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 .
Status of Claims
This Office Action is responsive to the claims filed on 07 April 2026. Claims 13, 15, 18, and 20 have been amended. Claims 14, 16, and 17 have been canceled. Claims 1-13, 15 and 18-20 are presently pending in this application.
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, 4, 6-10, 12, 13, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brunke (US 20120065507) in view of Ju (CN 116458919 A; Translation of CN 116458919 A relied upon herein) .
Regarding claim 1, Brunke teaches an ultrasound imaging catheter (Paragraph [0006]; a system is provided for reduction of motion artifacts in ultrasound imaging. A catheter includes an ultrasound transducer and a flexible portion) comprising,
a catheter housing (Paragraph [0099]; For example, the transducer 14 includes a rigid array supported in a housing) configured for insertion into a patient (Para. [0050]; flexible transducer while within the patient);
a first one-dimensional array of elements (Paragraph [0098]; transducer 14 is a 1-… dimensional array of piezoelectric or capacitive membrane elements) within the catheter housing (Paragraph [0044]; transducer 56 on a catheter 54, Fig. 4), the first one-dimensional array configured for ultrasound imaging of the patient (Paragraph [0029]; An image is then created with the transducer in the desired response mode. In another embodiment, the model is identified in real-time on the system. The model is identified based on input or output data, such as received ultrasound data or data from sensors on the transducer.) and
an acoustic transducer within the catheter housing wherein the acoustic transducer is configured for recoil compensation due to operation of the first one-dimensional array (Paragraph [0059]; pushing pulses are repeated for about 20-30 ms to position the transducer; Paragraph [0060]; The preliminary or initial pulse or pulses are shaped relative to each other and/or are themselves shaped to position the transducer to recoil (or not) in a desired way in response to pushing pulses during displacement measurement, Fig. 7; The use of the transducer to perform recoil compensation is considered to read on the claimed limitation of acoustic transducer is configured for recoil compensation due to operation of the first one-dimensional array; as understood in its broadest reasonable interpretation).
Brunke does not explicitly teach an acoustic transducer within the catheter housing, the acoustic transducer facing in a different direction than the first one-dimensional array, wherein the acoustic transducer is configured for recoil compensation due to operation of the first one-dimensional array.
Ju, however, teaches an acoustic transducer (Pg. 3, full para. 16; the active backing layer 107, Fig. 1), the acoustic transducer facing in a different direction than the first one-dimensional array (Pg. 4, full para. 5; the active backing layer 107 is located behind the piezoelectric emitting layer 102, the vibration stretching direction of the active backing layer 107 is always opposite to the piezoelectric emitting layer 102), wherein the acoustic transducer is configured for recoil compensation due to operation of the first one-dimensional array (Pg. 4, full para. 5; so as to reach the purpose of actively reducing the acoustic pressure emitted by the piezoelectric emitting layer 102 towards the back, The displacement ratio of the upper end displacement of the piezoelectric emitting layer 102 to the lower end displacement of the active backing layer 107 is less than 0.5, and the clutter signal generated by the active backing layer 107 is far less).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ultrasound imaging catheter of Brunke to have further included an acoustic transducer within the catheter housing, the acoustic transducer facing in a different direction than the first one-dimensional array, wherein the acoustic transducer is configured for recoil compensation due to operation of the first one-dimensional array as taught by Ju because it would have actively reduced the acoustic pressure emitted by the array (Pg. 4, full para. 5) and can achieve better sound pressure damping effect by applying excitation with different intensities and time sequence to multiple piezoelectric blocks of the active back lining layer (Abstract).
Regarding claim 3, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Brunke further teaches the first one-dimensional array is configured for transmission of an acoustic radiation force impulse (Paragraph [0021]; ARFI pushing pulses applied to a focused area… The displacement is measured) and tracking transmissions (Paragraph [0044]; he transducer 56 may be used to measure the motion of the transducer 54… The tissue motion is tracked over time), and wherein the acoustic transducer is configured to reduce the recoil of the first one-dimensional array in the catheter caused by the transmission of the acoustic radiation force impulse (Paragraph [0060]; The preliminary or initial pulse or pulses are shaped relative to each other and/or are themselves shaped to position the transducer to recoil (or not) in a desired way in response to pushing pulses during displacement measurement).
