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 § 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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rotman et al. (US 20160000341) in view of Van Der Horst (EP 3613339), both cited previously.
Regarding claim 1, Rotman discloses a computing device comprising:
at least one memory (Section 0070); and
processing circuitry in communication with the at least one memory (section 0070), wherein the processing circuitry is configured to:
obtain, for each location of a plurality of locations of a vessel of a patient, a corresponding indication of stiffness associated with the location of the vessel (section 0091);
determine whether the corresponding indications of stiffness satisfy a homogeneity condition distinguishing dynamically increased vessel stiffness from heterogeneous structural variability within the vessel (sections 0091, 0133); and
responsive to determining that the corresponding indications of stiffness satisfy the homogeneity condition (section 0069-0070), output an indication that the patient is a candidate for a denervation therapy (Section 0143-0144).
However, Rotman does not disclose wherein obtaining the corresponding indication of stiffness includes receiving at least one of: a corresponding localized pulse wave velocity measured using pulse wave imaging, or a corresponding shear wave speed measured using ultrasound shear wave elastography. Van Der Horst discloses obtaining the corresponding indication of stiffness includes receiving at least one of: a corresponding localized pulse wave velocity measured using pulse wave imaging, or a corresponding shear wave speed measured using ultrasound shear wave elastography (Sections 0025, 0030, 0043-0044). This allows for proper stiffness parameter to be used for specific locations. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Rotman by adding the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity as taught by Van Der Horst in order to facilitate proper stiffness parameter to be used for specific locations.
Regarding claim 2, Rotman discloses,
wherein the corresponding indications of stiffness is a first plurality of corresponding indications of stiffness (sections 0091, 0133), and
wherein the computing device (section 0069-0070) is further configured to:
obtain, for the plurality of locations of the vessel, a second plurality of corresponding indications of stiffness in response to a perturbation of blood flow through the vessel (Section 0144); and
determine a difference between the first plurality of corresponding indications of stiffness and the second plurality of corresponding indications of stiffness (section 0144),
wherein the computing device is configured to output the indication that the patient is the candidate for the denervation therapy (Section 0143-0144) in response to the computing device:
determining that the first plurality of corresponding indications of stiffness satisfy the homogeneity condition (sections 0091, 0133); and
determining that the difference satisfies a difference condition (Section 0144).
Regarding claim 4, Rotman discloses
wherein the vessel is an artery, wherein the artery is an aorta (section 0095), a renal artery (Fig. 7, section 0079, 0140, 0144), a splanchnic artery, a hepatic artery, or a mesenteric artery.
Regarding claim 5, Rotman discloses
wherein the computing device is configured to obtain, for each location of the plurality of locations, at least one of:
a corresponding localized pulse wave velocity measured using pulse wave imaging; or
a corresponding shear wave speed measured using ultrasound shear wave elastography (section 0133, 0168).
Regarding claim 6, Rotman discloses
the computing device is further configured to receive data representative of an image of the vessel, wherein the image is obtained using a contrast enhanced ultrasound, and wherein the image provides an indication of whether at least one of plaque (section 0117), extravascular calcification, aneurysm, or vessel dissection within the vessel is present.
Regarding claim 7, Rotman discloses
wherein the vessel comprises a renal vessel, and wherein the denervation therapy comprises renal denervation therapy (section 0144).
Regarding claim 8, a system (Figs. 4, 7, section 0144) comprising:
a generator configured to deliver denervation therapy to a patient (Section 0144);
a denervation device coupled to the generator (Section 0144;
a data collection device configured to collect data indicative of vessel stiffness (Section 0133, 0144); and
a computing device communicatively coupled to the data collection device (section 0069-0070), wherein the computing device is configured to:
obtain, for the location and at a first time, a first corresponding indication of stiffness (Section 0144);
obtain, for the location and at a second time, a second corresponding indication of stiffness, wherein the second time is subsequent to the first time (section 0144);
determine a difference between the first corresponding indication of stiffness and the second corresponding indication of stiffness (Section 0144); and
output an indication to end the delivery of denervation therapy in response to the difference satisfying a delivery condition (section 0144).
However, Rotman does not disclose wherein the data collection device is configured to measure, for a location of a vessel of the patient, at least one of a localized pulse wave velocity or a shear wave speed; wherein the first corresponding indication of stiffness includes a first corresponding localized pulse wave velocity or a first corresponding shear wave speed; wherein the second corresponding indication of stiffness includes a second corresponding localized pulse wave velocity or a second corresponding shear wave speed.
Van Der Horst discloses wherein the data collection device is configured to measure, for a location of a vessel of the patient, at least one of a localized pulse wave velocity or a shear wave speed; wherein the first corresponding indication of stiffness includes a first corresponding localized pulse wave velocity or a first corresponding shear wave speed; wherein the second corresponding indication of stiffness includes a second corresponding localized pulse wave velocity or a second corresponding shear wave speed (Sections 0025, 0030, 0043-0044). This allows for proper stiffness parameter to be used for specific locations. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Rotman by adding the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity as taught by Van Der Horst in order to facilitate proper stiffness parameter to be used for specific locations.
