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 Objections
Claims 2-12 objected to because of the following informalities: “A method” should read –The method--.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 & 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bappoo (US 2024/0180523) in view of Narrow (US 2025/0073398).
Regarding claim 1, Bappoo teaches a method of assessing health of a fistula using an ultrasound vascular access system, the ultrasound vascular access system comprising:
an ultrasound transducer arrangement (portable ultrasound device 109, [0101], Figure 1) comprising a first ultrasound transducer array (one of transducer arrays 300A, [0118], Figure 3b) parallel ([0118], Figure 3b) to a second ultrasound transducer array (another of transducer arrays 300A, [0118], Figure 3b), the first ultrasound transducer array being separated from the second ultrasound transducer array ([0119], Figure 3b); and
a control module (controller 250 & processor 350, [0102]) programmed with a geometry ([0031], [0055], & [0106]) and capabilities ([0109]) of the ultrasound vascular access system;
Paragraph [0031] teaches determining x-axis coordinates of veins and arteries, [0055] teaches determining a needle insertion angle to access the vasculature, and [0106] teaches creating a vein path as the ultrasound device is moved over the patient’s skin. All three of these functions require knowing the device’s relative geometry and position in space.
wherein the method comprises the steps of:
controlling adjacent elements of at least one ultrasound transducer array as a phased array ([0049]);
using the first transducer to generate a Doppler signal ([0103]) and measure blood flow through the fistula using the Doppler signal ([0122]); and
Although Bappoo does not explicitly teach that a patient can have a fistula, the device would be able to measure blood flow through the fistula in the event that one is present.
assessing a characteristic of the blood flow wherein the characteristic includes at least one of blood flow velocity ([0122]), volumetric blood flow rate ([0122]), pulsatility ([0103]), and flow direction ([0129]).
However, Bappoo fails to disclose: using the phased array to identify the fistula; and using at least one of the characteristics to assess the health of the fistula.
Narrow teaches: using the phased array to identify the fistula ([0074]).
Regarding the limitation of using the characteristics to assess the health of the fistula, Bappoo teaches measuring the flow characteristics of blood vessels. Although fistulae are not explicitly mentioned in Bappoo, the method would proceed identically when measuring the flow characteristics of a fistula. Nevertheless, Narrow teaches identifying a fistula in a patient. Examiner asserts that the combination of Bappoo and Narrow teaches identifying flow in a fistula to assess its health. Furthermore, [0048] of Narrow teaches using Doppler imaging and [0074] teaches determining a suitable location in which to cannulate the fistula; therefore, the suitability (health) of the fistula can be determined based on flow characteristics.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Bappoo to include: using the phased array to identify the fistula; and using at least one of the characteristics to assess the health of the fistula, as taught by Narrow. The use of fistulae is well-known to perform dialysis; these steps allow a proper location to be identified to perform dialysis.
Regarding claim 2, Bappoo in view of Narrow teach the method according to claim 1, and Bappoo further teaches that the method further comprises the step of collecting imaging data to create a three-dimensional model of the fistula ([0043]).
Paragraph [0043] teaches creating a three-dimensional model of the vasculature. If the patient has a fistula, a three-dimensional model would be made of the fistula. Nevertheless, Narrow explicitly teaches that the patient has a fistula.
Regarding claim 3, Bappoo in view of Narrow teach the method according to claim 2, and Bappoo further teaches that the method further comprises including landmarks (imaged pathway 104A, [0141]) in the three-dimensional model of the fistula (See rejection of claim 2).
Paragraph [0141] teaches using the imaged pathway 104A of the peripheral vein 101 to guide the user to the optimal cannulation spot. Thus, the path of the vein serves as a landmark to follow to locate the fistula. A similar approach is described in [0075] of Narrow.
Regarding claim 7, Bappoo in view of Narrow teach the method according to claim 1, and Bappoo further teaches that the method further comprises the step of detecting a presence of one or more of a stenosis (stenosis, [0059]) or a recirculation (recirculation (stasis) zone, [0136]).
Regarding claim 8, Bappoo in view of Narrow teach the method according to claim 1, and Narrow further teaches that the method further comprises the step of assessing a patient to determine whether the ultrasound vascular access system can be used for cannulation (cannulation suitability rating, [0049]) by moving the ultrasound vascular access system along a length of or a substantial portion of the fistula ([0055]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Bappoo to include the step of assessing a patient to determine whether the ultrasound vascular access system can be used for cannulation by moving the ultrasound vascular access system along a length of or a substantial portion of the fistula, as taught by Narrow. Finding the best-suited location for cannulation eliminates the possibility of any complications from cannulating a sub-optimal location.
Regarding claim 9, Bappoo in view of Narrow teach the method according to claim 1, and Narrow further teaches that the method further comprises the step of prompting (guidance feature, [0073] a user to move the ultrasound vascular access system in a pattern over the fistula ([0073]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Bappoo to include the step of prompting a user to move the ultrasound vascular access system in a pattern over the fistula, as taught by Narrow. Per [0073] of Narrow, these instructions help the operator not only locate the optimal cannulation site but also determine the optimal needle insertion angle. This allows for a more effective cannulation.
Regarding claim 10, Bappoo in view of Narrow teach the method according to claim 1, and Bappoo further teaches that the Doppler signal is used to determine peak (peak of the waveform 505/507, [0125]), average (mean blood velocity, [0103]), or flow rate distribution (gradient, [0130]) in the fistula ([0103], [0125], & [0130]).
If the patient has a fistula, the calculations of peak, average, and flow rate distribution would be calculated identically for the fistula than for other vessels. Nevertheless, Narrow explicitly teaches that the patient has a fistula.
Regarding claim 11, Bappoo in view of Narrow teach the method according to claim 1, and Bappoo further teaches that one or both of the first ultrasound transducer or the second ultrasound transducer can be tilted with respect to a flow of blood through the fistula ([0119]).
Regarding claim 12, Bappoo in view of Narrow teach the method according to claim 1, and Bappoo further teaches that the ultrasound vascular access system is moved along the fistula ([0106]) to assess the flow rate through the fistula ([0058]).
If the patient has a fistula, the calculation of flow rate would be calculated identically for the fistula than for other vessels. Nevertheless, Narrow explicitly teaches that the patient has a fistula.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bappoo in view of Narrow, as applied to claim 2, above, in further view of Kopperschmidt (US 2020/0338309).
Regarding claim 4, Bappoo in view of Narrow teach the method according to claim 2.
However, Bappoo in view of Narrow fail to disclose that the method further comprises the step of using the three-dimensional model of the fistula to identify a patient.
Kopperschmidt teaches the step of using the three-dimensional model of the fistula to identify a patient (“the identification can for example ensue in the control system by a program-controlled analysis of an image obtained by a vascular structure measuring device”, [0018]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Bappoo and Narrow to include the step of using the three-dimensional model of the fistula to identify a patient, as taught by Kopperschmidt. This results in a more succinct procedure, as the identification of the patient and imaging can be performed simultaneously.
Regarding claims 5-6, Bappoo in view of Narrow and Kopperschmidt teach the method according to claim 4, and Kopperschmidt further teaches the steps of accessing a treatment plan (program parameters, [0018]) and treatment history (historical data, [0017]) for the patient.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method of Bappoo and Narrow to include the steps of accessing a treatment plan and treatment history for the patient, as taught by Kopperschmidt. Knowing the previous procedures of the patient as well as the plan for the current procedure allows the operator to provide the best possible quality of treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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