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 Arguments
Applicant’s arguments, see Remarks page 9, filed 30 June 2026, with respect to the objections to the drawings have been fully considered and are persuasive in light of the amendments. The objections to the drawings have been withdrawn.
Applicant's arguments filed 30 June 2026 have been fully considered but they are not persuasive.
The examiner acknowledges that a specific mapping was not provided for the limitation “a capillary volume,” and apologizes for the typographical error. However, the examiner’s initial action does include reference to Figure 1C, which shows the capillary conduits of the microfluidic device. The rejection under 35 U.S.C. 102 and 103 are revised for clarity of the record and to address the newly added limitations. No new references or embodiments are relied upon.
Status of Claims
Applicant's amendments to the claims filed 30 June 2026 have been entered. Applicant's remarks filed 30 June 2026 are acknowledged.
Claims 1 and 10 are in status “Currently amended.” Claims 2 – 9, 11, and 12 are in status “Original” or “Previously presented.” Claims 13 and 14 are withdrawn as non-elected subject matter.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, and 7 – 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Escajeda et al (US 20230193366 A1, effectively filed 30 July 2020)
With regards to claim 1, Escajeda et al teaches;
The claimed “a plurality of interconnected volumes” has been read on the taught ([0004], “…the planar body comprising a sample chamber, optionally a lysis reservoir (or lysis buffer chamber), a first conduit, at least one reagent chamber, at least one metering chamber, at least one mixing chamber and at least one detection chamber…”; the variety of chambers reads on a plurality of interconnected volumes; see also Figure 1C detailing connections);
The claimed “a bulk fluid volume” has been read on the taught ([0004], “…the planar body comprising a sample chamber…”; The sample chamber reads on a bulk fluid volume);
The claimed “capillary volume” has been read on the taught ([0073], “…features of a microfluidic device have cross-sectional dimensions of less than a few hundred square micrometers and have passages, or channels, with capillary dimension…”; [0004], “…the planar body comprising […] a first conduit…”; A first conduit reads on a capillary volume.);
The claimed “the capillary volume having a smaller cross-section than a cross-section of that bulk fluid volume” has been read on the taught (Figure 1C shows sample chamber 1206 having a larger cross section than conduit 1208. See also [0073], which discusses the cross-sectional dimensions of the conduits of a microfluidic device.);
The claimed “the bulk fluid volume being upstream of the capillary volume” has been read on the taught ([0039], “The above configuration allows sample fluid (illustrated by gray shading) to move by the force of gravity (1235) from sample chamber (1206) through first conduit (1208)…”)
The claimed “a reservoir of reconstitution buffer positioned outside the plurality of interconnected volumes” has been read on the taught ([0039], “…one or more, or all, bioassay reagents may be stored in a blister pouch that releases the bioassay reagents by mechanical actuation…”);
The claimed “a buffer inlet chamber” has been read on the taught ([0004], “…the planar body comprising a […] a lysis reservoir (or lysis buffer chamber)…”; The lysis buffer chamber reads on a buffer inlet chamber.);
Escajeda et al additionally teaches that rehydration buffer may be stored in a reagent chamber and that multiple reagent chambers may be present in a given device (see [0010]);
The claimed “a reactant chamber connected to the buffer inlet chamber by a fluid channel, wherein the reactant chamber contains a reactant” has been read on the taught ([0010], “…the reagent chamber contains assay reagents for performing the analytical reaction.”; The reagent chamber reads on a reactant chamber);
The claimed “a reactant injection channel connecting the reactant chamber to the capillary volume” has been read on the taught ([0010], “…the reagent chamber contains assay reagents for performing the analytical reaction and is connected to the bottom of the metering chamber by a passage…”);
The limitations of “to receive a density gradient column,” to “receive the reconstitution buffer from the reservoir of the reconstitution buffer,” and “to inject the reconstitution buffer and reactant into the capillary volume” are functional language and have been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Escajeda et al teaches all of the structural limitations of the apparatus as defined in claim 1, these additional limitations do not define the instant application over the prior art.
With regards to claim 2, the device of claim 1 is anticipated by Escajeda et al.
Escajeda et al additionally teaches;
The claimed “wherein the reactant comprises dried PCR master mix reactants” has been read on the taught ([0056], “…an embodiment having a reagent chamber comprising a blister pack and a mixing chamber comprising dried reagents.”; [0059], “…cartridges of the invention may be used with a variety of assays for biomolecules, including polymerase chain reactions (PCRs)…”; [0071] teaches the variety of dried reagents possible for use.);
The limitation “wherein the reconstitution buffer is to reconstitute the dried PCR master mix” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Escajeda et al teaches all of the structural limitations of the apparatus as defined in claim 2, this additional limitation does not define the instant application over the prior art.
With regards to claim 7, the device of claim 1 is anticipated by Escajeda et al.
