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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21, 22, and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2005/0277824 to Aubry et al. “Aubry”.
Regarding claim 21, Aubry discloses an ultrasound transducer assembly (array of transducers integrated in a cap, Paragraph 0078; Fig. 2, cap, Ref. 2, with array of transducers, Ref. 17) connectable to an ultrasound system (microcomputer 7, Fig. 1; Paragraph 0079), the assembly comprising:
a mechanical substructure (rigid cup 11 of cap 2, See Fig. 2) having an outer surface (See Fig. 2, rigid cup 11 of cap 2, has an outer surface, that is facing away from head 3 of the subject) and an inner surface (inside face of cup 11, Paragraph 0080; also see Fig. 2), the inner surface shaped to define a cavity therein (Fig. 2, the inside face of cup 11 forms a convex cavity that contains the array of transducers 17);
one or more ultrasound transducer elements supported by the mechanical substructure (See Fig. 2, transducers 17, 17b, T1, T2 is attached to cup 11, which would read on supported; Paragraph 0078, array of transducers integrated in the cap); and
a fillable jacket (Fig. 2 and Paragraph 0080, flexible wall 12 defines a tank 13) coupled to the inner surface (See Fig. 2, flexible wall 12 in relation to rigid cup 11; rigid cup 11 co-operates with flexible wall 12 to define tank 13, Paragraph 0080) and in acoustic contact with the one or more transducer elements (See transducers 17, 17a, 17b in contact with the tank 13 formed by flexible wall 12 and rigid cup 11), the fillable jacket lining the inner surface (See Fig. 2, as seen in the figure, tank 13 with flexible wall 12 lines the inside face of rigid cup 11), and comprising:
a deformable receptacle (Fig. 2, flexible wall 12 defines a tank 13, Paragraph 0080, wherein the flexible wall conforms to the shape of the skull of the patient, Paragraph 0081, which reads on a deformable receptacle) for holding a volume of an acoustic transmission fluid in a deformable chamber of the deformable receptacle (tank 13 is filled with fluid such as a gel or liquid, Paragraph 0080; wherein the fluid allows for acoustic connection between the transducers and the skull of the patient, Paragraphs 0081, 0082); and
wherein, when the acoustic transmission fluid is introduced into the deformable chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject (tank 13 is filled with fluid such as a gel or liquid, Paragraph 0080; wherein the fluid allows for acoustic connection between the transducers and the skull of the patient, Paragraphs 0081, 0082; the flexible wall 12 fits closely to the shape of the skull of the patient, Paragraph 0081).
Regarding claim 22, Aubry discloses all the features of claim 21 above.
Aubry discloses wherein the fillable jacket is acoustically coupled to the mechanical substructure (See Fig. 2, flexible wall 12 that forms tank 13 is directly in contact with rigid cup 11).
Regarding claim 36, Aubry discloses a method (non-invasive method of obtaining a target soundwave field in the brain, Abstract) for using an ultrasound transducer assembly (array of transducers integrated in a cap, Paragraph 0078; Fig. 2, cap, Ref. 2, with array of transducers, Ref. 17) connectable to an ultrasound system (microcomputer 7, Fig. 1; Paragraph 0079), the method comprising:
providing a mechanical substructure (rigid cup 11 of cap 2, See Fig. 2) having an outer surface (See Fig. 2, rigid cup 11 of cap 2, has an outer surface, that is facing away from head 3 of the subject) and an inner surface (inside face of cup 11, Paragraph 0080; also see Fig. 2), the inner surface shaped to define a cavity therein (Fig. 2, the inside face of cup 11 forms a convex cavity that contains the array of transducers 17);
providing one or more ultrasound transducer elements supported by the mechanical substructure (See Fig. 2, transducers 17, 17b, T1, T2 is attached to cup 11, which would read on supported; Paragraph 0078, array of transducers integrated in the cap); and
providing a fillable jacket (Fig. 2 and Paragraph 0080, flexible wall 12 defines a tank 13) coupled to the inner surface (See Fig. 2, flexible wall 12 in relation to rigid cup 11; rigid cup 11 co-operates with flexible wall 12 to define tank 13, Paragraph 0080) and in acoustic contact with the one or more transducer elements (See transducers 17, 17a, 17b in contact with the tank 13 formed by flexible wall 12 and rigid cup 11), the fillable jacket lining the inner surface (See Fig. 2, as seen in the figure, tank 13 with flexible wall 12 lines the inside face of rigid cup 11), and comprising a deformable receptacle (Fig. 2, flexible wall 12 defines a tank 13, Paragraph 0080, wherein the flexible wall conforms to the shape of the skull of the patient, Paragraph 0081, which reads on a deformable receptacle) for holding a volume of an acoustic transmission fluid in a deformable chamber of the deformable receptacle (tank 13 is filled with fluid such as a gel or liquid, Paragraph 0080; wherein the fluid allows for acoustic connection between the transducers and the skull of the patient, Paragraphs 0081, 0082);
wherein, when the acoustic transmission fluid is introduced into the deformable chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject (tank 13 is filled with fluid such as a gel or liquid, Paragraph 0080; wherein the fluid allows for acoustic connection between the transducers and the skull of the patient, Paragraphs 0081, 0082; the flexible wall 12 fits closely to the shape of the skull of the patient, Paragraph 0081).
