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 .
Response to Amendment
Applicant’s amendments filed 01/09/2026 have been filed. Currently claims 1-9, 11-13 and 16-22 are pending.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5, 7, 11, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Castella et al., (US20080095714A1) in view of Campbell et al., (US20150202089A1) and in further view of Hoseit et al., (US20140180034A1), Chen et al., “Observation of Metal Nanoparticles for Acoustic Manipulation” , Adv. Sci. 2017, 4, 1600447., (hereinafter “Chen”).
Regarding claim 1, Castella teaches an intraluminal system to be at least partially positioned within an anatomical lumen of a subject ([0091] fig. 1 the imaging apparatus 10 includes a catheter body 20), the intraluminal system comprising:
an intraluminal device (fig. 1 catheter 20) having a length (see annotated fig. 1), extending between a proximal end (see annotated fig. 1), and a distal end (see annotated fig. 1), a distal portion with an imaging device associated therewith(fig. 1 [0029] thermal sensor 30, which is used to produce an enhanced thermal image of the macrophages 74, and would be on the distal part of the imaging apparatus 10), the imaging device configured to image an intraluminal space ([0029] “the temperature differences in the plaques 70 can be artificially increased by the nanoparticles selectively heated by a laser heating element 40, and thus an enhanced thermal image of the macrophages 74 can be produced.”) and to generate nanoparticle enhanced image data ([0029] “the temperature differences in the plaques 70 can be artificially increased by the nanoparticles selectively heated by a laser heating element 40, and thus an enhanced thermal image of the macrophages 74 can be produced.”); and
an external device operatively coupled to the imaging device, the external device configured to receive the image data from the imaging device ([0095] computing device receives the temperature data from the thermal sensor).
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However, Castella is silent regarding wherein the intraluminal device is configured as a guidewire that includes one or more distal ports, a lumen, disposed within the guidewire, through which a nanoparticle composition may be delivered, the lumen extending to the one or more distal ports of the guidewire.
In the same intraluminal guidewire field of endeavor, Campbell teaches wherein the intraluminal device is configured as a guidewire that includes one or more distal ports ([0048] the hollow guide has a plurality of apertures disposed at or near the distal end for delivering a drug), a lumen, disposed within the guidewire ([0048] hollow guide wire would be a lumen disposed in the guidewire), through which a nanoparticle composition may be delivered ([0048] the hollow guidewire would be able to deliver a nanoparticle composition since it can also deliver a drug), the lumen extending to the one or more distal ports of the guidewire ([0048] the lumen extends to the apertures);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Castella with the hollow guidewire of Campbell, as this would minimize invasion and reduce risk to healthy tissue (see Campbell [0019]).
However, the combination of references are silent regarding a guidewire; one or more proximal ports at least one ultrasound transducer configured to operate at a frequency.
In the same intraluminal device field of endeavor, Hoseit teaches a guidewire ([0046] guidewires), one or more proximal ports (fig. 6 the proximal end has a port 630 for attaching a container with a composition to be delivered and runs all the way to a distal end [0077]) at least one ultrasound transducer configured to operate at a frequency ([0012] the ultrasonic transducer may operate a frequency between 100kHz and 5MHz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of modified Castella with the proximal ports and transducers of Hoseit, as both inventions relate to intraluminal devices with methods for delivering compositions, and would yield the predictable results of a guidewire with proximal ports and an ultrasonic transducer to one of ordinary skill of art. One of ordinary skill in the art would be able to perform such a combination, and the results of the system of modified Castella having ultrasonic transducers and proximal ports on the guidewire are reasonably predictable. This would result in modified Castella having a guidewire with a lumen extending from a proximal port to a distal port.
However, the combination of references are still silent regarding applying ultrasound at a resonance frequency to activate nanoparticles.
