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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 21-26 and 30-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westberg et al (US 2006/0178611) in view of Vanderveen (US 2005/0107923).
Regarding Claim 21, Westberg discloses a bodily fluid separation device (10, Figs. 1 and 10) for use in combination with a fluid circuit (flow set 12/processing circuit 46, Figs. 1 and 10) comprising a plurality of containers (304, 308, 312, 288, 276, 280, Figs. 1 and 10) including a fluid container (288, Figs. 1 and 10) and a fluid conduit (tube 284, Figs. 1 and 10) connected to the fluid container (288, Figs. 1 and 10), the bodily fluid separation device (10, Figs. 1 and 10) comprising:
a pump (PP1, Fig. 9; ¶ [0041-0042]) configured to be actuated to draw a fluid from the fluid container (288, Figs. 1 and 10) via the fluid conduit (284, Figs. 1 and 10; ¶ [0041-0042]); and
a controller (16, Figs. 1 and 10) configured to initiate a priming phase of a bodily fluid separation procedure in which the pump (PP1, Fig. 9) is actuated to draw the fluid from the fluid container (288, Figs. 1 and 10) via the fluid conduit (284, Figs. 1 and 10; ¶ [0162, 0174, 0221-0223]).
Westberg is silent regarding a sensor configured to monitor a portion of the fluid conduit positioned between the fluid container and the pump, and wherein the controller is configured to receive at least one measurement from the sensor during the priming phase to determine whether the fluid container is properly connected to the fluid conduit to be in fluid communication with the sensor.
Vanderveen teaches a system for verifying the connections to a medical pump, thus being in the same field of endeavor, with a sensor (80, Fig. 3) configured to monitor a portion of the fluid conduit (30, Figs. 1 and 3) positioned between the fluid container (38, Fig. 1) and the pump (22, Fig. 3; ¶ [0041-0042]), and a controller (84, Fig. 4) configured to receive at least one measurement from the sensor (80, Fig. 3) during the priming phase to determine whether the fluid container (38, Fig. 1) is properly connected to the fluid conduit (30, Figs. 1 and 3) to be in fluid communication with the sensor (¶ [0046]; the pressure signal from the sensor 80 can be monitored to determine if a fluid conduit is attached to the pump). This allows the device to determine if a fluid conduit is actually connected to a specific pump (¶ [0046]).
Therefore, 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 Westberg to include a sensor configured to monitor a portion of the fluid conduit positioned between the fluid container and the pump, and wherein the controller is configured to receive at least one measurement form the sensor during the priming phase to determine whether the fluid container is properly connected to the fluid conduit to be in fluid communication with the sensor, as taught by Vanderveen, to allow the system to ensure that a fluid conduit is actually connected to the pump to prevent errors (as motivated by Vanderveen ¶ [0046]).
Regarding Claims 22 and 23, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 21.
The combination of Westberg/Vanderveen further teaches the controller is further configured to determine whether the fluid container is a priming fluid container/saline container based at least in part on said at least one measurement (Vanderveen ¶ [0004-0008, 0042-0048, 0050, 0059]; determining what fluid container is attached to the pump).
Regarding Claim 24, Westberg further discloses a hanger (248, Fig. 2) configured to support the fluid container (288, Figs. 1, 2, and 10).
Regarding Claim 25, Westberg further discloses a weight scale (246, Figs. 1, 2, and 10) associated with the hanger (248, Fig. 2).
Regarding Claim 26, Westberg further discloses the controller (16, Figs. 1 and 10) is configured to receive measurements from the weight scale (246, Figs. 1, 2, and 10) during the priming phase to determine whether the fluid is exiting the fluid container (288, Figs. 1, 2, and 10) via the fluid conduit (284, Figs. 1, 2, and 10; ¶ [0157, 0174, 0201, 0221-0223]).
Regarding Claim 30, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 21.
Westberg/Vanderveen further discloses a clamp (Westberg 282, Figs. 1 and 10) configured to engage the fluid conduit (Westberg 284, Figs. 1 and 10) at a position between the fluid container (Westberg 288, Figs. 1 and 10) and the sensor (the sensor of Vanderveen, when incorporated into the device of Westberg, will be positioned within cassette 28 of Westberg).
Regarding Claims 31-32, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 21.
