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 .
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.
Response to Arguments
Applicant's arguments filed 12 December 2025 have been fully considered but they are not persuasive.
Regarding claims 1, 7, and 14, Applicant argues that Lindner and Fletcher fail to teach or suggest the amended limitation requiring that “the light detector is configured to emit a signal having a pulse width corresponding to a spatial distribution of the collimated light received by a plurality of individual photodetectors of the light detector”, asserting that Linder and Fletcher rely on “image analysis” using CCD cameras rather than “signal analysis” (pages 8-9, Remarks). The examiner respectfully disagrees. The claims broadly recite a signal having a pulse width corresponding to a spatial distribution of light received by a plurality of individual photodetectors. Such claim language does not exclude digital signals such as digital images. Furthermore, image data is derived from signals from individual photodetectors, and processing image data would necessarily involve analyzing signals from individual photodetectors. The claims to not require a signal from each individual photodetector.
While Applicant asserts that “[t]he photoactive region of a CCD camera is a capacitor array” (page 8, Remarks), this characterization does not distinguish over the cited prior art. Each capacitor in a CCD would correspond and function as an individual photodetector, and since the capacitors are arranged in a two dimensional array, the resulting output signal represents a spatial distribution of light received across the detector.
Fletcher further teaches analyzing spatial distribution of detected light across a two-dimensional detector to identify phase boundaries by evaluating gradients and intensity variations across the light detector elements (page 6 lines 19-27). Such spatial analysis involves determining the spatial extent and position of detected light transitions, which corresponds to a width or span of detected signal values across the detector array. This spatial extent corresponds to a pulse width. The examiner notes that “pulse width” language does not impart a structural or functional distinction sufficient to overcome the combination of Linder and Fletcher. Therefore, claims 1, 7, and 14 remain unpatentable under 35 U.S.C. § 103 over Linder in view of Fletcher.
Drawings
The drawings were received on 14 April 2025. These drawings are acceptable.
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 1, 3, 7, 9, 13, 14, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/021633 (Lindner et al., hereinafter Lindner) in view of WO 2008/021626 (Fletcher et al., hereinafter Fletcher).
Regarding claim 1, Lindner discloses an interface monitoring assembly (optical monitoring system 40, Fig. 2) for use in combination with a centrifugal separator (centrifuge apparatus 10, Fig. 1) configured to rotate a centrifugal separation chamber (centrifuge rotor 12, Fig. 1) about a rotational axis, the interface monitoring assembly comprising: a light source (upper LED light source 76 and bottom pulsed LED light source 78, Fig. 3) configured to emit a light; a light detector (CCD camera 72, and/or light collection element 44 and detector 46, Fig. 2 and 3) configured as a photodetector array (inside CCD camera), and a collimator (part of upper LED light source 76 that is capable of directing a plurality of collimated upper light beams 82, and part of bottom pulsed LED light source 78 that is capable of directing a plurality of collimated bottom light beams 86, Fig. 3, page 13 line 28 – page 14 line 5) positioned between the light source and the light detector, wherein the collimator is configured to receive at least a portion of the light emitted by the light source and direct collimated light through a channel (optical cell 74 and/or the separation vessel 28, Fig. 3) defined by a centrifugal separation chamber (centrifuge rotor 12, Fig. 3) in a direction substantially parallel to the rotational axis (central rotation axis A-A, Fig. 2), the light detector (CCD camera 72, Fig. 3) is configured to receive at least a portion of the collimated light exiting the channel of the centrifugal separation chamber in said direction substantially parallel to the rotational axis, and the light detector is configured to emit a signal indicative of a location of an interface between separated fluid components within the channel of the centrifugal separation chamber (“using information gathered through the camera, the controller 60 regulates the position of interfaces between various blood components, such as plasma, buffy coat and red blood cells by controller the pumps 158, 160, and 162”, page 16 lines 1-4).