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.
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.
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) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubry, in view of US2018/0318611 to Chen et al. “Chen”.
Regarding claim 23, Aubry discloses all the features of claim 22 above.
However, Aubry does not disclose a first layer of acoustic coupling gel located between the fillable jacket and the mechanical substructure.
Chen teaches a similar system wherein multiple layers of acoustic coupling are between the mechanical substructure and a fillable tank (see Fig. 4, fluid container containing coupling fluid 110, with membranes 114 and 112, wherein there is additionally more acoustic coupling material between membrane 112, and the mechanical structure, i.e. the ultrasound window 24, Paragraph 0025).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Aubry’s invention wherein a first layer of acoustic coupling gel located between the fillable jacket and the mechanical substructure, as taught by Chen, in order to enhance the acoustic coupling at the interfaces (Chen, Paragraph 0025).
Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubry, in view of US2018/0271480 to Kawabata et al. “Kawabata”.
Regarding claims 24 and 25, Aubry discloses all the features of claim 21 above.
However, Aubry does not disclose an air bubble detector for detecting air bubbles in the acoustic transmission fluid, wherein the air bubble detector comprises at least one of the one or more ultrasound transducer elements configured to deliver a pulse of ultrasound energy.
Kawabata teaches a similar container for holding low attenuation liquid for use with ultrasound (Abstract, Paragraph 0029). Kawabata teaches an air bubble detector for detecting air bubbles in the acoustic transmission fluid, wherein the air bubble detector comprises at least one of the one or more ultrasound transducer elements configured to deliver a pulse of ultrasound energy (controller 4 with transmitting unit 86, receiving unit 87, and transducer array 92 for transmitting and receiving an ultrasonic signal S21 for detecting bubbles, Paragraph 0067, wherein the ultrasound signal S21 passes through a space 30 in the water tank 20, Paragraph 0053).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Aubry's invention wherein the assembly of Aubry includes an air bubble detector for detecting air bubbles in the acoustic transmission fluid, wherein the air bubble detector comprises at least one of the one or more ultrasound transducer elements configured to deliver a pulse of ultrasound energy, as taught by Kawabata, in order to determine if the an amount of bubbles in the solution exceeds a predetermined value that would indicate that the bubbles would cause unwanted interference with the ultrasound signal (Kawabata, Paragraphs 0035, 0037).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubry, in view of US2019/0247679 Vincenot et al. “Vincenot”.
Regarding claim 26, Aubry discloses all the features of claim 21 above.
However, Aubry does not disclose wherein the fillable jacket further comprises an O-ring extending around a perimeter of the deformable receptacle and wherein the fillable jacket is mechanically coupled to the mechanical substructure by insertion of an edge portion of the fillable jacket including the O-ring into a channel of the mechanical substructure.
