DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. Claims 1-37 as originally filed on 06/01/2023 are pending, and have been examined on the merits.
Claim Objections
3. Claims 1, 4, 13, 14, 17, & 26-30 are objected to because of the following informalities:
a. In claim 1, line 2, the recitation of “a transducer that can be controlled to emit a selective amount of energy” should instead recite --a transducer that is controlled to emit a selective amount of energy--.
b. In claim 1, line 14, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
c. In claim 1, lines 19-20, the recitation of “to sense the neural response” should instead recite --to sense a neural response” since the neural response sensed in step (e) is different than that of step (a) & (b).
d. In claim 4, line 9, the recitation of “in the tissue surrounding the biological” should instead recite --in the tissue surrounding the biological lumen--.
e. In claim 13, lines 14-15, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
f. In claim 14, lines 2-3, the recitation of “a transducer that can be controlled to emit a selective amount of energy” should instead recite --a transducer that is controlled to emit a selective amount of energy--.
g. In claim 14, line 7, the recitation of “memory” should instead recite --a memory--.
h. In claim 14, lines 24-25, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
i. In claim 14, line 30, the recitation of “to sense the neural response” should instead recite --to sense a neural response” since the neural response sensed is different than that the neural response sensed previously in the claim.
j. In claim 17, line 9, the recitation of “in the tissue surrounding the biological” should instead recite --in the tissue surrounding the biological lumen--.
k. In claim 26, lines 9-10, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
l. In claim 27, line 2, the recitation of “a transducer that can be controlled to emit a selective amount of energy” should instead recite --a transducer that is controlled to emit a selective amount of energy--.
m. In claim 27, lines 18-19, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
n. In claim 28, line 3, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
o. In claim 29, lines 3-4, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
p. In claim 30, lines 2-3, the recitation of “a transducer that can be controlled to emit a selective amount of energy” should instead recite --a transducer that is controlled to emit a selective amount of energy--.
q. In claim 30, lines 28-29, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
r. In claim 31, lines 3-4, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
s. In claim 32, line 4, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
t. In claim 36, line 3, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
u. In claim 37, lines 3-4, the recitation of “to denervate at least some the nerves” should instead recite --to denervate at least some of the nerves--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 11 & 24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
6. Claim 11 recites the limitation “a pair of electrodes” in line 5, “an electrode” in line 6, “an electrode” in line 8, and “an electrode” in line 10. These recitations render the claim indefinite, as it is not clear whether the recited electrodes are intended to comprise the “one or more electrodes” recited in claim 1 (from which claim 11 depends), or separate/additional electrodes. As such, the structure required by the claim is not clear. Clarification is required.
7. Claim 24 recites the limitation “a pair of electrodes” in line 5, “an electrode” in line 6, “an electrode” in line 8, and “an electrode” in line 10. These recitations render the claim indefinite, as it is not clear whether the recited electrodes are intended to comprise the “one or more electrodes” recited in claim 14 (from which claim 24 depends), or separate/additional electrodes. As such, the structure required by the claim is not clear. Clarification is required.
Claim Rejections - 35 USC § 102
8. 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.
9. Claim 33 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2012/0265198 to Crow et al. (“Crow”) [made of record in Applicant’s 02/26/24 IDS].
10. Regarding claim 33, Crow discloses a system, comprising:
a catheter [e.g., catheter (200) - ¶[0063]; FIG. 5];
one or more electrodes located on a distal portion of the catheter [see ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”); see also ¶’s [0025], [0068]] that is configured to [be] inserted into a biological lumen [renal artery] surrounded by tissue including nerves [see ¶[0063] (“a catheter 200 includes a flexible shaft 204 having a proximal end, a distal end, and a length sufficient to access a patient's renal artery 12”)]; and
a transducer also located on the distal portion of the catheter [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); and ¶[0068] (“…such as when the ablation arrangement 215 includes a high-intensity acoustic energy transducer (e.g., a high-intensity focused ultrasound (HIFU) device)”)] that is configured to inserted into the biological lumen [renal artery] surrounded by the tissue including the nerves [¶[0063]];
wherein the transducer is configured to be energized to emit a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0017] (“Embodiments of the disclosure utilize pain or other signals (e.g., physiologic responses) resulting from stimulation of the target renal nerves to detect which tissue locations are best to target”); ¶[0027] (“The nerve stimulation can utilize electrical energy as previously described, or other stimulation mechanisms or energies, or combinations of stimulation mechanisms and energies can be utilized. For example, renal nerves can be stimulated using a variety of mechanisms and energies, non-limiting examples of which include the following: visible, UV, or IR light or laser light; magnetism; sonic or ultrasonic energy, low-frequency vibration or mechanical impact loading, heating or cooling, microwave or RF energy, neurotransmitter or other chemical or drug, by pressure changes, or osmotic or pH changes, or by specific patterns or changes in these or other stimulatory mechanism”); and Abstract (“The stimulation energy is sufficient to elicit a physiologic response from the patient but insufficient to ablate renal nerves”); and ¶[0064] (“thermal energy”)]; and
wherein at least one of the one or more electrodes of the catheter is configured to sense the neural response that is evoked by the transducer being energized to emit the first amount of energy [e.g., ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”)].
Claim Rejections - 35 USC § 103
11. 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.
12. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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.
13. Claims 1-3, 11, 13-16, 24, 26-32, & 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Crow in view of U.S. Patent Application Publication No. 2014/0316402 to Shah ("Shah") [made of record in Applicant’s 02/26/24 IDS].
14. Regarding claim 1, Crow teaches a method for use with a catheter [e.g., catheter (200) - ¶[0063]; FIG. 5] including one or more electrodes [see ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”); see also ¶’s [0025], [0068]] and also including a transducer [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); and ¶[0068] (“…such as when the ablation arrangement 215 includes a high-intensity acoustic energy transducer (e.g., a high-intensity focused ultrasound (HIFU) device)”)] that can be controlled to emit a selective amount of energy [e.g., ¶[0006]], wherein the method is for use while at least a distal portion of the catheter is inserted into a biological lumen [renal artery] that is surrounded by tissue including nerves [see ¶[0063] (“a catheter 200 includes a flexible shaft 204 having a proximal end, a distal end, and a length sufficient to access a patient's renal artery 12”)] that are to be denervated [e.g., ¶’s [0003], [0053], [0056]] using the transducer of the catheter [¶’s [0006], [0053], [0056], [0066], [0068]], the method comprising:
(a) energizing the transducer of the catheter to emit a first instance of a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0017] (“Embodiments of the disclosure utilize pain or other signals (e.g., physiologic responses) resulting from stimulation of the target renal nerves to detect which tissue locations are best to target”); ¶[0027] (“The nerve stimulation can utilize electrical energy as previously described, or other stimulation mechanisms or energies, or combinations of stimulation mechanisms and energies can be utilized. For example, renal nerves can be stimulated using a variety of mechanisms and energies, non-limiting examples of which include the following: visible, UV, or IR light or laser light; magnetism; sonic or ultrasonic energy, low-frequency vibration or mechanical impact loading, heating or cooling, microwave or RF energy, neurotransmitter or other chemical or drug, by pressure changes, or osmotic or pH changes, or by specific patterns or changes in these or other stimulatory mechanism”); and Abstract (“The stimulation energy is sufficient to elicit a physiologic response from the patient but insufficient to ablate renal nerves”); and ¶[0064] (“thermal energy”)];
(b) using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy [e.g., ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”)],…;
(c) energizing the transducer of the catheter to emit a first instance of a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0023] (“The selected ablation sites are then treated with high-power RF energy to ablate the target nerves”); see also ¶[0066]];
(d) after energizing the transducer of the catheter to emit the first instance of the second amount of energy, energizing the transducer of the catheter to emit a second instance of the first amount of energy [e.g., ¶[0020] (“After ablation, selected excitation and sensing can be repeated to immediately confirm the ablation effect on the target nerves”); claim 22 (“selectively delivering the stimulation energy following renal nerve tissue ablation to determine effectiveness of the ablation”)];
(e) using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy [e.g., ¶[0020] (“After ablation, selected excitation and sensing can be repeated to immediately confirm the ablation effect on the target nerves”); see also ¶[0022]].
