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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6, 7, and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Varasani US Patent Application Publication 2023/0013525.
As to claim 1, Varasani teaches a method for automatically characterizing a vascular access of a dialysis patient who is or was connected to a dialysis machine, the method comprising the steps of:
determining a recirculation rate (para. 0004, 0013);
characterizing the vascular access based on the recirculation rate (para. 0004, 0013) – where Varasani teaches the processing circuitry of the hemodialysis system is configured to determine a change in the blood volume of a patient over time based on a signal generated by a hematocrit sensor, compare the change in blood volume over time with a threshold blood volume reduction over time, and determine whether there is vascular access recirculation based on the comparison (para. 0004). Varasani teaches the threshold amount of vascular access recirculation may be programmable by a clinician (para. 0035). The clinician or patient may receive notification via a user interface or communication circuitry of hemodialysis device 12 to a computing device 30, which may be a visual, audible, or tactile notification to adjust a which may be attached to arterial line 16 or venous line 14 needle (indicating vascular access), a notification to change a catheter that may be attached to either line, or a notification to pause dialysis treatment, and indication of the amount of vascular access recirculation, or the like (para. 0036, 0059).
As to claim 2, the vascular access is characterized as having a decreasing quality as the recirculation rate increases – where Varasani teaches while some degree of vascular access recirculation may be expected in hemodialysis treatment, a higher degree of vascular access recirculation may be indicative of a relatively ineffective hemodialysis treatment session (para. 0013)
As to claim 3, The method according to claim 1, wherein: the recirculation rate is determined quantitatively or qualitatively by (para. 0032):
changing at least one operational parameter of the dialysis machine – a clinician may prescribe a certain blood flow rate (para. 0038);
measuring a change in at least one blood value at an arterial access of the dialysis machine – measuring transit time for blood from when blood enters arterial line 16 to when blood exits venous line 14 (Fig. 1; para. 0038); and
determining the recirculation rate dependent on the change in the at least one blood value at the arterial access of the dialysis machine - where Varasani teaches using the transit time and a predetermined period of time to determine recirculation rate (para. 0039, 0059).
As to claim 6, the at least one operational parameter of the dialysis machine influences an ultrafiltration rate – where Varasani teaches after the predetermined period of time, hemodialysis device may return the ultrafiltration rate to the original programmed ultrafiltration rate, or may prevent or refrain from increasing the ultrafiltration rate a second time for at least another predetermined period of time (para. 0040); and the at least one blood value contains a hematocrit value (Varasani 0033).
As to claim 7, the ultrafiltration rate is increased, and the recirculation rate is determined dependent on an increase in the hematocrit value (Abstract, para. 0033).
As to claim 13, the method according to claim 1, further comprising the steps of:
ascertaining the recirculation rate with the dialysis machine or with another piece of measurement equipment – where Varasani teaches the hemodialysis device 12 may be communicatively coupled one or more external sensors, such as one or more sensors 18, via a link 20 (para. 0023). Varasani teaches comparing the arterial hematocrit sensor 22 with the venous hematocrit sensor 22 and the concentration of red blood cells in the blood sensed by venous hematocrit sensor 24 should be expected to be higher than the concentration of red blood cells in the blood sensed by arterial hematocrit sensor 22, as dialyzer 26 removes excess fluid from the blood of patient 10 (Fig. 1; para. 0023);
transmitting the recirculation rate to a central processing unit 30 (Fig. 1-2; para 0026-0028);
transmitting further data (from sensor 18) characteristic of a quality of the vascular access to the central processing unit 30 (para. 0028, 0031), and
characterizing the vascular access with the central processing unit based on the recirculation rate and the further data – where Varasani teaches the blood volume may be indicative of vascular access recirculation (para. 0031). Varasani teaches the body size, body weight, body mass index may is relative to blood volume, such that a larger patient may have a higher blood volume than a smaller body size (para. 0030). Varasani teaches the hemodialysis device 12 or another device stores the threshold blood volume and patient data (body weight, blood pressure) and determines the threshold blood volume reduction by reading the value from memory (para. 0030, 0055, 0061).
As to claim 14, the further data are selected from a set of data containing at least one of the following data elements:
a volumetric flow rate flowing through the vascular access (para. 0006-0007;
a Kt/V value;
dialysis patient-related data – where Varasani teaches patient-related data such as vitals of a patient (para. 0023, 0061);
a date the vascular access was established; and
a date of a preceding vascular access revision.
As to claim 15, the recirculation rate and the further data are evaluated by machine learning for characterizing the vascular access - where Varasani teaches the processing circuitry 116 may determine a threshold blood volume reduction over time for patient 10 based on a body size of the patient or read the threshold blood volume reduction from thresholds 122 in memory 118(para. 0055, 0061).
As to claim 16, an alert is output dependent on a characterization of the vascular access (para. 0035-0036).
