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 Amendment
Claims 1-4, 6-7, 10-11, 13, 15-24, and 47 remain pending in the application. Claims 10-11, 13, 15-22, 24 and 47 are withdrawn.
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 (reservoir 905 and reservoir 906);
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.
Response to Arguments
Applicant's arguments, see pages 2-4, filed 08/21/2026, with respect to the rejection of claims 1, 4, and 23 under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references since Bharadwaj employes a planar arrangement of separate reservoirs 905 and 906, Hooper similarly discloses a planar arrangement of a reservoir and channel, and that nothing in Bharadwaj or Hooper teaches or suggests replacing Bharadwaj’s spatially separated reservoirs with a common reagent reservoir with a common reagent reservoir as claimed (Remarks, pages 2-4), the examiner disagrees. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Bharadwaj in view of Hooper is not being modified to replace Bharadwaj’s planar spatially separated reservoirs. Rather, the microfluidic device of modified Bharadwaj is being modified 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.
More specifically, regarding the argued limitation of “g) a reagent reservoir in fluid communication with the first and second reagent inlets” (Remarks, pages 2-4), Bharadwaj fails to teach: g) a reagent reservoir in fluid communication with the first and second reagent inlets.
Bharadwaj provides teachings and suggestions that the device may be combined with external components, such as pumps, reservoirs, controllers, reagents, and sample (paragraph [0202]).
Hooper provides teachings and suggestions of a single, common supply reservoir is connected to reaction regions to introduce a common reagent or solution into regions (paragraph [0020]); and supplying reagents to reaction regions from a common single supply reservoir (paragraph [0022]).
Since Hooper teaches microfluidic devices for performing reactions (abstract), similar to and in the same field of endeavor as Bharadwaj, it would have been obvious to one of ordinary skill in the art to have modified the microfluidic device of modified Bharadwaj to incorporate Bharadwaj’s teachings of combining external components, such as reservoirs and reagents (paragraph [0202]) and Hooper ‘s teachings of a common supply reservoir connected to different regions of a microfluidic device to supply reagents to reaction regions (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.
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have modified the microfluidic device of Bharadwaj to include inlets and a reagent reservoir in fluid communication with the first and second reagent inlets in view of Bharadwaj and Hooper (e.g. an external reagent reservoir that is fluidly connected to the first and second reagent inlets) in order to combine and connect a reagent reservoir to inlets of Bharadwaj’s reagent reservoirs, thus allowing for control of introduction of desired reagent from a reagent source to the first and second reagent inlets.
Additionally, on response to applicant's argument regarding Bharadwaj and Hooper’s planar arrangement of reservoirs and channels (Remarks, page 4), the test for obviousness is not whether the features of a secondary reference (i.e. Hooper) may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As discussed above, since Hooper teaches microfluidic devices for performing reactions (abstract), similar to and in the same field of endeavor as Bharadwaj, it would have been obvious to one of ordinary skill in the art to have modified the microfluidic device of modified Bharadwaj to incorporate Bharadwaj’s teachings of combining external components, such as reservoirs and reagents (paragraph [0202]) and Hooper ‘s teachings of a common supply reservoir connected to different regions of a microfluidic device to supply reagents to reaction regions (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.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Remarks, page 3, “As illustrated in Fig. 39A, the claimed reagent reservoir is not merely a common reagent source. Rather, the reagent reservoir forms part of a particular configuration in which multiple reagent inlets [3902] communicate with a common reagent reservoir while preserving routing space for intervening sample channels [3902]. In this configuration, the common reagent reservoir extends across the intervening sample-channel structure, allowing multiple reagent channels [3904] to communicate with the same reservoir without obstructing the sample-channel layout. In particular, as shown, the arrangement allows for intersection of four channels from a single reservoir connected to [3903] with four channels from a reservoir connected to [3901]”; Remarks, page 4, “spatially separated reservoirs with the common reagent reservoir configuration as shown in Fig. 39A, where a common reagent reservoir communicates with multiple reagent inlets while one or more sample channels pass therebetween”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 common reagent reservoir (carrier well 132) in fluid communication with 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); wherein sample channels (140) are disposed between at least two reagent inlets (200). Cauley teaches the common reagent reservoir (Fig. 14 and paragraph [0074], carrier well 132) communicates with channels via vertical channels (paragraph [0074]).
Smith et al. (US 20200122143 A1) teaches a nanofluidic chips (abstract). Smith teaches a labeling fluid can be focus junction fed by a common labeling fluid reservoir defined by a gasket and in fluid communication with the one or more second local inlets (paragraph [0042]).
Hu et al. (US 20020074271 A1) teaches multilevel microfluidic structures (abstract). Hu teaches there may be inlets and/or reservoirs for other reagents, where there may be a single or plurality of sources for the reagents to be distributed to one or more flow systems; and reagents are processed in common channel manifolds or reservoirs (paragraph [0046]).
El Gamal et al. (US 20090075838 A1) teaches a microfluidic device (Fig. 1; paragraph [0033]), comprising a reagent reservoir (130) fluidly coupled to inlets of multiple reagent channels (132a, 132b, 132c).
Safir et al. (US 20030156989 A1) teaches a fluidic system (Fig. 2A) comprising a reagent reservoir (Fig. 2A, reagent source vessel 100) fluidly coupled to a plurality of reactors (Fig. 2A, reactors Rn). Safir teaches reagent be simultaneously fed to any or each of the eight reaction vessels, serially or simultaneously with any or each of the other reagents (paragraph [0089]). Safir teaches an alternative of one or more pumps that service a plurality of different reagent source vessels, rather than having dedicated association with one reagent source vessel (paragraph [0038]).
THIS ACTION IS MADE FINAL. 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 HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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