DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/28/2025 has been entered.
Response to Amendment
The amendment of 02/13/2026 has been entered and fully considered by the examiner. Claims 1, 5, 6, 8-11, 13, 17-19, and 24-28 are amended. Claims 1-30 are currently pending in the application with claims 1, 13, 19, and 25 being independent.
Claim Objections
Claim 5 is objected to because of the following informalities:
Amended claim 5 recites: “The ultrasound stimulation device of claim 1, wherein the microelectrode array includes electrical stimulating electrodes and recording electrodes. The ultrasound stimulation device of claim 1, wherein the microelectrode array includes both electrical stimulating electrodes and recording electrodes. electrodes to simultaneously record and stimulate neural activity. Since the preamble of the claim has been repeated twice, one instance should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-24 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding independent claims 1, 13, and 19, claims recite: “multiple probes implantable into a brain of a subject”, “micro-ultrasound transducers are implanted into the brain”, and “microelectrode array is implanted into the brain with the implantation of the platform into the brain”. The above cited limitations appear to be claiming the brain as part of the device. As a result, the claims are considered to be directed towards or encompassing a human organism.
Claims 2-12, 14-18 and 20-24 depend upon claims 1, 13, and 19 which are directed towards patentable subject matter and therefore are considered to be directed towards unpatentable subject matter as well due to their dependency.
Claim Rejections - 35 USC § 112
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 1-24 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.
The term “capable of reaching deep structures” in claims 1, 13, and 19 is a relative term which renders the claim indefinite. The term “deep” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular, it is not clear what length is considered to be “deep” and as a result which structures of the brain would be considered “deep structures”. The specification does not provide a range of depth that would be considered “deep” and the claim does not define the required depth. As a result, the claims are considered to be indefinite as the metes and bounds of the claims are not clear. for the purposes of examination, the broadest reasonable interpretation of the term has been used.
Claims 2-12, 14-18 and 20-24 are considered to be indefinite as well due to their dependency upon indefinite base claims.
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.
Claims 1-8, 10-16, and 18-24 are rejected under 35 U.S.C. 103 as being obvious over Chen et al. (“a Capacitive micromachined ultrasonic transducer array for minimally invasive medical diagnosis”, IEEE, 2008) hereinafter “Chen” ” in view of Maharbiz et al. (U.S. Publication No. 2019/0150884) hereinafter “Maharbiz.
Regarding claim 1, Chen discloses an ultrasound stimulation device [see abstract of Chen disclosing the device is used for stimulation using high frequency ultrasounds] comprising:
control circuitry; and [see FIG. 1, and 5c showing the CMOS control circuit and page 608, left column, section under A. preliminary flow measurement disclosing front end circuitry]
probe [the elongated probe; see FIG. 1] couplable to the control circuitry, [see FIG. 1; the probe is attached to the circuitry] the probe implantable into a brain of a subject [see page 600, left column, last paragraph disclosing that the device is smaller than human hair and is implantable into tissue or fine vessels; page 607, left column also discloses its use in brain function studies] , each probe including:
a platform compatible with implantation into the brain: [the elongated platform on the device of FIG. 1; caption discloses that the device is implantable into the tissue or organ; page 607, left side, paragraph before last discloses the use of such techniques in detecting function state of the brain] the platform having a length capable of reaching deep structures within the brain [see section IX. “conclusion” disclosing that the transducer is capable of reaching deep inside the tissue to stimulate]
an array of micro-ultrasound transducers on the platform, [see FIG. 1 and page 605, left column, section under VI. Device characteristics] the micro-ultrasound transducers arranged on the platform such that the micro-ultrasound transducers are implanted into the brain with implantation of the platform into the brain, [since the ultrasound array is located on the probe, they would inherently be implanted into the brain when the probe is implanted] the micro- ultrasound transducers configured to generate ultrasound stimulation to the brain to stimulate one or more neurons in the brain [see page 600, left column, last 10 lines of the page discloses using the array for stimulation of the organ; page 607, left side, paragraph before last discloses the use of such device in the brain]; and
a microelectrode array integrated with the array of micro-ultrasound transducers on the platform of the probe [see FIG. 1 and caption discloses a 1D array of Iridium electrodes on the probe] such that the microelectrode array is implanted into the brain with implantation of the platform into the brain. [since the microelectrode array is located on the probe, they would are implanted into the brain when the probe is implanted],
Chen does not disclose that there are multiple probes and the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz.
