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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 26, 2023 was considered by the examiner.
Claim Objections
Claims 17, 19, 22, and 30 are objected to because of the following informalities:
in claim 17, line 11: “a” should be inserted before “time-encoding”;
in claim 19, line 4: “data” should be “the one-bit data stream”;
in claim 22, line 2: “the at least two electric switches” should be inserted before “arranged”;
in claim 30, line 6: “signal, to arrive” should be “signal to arrive”;
Appropriate correction is required.
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 19-21 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.
Claim 19 recites “applying the stored time sequence of the one-bit data stream to the load modulation circuit at an increased data rate to provide a time compression of the data represented in the backscattered signal” in lines 2-4. As stated below with the 112(b) rejection, this recitation is interpreted to cover a time compression of the data. These are clearly computer-implemented recitations. See specification ¶[0022], the processor that executes the processing algorithm to receive the data, generate the one-bit data stream, and apply the stream to the modulator circuit; see also ¶[0020] and ¶[0064]-[0065], the data stream applied to the load modulation circuit is compressed.
Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably
conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 19, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the time-based compression algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function (i.e., the time-based compression). In particular, no specificity is provided with respect to the time-based compression. The specification ¶[0020] and ¶[0064]-[0065] indicate a time-based compression is utilized, and ¶[0073]-[0079] indicate the level of compression and data transmission based on the compression. However, the disclosure provides no algorithm, flow chart, or other detailed description of the time-based compression specifically, but only refers to the time-based compression in a “black box” description, meaning that time-based compression is referred to in a general sense but the specifics of the time-based compression itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the Applicant was in possession of the claimed invention, especially since it appears that the time-based compression the central feature of the claim 19.
Claims 20-21 are rejected by virtue of their dependence from claim 19.
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.
Claim 17 recites “being arranged to generate an electric power output” in lines 4-5, but it is not clear which component (i.e., the power management circuit or the piezoelectric transducer) is arranged to perform the claimed function. Appropriate correction is required.
Claims 18-31 are rejected by virtue of their dependence from claim 17.
Claim 19 recites “arranged to store a time sequence of the generated one-bit data stream in a memory, and applying the stored time sequence of the one- bit data stream to the load modulation circuit at an increased data rate to provide a time compression of data represented in the backscattered signal” in lines 1-4. However, it is not clear which component of the micro device, or the micro device itself, is arranged to perform the claimed function. Appropriate correction is required.
Claim 19 recites “applying the stored time sequence of the one-bit data stream to the load modulation circuit at an increased data rate to provide a time compression of the data represented in the backscattered signal” in lines 2-4. The claim is reciting that increasing the data rate would provide a time compression of the data represented in the backscattered signal. However, merely increasing the data rate or frequency of the data would not actually compress the data. In other words, merely increasing the rate would not compress the data because the amount of data would not actually change, even if the rate is increased. For example, Sodagar et al. (“Real-time, neural signal processing for high-density brain-implantable devices”, Bioelectric Medicine, 11:17, July, 19, 2025) reviews about intra-cortical neural interfacing devices (see abstract), and details that “there are two general categories of approaches: (a) data reduction techniques, in which part of the data conveying no or insignificant information is discarded, and (b) data compression techniques, which suggest more compact representation for the recorded data” (see pg. 6-7, § Data compression, ¶2). Sodagar further indicates that “temporal compression is the act of compressing a time series of signal samples recorded on a given channel” (see pg. 6-7, § Data compression, ¶3); see also pg. 7-8, § Temporal compression, for various temporal compression approaches of data. For example, the delta approach in Aziz et al. (“256-Channel Neural Recording and Delta Compression Microsystem With 3D Electrodes”, IEEE Journal of Solid-State Circuits, Vol. 44, No. 3, March 2009) “is performed by computing the difference of two subsequent neural activity frames and discarding any resulting values that are below a certain threshold as depicted in Fig. 9. The neural data is compressed since only change in the activity above a certain threshold is transmitted” (see pg. 1000 § III. Delta Compression, ¶2). As claim 19 does not change the representation/form or amount of data transmitted, it is not clear how the increased rate causes the time-based compression. For the purposes of examination, the increased data rate is not being given patentable weight (i.e., claim 19 requires a time compression of the data). Appropriate correction is required.
