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 7/16/2025 is acknowledged.
Claims 1 and 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.
Claim(s) 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ylihautala (US 20160089551 A1) in view of Wing (US 20110077555 A1) and Bockenstedt (US 20090171252 A1).
Regarding claim 1, Ylihautala teaches a head for ultrasound therapy ([abst] A high-intensity focused ultrasound (HIFU) therapy system)
comprising an upper portion and a lower portion ([0027] The lower (6a) and upper (6b) surfaces of the cavity (6) are formed by ultrasound “transparent” materials, i.e. materials through which majority of the ultrasound is transmitted through and only minor part of the ultrasound is reflected or absorbed)
wherein the lower portion comprises a space portion ([abst] A degassing module and preferably also a filter to remove volatile components from the coolant. Dissolved air or other gases are removed from the coolant, so that the formation of bubbles in the coolant is avoided or at least suppressed)
and an ultrasound transducer portion moving inside the space portion wherein the space portion is filled with coolant ([abst] A fluid cooling system to provide cooling of an object to which the focused ultrasound beam is directed. The fluid cooling system includes a fluid receptacle mounted adjacent to the ultrasound transparent window and a cooling unit to cool a coolant and pass the coolant trough the fluid receptacle to and from the fluid receptacle)
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wherein an ultrasound transmission portion is disposed in the lower portion (observe arrangements of ultrasound transducer 3 and lower portion 6a in fig. 1)
wherein the coolant is supplied by a coolant supply portion and the coolant supply portion is disposed in an upper and lower compartment portion between the upper and lower portions (observe arrangements of liquid reservoir 2 and upper and lower portions 6b and 6a in fig. 1)
the coolant supply portion comprises a coolant spray portion disposed inside the space portion, and the coolant spray portion sprays a coolant into an interior of the space portion ([abst] A degassing module and preferably also a filter to remove volatile components from the coolant. Dissolved air or other gases are removed from the coolant, so that the formation of bubbles in the coolant is avoided or at least suppressed)
Ylihautala fails to teach wherein the ultrasound transducer portion moves in back and forth and left and right directions inside the space portion, wherein the upper portion includes a first axial movement portion and a second axial movement portion, wherein the first axial movement portion moves in a back and forth direction and the second axial movement portion moves in a left and right direction with the first axial movement portion, wherein the first axial movement portion and the second axial movement portion include a motor, wherein the first axial movement portion is connected to a ball joint, the ball joint passes through an upper and lower compartment portion and is connected to the ultrasound transducer portion such that ultrasound transducer portion moves in back and forth and left and right directions with the ball joint as the center of rotation, wherein the ultrasound transmission portion is formed in a gently curved shape with a shape raised toward the outside, and the ultrasound transducer portion moves in back and forth and left and right directions via the ball joint in a path of pendulum movements in order to correspond to the gently curved inner surface of the ultrasound transmission portion.
However, Wing teaches the ultrasound transducer portion moves in back and forth and left and right directions inside the space portion ([0106] the transducer assembly is typically contained in a sealed enclosure filled with an appropriate ultrasound coupling medium, such as degassed water. The enclosure may be water tight. The enclosure may be made of plastic or other suitable material, and may have a lining on the interior of the compartment to prevent gas from seeping into the sealed enclosure and entering the degassed water...The transducer assembly is mounted to a mechanical arm or linkage that is able to engage a counterpart in the upper compartment. The upper compartment has an actuator assembly that moves the transducer assembly in the sealed enclosure by engaging directly (or indirectly) a control arm attached to the transducer assembly. The cartridge usually has a fluid tight interface built into that portion of the cartridge that engages the control arm extending down from the upper compartment. When the upper and lower compartments are properly connected, the control arm from the upper compartment engages a receptacle in the fluid tight interface...When the control arm of the upper compartment is moved by the actuator assembly, the transducer assembly in the lower compartment moves in a predictable fashion. The system controls the movement of the transducer assembly by controlling the motion of the control arm)
Ylihautala and Wing are considered analogous because both disclose ultrasonic therapy devices with compartments such as a degassing chamber. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the current invention to allow the user to control movement of the transducer within a compartment of the device in order to selectively position the high intensity ultrasonic transducer within the cartridge (Wing [0007]).