Storage & Comparison of Sensed Neural Responses
While Crow teaches that stimulation/sensing occurs both before and after denervation to “confirm the ablation effect” [see ¶[0020]], Crow does not explicitly teach the following emphasized claim limitations concerning storing and comparing information about the (pre/post) sensed neural responses:
(b) using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, and storing first information about the sensed neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy;
(e) using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, and storing second information about the sensed neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy; [and]
(f) comparing the second information to the first information and using results of the comparing to determine to what extent the nerves in the tissue surrounding the biological lumen were sufficiently denervated in response to the emission of the first instance of the second amount of energy.
However, such processing steps were well known in the art, before the effective filing date of the claimed invention.
As one example, Shah, in a similar field of endeavor, relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient, and further teaches monitoring parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at a treatment site before, during and/or after therapeutic energy delivery [Shah, Abstract].
More particularly, Shah teaches that it is believed that the reflection or absorption of ultrasound, electromagnetic energy or other diagnostic energies from adequately neuromodulated (e.g., ablated) tissue are different than those of non-neuromodulated or under-neuromodulated tissue (e.g., non- or under-ablated) [¶[0074]]. As a result, parameters of detected return energy, such as the amplitude, frequency and/or derivations of these parameters, can be used to indicate the extent of ablation or other alteration of the neural tissue [¶[0074]].
Shah further teaches the use of diagnostic algorithms, and that, during pre-neuromodulation stages, the pre-neuromodulation parameters of return energy can be determined and stored in the memory of a controller [¶[0076]].
Further, while modulating the nerves, and/or after terminating energy delivery, a transducer can emit energy and detect a return energy, and a diagnostic algorithm can determine one or more parameters of return energy during or after neuromodulation, and then compare and/or evaluate the post-neuromodulation parameters of return energy in view of the pre-neuromodulation parameters of return energy to characterize the tissue. A controller can then provide a characterization to a clinician and/or suggest a course of action, such as adjust a power-delivery control algorithm, terminate modulation, continue modulation, reposition, and other suitable choices [¶[0076]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Crow, which already teaches confirming an effect of ablation, to include the processing operations of storing first information about the sensed neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, storing second information about the sensed neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, and comparing the second information to the first information and using results of the comparing to determine to what extent the nerves in the tissue surrounding the biological lumen were sufficiently denervated in response to the emission of the first instance of the second amount of energy, since such a modification would allow for the benefit/advantage of allowing for the provision of meaningful, real-time or relatively contemporaneous feedback to the clinician regarding the efficacy of the ongoing and/or completed energy delivery while the patient is still catheterized, as explicitly taught by Shah [¶[0075]].
15. Regarding claim 2, the combination of Crow and Shah teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Crow, as modified, further teaches wherein steps (a), (b), (c), (d), and (e) are performed while the transducer of the catheter is positioned at a same location within the biological lumen [see ¶’s [0018]-[0020]; and note ¶[0019] (“The catheter can remain in position, performing RF ablation …avoiding the need for repositioning and complicated location indexing”)].
16. Regarding claim 3, the combination of Crow and Shah teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claim 3 further requires that the same or a greater amount of energy be delivered responsive to a determination that the nerves were not sufficiently denervated:
(g) in response to determining that the nerves in the tissue surrounding the biological lumen were not sufficiently denervated in response to the emission of the first instance of the second amount of energy, energizing the transducer of the catheter to emit a second instance of the second amount of energy or energizing the transducer of the catheter to emit a third amount of energy that is greater than the second amount of energy.
Shah, again, teaches determining one or more parameters of return energy during or after neuromodulation, and taking appropriate action including, e.g., to continue modulation [maintain energy level], or adjust a power-delivery control algorithm [increase or decrease energy as needed] [e.g., ¶[0076]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Crow and Shah to take whatever action is desired/required responsive to real-time (sensing) feedback during a procedure, including maintaining and/or increasing energy output responsive to a determination that the nerves were not sufficiently denervated, since such a modification would allow for denervation to continue until complete while the patient is still catheterized [Shah, ¶[0075]], which would help eliminate the need for subsequent/corrective procedures.
17. Regarding claim 11, the combination of Crow and Shah teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Crow further teaches wherein the (b) using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, comprises one of the following:
using a pair of electrodes of the catheter to sense the neural response [e.g., ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”)];
using an electrode of the catheter and an electrode of a guidewire to sense the neural response;
using an electrode of the catheter and an electrode of an introducer sheath to sense the neural response; or
using an electrode of the catheter and an external skin electrode to sense the neural response [see ¶[0064] regarding pad electrode (275)].
18. Regarding claim 13, the combination of Crow and Shah teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Shah further teaches:
wherein after the (a) energizing the transducer of the catheter to emit the first instance of the first amount of energy, after the (b) using the at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, and prior to the (d) energizing the transducer of the catheter to emit the second instance of the first amount of energy, the method further comprises:
determining one or more characteristics of the sensed neural response [detected return energy] of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type [see ¶[0068] (“the amplitude and frequency of the detected return energy can depend in part on the types of tissue through which the diagnostic energy propagates… return energy data could be collected in known anatomical locations and the histology of the tissue could then be correlated to the return energy data to characterize signals according to the type of reflecting tissue”), function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter [see ¶[0060] (“determining the proximity of the treatment assembly 114 to the vessel wall which can be determined based on the detected return energy”) and ¶’s [0061]-[0062]]; and
selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters [e.g., power output] to be used for (c) energizing the transducer of the catheter to emit the first instance of the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see, e.g., ¶[0052] (“the console 106 can be configured to deliver the neuromodulation energy (e.g., RF energy) via an automated control algorithm 132”) and ¶[0053] (“the control algorithm 132 includes monitoring one or more of the temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate, parameters of return energy, or other operating parameters. The operating parameters may be monitored continuously or periodically… the control algorithm 132 adjusts the commanded power output accordingly”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Crow and Shah such that wherein after the (a) energizing the transducer of the catheter to emit the first instance of the first amount of energy, after the (b) using the at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, and prior to the (d) energizing the transducer of the catheter to emit the second instance of the first amount of energy, the method further comprises: determining one or more characteristics of the sensed neural response of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter; and selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for the (c) energizing the transducer of the catheter to emit the first instance of the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen, since such a modification increases the quality and success of the purposeful application of energy, thereby enhancing patient outcomes [Shah, ¶[0058]].