Vincenot teaches a similar ultrasound transducer (Abstract) with a flexible membrane (Fig. 1, Ref. 8) that confines acoustic coupling fluid (Paragraph 0013), and contains an ultrasonic transducer unit therein (See Fig. 2, Ref. 3). Vincent teaches an O-ring (Fig. 2, Ref. 23) extending around a perimeter of the receptacle (See relationship between Ref. 23, and Ref. 8, also see Paragraph 0063) and wherein the fillable jacket is mechanically coupled to the mechanical substructure by insertion of an edge portion of the fillable jacket including the O-ring into a channel of the mechanical substructure (gasket 23 is mounted into the mounting groove 21g alone with the flexible membrane, Paragraph 0063).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Aubry's invention wherein the fillable jacket further comprises an O-ring extending around a perimeter of the deformable receptacle and wherein the fillable jacket is mechanically coupled to the mechanical substructure by insertion of an edge portion of the fillable jacket including the O-ring into a channel of the mechanical substructure, as taught by Vincenot, in order fasten the flexible membrane to the body of the ultrasound assembly in a sealed manner (Abstract, claim language of claim 3).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubry, in view of US4,231,373 Waxman et al. “Waxman”.
Regarding claim 28, Aubry discloses all the features of claim 21 above.
However, Aubry does not disclose one or more baffles located in the deformable chamber.
Waxman teaches a head for an ultrasonic imaging system with a liquid filled chamber containing the transducers (Abstract). Waxman teaches the liquid filled chamber is made from rubber, which reads on deformable (Col. 4, Paragraph starting at line 50, rubber chamber 46). The rubber chamber includes baffles 65 (See Fig. 4, Ref. 65; Col. 4, Paragraph starting at line 50).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Aubry's invention wherein one or more baffles are located in the deformable chamber, as taught by Waxman, in order to dampen reflected ultrasound within the chamber which greatly reduces reverberation (Waxman, Col. 4, Paragraph starting at line 62).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubry, in view of US2014/0316269 Zhang et al. “Zhang”
Regarding claim 29, Aubry discloses all the features of claim 21 above.
However, Aubry does not disclose wherein the fillable jacket further comprises one or more of: an electroencephalography sensor, a motion sensor, and an accelerometer.
Zhang teaches wherein the fillable jacket further comprises one or more of: an electroencephalography sensor, a motion sensor, and an accelerometer (Zhang teaches placing sensors close to the membrane, that contains the coupling fluid, wherein the sensor can be an accelerometer, Paragraph 0370).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Aubry's invention wherein the fillable jacket further comprises one or more of: an electroencephalography sensor, a motion sensor, and an accelerometer, as taught by Zhang, in order to provide control and safety feedback (Zhang, Paragraph 0370).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubry, in view of US8353853 to Kyle et al. “Kyle”
Regarding claim 30, Aubry discloses all the features of claim 21 above.
However, Aubry does not explicitly disclose wherein the mechanical substructure comprises a retention mechanism for securing the mechanical substructure and fillable jacket coupled thereto to the head of the subject.
Kyle teaches a similar headset/headpiece shaped ultrasound transducer device (See Fig. 1 A), with a fillable jacket detachably coupleable to the mechanical substructure, the fillable jacket comprising a deformable receptacle (Figs. 4A, 4B, Pouch 50; Fig. 5, Ref. 52, which is the rear face of pouch 50; wherein as seen in Fig. 5, pouch 50 is detachable from frame portion of the headset) for receiving acoustic transmission fluid in a chamber of the receptacle (Col. 7, Paragraph starting at line 25, the pouch 50 is filled with coolant such as water, and provides acoustic coupling between the transducers and the skull), such that, when the acoustic transmission fluid is introduced into the chamber, the deformable receptacle deforms to conform to the shape of a head of a subject (Col. 7, Paragraph starting at line 25, "When coolant (typically water) flows through them, the pouches preferably assume a somewhat convex shape in order to snugly fit to the skull when the transducers are fitted over the pouch as shown in FIG. 6").
