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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 09/15/2026 has been entered.
Remarks
This office action fully acknowledges Applicant’s arguments and amendments filed 15 September 2026.
Claims 1-6 and 10-19 are pending.
Claims 15-17 are withdrawn.
Claims 7-9 are canceled.
No claims are newly added.
Claims 1-2 and 19 are amended.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“A fluid regulation and control system…[which] provides a defined and controllable pressure difference between the plurality of input source containers and the output container”, as in Claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“Pneumatic control system and pinch manifold, in conjunction with flow rate sensor”, as in [0044] of Applicant’s instant as-filed specification…and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-6, 10-12, 14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Schultz et al. (US 2014/0261736 A1), referred to hereinafter as “Schultz”.
Regarding Claim 1, Schultz teaches a fluidic device ([0005]: “…the invention provides a passive fluidics circuit for sequentially directing different fluids to a common volume, such as a reaction chamber or flow cell, without intermixing or cross contamination. As used herein, such sequential directing is sometimes referred to as “multiplexing” a plurality of fluid flows.”) comprising:
a fluidic multiplexer block comprising a plurality of fluidic multiplexer units (Fig. 4B and [0022]: “…a planar fluidics circuit (multiplexer unit) which accommodates four input reagents and whose design can accommodate further input reagents by stacking of the planar fluidics circuit and connecting their fluidics nodes (multiplexer block).” – See Fig. 7 which shows two flow cell lanes connected to the fluidics circuit.),
each fluidic multiplexer unit including a substrate with a fluidic distribution circuit formed therein (Fig. 3A and [0025]: “In one aspect, plastics such as polycarbonate, polymethyl methacrylate, and the like, may be used to fabricate fluidics circuits of the invention.”),
the fluidic distribution circuit including a plurality of fluidic branches (Fig. 3B and [0018]: “In one aspect, the fluidics circuit of the invention provides a junction where a flow of a selected fluid is split into at least two branches: one branch is directed to an outlet and from there to a flow cell or reaction chamber for use and the other branch is directed past the unselected fluid inlets and from there away from the outlet and to a waste port.”);
a first fluidic interface block assembly (reagent reservoirs 604, 606, 608, 610, and 612) connected to a first face of the fluidic multiplexer block, the first fluidic interface block including a first set of flexible tubes (Fig. 6: the tubes connecting the reagent reservoirs 604, 606, 608, 610, and 612 to the multiplexor block 600) and a second set of flexible tubes (Fig. 6: the tubes connecting the multiplexor block 600 to the waste 620 and to the flow cell 634), each set of tubes connected, respectively, to each corresponding port of a first set of ports (Fig. 6: inlet ports 370) and a second set of ports (Fig. 4B: outlet ports “to waste” and “to flow cell”) on the first face of the fluidic multiplexer block (Fig. 6 shows the reagent reservoirs 604, 606, 608, 610, and 612 connected to a face of the multiplexer unit 600 via fluidic lines metered by valves 614. -- Fig. 4B specifically shows inlet ports 412 and outlet ports 402 to which said fluidic lines are connected.),
a fluid distribution manifold assembly in fluid communication with a plurality of fluidic paths, each fluidic path being in communication with a respective reagent source and a corresponding flexible tube of the first and second sets of flexible tubes of the first, second, third, and fourth fluidic interface block assemblies, the fluid distribution manifold assembly comprising a plurality of valves configured to selectively control fluid flow through the fluidic paths to the corresponding flexible tubes (See Fig. 3B and [0021]: “The modes of operation are implemented by valves (350) associated with each of the input reagents and with the wash solution. In a first mode of operation (selected reagent valve open, all other reagent valves closed, wash solution valve closed) (FIG. 3B) a selected reagent is delivered to a flow cell; in a second mode of operation (selected reagent valve open, all other reagent valves closed, wash solution valve open) (FIG. 3C) the fluidic circuit is primed to deliver a selected reagent; and in a third mode of operation (all reagent valves closed wash solution valve open) (not shown), all passages in the fluidics circuit are washed.” – Therein, the collection of valves 350 and respective fluidic paths thereof represents a “a fluid distribution manifold assembly” in as much as is claimed. – See also Fig. 6 showing the commensurate valve arrangement controlling the flow of Reagents 1-5.);
each valve being configured to control fluid communication between a corresponding fluidic path and a corresponding flexible tube ([0026]: “Reagents from reservoirs (604, 606, 608, 610, and 612) may be driven to fluidic circuit (602) by a variety of methods including pressure, pumps, such as syringe pumps, gravity feed, and the like, and are selected by control of valves (614), as described above. The foregoing comprises a fluidics system of the instrument of FIG. 6. Control system (618) includes controllers for valves (614) that generate signals for opening and closing via electrical connection (616).”),
as in Claim 1.
