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 .
Response to Amendment
The Amendments filed 09/15/2025 have been entered.
Claims 11 and 14 have thereby been amended.
Claims 1-10 are withdrawn from consideration.
Claims 11-19 are being examined in this office action.
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.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lamb (US 20130102975) in view of Szamosfalvi (WO 2009016504).
Regarding claim 11, Lamb discloses an infusion pump system, comprising: a first pump (Fig. 2: pump attached to 235a) configured to pump a first fluid from a first fluid reservoir (Fig. 2: 205; blood) for infusion into a patient; a second pump (Fig. 2: pump attached to 265) configured to pump a second fluid from a second fluid reservoir (Fig. 2; 210; saline) for infusion into the patient; wherein the first fluid comprises blood (205; page 1, para. [0011], first sentence). However, Lamb fails to disclose the second fluid containing calcium, a sensor, and a controller for controlling the flow rate of the first and second pumps.
Szamosfalvi teaches an analogous multi-fluid and multi-pump blood infusion system with the second fluid comprises a calcium-containing solution (Fig. 41: second fluid being Calcium Magnesium +/- Dextrose in 246), a controller (control program; page 21, lines 19-22) configured to control a flow rate of the first pump and the second pump (page 44, lines 13-25), such that the first fluid and the second fluid are provided in a preselected ratio (page 21, lines 19-22) responsive to the measured concentration of the second fluid in order to maintain the preselected ration of the first fluid to the second fluid (page 101, lines 21-28, the detection of the calcium concentrations may cause the control program to automatically change the treatment delivery settings); and a sensor (256) in communication with the controller (page 101, lines 21-22) and configured to measure a concentration of the second fluid pumped from the second pump (page 98, lines 1-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb pumping system by replacing the saline fluid with the calcium solution (264) taught by Szamosfalvi in order to prevent/reduce the risk of hypocalcemia that may occur when receiving blood from the first fluid (Szamosfalvi: page 95 line 4). It would also have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb pumping system with the sensor and controller taught by Szamosfalvi in order to monitor and achieve the optimal concentrations of supplements—in this case, the calcium being delivered—in the blood infused to the patient (page 44, lines 13-25). Upon this combination, it would have been obvious for the sensor to be placed along the fluid line of the Lamb system in order to achieve the same role of measuring the calcium ratio in the blood being delivered to the patient as it does in the placement in the Szamosfalvi system.
Regarding claim 12, Lamb in view of Szamosfalvi teaches the infusion pump system of claim 11, as described above, further comprising a first inflow line (see annotated figure below) operable to fluidically couple the first pump to the first fluid reservoir (see annotated figure below; Lamb: 205), and a second inflow line (see annotated figure below) operable to fluidically couple the second pump to the second fluid reservoir (see annotated figure below; Lamb: 210).
Regarding claim 13, Lamb in view of Szamosfalvi teaches the infusion pump system of claim 12, as described above, further comprising a first fluid line (see annotated figure below) fluidically coupled to the first pump (see annotated figure below; Lamb: pump at 235a) and a second fluid line (see annotated figure below) fluidically coupled to the second pump (see annotated figure below; Lamb: pump at 265) in order to receive the first fluid and the second fluid when the first pump and the second pump are respectively operating to pump the first fluid from the first fluid reservoir and the second fluid from the second fluid reservoir.
Regarding claim 14, Lamb in view of Szamosfalvi teaches the infusion pump system of claim 13, as described above, wherein the sensor (Szamosfalvi: 256) is coupled to the first fluid line and the second fluid line, wherein the sensor is operable to measure a concentration of the second fluid in the second fluid line and the controller is configured to adjust the flow rate of the second pump responsive to the measured concentration of the second fluid in the fluid line in order to maintain the preselected ratio of the first fluid to the second fluid (Szamosfalvi: page 88 line 28 – page 89 line 10; page 94 line 30 – page 95 line 4). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb pumping system with the sensor taught by Szamosfalvi in order to monitor and achieve the optimal concentrations of supplements—in this case calcium—in the blood infused to the patient in order to prevent hypocalcemia when receiving blood (Szamosfalvi: page 95 line 4).
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Annotated Fig. 2, Lamb
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lamb (US 20130102975) in view of Szamosfalvi (WO 2009016504) in further view of Planas (EP 3593830).
Regarding claim 15, Lamb in view of Szamosfalvi teaches the infusion pump system of claim 11, as described above, but fails to disclose the type of pump attached to the pump adaptors for operation as peristaltic pumps.
Planas teaches an analogous infusion system wherein the first pump (18) is a peristaltic pump (col. 7, para. [0023], first sentence). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb-Szamosfalvi device with the peristaltic pump taught by Planas in order to achieve the effective pumping (col. 7, para. [0023], first sentence) with a simple, low cost, low maintenance pump type.
