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 .
Remarks
This office action fully acknowledges Applicant’s arguments and amendments filed 23 April 2026.
Claims 1-6 and 10-19 are pending.
Claims 15-17 are withdrawn.
Claims 7-9 are canceled.
Claims 18-19 are newly added.
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 § 112
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 2-6 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “wherein the device is operably connected to a sequencing system”. Herein, the “a sequencing system” is indefinitely defined with no particulars to its structural constituency that provides for a sequencing system nor does the claim provide structural and/or functional relation to the multiplexor block assembly.
The recitation presents a combination-type claim, wherein the metes and bounds of the operative arrangement of the device and a sequencing system are indefinitely provided. A recitation to the device as a whole being generally “operably connected…” fails to provide clear metes and bounds to the operative arrangement of the sought embodiment, let alone what structure(s) constitutes a “sequencing system” in which such language amounts to a nominally-designated “system” that is absent any particular structure/arrangements thereof and that affords and defines the system and one in which “sequencing” functionality is found.
Claim 2 is indefinitely defined for these reasons and provides a recitation to a use-type claim wherein it is generally set forth that the base fluidic device is for use with a sequencing system that is indefinitely provided for herein.
Claim 19 recites “wherein the plurality of valves are arranged in blocks, each block being in fluid communication with a corresponding set of fluidic paths” wherein the fluid communication aspect is unclear given that the “blocks” appear to refer to a material structure inside which the valves are encased, however, the “blocks” themselves cannot be in fluid communication with a corresponding set of fluidic paths as the blocks seemingly refer to a mere solid having no fluidic components themselves which provide for any fluid communication. Applicant may intend to recite that the valves of each block are what are each in fluid communication with a corresponding set of fluidic paths as the valves are fluidic components.
Further, it is unclear if “blocks” refer to a casing of the valves as discussed above, or if the blocks refer to a spatial arrangement of the valves being aligned in groupings.
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.
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 operably connected to a sequencing system ([0026]: “FIG. 6 diagrammatically illustrates an apparatus employing a fluidics circuit of the invention for carrying out pH-based nucleic acid sequencing in accordance with Rothberg et al (cited above).”), 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 the plurality of valves are arranged in blocks (Fig. 6 shows the valves 614 aligned together in a block. See further the 35 USC 112 section above.), each block being 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 (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 a block of valves 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 rejection of Claims 1 and 7-14 set forth by the previous office action. However, Claims 2-6 and 19 are rejected herein, wherein the rejection of Claims 2-6 is maintained from the prior office action, and the rejection of Claim 19 is added herein as necessitated by Claim 19 being a newly added claim.
35 USC 103
Regarding Claim 1, Applicant’s arguments are on the alleged grounds that Schultz fails to teach the Claim 1 amendments requiring 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; and each valve being configured to control fluid communication between a corresponding fluidic path and a corresponding flexible tube.
Applicant’s arguments are not persuasive because Schulz teaches the above discussed amendments of the device wherein 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 discussed above in the body of the action.
Applicant alleges that simply replicating the fluidic circuits would merely provide for unit-level, isolated inputs. However, Claim 1 does not require the inputs access each of the stacked units from a single source, but rather merely requires the valves be configured to selectively control fluid flow through the fluidic paths to the corresponding flexible tubes. Even Claim 18 reciting “fluid is selectively provided to one fluidic multiplexer unit, a plurality of fluidic multiplexer units, or all of the fluidic multiplexer units” remains satisfied by a duplicated arrangement of Schulz because the claim merely discusses actuating valves respective to each path/flexible tube.
As such, Examiner maintains the rejection of Claim 1 under 35 USC 103 as unpatentable over Schulz.
Regarding Claims 11-13, Applicant’s arguments are on the alleged grounds that Schultz does not teach the amended Claim 11 recitations requiring the device wherein the fluid distribution manifold assembly is configured to control fluid communication such that a first solution flows through a sensor device while a second solution flows through the fluidic multiplexer block assembly to a waste channel.
Applicant’s arguments are not persuasive because the broad flow-based recitation discussed above is covered by Schultz, wherein Schultz teaches the device 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)”); as discussed above in the body of the action. Applicant may wish to recite the first and second solutions are fluidically isolated or specify the locations of the sensor and/or waste channel.
As such, Examiner maintains the rejection of Claim 11 under 35 USC 103 as unpatentable over Schulz.
New Claims 18-19
Applicant argues on the alleged grounds that Schulz does not teach the requirements of newly added Claims 18-19. However, Applicant’s arguments are not persuasive because Schulz (modified with replicated fluidics circuits 602 and connections thereto/therefrom) teaches each and every requirement of Claims 18-19 as discussed above in the body of the action.
As such, Examiner sets forth the rejection of Claims 18-19 as unpatentable under 35 USC 103 over Schulz.
Conclusion
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.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
Prosecution Insights