Escajeda et al describes the construction of microfluidic devices in [0073], and therein incorporates by references US Patent No. 6,613,525 B2 (“Nelson et al”).
The incorporated reference of Nelson et al teaches the limitations of claim 7.
The claimed “wherein the buffer inlet chamber and the reactant chamber are formed as depressions in a surface of a solid device body, wherein a sealing layer is placed over the surface of the solid device body to enclose the depressions.” has been read on the taught (Column 11, line 24, “The devices may be fabricated using any convenient means, including conventional molding and casting techniques. […] Finally, a cover plate may be placed over, and sealed to, the surface of the substrate, thereby forming an integrated device.”; A cover plate reads on a sealing layer. Molding techniques read on a depression in the surface of a device.)
With regards to claim 8, the device of claim 7 is anticipated by Escajeda et al.
Escajeda et al additionally teaches;
The claimed “wherein the reservoir of reconstitution buffer is a flexible fluid-filled blister separated from the buffer inlet chamber by the sealing layer” has been read on the taught ([0039], “…one or more, or all, bioassay reagents may be stored in a blister pouch that releases the bioassay reagents by mechanical actuation…”).
With regards to claim 9, the device of claim 1 is anticipated by Escajeda et al.
Escajeda et al additionally teaches;
The claimed “a solid material in the buffer inlet chamber to reduce available volume in the buffer inlet chamber, wherein the solid material is not soluble in the reconstitution buffer” has been read on the taught ([0004], “In some embodiments, microfluidics and nanofluidics devices may further include […] filters […], e.g. to prevent adsorption of sample components or reactants, facilitate reagent movement by electroosmosis, or the like.”; A filter reads on a solid material. [0046] describes other chambers which may have filters.);
The limitations of “to reduce available volume in the buffer inlet chamber” is functional language and have been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Escajeda et al teaches all of the structural limitations of the apparatus as defined in claim 9, these additional limitations do not define the instant application over the prior art.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3 – 5, 10, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Escajeda et al (US 20230193366 A1).
Escajeda et al teaches a variety of arrangements of channels, valves, and chambers, as in [0073], which describes the basic arrangements of microfluidic devices.
Escajeda et al further teaches that the device may include components arranged so as to ensure specific metering chambers are completely filled with fluid, as read on the taught ([0031], “A feature of some embodiments of the cartridges (when inserted into an appliance) is that components (i.e. passages, chambers and vent ports) are spatially arranged so that a released lysis buffer reaches a predetermined level in the cartridge under gravity and the predetermined level is selected to ensure that each metering chamber is entirely filled with lysis buffer (containing the biomolecule of interest if present in the sample).”);
MPEP 2144.04(VI)(C) teaches that the rearrangement of parts may be prima facie obvious, especially in cases of obvious matters of design choice; please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
With regards to claim 3, the device of claim 1 is anticipated by Escajeda et al.
Regarding the limitation of “wherein the fluid channel connects the reactant chamber to the buffer inlet chamber such that reconstitution buffer flows to the reactant chamber after the reconstitution buffer flows into the buffer inlet chamber,” this would amount to the blister containing buffer being released into a metering chamber such as described in [0031], “A feature of some embodiments of the cartridges (when inserted into an appliance) is that components (i.e. passages, chambers and vent ports) are spatially arranged so that a released lysis buffer reaches a predetermined level in the cartridge under gravity and the predetermined level is selected to ensure that each metering chamber is entirely filled with lysis buffer (containing the biomolecule of interest if present in the sample).”
Given these teachings, 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 as taught by Escajeda et al with the limitation of claim 3, for the predictable result of allowing the buffer to reach a predetermined level within the cartridge before interacting with reagents (see [0031] and [0042]).
With regards to claim 4, the device of claim 3 is obvious over Escajeda et al.
Regarding the limitation of “wherein the fluid channel connects to the buffer inlet chamber at a top portion of the buffer inlet chamber such that the buffer inlet chamber fills up to the top portion with the reconstitution buffer before the reconstitution buffer flows through the fluid channel to the reactant chamber,” this would amount to the blister containing buffer being released into a metering chamber to reach a predetermined such as described in [0031], “A feature of some embodiments of the cartridges (when inserted into an appliance) is that components (i.e. passages, chambers and vent ports) are spatially arranged so that a released lysis buffer reaches a predetermined level in the cartridge under gravity and the predetermined level is selected to ensure that each metering chamber is entirely filled with lysis buffer (containing the biomolecule of interest if present in the sample).”
Given these teachings, 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 as taught by Escajeda et al with the limitation of claim 4, for the predictable result of allowing the buffer to reach a predetermined, metered level within the cartridge before interacting with reagents (see [0031] and [0042]).
With regards to claim 5, the device of claim 3 is obvious over Escajeda et al.
