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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 has been entered.
Response to Amendment
This office action is in response to the remarks filed on 12/23/2025.
The amendment filed 07/01/2025 has been entered. Claims 1-2, 4-5,and 7-8 remain pending in the application, and claims 3 and 6 have been canceled.
The claims are no longer interpreted under 112(f) in light of claim amendments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Vo et al. (US 20210177456 A1, hereinafter "Vo") in view of Yoshida (US 20180271487 A1) and Nagata et al. (US 20200352449 A1, of record, hereinafter "Nagata")
Regarding claim 1, Vo teaches an ultrasonic probe comprising:
an ultrasonic device (204; fig. 13 [0028]) configured to transmit an ultrasonic wave (ultrasonic transducer 204 [0048]; ultrasonic transducers are known in the art to transmit ultrasound waves); and
an acoustic sheet (pad 202 [0048]; figs 13 and 14) provided at a transmission surface of the ultrasonic wave of the ultrasonic device (The ultrasonic transducer pad 202 may be coextensive with an ultrasonic transducer attachment site 216 (as shown in FIGS. 13-14) [0048]; figs 13 and 14, reproduced below, show the acoustic sheet 202 at the transmission surface of the ultrasonic device 204),
wherein the acoustic sheet includes:
an acoustic lens (212; fig. 14 [0048]) configured to guide the ultrasonic wave output from the transmission surface in a predetermined direction (layer 212 guides acoustic transmission towards the vein, i.e. predetermined direction, as disclosed in [0048]),
a base material (214; figs. 13 and 14) covering at least a part of the acoustic lens (layer 214 covers acoustic layer/ “lens” as shown in figs. 13 and 14) and having a difference in acoustic impedance with a measurement target less than a predetermined threshold; and
PNG
media_image1.png
800
559
media_image1.png
Greyscale
PNG
media_image2.png
817
601
media_image2.png
Greyscale
Figs. 13 and 14 of Vo reproduced above
a first adhesive layer provided at least at a first surface of the base material and configured to detachably fix the acoustic sheet to the measurement target ([0051] discloses that there is an liner is on the device that used to attach to the target/site, figs. 6 depicts the adhesive layer 132 which has the same layers as shown in figs. 13-14 and disclosed in paragraphs [0048] and [0037]), the first surface being configured to face the measurement target, the acoustic lens and the base material have different acoustic impedances (The adhesive layer 132 is exposed and able to adhere to a patient's skin [0037]);
PNG
media_image3.png
490
1027
media_image3.png
Greyscale
Fig. 6 of Vo reproduced above
Vo, however, does not teach: the acoustic lens being in a cylindrical shape, a flat portion and a convex portion of the acoustic lens being outwardly opposite to each other, the flat portion directly facing the transmission surface of the ultrasonic device;
the ultrasonic probe has a sound intensity reflectance of less than 5% with respect to the measurement target, and the base material includes an opening window through which part of the convex portion of the acoustic lens is exposed to an outside without having any layer on the part of the convex portion or through which the part of the convex portion of the acoustic lens is exposed to the outside via the first adhesive layer.
Yoshida is considered analogous to the instant application as “Ultrasonic Device Unit, Ultrasonic Probe, And Ultrasonic Apparatus” is disclosed (title).
Yoshida teaches:
the acoustic lens being in a cylindrical shape ( the acoustic lens 54 … is formed to have a cylindrical shape with an axis parallel to the X direction [0058]) , a flat portion and a convex portion of the acoustic lens being outwardly opposite to each other, the flat portion directly facing the transmission surface of the ultrasonic device (flat surface of acoustic lens is facing the transmission surface 51 as shown in fig. 6; ultrasonic substrate 51 );
PNG
media_image4.png
779
983
media_image4.png
Greyscale
Fig. 6 of Yoshida reproduced above
and the base material (211) includes an opening window through which part of the convex portion of the acoustic lens is exposed to an outside without having any layer on the part of the convex portion (a sensor window 211B in a bottom part 211A, wherein the acoustic lens 54 of the ultrasonic device 5 is exposed to the outside from the sensor window 211B [0159]; fig.4 [0159]; figure 4 reproduced below).
