DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment filed 12/29/2025 is acknowledged.
Claims 1-6 remain pending in the current application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra (US 20230404530 A1) in view of Song (US 20210330292 A1).
Regarding claim 1, Ben-Ezra teaches an ultrasonic wave probe ([0019] ultrasound imaging probe)
an ultrasonic wave transmitter and receiver that transmits ultrasonic waves to a living body and that receives ultrasonic waves that were reflected inside the living body ([0018] a first transducer transmitting a first acoustic field at a first frequency into a region of a medium, generating oscillatory motion of scatterers disposed in the region. A second transducer transmits acoustic pulses into the region, and receives respective echoes of each pulse scattering off an oscillating scatterer in the region)
and a housing that accommodates the ultrasonic wave transmitter and receiver the housing having an outer side wall on a first plane ([0029] a housing of the treatment head; a device housing will implicitly comprise walls)
wherein the housing is provided with a guide that indicates a contact angle of the ultrasonic wave transmitter and receiver corresponding to a measurement site inside the living body ([0142] housing 42 of treatment head 20 are arranged such that…treatment head 20 can rotate by an angle θ (theta) of +/−30 degrees about an axis that is perpendicular to longitudinal axis 52 of treatment head 20 without contact portion 72 of flexible membrane 38 that is in contact with perineum 34 of subject 25 sliding with respect to perineum 34 of subject 25).
Ben Ezra fails to teach the guide includes a straight line drawn on the outer side wall of the housing, and the straight line is parallel to a normal line of the transmission and reception surface.
However, Song teaches the guide includes a straight line drawn on the outer side wall of the housing, and the straight line is parallel to a normal line of the transmission and reception surface ([0043] As shown in FIG. 2, in some embodiments the housing 102 can be designed in such a way to aid in scanning with the FASTER imaging device 100. In the example shown in FIG. 2, the housing 102 includes a visual guide 202 to help the operator align the underlying tissue anatomy with the actual ultrasound beam position. Because of the ultrasound beam reflections occurring inside the FASTER imaging device 100 (i.e., within the housing 102), the ultrasound beam position is no longer directly under the ultrasound transducer 110, which can be problematic for targeting the tissue during imaging. The visual guide 202 marks the position where the ultrasound beam enters the tissue and can be clearly visualized by the operator when using the FASTER imaging device 100)
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Ben Ezra and Song are considered analogous because both disclose medical devices that apply ultrasound to patients. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the of the pending application to include a visual aid on the external housing of the device that allows a user to visualize the trajectory with which the probe is directed at the patient in order to operator align the underlying tissue anatomy with the actual ultrasound beam position (Song [0043]).
Regarding claim 2, Ben-Ezra teaches the straight line of the guide shown on an exterior surface of the housing ([0129] focusing and steering capabilities are achieved by electronic beam forming. In accordance with another application of the present invention, the ten sectors 68 are flat, but each of them is tilted towards a common focal point; the sectors 68 that guide the device’s steering are made up of straight lines radiating outwards as shown in fig. 3b).
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Regarding claim 3, Ben-Ezra teaches a plurality of the straight lines are provided and the straight lines extend in different directions (observe arrangement of guide lines in fig. 3b)
Regarding claim 4, Ben-Ezra teaches the straight lines include a reference line that is orthogonal to an ultrasonic wave transmission and reception surface of the ultrasonic wave transmitter and receiver, and others of the straight lines are inclined at different angles with respect to the reference line ([0129] all the central-orthogonal lines intersect at the focal point; the central-orthogonal line is the normal to the sector plane that crosses the center of the sector)
Regarding claim 5, Ben-Ezra teaches the straight lines are provided within an angle range of 5 degrees or more and 25 degrees or less with respect to the reference line ([0142] an angle θ (theta) of 5 degrees about an axis that is perpendicular to longitudinal axis 52 of treatment head 20 without contact portion 72 of flexible membrane 38 that is in contact with perineum 34 of subject 25 sliding with respect to perineum 34 of subject 25. Tilt angle θ (theta) is also shown in FIGS. 2C-D. Typically, treatment head 20 tilts by rotating about the x-axis and/or the y-axis as shown in FIG. 2B. For some applications, treatment head 20 can rotate by an angle θ (theta) of +/−30 degrees about an axis that is perpendicular to longitudinal axis 52 of treatment head 20 without contact portion 72 of flexible membrane 38 that is in contact with perineum 34 of subject 25 sliding with respect to perineum 34 of subject 25).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra in view of Song as applied to claim 1 above, and further in view of Blaivas (US 20130131501 A1)
Regarding claim 6, Ben-Ezra fails to teach the housing includes a head provided with the ultrasonic wave transmitter and receiver, a grip that supports the head and that is gripped by a user, and a hinge that connects the head and the grip together and that is configured to enable change of an inclination angle of the head with respect to the grip, wherein the hinge is switchable between an unlocked state in which the inclination angle of the head with respect to the grip is changeable and a locked state in which change of the inclination angle of the head with respect to the grip is restricted and the guide is a straight line displayed on the exterior surface of the grip.
However, Blaivas teaches the housing includes a head provided with the ultrasonic wave transmitter and receiver ([0044] ultrasound transceiver)
a grip that supports the head and that is gripped by a user ([0044] a handset having an ultrasound transceiver occupying a swivelable housing that allows left-handed or right-handed holding of the ultrasound transceiver against the surface of a patient)
and a hinge that connects the head and the grip together and that is configured to enable change of an inclination angle of the head with respect to the grip, wherein the hinge is switchable between an unlocked state in which the inclination angle of the head with respect to the grip is changeable and a locked state in which change of the inclination angle of the head with respect to the grip is restricted and the guide is a straight line displayed on the exterior surface of the grip ([0077] FIG. 13 schematically depicts a cross-sectional perspective view of the injector arm 40 in the region of the friction hinge housing 38 that provides pivotable connection between the injector arm 40 and the transducer base 16 of the transceiver housing 12. The friction hinge 38 pivotably connects the injector arm 40 to the transceiver housing 12 and allows the user to change the angle at which the needle enters the patient's tissue).
Ben-Ezra and Blaivas are considered analogous because both disclose ultrasound probes with adjustable contact to a patient. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to design the device housing in such a way that the angle at which the probe contacts the body is adjustable with a hinge in order to provide ultrasound treatment to difficult-to-access blood vessels and nerves that in a way that does not require two people to perform (Blaivas [0003]).
Response to Arguments
Applicant’s arguments, see page 6, filed 12/29/2025, with respect to the rejection of independent claim 1 under 35 USC 102 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 cited Song reference. Applicant argues persuasively that the new amendment regarding the guide line on the external housing of the device is not disclosed in the primary Ben-Ezra reference. However, an analogous feature is clearly described in the Song reference and depicted in Fig. 2 of the Song disclosure. Thus, the claims remain rejected under 35 USC 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3798 /SERKAN AKAR/ Primary Examiner, Art Unit 3797