transducer arrangement ([000128], “For example, the IVUS transducer can be located on the distal tip of the catheter while the pressure sensor(s) can be located proximally of the IVUS transducer at one or more locations along the catheter body, from the distal portion of the catheter to an intermediate portion of the catheter to the proximal portion of the catheter.”; see also [000126]-[000127]).
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, and Whiseant ‘124 to incorporate the pressure sensor proximal of the imaging element on the medical instrument as taught by Johnson because it enables measurements of pressure within various positions of the vasculature which can be used to measure blood flow during a procedure leading to additional data when placing or navigating the device (Johnson, [000126]-[000128]). This leads to improved interventional outcomes.
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Corl, in view of Wang, in view of Dekker, in further view of Whiseant ‘124 as applied to claim 1 above, and further in view of Naghavi et al. (U.S. Pub. No. 20080281205) hereinafter Naghavi.
Regarding claim 13, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further fails to teach:
wherein the medical device is a micro-catheter
However, the analogous art of Naghavi of a method for analysis of data using a catheter system (abstract) teaches:
wherein the medical device is a micro-catheter ([0050], micro-catheter with an ultrasound probe on the distal end; [0076]-[0080], micro-catheter in use with ultrasound imaging).
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, and Whiseant ‘124 to incorporate the micro-catheter imaging catheter device as taught by Naghavi because the use of the small micro-catheter enables imaging within small blood vessel regions, leading to better anatomical and functional analysis of the target tissue regions of interest (Naghavi, [0022]-[0023]). This leads to improved diagnostics and better clinical outcomes.
Regarding claim 16, the combined references of Corl, Wang, Dekker, Whiseant ‘124 and Naghavi teach all of the limitations of claim 13. Primary reference Corl further fails to teach:
wherein the micro-catheter is operable as an infusion catheter.
However, the analogous art of Naghavi of a method for analysis of data using a catheter system (abstract) teaches:
wherein the micro-catheter is operable as an infusion catheter ([0050], micro-catheter with an ultrasound probe on the distal end and providing injection of contrast agent in to the vessel forms operability as an infusion catheter; [0075]-[0096], micro-catheter in use with ultrasound imaging with contrast agent injection (including microbubbles) which forms an infusion catheter operability).
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, Whiseant ‘124 and Naghavi to incorporate the micro-catheter imaging catheter device including injection of contrast agent as taught by Naghavi because the use of the small micro-catheter enables imaging with contrast agents within small blood vessel regions, leading to better anatomical and functional analysis of the target tissue regions of interest (Naghavi, [0022]-[0023]). This leads to improved diagnostics and better clinical outcomes.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Corl, in view of Wang, in view of Dekker, in further view of Whiseant ‘124 as applied to claim 1 above, and further in view of Stigall (U.S. Pub. No. 20140180118) hereinafter Stigall.
Regarding claim 14, the combined references of Corl, Wang, Dekker, and Whiseant ‘124 teach all of the limitations of claim 1. Primary reference Corl further fails to teach:
and a control unit adapted to control the ultrasound transducer arrangement of the medical device at least in a Doppler ultrasound mode
However, the analogous art of Stigall of an intraluminal imaging device with a transducer on the distal end of the device (abstract) teaches:
and a control unit adapted to control the ultrasound transducer arrangement of the medical device at least in a Doppler ultrasound mode ([0068]-[0071], processing system or computer; [0072], Doppler echo signals ultrasound mode; [0087], Doppler processing; [0088]; [0097]).
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, and Whiseant ‘124 to incorporate the Doppler ultrasound imaging mode as taught by Stigall because it provides measurements of targets moving within an area of interest or parallel to the imaging device (Stigall, [0072]). This enables enhanced diagnostics of blood flow motion, leading to better cardiovascular monitoring.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Corl, in view of Wang, in view of Dekker, in view of Whiseant ‘124, in further view of Stigall as applied to claim 14 above, and further in view of Routh (U.S. Pat. No. 5606972) hereinafter Routh.
