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 filed 4/3/2026 regarding the 112 rejections of claims 7 and 9-23 have been fully considered and are considered persuasive. The 112 rejections of the Non-Final office Action filed 1/13/2026 are now withdrawn.
In the arguments presented on page 8 of the amendment, the applicant argues that the amended claims overcome the rejection on record. In response to this argument, the Examiner does not agree and the amended claims are still rejected over Lebl et al. (US PG Pub 2011/0072914, cited on IDS dated 12/13/2023) in view of Stone et al. (US 2015/0045234, cited on IDS dated 12/13/2023), and Reed et al. (US 20100009871 A1). The Examiner notes that the structural relationship between the flow cell and sample cartridge have not been fully clarified (i.e. the sample cartridge being located upstream or downstream of the fluidic interface) and therefore has not overcome the previous rejection of claim 9, where the subject matter of claim 9 has been moved to claim 7.
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 7, 10-13 and 16-28 are rejected under 35 U.S.C. 103 as being unpatentable over Lebl et al. (US PG Pub 2011/0072914, cited on IDS dated 12/13/2023) in view of Stone et al. (US 2015/0045234, cited on IDS dated 12/13/2023) and Reed et al. (US 20100009871 A1).
Regarding claim 7, Lebl et al. teaches an apparatus (fluid flow system 1100 used with subassembly 800, see Fig. 9 and 19, [0028], [0048], and [0074]), comprising:
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Annotated Fig. 19
a flow cell interface (806) adapted to be coupled to a flow cell comprising a plurality of channels (holder 806 is coupled to flow cell 802/1110, see Fig. 9 and 19, [0057], and [0074]);
a central valve upstream of the flow cell interface (waste valve 1124, see Fig. 19 and [0075]); and
an auxiliary waste fluidic line coupled to the central valve and adapted to be coupled to a waste reservoir, wherein the central valve is coupled to the flow cell interface and movable between a first position fluidically connecting an inlet of the plurality of channels to the auxiliary waste fluidic line and a second position fluidically connecting a reagent reservoir and the plurality of channels (connects to an inlet of the flow cell interface in a first position at 1110, and second position it connects reagent reservoirs 1102-1105 to flow cell interface 806, see annotated Fig. 19 and [0075]).
a pump manifold assembly (to pump 1130, see annotated Fig. 19 and [0075])
wherein the sample cartridge interface is positioned downstream of the flow cell interface to enable the sample of interest to be back loaded into the flow cell (the pump 1130 is bi-directional as it is analogous to pump 830 and is therefore able to pump a fluid back into the flow cell, see [0075]) and wherein the pump manifold assembly is fluidically coupled to the flow cell interface and the sample cartridge interface to allow the sample of interest to be flowed from the sample cartridge to the flow cell (the pump 1130 is connected to the flow cell and the representative sample cartridge interface via the flow cell lines, see Fig. 19); and
a sample loading manifold assembly (base 836 and body 838) positioned between the flow cell interface (806) and the sample cartridge interface (824) and comprising a body carrying a plurality of sample valves (EO pumps 833) and defining a plurality of sample ports (discharge lines 884) and a plurality of flow cell ports (base 836 and body 838 contain a plurality of pumps 833 acting as bi-directional valves and contains discharge lines 884 and channel connectors 824 that connect the flow cell 802, see Figs. 9-11, [0057]- [0059], and [0068]- [0069]).
However, Lebl et al. does not teach a sipper manifold assembly comprising a reagent sipper positioned upstream of the flow cell interface, the reagent sipper to be coupled to a reagent reservoir and a sample cartridge interface comprising a sipper tube adapted to draw a sample of interest from a sample cartridge at the sample cartridge interface using the pump manifold assembly.
In the analogous art of introducing fluids into flow cells, Stone et al. teaches a fluidic system comprising a flow cell, where the device comprises a sipper manifold assembly comprising a reagent sipper positioned upstream of the flow cell interface, the reagent sipper to be coupled to a reagent reservoir (the reagent sipper of the reagent cartridge, see Fig. 6 and 9, is coupled to the reagent reservoirs and has channels upstream to the flow cell 2030, see Fig. 9 and [0050]-[0055]) and a pump at the downstream end for supplying a fluid through a sipper tube (see Fig. 9, [0040], [0044], [0050]-[0053]). The reagent cartridge of Stone et al. contains sample and reagent and is therefore capable of providing different fluids to each flow cell channel as the fluid flows to an upstream and downstream end of the flow cell, see Fig. 9 and [0050].
The modification of the prior art of Lebl et al. to include sippers to introduce fluid into both ends of a flow cell was known in the art before the effective filing date of the instant invention, as evidenced by Stone 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 invention of Lebl et al. comprising a flow cell interface and a pump manifold to further include the sipper tube of Stone et al. for the benefit of providing a fluid to an already introduced analyte within a flow cell for analysis. The modification of the invention of Lebl et al. to include the sipper of Stone et al. would have resulted in the reasonable expectation of introducing a fluid to a chip for fluidic operations such as mixing or rehydrating of a reagent.
