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 15 January 2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 22, Applicant argues that Felt does not disclose the claimed “flow rate stoppage phase”, because “Felt’s ‘pause all pumps’ behavior is explicitly pressure dependent. Felt’s system pauses all pumps when the pressure reaches an alarm point”, whereas Applicant contends the present claims require a “time-governed end condition for the stoppage phase followed by resumption of the interrupted stage or advancement to a subsequent stage” (page 10, Remarks). This argument is not persuasive.
First, claim 1 does not recite any limitation as to what initiates the flow rate stoppage phase. Claim 1 merely requires “executing a flow rate stoppage phase to interrupt at least one of the priming, blood separation, and blood component collection stages”. Thus, the fact that Felt initiates the flow rate stoppage phase when pressure reaches an alarm point does not distinguish Felt from the claimed subject matter, because the claims do not recite a trigger for the flow stoppage phase.
Second, Applicant asserts that “Felt discloses a set time period (e.g., a 6-second delay) only as a window for pressure to resolve, not as a time after which the system must resume” (page 10, Remarks). The examiner notes that claim 1 requires that after a selected time, the flow rate stoppage phase ends, and the interrupted stage is resumed or a subsequent stage is advanced to. Felt teaches if pressure resolves within the specified delay time, then the alarm condition is disabled and pumping resumes (col. 14 lines 44-58), thereby disclosing one of the claimed alternatives, namely, “resuming the interrupted stage”. Even if the pressure does not return to within range, the system is not paused indefinitely, but proceeds to a full alarm phase where operator intervention is required.
The rejection over Felt and other cited references of record are therefore 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 16 January 2023. These drawings are 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 1-3, 18, 22-24, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Felt et al. (U.S. Patent No. 7,780,618, hereinafter Felt).
Regarding claim 1, Felt discloses a method for separating whole blood, comprising: executing a priming stage in which a pump system (pumps 1020, 1030, 1040, 1060, 1090, Fig. 3) and a valve system (valve assemblies 1100, 1110, and 1120, Fig. 3) of a blood processing device (blood component separation device 6, Fig. 1) are controlled to prime a processing chamber (blood processing vessel 352, Fig. 5) positioned within a centrifuge (centrifuge rotor assembly 568) of the blood processing device (col. 25 lines 58 – 67); executing a blood separation stage in which the pump system, the valve system, and the centrifuge are controlled to separate blood in the processing chamber into at least two blood components (col. 26 line 1 - 19); executing a blood component collection stage in which the pump system and the valve system are controlled to collect at least a portion of one of said at least two blood components (col. 26 line 26 – col. 30 line 3); and executing a flow rate stoppage phase to interrupt at least one of the priming, blood separation, and blood component collection stages (col. 14 lines 36 - 58), the flow rate stoppage phase including: (i) controlling the pumping system and the valve system to prevent fluid flow into and from the processing chamber (“separation device 6 will pause all pumps”, col. 14 lines 36-37); (ii) controlling the centrifuge at a selected rate and/or a selected relative centrifugal force (e.g., 3000 RPM, col. 26 lines 1 – 6); (iii) after a selected time, ending the flow rate stoppage phase (“for a period of for example 6 seconds”, col. 14 lines 44 – 45); and (iv) resuming the interrupted stage or advancing to a subsequent stage of the method after ending the flow rate stoppage phase (col. 14 lines 44 – 58).