19. Regarding claim 14, Crow teaches a system, comprising:
a catheter [e.g., catheter (200) - ¶[0063]; FIG. 5] including one or more electrodes [see ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”); see also ¶’s [0025], [0068]] and also including a transducer [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); and ¶[0068] (“…such as when the ablation arrangement 215 includes a high-intensity acoustic energy transducer (e.g., a high-intensity focused ultrasound (HIFU) device)”)] that can be controlled to emit a selective amount of energy [e.g., ¶[0006]], wherein the catheter is configured such that at least a distal portion of the catheter is insertable into a biological lumen [renal artery] that is surrounded by tissue including nerves [see ¶[0063] (“a catheter 200 includes a flexible shaft 204 having a proximal end, a distal end, and a length sufficient to access a patient's renal artery 12”)] that are to be denervated [e.g., ¶’s [0003], [0053], [0056]] using the transducer of the catheter [¶’s [0006], [0053], [0056], [0066], [0068]];
***
an excitation source configured to selectively provide energy to the transducer of the catheter [ablation unit (225) of external system (220) - ¶’s [0066]-[0067], [0070]];
a sensing subsystem electrically coupled to at least one of the one or more electrodes of the catheter [sensor unit (174) - ¶[0067]]; and
a controller [control unit (170) - ¶[0067]] communicatively coupled to the excitation source [(225)], the sensing subsystem [(174)], …, the controller [(170)] configured to:
cause the excitation source to energize the transducer of the catheter to emit a first instance of a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0017] (“Embodiments of the disclosure utilize pain or other signals (e.g., physiologic responses) resulting from stimulation of the target renal nerves to detect which tissue locations are best to target”); ¶[0027] (“The nerve stimulation can utilize electrical energy as previously described, or other stimulation mechanisms or energies, or combinations of stimulation mechanisms and energies can be utilized. For example, renal nerves can be stimulated using a variety of mechanisms and energies, non-limiting examples of which include the following: visible, UV, or IR light or laser light; magnetism; sonic or ultrasonic energy, low-frequency vibration or mechanical impact loading, heating or cooling, microwave or RF energy, neurotransmitter or other chemical or drug, by pressure changes, or osmotic or pH changes, or by specific patterns or changes in these or other stimulatory mechanism”); and Abstract (“The stimulation energy is sufficient to elicit a physiologic response from the patient but insufficient to ablate renal nerves”); and ¶[0064] (“thermal energy”)];
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy [e.g., ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”)],…;
cause the excitation source to energize the transducer of the catheter to emit a first instance of a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0023] (“The selected ablation sites are then treated with high-power RF energy to ablate the target nerves”); see also ¶[0066]];
cause the excitation source to energize the transducer of the catheter to emit a second instance of the first amount of energy, after the first instance of the second amount of energy has been emitted [e.g., ¶[0020] (“After ablation, selected excitation and sensing can be repeated to immediately confirm the ablation effect on the target nerves”); claim 22 (“selectively delivering the stimulation energy following renal nerve tissue ablation to determine effectiveness of the ablation”)];
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy [e.g., ¶[0020] (“After ablation, selected excitation and sensing can be repeated to immediately confirm the ablation effect on the target nerves”); see also ¶[0022]].
Storage & Comparison of Sensed Neural Responses
While Crow teaches that stimulation/sensing occurs both before and after denervation to “confirm the ablation effect” [see ¶[0020]], Crow does not explicitly teach a memory along with the following emphasized claim limitations concerning storing and comparing information about the (pre/post) sensed neural responses:
a controller communicatively coupled to the excitation source, the sensing subsystem, and the memory, the controller configured to:
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, and store in the memory first information about the sensed neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy;
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, and store in the memory second information about the sensed neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy; and
compare the second information to the first information and use results of the comparison to determine to what extent the nerves in the tissue surrounding the biological lumen were sufficiently denervated in response to the emission of the first instance of the second amount of energy.
However, use of a memory and such processing steps were well known in the art, before the effective filing date of the claimed invention.
As one example, Shah, in a similar field of endeavor, relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient, and further teaches monitoring parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at a treatment site before, during and/or after therapeutic energy delivery [Shah, Abstract].
More particularly, Shah teaches that it is believed that the reflection or absorption of ultrasound, electromagnetic energy or other diagnostic energies from adequately neuromodulated (e.g., ablated) tissue are different than those of non-neuromodulated or under-neuromodulated tissue (e.g., non- or under-ablated) [¶[0074]]. As a result, parameters of detected return energy, such as the amplitude, frequency and/or derivations of these parameters, can be used to indicate the extent of ablation or other alteration of the neural tissue [¶[0074]].
Shah further teaches the use of diagnostic algorithms, and that, during pre-neuromodulation stages, the pre-neuromodulation parameters of return energy can be determined and stored in the memory of a controller [¶[0076]].
Further, while modulating the nerves, and/or after terminating energy delivery, a transducer can emit energy and detect a return energy, and a diagnostic algorithm can determine one or more parameters of return energy during or after neuromodulation, and then compare and/or evaluate the post-neuromodulation parameters of return energy in view of the pre-neuromodulation parameters of return energy to characterize the tissue. A controller can then provide a characterization to a clinician and/or suggest a course of action, such as adjust a power-delivery control algorithm, terminate modulation, continue modulation, reposition, and other suitable choices [¶[0076]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Crow, which already teaches confirming an effect of ablation, to include a memory, as well as the processing operations of storing first information about the sensed neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, storing second information about the sensed neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, and comparing the second information to the first information and using results of the comparing to determine to what extent the nerves in the tissue surrounding the biological lumen were sufficiently denervated in response to the emission of the first instance of the second amount of energy, since such a modification would allow for the benefit/advantage of allowing for the provision of meaningful, real-time or relatively contemporaneous feedback to the clinician regarding the efficacy of the ongoing and/or completed energy delivery while the patient is still catheterized, as explicitly taught by Shah [¶[0075]].
