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 . 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 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.
Claim Objections
Claims 8 and 9 are objected to because of the following informalities: the recitations of “in monolithic” should instead read –in a monolithic--.
Appropriate correction is required.
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 4, 11-13, and 15 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 pre-AIA the applicant regards as the invention.
Regarding claim 4, there is insufficient antecedent basis for the recitation of “the voting protocol.”
Regarding claim 11, the recitation of “receive VBASEBAND from and generate” is unclear because there is no description of what VBASEBAND is received from.
Regarding claim 15, there is insufficient antecedent basis for the recitation of “the energy feature extractor circuitry.”
Claims 12 and 13 are rejected because they depend on rejected claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-15 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites (“sets forth” or “describes”) the abstract idea of a mental process and mathematical concept, substantially as follows:
extracting a baseband Doppler blood flow signal, VBASEBAND, from the scattered signal, extracting a plurality of features from VBASEBAND, the plurality of features including a measure of a zero crossing rate of VBASEBAND and a measure of an energy of VBASEBAND; and classifying the plurality of features and generating a binary signal based on the classification of the plurality of features, wherein the binary signal will have a first state responsive to the classification of the plurality of features indicating that a flow rate within the blood vessel is less than a predetermined level and a second state responsive to the classification of the plurality of features indicating the flow rate within the blood vessel is greater than or equal to the predetermined level.
The extracting and classifying can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of e.g. the received scattered signal, they would be able to extract features therefrom for performing a classification. There is nothing to suggest an undue level of complexity in the extraction or classification. Therefore, a person would be able to perform the calculations mentally or with pen and paper.
The steps also involve the mathematical concepts of signal processing, feature extraction, classification, and signal generation. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claim 1 does not include additional elements that integrate the mental process into a practical application. Therefore, the claims are “directed to” the mental process. The additional elements merely:
add insignificant extra-solution activity (the pre-solution activity of: insonifying a blood flow volume and receiving a scattered signal).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the classification is not outputted in any way such that a diagnostic or real-world benefit is realized. Nothing is done with the binary signal. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. zero crossing extraction, energy feature extraction, and signal sampling (claim 2), implementing a hyperplane (claims 5, 7-9), implementing a voting protocol (claims 3, 4, 6), etc.), and
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a monolithic decision circuit (claims 8 and 9), hardware-only circuity modules (claims 10-15), etc.).
With respect to e.g. claims 13 and 15, the structure is merely used in extra-solution activity (since e.g. the structure for performing the steps of claim 1 is separated in different claims such as 13 and 15, the feature extraction, classification, etc., is not performed entirely by specific hardware circuitry), such that the abstract idea is not considered applied via a “particular machine.” See MPEP 2106.05(b).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way (e.g. the classification remains in a processing “black box” and is not taken out into the real world). They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5, 7-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2013/0116575 (“Mickle”) in view of US Patent Application Publication 2005/0070799 (“Vilkomerson”) and non-patent publication Gestner, Brian, Jason Tanner, and David Anderson. "Glass break detector analog front-end using novel classifier circuit." 2007 IEEE International Symposium on Circuits and Systems (ISCAS). IEEE, 2007 (“Gestner”).
Regarding claim 1, Mickle teaches [a] method of monitoring patency of a free flap connected to a blood supply including a blood vessel (a totally implantable wireless Doppler blood flow monitor is not tethered, and it allows for remote monitoring of free tissue transfers and other blood flow monitoring which is part of any patient diagnosis or treatment, para 0034), comprising: insonifying a blood flow volume within the blood vessel (¶¶s 0005, 0039, 0059, etc., Doppler ultrasound - also see the transmitter and transducers described in ¶ 0036); receiving a scattered signal, the scattered signal being generated in response to the blood flow volume being insonified (¶¶s 0005, 0039, 0059, etc., via Doppler ultrasound – also see the transmitter and transducers described in ¶ 0036); … .