Claims 20-21 are rejected by virtue of their dependence from claim 19.
Regarding claim 27, 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). For the purposes of examination, the limitations “a Local Field Potential sensor or a single cell sensor” are not interpreted to be part of the claimed invention. Appropriate correction is required.
Claim 28 recites “being configured for implantation into brain tissue” in lines 1-2, but it is not clear what is “being configured for implantation into brain tissue”. Appropriate correction is required.
Claim 29 recites “having a total volume of less than 1 mm3, such as less than 0.5 mm3, such as less than 0.2 mm3” in lines 1-2, but it is not clear what has the total volume. Appropriate correction is required.
Regarding claim 29, the phrases "such as" render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitations “such as less than 0.5 mm3, such as less than 0.2 mm3” are not interpreted to be part of the claimed invention. Appropriate correction is required.
Claim 30 recites “a micro device” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a micro device” in claim 17, line 1. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the micro device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same. Appropriate correction is required.
Claim 30 recites “an ultrasonic power signal” in line 3, but it is not clear if this recitation is the same as, related to, or different from the recitation “an ultrasonic power signal” in claim 17, line 6. The similar phraseology suggests that they are the same, but the indefinite article “an” suggests that they are different. If the recitations are the same, the present recitation should be “the ultrasonic power signal”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same. Appropriate correction is required.
Claim 30 recites “a representation of a time sequence of the physical parameter” in lines 6-7. However, claim 17 recites “a sensor arranged to measure a physical parameter or a neural activity” (emphasis added) in line 8. As the recitation of claim 17 uses “or”, the representation of claim 30 would not have basis in the neural activity “or” scenario. This inconsistency renders claim 30 indefinite. Amending the recitation to recite “a representation of a time sequence of the physical parameter or the neural activity” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 31 is rejected by virtue of its dependence from claim 30.
Claim 31 recites “the sensor” in line 2. There is insufficient antecedent basis for this recitation in this claim. Note that this recitation is being interpreted as different from “the sensor” in claim 17, line 8, because the sensor of claim 31 is referring to the sensors in the plurality of micro devices. Amending the recitation to recite “a sensor” would overcome this rejection. The claim is being read as such for the purposes of examination. Appropriate correction is required.
Claim 32 recites “a micro device” in line 3, but it is not clear if this recitation is the same as, related to, or different from the recitation “a micro device” in line 1. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the micro device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17-19, 21, and 23-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 20, 23, 26-29, and 31 of copending Application No. 18/023,809 in view of Maharbiz et al. (US Patent Application 2020/0324148, Applicant cited to related application WO 2018/009905), hereinafter Maharbiz, and in view of Cherkassky et al. (US Patent Application Publication 2018/0067063), hereinafter Cherkassky.
This is a provisional nonstatutory double patenting rejection.
Regarding Claims 17-19, 21, and 26-32, all elements of application claims 17-18, 21, and 26-32 are present in and correspond to copending claims 17, 20, 23, 26-29, and 31, except the modulation circuit, the ultrasound transducer is a piezoelectric transducer, and the usage of the analog-to-digital converter.
