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 Rejections - 35 USC § 102
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 13-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mori et al. (US 2004/0129616).
With respect to Claim 13, Mori teaches a computer-implemented method of monitoring blood circulation (Figures 1 and 3; Abstract; paragraphs [0013-0021] and [0040-0079]), the method comprising:
obtaining a physical quantity in an artery-side blood circuit 1a that allows blood to flow into a blood purifier (first measuring means 5a measures hematocrit in the arterial side (Figure 1; paragraphs [0040-0044]);
obtaining a physical quantity in a vein-side blood circuit 1b that allows the blood to flow out of the blood purifier (second measuring means 5b measures hematocrit in the venous side (Figure 1; paragraphs [0040-0044]);
obtaining, by using at least one of the physical quantity obtained in the artery-side blood circuit and the physical quantity obtained in the vein-side blood circuit, a theoretical value of the physical quantity in the artery-side blood circuit or the vein-side blood circuit to determine an abnormality of a mechanism that supplies a dialysis fluid to the blood purifier (paragraph [0013]: “the blood concentration ratio as a theoretical value obtained by designated formula using the preset blood flow rate of the blood pump and the blood purifying rate by the blood purifier as parameters”);
determining occurrence of the abnormality based on the theoretical value, the physical quantity in the artery-side blood circuit or the vein-side blood circuit, and a given threshold value (the measured arterial and venous hematocrit values are compared to the theoretical values; paragraphs [0040-0068]); and
performing an operation abnormality process when it is determined that the abnormality has occurred (paragraph [0050]).
With respect to Claim 14, Mori teaches that the obtaining of the theoretical value includes calculating a theoretical value of an indicator of a blood concentration in the vein-side blood circuit based on an indicator of a blood concentration obtained in the artery-side blood circuit, and the determining of the occurrence of the abnormality includes determining that the abnormality has occurred when a difference between the theoretical value and an indicator of a blood concentration obtained in the vein-side blood circuit is more than or equal to the given threshold value. Specifically, the theoretical value is calculated as a ratio of the venous hematocrit and the arterial hematocrit. When the ratio falls outside of a predefined range, the abnormality has occurred and the pump is stopped. See paragraphs [0011-0021], [0040-0051], [0058], [0073-0079], and [0092].
With respect to Claim 15, Mori teaches that the obtaining of the theoretical value includes finding a theoretical value of a blood flow rate in the vein-side blood circuit based on a blood flow rate obtained in the artery-side blood circuit (the theoretical value is based on the blood flow rate from the blood pump and the blood purifying rate of the filter, as measured by the hematocrit sensors; paragraph [0013]), and
the determining of the occurrence of the abnormality includes determining that the abnormality has occurred when a difference between the theoretical value and a blood flow rate obtained in the vein-side blood circuit is more than or equal to the given threshold value (when a calculated ratio/value falls outside of a predefined range, the abnormality has occurred and the pump is stopped (paragraphs [0011-0021], [0040-0051], [0058], [0073-0079], and [0092]).
With respect to Claim 16, Mori teaches that a flow rate of a blood pump provided to send the blood in the artery-side blood circuit is used as the blood flow rate obtained in the artery-side blood circuit (paragraphs [0013-0017] and [0044]).
With respect to Claims 17-19, Mori teaches that the theoretical value is further based on a water removal rate in the blood purifier (paragraph [0044]).
With respect to Claim 20, Mori teaches that the obtaining of the theoretical value includes storing, into a storage device as the theoretical value, an indicator of a blood concentration obtained in the artery-side blood circuit or the vein-side blood circuit at a first timing at which a dialysis fluid pump that promotes discharging of the dialysis fluid from the blood purifier is not operated (a preset value is calculated prior to the treatment being performed; paragraphs [0040-0048]), and
the determining of the occurrence of the abnormality includes determining that the abnormality has occurred when a difference between the theoretical value and the indicator obtained at a second timing at which the dialysis fluid pump is not operated is more than or equal to the given threshold value (an abnormality is determined when the ratio of blood concentrations falls outside of a predetermined range based on the threshold value; [0040-0079], [0092].
With respect to Claim 21, Mori teaches that the determining of the abnormality is performed before starting the dialysis treatment. Specifically, the determining step is performed by calculating a theoretical value ratio based on flow rates and comparing it to a threshold value (paragraphs [0040-0092]).
With respect to Claim 22, Mori teaches that the obtaining of the theoretical value includes obtaining a first difference that is a difference between an indicator of a blood concentration obtained in the artery-side blood circuit at a first timing and an indicator of a blood concentration obtained in the vein-side blood circuit at the first timing (a preset value is calculated prior to the treatment being performed; paragraphs [0040-0048]), and
the determining of the occurrence of the abnormality includes obtaining a second difference that is a difference between an indicator of a blood concentration obtained in the artery-side blood circuit at a second timing and an indicator of a blood concentration obtained in the vein-side blood circuit at the second timing, and determining that the abnormality has occurred when a difference between the first difference and the second difference is more than or equal to the given threshold value (if the measured ratio falls outside of a threshold range based on the preset value, an abnormality is identified; paragraphs [0040-0079], [0092]).
With respect to Claim 23, when Mori’s system is operating normally, the water removal rate in the blood purifier at the first timing will be substantially equal to the water removal rate of the blood purifier at a second timing (i.e. the ratio based on the measured physical quantities falls within the normal operating range and an abnormality has not been determined.
With respect to Claim 24-26, Mori teaches that each of the indicators (measured by measuring means 5a and 5b) of the blood concentrations includes hematocrit (see Abstract and paragraphs [0040-0049]; the measuring means 5a and 5b include hematocrit sensors [0041]).
With respect to Claim 27, Mori teaches a dialysis device (Abstract, Figure 1; paragraphs [0030-0036]) comprising:
a blood purifier 2;
an artery-side blood circuit 1a that allows blood to flow into the blood purifier;
a vein-side blood circuit 1b that allows the blood to flow out of the blood purifier;
a blood pump 3 provided to pump the blood in the artery-side blood circuit; and
a controller 6 (including calculating means, evaluating means, and reporting means; see Figure 3) that controls an operation of the blood pump (paragraphs [0040-0082],
wherein the controller performs the method of monitoring the blood circulation according to claim 13 (see the rejection of Claim 13 above; Figures 1 and 3; paragraphs [0011-0082].
With respect to Claim 28, More teaches a non-transitory computer-readable storage medium (controller 6) storing a program for causing, when executed by a computer, the computer to perform the method of monitoring the blood circulation according to Claim 13 (see the rejection of Claim 13 above; Figures 1 and 3; paragraphs [0011-0082]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kleinekofort (US 2009/0292236) teaches a dialysis system comprising a plurality of sensors for monitoring the performance of the dialyzer.
Krause (US 2016/0045657) teaches a dialysis system with means for optimizing flow and clearance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781