DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/06/2026 has been entered.
Response to Amendment
Currently claims 1, 2, and 5-21, and 24-26 are pending with claims 14-21 withdrawn.
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, 2, 5, 8, 10, 11, 13, 24, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Courtney et al., (US20190374196A1) in view of Ryan et al., (US20220395255A1), and further in view of Hajati et al., (US 20130293065 A1) and Kemp (US20140276084A1).
Regarding claim 1, Courtney teaches an ultrasonic catheter comprising (fig. 1 imaging probe is a catheter 100 [0055]; [0061]the catheter may include an ultrasound transducer):
a body (see annotated fig. 6a) having a longitudinal axis and a distal end (see annotated fig. 6A); and
a transducer ([0061] imaging assembly 170 may be an ultrasound transducer) disposed within the distal end of the body (annotated fig. 6A imaging assembly 170 is inside the distal end of the body),
wherein a material is disposed over and completely encapsulates the distal end of the body (see annotated fig. 6A the distal tip 140 completely encapsulates the distal end [0092]; [0065] the distal tip 140 made be made from a plastic) along a longitudinal shaft of the body, and over an imaging window (annotated fig. 6A the material between the imaging assembly 170 and the distal tip 140 constitutes an imaging window as the imaging assembly 170 would transmit signals through that material) and allow transmission of ultrasound signals (fig. 6A the distal tip 140 allows for transmission of imaging energy through its wall [0056]).
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However, Courtney is silent regarding a piezoelectric micromachined ultrasonic transducer (pMUT) array, wherein the pMUT array comprises a plurality of pMUT array elements arranged on a substrate and, an insulating material to provide electrical isolation.
In the same ultrasound field of endeavor, Ryan teaches of a Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array (fig. 1 transducers 18 may be PMUTs [0083]) wherein the pMUT array comprises a plurality of pMUT array elements (fig. 18b transducers 1802 [0154]) arranged on a substrate (fig. 18B flex circuit 1823 [0154]), and an insulating material to provide electrical isolation (Merriam Webster’s defines insulating as “to separate from conducting bodies by means of nonconductors so as to prevent transfer of electricity”, therefore insulating material 1820 would be able to provide electrical isolation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Courtney with the pMUT array elements and insulating material of Ryan, as this would improve the efficiency of imaging systems while not sacrificing speed and accuracy (see Ryan [0077]).
However the combination of references are silent regarding wherein each of the pMUT array elements comprises a plurality of pMUT cells, wherein one of the plurality of pMUT array elements has periodic varied spacing between the pMUT cells in a lateral direction along a longitudinal length of the one of the plurality of pMUT array elements, wherein the lateral direction is perpendicular to the longitudinal length that the one of the plurality of pMUT array elements extends.
However, in the same ultrasound field of endeavor Hajati teaches wherein one of the plurality of the pMUT array elements (fig. 7A electrode rails 110, 120, 130, and 140 [0069]) comprises a plurality of pMUT cells arranged in a linear array (fig. 7A cells 712A-716A form a linear array [0069]) wherein one of the plurality of pMUT array elements has periodic varied spacing between the pMUT cells in a lateral direction along a longitudinal length of the one of the plurality of pMUT array elements, wherein the lateral direction is perpendicular to the longitudinal length that the one of the plurality of pMUT array elements extends (see annotated fig. 7A the electrode rails contain different sized transducer elements, and are periodically spaced laterally along a longitudinal length, as there is a pattern of small->large then back to small->large and are perpendicular to the longitudinal length of one of the pMUT array elements [0063]-[0066] and [0070]).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Courtney with the spacing of Hajati, as they provide the plurality of resonances for wider bandwidth spectral response(see Hajati [0072]).
However the combination of references are still silent regarding wherein each of the plurality of pMUT array elements is a linear phased array.
In the same ultrasound field of endeavor, Kemp teaches wherein each of the plurality of pMUT array elements is a linear phased array ([0040] the linear-phased imaging array is a PMUT).
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 transducer array of modified Courtney with the linear phased array of Kemp, as both inventions relate to IVUS devices, and would yield the predictable result of an IVUS catheter that comprises pMUT array elements that are a linear phased array to one of ordinary skill in the art. One of ordinary skill would be able to perform such as substitution, and the results of modified Courtney using a pMUT that is a linear phased array are reasonably predictable
Regarding claim 2, modified Courtney teaches the catheter of claim 1, but is silent regarding the pMUT array is configured to be electrically isolated from a patient using the insulating material.
