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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/11/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s arguments and amendments filed 11 September 2025.
Claims 1-17 are pending.
Claims 15-17 are withdrawn.
No claims are cancelled.
No claims 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 following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 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 1 recites “a plurality of fluidic multiplexer units each in fluid communication with a respective flow lane” wherein the “flow lane” is unclear. It appears Applicant may intend to recite “a respective cell flow lane” given the lack of antecedent basis of “the respective to flow cell lanes” further in the claim. Further, the claim recites “the fluid connections from each interface block assembly remain isolated and no fluidic branch of one multiplexer unit is in fluid communication with another multiplexer unit prior to the respective flow cell lane” wherein the “prior to the respective flow cell lane” is unclear given no directional flow is within the static device claim, thereby rendering the “prior” aspect unclear.
Further herein, the “respective flow lane(s)” are only established with respect to the fluidic multiplexor block as being in fluidic communication therewith, and the relation of such “respective flow lane(s)” with the various fluidic interface blocks is indefinitely defined so as to clearly establish the “isolation” functionality to the confluence of these elements (i.e. fluidic multiplexor block, respective flow lanes, and fluidic interface blocks).
For example, are the respective flow [cell] lanes connected to each different set of ports of the various fluidic interface block assemblies. It is further not herein that the claims themselves do not make clear the various inlets and outlets throughout the claimed fluidic device to breathe life and clarity into the sought functionality provided at the end of claim 1.
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.
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.
Clarification to these ends discussed above is required.
Applicant should claim the particular structure of the sequencing system and its connection to the multiplexor block.
Claim 3 appears to provide additional elements of the “a sequencing system” of Claim 2; however, Claim 3 fails to relate the additional elements of the first and second nucleotide reagent sources to the sequencing system, and the Claim 3 lacks a recitation positively providing said additional elements, such as on the order of “wherein the system further comprises a first/second nucleotide reagent source”. This issue further pervades through the dependent Claims 4-9 particularly wherein Claim 4 introduces a third nucleotide reagent source, Claim 5 provides a calibration solution source, which is indefinitely defined in its structural constituency and functionality in the device. This is similarly seen in Claim 6, which provides a wash solution source, Claim 7 provides additional connector ports, and Claim 8 provides functional particulars to the ports of Claim 7. Therein, none of the additional elements are positively provided in relation to the multiplexor block and are unclearly related to the sequencing system on which they depend.
Further, Claim 9 adds “a multi-lane sensor device”, wherein this element is generically provided and lacking a structural or functional recitation thereto as to what structure(s) constitutes a “multi-lane sensor device.”
Claim 11 recites “the fluidic multiplexer block assembly in a fluidic path between a fluid distribution manifold assembly” wherein it is unclear if the manifold element is positively required by the claim or a mere intended use of the claimed multiplexor block.
If the manifold element is intended to be positively claimed, Applicant may wish to amend the claim to provide on the order of “the device further comprising a fluid distribution manifold assembly”.
Additionally, Claim 12 recites “a fluid handling manifold, wherein the fluid handling manifold controls distribution of solutions used in cleaning and filling operations” wherein it is unclear if this fluid handling manifold controlling distributions refers to the distribution manifold of Claim 11, or is a separate valve assembly for controlling flow.
Claim 13 recites “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” wherein the “a bulk reagent container assembly” is only provided by way of the capability of the “a reagent concentrate cartridge for...” and is thereby not a positive element of the claim. Thus, the “wherein the reagent concentrate cartridge is in a fluidic path between the fluid handling manifold and the bulk reagent container assembly” is interpreted as mere intended use herein.
Claim 14 recites “wherein the fluidic multiplexer block assembly is configured to be reversibly coupled to a sensor device” wherein the “a sensor device” is n\generically provided without particular structure such that one skilled in the art would not be capable of determining what constitutes the reversible coupling.