Lindner does not explicitly disclose that the signal emitted by the light detector has a pulse width corresponding to a spatial distribution of the collimated light received by a plurality of individual photodetectors of the light detector.
Fletcher discloses analogous art related to an interface detector, analyzing spatial distributions of detected light across a two-dimensional detector to identify phase boundaries by evaluating gradients and intensity variations across light detector elements (“scanning a field of pixel values to detect phase boundaries between blood components by determining a set of gradients of said pixel values”, page 6 lines 19-27; the two-dimensional detector, positioned to receive and detect light transmitted, scattered or both from the observation region provided by said light collection element, page 27 lines 11-24). The spatial extent and position of detected light transitions corresponds to a pulse width corresponding to a spatial distribution of the collimated light received by a plurality of individual photodetectors of the light detector. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the interface monitoring assembly of Lindner with the two-dimensional array of photodetectors of Fletcher to generate and utilize a signal corresponding to the spatial extent or pulse width of detected light across the photodetector array, for the purpose of more accurately identifying and tracking the location of an interface between separated fluid components in the centrifugal separation chamber (page 27 lines 11-24, Fletcher).
Regarding claim 7, Lindner discloses a fluid separation device comprising: a centrifugal separator (centrifuge apparatus 10, Fig. 1); a pump system (pumps 158, 160, and 162, Fig. 4); and a controller (device controller 60) configured to control the pump system to convey fluid from a fluid source into a channel (optical cell 74 and/or the separation vessel 28, Fig. 3) defined by a centrifugal separation chamber (centrifuge rotor 12, Fig. 3) positioned within the centrifugal separator (“Device controller 60 is operationally connected to centrifuge apparatus 10 and is capable of adjusting selected operating conditions of the centrifuge apparatus, such as the flow rates of cellular and non-cellular components out of the separation vessel 28 or fluid chamber 30”, page 11 line 23 – page 12 line 5) and to control the centrifugal separator to rotate the centrifugal separation chamber about a rotational axis so as separate at least a portion of the fluid in the channel of the centrifugal separation chamber (“rotational velocity of the rotor about central rotation axis A-A”, page 11 line 23 – page 12 line 5), wherein the centrifugal separator includes an optical monitor assembly (optical monitoring system 40, Fig. 2) comprising: a light source (upper LED light source 76 and bottom pulsed LED light source 78, Fig. 3) configured to emit a light; a light detector (CCD camera 72, and/or light collection element 44 and detector 46, Fig. 2 and 3) configured as a photodetector array (inside CCD camera), and a collimator (part of upper LED light source 76 that is capable of directing a plurality of collimated upper light beams 82, and part of bottom pulsed LED light source 78 that is capable of directing a plurality of collimated bottom light beams 86, Fig. 3, page 13 line 28 – page 14 line 5) positioned between the light source and the light detector, the collimator is configured to receive at least a portion of the light emitted by the light source and direct collimated light through the channel (optical cell 74 and/or the separation vessel 28, Fig. 3) of the centrifugal separation chamber (centrifuge rotor 12, Fig. 3) in a direction substantially parallel to the rotational axis (central rotation axis A-A, Fig. 2), the light detector (CCD camera 72, Fig. 3) is configured to receive at least a portion of the collimated light exiting the channel of the centrifugal separation chamber in said direction substantially parallel to the rotational axis, and the light detector is configured to emit a signal indicative of a location of an interface between separated fluid components within the channel of the centrifugal separation chamber (“using information gathered through the camera, the controller 60 regulates the position of interfaces between various blood components, such as plasma, buffy coat and red blood cells by controlling the pumps 158, 160, and 162”, page 16 lines 1-4), and the controller is configured to receive the signal from the light detector and determine the location of the interface between the separated fluid components within the channel of the centrifugal separation chamber based at least in part on the signal (“the position of one or more phase boundaries”, page 11 line 23 – page 12 line 5; “using information gathered through the camera, the controller 60 regulates the position of interfaces between various blood components, such as plasma, buffy coat and red blood cells by controlling the pumps 158, 160, and 162”, page 16 lines 1-4).