Maharbiz teaches one or more implantable devices with sensors to measure data from the subject, which modifies an ultrasonic backscatter that is received by ultrasonic transducers (see abstract and Fig. 1). Maharbiz teaches a micro device, arranged for implantation into biological tissue (see ¶[0101]-[0103], the implantable devices, which are miniaturized; Figs. 1-3A),
the micro device comprising:
a piezoelectric transducer (¶[0008], ¶[0078], ¶[0101], ¶[0105], and ¶[0107]-[0111] the ultrasonic transducer, which is a piezoelectric transducer);
a power management circuit (¶[0113] the power circuit; Figs. 8A-8B) connected to the piezoelectric transducer (¶[0111]-[0113] the ASIC includes the power circuit and may be connected to the miniaturized ultrasonic transducer), and being arranged to generate an electric power output for powering components of the micro device in response to an ultrasonic power signal received by the piezoelectric transducer from an external source (¶[0113] the power circuit receives power from received ultrasonic waves, and then manages/powers the various components of the implanted device);
a sensor arranged to measure a physical parameter or a neural activity, and to generate an electric signal accordingly (¶[0101] and ¶[0119]-[0134] the various sensors that may be utilized, ¶[0097], ¶[0114], and ¶[0134] the analog signal is converted to a digital signal, indicating an electric signal output);
an electric circuit arranged to receive the electric signal from the sensor, and to digitize the electric signal by means of time-encoding analog-to-digital converter, to generate a data stream representing the electric signal from the sensor (¶[0097] and ¶[0114]-[0115] the digital circuit to receive the analog signal from the sensor, convert the analog signal to the digital signal via an analog-to-digital converter, so that the digital signal may be compressed); and
a load modulation circuit comprising at least one electric switch connected to terminals of the piezoelectric transducer, so as to allow modulation of electric load of the piezoelectric transducer in response to the data stream, so that a backscattered signal from the piezoelectric transducer is modulated by the data stream (¶[0093], ¶[0095], ¶[0101], ¶[0114]-[0115], ¶[0124]-[0126], ¶[0134], and ¶[0138] the modulation circuit, including the switch, such as a FET, for modulating the impedance of current flowing to the ultrasonic transducer, which is the backscatter signal that is modulated).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the modulation circuit of Maharbiz with copending claims 17, 20, 23, 26-29, and 31 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the copending claims 17, 20, 23, 26-29, and 31 require a modality to transmit the sensor data to the first device with ultrasound waves and Maharbiz teaches one such ultrasound wave transmission modality.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the analog-to-digital converter and data compression of Maharbiz with the modified copending claims 17, 20, 23, 26-29, and 31 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) utilizing the ADC would enable the data to be compressed, which would provide less data to be transmitted outside of the implantable device, requiring less resources.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the piezoelectric ultrasound transducer of Maharbiz as the ultrasound transducer the modified copending claims 17, 20, 23, 26-29, and 31 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified copending claims 17, 20, 23, 26-29, and 31 require an ultrasound transducer and Maharbiz teaches one such ultrasound transducer.
The modified copending claims 17, 20, 23, 26-29, and 31 does not specifically teach that a time-encoding analog-to-digital converter generates a one-bit data stream.
Cherkassky teaches the circuits and methods related for extracting magnitude and phase information from waveforms, involving the usage of an analog-to-digital converter (ADC) (see abstract; Fig. 2), in which the device may be a biometric monitoring device for various metrics, such as temperature (see ¶[0027]), and the device may be implantable (see ¶[0028] and Fig. 2), in which the ADC utilized may be a sigma-delta ADC comprising a sigma-delta modulator, configured to convert the input analog signal into a 1-bit data stream, used with a low-pass digital filter and a decimation filter (see ¶[0011] and ¶[0055]-[0056]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sigma-delta ADC of Cherkassky as the ADC in the modified copending claims 17, 20, 23, 26-29, and 31 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the sigma-delta ADC with the low-pass digital filter and the decimation filter would shape noise into higher frequencies because of the oversampling, followed by the filtering to reduce noise, provides a high-resolution ADC (see for example Baker, § Conclusions in Part 1 and Part 2, “How delta-sigma ADCs work”, Parts 1 and 2, Analog Applications Journal, High-Performance Analog Products, 3Q and 4Q 2011).
Regarding Claims 23-25, all elements of application claims 23-25 are present in and correspond to the modified copending claims 17, 20, 23, 26-29, and 31, except the first and second load states.