Maharbiz, directed towards PMUT sensors for brain stimulation and recording [see abstract od Maharbiz] further discloses wherein the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz. [see [0114] of Maharbiz]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Chen further such that the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz according to the teachings of Maharbiz since higher frequencies allow for a smaller transducer [see [0014] of Maharbiz]
Chen in view of Maharbiz does not disclose that the device includes a plurality of probes. However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to duplicate the probe and make multiple probe implantable into the brain sine it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V. Bemis Co, 193, USPQ 8.
Regarding claim 2, Chen further discloses that the array of micro- ultrasound transducers includes capacitive micro-ultrasound transducers or piezoelectric micro- ultrasound transducers. [see abstract of Chen disclosing capacitive micro-machined ultrasound transducers].
Regarding claim 3, Chen further discloses that the micro-ultrasound transducers of the array of micro-ultrasound transducers are piezoelectric micro-ultrasound transducers [see page 606, right column, section under “VII. Imaging characteristic”.]
Regarding claim 4, Chen discloses all the limitations of claim 3 [see rejection of claim 3 above]
Chen does not expressly disclose that piezoelectric material of the piezoelectric micro-ultrasound transducers includes one or more of aluminum nitride, zinc oxide, lead zirconate titanate, polyvinylidene fluoride, or lead magnesium niobate-lead titanate.
Maharbiz, directed towards PMUT sensors for brain stimulation and recording [see abstract od Maharbiz] further discloses that piezoelectric material of the piezoelectric micro-ultrasound transducers includes one or more of aluminum nitride, zinc oxide, lead zirconate titanate, polyvinylidene fluoride, or lead magnesium niobate-lead titanate. [see [0141] of Maharbiz disclosing that PMUTs could be made of Zinc Oxide (ZO), Aluminum nitride (AlN), etc.]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Chen such that the piezoelectric material of the piezoelectric micro-ultrasound transducers includes one or more of aluminum nitride, zinc oxide, lead zirconate titanate, polyvinylidene fluoride, or lead magnesium niobate-lead titanate according to the teachings of Maharbiz since doing so would have been substituting one material for fabricating micro-ultrasound transducers with another and would have been obvious to try by an ordinary skilled in the art. (KSR Rationale B)
Regarding claim 5, Chen further discloses that the microelectrode array includes both electrical stimulating electrodes and recording electrodes to simultaneously record and stimulate neural activity [see FIG. 1 and caption disclosing that the array of electrodes is used for electrical stimulation or recording; see page 600, right column, section under II. Ultrasonic transducer design discloses that the device is capable of performing electoral and ultrasound stimulation and recording; it is inherent the such stimulation and recording should be done simultaneously in order to record the naturally fast responses of the brain neurons]
Regarding claim 6, Chen discloses all the limitations of claim 5 [see rejection of claim 5 above]
Maharbiz further discloses that the recording electrodes include electrically conducting polymers. [see [0175] of Maharbiz discloses using conductive polymers such as PDMS or polyimide to make the electrodes]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Chen such that the recording electrodes include conductive polymers according to the teachings of Maharbiz since doing so would have been substituting one material for fabricating the electrodes with another and would have been obvious to try by an ordinary skilled in the art. (KSR Rationale B)
Regarding claim 7, Chen further discloses that the array of micro- ultrasound transducers includes a silicon substrate. [see page 600, right column, first paragraph and caption of FIG. 1]
Regarding claim 8, Chen further discloses that the probe are silicon-based probes. [see FIG. 1 and Caption and page 600, right column, first paragraph disclosing at least the substrate is silicon so the probes are silicon based]
Chen in view of Maharbiz does not disclose that the device includes a plurality of probes. However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to duplicate the probe and make multiple probe implantable into the brain sine it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V. Bemis Co, 193, USPQ 8.
Regarding claim 10, Chen further discloses wherein an end of each probe of the probe in tapered, the end being distal from an end of the probe couplable to the control circuitry. [see FIG. 1 of Chen]
Chen in view of Maharbiz does not disclose that the device includes a plurality of probes. However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to duplicate the probe and make multiple probe implantable into the brain sine it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V. Bemis Co, 193, USPQ 8
Regarding claim 11, Chen in view of Maharbiz discloses all the limitations of claim 1 [see rejection of claim 1]
Maharbiz further discloses that the array of micro- ultrasound transducers and the control circuitry are operable to focus sound by beamforming. [see [0361]-[0362] of Maharbiz]
it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Chen as modified by Maharbiz further such that it includes beamforming in order to achieving sufficient interference suppression from nearby implantable devices [see [0362] of Maharbiz]
Regarding claim 12, Chen as modified by Maharbiz discloses all the limitations of claim 10 [see rejection of claim 10 above]
Maharbiz further discloses that the control circuitry is disposed on a platform attachable to an exterior of the subject. [see FIG. 3D and [0105] of Maharbiz disclosing that the interrogator circuitry (i.e. part of the control circuitry) could be attached to the subject with harness 314]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Chen as modified by Maharbiz such that the control circuitry is disposed on a platform attachable to an exterior of the subject according to the teachings of Maharbiz in order to allow access to the control circuitry by placing them outside the subject.
