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 group I, claims 32-58 in the reply filed on 01/14/2026 is acknowledged.
Claims 59-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/14/2026. Applicant’s traverse solely to the extent of reserving the right to request rejoinder of Group II to Group I is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 05/02/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
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 48-49 and 52 are 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.
Claim 48 recites the limitation "the net buffer load" in ln. 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution, claim 48 will be interpreted as being dependent on claim 47.
Claim 49 recites the limitation "the net buffer load" in ln. 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution, claim 49 will be interpreted as being dependent on claim 48.
Claim 52 recites the limitation “the normalized net buffer load” in ln. 3. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 48 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 48 defines a net buffer load. However, such recitation of a net buffer load does not further limit the apparatus of claim 32 from which claim 48 depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For the purposes of compact prosecution, claim 48 will be interpreted as being dependent from claim 47.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 32-47 and 50-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pouchoulin (Pub. No.: US 2015/0034557 A1) further in view of Bene et al. (US Pat. No.: 5,725,775).
Regarding claim 32¸ Pouchoulin discloses (fig. 1) a continuous renal replacement therapy apparatus (extracorporeal blood treatment apparatus 1, ¶ 0001) comprising:
A filtration unit (2) having a primary chamber (3) and a secondary chamber (4) separated by a semi-permeable membrane (5) (¶ 0441);
An extracorporeal blood circuit having a blood withdrawal line (6) connected to an inlet of the primary chamber (¶ 0442), and a blood return line (7) connected to an outlet of the primary chamber (¶ 0442), said extracorporeal circuit being configured for connection to a patient cardiovascular system (¶ 0442);
A blood pump (11) configured to control the flow of blood through the extracorporeal blood circuit (¶ 0442);
An effluent line (13) connected to an outlet of the secondary chamber (¶ 0443);
One or more further fluid lines selected from a fluid line group comprising:
A pre-dilution infusion line (15) connected to the blood withdrawal line (¶ 0117),
A post-dilution infusion line (25) having one end connected to the blood return line (¶ 0118),
A post-dilution bicarbonate infusion line having one end connected to the blood return line,
An ion balancing infusion line having one end connected either to the blood return line or to a patient catheter,
A dialysis liquid (19) supply line connected to the inlet of the secondary chamber (¶ 0443),
A pre-blood pump infusion line having one end connected to the blood withdrawal line in a region of the blood withdrawal line which is upstream from the blood pump when in use,
An anticoagulant infusion line having one end connected to the blood withdrawal line in a region of the blood withdrawal line which is in use upstream from the blood pump, and
A syringe fluid line (50) having one end connected to the blood withdrawal line (¶ 0113);
One or more actuators for regulating the flow of fluid through said one or more further fluid lines (means for regulating the flow of fluid 18, 21, 27, ¶ 0100); and
A control unit (10) connected to memory (10a) storing one or more mathematical relations (¶ 0476) and to the one or more actuators (¶ 0444), the control unit configured to execute a flow-rate setup procedure comprising:
Receiving a patient prescription comprising clinical prescription parameters, the receiving step including:
Allowing entry of a set value for a prescribed dialysis dose to be delivered (¶ 0411),
Determining one or more operating parameters using said one or more mathematical relations, the determining of the one or more operating parameters comprising calculating a set value of at least two fluid flow rates (¶ 0333-¶ 0334) selected from a flow rate group comprising:
A fluid flow rate through the anticoagulant infusion line,
A fluid flow rate through the PBP infusion line (Qpbp) when the one or more further fluid lines includes the PBP infusion line (¶ 0337),
A fluid flow rate through the pre-dilution line (Q-rep1) when the one or more further fluid lines includes the pre-dilution infusion line (¶ 0335),
A fluid flow rate through the post-dilution infusion line (Qrep2) when the one or more further fluid lines includes the post-dilution infusion line (¶ 0336),
A fluid flow rate through the post-dilution bicarbonate infusion line when the one or more further fluid lines includes the post-dilution bicarbonate infusion line,
A fluid flow rate through the ion balancing infusion line when the one or more further fluid lines includes the ion balancing infusion line,
A blood fluid flow rate through the extracorporeal blood circuit,
A fluid flow rate through the syringe fluid line (Qsyr) when the one or more further fluid lines includes the syringe fluid line (¶ 0339),
A fluid flow rate through the dialysis liquid supply line (Qdial) when the one or more further fluid lines includes the dialysis liquid supply line (¶ 0338), and
A fluid flow rate through the effluent fluid line (Qeff) (¶ 0340);
Wherein calculating the set value of the at least two fluid flow rates is based on at least said set value of the prescribed dialysis dose (¶ 0412).