Regarding claim 4, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Ju further teaches wherein the acoustic transducer is configured to transmit acoustic energy during transmission of acoustic energy by the first one-dimensional array (Pg. 4, full para. 5; A positive voltage is applied to the piezoelectric emitting layer 102, and a negative voltage is applied to the active backing layer 107, and the applied voltage needs to be adjusted according to the size of the emitted sound pressure; Pg. 5, full para. 5; active backing layer 107 needs to be adjusted according to the magnitude of the sound pressure emitted by the piezoelectric emitting layer 102… , so as to suppress the reverse sound pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Brunke in view of Ju to have the acoustic transducer is configured to transmit acoustic energy during transmission of acoustic energy by the first one-dimensional array as further taught by Ju because it would have allowed reducing the reducing the acoustic pressure emitted by the transducer towards the back direction, thereby improving stability.
Regarding claim 6, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Ju further teaches the acoustic transducer comprises a transmitting face having an area of less than 20 percent different than an area of a transmitting face of the first one-dimensional array (Figs. 1 and 4 shows the width and length of active layer (bottom edge) is the same as the width and length of the array (top edge) which is considered to read on the claimed limitations as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Brunke in view of Ju such that the acoustic transducer comprises a transmitting face having an area of less than 20 percent different than an area of a transmitting face of the first one-dimensional array as further taught by Ju because it would have ensured proper reduction of vibrations while reducing the overall structure size, simplifying the probe preparation process, and facilitating the miniaturization of the probe (Pg. 5).
Regarding claim 7, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Ju further teaches the acoustic transducer is stacked in the catheter with the first one-dimensional array, and wherein a transmitting face of the acoustic transducer faces in a substantially opposite direction as a transmitting face of the first one-dimensional array (Pg. 4, full para. 5; the active backing layer 107 is located behind the piezoelectric emitting layer 102, the vibration stretching direction of the active backing layer 107 is always opposite to the piezoelectric emitting layer 102; Figs. 1 and 4 show the acoustic transducer faces in a substantially opposite direction as a transmitting face of the first one-dimensional array).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Brunke in view of Ju such that the acoustic transducer is stacked in the catheter with the first one-dimensional array, and wherein a transmitting face of the acoustic transducer faces in a substantially opposite direction as a transmitting face of the first one-dimensional array as taught by Ju because it would have would have actively reduced the acoustic pressure emitted by the array (Pg. 4, full para. 5).
Regarding claim 8, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Together Brunke and Ju do not explicitly teach the acoustic transducer is configured to operate with a center frequency different than a center frequency of the first one-dimensional array.
Brunke, however, further teaches provides a shaped pulse in which transducer motion to behave in a desired way, such that the pulse is modulated in amplitude, time (duration), or amplitude and time. For temporal modulation, pulse width, frequency, or other temporal changes in the pulse may be used.
One of ordinary skill in the art would have realized combining the act of recoil compensation described by Brunke with the acoustic transducer of Ju would have resulted in the acoustic transducer is configured to operate with a center frequency different than a center frequency of the first one-dimensional array.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Brunke in view of Ju to further provide recoil compensation pulses described by Brunke with the acoustic transducer such that the acoustic transducer is configured to operate with a center frequency different than a center frequency of the first one-dimensional array because it would have allowed controlling the transducers with more predictable movement (Paragraph [0057]) and further would have improved the dynamic motion correction (Paragraph [0052]). Furthermore, it would have allowed fine tuning the recoil compensation based on the amount of recoil as the recoil may be reduced with lower power push pulses and thus prevent misalignment for low power transmission (Paragraph [0063]).
Regarding claim 9, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Brunke, further teaches a sensor configured to sense recoil (Paragraph [0045]; By positioning one or more sensors on the catheter 54 and/or the transducer 56, the motion may be determined; Fig. 4), and a processor (Paragraph [0090]; The system 10 includes… an image processor 18; Fig. 8) configured to adjust the recoil compensation based on the sensed recoil (Paragraph [0060]; The preliminary or initial pulse or pulses are shaped relative to each other and/or are themselves shaped to position the transducer to recoil (or not) in a desired way in response to pushing pulses during displacement measurement.).