Further regarding Claim 1 Schultz does not specifically teach a second/third/fourth fluidic interface block assembly connected to a second/third/fourth face of the fluidic multiplexer block, the second/third/fourth fluidic interface block including a first set of flexible tubes and a second set of flexible tubes, each set of tubes connected, respectively, to each corresponding port of a first set of ports and a second set of ports on the second/third/fourth face of the fluidic multiplexer block, as in Claim 1.
However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, one skilled in the art would find it obvious to provide additional multiplexor units so as to increase throughput, as would be an obvious and expected result given merely duplicating the multiplexor unit provides additional fluidic systems for processes undertaken therein. Further, while Schultz discusses stacking additional units and connecting their fluidic nodes/outlets ([0022] and Fig. 4B), one skilled in the art operating under a duplication of parts rationale for increasing throughput would find it obvious to provide the multiplexor units having independent, non-connected fluidics nodes for passing fluid along to independent flow cells. The disclosure of Schultz provides for a stacked arrangement having connected nodes so as to provide additional reagents through additional inlets to a same flow cell, whereas obvious duplication of the multiplexor unit as asserted herein would provide separate and independent nodes and flow cells.
Further regarding Claim 1, regarding the amended recitation “wherein the valves are arranged in valve blocks, each valve block corresponding to a respective reagent source, the valves of each valve block being configured to control fluid communication through corresponding fluidic paths between the respective reagent source and a corresponding set of flexible tubes”, Schultz Fig. 4B shows an exemplary stacked arrangement having the central connecting channel not pertinent herein but remaining representative of the alignment of the plural inlets 412 into columns/blocks. A valve is accompanied to each inlet as seen through Fig. 3C, thus the valves are arranged in blocks by way of the fluidic lines holding each valve. Herein, even if the duplicated fluidic circuit was not arranged as stacked layers, the valves may still further be designated in blocks, as Applicant has clarified that a block is merely a grouping (Claim 19), and the instant claim does not specify what particular a block is.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the device is fluidically connected to a flow cell 634 of a sequencing system through the respective flow lanes (See Fig. 6 showing flow cell 634 connected by fluidic passage 632 to the fluidics circuit 602. The sequencing system being the flow cell and waste system. – See also the Abstract: “The invention is particularly advantageous in apparatus for performing sensitive multistep reactions, such as pH-based DNA sequencing reactions.”, and para. [0026].), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 2 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the first set of flexible tubes of the first fluidic interface block assembly provides fluid communication between each of a first fluidic branch of each fluidic multiplexer unit and a first nucleotide reagent source and the second set of flexible tubes of the first fluidic interface block assembly provides fluid communication between each of a second fluidic branch of each fluidic multiplexer unit and a second nucleotide reagent source (Fig. 3B shows a fluidic multiplexor unit having five fluidic lines attached to each of the branches 370 of the structure, thus having a first and second line connected to a first and second branch. – Examiner additionally notes that the recitation to the reagent being a nucleotide source is merely drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the device of Schultz is fully capable of being used with reagents that are nucleotide sources.), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 2 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the first set of flexible tubes of the second first fluidic interface block assembly provides fluid communication between each of a third fluidic branch of each fluidic multiplexer unit and a third nucleotide reagent source and the second set of flexible tubes of the second fluidic interface block assembly provides fluid communication between each of a fourth fluidic branch of each fluidic multiplexer unit and a fourth nucleotide reagent source (Fig. 3B shows a fluidic multiplexor unit having five fluidic lines attached to each of the branches 370 of the structure, thus having a third and fourth line connected to a third and fourth branch. – Examiner additionally notes that the recitation to the reagent being a nucleotide source is merely drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the device of Schultz is fully capable of being used with reagents that are nucleotide sources.), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 2 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the first set of flexible tubes of the third fluidic interface block assembly provides fluid communication between each of a fifth fluidic branch of each fluidic multiplexer unit and a calibration solution source and the second set of flexible tubes of the third fluidic interface block assembly provides fluid communication between each of main waste channel of each fluidic multiplexer unit and a waste container (Fig. 6 shows the fluidic multiplexor unit 600 connected to reagents 1-5, of which any may be a calibration solution, and to waste 620. – Examiner additionally notes that the recitation to the reagent being a calibration solution is merely drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the device of Schultz is fully capable of being used with reagents that are calibration solutions.