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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to Provisional App. No. 63/511,617 filed June 30, 2023 and Provisional App. No. 63/598,886 filed November 14, 2023.
Status of Claims
This Office Action is responsive to the claims filed on 03/30/2026. Claims 1, 2, 29, and 31 have been amended. Claim 5 was previously canceled. Claims 32-35 are newly presented. Claims 1-4 and 6-35 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed limitation “configured to extend to 2-45 mm on a surface of the skull” (Claim 32, lines 2) is not described in sufficient detail that it would be clear that the applicant had possession of the claimed invention. The specification lacks the specific detail of “2-45 mm on a surface of the skull” as claimed. Specification paragraphs [0517] describes “The implant extends to 35 mm”, but the Specification fails to describe any range of “2-45 mm”. Thus, such limitations are rendered as new matter. As such the claims are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. Therefore, the claims are rejected for including new matter.
The claimed limitation “a 15-35 mm diameter” (Claim 33, lines 2) is not described in sufficient detail that it would be clear that the applicant had possession of the claimed invention. The specification lacks the specific detail of “a 15-35 mm diameter” as claimed. Specification paragraphs [0517] describes “the numerical model assumes a three-dimensional 25 mm diameter cylindrical model of the cranial implant”, but the Specification fails to describe any range of “15-35 mm”. Thus, such limitations are rendered as new matter. As such the claims are not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. Therefore, the claims are rejected for including new matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 32-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32, line 1-2 recites the claim limitation “the implantable transducer is configured to extend to 2-45 mm on a surface of the skull” which is indefinite because it is unclear what the metes and bounds of limitation is as the Specification fails to describe a range of depths for which the transducer can extend.
Claim 33, line 1-2 recites the claim limitation “the implantable transducer comprises a 15-35 mm diameter” which is indefinite because it is unclear what the metes and bounds of limitation is as the Specification fails to describe a range of diameters which the transducer can be.
The term “2 degrees” in claim 34, line 2 is a relative term which renders the claim indefinite. It is unclear what measurement system 2 degrees refers to. For the purpose of examination, this is understood to mean “2 degrees Celsius” as understood by Specification paragraph [0515].
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 1-4, 6-9, 12, 13, 16-21, 26, 27, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 (WO-2011101492-A2) in view of Carpentier-374 (US 20190030374) and Firouzi (US 20210000444 A1).
Regarding claim 1, Carpentier-492 teaches an implantable transducer (Pg. 11, ln. 24-30; implantable generator 4, Figs. 1 and 5) comprising:
a unibody housing (Pg. 11, ln. 30-Pg. 12, ln. 6; implantable generator 4 is formed of a casing 7, Figs. 1 and 5);
a sonolucent window disposed (Pg. 1, ln. 27-31; the lower wall of the implantable casing of the apparatus is advantageously permeable to ultrasound waves and to light), at least in part, at a first end of the unibody housing (Pg. 1, ln. 27-31; the lower wall), wherein the sonolucent window is permanently bonded to the unibody housing (Pg. 11, ln. 30-Pg. 12, ln. 2; Said casing 7 comprises an upper wall 8 and a lower wall 9 connected by a circular peripheral wall 1; Fig. 1 shows the lower wall is a part of the casing and is considered to be permanently bonded to the unibody housing as understood in its broadest reasonable interpretation and in view of the specification Paragraph [0173] and Fig. 3A); and
an ultrasound array (Pg. 12, ln. 27-Pg. 13, ln. 2; preferably several therapy ultrasound transducers 13, Fig. 1-5; Pg. 13, ln. 31-Pg. 14, ln. 6; imaging transducer 17, Fig. 1) disposed within the unibody housing proximate the first end (Pg. 12, ln. 27-Pg. 13, ln. 2; several therapy ultrasound transducers 13 applied onto the inner face of the lower wall 9 of the casing 7, Figs. 1 and 5), the ultrasound array configured to emit ultrasound waves to an outside environment via the sonolucent window (Pg. 12, ln. 20-26; emitting high intensity physical waves into the brain through the lower wall 9 of the casing; Pg. 13, ln. 7-20; configured to allow HIFU (for High Intensity Focused Ultrasound) techniques for the treatment of brains affections, and for instance brain tumors), wherein the ultrasound array is bonded to the sonolucent window (Pg. 12, ln. 3-6; The cylindrical casing 7 accommodates a treating device 11 designed for emitting physical waves directly into the brain 2 through; Pg. 12, ln. 23-30; The treating device 11 located in the casing 7 comprises means for emitting high intensity physical waves into the brain; several therapy ultrasound transducers 13 applied onto the inner face of the lower wall 9 of the casing 7; Figs. 1 and 5; The ultrasound transducers 13 are encapsulated and in the lower wall of the casing as shown in Figs. 1 and 5),
wherein the ultrasound array comprises a micromachined ultrasonic transducer (MUT) (Pg. 13, ln. 3-6; therapy ultrasound transducers 13 are preferably chosen… C-MUT elements), wherein the unibody housing is positioned in contact with a burr-hole in a skull of a subject (Pg. 3, ln. 9-14; implantable generator made of nonferromagnetic material for implantation into a burr hole performed in the skull of a patient, Fig. 1 and 5).
Carpentier-492 does not explicitly teach the ultrasound array is permanently bonded to the sonolucent window; and
an ultrasound integrated circuit comprising an analog front end circuit configured to process one or more signals generated in response to ultrasound waves received by one or more transducer elements.