Regarding claim 10, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Ju further teaches a stiffener positioned between the first one-dimensional array and the acoustic transducer (Pg. 5, Full Para. 1; and the gap 105 is formed when the array is formed by cutting with a cutter, and the gap 105 is filled with an isolation filling… between the adjacent piezoelectric blocks).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Brunke in view of Ju to include a stiffener positioned between the first one-dimensional array and the acoustic transducer as further taught by Ju because it would have reduced the interference between the adjacent piezoelectric blocks.
Regarding claim 12, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Ju further teaches comprising a sheet of flexible circuit material (Pg. 5, Full para. 2; the front electrode layer 103 and the front and back electrode layer 107 both comprise a plurality of electrode sheets) with only one or two transmission lines connected with the acoustic transducer (Pg. 4, Full para. 2; common electrode layer 106 is the ground layer of the piezoelectric emitting layer 102 and the active
backing layer 107; the back electrode layer 104; Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Brunke in view of Ju to comprise a sheet of flexible circuit material with only one or two transmission lines connected with the acoustic transducer as further taught by Ju because it would have allowed applying excitation voltage according
to the specific requirement so as to reach the effect of focusing different targets (Pg. 5).
Regarding claim 13, Brunke teaches a method for ultrasound imaging with a catheter probe (Paragraph [0005]-[0006]; methods, instructions, and systems for reduction of motion artifacts in ultrasound imaging; a system is provided for reduction of motion artifacts in ultrasound imaging. A catheter includes an ultrasound transducer and a flexible portion), the method comprising:
imaging a patient (Paragraph [0029]; The optimal ARFI push pulse is fired. Optionally, the results are fed back to adjust the ARFI pulse to further minimize motion. An image is then created with the transducer in the desired response mode.) with an imaging array (Paragraph [0098]; transducer 14 is a 1-… dimensional array of piezoelectric or capacitive membrane elements) in the catheter probe (Paragraph [0045]; the transducer 56 on a catheter 54), the imaging comprising transmitting a first focused acoustic pulse from the imaging array (Paragraph [0021]; ARFI pushing pulses applied to a focused area induces a shear and/or longitudinal wave. In response, tissue's displacement increases and then recovers, resulting in a temporal displacement profile. The displacement is measured), the transmission of the first focused acoustic pulse causing a recoil motion force on the imaging array (Paragraph [0062]; In act 38, the flexible transducer moves due to recoil from the initial pushing pulse); and
countering the motion force to the catheter probe during the imaging (Paragraph [0060]; The preliminary or initial pulse or pulses are shaped relative to each other and/or are themselves shaped to position the transducer to recoil (or not) in a desired way in response to pushing pulses during displacement measurement.; Paragraph [0068]; By modulating the acoustic radiation force, the flexible transducer is stabilized in a first position or in a linear movement).
Brunke does not explicitly teach countering the motion force by transmitting a second pulse from a separate transducer, wherein the second acoustic pulse comprises unfocused, defocused, and/or diffused acoustic energy transmitted in a direction opposite to the recoil motion force.
Ju, however, teaches countering the motion force by transmitting a second pulse (Pg. 4, full para. 5; so as to reach the purpose of actively reducing the acoustic pressure emitted by the piezoelectric emitting layer 102 towards the back, The displacement ratio of the upper end displacement of the piezoelectric emitting layer 102 to the lower end displacement of the active backing layer 107 is less than 0.5, and the clutter signal generated by the active backing layer 107 is far less) from a separate transducer (Pg. 4, full para. 5; the active backing layer 107 is located behind the piezoelectric emitting layer 102, the vibration stretching direction of the active backing layer 107 is always opposite to the piezoelectric emitting layer 102), wherein the second acoustic pulse comprises unfocused, defocused, and/or diffused acoustic energy (Pg. 4, full Para. 5; actively reducing the acoustic pressure emitted by the piezoelectric emitting layer 102 towards the back; Fig. 1 shows there is no backing or acoustic lens on the active backing layer which would result in unfocused, defocused, and/or diffused acoustic energy) transmitted in a direction opposite to the recoil motion force (Pg. 4, full para. 5; the active backing layer 107 is located behind the piezoelectric emitting layer 102, the vibration stretching direction of the active backing layer 107 is always opposite to the piezoelectric emitting layer 102).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Brunke to have included countering the motion force by transmitting a second pulse from a separate transducer, wherein the second acoustic pulse comprises unfocused, defocused, and/or diffused acoustic energy transmitted in a direction opposite to the recoil motion force as taught by Ju because it would have actively reduced the acoustic pressure emitted by the array (Pg. 4, full para. 5) and can achieve better sound pressure damping effect by applying excitation with different intensities and time sequence to multiple piezoelectric blocks of the active back lining layer (Abstract).