20. Regarding claims 15 & 16, the combination of Crow and Shah teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Claims 15 & 16 further require that the same or a greater amount of energy be delivered responsive to a determination that the nerves were not sufficiently denervated:
[claim 15] cause the excitation source to energize the transducer of the catheter to emit a second instance of the second amount of energy, in response to the controller determining that the nerves in the tissue surrounding the biological lumen were not sufficiently denervated in response to the emission of the first instance of the second amount of energy.
[claim 16] cause the excitation source to energize the transducer of the catheter to emit a third amount of energy that is greater than the second amount of energy, in response to the controller determining that the nerves in the tissue surrounding the biological lumen were not sufficiently denervated in response to the emission of the first instance of the second amount of energy.
Shah, again, teaches determining one or more parameters of return energy during or after neuromodulation, and taking appropriate action including, e.g., to continue modulation [maintain energy level], or adjust a power-delivery control algorithm [increase or decrease energy as needed] [e.g., ¶[0076]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Crow and Shah to take whatever action is desired/required responsive to real-time (sensing) feedback during a procedure, including maintaining and/or increasing energy output responsive to a determination that the nerves were not sufficiently denervated, since such a modification would allow for denervation to continue until complete while the patient is still catheterized [Shah, ¶[0075]], which would help eliminate the need for subsequent/corrective procedures.
21. Regarding claim 24, the combination of Crow and Shah teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Crow further teaches wherein the controller is configured to cause the sensing subsystem to use at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, by causing the sensing subsystem to:
use a pair of electrodes of the catheter to sense the neural response [e.g., ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”)];
use an electrode of the catheter and an electrode of a guidewire to sense the neural response;
use an electrode of the catheter and an electrode of an introducer sheath to sense the neural response; or
use an electrode of the catheter and an external skin electrode to sense the neural response [see ¶[0064] regarding pad electrode (275)].
22. Regarding claim 26, the combination of Crow and Shah teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Shah furth teaches wherein the controller is further configured to:
determine one or more characteristics of the sensed neural response [detected return energy] that is evoked by energizing the transducer to emit the first instance of the first amount of energy, the one or more characteristics indicative of one or more of a size, type [see ¶[0068] (“the amplitude and frequency of the detected return energy can depend in part on the types of tissue through which the diagnostic energy propagates… return energy data could be collected in known anatomical locations and the histology of the tissue could then be correlated to the return energy data to characterize signals according to the type of reflecting tissue”), function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter [see ¶[0060] (“determining the proximity of the treatment assembly 114 to the vessel wall which can be determined based on the detected return energy”) and ¶’s [0061]-[0062]]; and
select, based on the one or more characteristics of the sensed neural response, one or more denervation parameters [e.g., power output] to be used for energizing the transducer of the catheter to emit the first instance of the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see, e.g., ¶[0052] (“the console 106 can be configured to deliver the neuromodulation energy (e.g., RF energy) via an automated control algorithm 132”) and ¶[0053] (“the control algorithm 132 includes monitoring one or more of the temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate, parameters of return energy, or other operating parameters. The operating parameters may be monitored continuously or periodically… the control algorithm 132 adjusts the commanded power output accordingly”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Crow and Shah such that the controller is further configured to: determine one or more characteristics of the sensed neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter; and select, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for energizing the transducer of the catheter to emit the first instance of the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen, since such a modification increases the quality and success of the purposeful application of energy, thereby enhancing patient outcomes [Shah, ¶[0058]].
23. Regarding claim 27, Crow teaches a method for use with a catheter [e.g., catheter (200) - ¶[0063]; FIG. 5] including one or more electrodes [see ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”); see also ¶’s [0025], [0068]] and also including a transducer [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); and ¶[0068] (“…such as when the ablation arrangement 215 includes a high-intensity acoustic energy transducer (e.g., a high-intensity focused ultrasound (HIFU) device)”)] that can be controlled to emit a selective amount of energy [e.g., ¶[0006]], wherein the method is for use while at least a distal portion of the catheter is inserted into a biological lumen [renal artery] that is surrounded by tissue including nerves [see ¶[0063] (“a catheter 200 includes a flexible shaft 204 having a proximal end, a distal end, and a length sufficient to access a patient's renal artery 12”)] that are to be denervated [e.g., ¶’s [0003], [0053], [0056]] using the transducer of the catheter [¶’s [0006], [0053], [0056], [0066], [0068]], the method comprising:
energizing the transducer of the catheter to emit a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0017] (“Embodiments of the disclosure utilize pain or other signals (e.g., physiologic responses) resulting from stimulation of the target renal nerves to detect which tissue locations are best to target”); ¶[0027] (“The nerve stimulation can utilize electrical energy as previously described, or other stimulation mechanisms or energies, or combinations of stimulation mechanisms and energies can be utilized. For example, renal nerves can be stimulated using a variety of mechanisms and energies, non-limiting examples of which include the following: visible, UV, or IR light or laser light; magnetism; sonic or ultrasonic energy, low-frequency vibration or mechanical impact loading, heating or cooling, microwave or RF energy, neurotransmitter or other chemical or drug, by pressure changes, or osmotic or pH changes, or by specific patterns or changes in these or other stimulatory mechanism”); and Abstract (“The stimulation energy is sufficient to elicit a physiologic response from the patient but insufficient to ablate renal nerves”); and ¶[0064] (“thermal energy”)]; [and]
using at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first amount of energy [e.g., ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”)]; [and]
… energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0023] (“The selected ablation sites are then treated with high-power RF energy to ablate the target nerves”); see also ¶[0066]].
Characteristic Determination & Denervation Parameters
Crow generally teaches that sensed neural responses can be used to influence ablation [e.g., ¶[0023] (“determines the optimal choice of sites to provide the most effect in ablating the target nerves”), but does not explicitly teach:
determining one or more characteristics of the sensed neural response of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter; and
selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen.
However, the use of characteristics of a sensed neural response to select denervation parameters was well known in the art, before the effective filing date of the claimed invention.
As one example, Shah, in a similar field of endeavor, relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient, and further teaches monitoring parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at a treatment site before, during and/or after therapeutic energy delivery [Shah, Abstract].
More particularly, Shah teaches:
determining one or more characteristics of the sensed neural response [detected return energy] of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type [see ¶[0068] (“the amplitude and frequency of the detected return energy can depend in part on the types of tissue through which the diagnostic energy propagates… return energy data could be collected in known anatomical locations and the histology of the tissue could then be correlated to the return energy data to characterize signals according to the type of reflecting tissue”), function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter [see ¶[0060] (“determining the proximity of the treatment assembly 114 to the vessel wall which can be determined based on the detected return energy”) and ¶’s [0061]-[0062]]; and
selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters [e.g., power output] to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see, e.g., ¶[0052] (“the console 106 can be configured to deliver the neuromodulation energy (e.g., RF energy) via an automated control algorithm 132”) and ¶[0053] (“the control algorithm 132 includes monitoring one or more of the temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate, parameters of return energy, or other operating parameters. The operating parameters may be monitored continuously or periodically… the control algorithm 132 adjusts the commanded power output accordingly”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Crow to include determining one or more characteristics of the sensed neural response of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter, and selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen, since such a modification increases the quality and success of the purposeful application of energy, thereby enhancing patient outcomes [Shah, ¶[0058]].
