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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/05/2026 has been entered.
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 1-5, 8-11, 14-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoseit et al. (US 2014/0275844; hereinafter Hoseit), in view of Sabata (US 2011/0015523).
Regarding claim 1, Hoseit discloses an universal patient interface module and associated devices, systems and method. Hoseit shows an intraluminal ultrasound system (see abstract; fig. 1-3), comprising: a first intraluminal imaging device comprising a first ultrasound imaging component (see 108 in fig. 1, 216 in fig. 2 and 906 in fig. 9; par. [0040]); a patient interface module (see par. [0035], [0062]; 114 in fig. 1, 300 in fig. 3, 800 in fig. 4 & 8 and 900 in fig. 8-9) configured for communication with the first intraluminal imaging device (see fig. 1, 2 and 9) and a different, second intraluminal imaging device comprising a second ultrasound imaging component (see 110 in fig. 1, 218 in fig. 2, and 908 in fig. 9; par. [0040]); wherein the PIM comprises: a controller (see fig. 4 and 8; par. [0043]-[0045], [0057]); and a memory (see fig. 4 and 8; par. [0043]-[0045], [0057]) configured to store a first parameter configuration specific to the first ultrasound imaging component (see “first configuration” in par. [0061], [0071], [0076]) and a different, second parameter configuration specific to the second ultrasound imaging component (see “second configuration” in par. [0061], [0071]); wherein, when the PIM is in communication with the first intraluminal imaging device, the controller of the PIM is configured to: read first device information from the first intraluminal imaging device, wherein the first device information is representative of the first ultrasound imaging component (see par. [0044], [0061], [0071]); retrieve, based on the first device information, the stored first parameter configuration from the memory of the PIM (see par. [0044], [0057], [0059], [0060], [0061], [0071]); and control, using the retrieved first parameter configuration, the first ultrasound imaging component to produce first ultrasound wave emissions (see par. [0044], [0057], [0059], [0060], [0061], [0071]), wherein, when the PIM is in communication with the second intraluminal imaging device, the controller of the PIM is configured to: read second device information from the second intraluminal imaging device, wherein the second device information is representative of the second ultrasound imaging component (see par. [0044], [0061], [0071]); retrieve, based on the second device information, the stored second parameter configuration from the memory of the PIM (see par. [0044], [0058], [0059], [0060], [0061], [0071]); and control, using the retrieved second parameter configuration, the second ultrasound imaging component to produce second ultrasound wave emissions (see par. [0044], [0058], [0059], [0060], [0061], [0071]).
Furthermore, Hoseit shows wherein the intraluminal ultrasound imaging system is configured to perform transmit operations associated with transmission of ultrasound energy into anatomy and receiver operations associated with ultrasound echo received from patient anatomy (see par. [0044], [0057], [0059], [0060], [0061], [0071])). Furthermore, as stated above, Hoseit shows plurality of intraluminal imaging devices (see fig. 3) and these intraluminal imaging devices would require instructions for control transmission operation (fig. 3 shows memory 308 and control processor 306, and the memory and control processor would store control transmission operation), but Hoseit does not explicitly discloses that the first and second parameter configures are transmit parameters, that the memory storing control transmission operations, and wherein the first ultrasound wave emissions and the second ultrasound wave emissions are different from one another based on a difference between the first transmit parameter configuration and the second transmit parameter configuration.
Sabata discloses ultrasound observation apparatus. Sabata teaches memory storing first parameter configuration (see 39B-C, 52 and 56 in fig. 1)) and second parameter configuration (see 39B-C, 41 and 44 in fig. 1), and that the first and second parameter configuration are configured to control transmit operations (see par. [0079], [0087]), wherein the first ultrasound wave emissions and the second ultrasound wave emissions are different from one another based on a difference between the first transmit parameter configuration (see par. [0085], [0087]) and the second transmit parameter configuration (see par. [0078], [0079], [0082]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of that the first and second parameter configures are transmit parameters, that the memory storing control transmission operations, and wherein the first ultrasound wave emissions and the second ultrasound wave emissions are different from one another based on a difference between the first transmit parameter configuration and the second transmit parameter configuration in the invention of Hoseit, as taught by Sabata, to be able to specifically control the different intraluminal imaging devices for different types of imaging.
Regarding claim 2, Hoseit shows a host system separate from and configured for communication with the PIM (see 106 and 116 in fig. 2; par. [0037]); the host system is configured to generate a first ultrasound image associated with the first ultrasound wave emissions (see par. [0032], [0033], [0036], [0060], [0061]); and generate a second ultrasound image associated with the second ultrasound wave emissions ((see par. [0032], [0033], [0036], [0060], [0061]).
