DETAILED ACTION
Applicant’s preliminary amendment, filed June 26, 2024, is fully acknowledged by the Examiner. Currently, claims 21-40 are pending and newly added and claims 1-20 cancelled. The following is a complete response to the June 26, 2024 communication.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21-32 and 34-39 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Scheuermann et al. (US Pat. Pub. 2013/0165764 A1).
Regarding claim 21, Scheuermann provides for a system, comprising: an elongated shaft including a distal portion configured to be positioned in a lumen of a patient (see figure 1 with the shaft at 106 with the portion 102 being configured to be located within a lumen of a human),
and a treatment assembly coupled to the elongated shaft (element at 102), the treatment assembly including:
a neuromodulation element configured to deliver a therapeutic energy using a first
energy modality, wherein the therapeutic energy includes ultrasound energy (ablation element 114; see [0062] providing for such to be and ultrasound ablation element), and
one or more diagnostic elements configured to emit diagnostic energy (sensing elements 112a/b), using a second energy modality that is different than the first energy modality, toward tissue of the lumen, wherein the diagnostic energy includes electromagnetic energy (see [0057] and [0058] providing for photo-acoustic monitoring that utilizes electromagnetic energy),
and a controller including processing circuitry (controller 118 includes processing circuitry),
wherein the controller is configured to: determine, based on the diagnostic energy, a relative distance of at least a portion of the treatment assembly to a target nerve when the treatment assembly is positioned within the lumen (see [0052] disclosing the controller, see [0059] providing for the controller to generate a three-dimension map that includes depth through the vessel wall … to identify the presence of nerve tissue; see also [0058]-[0060] for the detection to be based on the emitted electromagnet energy forming the diagnostic energy; see also [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve), and
cause the treatment assembly to deliver the therapeutic energy based on the relative distance (again, see [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve).
Regarding claim 22, Scheuermann provides that the one or more diagnostic elements
comprises an electromagnetic transducer (at least one of 112a/b functions to output the electromagnetic energy as disclosed in [0058]).
Regarding claim 23, Scheuermann provides that the one or more diagnostic elements further comprises a detector configured to detect return energy associated with the diagnostic energy (see [0059] providing for at least 112b to function as a detector).
Regarding claim 24, the controller is configured to determine one or more parameters of return energy associated with the diagnostic energy (via 118 processing data from the sensor element 112b with [0059] providing that controller 118 processing the feedback), and determine the relative distance based on the one or more parameters (see [0052] disclosing the controller, see [0059] providing for the controller to generate a three-dimension map that includes depth through the vessel wall … to identify the presence of nerve tissue; see also [0058]-[0060] for the detection to be based on the emitted electromagnet energy forming the diagnostic energy; see also [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve).
Regarding claim 25, Scheuermann provides that the one or more parameters of the return
energy include one or more of an amplitude of the return energy, a frequency of the return
energy, a temperature of the return energy, or a time of the return energy (see [0058] in discussing the photo-acoustic imaging to utilize parameter such as the amplitude of the return energy in the form of the disclosed “strength of the acoustic return signal”).
Regarding claim 26, Scheuermann provides that, in order to cause the treatment assembly to deliver therapeutic energy based on the relative distance, the controller is configured to cause the treatment assembly to deliver therapeutic energy when the one or more parameters of the return energy are within a predetermined range (the controller 118 is configured to deliver the therapeutic energy when the feedback parameters are within a predetermined range to focus the ultrasound energy to the nerve).
Regarding claim 27, Scheuermann provides for an indicator configured to notify a user of a position of the treatment assembly (See [0049] providing for the visual display that is capable of displaying the generated maps of the body).
Regarding claim 28, Scheuermann provides that the controller is configured to determine the relative distance based on one or more of a frequency or a signal amplitude of the diagnostic
energy (see [0058] in discussing the photo-acoustic imaging to utilize parameter such as the amplitude of the return energy in the form of the disclosed “strength of the acoustic return signal”).
Regarding claim 29, Scheuermann provides that the controller is configured to cause the
therapeutic energy and the diagnostic energy to be delivered to tissue of the patient at different
times to perform coordinated delivery of the therapeutic energy and the diagnostic energy (see [0063] providing that the diagnostic energy is activated at a first time and the therapeutic energy is activated at a second, different time).
Regarding claim 30, Scheuermann provides that the electromagnetic energy comprises optical energy (see [0057] and [0058] providing for the use of photo-acoustic imaging with such including optical energy as claimed).
Regarding claim 31, Scheuermann provides that the treatment assembly comprises an
expandable element configured to be deployed to a deployed state (balloon 102), and wherein the neuromodulation element is configured to deliver the therapeutic energy while the treatment
assembly is in the deployed state in the lumen (see [0063] providing that the therapeutic energy from 114 is configured to be delivered when 102 is expanded).
Regarding claim 32, Scheuermann provides that the expandable element comprises a balloon (102 is a balloon).
