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 amendment filed 03/17/2026 has been entered. Claims 1, 3, 9-11, 13-14 have been amended. Claims 4 and 15-52 are cancelled. Claims 1-3, 5-14 remain pending in this application.
Response to Arguments
The amendments to the claims overcome the claim objections and rejections under 35 USC §112(b) and such objections and rejections are therefore withdrawn.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the same interpretation of Pouchoulin for any teaching or matter specifically challenged in the argument.
Applicant argues that Pouchoulin’s controller is operatively connected to the infusion pump and Pouchoulin would have no need to determine an operational state of the infusion pump by using signal analysis of pressure signals sensed by a separate and distinct blood filtration system. Applicant argues that Pouchoulin would not include functionality to determine the operational state of the infusion pump since Pouchoulin already knows the operational state of the infusion pump. However, a new grounds of rejection is made no longer relying on an external infusion pump of Pouchoulin. As discussed in the rejection below, such recitation of the external infusion pump is not explicitly required by claim 1 and Pouchoulin is capable of being fluidly coupled to a separate and distinct external infusion pump.
Accordingly, claim 1 remains obvious over Pouchoulin.
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) 1, 3 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pouchoulin (Pub. No.: US 2015/0034557 A1).
Regarding claim 1, Pouchoulin discloses (fig. 2) a blood filtration system (extracorporeal blood treatment apparatus 1) configured to reduce one or more plasma constituents in blood of a patient (¶ 0001) comprising:
A blood circuit (characterized by blood withdrawal line 6 and blood return line 7) for coupling with a catheter (¶ 0442), and the blood circuit is configured for fluidic communication with vasculature of a patient (¶ 0442), wherein the blood circuit is configured to transport blood through a filter (filtration unit 2), and the filter is configured to remove one or more plasma constituents in the blood (¶ 0441);
An infusion port (see post infusion fluid line 25) in fluidic communication with the blood circuit (¶ 0443), and the infusion port configured for fluidic communication with the external infusion pump to receive an infusion fluid from the external infusion pump (¶ 0443);
At least one pressure sensor (6b) configured to sense one or more pressure signals indicative of a pressure in a portion of the blood circuit (¶ 0442);
A blood filtration controller (control unit 10) including a signal analyzer, the signal analyzer configured to analyze the one or more pressure signals sensed by the at least one pressure sensor of the blood filtration system (¶ 0442),
Wherein the blood filtration controller includes a pump adjuster configured to adjust an ultrafiltration rate (¶ 0444).
Pouchoulin fails to disclose the blood filtration system configured for fluidly coupling with a separate and distinct external infusion pump, however, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The blood filtration system of Pouchoulin is fluidly coupled to an infusion pump (infusion pump 27, ¶ 0443) and is thus capable of being configured for fluidly coupling with a separate and distinct external infusion pump and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Regarding the limitations of the separate and distinct external infusion pump being separately and independently controlled from the blood filtration system, without requiring electrical signal communication between the blood filtration system and the separate and distinct external infusion pump, such limitations further limit the external infusion pump which is not explicitly required by claim 1. Accordingly, since the system of Pouchoulin is capable of being fluidly coupled with a separate and distinct external infusion pump, such limitations relating to the external infusion pump are considered to be disclosed by Pouchoulin.
Regarding the limitations of the blood filtration controller including an infusion pump state detector, Pouchoulin discloses that the blood filtration controller receives a pressure signal from the at least one pressure sensor (¶ 0442) and the at least one pressure sensor is capable of being in fluid communication with the external infusion pump (fig. 2). Thus, Pouchoulin discloses an infusion pump state detector.
The claim limitations of the infusion state detector configured to detect an operational state of the external infusion pump, and wherein the ultrafiltration rate is configured to be adjusted based on the detected operational state of the external infusion pump, such limitation relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. Blood filtration controller of Pouchoulin includes an infusion pump detector and a pump adjuster, as discussed above, and is thus capable of being configured to detect an operational state of the external infusion pump, and wherein the ultrafiltration rate is configured to be adjusted based on the detected operational state of the external infusion pump and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Further, since the system of Pouchoulin is capable of being fluidly coupled with a separate and distinct external infusion pump, such limitation of the infusion state pump detector being configured to detect an operational state of the external infusion pump using an outcome of the analysis without requiring electrical signal communication between the blood filtration system and the separate and distinct external infusion pump that is separately and independently controlled from the blood filtration system is disclosed by Pouchoulin since the system of Pouchoulin is capable of being fluidly coupled to a separate and distinct external infusion pump that is separately and independently controlled from the blood filtration system and the external infusion pump is not explicitly required by claim 1.