24. Regarding claim 28, the combination of Crow and Shah teaches all of the limitations of claim 27 for the reasons set forth in detail (above) in the Office Action.
Crow was modified above in the rejection of claim 27 above to include Shah’s processing operation of selecting one or more denervation parameters.
Shah further teaches using the selected one or more denervation parameters for energizing the transducer of the catheter to emit the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [e.g., ¶[0053]].
25. Regarding claim 29, the combination of Crow and Shah teaches all of the limitations of claim 27 for the reasons set forth in detail (above) in the Office Action.
Crow was modified above in the rejection of claim 27 above to include Shah’s processing operation of selecting one or more denervation parameters.
Crow (as modified) further teaches using the selected one or more denervation parameters for energizing a different transducer of the catheter, or of a different catheter, to emit the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [Crow teaches that an ablation catheter may be used separate from the sensing catheter (e.g., ¶[0070])]. Note also Shah’s teaching that it was known for a single catheter to include two or more energy delivery elements for neuromodulation (¶[0040]).
26. Regarding claim 30, Crow teaches a system, comprising:
a catheter [e.g., catheter (200) - ¶[0063]; FIG. 5] including one or more electrodes [see ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”); see also ¶’s [0025], [0068]] and also including a transducer [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); and ¶[0068] (“…such as when the ablation arrangement 215 includes a high-intensity acoustic energy transducer (e.g., a high-intensity focused ultrasound (HIFU) device)”)] that can be controlled to emit a selective amount of energy [e.g., ¶[0006]], wherein the catheter is configured such that at least a distal portion of the catheter is insertable into a biological lumen [renal artery] that is surrounded by tissue including nerves [see ¶[0063] (“a catheter 200 includes a flexible shaft 204 having a proximal end, a distal end, and a length sufficient to access a patient's renal artery 12”)] that are to be denervated [e.g., ¶’s [0003], [0053], [0056]] using the transducer of the catheter [¶’s [0006], [0053], [0056], [0066], [0068]];
***
an excitation source configured to selectively provide energy to the transducer of the catheter [ablation unit (225) of external system (220) - ¶’s [0066]-[0067], [0070]]; and
a sensing subsystem electrically coupled to at least one of the one or more sensing electrodes of the catheter [sensor unit (174) - ¶[0067]]; and
a controller [control unit (170) - ¶[0067]] communicatively coupled to the excitation source [(225)], the sensing subsystem [(174)],… the controller [(170)] configured to:
cause the excitation source to energize the transducer of the catheter to emit a first amount of energy that is sufficient to heat the nerves in the tissue surrounding the biological lumen to an extent that a neural response is evoked without denervating the nerves [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0017] (“Embodiments of the disclosure utilize pain or other signals (e.g., physiologic responses) resulting from stimulation of the target renal nerves to detect which tissue locations are best to target”); ¶[0027] (“The nerve stimulation can utilize electrical energy as previously described, or other stimulation mechanisms or energies, or combinations of stimulation mechanisms and energies can be utilized. For example, renal nerves can be stimulated using a variety of mechanisms and energies, non-limiting examples of which include the following: visible, UV, or IR light or laser light; magnetism; sonic or ultrasonic energy, low-frequency vibration or mechanical impact loading, heating or cooling, microwave or RF energy, neurotransmitter or other chemical or drug, by pressure changes, or osmotic or pH changes, or by specific patterns or changes in these or other stimulatory mechanism”); and Abstract (“The stimulation energy is sufficient to elicit a physiologic response from the patient but insufficient to ablate renal nerves”); and ¶[0064] (“thermal energy”)]; [and]
cause the sensing subsystem to sense, using at least one of the one or more electrodes of the catheter, the neural response that is evoked by energizing the transducer to emit the first amount of energy [e.g., ¶[0022] (“A response to the nerve stimulation can be sensed locally or remotely by electrodes and/or one or more sensors on the catheter”)];
… energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0023] (“The selected ablation sites are then treated with high-power RF energy to ablate the target nerves”); see also ¶[0066]].
Characteristic Determination & Denervation Parameters
Crow generally teaches that sensed neural responses can be used to influence ablation [e.g., ¶[0023] (“determines the optimal choice of sites to provide the most effect in ablating the target nerves”), but does not explicitly teach a memory, nor:
a controller communicatively coupled to the excitation source, the sensing subsystem, and the memory, the controller configured to:
determine one or more characteristics of the sensed neural response of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter; and
select, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen.
However, the use of characteristics of a sensed neural response to select denervation parameters was well known in the art, before the effective filing date of the claimed invention.
As one example, Shah, in a similar field of endeavor, relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient, and further teaches monitoring parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at a treatment site before, during and/or after therapeutic energy delivery [Shah, Abstract].
More particularly, Shah teaches:
determining one or more characteristics of the sensed neural response [detected return energy] of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type [see ¶[0068] (“the amplitude and frequency of the detected return energy can depend in part on the types of tissue through which the diagnostic energy propagates… return energy data could be collected in known anatomical locations and the histology of the tissue could then be correlated to the return energy data to characterize signals according to the type of reflecting tissue”), function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter [see ¶[0060] (“determining the proximity of the treatment assembly 114 to the vessel wall which can be determined based on the detected return energy”) and ¶’s [0061]-[0062]; Shah further teaches storing pre-neuromodulation parameters of return energy in a memory of the controller - ¶[0076]]; and
selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters [e.g., power output] to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see, e.g., ¶[0052] (“the console 106 can be configured to deliver the neuromodulation energy (e.g., RF energy) via an automated control algorithm 132”) and ¶[0053] (“the control algorithm 132 includes monitoring one or more of the temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate, parameters of return energy, or other operating parameters. The operating parameters may be monitored continuously or periodically… the control algorithm 132 adjusts the commanded power output accordingly”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Crow to include a memory, and to have the controller configured to determine one or more characteristics of the sensed neural response of the nerves within the tissue surrounding the biological lumen, the one or more characteristics indicative of one or more of a size, type, function or health of the nerves and/or indicative of proximity of the nerves relative to the at least one of the one or more electrodes of the catheter, and select, based on the one or more characteristics of the sensed neural response, one or more denervation parameters to be used for energizing the transducer of the catheter to emit a second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen, since such a modification increases the quality and success of the purposeful application of energy, thereby enhancing patient outcomes [Shah, ¶[0058]].
27. Regarding claim 31, the combination of Crow and Shah teaches all of the limitations of claim 30 for the reasons set forth in detail (above) in the Office Action.
Crow was modified above in the rejection of claim 30 above to include Shah’s processing operation of selecting one or more denervation parameters.