However, in the same ultrasound field of endeavor, Ryan teaches the pMUT array is configured to be electrically isolated from a patient using the insulating material ([0155] “An insulating material 1820 is applied over the transducer array to seal it from environmental/external factors and/or to provide a biocompatible surface to the array 1801” the insulating material would also electrically isolate the device from the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Courtney with the insulating material of Ryan, as this would improve the efficiency of imaging systems while not sacrificing speed and accuracy (see Ryan [0077]).
Regarding claim 5, modified Courtney teaches the catheter of claim 1, but is silent regarding wherein the longitudinal shaft is electrically isolated and coated with the insulating material to cover a shaft past the imaging window towards the distal end of the body.
In the same ultrasound field of endeavor Ryan teaches wherein the longitudinal shaft is (fig. 18C sealant 1818 creates an isolated shaft [0155])) electrically isolated and coated with the insulating material (fig. 18C insulating material 1820 coats the sealant, thereby also electrically isolating the shaft) to cover the longitudinal shaft past the imaging window towards the distal end of the body (see annotated fig. 18C, the insulating material covers past the imaging window towards the distal end of the body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Courtney with the insulating material of Ryan, as this would improve the efficiency of imaging systems while not sacrificing speed and accuracy (see Ryan [0077]).
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Regarding claim 8, modified Courtney teaches the catheter of claim 1, but is silent regarding wherein the insulating material prevents the distal end of the ultrasonic catheter against electrical leakage to the patient and against electrical break down voltage
In the same ultrasound field of endeavor, Ryan further discloses wherein the insulating material prevents the distal end of the ultrasonic catheter against electrical leakage to the patient and against electrical break down voltage ([0155] An insulating material 1820 is applied over the transducer array to seal it from environmental/external factors; the insulating material 1820 would be able to prevent electrical leakage to the patient and against electrical break down voltage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Courtney with the insulating material of Ryan, as this would improve the efficiency of imaging systems while not sacrificing speed and accuracy (see Ryan [0077]).
Regarding claim 10, modified Courtney teaches the catheter of claim 1, wherein Courtney further teaches the insulating material provides an acoustic window (fig. 6A the distal tip 140 allows for transmission of imaging energy through its wall [0056]).
Regarding claim 11, modified Courtney teaches the catheter of claim 1, but is silent regarding wherein the pMUT array is configured to scan a patient for generating images to assist a physician.
In the same ultrasound field of endeavor, Ryan teaches wherein the pMUT array is configured to scan a patient for generating images to assist a physician ([0074] the imaging catheters provide image blood vessels that may be interpreted by physicians to determine characteristics of the lumen surrounding the catheter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Courtney with the pMUT array elements of Ryan, as this would improve the efficiency of imaging systems while not sacrificing speed and accuracy (see Ryan [0077]).
Regarding claim 24, modified Courtney teaches the catheter of claim 1, but fails to explicitly disclose wherein the one of the plurality of pMUT array elements has periodically varied spacing between the pMUT cells along the longitudinal length of the one of the plurality of pMUT array elements.
However, in the same ultrasound field of endeavor Hajati teaches wherein the one of the plurality of pMUT array elements has periodically varied spacing between the pMUT cells along the longitudinal length of the one of the plurality of pMUT array elements (fig. 8A the electrode rails contain different sized transducer elements, and are periodically spaced longitudinally [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Courtney with the spacing of Hajati, as they provide the plurality of resonances for wider bandwidth spectral response(see Hajati [0072]).
Regarding claim 25, modified Courtney teaches the catheter of claim 1, but fails to explicitly disclose wherein the periodically varied spacing of the pMUT cells in the lateral direction is measured center-on-center.
In the same ultrasound field of endeavor, Hajati teaches wherein the periodically varied spacing of the pMUT cells in the lateral direction is measured center-on-center (fig. 8A the electrode rails contain different sized transducer elements, and are periodically varied spaced laterally [0072]; this distance would also vary from center to center).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Courtney with the spacing of Hajati, as they provide the plurality of resonances for wider bandwidth spectral response(see Hajati [0072]).
Regarding claim 26, modified Courtney teaches the catheter of claim 4, but fails to explicitly disclose wherein the periodically varied spacing of the pMUT cells in the lateral direction is measured center-on-center.