The combination of Westerberg/Vanderveen further teaches the controller is configured to execute a response action upon determining that the fluid container is not properly connected to the fluid conduit to be in fluid communication with the sensor, wherein the response action comprises at least one of terminating the bodily fluid separation procedure, pausing the bodily fluid separation procedure, alerting an operator of an error, and prompting the operator to enter credentials for manual override (Vanderveen ¶ [0050, 0059]).
Regarding Claim 33, Westberg further discloses a centrifuge (20, Figs. 1 and 10) configured to separate a bodily fluid into two or more components during said bodily fluid separation procedure (¶ [0065]).
Regarding Claims 34-36, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 21.
The combination of Westberg/Vanderveen discloses the at least one measurement comprises a first measurement from the sensor measured at a first time when the fluid container is not in fluid communication with the portion of the fluid conduit monitored by the sensor, and a second measurement from the sensor measured at a second time when the fluid container is in fluid communication with the portion of the fluid conduit monitored by the sensor, wherein the second time is when fluid communication between the fluid container and said portion of the fluid conduit is first established, and wherein the controller is configured to compare a difference between the second measurement and the first measurement to determine whether the fluid container is properly connected to the fluid conduit to be in fluid communication with the sensor (Vanderveen ¶ [0046]; the controller senses when the pressure signals from the pressure sensors have changed after a connection has been established).
Regarding Claim 37, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 36.
The combination of Westberg/Vanderveen discloses the controller is configured to compare the difference to an authorized range of values to determine whether the fluid container is properly connected to the fluid conduit to be in fluid communication with the sensor (Vanderveen ¶ [0046]; there would be some sort of range programmed into the controller to allow the device to recognize that the change in the pressure sensor signal is indicative of a container being connected, even if the range is “every value other than the previous value”).
Regarding Claim 38, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 37.
The combination of Westberg/Vanderveen discloses the controller is configured to execute a response action when the difference is not within the authorized range of values (Vanderveen ¶ [0046]; the response action is not beginning the connection verification mode).
Regarding Claim 39, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 37.
The combination of Westberg/Vanderveen discloses the controller is configured to select the authorized range of values based on inputted information of at least one of the fluid container’s product code, serial number, product name, manufacturer name, and manufacturer code (Vanderveen ¶ [0037]).
Regarding Claim 40, the combination of Westberg/Vanderveen discloses the claimed invention substantially as claimed as set forth above for Claim 21.
The combination of Westberg/Vanderveen discloses the sensor comprises a pressure sensor (Vanderveen ¶ [0046]).
Claim(s) 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westberg et al (US 2006/0178611) in view of Vanderveen (US 2005/0107923) further in view of Griessmann et al (US 2020/0215249).
Regarding Claims 27-29, Westberg/Vanderveen is silent whether the controller is configured to receive a measurement from the weight scale to determine whether the fluid container is a priming fluid container, wherein the controller is configured to compare the measurement from the weight scale to an authorized range of weight values to determine whether the fluid container is a priming fluid container, and wherein the controller is configured to execute a response action when the measurement from the weight scale is not within the authorized range of weight values.
Griessmann teaches a dialysis device, thus being in the same field of endeavor, with a controller that is configured to receive a measurement from a weight scale to determine whether the fluid container is a priming fluid container, wherein the controller is configured to compare the measurement from the weight scale to an authorized range of weight values to determine whether the fluid container is a priming fluid container (¶ [0007, 0034, 0040]), and wherein the controller is configured to execute a response action when the measurement from the weight scale is not within the authorized range of weight values (¶ [0040]). This ensures that the correct container is attached to ensure the correct fluid is delivered to the patient (¶ [0006-0007]).
Therefore, it would have been obvious to modify the controller of Westberg/Vanderveen to include the controller configured to receive a measurement from the weight scale to determine whether the fluid container is a priming fluid container, wherein the controller is configured to compare the measurement from the weight scale to an authorized range of weight values to determine whether the fluid container is a priming fluid container, and wherein the controller is configured to execute a response action when the measurement from the weight scale is not within the authorized range of weight values, as taught by Griessmann, to ensure that the correct container is attached to the system so that the correct fluid is delivered to the patient (as motivated by Griessmann ¶ [0007, 0034, 0040]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gelfand et al (US 2006/0270971)
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781