Regarding claim 3, Pouchoulin fails to disclose wherein the signal analyzer is configured to analyze the one or more pressure signals by processing an individual pressure signal of the one or more pressure signals to produce at least one of a Fourier transform of the individual pressure signal, an autocorrelation of the individual pressure signal, or a change in the individual pressure signal associated with a pause of the blood pump.
However, the limitation of “configured to analyze the one or more pressure signals by processing an individual pressure signal of the one or more pressure signals to produce at least one of a Fourier transform of the individual pressure signal, an autocorrelation of the individual pressure signal, or a change in the individual pressure signal associated with a pause of the blood pump” relates to a function of the system which, in this case, imparts no further limitations on the structure of the device. Pouchoulin discloses the pressure sensor in fluid communication with the blood pump (11) (fig. 2).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to program the signal analyzer is configured to analyze the one or more pressure signals by processing an individual pressure signal of the one or more pressure signals to produce at least one of a fourier transform of the individual pressure signal, an autocorrelation of the individual pressure signal, or a change in the individual pressure signal associated with a pause of the blood pump in order as such signal is indicative of a pressure in the blood circuit.
Regarding claim 5, Pouchoulin discloses wherein: the blood circuit includes a withdrawal line (6) configured for coupling with the catheter to receive the blood from the patient through the catheter (¶ 0442);
The blood circuit includes an infusion line (blood return line 7) configured for coupling with the catheter to return blood into the patient through the catheter (¶ 0442); and
The blood circuit includes the filter (fig. 2, ¶ 0441), and the filter is configured for coupling between the withdrawal line and the infusion line (fig. 2), and the filter is configured to produce filtered blood by removing portions of the one or more plasma constituents in the blood (¶ 0001, ¶ 0441).
Regarding claim 6, Pouchoulin discloses wherein the at least one pressure sensor includes one or more of a withdrawal pressure sensor (fig. 2, ¶ 0442) or an infusion pressure sensor;
The withdrawal pressure sensor is configured for coupling with the withdrawal line to sense a withdrawal pressure signal indicative of a pressure in the withdrawal line (¶ 0442, fig. 2); and
The one or more pressure signals includes at least one of the withdrawal pressure signal (¶ 0442) or the infusion pressure signal.
Regarding claim 7, Pouchoulin discloses a blood pump (11) configured to engage the withdrawal line to pump the blood through the withdrawal line and into the filter at an extracorporeal blood flow rate (Qblood) (¶ 0442); and
A filtration pump (effluent pump 17) configured to remove a filtrate fluid including the removed portions of the one or more plasma constituents from the filter at an ultrafiltration rate (Qeff-) (¶ 0443).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pouchoulin, as applied to claim 1 above, and further in view of Lerner et al. (WO 2020/142533 A1).
Regarding claim 2, Pouchoulin fails to disclose a hematocrit sensor configured for coupling with the blood circuit to sense a hematocrit signal indicative of a hematocrit of the blood; and wherein the signal analyzer is configured to analyze the hematocrit signal and the one or more pressure signals to detect the operational state of the infusion pump.
Lerner teaches (fig. 1) a blood filtration system (100) to reduce one or more plasma constituents in blood of a patient (abstract) and thus in the same field of endeavor, comprising: a hematocrit sensor (126) configured for coupling with a blood circuit to sense a hematocrit signal indicative of a hematocrit of the blood (pg. 16, ln. 1-10).
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 system of Pouchoulin such that it comprises the hematocrit sensor of Lerner, as such measurement can be used to determine the amount of plasma constituents remaining in a patient (Lerner, pg. 4, ln. 28-pg. 5, ln. 2).
Regarding the limitation of “the signal analyzer is configured to analyze the hematocrit signal and the one or more pressure signals to detect the operational state of the infusion pump”, such limitation relates to a function of the system which, in this case, imparts no further limitations on the structure of the device. While Pouchoulin does not disclose the signal analyzer is configured to analyze the hematocrit signal and the one or more pressure signals to detect the operational state of the infusion pump, Pouchoulin discloses that the controller comprises a processor and is programmable (¶ 0474).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to program the controller of Pouchoulin such that the signal analyzer is configured to analyze the hematocrit signal and the one or more pressure signals to detect the operational state of the infusion pump as hematocrit can indicate the amount of plasma constituents and therefore the operational state of the infusion pump.