As to claim 17, Varasani teaches a system for automatically characterizing a vascular access of a dialysis patient who is or was connected to a dialysis machine, comprising: the dialysis machine 12/112; and a central processing unit (Fig. 2; para. 0042), the dialysis machine 12/112 and the central processing unit being designed to carry out a method according to claim 1 (para. 0042-0047).
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.
Claims 4, 5, 8, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Varasani US 2023/0013525 (herein known as Varasani ‘525) in view of Varasani US Patent Application Publication 2023/0018668 (herein known as Varasani ‘668).
As to claim 4, Varasani ‘525 teaches the present invention substantially as claimed. Varasani ‘525 does not specifically teach the recirculation rate is determined as having greater values as the change (in the operational parameter) increases. Varasani ‘668 teaches a hemodialysis device that is configured to determine that sensed parameters of interest indicate that a change in hemodialysis treatment parameters should be made (‘668 para. 0018). Varasani ‘668 teaches the one or more sensors are configured to sense one or more parameters of interest such as blood pressure, heart rate, blood volume change, and the like (‘668 para. 0018). Varasani teaches the treatment parameters may include sodium concentration of a dialysis solution, an ultrafiltration rate, and ultrafiltration volume, a duration of a hemodialysis session, temperature of filtration, and the like (“668 para. 0019). Varasani ‘668 teaches stored associations between parameters of interest and treatment parameters may be used, by the hemodialysis device, for example, to automatically change any of the hemodialysis treatment parameters based on one or more events occurring involving any of the parameters of interest (‘668 para. 0020, 0040). Varasani ‘668 teaches an example of an investigatory action is measuring systemic blood pressure in response to determining a reduction in blood volume reaches a predetermined threshold value. Although Varasani ‘525 does not specifically teach the recirculation rate is determined as having greater values as the change (in the operational parameter) increases, it would have been obvious to one having ordinary skill in the art before the invention was originally filed to take corrective action by adjusting an operational parameter to increase the recirculation rate as taught in Varasani ‘668 (para. 0086) and to improve the efficacy of the hemodialysis treatment (Varasani ‘668 para. 0016).
As to claim 5, the at least one operational parameter influences a change of a dialysate flow through a dialyzer of the dialysis machine (Varasani ‘668 para. 0086).
As to claim 8, the at least one operational parameter influences a change in the temperature of outflowing blood at a venous access of the dialysis machine, and the at least one blood value contains a temperature of blood flowing through the arterial access of the dialysis machine – where Varasani ‘668 teaches adjusting the dialysate temperature (operational parameter) in response to a blood temperature not being within an expected predetermined temperature range (Varasani ‘668 para. 0047), thereby taking corrective action to adjust or increase the blood temperature to meet the predetermined range.
As to claim 9, the at least one operational parameter influences a temperature of a dialysis fluid, and the at least one blood value contains a temperature of blood flowing through the arterial access of the dialysis machine – where Varasani ‘668 teaches adjusting the dialysate temperature in response to a blood temperature not being within an expected predetermined temperature range (Varasani ‘668 para. 0047).
As to claim 12, the recirculation rate is ascertained quantitatively or qualitatively based on a comparison between a measured clearance and a nominal clearance for the dialysis machine (Varasani ‘668 para. 0043).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable Varasani US Patent Application Publication 2023/0013525 in view of Cole et al. USPN 6189388.
As to claims 10 and 11, Varasani teaches the present invention substantially as claimed. Varasani does not teach the at least one operational parameter influences an addition of a substance into outflowing blood at the venous access of the dialysis machine, and the at least one blood value contains a concentration of the substance in the blood flowing through an arterial access of the dialysis machine. Cole teaches a system and method of detecting blood flow in a fistula by comparing the property of blood entering the fistula to the property of bleed being withdrawn from the fistula. Cole teaches a method of quantitatively determining the degree of recirculation in a fistula is using a bolus of marker fluid having a conductivity different from that of blood that is injected through an injection site in the outlet line. Cole teaches a differential conductivity monitor quantitatively measures the degree of recirculation in a fistula by comparing the conductivity of blood entering the fistula to the conductivity of blood being withdrawn from the fistula. This measurement is made as blood flows in the predominant direction from artery to vein. Cole teaches other fluid properties utilized for the measurement of recirculated blood are temperature of the fluid and speed of conduction of sound, and some of these measurement techniques also involve injection of a bolus of marker material into the blood flow (Cole col. 1, line 60 through col. 2, line 10). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to have substituted the method taught in Cole since this method performs the same function of providing a method of determining the degree of recirculation in a fistula during dialysis. See MPEP 2143.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Buffaloe, IV et al. USPN 5510707 is cited to show a recirculation monitor using a bolus. Aldag et al. US Patent Application Publication 2022/0203002 is cited to show a method of recirculation measurement and Calvalcanti et al. USPN 7172570 is cited to show an apparatus and method for monitoring vascular access of an extracorporeal circuit.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781