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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-20, 22-24, 26-30, 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emery (Pub. No.: US 2015/0080926)
Regarding claim 16, Emery discloses a method of performing a therapeutic procedure, comprising:
applying a first focused ultrasound (FUS) stimulation energy to tissue in or proximate a
blood vessel wall [see 0119];
observing a patient parameter in response to the first stimulation energy [see 0123];
applying a therapy to the blood vessel wall [see 0123];
applying a second (by disclosing series of fus pulses) FUS stimulation energy to the blood vessel wall [see 0119];
observing the patient parameter in response to the second FUS stimulation energy [see 0037, 0123];
determining whether the therapy has been successful (efficacious treatment) based on the observed patient parameter in response to the second FUS stimulation energy [see 0139].
Regarding claim 17, Emery discloses wherein the patient parameter comprises at least one of:
blood pressure [see 0037]; pulse wave velocity (PWV) within a blood vessel associated with the blood vessel wall [see 0071]
or
electrically evoked compound action potential (ECAP) from a nerve in or proximate the blood vessel wall.
Regarding claim 18, Emery discloses applying FUS to sympathetic nerves [see 0046,0053, 0146] by disclosing Sympathetic nerves proximate to or encircling the arterial blood vessel known as the celiac trunk may pass through the celiac ganglion [see 0146].
Regarding claim 19, Emery discloses wherein the blood vessel is a hepatic or a renal artery [see 0053].
Regarding claim 20, Emery discloses determining whether the at least one of
blood pressure, PWV, or ECAP observed following the application of the second FUS stimulation energy is less than the at least one of blood pressure, PWV, or ECAP observed following the first FUS stimulation energy [see 0047].
Regarding claim 22, Emery discloses navigating a therapy device to a location within an artery of the patient [see 0011, 0030].
Regarding claim 23, Emery discloses an ultrasound transducer may be coupled to a targeting system that may be extracorporeal or intravascular [see abstract, 0024]; laparoscopically placing a FUS energy delivery device extravascularly proximate the blood vessel wall [see 0138]
Regarding claim 24, Emery discloses applying FUS energy from outside a body of a patient to a nerve in or proximate the blood vessel wall [see abstract, 0024]
Regarding claim 26, Emery discloses wherein the first FUS stimulation energy and the second
FUS stimulation energy are part of a sequential session, an alternating session, or a simultaneous session [see 0031, 0119] by disclosing HIFU treatment device 12 may target multiple foci simultaneously or in a series [see 0119].
Regarding claim 27, Emery discloses a system for denervation of nerves of a blood vessel [see 0009] comprising:
a catheter configured for navigation within a blood vessel of a patient [see 0011, 0030];
at least one energy element formed on a distal portion of the catheter [see 0012];
a sensor configured to measure one or more patient parameters operably connected to the
catheter [see 0011];
a focused ultrasound (FUS) stimulation energy source operably connected to the catheter [see 0012];
a therapeutic energy source configured to apply therapy to the blood vessel [see 0012];
a computing device including a memory and a processor and storing thereon instructions
that when executed cause the computing device to:
cause the FUS stimulation energy source to generate a first FUS stimulation energy for application to a blood vessel wall via the at least one energy element [see 0037, 0119, 0123, 0139];
cause the sensor to sense a first change in a patient parameter as a result of the
application of the first FUS stimulation energy to the blood vessel wall [see 0037, 0119, 0123, 0139];
cause the therapeutic energy source to generate a therapeutic energy for application to or proximate the blood vessel [see 0037, 0119, 0123, 0139];
cause the FUS stimulation energy source to generate a second FUS stimulation energy for application to the blood vessel wall via the at least one energy elements [see 0037, 0119, 0123, 0139];
cause the sensor to sense a second change in the patient parameter as result of the application of the second FUS stimulation energy to the blood vessel wall [see 0037, 0119, 0123, 0139];
determine whether the therapy has been successful based on the sensed second change in the patient parameter in response to the second FUS stimulation energy. [see 0037, 0119, 0123, 0139];
Regarding claim 28, Emery discloses wherein the patient parameter comprises at least one of blood pressure, pulse wave velocity (PWV) within the blood vessel or electrically evoked compound
action potential (ECAP) from a nerve in or proximate the blood vessel wall [see 0037, 0071].
Regarding claim 29, Emery discloses wherein the first FUS stimulation energy and the second FUS stimulation energy are applied to sympathetic nerves in or proximate the blood vessel wall [see fig 1, 0046,0053, 0146].
Regarding claim 30, Emery discloses wherein the blood vessel is a hepatic or a renal artery [see fig 1, 0046,0053, 0146]
Regarding claim 33, Emery discloses wherein the generated first ultrasound stimulation energy and the generated second ultrasound stimulation energy are part of a sequential session, an
alternating session, or a simultaneous session [see 0031, 0119] by disclosing HIFU treatment device 12 may target multiple foci simultaneously or in a series [see 0119].
Regarding claim 34, Emery discloses wherein the therapeutic energy source is a focused ultrasound energy source in communication with one of the at least one energy element formed on a distal portion of the catheter [see figs 5-19]
Regarding claim 35, Emery discloses an external focused ultrasound transducer
operably connected to the therapeutic energy source and configured to apply high intensity
focused ultrasound energy to or proximate to the blood vessel [see 0031, 0119] by disclosing HIFU treatment device 12 may target multiple foci simultaneously or in a series [see 0119].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21, 25, 31, 32 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Emery (Pub. No.: US 2015/0080926) in view of Sverdlik et al (Pub. No.: US 2014/0012133)
Regarding claims 21, 25, 31, 32, Emery doesn’t disclose imaging the blood vessel to determine a PWV within the blood vessel, wherein a PWV in excess of a threshold is indicative a patient that is a candidate for a denervation procedure and determining whether a change in the at least one of blood pressure, PWV, or ECAP between the first FUS stimulation energy and the second FUS stimulation is greater than a threshold, wherein if the change is greater than the threshold the therapy is determined to be successful.
Nonetheless, Sverdlik et al disclose determining whether a change in the at least one of blood pressure, PWV, or ECAP between the first FUS stimulation energy and the second FUS stimulation is greater than a threshold, wherein if the change is greater than the threshold the therapy is determined to be successful [see 0066].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Sverdlik et al and Emery by determining whether a change in the at least one of blood pressure, PWV, or ECAP between the first FUS stimulation energy and the second FUS stimulation is greater than a threshold, wherein if the change is greater than the threshold the therapy is determined to be successful; in order to decide if the treatment should be repeated [see 0066, Sverdlik et al].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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