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pouchoulin, as applied to claim 1 above, and further in view of Kelly et al. (Pub. No.: US 2005/0131331 A1).
Regarding claim 8, Pouchoulin discloses an external infusion line for fluidic communication with the infusion port (post-dilution fluid line 25).
Pouchoulin fails to disclose a damping system, the damping system configured to damp flow of fluid, the damping system including: a flow restrictor in fluidic communication with the external infusion line, the flow restrictor having an orifice to restrict flow through the external infusion line; and a check-valve in fluidic communication with one or more of the flow restrictor or the external infusion line, wherein: the check-valve configured to permit flow of fluid through a valve body in a first direction; and the check-valve is configured to restrict the flow of fluid through the valve body in a second direction.
Kelly teaches (fig. 1) a blood filtration system (10) and thus in the same field of endeavor, comprising: a flow restrictor (pinch clamp 114), the flow restrictor having an orifice to restrict flow (¶ 0071); and a check-valve (110) in fluidic communication with one or more of the flow restrictor, wherein: the check-valve configured to permit flow of fluid through a valve body in a first direction; and the check-valve is configured to restrict the flow of fluid through the valve body in a second direction (¶ 0058, ¶ 0071).
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 external infusion line of Pouchoulin such that it comprises the flow restrictor and check valve of Kelly, disposed on the external infusion line of Pouchoulin, thus providing a damping system as such check valve and flow restrictor are suitable controlling the delivery of a volume of fluid (Kelly, ¶ 0071).
Regarding claim 9, Pouchoulin discloses a blood circuit pump (blood pump 11) in fluidic communication with the infusion port (fig. 2), and the blood circuit pump is configured to pump fluid in one or more of the external infusion line or the blood circuit (¶ 0442).
Regarding claim 10, Pouchoulin discloses wherein operation of one or more of the blood circuit pump or the external infusion pump generates variations in flow of fluid in one or more of the external infusion line or the blood circuit (¶ 0442).
As discussed above, Pouchoulin in view of Kelly disclose the damping system. Accordingly, Pouchoulin in view of Kelly disclose that the damping system is configured to damp the variations in flow of fluid.
Regarding claim 11, Pouchoulin discloses wherein the blood circuit pump is a peristaltic pump (¶ 0442).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pouchoulin in view of Kelly, as applied to claim 9 above, and further in view of Lerner.
Regarding claim 12¸ Pouchoulin view of Kelly fail to disclose a flow sensor in communication with one or more of the external infusion line or the blood circuit, and the flow sensor is configured to sense a flow rate signal indicative of flow rate within one or more of the external infusion line or the blood circuit.
Lerner teaches (fig. 1) a blood filtration system (100) to reduce one or more plasma constituents in blood of a patient (abstract) and thus in the same field of endeavor, comprising: a flow sensor (124E) in fluid communication with a blood circuit (140), and the flow sensor is configured to sense a flow rate signal indicative of flow rate within the blood circuit ( pg. 9, ln. 20-24).
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 system of Pouchoulin in view of Kelly such that it comprises a flow sensor in communication with one or more of the external infusion line or the blood circuit, and the flow sensor is configured to sense a flow rate signal indicative of flow rate within one or more of the external infusion line or the blood circuit, as taught by Lerner, in order to measure a flow rate of the blood circuit such that a performance of the system can be monitored (Lerner, pg. 21, ln. 25-pg. 22, ln. 10).
Regarding claim 14, Pouchoulin in view of Kelly and further in view of Lerner disclose wherein the damping system is located proximal to the infusion port (see claim 8 above).
Allowable Subject Matter
Claim 13 is 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 13 recites the damping system cooperates with the flow sensor to damp variations in the flow rate signal based on operation of the one or more of the external infusion pump or the circuit pump.
The closest prior art is Pouchoulin which discloses an infusion port and an external infusion pump. Pouchoulin discloses that the flow rate of the infusion line can be regulated by controlling the external infusion pump. Such modification of Pouchoulin such that the damping system cooperates with the flow sensor to damp variations in the flow rate signal based on operation of the one or more of the external infusion pump or the circuit pump requires a substantial modification to the infusion line of Pouchoulin. While Lerner discloses a flow sensor and Kelly discloses a flow restrictor and a check valve, the prior art of record fails to disclose, teach or suggest the feature of a damping system that cooperates with a flow sensor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Caleffi et al. (Pat. No.: US 8,728,020 B2) discloses an infusion apparatus.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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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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/MEAGAN NGO/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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