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 .
Claim Rejections - 35 USC § 102
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 1-14 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Numajiri (US 20080206852 A1).
Regarding claim 1, Numajiri teaches a system for measuring a biological sample (sample processing apparatus used for analyzing samples, see [0002]) comprising:
a sample collection vessel (container 1, see Fig. 1 and [0026]) and
a removable analysis cartridge that is removable from the sample collection vessel (microfluidic device 16, see Fig. 2 and [0029])
Regarding claim 2, Numajiri teaches the system of claim 1, wherein the sample collection vessel (1) comprises one or more holes that allow the biological sample to flow from a sample holding potion of the sample collection vessel onto and/or into the removable analysis cartridge (channel 6 of sample container 1, see Fig. 1 and [0026] – [0027]).
Regarding claim 3, Numajiri teaches the system of claim 2, wherein the sample collection vessel comprises a slot underneath the holes and fluidly connected to the holes to house the removable analysis cartridge (device retainer 20 to hold microfluidic strip, see Fig. 2 and [0029]) wherein the removable analysis cartridge is in the form of a flat strip (microfluidic device 16, see Fig. 2), wherein the slot orients the removable analysis cartridge such that major faces of the removable analysis cartridge are perpendicular to the one or more holes (the retainer 20 holds microfluidic device perpendicular, see Fig. 2 and [0029]).
Regarding claim 4, Numajiri teaches the system of claim 1, wherein the sample collection vessel further comprises a flow locking mechanism to allow or prevent flow of the biological sample to the removable analysis cartridge (locking member 4 and sample channel 6 within sample container 1, see Fig. 1 and [0026]).
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Annotated Fig. 2B
Regarding claim 5, Numajiri teaches the system of claim 4, wherein the flow locking mechanism comprises a sample holding portion bottom layer (portion with channel 6, see annotated Fig. 2B) and a flow locking layer each comprising one or more holes (locking member 4 with channel 7, see Fig. 2A and [0027]), wherein the one or more holes of the sample holding portion bottom layer and the flow locking layer move into alignment during unlocking of the flow locking mechanism, and wherein the one or more holes of the sample holding portion bottom layer and the flow locking layer move out of alignment during locking the of the flow locking mechanism (the channels are rotated into alignment to allow flow therethrough and are rotated out of alignment to block fluid flow, see Figs. 2A-B and [0027]).
Regarding claim 6, Numajiri teaches the system of claim 4, wherein the flow locking mechanism is opened or closed by a rotational mechanism comprising a central axis that aligns with a central axis of the sample collection vessel (rotational elements 11, 12, and 5 rotate around a center to block central flow channel 6/7, see Fig. 2A-B and [0027]-[0028]).
Regarding claim 7, Numajiri teaches the system of claim 1, wherein the sample collection vessel further comprises an analysis cartridge locking mechanism that locks the removable analysis cartridge in place after insertion into the sample collection vessel and that releases the removable analysis cartridge for removal from the sample collection vessel (rotational elements 21/22 and locking member retainer 5 that lock microfluidic device and sample body together after insertion and releases microfluidic device after turning, see Fig. 2A and [0027]).
Regarding claim 8, Numajiri teaches the system of claim 7, wherein the analysis cartridge locking mechanism is opened or closed by a rotational mechanism comprising a central axis that aligns with a central axis of the sample collection vessel (plates 21 and 22 that microfluidic device and sample body together after insertion and releases microfluidic device after rotation around the center to stop flow, see Fig. 2A-B and [0027]-[0028]).
Regarding claim 9, Numajiri teaches the system of claim 7, wherein the analysis cartridge locking mechanism comprises one or more extendible pins that extend between the removable analysis cartridge and the sample collection vessel and hold the removable analysis cartridge in place in the sample collection vessel (rotatable plates 21 and 22 are used to hold microfluidic device 16 in place using grooves 9 and 10 of sample container, see Fig. 1A-2B and [0032]).