Escajeda et al further teaches;
The claimed “a gas reservoir and a gas channel connecting the gas reservoir to the fluid channel to inject gas into the fluid channel to push buffer in the fluid channel and buffer in the reactant chamber with the reactant into the capillary volume, while bypassing reconstitution buffer in the buffer inlet chamber” has been read on the taught ([0004], “An aspect of the invention is the use of a mixing chamber to pneumatically mix assay reagents of a reaction mixture by forcing a gas, e.g. air, into the bottom of the mixing chamber where it passes through the surface of the reaction mixture and is exhausted through a vent port associated with the mixing chamber.”; [0010], “The reagent vent port is capable of being sealingly connected to a valve and pump in the appliance so that the reagent port is capable of accepting air pressure for forcing the assay reagents into the bottom of metering chamber.”; The vent port reads on a gas channel. A pump in the appliances reads on a gas reservoir);
The limitation “to inject gas into the fluid channel to push buffer in the fluid channel and buffer in the reactant chamber with the reactant into the capillary volume, while bypassing reconstitution buffer in the buffer inlet chamber” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Escajeda et al teaches all of the structural limitations of the apparatus, and as modifications of rearrangement of parts may be prima facie obvious as discussed on page 6, the limitations of claim 5 do not define the instant application over the prior art.
With regards to claim 10, Escajeda et al teaches;
The claimed “a plurality of interconnected volumes” has been read on the taught ([0004], “…the planar body comprising a sample chamber, optionally a lysis reservoir (or lysis buffer chamber), a first conduit, at least one reagent chamber, at least one metering chamber, at least one mixing chamber and at least one detection chamber…”; the variety of chambers reads on a plurality of interconnected volumes; see also Figure 1C detailing connections);
The claimed “a bulk fluid volume” has been read on the taught ([0004], “…the planar body comprising a sample chamber…”; The sample chamber reads on a bulk fluid volume);
The claimed “a capillary volume” has been read on the taught ([0073], “…features of a microfluidic device have cross-sectional dimensions of less than a few hundred square micrometers and have passages, or channels, with capillary dimension…”; [0004], “…the planar body comprising […] a first conduit…”; A first conduit reads on a capillary volume.);
The claimed “the capillary volume having a smaller cross-section than a cross-section of that bulk fluid volume” has been read on the taught (Figure 1C shows sample chamber 1206 having a larger cross section than conduit 1208. See also [0073], which discusses the cross-sectional dimensions of the conduits of a microfluidic device.);
The claimed “the bulk fluid volume being upstream of the capillary volume” has been read on the taught ([0039], “The above configuration allows sample fluid (illustrated by gray shading) to move by the force of gravity (1235) from sample chamber (1206) through first conduit (1208)…”)
The claimed “a reservoir of a wash buffer positioned outside the plurality of interconnected volumes” and “a reservoir of a reconstitution buffer positioned outside the plurality of interconnected volumes” have been read on the taught ([0039], “…one or more, or all, bioassay reagents may be stored in a blister pouch that releases the bioassay reagents by mechanical actuation…”); [0010] describes use of other buffer solutions; [0046] describes further use of blister pouches);
The claimed “a first fluid injection opening in the plurality of interconnected volumes to inject the wash buffer into the plurality of interconnected volumes, wherein the first fluid opening in connected to the reservoir of the wash buffer” and “a buffer inlet chamber to receive reconstitution buffer from the reservoir of reconstitution buffer” has been read on the taught ([0046], “Lysis buffer chamber (204) may be a conventional blister pouch (or fitted to contain a conventional blister pouch) that is design to puncture and release its fluid contents through passage (228) whenever pressed by actuator…”; Passage 228 reads on a first fluid injection opening.);
Escajeda et al additionally teaches that rehydration buffer may be stored in a reagent chamber and that multiple reagent chambers may be present in a given device (see [0010]);
The claimed “a reactant chamber connected to the buffer inlet chamber by a fluid channel, wherein the reactant chamber contains a reactant” has been read on the taught ([0010], “…the reagent chamber contains assay reagents for performing the analytical reaction.”; The reagent chamber reads on a reactant chamber);
The claimed “a reactant injection channel connecting the reactant chamber to the capillary volume” has been read on the taught ([0010], “…the reagent chamber contains assay reagents for performing the analytical reaction and is connected to the bottom of the metering chamber by a passage…”);
The limitations of “to inject the wash buffer into the plurality of interconnected volumes” and “to receive reconstitution buffer from the reservoir of reconstitution buffer” are functional language and have been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Escajeda et al teaches all of the structural limitations of the apparatus as defined in claim 10, these additional limitations do not define the instant application over the prior art.