Regarding claim 15, the combined references of Corl, Wang, Dekker, Whiseant ‘124 and Stigall teach all of the limitations of claim 14. Primary reference Corl further teaches
wherein the ultrasound transducer arrangement comprises a plurality of individually addressable ultrasound transducer elements ([0044]-[0047], ultrasound transducers 312 of the ultrasound array are PMUTs in which drive signals can select one or more of the transducers individually to emit ultrasound and receive the reflected echo; see also figures 3 and 4-6 and [0056]), and wherein the control unit is adapted to:
Primary reference Corl further fails to teach:
for each ultrasound transducer element, determine a peak blood flow velocity from the ultrasound data obtained with said ultrasound transducer element
electronically steer an ultrasound beam produced by the plurality of individually addressable ultrasound transducer elements based on the determined peak blood flow velocities
However, the analogous art of Routh of a Doppler signal processing system for use with ultrasound imaging of flow within a body (abstract) teaches:
for each ultrasound transducer element, determine a peak blood flow velocity from the ultrasound data obtained with said ultrasound transducer element (col 3, lines 34-49, “each element of the array will exhibit its own unique angle between the path of its transmitted and received signal and the blood flow direction” with the peak velocity detector detecting based upon echo signal components of each of the transducer elements; col 4, lines 33-67, peak velocity components for each transducer element; col 5, lines 1-36); and
electronically steer an ultrasound beam produced by the plurality of individually addressable ultrasound transducer elements based on the determined peak blood flow velocities (col 3, lines 34-67, “each element of the array will exhibit its own unique angle between the path of its transmitted and received signal and the blood flow direction” with the peak velocity detector detecting based upon echo signal components of each of the transducer elements; col 4, lines 33-67, peak velocity components for each transducer element are utilized for determining the steering angle A and computation of a Doppler angle; col 5, lines 1-36).
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 lumen body medical device with an ultrasound transducer of Corl, Wang, Dekker, Whiseant ‘124, and Stigall to incorporate the peak flow velocity measurements for steering of transducer elements as taught by Routh because since the Doppler shift is a function of the angle of incidence between the ultrasound path and the flow direction, each transducer element will detect a slightly different shift, depending upon the angle of incidence of its signal (Routh, col 1, lines 60-67). By utilizing these angles in steering and processing, better quality Doppler data can be produced.
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive. Responses to each of the applicant’s arguments are detailed below.
Regarding the applicant’s arguments on pages 6-7 of the remarks, the applicant argues that the combined prior art references fail to teach to the present claim amendments of independent claim 1. The applicant argues that Whiseant ‘124 fails to cure the deficiencies of the other prior art references not utilized to teach to the present related claim limitations of the previously set forth dependent claim 5. The applicant argues that the tapered portion 412 is of a flexible elongate member and is different from the claimed carrier because it contains a flat configuration. As provided in the 112(a) and 112(b) rejections above, the scope of the limitation is unclear and not sufficiently supported within the specification. Therefore, the substantially flat tapered angle of the second portion of Whiseant ‘124 that is at the distal end of the mounted transducers (Whiseant ‘124, [0070]) is sufficient to teach to the current interpretation of the “flat configuration” in light of the present 112 rejections above. This tapered portion folds over the circumference of the catheter sheath device 404, forming a smaller diameter and circumference at the furthermost distal tip of the tapered portion 412. This in combination with the teachings of the mounting structures of the silicon islands of Dekker would result in a combined prior art invention that teaches to the broadest reasonable interpretation of each element of independent claim 1. Both Dekker and Whiseant ‘124 teach to the mounting of ultrasound transducers at the interventional device, and therefore one of ordinary skill in the art would reasonably combine the features to achieve more efficient mounting of transducers and enhanced field of viewing.
For these reasons, the applicant’s arguments have been considered but are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sarna (U.S. Pub. No. 20140323859) teaches to an interventional imaging device that includes a front taper at the ultrasound transducer distal end of the device for prevention of injury to a patient during use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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