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 1-12 and 14, as best understood, 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 in fluid communication with respective to flow cell lanes (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.)
wherein the fluidic multiplexer block is configured to have the plurality of fluidic branches to direct fluids to and from each fluidic multiplexer unit independently, via the first fluidic interface block assembly, the second fluidic interface block assembly, the third fluidic interface block assembly, and the fourth fluidic interface block assembly (Fig. 6 shows the multiplexer 600 configured as having the fluidic lines of each of the reagents 604/606/608/610/612. As such, when the fluidic multiplexer units are stacked and connected by the central node 630 (as discussed in para. [022]), the plurality of fluidic branches thereby direct fluids to and from each fluidic multiplexer unit independently, via the various fluidic interface block assemblies.),
as in 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, each of the first fluidic interface block assembly, the second fluidic interface block assembly, the third fluidic interface block assembly, and the fourth fluidic interface block assembly being connected to a different set of ports on the fluidic multiplexer block, each of the set of ports being fluidically isolated from the sets of ports connected to every other fluidic interface block assemblies, such that the fluid connections from each interface block assembly remain isolated and no fluidic branch of one multiplexer unit is in fluid communication with another multiplexer unit prior to the respective flow cell lane, 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 7, the prior art meets the limitations of Claim 2 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above further comprising a set of sensor device interface connector ports on a fourth face of the fluidic multiplexer block (Fig. 6 shows the fluidic multiplexor unit 600 fluidically connected to the flow cell sensor 634. Fig. 4B specifically shows the interface connector port that runs to the flow cell. Further, the location of said ports as on a fourth face of the fluidic multiplexor block is merely an obvious matter of design choice.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the set of sensor interface connector ports of the fourth face of the fluidic multiplexer block includes a set of sensor device interface inlet connector ports and a set of sensor device interface outlet connector ports (Fig. 6 shows the fluidic multiplexor unit 600 fluidically connected to the flow cell sensor 634. Fig. 4B specifically shows the outlet port that runs to the flow cell “to flow cell” and an inlet port “wash solution”. Further, the location of said ports as on a fourth face of the fluidic multiplexor block is merely an obvious matter of design choice.), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above wherein the fluidic device is operably connected a multi-lane sensor device, such that: a set of sensor device inlet ports of the multi-lane sensor device is connected and sealed to each of a corresponding interface inlet connector port of the set of sensor device interface inlet connector ports of the fourth face of the fluidic multiplexer block; and a set of sensor device outlet ports of the multi-lane sensor device is connected and sealed to each of a corresponding interface outlet connector port of the set of sensor device interface outlet connector ports of the fourth face of the fluidic multiplexer block (Fig. 7 shows the fluidics circuit connected to a flow cell having two flow chambers, thus being a “multi-lane” sensor device. Therein, said flow cell is connected and sealed to the fluidic inlets/outlets of the fluidic multiplexor block assembly.), as in Claim 9.
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).”);
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 11 as discussed above. Further, Schultz teaches the fluidic multiplexor discussed above further comprising:
a fluid handling manifold, 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).”), 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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to Claims 1-12 and 14 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 12 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
Claims Rejected under 35 USC 103
Applicant’s arguments are on the grounds that Schultz does not teach the amended Claim 1 recitations requiring fluidic isolation of each respective set of ports of the fluidic block assembly, noting that the device of Schultz provides each fluidic block assembly as connected via a common central node thereby fluidically connecting each respective set of ports.
Applicant’s arguments are not persuasive because, as discussed above in the body of the action, one skilled in the art would find it obvious to merely duplicate each fluidic multiplexor unit having separate and independent fluidic notes connected to separate and independent flow cells to increase throughput, as opposed to the connected-node stacking described by Schultz for providing additional reagent lines for use with a same flow cell. This grounds of rejection is provided herein as necessitated by Applicant’s amendments specifying the fluidic isolation of each set of ports of each fluidic multiplexor unit of the fluidic multiplexor block. Examiner further notes that Claim 1 merely requires “a fluidic multiplexer block comprising a plurality of fluidic multiplexer units” and does not specifically discuss the stacked arrangement resulting in the fluidic multiplexor block. As such, the plurality of duplicated multiplexor units of Schultz is interpreted as comprising the fluid multiplexor block as no specific structural limitations regarding the orientation of each respective multiplexor unit appears to provided thereto.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JOSEPH KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (703)756-5501. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798