Regarding claim 13, Chen discloses a therapeutic method [see abstract of Chen disclosing the device is used for stimulation using high frequency ultrasounds] comprising:
Applying an ultrasound stimulation device to a subject with probe of the ultrasound stimulation device implanted, the ultrasound stimulation device including:
control circuitry; and [see FIG. 1, and 5c showing the CMOS control circuit and page 608, left column, section under A. preliminary flow measurement disclosing front end circuitry]
probe [the elongated probe; see FIG. 1] couplable to the control circuitry, [see FIG. 1; the probe is attached to the circuitry] the probe implantable into a brain of a subject, each probe including:
a platform compatible with implantation into the brain: [the elongated platform on the device of FIG. 1; caption discloses that the device is implantable into the tissue or organ; page 607, left side, paragraph before last discloses the use of such techniques in detecting function state of the brain]
an array of micro-ultrasound transducers on the platform, [see FIG. 1 and page 605, left column, section under VI. Device characteristics] the micro-ultrasound transducers arranged on the platform such that the micro-ultrasound transducers are implanted into the brain with the implantation of the probe into the brain, [since the ultrasound array is located on the probe, they would inherently be implanted into the brain when the probe is implanted] the micro- ultrasound transducers configured to generate ultrasound stimulation to the brain [see page 600, left column, last 10 lines of the page discloses using the array for stimulation of the organ; page 607, left side, paragraph before last discloses the use of such device in the brain]; and
a microelectrode array integrated with the array of micro-ultrasound transducers on the platform of the probe [see FIG. 1 and caption discloses a 1D array of Iridium electrodes on the probe] such that the microelectrode array is implanted into the brain with the implantation of the probe into the brain. [since the microelectrode array is located on the probe, they would inherently be implanted into the brain when the probe is implanted]
activating one or more micro-ultrasound transducers of the array of micro-ultrasound transducers on a probe of the one or more probes implanted into the subject, and [see FIG. 1 and its caption disclosing using the device for stimulation and activation of tissue or organ]
Chen does not disclose that there are multiple probes and the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz.
Maharbiz, directed towards PMUT sensors for brain stimulation and recording [see abstract od Maharbiz] further discloses wherein the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz. [see [0114] of Maharbiz] and that the tissue being stimulated and recorded in a brain of a subject [see [0122] of Maharbiz disclosing implantable device could be placed in close proximity of the central nervous system such as brain].
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Chen further such that the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz according to the teachings of Maharbiz since higher frequencies allow for a smaller transducer [see [0014] of Maharbiz] It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the method of Chen such the tissue being stimulated and recorded is the brain of the subject according to the teachings of Maharbiz in order to allow for modulation of the activity of the brain and consider its response.
Chen in view of Maharbiz does not disclose that the device includes a plurality of probes. However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to duplicate the probe and make multiple probe implantable into the brain sine it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V. Bemis Co, 193, USPQ 8.