Mickle does not appear to explicitly teach extracting a baseband Doppler blood flow signal, VBASEBAND, from the scattered signal; extracting a plurality of features from VBASEBAND, …; and classifying the plurality of features and generating a binary signal based on the classification of the plurality of features, wherein the binary signal will have a first state responsive to the classification of the plurality of features indicating that a flow rate within the blood vessel is less than a predetermined level and a second state responsive to the classification of the plurality of features indicating the flow rate within the blood vessel is greater than or equal to the predetermined level.
Vilkomerson is in the field of measuring scattering fluid, such as blood in artificial and natural vessels in the human body (para 0002) and discloses a plurality of circuitry modules structured to insonify a blood flow volume within the blood vessel through a transmit transducer and receive a scattered signal from a receive transducer, the scattered signal being generated in response to the blood flow volume being insonified (paras 0006 and 0007: Doppler ultrasound is useful for assessing flow. To measure the velocity by Doppler effect, however, the measuring ultrasound beam must have a substantial component of its direction in the direction of flow. More particularly, the Doppler shift frequency, Fdop may be found from: formula ( a ) where v is the velocity of the back-scattering material, .lambda. is the wavelength of the ultrasound used, and .theta. is the angle between the insonifying beam and the velocity vector; para 0054: When transducers must be driven by implanted circuits, configurations requiring simpler, lower-power circuits may be necessary, even at the expense of more transducers and more cables. Arrangement 200 of FIGS. 2 and 2A can be used for either pulsed or CW modes of operation. In pulsed operation, a transmit/receive switch is not needed; while in CW mode, narrower bandwidths, lower voltage drive, and simpler circuitry may be used. The same geometry of insonifying beams and flow velocity control as has been discussed with regard to FIGS. 1 and 1A, with earlier equations 1-8 being modified so that the factor of two multiplying V (generated by a similar Doppler shift being produced on both transmission and on reception) is replaced by a factor of one-as the scattered ultrasound generated by the moving blood cells are received by the inter-connected slab transducers at right angles to the flow velocity such that no additional Doppler shift is produced on reception), extract a baseband Doppler blood flow signal, VBASEBAND, from the scattered signal (para 0082: implanted unit 1010 may drive system 1050 for a few seconds. The received signal may be conventionally processed in implant 1010, i.e., mixed with the drive frequency to obtain baseband I & Q signals, amplified over the band of interest (100 Hz-13 KHz), sampled and digitized at 10 bits at 40 KHz. The resulting data, which may be on the order of 250 Kbytes, may be stored in memory, and then transmitted wirelessly to a bedside monitor 1040), extract a plurality of features from VBASEBAND (para 0082: Transmission may occur utilizing the special Medical Implant Communication Service, the 402-405 MHz band the FCC reserves for such use, for example. Bedside monitor 1040 may process the transmitted data to calculate the flow volume, and determine if the calculated flow rate appears valid, e.g., the flows for each cardiac cycle are similar, and that the velocity waveforms are regular), and classify the plurality of features and generate a binary signal based on the classification of the plurality of features (para 0082: Bedside monitor 1040 may process the transmitted data to calculate the flow volume, and determine if the calculated flow rate appears valid. I.e., the binary signal represents the states valid and invalid), wherein the binary signal will have a first state responsive to the classification of the plurality of features indicating that a flow rate within the blood vessel is less than a predetermined level and a second state responsive to the classification of the plurality of features indicating the flow rate within the blood vessel is greater than or equal to the predetermined level (para 0082: If the data are valid, and the flow within the expected range, bedside monitor 1040 may transmit a signal to implant 1000 to "go to sleep" for 24. If the data are not in the expected range or appear unreliable, implant 1000 may be instructed to operate for another few seconds, to acquire additional Doppler data. If monitor 1040 determines that the flow has been reduced below a threshold, or that the rate of fall of flow is ominous, bedside monitor 1040 may send an e-mail message, or otherwise alert, suitable personnel, such as an attending physician, who may then intervene, for example).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the specific vessel flow monitoring of Vilkomerson into Mickle (as already contemplated by Mickle: Abstract - continuous wave Doppler technology) for the purpose of monitoring blood flow confined by at least one vessel wall (Vilkomerson: Abstract), and to include the classification as described in Vilkomerson for the purpose of providing timely warnings (Vilkomerson: ¶ 0082).