Carpentier-374, however, teaches an implantable transducer (Paragraph [0144]; the ultrasound generating treating device 12, Fig. 1) implantable device comprising an ultrasound array (Paragraph [0146]; e ultrasound generating transducers 20a-g, Fig. 1) and a sonolucent window (Paragraph [0273]; the holder 22 may advantageously hold at least one detection ultrasound transducer designed for echo-monitoring of the brain 3, Fig. 1); wherein the ultrasound array is permanently bonded to the sonolucent window (Paragraph [0174]; the ultrasonic transducers 20 are sealed inside the holder 22 in a watertight manner, for example by being embedded in a flexible material of the holder, or by being encapsulated between two layers of flexible material, Fig. 1and 3-6; Paragraph [0267]; They can be held by being partially embedded or encapsulated in the material forming the holder 22. They can be held on the holder 22 by gluing, by riveting, or by stitching.; The ultrasonic transducers being sealed inside the holder in a watertight manner, by being embedded the material of the holder is considered to read on the claimed limitation as understood in its broadest reasonable interpretation and in view of specification paragraphs [0173] and [0356], and Fig. 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ultrasound array of Carpentier-492 to have been permanently bonded to the sonolucent window as taught by Carpentier-374 because it would have been a known method of assembling a ultrasound generating treating device for the treatment of brain disorders which further would have had the advantage of being watertight (Carpentier-374, paragraph [0174]) thus reducing the possibility of damage to the ultrasound transducing while implanted in the skull. It further would have ensured the ultrasound transducers remain fixed in position with a target.
Together Carpentier-492 and Carpentier-374 do not explicitly teach an ultrasound integrated circuit comprising an analog front end circuit configured to process one or more signals generated in response to ultrasound waves received by one or more transducer elements.
Firouzi, however, teaches an implantable transducer (Paragraph [0119]; systems and methods provide for a novel wearable or implantable intracranial pressure (ICP) monitoring unit… the measurement is conducted by pulsing an acoustic transducer, Fig. 1) comprising:
a unibody housing (Paragraph [0127]-[0128]; the devices described herein include ultrasonic transducers, either standalone; Fig. 1);
an ultrasound array (Paragraph [0151] and [0153]; implantable transducer over the head; an array of ultrasonic transducers at high), wherein the ultrasound array comprises a micromachined ultrasonic transducer (MUT) (Paragraph [0139]; Transducers can be of a variety of types such as Piezoelectric, CMUT (Capacitive Micromachined Ultrasonic Transducer)… Piezoelectric Micromachined Ultrasonic Transducer (PMUT), etc.); and
an ultrasound integrated circuit (Paragraph [0140]-[0141]; Thus, viable devices can be realized and even integrated directly on electronic circuits) comprising an analog front end circuit (Paragraph [0140]; FIGS. 3A-3D shows illustrations 300, 310, 320, and 330 of a CMUT cell; Fig. 3 show front end analog circuits as understood in its broadest reasonable interpretation) configured to process one or more signals generated in response to ultrasound waves received by one or more transducer elements (Paragraph [0003]; In some embodiments, sensors such as ultrasonic transducers, either standalone or in pairs, are utilized to send and receive acoustic waves into/from the brain; Paragraph [0138]; intracranial pressure is determined from the acquired data, e.g., as shown in FIG. 10. For example, determining the intracranial pressure may include assessing changes in amplitude, bandwidth, and/or frequency of the standing waves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the implantable transducer of Carpentier-492 in view of Carpentier-374 to have included an ultrasound integrated circuit comprising an analog front end circuit configured to process one or more signals generated in response to ultrasound waves received by one or more transducer elements as taught by Firouzi because it would have allowed for real-time monitoring and diagnosis of epileptic conditions and other abnormal brain functions (Paragraphs [0116] and [0120]).
Regarding claim 2, together Carpentier-492 and Carpentier-374 teach all of the limitations of claim 1 as noted above.
Carpentier-492 further teaches one or more circuit boards (Pg. 16, ln. 4-15; the power controller PwC then advantageously comprises wireless programmable means 28 and is also preferably implemented onto an electronic card 29 or in the form of an integrated circuit including, Fig. 5), the one or more circuit boards comprising one or more electronic components disposed thereon (Pg. 16, ln. 4-15; an electronic card 29 or in the form of an integrated circuit including said wireless communication means), the one or more electronic components configured to send one or more signals to the ultrasound array (Pg. 15, ln. 27-Pg. 16, ln. 3; which includes a second multiplexing calculator 27 to receive and convert the digital signal from the power controller PwC into an analogic signal usable by said treating device to drive the ultrasound transducers.).
Carpentier-492 does not explicitly teach the circuit board disposed within the unibody housing.
Firouzi, however, teaches the circuit board disposed within the unibody housing (Paragraph [0127]-[0128]; the devices described herein include ultrasonic transducers, either standalone; Fig. 1; Paragraph [0140]-[0141]; Thus, viable devices can be realized and even integrated directly on electronic circuits).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Carpentier-492 in view of Carpentier-374 and Firouzi to have further included the circuit board disposed within the unibody housing as taught by Firouzi because it would have allowed for continuous monitoring of the brain (Paragraph [0003]).
Regarding claim 3, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 2 as noted above.
Carpentier-492 further teaches the one or more electronic components disposed on the circuit board are configured to process data received from the ultrasound array (Pg. 13, ln. 31-Pg. 14, ln. 4; imaging transducer 17 being connected to the power controller PwC to work at a different frequency from the therapy ultrasound transducers 13 and to produce echo-imaging onto a monitor implemented in or connected to the power controller PwC.), the data indicative of brain function in a subject (Pg. 5, ln. 11-19; receiving and analysing ultrasound waves reflected by the brain, also called backscattered waves, or, more specifically, reflected by contrast agents diffused in the brain's blood.).
Regarding claim 4, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 3 as noted above.