Lindner does not explicitly disclose that the signal emitted by the light detector has a pulse width corresponding to a spatial distribution of the collimated light received by a plurality of individual photodetectors of the light detector.
Fletcher discloses analogous art related to an interface detector, analyzing spatial distributions of detected light across a two-dimensional detector to identify phase boundaries by evaluating gradients and intensity variations across light detector elements (“scanning a field of pixel values to detect phase boundaries between blood components by determining a set of gradients of said pixel values”, page 6 lines 19-27; the two-dimensional detector, positioned to receive and detect light transmitted, scattered or both from the observation region provided by said light collection element, page 27 lines 11-24). The spatial extent and position of detected light transitions corresponds to a pulse width corresponding to a spatial distribution of the collimated light received by a plurality of individual photodetectors of the light detector. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the fluid separation device of Lindner with the two-dimensional array of photodetectors of Fletcher to generate and utilize a signal corresponding to the spatial extent or pulse width of detected light across the photodetector array, for the purpose of more accurately identifying and tracking the location of an interface between separated fluid components in the centrifugal separation chamber (page 27 lines 11-24, Fletcher).
Regarding claim 14, Lindner discloses a method for separating a fluid comprising: conveying fluid from a fluid source into a channel (optical cell 74 and/or the separation vessel 28, Fig. 3) defined by a centrifugal separation chamber (centrifuge rotor 12, Fig. 3) (page 20 lines 19-26); rotating the centrifugal separation chamber about a rotational axis so as separate at least a portion of the fluid in the channel of the centrifugal separation chamber (page 21 lines 1-12); directing collimated light through the channel of the centrifugal separation chamber in a direction substantially parallel to the rotational axis (part of upper LED light source 76 that is capable of directing a plurality of collimated upper light beams 82, and part of bottom pulsed LED light source 78 that is capable of directing a plurality of collimated bottom light beams 86, Fig. 3, page 13 line 28 – page 14 line 5); receiving at least a portion of the collimated light exiting the channel of the centrifugal separation chamber in said direction substantially parallel to the rotational axis (central rotation axis A-A, Fig. 2); emitting a signal indicative of a location of an interface between separated fluid components within the channel of the centrifugal separation chamber (“using information gathered through the camera, the controller 60 regulates the position of interfaces between various blood components, such as plasma, buffy coat and red blood cells by controlling the pumps 158, 160, and 162”, page 16 lines 1-4); and determining the location of the interface between the separated fluid components within the channel of the centrifugal separation chamber based at least in part on the signal (page 23 line 5 – page 24 line 23).
Lindner does not explicitly disclose that the signal emitted by the light detector has a pulse width corresponding to a spatial distribution of the collimated light received by a plurality of individual photodetectors of the light detector.
Fletcher discloses analogous art related to an interface detector, analyzing spatial distributions of detected light across a two-dimensional detector to identify phase boundaries by evaluating gradients and intensity variations across light detector elements (“scanning a field of pixel values to detect phase boundaries between blood components by determining a set of gradients of said pixel values”, page 6 lines 19-27; the two-dimensional detector, positioned to receive and detect light transmitted, scattered or both from the observation region provided by said light collection element, page 27 lines 11-24). The spatial extent and position of detected light transitions corresponds to a pulse width corresponding to a spatial distribution of the collimated light received by a plurality of individual photodetectors of the light detector. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of Lindner with the two-dimensional array of photodetectors of Fletcher to generate and utilize a signal corresponding to the spatial extent or pulse width of detected light across the photodetector array, for the purpose of more accurately identifying and tracking the location of an interface between separated fluid components in the centrifugal separation chamber (page 27 lines 11-24, Fletcher).
