DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 101
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 20 recites a computer-readable medium that is not limited to just statutory subject matter as outlined in the Specification; therefore, the claimed invention is directed to non-statutory subject matter. Examiner suggests inserting "non-transitory" prior to computer-readable medium to exclude any non-statutory subject matter.
Reasons for Allowance
Claims 1-19 are allowed.
Claim 20 would be allowed provided the 35 USC 101 rejection is overcome.
The present invention is directed to a technique for measurement of fluid flow rate in a vascular access of a patient when connected to a blood treatment machine. Each independent claim identifies the uniquely distinct features:
connecting, to the vascular access, first and second access devices of an extracorporeal blood flow circuit in a blood treatment machine that comprises a blood pump operable to generate a flow of blood in the extracorporeal blood flow circuit from the first access device through a blood compartment of a dialyzer and to the second access device, the blood compartment being separated from a treatment fluid compartment of the dialyzer by a semi-permeable membrane and the blood treatment machine comprising a treatment fluid flow circuit configured to generate a flow of treatment fluid through the treatment fluid compartment;
causing the blood treatment machine to switch from a first operating state to a second operating state, wherein the second operating state at least differs from the first operating state by a change of flow direction of the blood or the treatment fluid through the dialyzer;
acquiring an output signal of at least one sensor in the blood treatment machine in the first and second operating states;
computing, based on the output signal, a measurement value of a comparison parameter that compares treatment efficiency in the first operating state to treatment efficiency in the second operating state;
obtaining, for first and second sets of control values of operating parameters of the blood treatment machine in the first and second operating states, a current function that relates the comparison parameter to the fluid flow rate in the vascular access, the operating parameters including a cardiac output of the patient, a characteristic parameter of the dialyzer, a flow rate of the treatment fluid through the dialyzer, and a flow rate of the blood through the dialyzer; and
determining, based on the measurement value, an estimated value of the fluid flow rate in the vascular access so that the current function yields the measurement value.
The closest prior art, US 2005/0082226 A1 (“Bene et al.”); US 2004/0168969 A1 (“Sternby et al.”); US 2013/0193039 A1 (“Kopperschmidt”), fail to anticipate or render obvious at least the above limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLOTTE M BAKER whose telephone number is (571)272-7459. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER MEHMOOD can be reached at (571)272-2976. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLOTTE M BAKER/Primary Examiner, Art Unit 2664
30 January 2026
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