Carpentier-492 further teaches the data comprises image data indicative of anatomical features of the subject (Pg. 20, ln. 5-20; short ultrasound waves emission El for echo-imaging; the power controller PwC by reception of an echography signal (curve 3) generated by reflection of ultrasound waves emitted in the brain by the bubbling or constituents of the contrast agent A… induce opening of the haematoencephalic barrier of the brain and ultrasound transmission to the area to treat; the monitoring of the opening of the haematoencephalic barrier is considered to be an anatomical feature as understood in its broadest reasonable interpretation; Pg. 13, ln.32-Pg.14, ln. 14; can advantageously comprise at least one imaging ultrasound transducer 17 designed for echo-imaging of the brain 3… apparatus of the invention to treat a brain affection by ultrasound emission while in the same time echo-imaging the area of the brain being treated).
Regarding claim 6, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 further teaches the implantable transducer is positioned in contact with a soft tissue of the subject (Pg. 8, ln. 22-30; inserted in the skull the lower wall of the casing accommodating the treating device directly faces the brain; pg. 14, ln. 24-29; provide a continuous interface with the brain 2 or dura-matter for the propagation of ultrasound waves into the brain).
Regarding claim 7, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 further teaches the implantable transducer is positioned in contact with a dura mater of the subject (pg. 14, ln. 24-29; provide a continuous interface with the brain 2 or dura-matter for the propagation of ultrasound waves into the brain; Pg. 21, ln. 9-11; In that burr-hole an implantable generator comprising a mono element 1.05 MHz piezo composite treating device prototype was placed on the dura-matter of the rabbits brains).
Regarding claim 8, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 further teaches the housing comprises a lip (Pg. 12, ln. 7-9; peripheral tabs 12, Fig. 1) disposed at a second end of the housing (Fig. 1 shows the tabs 12 are on the opposite end of the lower wall 9), the lip configured to be mounted to an outer surface of the skull of the subject (Pg. 12, ln. 7-9; peripheral tabs 12 with hole(s) for receiving the bone screws 5 to fix the implantable generator 4 to the skull 1, Fig. 1).
Regarding claim 9, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 further teaches the implantable transducer comprises a cable (Pg. 12, ln. 27-Pg. 13, ln. 2; said therapy ultrasound transducers 13 being connected by wires 14, Fig. 1-5) configured to transmit power or data to or from the implantable transducer (Pg. 12, ln. 27-Pg.13, ln. 2; into which power supply connectors 16 of the power controller PwC can fit; Pg. 15, ln. 26-Pg. 16, ln. 3; treating device can also be connected and commanded by the power controller PwC).
Regarding claim 12, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 further teaches the micromachined ultrasonic transducer comprises a capacitive micromachined ultrasonic transducer (CMUT) (Pg. 13, ln. 3-6; chosen into the group formed by… C-MUT elements).
Regarding claim 13, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 further teaches the implantable transducer is configured to couple to one or more wires (Pg. 12, ln. 27-Pg. 13, ln. 2; said therapy ultrasound transducers 13 being connected by wires 14, Fig. 1-5), the implantable transducer configured to send and further configured to receive data via the one or more wires (Pg. 12, ln. 27-Pg.13, ln. 2; into which power supply connectors 16 of the power controller PwC can fit; Pg. 15, ln. 26-Pg. 16, ln. 3; treating device can also be connected and commanded by the power controller PwC; Pg. 15, ln. 27-Pg. 16, ln. 3; power controller PwC including a multiplexing assembly 25. In that embodiment, said multiplexing assembly then preferably comprises at least a first multiplexing calculator embedded into said power controller PwC connected by at least one communication bus 26 for digital signal transmission of the command signal to the treating device of the implantable generator 4, which includes a second multiplexing calculator 27 to receive and convert the digital signal from the power controller PwC into an analogic signal usable by said treating device to drive the ultrasound transducers).
Regarding claim 16, together Carpentier-492, Carpentier-374, and Firouzi teach system for monitoring or modulating a physiological activity of the subject (Pg. 7, ln. 24-Pg. 8, ln. 21; particularly for tumor treatment but also at a lower energy to modulate cerebral activities in the case of brain disorder pathologies), comprising:
one or more implantable transducers (Pg. 11, ln. 24-30; implantable generator 4, Figs. 1 and 5), an implantable transducer of the one or more implantable transducers corresponding to the implantable transducer of claim 1 as noted above in the rejection of claim 1;
and a controller (Pg. 11, ln. 24-29; comprises an extraneous power controller PwC to supply electricity and command signals to the implantable generator) coupled to each of the one or more implantable transducers, the controller comprising a power source (Pg. 15, ln. 23-Pg. 16, ln. 15; commanded by the power controller PwC including a multiplexing assembly 25) and a processor (Pg. 16, ln. 4-15; who sets the working parameters of the implantable generator with an external remote control 30 or computer),
wherein the power source is configured to power each of the one or more implantable transducers (Pg. 11, ln. 24-29; comprises an extraneous power controller PwC to supply electricity and command signals to the implantable generator), and
wherein the processor is configured to:
send one or more signals to the one or more implantable transducers (Pg. 15, ln. 27-Pg. 16, ln. 3; least one communication bus 26 for digital signal transmission of the command signal to the treating device of the implantable generator 4); and
receive data from the one or more implantable transducers (Pg. 13, ln. 31-Pg.14, ln. 4; being
connected to the power controller PwC to work at a different frequency from the therapy ultrasound transducers 13 and to produce echo-imaging onto a monitor implemented in or connected to the power controller PwC).
Regarding claim 17, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 further teaches the one or more implantable transducers are configured to emit ultrasound waves (Pg. 12, ln. 20-26; emitting high intensity physical waves into the brain through the lower wall 9 of the casing; Pg. 13, ln. 7-20; configured to allow HIFU (for High Intensity Focused Ultrasound) techniques for the treatment of brains affections, and for instance brain tumors), wherein the ultrasound waves are configured to modify the physiological activity of the subject (Pg. 19, ln. 1-5; It can also induce modification of electrophysiological brain activity by mechanical shear stress, sonoporation, or hyperthermia by ultrasound emission).
