DETAILED ACTION
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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the previous combination of reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In view of the amendments and new claims, an updated search was conducted resulting in the modified 103 Rejection set forth below.
In view of the amendments made to the claims, the 112(b) Rejection is withdrawn.
Claim Rejections - 35 USC § 103
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) 70-75, 78-82, and 85-87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery (2015/0080926) in view of Sawkey et al. (2015/0045604).
With respect to claims 70, 80, and 85, Emery teaches of a method of treating target issue associated with a renal artery of a patient where the renal artery is moving during treatment due to breathing and blood flow [0070, 0071, 0073, 0091, 0108]. Emery teaches of identifying the renal artery and the target tissue, applying therapeutic energy to the target tissue [0091], tracking the location of the renal artery and location of the target tissue during the applying, and adjusting based on the tracking to apply therapeutic energy to a tracked location of the target tissue [0108, 0120-0123]. Emery teaches of potentially shutting down the HIFU treatment if the operator ventures too far off the target and imaging with the intravascular device that tracks the target on the renal artery and communicate this information back to the HIFU treatment device so that the energy may still be delivered through the breathing or cardiac cycle [0108]. Emery therefore teaches of the imaging to track any displacement of the renal artery due to breathing or cardiac cycle and may accommodate the focus of the HIFU treatment device and also guide the operator back to the treatment site or dynamically modify the beam delays or positioning of HIFU to stay on target [0108]. Emery teaches of monitoring the location of the renal artery during the applying to generate feedback and utilizing the feedback to adjust the applying where feedback may be used to place the HIFU treatment device directly above the intended target [0104, 0114].
With respect to claims 70, 80, and 85, Emery does not explicitly teach of predicting a future position of the target tissue from the previous tracked positions. In a similar field of endeavor Sawkey et al. teach of a system method for energy delivery for a treatment plan to ensure accuracy in a prediction of a future position where a marker system may be used with an algorithm to predict a future position and deliver energy for treatment at the predicted future position [0097, 0099]. Sawkey et al. therefore teach of combining multiple uncertainties in a medical process to make a prediction of how accurate a treatment will be or probability of hitting a target and with such prediction, various treatment delivery scenarios may be compared such as to perform the best treatment delivery plan for a patient [0007]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Sawkey et al. to modify Emery to increase the accuracy in a prediction of a future position and determine best treatment delivery plan [Sawkey, 0007, 0023].
With respect to claim 71, Emery in view of Sawkey et al. teaches of tracking blood flow through the renal artery during the applying step or where treatment is targeted using blood flow information [Emery, 0122].
With respect to claims 72, Emery in view of Sawkey et al. teaches of catheterizing the patient with a catheter and wherein the therapeutic energy is performed with the catheter and the target tissue is renal nerve [Emery, 0026, 0148, 0177].
With respect to claims 73, 74, and 81, Emery in view of Sawkey et al. teaches of the therapeutic energy to be ultrasound energy with therapeutic transducer and the identifying and monitoring are performed by ultrasound imaging [Emery, 0034, 0127].
With respect to claims 75 and 78, Emery teaches of applying, monitoring, and adjusting repeatedly to form a plurality of lesions in the target tissue or formation of more complex lesions along a longitudinal dimension of the renal artery [Emery, 0069, 0133-0136]. Emery therefore teaches of linear pattern or a continuous or non-continuous helical pattern [0069].
With respect to claim 79 and 86, Emery in view of Sawkey et al. teaches of imaging the target with a two-dimensional array where the transducer 14 may be multiple transducers or an array of transducers [0086, 0107] to acquire three-dimensional ultrasound images inside the body of the patient [0110] to obtain a position of the target tissue during period of time of the applying or producing ultrasound images of kidney and surrounding tissues or real-time ultrasound imaging of the renal vasculature [Emery, 0034, 0156, 0160].
With respect to claim 81, Emery in view of Sawkey et al. teaches of utilizing the feedback to adjust the location and output of the applying the therapeutic energy [Emery, 0069].
With respect to claims 88-90, Emery does not teach of the comparison of results to stored data to determine degree of mismatch. Sawkey et al. teach of generating a template library comprising a plurality of templates identifying a prior location and prior feature of the target tissue or a database storing different respective probability density functions that are organized based on certain parameters [0102-0104]. Sawkey teach of determining the degree of mismatch within a threshold value or processing the first and second probability density functions resulting in a margin or threshold for gating purposes [0105] and outputting position information of the target tissue from the template or database in response to determining the mismatch within the threshold or where multiple probability density functions are displayed together and a margin may be determined based on the composite probability density function [0107, 0113]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Sawkey et al. to modify Emery to increase the accuracy in a prediction of a future position and determine best treatment delivery plan [Sawkey, 0007, 0023].
Claim(s) 76, 77, 83, and 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Sawkey et al. and further in view of Mauch et al. (2012/0116383). Emery teaches of spacing the lesion circumferentially along the longitudinal axis of the renal artery such that each lesion cover at least about 10% of the vessel circumference [0134] but do not teach of the exact spacing between the lesions. In a similar field of endeavor Mauch et al. teach of forming lesions by energy delivery elements on the renal artery wall that are non-overlapping and separated by various distances that could be less than 2 mm-5 mm [0133, fig. 4A/B]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Mauch et al. to modify to effectively create lesions having a variety of shapes and patterns that are non-overlapping and preventing undesirable thermal application to the vessel wall [Mauch, 0137].
Claim(s) 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emery in view of Sawkey et al. and further in view of Lavi et al. (2016/0247279). The previous references do not teach of predicting using a weighted function. In a related field of endeavor Lavi et al. teach of using a weighted function by adjusting it for assessment of uncertainties with respect to target size [0313]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Lavi et al. to modify the previous references to account for vascular deviations where the weightings are adjusted so that best-fit deviations from wider or less-diseased points along the segment are weighted as more important than deviations from narrower points and thereby allowing better tracking and treatment of diseased regions [Lavi, 0313].
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.
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BR
/BAISAKHI ROY/
Primary Examiner, Art Unit 3797
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