In the same nanoparticle field of endeavor, Chen teaches applying ultrasound at a resonance frequency to activate nanoparticles (pg. 1 col. 2 Section 2.2 Acoustic Manipulation the experiments were carried out in continued sine waves with a resonant frequency of 4.5 MHz, and that with this acoustic field the nanoparticles would be activated; One of ordinary skill would understand from the applicant’s specification that frequencies used for activating nanoparticles depend on resonant properties of the nanoparticles themselves (see [0031]). Thus, a frequency that activates the nanoparticles would also be a resonant frequency of that nanoparticle. Therefore, Chen would read upon the limitation of “operate a frequency that matches a resonant frequency of nanoparticles contained in the nanoparticle composition ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the nanoparticles of modified Castella with a nanoparticle that has a resonant frequency of 4.5 MHz as taught by Chen, as the metal nanoparticles can improve drug loading efficiency (see Chen pg. 8). One of ordinary skill would understand this combination would result in at least one ultrasound transducer configured to operate at a frequency that matches a resonant frequency of nanoparticles contained in the nanoparticle composition, as the transducer of modified Castella may operate at a frequency of 100kHz-5MHz, or 4.5 MHz, which is the frequency that the nanoparticle is activated, and is therefore a resonant frequency of the nanoparticle.
Regarding claim 2, the combination of references teaches the system of claim 1, wherein Castella further teaches a transmitter (fig. 1 thermal sensor 30) and a receiver ([0095] computing device receives the temperature data from the thermal sensor), the transmitter coupled to the intraluminal device (fig. 1 the thermal sensor 30 is coupled to the catheter 20) and the receiver coupled to the external device (fig. 4 the computer 101 is external to the subject 121 [0113]).
Regarding claim 5, the combination of references teaches the system of claim 1, wherein Castella further teaches the external device operates to display the image data received from the imaging device on a display screen (fig. 4 display device 127 [0122]) of the external device to thereby display nanoparticle-enhanced images of the intraluminal space(fig. 4 display device 127 would be able to display the enhanced images [0122]).
Regarding claim 7, the combination of references teaches the system of claim 1, wherein Castella further teaches the imaging device emits and receives ultrasonic waves ([0030] the imaging apparatus 10 comprises an ultrasound system; [0140] the system emits ultrasonic from the transducer and receives the reflected acoustic waves to process).
Regarding claim 11, the combination of references teaches the system of claim 1, wherein Castella further teaches the at least one ultrasound transducer is configured to function as both the imaging device ([0140] “Ultrasound imaging systems can be equipped with a 38 mm aperture, broadband (5-10 MHz) linear array transducer. Cells can be imaged in color power Doppler, power Doppler, M-mode and B-scan modes.”) and a treatment device ([0138] “If ultrasound is used in the OCT nanoparticle system, then the ultrasound could be employed either alone or in combination with the light (OCT or other) to create the desired release and or activation of the compound(s) associated with the nanoparticle.”).
Regarding claim 16, Castella teaches a kit for imaging and/or treating an irregularity in an anatomical lumen (fig. 1 [0029] the temperature of the plaques 70 is increased and imaged using thermal imaging apparatus 10, and is in a blood vessel 72), the kit comprising:
an intraluminal device (fig. 1 catheter 20) that includes
a proximal end (see annotated fig. 1), a distal end (see annotated fig. 1), and
a distal portion with an imaging device (fig. 1 [0029] thermal sensor 30, which is used to produce an enhanced thermal image of the macrophages 74, and would be on the distal end of the imaging apparatus 10),
wherein the nanoparticle composition comprises nanoparticle-probe conjugates ([0033] “Moreover, administered nanoparticles, for example, small superparamagnetic and ultra small superparamagnetic particles of iron oxide, are avidly taken up, or engulfed by, macrophages located in unstable plaques.”), the nanoparticle-probe conjugates comprises one or more probe molecules coupled to the nanoparticles ([0033] “Moreover, administered nanoparticles, for example, small superparamagnetic and ultra small superparamagnetic particles of iron oxide, are avidly taken up, or engulfed by, macrophages located in unstable plaques.”).