Regarding claim 22, Felt discloses a blood processing system (blood apheresis system 2, Fig. 1), comprising: a pump system (pumps 1020, 1030, 1040, 1060, 1090, Fig. 3); a valve system (valve assemblies 1100, 1110, and 1120, Fig. 3); a centrifuge (centrifuge rotor assembly 568); and a controller (col. 8 lines 55-63), wherein the controller is configured to execute a blood separation procedure including executing a priming stage in which the pump system and the valve system are controlled to prime a processing chamber (blood processing vessel 352, Fig. 5) positioned within the centrifuge (col. 25 lines 58 – 67); executing a blood separation stage in which the pump system, the valve system, and the centrifuge are controlled to separate blood in the processing chamber into at least two blood components (col. 26 line 1 - 19); executing a blood component collection stage in which the pump system and the valve system are controlled to collect at least a portion of one of said at least two blood components (col. 14 lines 36 - 58); and executing a flow rate stoppage phase to interrupt at least one of the priming, blood separation, and blood component collection stages (col. 14 lines 36 - 58), the flow rate stoppage phase including: (i) controlling the pumping system and the valve system to prevent fluid flow into and from the processing chamber (“separation device 6 will pause all pumps”, col. 14 lines 36-37), (ii) controlling the centrifuge at a selected rate and/or a selected relative centrifugal force (e.g., 3000 RPM, col. 26 lines 1 – 6); (iii) after a selected time, ending the flow rate stoppage phase (“for a period of for example 6 seconds”, col. 14 lines 44 – 45); and (iv) resuming the interrupted stage or advancing to a subsequent stage of the blood separation procedure after ending the flow rate stoppage phase (col. 14 lines 44 – 58).
Regarding claims 2 and 23, Felt discloses wherein the blood comprises whole blood and the at least two blood components comprise red blood cells and plasma (col. 26 lines 16-19).
Regarding claims 3 and 24, Felt discloses wherein the controlling the centrifuge at a selected rate during the flow rate stoppage phase includes spinning at a rate of between 500 and 5500 (e.g., 3000 RPM, col. 26 lines 1 – 6).
Regarding claims 18 and 39, Felt discloses wherein the pump system comprises a plurality of pumps, and executing a flow rate stoppage phase comprises stopping one or more of the plurality of pumps (“separation device 6 will pause all pumps when the pressure reaches an alarm point”, col. 14 lines 36-37).
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 4-6, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Felt.
Regarding claims 4 and 25, Felt discloses spinning at a rate of about 2750 RPM to about 3250 RPM (col. 26 lines 1 – 6), but does not specifically disclose wherein the controlling the centrifuge at a selected rate during the flow rate stoppage phase includes spinning at a rate of about 1500, about 3500 or about 5000. However, 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). See MPEP 2144.05. It has also been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946); see also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). See MPEP 2144.05. Without evidence to indicate why a spinning rate of 1500, 3500, or 5000 is critical, it would have been obvious for one having ordinary skill in the art, to have provided the method of Felt with a spinning rates in the claimed ranges, which would not produce any new or unexpected results.
Regarding claims 5, 6, 26, and 27, Felt discloses wherein the selected time for the flow rate stoppage phase comprises 6 seconds (col. 14 lines 44 – 45), but does not specifically disclose wherein the selected time of the flow rate stoppage phase comprises between 15 seconds and 45 seconds; about 30 seconds. Felt teaches that the set time limit for the flow rate stoppage phase is the time given for an automatic resolution for the pressure to rise above the alarm or other pre-selected set point (col. 14 lines 36-58). It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the selected time to be in the claimed ranges for the purpose of providing suitable time for automatic resolution (col. 14 lines 36-58) for given process conditions, which is considered at most optimum choices, lacking any disclosed criticality.
With respect to the limitations of the parameter regarding the selected time of the flow rate stoppage phase, which are present in the claims at issue, the examiner has found that the specification contained no disclosure of any unexpected results arising therefrom, and that as such the parameters are arbitrary and therefore obvious. Such unsupported limitations cannot be a basis for patentability, since where patentability is said to be based upon particular chosen parameters or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990) and MPEP 2144.05(III).
Applicant has the burden of proving such criticality. In re Swenson et al., 56 USPQ 372; In re Scherl, 70 USPQ 204. However, even though applicant's modification may result in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art. In re Sola, 25 USPQ 433; In re Normannet et al., 66 USPQ 308; In re Irmscher, 66 USPQ 314.
More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.20 454, 456, 105 USPO 233, 238 (CCPA 1955); In re Swain et al., 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 38 USPQ 213; Allen et al. v. Coe, 57 USPQ 136; MPEP 2144.05(II)(A).