Mickle-Vilkomerson does not appear to explicitly teach the plurality of features including a measure of a zero crossing rate of VBASEBAND and a measure of an energy of VBASEBAND.
Gestner teaches an analog front end circuit that uses signal energy and zero-crossings to classify a window of sound in an energy efficient manner (Abstract, § 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate zero crossing rate and energy features into the classification of the combination, as in Gestner, for the purpose of implementing an energy efficient classifier (Gestner: Abstract, § 1, Fig. 1, etc.).
Regarding claim 2, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 1, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the extracting the plurality of features from VBASEBAND comprises generating, for a predetermined window period (Gestner: Abstract, Fig. 1, etc.), a first voltage signal, VZCR, based on VBASEBAND, VZCR being the measure of the zero crossing rate of VBASEBAND (Gestner: Fig. 2, second paragraph in the right column of page 3587), and generating, for the predetermined window period (Gestner: as above), a second voltage signal, VENERGY, based on VBASEBAND, VENERGY being the measure of the energy of VBASEBAND (Gestner: first paragraph in the right column of page 3587 – also see § II.C., describing classification based on voltage signals of the features), and wherein the classifying the plurality of features and the generating the binary signal comprises generating a first sampled signal, VZCR,SH, from VZCR, generating a second sampled signal, VENERGY,SH, from VENERGY, and classifying the plurality of features and generating the binary signal based on at least VZCR,SH and VENERGY,SH (Gestner: Fig. 1, § II.C., etc., different windows over time, for different sounds, sampling based on the clock, etc.).
Regarding claim 5, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 2, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the classifying the plurality of features and generating the binary signal based on at least VZCR,SH and VENERGY,SH employs a two-dimensional dividing hyperplane where VZCR,SH and VENERGY,SH are classified as being on one side of the dividing hyperplane or the other (Gestner: Figs. 5 and 6).
Regarding claim 7, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 1, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the classifying the plurality of features and generating the binary signal employs a two-dimensional dividing hyperplane (Gestner: Figs. 5 and 6).
Regarding claim 8, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 7, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the two-dimensional dividing hyperplane is implemented in monolithic decision circuit (Mickle: ¶ 0071, single silicon chip small enough to not be noticed by a human subject after implantation; ¶ 0050, the electronics interpret the received signal; Gestner: Fig. 4).
Regarding claim 9, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 5, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the two-dimensional dividing hyperplane is implemented in monolithic decision circuit (Mickle: ¶ 0071, single silicon chip small enough to not be noticed by a human subject after implantation; ¶ 0050, the electronics interpret the received signal; Gestner: Fig. 4).
Regarding claim 10, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 1, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein at least the extracting the baseband Doppler blood flow signal, VBASEBAND, the extracting the plurality of features from VBASEBAND, the classifying the plurality of features, and the generating the binary signal are performed within a plurality of hardware-only circuitry modules implanted within a patient (Mickle: Title, Abstract, Fig. 1, etc., implantable; ¶ 0071, single silicon chip small enough to not be noticed by a human subject after implantation; ¶ 0050, the electronics interpret the received signal; Gestner: Abstract, Figs. 1, 2, 4, etc.).
Regarding claim 11, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 10, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the plurality of hardware-only circuitry modules include zero crossing feature extractor circuitry structured to receive VBASEBAND from and generate the measure of the zero crossing rate of VBASEBAND (Gestner: Fig. 2).
Regarding claim 12, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 11, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the zero crossing feature extractor circuitry is structured to detect negative-going (i.e., high-to-low) zero-crossings (Gestner: second paragraph in the right column on page 3587).
Regarding claim 14, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 10, as outlined above. Mickle-Vilkomerson-Gestner further teaches wherein the plurality of hardware-only circuitry modules include energy feature extractor circuitry structured to receive VBASEBAND from and generate the measure of the energy of VBASEBAND (Mickle: Title, Abstract, Fig. 1, etc., implantable; ¶ 0071, single silicon chip small enough to not be noticed by a human subject after implantation; ¶ 0050, the electronics interpret the received signal; Gestner: Abstract, Figs. 1, 2, 4, etc.).