Regarding claim 18, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 further teaches the one or more signals are configured to specify the amplitude or the timing of one or more transducer elements of a plurality of transducer elements (Pg. 25; Such beam steering elements comprise phase difference inducing electrical components implemented in the power controller PwC and/or the treating device 11; the phase difference inducing components are integrated or associated to the therapy ultrasound transducers 13; Performing phased steering is considered to be a specified timing of the transducer elements as understood in its broadest reasonable interpretation).
Regarding claim 19, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 further teaches one implantable transducers (Pg. 26, ln. 11-28; performing at least one burr-hole (3) into the skull (1) of a patient, implanting into said at least one burr-hole an implantable generator (4) of an apparatus for treating brain affections according to any of claims 1 to 25).
Regarding claim 20, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 further teaches the implantable transducer and the controller are configured to communicate wirelessly (Pg. 16, ln. 4-15; To fulfil this design, the power controller PwC then advantageously comprises wireless programmable means 28 and is also preferably implemented onto an electronic card 29 or in the form of an integrated circuit 10 including said wireless communication means to be remotely controlled by an operator, Fig. 5).
Regarding claim 21, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 further teaches the one or more signals are configured to coordinate emission of ultrasound waves via the implantable transducer (Pg. 15, ln. 27-Pg. 16, ln. 3; convert the digital signal from the power controller PwC into an analogic signal usable by said treating device to drive the ultrasound transducers.) and further configured to coordinate receipt of the ultrasound waves (Pg. 20, ln. 5-2; which is detected at time t2 by the power controller PwC by reception of an echography signal).
Regarding claim 26, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 further teaches the system is configured to modify the physiological activity of the subject (Pg. 10, ln. 7-13; Another advantage of the method of the invention relates to the possibility of modification of electrophysiological brain activity by mechanical shear stress, through ultrasound emission for the treatment of specific brain disorders or diseases.) based on the data (Pg. 20, ln. 5-26; Then, once ultrasound emission and contrast agent A injection is terminated at a time t3, injection of chemotherapeutic drug B is commanded by the PwC (curve 4). Such monitoring and synchronisation further enhances the benefits of the combination of ultrasound waves stimulation of the area of the brain to treat and of the chemotherapeutic drugs).
Regarding claim 27, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 26 as noted above.
Carpentier-492 further teaches modifying the physiological activity of the subject based on the data occurs in real-time (Pg. 20, ln. 5-21; This detection of the echography signal then triggers automatically a continuous emission of ultrasounds during an emission period TE (curve 1) to induce opening of the haematoencephalic barrier of the brain and ultrasound transmission to the area to treat. The injection of contrast agent A is maintained during the whole ultrasound emission period TE (curve 2).).
Regarding claim 29, Carpentier-492 teaches a method for monitoring a physiological activity of a subject (Pg. 9, ln. 29-Pg. 10, ln. 13; According to the method of the invention the ultrasound waves emission and injections of contrast agent(s) and/or drug(s) can furthermore advantageously be monitored and synchronized by means of the power controller of the apparatus of the invention.), the method comprising:
sending, via a controller (Pg. 11, ln. 24-29; comprises an extraneous power controller PwC to supply electricity and command signals to the implantable generator), one or more signals to one or more implantable transducers (Pg. 15, ln. 27-Pg. 16, ln. 3; least one communication bus 26 for digital signal transmission of the command signal to the treating device of the implantable generator 4),
wherein the controller is located remotely from the one or more implantable transducers (Pg. 16, ln. 4-15; To fulfil this design, the power controller PwC then advantageously comprises wireless programmable means 28 and is also preferably implemented onto an electronic card 29 or in the form of an integrated circuit 10 including said wireless communication means to be remotely controlled by an operator, Fig. 5) and wherein the one or more implantable transducers (Pg. 11, ln. 24-30; implantable generator 4, Figs. 1 and 5) are within a unibody housing (Pg. 11, ln. 30-Pg. 12, ln. 6; implantable generator 4 is formed of a casing 7, Figs. 1 and 5), wherein the unibody housing is positioned in contact with a burr-hole in a skull of the subject (Pg. 3, ln. 9-14; implantable generator made of nonferromagnetic material for implantation into a burr hole performed in the skull of a patient, Fig. 1 and 5);
emitting, via an ultrasound array of the one or more implantable transducers (Pg. 12, ln. 27-Pg. 13, ln. 2; preferably several therapy ultrasound transducers 13, Fig. 1-5; Pg. 13, ln. 31-Pg. 14, ln. 6; imaging transducer 17, Fig. 1), ultrasound waves through a sonolucent window based on the one or more signals (Pg. 12, ln. 20-26; emitting high intensity physical waves into the brain through the lower wall 9 of the casing; Pg. 13, ln. 7-20; configured to allow HIFU (for High Intensity Focused Ultrasound) techniques for the treatment of brains affections, and for instance brain tumors), wherein the ultrasound array comprises a micromachined ultrasonic transducer (MUT), wherein the ultrasound array is within the unibody housing, the ultrasound array being bonded to the sonolucent window (Pg. 12, ln. 3-6; The cylindrical casing 7 accommodates a treating device 11 designed for emitting physical waves directly into the brain 2 through; Pg. 12, ln. 23-30; The treating device 11 located in the casing 7 comprises means for emitting high intensity physical waves into the brain; several therapy ultrasound transducers 13 applied onto the inner face of the lower wall 9 of the casing 7; Figs. 1 and 5; The ultrasound transducers 13 are encapsulated and in the lower wall of the casing as shown in Figs. 1 and 5), and the sonolucent window being permanently bonded to the unibody housing (Pg. 11, ln. 30-Pg. 12, ln. 2; Said casing 7 comprises an upper wall 8 and a lower wall 9 connected by a circular peripheral wall 1; Fig. 1 shows the lower wall is a part of the casing and is considered to be permanently bonded to the unibody housing as understood in its broadest reasonable interpretation and in view of the specification Paragraph [0173] and Fig. 3A); and
receiving data from the one or more implantable transducers (Pg. 13, ln. 31-Pg. 14, ln. 4; imaging transducer 17 being connected to the power controller PwC to work at a different frequency from the therapy ultrasound transducers 13 and to produce echo-imaging onto a monitor implemented in or connected to the power controller PwC.).
