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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18 in the reply filed on May 13, 2026 is acknowledged.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 13, 2026.
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 (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 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, 2, 6, 7, 8, 9, 13, 15, and 17 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Peytavi (US 8444934 B2).
Regarding claim 1, Pevtavi teaches “A flow cell assembly comprising:” (Abstract, A microfluidic flow cell);
“a first solid support”;
“a resist attached to the first solid support, wherein the resist is a polydimethylsiloxane (PDMS), poly(methyl methacrylate) (PMMA), cyclic olefin copolymer (COC), silsesquioxane resist, an epoxy-based polymer resist, poly(vinylpyrrolidone-vinyl acrylic acid) copolymer resist, an Off-stoichiometry thiol-enes (OSTE) resist, amorphous fluoropolymer resist, a crystalline fluoropolymer resist, polysiloxane resist, or an organically modified ceramic polymer resist;” (col. 9 lines 47-48, The microfluidic flow cell 10 is a PDMS substrate unit 11)
“a coupling agent attached to the resist;” (col. 16 lines 59- col. 17 lines 7 and col. 22 lines 27-28, Preparation of Glass Slides, The amine modified slides were activated by overnight sonication in 1,4-dioxane (40 mL) containing 0.32 g (2 mmol) of carbonyldiimidazole as the coupling agent, followed by washing with dioxane and diethyl ether, and drying under a stream of nitrogen. The microfluidic device according to 1, wherein said substrate comprises glass.).
The recitation “a cell or tissue attached to the coupling agent” is capability of the flow cell. Peytavi teaches a sample within the reaction chamber which is the reaction chamber on the coupling agent and therefore is capable of also attaching a cell or tissue. The sample within the reaction chamber is taught within (col. 6 lines 24-26, placing at least one sample fluid product within the network and at least one reacting product in one of the network and the reaction chamber).
Peytavi further teaches “a second solid support attached to the first solid support,” (col. 9 lines 48-49, With engraved microfluidic network N applied to support 12); “wherein the second solid support is configured to define a reaction chamber when attached to the first solid support.” (col. 9 lines 40-41 and col. 11 lines 1-9, Reaction chamber 14. microfluidic device 132 having removable member 134 in the form of a removably positioned on a microfluidic flow cell 136. The reaction chamber 138 is defined by a cavity 140, formed within the microfluidic flow cell 136 and by the enclosure member 134 when interfaced therewith.).
Regarding claim 2, Peytavi teaches all of claim 1 as above in addition to “further comprising a frame configured to retain the flow cell assembly.” (col. 14 lines 28-31, The microfluidic device 40 (glass slide 12 and PDMS 11) was introduced into a custom-made plastic disc shape support 42 comprising an opening and fixed on the actuator hub 174 of a motor M.).
Regarding claim 6, Peytavi teaches all of claim 1 as above in addition to “wherein the second solid support comprises a channel bored into the second solid support.” (col. 9 lines 46-49, With engraved microfluidic network N applied to support 12).
Regarding claim 7, Peytavi teaches all of claim 1 as above in addition to “wherein the second solid support comprises a gasket, wherein the gasket defines the reaction chamber.” (col. 11 lines 10-18, FIG. 9 shows a microfluidic flow device 146 having a removable member 148 in the form of seal which, when interfaced with the microfluidic flow cell 150 at the cavity 152 thereof, defines the reaction chamber 154. Again as before, the conduit 156 and the fluid-receiving portion 158 may be cavities enclosed by the removable seal member 148 or may be fully formed within the microfluidic flow cell 150. The seal 148 may be mounted to the microfluidic flow cell 150 by a variety of adhesive materials as is known in the art.). Therefore the seal that defines the reaction chamber is the gasket.
Regarding claim 8, Peytavi teaches all of claim 7 as above in addition to “wherein the gasket comprises silicone, polyimide, fluorocarbon elastomer, ethylene propylene diene, polychloroprene, polytetrafluoroethylene, nitrile rubber, butyl rubber, natural rubber, thermoplastic elastomer, or a combination thereof.” (col. 2 lines 17-19, Channels and chambers are microfabricated in a base of silicon, hard plastic or soft elastomers such as PDMS (Poly-dimethylsiloxane).
Regarding claim 9, Peytavi teaches all of claim 1 as above in addition to “further comprising 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 reaction chambers.” (col. 11, lines 56-59, microfluidic device having one or more individual chambers connected with one or several reaction chamber(s).