Regarding claims 3, 9, and 16, the combination of Lindner and Fletcher discloses analogous art related to image processing interface detector, wherein the light detector is configured as a two-dimensional array of photodetectors (the two-dimensional detector, positioned to receive and detect light transmitted, scattered or both from the observation region provided by said light collection element, page 27 lines 11-24, Fletcher).
Regarding claim 13, the combination of Lindner and Fletcher discloses wherein the controller is further configured to determine whether the interface is at a target location, and after determining that the interface is not at the target location, control the centrifugal separator and/or the pump system so as to cause the interface to move to the target location (“using information gathered through the camera, the controller 60 regulates the position of interfaces between various blood components, such as plasma, buffy coat and red blood cells by controlling the pumps 158, 160, and 162”, page 16 lines 1-4, Fletcher).
Regarding claim 20, the combination of Lindner and Fletcher discloses determining whether the interface is at a target location, and after determining that the interface is not at the target location, causing the interface to move to the target location (“using information gathered through the camera, the controller 60 regulates the position of interfaces between various blood components, such as plasma, buffy coat and red blood cells by controlling the pumps 158, 160, and 162”, page 16 lines 1-4, Lindner).
Claims 2, 8, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lindner in view of Fletcher, as applied to claim 1, 7, and 14 above, and further in view of O’Meara.
Regarding claims 2, 8, and 14, the combination of Lindner and Fletcher does not expressly disclose wherein the light detector is configured as a linear array of photodetectors.
O’Meara discloses analogous art related to a centrifugal analyzer, wherein the light detector is configured as a linear array of photodetectors (“a photodiode array to image the position of the fluid or fluids in a rotating collection tube. The array is mounted in a suitable camera and aligned parallel to the major axis of the liquid collection tube”, col. 1 lines 64-68). 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 interface monitoring assembly, fluid separation device, or method of the combination of Lindner and Fletcher with the linear array of photodetectors as taught by O’Meara for the purpose of providing a sharper demarcation between two or more fluids in the collecting tube, thus facilitating the monitoring of a plurality of fluids produced by the sample during centrifugation (col. 2 liens 9-14, O’Meara).
Claim 4, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lindner in view of Fletcher, as applied to claim 1, 7, and 14 above, and further in view of WO 90/01682 (Finney et al., hereinafter Finney).
Regarding claims 4, 10, and 17, the combination of Lindner and Fletcher does not disclose wherein the collimator is configured as a collimating lens.
Finney discloses analogous art related to optical sensors, wherein the collimator is configured as a collimating lens (89, Fig. 8). 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 interface monitoring assembly, fluid separation device, or method of the combination of Lindner and Fletcher with the collimating lens as taught by Finney for the purpose of taking optical measurements of liquid by refractive and absorptive techniques (page 3 lines 39-40, Finney).
Claims 5, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lindner in view of Fletcher, as applied to claim 1, 7, and 14 above, and further in view of Mendelson et al. (U.S. Patent No. 5,277,181, hereinafter Mendelson).
Regarding claims 5, 11, and 18, the combination of Lindner discloses directing collimated light through the channel (optical cell 74, Fig. 3) defined by a centrifugal separation chamber (centrifuge rotor 12, Fig. 3), but does not disclose wherein the collimated light includes at least one wavelength of light configured to be substantially transmitted through a separated plasma component of whole blood within the channel of the centrifugal separation chamber and substantially not transmitted through a separated red blood cell component of the whole blood within the channel of the centrifugal separation chamber.
Mendelson discloses analogous art related to optical measurement of blood hematocrit, wherein the collimated light includes at least one wavelength of light configured to be substantially transmitted through plasma component of whole blood and substantially not transmitted through a separated red blood cell component of the whole blood (col. 5 lines 61-68). 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 interface monitoring assembly, fluid separation device, or method of the combination of Lindner and Fletcher with the wavelength as taught by Mendelson when directing collimated light through the channel defined by a centrifugal separation chamber for the purpose of measurement of blood hematocrit and hemoglobin content using differential optical absorption of two or more wavelengths of light (Abstract, Mendelson).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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