Ylihautala in view of Wing fails to teach wherein the upper portion includes a first axial movement portion and a second axial movement portion, wherein the first axial movement portion moves in a back and forth direction and the second axial movement portion moves in a left and right direction with the first axial movement portion, wherein the first axial movement portion and the second axial movement portion include a motor, wherein the first axial movement portion is connected to a ball joint, the ball joint passes through an upper and lower compartment portion and is connected to the ultrasound transducer portion such that ultrasound transducer portion moves in back and forth and left and right directions with the ball joint as the center of rotation, wherein the ultrasound transmission portion is formed in a gently curved shape with a shape raised toward the outside, and the ultrasound transducer portion moves in back and forth and left and right directions via the ball joint in a path of pendulum movements in order to correspond to the gently curved inner surface of the ultrasound transmission portion.
However, Bockenstedt teaches the upper portion includes a first axial movement portion and a second axial movement portion, wherein the first axial movement portion moves in a back and forth direction and the second axial movement portion moves in a left and right direction with the first axial movement portion ([0010] an upper end disposed within the upper compartment and a lower end disposed within the lower compartment. The control arm is movable within the aperture while the aperture is sealed between the upper and lower compartments. The actuation assembly is coupled with the upper end of the control arm such that the control arm is movable by the actuation assembly in at least two planes)
the first axial movement portion and the second axial movement portion include a motor ([0049] actuation assembly describe above includes two motors)
the first axial movement portion is connected to a ball joint, the ball joint passes through an upper and lower compartment portion and is connected to the ultrasound transducer portion such that ultrasound transducer portion moves in back and forth and left and right directions with the ball joint as the center of rotation ([0029] FIG. 13B is a perspective view illustration of the enclosure of FIG. 11, showing a partition between an upper compartment and a lower compartment and movement directions of an ultrasound transducer disposed within the lower compartment, in accordance with an embodiment; ball-joint 104)
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the ultrasound transmission portion is formed in a gently curved shape with a shape raised toward the outside, and the ultrasound transducer portion moves in back and forth and left and right directions via the ball joint in a path of pendulum movements in order to correspond to the gently curved inner surface of the ultrasound transmission portion ([0064] An effect of the pendulum design is that as the transducer swings about the pivot point, the transducer focal point Z depth will change relative to a flat plane. This is driven by the distance between the pivot point and the transducer focal point. This distance creates an effective radius, so that the Z elevation change can be calculated as a function of actuation assembly position/rotation)
Ylihautala as modified and Bockenstedt are considered analogous because both involve constructional details of an apparatus that controls motion of an ultrasound transducer. 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 include a movement design including motors and a ball joint that allows for movement in multiple directions as well as allowing the transducer to move in a pendulum fashion in order to create a HIFU applicator that can be easily manipulated by a user while still providing reliable and uniform treatment (Bockenstedt [0005]).
Regarding claim 6, Ylihautala teaches a supply flow rate of a coolant is continuously regulated when the head for ultrasound therapy operates ([0027] Instead of controlling only liquid temperature, the system could also regulate liquid flow or mix suitable temperature liquid from two temperature liquid sources).
Response to Arguments
Applicant’s arguments, see pages 4-6, filed 7/16/2025, with respect to the rejection(s) of independent claim 1 under 35 USC 102(a)(1) 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 uncovered Bockenstedt reference. Applicant has amended the independent claim to include subject matter of most of the dependent claims as well as new limitations that provide more detail on the manner in which the movement of the ultrasound transducer is controlled and argues persuasively that these features are not taught in the primary reference. However, an updated search has uncovered the newly cited Bockenstedt reference which teaches a motion apparatus that under broadest reasonable interpretation is considered analogous to the one described in the claims. As a result, the claims remain rejected under 35 USC 103.
Conclusion
THIS ACTION IS MADE FINAL. 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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/GABRIEL VICTOR POPESCU/ Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798