Carpentier-492 does not explicitly teach the ultrasound array is permanently bonded to the sonolucent window; and processing, via an analog front end circuit, one or more signals generated in response to ultrasound waves received by one or more transducer elements.
Carpentier-374, however, teaches an implantable transducer (Paragraph [0144]; the ultrasound generating treating device 12, Fig. 1) implantable device comprising an ultrasound array (Paragraph [0146]; e ultrasound generating transducers 20a-g, Fig. 1) and a sonolucent window (Paragraph [0273]; the holder 22 may advantageously hold at least one detection ultrasound transducer designed for echo-monitoring of the brain 3, Fig. 1); wherein the ultrasound array is permanently bonded to the sonolucent window (Paragraph [0174]; the ultrasonic transducers 20 are sealed inside the holder 22 in a watertight manner, for example by being embedded in a flexible material of the holder, or by being encapsulated between two layers of flexible material, Fig. 1and 3-6; Paragraph [0267]; They can be held by being partially embedded or encapsulated in the material forming the holder 22. They can be held on the holder 22 by gluing, by riveting, or by stitching.; The ultrasonic transducers being sealed inside the holder in a watertight manner, by being embedded the material of the holder is considered to read on the claimed limitation as understood in its broadest reasonable interpretation and in view of specification paragraphs [0173] and [0356], and Fig. 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ultrasound array of Carpentier-492 to have been permanently bonded to the sonolucent window as taught by Carpentier-374 because it would have been a known method of assembling a ultrasound generating treating device for the treatment of brain disorders which further would have had the advantage of being watertight (Carpentier-374, paragraph [0174]) thus reducing the possibility of damage to the ultrasound transducing while implanted in the skull. It further would have ensured the ultrasound transducers remain fixed in position with a target.
Together Carpentier-492 and Carpentier-374 do not explicitly teach processing, via an analog front end circuit, one or more signals generated in response to ultrasound waves received by one or more transducer elements.
Firouzi, however, teaches an implantable transducer (Paragraph [0119]; systems and methods provide for a novel wearable or implantable intracranial pressure (ICP) monitoring unit… the measurement is conducted by pulsing an acoustic transducer, Fig. 1) comprising:
a unibody housing (Paragraph [0127]-[0128]; the devices described herein include ultrasonic transducers, either standalone; Fig. 1);
an ultrasound array (Paragraph [0151] and [0153]; implantable transducer over the head; an array of ultrasonic transducers at high), wherein the ultrasound array comprises a micromachined ultrasonic transducer (MUT) (Paragraph [0139]; Transducers can be of a variety of types such as Piezoelectric, CMUT (Capacitive Micromachined Ultrasonic Transducer)… Piezoelectric Micromachined Ultrasonic Transducer (PMUT), etc.); and
processing, via an analog front end circuit (Paragraph [0140]-[0141]; Thus, viable devices can be realized and even integrated directly on electronic circuits; FIGS. 3A-3D shows illustrations 300, 310, 320, and 330 of a CMUT cell; Fig. 3 show front end analog circuits as understood in its broadest reasonable interpretation), one or more signals generated in response to ultrasound waves received by one or more transducer elements (Paragraph [0003]; In some embodiments, sensors such as ultrasonic transducers, either standalone or in pairs, are utilized to send and receive acoustic waves into/from the brain; Paragraph [0138]; intracranial pressure is determined from the acquired data, e.g., as shown in FIG. 10. For example, determining the intracranial pressure may include assessing changes in amplitude, bandwidth, and/or frequency of the standing waves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Carpentier-492 in view of Carpentier-374 to have included processing, via an analog front end circuit, one or more signals generated in response to ultrasound waves received by one or more transducer elements as taught by Firouzi because it would have allowed for real-time monitoring and diagnosis of epileptic conditions and other abnormal brain functions (Paragraphs [0116] and [0120]).
Regarding claim 30, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 29 as noted above.
Carpentier-492 further teaches the ultrasound waves are configured to modify the physiological activity of the subject (Pg. 10, ln. 7-13; Another advantage of the method of the invention relates to the possibility of modification of electrophysiological brain activity by mechanical shear stress, through ultrasound emission for the treatment of specific brain disorders or diseases.).
Claims 10 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claims 1 and 16 above, and further in view of Christopher (US 20230020551).
Regarding claim 10, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach sonolucent window comprises a biocompatible polymer, wherein the biocompatible polymer is polymethyl methacrylate (PMMA), or Poly(ether) ether ketone (PEEK), polychlorotrifluoroethylene (PCTFE), polytetrafluoroethylene (PTFE), ultra-high-molecular- weight polyethylene (UHMWPE), polyethylene terephthalate (PET), low density polyethylene (LDPE), polyether block amide (PEBAX), and/or high-density polyethylene (HDPE).
Christopher, however, teaches the sonolucent window comprises a biocompatible polymer, wherein the biocompatible polymer is polymethyl methacrylate (PMMA) (Paragraph [0080]; implant preferably manufactured from clear sonolucent poly (methyl methacrylate) (PMMA)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sonolucent window of Carpentier-492 in view of Carpentier-374 and Firouzi to have comprised a biocompatible polymer, wherein the biocompatible polymer is polymethyl methacrylate (PMMA) as taught by Christopher because it would have been a known material for making a sonolucent window that is safe for use in a cranial implant (Christopher, Paragraph [0080]) that would have further allowed additional optical transparency for delivery of laser light for imaging and treatment of brain tissue (Paragraph [0085]).
