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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
1. Claims 1-3, 6 and 7 are rejected under 35 USC 103 as being unpatentable over U.S. Patent No. 10,962,525 to Rendu et al. (hereafter Rendu et al. ’525) in view of U.S. Patent No. 8,673,215 to Rendu et al. (English equivalence of WO2009/053841; hereafter Rendu et al. ‘215).
Rendu et al. ’525 teaches an apparatus for determining the viscosity of blood.
The apparatus includes a device 1 (“holder”) having a channel 2 in which a blood sample is provided together with a gas that together form a “front.” (column 3, line 50 through column 4, line 3; column 5, lines 41-52)
The velocity of the front moving through the channel is detected by electrodes and used to determine the viscosity of the blood sample. (column 12, lines 50-60).
Rendu et al. ‘525 does not teach using a blood sample, but cites WO2009/053841 to Rendu et al. for teaching a process of pre-filling a capillary tube with water, then introducing a blood sample into the capillary tube. The passage of the front separating the two liquids produces a variation in capacitance between two measurement electrodes, which is measured and makes it possible to detect and/or characterize the state of activation of the platelets in the blood sample. (column 1, line 14-24)
Rendu et al. ‘215 teaches providing a whole blood sample together with distilled water in a channel to form a “front” therebetween and detecting the front as it moves through the channel using electrodes. (column 4, lines 13-19 and 46-48)
It would have been obvious to one of ordinary skill in the art before applicant’s claimed invention to modify Rendu et al. ‘252 to determine the viscosity of the blood using the velocity of the front as it moves through the electrodes as taught by Rendu ‘215.
Since the “front” in Rendu et al. ‘252 as modified by Rendu et al. ‘215 is formed between the blood sample and the distilled water (“mediator”) the viscosity is “measured via a mediator in contact with the held blood sample” as recited in claim 1. Note, applicant teaches that the mediator can be water on page 9, lines 16-18 of applicant’s specification.
I.) Regarding applicant’s claim 1, as noted above Rendu et al. ‘252 in view of Rendu et al. ‘215 renders all the limitations of claim 1 obvious.
Therefore, Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that processing circuitry is further configured to calculate an index regarding the at least one of the viscoelasticity or the viscosity of the held blood sample on the basis of results of the measurement.
Rendu et al. ‘252 in view of Rendu et al. ‘215 does not teach that the processing circuitry is further configured to calculate an index regarding the at least one of the viscoelasticity or the viscosity of the held blood sample on the basis of results of the measurement.
It would have been obvious to one of ordinary skill in the art to modify Rendu et al. ‘252 in view of Rendu et al. ‘215 to include circuitry that calculates any desired index related to the velocity of the sample for comparison and analysis purposes between different samples tested.
Therefore, Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 2 obvious
III.) Regarding applicant’s claim 3, as noted above Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 1 obvious from which claim 2 depends.
Claim 3 recites an operating mechanism configured to suck and/or discharge the mediator from and/or to the holder, wherein the processing circuitry is further configured to measure the at least one of the viscoelasticity or the viscosity of the held blood sample by measuring a response of a pressure within the holder to operation of the operating mechanism.
Rendu et al. ‘252 teaches creating a pressure differential, including suction to cause fluids to flow through the channel and regulating the pressure differential, which would provide for monitoring pressures. (column 14, lines 24-36)
In Rendu et al. ‘252 in view of Rendu et al. ‘215 it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to include the pressure in the channel when determining the flow velocity/rate as another variable in determining the viscosity.
Therefore, Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 3 obvious.
IV.) Regarding applicant’s claim 6, as noted above Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the holder includes a measurement flow channel that forms a measurement area, and the measurement flow channel is provided with an inlet through which the blood sample flows into the measurement flow channel, and an outlet through which the blood sample flows out from the measurement flow channel.
The channel (“holder”) in Rendu et al. ‘252 in view of Rendu et al. ‘215 includes a measurement area where the distance the sample moves is measured.
Rendu et al. ‘252 teaches an inlet and outlet for the channel. (Abstract)
Therefore, Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 6 obvious.
V.) Regarding applicant’s claim 7, as noted above Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 6 obvious from which claim 7 depends.