Maharbiz further teaches the load modulation circuit is arranged to control electric load of the piezoelectric transducer between a first load state and a second load state in response to the one-bit data stream, wherein the at least one electric switch is controlled so as to provide different electric loads of the piezoelectric transducer in the first load state than in the second load state (¶[0406]-[0409] to validate the implanted device to transducer system, an example communication of “hello world” is utilized, in use, the dust mote piezocrystal electrodes (i.e., the implanted devices/motes) are in the shorted/closed configuration (the first load state) and the opened configuration (the second load state), which provide different electric loads in the different states, that results in a backscattered peak amplitude that is 11.5 mV greater in the open switch configuration; Figs. 32A-33). See also cited reference in Maharbiz ¶[0004], Seo et al., “Model validation of untethered, ultrasonic neural dust motes for cortical recording”, Journal of Neuroscience Methods, vol. 224, pp. 114-122, August 07, 2014; see specifically pg. 121 § 4.3 Measured backscatter signal levels for dust motes match simulation, the shorted and open configurations. In this case, as the backscatter is not modulated in the shorted/closed configuration, the backscatter would be maximized (i.e., not modulated by signal values); conversely, in the open configuration, the backscatter is modulated, and thus the backscatter minimized.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the shorted/closed and open configurations (i.e., first and second load states) of Maharbiz with the modified copending claims 17, 20, 23, 26-29, and 31 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the shorted/closed and open configurations would result in in a backscattered peak amplitude that is 11.5 mV greater in the open switch configuration (see Maharbiz ¶[0407]).
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 20, 23, 26-29, and 31 of copending Application No. 18/023,809 in view of Maharbiz and Cherkassky as applied to claim 19 above, and in view of Farsiani et al. (“Hardware and Power-Efficient Compression Technique Based on Discrete Tchebichef Transform for Neural Recording Microsystems”, Annu Int Conf IEEE Eng Med Biol Soc., 3489-3492, July 2020, citing to the abstract), hereinafter Farsiani.
Regarding Claim 20, all elements of application claim 20 is present in and corresponds to the modified copending claims 17, 20, 23, 26-29, and 31, except that the increased data rate is at least a factor of 5, compared to a data rate of the one-bit data stream generated by the time- encoding analog-to-digital converter.
Farsiani teaches a truncated Tchebichef transform for hardware and power-efficient compression for neural signals, which yields a compression rate of 26.15 while the root-mean-square of error is kept as low as 1.1% (see abstract). The Tchebichef transform is a temporal compression. See for example Sodagar et al. (“Real-time, neural signal processing for high-density brain-implantable devices”, Bioelectric Medicine, 11:17, July, 19, 2025) pg. 7-8, § Temporal compression, the truncated Tchebichef is listed under the temporal compressions.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the truncated Tchebichef transform of Farsiani as the compression of the modified copending claims 17, 20, 23, 26-29, and 31 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified copending claims 17, 20, 23, 26-29, and 31 contemplates various compression algorithms (see Maharbiz ¶[0097]) and Farsiani teaches one such compression algorithm; and/or (3) the truncated Tchebichef transform provides a compression rate of 26.15 with a low root-mean-square error of 1.1%, while also reducing hardware complexity by up to 74% (see Farsiani abstract).
Claim 22 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17, 20, 23, 26-29, and 31 of copending Application No. 18/023,809 in view of Maharbiz and Cherkassky as applied to claim 17 above, and in view of Maharbiz et al. (WIPO Publication 2020/142733 – cited by Applicant), hereinafter Maharbiz ‘733.
Regarding Claim 22, all elements of application claim 22 is present in and corresponds to the modified copending claims 17, 20, 23, 26-29, and 31. except that the load modulation circuit comprises at least two electric switches connected to the piezoelectric transducer and arranged for being controlled to modulate electric load of the piezoelectric transducer in response to the one-bit data stream.