Regarding claim 14, Chen as modified by Maharbiz discloses all the limitations of claim 13 above. [see rejection of claim 13]
Maharbiz further discloses that the therapeutic method includes making neural recordings of signals received by the array of micro-ultrasound transducers in response to the activating of the one or more micro-ultrasound transducers. [see [0059], [0061]-[0062] and FIG. 32A of Maharbiz]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the probe of Chen as modified by Maharbiz such that the therapeutic method includes making neural recordings of signals received by the array of micro-ultrasound transducers in response to the activating of the one or more micro-ultrasound transducers according to the teachings of Maharbiz in order to study the functioning of the neurons in the brain of the subject [see abstract of Maharbiz]
Regarding claim 15, Chen as modified by Maharbiz discloses all the limitations of claim 14 above. [see rejection of claim 14]
Maharbiz further discloses that the therapeutic method includes monitoring neural activity of the subject from the neural recordings. [see [0061]-[0066] of Maharbiz and FIGs. 32-57 disclosing various monitoring and recordings of the neural activity using the method; see also [0381]]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the probe of Chen as modified by Maharbiz such that the therapeutic method includes monitoring neural activity of the subject from the neural recordings according to the teachings of Maharbiz in order to study the functioning of the neurons in the brain of the subject [see abstract of Maharbiz]
Regarding claim 16, Chen as modified by Maharbiz discloses all the limitations of calim 15 above. [see rejection of claim 15]
Maharbiz further discloses that the therapeutic method includes adjusting or re-activating the one or more micro-ultrasound transducers in response to the monitoring of the neural activity. [see [0079] reciting: “the body implantable device may further be configured to record and report sensed biologic conditions to provide feedback to adjust stimulation parameters.”]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the probe of Chen as modified by Maharbiz such that the therapeutic method includes adjusting or re-activating the one or more micro-ultrasound transducers in response to the monitoring of the neural activity according to the teachings of Maharbiz in order to study the functioning of the neurons in the brain of the subject [see abstract of Maharbiz]
Regarding claim 18, Chen as modified by Maharbiz discloses all the limitations of claim 15 above. [see rejection of claim 15]
Maharbiz further discloses that the array of micro- ultrasound transducers and the control circuitry are operable to focus sound by beamforming. [see [0361]-[0362] of Maharbiz]
it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Chen as modified by Maharbiz further such that it includes beamforming in order to achieving sufficient interference suppression from nearby implantable devices [see [0362] of Maharbiz]
Regarding claim 19, Chen discloses a method of forming an ultrasound stimulation device [see abstract of Chen disclosing the device is used for stimulation using high frequency ultrasounds], the method comprising:
Forming a structure having control circuitry [see FIG. 1, and 5c showing the CMOS control circuit and page 608, left column, section under A. preliminary flow measurement disclosing front end circuitry]
Forming probe [the elongated probe; see FIG. 1] couplable to the structure [see FIG. 1; the probe is attached to the circuitry] having control circuitry, including forming each probe by:
Providing a platform for the probe, the platform being implantable into a brain of a subject, [the elongated platform on the device of FIG. 1; caption discloses that the device is implantable into the tissue or organ; page 607, left side, paragraph before last discloses the use of such techniques in detecting function state of the brain] and being structured to extend from the structure having control circuitry into the brain; [see FIG. 1]
Forming a microelectrode array on the platform [see FIG. 1 and caption discloses a 1D array of Iridium electrodes on the probe] such that the microelectrode array is implanted into the brain with the implantation of the platform into the brain. [since the microelectrode array is located on the probe, they would inherently be implanted into the brain when the probe is implanted]
Integrating an array of micro-ultrasound transducers [see FIG. 1 and page 605, left column, section under VI. Device characteristics] with the microelectrode array on the platform [see FIG. 1], with the micro-ultrasound transducers arranged on the platform such that the micro-ultrasound transducers are implanted into the brain with implantation of the platform into the brain, [since the ultrasound array is located on the probe, they would inherently be implanted into the brain when the probe is implanted] including configuring the micro- ultrasound transducers to stimulate one or more neurons of the brain [see page 600, left column, last 10 lines of the page discloses using the array for stimulation of the organ; page 607, left side, paragraph before last discloses the use of such device in the brain];
Chen does not disclose that there are multiple probes and the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz.
Maharbiz, directed towards PMUT sensors for brain stimulation and recording [see abstract od Maharbiz] further discloses wherein the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz. [see [0114] of Maharbiz]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Chen further such that the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz according to the teachings of Maharbiz since higher frequencies allow for a smaller transducer [see [0014] of Maharbiz]
Chen in view of Maharbiz does not disclose that the device includes a plurality of probes. However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to duplicate the probe and make multiple probe implantable into the brain sine it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V. Bemis Co, 193, USPQ 8.
Regarding claim 20, Chen further discloses that integrating the array of micro-ultrasound transducers include integrating micro-ultrasound transducers having membranes that displace in response to an applied electrical bias. [see page 600, right column, section under “II. Ultrasonic transducer design” disclosing that the CMUT structures of FIG. 1 include suspended membrane, continued in page 601, left column disclosing the displacement of the membrane as the voltage is applied]
Regarding claim 21, Chen further discloses that each membrane is arranged as component of a capacitor of the micro-ultrasound transducer in which the membrane is disposed. [see page 599, right column, last paragraph, last 10 lines disclosing that the membranes deformation results in the changes in capacitance of the transducer]
Regarding claim 22, Chen discloses all the limitations of claim 20 [see rejection of claim 20 above]
Chen does not discloses forming a piezoelectric film on each membrane.