Regarding claim 9, Rotman discloses
the first time is prior to the generator initiating the delivery of denervation therapy, and wherein the second time is subsequent to the generator initiating the delivery of denervation therapy (section 0144)
Regarding claims 10, Rotman discloses the invention substantially as claimed however
does not show wherein the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity.
Van Der Horst discloses wherein the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity (Sections 0025, 0030, 0043-0044). This allows for proper stiffness parameter to be used for specific locations. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Rotman by adding the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity as taught by Van Der Horst in order to facilitate proper stiffness parameter to be used for specific locations.
Regarding claim 12, Rotman discloses
wherein the image is obtained using a contrast enhanced ultrasound, wherein discriminating between reversible vessel stiffness and irreversible vessel stiffness is based on identifying at least one of plaque, extravascular calcification, aneurysm, or vessel dissection within the vessel based on the image of the vessel (Section 0117)
Regarding claim 13, Rotman discloses a method comprising:
obtaining, by a computing device (Section 0069-0070), for each location of a plurality of locations of a vessel of a patient, a corresponding indication of a stiffness of the associated with the location of the vessel (Section 0091);
determining, by the computing device (section 0069-0070), whether the corresponding indications of stiffness satisfy a homogeneity condition (sections 0091, 0133); and
in response to determining that the corresponding indications of stiffness satisfy the homogeneity condition, outputting, by the computing device (section 0069-0070), an indication that the patient is a candidate for a denervation therapy (Section 0143-0144).
However, Rotman does not disclose wherein obtaining the corresponding indication of stiffness includes receiving at least one of: a corresponding localized pulse wave velocity measured using pulse wave imaging, or a corresponding shear wave speed measured using ultrasound shear wave elastography; distinguishing dynamically increased vessel stiffness from heterogeneous structural variability within the vessel.
Van Der Horst discloses wherein obtaining the corresponding indication of stiffness includes receiving at least one of: a corresponding localized pulse wave velocity measured using pulse wave imaging, or a corresponding shear wave speed measured using ultrasound shear wave elastography; distinguishing dynamically increased vessel stiffness from heterogeneous structural variability within the vessel. (Sections 0025, 0030, 0043-0044). This allows for proper stiffness parameter to be used for specific locations. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Rotman by adding the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity as taught by Van Der Horst in order to facilitate proper stiffness parameter to be used for specific locations.
Regarding claim 14, Rotman discloses corresponding indications of stiffness is a first plurality of corresponding indications of stiffness, and wherein the method further comprises:
obtaining, by the computing device, for the plurality of locations of the vessel, a second plurality corresponding indications of stiffness in response to a perturbation of blood flow through the vessel (section 0091, 0144); and
determining, by the computing device, a difference between the first plurality of corresponding indications of stiffness and the second plurality of corresponding indications of stiffness (section 0144); and
wherein outputting the indication that the patient is a candidate for the denervation therapy comprises outputting the indication that the patient is a candidate for the denervation therapy in response to determining that the first plurality of corresponding indications of stiffness satisfy the homogeneity condition and determining that the difference satisfies a difference condition (section 0143-0144).
Regarding claim 16, Rotman discloses wherein
outputting the indication that the patient is a candidate for the denervation therapy comprises outputting the indication that the patient is the candidate for the denervation therapy in response to determining that the corresponding indications of stiffness satisfy the homogeneity condition (Section 0091, 0133),
determining that the difference satisfies the difference condition (section 0143-0144), and
determining that the second plurality of corresponding indications of stiffness satisfies a maximum condition (section 0144).
Regarding claim 17, Rotman discloses wherein
the vessel is an artery, wherein the artery is an aorta (section 0095), a renal artery (Fig. 7, section 0079, 0140, 0144), a splanchnic artery, a hepatic artery, or a mesenteric artery.
Regarding claim 19, Rotman discloses further comprising:
receiving, by the computing device, data representative of an image of the vessel; and discriminating, by the computing device, based on the image of the vessel, between reversible vessel stiffness and irreversible vessel stiffness, wherein discriminating between reversible vessel stiffness and irreversible vessel stiffness is based on identifying at least one of plaque (section 0117), extravascular calcification, aneurysm, or vessel dissection within the vessel based on the image of the vessel.
Regarding claim 20, Rotman discloses wherein
the computing device is configured to output the indication that the patient is the candidate for the denervation therapy in response to the computing device determining that the first and second pluralities of corresponding indications of stiffness satisfy the homogeneity condition (Section 0091, 0133),
determining that the difference between the first and second pluralities of corresponding indications of stiffness satisfies the difference condition (Section 0143-0144), and
determining that the second plurality of corresponding indications of stiffness satisfies a maximum condition (Section 0144).
Regarding claim 22, Rotman discloses the computing device of claim 1,
however does not specfically disclose wherein to obtain the corresponding indication of stiffness, the processing circuitry is further configured to control a data collection device to perform at least one of the pulse wave imaging or the shear wave elastography.
Van Der Horst discloses wherein to obtain the corresponding indication of stiffness, the processing circuitry is further configured to control a data collection device to perform at least one of the pulse wave imaging or the shear wave elastography (Sections 0025, 0030, 0043-0044). This allows for proper stiffness parameter to be used for specific locations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-17, 19-22 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.
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 JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