Regarding claim 34, Scheuermann provides for a system comprising an elongated shaft including a distal portion configured to be positioned in a lumen of a patient (see figure 1 with the shaft at 106 with the portion 102 being configured to be located within a lumen of a human),
a treatment assembly coupled to the elongated shaft (element at 102), the treatment assembly including:
a neuromodulation element configured to deliver a therapeutic energy using a first energy
modality, wherein the therapeutic energy includes ultrasound energy (ablation element 114; see [0062] providing for such to be and ultrasound ablation element),
an emitter configured to emit diagnostic energy, using a second energy modality that is different than the first energy modality, toward tissue of the lumen, wherein the diagnostic energy includes electromagnetic energy (one of elements 112a/b configured to emit the optical energy; see [0057] and [0058] providing for photo-acoustic monitoring that utilizes electromagnetic energy),
a detector configured to detect a return energy associated with the diagnostic energy (the other of the elements 112a/b configured to detect the returned acoustic energy from the emitted optical energy; see again [0057] and [0058] providing for photo-acoustic monitoring), and
a controller including processing circuitry (controller 118 includes processing circuitry), the controller configured to:
determine, based on the detected return energy, a proximity of at least a portion of the treatment assembly to a target nerve when the treatment assembly is positioned within the lumen (see [0052] disclosing the controller, see [0059] providing for the controller to generate a three-dimension map that includes depth through the vessel wall … to identify the presence of nerve tissue; see also [0058]-[0060] for the detection to be based on the emitted electromagnet energy forming the diagnostic energy; see also [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve), and
based on the proximity, cause the treatment assembly to deliver the therapeutic
energy (again, see [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve).
Regarding claim 35, Scheuermann provides that the controller is configured to determine the proximity based on one or more of a frequency or a signal amplitude of the detected return
energy (see [0058] in discussing the photo-acoustic imaging to utilize parameter such as the amplitude of the return energy in the form of the disclosed “strength of the acoustic return signal”).
Regarding claim 36, Scheuermann provides that the controller is configured to: determine one or more parameters of the detected return energy (via 118 processing data from the sensor element 112b with [0059] providing that controller 118 processing the feedback), and
determine the proximity based on the one or more parameters (see [0052] disclosing the controller, see [0059] providing for the controller to generate a three-dimension map that includes depth through the vessel wall … to identify the presence of nerve tissue; see also [0058]-[0060] for the detection to be based on the emitted electromagnet energy forming the diagnostic energy; see also [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve),
wherein the one or more parameters of the return energy include one or more of an amplitude of the return energy, a frequency of the return energy, a temperature of the return energy, or a time of the return energy (see [0058] in discussing the photo-acoustic imaging to utilize parameter such as the amplitude of the return energy in the form of the disclosed “strength of the acoustic return signal”).
Regarding claim 37, Scheuermann provides that the system comprises an indicator configured to notify a user of a position of the treatment assembly (See [0049] providing for the visual display that is capable of displaying the generated maps of the body).
Regarding claim 38, Scheuermann provides for a system comprising an elongated shaft including a distal portion configured to be positioned in a lumen of a patient (see figure 1 with the shaft at 106 with the portion 102 being configured to be located within a lumen of a human),
a treatment assembly coupled to the elongated shaft (element at 102), the treatment assembly comprising:
a neuromodulation element configured to deliver therapeutic ultrasound energy (ablation element 114; see [0062] providing for such to be and ultrasound ablation element), and
an expandable element configured to expand to a deployed state to position the
neuromodulation element in the lumen (balloon 102),
one or more diagnostic elements configured to emit diagnostic electromagnetic energy (sensing elements 112a/b; (see [0057] and [0058] providing for photo-acoustic monitoring that utilizes electromagnetic energy), and
a controller including processing circuitry (controller 118 includes processing circuitry), the controller configured to:
determine, based on the diagnostic electromagnetic energy, a proximity of at least
a portion of the treatment assembly to a target nerve when the treatment assembly is
positioned within the lumen (see [0052] disclosing the controller, see [0059] providing for the controller to generate a three-dimension map that includes depth through the vessel wall … to identify the presence of nerve tissue; see also [0058]-[0060] for the detection to be based on the emitted electromagnet energy forming the diagnostic energy; see also [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve), and
based on the proximity, cause the treatment assembly to deliver the therapeutic
ultrasound energy (again, see [0062]-[0064] providing that therapeutic energy that is output is “at a selected depth of focus” with the element 114 able to be focused only on the targeted nerve).
Regarding claim 39, Scheuermann provides that the expandable element comprises a balloon (102 is a balloon).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 33 and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Scheuermann et al. (US Pat. Pub. 2013/0165764 A1) as applied to claims 21 and 38 respectively above, and further in view of Krocak (US Pat. Pub. 2014/0058244 A1).
Regarding claims 33 and 40, while Scheuermann provides for a neuromodulation energy source configured to generate the therapeutic energy (via the necessary ultrasound source to provide the disclosed ultrasonic energy to the element 114) and a diagnostic energy source configured to generate the diagnostic energy (via the necessary source of to provide for optical energy for the photo-acoustic imaging for 112a/b), Scheuermann fails to specifically disclose that the neuromodulation energy source is separate from the diagnostic energy source.
The Examiner is of the position, however, that the separating of the neuromodulation energy source from the diagnostic energy source would have been an obvious consideration to one of ordinary skill in the art at the time the invention was made. Specifically, Krocak provides for a similar system that performs both ablation as well as photoacoustic monitoring of tissue where the ablation module 90 is separate from the photoacoustic module 80 (see figure 1). Therefore, it is the Examiner’s position that it would have been an obvious consideration to one of ordinary skill in the art to provide separate sources for the neuromodulation energy source and the diagnostic energy source to the system of Scheuermann in view of the teaching in Krocak. Such represents one of a known number of ways of providing the two energy sources (separate or integrated) in the art, with each functioning equally as well as one another to provide for the requisite energy delivery already provided for in the Scheuermann reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Harks et al. (US Pat. Pub. 2012/0004547 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794