Additionally, the prior art combination of Lebl et al. in view of Stone et al. does not teach that the device comprises a sample cartridge receptacle to receive a sample cartridge.
However, in the analogous art of providing fluid to a flow cell, Reed et al. teaches a device wherein sample is provided to a flow cell via a manifold where a secondary manifold is used to supply the reagent to the flow cell, see [0008], [0101] – [0104]).
The use of an additional manifold to draw sample from a separate reservoir using a pipette/sipper arrangement was known in the art before the effective filing date of the instant invention as evidenced by Reed et al. 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 invention of previously modified Lebl et al. to further include a separate sample manifold as exemplified by Reed et al. for the benefit of preventing the contamination of the sample lines with reagent and vice versa (see [0101]). Further, because the invention of Lebl et al. (as modified previously), comprises a channel and sipper for supplying sample and reagent to a flow cell, the implementation of the sample manifold of Lebl et al. would have facilitated the expected result of supplying sample to a flow cell for nucleic acid processing.
Regarding claim 10, modified Lebl et al. teaches the apparatus of claim 9, wherein each sample port is coupled to a corresponding port of the sample cartridge interface via a sample fluidic line (each discharge line 884 is coupled to the terminating end 854 via a receptacle 880 for flow communication, see Fig. 11 and [0059]).
Regarding claim 11, modified Lebl et al. teaches the apparatus of claim 10, further comprising flow cell fluidic lines (passages 825) coupling the corresponding flow cell ports (824) and the ports of the flow cell interface (806), each flow cell fluidic line associated with one of the plurality of channels of the flow cell (each passage 825 connects to a channel of the flow cell 802, see Fig. 9-11 and [0058])
Regarding claim 12, modified Lebl et al. teaches the apparatus of claim 11, wherein each of the sample valves (EO pumps 830/1130) are movable between a first position fluidically connecting a corresponding sample port and a corresponding outlet of the plurality of channels and a second position fluidically coupling the corresponding outlet of the plurality of channels and the waste reservoir (the pump is switchable between a position that moves fluid within the flow cell and a second position to couple the flow cell to the outlet, see Fig. 9 and 19, and [0075]).
Regarding claim 13, modified Lebl et al. teaches the apparatus of claim 7, further comprising a shared line valve and a shared reagent fluidic line, the shared reagent fluidic line to couple the shared line valve and the central valve and is adapted to flow one or more reagents to the flow cell via the central valve (valve 1120 and shared fluidic line are coupled to the central valve 1124 to supply reagent to the flow cell, see annotated Fig. 19 and [0075]).
Regarding claim 16, modified Lebl et al. teaches the apparatus of claim 7, further comprising a plurality of flow cell fluidic lines corresponding to each channel of the flow cell and a pump manifold assembly comprising a pump for each flow cell fluidic line (each flow cell fluidic line is connected to pump 1130, see annotated Fig. 19 and [0075]).
Regarding claim 17, modified Lebl et al. teaches the apparatus of claim 16, wherein the pump manifold assembly is positioned downstream of the flow cell interface (the pump is located downstream of the flow cell 1110, see Fig. 19).
Regarding claim 18, modified Lebl et al. teaches the apparatus of claim 16, wherein each pump of the pump manifold assembly is fluidically coupled to the central valve by the corresponding flow cell fluidic line (the pump 1130 is connected to the central valve 1124 via the flow cell lines, see Fig. 19).
Regarding claim 19, modified Lebl et al. teaches the apparatus of claim 16, wherein the pumps are selectively actuated to urge a sample of interest toward the flow cell and into the respective channels of the flow cell (the pump 1130 is activated to draw fluid to and through a flow cell 1110, see Fig. 19 and [0075]).
Regarding claim 20, modified Lebl et al. teaches the apparatus of claim 19, wherein the pumps are to draw reagent from the reagent reservoir and through the channels of the flow cell (pump 1130 draws reagent solutions from 1102-1105 through flow cell, see Fig. 19 and [0075]).
Regarding claim 21, modified Lebl et al. teaches the apparatus of claim 16, wherein the pumps of the pump manifold assembly are fluidically coupled to the auxiliary waste fluidic line by the central valve (the pumps are fluidically connected to the aux. waste line via the central valve 1124, see annotated Fig. 19).
Regarding claim 22, modified Lebl et al. teaches the apparatus of claim 16, further comprising a flow cell cartridge assembly comprising the flow cell comprising the channels and a flow cell manifold (inlet manifold 808), wherein the flow cell manifold comprises a single upstream opening in communication with each of the channels and the channels each comprise a downstream opening fluidically coupled the corresponding flow cell fluidic line (flow cell assembly 804/1110 comprises the flow cell 802 and holder 806 with a single upstream opening 812 in communication with the flow cell channels with downstream openings coupled to the flow cell fluidic lines, see annotated Fig. 19 and [0057]).
Regarding claim 23, modified Lebl et al. teaches the apparatus of claim 22, wherein the flow cell manifold comprises a laminate (flow cell manifolds 808 and 810 are constructed of multiple layers and are therefore laminates, see Fig. 9 and [0057] – [0059]).