PNG
media_image5.png
1251
922
media_image5.png
Greyscale
Fig. 4 of Yoshida reproduced above
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 invention of Vo to include the acoustic lens being in a cylindrical shape, a flat portion and a convex portion of the acoustic lens being outwardly opposite to each other, the flat portion directly facinq the transmission surface of the ultrasonic device and the base material includes an opening window through which part of the convex portion of the acoustic lens is exposed to an outside without having any layer on the part of the convex portion, as taught by Yoshida. Doing so would allow for miniaturization of the ultrasonic device unit can also be achieved, as suggested by Yoshida ([0010]).
The combined invention still does not teach the acoustic lens and the base material have different acoustic impedances, and the ultrasonic probe has a sound intensity reflectance of less than 5% with respect to the measurement target.
Nagata is considered analogous to the instant application as an ultrasound transducer assembly is disclosed (abstract).
Nagata teaches: the acoustic lens (an ultrasound lens 114, which may be included as part of the ultrasound transducer assembly 110 [0026]; The transducer assembly 110 includes a plurality of transducer elements 123 [0028]) and the base material (122) have different acoustic impedances (As shown in FIG. 3, a first matching layer 122 and a second matching layer 121 may be formed on the transducer elements 123, with each of the transducer elements 123 being covered by respective portions of the first and second matching layers 122, 121. The first and second matching layers 122, 121 generally function to increase the transmission of acoustic energy from the high impedance piezoelectric transducer elements 123 to the much lower acoustic impedance of the target to be imaged, such as an organ or other biological structure in a human body [0030]; An acoustic-wave-probe resin material according to the present invention has a small difference from the acoustic impedance (1.40 to 1.70×106 kg/m2/sec) of a living body, and hence can be suitably used as a material for the acoustic matching layer [0154]; the lens has inherently has a different acoustic impedance compared to the base material 112 as the base material has an impedance close to the body, and the acoustic lens assembly is higher), and the ultrasonic probe has a sound intensity reflectance … with respect to the measurement target (The first and second matching layers 122, 121 generally function to increase the transmission of acoustic energy from the high impedance piezoelectric transducer elements 123 to the much lower acoustic impedance of the target to be imaged, such as an organ or other biological structure in a human body. By selecting appropriate matching layer materials and thicknesses, the acoustic impedance can be graded to minimize reflection such that ultrasonic waves emitted by the transducer elements 123 efficiently enter the target for ultrasound imaging [0153]; acoustic impedance ratios between different mediums are used to calculate sound intensity reflectance1, as well known in the art, and matching/reducing the difference between two mediums impacts the sound intensity reflectance).
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 invention of Vo to include the acoustic lens and the base material have different acoustic impedances, and the ultrasonic probe has a sound intensity reflectance with respect to the measurement target, as taught by Nagata. Doing so would achieve efficient transmission and reception of ultrasonic waves, as suggested by Nagata ([0153]).