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However, Castella is silent regarding the intraluminal device is configured as a guidewire that includes one or more distal ports, a lumen extending through the guidewire to the one or more distal ports, wherein the guidewire is configured for passage of a nanoparticle composition through the lumen of the guidewire.
In the same intraluminal guidewire field of endeavor, Campbell teaches wherein the intraluminal device is configured as a guidewire that includes one or more distal ports ([0048] the hollow guide has a plurality of apertures disposed at or near the distal end for delivering a drug), a lumen extending through the guidewire ([0048] hollow guide wire would have a lumen extending through the guidewire) to the one or more distal ports([0048] the lumen extends to the apertures), wherein the guidewire is configured for passage of a nanoparticle composition through the lumen of the guidewire ([0048] the hollow guidewire would be able to deliver a nanoparticle composition since it can also deliver a drug).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Castella with the hollow guidewire of Campbell, as this would minimize invasion and reduce risk to healthy tissue (see Campbell [0019]).
However, the combination of references are silent regarding a guidewire; one or more proximal ports at least one ultrasound transducer configured to operate at a frequency.
In the same intraluminal device field of endeavor, Hoseit teaches a guidewire ([0046] guidewire); one or more proximal ports (fig. 6 the proximal end has a port 630 for attaching a container with a composition to be delivered and runs all the way to a distal end [0077]) at least one ultrasound transducer configured to operate at a frequency ([0012] the ultrasonic transducer may operate a frequency between 100kHz and 5MHz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of modified Castella with the proximal ports and transducers of Hoseit, as both inventions relate to intraluminal devices with methods for delivering compositions, and would yield the predictable results of a guidewire with proximal ports and an ultrasonic transducer to one of ordinary skill of art. One of ordinary skill in the art would be able to perform such a combination, and the results of the system of modified Castella having ultrasonic transducers and proximal ports on the guidewire are reasonably predictable. This would result in modified Castella having a guidewire with a lumen extending from a proximal port to a distal port.
However, the combination of references are still silent regarding applying ultrasound at a resonance frequency to activate nanoparticles.
In the same nanoparticle field of endeavor, Chen teaches applying ultrasound at a resonance frequency to activate nanoparticles (pg. 1 col. 2 Section 2.2 Acoustic Manipulation the experiments were carried out in continued sine waves with a resonant frequency of 4.5 MHz, and that with this acoustic field the nanoparticles would be activated; One of ordinary skill would understand from the applicant’s specification that frequencies used for activating nanoparticles depend on resonant properties of the nanoparticles themselves (see [0031]). Thus, a frequency that activates the nanoparticles would also be a resonant frequency of that nanoparticle. Therefore, Chen would read upon the limitation of “operate a frequency that matches a resonant frequency of nanoparticles contained in the nanoparticle composition ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the nanoparticles of modified Castella with a nanoparticle that has a resonant frequency of 4.5 MHz as taught by Chen, as the metal nanoparticles can improve drug loading efficiency (see Chen pg. 8). One of ordinary skill would understand this combination would result in at least one ultrasound transducer configured to operate at a frequency that matches a resonant frequency of nanoparticles contained in the nanoparticle composition, as the transducer of modified Castella may operate at a frequency of 100kHz-5MHz, or 4.5 MHz, which is the frequency that the nanoparticle is activated, and is therefore a resonant frequency of the nanoparticle.
