DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-3 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham et al. (US 2017/0056104) in view of Toth et al. (US 2015/0173673).
Regarding claim 2, Asirvatham discloses a method (see Fig. 2) comprising: applying a first stimulus at a site within a blood vessel of a patient (see stimulation of the renal artery in step 210; [0050], Figs. 1 and 2); determining a first hemodynamic caused by one of efferent nerve activity or afferent nerve activity of the patient to the first stimulus (see measuring of blood pressure after stimulation in steps 212 and/or 220 caused at least by efferent nerves acting on the renal artery; [0050] and [0053], Fig. 2); after the first stimulus is applied at the site, modulating activity of nerves at the site by neuromodulation (see ablation of the nerves at step 218 occurring after step 210, Fig. 2); after the activity of the nerves at the site is modulated, applying a second stimulus at the site (see stimulation applied at step 222 after step 218; [0053], Fig. 2); and determining a second hemodynamic response caused by the one of efferent nerve activity or afferent nerve activity of the patient to the second stimulus (see measuring of blood pressure at step 224 after step 223 caused at least by efferent nerves acting on the renal artery, [0053], Fig. 2). However, Asirvatham fails to disclose the first hemodynamic response comprising a first vessel dimension change of the blood vessel, and the second hemodynamic response comprising a second vessel dimension change of the blood vessel.
Toth teaches a method of modulating nerves at sites in a blood vessel comprising monitoring combinations of blood pressure and vasodilation in order to determine completeness of the neuromodulation procedure (see [0325]-[0327]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second hemodynamic responses as disclosed by Asirvatham to have further included a first vessel dimension change of the blood vessel and a second vessel dimension change of the blood vessel in light of Toth, the motivation being to provide the additional advantage of providing a more holistic view of the effect of the neuromodulation in order to determine whether to continue with, stop, or alter the surgical procedure (see Toth [0327]).
Regarding claim 3, Asirvatham further discloses wherein the one of efferent nerve activity or afferent nerve activity is an efferent nerve activity (see efferent nerves acting on the renal artery causing constriction, [0050] and [0053]).
Regarding claim 5, Asirvatham further discloses wherein applying the first stimulus comprises delivering an electrical stimulus via one or more electrodes of a catheter positioned within the blood vessel (see mapping/ablation electrodes 110 within the blood vessel, [0034]-[0035], Fig. 1) or applying the first stimulus comprises delivering a pharmacological agent into a wall of the blood vessel or into a lumen of the blood vessel (see administration of adenosine or capsaicin, [0050]).
Regarding claim 6, Asirvatham in view of Toth further teaches wherein one or both of the first vessel dimension change or the second vessel dimension change of the blood vessel corresponds to pressure within the blood vessel (see Asirvatham: blood pressure within the vessel, [0053]; Toth: vasodilation that corresponds to pressure within a blood vessel, [0326]).
Regarding claim 7, Asirvatham further discloses wherein determining the first hemodynamic response comprises sensing, via one or more sensors, a patient parameter indicative of a response of the patient to the first stimulus (see sensing of blood pressure via a pressure sensor indicative a response of the patient to the first stimulation at step 212, [0049]-[0050], Fig. 2).
Regarding claim 8, Asirvatham further discloses wherein modulating activity of nerves at the site comprises at least one of applying cryogenic cooling at the site, applying neuromodulation energy at the site, or delivering a chemical at the site (see [0035]).
Regarding claim 9, Asirvatham further discloses determining whether the site is a suitable location for neuromodulation therapy based on the first and second hemodynamic responses (see determination at step 226 on if the site is suitable for further ablation based on the change between the measurements at steps 220 and 224; [0054], Fig. 2).
Regarding claim 10, Asirvatham further discloses wherein determining whether the site is the suitable location for neuromodulation therapy based on the first and second hemodynamic responses comprises: determining a difference between the first and second hemodynamic responses (see determination at step 226 on if the site is suitable for further ablation based on the change between the measurements at steps 220 and 224; [0054], Fig. 2); determining the site is the suitable location for neuromodulation therapy in response to determining the difference is greater than or equal to a predetermined threshold (see determining an amount of change is equal to or greater than a predetermined “substantial” change threshold and determining that further ablation is necessary, [0054]); and determining the site is not the suitable location for neuromodulation therapy in response to determining the difference is less than the predetermined threshold (see determining the site is not in further need of ablation based on there being no substantial change, [0053], this implies it being less than a predetermined threshold for “substantial” change).
Regarding claim 11, Asirvatham further discloses wherein determining whether the site is a suitable location for neuromodulation therapy based on the first and second hemodynamic responses comprises determining that the site is the suitable location (see Yes decision at step 226, Fig. 2), the method further comprising, after determining the site is the suitable location for neuromodulation therapy, causing delivery of the neuromodulation therapy at the site within the blood vessel (see additional ablation at step 218 without repositioning; [0054], Fig. 2).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham in view of Toth and in further view of Gross (US 2014/0128865).
Regarding claim 4, Asirvatham in view of Toth teaches the limitations of claim 2, however Asirvatham in view of Toth fails to teach wherein the one of efferent nerve activity or afferent nerve activity is an afferent nerve activity.