Regarding claim 3, Hoseit shows further comprising a display configured for communication with the host system (see par. [0030], [0035]; fig. 1-3), wherein the display is configured to display the first and second ultrasound image (see par. [0030], [0035]; fig. 1-3).
Regarding claim 4, Hoseit shows wherein the first intraluminal imaging device comprising a first IVUS catheter (see par. [0040]); and wherein the second intraluminal imaging device comprises a second IVUS catheter (see par. [0040]).
Regarding claim 5, Hoseit shows wherein the first IVUS catheter comprising an array IVUS catheter (see par. [0048]); and the second IVUS catheter comprises a rotational IVUS catheter (see par. [0048]).
Regarding claim 8, Hoseit shows further comprising the second intraluminal imaging device (see fig 1 and 2).
Regarding claim 9, Hoseit shows wherein, to control the first ultrasound imaging component to produce first ultrasound wave emissions, the PIM is configured to generate a first trigger signal based on the retrieved first parameter configuration (see fig. 11-12; par. [0060], [0061], [0073]-[0076]), wherein, to control the second ultrasound imaging component to produce second ultrasound wave emissions, the PIM is configured to generate a different, second trigger signal based on the retrieved second parameter configuration (see fig. 11-12; par. [0060], [0061], [0073]-[0076]), and as stated above for claim 1, Sabata teaches that the first and second parameter configuration are configured to control transmit operations (see par. [0079], [0087]).
Regarding claim 10, Hoseit shows wherein the first ultrasound wave emissions comprise a first waveform (see fig. 11-12; par. [0036], [0060], [0061] [0073]-[0076]), and wherein the second ultrasound wave emissions comprise a different, second waveform (see fig. 11-12; par. [0036], [0060], [0061], [0073]-[0076]), and Sabata teaches wherein the first and second waveform differ in a number of pulses (see par. [0057], [0058], [0086], [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the first and second waveform differ in a number of pulses in the invention of Hoseit, as taught by Sabata, to be able to specifically control the different intraluminal imaging devices for different types of imaging.
Regarding claim 11, Hoseit shows wherein the PIM is configured to: detect whether the first intraluminal imaging device or the second intraluminal imaging device is attached (see par. [0044], [0061], [0071]); and determine whether to retrieve the first parameter configuration or the second parameter from the memory of the PIM based on the detection (see par. [0044], [0061], [0071]), and as stated above for claim 1, Sabata teaches that the first and second parameter configuration are configured to control transmit operations (see par. [0079], [0087]).
Regarding claim 14, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Sabata teaches wherein the first and second waveform differ in a number of pulses (see par. [0057], [0058], [0086], [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the first and second waveform differ in a number of pulses in the invention of Hoseit, as taught by Sabata, to be able to specifically control the different intraluminal imaging devices for different types of imaging.
Regarding claim 15, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Hoseit teaches non-volatile memory storing the first (see par. [0030], [0044]) and second parameter configuration (see par. [0030], [0044]).
Regarding claim 16, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Hoseit shows that the PIM comprises a FPGA (see par. [0043]), and Sabata teaches that the FPGA comprising a plurality of registers (see par. [0069], [0070], [0071], [0093], [0107], [0108], [0160], [0161]), wherein the controller of the PIM is configured to load values of the first transmit parameter configuration into the plurality of registers (see par. [0069], [0070], [0071], [0093], [0107], [0108], [0160], [0161]), and wherein the first trigger signal is generated based on the values of the plurality of registers (see par. [0069], [0070], [0071], [0093], [0107], [0108], [0160], [0161]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of FPGA comprising a plurality of registers, wherein the controller of the PIM is configured to load values of the first transmit parameter configuration into the plurality of registers, and wherein the first trigger signal is generated based on the values of the plurality of registers in the invention of Hoseit, as taught by Sabata, to provide a synchronized operations between the two different imaging devices.
Regarding claim 17, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Sabata teaches wherein the first trigger signal comprises a plurality of pulses (see fig. 4-6, 9), each pulse of the plurality of pulses comprising a first signal zone having a first duration (see fig. 4-6, 9) and a first signal level (see fig. 4-6, 9) and a second signal zone having a second duration (see fig. 4-6, 9) and a second signal level (see fig. 4-6, 9), and wherein the first transmit parameter configuration comprises values of the first duration (see fig. 4-6, 9), the first signa l (see fig. 4-6, 9), the second duration (see fig. 4-6, 9), the second signal level (see fig. 4-6, 9), and a number of the plurality of pulses (see fig. 4-6, 9).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the first trigger signal comprises a plurality of pulses , each pulse of the plurality of pulses comprising a first signal zone having a first duration and a first signal level and a second signal zone having a second duration and a second signal level , and wherein the first transmit parameter configuration comprises values of the first duration, the first signal, the second duration, the second signal level, and a number of the plurality of pulses in the invention of Hoseit, as taught by Sabata, to be able to specifically control the different intraluminal imaging devices for different types of imaging provide, and provide a synchronized operations between the two different imaging devices.