The modified copending claims 17, 20, 23, 26-29, and 31further teaches the load modulation circuit comprises at least two electric switches connected to the piezoelectric transducer and arranged for being controlled to modulate electric load of the piezoelectric transducer in response to the one-bit data stream (see Maharbiz ¶[0032]-[0033], ¶[0085]-[0087], ¶[0093]-[0095], ¶[0098], and ¶[0101] the interrogator comprising at least one array of ultrasonic transducers with switches to configure each ultrasonic transducer to transmit ultrasonic waves to the implantable device(s); Figs. 1-2A, 3A, and 4-5D).
Alternatively and/or additionally, Maharbiz further teaches that to validate the implanted device to transducer system, an example communication of “hello world” is utilized, in use, the dust mote piezocrystal electrodes (i.e., the implanted devices/motes) are in a shorted/closed configuration (the first load state) and an opened configuration (the second load state), which provide different electric loads in the different states, that results in a backscattered peak amplitude that is 11.5 mV greater in the open switch configuration (see ¶[0406]-[0409] and Figs. 32A-33). Maharbiz does not specifically teach how the configurations are implemented.
Maharbiz ‘733 teaches a method and system for controlling power supplied to an implantable device via ultrasonic waves (see abstract), in which, in the power supply circuit, the power may be controlled to be in an open configuration via a switch opened of one or more switches, and a switch to shunt the ultrasonic transducer in a short circuit configuration (see ¶[0158]). Examiner’s note, as two switches in the “one or more switches” are each stated with the indefinite article “a”, the two switches are being interpreted as distinct switches.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the two switch modality of Maharbiz ‘733 with the open/closed configuration switching of Maharbiz with the modified copending claims 17, 20, 23, 26-29, and 31 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the shorted/closed and open configurations would result in in a backscattered peak amplitude that is 11.5 mV greater in the open switch configuration (see Maharbiz ¶[0407]); and/or (3) the modified copending claims 17, 20, 23, 26-29, and 31 require an implementation for the open/closed configuration switching, and Maharbiz ‘377 teaches one such implementation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 17-19 and 23-32 are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz et al. (US Patent Application 2020/0324148, Applicant cited to related application WO 2018/009905), hereinafter Maharbiz, and in view of Cherkassky et al. (US Patent Application Publication 2018/0067063), hereinafter Cherkassky.
Regarding Claim 17, Maharbiz teaches one or more implantable devices with sensors to measure data from the subject, which modifies an ultrasonic backscatter that is received by ultrasonic transducers (see abstract and Fig. 1). Maharbiz teaches a micro device, arranged for implantation into biological tissue (see ¶[0101]-[0103], the implantable devices, which are miniaturized; Figs. 1-3A),
the micro device comprising:
a piezoelectric transducer (¶[0008], ¶[0078], ¶[0101], ¶[0105], and ¶[0107]-[0111] the ultrasonic transducer, which is a piezoelectric transducer);
a power management circuit (¶[0113] the power circuit; Figs. 8A-8B) connected to the piezoelectric transducer (¶[0111]-[0113] the ASIC includes the power circuit and may be connected to the miniaturized ultrasonic transducer), and being arranged to generate an electric power output for powering components of the micro device in response to an ultrasonic power signal received by the piezoelectric transducer from an external source (¶[0113] the power circuit receives power from received ultrasonic waves, and then manages/powers the various components of the implanted device);
a sensor arranged to measure a physical parameter or a neural activity, and to generate an electric signal accordingly (¶[0101] and ¶[0119]-[0134] the various sensors that may be utilized, ¶[0097], ¶[0114], and ¶[0134] the analog signal is converted to a digital signal, indicating an electric signal output);
an electric circuit arranged to receive the electric signal from the sensor, and to digitize the electric signal by means of time-encoding analog-to-digital converter, to generate a data stream representing the electric signal from the sensor (¶[0114]-[0115] the digital circuit to receive the analog signal from the sensor, convert the analog signal to the digital signal via an analog-to-digital converter); and
a load modulation circuit comprising at least one electric switch connected to terminals of the piezoelectric transducer, so as to allow modulation of electric load of the piezoelectric transducer in response to the data stream, so that a backscattered signal from the piezoelectric transducer is modulated by the data stream (¶[0093], ¶[0095], ¶[0101], ¶[0114]-[0115], ¶[0124]-[0126], ¶[0134], and ¶[0138] the modulation circuit, including the switch, such as a FET, for modulating the impedance of current flowing to the ultrasonic transducer, which is the backscatter signal that is modulated).
