Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Application Status
This communication is in response to the Request for Reconsideration filed 22 January 2026. Claims 1-29 are pending in the application. No amendments have been filed. Claims 1-18 are subject to examination on the merits. Claims 19-29 were withdrawn from consideration as being drawn to a non-elected invention.
The nonstatutory double patenting rejections have been overcome by the terminal disclaimer filing. The rejections are withdrawn.
Terminal Disclaimer
The terminal disclaimer filed on 25 January 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U. S. Patent No. 12,140,127 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 8-12, 17 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lucke et al. (U. S. Patent No. 7,611,478) in view of Sahlin et al. (U. S. Patent No. 5,947,692)
Regarding claims 1 and 10, Lucke et al. disclose a method/apparatus1 for pumping a fluid (FIG.’s 1-13, col. 2, ll. 35-40, blood), comprising:
connecting a pump 12 (col. 2, ln. 62) [configured for connection] to an outlet of a fluid reservoir (refer to an annotated copy of Lucke FIG. 1, attached below, as shown and indicated, “venous reservoir” and “outlet”), which has an inlet (Id., as shown and indicated) connected to a fluid source Id., and which stretches and contracts (see claim 2, “flexible reservoir”; and FIG. 3) in response to changes in a volume of the fluid within the reservoir (as described, during normal operation);
sensing a pressure 8 (col. 2, ll. 43-50, using pressure sensor 8) [a pressure sensor 8 configured to coupled] of the outlet of the fluid reservoir (Annotated Lucke FIG.1, as shown, col. 2, ll. 43-50); and
using a controller 4 (col. 2, ll. 58-65, inter alia) coupled to the sensor 8 [and configured, when the sensed pressure reaches a defined threshold (col. 3, ll. 16-22, “set of coefficients”),] activating the pump 12 (col. 3, ln. 62, “automatic regulation”) to displace a known volume of the fluid (col. 2, ll. 58-63) from the fluid reservoir (FIG. 1, “venous reservoir’).
Lucke is silent as to activating the pump when the sensed pressure reaches a defined threshold. In this regard, Sahlin teaches a roller pump system 10 having a controller 28 (FIG. 1, col. 3, ll. 5-10) that activates pump 12 when the sensed pressure (Pi, pressure at 30) reaches a defined threshold (col. 7, ll. 31-40) to displace a known volume of fluid (col. 3, ll. 15-30). Sahlin further teaches that using defined threshold(s) advantageously increases the accuracy of controlling pump speed over a wide range of pressures (col. 1, ll. 29-45, inter alia). With this in mind, it would have been obvious to one of ordinary skill in the art at the time the invention was made to adapt Lucke’s controller to use defined pressure threshold(s) to active the pump in order to increase the accuracy of controlling pump speed over a wide range of pressures as suggested by Sahlin, Id.
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Annotated Lucke FIG. 1
As to claims 1 and 4-9, these claims recite method steps inherent during the normal operation of Lucke.2
As to claims 2 and 11, once modified, Sahlin further teaches the controller 28 is configured to activate the pump 12 when the pressure (Spi) reaches an upper threshold (col. 7, ll. 34-41, “upper pressure threshold”) and to continue to activate (Id., “remains unchanged”) the pump until the sensed pressure (Pi) falls below a lower threshold (col. 7, ll. 34-41, “lower pressure threshold”).
As to claims 3 and 12, Lucke discloses most of the limitations of the claim, including an outlet of a reservoir (FIG. 1, “venous reservoir’) connected to pump 12. However, Lucke is silent as to the controller being configured to count a number of cycles of the pump over a period of time, wherein the cycles displace respective cycle volumes, and to calculate a rate of flow of the fluid based on the counted number and the cycle volumes. In this regard, Sahlin teaches a roller pump system 10 having a controller 28 configured to count a number of cycles (col. 3, ll. 10-30, revolutions) of the pump over a period of time (FIG.’s 4-6, col. 6, ll. 13-23, minutes, see RPM at 30 RPM at 60 RPM and at 100 RPM), wherein the cycles displace respective cycle volumes (col. 3, lines 15-30), and to calculating a rate of flow (col. 3, ln. 3., “desired flow rate”) of the fluid based on the counted number and the cycle volumes (Id. at ll. 25-30, “fluid volume that is displaced by one revolution”; flow rate is a function of the RPM, interpreted as calculating the flow rate based up number and cycle volumes). Sahlin et al. teaches counting the number of cycles advantageously increased the accuracy of controlling the pump speed over a wide range of pressures (col. 1, ll. 29-45). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to count the number of cycles to calculate flow rate so as to increase the accuracy of controlling pump speed over a wide range of pressures, Id.
