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 .
Election/Restrictions
Applicant’s election without traverse of Invention II, Species A, and Species C in the reply filed on 05/22/2026 is acknowledged.
Claims 1-4 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/22/2026.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/375,206, PCT/US2023/073675, and 19109041, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, it is noted that the provisional application, ‘206, does not provide any textual nor implied support for the multiple-modality system configured to determine a modality to use based on the type of catheter coupled to the catheter handle. Specifically, it is noted that while there appears to be disclosure that a catheter handle may connect to different types of catheters, the disclosure is silent with respect to any determining of a modality to use and/or any disclosed steps/algorithms for how such a determination would occur. Examiner notes that while ‘675 and ‘041 appear to include disclosure of a method which includes receiving an indication for the type of catheter connected to a catheter handle and determining a modality to use to operate the catheter based on the indication in for example [0021] and further includes disclosure that the type of catheter being used can be automatically sensed or determined, or selected by a user, such that the modality corresponding to the catheter can be used… in [0088] and provides disclosure that the type of catheter is determined by an RFID on the catheter that is sensed by a corresponding RFID sensor on the handle or it can be configured by a physician on the control console in [0082]. Such disclosure is broad and does not provide implicit nor explicit support for a multi-modality system, including modality circuitry module and computing module, that is configured to determine a modality to use based on the type of catheter coupled to the catheter handle as currently recited in claim 5. Examiner thus notes that the effective filing date for the claimed invention is understood to be the filing date of the instant application (03/27/2025).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 recites the limitation “the multiple-modality system comprising: a modality circuitry module; and a computing module; wherein the multiple-modality system is configured to determine a modality to use based on the type of catheter coupled to the catheter handle”. This is understood to be a computer-implemented functional limitation which requires disclosure of the underlying algorithm(s) for obtaining the result in order to comply with the written description requirement. See MPEP § 2161.01(I). Examiner notes that the instant application provides literal textual support for the limitation only in the instant claims, however, there is insufficient written description as to the algorithms/steps taken to perform such a determination of a modality. Examiner further notes that although there is vague detail in the parent applications ‘675 and ‘041 regarding a method which determines a modality to use based on an indication of the type of catheter, and further provides support that an RFID sensor may be used to sense the type of catheter, there is no implicit nor explicit disclosure of how the multiple-modality system makes the determination of the modality to use. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The limitation “computing module” in claim 5 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “module” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “module”) is modified by functional language (“computing”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function. Examiner notes that computing is merely a functional modifier of the “module” which does not provide sufficient structure for the module.
A review of the specification shows that includes microelectronics, such as ASIC, CPU, GPU or FPGA, and other electrical components, and software loaded on a memory chip or a hard drive to process image data acquired from and to send control commands to the catheter 151 or handle 135 ([0077]) appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 5-15 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation “the multiple-modality system comprising: a modality circuitry module; and a computing module; wherein the multiple-modality system is configured to determine a modality to use based on the type of catheter coupled to the catheter handle”. It is unclear which element (modality module, computing module, or other module) of the multiple-modality system is considered to perform the action of determining a modality to use based on the type of catheter. This is further unclear due to the lack of disclosure regarding the limitation as noted above in the 112(a) rejection as it is unclear which element of the multiple-modality system determines the modality and further how such determining is performed. For examination purposes, it has been interpreted to mean any element of the multiple-modality system, however, clarification is required.
Claims 7-9 recite “an intracardiac echocardiography (ICE) catheter coupled to the catheter handle”, “a transthoracic echocardiography (TEE) probe coupled to the catheter handle”, “an intravascular ultrasound (IVUS) catheter coupled to the catheter handle”, respectively. It is unclear if the catheter(s) are the same as the type of catheter coupled to the catheter handle or if these are different catheters. In other words, it is unclear if the claim intends to define different/additional catheters which are coupled to the catheter or if the claim intends to further narrow the type(s) of catheter coupled to the catheter handle and of which the modality to use is based on to be the ICE catheter, the TEE probe, the IVUS catheter, respectively. For examination purposes, it has been interpreted that they may be the same as or different from the type of catheter used in the determination of modality to use, however, clarification is required.
Claim 10 recites the limitation “a radiofrequency (RF) ablation catheter”. It is unclear if the RF ablation catheter is any of the two or more types of catheters recited previously, are the type of catheter coupled to the catheter handle or if this is a different catheter. For examination purposes, it has been interpreted to mean any RF ablation catheter which may or may not be connected to the catheter handle, however, clarification is required.