Regarding claim 24, modified Lebl et al. teaches the apparatus of claim 7, wherein central valve is operable to allow excess fluid from the sample of interest to flow to the waste reservoir from the flow cell (valve 1124 is used to direct fluid from flow cell to waste reservoir, see [0075]).
Regarding claim 25, modified Lebl et al. teaches the apparatus of claim 7, wherein the sample of interest is to be loaded into the flow cell in a first direction (a pump at the downstream end supplies a fluid through a sipper tube, see Fig. 9, [0040], [0044], [0050]-[0053] of Stone et al.) and wherein reagent from the reagent reservoir is to be flowed through the flow cell in a second direction opposite the first direction (reagent from reservoirs 1102-1105 is flowed upstream of the flow cell interface, see annotated Fig. 19).
Regarding claim 26, modified Lebl et al. teaches the apparatus of claim 7, wherein the sample of interest is to be flowed into the flow cell from the sample cartridge positioned downstream of the flow cell interface (a pump at the downstream end supplies a fluid through a sipper tube, see Fig. 9, [0040], [0044], [0050]-[0053] of Stone et al.). and wherein reagent from the reagent reservoir is to be flowed into the flow cell from the reagent reservoir positioned upstream of the flow cell interface (reagent from reservoirs 1102-1105 is flowed upstream of the flow cell interface, see annotated Fig. 19).
Regarding claim 27, modified Lebl et al. teaches the apparatus of claim 7, further comprising a system, the flow cell interface, the central valve, the auxiliary waste fluidic line, and the pump manifold assembly being positioned within the system (all fluidic features are located within a microfluidic analysis system, see [0007] in Lebl et al.).
Regarding claim 28, modified Lebl et al. teaches the apparatus of claim 27, wherein the sample cartridge receptacle and the sample cartridge interface being positioned within the system (all fluidic features are located within a microfluidic analysis system, see [0007] in Lebl et al.).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lebl et al. (US PG Pub 2011/0072914, cited on IDS dated 12/13/2023) in view of Stone et al. (US 2015/0045234, cited on IDS dated 12/13/2023) as applied to claim 13 above, and further in view of Whitacre et al. (US PG Pub US 2018/0188279, cited on IDS dated 12/13/2023).
Regarding claim 14, Lebl et al. teaches the apparatus of claim 13, further comprising a plurality of dedicated reagent fluidic lines (reagent lines, see annotated Fig. 19), where each dedicated reagent fluidic line is adapted to flow a reagent to the flow cell via the central valve (each reagent line can be used to flow a reagent to the flow cell 1110 via valve 1124, see annotated Fig. 19 and but does not teach that the apparatus comprises a bypass valve wherein each dedicated reagent fluidic line couples the bypass valve and the central valve and is adapted to flow a reagent to the flow cell via the central valve.
However, in the analogous art of fluidic systems comprising flow cells, Whitacre et al. teaches
a bypass valve (common line selector valve 68) and where each dedicated reagent fluidic line couples the bypass valve and the central valve (66) (the reagent lines 64 fluidically connect the common line valve 68 and reagent selector valve 66, see Fig. 2 and [0052]- [0054]). The modification of a fluidic system to include an additional valve that is coupled to another valve was known in the art before the effective filing date of the instant application as exemplified by Whitacre et al. (see [0052] –[0054] in Whitacre).
A person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the reagent lines of Lebl et al. to include the common line valve of Whitacre et al. for the benefit of controlling whether the reagent will enter a bypass channel, see [0052] in Whitacre. The modification of the fluidic system of Lebl et al. to include the valve of Whitacre would have yielded the reasonable expectation of successfully facilitating selective fluid introduction to different channels of a fluidic system.
Regarding claim 15, modified Lebl et al. teaches the apparatus of claim 14, however, previously modified Lebl et al. does not teach that the system comprises a bypass fluidic line and a pump manifold assembly comprising a cache, the bypass fluidic line coupling the bypass valve and the cache.
However, the analogous art of Whitacre teaches that the fluidic system comprises a bypass fluidic line (bypass line 62) and a pump manifold assembly comprising a cache (pump 38 that draws fluid into cache 118, see [0066]), the bypass fluidic line coupling the bypass valve and the cache (the bypass line 62 connects the common line valve 68 to the cache, see Fig. 2 and [0052]). The modification of a fluidic system to include a bypass line and a cache as additional reagent storage was known in the art before the effective filing date of the instant application as evidenced by Whitacre (see [0052]).
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 connected the bypass line and subsequent pump manifold including the cache of Whitacre prior to the flow cell of Lebl for the benefit of providing temporary storage of reagents and initial mixing of the reagents before introduction of fluids to the flow cell (see [0052] in Whitacre et al.). Further, the modification of the fluidic system of Lebl et al. to include the bypass line and cache of Whitacre would have had the reasonable expectation of successfully facilitating reagent priming or mixing prior to exposure to a sample within a flow cell.
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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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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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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