Pouchoulin fails to disclose: allowing entry of a target value for a parameter indicative of a steady state acid-base balance in the blood of a patient
and wherein calculating the set value of the at least two fluid flow rates is based on said target value for the parameter indicative of a steady state acid-base balance in the blood.
Bene teaches (fig. 2) a continuous renal replacement therapy apparatus (abstract) and thus in the same field of endeavor, comprising: a control unit configured to execute a receiving step including: allowing entry of a target value for a parameter indicative of a steady state acid-base balance in the blood of the patient who has to undergo a CRRT blood treatment (desired concentration of bicarbonate in the blood; col. 3, ln. 67-col. 4, ln. 6), wherein calculating the set value is based on said target value for the parameter indicative of a steady state acid-base balance in the blood (col. 3, ln. 57-col. 4, ln. 6; col. 4, ln. 13-20), wherein regulating the acid-base equilibrium combats acidosis (col. 1, ln. 31-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Bene such that it allows for entry of a target value for a parameter indicative of a steady state acid-base balance in the blood of a patient and wherein calculating the set value of the at least two fluid flow rates is based on said target value for the parameter indicative of a steady state acid-base balance in the blood, as taught by Bene, in order to prevent acidosis (Bene col. 1, ln. 31-41).
Regarding claim 33, Pouchoulin discloses wherein receiving a patient prescription further comprises:
Allowing entry of a set value for the blood flow rate (¶ 0475) and calculating the set value comprises calculating at least three fluid flow rates and calculating one set value out of the at least three fluid flow rates is based at least on said set value for the blood flow rate using said one or more mathematical relations (¶ 0476-¶ 0479); and/or
Allowing entry of a set value for at least a fluid removal rate from the patient and calculating the set value comprises calculating at least three fluid flow rates and calculating one set value out of the at least three fluid flow rates is further based at least on said set value for the fluid removal rate from the patient using said one or more mathematical relations.
Regarding claim 34, Pouchoulin discloses wherein the control unit is configured to mathematically relate, using an effluent flow rate mathematical relation, the fluid flow rate through the effluent fluid line with the set value for the fluid removal rate, the control unit configured to calculate the fluid flow rate through the effluent fluid line based on the set value for the fluid removal rate (¶ 0131); wherein the control unit is configured to calculate the fluid flow rate through the effluent fluid line based on an effluent flow rate mathematical relation comprised in said one or more mathematical relations:
Qeff = QPBP +Qcit+ Qsyr +Qdial + Qrep.pre + Qrep.post + QHCO3+ QPFR +Qca
wherein the significance of the denotations is given in the Glossary and when any of the infusion lines or the dialysis liquid supply line is missing, the corresponding flow rate being absent from the mathematical relation, or the corresponding flow rate is set to zero (¶ 0131).
Regarding claim 35, Pouchoulin in view of Bene disclose wherein the target value for the parameter indicative of a steady state acid-base balance in the blood of the patient affects the set value of one or more of:
the fluid flow rate through the pre-dilution infusion line, the set value of the fluid flow rate through the pre-dilution infusion line being an operating parameter calculated by the control unit;
fluid flow rate through the post-dilution infusion line, the set value of the fluid flow rate through the post-dilution infusion line being an operating parameter calculated by the control unit;
the fluid flow rate through the post-dilution bicarbonate infusion line, the set value of the fluid flow rate through the post-dilution bicarbonate infusion line being an operating parameter calculated by the control unit (Bene col. 4, ln. 13-20);
the fluid flow rate through the ion balancing infusion line, the set value of the fluid flow rate through the ion balancing infusion line being an operating parameter calculated by the control unit;
the fluid flow rate through the dialysis liquid supply line, the set value of the fluid flow rate through the dialysis liquid supply line being an operating parameter calculated by the control unit;
the fluid flow rate through the anticoagulant infusion line, the set value of the fluid flow rate through the anticoagulant infusion line being an operating parameter calculated by the control unit;
the fluid flow rate through the PBP infusion line, the set value of the fluid flow rate through the PBP infusion line being an operating parameter calculated by the control unit;
the blood fluid flow rate through the extracorporeal blood circuit, the set value of the blood fluid flow rate through the extracorporeal blood circuit being an operating parameter calculated by the control unit;
the fluid flow rate through the effluent fluid line, the set value of the fluid flow rate through the effluent fluid line being an operating parameter calculated by the control unit.