No probative evidence is of record to demonstrate that the selected time of the flow rate stoppage phase, and/or other variables of the invention are significant or are anything more than one of numerous dimensions a person of ordinary skill in the art would find obvious for purposes of merely changing the configurations and/or dimensions to obtain different results. Graham v. John Deere Co., 148 USPQ 459. Accordingly, the examiner argues that these parameters are rather arbitrary and thus obvious over the prior art per MPEP 2144.05(II)(III).
Furthermore, the Federal Circuit has explained that a reason to optimize prior art parameters may be found in a PHOSITA’s desire to improve on the prior art. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017) (“The normal desire of artisans to improve upon what is already generally known can provide the motivation to optimize variables such as the percentage of a known polymer for use in a known device.”’).
Claims 7 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Felt in view of Mari et al. (U.S. Patent No. 6,488,860, hereinafter Mari).
Regarding claims 7 and 28, Felt discloses wherein the blood component collection stage further includes: (ii) the centrifuge being controlled to separate the whole blood in the processing chamber into plasma and red blood cells, the separated plasma is conveyed out of the processing chamber and into a plasma collection container (reservoir 94, col. 27 lines 37-47), the separated red blood cells are conveyed out of the processing chamber, and an additive solution (AC/anticoagulant) is conveyed out of an additive solution container (drip chamber 52, Fig. 2A) of a fluid flow circuit (tubing circuit 10), with the separated red blood cells and the additive solution being combined as a mixture and conveyed into a red blood cell collection container (RBC collection reservoir 954) of the fluid flow circuit (“During the RBC collection phase, the inlet flow into vessel 352 is limited by the above-noted maximum, acceptable ACIR (acceptable anticoagulant infusion rate) to the donor/patient, col. 29 lines 6-49), but does not disclose (i) whole blood being conveyed from a blood source to the processing chamber until a total of one unit of whole blood has been conveyed from the blood source to the processing chamber.
Mari discloses analogous art related to a method for separating blood, wherein (i) whole blood being conveyed from a blood source to the processing chamber until a total of one unit of whole blood has been conveyed from the blood source to the processing chamber (Abstract, a collecting the donor’s whole blood in the collecting container and conveying it into the primary container for blood separation by centrifugation). 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 Felt with the step of conveying whole blood from a unit of whole blood to the processing chamber for the purpose of allowing a donor to be free from being connected to the processing chamber during blood processing.
Claims 16 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Felt in view of Barry, Jr. et al. (U.S. Patent No. 8,852,140, hereinafter Barry).
Regarding claims 16 and 37, Felt does not disclose wherein the blood separation stage comprises conveying the separated plasma and red blood cells out of the processing chamber and recombining the plasma and red blood cells as recombined whole blood, and conveying the recombined whole blood into the processing chamber.
Barry discloses analogous art related to a method for blood separation, comprising conveying the separated plasma and red blood cells out of the processing chamber and recombing the plasma and red blood cells as recombined whole blood, and conveying the recombined whole blood into the processing chamber (col. 12 line 56 – col. 13 line 26). 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 Felt with the steps of conveying and recombining the plasma and red blood cells into and out of the processing chamber as taught by Barry for the purpose of subsequent platelet harvesting (col. 14 lines 26-30, Barry).
Claims 19 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Felt in view of Kelly et al. (U.S. Patent No. 8,834,403, hereinafter Kelly).
Regarding claims 19 and 40, Felt does not disclose wherein the valve system comprises a plurality of clamps, and executing a flow rate stoppage phase comprises closing one or more of the plurality of clamps.
Kelly discloses analogous art related to a blood circuit, wherein the valve system comprises a plurality of clamps, and executing a flow rate stoppage phase comprises closing one or more of the plurality of clamps (“closing all valves and patient line clamps and stopping all pumps”, col. 10 lines 31-33). 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 Felt with the closing one or more clamps taught by Kelly for the purpose of placing the system in a safe state (col. 10 lines 31-33, Kelly).
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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