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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 July 2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks page 6, filed 10 June 2026, with respect to the rejection(s) of claim(s) 1 -3, 5, 7 – 9, 11, and 16 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Thakore et al (EP 0408223 A1, cited on the IDS submitted 29 December 2022) and further in view of Mai et al (US 20190366336 A1).
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.
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 1 – 3, 5, 7, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Thakore et al (EP 0408223 A1, cited on the IDS submitted 29 December 2022) and further in view of Mai et al (US 20190366336 A1).
With regards to claim 1, Thakore et al teaches;
The claimed “an assay device for analyzing a blood fluid sample” has been read on the taught (Abstract, “The present invention involves a method and device for obtaining plasma from whole blood and determining one or more analytes contained therein.”);
The claimed “a metering stack configured to collect the blood fluid sample into a channel via capillary action” has been read on the taught (Column 10, line 55, “…physical transport medium 19 is now channels or grooves established in substrate 17 itself.”; Physical transport medium 19 reads on a metering stack);
The claimed “a separation membrane” and “wherein the separation membrane separates red blood cells from the blood fluid sample” have been read on the taught (Column 5, line 57, “…the present invention utilizes tangential flow of blood underneath a suitable microporous plasma separation membrane so that the red cells are retained on the underside but clean plasma is obtained on the top surface of the membrane.”);
The claimed separation membrane “containing a first reagent for precipitating a first protein contained in the blood fluid sample” has been read on the taught (Column 9, line 56, “The precipitants, for example, can be incorporated within the microporous plasma separation membrane…”);
The claimed “wherein the first reagent comprises a polyanionic non-high density lipoprotein binding reagent” has been read on the taught (Column 10, line 11, “…precipitation steps using precipitants such as […] dextran sulfate…”; [0070] of the instant specification teaches that a sulfonated polysaccharide is a polyanionic non-high density lipoprotein binding reagent. Dextran sulfate reads on a sulfonated polysaccharide.).
The claimed “a detection membrane configured to elicit a quantifiable response in the presence of a second protein present in the blood fluid sample” has been read on the taught (Column 4, line 42, “This test membrane is capable of reacting with the plasma (i.e. one of its components) to display at least one analyte characteristic thereof.”);
The claimed detection membrane “wherein the quantifiable response corresponds to an amount of the second protein present in the detection membrane” has been read on the taught (Column 4, line 45, “Preferably, colori-metric reaction takes place and color intensity indicates concentration level of the analyte in the blood.”; Column 9, line 16, “For analyzing analytes such as albumin or other proteins…”);
The claimed “wherein the separation membrane concurrently precipitates the first protein and separates the red blood cells from the blood fluid sample that reaches the detection membrane” has been read on the taught (Column 9, line 56, “The precipitants, for example, can be incorporated within the microporous plasma separation membrane […] so that the precipitation step occurs on-line and the plasma reaching the test membrane is free of the interferent.”).
Thakore et al does not explicitly disclose wherein the first reagent is present in the separation membrane at a concentration ranging from about 0.7 milligrams/square centimeter to about 10 milligrams/square centimeter based on a dry weight of the first reagent present on the separation membrane.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thakore et al with a first reagent concentration ranging from about 0.7 milligrams/square centimeter to about 10 milligrams/square centimeter based on a dry weight of the first reagent present on the separation membrane, as optimization of a results-dependent variable. In the case of the instant invention, one of ordinary skill in the art would be motivated by the differing dry weights of possible first reagents, the differing binding efficiencies of possible first reagents, the differing detection efficiencies of possible detection membranes, possible cross-talk between the first reagent and the detection membrane, and different sample concentrations to optimize the concentration of the first reagent based on the result of the detected signal from the detection membrane.
However, Thakore et al does not explicitly disclose wherein the assay device further comprises a compressible spacer material positioned between the metering stack and the assay stack, wherein the compressible spacer material is configured to provide a gap between the metering stack and the assay stack so as to prevent the blood fluid sample from flowing from the metering stack to the assay stack when the assay device is in an uncompressed state.