Shah further teaches wherein the controller is also configured to use the selected one or more denervation parameters to cause the excitation source to energize the transducer of the catheter to emit the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [e.g., ¶[0053]].
28. Regarding claim 32, the combination of Crow and Shah teaches all of the limitations of claim 30 for the reasons set forth in detail (above) in the Office Action.
Crow was modified above in the rejection of claim 27 above to include Shah’s processing operation of selecting one or more denervation parameters.
Crow (as modified) further teaches using the selected one or more denervation parameters to cause the excitation source to energize a different transducer of the catheter, or of a different catheter, to emit the second amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [Crow teaches that an ablation catheter may be used separate from the sensing catheter (e.g., ¶[0070])]. Note also Shah’s teaching that it was known for a single catheter to include two or more energy delivery elements for neuromodulation (¶[0040]).
29. Regarding claims 34 & 35, Crow discloses all of the limitations of claim 33 for the reasons set forth in detail (above) in the Office Action.
While Crow discloses that stimulation/sensing occurs both before and after denervation to “confirm the ablation effect” [see ¶[0020]], Crow does not explicitly disclose:
[claim 34] wherein the neural response that is sensed is used as a baseline neural response prior to an ablation procedure being performed; nor
[claim 35] wherein the neural response that is sensed is used as a post-ablation neural response to determine an efficacy of an ablation procedure that had been performed.
However, use of such processing steps were well known in the art, before the effective filing date of the claimed invention.
As one example, Shah, in a similar field of endeavor, relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient, and further teaches monitoring parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at a treatment site before, during and/or after therapeutic energy delivery [Shah, Abstract].
More particularly, Shah teaches that it is believed that the reflection or absorption of ultrasound, electromagnetic energy or other diagnostic energies from adequately neuromodulated (e.g., ablated) tissue are different than those of non-neuromodulated or under-neuromodulated tissue (e.g., non- or under-ablated) [¶[0074]]. As a result, parameters of detected return energy, such as the amplitude, frequency and/or derivations of these parameters, can be used to indicate the extent of ablation or other alteration of the neural tissue [¶[0074]].
Shah further teaches the use of diagnostic algorithms, and that, during pre-neuromodulation stages, the pre-neuromodulation parameters of return energy can be determined and stored in the memory of a controller [¶[0076]].
Further, while modulating the nerves, and/or after terminating energy delivery, a transducer can emit energy and detect a return energy, and a diagnostic algorithm can determine one or more parameters of return energy during or after neuromodulation, and then compare and/or evaluate the post-neuromodulation parameters of return energy in view of the pre-neuromodulation parameters of return energy to characterize the tissue. A controller can then provide a characterization to a clinician and/or suggest a course of action, such as adjust a power-delivery control algorithm, terminate modulation, continue modulation, reposition, and other suitable choices [¶[0076]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Crow, which already teaches confirming an effect of ablation, such that the neural response that is sensed is used as a baseline neural response prior to an ablation procedure being performed, and wherein the neural response that is sensed is used as a post-ablation neural response to determine an efficacy of an ablation procedure that had been performed, since such a modification would allow for the benefit/advantage of allowing for the provision of meaningful, real-time or relatively contemporaneous feedback to the clinician regarding the efficacy of the ongoing and/or completed energy delivery while the patient is still catheterized, as explicitly taught by Shah [¶[0075]].
30. Regarding claim 36, Crow discloses all of the limitations of claim 33 for the reasons set forth in detail (above) in the Office Action.
Crow further discloses energizing the transducer of the catheter to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0023] (“The selected ablation sites are then treated with high-power RF energy to ablate the target nerves”); see also ¶[0066]].
Crow generally teaches that sensed neural responses can be used to influence ablation [e.g., ¶[0023] (“determines the optimal choice of sites to provide the most effect in ablating the target nerves”), but does not explicitly teach:
wherein the neural response that is sensed is used to select one or more denervation parameters for energizing the transducer of the catheter to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen.
However, the use of a sensed neural response to select denervation parameters was well known in the art, before the effective filing date of the claimed invention.
As one example, Shah, in a similar field of endeavor, relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient, and further teaches monitoring parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at a treatment site before, during and/or after therapeutic energy delivery [Shah, Abstract].
More particularly, Shah teaches:
determining one or more characteristics of the sensed neural response [detected return energy] [see ¶’s [0060]-[0062], [0068]] and selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters [e.g., power output] to be used for energizing the transducer of the catheter to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see, e.g., ¶[0052] (“the console 106 can be configured to deliver the neuromodulation energy (e.g., RF energy) via an automated control algorithm 132”) and ¶[0053] (“the control algorithm 132 includes monitoring one or more of the temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate, parameters of return energy, or other operating parameters. The operating parameters may be monitored continuously or periodically… the control algorithm 132 adjusts the commanded power output accordingly”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Crow such that the neural response that is sensed is used to select one or more denervation parameters for energizing the transducer of the catheter to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen, since such a modification increases the quality and success of the purposeful application of energy, thereby enhancing patient outcomes [Shah, ¶[0058]].
31. Regarding claim 37, Crow discloses all of the limitations of claim 33 for the reasons set forth in detail (above) in the Office Action.
Crow further discloses energizing [a] transducer of the catheter to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see ¶[0006] (“the same transducer can apply a low-energy acoustic stimulation energy and a high-energy acoustic ablation energy, for example”); ¶[0023] (“The selected ablation sites are then treated with high-power RF energy to ablate the target nerves”); see also ¶[0066]].
Crow generally teaches that sensed neural responses can be used to influence ablation [e.g., ¶[0023] (“determines the optimal choice of sites to provide the most effect in ablating the target nerves”), but does not explicitly teach:
wherein the neural response that is sensed is used to select one or more denervation parameters for energizing a … transducer… to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen.
However, the use of a sensed neural response to select denervation parameters was well known in the art, before the effective filing date of the claimed invention.
As one example, Shah, in a similar field of endeavor, relates to devices, systems and methods for positioning a neuromodulation device at a treatment site and evaluating the effects of therapeutic energy delivery applied to tissue in a patient, and further teaches monitoring parameters or values relevant to efficacious neuromodulation by emitting and detecting diagnostic energy at a treatment site before, during and/or after therapeutic energy delivery [Shah, Abstract].
More particularly, Shah teaches:
determining one or more characteristics of the sensed neural response [detected return energy] [see ¶’s [0060]-[0062], [0068]] and selecting, based on the one or more characteristics of the sensed neural response, one or more denervation parameters [e.g., power output] to be used for energizing the transducer of the catheter to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [see, e.g., ¶[0052] (“the console 106 can be configured to deliver the neuromodulation energy (e.g., RF energy) via an automated control algorithm 132”) and ¶[0053] (“the control algorithm 132 includes monitoring one or more of the temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate, parameters of return energy, or other operating parameters. The operating parameters may be monitored continuously or periodically… the control algorithm 132 adjusts the commanded power output accordingly”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Crow such that the neural response that is sensed is used to select one or more denervation parameters for energizing the transducer to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen, since such a modification increases the quality and success of the purposeful application of energy, thereby enhancing patient outcomes [Shah, ¶[0058]].
