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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 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 claim 1, claim 1 recites the limitation “HV protection”. The abbreviation “HV” should be defined before it is used because it is otherwise unclear what HV stands for. For examination purposes, HV will be interpreted as meaning high-voltage.
Regarding claim 1, the term “high-voltage” is a relative term which renders the claim indefinite. The term “high-voltage switch” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, a person having ordinary skill in the art would not understand what voltage level would be required to be considered “high” within the context of the claims. For examination purposes, any switch providing voltage protection will be interpreted as meeting this limitation in the claim.
Regarding claim 1, claim 1 recites “a plurality of HV protection and bypass switches” and “a plurality of electronic switches used to bypass”. It is unclear how these switches related to each other. For examination purposes, a reference disclosing a plurality of switches will be interpreted as meeting these limitations in the claims.
Regarding claims 1 and 6, the claims recite the limitation “pulser/beamformer”. It is unclear if the claim is requiring both a pulser and a beamformer or only one of these. Clarification is required. For examination purposes, the claims will be interpreted as requiring only one of these.
Regarding claim 2, claim 2 recites “said pulser” but based on the Examiner’s understanding a pulser is not necessarily required by claim 1. Therefore it is unclear whether claim 2 requires a pulser or not. Clarification is required.
Regarding claim 5, the claim recites the limitation “pulser/beamformer” circuit. It is unclear if the claim is requiring both a pulser and a beamformer circuit or only one of these. Clarification is required. For examination purposes, the claims will be interpreted as requiring only one of these.
Regarding claim 6, claim 6 recites “its HV circuitry” but the claims have never previously set forth that HV circuitry is required. Therefore it is unclear what circuitry is being referred to. For examination purposes, a reference disclosing connecting and disconnecting the pulser/beamformer from the preamplifier will be interpreted as meeting this limitation in the claim since that is what is described in the published specification. [0067-75].
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 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.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kanayama et al. (US20110066023, hereafter Kanayama), Hashimoto et al. (US20180199821, hereafter Hashimoto), DaCosta (US20160287211, hereafter DaCosta), and Solek (US20140031694)
Regarding claim 1, Kanayama discloses in Figure 2 an instrument for dual-modality ultrasound and thermoacoustic data acquisition and/or imaging (Kanayama, Para 3; “a method and apparatus which acquire and superimpose two acoustic images, one generated from the energy of light radiated into a subject to be examined and the other is an ultrasound echo image generated from ultrasonic waves directed into the subject”) (Kanayama, Para 50-51; “By using this arrangement, volume data corresponding to a three-dimensional region representing a living body function is acquired by two-dimensional electroacoustic scanning based on light irradiation from the irradiation unit and detection of the resultant acoustic waves generated by the electroacoustic conversion unit […] Hereinafter, the sound waves generated by the photoacoustic scanning method will be referred to as “acoustic waves” and the sound waves transmitted/received in normal ultrasonic scanning will be referred to as “ultrasonic waves”, thus discriminating them from each other”), comprising:
a transducer or a transducer array for applying mechanical energy to an interrogated object and receiving signals from the interrogated object (Kanayama, Para 50; “a plurality of electroacoustic transducer elements are two-dimensionally arranged at predetermined intervals in the vertical and horizontal directions, and the output ends of a plurality of optical fibers for light irradiation are arranged in the gaps between the electroacoustic transducer elements, thereby forming an applicator in which an irradiation unit is integrated with an electroacoustic conversion unit. By using this arrangement, volume data corresponding to a three-dimensional region representing a living body function is acquired by two-dimensional electroacoustic scanning based on light irradiation from the irradiation unit and detection of the resultant acoustic waves generated by the electroacoustic conversion unit”);