Although Nagata discloses minimizing the acoustic impedance difference between the probe and the body ([0153]), Nagata does not explicitly disclose and the ultrasonic probe has a sound intensity reflectance of less than 5% with respect to the measurement target. Such a specific value or range of less than 5% amounts to an optimized parameter, the optimized parameter a result-effective variable, wherein the percentage of the sound intensity reflectance affects the ultrasound transmission. The claimed range of less than 5% is merely an optimum or workable range, there being no evidence disclosed by the applicant of the sound intensity reflectance of less than 5% being critically important or yielding unexpected results. Nagata teaches adjusting the thickness/material of the matching material, i.e. the backing material, in order to reduce the difference in acoustic impedance between the piezoelectric element layer and the determination target, to achieve efficient transmission and reception of ultrasonic waves ([0153]-[0154]). See MPEP §2144.05(II), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 2, modified Vo teaches the ultrasonic probe according to claim 1, as discussed above. Vo further teaches wherein the acoustic sheet includes a second adhesive layer (208 [0048]) provided at a second surface of the base material (adhesive portion 208 is on the top surface/second surface of the acoustic sheet 202 as shown in fig. 13) and configured to detachably fix the acoustic sheet to the ultrasonic device (The ultrasonic transducer pad 202 may be removed and replaced for additional procedure [0048]; the adhesive layers can be detached as disclosed in [0046], and [0048]-[0049]), and the second surface faces the ultrasonic device (layer 208 faces ultrasonic device 204 as shown in fig. 14 below)
PNG
media_image6.png
765
676
media_image6.png
Greyscale
PNG
media_image7.png
625
667
media_image7.png
Greyscale
Figs. 13 and 14 of Vo reproduced above
Regarding claim 4, modified Vo teaches the ultrasonic probe according to claim 1, as discussed above. Vo further teaches herein the first adhesive layer covers an entirety of the first surface of the base material ([0051] discloses that there is an liner is on the device that used to attach to the target/site, figs. 6 depicts the adhesive layer 132 which has the same layers as shown in figs. 13-14 and disclosed in paragraphs [0048] and [0037]; the adhesive layer 132 is exposed and able to adhere to a patient's skin [0037]; [0034] discloses that the adhesive layer may be coextensive with the bottom surface, i.e. portion covers the entire first surface of the base material).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Vo et al. (US 20210177456 A1, hereinafter "Vo") in view of Yoshida (US 20180271487 A1) and Nagata et al. (US 20200352449 A1, hereinafter "Nagata"), and Fujimoto et al. (US 20200390418 A1, hereinafter “Fujimoto”).
Regarding claim 5, modified Vo teaches the ultrasonic probe according to claim 1, as discussed above. Vo however, does not teach herein when viewed from a direction orthogonal to the transmission surface, the base material includes a recess that is recessed from a side facing the measurement target toward the acoustic lens in a region overlapping the acoustic lens, and the first adhesive layer covers a portion of the base material in which the recess is not provided.
Fujimoto is considered analogous to the instant application as “Attachment and ultrasound probe” is disclosed (title).
Fujimoto teaches: when viewed from a direction orthogonal to the transmission surface (orthogonal direction view is shown/annotated below, along with transmission surface), the base material includes a recess that is recessed from a side facing the measurement target toward the acoustic lens (90) in a region overlapping the acoustic lens (base material 83B has recessed portions circled below, that overlaps the acoustic layer 90 below), and the first …portion covers a portion of the base material in which the recess is not provided (the sides of 83A/base material outside of the circled recessed portion do not have a recess, as shown in fig. 6C below; [0063]).
PNG
media_image8.png
311
605
media_image8.png
Greyscale
Fig. 6C of Fujimoto reproduced above with annotations
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 combined invention of Vo to include, herein when viewed from a direction orthogonal to the transmission surface, the base material includes a recess that is recessed from a side facing the measurement target toward the acoustic lens in a region overlapping the acoustic lens, and modify the first adhesive layer in Vo such that the layer covers a portion of the base material in which the recess is not provided, as taught by Fujimoto. Doing so would allow for a high ultrasonic wave transmittance, as suggested by Fujimoto ([0072]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vo et al. (US 20210177456 A1, hereinafter "Vo") in view of Yoshida (US 20180271487 A1) and Nagata et al. (US 20200352449 A1, hereinafter "Nagata") and Namakura et al. (US 20170156695 A1, hereinafter "Namakura").
Regarding claim 7, modified Vo teaches ultrasonic probe according to claim 2, as discussed above. Vo, however, does not teach wherein the ultrasonic device includes an alignment portion configured to position the acoustic sheet such that the acoustic lens is disposed at a position configured to face the transmission surface.
