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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-14 in the reply filed on 10/07/2025 is acknowledged.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/07/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 6, 9, 11, 12, and 14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 2, 6, 11, 12, and 14 recite the limitation “such as ” which renders the claim indefinite. The term “such as” is unclear on the what the claim entails. Therefore, the claims are indefinite.
Claim 9 recites the limitation “preferably” in line 6. It is unclear what preferably entails. Therefore, the claims are indefinite.
Allowable Subject Matter
This application is in condition for allowance except for the 112(b) rejections of Claims 1, 2, 6, 9, 11, 12, and 14.
The following is an examiner’s statement of reasons for allowance:
Claims 1, 11, and 14 are allowable for reciting, inter alia, “the system computing unit is adapted for receiving a desired blood concentration value KETONEb of a ketone body, such as acetoacetate, beta-hydroxybutyrate or pharmaceutically acceptable derivatives, esters and salts thereof within the range of 1 - 15 mM;
the system computing unit is adapted for receiving a concentration value GLNp representing the concentration of glutamine or pharmaceutically acceptable glutamine-containing compounds in fresh dialysate fluid ;
the system computing unit is adapted for controlling said blood pump and said dialysate fluid pump in such a way that the actual blood concentration value GLNa of glutamine is driven towards or below GLNb and the actual blood concentration value GLUCOSEa of glucose is driven towards or below GLUCOSEb”.
Mathews (WO 2011070527 A2) is considered the closest prior art and teaches an extracorporeal blood treatment system for treating a subject suffering from cancer (see pg. 25 ln 24-33), the system comprising:
an extracorporeal blood circuit (blood flow to and from a patient. see Figures 3-4);
a dialysate fluid circuit (water inlet to waste outlet, see Figure 3);
said extracorporeal blood circuit and dialysate fluid circuit being divided by a membrane of a filtration unit (machine shown in Figures 3-4 is a hemodialysis machine);
at least one blood pump for controlling the flow of blood through the extracorporeal blood circuit (implicit);
at least one dialysate fluid pump for controlling the flow of dialysate fluid through the dialysate fluid circuit (implicit);
optionally one or more infusion lines (pharmaceutical composition dispensing unit 33 and glucose/energy source dispensing unit 28), each infusion line being connected to the extracorporeal blood circuit (see Figure 3) or adapted for being directly connected to the vascular system of the subject to be treated, each infusion line comprising an infusion pump;
a system computing unit (central control unit 11) operatively connected to the blood pump and the dialysate fluid pump and optionally to the one or more infusion pumps of the one or more infusion lines,
wherein the system computing unit is adapted for receiving a desired blood concentration value GLNb of glutamine (required blood glutamine concentration at the return-flow blood glutamine sensor, see pg. 15 ln 33-34);
the system computing unit is adapted for receiving a desired blood concentration value GLUCOSEb of glucose (required blood glucose concentration at the return-flow blood glucose sensor, see pg. 15 ln 32-33);
the system computing unit is adapted for receiving a concentration value GLUCOSEp representing the concentration of glucose in fresh dialysate fluid (from the dialysate glucose sensor 35);
the system computing unit is adapted for receiving an actual concentration value GLNa of glutamine in blood from said treated subject (from the intake flow and return flow blood glutamine sensor), and receiving an actual concentration value GLUCOSEa of glucose in blood from said treated subject (form the intake flow and return flow blood glucose sensors), and receiving an actual concentration value KETONEa of a ketone body such as acetoacetate and/or beta-hydroxybutyrate (from the multi-dimensional concentration sensor 32 on the blood intake flow line).
However, Matthews fails to teach how the blood concentrations of glutamine and glucose are controlled and does not describe controlling any blood pumps or dialysate fluid pumps to drive actual blood concentrations towards a desired concentration. Mathews also fails to mention the system computing unit receiving desired values for ketone bodies and receiving concentration values of glutamine in fresh dialysate.
Prior art like Chevallet et al. (US 5441636 A) teaches an extracorporeal blood treatment system for treating a subject suffering from cancer (see Abstract; Figure 1), the system comprising: an extracorporeal blood circuit (blood fluid circuit 50); a dialysate fluid circuit (treatment fluid circuit 90 and waste fluid circuit 100); said extracorporeal blood circuit and dialysate fluid circuit being divided by a membrane of a filtration unit (dialyzer 40); at least one blood pump for controlling the flow of blood through the extracorporeal blood circuit (blood pump 112); at least one dialysate fluid pump for controlling the flow of dialysate fluid through the dialysate fluid circuit (pump 114 ).
However, Chevallet fails to teach a system computing unit that is configured to receive concentration values of glutamine, glucose and ketones. Chevallet does not teach a controller or computing unit of any kind.
Prior art like Scott et al. (WO 2019035073 A2) teaches a medical device (see Abstract) that is used to measure or monitor an analyte (e.g., glutamine, glucose, or ketone bodies, see Paragraph [0087]) and a system computing unit (data processing terminal 105) include a drug delivery device (e.g., an infusion device) such as an insulin infusion pump or the like, which may be configured to administer a drug (e.g., insulin) to the user.
However, Scott fails to teach the system computing unit adapted for receiving a desired concentration value of glutamine, glucose, and ketone bodies specifically and receiving concentration values of the analytes in in fresh dialysate. Scott also fails to teach controlling a blood pump and dialysate pump to drive actual blood concentrations towards a desired concentration. There is no prior art found that reads on the limitations of claims. Therefore, the combinations of limitations in claims 1, 11 and 14 are allowable. Claims 2-10 would be allowable for depending on claim 1. Claims 12-13 would be allowable for depending on claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (2/8/2026)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781