a pulser/beamformer for applying non-stationary electromagnetic energy to said transducer or said transducer array enabling the instrument's operation in ultrasound emit mode (Kanayama, Para 63; “As FIG. 2 shows, the transmission/reception unit 22 includes […] pulsers 52 […] The circuits 51 impart corresponding timings to the rate pulse output from the rate signal generating unit 21, and supplies the resultant pulses to the pulsers 52. The pulsers 52 are driving circuits which generate high-voltage pulses for driving the conversion elements 54. The pulsers 52 generate impulses having peak values of several hundred volts by using output signals from the transmission delay circuits 51 as trigger signals”) (Kanayama, Para 61; “The rate signal generating unit 21 outputs a rate pulse for setting the repeating period of transmission ultrasonic waves to be radiated into the subject 7. The signal processing unit 25 performs various processes on the signals received from the transmission/reception unit 22”);
a thermoacoustic preamplifier (preamplifier 55) (Kanayama, Para 84; “These signals are supplied to the preamplifier 55 via the electronic switch 53. The preamplifier 55 amplifies the signals to a predetermined amplitude”);
an analog-to-digital converter (A/D converter 60) for providing analog to digital conversion of signals received by said transducer or said transducer array; (Kanayama, Para 88; “The A/D convertor 60 converts the signal into a digital signal.”) (Kanayama, Para 69; “The A/D convertor 60 A/D converts the output signal from the envelope detector 59 into volume data”) (Kanayama, Para 109; “The conversion element 54 converts a reception ultrasonic wave from the subject 7 from an ultrasonic wave to an electrical signal (ultrasonic reception signal). The ultrasonic reception signal is sent to the filter 66 of the signal processing unit 25 through the transmission/reception unit 22. The filter 66 has a bandpass characteristic centered on 2fo and a bandpass characteristic (not shown) centered on fo. In the harmonic imaging method, the filter 66 extracts a second harmonic component. The output of the filter 66 is stored in the image data memory B 62 via the logarithmic transformation unit 58, envelope detector 59, and A/D convertor 60. In the photoacoustic scanning method, the filter 66 extracts a fundamental wave component, and the output of the filter 66 is stored in the image data memory B 62 via the logarithmic transformation unit 58, envelope detector 59, and A/D convertor 60, as in the first embodiment”) (Kanayama, Para 98);
a circuit (system control unit 4) providing digital processing and/or digital control in the instrument (Kanayama, Para 53; “The non-invasive subject-information imaging apparatus of this embodiment is comprised of an optical transmission unit 1, image data generating unit 2, display unit 6, operation unit 5, and system control unit 4 […] The system control unit 4 systematically controls the respective units”);
wherein the instrument is configured such that a plurality of transducer elements and a plurality of channels are used in both ultrasound and thermoacoustic modalities (Kanayama, Figure 2 showing this) (Kanayama, Para 62; “The electroacoustic conversion unit 23 receives both the acoustic waves generated in the subject upon irradiation with light from the irradiation unit 15 and the echoes of the ultrasonic waves transmitted from the electroacoustic conversion unit 23”).
Kanayama does not clearly and explicitly disclose an analog front end for providing analog to digital conversion of signals received by said transducer or said transducer array; wherein the instrument is configured with a plurality of electronic switches used to bypass the thermoacoustic preamplifier in ultrasound mode and enable the thermoacoustic preamplifier in thermoacoustic mode; and wherein the instrument is configured to use a plurality of HV protection and bypass switches.