Regarding claim 10, Numajiri teaches the system of claim 7, wherein the analysis cartridge locking mechanism comprises a door that covers an opening of a slot for housing the removable analysis cartridge during locking of the analysis cartridge locking mechanism, and that exposes the opening of the slot during unlocking of the analysis cartridge locking mechanism (seal S that covers slot for microfluidic device 16 and is opened upon connection, see Fig. 1A-2B and [0062]).
Regarding claim 11, Numajiri teaches the system of claim 7, wherein the analysis cartridge locking mechanism comprises a portion underneath a slot for housing the removable analysis cartridge in the sample collection vessel that applies pressure against the removable analysis cartridge during locking of the analysis cartridge locking mechanism, and that releases the pressure during unlocking of the analysis cartridge locking mechanism (fluid outlet port 15 under locking member mechanism presses against opening of microfluidic cartridge while locked together and the pressure is released for removal after rotation, see Fig. 1A- 2B and [0032])
Regarding claim 12, Numajiri teaches the system of claim 7, wherein the analysis cartridge locking mechanism comprises a resilient member in a slot for housing the removable analysis cartridge in the sample collection vessel, wherein the resilient member pushes the removable analysis cartridge at least partially out of the slot during unlocking of the analysis cartridge locking mechanism (spring 12 in locking mechanism 5 that pushes microfluidic device 16 out of slot after rotation, see Fig. 1A-2B and [0027]).
Regarding claim 13, Numajiri teaches the system of claim 7, wherein the sample collection vessel comprises a non- reinsertion mechanism that prevents the removable analysis cartridge from being re- inserted into the sample collection vessel after the biological sample has been placed in and/or on the removable analysis cartridge by the sample collection vessel (protective seal S that prevents sample from leaving and re-entering sample container 1, see Fig. 1 and [0027]).
Regarding claim 14, Numajiri teaches the system of claim 1, wherein the analysis cartridge further comprises a microfluidic system that delivers sample volumes of the biological sample to at least one micro-well and/or sample pad on the removable analysis cartridge (microfluidic device 16 delivers sample to analysis processing portion B, see Fig. 2A and [0033]).
Regarding claim 19, Numajiri teaches a sample collection vessel (sample container 1, see Fig. 1) comprising:
one or more holes that allow a biological sample to flow from a sample holding potion of the sample collection vessel onto and/or into a removable analysis cartridge (channel 6 of sample container 1, see Fig. 1 and [0026] – [0027]),
a slot underneath the holes to house the removable analysis cartridge (device retainer 20 to hold microfluidic strip, see Fig. 2 and [0029]), a flow locking mechanism to allow and prevent flow of the biological sample to the removable analysis cartridge (locking member 4 and sample channel 6 within sample container 1, see Fig. 1 and [0026]), an analysis cartridge locking mechanism that locks the removable analysis cartridge in place after insertion into the sample collection vessel and that releases the removable analysis cartridge for removal from the sample collection vessel (rotational elements 21/22 and locking member retainer 5 that lock microfluidic device and sample body together after insertion and releases microfluidic device after turning, see Fig. 2A and [0027]).
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gurkan et al. (US 20200246794).
Regarding claim 20, Gurkan et al. teaches an analysis cartridge (cartridge electrophoresis device 20, see Fig. 1A-B and [0045]) comprising:
a flat strip comprising one or more micro-wells comprising a chemical reagent and/or preservative (the microfluidic device comprises an EDTA buffer and sulfate 32 used to preserve a sample, see Fig. 4 and [0064] and [0125]), one or more sample-absorbent pads treated with a chemical reagent (cellulose acetate test paper 80 comprises reagents for analytes of sample, see Fig. 4 and [0054]), or a combination thereof; and
an optical collection well for presentation of a biological sample for optical analysis (microchannel 30 that is transparent for optical analysis, see [0058]).
Claim Rejections - 35 USC § 103
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.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Numajiri (US 20080206852 A1) as applied above, and further in view of Gurkan et al. (US 20200246794)
Regarding claim 15, Numajiri teaches the system of claim 1, wherein the removable analysis cartridge comprises one or more micro-wells (analysis processing portion B, see Fig. 2A and [0033]), but does not teach that the well contains one or more preservatives; and/or the removable analysis cartridge comprises one or more sample-absorbent pads, wherein at least one of the sample-absorbent pads is treated with a chemical reagent.