As modified to include Shah’s processing operation of selecting one or more denervation parameters, Crow further teaches using the selected one or more denervation parameters for energizing a different transducer of the catheter, or of a different catheter, to emit a further amount of energy that is sufficient to denervate at least some the nerves in the tissue surrounding the biological lumen [Crow teaches that an ablation catheter may be used separate from the sensing catheter (e.g., ¶[0070])]. Note also Shah’s teaching that it was known for a single catheter to include two or more energy delivery elements for neuromodulation (¶[0040]).
32. Claims 4-10 & 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Crow and Shah, and further in view of in view of U.S. Patent Application Publication No. 2014/0088629 to Hastings et al. ("Hastings").
33. Regarding claims 4 & 17, the combination of Crow and Shah teaches all of the limitations of claims 1 & 14, respectively, for the reasons set forth in detail (above) in the Office Action.
The combination of Crow and Shah does not, however, teach:
the first amount of energy emitted from the transducer, that is sufficient to heat the nerves in the tissue surrounding the biological lumen to the extent that a neural response is evoked without denervating the nerves, is provided by causing the transducer to emit energy within a specified frequency range for a first duration and having a first power level that are collectively sufficient to heat the tissue surrounding the biological lumen to a temperature of at least 38 degrees Celsius, but not to exceed 52 degrees Celsius;
the second amount of energy emitted from the transducer, that is sufficient to denervate at least some the nerves in the tissue surrounding the biological, is provided by causing the transducer to emit energy within the same specified frequency range for a second duration and having a second power level that are collectively sufficient to heat the tissue surrounding the biological lumen to a temperature of at least 43 degrees Celsius, but not to exceed 100 degrees Celsius; and
the second duration is greater than the first duration and/or the second power level is greater than the first power level.
Hastings, in a similar field of endeavor, teaches systems for nerve and tissue modulation [Abstract]. For stimulation, Hastings teaches heating surrounding nerves to approximately 40° to 49°C [see ¶[0035]], which falls within Applicant’s claimed range of 38° to 52°C. Hastings further teaches that it is known that tissue begins to denature or irreversibly change at approximately 50° to 60°C [see ¶[0035]], which falls within Applicant’s claimed range of 43° to 100°C [see ¶[0035] (“Power may be supplied to the stimulation transducer 114 through an electrical conductor 118 such that the surrounding nerves are heated approximately 5-10°C. greater than the surrounding body temperature. Thus, the surrounding nerves are heated to approximately 40-49° C., depending on the body temperature of the patient. However, these ranges are merely exemplary and the thermal block may be performed at temperature outside these ranges. However, it is contemplated that the location 126 at which the thermal nerve block is performed should not be heated to the point at which tissue begins to denature or irreversibly change, for example, approximately 50-60°C.”)]. Hastings additionally teaches that it was known in the art for power level, frequency and/or duration of the energy application to be adjusted to achieve a desired temperature rise [¶[0025]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Crow and Shah such that stimulation (without denervation) occur by causing the transducer to emit energy within a specified frequency range for a first duration and having a first power level that are collectively sufficient to heat the tissue surrounding the biological lumen to a temperature of at least 38 degrees Celsius, but not to exceed 52 degrees Celsius, and that denervation of at least some the nerves in the tissue surrounding the biological, is provided by causing the transducer to emit energy within the same specified frequency range for a second duration and having a second power level that are collectively sufficient to heat the tissue surrounding the biological lumen to a temperature of at least 43 degrees Celsius, but not to exceed 100 degrees Celsius, and the second duration is greater than the first duration and/or the second power level is greater than the first power level, since such known energy delivery and heating parameters were recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Hastings, and one of ordinary skill in the art would have been capable of applying these known parameters to the method/system of Crow/Shah, and the results (heating for stimulation, and heating for denervation) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
34. Regarding claims 5 & 18, the combination of Crow, Shah, & Hastings teaches all of the limitations of claims 4 & 17, respectively, for the reasons set forth in detail (above) in the Office Action.
Claims 5 & 18 each further require wherein:
the second duration is greater than the first duration; and
the second power level is greater than the first power level.
Hastings teaches that it was known in the art for power level, frequency and/or duration of the energy application to be adjusted to achieve a desired temperature rise [¶[0025]].
As such, it would have been routine and obvious for the skilled artisan, before the effective filing date of the claimed invention, to further modify the combination of Crow, Shah, & Hastings such that at least duration and power level be adjusted as desired in a number of different ways including, e.g., wherein the second duration is greater than the first duration, and the second power level is greater than the first power level, to achieve the predictable results of providing both heating for stimulation, and heating for denervation.
35. Regarding claims 6 & 19, the combination of Crow, Shah, & Hastings teaches all of the limitations of claims 4 & 17, respectively, for the reasons set forth in detail (above) in the Office Action.
Claims 6 & 19 each further require wherein:
the second duration is greater than the first duration; and
the second power level is the same as the first power level.
Hastings teaches that it was known in the art for power level, frequency and/or duration of the energy application to be adjusted to achieve a desired temperature rise [¶[0025]].
As such, it would have been routine and obvious for the skilled artisan, before the effective filing date of the claimed invention, to further modify the combination of Crow, Shah, & Hastings such that at least duration and power level be adjusted as desired in a number of different ways including, e.g., wherein the second duration is greater than the first duration, and the second power level is the same as the first power level, to achieve the predictable results of providing both heating for stimulation, and heating for denervation.
36. Regarding claims 7 & 20, the combination of Crow, Shah, & Hastings teaches all of the limitations of claims 4 & 17, respectively, for the reasons set forth in detail (above) in the Office Action.
Claims 7 & 20 each further require wherein:
the second duration is the same as the first duration; and
the second power level is greater than the first power level.
Hastings teaches that it was known in the art for power level, frequency and/or duration of the energy application to be adjusted to achieve a desired temperature rise [¶[0025]].
As such, it would have been routine and obvious for the skilled artisan, before the effective filing date of the claimed invention, to further modify the combination of Crow, Shah, & Hastings such that at least duration and power level be adjusted as desired in a number of different ways including, e.g., the second duration is the same as the first duration, and the second power level is greater than the first power level, to achieve the predictable results of providing both heating for stimulation, and heating for denervation.
37. Regarding claims 8 & 21, the combination of Crow, Shah, & Hastings teaches all of the limitations of claims 4 & 17, respectively, for the reasons set forth in detail (above) in the Office Action.
Claims 8 & 21 each further require wherein:
the transducer of the catheter comprises an ultrasound transducer; and
the specified frequency range comprises 5 MHz to 20 MHz.