In an analogous photoacoustic and ultrasonic imaging device field of endeavor Hashimoto discloses an instrument configured with a plurality of electronic switches (Hashimoto, selection switch 105 and the transmission and reception changeover switch 106 ) used to bypass a thermoacoustic preamplifier (Hashimoto, Para 38; “The bypass unit 104 includes a selection switch 105 for selecting whether or not an input node of the preamplifier 103 and an output node of the preamplifier 103 are to be short-circuited”) (Hashimoto, Para 36; “The transmission and reception changeover switch 106 switches a connection destination of the acoustic wave detector 101 between the preamplifier 103 (an input node thereof) and the transmission circuit 29 (an output node thereof) arranged in the ultrasonic unit 12 (see FIG. 1)”) in ultrasound mode (Hashimoto, Para 42; “In a case where the reflected ultrasonic waves are detected, the controller 28 stops the amplification operation of the preamplifier 103, and selects a path (a second path) in which the detection signal is input to the reception circuit via the bypass unit 104 (the selection switch 105) without passing through the preamplifier 103, as the signal path between the acoustic wave detector 101 and the reception circuit 21. Specifically, the controller 28 selects the second path by closing the selection switch 105 and short-circuiting the input node and the output node of the preamplifier 103. Generally, the reflected ultrasonic waves are stronger than photoacoustic waves, and even in a case where the reflected ultrasonic waves are amplified by the preamplifier 103, a merit of improving an SN ratio is often small. In the case where reflected ultrasonic waves are detected, heat generation is suppressed by selecting the second path which does not pass through the preamplifier 103 and stopping the amplification in the preamplifier 103”) and enable the thermoacoustic preamplifier in thermoacoustic mode (Hashimoto, Para 41; “In a case where the photoacoustic waves are detected, the controller 28 causes the preamplifier 103 to enter the operating state. Further, the controller 28 selects a path (a first path) in which the detection signal is amplified by the preamplifier 103 and then is input to the reception circuit 21, as a signal path between the acoustic wave detector 101 and the reception circuit 21. Specifically, the controller 28 selects the first path by opening the selection switch 105 so that the input node and the output node of the preamplifier 103 are not short-circuited. In a case where the photoacoustic waves are detected, it is possible to improve a signal to noise ratio (an SN ratio) of the detection signal of the photoacoustic wave that is sampled in the reception circuit 21 and used in subsequent signal processing by amplifying the detection signal of a weak photoacoustic wave using the preamplifier 103”) (Hashimoto, Para 36; “The transmission and reception changeover switch 106 switches a connection destination of the acoustic wave detector 101 between the preamplifier 103 (an input node thereof) and the transmission circuit 29 (an output node thereof) arranged in the ultrasonic unit 12 (see FIG. 1)”);.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama wherein the instrument is configured with a plurality of electronic switches used to bypass the thermoacoustic preamplifier in ultrasound mode and enable the thermoacoustic preamplifier in thermoacoustic mode; in order to amplify the weaker photoacoustic signal and reduce heat generation in the ultrasound signal where improvements by the pre-amplifier are generally small as taught by Hashimoto (Hashimoto, Para 80).
The prior art is interpreted as disclosing this limitation in the claims because as discussed previously Kanayama discloses a thermoacoustic preamplifier in an analog signal chain (Figure 2) and Hashimoto modifies Kanayama wherein the instrument is configured with a plurality of electronic switches used to bypass the thermoacoustic preamplifier in ultrasound mode and enable the thermoacoustic preamplifier in thermoacoustic mode.
In an analogous photoacoustic and ultrasound imaging device field of endeavor DaCosta discloses an analog front end for providing analog to digital conversion of input signals (DaCosta, Para 106; “The raw radio-frequency (RF) US and PA data may be digitized in the analog front-end”).
The use of the techniques of an analog front end taught by DaCosta in the invention of a photoacoustic imaging device would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of performing analog to digital conversion with an analog front end; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama as modified by Hashimoto above to use an analog front end for providing analog to digital conversion of input signals as taught by DaCosta in order to improve the quality of measured information.
The prior art is interpreted as disclosing analog front-end channels used in both ultrasound and thermoacoustic modalities because Kanayama is modified by DaCosta to use analog front-end channels above for both PA and US signals (DaCosta, Para 106; “The raw radio-frequency (RF) US and PA data may be digitized in the analog front-end”).