However, in the analogous art of devices for sample introduction and analysis and diagnosis, Gurkan et al. teaches a device comprising a microfluidic device (20, see Fig. 4), wherein at least one of the micro-wells contain one or more preservatives (the microfluidic device comprises an EDTA buffer 32 used to preserve a sample, see Fig. 4 and [0125]); and/or
the removable analysis cartridge comprises one or more sample-absorbent pads, wherein at least one of the sample-absorbent pads is treated with a chemical reagent (cellulose acetate test paper 80 comprises reagents for analytes of sample, see Fig. 4 and [0054]).
While the invention of Numajiri does not teach that the microfluidic device comprises a preservative or a sample absorbent pad, the invention does teach that the microfluidic device is used to complete a composition analysis of substances contained in the sample fluid, as exemplified by Gurkan et al.
Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the invention of Numajiri to incorporate the microfluidic device of Gurkan et al. for the benefit of providing a test strip for the quantitative analysis for a biological fluid, see [0003] and [0016]. Further, the modification of the invention of Numajiri to incorporate the microfluidic device of Gurkan et al. would not have deviated from the scope or structure of each invention as they are both drawn to microfluidic devices and would have resulted in the predictable result of providing a suitable analysis platform for a biological sample.
Regarding claim 16, Numajiri teaches the system of claim 1, wherein the removable analysis cartridge comprises another chamber (see Fig. 2A), but does not teach that the microfluidic device comprises an optical collection well for presentation of the biological sample for optical analysis.
However, in the analogous art of microfluidic devices for sample analysis, Gurkan et al. teaches a device that comprises an optical collection well for presentation of the biological sample for optical analysis (microchannel 30 that is transparent for optical analysis, see [0058]).
While the invention of Numajiri does not teach that the microfluidic device comprises an optical collection well for presentation of the biological sample for optical analysis, the invention does teach that the microfluidic device is used to complete a composition analysis of substances contained in the sample fluid, as exemplified by Gurkan et al.
Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the invention of Numajiri to incorporate the microfluidic device of Gurkan et al. for the benefit of providing a reading window for the quantitative analysis for a biological fluid, see [0003] and [0016]. Further, the modification of the invention of Numajiri to incorporate the microfluidic device of Gurkan et al. would not have deviated from the scope or structure of each invention as they are both drawn to microfluidic devices and would have resulted in the predictable result of providing a suitable analysis platform for a biological sample.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Numajiri (US 20080206852 A1) as applied above, and further in view of Jones et al. (US 20170328924 A1).
Regarding claim 17, Numajiri teaches the system of claim 1, but does not teach that the system further comprises an analyzer for measuring features of the biological sample, the analyzer comprising an imaging module.
However, in the analogous art of valved microfluidic analyzers, Jones et al. teaches a microfluidic device that is developed for measuring elements of a biological sample within a test strip comprising an analyzer comprising a camera, see [0098], where the camera is used to quantify a cell within a microfluidic cartridge, see [0006].
The modification of the device of Numajiri to include the analyzer of Jones et al. would not have deviated in either invention’s scope as both inventions are drawn to the analysis of a biological sample within a pass-through microfluidic device. Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the invention of Numajiri to incorporate the imaging analyzer of Jones et al. for the benefit of providing a record of test results and to decrease the test cartridge processing time as both inventions are drawn to the quantification of a target analyte, see [0098] in Jones et al. The modification of the invention of Numajiri to incorporate the camera/imaging analyzer of Jones et al. would have resulted in the predictable result of interpreting the results of an analysis within a microfluidic device.
Regarding claim 18, modified Numajiri teaches the system of claim 17, wherein the analyzer further comprises a processor configured with instructions stored on a non-transitory computer readable medium to (analyzer comprises result processor 115, see [0055] in Jones et al.), when executed, cause the processor to perform acts comprising:
obtaining one or more measurements of the biological sample (results processor obtains results of analysis, see [0055]); and
interpolating a result from the one or more measurements (results processor determines results of analysis, see [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758