Maharbiz teaches the usage of one-bit data streams (see for example Figs. 5A-5D, the one dimensional signal of voltage over time), but not specifically that a time-encoding analog-to-digital converter generates a one-bit data stream.
Cherkassky teaches the circuits and methods related for extracting magnitude and phase information from waveforms, involving the usage of an analog-to-digital converter (ADC) (see abstract; Fig. 2), in which the device may be a biometric monitoring device for various metrics, such as temperature (see ¶[0027]), and the device may be implantable (see ¶[0028] and Fig. 2), in which the ADC utilized may be a sigma-delta ADC comprising a sigma-delta modulator, configured to convert the input analog signal into a 1-bit data stream, used with a low-pass digital filter and a decimation filter (see ¶[0011] and ¶[0055]-[0056]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sigma-delta ADC of Cherkassky as the ADC in Maharbiz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the sigma-delta ADC with the low-pass digital filter and the decimation filter would shape noise into higher frequencies because of the oversampling, followed by the filtering to reduce noise, provides a high-resolution ADC (see for example Baker, § Conclusions in Part 1 and Part 2, “How delta-sigma ADCs work”, Parts 1 and 2, Analog Applications Journal, High-Performance Analog Products, 3Q and 4Q 2011).
Regarding Claim 18, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. Maharbiz further teaches the load modulation circuit is arranged to control the at least one electric switch according to the one-bit data stream at a modulation frequency (¶[0093], ¶[0095], ¶[0101], ¶[0114]-[0115], ¶[0124]-[0126], ¶[0134], and ¶[0138] the modulation circuit, including the switch, such as a FET, for modulating the impedance of current flowing to the ultrasonic transducer, which is the backscatter signal that is modulated, via the variation in current, the information encoded by changes in amplitude, frequency, or phase of the backscattered signal).
Regarding Claim 19, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. Maharbiz further teaches arranged to store a time sequence of the generated one-bit data stream in a memory (¶[0097] and ¶[0114] the implantable device may comprise an ADC and memory), and applying the stored time sequence of the one- bit data stream to the load modulation circuit at an increased data rate to provide a time compression of data represented in the backscattered signal (¶[0097] the compression of the data, such as using singular value decomposition, of the analog data would be in the time domain).
Regarding Claim 23, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. Maharbiz further teaches the load modulation circuit is arranged to control electric load of the piezoelectric transducer between a first load state and a second load state in response to the one-bit data stream, wherein the at least one electric switch is controlled so as to provide different electric loads of the piezoelectric transducer in the first load state than in the second load state (¶[0406]-[0409] to validate the implanted device to transducer system, an example communication of “hello world” is utilized, in use, the dust mote piezocrystal electrodes (i.e., the implanted devices/motes) are in the shorted/closed configuration (the first load state) and the opened configuration (the second load state), which provide different electric loads in the different states, that results in a backscattered peak amplitude that is 11.5 mV greater in the open switch configuration; Figs. 32A-33).
Regarding Claim 24, Maharbiz in view of Cherkassky teaches the device of claim 23 as stated above. Maharbiz further teaches in the first load state the at least one electric switch is controlled to short-circuit the terminals of the piezoelectric transducer (¶[0406]-[0409] the shorted/closed configuration (the first load state); Figs. 32A-33).