Gross teaches a method of stimulation and denervation of a vessel (see [0099], [0111], Fig. 2H) including stimulation and ablation of afferent and efferent nerve conduction (see efferent and afferent action potentials 40 and 42, and 50 and 52; [0099], [0101], [0111], Figs. 2B and 2H). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determinations as taught by Asirvatham in view of Toth to be based on hemodynamic responses caused by efferent and afferent nerve activity in light of Gross, the motivation being to advantageously capture blood pressure effects caused by both local and systemic pathways (see Gross [0102]).
Claims 12-14 and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham in view of Toth and in further view of Lee et al. (US 2014/0012242) (“Lee”).
Regarding claim 12, Asirvathamin view of Toth teaches the limitations of claim 9, however Asirvatham in view of Toth fails to specifically teach providing feedback to a user as to whether the site is the suitable location for neuromodulation therapy.
Lee teaches a system for determining efficacy of an ablation procedure (see Figs. 11-12) comprising a controller (see 1213 and 1215, Fig. 12) that interprets sensor data, determines efficacy of a nerve disruption procedure, and controls the medical device and executes the method accordingly (see [0185]-[0186]), the controller further configured to provide feedback to a user as to whether the nerve disruption procedure was effective or not (see [0186]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and determination as disclosed by Asirvatham in view of Toth to have been conducted using a controller, and further included providing, by the controller, feedback to a user as to whether the site is the suitable location for neuromodulation therapy in light of Lee, the motivation being to ensure that the physician is apprised of the status of the procedure and to also provide suggestions for possible modifications to the procedure (see Lee [0186]).
Regarding claim 13, Asirvatham discloses a system (see Fig. 1), determining a first hemodynamic response of a patient to a first stimulus applied at a site within a blood vessel of the patient (see measuring of blood pressure in response to the stimulation applied in step 210 in steps 212; [0050], Fig. 2); controlling a medical device to cause modulation of activity of nerves at the site after the first stimulus is applied at the site (see ablation of the nerves at step 218 occurring after step 210, Fig. 2); and determining a second hemodynamic response caused by the one of efferent nerve activity or afferent nerve activity of the patient to a second stimulus applied at the site after the activity of the nerves at the site is modulated (see measuring of blood pressure at step 224 after step 223 caused at least by efferent nerves acting on the renal artery, [0053], Fig. 2). However, Asirvatham fails to specifically disclose a controller configured to perform the claimed method steps; and the first hemodynamic response comprising a first vessel dimension change of the blood vessel, and the second hemodynamic response comprising a second vessel dimension change of the blood vessel.
Toth teaches a method of modulating nerves at sites in a blood vessel comprising monitoring combinations of blood pressure and vasodilation in order to determine completeness of the neuromodulation procedure (see [0325]-[0327]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second hemodynamic responses as disclosed by Asirvatham to have further included a first vessel dimension change of the blood vessel and a second vessel dimension change of the blood vessel in light of Toth, the motivation being to provide the additional advantage of providing a more holistic view of the effect of the neuromodulation in order to determine whether to continue with, stop, or alter the surgical procedure (see Toth [0327]). However, Asirvatham in view of Toth fails to specifically teach a controller configured to perform the claimed method steps.
Lee teaches a system for determining efficacy of an ablation procedure (see Figs. 11-12) comprising a controller (see 1213 and 1215, Fig. 12) that interprets sensor data, determines efficacy of a nerve disruption procedure, and controls the medical device and executes the method accordingly (see [0185]-[0186]), the controller further configured to provide feedback to a user as to whether the nerve disruption procedure was effective or not (see [0186]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and determination as disclosed by Asirvatham in view of Toth to have been conducted using a controller, and further included providing, by the controller, feedback to a user as to whether the site is the suitable location for neuromodulation therapy in light of Lee, the motivation being to provide the additional benefits of automatic control of the device, ensuring that the physician is apprised of the status of the procedure, and to also provide suggestions for possible modifications to the procedure (see Lee [0186]).
Regarding claims 14 and 17-24, the claims are rejected under the same citations and rationale as that applied to claims 2-3 and 5-12 above.
Regarding claim 16, Asirvatham further discloses a neuromodulation catheter configured to be positioned in the blood vessel, the neuromodulation catheter being configured to deliver the first and second stimuli to the site (see Fig. 1).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham in view of Toth, Lee, and in further view Gross.
Regarding claim 15, Asirvatham in view of Toth and Lee teaches the limitations of claim 13, however Asirvatham in view of Toth and Lee fails to specifically teach wherein the one of efferent nerve activity or afferent nerve activity is an afferent nerve activity. However, the further limitations of claim 15 are obvious in further view of Gross under the same rationale as that applied in the rejection of claim 4 above.
Response to Arguments
Applicant’s arguments with respect to the rejected claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In the instant case, the newly presented grounds of rejection are now based on the newly cited Toth reference in combination with other references as identified above, which has not been addressed in the current arguments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached on M-F 9:00 AM-5:00 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
Prosecution Insights