Claim 11 recites the limitation “an intracardiac echocardiography (ICE) catheter, an intravascular ultrasound (IVUS) catheter, and a radiofrequency (RF) ablation catheter”. It is unclear if the recited catheters are or are included in the two or more types of catheters recited previously, are the type of catheter coupled to the catheter handle or if these are different catheters. For examination purposes, it has been interpreted to mean any catheters which may or may not be connected to the catheter handle, however, clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 5, 7-9 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffman et al. (US 20200323518 A1), hereinafter Hoffman.
Regarding claim 5,
Hoffman teaches a catheter handle (at least fig. 2 (202) and corresponding disclosure in at least [0022] and [0028] which discloses the PIM can comprise a housing having any suitable shape and can be sized and shaped, structurally arranged, and/or otherwise configured for handheld use) configured to be coupled to two or more types of catheters (at least fig. 2 (203-1 through 203-N) and corresponding disclosure in at least [0022] and [0023] which discloses Generally, intraluminal devices 203-1, 203-2 and 203-N can be guidewires, catheters, guide catheters, and/or combinations thereof and further discloses the sensing component of the intraluminal devices 203-1, 203-2 and 203-N can be configured for imaging, such as near infrared (NIR) imaging, optical coherence tomography (OCT), intravascular photoacoustic (IVPA) imaging, transesophageal echocardiography (TEE), and intracardiac echocardiography (ICE));
And
A multiple-modality system ([0036] which discloses multiple components, such as signal amplifiers, signal filters, physical layer signal modulators, and analog to digital converter (ADC)) electrically coupled to the catheter handle, the multiple-modality system comprising:
A modality circuitry module ([0036] which discloses multiple components, such as signal amplifiers, signal filters, physical layer signal modulators, and analog to digital converter (ADC)); and
A computing module ([0036] which discloses multiple components, such as signal amplifiers, signal filters, physical layer signal modulators, and analog to digital converter (ADC));
Wherein the multiple-modality system is configured to determine a modality to use based on the type of catheter coupled to the catheter handle ([0024] which discloses these different configurations allow the PIM 202 to identify the sensor type of the intraluminal device that is currently connected to the PIM 202. Once the sensor type of the intraluminal device is identified, the PIM 202 can, in some implementations, configure itself and the console 201 based on the attributes of the identified sensor type, [0034] which discloses By detecting the change in the plurality of signals carried by the plurality of pins of the PIM connector, the PIM can detect and identify a sensor type of an intraluminal device connected to the PIM and [0036] which discloses In some embodiments, the PIM can include multiple components, such as signal amplifiers, signal filters, physical layer signal modulators, and analog to digital converter (ADC). These components require different parameters to correctly operate with different type of sensors. Configuring the PIM involves at least changing or resetting these parameters so that the PIM can function properly with the connected intraluminal device. In some implementations, the console also needs to be configured by the PIM once the sensor type of the intraluminal device is identified, such that the console can properly process the medical data obtained by the intraluminal device and generate a graphical representation of the medical data. Examiner notes that in order for the PIM to identify, detect, and configure itself and console 201 as disclosed in at least [0024], [0034], and [0036]).
Regarding claim 7,
Hoffman further discloses further comprising an intracardiac echocardiography (ICE) catheter coupled to the catheter handle ([0023] which discloses the sensing component of the intraluminal devices 203-1, 203-2 and 203-N can be configured for imaging, such as near infrared (NIR) imaging, optical coherence tomography (OCT), intravascular photoacoustic (IVPA) imaging, transesophageal echocardiography (TEE), and intracardiac echocardiography (ICE)).
Regarding claim 8,
Hoffman further discloses further comprising a transthoracic echocardiography (TEE) probe coupled to the catheter handle ([0023] which discloses the sensing component of the intraluminal devices 203-1, 203-2 and 203-N can be configured for imaging, such as near infrared (NIR) imaging, optical coherence tomography (OCT), intravascular photoacoustic (IVPA) imaging, transesophageal echocardiography (TEE), and intracardiac echocardiography (ICE)).
Regarding claim 9,
Hoffman further discloses further comprising an intravascular ultrasound (IVUS) catheter coupled to the catheter handle ([0022] which discloses the first, second and N.sup.th intraluminal devices 203-1, 203-2 and 203-N may be IVUS devices operating at different center frequencies or IVUS catheter with different ultrasound transducers).