In analogous ultrasound imaging field of endeavor Solek discloses wherein an instrument is configured to use a plurality of high-voltage protection switches and bypass switches (Solek, Para 57; “the Tx/Rx switches can be used to connect a selected set of the MUTs to either the pulser 224 or the analog summing, amplification and processing circuitry 215. When a high voltage pulse is produced by the pulser 224, the Tx/Rx switches would automatically block the high voltage from damaging the analog summing, amplification and processing circuitry 215. When the HV pulser 224 is not producing a pulse, the Tx/Rx switches would disconnect the selected set of MUTs from the pulser 224, and to connect the selected set of MUTs to the analog summing, amplification and processing circuitry 215.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama as modified by Hashimoto and DaCosta above wherein the instrument is configured to use a plurality of high-voltage protection switches and bypass switches in order to prevent damage to the circuitry as taught by Solek (Solek, Para 57).
Regarding claim 3, Kanayama as modified by Hashimoto, DaCosta, and Solek above discloses all of the limitations of claim 1 as discussed above.
Kanayama does not clearly and explicitly disclose wherein one or more of the instrument's components are integrated into a portable and/or battery-operated device.
However, DaCosta further discloses wherein one or more of an instrument's components are integrated into a portable (DaCosta, Para 16; “In at least one embodiment, the probe is portable and handheld”) (DaCosta, Para 134; “The multi-modal imaging system described herein that integrates US, PA and FL imaging into a single device has been shown to be suitable for in vivo imaging in animal models and is compact and lightweight enough for handheld use”) and/or battery-operated device (DaCosta, Para 83; “The power unit 26 can be any suitable power source that provides power to the operator unit 12 such as a power adaptor or a rechargeable battery pack depending on the implementation of the operator unit 12 as is known by those skilled in the art”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama as modified by Hashimoto, DaCosta, and Solek above wherein one or more of the instrument's components are integrated into a portable and/or battery-operated device in order to allow for clinical use as taught by DaCosta (DaCosta, Para 72) and to allow for easier maneuvering of the device by the user.
Regarding claim 4, Kanayama as modified by Hashimoto, DaCosta, and Solek above discloses all of the limitations of claim 1 as discussed above.
Kanayama does not clearly and explicitly disclose wherein one or more of the instrument's components are integrated into a handheld device.
However, DaCosta further discloses wherein one or more of the instrument's components are integrated into a handheld device (DaCosta, Para 16; “In at least one embodiment, the probe is portable and handheld”) (DaCosta, Para 134; “The multi-modal imaging system described herein that integrates US, PA and FL imaging into a single device has been shown to be suitable for in vivo imaging in animal models and is compact and lightweight enough for handheld use”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama as modified by Hashimoto, DaCosta, and Solek above wherein one or more of the instrument's components are integrated into a handheld device in order to allow for clinical use as taught by DaCosta (DaCosta, Para 72) and to allow for easier maneuvering of the device by the user.
Regarding claim 5, Kanayama as modified by Hashimoto, DaCosta, and Solek above discloses all of the limitations of claim 1 as discussed above.
Kanayama does not clearly and explicitly disclose wherein the plurality of HV protection and bypass switches are integrated inside a pulser/beamformer circuit.
In analogous ultrasound imaging field of endeavor Solek discloses wherein a plurality of high-voltage protection switches and bypass switches are integrated inside a pulser/beamformer circuit (Solek, Para 57; “the Tx/Rx switches can be used to connect a selected set of the MUTs to either the pulser 224 or the analog summing, amplification and processing circuitry 215. When a high voltage pulse is produced by the pulser 224, the Tx/Rx switches would automatically block the high voltage from damaging the analog summing, amplification and processing circuitry 215. When the HV pulser 224 is not producing a pulse, the Tx/Rx switches would disconnect the selected set of MUTs from the pulser 224, and to connect the selected set of MUTs to the analog summing, amplification and processing circuitry 215.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama as modified by Hashimoto, DaCosta, and Solek wherein the plurality of HV protection and bypass switches are integrated inside a pulser/beamformer circuit in order to prevent damage to the circuitry as taught by Solek (Solek, Para 57).