Regarding claim 15, together Brunke and Ju teach all of the limitations of claim 14 as noted above.
Brunke further teaches the first focused acoustic pulse comprises a pushing pulse of acoustic radiation force impulse imaging (Paragraph [0021]; ARFI pushing pulses applied to a focused area… The displacement is measured; Paragraph [0023]; achieves both the required level of acoustic insonification to support the imaging mode (ARFI)).
Regarding claim 18, together Brunke and Ju teaches all of the limitations of claim 13 as noted above.
Brunke further teaches countering comprises maintaining a tip of the catheter probe (Paragraph [0048]-[0049]; scanning indicates a position of a catheter, such as at what distance from the tip the catheter is in contact with tissue or a guide) substantially in position (Paragraph [0096]-[0097]; pre-loading pushing pulses have a shape to position the ultrasound transducer in a stable position) relative to the patient during the imaging despite the motion force (Paragraph [0040]; The motion of the transducer is determined by accounting for tissue motion. The tissue motion is measured with low amplitude pulses associated with less transducer recoil. The tissue motion is measured again in response to an ARFI push pulse).
Regarding claim 19, together Brunke and Ju teaches all of the limitations of claim 13 as noted above.
Brunke further teaches sensing motion of the catheter probe (Paragraph [0045]; By positioning one or more sensors on the catheter 54 and/or the transducer 56, the motion may be determined; Fig. 4) and adjusting the countering of the motion force based on the sensed motion (Paragraph [0060]; The preliminary or initial pulse or pulses are shaped relative to each other and/or are themselves shaped to position the transducer to recoil (or not) in a desired way in response to pushing pulses during displacement measurement.).
Regarding claim 20, Brunke teaches an ultrasound imaging catheter (Paragraph [0006]; a system is provided for reduction of motion artifacts in ultrasound imaging. A catheter includes an ultrasound transducer and a flexible portion) comprising:
a catheter housing (Paragraph [0099]; For example, the transducer 14 includes a rigid array supported in a housing) configured for insertion into a patient (Para. [0050]; flexible transducer while within the patient);
a one-dimensional array of elements (Paragraph [0098]; transducer 14 is a 1-… dimensional array of piezoelectric or capacitive membrane elements) within the catheter housing (Paragraph [0044]; transducer 56 on a catheter 54, Fig. 4), the one-dimensional array configured for ultrasound imaging of the patient (Paragraph [0029]; An image is then created with the transducer in the desired response mode. In another embodiment, the model is identified in real-time on the system. The model is identified based on input or output data, such as received ultrasound data or data from sensors on the transducer.) by transmitting a first acoustic radiation force impulse causing a recoil motion force on the catheter housing (Paragraph [0062]; In act 38, the flexible transducer moves due to recoil from the initial pushing pulse); and
a recoil compensator configured to limit the recoil motion force of the catheter housing due to operation of the one-dimensional array (Paragraph [0060]; The preliminary or initial pulse or pulses are shaped relative to each other and/or are themselves shaped to position the transducer to recoil (or not) in a desired way in response to pushing pulses during displacement measurement, Fig. 7).
Brunke does not explicitly teach transmitting a second acoustic pulse in a direction opposite to the recoil motion force.
Ju, however, teaches an acoustic transducer (Pg. 3, full para. 16; the active backing layer 107, Fig. 1) and transmitting a second acoustic pulse in a direction opposite to the recoil motion force (pg. 4, full para. 5; the active backing layer 107 is located behind the piezoelectric emitting layer 102, the vibration stretching direction of the active backing layer 107 is always opposite to the piezoelectric emitting layer 102; Pg. 4, full para. 5; so as to reach the purpose of actively reducing the acoustic pressure emitted by the piezoelectric emitting layer 102 towards the back, The displacement ratio of the upper end displacement of the piezoelectric emitting layer 102 to the lower end displacement of the active backing layer 107 is less than 0.5, and the clutter signal generated by the active backing layer 107 is far less).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ultrasound imaging catheter of Brunke to have further included transmitting a second acoustic pulse in a direction opposite to the recoil motion force as taught by Ju because it would have actively reduced the acoustic pressure emitted by the array (Pg. 4, full para. 5) and can achieve better sound pressure damping effect by applying excitation with different intensities and time sequence to multiple piezoelectric blocks of the active back lining layer (Abstract).
