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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 11, 14, and 20 are objected to because of the following informalities:
Claim 11 is objected to because the claim recites the micro-cables in an active state of carrying (i.e., “interiors of the micro-cables carry the voltage pulses …”), thus reading on an activity as opposed to clearly setting forth a structural feature of the claimed micro-cables. Examiner suggests amending the claim to recite that the micro-cables are “configured to carry” the pulses.
Claim 14 is objected to because the claim recites the amplifier in an active state of receiving (i.e., “the dual-stage amplifier receives…”), thus reading on an activity as opposed to clearly setting forth a structural feature of the claimed system. Examiner suggests amending the claim to recite that the dual-stage amplifier “is configured to receive” the echoes.
Claim 20 is objected to because ASIC should be defined, as in claim 12.
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 3 - 4, 9 - 11, and 15 - 20 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 3 is indefinite because there is insufficient antecedent basis for “the integrated circuit”. It is unclear what circuit is being referred to.
Claim 4 is indefinite by virtue of dependency.
Claim 9 is indefinite because there is insufficient antecedent basis for “the output voltage”. It is unclear what voltage is being referred to.
Claim 10 is indefinite because there is insufficient antecedent basis for “the micro-cables configured to connect the transducer and the interface chip with a power source and a controller”. The micro-cables have not been set forth as being so configured. It is unclear if the claimed configuration is required or not.
Claim 11 is indefinite by virtue of dependency.
Claim 15 is indefinite because it is unclear what is meant by “an ultrasound transducer of an intravascular ultrasound” in the preamble. The limitation appears to be missing one or more words. It is unclear what is being referred to by “an intravascular ultrasound”.
Claims 16 - 20 are indefinite by virtue of dependency.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 14 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 14 reads on a human organism because the claim recites that the “dual-stage amplifier receives sub-mV echoes from targets less than 3 mm away from the ultrasound transducer”, thus requiring “targets less than 3 mm away from the ultrasound transducer” as part of the claimed system. Examiner suggests amending the claim to recite that the dual-stage amplifier “is configured to receive” the echoes, as noted in the claim objections above.
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.
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 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 - 6, 8, and 12 - 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fleischman (US 2022/0330913, of record) in view of Singh et al. (US 2018/0360426).
Regarding claim 1, Fleischman shows a system comprising:
an intravascular ultrasound (IVUS) catheter (“intravascular ultrasound … catheter”, [0045]);
an ultrasound transducer (transducer assembly 10, [0045] and fig. 1) with a broad excitation bandwidth (“… wide-bandwidth … broadband …”, [0043]); and
an interface chip (computer chips, [0053]) sized to be integrated within a tip of the IVUS catheter (“… catheter … that the H-IVUS transducer assembly 10 can reside … within”, [0045]; “… form factors for placement within a 3 F catheter…”, [0053]; standard 1 mm catheter, [0072], [0089]) to connect micro-cables within the IVUS catheter to the ultrasound transducer (“… attached to fine wire cables …”, [0053]) and comprising an amplifier (amplifier, [0046], [0058]; “one or more front-end interface amplifiers”, [0064]; “Low Noise Amplifier (LNA) and Buffer”, [0085] - [0086]) having a pulsing mode configured to withstand voltage pulses greater than a voltage on a level of volts during pulsing (“… withstand high-voltage pulses during imaging, while retaining low noise amplification of acoustic echoes from tissue targets …”, [0071]; [0072] - [0075]) and an echo reception mode configured to receive sub-mV echoes during echo reception ([0071]; [0072] - [0075]; “… amplifier to recover quickly post-pulsing to receive the small signal echo from tissue…”, [0094] - [0095]).
Fleischman is not specific to the amplifier comprising a dual-stage amplifier.
Singh discloses a multi-stage trans-impedance amplifier for an ultrasound device. Singh teaches an amplifier that comprises a dual-stage amplifier (multi-stage trans-impedance amplifier, abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleischman to have the amplifier comprise a dual-stage amplifier, as taught by Singh, in order to facilitate low power consumption and provide a desired output gain, as suggested by Singh ([0012]).
Regarding claim 2, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the amplifier comprises an active limiter (active limiter, [0074], [0077], [0080] - [0082]) configured to switch between the pulsing mode and the echo reception mode quickly; and a buffer (buffer, [0072] - [0074]).
Fleischman is silent as to the amplifier comprising a transimpedance amplifier.