Regarding Claim 25, Maharbiz in view of Cherkassky teaches the device of claim 23 as stated above. Maharbiz further teaches in the second load state the at least one electric switch is controlled to provide an electric load of the terminals of the piezoelectric transducer to cause a minimal backscattering from the piezoelectric transducer (¶[0406]-[0409] the opened configuration (the second load state), which provide different electric loads in the different states, that results in a backscattered peak amplitude that is 11.5 mV greater in the open switch configuration; Figs. 32A-33). See also cited reference in Maharbiz ¶[0004], Seo et al., “Model validation of untethered, ultrasonic neural dust motes for cortical recording”, Journal of Neuroscience Methods, vol. 224, pp. 114-122, August 07, 2014; see specifically pg. 121 § 4.3 Measured backscatter signal levels for dust motes match simulation, the shorted and open configurations. In this case, as the backscatter is not modulated in the shorted/closed configuration, the backscatter would be maximized (i.e., not modulated by signal values); conversely, in the open configuration, the backscatter is modulated, and thus the backscatter minimized.
Regarding Claim 26, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. The modified Maharbiz further teaches the time-encoding analog-to- digital converter is a delta-sigma modulator (see Cherkassky ¶[0011] and ¶[0055]-[0056] the sigma-delta ADC comprising a sigma-delta modulator, configured to convert the input analog signal into a 1-bit data stream, used with a low-pass digital filter and a decimation filter).
Regarding Claim 27, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. Maharbiz further teaches the sensor is one of: a neural activity sensor such as a Local Field Potential sensor or a single cell sensor, a bio-chemical sensor, a temperature sensor, or a pressure sensor (¶[0101] and ¶[0119]-[0134] the various sensors that may be utilized, such as an oxygen concentration sensor, a pH sensor, a temperature sensor, or a pressure sensor).
Regarding Claim 28, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. Maharbiz further teaches being configured for implantation into brain tissue (¶[0004], ¶[0127], and ¶[0139] the motes/sensors may be implanted into brain tissue, so as to measure cranial pressure; see also Fig. 1, the motes/sensors implanted in the cortex).
Regarding Claim 29, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. Maharbiz further teaches having a total volume of less than 1 mm3, such as less than 0.5 mm3, such as less than 0.2 mm3 (¶[0103] the implantable device may have a volume of about 0.5 mm3 to 5 mm3). Here, as 0.5 mm3 would be less than 1 mm3, the claimed element is taught by the modified Maharbiz.
Regarding Claim 30, Maharbiz in view of Cherkassky teaches the device of claim 17 as stated above. Maharbiz further teaches an ultrasonic transmitter arranged to transmit an ultrasonic power signal to the micro device (¶[0032]-[0033], ¶[0085]-[0087], ¶[0093]-[0095], ¶[0098], and ¶[0101] the interrogator comprising at least one array of ultrasonic transducers with switches to configure each ultrasonic transducer to transmit ultrasonic waves to the implantable device(s); Figs. 1-2A, 3A, and 4-5D); and
an ultrasonic receiver arranged to receive the backscattered signal from the piezoelectric transducer of the micro device (¶[0032]-[0033], ¶[0085]-[0087], ¶[0093]-[0095], ¶[0098], and ¶[0101] the interrogator comprising at least one array of ultrasonic transducers with switches to configure each ultrasonic transducer to receive backscatter echo from the implantable device(s), these are the modulated signals; Figs. 1-2A, 3A, and 4-5D),
and to de-modulate the backscattered signal, to arrive at a representation of a time sequence of the physical parameter measured by the sensor in the micro device (¶[0095] and ¶[0101] the backscatter is analyzed, such as via filtering, rectifying, and integration, to determine the time sequence of the physical parameter; Figs. 5A-5D, see specifically 5D, the voltage over time representation of the physical parameter; see also ¶[0406]-[0409] to validate the implanted device to transducer system, an example communication of “hello world” is utilized, Figs. 32A-33).