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 2 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the first set of flexible tubes of the fourth fluidic interface block assembly provides fluid communication between each of a wash solution channel of each fluidic multiplexer unit and a wash solution source and the second set of flexible tubes of the fourth fluidic interface block assembly provides fluid communication between each of main sensor device waste channel of each fluidic multiplexer unit and a waste container (Fig. 6 shows the fluidic multiplexor unit 600 connected to wash solution 626 and to flow cell sensor 634, which is then connected to waste 636. – Examiner additionally notes that the recitation to the reagent being a wash solution is merely drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the device of Schultz is fully capable of being used with reagents that are wash solutions.), as in Claim 6.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the substrate is a polymeric material selected from polycarbonate, polymethyl methacrylate, polyether imide and polyimide (Fig. 3A and [0025]: “In one aspect, plastics such as polycarbonate, polymethyl methacrylate, and the like, may be used to fabricate fluidics circuits of the invention.”), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above comprising:
a plurality of input source containers 604/606/608/610/612 and at least one output container 620/636 (Fig. 6),
wherein the plurality of input source containers hold solutions used for a sequencing run (Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the device of Schultz is fully capable of being used with reagents that are used for sequencing.);
the fluidic multiplexer block assembly 600 in a fluidic path between a fluid distribution manifold assembly 618 and the at least one output container 620/636 (Fig. 6),
wherein the fluid distribution manifold controls the distribution of the solutions used for a sequencing run ([0026]: “Control system (618) includes controllers for valves (614) that generate signals for opening and closing via electrical connection (616). Control system (618) also includes controllers for other components of the system, such as wash solution valve (624) connected thereto by (622), and reference electrode (628). Control system (618) may also include control and data acquisition functions for flow cell (634).”);
wherein the fluid distribution manifold assembly is configured to control fluid communication such that a first solution flows through a sensor device (See Figs. 6-7 and [0027]: “FIG. 7 illustrates how the fluidics circuit design concepts may be used to make a plurality of separate flow chambers using a single large flow cell and sensor array, wherein reagent access to each flow chamber is separately controlled while still maintaining uninterrupted fluid pathways to the reference electrode for all sensors in all the flow chambers. FIG. 7 is a top view of flow cell (700) that has fluidics interface member (702) mounted on and is sealingly attached to a housing (not shown) that holds sensor array (704)” – Note that any of the reagents flowing from the reagent containers shown in Fig. 6 eventually flows to the sensor array and is configured to be controlled by the valve manifold.) while a second solution flows through the fluidic multiplexer block assembly to a waste channel (See Figs. 6-7 and [0028]: “reagent from the fluidics circuit is directed solely to waste reservoir (744)”);
and a fluid regulation and control system, wherein the fluid regulation and control system provides a defined and controllable pressure difference between the plurality of input source containers and the output container ([0026]: “Reagents from reservoirs (604, 606, 608, 610, and 612) may be driven to fluidic circuit (602) by a variety of methods including pressure, pumps, such as syringe pumps, gravity feed, and the like…”), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above further comprising:
wherein the fluid handling manifold controls distribution of solutions used in cleaning and filling operations ([0026]: “Control system (618) includes controllers for valves (614) that generate signals for opening and closing via electrical connection (616). Control system (618) also includes controllers for other components of the system, such as wash solution valve (624) connected thereto by (622), and reference electrode (628). Control system (618) may also include control and data acquisition functions for flow cell (634).” – [0028]: “When valve (723) is open, wash solution from the auxiliary wash reservoir 1 (722) passes through passage (729)”), as in Claim 12.
