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 .
Specification
The disclosure is objected to because of the following informalities:
In the opening paragraph, the priority information should be set forth.
Appropriate correction is required.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Narrow et al (US Pub 2025/0073398 -previously cited) in view of Bappoo et al (US Pub 2024/0180523 -cited by applicant), and further in view of Yarmush et al (US Pub 2021/0378627 -cited by applicant).
Re claims 1, 12: Narrow discloses a method of inserting at least one needle into an arm using an ultrasound vascular access system placed on the arm, the ultrasound vascular access system comprising: an ultrasound transducer arrangement comprising a first ultrasound transducer array parallel to a second ultrasound transducer array, the first ultrasound transducer array being separated from the second ultrasound transducer array; and a control module programmed with a geometry and capabilities of the ultrasound vascular access system [0050, 0053, 0084; see the 3D probe 110 and 2D array which includes adjacent arrays of linear or matrix elements and see the control module as a processor/software configuration]; wherein the method comprises the steps of:
controlling adjacent elements of at least one of the first ultrasound transducer and the second ultrasound transducer to identify a fistula in the patient arm, wherein the module determines a first center under the first array of a first plane and a second center under the second array of a second plane [0053, 0078; see the steering to identify and track a fistula, wherein the center of each transverse plane is determined];
moving the system along a portion of the arm over the fistula while scanning the fistula in the at least two different planes, wherein the planes are offset from each other by the separated distance [0050, 0055, 0056, 0073; see the multiple transverse planes or transverse-orthogonal planes that are separated, wherein the system is moved while data is captured];
obtaining information on a directionality of the fistula [0048; see the Doppler info which gives directional data];
establishing an entry point into the fistula relative the first center and a stopping point in the fistula relative the second center for the at least one needle wherein the entry and stopping points are established by providing data from the ultrasound transducer arrangement to the control module to determine a needle path and wherein the path is determined from the first and second centers [0069, 0070; see the needle and cannulation path that is obtained from ultrasound data and provided to the control to establish a needle path includes a start and stop points relative the first and second centers; 0050, 0058, 0060, 0079, 0083; see that the blood vessel itself is a center determined as each image is segmented or alternatively that the centroid 320 or center of each sectional image is determined, wherein the centers in each instance are used for alignment in determining an optimal needle path];
prompting a user to move the ultrasound vascular access system to align the ultrasound vascular access system to the insertion site [0073, 0074; see the instructions provided to move the probe]; and
prompting the user to hold the ultrasound vascular access system in place [0073, 0074; see the instructions to find a viable cannulation location which includes a position to hold the probe in place].
Narrow discloses all features including that the array can be a linear array or a 2D array to obtain the transverse images [0053], but does not disclose two arrays with no transducer in between. However, Bappoo teaches of a portable ultrasound device to non-invasively image subcutaneous structures that includes a first and second arrays 300A that are parallel and which image multiple transverse planes, wherein the arrays are separated by about 14mm [0118, 0119; see the arrays 300A to image a blood vessel with the distance between arrays being about 14mm]. It would have been obvious to the skilled artisan to substitute Narrow’s transducer for Bappoo’s plurality of array via simple substitution of one known element for another to obtain predictable results.
Narrow/Bappoo discloses all features except for determining a remote center of motion. However, Yarmush teaches determining a remote center of motion such that the needle has a virtual pivot point at a site of insertion on the arm or fistula [0110; see the RCM such that the needle tip point of rotational is viewed]. It would have been obvious to the skilled artisan to modify Narrow/Bappoo, to determine an RCM as taught by Yarmush, in order to improve cannula maneuvering by viewing any tip rotation in the FOV of the imager.
Re claim 2: Narrow discloses the method comprises the steps of: using the first ultrasound transducer to generate a doppler signal and measure a blood flow using the doppler signal; assessing a characteristic of the blood flow wherein the characteristic includes at least one of: the blood flow velocity, volumetric blood flow rate, pulsatility and flow direction; using at least one characteristics to confirm the ultrasound vascular access system is facing a correct direction before prompting the user to trigger the ultrasound vascular access system [0048, 0053; see that the steering that is a phased array and see the Doppler to measure blood flow direction which is performed prior to triggering the ultrasound during the needle guidance step].
Re claim 3: Narrow discloses the characteristic is used to determine a centerline of the fistula and ensure the ultrasound vascular access system is translationally aligned to the centerline of the fistula [0072; see the determined vessel centerline that is used for needle guidance alignment].
Re claim 4: Narrow discloses the method comprises inserting a first needle and a second needle into the arm, the second needle returning clean blood to the arm, wherein the characteristic is used to confirm that the second needle is facing with a flow of blood [0070, 0082; see that two needles are used for the hemodialysis procedure the second needle returns clean blood and is confirmed to face the blood flow].