Regarding claim 28, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 further does not explicitly teach the physiological activity of the subject comprises neural activity.
Christopher, however, teaches the physiological activity of the subject comprises neural activity (Paragraph [0102]; ultrasound transducer, that may be used, but are not limited to the following, include: Deep Brain Stimulators (DBS)… including neuromodulation devices; Paragraph [0227]; Paragraph [0078]; craniofacial implants to enhance the diagnosis and treatment of neurological disorders; Paragraph [0227]; HIFU precisely delivers focused ultrasound waves to tissue in a manner for altering the tissue… neuromodulation procedures are known to use ultrasound transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Carpentier-492 in view of Carpentier-374 and Firouzi such that the physiological activity of the subject comprises neural activity as taught by Christopher because it would have allowed monitoring and further treating of neurological disorders such as seizures (Paragraph [0102]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claim 1 above, and further in view of Kiani (US 20210346726).
Regarding claim 11, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach the ultrasound array is fabricated on a complementary metal-oxide semiconductor (CMOS) application specific integrated circuit (ASIC).
Kiani, however, teaches an implantable transducer (Paragraph [0067]; ultrasonic transducer is implanted) comprising an ultrasound array (Paragraph [0066]; beamforming with a 2D transducer array) fabricated on a complementary metal-oxide semiconductor (CMOS) (Paragraph [0130]; multi-functional chip, which may be designed in a high-voltage CMOS process) application specific integrated circuit (ASIC) (Paragraph [0065]; A piezoelectric material is integrated as a 2D array 120 onto an application-specific integrated circuit (ASIC) 540, Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified ultrasound array of Carpentier-492 in view of Carpentier-374 and Firouzi to have been fabricated on a complementary metal-oxide semiconductor (CMOS) application specific integrated circuit (ASIC) as taught by Kiani because it would have been well understood method of manufacturing the transducer that would have allowed more easily integrating the electronics and the US transducer (Kiani, Paragraphs [0064] and [0067]), and further allowed integrating a power management circuitry to provide enough voltage and power levels required in µUS (Kiani, Paragraph [0130]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claim 1 above, and further in view of Alford (US 20190269942).
Regarding claim 14, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach the ultrasound array comprises a plurality of transducer elements, wherein the plurality of transducer elements comprises 100-199, 200-399, 400-999, 1,000-1,499, 1,500-9,999, 10,000- 11,999, 12,000-99,000, or 100,000-120,000 transducer elements.
Alford, however, teaches an ultrasound array (Paragraph [0026]; wearable ultrasound device 30, Fig. 1) comprising a plurality of transducer elements (Paragraph [0026]; plurality of ultrasound transducers), wherein the plurality of transducer elements comprises 100-199, 200-399, 400-999, 1,000-1,499, 1,500-9,999, 10,000-11,999, 12,000-99,000, or 100,000-120,000 transducer elements (Paragraph [0026]; set of ultrasound transducers may include tens, hundreds, or even thousands of ultrasound transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ultrasound array of Carpentier-492 in view of Carpentier-374 and Firouzi to have comprised a plurality of transducer elements, wherein the plurality of transducer elements comprises 100-199, 200-399, 400-999, 1,000-1,499, 1,500-9,999, 10,000-11,999, 12,000-99,000, or 100,000-120,000 transducer elements as taught by Alford because it each may be configured to deliver ultrasound energy 32 defined by different sets of parameters, for different purposes, or the like (e.g., each set of ultrasound transducers is configured a particular way to deliver a particular ultrasound energy 32). In other examples, the one or more sets may be configured to deliver ultrasound energy 32 defined by multiple sets of parameters, for different purposes, or the like (e.g., one or more of the sets of ultrasound transducers can deliver a wider range of ultrasound energy 32) (Alford, Paragraph [0041]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374, Firouzi, and Alford as applied to claim 14 above, and further in view of Bhuyan (US 20190076130).
Regarding claim 15, together Carpentier-492, Carpentier-374, Firouzi, and Alford teach all of the limitations of claim 14 as noted above.
Carpentier-492 does not explicitly teach the ultrasound array comprises an n x m matrix, wherein n is in a range of 16-256 transducer elements and m is in a range of 1-256 transducer elements.
Bhuyan, however, teaches an ultrasound array (Paragraph [0027]; transducer array 102, Fig. 2) comprises an n x m matrix, wherein n is in a range of 16-256 transducer elements and m is in a range of 1-256 transducer elements (Paragraph [0027]; enable large array sizes (e.g., 32×32 or larger); Claim 25; 32 transducer elements in a first dimension by 32 transducer elements in a second dimension).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the ultrasound array of Carpentier-492 in view of Carpentier-374, Firouzi, and Alford to be the ultrasound comprising an n x m matrix, wherein n is in a range of 16-256 transducer elements and m is in a range of 1-256 transducer elements because it would have been a predictable substitution of conventional ultrasound transducer components for performing imaging and therapy, and further allowing advanced beam forming for adjusting the focus to be any selected location within the field of view (Bhuyan, Paragraph [0036]).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claim 16 above, and further in view of Berger (US 20160338676).
Regarding claim 22, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 does not explicitly teach the controller comprises a clock, and wherein the one or more signals are sent based on predetermined intervals associated with the clock.
Berger, however, teaches an ultrasound system (Abstract, Paragraph [0007]; ultrasonic imaging system) wherein the controller comprises a clock (Paragraph [0111]; system controller 218 maintains proper clocking… it generates clocks and control signals; Fig. 3A), and wherein the one or more signals are sent based on predetermined intervals associated with the clock (Paragraph [0111]; generates clocks and control signals for the various operating modules of the system so that they know when the data output is for them).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the controller of Carpentier-492 in view of Carpentier-374 and Firouzi to have comprised a clock, and wherein the one or more signals are sent based on predetermined intervals associated with the clock as taught by Berger because it would have allowed properly operating various modules of a system by outputting data at specific times for each component (Berger, Paragraph [0111]).