Re. claims 4 and 13, Lucke discloses the pump 12 comprises a positive-displacement pump (col. 6, ll. 45-46, “peristaltic roller pump” well known in the art as a positive-displacement type pump).
Re. claims 8 and 17, Lucke discloses biasing the pressure of the fluid within the reservoir [wherein the controller 4 is configured to control the pump 12 so as to bias (see Claim 2, and FIG. 3, the controller is causing the flexible reservoir stretch and contract, see Applicant's disclosure pp. 66-67, F4 and F5, interpreted as controlling the pump so as to bias in the manner claimed) the pressure of the fluid (col. 2, ll. 45-63) within the reservoir (FIG. 1, “venous reservoir’)]3.
Re. claims 9 and 18, Lucke discloses regulating an outlet pressure of the pump 12 [wherein the controller 4 is configured to regulate (col. 2, ln. 62, “automatic regulation”) an outlet pressure (col. 2, ll. 57-63, the controller regulates the flow out of the reservoir, pressure is a physical property of flow) of the pump 12].4
Claims 5 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lucke et al. (U. S. Patent No. 7,611,478) in view of Sahlin (U. S. Patent No. 5,947,692) as applied to claims 1 and 10 above, further in view of Voyeux et al. (U. S. Patent Application Publication No. 2007/0212240)
As to claims 5 and 14, the applied art is discussed above but is silent as to the pump comprises a pneumatic actuator. However, Voyeux teaches that it is well known in the art to use a pneumatic actuator (para. 0021) as a pumping mechanism. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to replace the pump of Lucke with the pneumatic actuator of Voyeux __a pumping mechanism known to provide predictable pumping performance with expected results. The use of the pneumatic actuator of Voyeux in the combination of the applied art to Lucke and Sahlin is considered a simple substitution of one known pumping mechanism for that of another. Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). MPEP 2143(I)B.5
Claims 6, 7, 15 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lucke et al. (U. S. Patent No. 7,611,478) in view of Sahlin (U. S. Patent No. 5,947,692) as applied to claims 1 and 10 above, further in view of Van Bork (U. S. Patent No. 5,056,036). As to claims 6 and 15, the applied art is discussed above but is silent as to the pump comprises a movable diaphragm. Van Bork teaches that it is common to use a movable diaphragm 14 (FIG. 5, col. 3, ll. 60-65) as a pumping mechanism. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to replace the pump of Lucke with the movable diaphragm pump of Van Bork __a pumping mechanism known to provide predictable pumping performance with expected results. The use of the movable diaphragm pump of Van Bork in the combination of the applied art to Lucke and Sahlin is considered a simple substitution of one known pumping mechanism for that of another. Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). MPEP 2143(I)B.6
As to claims 7 and 16, the applied art is discussed above but is silent as to the pump comprises a piston. Van Bork teaches that it is common to use a piston 11 (FIG. 1A, col. 2, ll. 45-50) as a pumping mechanism. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to replace the pump of Lucke with the piston pump of Van Bork __a pumping mechanism known to provide predictable pumping performance with expected results. The use of the piston pump of Van Bork in the combination of the applied art to Lucke and Sahlin is considered a simple substitution of one known pumping mechanism for that of another. Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). MPEP 2143(I)B.7
Response to Arguments
Applicant's remarks with respect to the 35 U.S.C. 103 rejections over Lucke and Sahlin have been fully considered but they are not persuasive.
