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 1-4, 6-7, 10-11, 13, and 15-23, and species of Example 35 (Figs. 39A-39C, 40A-40B) of claims 1-2, 4, and 23, in the reply filed on 12/16/2025 is acknowledged.
Claims 24 and 47 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
Claims 10-11, 13, 15-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
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 1, 4, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bharadwaj et al. (US 20190060906 A1) in view of Hooper et al. (US 20030027352 A1).
Regarding claim 1, Bharadwaj teaches a microfluidic device (abstract; Figs. 9A-9B), comprising:
a) a sample reservoir (904);
b) one or more collection reservoirs (907);
c) first and second reagent reservoirs;
d) first and second sample channels in fluid communication with the sample reservoir (see below annotated Fig. 9A; two channels 901 in fluid communication with reservoir 904);
e) a first reagent channel in fluid communication with the first reagent reservoir (see below annotated Fig. 9A; channel 902 fluidly connected to reservoir 905) and a second reagent channel in fluid communication with the second reagent reservoir (see below annotated Fig. 9A; channel 902 fluidly connected to reservoir 906);
f) first and second droplet source regions (see below annotated Fig. 9A); and
g) wherein the first sample channel intersects with the first reagent channel at a first intersection (see below annotated Fig. 9A), the second sample channel intersects with the second reagent channel at a second intersection (see below annotated Fig. 9A), the first droplet source region is fluidically disposed between the first intersection and the one or more collection reservoirs (see below annotated Fig. 9A), and the second droplet source region is fluidically disposed between the second intersection and the one or more collection reservoirs (see below annotated Fig. 9A); and
wherein the first sample channel and/or the second sample channel is disposed between the first and second reagent reservoirs (see below annotated Fig. 9A, second sample channel 901 is disposed between reservoirs 905, 906).
Bharadwaj fails to explicitly teach (i.e. in the embodiment shown in Figs. 9A-9B):
a) a sample inlet;
c) first and second reagent inlets;
d) the first and second sample channels in fluid communication with the sample inlet;
e) the first reagent channel in fluid communication with the first reagent inlet and the second reagent channel in fluid communication with the second reagent inlet; and
g) a reagent reservoir in fluid communication with the first and second reagent inlets;
and wherein the first sample channel and/or the second sample channel is disposed between the first and second reagent inlets.
Bharadwaj teaches a reservoir may have an inlet and/or an outlet for the addition of continuous phase, flow of continuous phase, or removal of the continuous phase and/or droplets (paragraph [0151]). Bharadwaj teaches additional components of the invention can include pumps for pumping in the channels; and one or more inlets and or outlets, e.g., to introduce liquids and/or remove droplets (paragraph [0154]). Bharadwaj teaches the device may be combined with external components, such as pumps, reservoirs, controllers, reagents, and sample (paragraph [0202]).
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 the sample reservoir, reagent reservoirs, sample channels, and reagent channels of the microfluidic device of Bharadwaj to incorporate the teachings of inclusion of inlets for reservoirs of Bharadwaj (paragraphs [0151],[0154],[0202]) to provide: a) a sample inlet; c) first and second reagent inlets; d) the first and second sample channels in fluid communication with the sample inlet; e) the first reagent channel in fluid communication with the first reagent inlet and the second reagent channel in fluid communication with the second reagent inlet; and g) wherein the first sample channel and/or the second sample channel is disposed between the first and second reagent inlets. Doing so would have a reasonable expectation of successfully allowing for introduction and control of fluids to the sample channels and reagent channels.
Modified Bharadwaj fails to teach: g) a reagent reservoir in fluid communication with the first and second reagent inlets.
Bharadwaj teaches the device may be combined with external components, such as pumps, reservoirs, controllers, reagents, and sample (paragraph [0202]).
Hooper teaches an apparatus for performing reactions (abstract) including microfluidic devices (Figs. 1-2). Hooper teaches an embodiment where a single, common supply reservoir is connected to reaction regions to introduce a common reagent or solution into regions (paragraph [0020]). Hooper teaches supplying reagents to reaction regions from a common single supply reservoir (paragraph [0022]).