Regarding Claim 14, the prior art meets the limitations of Claim 11 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the fluidic multiplexer block assembly is configured to be reversibly coupled to a sensor device (Fig. 6 shows the fluidic multiplexor block 600 reversibly coupled via line 632 to the flow cell 634, which serves as the sensor device.), as in Claim 14.
Regarding Claim 18, the prior art meets the limitations of Claim 1 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the plurality of valves are selectively actuable to control fluid communication through the corresponding fluidic paths and corresponding flexible tubes such that fluid is selectively provided to one fluidic multiplexer unit, a plurality of fluidic multiplexer units, or all of the fluidic multiplexer units ([0026]: “Control system (618) includes controllers for valves (614) that generate signals for opening and closing via electrical connection (616).” – Such a controller/valve arrangement if fully capable of actuating the valves such that fluid is selectively provided to one fluidic multiplexer unit, a plurality of fluidic multiplexer units, or all of the fluidic multiplexer units given duplication of the valves and reagent sources wherein each valve of a unit may be open to provide reagent to all the units, or all the valves may be closed such that reagent is supplied to none of the units.), as in Claim 18.
Regarding Claim 19, the prior art meets the limitations of Claim 1 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein each valve block comprises a group of valves in fluid communication with a corresponding set of fluidic paths associated with a respective reagent source and a corresponding set of flexible tubes of a respective fluidic interface block assembly on a corresponding face of the fluidic multiplexer block (Fig. 6 shows the valves 614 aligned together in a block. See further the 35 USC 112 section above. See Fig. 6 showing the reagent paths connecting to the fluidic multiplexor, each path actuated by a valve 614, and wherein duplicating and stacking this arrangement as discussed in Claim 1 would result in the tubes in blocks attaching to faces of the device with respect to each corresponding path.), such that selective actuation of the valves of each valve block controls fluid communication between the corresponding fluidic paths and the corresponding set of flexible tubes ([0026]: “Control system (618) includes controllers for valves (614) that generate signals for opening and closing via electrical connection (616).”), as in Claim 19.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to Claims 1-6, 10-12, 14, and 18-19 above, in view of Bagnato et al. (US 2015/0343445 A1), referred to hereinafter as “Bagnato”.
Regarding Claim 13, the prior art meets the limitations of Claim 11 as discussed above. Further, Schultz does not specifically teach a reagent concentrate cartridge for preparation of bulk reagents in a bulk reagent container assembly, wherein the reagent concentrate cartridge is in a fluidic path between the fluid handling manifold and the bulk reagent container assembly, as in Claim 13.