In the analogous art of layered and microfluidic blood analyzers, Mai et al teaches;
The claimed “an assay device for analyzing a blood fluid sample” has been read on the taught ([0047], “In some embodiments, the target analyte is blood, and the cartridge can be used to collect a sample of blood from a skin prick and deliver the sample to the assay stack consistently with minimal user intervention.”);
The claimed “a metering stack configured to collect the blood fluid sample into a channel via capillary action” has been read on the taught ([0028], “The cartridge includes a metering stack configured to receive and distribute a target analyte along a first channel.”);
The claimed “an assay stack” has been read on the taught ([0028], “The cartridge further includes an assay stack comprising at least one assay component that includes one or more assay pad.”);
Mai et al further teaches wherein the assay device may be used for separation of a blood sample, as read on the taught ([0053], “For example, when the target analyte is blood, the pores of the porous or mesh material may be of a size that is suitable for separating erythrocytes from other blood components, such as plasma.”)
The claimed “a compressible spacer material positioned between the metering stack and the assay stack, wherein the compressible spacer material is configured to provide a gap between the metering stack and the assay stack so as to prevent the blood fluid sample from flowing from the metering stack to the assay stack when the assay device is in an uncompressed state” has been read on the taught ([0042], “The spacer material 225 is a compressible layer that may be positioned between the metering stack 224 and assay stack 22… When the spacer material 225 is compressed, the metering stack 224 and assay stack 226 can come into contact with or brought into close proximity to each other.”; [0043], “The compression of the spacer layer causes a predetermined volume of at least a portion of the collected target analyte to flow to assay components in the assay stack.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blood assay device as taught by Thakore et al with the compressible spacer as taught by Mai et al, for the predictable benefit of preventing a chemical reaction from occurring before the desired start time, as taught by Mai et al ([0042], “…the separation between the metering stack and the assay stack prevent a chemical reaction from starting during the target analyte collection step.”; [0043], “In this way, the act of compressing the metering and assay stacks together can, in certain embodiments, provide a well-defined point in time that marks the start of the assays of the assay components in the assay stack.”).
With regards to claim 2, the device of claim 1 is obvious over Thakore et al in view of Mai et al.
Thakore et al additionally teaches;
The claimed “wherein the first reagent is not immobilized on the separation membrane” has been read on the taught (Column 15, line 50, “…in this case was first soaked in an aqueous 20% by weight solution of PEG 2000 ( a precipitating agent for LDL and VLDL cholesterol) and allowed to dry prior to use.”; A solution soaking and being allowed to dry reads on the reagent not being immobilized on the separation membrane.).
With regards to claim 3, the device of claim 1 is obvious over Thakore et al in view of Mai et al.
Thakore et al additionally teaches;
The claimed “wherein the first protein comprises a non-high density lipoprotein, wherein the second protein comprises a high density lipoprotein” has been read on the taught (Column 10, line 8, “An application that makes use of the precipitation step is the measurement of high density lipoprotein cholesterol (HDL cholesterol) which typically needs precipitation steps […] to precipitate out cholesterol in low density and very low density lipoproteins (LDL and VLDL), followed by centrifugation. The present invention device achieves this on-line by loading the precipitant into the microporous plasma separation membrane.”; Measurement of high density lipoprotein cholesterol reads on the second protein comprising a high density lipoprotein. Precipitation of LDL and VLDL reads on the first protein comprising a non-high density lipoprotein.).
With regards to claim 5, the device of claim 1 is obvious over Thakore et al in view of Mai et al.
Thakore et al additionally teaches;
The claimed “wherein the separation membrane includes pores having a pore size ranging from about 0.1 micrometers to about 7.5 micrometers” has been read on the taught (Column 6, line 41, “In general, suitable pore-sizes of such mem-branes should be between about 0.02 to 10 microns, with the preferred range between 1 to 5 microns.”; The preferred range being between 1 and 5 microns reads on the separation membrane being between 0.1 micrometers to about 7.5 micrometers).
With regards to claim 7, the device of claim 1 is obvious over Thakore et al in view of Mai et al.