Regarding claim 23, together Carpentier-492, Carpentier-374, Firouzi, and Berger teach all of the limitations of claim 22 as noted above.
Carpentier-492 does not explicitly teach the controller comprises a central clock and the one or more implantable transducers each comprise the clock, and wherein the signals correspond to reset signals associated with the central clock.
Berger further teaches controller comprises a central clock (Paragraph [0111]; system controller 218 maintains proper clocking… it generates clocks and control signals; Fig. 3A) and the one or more implantable transducers each comprise the clock (Paragraph [0105]; Fig. A shows, each beamformer for each transducer comprises its own clock 623), and wherein the signals correspond to reset signals associated with the central clock (Paragraph [0178]; pulse of NEWRUNCLOCK at clock 1 lets the modules know that the next clock will be the first in a run. They thus reset their internal run-related state if necessary).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Carpentier-492 in view of Carpentier-374, Firouzi, and Berger such that the controller comprises a central clock and the one or more implantable transducers each comprise the clock and wherein the signals correspond to reset signals associated with the central clock as taught by Berger because it would have ensured the data is transmitted and received at the correct timings to properly beamform the signals and thereby improve scanning and imaging with the ultrasound beam (Berger, Paragraph [0110]).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claims 24, 16, and 29 above, and further in view of Eisaman (US 20220379142).
Regarding claim 24, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 16 as noted above.
Carpentier-492 does not explicitly teach the subject engages in a clinically relevant behavior while the implantable transducer obtains the data.
Eisaman, however, teaches a system for monitoring or modulating a physiological activity of the subject using ultrasound transducers (Paragraphs [0004]-[0008]; structural brain imaging using super-resolution ultrasound computed tomography… perform transcranial stimulation of large-scale brain networks in real-time) wherein the subject engages in a clinically relevant behavior while the implantable transducer obtains data (Paragraph [0190]; Sensing system 114 can measure other responses, such as heart rate, blood pressure, and pupil dilation, among other parameters, of subject).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Carpentier-492 in view of Carpentier-374 and Firouzi to monitor or modulate a physiological activity of the subject using ultrasound transducers because it would allow analyzing the subject's physical and neurological response to stimulation, and to determine future stimulation parameters, among other processes to quantify the effectiveness of a particular set of stimulation parameters and further use additional biomarker inputs to determine the stimulation parameters or classify feedback (Eisaman, Paragraph [0007]) thereby improving the ability to treat neurological and psychiatric disorders as well as treating the physical symptoms of various disorders, diseases, and conditions (Eisaman, Paragraph [0021]).
Regarding claim 25, together Carpentier-492, Carpentier-374, and Firouzi, in view of Eisaman teach all of the limitations of claim 24 as noted above.
Carpentier-492 does not explicitly teach the clinically relevant behavior comprises activities of daily living, estimates of movement, motion capture, facial expression and response time, self-reported mood, self-reported cognitive state, heart rate, heart rate variability, breathing rate, oxygenation, galvanic skin response, inertial monitoring, or a combination thereof.
Eisaman, however, teaches a system for monitoring or modulating a physiological activity of the subject using ultrasound transducers (Paragraphs [0004]-[0008]; structural brain imaging using super-resolution ultrasound computed tomography… perform transcranial stimulation of large-scale brain networks in real-time) wherein the subject engages in a clinically relevant behavior while the implantable transducer obtains data (Paragraph [0190]; Sensing system 114 can measure other responses, such as heart rate, blood pressure, and pupil dilation, among other parameters, of subject);
wherein the clinically relevant behavior comprises activities of daily living (Paragraph [0185]; aid in relaxation, improve focus during travel), facial expression (Paragraph [0086]; use techniques such as facial recognition; Paragraph [0136]; eye movement data), self-reported cognitive state (Paragraph [0136]-[0137]; detect cognitive load parameters), heart rate (Paragraph [0190]; heart rate; correlate physiological signals with a subject's brain state), breathing rate (Paragraph [0084]; respiratory rate), or a combination thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Carpentier-492 in view of Carpentier-374 and Firouzi such that the clinically relevant behavior comprises activities of daily living, facial expression, self-reported cognitive state, heart rate, breathing rate, or a combination thereof as taught by Eisaman because it would allow analyzing the subject's physical and neurological response to stimulation, and to determine future stimulation parameters, among other processes to quantify the effectiveness of a particular set of stimulation parameters and further use additional biomarker inputs to determine the stimulation parameters or classify feedback (Eisaman, Paragraph [0007]) thereby improving the ability to treat neurological and psychiatric disorders as well as treating the physical symptoms of various disorders, diseases, and conditions (Eisaman, Paragraph [0021]).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claim 1 above, and further in view of Whitehead (US 20190290911 A1).
Regarding claim 31, together Carpentier-492, Carpentier-374, and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach the permanent bonding of the sonolucent window to the unibody housing or the ultrasound array to the sonolucent window comprises at least one of: laser welding, electron beam welding, TIG welding, thermal welding, and epoxy sealing.