However, Bagnato teaches a method of producing a reagent on-board an instrument wherein a reagent concentrate cartridge for preparation of bulk reagents is in a fluidic path between the fluid handling manifold and the bulk reagent container assembly (Fig. 2 and [0009]: “…the instrument includes a probe having an in-line mixing chamber adapted to receive the concentrate and the diluent to provide the reagent at the required concentration.” See also [0010] for description of cartridge embodiment.). Bagnato further describes the benefit of this arrangement as allowing for samples of a variety of concentrations to be produced from a single concentrate, eliminating waste associated with obtaining and storing each desired concentration as a stock solution.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluidic multiplexor taught by Schultz with an in-line reagent concentrate cartridge, such as suggested by Bagnato, so as to provide a structure capable of producing multiple different concentrations of a reagent from a single concentrated reagent stock solution, thereby eliminating waste.
Response to Arguments
35 USC 112(b)
Applicant’s amendments overcome the indefiniteness rejections of Claims 2-6 and 19 set forth under 35 USC 112(b) by the previous office action. As such, those rejections of Claims 2-6 and 19 under 35 USC 112(b) are withdrawn herein.
35 USC 103
Regarding Claim 1, Applicant’s arguments are on the alleged grounds that Schultz does not teach valves arranged in valve blocks, and that duplication of the fluidics circuit would leave each valve block connected to its respective reagent source, thereby lacking the source-centric design Applicant intends where each valve of the valve block may control a different reagent flow.
Applicant’s argument is not persuasive because Claim 1 does not particularly define the meaning of a valve arrangement where the valves are arranged in blocks, and Claim 19 further clarifies that the block arrangement merely requires the valves to be in designated groups. Each of these limitations is satisfied when the entire fluidics circuit connected to reagents is duplicated to provide improved throughput, the valves being in groups aligned along faces of a stacked circuit arrangement, and even without such a particular arrangement the valves are fully capable of being designated differently and arranged into groups based on the designation. Further, Applicant’s source-centric argument is not persuasive because duplicating the fluidics circuit may include duplicating each reagent bottle/connection thereto and filling the reagent bottle with a different reagent. If this is applicant’s specific intent, Applicant is suggested to require in the claim that each reagent connected to each valve is different.
Thus, Examiner maintains the rejection of Claim 1 under 35 USC 103 as being unpatentable over Schultz.
Regarding Claims 2-6, 10-12, 14, and 18, Applicant’s arguments are on the alleged grounds that these dependent claims are allowable by virtue of dependence on allegedly allowable Claim 1. However, Claim 1 is maintained rejected under 35 USC 103, thus rendering Applicant’s argument moot as Claim 1 is not allowable. Thus, Examiner maintains the rejection of Claims 2-6, 10-12, 14, and 18 under 35 USC 103.
Regarding Claim 13, Applicant’s arguments are on the alleged grounds that Bagnato does not account for the Claim 13 requirement “wherein the reagent concentrate cartridge is in a fluidic path between the fluid handling manifold and the bulk reagent container assembly”.
Applicant’s argument is not persuasive because the cartridge requires a feed channel corresponding to a portion of the fluid manifold, such feed channel of the manifold encompassing the cartridge on the other side of a bulk preparation/mixing container for holding the diluted reagent. See Bagnato Fig. 2, for example. A person of ordinary skill in the art would recognize such necessities, such as a fluid to mix with the reagent concentrate, when applying the modification to Schultz.
Thus, Examiner maintains the rejection of Claim 13 under 35 USC 103 as unpatentable over Bagnato.
Regarding Claim 19, Applicant’s arguments are on the alleged grounds, similar to those above discussed regarding Claim 1, that Schultz does not disclose the claimed valve block arrangement or reagent connections.
However, as discussed above regarding Claim 1, the claims merely require valve blocks to be groupings of valves, wherein the valves of Schultz are fully capable of being designated with different designations and grouped into non-physical groups based on the designation, each being a member of a group of those designations. Further, duplicating the fluidics circuit may include duplicating each of the fluidic lines and reagent sources therewith. Further, the claim does not require each reagent be different.
Thus, Examiner maintains the rejection of Claim 9 under 35 USC 103 as unpatentable over Schultz.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
