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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/1/2023 and 8/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-12 are pending and being examined.
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 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.
Claim(s) 1-2 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McPeak et al (US 20170059590 A1; hereinafter “McPeak”; already of record on IDS filed 8/1/2023).
Regarding claim 1, McPeak teaches a microfluidic device (McPeak; Abstract) comprising at least one separation chamber (McPeak; Fig. 3; para [4]; micro-features can allow for the measurement of particulate concentration within a particle-laden fluid based on the volumetric displacement of the fluid through the micro-feature) with an inlet (McPeak; Fig. 3; para [60]; the chamber 110 may also be attached to both the inlet ports 122 and 124) and an outlet (McPeak; Fig. 3; para [59]; a chamber 110 to receive and hold a fluid sample, and an outlet port 112 to dispense the fluid sample from the chamber 110) wherein the inlet is configured to open into the separation chamber at a lower height than the outlet (McPeak; Fig. 3; para [60]; an inlet port 124 that transports the sample fluid into the bottom region 124).
Regarding claim 2, McPeak teaches the microfluidic device according to claim 1, wherein at least one sensor is arranged in the separation chamber (McPeak; Fig. 3; para [74]; the analyzer device 30 may include a light emitter 130 that illuminates a channel connected to the outlet port 112 such that as the particles 120 b pass through the channel, a light detector 140 that collects a detection signal based on the number of scattering events over a particular period of time). The examiner interprets the “arrangement” inside the separation chamber is interpreted as being capable of detecting the contents inside the separation chamber. As seen in Figure 8 of the instant specification, the sensor is arranged adjacent to the chamber to detect the content inside of the chamber.
Regarding claim 4, McPeak teaches the microfluidic device according to claim 1, wherein the outlet is disposed in a side wall of the separation chamber (McPeak; Fig. 3) and a sample inlet is disposed in a top of the separation chamber (McPeak; Fig. 3; para [60]; the chamber 110 can be attached to an inlet port 122 that transports the sample fluid into the top region 114).
Regarding claim 5, McPeak teaches the microfluidic device according to claim 4, wherein the outlet is configured to open into another chamber having a common wall with the separation chamber (McPeak; Fig. 1).
Regarding claim 6, McPeak teaches the microfluidic device according to claim 5, wherein the separation chamber and the further chamber are inclined together towards the further chamber (McPeak; Fig. 1, 3). The examiner notes that the outlet leads to chambers downstream of the micro-feature. The limitation “inclined” is interpreted as being higher/above, and the bottom of the separation chamber is below the outlet which leads downstream. Further, the inclined limitation would be met if a user were to tilt/turn the cartridge 10 in the desired direction.
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 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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McPeak in view of Puleo et al (US 20180001231 A1; hereinafter “Puleo”).
Regarding claim 3, McPeak teaches the microfluidic device according to claim 1, with the outlet.
McPeak does not teach the microfluidic device further comprising a filter is arranged at and/or in the outlet.
However, Puleo teaches an analogous art of a separation device (Puleo; Abstract) comprising a separation chamber with an inlet and outlet (Puleo; para [117]; the device 8 comprises an inlet 12, first microchannel 17, a mesofluidic collection chamber 22 and a first fluid outlet 14A), comprising a filter is arranged at and/or in the outlet (Puleo; para [173]; a clean-up filter placed between the fluid outlet and the output chamber). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the outlet of McPeak to comprise the filter as taught by Puleo, because Puleo teaches that filter purifies trace contaminants in the extracted samples (Puleo; para [173]).
Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over McPeak in view of Schaff et al (US 20210156842 A1; hereinafter “Schaff”; priority filed on 7/9/2019).
Regarding claim 7, McPeak teaches a method for separating blood plasma from whole blood, comprising: introducing the whole blood into the separation chamber of a microfluidic device according to claim 1 (McPeak; para [57]; a whole blood sample can be injected into cartridge 10 and received in the chamber 110 as part of the fluid holding and dispensing micro-feature 100), sedimenting blood cells from the whole blood (McPeak; para [28]; McPeak teaches that whole blood is introduced into the chamber and sediments over a period of time discussed in paragraph 28).
