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 .
The current application has the priority date of 06/16/2022 according to the priority chain on the record.
Claim Status
As per preliminary claim amendment received on 02/28/2023, claims 1-16 have been cancelled, and claims 17-32 have been newly added.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “stimulating means” in claim 22.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 17- 32 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.
Regarding claims 17, 21, 24, 31 and 32, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 19, the phrase “the at least second light source” lack antecedent basis in the claim. The Examiner suggests amending claim 19 to depend from claim 18 for proper antecedent basis.
Regarding claim 28, the phrase “the one or more sensors” lack antecedent basis in the claim. It is further unclear whether this refers to and/or inclusive of the “at least a first sensor” of the “micro device” recited in claim 17.
Regarding claim 32, the last claim clause is indefinite “wherein the method further comprises to receive and/or send data from/to the ultrasonic transducer of the second device.” It is unclear in this clause, which of the recited “first device” and/or “micro device” is to receive and/or send data.
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 17, 20-23, 26-29, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz et al. WO 2020/142733 A1 (hereinafter “Maharbiz”, submitted by the Applicant) in view of Kiani et al. WO 2020/077168 A1 (hereinafter “Kiani”, PDF attached).
Regarding claim 17, Maharbiz discloses a brain-computer interface system (Abstract, [0075, 0078], and Fig.1: system 100 adapted for deep brain stimulation), the system (100) comprising
a first device (external computer system) for communicating with one or more implanted devices ([0102] computer system wirelessly communicates with interrogator 202), the first device comprising;
a wireless data communication unit (inherent, see [0102] “The computer system can wirelessly communicate to interrogator 202…”);
a second device (Fig.2: interrogator 102; also see devices 202, 302) for implantation into tissue, such as brain tissue, central nervous system (CNS) tissue or spinal cord tissue ([0041] “…interrogator 102 can be a separate device that is external to (i.e., non- implanted) or fully-implanted in the subject.” Also see [0078] implanted devices for stimulating nerves in brain tissue), the second device (102) comprising;
a power supply (power supply 203, see [0085]) for powering the second device (102);
a wireless data communication unit (inherent feature, see [0102]) for transmitting/receiving data to/from the wireless data communication unit of the first device ([0102] “The computer system can wirelessly communicate to interrogator 202”);
an ultrasonic transducer (ultrasonic transducer circuit 204) for transmitting and receiving ultrasound; and
a controller (controller circuit 210) configured for controlling at least the wireless data communication unit (see) and the ultrasonic transducer (204) of the second device ([0102] controlling wireless communication with computer system, [0094, 0109] controlling internal operations, and communication with another implanted device, e.g. 104/204/304 exemplary as shown in Fig.1);
a micro device (Fig.1: implantable device 104, also see devices 204, 304 and Fig. 5:511) for implantation into tissue ([0068-0069] implanted for nerve stimulation), such as brain tissue, CNS tissue or spinal cord tissue ([0161, 0170] implanted for stimulation of spinal cord, somatic nerve, etc.), the micro device (104/204/304/511) comprising;
an ultrasonic transducer (ultrasonic transducer circuit 106) for receiving and/or transmitting ultrasound ([0058] 106 receives ultrasonic waves from 102, which generates a voltage across ultrasonic transducer 103 and imparts electrical current to power implantable device 104; also see [0041]);
a power circuit (power circuit 130) for receiving power for powering the micro device (104/204/304) by an ultrasonic signal received by the ultrasonic transducer of the micro device, from the ultrasonic transducer of the second device (102/202/302) ([0041, 0048, 0058] 130 receives and process the electrical signal generated by 106, to power the implantable device 104);
at least a first sensor (Fig.1: sensors 140A, 140B, 140C, electrode pads 142) configured for measuring signals from the tissue ([0061-0062] sensors detect physiological condition, e.g. pressure, temperature, strain, etc.) and to generate an analog electrical signal ([0042] detection circuit 116 for receiving sensor signals can be analog, digital or mix signal integrated circuit) accordingly;
at least a first light source ([0063] sensors 140A-C can include an optical sensor, i.e. light source and an optical detector);
a controller (controller circuit 120) for controlling at least the first light source (see Fig. 1); and
a processing unit (command processor 122) for processing data to/from at least the ultrasonic transducer, the at least first sensor and the controller (see Fig. 1, and [0061, 0079-0082] controller circuit 120 receives sensor data, and command processor 122 receives instructions from received ultrasonic waves); and
wherein the ultrasonic transducer (106) of the micro device (102/202/302/511) is further configured to receive data from the ultrasonic transducer (204) of the second device (102/202/302). ([0044] the “second device” (i.e. interrogator102/202/302) and “micro device” (i.e. 102/202/302/511), communicate bi-directionally via respective ultrasonic wave transceivers; also see [0011-0012, 0028-0030, 0102] regarding communication ultrasonic waves between the interrogator and implantable device(s))
Maharbiz discloses that the first device (external computer system) and second device (interrogator 102/202/302) communicates via wireless communication; and wherein the first device can turn on or off the second device, and analyzes the data received from the second device (see [0102]); but Maharbiz does not disclose wherein the first device comprises a wireless power transmitter. Maharbiz also discloses wherein the second device (interrogator 102/202/302) comprises a power supply (203) for powering the second device, this power supply is a battery ([0085: last sentence] battery); but does not disclose that the power supply is a wireless power receiver for powering the second device, from the wireless power transmitter of the first device. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Maharbiz so as to replace the battery (203) with a wireless rechargeable power receiver, and to modify the first device to include a wirelessly power transmitter, the motivation is because wirelessly charging an implanted device provides advantage of avoiding invasive surgery to remove the second device (i.e. implanted interrogator) for the simple task of replacing a battery.
