DETAILED ACTION
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 Pages 5-7, filed 3/2/2026, with respect to the newly amended claim limitation of “a fluidic reservoir, wherein a fluid can be introduced into the fluidic reservoir from the bottom of the fluidic reservoir” have been fully considered and are not considered persuasive.
The Applicant asserts that Fig. 4 of the prior art reference of Singer does not teach the limitation of the fluid being able to be introduced from the bottom of the reservoir and instead teaches “that the fluidic channel is perpendicular to a longitudinal axis of the fluidic reservoir.”
In response to this argument, the Examiner respectfully disagrees as the channel shown is located below the fluidic reservoir in Fig. 4, and would thus allow fluid to be introduced into the bottom of the fluidic reservoir, which is analogous to the intended use limitation incorporated into newly amended Claim 1. A channel being placed perpendicular to a reservoir’s longitudinal axis would require vertical movement of the fluid into the reservoir, as seen in Fig. 4 of Singer.
The Applicant also asserts Singer does not suggest that it would be necessary or desirable to control the flow of a liquid into a fluidic reservoir such that the liquid is only exposed to a particular portion or volume of the fluidic reservoir. However, it is noted that the channel leading to the reservoir 410 is a branching channel, see [0075], and the branching channels of the current system contain valves 122 that control fluid input from a fluidic hub to each fluidic reservoir, see [0084] – [0085].
In response to Applicant’s assertion that the current prior art of record (Singer et al. (US 2017/0259257) in view of Shaffer et al. (US 3874503), and Chiou et al. (US 2015/0005203)) does not teach newly added claim 27, the Examiner respectfully disagrees as the reference of Shaffer et al. (US 3874503) teaches that the liquid film is disposed on a first portion of the carrier body, and wherein the fluidic system further comprises a second liquid film disposed on at least a second portion of the carrier body (gelled media 49 within different chambers 48 along different dimensions which would necessarily allow contact to different areas of the gelled media based on liquid levels, see Fig. 6).
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 1, 4-12, 14-18, 22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Singer et al. (US 2017/0259257) in view of Shaffer et al. (US 3874503), and Chiou et al. (US 2015/0005203).
Regarding claim 1, Singer et al. teaches a fluidic system (fluidic device 400, see Fig. 4 and Abstract, [0007] – [0010], and [0074]), comprising:
a fluidic reservoir, wherein a fluid can be introduced into the fluidic reservoir from the bottom of the fluidic reservoir; (fluidic reservoir 410, see Fig. 4 and [0074]);
a channel in fluidic communication with the fluidic reservoir (channel 420 connected to reservoir 410, see Fig. 4 and [0074]);
and a reagent carrier positioned in the fluidic reservoir for use in a fluidic system (support substrate with anion exchange membrane on its surface positioned within first reservoir 410, see [0095], [0098], and [0196]) and a reagent, (see [0102], where Fig. 4 is an alternative configuration to Fig. 3, see [0074]).
However, Singer et al. does not explicitly teach that the reagent carrier comprises a carrier body; and a liquid film disposed on at least a portion of the carrier body, wherein: the reagent carrier is separable from the fluidic reservoir, the reagent carrier and the liquid film are positioned such that it is possible to introduce a first liquid into the fluidic reservoir without exposing the liquid film thereto.
However, in the analogous art of fluidic devices for diagnostics, Shaffer et al. teaches a device for fluidic operations and a reagent carrier (a member 25a housed within a container 21, see Figs. 2 and 5 and Col. 3, Lines 14-31) where the reagent carrier comprises a carrier body (head 44, see Fig. 5); and a liquid film disposed on at least a portion of the carrier body (gelled media 49 within chambers 48, see Fig. 6), wherein: the reagent carrier is separable from the fluidic reservoir (head 44 is separable from container 21, see Figs. 2 and 5 and Col. 3, Lines 13-53), the reagent carrier and the liquid film are positioned such that it is possible to introduce a first liquid into the fluidic reservoir without exposing the liquid film thereto (divider 50 and projection 51 prevent fluid from contacting gelled media, see Fig. 5 and Col. 3, Lines 32-53). Modifying a fluidic reservoir to include a device that allows for the introduction of a gelled reagent was known in the art before the effective filing date of the instant application as shown by Shaffer et al., see Col. 3, Lines 54-68.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the fluidic reservoir of Singer et al. to have incorporated the gelled media of Shaffer et al. for the benefit of using a liquid to provide an improved structural device for housing and retaining small volumes of nutrient media for diagnostic use, see Col. 1, Lines 28-43). Further the modification of the fluidic reservoir of Singer et al. to include the gelled media storage device of Shaffer et al. would have resulted in the predictable result of successfully facilitating the detection of an analyte using a liquid film on a substrate.
Further, the combination of Singer et al. in view of Shaffer et al. does not explicitly teach that the liquid film comprises a solid reagent, and the liquid film is substantially free of water.
However, in the analogous art of platforms for conducting biological fluid analyses, Chiou et al. teaches a carrier body (reaction vessel, see [0013]) with a liquid film disposed on at least a portion of the carrier body (controlled release substance within vessel, see [0013]), wherein the liquid film comprises a solid reagent, and the liquid film is substantially free of water (the controlled release substance contains a dried, or solid, reagent, where the controlled release substance is dried of all water, see [0061] and Example VII).