In the same ultrasound field of endeavor, Hajati teaches wherein the periodically varied spacing of the pMUT cells along the longitudinal length is measured center-on-center. (fig. 8A the electrode rails contain different sized transducer elements, and are periodically varied spaced along the longitudinal length [0072]; this distance would also vary from center to center).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Courtney with the spacing of Hajati, as they provide the plurality of resonances for wider bandwidth spectral response(see Hajati [0072]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Courtney as modified by Ryan, Hajati, and Kemp as applied to claim 1 above, and further in view of Morneau et al., (US20200155217A1).
Regarding claim 6, modified Courtney teaches the catheter of claim 1, but fails to explicitly disclose wherein the insulating material corresponds to a polyether block amide.
However, in the same ultrasonic catheter field of endeavor, Morneau teaches wherein the insulating material corresponds to a polyether block amide (fig. 7a tip 410 can be made of polyether block amide [0285]).
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 insulating material of modified Courtney with the material of Morneau, as both inventions relate to ultrasonic catheters, and would yield the predictable result of the distal end of the ultrasonic catheter being covered with an PEBA to one of ordinary skill in the art. One of ordinary skill would be able to make such a combination, and the result of modified Courtney having an insulated material being made of PEBA is reasonably predictable.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Courtney as modified by Ryan, Hajati, and Kemp as applied to claim 1 above, and further in view of Hadani et al., (US20120089028A1).
Regarding claim 7, modified Courtney teaches the catheter of claim 1, but fails to explicitly disclose wherein the insulating material corresponds to a thermoplastic elastomer (TPE).
However in the same ultrasound field of endeavor, Hadani teaches wherein the insulating material corresponds to a thermoplastic elastomer (TPE) (fig. 1 chamber 104 is made of a thermoplastic elastomer [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Courtney to be made of a thermoplastic elastomer, as this would result in device with an increased ultrasound wave conductivity without having to move the catheter (see Hadani [0049]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Courtney as modified by Ryan, Hajati, and Kemp as applied to claim 1 above, and further in view of Zhai et al., (US20180064415A1).
Regarding claim 9, modified Courtney teaches the catheter of claim 1, but fails to explicitly disclose wherein the insulating material dampens transverse waves of the pMUT array.
However in the same ultrasound field of endeavor, Zhai teaches wherein the insulating material dampens transverse waves of the pMUT array (fig. 3 the housing 20 is Pebax and covers the array [0020]; this would dampen the transverse waves of the pMUT array as applicant has listed Pebax as a material suitable for such cases in the specification(see applicant’s specification [0033])).
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 material of the insulating material of modified Courtney with the Pebax material of Zhai, as it is advantageous from a manufacturing cost perspective (see Zhai [0040]). Additionally, one of ordinary skill in the art would recognize that the use of PEBAX material dampens the waves.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Courtney as modified by Ryan, Hajati, and Kemp as applied to claim 1 above, and further in view of Ramm et al., (US20150265245A1)
Regarding claim 12, modified Courtney teaches the catheter of claim 1, but fails to explicitly disclose wherein each of the plurality of pMUT array elements having pMUT cells of multiple diameters.
However, in the same ultrasound field of endeavor, Ramm teaches wherein each of the plurality of pMUT array elements having pMUT cells of multiple diameters (fig. 6A, the multiple pMUTs 17 have different sizes, and increases the bandwidth [0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Courtney to have pMUTs of different sizes as taught by Ramm, as this would increase resolution and bandwidth (see Ramm [0049]).
Regarding claim 13, modified Courtney teaches the catheter of claim 12, but is silent regarding wherein each of the plurality of pMUT array elements having the pMUT cells activated by beamforming during transmission of ultrasound beams and reception of reflected echoes to form an ultrasound image.
However in the same ultrasound field of endeavor, Ryan teaches wherein each of the plurality of pMUT array elements having the pMUT cells activated by beamforming during transmission of ultrasound beams and reception of reflected echoes to form an ultrasound image ([0084] the pMUT transducers 18 transmit and receive the reflected ultrasound signals; [0088] the transducers would result in high quality ultrasound images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Courtney with the pMUT array elements of Ryan, as this would improve the efficiency of imaging systems while not sacrificing speed and accuracy (see Ryan [0077]).
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive for the same reasons listed in the Advisory Action
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798