Re claim 5: Narrow discloses the method includes the step of using the ultrasound transducer arrangement to build at least two separate B-mode ultrasound images [0057; seethe B-mode images].
Re claim 6: Narrow discloses the method comprises the step of using a machine learning algorithm to identify an access in at least one of the B-mode ultrasound images [0065; see the deep learning used to identify the access for the procedure].
Re claim 7: Narrow discloses the method comprises the step of computing the needle path prior to the step of prompting the user to trigger the ultrasound system [0074; see the triggering of the ultrasound scan which is performed after determining the needle path].
Re claim 8: Narrow discloses the step of using the array (modified as above with Bappoo to correspond to the first and second array) to identify a fistula comprises identifying a depth and location of the fistula [0064; see the location and depth of the fistula determined with the 3D probe].
Re claims 9, 10: Narrow discloses the step of prompting the user to move the ultrasound vascular access system to align the ultrasound vascular access system to an insertion site comprises communicating instructions to the user to move the ultrasound vascular access system in a certain direction or a certain distance to align the ultrasound vascular access system to the insertion site and comprises prompting the user to move the ultrasound system to a position wherein the ultrasound vascular access system is centered on and aligned with the fistula. [0073, 0074; see the instructions to find a viable cannulation location which includes moving the probe in a particular direction and distance to be centered on an aligned with the fistula]
Re claim 11: Narrow discloses one or both of the first ultrasound transducer or the second ultrasound transducer is tilted with respect to a flow of blood through the fistula [0073; see the probe manipulated at an angle to be aligned with a cannulation angle].
Re claim 13: Narrow discloses prompting a user to move the ultrasound vascular access system in a set pattern over the target location [0073, 0074; see the instructions provided to move the probe at a determined direction, distance, and location which is a pattern].
Re claim 14: Narrow discloses scanning the fistula with the ultrasound vascular access system to provide an identification of the patient [0065; see id of a particular patient having arteriovenous fistulae].
Re claim 15: Narrow/Bappoo disclose all features except scanning the patient's arm on a periodic basis with the ultrasound vascular access system; and developing a plan to map an approach to guide the at least one needle through a range of acceptable paths. However, Yarmush teaches scanning the patient's arm on a periodic basis with the ultrasound vascular access system; and developing a plan to map an approach to guide the at least one needle through a range of acceptable paths (figure 7; see the additional imaging and new trajectory which comprises a plan to guide the needle along an acceptable path). It would have been obvious to the skilled artisan to modify Narrow/Bappoo, to develop a plan as taught by Yarmush, in order to improve needle guidance and determine an optimal path to the target.
Re claims 16, 18: Narrow (with Yarmush) discloses all features except tracking insertion locations and insertion dates or alerting the user that an obstruction has been detected. However, Bappoo teaches tracking insertion locations and insertion dates or alerting the user that an obstruction has been detected [0068, 0136; see the tracking of location and dates and see the display alert that there is an obstruction causing low flow]. It would have been obvious to the skilled artisan to modify Narrow, to track and alert as taught by Bappoo, in order to provide improve the guidance via informing the operator of prior insertions and of any issues with an insertion.
Re claim 17: Narrow discloses assessing a condition of the fistula [0076; see the cannulation suitability which is a condition].
Re claim 19: Narrow/Bappoo discloses all features except using an encoder associated with the control module to facilitate dynamically adjusting a trajectory of the at least one needle along the needle path. However, Yarmush teaches using an encoder associated with the control module to facilitate dynamically adjusting a trajectory of the at least one needle along the needle path [0056; see the motor encoders for the cannulation and the associated paths with trajectories]. It would have been obvious to the skilled artisan to modify Narrow/Bappoo, to include encoders as taught by Yarmush, in order to facilitate dynamic adjustment to the needle for improved guidance.
Response to Arguments
Applicant's arguments filed 5/22/26 have been fully considered but they are not persuasive. Applicant argues that Narrow discloses a cannulation path determination rather than determining a needle path from a first and second center. Respectfully, the Examiner disagrees and finds that Narrow meets the limitation. Narrow discloses determining a path for the needle to be advanced [0069] into the fistula [0045]. The blood vessel itself is a center determined as each image is segmented or alternatively that the centroid 320 or center of each sectional image is determined, and the centers in each instance are used for alignment in determining an optimal needle path [0050, 0058, 0060, 0079, 0083]. Therefore, the limitation is met.
The specification objection in regard to the opening paragraph is maintained as it has not been addressed. The claim objections are withdrawn due to amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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