Singh teaches an amplifier that comprises a transimpedance amplifier (multi-stage trans-impedance amplifier, abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleischman to have the amplifier comprise a transimpedance amplifier, as taught by Singh, in order to further facilitate low power consumption and provide a desired output gain, as suggested by Singh ([0012]).
Regarding claim 3, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the amplifier comprises an off-chip high voltage coupling capacitor (“High Voltage Coupling Capacitor”, [0076] - [0079]; isolated high voltage capacitor, [0089]) configured to protect the integrated circuit from damage due to the voltage pulses greater than the voltage on a level of 30 VPP or more during pulsing (“…withstand high-voltage pulses during imaging, while retaining low noise amplification of acoustic echoes from tissue targets”, [0071]; voltage tolerance, [0079]) and to demonstrate low distortion during the echo reception (note: the amount of distortion during the echo reception is interpreted as being “low”, lacking any further limiting features of the claim).
Regarding claim 4, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further suggests the amplifier and the off-chip high voltage coupling capacitor are in a shunt duplexer connection to the ultrasound transducer (“FIG. 10 is a diagram of a shunt duplicator (a) and a series duplicator (b), both using an active limiter from the experiment described below”, [0015]; shunt/series-duplexer topology, [0073]).
Regarding claim 5, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the amplifier has a series duplexer connection to the ultrasound transducer (“FIG. 10 is a diagram of a shunt duplicator (a) and a series duplicator (b), both using an active limiter from the experiment described below”, [0015]; shunt/series-duplexer topology, [0073]; series-duplexer topology, [0077]).
Regarding claim 6, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the active limiter comprises a clamping limiter (“active limiter clamps the voltage below the FET gate breakdown voltage during the pulsing period …”, [0081]).
Regarding claim 8, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the active limiter is activated by feedback from the transimpedance amplifier or the buffer (resistive feedback, [0086]).
Regarding claim 12, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the amplifier is an analog front end (AFE) application specific integrated circuit (ASIC) on the interface chip (analog front end (AFE) application specific integrated circuit (ASIC), [0013]; [0064]; [0071]).
Regarding claim 13, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the amplifier is sized to fit within a diameter of the IVUS catheter of 1 mm or less (within a standard 1 mm diameter catheter, [0072], [0089]).
Regarding claim 14, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the amplifier is configured to receive sub-mV echoes from targets less than 3 mm away from the ultrasound transducer (image blood vessel walls only 0.5 mm away from the tip of the catheter, [0094]).
Regarding claim 15, Fleischman shows an amplifier (amplifier, [0046], [0058], [0064]; “Low Noise Amplifier (LNA) and Buffer”, [0085] - [0086]) that connects an ultrasound transducer (transducer assembly 10, [0045] and fig. 1) of an intravascular ultrasound (“intravascular ultrasound … catheter”, [0045]) with a controller (implicit during use of the IVUS catheter), the amplifier comprising:
an active limiter (active limiter, [0074], [0077], [0080] - [0082]) comprising a pulsing channel configured to withstand voltage pulses greater than a voltage on a level of volts (“… withstand high-voltage pulses during imaging, while retaining low noise amplification of acoustic echoes from tissue targets …”, [0071]; [0072] - [0075]) and an echo reception channel configured to receive sub-mV echoes ([0071]; [0072] - [0075]; “… amplifier to recover quickly post-pulsing to receive the small signal echo from tissue…”, [0094] - [0095]); and
a buffer (buffer, [0072] - [0074]), wherein the amplifier is configured to fit within a tip of an intravascular ultrasound (IVUS) catheter (“… catheter … that the H-IVUS transducer assembly 10 can reside … within”, [0045]; “… form factors for placement within a 3 F catheter…”, [0053]; standard 1 mm catheter, [0072], [0089]).
Fleischman is not specific to the amplifier comprising a dual-stage amplifier comprising a transimpedance amplifier.
Singh discloses a multi-stage trans-impedance amplifier for an ultrasound device. Singh teaches an amplifier that comprises a dual-stage amplifier comprising a transimpedance amplifier (multi-stage trans-impedance amplifier, abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleischman to have the amplifier comprise a dual-stage amplifier comprising a transimpedance amplifier, as taught by Singh, in order to facilitate low power consumption and provide a desired output gain, as suggested by Singh ([0012]).
Regarding claim 16, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the active limiter is configured to protect the amplifier from an excitation pulse input greater than 30 VPP during pulsing (“…withstand high-voltage pulses during imaging, while retaining low noise amplification of acoustic echoes from tissue targets”, [0071]; voltage tolerance, [0079]) and provide low distortion during echo reception (note: the amount of distortion during the echo reception is interpreted as being “low”, lacking any further limiting features of the claim).