Applicant argues, on pp. 2-3 of the response that, inter alia, “Lucke is concerned with regulating a continuous flow.” “She does not teach or suggest the possibility of sensing pressure in a reservoir, nor does she teach or suggest activating the pump when some condition is met - let alone when a pressure reaches a defined threshold as required by claim 1.” And, “Lucke does not even hint that the pump not only might be activated when some condition is satisfied, but should be activated to displace a particular volume of fluid.” “For at least these reasons, Lucke would have taught away from activating a pump to displace a known volume of fluid when the sensed pressure in a reservoir reaches a threshold, as recited in claim 1.” The Examiner respectfully disagrees. Lucke controls a pump based upon pressure conditions by “automatic regulation of the pump 12, thereby dynamically adjusting the flow of blood through the cardiopulmonary bypass circuit” (col. 2, ll. 60-65). Operating a pump under these conditions is not inconsistent with using a pressure threshold to activate the pump to displace a known volume of fluid in accordance with the teachings of Sahlin because there is no periodic or aperiodic time scale implied here.8 That is, the claims argued here are broad__failing to distinguish between continuous or periodic/pulsed in contrast to Applicant’s arguments. A pressure threshold can be used to activate or otherwise operate the pump in either case. For these reasons, Lucke is not found to teach away from using a pressure threshold in the claimed manner. This argument is not persuasive.
Applicant further argues that “Sahlin does not teach or suggest sensing a pressure of the fluid in a fluid reservoir using a sensor coupled to the outlet of the fluid reservoir.” “Rather, Sahlin uses a pressure sensor at the inlet of the pump (abstract), which does not necessarily reflect the pressure in the fluid reservoir.” The Examiner understands this point but Sahlin is not being relied upon to teach the location of the pressure sensor, that is disclosed by Lucke. Sahlin is relied upon to teach using a pressure threshold in the manner claimed. Doing so is commonplace for a variety of reasons whether it being displacing a known volume over a finite period of time or producing a desired flow rate. In this instance, the claims do not distinguish between these two results. This argument is unpersuasive.
Applicant continues, arguing that “Sahlin does not teach or suggest applying a threshold to this pressure for the purpose of activating the pump to displace a known volume of fluid from the reservoir.” “Rather, Sahlin applies the thresholds described in col. 7 to set a scale factor Spi for controlling the pump speed (col. 3, lines 37-39). The pump is not activated to displace a known volume of fluid, but rather operates continuously.” The Examiner disagrees. Assuming arguendo that Applicant’s point is correct, a pump operating continuously at a known flow rate still displaces a known volume of fluid over a period of time. Importantly, the subject claims do not require a finite time scale.9 Whether Sahlin does this continuously or periodically is irrelevant. The claims fail to require that activation be stopped and started to produce a pulsed flow. Operating a pump at a specific flow rate displaces a volume of fluid over a period of time thereby meeting the claims currently presented. This argument must also fail.
Applicant has not presented any substantive arguments with regard to the rejections of the dependent claims over the art of record including the combinations of proposed modification, rationale, or motivations to make those combinations. Applicant simply asserts that they are allowable for the same reasons made for the independent claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH J HANSEN whose telephone number is (571)272-6780. The examiner can normally be reached Monday Friday 7:00 AM to 4:00 PM (MT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Laurenzi can be reached at (571) 270-7878. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNETH J HANSEN/ Primary Examiner, Art Unit 3746
1 Claims 1 and 10 are method and apparatus claims commensurate in scope. The statement of the rejections lists both method and apparatus claim limitations. Brackets [] indicate terminology in the apparatus claim that differs from the method claim.
2 Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02(I).
3 The statement of the rejections lists both method and apparatus limitations. Brackets [] indicate terminology in the apparatus claim that differs from the method claim. The claims are commensurate in scope.
4 Ibid.
5 Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at 1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
6 Ibid.
7 Ibid.
8 At least with regard to independent claims 1 and 10.
Prosecution Insights