Regarding claim 19, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Hoseit shows wherein the first device information comprises a catheter type of the first intraluminal imaging device (see par. [0071).
Regarding claim 20, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Sabata teaches receive, during an imaging procedure performed using the first intraluminal imaging device, a user input modifying a waveform parameter (see par. [0095], [0096], [0104], [0108], [0145]); generate an updated first trigger signal based on the modified waveform parameter (see par. [0095], [0096], [0104], [0108], [0145]); and apply the updated first trigger signal to the first ultrasound imaging component during the imaging procedure (see par. [0095], [0096], [0104], [0108], [0145]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of receive, during an imaging procedure performed using the first intraluminal imaging device, a user input modifying a waveform parameter; generate an updated first trigger signal based on the modified waveform parameter; and apply the updated first trigger signal to the first ultrasound imaging component during the imaging procedure in the invention of Hoseit, as taught by Sabata, to be able to specifically control the different intraluminal imaging devices for different types of imaging.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hoseit et al. (US 2014/0275844), in view of Sabata (US 2011/0015523) as applied to claims 1 and 4 above, and further in view of in view of Hubbard et al. (US 2013/0303910).
Regarding claim 6, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Hoseit shows an array of transducer elements (see par. [0048], but fails to explicitly state a single transducer element ultrasound imaging component.
Hubbard discloses an ultrasound flow imaging. Hubbard teaches a single transducer element ultrasound imaging device (see par. [0053], [0061]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a single transducer element ultrasound imaging device in the invention of Hoseit and Sabata, as taught by Hubbard, to be able to prove an image of the vessel with just one transducer element which would save cost by avoiding needing to an array of transducer elements.
Regarding claim 7, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Hoseit shows IVUS catheter configured for imaging a peripheral vessel (see par. [0028]), but fails to explicitly state IVUS catheter configured to image a coronary vessel.
Hubbard discloses an ultrasound flow imaging. Hubbard teaches imaging coronary vessel (see par. [0090], [0091]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of imaging coronary vessel in the invention of Hoseit and Sabata, as taught by Hubbard, to be able to detect disease in coronary artery.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hoseit et al. (US 2014/0275844), in view of Sabata (US 2011/0015523) as applied to claim 1 above, and further in view of Elbert (US 2014/0343434).
Regarding claim 12, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Hoseit teaches memory storing first device information (see fig. 3) and second device information (see fig. 3).
But, Hoseit fails to explicitly state that the first and second intraluminal imaging device comprising the memory devices.
Elbert discloses a catheter with embedded memory in IVUS system. Elbert teaches that processor configured to read device information from a memory of the imaging device (see par. [0020], [0026], [0027]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the processor configured to read device information from a memory of the imaging device in the invention of Hoseit and Sabata, as taught by Elbert, to be able to access transducer information such as usage time, date, duration, and other transducer-specific information which is useful for cather operation.
Claim 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoseit et al. (US 2014/0275844), in view of Sabata (US 2011/0015523) as applied to claims 1, 9 and 16 above, and further in view of in view of Melodia et al. (US 2018/0027077; hereinafter Melodia).
Regarding claim 18, Hoseit and Sabata disclose the invention substantially as described in the 103 rejection above, furthermore, Sabata teaches generating the first trigger signal based on the values in the plurality of registers (see par. [0069], [0070], [0071], [0093], [0107], [0108], [0160], [0161]), fails to explicitly state that the FPGA comprises a plurality of counters and a finite state machine.
Melodia discloses an ultrasound device and teaches plurality of counters (see par. [0177) and a finite state machine (see par. [0177). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of plurality of counters and a finite state machine in the invention of Hoseit and Sabata, as taught by Melodia, to provide a automated change to different imaging system in response to inputs.
Response to Arguments
Applicant's arguments filed 08/05/2026have been fully considered but they are not persuasive.
In response to Applicant’s argument on pages 8-9, with respect to prior arts Hoseit and Sabata, the examiner respectfully disagrees.
On page 9, the Applicant argues that that the first and second configuration of Hoseit are receive-side configurations and prior art Sabata does not teaches transmit-side hardware but does not teach memory storing transmit configuration, the examiner respectfully disagrees. Hoseit does teach first and second configuration which are directed to transmit-side configuration too (in par. [0061], [0071], [0076], Hoseit mention upon detecting which type of the imaging device, the PIM controls the imaging device according to the first and second configuration which are saved in the memory. With respect to prior art Sabata, the examiner notes that the transmit side electronics (see 39B-C, 41, 44, 52, 56 in fig. 1) would save the transmit configuration for the two different ultrasound imaging devices to properly control the transmission of the imaging devices.
Conclusion
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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