Alternatively, Kiani, a prior art reference in the analogous field of method and system for neural stimulation and imaging of the nervous system of a subject (see Abstract). As shown in Figs. 4A-4B and Figs. 7A-7D, a plurality of implants 120 are implanted within a user’s brain tissue, these implants are adapted to detect sensor data, provide stimulation, and/or acquire imaging data of the respected implanted sites ([0063]). Moreover, these implants 120 are adapted to communicate with an external coil array 110/210 via ultrasonic waves for wireless power and data communication ([0064]). Specifically, the external coil array device 110/210 comprises a wireless power transmitter (ultrasonic transducer) and a wireless data communication unit ([0065] and see Figs. 4A-4B); and each of the implant 120 comprises a wireless power receiver (ultrasonic transducer array 120) for powering the implanted device, from the wireless power transmitter of the external device (Fig. 5A-5B: comprising data transducer 570 and power transducer 580; see [0063-0066]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Maharbiz, so as to modify the first device (external computer system) to include an external coil array and the second device to include a wireless power receiver (interrogator 102/202/302), for power and data communication via ultrasonic waves, in view of Kiani; the motivation for doing so is because Maharbiz’s system already utilizes ultrasonic wave for power and data communication (Maharbiz: ultrasonic communication between interrogator and implants), and the Kiani has shown that ultrasonic wave is suitable for both power and data communication, with the advantage of avoiding unnecessary surgery to replace a battery in an implantable device (Marharbiz: [0005] lithium batteries cause discomfort; [0085: last sentence] and Kiani: [0064]).
Regarding claim 20, Maharbiz modified discloses the system according to claim 17, Maharbiz further discloses the first (external computer system) and/or second device (interrogator 102/202/302) further comprising a signal processing unit and/or a memory. (Fig.2: interrogator has data processor 211 and memory 216)
Regarding claim 21, Maharbiz modified discloses the system according to claim 17, Maharbiz further discloses the second device (interrogator 102/202/302) further comprising one or more sensors ([0060] interrogator senses ultrasonic backscatter), such as electrodes for sensing electrical signals from tissue (electrodes 142).
Regarding claim 22, Maharbiz modified discloses the system according to claim 17, Maharbiz further discloses the micro device (implantable device 104/204/304/511) further comprising stimulation means (stimulation circuit 114) configured for stimulating tissue ([0081] neural stimulation mode; [0121] nerve stimulation mode), said stimulation means being controlled by the controller ([0054] controller circuit 120 controls power circuit 130 for stimulation).
Regarding claim 23, Maharbiz modified discloses system according to claim 17, Maharbiz further discloses wherein the ultrasonic transducer (106) of the micro device (102/202/302/511) is configured to transmit data from the processing unit (122) to the ultrasonic transducer (206) of the second device (102/202/302). (see Maharbiz Fig.2 and [0060-0062])
Regarding claim 26, Maharbiz modified discloses system according to claim 17, Maharbiz further discloses, wherein at least a first sensor of the micro device comprises a Local Field Potential and/or an Action Potential sensor. (Maharbiz: [0069 detecting electrophysiological signals or compound action potentials, this is taken to encompass “Local Field Potential and/or an Action Potential sensor” in the claim)
Regarding claim 27, Maharbiz modified discloses system according to claim 17, Maharbiz further discloses wherein the micro device further comprises a temperature sensor and/or a pressure sensor and/or a biochemical sensor. ([0062, 0065] sensor 140A-C can detect temperature, pressure, and presence of analyte)
Regarding claim 28, Maharbiz modified discloses system according to claim 17, Maharbiz further discloses wherein the micro device (102/202/302/511) is configured to accumulate a time period T of data from the one or more sensors, before transmitting said data to the second device. ([0079] memory 126 is a non-transitory storage memory, which is inherently capable for storing data accumulated over a time period T; also see [0166: last sentence] “…the controller circuit can access non-transitory memory (e.g., memory 126) to store data related to the detected electrophysiological signal.”)