Claim 7 recites an inflow tube that is connected to the inlet and allows the blood sample to flow into the measurement flow channel; and an outflow tube that is connected to the outlet and allows the blood sample within the measurement flow channel to be discharged, wherein at least one of the measurement flow channel, the inflow tube, or the outflow tube is removable.
As noted above, Rendu et al. ‘252 teaches an inlet and outlet for the channel. (Abstract)
Therefore, Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 6 obvious.
2. Claim 8 is rejected under 35 USC 103 as being unpatentable over Rendu et al. ‘252 in view of Rendu et al. ‘215
Rendu et al. ’522 teaches an apparatus for determining the viscosity of blood.
The apparatus includes a device 1 (“holder”) having a channel 2 in which a blood sample is provided together with a gas that together form a “front.” (column 3, line 50 through column 4, line 3; column 5, lines 41-52)
The velocity of the front moving through the channel is detected by electrodes and used to determine the viscosity of the blood sample. (column 12, lines 50-60).
Rendu et al. ‘525 does not teach using a blood sample, but cites WO2009/053841 to Rendu et al. for teaching a process of pre-filling a capillary tube with water, then introducing a blood sample into the capillary tube. The passage of the front separating the two liquids produces a variation in capacitance between two measurement electrodes, which is measured and makes it possible to detect and/or characterize the state of activation of the platelets in the blood sample. (column 1, lines 14-24)
U.S. Patent No. 8,673,215 to Rendu et al. (English equivalence of WO2009/053841; hereafter Rendu et al. ‘215) teaches providing a whole blood sample together with distilled water in a channel to form a “front” therebetween and detecting the front as it moves through the channel using electrodes. (column 4, lines 13-19 and 46-48)
It would have been obvious to one of ordinary skill in the art before applicant’s claimed invention to modify Rendu et al. ‘252 to determine the viscosity of the blood using the velocity of the front as it moves through the electrodes as taught by Rendu ‘215.
Since the “front” in Rendu et al. ‘252 as modified by Rendu et al. ‘215 is formed between the blood sample and the distilled water (“mediator”) the viscosity is “measured via a mediator in contact with the held blood sample” as recited in claim 1. Note, applicant teaches that the mediator can be water on page 9, lines 16-18 of applicant’s specification.
I.) Regarding applicant’s claim 8, as noted above Rendu et al. ‘252 in view of Rendu et al. ‘215 renders all the limitations of claim 8 obvious.
Therefore, Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 8 obvious.
3. Claim 9 is rejected under 35 USC 103 as being unpatentable over Rendu et al. ‘252 in view of Rendu et al. ‘215.
Rendu et al. ’522 teaches an apparatus for determining the viscosity of blood.
The apparatus includes a device 1 (“holder”) having a channel 2 in which a blood sample is provided together with a gas that together form a “front.” (column 3, line 50 through column 4, line 3; column 5, lines 41-52)
The velocity of the front moving through the channel is detected by electrodes and used to determine the viscosity of the blood sample. (column 12, lines 50-60).
Rendu et al. ‘525 does not teach using a blood sample, but cites WO2009/053841 to Rendu et al. for teaching a process of pre-filling a capillary tube with water, then introducing a blood sample into the capillary tube. The passage of the front separating the two liquids produces a variation in capacitance between two measurement electrodes, which is measured and makes it possible to detect and/or characterize the state of activation of the platelets in the blood sample. (column 1, lines 14-24)
Rendu et al. ‘252 further teaches a computer central processing unit, a processor and/or software means for performing calculations. (column 8, lines 57-60)
U.S. Patent No. 8,673,215 to Rendu et al. (English equivalence of WO2009/053841; hereafter Rendu et al. ‘215) teaches providing a whole blood sample together with distilled water in a channel to form a “front” therebetween and detecting the front as it moves through the channel using electrodes. (column 4, lines 13-19 and 46-48)
It would have been obvious to one of ordinary skill in the art before applicant’s claimed invention to modify Rendu et al. ‘252 to determine the viscosity of the blood using the velocity of the front as it moves through the electrodes as taught by Rendu ‘215.