Regarding claim 12,
Hoffman further teaches wherein the catheter handle comprises a plurality of connectors (at least fig. 6 (Pins 01, 02, 06, 07, and/or 10) and corresponding disclosure in at least [0031]) each configured to connect to one of an intracardiac echocardiography (ICE) catheter, an intravascular ultrasound (IVUS) catheter, and a radiofrequency (RF) ablation ([0034] which discloses by detecting the change in the plurality of signals carried by the plurality of pins of the PIM connector, the PIM can detect and identify a sensor type of an intraluminal device connected to the PIM and [0006] which discloses At least one of the second plurality of pins is connected to a first electrically erasable programmable read-only memory (EEPROM) storing first data. At least one of the third plurality of pins is connected to a second EEPROM storing second data different from the first data. In these implementations, the PIM is operable to read the first data, thereby identifying the first intraluminal device, and the PIM is further operable to read the second data, thereby identifying the second intraluminal device. See also the first intraluminal device 103-1 can be an intravascular ultrasound (IVUS) catheter with ultrasound transducers operating at 10 MHz. The second intraluminal device 103-2 can be an IVUS catheter with ultrasound transducers operating at 20 MHz. Therefore the plurality of connectors are each configured to connect to one of intravascular ultrasound catheter or an intracardiac echocardiography (ICE) catheter)
Regarding claim 13,
Hoffman teaches the elements of claim 5 as previously stated. Hoffman further teaches wherein the modality circuitry module comprises an RF ablation circuitry module, an intracardiac echocardiography circuitry module, and an intravascular ultrasound (IVUS) circuitry module ([0036] which discloses based on attributes of the identified sensor type. In some embodiments, the PIM can include multiple components, such as signal amplifiers, signal filters, physical layer signal modulators, and analog to digital converter (ADC). These components require different parameters to correctly operate with different type of sensors. Configuring the PIM involves at least changing or resetting these parameters so that the PIM can function properly with the connected intraluminal device. Examiner thus notes that the modality circuitry functions as each of the ablation circuitry module, intracardiac echocardiography circuitry module, and an intravascular ultrasound (IVUS) circuitry module depending on the sensor type identified))
Regarding claim 14,
Hoffman teaches the elements of claim 5 as previously stated. Hoffman further teaches wherein the modality circuitry comprises an RF ablation circuitry module and the catheter handle further comprises an intracardiac echocardiography (ICE) circuitry module and an intravascular ultrasound (IVUS) circuitry module ([0036] which discloses based on attributes of the identified sensor type. In some embodiments, the PIM can include multiple components, such as signal amplifiers, signal filters, physical layer signal modulators, and analog to digital converter (ADC). These components require different parameters to correctly operate with different type of sensors. Configuring the PIM involves at least changing or resetting these parameters so that the PIM can function properly with the connected intraluminal device. Examiner thus notes that the modality circuitry functions as each of the RF ablation circuitry module, intracardiac echocardiography circuitry module, and an intravascular ultrasound (IVUS) circuitry module depending on the sensor type identified)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman in view of Perez et al. (US 202030016612 A1), hereinafter Perez.
Regarding claim 6,
Hoffman teaches the elements of claim 5 as previously stated.
Hoffman further teaches wherein the multiple-modality system is configured to electrically communicate with a control console, a display, and a remote control ([0022] which discloses the PIM 202 is connected to a console 201 by a cable and also includes a connector 204).
Hoffman fails to explicitly teach wherein the multi-modality system comprises: a battery pack; and a wireless module configured to electrically communicate with the control console, the display, and the remote control.