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over in view Brunke in view of Ju as applied to claim 1 and further in view of Brisken (US 6228046).
Regarding claim 2, together Brisken and Brunke teach all of the limitations of claim 1 as noted above.
Together Brunke and Ju do not explicitly teach the catheter housing comprises a diameter of ten French or smaller.
Brisken, however, teaches the catheter housing comprises a diameter of ten French or smaller (Col. 6, ln. 41-55; and the diameter will be from 1 mm to 5 mm, usually being from 2 mm to 4 mm, 1 and 2mm are less than the 3.33mm of 10Fr gauge).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the catheter housing of Brunke in view of Ju to have comprised a diameter of ten French or smaller as taught by Brisken because it would have been a known size and method of manufacturing catheters that further would have allowed reaching parts within the patient vasculature (Col. 6, ln. 41-55).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Brunke in view of Ju as applied to claim 1 above, and further in view of Freiburger (US 20150272547).
Regarding claim 5, together Brunke and Ju teach all of the limitations of claim 1 as noted above.
Ju further teaches the acoustic transducer comprises fewer than six elements (Pg. 5, Full Para. 6; the specific numbers may vary depending on the different examples, and are all reasonably varied within the design range).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the acoustic transducer of Brunke in view of Ju to comprise fewer than six elements as taught by Ju because it would have been a design choice within a given design range.
Together Brunke and Ju do not explicitly teach the first one-dimensional array comprises a linear array of thirty-two or more of the elements.
Freiburger however teaches a ultrasound imager (Paragraph [0013]; transducer and/or tissue motion are determined while imaging. The system calculates an appropriate ARFI) wherein the first one-dimensional array comprises a linear array of thirty-two or more of the elements (Paragraph [0075]; . The transducer 14 includes a plurality of elements for transducing between acoustic and electrical energies. For example, the transducer 14 is a one-dimensional PZT array with about 64-256 elements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first one-dimensional array of Brunke in view of Ju to have comprised a linear array of thirty-two or more of the elements because it would have been a well understood method of constructing an imaging transducer that further would have allowed applying beamformed pulses to transmit acoustic waves for scanning and displacing tissue (Paragraphs [0072]-[0073]) and thereby improving imaging using the ARFI by monitoring specific areas and depths (Paragraph [0064]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Brunke in view of Ju as applied to claim 1 above, and further in view of Allison (WO-2006045011-A2).
Regarding claim 11, together Brisken and Brunke teach all of the limitations of claim 1 as noted above.
Together Brunke and Ju do not explicitly teach a matching layer covering a transmitting face of the acoustic transducer.
Allison, however, teaches an ultrasound imaging device (Paragraph [0009]; remote sensing capsule for sensing features within a fluid medium; Paragraph [0015]; configured for use within a subject's body) comprising an acoustic transducer within the housing (Paragraph [0156]-[0157]; propulsion system is one in which thrust is provided by acoustic streaming produced by an acoustic stream generator (also referred to as a transducer); system provides propulsion by producing acoustic waves and projecting them into the liquid medium to generate thrust) comprising a matching layer covering a transmitting face of the acoustic transducer (Paragraph [0159]; the backing and matching layers are layered onto a peizoceramic material to which a voltage is applied, resulting in thrust being applied into the fluid medium, Fig. 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Brunke in view of Ju to have included a matching layer covering a transmitting face of the acoustic transducer as taught by Allison because it would have been a known way of assembling a transducer for applying force within a fluid environment that further would have allowed maximizing the transfer of acoustic energy from the transducer to the desired direction of thrust (Paragraph [0161]), thereby improving the ability of the transducer to provide a stabilization force to the catheter.
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to the claims and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 102 rejections of claims 13 and 20 have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Applicant’s arguments, see Remarks, filed 04/07/2026, with respect to rejection of Claim 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly presented prior art of Ju (CN 116458919 A). Examiner would like to point out that Ju teaches a second acoustic transducer configured for recoil compensation of the first one-dimensional array, as noted in the rejection above. Furthermore, the acoustic transducer of Ju is directed toward reducing pressure toward one side and would not interfere with the imaging catheter of Brunke.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
07/08/26
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