FINAL 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 Arguments
Applicant's arguments filed 4 December 2025 have been fully considered but they are not persuasive.
Meisberger performs multiple parameter adjustments during one separation procedure (“the control unit 24 can be provided to control simultaneously several process parameters determining the flow rate of the washing solution 18, the flow rate of the initial liquid medium 4, the flow rate of the product liquid medium 4’ and the rotational speed of the separator 6”, para. [0032], “the second sensor 22’ monitors the hematocrit value of the product liquid medium 4’ and thus the effect of the control that is based on the measurements of the first sensor 22. The second sensor 22’ may provide an instantaneous feedback to the control unit 24 in order to further modify the process parameters of the device if necessary”, para. [0039], Table 1), so the claim amendment “during the separation procedure” does not distinguish over Meisberger.
In response to Applicant’s argument that “Meisberger focuses on adjustments made to fluid flow rates in order to add the proper volume of an additive fluid to a separated fluid component” (page 8, Remarks), the examiner points out that Meisberger expressly teaches control unit adjustment of the first and second rotation rates as claimed, i.e., based at least in part on a concentration of a fluid component within the fluid (hematocrit value of the incoming blood, Table 1), the rate at which the pump system is conveying said fluid into the centrifuge chamber (flow rate of the incoming blood and flow rate of the washing solution, Table 1), and a target concentration of the fluid component in one of said first and second constituents (hematocrit of the erythrocyte fraction, para. [0028]).
The added claim limitation “to achieve a substantially uniform separation efficiency” is function or result-oriented language that is not tied to any structure or control algorithm, so said limitation is deemed met if a control system attempts to maintain process performance, which Meisberger does through using the controller to modify process parameters (para. [0032], [0039], Table 1). In Meisberger, the control unit is “configured to control at least one process parameter of the device 2 such that the product concentration of the cells in the product liquid medium 4’ is within a predefined concentration range that can depend on national standards and customer requirements. The hematocrit of the erythrocyte fraction 4’ is preferably between 55 and 70% and more preferably between 60 and 65%” (para. [0028]). Since Meisberger’s control system controls process parameters to maintain the product within a predetermined concentration range, Meisberger inherently operates to maintain consistent separation performance which corresponds to controlling the system so as to achieve a substantially uniform separation efficiency.
The rejection over Meisberger is therefore still deemed valid and is maintained.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings were received on 7 December 2022. These drawings are acceptable.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware of in the specification.
The abstract of the disclosure is acceptable.
The title of the invention is acceptable.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4- 8, 10-12, 14-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meisberger et al. (U.S. Patent Application Pub. No. 2016/00339451, hereinafter Meisberger).
Regarding claim 1, Meisberger discloses a fluid processing device (device 2), comprising: a controller (control unit 24) programmed to execute a separation procedure; a centrifuge (separator 6) configured to receive and rotate a continuous-flow centrifuge chamber (separation chamber 16) of a fluid flow circuit (connected to supply systems 8, 10 and outlet systems 12, 14) so as to separate a fluid in the centrifuge chamber into at least first and second constituents (e.g., red blood cells and plasma, para. [0017]); and a pump system (adjustable pump 8c, 10c, 12c) configured to convey said fluid through the fluid flow circuit and into the centrifuge chamber at first and second rates, wherein the controller is configured to control the centrifuge to rotate the centrifuge chamber at a first rotation rate when the pump system is conveying said fluid into the centrifuge chamber at the first rate, the controller is configured to control the centrifuge to rotate the centrifuge chamber at a second rotation rate when the pump system is conveying said fluid into the centrifuge chamber at the second rate, and said first and second rotation rates are different (e.g., Table 1 Row 1 shows a first rotation rate and a first incoming blood flow rate, and Row 2 shows a different second rotation rate and a different second incoming blood flow rate), with each of the first and second rotation rates being based at least in part on a concentration of a fluid component within the fluid (“hematocrit value of the incoming blood”, Table 1), the rate at which the pump system is conveying said fluid into the centrifuge chamber (“flow rate of the incoming blood” and “flow rate of the washing solution”, Table 1), and a target concentration of the fluid component in one of said first and second constituents (“The second sensor 22’ monitors the hematocrit value of the product liquid medium 4’ and thus the effect of the control that is based on the measurement of the first sensor 22. The second sensor 22’ may provide an instantaneous feedback to the control unit 24 in order to further modify the process parameters of the device 2 if necessary”, para. [0039]) and being controlled so as to achieve a substantially uniform separation efficiency (“[t]he control unit 24 is provided and configured to control at least one process parameter of the device 2 such that the product concentration of the cells in the product liquid medium 4’ is within a predefined concentration range that can depend on national standards and customer requirements. The hematocrit of the erythrocyte fraction 4’ is preferably between 55 and 70% and more preferably between 60 and 65%”, para. [0028]). Since Meisberger’s control system controls process parameters to maintain the product within a predetermined concentration range, Meisberger inherently operates to maintain consistent separation performance which corresponds to controlling the system so as to achieve a substantially uniform separation efficiency.