Regarding claim 29, Maharbiz discloses the system according to claim 17, but does not disclose further comprising a plurality of micro devices, said plurality of micro devices configured so as to transmit data to the second device at off-set intervals. However, this is taught in Kiani, see Figs. 4A-4B both illustrating a plurality of implants 120/220, and also see Fig. 8: implants 120 and 220; wherein each of the plurality of implants is in data and power communication with an external coil array (see rejection and modification to claim 17, Kiani: [0064]). Kiani further discusses in [0144-0147] regarding ultrasonic beam formation at transmission intervals (i.e. ultrasonic harmonic modulation, and exclusive inductive link). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time to further modify Maharbiz in view of Kiani to transmit data via inductive ultrasonic link at off-set time intervals, the motivation for doing so is to avoid data collision from multiple data transmissions.
Regarding claim 31, Maharbiz modified discloses system according to claim 17, Maharbiz further discloses wherein the micro device has a total volume of less than 1 mm3, such as less than 0.5 mm3, such as less than 0.2 mm3. ([0005] “sub-mm dimensions”; also see [0181-0183])
Regarding claim 32, this claim is rejected by Maharbiz in view of Kiani under the same rationale as discussed to claim 17 above. Regarding the last claim clause “wherein the method further comprises…”, it is the Examiner’s best guess that the micro device is to receive and/or send data from/to the ultrasonic transducer of the second device, this is taught in Maharbiz [0011-0012, 0028-0030, 0102] communication ultrasonic waves between the interrogator and implantable device(s).
Claims 18-19 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz in view of Kiani as applied to claim 17 above, and further in view of Zand et al. US 2014/0288386 A1 (hereinafter “Zand”).
Note: claim 19 is rejected under 35 SUC 112(b), it is the Examiner’s best guess that claim 19 is dependent from 18, based on the claims recited features.
Regarding claims 18 and 19, Maharbiz modified discloses the system according to claim 17 comprising a first light source, that can detect blood pressure, pulse or glucose (Maharbiz: [0063]), but Maharbiz does not disclose wherein the micro device further comprises at least a second light source. Maharbiz also does not disclose wherein the light wavelength emitted by the first light source is different from the light wavelength emitted by the at least second light source.
Zand, another prior art reference in the analogous field of brain tissue implants ([0056: last 2 sentences]) discloses a continuous monitoring/sensing instrument comprising LEDs 1127 which sequentially emit two wavelengths, and the time response for each wavelengths provides oxygen-dependent information of the implanted site ([0091: last 3 sentences]). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Maharbiz, in view of Zand, so as to include at least two light sources that emits at two wavelengths, the motivation for doing so is to detect oxygen dependent analyte information (Maharbiz: [0062-0063] optical sensor adapted to detect oxygen tension, and analyte information).
Regarding claim 24, Maharbiz modified discloses system according to claim 18, Maharbiz further discloses wherein the first or second light source is configured to provide stimulus/therapy to tissue, such as optogenetic or photodynamic stimulus/therapy. (Maharbiz: [0007] neuromodulation via current or light delivery, in here optical stimulation is interpreted as “photodynamic stimulus/therapy” in the claim. Alternatively, Zand: [0091])
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz in view of Kiani as applied to claim 17 above, and further in view of Howard US 2021/0138249.
Regarding claim 30, Maharbiz modified discloses the system according to claim 17, wherein the detection circuit of the micro device comprises software to analyze detected physiological parameters ([0069]), and wherein the first device receives data and analyzes information encoded in ultrasonic waves received from the second device ([0102]), but does not disclose wherein the processing unit in any of the first device, the second device or the micro device comprises a spike-based neural network.
Howard, another prior art reference in the analogous field of deep brain stimulation and monitoring systems and method, discloses a monitoring system (Fig. 8: 800) comprising sensing and stimulating implant 804 and 806, in communication with an external interrogator 802. Howard further discloses that the data analyzed using machine learning models, including simulated, statis and spiking neural network models/SNNs (see [0631: end of paragraph]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Maharbiz to include the use of spiking neural network models in view of Howard, the motivation for doing so is to utilize “[r]obust computational models […] for optimal control of simple models of spiking neural networks and for individually controlling coupled oscillators using multilinear feedback.” (Howard: [0352])
Claim Objection/Allowable Subject Matter
Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. (Claim 25 is further rejected under 35 USC 112(B) as it depends from a rejected independent claim.)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: To claims 18, 19 and 24, Luu et al. (US 2021/0113852 or US 11,141,602) discloses a micro-implantable device for deep brain stimulation, comprising at least two light sources, e.g. LEDs, wherein the LEDs emit a single wavelength of light or several wavelengths of light; see [0040]. This reference does not predate the current application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
November 13, 2025