Maharbiz further discloses forming a piezoelectric film on each membrane. [see [0076] of Maharbiz disclosing that the micro machined ultrasound transducers are piezo ultrasound transducers]]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the teachings of Chen such that it includes forming a piezoelectric film on each membrane according to the teachings of Maharbiz since doing so would have been substituting one material for fabricating micro-ultrasound transducers with another and would have been obvious to try by an ordinary skilled in the art. (KSR Rationale B)
Regarding claim 23. Chen as modified by Maharbiz discloses all the limitations of claim 22 [see rejection of claim 22 above]
Maharbiz, directed towards PMUT sensors for brain stimulation and recording [see abstract od Maharbiz] further discloses that piezoelectric material of the piezoelectric micro-ultrasound transducers includes one or more of aluminum nitride, zinc oxide, lead zirconate titanate, polyvinylidene fluoride, or lead magnesium niobate-lead titanate. [see [0141] of Maharbiz disclosing that PMUTs could be made of Zinc Oxide (ZO), Aluminum nitride (AlN), etc.]
the piezoelectric material of the piezoelectric micro-ultrasound transducers includes one or more of aluminum nitride, zinc oxide, lead zirconate titanate, polyvinylidene fluoride, or lead magnesium niobate-lead titanate according to the teachings of Maharbiz since doing so would have been substituting one material for fabricating micro-ultrasound transducers with another and would have been obvious to try by an ordinary skilled in the art. (KSR Rationale B)
Regarding claim 24, Chen as modified by Maharbiz discloses all the limitations of claim 20 [see rejection of claim 20 above]
Maharbiz further discloses that the method includes forming material of the membranes having a size and material stiffness to operate the micro-ultrasound transducers to generate sound waves having a frequency in a range from 1 MHz to 200 MHz. [see [0114] of Maharbiz]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of Chen further such that the array of micro-ultrasound transducers in conjunction with the control circuitry are operable to generate sound waves having a frequency in a range from 15 MHz to 200 MHz according to the teachings of Maharbiz since higher frequencies allow for a smaller transducer [see [0014] of Maharbiz]
Claims 9 and 17 are rejected under 35 U.S.C. 103 for being obvious over Chen et al. (“a Capacitive micromachined ultrasonic transducer array for minimally invasive medical diagnosis”, IEEE, 2008) hereinafter “Chen” in view of in view of Maharbiz et al. (U.S. Publication No. 2019/0150884) hereinafter “Maharbiz as applied to claims 1 and 13 above, and further in view of O’Connell et al. (US Publication No. 2018/0243565) hereinafter “O’Connell”.
Regarding claim 9, Chen as modified by Maharbiz discloses all the limitations of claim 1 [see rejection of claim 1 above]
Chen as modified by Maharbiz does not expressly disclose that at least one probe of the one or more probes includes one or more microfluidic channels arranged to deliver a drug.
O’Connell, directed towards brain stimulating [see abstract of O’Connell] discloses that the at least one probe of the one or more probes includes one or more microfluidic channels arranged to deliver a drug. [see [0099] of O’Connell disclosing fluid delivery tubes included in the probe]
It would have been obvious to a person of ordinary skill level at the time of the invention to modify the probe of Chen as modified by Maharbiz further such that the at least one probe of the one or more probes includes one or more microfluidic channels arranged to deliver a drug according to the teachings of O’Connell in order to deliver pharmaceutical agents through them [see [0095] of O’Connell]
Regarding claim 17, Chen as modified by Maharbiz discloses all the limitations of claim 13 [see rejection of claim 13 above]
Chen as modified by Maharbiz does not expressly disclose that the method includes delivering a drug using one or more microfluidic channels in the probe.
O’Connell further discloses that the method includes delivering a drug using one or more microfluidic channels in the probe. [see [0095] and [0099] of O’Connell disclosing fluid delivery tubes included in the probe to deliver drug to the area]
It would have been obvious to a person of ordinary skill level at the time of the invention to modify the probe of Chen as modified by Maharbiz further such that the method includes delivering a drug using one or more microfluidic channels in the probe according to the teachings of O’Connell in order to deliver pharmaceutical agents through them [see [0095] of O’Connell]
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive.