Regarding claim 11, Meisberger discloses a method of separating a fluid, comprising: conveying a fluid into a continuous-flow centrifuge chamber (separation chamber 16) of a fluid flow circuit (connected to supply systems 8, 10 and outlet systems 12, 14) at first and second rates during a separation procedure; and rotating the centrifuge chamber with a centrifuge so as to separate the fluid in the centrifuge chamber into at least first and second constituents (e.g., red blood cells and plasma, para. [0017]), with the centrifuge rotating the centrifuge chamber at a first rotation rate when the fluid is being conveyed into the centrifuge chamber at the first rate and at a second rotation rate when the fluid is being conveyed into the centrifuge chamber at the second rate, wherein said first and second rotation rates are different (e.g., Table 1 Row 1 shows a first rotation rate and a first incoming blood flow rate, and Row 2 shows a different second rotation rate and a different second incoming blood flow rate), with each of the first and second rotation rates being based at least in part on a concentration of a fluid component within the fluid (“hematocrit value of the incoming blood”, Table 1), the rate at which the fluid is being into the centrifuge chamber (“flow rate of the incoming blood”, Table 1), and a target concentration of the fluid component in one of said first and second constituents (“The second sensor 22’ monitors the hematocrit value of the product liquid medium 4’ and thus the effect of the control that is based on the measurement of the first sensor 22. The second sensor 22’ may provide an instantaneous feedback to the control unit 24 in order to further modify the process parameters of the device 2 if necessary”, para. [0039]) and being controlled so as to achieve a substantially uniform separation efficiency (“[t]he control unit 24 is provided and configured to control at least one process parameter of the device 2 such that the product concentration of the cells in the product liquid medium 4’ is within a predefined concentration range that can depend on national standards and customer requirements. The hematocrit of the erythrocyte fraction 4’ is preferably between 55 and 70% and more preferably between 60 and 65%”, para. [0028]). Since Meisberger’s control system controls process parameters to maintain the product within a predetermined concentration range, Meisberger inherently operates to maintain consistent separation performance which corresponds to controlling the system so as to achieve a substantially uniform separation efficiency.
Regarding claims 2 and 12, Meisberger discloses said fluid comprises whole blood (said initial liquid medium 4 can be blood comprising blood cells and plasma, para. [0017]), one of said first and second constituents comprises packed red blood cells (the product liquid medium 4’ shall be the erythrocyte fraction separated from the blood, para. [0017]), said fluid component comprises red blood cells (“hematocrit value of the incoming blood”, Table 1), and said target concentration of the fluid component in said one of said first and second constituents comprises a target hematocrit of the packed red blood cells (the second sensor 22’ monitors the hematocrit value of the product liquid medium 4’, para. [0039]).
Regarding claims 4 and 14, Meisberger discloses wherein the controller is configured to control the pump system to draw said fluid into the fluid flow circuit via a first fluid access device (connection of supply line 8b from reservoir 8a) and to convey at least a portion of a separated fluid constituent out of the fluid flow circuit via a second fluid access device (connection of output line 12b to reservoir 12a, para. [0022]).
Regarding claims 5-7 and 15-17, Meisberger discloses wherein said concentration of the fluid component within the fluid is substantially constant; wherein said target concentration of the fluid component in said one of said first and second constituents is substantially constant; wherein said concentration of the fluid component within the fluid and said target concentration of the fluid component in said one of said first and second constituents are substantially constant (in a first separation phase, the concentration of the fluid component within the fluid is enriched to a hematocrit of approximately 80%, which is substantially constant concentration of the fluid component for the subsequent phase, para. [0047]; in the second separation phase, the erythrocytes are packed to a hematocrit of 60 to 65% and thus substantially constant, para. [0049]).
Moreover, regarding claims 5-7, the limitations wherein said concentration of the fluid component within the fluid is substantially constant, wherein said target concentration of the fluid component in said one of said first and second constituents is substantially constant and wherein said concentration of the fluid component within the fluid and said target concentration of the fluid component in said one of said first and second constituents are substantially constant do not impose any structural limitations on the claimed apparatus. Said limitations describe the properties of the fluid being processed and the desired target concentrations predetermined by the user. Such limitations relates to the material worked on, rather than a structural feature of the claimed apparatus. Recitations with respect to the materials intended to be worked upon by a claimed apparatus (said materials in this instance) do not impose any structural limitations upon the claimed apparatus which differentiates it from a prior art apparatus satisfying the structural limitations of that claimed. It has been held that "[i]nclusion of the materials or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPW 458, 459 (CCPA 1963). See MPEP 2115. It has been held that “expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). “Inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Young, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 136 USPQ 458, 459 (CCPA 1963)).
Regarding claims 8 and 18, Meisberger discloses wherein the controller is configured to control the pump system to convey said fluid though the fluid flow circuit and into the centrifuge chamber at said first and second rates during a single stage of a multi-stage separation procedure (“the control unit 24 is configured to reduce the flow rate of the washing solution 18, the flow rate of the incoming blood and the rotational speed of the separator 6 and to increase the flow rate of the erythrocyte fraction as the hematocrit value increases”, para. [0032]).