Regarding claim 18, Castella teaches
A method for imaging and/or treating an irregularity in an anatomical lumen (fig. 1 [0029] the temperature of the plaques 70 is increased and imaged using thermal imaging apparatus 10), the method comprising:
providing an intraluminal device (fig. 1 catheter 20 [0029]) that includes:
a proximal end (see annotated fig. 1), a distal end (see annotated fig. 1), and
a distal portion with an imaging device (fig. 1 [0029] thermal sensor 30, which is used to produce an enhanced thermal image of the macrophages 74, and would be on the distal end of the imaging apparatus 10),
advancing the intraluminal device within the anatomical lumen (fig. 1 pullback mechanism 50 [0096]);
delivering the nanoparticle composition to the anatomical lumen ([0029] “Macrophages selectively uptake nanoparticles 60, such as when they are administered into the bloodstream, and therefore the nanoparticles 60 will selectively accumulate at the site of macrophage concentration”; [0033] “One or more administered nanoparticle can localize to a desired target within the subject”) and allowing the nanoparticle composition to interact with an irregularity of the anatomical lumen ([0029] “the nanoparticles 60 will selectively accumulate at the site of macrophage concentration, such as in atherosclerotic plaques. Therefore, the temperature differences in the plaques 70 can be artificially increased by the nanoparticles selectively heated by a laser heating element 40,”); and
performing one or both of
activating the imaging device to image the anatomical lumen with images enhanced by the nanoparticles ([0029] “the temperature differences in the plaques 70 can be artificially increased by the nanoparticles selectively heated by a laser heating element 40, and thus an enhanced thermal image of the macrophages 74 can be produced.”);
activating the treatment device to cause the nanoparticles to increase in motion at a frequency of the nanoparticles ([0029] “Therefore, the temperature differences in the plaques 70 can be artificially increased by the nanoparticles selectively heated by a laser heating element 40”; [0138] ultrasound can be used in conjunction with the light to create the desired release and or activation of the compounds with the nanoparticle, and would have a frequency used).
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However, Castella is silent regarding the intraluminal device is configured as a guidewire that includes one or more distal ports, a lumen extending through the guidewire to the one or more distal ports, wherein the guidewire is configured for passage of a nanoparticle composition through the lumen of the guidewire.
In the same intraluminal guidewire field of endeavor, Campbell teaches wherein the intraluminal device is configured as a guidewire that includes one or more distal ports ([0048] the hollow guide has a plurality of apertures disposed at or near the distal end for delivering a drug), a lumen extending through the guidewire ([0048] hollow guide wire would have a lumen extending through the guidewire) to the one or more distal ports([0048] the lumen extends to the apertures), wherein the guidewire is configured for passage of a nanoparticle composition through the lumen of the guidewire ([0048] the hollow guidewire would be able to deliver a nanoparticle composition since it can also deliver a drug).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Castella with the hollow guidewire of Campbell, as this would minimize invasion and reduce risk to healthy tissue (see Campbell [0019]).
However, the combination of references are silent regarding a guidewire; one or more proximal ports.
In the same intraluminal device field of endeavor, Hoseit teaches a guidewire ([0046] guidewires); one or more proximal ports (fig. 6 the proximal end has a port 630 for attaching a container with a composition to be delivered and runs all the way to a distal end [0077])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of modified Castella with the proximal ports of Hoseit, as both inventions relate to intraluminal devices with methods for delivering compositions, and would yield the predictable results of a guidewire with proximal ports to one of ordinary skill of art. One of ordinary skill in the art would be able to perform such a combination, and the results of the system of modified Castella having proximal ports on the guidewire are reasonably predictable. This would result in modified Castella having a guidewire with a lumen extending from a proximal port to a distal port.
However, the combination of references are still silent regarding applying ultrasound at a resonance frequency to activate nanoparticles.
In the same nanoparticle field of endeavor, Chen teaches applying ultrasound at a resonance frequency to activate nanoparticles (pg. 1 col. 2 Section 2.2 Acoustic Manipulation the experiments were carried out in continued sine waves with a resonant frequency of 4.5 MHz, and that with this acoustic field the nanoparticles would be activated; One of ordinary skill would understand from the applicant’s specification that frequencies used for activating nanoparticles depend on resonant properties of the nanoparticles themselves (see [0031]). Thus, a frequency that activates the nanoparticles would also be a resonant frequency of that nanoparticle. Therefore, Chen would read upon the limitation of “operate a frequency that matches a resonant frequency of nanoparticles contained in the nanoparticle composition ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the nanoparticles of modified Castella with a nanoparticle that has a resonant frequency of 4.5 MHz as taught by Chen, as the metal nanoparticles can improve drug loading efficiency (see Chen pg. 8). One of ordinary skill would understand this combination would result in at least one ultrasound transducer configured to operate at a frequency that matches a resonant frequency of nanoparticles contained in the nanoparticle composition, as the transducer of modified Castella may operate at a frequency of 100kHz-5MHz, or 4.5 MHz, which is the frequency that the nanoparticle is activated, and is therefore a resonant frequency of the nanoparticle.