Regarding claim 13, Peytavi teaches all of claim 1 as above in addition to “ wherein the second solid support is attached to the first solid support via a pressure sensitive adhesive.” ( col. 4 line 60- col. 5 line 3, col. 14 lines 20-23, and col. 11 lines 10-18, In an embodiment, the microfluidic flow cell is adapted to be actuated so as to provide for the fluid in the fluid-receiving portion to flow to the reaction chamber. In an embodiment, this actuation is provided by forces selected from the group consisting of: gravity, centrifugation, capillary force, centripetal force, gas-pressure, electro-osmosis, DC and AC electrokinetics, electrophoresis, electrowetting, magnetic force, acoustic force, pneumatic drive force, mechanical micropump force, positive and negative displacement force, thermal force, electrochemical bubble generation force, and combinations thereof.
The PDMS substrate 11 is aligned and reversely bound to a microarray (not shown) printed onto a glass slide 12 by applying pressure to form a functional microfluidic device 40. FIG. 9 shows a microfluidic flow device 146 having a removable member 148 in the form of seal which, when interfaced with the microfluidic flow cell 150 at the cavity 152 thereof, defines the reaction chamber 154. Again as before, the conduit 156 and the fluid-receiving portion 158 may be cavities enclosed by the removable seal member 148 or may be fully formed within the microfluidic flow cell 150. The seal 148 may be mounted to the microfluidic flow cell 150 by a variety of adhesive materials as is known in the art.). Therefore the gas- pressure along with the seal of an adhesive material teaches to both solid supports are attached via a pressure sensitive adhesive.
Regarding claim 15, Peytavi teaches all of claim 1 as above in addition to “wherein the first solid support or the second solid support comprises an inlet port and an outlet port.” (col. 14 line 49 and col. 5 lines 26-27, a sample inlet 18, fluid outlet in communication with said reaction chamber.).
Regarding claim 17, Peytavi teaches all of claim 1 as above in addition to “wherein the first solid support further comprises a plurality of particles.” (col. 15 lines 32-33 and col. 1 lines 49 and 50, The probes or samples could be on bead or particles located on the support. The biomolecule binds to a specific probe attached onto the solid support).
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.
Claims 3-5, 10-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Peytavi (US 8444934 B2) as applied to claims 1 and 2 and in further view of Kovacs et. al. (US 20210190668 A1).
Regarding claim 3, Peytavi teaches all of claim 2 as above in addition to teaching a magnetic force within col. 4 line 66 but does not explicitly teach “wherein the frame comprises a ferromagnetic pin”.
Kovacs teaches a flow cell carrier in addition to “wherein the frame comprises a ferromagnetic pin” (Para [0008], The frame can be further configured to provide a gap between a work surface and the flow cell. The frame further can include at least one ferromagnetic pin. ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Kovacs wherein the frame has a ferromagnetic pin. Doing so allows the flow cell to be used with magnetic beads which can increase fluid mixing and increase samples and reagents to be used with the flow cell making the flow cell more versatile.
Regarding claim 4, Peytavi teaches all of claim 1 as above in addition to teaching a biochip within col. 18 line 4 but does not explicitly teach “further comprising a microchip”.
Kovacs teaches “further comprising a microchip” (Para [0008], The at least one biasing feature can be a tab. The flow cell can further include a microchip.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Kovacs by having a microchip. Doing so allows for decreased reagent and sample consumption.
Regarding claim 5, modified Peytavi teaches all of claim 4 as above however Peytavi does not teach “wherein the microchip is an electronically erasable programmable read only memory (EEPROM) chip.”.
Kovacs teaches “wherein the microchip is an electronically erasable programmable read only memory (EEPROM) chip.” (Para [0008], The microchip can be an electronically erasable programmable read only memory (EEPROM) chip.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Kovacs by having a microchip. Doing so allows the flow cell to track its use for future data analysis to optimize future uses.
Regarding claim 10, Peytavi teaches all of claim 1 as above however Peytavi does not teach “wherein the reaction chamber comprises a depth of about 50 µm to about 150 µm.”.
Kovacs teaches “wherein the reaction chamber comprises a depth of about 50 µm to about 150 µm.”. (Para [0051], Additionally, the flow cell can include channels of different depths and/or widths (different both between channels in different flowcells and different between channels within the same flow cell). For example, while the channels may be 50 μm deep, 100 μm deep, or 500 μm deep.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Kovacs by having a reaction chamber comprises a depth of about 50 µm to about 150 µm. Doing so allows for increase binding within the reaction chamber.