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 the microfluidic device of modified Bharadwaj to incorporate the teachings of combining external components, such as reservoirs and reagents of Bharadwaj (paragraph [0202]) and the teachings of a common supply reservoir connected to different regions of a microfluidic device of Hooper (paragraphs [0020],[0022]) to provide: g) a reagent reservoir in fluid communication with the first and second reagent inlets. Doing so would have a reasonable expectation of successfully improving and simplifying introduction of desired reagent from a reagent source to the first and second reagent inlets.
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Annotated Fig. 9A of Bharadwaj
Regarding claim 4, modified Bharadwaj teaches the device of claim 1, wherein the first reagent channel comprises a first reagent funnel fluidically connected to the first reagent inlet (see below annotated Fig. 9A; first reagent channel 902 includes a first reagent funnel connected to the first reagent reservoir 905 which includes the first reagent inlet as modified above in claim 1) and the second reagent channel comprises a second reagent funnel fluidically connected to the second reagent inlet (see below annotated Fig. 9A; second reagent channel 902 includes a second reagent funnel connected to the second reagent reservoir 906 which includes the second reagent inlet as modified above in claim 1).
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Annotated Fig. 9A of Bharadwaj
Regarding claim 23, Bharadwaj further teaches the device of claim 1, wherein at least one of the droplet source regions comprises a shelf (Fig. 9B, shelf region 920) that allows a liquid to expand in one dimension (interpreted as an intended use, see MPEP 2114; paragraphs [0005],[0280]) and a step (Fig. 9B, step region 908) that allows the liquid to expand in an orthogonal dimension (interpreted as an intended use, see MPEP 2114; paragraphs [0004]-[0005],[0280]).
Allowable Subject Matter
Claims 2-3 and 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is suggested to incorporate all of the limitations of claim 2 into claim 1.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the closest prior art of Bharadwaj et al. (US 20190060906 A1) in view of Hooper et al. (US 20030027352 A1) further teaches a third sample channel in fluid communication with the sample inlet (Bharadwaj, Fig. 9A teaches a third sample channel coupled to element 904, which is interpreted as comprising the sample inlet as modified above in claim 1).
Bharadwaj fails to teach: the device of claim 1, further comprising:
a third reagent channel in fluid communication with the first reagent inlet;
a fourth reagent channel in fluid communication with the second reagent inlet;
a fourth sample channel in fluid communication with the sample inlet; and
third and fourth droplet source regions;
wherein the third sample channel intersects with the third reagent channel at a third intersection, the fourth sample channel intersects with the fourth reagent channel at a fourth intersection, the third droplet source region is fluidically disposed between the third intersection and the one or more collection reservoirs and the fourth droplet source region is fluidically disposed between the fourth intersection and the one or more collection reservoirs.
Bharadwaj teaches an embodiment (Figs. 13a-13b) comprising two fluid reservoirs (1305,1306) each comprising two reagent channels (1302,1303); wherein two sample channels (1301) intersects with each reagent channels at four intersections (Fig. 13a); wherein the embodiment includes four droplet source regions between each intersection and a collection reservoir (Figs. 13a-13b shows four shelf and step regions 1320,1308, i.e. droplet source region, between the intersections and reservoir 1307). However, Bharadwaj embodiment of Figs. 13a-13b fails to teach four sample channels in fluid communication with a sample inlet, and the respective sample channels intersecting the respective reagent channels as claimed.
A reference Cauley et al. (US 20140312534 A1) teaches a microfluidic device for making droplets (Fig. 14; abstract), comprising a sample well (134) with three sample channels (140), a reagent reservoir (carrier well 132) coupled to multiple reagent inlets (200), and reagent channels (138) coupled to teach reagent inlet (200), the sample channels and reagent channels intersecting at regions (82) and coupled to a collection reservoir (136). While Cauley teaches a plurality of droplet generators, such as at least 4 (paragraph [0022]), Cauley fails to teach or suggest all of the limitations of claim 2.
None of the prior art teaches or fairly suggest, alone or in combination, all of the limitations of claim 2, specifically the configurations of the reagent channels, sample channels, drop source regions, and intersections. Therefore, claim 2 is deemed allowable. Claim 3 and 6-7 are deemed allowable based on their dependencies on claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758