Regarding claim 19, the combination of references teaches the method of claim 18, wherein Castella further teaches the nanoparticle composition comprises particle-probe conjugates ([0033] “Moreover, administered nanoparticles, for example, small superparamagnetic and ultra small superparamagnetic particles of iron oxide, are avidly taken up, or engulfed by, macrophages located in unstable plaques.”) configured to preferentially interact with the irregularity of the anatomical lumen ([0030] “the light energy used to locate the nanoparticle bearing macrophages could be applied to selectively kill or inactivate or otherwise modify the activity of the macrophages”).
Regarding claim 20, the combination of references teaches the method of claim 18, wherein Castella further teaches the lumen is a blood vessel ([0037] “The target site can be selected from the group consisting of an organ, cell, cell type, blood vessel”) and the irregularity is a plaque (fig. 1 [0029] the plaque).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Castella as modified by Campbell, Hoseit, and Chen as applied to claim 2 above, and further in view of Hoffman et al., (US20190117191A1).
Regarding claim 3, the combination of references teaches the device of claim 2, but fails to explicitly disclose a housing associated with a proximal portion of the intraluminal device, the transmitter being integrated with the housing.
However, in the same intraluminal device field of endeavor, Hoffman teaches a housing (fig. 3 housing 201 [0017]) associated with a proximal portion of the intraluminal device (fig. 3 the housing is connected with the proximal portion of the intraluminal device 202 through the connection port [0017]), the transmitter (fig. 3 Communication module 216[0025]) being integrated with the housing (fig. 3 communication module is a part of the housing 201).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of modified Castella with the housing of Hoffman, as both inventions relate to the architecture of intraluminal imaging devices, and would yield the predictable result of an intraluminal device comprising a housing with a transmitter integrated into the housing to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Castella using a housing with a communications module are reasonably predictable.
Regarding claim 4, the combination of references teaches the system of claim 3, but is silent regarding comprising one or more power and/or data wires connecting the imaging device at the distal portion of the intraluminal device to the transmitter at the proximal portion of the intraluminal device.
However in the same intraluminal device field of endeavor, Hyun teaches comprising one or more power and/or data wires (fig. 3 [0017] “the intraluminal device 202 is connected to the handheld interface device 220 via an analog cable”; the handheld device 220 includes the communications module 216) connecting the imaging device (fig. 3 [0020] intraluminal device 202, which may be an IVUS, NIR, OCT, etc.) at the distal portion of the intraluminal device ([0020] “A sensor configured to obtain physiology data (e.g., imaging, pressure, flow, temperature, etc.) associated with the body lumen is disposed at the distal portion of the intraluminal device.”) to the transmitter at the proximal portion of the intraluminal device (fig. 3 [0017] “the intraluminal device 202 is connected to the handheld interface device 220 via an analog cable”; the handheld device 220 includes the communications module 216, and would be at the proximal end of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of modified Castella with the cabling and architecture of Hoffman, as both inventions relate to the architecture of intraluminal imaging devices, and would yield the predictable result of an intraluminal device with data wires connecting different components of the intraluminal device to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Castella using a cable to combine a transmitter to the IVUS device are reasonably predictable.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Castella as modified by Campbell, Hoseit, and Chen as applied to claim 1 above, and further in view Hyun et al., (US20210106307A1).
Regarding claim 6, the combination of references teaches system of claim 1, but is silent regarding the lumen of the intraluminal device includes a lumen wall defining the lumen of the intraluminal device, the imaging device being integrated with the lumen wall.