Regarding claim 6, Kanayama as modified by Hashimoto, DaCosta, and Solek above discloses all of the limitations of claim 1 as discussed above.
Kanayama does not clearly and explicitly disclose wherein the instrument is configured such that when the instrument operates in ultrasound receive mode or thermoacoustic mode, the pulser/beamformer is idle allowing received signals through while having said HV circuitry disconnected; and when the instrument operates in ultrasound transmit mode, the pulser/beamformer is connected to HV circuitry, is actively applying electromagnetic energy to said transducer or said transducer array, and is disconnected from the thermoacoustic preamplifier and the analog front end.
However, Solek further discloses wherein an instrument is configured such that when the instrument operates in ultrasound receive mode, the pulser is idle allowing received signals through while having its HV circuitry disconnected; and when the instrument operates in ultrasound transmit mode, the pulser, is actively applying electromagnetic energy to said transducer or said transducer array, and is disconnected from receive circuitry (Solek, Para 57; “the Tx/Rx switches can be used to connect a selected set of the MUTs to either the pulser 224 or the analog summing, amplification and processing circuitry 215. When a high voltage pulse is produced by the pulser 224, the Tx/Rx switches would automatically block the high voltage from damaging the analog summing, amplification and processing circuitry 215. When the HV pulser 224 is not producing a pulse, the Tx/Rx switches would disconnect the selected set of MUTs from the pulser 224, and to connect the selected set of MUTs to the analog summing, amplification and processing circuitry 215.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama as modified by Hashimoto, DaCosta, and Solek above wherein the instrument is configured such that when the instrument operates in ultrasound receive mode or thermoacoustic mode, the pulser/beamformer is idle allowing received signals through while having said HV circuitry disconnected; and when the instrument operates in ultrasound transmit mode, the pulser/beamformer is connected to HV circuitry, is actively applying electromagnetic energy to said transducer or said transducer array, and is disconnected from the thermoacoustic preamplifier and the analog front end in order to prevent damage to the circuitry as taught by Solek (Solek, Para 57).
The prior art is interpreted as disclosing disconnected from the analog front end because Kanayama is modified by DaCosta to use an analog front end as part of its receive circuitry and Solek modifies Kanayama to disconnect receive circuitry during HV transmission to prevent damage.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kanayama, Hashimoto, DaCosta, and Solek as applied to claim 1 above, and in further view of Hashimoto et al. (US20180199820, hereafter Hashimoto ‘820).
Regarding claim 2, Kanayama as modified by Hashimoto, DaCosta, and Solek above discloses all of the limitations of claim 1 as discussed above.
Kanayama does not clearly and explicitly disclose wherein the thermoacoustic preamplifier of said thermoacoustic data acquisition unit is placed within a housing incorporating said transducer or said transducer array.
In an analogous photoacoustic imaging device field of endeavor Hashimoto ‘820 discloses in Figure 2 wherein a thermoacoustic preamplifier (preamplifier 44) of a thermoacoustic data acquisition unit is placed within a housing incorporating a transducer or transducer array (transducer array 20) (Hashimoto ‘820, Figure 2; showing this) (Hashimoto ‘820, Para 49; “In the present embodiment, the transducer array 20 also functions as an ultrasound wave transmission element. The transducer array 20 is connected to a preamplifier 44 to be described later, a circuit for ultrasound wave transmission, a circuit for acoustic wave reception, and the like through a terminal 41 and a wiring 42”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kanayama as modified by Hashimoto, DaCosta, and Solek above wherein said pulser and/or thermoacoustic preamplifier are placed within a housing incorporating said transducer or said transducer array wherein the thermoacoustic preamplifier of said thermoacoustic data acquisition unit is placed within a housing incorporating said transducer or said transducer array in order to allow efficient use of one heat management system to be used for both the transducers and the circuitry as taught by Hashimoto ‘820 (Hashimoto ‘820, Para 10-13).
Conclusion
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/JOHN D LI/Primary Examiner, Art Unit 3798