Whitehead, however, teaches an implantable device (Paragraph [0050]; The coil(s) may be incorporated internal and/or external relative to the housing the IMB, e.g., internally and/or externally located relative to a hermetically sealed device housing; may be applicable to other types of IMDs, such as, IMDs configured to deliver spinal cord stimulation, peripheral nerve stimulation, or other types of neurostimulation) wherein permanent bonding of the sonolucent window to the unibody housing or the ultrasound array to the sonolucent window comprises at least one of: laser welding, electron beam welding, TIG welding, thermal welding, and epoxy sealing (Paragraph [0221]; In other examples, connectors 648 be electrically coupled (e.g., laser welded) to other discrete components at openings 604, such that the other components are electrically coupled (e.g., soldered) to the circuit board. For example, connectors 648 may be laser welded at openings 604 to pins that extend in to electrically couple to internal components as described and depicted herein.; Paragraph [0222]; funneling section 618 may be formed of a polymeric material such as epoxy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the permanent bonding of the sonolucent window to the unibody housing or the ultrasound array to the sonolucent window of Carpentier-492 in view of Carpentier-374 and Firouzi to have comprised at least one of: laser welding and epoxy sealing because it would have been known methods of sealing a implantable device that further would have allowed hermetically sealing the device (Paragraph [0064]).
Claims 32, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claim 1 above, and further in view of Moon (US 20170108926 A1).
Regarding claim 32, together Carpentier-492 in view of Carpentier-374 and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach the implantable transducer is configured to extend to 2-45 mm on a surface of the skull.
Moon, however, teaches an implantable transducer (Paragraph [0012]; a biocompatible container housing an ultrasonic wireless power module, said power module comprises a piezoelectric composite transducer) configured to extend to 2-45 mm on a surface of the skull (Paragraph [0014] and [0107]; biocompatible container is a circular disc having a diameter ranging from 25-100 mm, and a height ranging from 8-30 mm; Paragraph [0111]; The electrode as well as the data acquisition electronics are implanted through a small burr hole in the skull and secured to the skull as shown in FIG. 3(c)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the implantable transducer of Carpentier-492 in view of Carpentier-374 and Firouzi to extend to 2-45 mm on a surface of the skull as taught by Moon because it would have been a known method of implementing brain monitoring devices which allows better quality of life for patients due to the small form-factor while ensuring structural soundness, ease of battery charging for the implant, charging efficiency (Paragraphs [0150]-[0152]).
Regarding claim 33, together Carpentier-492 in view of Carpentier-374 and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach the implantable transducer comprises a 15-35 mm diameter.
Moon, however, teaches an implantable transducer (Paragraph [0012]; a biocompatible container housing an ultrasonic wireless power module, said power module comprises a piezoelectric composite transducer) comprising a 15-35 mm diameter (Paragraph [0107]; the BBMI device has a diameter ranging from 25-100 mm… or a diameter less than or equal to 35 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the implantable transducer of Carpentier-492 in view of Carpentier-374 and Firouzi to comprise a 15-35 mm diameter as taught by Moon because it would have been a known method of implementing brain monitoring devices which allows better quality of life for patients due to the small form-factor while ensuring structural soundness, ease of battery charging for the implant, charging efficiency (Paragraphs [0150]-[0152]).
Regarding claim 35, together Carpentier-492 in view of Carpentier-374 and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach the a steady-state thermal budget of the implantable transducer is less than or equal to 350 mW.
Moon, however, teaches an implantable transducer (Paragraph [0012]; a biocompatible container housing an ultrasonic wireless power module, said power module comprises a piezoelectric composite transducer) wherein the a steady-state thermal budget of the implantable transducer is less than or equal to 350 mW (Pg. 8, Table 1; ENERGY BUDGET FOR IMPLANTABLE BBMI… Total power 3.4 mW 10.62 mW consumption; Paragraph [0138]; the mean power usage in broadcasting mode is approximately 78.25 mW. The power consumption during data transmission is measured about 74.05 mW.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Carpentier-492 in view of Carpentier-374 and Firouzi such that a steady-state thermal budget of the implantable transducer is less than or equal to 350 mW as taught by Moon because it would provide extend usage of working time without recharging the battery (Paragraph [0139]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier-492 in view of Carpentier-374 and Firouzi as applied to claim 1 above, and further in view of Wetmore (US 20160008632 A1).
Regarding claim 34, together Carpentier-492 in view of Carpentier-374 and Firouzi teach all of the limitations of claim 1 as noted above.
Carpentier-492 does not explicitly teach the implantable transducer is configured to heat a tissue of the subject tissue by less than 2 degrees.
Wetmore, however, teaches a transducer is configured tissue of the subject tissue by less than 2 degrees (Paragraph [0009]; appropriate pulsing and other waveform characteristics to ensure that heating of a targeted brain region does not exceed about 2 degrees Celsius for more than about 5 seconds).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Carpentier-492 in view of Carpentier-374 and Firouzi such that the implantable transducer is configured to heat a tissue of the subject tissue by less than 2 degrees because it would allow neuromodulation using appropriate ultrasound waveform parameters while being nondestructive and reduce risk of damage to the patient (Paragraph [0009]).
Response to Arguments
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Applicant's arguments regarding claims 3 and 4 have been fully considered but they are not persuasive. The method of Carpentier-492 in pg. 20, ln.5-20 describes monitoring using echo-imaging the brain during a treatment and further produce echo-imaging onto a monitor. This is further described in Carpentier-492, for example in at least Pg. 13, ln.32-Pg.14, ln. 14, which describes the transducer comprising at least one imaging ultrasound transducer designed for echo-imaging of the brain and producing echo-imaging onto a monitor and treating a brain affection by ultrasound emission while in the same time echo-imaging the area of the brain being treated. These echo-imaging obtained during the brain during the treatment operation is considered to read on the claimed limitation of data comprising imaging data indicative of anatomical features of the subject as understood in its broadest reasonable interpretation. For these reasons, rejection of claims 3 and 4 is maintained.
Examiner would further like to point out the newly cited reference of Firouzi further teaches monitoring brain function using received acoustic data, as described in at least paragraph [0160].
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 Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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, Anh Tuan Nguyen can be reached at (571)272-4963. 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.
/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/16/26
Prosecution Insights