However in the same intraluminal field of endeavor, Hyun teaches the lumen of the intraluminal device (fig. 1 elongate member 106 is a lumen [0022]) includes a lumen wall (fig. 1 elongate member 106 has a lumen wall [0022]) defining the lumen of the intraluminal device (fig. 1 elongate member 106 has a lumen wall as its exterior, therefore it defines the intraluminal device [0022]), the imaging device (fig. 1 ultrasound imaging assembly 110 [0022]) being integrated with the lumen wall (fig. 1 ultrasound imaging assembly 110 is integrated into the wall of elongate member 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of modified Castella with the elongate member architecture of Hyun, as both inventions relate to intraluminal devices, and would yield the predictable result of an intraluminal device for imaging nanoparticles that has an imaging device integrated in the lumen of the intraluminal device to one of ordinary skill in the art. One of ordinary skill would be able to make such a combination, and the results of the system of modified Castella are reasonably predictable.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Castella as modified by Campbell, Hoseit, and Chen as applied to claim 7 above, and further in view of Soper et al., (US20210100627A1).
Regarding claim 8, the combination of references teaches the system of claim 7, but fails to explicitly disclose the imaging device is configured as a forward-looking ultrasound transducer.
However in the same intraluminal device field of endeavor, Soper teaches the imaging device is configured as a forward-looking ultrasound transducer (fig. 4 [0062] the ultrasound probe 406 may use forward-facing transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the ultrasound transducers of modified Castella with the forwarding facing transducers of Soper, as both inventions relate to ultrasound transducers coupled intraluminal devices, and would yield predictable results to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Castella using forward facing transducers are reasonably predictable.
Regarding claim 9, the combination of references teaches the system of claim 7, but fails to explicitly disclose the ultrasound transducer is configured as a side-looking ultrasound transducer.
However in the same intraluminal device field of endeavor, Soper teaches the imaging device is configured as a side-looking ultrasound transducer (fig. 4 [0062] the ultrasound probe 406 may use side-facing transducers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the ultrasound transducers of modified Castella with the side facing transducers of Soper, as both inventions relate to ultrasound transducers coupled intraluminal devices, and would yield predictable results to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Castella using side facing transducers are reasonably predictable.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Castella as modified by Campbell, Hoseit, and Chen as applied to claim 11 above, and further in view of Stigall et al., (US20190053783A1).
Regarding claim 12, the combination of references teaches the system of claim 11, but fails to explicitly disclose the ultrasound transducer operates at a first frequency when functioning as the imaging device and operates the resonant frequency when functioning as the treatment device.
However in the same intraluminal device field of endeavor, Stigall teaches the ultrasound transducer or the array of ultrasound transducers ([0005] The ultrasound device may include a transducer array with a number of transducer elements) operate at a first frequency ([0006] “the first segment is configured to emit a first ultrasound signal with a first frequency”; [0007] this frequency may be between 10MHz and 70 MHz) when functioning as the imaging device ([0005] “The transducer array may include a first portion and a second portion. The first portion may be used for diagnostic procedures that may include transmitting ultrasound signals and receiving ultrasound echoes with the first portion.”; [0007] this frequency may be between 1kHz and 5MHz) and operates at a frequency ([0007] “the second frequency is lower than the first frequency”) when functioning as the treatment device ([0005] “The second portion may be used for therapeutic procedures including transmitting ultrasound signals.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the transducer of modified Castella with the multi frequency transducer array of Stigall, as this would reduce the number of tools required, and minimize the removal and insertion of multiple tools, results in time saved and decrease to health risks to patients (See Stigall [0004]).
However the combination of references are silent regarding the resonant frequency.