Regarding claim 36, Pouchoulin discloses wherein the control unit is configured to calculate three or more fluid flow rates selected from the flow rate group (¶ 0333-¶ 0340).
Regarding claim 37, Pouchoulin in view of Bene disclose wherein the control unit is configured to receive the number 'n' of clinical prescription parameters comprising said prescribed dialysis dose and said parameter indicative of a steady state acid-base balance in the blood of the patient.
Pouchoulin further discloses the control unit configured to receive one or more of:
a regional anticoagulation dose plus an ion re-establishing solution parameter,
a fluid removal rate from the patient (Qpfr) (¶ 0403-¶ 0410),
a blood flow rate, and
a syringe flow rate;
wherein the control unit is further configured to calculate a plurality of fluid flow rates selected in the fluid flow rate, wherein the plurality of fluid flow rates is greater than or equal to the number of clinical parameters such that m => n (¶ 0333-¶ 0340).
Regarding claim 38, Pouchoulin discloses wherein when m>n, the control unit is configured to provide for additional therapy configuration parameters to be selectable, said additional therapy configuration parameters adding further mathematical relations to be used for calculating the ‘m’ fluid flow rates,
Wherein, when m=n+1, one additional therapy configuration parameter is selectable, when m=n+2, two additional therapy configurations are selectable, wherein said further mathematical relations include one or more of a convection-diffusion relation, a blood pre-dilution relation, and a pre-post infusion relation (¶ 0031-¶ 0041).
Regarding claim 39, Pouchoulin discloses wherein the control unit is further configured to control said actuators for regulating the flow of fluid based on said set value and calculated value of the fluid flow rates, wherein the actuators for regulating the flow of fluid comprise pumps and valves (¶ 0444).
Regarding claim 40, Pouchoulin discloses:
a preset number of pre-dilution lines selected from the fluid line group including said pre-dilution infusion line connected at one end thereof to the blood withdrawal line (15), said pre-blood pump - PBP - infusion line connected at one end thereof to the blood withdrawal line in a region of the blood withdrawal line which is positioned in use upstream from the blood pump, and said anticoagulant infusion line connected at one end thereof to the blood withdrawal line in a region of the blood withdrawal line which is positioned in use upstream from the blood pump;
- a preset number of post-dilution lines selected from the fluid line group including said post-dilution infusion line connected at one end thereof to the blood return line (25), said post-dilution bicarbonate infusion line connected at one end thereof to the blood return line, and said ion balancing infusion line connected at one end thereof either to the blood return line or to a patient catheter;
wherein further mathematical relations stored in said memory (¶ 0031) comprise one or more of the following:
- a convection-diffusion relation, relating the total fluid flow rate through said preset number of pre- and post-dilution lines with the fluid flow rate through said dialysis liquid supply line (¶ 0032),
- a blood pre-dilution relation, relating the flow rate of blood or of plasma and a total fluid flow rate infused in the blood withdrawal line through said preset number of pre-dilution lines (¶ 0033),
-a pre-post relation, relating a total fluid flow rate through said preset number of pre-dilution lines with a total fluid flow rate through said preset number of post-dilution lines (¶ 0034).
Regarding claim 41, Pouchoulin discloses wherein the convection-diffusion relation defines a first split between the total fluid flow rate through said preset number of pre- and post-dilution lines and the fluid flow rate through said dialysis liquid supply line, the convection-diffusion relation defines a first percentage split or a first ratio R1 dividing the total fluid flow rate through said preset number of pre- and post-dilution lines by the fluid flow rate through said dialysis liquid supply line (¶ 0037); and/or
wherein the blood pre-dilution relation defines a second ratio R2 dividing the flow rate of blood or of plasma by the total fluid flow rate infused in the blood withdrawal line through said preset number of pre-dilution lines (¶ 0038); and/or
wherein the pre-post relation defines a third split between the total fluid flow rate through said preset number of pre-dilution lines and total fluid flow rate through said preset number of post-dilution lines, the pre-post relation defines a third percentage split or a third ratio R3 dividing the total fluid flow rate through said preset number of pre-dilution lines by total fluid flow rate through said preset number of post-dilution lines (¶ 0039).