McPeak does not teach at least partially discharging blood plasma separated by sedimentation via the outlet.
However, Schaff teaches an analogous art an analogous art of a centrifugal cartridge for extracting samples (Schaff; Abstract) comprising one separation chamber (Schaff; Fig. 13B; para [53]; The whole blood or sample fluid 301 may remain in the sample receiving cavity 102) with an inlet (Schaff; Fig. 13B; para [80]; an inlet hole 109) and an outlet (Schaff; Fig. 13B; para [80];The cartridge may further comprise an outlet hole 1303) wherein blood plasma is partially discharged and separated by sedimentation via the outlet (Schaff; Fig. 13B; para [80]; an outlet hole 1303 and a foil seal 1304 placed over the outlet hole, to allow extraction of lighter portion of sample fluid (i.e. blood plasma) by means for fluid withdrawal). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method of McPeak to comprise the step of discharging blood plasma as taught by Schaff, because Schaff teach plasma being separated to be analyzed (Schaff; para [12]). McPeak and Schaff teach plasma is supernatant of the whole blood (McPeak; para [8]; Schaff; para [45]). McPeak teaches that the outlet port 112 can be positioned at different planes to correspond to the desired fluid/particulate matter (McPeak; para [83]). Thus, one of ordinary skill in the art may position the outlet to separate plasma as taught by Schaff for further analyzing.
Regarding claim 8, modified McPeak teaches the method according to claim 7, wherein the step of at least partially discharging blood plasma is performed by sublayering with a transport medium (McPeak; para [66, 71]; The fluid sample can be displaced through the chamber 110 by injecting another fluid (e.g., a reagent fluid, inert fluid) into the chamber 110…where the fluid sample is whole blood, sedimentation can cause the top region 114 to contain a plasma supernatant of the whole blood, the middle region 116 to contain pristine blood with concentrations of blood cells that are the same or similar as concentrations when the whole blood was first received in the chamber 110, and the bottom region 118 can contain a packed cell layer with the greatest concentration of cells; Schaff; para [36]; a sample comprising a separable mixture (corresponding to whole blood) that may be separated into a higher density heavy fraction (corresponding to the cellular fraction) and a lower density light fraction (corresponding to the plasma fraction)). Examiner notes Schaff teaches the step of discharging plasma, both McPeak and Schaff teach a medium to separate the whole blood components based on the density.
Regarding claim 9, modified McPeak teaches the method according to claim 8, wherein the step of sublayering is continued until a phase boundary between the blood plasma and a residue of the whole blood has reached a predeterminable height in the separation chamber (McPeak; para [8, 59]; the top region contains a plasma supernatant of the whole blood…the fluid sample is received by the chamber 110, regions 114, 116, and 118, representing fragmented portions of the fluid sample).
Regarding claim 10, modified McPeak teaches the method according to 8, wherein the step of sublayering is continued until a predeterminable amount of the transport medium has been introduced into the separation chamber (McPeak; para [85]; the analyzer device 30 may have predetermined values for the time period 530 that are specific to various fluids, particulate matter, and/or micro-feature 100 configurations).
Regarding claim 11, modified McPeak teaches the method according to claim 7, wherein a remainder of the whole blood is transported out of the separation chamber by way of a transport medium (McPeak; para [95]; the calculated red blood cell concentration exceeds the threshold concentration, then the analyzer device 30 may determine that only whole blood that includes the packed cell layer is being dispensed through the outlet port 112). The examiner notes that the whole blood is transported out under the condition that the calculated concentration is exceeded.
Regarding claim 12, modified McPeak teaches the method according to claim 7 (the method of McPeak is modified to comprise the step of at least partially discharging blood plasma), wherein the step of at least partially discharging blood plasma is performed by sublayering with a transport medium which has a higher density than the blood plasma (Schaff; para [36]; a sample comprising a separable mixture (corresponding to whole blood) that may be separated into a higher density heavy fraction (corresponding to the cellular fraction) and a lower density light fraction (corresponding to the plasma fraction)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796