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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/25 has been entered.
Specification
The disclosure is objected to because of the following informalities:
In the opening paragraph, the priority information should be set forth.
In the detailed description, [0109] refers to Fig “6E”, but it appears this should be “24E”.
Appropriate correction is required.
Claim Objections
Claims 1, 9, 10, 13, and 13 are objected to because of the following informalities:
In claim 1, line 29, it appears ‘an’ should be ‘the’ as the site is already introduced.
In claim 9 line 3 and claim 10 line 2, it appears ‘an’ should be ‘the’.
In claim 13 line 1 and claim 14 line 2, it appears ‘a’ should be ‘the’.
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 [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];
prompting a user to move the ultrasound vascular access system to align the ultrasound vascular access system to an 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 a 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 a 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 with respect to claims 1-19 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.
It is noted that “into the fistula” and “in the fistula” in lines 24 and 25 should have been underlined to properly set forth as an amendment.
The specification objection remains as it has not been addressed.
Conclusion
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797