Perez, in a similar field of endeavor involving patient interface modules for intraluminal devices, teaches, wherein a multi-modality system (at least figs. 2 and/or 3 (150) and corresponding disclosure in at least [0053] and [0034] which discloses the ultrasound imaging component 130 can obtain imaging data associated with intravascular ultrasound (IVUS) imaging, forward looking intravascular ultrasound (FL-IVUS) imaging, intravascular photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and/or other suitable imaging modalities. In some embodiments, the device 110 can include an imaging component of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, the device 110 can include any suitable sensing component, including a pressure sensor, a flow sensor, a temperature sensor, an optical fiber, a reflector, a mirror, a prism, an ablation element, a radio frequency (RF) electrode, a conductor, and/or combinations thereof) comprises a battery pack (at least figs. 2 and/or 3 (344) and corresponding disclosure in at least [0053]), and a wireless module (at least figs. 2 and/or 3 (312) and corresponding disclosure in at least [0050]) configured to electrically communicate with a control console (at least fig. 1 (160) and corresponding disclosure in at least [0022]), a display (at least fig. 1 (170) and corresponding disclosure in at least [0022]), and a remote control ([0042] which discloses the PIM 150 may be configured to transmit imaging data with a wireless Ethernet protocol. The PIM 150 and ultrasound processing system 160 may include a wireless transmitter and receiver, such as a wireless router. Examiner notes that the remote control is considered merely intended use as it is not recited as a part of the claimed invention and the wireless module must merely be capable of electrically communicating with such a remote control in its broadest reasonable interpretation. Examiner notes that the wireless transmitter which is configured for wireless protocols including WiFi, Bluetooth, LTE, Z-wave, Zigbee, WirelessHD, WiGig, etc. In some embodiments, the wireless transmitter 312 is configured to transmit wireless Ethernet signals as disclosed in [0050] would therefore be capable of such communication to a remote control and therefore reads on the claimed invention).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman to include the batter pack and wireless module as taught by Perez in order to allow for a portable patient interface module (Perez [0040]). Such a modification would reduce the need for large cables which would reduce their portability and improve the imaging system (Perez [0004]) and imaging procedure of Hoffman accordingly.
Claims 10-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman in view of Mansker et al. (US 20190313909 A1), hereinafter Mansker.
Regarding claim 10,
Hoffman teaches the elements of claim 5 as previously stated. Hoffman further teaches further comprising an ablation catheter ([0023] which discloses one or more of the intraluminal devices 203-1, 203-2 and 203-N can include any suitable sensing component, including a pressure sensor, a flow sensor, a temperature sensor, an optical fiber, a reflector, a mirror, a prism, an ablation element, a radio frequency (RF) electrode, a conductor, and/or combinations thereof)
Although Hoffman teaches an ablation element and a radio frequency (RF) electrode it is not explicitly clear if the catheter is an RF ablation catheter.
Mansker, in a similar field of endeavor involving multi-modality systems teaches a system comprising an RF ablation device ([0035]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman to further include an RF ablation device as taught by Mansker in order to perform corresponding treatment on a patient. Such a modification would provide additional uses for the system of Hoffman for performing corresponding treatment procedures in addition to imaging.
Examiner notes that in the modified system the RF ablation device is considered to be catheter due to the intraluminal devices of Hoffman being directed towards catheters.
Regarding claim 11,
Hoffman teaches the elements of claim 5 as previously stated. Hoffman further teaches further comprising an intracardiac echocardiography (ICE) catheter ([0023] which discloses the sensing component of the intraluminal devices 203-1, 203-2 and 203-N can be configured for imaging, such as near infrared (NIR) imaging, optical coherence tomography (OCT), intravascular photoacoustic (IVPA) imaging, transesophageal echocardiography (TEE), and intracardiac echocardiography (ICE)), an intravascular ultrasound (IVUS) catheter ([0022] which discloses the first, second and N.sup.th intraluminal devices 203-1, 203-2 and 203-N may be IVUS devices operating at different center frequencies or IVUS catheter with different ultrasound transducers), and an ablation catheter ([0023] which discloses one or more of the intraluminal devices 203-1, 203-2 and 203-N can include any suitable sensing component, including a pressure sensor, a flow sensor, a temperature sensor, an optical fiber, a reflector, a mirror, a prism, an ablation element, a radio frequency (RF) electrode, a conductor, and/or combinations thereof), wherein each of the ICE catheter, the IVUS catheter, and the ablation catheter comprise an indicator indicating an associated catheter type ([0024] which discloses The first intraluminal device 203-1 includes a first device connector 206-1, the second intraluminal device 203-2 includes a second device connector 206-2 and the N.sup.th intraluminal device 203-N includes an N.sup.th device connector 206-N and while device connectors 206 are identical in physical dimensions, they have different configurations in various embodiments of the present disclosure. These different configurations allow the PIM 202 to identify the sensor type of the intraluminal device that is currently connected to the PIM 202. The different configurations of the connectors are considered indicators indicating an associated catheter type).