Regarding claim 16, Lamb in view of Szamosfalvi in further view of Planas teaches the infusion pump system of claim 15, as described above, but fails to disclose the type of pump attached to the pump adaptors for operation as peristaltic pumps. Planas teaches an analogous infusion system wherein the second pump (20) is a peristaltic pump (col. 7, para. [0024], sentences 1-2). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb-Szamosfalvi device with the peristaltic pump taught by Planas in order to achieve the effective pumping (col. 7, para. [0023], first sentence) with a simple, low cost, low maintenance pump type.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lamb (US 20130102975) in view of Szamosfalvi (WO 2009016504) in further view of Kraft (Treatment of electrolyte disorders in adult patients in the intensive care unit, Am J Health-Syst Parm—Vol 62, 2005) in further view of Katz (Pharmacotherapy Principles & Practice, Conversion Factors, 5th Edition, 2019).
Regarding claim 17, Lamb in view of Szamosfalvi teaches the infusion pump system of claim 11, as described above, but fails to disclose the concentrations of calcium chloride in the blood infused.
Kraft teaches analogous calcium chloride supplementation for blood infusion with increased efficacy, wherein the preselected ratio is between zero and 1.5 mg of calcium chloride per mL of blood (Kraft: page 1676, col. 1, lines 8-9; 1.35mEq calcium chloride/100mL blood is equivalent to 0.96mg calcium chloride/mL blood as evidenced by Katz conversions in Appendix A – Part 1). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb-Szamosfalvi device with the calcium chloride to blood ratio taught by Kraft in order to treat hypocalcemia and minimize the risk of dosing errors (Kraft: page 1675, col. 2, lines 1-17 of the last paragraph).
Regarding claim 18, Lamb in in view of Szamosfalvi in further view of Kraft and Katz teaches the infusion pump system of claim 17, as described above, but fails to disclose the concentrations of calcium chloride in the blood infused. Kraft teaches analogous calcium chloride supplementation for blood infusion with increased efficacy, wherein the preselected ratio is between 0.39 mg of calcium chloride per mL of blood and 1.39 mg of calcium chloride per mL of blood (Kraft: page 1676, col. 1, lines 8-9; 1.35mEq calcium chloride/100mL blood is equivalent to 0.96mg calcium chloride/mL blood as evidenced by Katz conversions in Appendix A – Part 1). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb-Szamosfalvi device with the calcium chloride to blood ratio taught by Kraft in order to treat hypocalcemia and minimize the risk of dosing errors (Kraft: page 1675, col. 2, lines 1-17 of the last paragraph).
Regarding claim 19, Lamb in in view of Szamosfalvi in further view of Kraft and Katz teaches the infusion pump system of claim 18, as described above, but fails to disclose the concentrations of calcium chloride in the blood infused. Kraft teaches analogous calcium chloride supplementation for blood infusion with increased efficacy, wherein the preselected ratio is between 0.79 mg of calcium chloride per mL of blood and 1.39 mg of calcium chloride per mL of blood (Kraft: page 1676, col. 1, lines 8-9; 1.35mEq calcium chloride/100mL blood is equivalent to 0.96mg calcium chloride/mL blood as evidenced by Katz conversions in Appendix A – Part 1). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Lamb-Szamosfalvi device with the calcium chloride to blood ratio taught by Kraft in order to treat hypocalcemia and minimize the risk of dosing errors (Kraft: page 1675, col. 2, lines 1-17 of the last paragraph).
Response to Arguments
Applicant’s Arguments filed 09/15/2025 regarding the prior art rejection of independent claim 11 has been fully considered and are persuasive. However, in light of the amendments to claims 11 and 14 filed 09/15/2025, a new ground of rejection is made as recited above. Independent claim 11 stands rejected by Lamb in view of Szamosfalvi, wherein Lamb has been reinterpreted and additional features of Szamosfalvi have also been incorporated into the combination.
Applicant argues that the Lamb-Szamosfalvi combination fails to teach the controller to control flow rates of blood and a calcium containing solution. However, these limitations are taught by Szamosfalvi in the Lamb-Szamosfalvi combination, as described above in the rejection of claim 11. Specifically, as cited above, lines 13-25 on page 44 of Szamosfalvi describes the control of the infusion rates of the calcium (and upon the combination, blood of Lamb) in order to maintain a desired concentration/ratio. Applicant further argues that Lamb and Szamosfalvi teach different systems and would therefore not have been obvious for one of ordinary skill in the art to have combined. However, Examiner maintains that Lamb and Szamosfalvi are analogous in their teachings of blood infusion systems with separate pumps to achieve a desired combination of the two liquids being infused into the patient. Therefore, Szamosfalvi’s teachings such as the controller and sensor, which are well known in the art, would have been obvious for one to modify the Lamb system with. Finally, Applicant argues that the Szamosfalvi sensor for measuring calcium concentrations does not teach the claimed sensor because it measures concentrations of the calcium solution in the effluent line. However, as the claims are presently written, the Szamosfalvi sensor reads on the limitations of the sensor being “configured to measure a concentration of the second fluid,” as the Szamosfalvi sensor measures the concentration of the calcium and magnesium, which is the second fluid contents. Further, as seen in Figure 41 of Szamosfalvi, sensor system 256 is in fact coupled to the first and second fluid lines, as stated in claim 14, though not directly placed on the lines themselves, which is not claimed.
For these reasons, independent claim 11 and its depending claims 12-19 stand rejected as described above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783