Kyle teaches wherein the mechanical substructure comprises a retention mechanism for securing the mechanical substructure and fillable jacket coupled thereto to the head of the subject (See Figs. 1B and 2, wherein frame 14 is secured to the skull via straps 18, 20, and 22; See Figs. 4B, 5, and 6, wherein the frame 14 includes the fillable jacket coupled thereto, wherein in Fig. 5, where the fillable jacket, represented by reference numeral 52, going into the cavity of the frame as shown, and in Fig. 6, the fully coupled configuration is shown).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Aubry’s invention wherein the mechanical substructure comprises a retention mechanism for securing the mechanical substructure and fillable jacket coupled thereto to the head of the subject, as taught by Kyle, in order to have a means to secure the headpiece to the patients skull (Col. 7, Paragraph starting at line 55), while being adjustable to accommodate for heads of various sizes (Col. 6, Paragraph starting at line 21).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubry, in view of US2006/0235303 to Vaezy et al. “Vaezy”.
Regarding claim 37, Aubry discloses all the features of claim 36 above.
However, Aubry does not disclose controlling a valve which to thereby control fluid flow through a port in fluid communication with the deformable chamber to thereby control the volume of the acoustic transmission fluid in the deformable chamber.
Vaezy teaches a similar fillable jacket (“water pillow”, Abstract; Fig. 1C) with a port (inlet 14 or 16, See Fig. 1A) in fluid communication with the chamber (inlet 14 or outlet 16 are on either side of liquid chamber 16, See Fig. 1A; wherein inlet 14 allows liquid to be introduced into the liquid chamber 12, Paragraph 0038, which would read on port 14 being in fluid communication with liquid chamber 12). Vaezy further teaches a flow meter implemented using one or more valves that controls the flow rate of the liquid (Paragraph 0051), wherein the flow meter is in fluid communication with the water pillow (See Fig. 3, flow meter 37 preceding the pillow 10b in the functional block diagram). This would read on a valve for controlling fluid flow through the port to thereby control the volume of the acoustic transmission fluid in the chamber, since the valve of the flow meter controlling the flow rate of the liquid would control the flow of the liquid into port 14, which is the inlet port, since Fig. 3 shows the direction of the fluid flow is from the flow meter 37 to the pillow 10b.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Aubry's invention wherein the method includes controlling a valve which to thereby control fluid flow through a port in fluid communication with the deformable chamber to thereby control the volume of the acoustic transmission fluid in the deformable chamber, as taught by Vaezy, in order to able to vary the flow rate of liquid going into the pillow (Vaezy, Paragraph 0051) to increase heat removal relative to a focal depth of the transducer (Vaezy, Paragraph 0059).
Claim(s) 38-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyle, in view of Vincenot.
Regarding claim 38, Kyle teaches a fillable jacket (Figs. 4A, 4B, Pouch 50; Fig. 5, Ref. 52, which is the rear face of pouch 50) attachable to an inner surface of a cap (See Figs. 2 and 5, and Col. 7, Paragraph starting at line 26, pouch 50 is attachable to the inner aperture 30 defined by side walls 14a and 14b) supporting one or more ultrasound transducer elements (See Figs. 5 and 6, transducer array housing 90 is supported by the rear wall 52 of the pouch 50), the fillable jacket comprising:
a deformable receptacle (pouch 50 with interior cavity 56 is conformable and flexible, Col. 7, Paragraph starting at line 14) for holding a volume of an acoustic transmission fluid in a deformable chamber of the deformable receptacle (Col. 7, Paragraph starting at line 26, coolant flows through the pouch, wherein the coolant not only provides cooling, but as for acoustic coupling);
a port in fluid communication with the deformable chamber (See Fig. 4B, tubing with connectors 62 and 64, that carries fluid to and from the cavity of pouch 50, Col. 7, Paragraph starting at line 14).
However, Kyle does not disclose an O-ring extending around a perimeter of the deformable receptacle.
Vincenot teaches a similar ultrasound transducer (Abstract) with a flexible membrane (Fig. 1, Ref. 8) that confines acoustic coupling fluid (Paragraph 0013), and contains an ultrasonic transducer unit therein (See Fig. 2, Ref. 3). Vincent teaches an O-ring (Fig. 2, annular sealing gasket, Ref. 23) extending around a perimeter of the deformable receptacle (See relationship between Ref. 23, and the flexible membrane, Ref. 8, which when fully assembled as seen in Fig. 1, the annular sealing gasket 23 would extend around the perimeter of the flexible membrane 8; also see Paragraph 0063)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kyle's invention wherein the fillable jacket further comprises an O-ring extending around a perimeter of the deformable receptacle, as taught by Vincenot, in order for the flexible membrane to not come in direct contact with the mechanical substructures such as a washer or frame.