Regarding Claim 31, Maharbiz in view of Cherkassky teaches the device of claim 30 as stated above. Maharbiz further teaches a plurality of micro devices (¶[0098] the interrogator may communicate with a plurality of implantable device, ¶[0032]-[0033], ¶[0085]-[0087], ¶[0093]-[0095], ¶[0098], and ¶[0101] the interrogator comprising at least one array of ultrasonic transducers with switches to configure each ultrasonic transducer to transmit ultrasonic waves or receive the modulated backscatter echo from the implantable device(s); Figs. 1-2A, 3A, and 4-5D), and
wherein the ultrasonic receiver is arranged to receive backscattered signals from the plurality of micro devices (¶[0032]-[0033], ¶[0085]-[0087], ¶[0093]-[0095], ¶[0098], and ¶[0101] the interrogator comprising at least one array of ultrasonic transducers with switches to configure each ultrasonic transducer to receive backscatter echo from the implantable device(s), these are the modulated signals; Figs. 1-2A, 3A, and 4-5D), and
to de-modulate the backscattered signals to arrive at representations of respective time sequences of neural activities measured by the plurality of micro devices (¶[0095] and ¶[0101] the backscatter is analyzed, such as via filtering, rectifying, and integration, to determine the time sequence of the physical parameter; Figs. 5A-5D, see specifically 5D, the voltage over time representation of the physical parameter; see also ¶[0406]-[0409] to validate the implanted device to transducer system, an example communication of “hello world” is utilized, Figs. 32A-33).
Maharbiz further teaches that the sensor in each of the plurality of micro devices comprises a neural activity sensor (¶[0101] and ¶[0119]-[0134] the various sensors that may be utilized, such as an oxygen concentration sensor, a pH sensor, a temperature sensor, or a pressure sensor). Here, the specification indicates that neural activity may include biochemical or biomechanical signals (see specification ¶[0008], “a sensor arranged to measure a physical parameter or a neural activity, such as a bio-potential signal, a biochemical signal, or a biomechanical signals, and to generate an electric signal accordingly”).
Alternatively and/or additionally, cited reference in Maharbiz ¶[0004], Sei et al., “Neural Dust: An Ultrasonic, Low Power Solution for Chronic BrainMachine Interfaces, arXiv: 1307.2196v1, July 8, 2013, teaches the usage of the dust/mote sensors in a passive node neural activity sensor with a mote size of about 100 µm (see pg. 7-9, § System design and constraints: Passive node and § System design and constraints: Interrogator).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the neural activity dust/mote sensor of Sei with the sensors (i.e., mote/dust size of about 100 µm contemplated, see Maharbiz ¶[0383]-[0385] and Figs. 22A-22C) of the modified Maharbiz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Maharbiz contemplates various sensors and Sei teaches one such sensor; and/or (3) the neural activity dust/mote sensor would provide useful information for a medical professional providing care for the subject/patient.
Regarding Claim 32, Maharbiz teaches one or more implantable devices with sensors to measure data from the subject, which modifies an ultrasonic backscatter that is received by ultrasonic transducers (see abstract and Fig. 1). Maharbiz teaches a method for transmitting sensor data from a micro device implanted in biological tissue (see ¶[0101]-[0103], the implantable devices, which are miniaturized, with sensors to measure data from the subject, which modifies an ultrasonic backscatter that is received by ultrasonic transducers; Figs. 1-3A),
the method comprises:
providing a micro device (¶[0101]-[0103], the implantable devices, which are miniaturized; Figs. 1-3A) comprising
a piezoelectric transducer (¶[0008], ¶[0078], ¶[0101], ¶[0105], and ¶[0107]-[0111] the ultrasonic transducer, which is a piezoelectric transducer)
connected to (¶[0111]-[0113] the ASIC includes the power circuit and may be connected to the miniaturized ultrasonic transducer) a power management circuit (¶[0113] the power circuit; Figs. 8A-8B) for powering power con