Regarding claim 42, Pouchoulin discloses wherein the control unit is further configured to allow the user to select one or more therapy configurations comprising at least one further mathematical relations, and to calculate the set values of at least two of said fluid flow rates by applying the set value of the prescribed dose and the target value of the parameter indicative of a steady state acid-base balance in the blood of the patient entered by the operator to both the mathematical relations and the further mathematical relation/s selected by the user;
wherein selecting said therapy configurations comprises choosing the parameter indicative of a steady state acid-base balance in the blood of the patient who has to undergo a CRRT blood treatment between a net buffer load and a steady state patient bicarbonate; and/or
wherein selecting said therapy configurations comprises choosing a definition for the prescribed dialysis dose (¶ 0411-¶ 0412); and/or
wherein selecting said therapy configurations comprises choosing blood flow rate as clinical prescription parameter or as operating parameter.
Regarding claim 43, Pouchoulin discloses wherein the control unit is further configured to allow the user to enter treatment configuration values including receiving entries for one or more of:
- patient body weight (¶ 0549-¶ 0550);
- patient hematocrit;
- filtration unit parameters, such as filter mass transfer coefficient by surface area, sieving coefficient, solute clearance, filtration unit surface, diffusive mass transfer resistance or any combination thereof;
- substance concentration for one or more containers feeding said lines, said substance concentration being bicarbonate concentration and/or lactate concentration and/or citrate concentration and/or calcium concentration,
wherein the control unit is further configured to calculate the set values of the at least two fluid flow rates by applying the treatment configuration values to said mathematical relations (¶ 0463).
Regarding claim 44, Pouchoulin discloses wherein said prescribed dialysis dose value comprises a prescribed value of a flow rate or a combination of flow rates (¶ 0053).
Regarding claim 45, Pouchoulin discloses wherein said prescribed dialysis dose value comprises a prescribed value (¶ 0054) for one of:
- an effluent dose flow rate, which is the prescribed value of the flow rate through the effluent line (¶ 0055),
- a convective dose flow rate, which is the prescribed value of the sum of the flow rates through all infusion lines and the patient fluid removal rate (¶ 0056),
- a diffusive dose flow rate, which is the prescribed value of the flow rate through the dialysis fluid line (¶ 0057),
- a urea dose, which is a prescribed value for an estimated urea clearance (¶ 0058),
- a clearance dose, which is a prescribed value for an estimated clearance for a given solute (¶ 0059).
Regarding claim 46, Pouchoulin in view of Bene disclose wherein the calculating the set value of at least two fluid flow rates comprises calculating each set value of the at least two fluid flow rates is based at least on both said set value of the prescribed dialysis dose (Pouchoulin ¶ 0412) and on said target value for the parameter indicative of a steady state acid-base balance in the blood (Bene; col. 3, ln. 57-col. 4, ln. 6; col. 4, ln. 13-20).
Regarding claim 47, Pouchoulin in view of Bene disclose wherein the parameter indicative of a steady state acid-base balance in the blood of the patient undergoing a CRRT treatment is a parameter function of a net buffer load in the patient expected at a steady state, wherein the net buffer load is a sum of bicarbonate generation from bicarbonate precursor metabolism, bicarbonate balance in the extracorporeal blood circuit and/or of bicarbonate infusions into the patient and/or of acid infusion in the extracorporeal blood circuit (Bene; col. 3, ln. 57-col. 4, ln. 6).
Regarding claim 50, Pouchoulin in view of Bene disclose wherein the parameter indicative of a steady state acid-base balance in the blood of the patient undergoing treatment is a parameter defined assuming a constant value for patient plasma bicarbonate concentration (Bene; desired concentration of bicarbonate; col. 4, ln. 33-37).
Regarding claim 51, Pouchoulin in view of Bene disclose wherein the parameter indicative of a steady state bicarbonate concentration in the blood of the patient is based on an estimated net buffer load indicative of a steady state acid-base balance in the blood of the patient (Bene; desired concentration of bicarbonate; col. 4, ln. 33-37).
Regarding claim 52, Pouchoulin in view of Bene disclose wherein the parameter indicative of a steady state bicarbonate concentration in the blood of the patient is defined imposing a constant value for the normalized net buffer load for the patient at steady state (Bene; desired concentration of bicarbonate; col. 4, ln. 33-37).