Regarding claim 39, the modifications of Kyle and Vincenot disclose all the features of claim 38 above.
Kyle teaches wherein, when the acoustic transmission fluid is introduced into the deformable chamber, the deformable receptacle deforms to conform to the shape of a head of a subject (Col. 7, Paragraph starting at line 14, coolant pouch is conformable, with tubing 58 and 60 carrying fluid to and from the cavity of the pouch; Col. 7, Paragraph starting at line 26, when coolant flows through the pouch, the pouch assumes a somewhat convex shape in order to snugly fit to the skull).
Regarding claim 40, the modifications of Kyle and Vincenot disclose all the features of claim 38 above.
Kyle discloses wherein the fillable jacket is detachably coupleable to a mechanical substructure (See Fig. 5, pouch 50 is detachable from frame portion of the headpiece; See claim language of claim 1, the coolant pouch is removably retained).
Regarding claim 41, the modifications of Kyle and Vincenot discloses all the features of claim 38 above.
Vincenot teaches wherein the fillable jacket is mechanically coupled to a mechanical substructure by insertion of an edge portion of the fillable jacket including the O-ring into a channel of the mechanical substructure (gasket 23 is mounted into the mounting groove 21g alone with the flexible membrane, Paragraph 0063).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention as described by Kyle and Vincenot, wherein the fillable jacket is mechanically coupled to the mechanical substructure by insertion of an edge portion of the fillable jacket including the O-ring into a channel of the mechanical substructure, as taught by Vincenot, in order to fasten the flexible membrane to the body/frame of the assembly.
Allowable Subject Matter
Claim 27 would be allowable if rewritten to overcome double patenting rejection set forth in this Office action or the timely filing of terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d), and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
No prior art can be found, alone, or in combination with any other prior art to teach wherein a fillable jacket further comprises an O-ring extending around a perimeter of the deformable receptacle and wherein the fillable jacket is mechanically coupled to the mechanical substructure by insertion of an edge portion of the fillable jacket including the O-ring into a channel of the mechanical substructure, wherein the O-ring comprises segments of an electrically conductive material, the segments in electrical contact with corresponding electrically conductive portions of the channel when the O-ring is inserted in the channel.
The closest prior art found regarding the O-ring is Vincenot (US2019/0247679), wherein an O-ring surrounds a flexible membrane container that hold acoustic coupling fluid, wherein the O-ring and the flexible membrane are secured to a structure via an O-ring channel (See the claim 73 rejection above). However, Vincenot does not teach wherein the O-ring comprises segments of an electrically conductive material, the segments in electrical contact with corresponding electrically conductive portions of the channel when the O-ring is inserted in the channel.
Additionally, no other relevant prior art could be found.
Claim 31 would be allowable if rewritten to overcome double patenting rejection set forth in this Office action or the timely filing of terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d), and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art teaches a fillable jacket detachably coupleable to the inner surface of the mechanical substructure, the fillable jacket comprising a deformable receptacle for receiving acoustic transmission fluid in a chamber of the receptacle, such that, when the acoustic transmission fluid is introduced into the chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject. More specifically, Aubrey (US2005/0277824) teaches a fillable jacket comprising a deformable receptacle for receiving acoustic transmission fluid in a chamber of the receptacle, such that, when the acoustic transmission fluid is introduced into the chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject. However, the fillable jacket of Aubrey is not detachably coupleable to the inner surface of the mechanical substructure, and actually uses the inner surface of the mechanical substructure as part of the fillable jacket.