Since the “front” in Rendu et al. ‘252 as modified by Rendu et al. ‘215 is formed between the blood sample and the distilled water (“mediator”) the viscosity is “measured via a mediator in contact with the held blood sample” as recited in claim 1. Note, applicant teaches that the mediator can be water on page 9, lines 16-18 of applicant’s specification.
I.) Regarding applicant’s claim 9, as noted above Rendu et al. ‘252 in view of Rendu et al. ‘215 renders all the limitations of claim 9 obvious.
Therefore, Rendu et al. ‘252 in view of Rendu et al. ‘215 renders claim 9 obvious.
4. Claims 4 and 5 are rejected under 35 USC 103 as being unpatentable over Rendu et al ‘252 in view of Rendu et al. ‘215 as applied to claim 1 and further in view of Japanese Patent Application Publication No. JP2007017207 to Kano (cited by applicant),
I.) Regarding applicant’s claim 4, as noted above Rendu et al ‘252 in view of Rendu et al. ‘215 renders claim 1 obvious from which claim 4 depends.
Claim 4 recites a generator configured to generate bubbles by heating the mediator, wherein the processing circuitry is further configured to measure the at least one of the viscoelasticity or the viscosity of the held blood sample by measuring geometric characteristics of the bubbles and/or a response due to generation of the bubbles.
Rendu et al ‘252 in view of Rendu et al. ‘215 does not teach a generator configured to generate bubbles by heating the mediator, wherein the processing circuitry is further configured to measure the at least one of the viscoelasticity or the viscosity of the held blood sample by measuring geometric characteristics of the bubbles and/or a response due to generation of the bubbles.
Kano teaches a method and instrument for measuring characteristics of liquid, including measuring the viscosity by measuring time and a bubble type that measures the time by which the bubble in the measuring tube rises a certain distance by sealing the sample liquid and bubbles in the measuring tube and then falls. [0002]
Kano further teaches heating the liquid to a boiling temperature to generate bubbles. [0008]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Rendu et al ‘252 in view of Rendu et al. ‘215 to include a generator configured to generate bubbles by heating the mediator, wherein the processing circuitry is further configured to measure the at least one of the viscoelasticity or the viscosity of the held blood sample by measuring geometric characteristics of the bubbles and/or a response due to generation of the bubbles, in view of Kano teaching the use of bubbles to measure viscosity.
Therefore, Rendu et al ‘252 in view of Rendu et al. ‘215 and Kano renders claim 4 obvious.
II.) Regarding applicant’s claim 5, as noted above Rendu et al ‘252 in view of Rendu et al. ‘215 and Kano renders claim 4 obvious from which claim 5 depends.
Claim 5 recites processing circuitry is further configured to measure the at least one of the viscoelasticity or the viscosity of the held blood sample based on sizes of the bubbles or an inflow amount of the blood sample from the holder due to generation of the bubbles.
Rendu et al ‘252 in view of Rendu et al. ‘215 does not teach processing circuitry is further configured to measure the at least one of the viscoelasticity or the viscosity of the held blood sample based on sizes of the bubbles or an inflow amount of the blood sample from the holder due to generation of the bubbles.
As noted above, Kano teaches a method and instrument for measuring characteristics of liquid, including measuring the viscosity by measuring time and a bubble type that measures the time by which the bubble in the measuring tube rises a certain distance by sealing the sample liquid and bubbles in the measuring tube and then falls. [0002]
Kano further teaches heating the liquid to a boiling temperature to generate bubbles. [0008]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Rendu et al ‘252 in view of Rendu et al. ‘215 include processing circuitry that is configured to measure the at least one of the viscoelasticity or the viscosity of the held blood sample based on sizes of the bubbles or an inflow amount of the blood sample from the holder due to generation of the bubbles in view of Kano teaching the use of bubbles to measure viscosity.
Therefore, Rendu et al ‘252 in view of Rendu et al. ‘215 and Kano renders claim 5 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 1-9 have been considered but are moot because the new ground of rejection relies upon new prior art including Rendu et al. ‘215 in view of Rendu et al. ‘252 as necessitated by applicant’s amendments to the claims.
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.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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