Claims 3, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Mickle-Vilkomerson-Gestner in view of US Patent Application Publication 2004/0110221 (“Twine”).
Regarding claims 3 and 4, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 2, as outlined above. Mickle-Vilkomerson-Gestner does not appear to explicitly teach wherein the classifying the plurality of features and generating the binary signal based on at least VZCR,SH and VENERGY,SH employs a voting protocol to generate the binary signal based on VZCR,SH and VENERGY,SH, wherein the voting protocol to generate the binary signal is based on VZCR,SH, VENERGY,SH and a number of additional sampled signals generated from VBASEBAND during a predetermined time period (although Gestner: Abstract does teach the relevance of additional parameters, like high-band energy, and Vilkomerson: ¶ 0082 teaches also evaluating an expected range, and acquiring additional data to confirm a result).
Twine teaches performing a binary classification using a weighted voting algorithm (¶¶s 0553-0556, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement a voting protocol like that of Twine into the combination, including additional features as in Gestner and Vilkomerson, as the simple substitution of one type of classification for another, with predicable results (making a binary decision – Twine: ¶ 0555), and for the purpose of more comprehensively evaluating the data, including by assigning more weight to more important features (Twine: ¶ 0555).
Regarding claim 6, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 1, as outlined above. Mickle-Vilkomerson-Gestner does not appear to explicitly teach wherein the classifying the plurality of features and generating the binary signal employs a voting protocol.
Twine teaches performing a binary classification using a weighted voting algorithm (¶¶s 0553-0556, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement a voting protocol like that of Twine into the combination, including additional features as in Gestner and Vilkomerson, as the simple substitution of one type of classification for another, with predicable results (making a binary decision – Twine: ¶ 0555), and for the purpose of more comprehensively evaluating the data, including by assigning more weight to more important features (Twine: ¶ 0555).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mickle-Vilkomerson-Gestner in view of US Patent Application Publication 2016/0226508 (“Kurooka”) and US Patent 4,802,024 (“Knowlton”).
Regarding claim 13, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 12, as outlined above. Mickle-Vilkomerson-Gestner does not appear to explicitly teach wherein the zero crossing feature extractor circuitry includes a comparator, a one-shot pulse generator which is falling-edge triggered, a current source triggered by pulses from the one-shot pulse generator that drives a current onto a sampling capacitor for integration.
Kurooka teaches a switch control circuit based on a zero crossing detector that uses a comparator and one-shot pulse generator that is falling-edge triggered (Fig. 14, ¶¶s 0083-0085).
Knowlton teaches, in a zero crossing detector, using a one-shot pulse generator to trigger a current source that drives a current onto a sampling capacitor for integration (col. 6, line 63 to col. 7, line 47).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the zero crossing circuit elements of Kurooka and Knowlton into the combination, as the simple substitution of one zero-crossing circuit for another with predictable results (detecting zero-crossings – Kurooka: ¶ 0085; Knowlton: col. 7, lines 18-28), for the purpose of toggling when any zero-crossing is detected (Kurooka: ¶¶s 0083-0085), and for the purpose of sampling with each zero crossing (Knowlton: col. 6, line 63 to col. 7, line 47).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mickle-Vilkomerson-Gestner in view US Patent 4,752,843 (“Kim”).
Regarding claim 15, Mickle-Vilkomerson-Gestner teaches all the features with respect to claim 12, as outlined above. Mickle-Vilkomerson-Gestner does not appear to explicitly teach wherein the energy feature extractor circuitry comprises a peak detector formed by two op-amps which perform level shifting, and a diode, a resistor, and a capacitor located between the op-amps.
Kim teaches a peak detector formed by two op-amps which perform level shifting, and a diode, a resistor, and a capacitor located between the op-amps (Fig. 2, showing e.g. D1, C1, and R1 between U1 and/or U2 and U3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the peak detector of Kim into the combination as the simple substitution of one know peak detector for another with predictable results (Kim: Figs. 1 and 2, peak value detecting and holding circuit).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791