In the same nanoparticle field of endeavor, Chen teaches a resonant frequency (pg. 2 the resonant frequency is 4.5 MHz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the frequency treatment of ultrasound device of modified Castella to employ a frequency of 4.5 MHz (which the treatment device of modified Castella would be able to employ (see above)), which is the resonant frequency of the nanoparticles as taught by Chen, as the metal nanoparticles with such resonant frequency can improve drug loading efficiency (see Chen pg. 8). One of ordinary skill would understand this combination would result in the transducer operating at the resonant frequency when functioning as the treatment device, as the transducer of modified Castella may operate at a frequency of 100kHz-5MHz, or 4.5 MHz, which is the resonant frequency of the nanoparticle.
Claims 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Castella as modified by Campbell, Hoseit, and Chen as applied to claim 1 above, and further in view of Agah et al., (US20210268107A1).
Regarding claim 13, the combination of references teaches the system of claim 1, wherein Castella further teaches one or more occluders configured to limit passage of the nanoparticle composition beyond an area ([0091] the catheter may be balloon catheter which applicant has listed as an acceptable occluder in applicant’s specification ([0057]); given that this claim recites intended use, the balloon catheter of Castella would be capable of achieving the function recited in the claim limitation).
However, modified Castella is silent regarding an area at the distal end of the intraluminal device.
In the same intraluminal device field of endeavor, Agah teaches an area at the distal end of the intraluminal device (fig. 1 the occluder 104 blocks the segment 120 off and is at the distal end of the intraluminal device[0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Castella with the occluders of Agah, as this would advantageously increase the concentration of the target particle at the isolated segment of the body lumen (See Agah [0074]).
Regarding claim 21, the combination of references teaches the method of claim 18, wherein Castella further teaches expanding one or more occluders within the anatomical lumen to limit passage of nanoparticle composition ([0091] the catheter may be balloon catheter, which applicant has listed as an acceptable occlude in their specification ([0057]) and thus would have a similar function).
However, modified Castella is silent regarding limiting passage beyond the distal end of the intraluminal device.
In the same intraluminal device field of endeavor, Agah teaches limiting passage beyond the distal end of the intraluminal device (fig. 1 the occluder 104 blocks the segment 120 off and is at the distal end of the intraluminal device [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Castella with the occluders of Agah, as this would advantageously increase the concentration of the target particle at the isolated segment of the body lumen (See Agah [0074]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Castella as modified by Campbell, Hoseit, and Chen as applied to claim 16 above, and further in view of Labhasetwar (US20220211634A1).
Regarding claim 17, the combination of references teaches the kit of claim 16, but fails to explicitly disclose the nanoparticle-probe conjugates comprise one or more of tissue plasminogen activator (TPA).
However, in the same nanoparticle field of endeavor, Labhasetwar teaches the nanoparticle-probe conjugates comprise one or more of tissue plasminogen activator (TPA) ([0017] “Provided herein are compositions, systems, kits, and methods for treating a patient with a thromboembolism by administering nanoconjugates comprising nanoparticles encapsulating and/or conjugated to: i) tissue-type plasminogen activator (tPA),”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the nanoparticle conjugate of modified Castella with the tPA nanoconjugate of Labhasetwar, as this would prevent edema formation and facilitate neurogenesis/angiogenesis at the infarcted brain by promoting migration of progenitor/stem cells (See Labhasetwar [0026]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Castella as modified by Campbell, Hoseit, and Chen as applied to claim 1 above, and further in view of Nishino (US 20090192351 A1) and Ramamurthy et al., (US6174286B1)
Regarding claim 22, modified Castella teaches the system of claim 1, but fails to explicitly disclose allocating a signal space into a plurality of unique contiguous regions of frequency to one or more signal channels.
In the same imaging field of endeavor, Nishino teaches allocating a signal space into a plurality of unique contiguous regions of frequency ([0067] teaches frequency band selection for transmission power settings though the use of orthogonal frequency division multiplex).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of using orthogonal frequency division multiplex for the power settings as taught by Nishino to the system of modified Castella, as both inventions relate to imaging within the body, and would yield the predictable result of an ultrasound sound system wherein the power is distributed across multiple frequency bands to one ordinary skill in the art. One of ordinary skill would be able to apply such a technique, and the results of modified Castella using multiple frequency bands for power distribution are reasonably predictable. This would allow transmission power to be managed across different frequency bands and thus improving control over power delivery.
