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 .
Response to Amendment
The amendments and remarks, filed on 2/24/2026, has been entered. The claim amendments do not overcome the previous prior art rejection, and Applicants' arguments are addressed below.
Claim Status
Claims 1 are pending and being examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the further chamber" in line 5 and line 6. There is insufficient antecedent basis for this limitation in the claim, thus the limitation. Specifically, it is unclear if “the further chamber” is the same structural limitation as “another chamber” recited in claim 5. The Examiner suggest Applicant recite “open into a further chamber” in claim 5.
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 and 4-5 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); and
at least one sensor configured to detect a condition within 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. The limitation is directed to the function and/or the manner of operating the sensor, all the structural limitations of the claim has been disclosed McPeak and the sensor of McPeak is capable of being “configured to detect a condition within the separation chamber”. As such, it is deemed that the claimed sensor is not differentiated from the sensor of McPeak (see MPEP §2114).
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, 2). The Examiner notes that the outlet leads to other channels/chambers within the cartridge and that the separation chamber is a single part of the cartridge. The limitation is directed to the function and/or the manner of operating the outlet, all the structural limitations of the claim has been disclosed McPeak and the outlet of McPeak is capable of being “configured to open into another chamber having a common wall with the separation chamber”. As such, it is deemed that the claimed outlet is not differentiated from the outlet of McPeak (see MPEP §2114).
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”; already of record).
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 and 10-13 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; already of record).
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, wherein the step of at least partially discharging blood plasma is performed by sublayering with a transport medium, and 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.
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. Therefore, modified McPeak teaches 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), and 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 7, 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)).
Regarding claim 13, modified McPeak teaches the method according to claim 7, wherein sublayering is terminated based upon sensing the phase boundary between the blood plasma and the residue of the whole blood at the predeterminable height in the separation chamber with the at least one sensor (McPeak; para [84]; The analyzer device 30 can be configured to determine the time point 530 at which fluid should stop being dispensed from the chamber 110 and through the outlet port 112).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over McPeak in view of Li (US 20080067068 A1; hereafter “Li”).
Regarding claim 14, McPeak teaches the microfluidic device according to claim 4.
McPeak does not teach a wall within the separation chamber, wherein the wall is located fluidically between the inlet and the outlet, and the at least one sensor is configured to detect a fluid boundary located near the wall.
However, Li teaches an analogous art of an apparatus for separating particles or cells (Li; Abstract) comprising the a separation chamber (Li; Fig. 2C; para [72]; a microchannel structure 200) further comprising a wall with the separation chamber (Li; Fig. 2B; para [72]; insulating hurdle member 250), wherein the wall is located fluidically between the inlet and the outlet (Li; para [115]; the cells in the inputting branches 260 will move towards the hurdle 250 and eventually flow into the two separation branches 243a, 243b). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the separation chamber of McPeak to comprise the wall as taught by Li, because Li teaches that the hurdle separates the smaller and larger cells (Li; para [111]). The Examiner notes that the hurdle can be size and dimensions for optimal separation (Li; para [113]). Thus, modified McPeak teaches that the at least one sensor is configured to detect a fluid boundary located near the wall (McPeak; Fig. 3; para [74]; the analyzer device 30). The limitation is directed to the function and/or the manner of operating the sensor, all the structural limitations of the claim has been disclosed McPeak and the sensor of McPeak is capable of being “configured to detect a fluid boundary located near the wall”. As such, it is deemed that the claimed sensor is not differentiated from the sensor of McPeak (see MPEP §2114). The boundary is interested as the cells that pass through in the direction of the outlet.
Allowable Subject Matter
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach “the flat bottom surface of the separation device is inclined with respect to the bottom side of the microfluidic device, towards the further chamber such that gravity facilitates transport of a sample in the further chamber the further chamber inclined together towards the further chamber”. Specifically, the prior art does not teach the separation device comprising an inclined surface with respect to the bottom of the microfluidic device such that gravity facilitates transport of the sample into the further chamber. The Examiner notes that claim 6 is dependent upon claim 5 which is further dependent upon claim 4. All limitations from the claims would be required if rewritten into claim 1. Shinoda (US 20100123457 A1) teaches a microfluidic wherein the flat bottom surface of a channel is angled with respect to the microfluidic device. However, the channel is unable to facilitate separation through gravity.
Response to Arguments
Applicant's arguments have been fully considered, and some of the arguments are not found to be persuasive. The non-persuasive arguments are addressed below.
In the Applicant’s arguments, on page pages 2-3, the Applicant argues that McPeak does not teach the claim amendments of claim 1. The Examiner respectfully disagrees. Specifically, Applicant argues McPeak teaches that the detector is detecting events at the outlet port. Claim 1 recites that the microfluidic device comprises “at least one separation chamber with an inlet and an outlet”. The outlet is a portion of the separation chamber, thus the limitation is met. Furthermore, the limitation is directed to the function of the sensor which is deemed that the claimed sensor is not differentiated from the sensor of McPeak (see MPEP §2114).
In the applicant’s arguments on pp 3-6, the arguments regarding the dependent claims merely refer back to the teachings of the references not meeting independent claim 1. However, the arguments regarding claim 1 are addressed above.
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 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, Curtis Mayes can be reached at (571) 272-1234. 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
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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