Kyle (US8,353,853) teaches a headset/headpiece shaped ultrasound transducer device (See Fig. 1 A), with a fillable jacket detachably coupleable to the mechanical substructure, the fillable jacket comprising a deformable receptacle (Figs. 4A, 4B, Pouch 50; Fig. 5, Ref. 52, which is the rear face of pouch 50; wherein as seen in Fig. 5, pouch 50 is detachable from frame portion of the headset) for receiving acoustic transmission fluid in a chamber of the receptacle (Col. 7, Paragraph starting at line 25, the pouch 50 is filled with coolant such as water, and provides acoustic coupling between the transducers and the skull), such that, when the acoustic transmission fluid is introduced into the chamber, the deformable receptacle deforms to conform to the shape of a head of a subject (Col. 7, Paragraph starting at line 25, "When coolant (typically water) flows through them, the pouches preferably assume a somewhat convex shape in order to snugly fit to the skull when the transducers are fitted over the pouch as shown in FIG. 6"). However, Kyle does not teach the fillable jacket/deformable receptacle is coupled to the inner surface of the mechanical substructure, and couples to the mechanical substructure from the outer side of the mechanical substructure into a cavity of the mechanical substructure (See Fig. 5).
Staebler (US2022/0134608) teaches an acoustic probe device (See Figs. 19A, 19B, 19C) with a mechanical substructure (Fig. 19A and 19B, Ref. 1901) and an acoustic coupler (Fig. 19A and 19B, Ref. 1905). The acoustic coupler 1905, via a flexible bracket, attaches to the housing 1901 by flexing the flexible bracket such that the chamfered lip of the flexible bracket flexes over the lip on the curved section of the housing 1901 (Paragraph 0154), which infers a type of snap fitting, and therefore infers detachability from the housing 1901.
However, the acoustic coupler 1905 of Staebler does not teach a fillable jacket such that when the acoustic transmission fluid is introduced into the chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject. Instead, the acoustic coupler 1905 of Staebler is filled with gel-sol or a hydrogel that is allowed to cure to produce a semi-rigid structure (Paragraph 0158). Staebler explicitly states the deficiencies of using a liquid or gel contained in a deformable receptacle such as a polymer balloon as the acoustic coupler, since the use of liquid or gel can create entrained air and creases at inflexion points along the outer membrane and within the fluidic interior of the deformable receptacle (Paragraph 0035). Therefore, it would not be obvious to modify the acoustic coupler of Staebler to receive acoustic transmission fluid, instead of the gel-sol, which is then cured into a solid, since Staebler explicitly teaches away from the use of fluids, and therefore, Staebler does not teach when the acoustic transmission fluid is introduced into the chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject.
Further, it would not have been obvious to use Aubry, Kyle, and/or Staebler in combination with each other. Using Aubry as the primary prior art to teach the ultrasound transducer assembly, there is no motivation to substitute the integrated fluid filled tank of Aubrey with the pouch 50 of Kyle, or the acoustic coupler 1905 of Staebler, without the use of impermissible hindsight. Further, as stated above, Kyle's pouch 50 attaches from the outside of the mechanical substructure, which is counter to that of Aubrey. Using Staebler as the primary prior art to teach the ultrasound transducer assembly, there would be no reason to combine Staebler with Kyle, or Staebler with Aubry since both Kyle and Aubry uses fluid to fill the deformable receptacle, which Staebler explicitly teaches away from.
In addition, no other references or reasonable combinations thereof, could be found that
would teach the missing limitations.
Claims 32-35 would be allowable if rewritten to overcome double patenting rejection set forth in this Office action or the timely filing of terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d), and to include all of the limitations of the base claim and any intervening claims, for at least the reason that they inherit the allowable limitations of claim 31.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 10-11, 14-15, 20, 23-26, and 28 of U.S. Patent No. 12,433,569, in view of US2005/0277824 to Aubry et al. “Aubry”.