However, the combination of references fails to explicitly disclose providing power to at least one ultrasound transducer to one or more power channels
In the same ultrasound field of endeavor, Ramamurthy teaches providing power to at least one ultrasound transducer (col. 5 line 17 the power supply drives the transmit channel) to one or more power channels (col. 3 lines 43-50 the transformer beamformer 14 includes a plurality of transmit channels that can generate an excitation waveform; col. 4 lines 14-16 the excitation waveforms are provided to the transducer elements; col. 5 lines 17-18 the power supply drives the transmit channels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the powering of the transducers of modified Castella with the power system of Ramamurthy, as this would provide a cost effective method of increasing transmitted acoustic power (see Ramamurthy col. 5 lines 38-44).
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant has argued that Chen fails to teach what the Examiner asserts in the office action, and would not lead one of one of ordinary skill in the art to combine its teachings with the other cited references in a way to render the claims as being obvious. Specifically, Applicant argues that Chen does not teach the nanoparticles as having a resonant frequency of 4.5 MHz, and instead teaches the sine wave having a frequency of 4.5 MHz.
Examiner disagrees. Chen teaches that the activation of the nanoparticles depends on the interaction between the applied acoustic field and the properties of the nanoparticles. In Chen’s case, the applied acoustic field has a resonant field of 4.5 MHz, and a person of ordinary skill in the art would have understood that effective activation of the nanoparticles requires selecting an operating frequency that produces a desired interaction with the nanoparticles, and that such interaction reflects a resonance condition of the system. This understanding is consistent with the Applicant’s own disclosure. [0031] of the applicant’s specification states that frequencies used for activating the nanoparticles depend on the resonant properties of the nanoparticles themselves, and serves as evidence of how one of ordinary skill in the art would have understood the relationship between acoustic resonant frequency and nanoparticles behavior. Accordingly, Chen’s teaching of an acoustic frequency that activates the nanoparticles, in view of the above, reasonably suggests selecting an operating frequency that corresponds to a resonance condition associate with the nanoparticles, and thus renders obvious operating at a frequency that matches a resonant frequency of nanoparticles contained in the nanoparticle composition.
Applicant further argues that there is no motivation to combine the cited references, asserting that (1) none of the cited references teaches or suggest a guidewire having both a lumen for passing a nanoparticle composition and an ultrasound transducer and (2) that the Examiner has improperly selected elements from catheter devices and guidewire devices, and that such devices differ in structure, size, and purpose and would there would be a lack of motivation to combine them.
Examiner disagrees. In response to applicant's argument (1), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Further, while the references may disclose different types of devices, the references are still all directed to intraluminal medical devices for delivering compositions and/or interacting with biological tissues within a lumen. A person of ordinary skill would have recognized that these teachings address complementary aspects of the same problem space of delivering and controlling compositions within an intraluminal environment. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, a person of ordinary skill in the art would have been motivated to combine the teaches of the cited reference to improve the delivery, localization and control of compositions, within an intraluminal environment.
Specifically, Campbell teaches a guidewire having a lumen and distal ports for delivering a composition, while Hoseit teaches a guidewire including an ultrasound transducer configured to operate at a frequency. It would have been obvious to incorporate the ultrasound transducer of Hoseit into the guidewire delivery system of Campbell in order to provide both delivery and ultrasound based interaction within a single ultrasound system. Further, Chen teaches that acoustic energy may be used to activate nanoparticles, and thus one of ordinary skill would have been to understanding utilizing ultrasound in conjunction with nanoparticles.
Such a combination represents the use of known elements according to their established functions, and would have yielded predictable results, including a guidewire capable of delivering a nanoparticle composition and providing ultrasound-based interaction or activation of the nanoparticles within the body.
For these reasons, claim 1 remains rejected.
The remaining claims are rejected for substantially the same reasons.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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