Thakore et al additionally teaches;
The claimed “wherein the first reagent comprises a sulfonated polysaccharide, heparin, or phosphotungstic acid” has been read on the taught (Column 10, line 11, “…precipitation steps using precipitants such as […] dextran sulfate…”; Dextran sulfate reads on a sulfonated polysaccharide.).
With regards to claim 11, the device of claim 1 is obvious over Thakore et al in view of Mai et al.
Thakore et al additionally teaches;
The claimed “wherein the separation membrane comprises a polysulfone, a polyethersulfone, a polyarylsulfone, a nylon, a nitrocellulose, cellulose filter paper, glass fiber, or a combination thereof” has been read on the taught (Column 6, line 37, “… a 5 micron microporous membrane made from nitrocellulose of Schleicher and Schuell (Keene, New Hampshire) performed optimally in separating plasma from whole blood.”; A microporous membrane made from nitrocellulose reads on the separation membrane comprising a nitrocellulose.).
With regards to claim 16, the device of claim 1 is obvious over Thakore et al in view of Mai et al.
Thakore et al additionally teaches;
The claimed “wherein the quantifiable response in the presence of a second protein present in the blood fluid sample comprises a color change of at least a portion of the detection membrane” has been read on the taught (Column 5, line 42, “The present invention plasma separation method can be utilized for colorimetric detection of blood analytes.”; Colorimetric detection reads on the response comprising a color change.).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Thakore et al (EP 0408223 A1) in view of Mai et al (US 20190366336 A1) and further in view of Jones (US 20040235182 A1).
With regards to claim 8, the device of claim 7 is obvious over Thakore et al in view of Mai et al.
Thakore et al additionally teaches the use of a Group II cation with a precipitant, as read on the taught (Column 10, line 13, “…precipitants such as […] magnesium tungstate…”).
However, neither Thakore et al nor Mai et al explicitly teach wherein the first reagent comprising a sulfonated polysaccharide, heparin, or phosphotungstic acid further comprises a Group II cation selected from the group of Mg, Mn, and Ca.
In the analogous art of assay devices for blood analysis, Jones teaches;
The claimed “the first reagent comprising a sulfonated polysaccharide, heparin, or phosphotungstic acid” and “wherein the first reagent further comprises a Group II cation selected from the group of Mg, Mn, and Ca” has been read on the taught ([0032], “The reagent pad […] contains at least one reagent effective to selectively remove LDL and VLDL particles from the fluid sample… Such reagents, which are known in the art, include sulfonated polysaccharides, heparin, and phosphotungstate, in the presence or absence of a group II cation, such as Mg2+, Mn2+, or Ca2+.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the precipitant reagent as taught by Thakore et al with the specific sulfonated polysaccharide in the presence of a group II cation as taught by Jones. Per MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Thakore et al teaches a device including a precipitating reagent. The prior art of Jones teaches the use of a specific precipitating reagent, and the only different between the claimed invention and the prior art is the lack of the combination. One of ordinary skill in the art could have combined the elements as claimed by the known methods, for the predictable result of removing non-high density lipoproteins from the plasma.
With regards to claim 9, the device of claim 8 is obvious over Thakore et al in view of Mai et al and further in view of Jones.
Neither Thakore et al nor Mai et al explicitly disclose wherein the first reagent comprises phosphotungstic acid and Mg.
Jones additionally teaches;
The claimed “wherein the first reagent comprises phosphotungstic acid and Mg” has been read on the taught ([0032], “The reagent pad […] contains at least one reagent effective to selectively remove LDL and VLDL particles from the fluid sample… Such reagents, which are known in the art, include sulfonated polysaccharides, heparin, and phosphotungstate, in the presence or absence of a group II cation, such as Mg2+, Mn2+, or Ca2+.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the precipitant reagent as taught by Thakore et al with the specific sulfonated polysaccharide in the presence of a group II cation as taught by Jones. Per MPEP 2143(I)(A), combining prior art elements according to known methods to yield predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Thakore et al teaches a device including a precipitating reagent. The prior art of Jones teaches the use of a magnesium phosphotungstate, and the only different between the claimed invention and the prior art is the lack of the combination. One of ordinary skill in the art could have combined the elements as claimed by the known methods, for the predictable result of removing non-high density lipoproteins from the plasma.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