Crow further teaches wherein the transducer of the catheter comprises an ultrasound transducer [e.g., ¶[0068]].
Shah further teaches wherein the transducer of the catheter comprises an ultrasound transducer [e.g., ¶[0034]]
Hastings further teaches wherein the transducer of the catheter comprises an ultrasound transducer [e.g., ¶[0026], and that any desired frequency range may be utilized including, e.g., from 1-20 MHz [¶[0026]]. It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
38. Regarding claims 9 & 22, the combination of Crow, Shah, & Hastings teaches all of the limitations of claims 4 & 17, respectively, for the reasons set forth in detail (above) in the Office Action.
Claims 9 & 22 each further require wherein:
the transducer of the catheter comprises a radio frequency (RF) transducer; and
the specified frequency range comprises 300 kHz to 600 kHz.
Crow further teaches wherein the transducer of the catheter comprises a radio frequency (RF) transducer [e.g., ¶’s [0006], [0023]].
Shah further teaches wherein the transducer of the catheter comprises a radio frequency (RF) transducer [e.g., ¶’s [0031], [0034]].
Hastings further teaches wherein the transducer of the catheter comprises a radio frequency (RF) transducer [e.g., ¶[0029]].
Selection of a specified frequency range including, e.g., 300 kHz to 600 kHz, would have been routine and obvious for the skilled artisan given Hastings’ teaching that was known in the art for power level, frequency and/or duration of the energy application to be adjusted to achieve a desired temperature rise [¶[0025]].
39. Regarding claims 10 & 23, the combination of Crow, Shah, & Hastings teaches all of the limitations of claims 4 & 17, respectively, for the reasons set forth in detail (above) in the Office Action.
Claims 10 & 23 each further require wherein:
the transducer of the catheter comprises a microwave transducer; and
the specified frequency range comprises 300 MHz to 30 GHz.
Crow further teaches wherein the transducer of the catheter comprises a microwave transducer [e.g., ¶[0027]].
Shah further teaches wherein the transducer of the catheter comprises a microwave transducer [e.g., ¶[0034]].
Hastings further teaches wherein the transducer of the catheter comprises a microwave transducer [e.g., ¶[0029]].
Selection of a specified frequency range including, e.g., 300 MHz to 30 GHz, would have been routine and obvious for the skilled artisan given Hastings’ teaching that was known in the art for power level, frequency and/or duration of the energy application to be adjusted to achieve a desired temperature rise [¶[0025]].
40. Claims 12 & 25 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Crow and Shah, and further in view of in view of U.S. Patent Application Publication No. 2013/0165917 to Mathur et al. ("Mathur").
41. Regarding claim 12, the combination of Crow and Shah teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Shah further teaches wherein:
the (a) energizing the transducer of the catheter to emit the first instance of the first amount of energy, and the (b) using the at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, are performed contemporaneously [Shah, e.g., ¶’s [0074]-[0075]; stimulation and sensing of diagnostic energies provides real-time, relatively contemporaneous feedback];
the (d) energizing the transducer of the catheter to emit the second instance of the first amount of energy, and the (e) using the at least one of the one or more electrodes of the catheter to sense the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, are performed contemporaneously [Shah, e.g., ¶’s [0074]-[0075]; stimulation and sensing of diagnostic energies provides real-time, relatively contemporaneous feedback].
The combination of Crow and Shah does not, however, teach:
using a lowpass filter or a bandpass filter to distinguish the sensed neural responses to the energy emitted by the transducer from the energy emitted by the transducer.
Mathur, in a similar field of endeavor, teaches a renal-denervation treatment method [Abstract], and teaches that it was known to use a lowpass filter or a bandpass filter to distinguish the sensed neural responses to the energy emitted by the transducer from the energy emitted by the transducer [see ¶[0446] (“Nerve signal measurement may be optimized using signal filtering such that the influence of cardiac electrical signals, stimulation signals, and system noise are filtered out of the nerve sensing circuit so as to optimize the accuracy and sensitivity of the circuit. Signal filtering may be accomplished through means such as band-pass filters. For example, a low-pass filter in the range of about 1 Hz to about 500 Hz, with an example value of 100 Hz and a high-pass filter in the range of about 1 kHz to about 10 kHz, with an example value of 5 kHz may be employed to establish the frequency band of signals to be sensed and measured by the circuit. Measurements are then used as feedback applied to the energy control algorithm used to regulate the delivery of therapeutic energy”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Crow and Shah to include using a lowpass filter or a bandpass filter to distinguish the sensed neural responses to the energy emitted by the transducer from the energy emitted by the transducer, so as to optimize the accuracy and sensitivity of the nerve sensing circuit, as explicitly taught by Mathur [¶[0446]].
42. Regarding claim 25, the combination of Crow and Shah teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Shah further teaches wherein the controller is configured to cause the sensing subsystem to:
sense the neural response that is evoked by energizing the transducer to emit the first instance of the first amount of energy, contemporaneously with controlling the excitation source to energize the transducer of the catheter to emit the first instance of the first amount of energy [Shah, e.g., ¶’s [0074]-[0075]; stimulation and sensing of diagnostic energies provides real-time, relatively contemporaneous feedback]; and
sense the neural response that is evoked by energizing the transducer to emit the second instance of the first amount of energy, contemporaneously with controlling the excitation source to energize the transducer of the catheter to emit the second instance of the first amount of energy [Shah, e.g., ¶’s [0074]-[0075]; stimulation and sensing of diagnostic energies provides real-time, relatively contemporaneous feedback].
The combination of Crow and Shah does not, however, teach:
wherein the system further comprises a lowpass filter or a bandpass filter configured to distinguish the sensed neural responses to the energy emitted by the transducer from the energy emitted by the transducer.
Mathur, in a similar field of endeavor, teaches a renal-denervation treatment method [Abstract], and teaches that it was known to use a lowpass filter or a bandpass filter to distinguish the sensed neural responses to the energy emitted by the transducer from the energy emitted by the transducer [see ¶[0446] (“Nerve signal measurement may be optimized using signal filtering such that the influence of cardiac electrical signals, stimulation signals, and system noise are filtered out of the nerve sensing circuit so as to optimize the accuracy and sensitivity of the circuit. Signal filtering may be accomplished through means such as band-pass filters. For example, a low-pass filter in the range of about 1 Hz to about 500 Hz, with an example value of 100 Hz and a high-pass filter in the range of about 1 kHz to about 10 kHz, with an example value of 5 kHz may be employed to establish the frequency band of signals to be sensed and measured by the circuit. Measurements are then used as feedback applied to the energy control algorithm used to regulate the delivery of therapeutic energy”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Crow and Shah such that the system further comprises a lowpass filter or a bandpass filter configured to distinguish the sensed neural responses to the energy emitted by the transducer from the energy emitted by the transducer, so as to optimize the accuracy and sensitivity of the nerve sensing circuit, as explicitly taught by Mathur [¶[0446]].
Conclusion
43. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794