Although Hoffman teaches an ablation element and a radio frequency (RF) electrode it is not explicitly clear if the catheter is an RF ablation catheter.
Nonetheless, Mansker, in a similar field of endeavor involving multi-modality systems teaches a Radio-frequency ablation device, wherein the radio-frequency ablation device comprises an indicator indicating an associated catheter type ([0035] which discloses patient treatment devices may be communicatively coupled to the processing system 101 such as devices associated with radiofrequency ablation (RFA), cryotherapy, or atherectomy and any PIMs or other control equipment associated with such treatment procedures. In such an embodiment, the modality “N” acquisition component 224 and the modality “N” workflow component 226 may be configured to communicate with and control the treatment devices such as by relaying control signals, relaying power levels, receiving device feedback, and receiving data collected by sensors disposed on the treatment devices. Examiner notes that any of the control equipment/PIM, control signals, power levels, etc. are considered indicators which indicate the catheter type in its broadest reasonable interpretation)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman to further include an RF ablation device as taught by Mansker in order to perform corresponding treatment on a patient. Such a modification would provide additional uses for the system of Hoffman for performing corresponding treatment procedures in addition to imaging.
Examiner notes that in the modified system the RF ablation device is considered to be catheter due to the intraluminal devices of Hoffman being directed towards catheters.
Regarding claim 15,
Hoffman teaches the elements of claim 5 as previously stated. Hoffman fails to explicitly teach wherein the multiple-modality system further comprises a synchronization circuitry for synchronizing simultaneous use of two or more modalities.
Mansker, in a similar field of endeavor involving multiple modality systems, teaches a multiple-modality system comprising a synchronization circuitry ([0051] which discloses the system controller may retrieved a combination of static and dynamic configuration information, and also dynamically detecting which medical sensing devices are coupled to the processing system 101 and only starting the executable components associated with the detected medical sensing devices) for synchronizing simultaneous use of two or more modalities ([0040] which discloses for instance, in the event the processing system 101 is simultaneously acquiring data associated with more than one modality, the UI framework services 240 and 242 may present the user with a modality selector screen on which a desired user interface may be selected. Examiner notes that such simultaneous acquiring of data would require a synchronization circuit accordingly)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Hoffman to include a synchronization circuitry as taught by Mansker in order to allow for multiple modalities to be imaged at the same time. Such a modification would allow for multiple procedures or image acquisitions from different devices/modalities to be acquired such that a plurality of data types is acquired in a synchronous manner thereby improving the overall diagnostic information provided by the system of Hoffman.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Govari et al. (US 20230172512 A1) teaches a system configured to connect to a plurality of different catheter types and processing circuitry configured to determine a modality to use based on the catheter which is connected ([0041] which discloses the connection configuration may be found in a more systematic fashion, for example using the matching process described with reference to FIG. 5. In some examples, connection configurations of different combination of catheters 40 with the ports 46 via different cables 38 may be pre-computed and saved so that when a given catheter combination is selected, the pre-computed optimal connection configuration may be retrieved from the memory 51) , and a plurality of connects each configured to connect to a different catheter (See at least fig. 2).
Corrigan et al. (US 20200121286 A1) teaches a catheter system comprising a catheter handle (at least fig. 4A (110) and corresponding disclosure in at least [0030]) configured to connect to a plurality of types of catheters ([0048] which discloses Drive units are typically reusable and can be compatible with a variety of different catheters 102. The different catheters that are compatible with a drive unit may house transducers having different operational frequencies at which the transducers operate or other different operational settings or differences) and processing circuitry configured to determine a modality to use based on the catheter connected to the catheter handle ([0048] which discloses It is useful if the drive unit 110, and associated processor 106 (FIG. 1), can automatically determine which type of catheter 102 is attached to the drive unit 110 and [0050] which discloses the ultrasound system can use this identification information for settings for the system or to limit or provide system features based on the identification of the catheter or otherwise use the identification to facilitate operation or use of the catheter and [0011] which discloses processor is further configured for altering or setting one or more settings of the ultrasound system in response to the identification of the catheter. See also [0049]) and each catheter has an indicator indicating an associated catheter type ([0032] which discloses the catheter 102 can also include a marker 211 which, when read, can identify the catheter. For example, the marker 211 can identify the type of the catheter (using, for example, an identification code or a name or any other suitable identification information) or can include a serial number for the catheter or any other catheter identification information or any combination thereof)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
Prosecution Insights