The modification of a substrate within a device comprising fluidic reservoirs that include a reagent to further include the deposited reagent and controlled release substance was known in the art before the effective filing date of the instant application as evidenced by Chiou et al. Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the solid support substrate comprising the gelled media of modified Singer et al. to also comprise a deposited reagent formulation such as the composition of Chiou et al. for the benefit of preventing cross-contamination of sample caused by the leakage of a reagent into other areas of an assay platform (see [0075] – [0077] in Chiou et al.). Additionally, the modification of the platform of Singer et al. to include the deposited controlled release-substance and reagent formulation of Chiou et al. would not have deviated from the scope of either invention and would have had the reasonable expectation of successfully facilitating the reaction of a biological sample with a target reagent within a reaction chamber.
Regarding claim 4, modified Singer et al. teaches a fluidic system as in claim 1, wherein at least a portion of the liquid film is soluble in water (the controlled release substance includes glycerol, which is soluble in water, see [0016] in Chiou et al. and Page 25 of the Instant Application).
Regarding claim 5, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises particles soluble and/or suspendable in water (the controlled release substance includes the reagent, which is dissolvable in water, see [0071] and Example VII in Chiou et al.).
Regarding claim 6, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises a material unstable at room temperature in liquid form (the reagent is unstable in liquid form at room temperature as it dries up immediately upon deposition, see [0073] and Example VII in Chiou et al.).
Regarding claim 7, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises a defoaming agent (lysing reagent comprises at least one anti-foaming agent, see [0158]).
Regarding claim 8, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises a buffering agent (the lysing reagent comprises monovalent salts acting as buffers, see [0159] and [0164]).
Regarding claim 9, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises a reducing agent (the lysing reagent comprises a reducing agent, see [0182]).
Regarding claim 10, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises a surfactant (the lysing reagent comprises a surfactant, see [0155]).
Regarding claim 11, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises a metal chelating agent (the lysing reagent comprises a metal chelating agent (see [0090]).
Regarding claim 12, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent comprises an enzyme (the lysing reagent comprises an enzyme (see [0166]).
Regarding claim 14, modified Singer et al. teaches a fluidic system as in any claim 1, wherein the liquid film is fully miscible in water (the controlled release substance includes glycerol, which is soluble in water, see [0016] in Chiou et al. and Page 25 of the Instant Application).
Regarding claim 15, modified Singer et al. teaches a fluidic system as in claim 1, wherein the liquid film comprises glycerol and/or DMSO (the controlled release substance includes glycerol, which is soluble in water, see [0016] in Chiou et al. and Page 25 of the Instant Application).
Regarding claim 16, modified Singer et al. teaches a fluidic system as claim 1, wherein the carrier body comprises a well and the liquid film is disposed in the well (reaction vessel where reagent is located is a micro-well, see [0007] in Chiou et al.).
Regarding claim 17, modified Singer et al. teaches a fluidic system as in claim 1, wherein the liquid film does not flow under the influence of gravity when positioned perpendicular to the direction of gravity for at least one month (the controlled release substance is located within the covered and valved fluidic reservoir, see Fig. 12, [0054], and [0123], and therefore does not flow through the device under the influence of gravity when positioned perpendicular).
Regarding claim 18, modified Singer et al. teaches a fluidic system as in claim 1, wherein the reagent carrier is formed from a material or combination of materials that have a density greater than water (the controlled release substance includes glycerol, which is thicker than water, see [0016] in Chiou et al. and Page 25 of the Instant Application).
Regarding claim 22, modified Singer et al. teaches a fluidic system as in claim 1, wherein a weight ratio of an amount of solid reagent in the film to an amount of liquid in the film is greater than or equal to 0.001 and less than or equal to 100 (the controlled release substance contains a dried, or solid, reagent, see [0061], where the amount of reagent is greater than 0.001 as it is entirely within the substance).
Regarding claim 24, modified Singer et al. teaches a fluidic system as in claim 1, wherein the carrier body and fluidic reservoir are configured to restrict the motion of the carrier body within the fluidic reservoir (reservoir 1210 would necessarily restrict motion of carrier as it is enclosed, see [0013] in Singer et al.).
Regarding claim 25, modified Singer et al. teaches a fluidic system as in claim 1, wherein the carrier body and fluidic reservoir are configured to restrict the position of the carrier body within the fluidic reservoir (reservoir 1210 would necessarily restrict position of carrier as it is enclosed, see [0013] in Singer et al.).
Regarding claim 27, modified Singer et al. teaches a fluidic system in claim 1, wherein the liquid film is disposed on a first portion of the carrier body, and wherein the fluidic system further comprises a second liquid film disposed on at least a second portion of the carrier body (gelled media 49 within different chambers 48 along different dimensions which would necessarily allow contact to different areas of the gelled media based on liquid levels, see Fig. 6 in Shaffer).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Singer et al. (US 2017/0259257), Shaffer et al. (US 3874503), and Chiou et al. (US 2015/0005203) as applied above and further in view of Kinoshita et al. (US 5728350).
Regarding claim 26, modified Singer et al. teaches the system as in claim 1, wherein the carrier body has a maximum width of greater than or equal to 0.5 cm (the head portion is smaller than the container to contain small volumes, see Abstract in Shaffer et al.).
However, in the analogous art of chemical tests comprising gelled reagents, Kinoshita et al. teaches a device comprising individual gelled reagent squares with widths of 5mm, or 0.5cm, see Example 2. It was known that the carrier body of Shaffer et al. Is adapted to fit into a smaller container to accommodate smaller volumes, and it was known it the art before the effective filing date that the use of a testing part with a width of 0.5cm would be sufficient to allow a user to test a liquid sample.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the carrier body of previously modified Singer al. to have given each well the width of 0.5cm to ensure enough surface area to test a biological sample for the analyte specific to the reagent embedded within the gelled media, see Example 2 in Kinoshita et al. The modification of the carrier body would have resulted in the predictable result of facilitating a colorimetric reaction using a suspended reagent within a gel matrix.
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.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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