Namakura is considered analogous to the instant application as “Ultrasonic probe unit, ultrasonic probe, and ultrasonic apparatus” is disclosed (title).
Namakura, however, teaches wherein the ultrasonic device includes an alignment portion configured to position the acoustic sheet such that the acoustic lens is disposed at a position configured to face the transmission surface ([0073]-[0075] discloses the use of magnets 31/alignment portion on the acoustic sheet/base that would fix/position the transmission surface and acoustic lens to the body).
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 combined invention of Vo to include, wherein the ultrasonic device includes an alignment portion configured to position the acoustic sheet such that the acoustic lens is disposed at a position configured to face the transmission surface, as suggested by Namakura. Doing so would improve the efficiency of the transmission and reception process of the ultrasonic wave, as suggested by Namakura ([0037]).
Regarding claim 8, modified Vo teaches ultrasonic probe according to claim 1, as discussed above. Vo further teaches wherein the ultrasonic device includes
an ultrasonic element having the transmission surface and configured to transmit the ultrasonic wave from the transmission surface (ultrasonic transducer 204 [0048]; transducer 204 to aid in transmissivity of ultrasound waves [0052]), and
a housing accommodating the ultrasonic element (the ultrasonic elements are in a housing as shown in figs. 13 and 14),
Vo, however, does not teach: the ultrasonic element includes a vibrating plate having the transmission surface and a piezoelectric element provided at the vibrating plate, and the ultrasonic element is configured to transmit the ultrasonic wave from the transmission surface by driving the piezoelectric element and vibrating the vibrating plate.
Namakura, however, teaches:
the ultrasonic element includes a vibrating plate having the transmission surface and a piezoelectric element provided at the vibrating plate (the element substrate 41 is provided with a substrate main body part 411, a vibrating film 412 disposed on the sealing plate 42 side of the substrate main body part 411, and piezoelectric elements 413 stacked on the vibrating film 412 [0079]),
the ultrasonic element is configured to transmit the ultrasonic wave from the transmission surface by driving the piezoelectric element and vibrating the vibrating plate the process of transmission of the ultrasonic wave by driving the piezoelectric element and vibrating the vibrating plate is disclosed in [0079]-[0083])).
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 combined invention of Vo to include, the ultrasonic element includes a vibrating plate having the transmission surface and a piezoelectric element provided at the vibrating plate, and the ultrasonic element is configured to transmit the ultrasonic wave from the transmission surface by driving the piezoelectric element and vibrating the vibrating plate, as suggested by Namakura. Doing so would improve the efficiency of the transmission and reception process of the ultrasonic wave, as suggested by Namakura ([0037]).
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are moot.
Regarding the 35 USC § 103 rejection of claim 1, applicant argues on pages 5-8 of remarks, that the prior art does not teach the newly added claim limitation regarding “the acoustic lens being in a cylindrical shape, a flat portion and a convex portion of the acoustic lens being outwardly opposite to each other, the flat portion directly facing the transmission surface of the ultrasonic device”, and “the base material includes an opening window through which part of the convex portion of the acoustic lens is exposed to an outside without having any layer on the part of the convex portion or through which the part of the convex portion of the acoustic lens is exposed to the outside via the first adhesive layer”. This argument is moot in view of new grounds of rejection which relies upon Yoshida (US 20180271487 A1), as discussed above.
Applicant argument’s on page 8 of remarks are premised upon the assertion that the claims 2, 4, 5, 7-8 are allowable for the same reasons as claim 1. The examiner respectfully disagrees for the reasons discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NESHAT BASET whose telephone number is (571)272-5478. The examiner can normally be reached M-F 8:30-17:30 CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PASCAL M. BUI-PHO can be reached on (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
1 https://phys.libretexts.org/Bookshelves/College_Physics/College_Physics_1e_(OpenStax)/17%3A_Physics_of_Hearing/17.07%3A_Ultrasound