The embodiments of Escajeda et al primarily teach the use of lysis buffer in a device, and one reagent blister. However, Escajeda et al does teach embodiments including multiple blister packs (see [0024]) and multiple types of buffers (see [0070]). Per MPEP 2144.04(VI)(B), duplication of parts may be prima facie obvious; please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Accordingly, 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 embodiments taught by Escajeda et al to include the separate reservoirs of wash buffer and reconstitution buffer, as well as the separate injection opening for wash buffer and buffer inlet chamber of claim 10. One of ordinary skill in the art would have found this modification to have the predictable benefit of allowing multiple steps involving liquid reagents to be performed sequentially.
With regards to claim 11, the device of claim 10 is obvious in view of Escajeda et al.
Escajeda et al further teaches;
The claimed “wherein the reactant comprises dried PCR master mix reactants” has been read on the taught ([0056], “…an embodiment having a reagent chamber comprising a blister pack and a mixing chamber comprising dried reagents.”; [0059], “…cartridges of the invention may be used with a variety of assays for biomolecules, including polymerase chain reactions (PCRs)…”; [0071] teaches the variety of dried reagents possible for use.);
The limitation “wherein the reconstitution buffer is to reconstitute the dried PCR master mix” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Escajeda et al teaches all of the structural limitations of the apparatus as defined in claim 2, this additional limitation does not define the instant application over the prior art.
With regards to claim 12, the device of claim 10 is obvious over Escajeda et al.
Escajeda et al further teaches;
The claimed “a gas reservoir and a gas channel connecting the gas reservoir to the fluid channel to inject gas into the fluid channel to push reconstitution buffer in the fluid channel and reconstitution buffer in the reactant chamber with the reactant into the capillary volume, while bypassing reconstitution buffer in the buffer inlet chamber” has been read on the taught ([0004], “An aspect of the invention is the use of a mixing chamber to pneumatically mix assay reagents of a reaction mixture by forcing a gas, e.g. air, into the bottom of the mixing chamber where it passes through the surface of the reaction mixture and is exhausted through a vent port associated with the mixing chamber.”; [0010], “The reagent vent port is capable of being sealingly connected to a valve and pump in the appliance so that the reagent port is capable of accepting air pressure for forcing the assay reagents into the bottom of metering chamber.”; The vent port reads on a gas channel. A pump in the appliances reads on a gas reservoir);
The limitation “to inject gas into the fluid channel to push buffer in the fluid channel and buffer in the reactant chamber with the reactant into the capillary volume, while bypassing reconstitution buffer in the buffer inlet chamber” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Escajeda et al teaches all of the structural limitations of the apparatus, and as modifications of rearrangement of parts may be prima facie obvious as discussed on page 6, the limitations of claim 5 do not define the instant application over the prior art.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Escajeda et al (US 20230193366 A1) in view of Marshall et al (US 20190071661 A1).
With regards to claim 6, the device of claim 1 is anticipated by Escajeda et al.
However, Escajeda et al does not explicitly disclose wherein the fluid channel connects to the reactant chamber at a top portion of the reactant chamber and adjacent to a front face of the reactant chamber, wherein the reactant chamber comprises a ramp formed along a wall of the reactant chamber leading from the fluid channel to a back face of the reactant chamber, wherein the ramp forms a sharp corner with the wall to draw reconstitution buffer toward the back face by capillary flow.
In the analogous art of microfluidic devices, Marshall et al teaches;
The claimed “wherein the fluid channel connects to the reactant chamber at a top portion of the reactant chamber and adjacent to a front face of the reactant chamber, wherein the reactant chamber comprises a ramp formed along a wall of the reactant chamber leading from the fluid channel to a back face of the reactant chamber, wherein the ramp forms a sharp corner with the wall to draw reconstitution buffer toward the back face by capillary flow” has been read on ([0020], “An aspect of the present disclosure provides a fluidic device, comprising a capillary barrier that (a) comprises a cross-sectional area with a trapezoidal shape; (b) protrudes from an interior surface of said fluidic channel; (c) has a plateau surface that is substantially parallel to said interior surface of said fluidic channel; (d) has a ramp surface connecting said plateau surface to said interior surface of said fluidic channel, wherein said ramp surface inclines or declines along a length of said fluidic channel; and (e) is configured and arranged to arrest and position a meniscus of a liquid flowing along a length of said fluidic channel.”; The ramp surface inside of a channel configured to position a meniscus of fluid reads on a ramp formed along a wall of the reactant chamber.);
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 Escajeda et al with the ramp as taught by Marshall et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the device of Escajeda et al teaches a base device comprising a microfluidic fluid channel connecting to a reactant channel. The prior art of Marshall et al teaches a comparable device with a microfluidic channel and chamber, which have been improved with a ramp in the same way as the claimed invention. One of ordinary skill in the art could have applied the known “improvement” technique in the same way to the base device of Escajeda, for the predictable benefit of controlling the flow of fluid into the chamber.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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