Finality of the Office Action:
The applicant has stated that in view of the missing rejection for claim 25, the examiner agreed to issue a non-final office action in a telephonic conversation and therefore the instant office action has to be final.
In response, the examiner notes that the art that was relevant to claim 25 had been presented in the notice of relevant art in the non-final office action of 11/14/2025 and used to reject some of the dependent claims which depended upon claim 25 such as claim 30. The applicant has accordingly amended claim 25 extensively to overcome Lee reference. As a result, claims 25-30 are allowed over prior art. Therefore, the need to reinstate the rejection of claim 25 is moot and the instant rejection is issued as a final rejection as a result of amendments to independent claim 1 which has a different scope and different pertinent prior art entirely.
Rejection of claims under U.S.C. 101:
The applicant has argued that the limitations such as: “the micro-ultrasound transducers arranged on the platform such that the micro-ultrasound transducers are implanted into the brain with the implantation of the platform into the brain” should overcome the rejection for the claims being directed towards encompassing a human organism.
In response, the examiner notes that the claim limitation should be used such that there is no indication that the human organism is part of the apparatus being used.
The examiner suggests using language such as: “the micro-ultrasound transducers arranged on the platform such that the micro-ultrasound transducers are configured to be implanted into the brain” and “a platform configured to be implanted into the brain” in order to overcome the rejection.
Rejection of claims under U.S.C. 102
Applicant’s arguments in view of amendments, see remarks, filed 02/13/2025, with respect to the rejection(s) of claim(s) 1, 13 and 19 in view of Chen have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chen as modified by Maharbiz.
Allowable Subject Matter
Claims 25-30 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding independent claim 25, the prior art fails to anticipate and/or render obvious either solely or in combination, among other features of the claim: “an array of conducting electrodes, with the microelectrode array integrated onto the chip; on an acoustically transparent substrate above the array of micro- ultrasound transducers on the platform, the acoustically transparent substrate separated from the micro-ultrasound transducers on the platform by a space, the array of conducting electrodes arranged to record electrical activity; and a chamber configured to contain, from a subject, a neuron sample or a brain slice in a culture solution, the chamber structured on [[a]] the acoustically transparent substrate of the microelectrode array integrated onto the chip, array, with the chamber structured acoustically transparent substrate having an opening to the space a channel to allow space between the micro-ultrasound transducers and the acoustically transparent substrate of the microelectrode array to allow the space to be filled with the culture solution.”
Claims 26-30 depend upon allowable base claim 25 and are considered to be allowable as well due to their dependency upon an allowable base claim.
Below is a comparison of the closest prior art and the allowable claims:
Lee et al. (“A MEMS ultrasound stimulation system for modulation of neural circuits with high spatial resolution in vitro”, Microsystems and Nanoengineering, 2019) hereinafter “Lee”: Lee is considered the closest prior art to the claims 25-30 and discloses many features of claim 25 including an in vitro ultrasound stimulation device which comprises of an array of micro-ultrasound transducers on a platform configured to stimulate the in vitro cell cultures, and a microelectrode array on the chip, and a chamber which contains a neuron sample or a brain slice and there is an opening between the transducers and microelectrode array to be filled with the culture solution. However, Lee fails to disclose that the micro-ultrasound transducers are on the platform while being separated from the microelectrode array and that the microelectrode array is placed on an acoustically transparent substrate.
Chen et al. (“a Capacitive micromachined ultrasonic transducer array for minimally invasive medical diagnosis”, IEEE, 2008) hereinafter “Chen”: Chen is directed towards interrogating brain neurons in tissue and discloses an array of micro ultrasound transducers and micro-electrodes, but Chen is directed towards in-vivo stimulation and recording of the brain cells and fails to disclose in vitro stimulation. Chen further fails to disclose the micro-ultrasound transducers are on the platform while being separated from the microelectrode array and that the microelectrode array is placed on an acoustically transparent substrate
Maharbiz et al. (U.S. Publication No. 2019/0150884) hereinafter “Maharbiz: Maharbiz is directed towards interrogating brain neurons in tissue and discloses an array of micro ultrasound transducers and micro-electrodes, but Maharbiz also is directed towards in-vivo stimulation and recording of the brain cells and fails to disclose in vitro stimulation. Maharbiz further fails to disclose the micro-ultrasound transducers are on the platform while being separated from the microelectrode array and that the microelectrode array is placed on an acoustically transparent substrate
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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, Michael Carey can be reached at (571) 270-7235. 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.
/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights