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 § 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 1-5, 8-9, 11-15, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dolecek (US 20020147101 A1) and as evidence by (“Viscosity of Blood”, published on December 27th, 2022 on https://cvphysiology.com/hemodynamics/h011).
Regarding Claim 1, Dolecek teaches a blood processing device (a belt-driven blood centrifuge 10, see Abstract; Figure 1 and 58), comprising:
a pump system (inlet pump 810);
a valve system (valve 806);
a centrifuge (centrifuge 820); and
a controller (centrifugal processing system 10 includes a controller 850) configured and/or programmed to control the operation of the pump system, the valve system, and the centrifuge to execute a blood separation procedure (numerous control devices may be utilized within the centrifugal processing system 10 to effectively monitor and control automated operations, see Paragraph [0238]) comprising:
pumping blood into the centrifuge at an inflow rate (the processing system 800 includes a blood source 802 connected with a fluid line 804 to an inlet pump 810, see Paragraph [0231]; controlling operation of the inlet pump 810 for an inflow rate),
separating the blood in the centrifuge into red blood cells and plasma (centrifugal processing system 10 allows for continuous, dynamic separation and collection of platelet rich plasma, white blood cells, red blood cells and platelet poor plasma, see Paragraph [0227]), with an interface between the red blood cells and plasma located at an interface position within the centrifuge (the first region 256 is the outermost of the four regions and contains red blood cells; the third region 260 contains the platelet rich plasma fraction, and the innermost region 262 contains the least dense platelet poor plasma fraction, see Figure 32; Paragraphs [0175]-[0176]), and
pumping at least a portion of the red blood cells and at least a portion of the plasma out of the centrifuge (when suction is applied to the inlet lumen 230 by inlet pump 810, red blood cells are pumped out of the centrifuge bag 226 and into the red blood cell collector 812; once substantial alignment of the desired component region and the outlet tube 250 is achieved, the outlet pump 830 is operated to remove all or a select quantity of the components in the aligned component region, see Paragraph [0237]), wherein the controller is configured and/or programmed to determine the inflow rate and/or the interface position based at least in part on a temperature of the blood (monitoring and controlling the temperature of fluids in the centrifuge bag 226 to facilitate separation processes, and controlling the operating temperature of temperature sensitive components of the processing system 900, see Paragraph [0258]; controller can determine if a sensed temperature is within a set operating range and/or audio alarms to indicate when the sensed temperature is outside the set operating range, see Paragraph [0262]).
Regarding Claim 2, Dolecek further teaches wherein the inflow rate is greater for warmer blood than colder blood (as evidence by cvphysiology.com, another important factor that influences blood viscosity is temperature; when blood gets cold, it becomes "thicker" and flows more slowly).
Regarding Claim 3, Dolecek further teaches wherein the interface position is higher for warmer blood than colder blood (based on the speeds and times the location of the WBC and platelets can be varied with respect to the red blood cells and plasma interface; as the rpm's are increased (1,400-1,700) the platelets will separate out of the plasma and reside at the plasma to RBC interface in greater concentrations. With increased speeds WBC reside deeper into the RBC pack, see Paragraph [0173]; it is understood that the higher speed of centrifuge the warmer the blood will be).
Regarding Claim 4, Dolecek further teaches wherein the plasma comprises platelet-poor plasma (harvesting platelet poor plasma, see Paragraph [0224]).
Regarding Claim 5, Dolecek further teaches wherein the blood is pumped into the centrifuge from a whole blood container (blood source 802, see Figure 58).
Regarding Claim 8, Dolecek further teaches a temperature sensor (908) configured to measure the temperature of the blood (see Paragraph [0260]).
Regarding Claim 9, Dolecek further teaches wherein the controller is configured to employ an equation to determine the inflow rate and/or the interface position (the temperature controller 904 includes a microprocessor for calculating sensed temperatures, memory for storing temperature and control algorithms and programs, and I/O portions for receiving feedback signals from thermo sensors and for generating and transmitting control signals to various temperature control device, see Paragraph [0259]).
Regarding Claim 11, Dolecek teaches a blood separation method (method of using a belt-driven blood centrifuge 10, see Abstract; Figure 1 and 58), comprising:
pumping blood into a centrifuge at an inflow rate (the processing system 800 includes a blood source 802 connected with a fluid line 804 to an inlet pump 810, see Paragraph [0231]); controlling operation of the inlet pump 810 for an inflow rate);
separating the blood in the centrifuge into red blood cells and plasma (centrifugal processing system 10 allows for continuous, dynamic separation and collection of platelet rich plasma, white blood cells, red blood cells and platelet poor plasma, see Paragraph [0227]), with an interface between the red blood cells and plasma located at an interface position within the centrifuge (the first region 256 is the outermost of the four regions and contains red blood cells; the third region 260 contains the platelet rich plasma fraction, and the innermost region 262 contains the least dense platelet poor plasma fraction, see Figure 32; Paragraphs [0175]-[0176]); and
pumping at least a portion of the red blood cells and at least a portion of the plasma out of the centrifuge (when suction is applied to the inlet lumen 230 by inlet pump 810, red blood cells are pumped out of the centrifuge bag 226 and into the red blood cell collector 812; once substantial alignment of the desired component region and the outlet tube 250 is achieved, the outlet pump 830 is operated to remove all or a select quantity of the components in the aligned component region, see Paragraph [0237]), wherein the inflow rate and/or the interface position is based at least in part on a temperature of the blood (monitoring and controlling the temperature of fluids in the centrifuge bag 226 to facilitate separation processes, and controlling the operating temperature of temperature sensitive components of the processing system 900, see Paragraph [0258]; controller can determine if a sensed temperature is within a set operating range and/or audio alarms to indicate when the sensed temperature is outside the set operating range, see Paragraph [0262]).
Regarding Claim 12, Dolecek further teaches wherein the inflow rate is greater for warmer blood than colder blood (as evidence by cvphysiology.com, another important factor that influences blood viscosity is temperature; when blood gets cold, it becomes "thicker" and flows more slowly).
Regarding Claim 13, Dolecek further teaches wherein the interface position is higher for warmer blood than colder blood (based on the speeds and times the location of the WBC and platelets can be varied with respect to the red blood cells and plasma interface; as the rpm's are increased (1,400-1,700) the platelets will separate out of the plasma and reside at the plasma to RBC interface in greater concentrations. With increased speeds WBC reside deeper into the RBC pack, see Paragraph [0173]; it is understood that the higher speed of centrifuge the warmer the blood will be).
Regarding Claim 14, Dolecek further teaches wherein the plasma comprises platelet-poor plasma (harvesting platelet poor plasma, see Paragraph [0224]).
Regarding Claim 15, Dolecek further teaches wherein the blood is pumped into the centrifuge from a whole blood container (blood source 802, see Figure 58).
Regarding Claim 18, Dolecek further teaches measuring the temperature of the blood using an infrared temperature sensor (temperature sensor 908 may be any temperature sensitive device useful for sensing temperature and, in response, generating a feedback signal useful by the temperature controller 904, such as a thermistor, thermocouple, and the like, see Paragraph [0260]).
Regarding Claim 19, Dolecek further teaches wherein an equation is employed to determine the inflow rate and/or the interface position (the temperature controller 904 includes a microprocessor for calculating sensed temperatures, memory for storing temperature and control algorithms and programs, and I/O portions for receiving feedback signals from thermo sensors and for generating and transmitting control signals to various temperature control device, see Paragraph [0259]).
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.
Claims 6 and 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dolecek (US 20020147101 A1).
Regarding Claim 6 and 16, Dolecek teaches all of the limitations as discussed above in claim 1 and 11 and further teaches wherein the controller is configured and/or programmed to determine the inflow rate and/or the interface position for blood having a temperature in the range of approximately 25*C- approximately 50*C (monitoring and controlling the temperature of fluids in the centrifuge bag 226, see Paragraph [0258]; the temperature range being 25 degree C to 50 degree C).
However, Dolecek does not explicitly disclose the temperature of blood in the range of approximately 4*C- approximately 30*C.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the temperature of Dolecek from between 25*C and 50*C to between 4*C and 30 degrees since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see pp. [0073] indicating the temperature is “approximately” be within the claimed range).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Dolecek (US 20020147101 A1) in view of Robinson et al. (WO 9507110 A1), hereinafter referred to as “Robinson”.
Regarding Claim 7 and 17, Dolecek teaches all of the limitations as discussed above in claim 1 and 11. However, Dolecek does not explicitly disclose wherein the inflow rate and/or the interface position is determined so as to achieve a target hematocrit for the red blood cells being pumped out of the centrifuge.
Robinson teaches a blood processing system (see Abstract) wherein the controller (83) is configured and/or programmed to determine the inflow rate and/or the interface position so as to achieve a target hematocrit for the red blood cells being pumped out of the centrifuge (the basic control concept is to maintain the main pump 124 at an average flow rate, to maintain the waste pump 65 at an average flow rate and to vary the wash fluid pump 62 to achieve a flow rate which depends upon inlet blood hematocrit (which, as described herein, is a function of the difference in pressure across the first separator) and which results in an outlet hematocrit of 35%-65% (nominally 50%), see Col. 26 Paragraphs 3-4).
Dolecek and Robinson are analogous art because both teach a blood processing system.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the controller of Dolecek and further include wherein the controller is programmed to determine the inflow rate and/or the interface position so as to achieve a target hematocrit for the red blood cells being pumped out of the centrifuge, as taught by Robinson. Robinson teaches the device is beneficial to provide pumping at a controllable rate with minimal damage to the blood cells and platelets and is useful in a number of blood processing applications (see Col. 8 last paragraph).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dolecek (US 20020147101 A1) in view of Bainbridge et al. (US 20180106778 A1), hereinafter referred to as “Bainbridge”.
Regarding Claims 10 and 20, Dolecek teaches all of the limitations as discussed above in claim 1 and 11. However, Dolecek does not explicitly disclose wherein the controller is configured to consult a database to determine the inflow rate and/or the interface position.
Bainbridge teaches a blood processing device (separating/collecting components from a multi-component fluid such as whole blood, see Abstract) wherein the controller (controller 316) is configured to consult a database to determine the inflow rate and/or the interface position (flow chart 800 processes consistent with embodiments of the present invention for separating/collecting component(s) from a composite fluid separated from a multi-component fluid, see Figure 8; Paragraphs [0060]-[0064]; step 808 comprises receiving stored data from a user input).
Dolecek and Bainbridge are analogous art because both teach a blood processing device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the controller of Dolecek and further include wherein the controller is configured to consult a database to determine the inflow rate and/or the interface position, as taught by Bainbridge. Bainbridge teaches there is therefore a need to perform separation processes that are efficient and collect a component product that is as free of other components as possible (see Paragraph [0004]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (1/4/2026)Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781