Regarding claim 21, ‘569 discloses an ultrasound transducer assembly connectable to an ultrasound system (claim 1, Col. 23, lines 52-53), the assembly comprising:
a mechanical substructure having an inner surface, the inner surface shaped to define a cavity therein (claim 1, Col. 23, lines 54-55);
one or more ultrasound transducer elements supported by the mechanical substructure (claim 1, Col. 23, lines 56-57); and
a fillable jacket coupled to the inner surface and in acoustic contact with the one or more transducer elements (claim 1, Col. 23, lines 58-60), the fillable jacket lining the inner surface (claim 1, Col. 23, lines 65-66) and comprising:
a deformable receptacle for holding a volume of an acoustic transmission fluid in a deformable chamber of the deformable receptacle (claim 1, Col. 23, lines 62-67); and
wherein, when the acoustic transmission fluid is introduced into the deformable chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject (claim 1, Col. 23, lines 62-67).
However, ‘569 does not disclose the mechanical substructure having an outer surface.
Aubry teaches a similar array of transducers integrated into a cap (Paragraph 0078; Fig. 2, cap, Ref. 2, with array of transducers, Ref. 17). Aubry teaches the mechanical substructure (rigid cup 11 of cap 2, See Fig. 2) having an outer surface (See Fig. 2, rigid cup 11 of cap 2, has an outer surface, that is facing away from head 3 of the subject).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘569, wherein the mechanical substructure has an outer surface, as taught by Aubry, in order to for the position of the mechanical substructure with the transducer array to be secured and positioned on the patient by a positioning system such as a robotic arm (Aubry, Paragraph 0078).
Regarding claim 36, ‘569 discloses an ultrasound transducer assembly connectable to an ultrasound system (claim 1, Col. 23, lines 52-53), the assembly comprising:
a mechanical substructure having an inner surface, the inner surface shaped to define a cavity therein (claim 1, Col. 23, lines 54-55);
one or more ultrasound transducer elements supported by the mechanical substructure (claim 1, Col. 23, lines 56-57); and
a fillable jacket coupled to the inner surface and in acoustic contact with the one or more transducer elements (claim 1, Col. 23, lines 58-60), the fillable jacket lining the inner surface (claim 1, Col. 23, lines 65-66) and comprising:
a deformable receptacle for holding a volume of an acoustic transmission fluid in a deformable chamber of the deformable receptacle (claim 1, Col. 23, lines 62-67); and
wherein, when the acoustic transmission fluid is introduced into the deformable chamber, the deformable receptacle deforms to line the inner surface and to conform to the shape of a head of a subject (claim 1, Col. 23, lines 62-67).
However, ‘569 does not disclose the mechanical substructure having an outer surface, and a method of using the ultrasound transducer assembly.
Aubry teaches a similar array of transducers integrated into a cap (Paragraph 0078; Fig. 2, cap, Ref. 2, with array of transducers, Ref. 17) and a method of using the array of transducers for non-invasive method of obtaining a target soundwave field in the brain (Abstract). Aubry teaches the mechanical substructure (rigid cup 11 of cap 2, See Fig. 2) having an outer surface (See Fig. 2, rigid cup 11 of cap 2, has an outer surface, that is facing away from head 3 of the subject).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘569, wherein the mechanical substructure has an outer surface and includes a method of using the ultrasound transducer assembly, as taught by Aubry, in order to for the position of the mechanical substructure with the transducer array to be secured and positioned on the patient by a positioning system such as a robotic arm (Aubry, Paragraph 0078) and obtain target soundwave field in the brain of the patient (Aubry, Abstract).
The following is mapping between claims of the instant application to the claims of the ‘569 Patent:
Instant Application
‘569 Patent
21
1+Aubry
22
2
23
3
24
10
25
11
26
14
27
15
28
20
29
23
30
24
31
1, Col. 23, lines 58-61
32
25
33
26
34
28
35
6
36
1+Aubry
37
6
Examiner notes that there is no double patenting rejection for claims 38-41.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Staebler (US2022/0134608) teaches an acoustic probe device (See Figs. 19A, 19B, 19C) with a mechanical substructure (Fig. 19A and 19B, Ref. 1901) and an acoustic coupler (Fig. 19A and 19B, Ref. 1905). The acoustic coupler 1905, via a flexible bracket, attaches to the housing 1901 by flexing the flexible bracket such that the chamfered lip of the flexible bracket flexes over the lip on the curved section of the housing 1901 (Paragraph 0154), which infers a type of snap fitting, and therefore infers detachability from the housing 1901.
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/MT/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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