Regarding claim 53, Pouchoulin view of Bene disclose wherein the target value for the parameter indicative of a steady state acid-base balance in the blood of the patient affects the set value for the fluid flow rate through the post-dilution line, the set value of the fluid flow rate through the post-dilution infusion line being an operating parameter calculated by the control unit (Pouchoulin ¶ 0027, ¶ 0115-¶ 0118, ¶ 0131).
Regarding claim 54, Pouchoulin view of Bene disclose wherein the target value for the parameter indicative of a steady state acid-base balance in the blood of the patient affects the set value for the fluid flow rate through the pre-dilution line, the set value of the fluid flow rate through the pre-dilution infusion line being an operating parameter calculated by the control unit (Pouchoulin ¶ 0027, ¶ 0115-¶ 0117, ¶ 0131).
Regarding claim 55, Pouchoulin view of Bene disclose wherein the target value for the parameter indicative of a steady state acid-base balance in the blood of the patient affects the set value for the fluid flow rate through the dialysis liquid supply line, the set value of the fluid flow rate through the dialysis liquid supply infusion line being an operating parameter calculated by the control unit (Pouchoulin ¶ 0027, ¶ 0115-¶ 0120, ¶ 0131).
Regarding claim 56, Pouchoulin in view of Bene disclose wherein the control unit is configured to calculate three or more fluid flow rates selected in the flow rate group based at least on both said target value for the parameter of a steady state acid-base balance in the blood and on set value of the prescribed dialysis does (see claim 32 above).
Regarding claim 57, Pouchoulin in view of Bene disclose wherein the control unit is configured to receive the number 'n' of clinical prescription parameters comprising said prescribed dialysis dose and said parameter indicative of a steady state acid-base balance in the blood of the patient.
Pouchoulin further discloses the control unit configured to receive one or more of:
a regional anticoagulation dose plus an ion re-establishing solution parameter,
a fluid removal rate from the patient (Qpfr) (¶ 0403-¶ 0410), and
a blood flow rate,
wherein the control unit is further configured to calculate a plurality of fluid flow rates selected in the fluid flow rate, wherein the plurality of fluid flow rates is greater than or equal to the number of clinical parameters such that m => n (¶ 0333-¶ 0340).
Regarding claim 58, Pouchoulin discloses (fig. 2)wherein the apparatus is configured to perform regional anticoagulation treatment and comprises:
- the anticoagulant infusion line (pre-blood pump infusion line 22) connected at one end thereof to the blood withdrawal line in a region of the blood withdrawal line which is positioned in use upstream from the blood pump (fig.2 ,¶ 0445);
- a source of regional anticoagulant providing an anticoagulant to the anticoagulant infusion line, said source including citrate (infusion fluid container 23, ¶ 0445);
-the ion balancing infusion line connected at one end thereof either to the blood return line or to the patient catheter (¶ 0283), and
-a source of ion balancing solution providing an ion balancing solution to the ion balancing infusion line, said source including calcium ions (¶ 0283);
wherein the control unit is configured to execute the flow-rate setup procedure comprising:
- receiving the patient prescription, the receiving step further including:
allowing entry of a set value for a prescribed anticoagulant dose to be delivered (¶ 0036-¶ 0072),
- determining of the operating parameters comprising calculating the at least two fluid flow rates, the set value for at least the fluid flow rate through the anticoagulant infusion line and the fluid flow rate through the ion balancing infusion line using said one or more mathematical relations (¶ 0283).
Allowable Subject Matter
Claims 48-49 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 48, which is interpreted as being dependent on claim 47, recites that the parameter indicative of a steady state acid-base balance in the blood of the patient undergoing CRRT treatment is a parameter function of a net buffer load in the patient expected at steady state, and further defines the net buffer load. The prior art of record fails to disclose, teach or suggest such definition for the net buffer load. Rather, Bene discloses a bicarbonate concentration as being the parameter indicative of a steady state acid-base balance in the blood of the patient undergoing a CRRT treatment and fails to take into account bicarbonate generated from metabolism of citrate and lactate.
Further, as discussed above, claim 49 is interpreted as being dependent on claim 48 and therefore includes allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lannoy (Pub. No.: US 2007/0066928 A1) discloses a CRRT apparatus. Szamosfalvi et al. (Pub. No.: US 2009/0221948 A1) discloses an extracorporeal blood circuit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781