Regarding claim 11, Peytavi teaches all of claim 1 as above however Peytavi does not teach “wherein the reaction chamber comprises a depth of about 80 µm to about 110 µm.”.
Kovacs teaches “wherein the reaction chamber comprises a depth of about 80 µm to about 110 µm.”. (Para [0051], Additionally, the flow cell can include channels of different depths and/or widths (different both between channels in different flowcells and different between channels within the same flow cell). For example, while the channels may be 50 μm deep, 100 μm deep, or 500 μm deep.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Kovacs by having a reaction chamber comprises a depth of about 80 µm to about 110 µm. Doing so decrease the changes of sample blockage and clogging within the reaction chamber.
Regarding claim 12, Peytavi teaches all of claim 1 as above however Peytavi does not teach “wherein the reaction chamber comprises a width of about 4 µm to about 15 µm.”.
Kovacs teaches “wherein the reaction chamber comprises a width of about 4 µm to about 15 µm.” (Para [0053], where the lane or channel has depth, it is between 10-300 microns, (e.g., between 10 and 150 microns deep).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Kovacs by having a reaction chamber comprises a width of about 4 µm to about 15 µm. Doing so is known in the art for its single-cell analysis and decreases the operating cost of the flow cell by minimizing the sample and reagent volume needed.
Regarding claim 14, Peytavi teaches all of claim 1 as above however Peytavi does not teach “wherein the tissue is embedded in an embedding material comprising paraffin wax, polyepoxide polymer, polyacrylic polymer, agar, gelatin, celloidin, cryogel, optimal cutting temperature (OCT) compositions, glycols, or a combination thereof.”. Peytavi discloses the positively claimed structural elements of the flow cell as claimed, such flow cell are said to be fully capable of the recited adaption in as much as recited and required herein. Further Kovacs teaches surfaces in contact with gels, polymers and polymers within (Para [0055]) and further show capability of a flow cell comprising gels and polymers.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Peytavi (US 8444934 B2) as applied to claim 1 and in further view of Wagner et. al. (US 20190187043 A1).
Regarding claim 16, Peytavi teaches all of claim 1 as above but does not teach “wherein the first solid support or the second solid support further comprises an IR reflective coating.”.
Wagner teaches flow and cells and are measured from multiple angles in addition to “wherein the first solid support or the second solid support further comprises an IR reflective coating.” (Para [0194], [0194] FIG. 7 shows another embodiment of the present disclosure, where cells are measured in a dry state. In this embodiment, a continuous tape is used as a substrate for the cells for measurement and separation. The tape may be metal-coated to provide high reflectivity in the mid-infrared.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Wagner by the first solid support or the second solid support further comprises an IR reflective coating. Doing so allows the reactions and samples to be shielded from increase temperatures.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Peytavi (US 8444934 B2) as applied to claim 1 and in further view of Krug (US 20160091410 A1).
Regarding claim 18, Peytavi teaches all of claim 1 as above but does not teach “wherein the coupling agent comprises (3-aminopropyl)triethoxysilane (APTES), (3-Aminopropyl)trimethoxysilane (APTMS), γ-Aminopropylsilatrane (APS), N-(6-aminohexyl)aminomethyltriethoxysilane (AHAMTES), polyethylenimine (PEI), 5,6-epoxyhexyltriethoxysilane, or triethoxysilylbutyraldehyde, or a combination thereof.”.
Krug teaches cell processing using magnetic particles in addition to “wherein the coupling agent comprises (3-aminopropyl)triethoxysilane (APTES), (3-Aminopropyl)trimethoxysilane (APTMS), γ-Aminopropylsilatrane (APS), N-(6-aminohexyl)aminomethyltriethoxysilane (AHAMTES), polyethylenimine (PEI), 5,6-epoxyhexyltriethoxysilane, or triethoxysilylbutyraldehyde, or a combination thereof.” (Para [0191], Coupling of proteins and ligands to the particle surfaces: Ligand attachment on silica-coated magnetic nanoparticles may be completed using (3-aminopropyl)triethoxysilane (APTS) to introduce amines on the particle surface while (3-mercaptopropyl)triethoxysilane (MPTMS) introduces SH groups. The heterobifunctional coupling agent (Succinimidyl 4-[N-maleimidomethyl]cyclohexane-1-carboxylate) may then be used to link thiols to the amines. As examples, amines on the particle surface may be linked to thiols on streptavidin molecules.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Peytavi to incorporate the teachings of Krug wherein the coupling agent is 3-aminopropyl)triethoxysilane. Doing so increases stability and versatility of the flow cell.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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