Regarding claims 10 and 20, Meisberger discloses wherein the first rate (flow rate of the incoming blood in Row 1 of Table 1) is greater than the second rate (flow rate of the incoming blood in Row 2 of Table 1) and the first rotation rate (rotational speed of the separator in Row 1 of Table 1) is greater than the second rotation rate (rotational speed of the separator in Row 2 of Table 1).
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.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Meisberger in view of Bainbridge et al. (U.S. Patent Application Pub. No. 2004/0230152, hereinafter Bainbridge).
Regarding claims 3 and 13, Meisberger does not disclose wherein the controller is configured to control the pump system to draw said fluid into the fluid flow circuit and to convey at least a portion of a separated fluid constituent out of the fluid flow circuit via a single fluid access device.
Bainbridge discloses analogous art related to a blood component separation device, wherein the controller (processors, para. [0087]) is configured to control the pump system (pump/valve/sensor assembly 1000) to draw said fluid into the fluid flow circuit and to convey at least a portion of a separated fluid constituent out of the fluid flow circuit via a single fluid access device (blood removal/return tubing assembly 20, Fig. 2A). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the fluid processing device of Meisberger with the single fluid access device as taught by Bainbridge for the purpose of providing a continuous blood component separation process where whole blood is withdrawn from a donor/patient and blood components removed or treated to be returned to the donor/patient (para. [0084], Bainbridge).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Meisberger in view of Hatamian et al. (U.S. Patent Application Pub. No. 2008/0200859, hereinafter Hatamian).
Regarding claim 9, Meisberger does not disclose an interface monitoring assembly configured to transmit a first signal to the controller indicative of a first radial position of an interface between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at the first rate during said single stage of said multi-stage separation procedure and to transmit a second signal to the controller indicative of a second radial position of the interface between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at the second rate during said single stage of said multi-stage separation procedure, wherein the controller is configured to determine the first radial position of said interface based at least in part on the first signal and on the first rotation rate and to determine the second radial position of said interface based at least in part on the second signal and on the second rotation rate.
Hatamian discloses an interface monitoring assembly (camera 48, para. [0043]) configured to transmit a first signal to the controller indicative of a first radial position of an interface (separation boundary 50, para. [0043]) between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at the first rate during said single stage of said multi-stage separation procedure and to transmit a second signal to the controller indicative of a second radial position of the interface between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at the second rate during said single stage of said multi-stage separation procedure (“camera and/or microcontroller may also be in communication with the peristaltic block 34 and thereby adjust the flow rate of individual components as may be necessary”, para. [0043]), wherein the controller is configured to determine the first radial position of said interface based at least in part on the first signal and on the first rotation rate and to determine the second radial position of said interface based at least in part on the second signal and on the second rotation rate (microcontroller uses the camera signal and the centrifuge rotor angular velocity to adjust separation of the blood components, and at the changed angular velocity, the controller redetermines the interface location, para. [0043]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the fluid processing device of Meisberger with the interface monitoring assembly as taught by Hatamian for the purpose of effectuating the desired separation of components (para. [0043], Hatamian).
Regarding claim 19, Meisberger does not disclose determining a first radial position of an interface between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at said first rate during said single stage of said multi-stage separation procedure, and determining a second radial position of said interface between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at said second rate during said single stage of said multi-stage separation procedure, wherein the first radial position is based at least in part on the first rotation rate and on a first signal transmitted by an interface monitoring assembly while said fluid is being conveyed into the centrifuge chamber at said first rate, and the second radial position is based at least in part on the second rotation rate and on a second signal transmitted by an interface monitoring assembly while said fluid is being conveyed into the centrifuge chamber at said second rate.
Hatamian discloses determining a first radial position of an interface (separation boundary 50, para. [0043]) between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at said first rate during said single stage of said multi-stage separation procedure, and determining a second radial position of said interface between separated fluid constituents within the centrifuge chamber while said fluid is being conveyed into the centrifuge chamber at said second rate during said single stage of said multi-stage separation procedure (“camera and/or microcontroller may also be in communication with the peristaltic block 34 and thereby adjust the flow rate of individual components as may be necessary”, para. [0043]), wherein the first radial position is based at least in part on the first rotation rate and on a first signal transmitted by an interface monitoring assembly while said fluid is being conveyed into the centrifuge chamber at said first rate, and the second radial position is based at least in part on the second rotation rate and on a second signal transmitted by an interface monitoring assembly while said fluid is being conveyed into the centrifuge chamber at said second rate (microcontroller uses the camera signal and the centrifuge rotor angular velocity to adjust separation of the blood components, and at the changed angular velocity, the controller redetermines the interface location, para. [0043]). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Meisberger with the interface monitoring assembly as taught by Hatamian for the purpose of effectuating the desired separation of components (para. [0043], Hatamian).
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 SHUYI S LIU whose telephone number is (571)272-0496. The examiner can normally be reached MON - FRI 9:30AM - 2:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shuyi S. Liu/ Examiner, Art Unit 1774
/CLAIRE X WANG/ Supervisory Patent Examiner, Art Unit 1774
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