Regarding claim 17, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the active limiter is in shunt duplexer or a series-duplexer connection with the ultrasound transducer of an intravascular ultrasound (IVUS) system (“FIG. 10 is a diagram of a shunt duplicator (a) and a series duplicator (b), both using an active limiter from the experiment described below”, [0015]; shunt/series-duplexer topology, [0073]; series-duplexer topology, [0077]).
Regarding claim 18, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further suggests the active limiter is in a shunt duplexer connection with the ultrasound transducer of an intravascular ultrasound (IVUS) system (“FIG. 10 is a diagram of a shunt duplicator (a) and a series duplicator (b), both using an active limiter from the experiment described below”, [0015]; shunt/series-duplexer topology, [0073]), the shunt duplexer connection further comprising an off-chip high voltage coupling capacitor (“High Voltage Coupling Capacitor”, [0076] - [0079]; isolated high voltage capacitor, [0089]).
Regarding claim 19, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the active limiter is the active limiter is configured for symmetrical switching (implicit, lacking any further limiting details), and is activated by hysteresis enabled positive feedback from the buffer and/or the transimpedance amplifier (resistive feedback, [0086]).
Regarding claim 20, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the amplifier is a custom analog front end (AFE) application specific integrated circuit (ASIC) (analog front end (AFE) application specific integrated circuit (ASIC), [0013]; [0064]; [0071]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fleischman and Singh as applied to claim 2 above, and further in view of Popek (US 5,164,627).
Regarding claim 7, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above.
Fleischman is silent as to whether or not the buffer is at least a 50 Ohm buffer.
Popek discloses acoustic signal processing systems. Popek suggests a buffer is at least a 50 Ohm buffer (col. 3, lines 5 - 10).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleischman and Singh to have the buffer be at least a 50 Ohm buffer, as suggested by Popek, in order to bring the impedance seen by downstream signal processing circuity up to standard, as suggested by Popek (col. 3, lines 5 - 10).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fleischman and Singh as applied to claim 8 above, and further in view of King (US 2015/0320533).
Regarding claim 9, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows a swing of the output voltage is restricted to an absolute value of a threshold voltage for a component of the amplifier to provide voltage clamping while preventing damage to the component (active limiter clamps the voltage below the FET gate breakdown voltage during the pulsing period, [0081]).
Fleischman fails to show the component is a MOSFET.
King discloses ultrasound techniques. King teaches a component that is a MOSFET (amplifier 220 includes any suitable structure for amplifying signals, such as one or more MOSFET transistors forming a radio frequency (RF) amplifier, [0030]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleischman and Singh to have the component be a MOSFET, as taught by King, in order to use suitable structures for amplifying the signals, as suggested by King ([0030]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fleischman and Singh as applied to claim 1 above, and further in view of Kahlman et al. (US 2024/0115231).
Regarding claim 10, the combined invention of Fleischman and Singh discloses the claimed invention substantially as noted above. Fleischman further shows the micro-cables configured to connect the transducer and the interface chip with a power source and a controller (“…fine wire cables …”, [0053]).
Fleischman is not specific to the micro-cables having a length of one meter or more.
Kahlman discloses intravascular ultrasound techniques. Kahlman teaches micro-cables having a length of one meter or more (length of two metres or more, [0036]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleischman and Singh to have the micro-cables have a length of one meter or more, as taught by Kahlman, in order to ensure that the power and control signals can reach the transducer as the catheter is used within the patient’s body, as is well-understood in the art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fleischman, Singh, and Kahlman as applied to claim 10 above, and further in view of Macaraeg et al. (US 2021/0330370).
Regarding claim 11, the combined invention of Fleischman, Singh, and Kahlman discloses the claimed invention substantially as noted above. Fleischman further shows the micro-cables are two micro-cables, having interiors configured to carry the voltage pulses to the transducer and an echo output to the controller (“…fine wire cables …”, [0053]).
Fleischman fails to show that the micro-cables comprise shield connections that are shared for power and ground.
Macaraeg discloses ultrasound techniques. Macaraeg teaches micro-cables comprising shield connections (abstract; TRS connector, [0147]) that are shared for power and ground ([0056]; [0089]; [0138]; [0296]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleischman, Singh, and Kahlman to have the micro-cables comprise shield connections that are shared for power and ground, as taught by Macaraeg, in order to use an appropriate connector for the micro-cables to ensure adequate power and ground connection, as is understood in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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