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 .
Claim Status
Claims 1-9 and 16-18 are pending examination in this response. Of them Claims 1,2, and 8 have been amended.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 8, 9, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi et. al. (US 20190111429 A1).
Regarding claim 1, Kobayashi teaches “A microfluidic treatment apparatus” (Title, fluidic device) “for treating a sample liquid” (Para [0066], In this state, the specimen liquid containing the sample material) “the microfluidic treatment apparatus comprising: at least one microfluidic channel system having” (Fig. 6 and Para [0128] The fluidic device 300 comprises a substrate board 209 in which flow paths and valves are formed);
“at least one filtering branch” (Para [0128], flow path 220) “and a pumping branch connected in parallel with the at least one filtering branch;” (Para [0128]; shared flow path 202);
“at least one filter chamber arranged in the at least one filtering branch” (Para [0145], capture unit 4A). The recitation “and configured to accommodate a filter element;” is capability of the filter chamber. Kobayashi teaches the positively claimed structural elements of the filter chamber as claimed, such filter chamber is said to be fully capable of the recited adaption in as much as recited and required herein. In addition, it is further taught within (Para [0084], include a column having a filler capable of being bound to the carrier particles).
Further taught “a first channel-crossover element” (Fig. 6, T- junction between W1 and W3). The recitation “configured to fluidically couple the at least one filtering branch to a channel inlet;” is capability however taught within (para [0138], Introduction flow paths 212 and 213).
Further taught “a second channel-crossover element” (Fig. 6, junction above W4 near W2). The recitation “configured to fluidically couple the at least one filtering branch to a channel outlet;” is capability however taught within (Para [0131], discharge flow path 227).
Further taught “at least two filter valves” (Para [0145], The second circulation flow path 220 has valves W3 and W4 serving as non-shared flow path end valves). The recitation “configured to fluidically isolate the at least one filter chamber from the rest of the at least one microfluidic channel system” is capability of the filter valves however taught within Para [0145].
Further taught “and a pumping device arranged in the pumping branch” (Para [0130], pump P). The recitation “and configured to produce a fluidic flow in the at least one microfluidic channel system” is capability of the pumping device however taught within (Para [0006], In this device, a plurality of solutions are mixed in the loop-shaped flow path by injecting the plurality of solutions into the loop-shaped flow path and then operating a pump.).
Further taught “the pumping device comprising at least one pumping valve” (Para [0132], pump valves Pa, Pb and Pc). (Para [0132] and Fig. 6, pump valves Pa, Pb, and Pc). The pump valves Pa, Pb, and Pc in the embodiment of Fig. 6 in Kobayashi are analogous to the metering valve V2 in the embodiment of Fig. 2, which can serve as a metering valve and/or the pump valve in both the first circulation flow path (10) and the second circulation flow path (20) (Para [0111]).
With regard to the limitation a “pumping chamber”, under broadest reasonable interpretation this limitation merely refers to any space capable of holding a volume liquid that may be subjected to applied pressure from a pressure source. For example, the term “pumping” in the limitation “pumping chamber” does not explicitly require the pneumatically-actuated flexible membrane disclosed in the specification (Applicant’s Spec., para [0008]).
Therefore, the pumping device “P” including valves Pa, Pb, and Pc is further considered to comprise at least one pumping chamber, since the valves Pa, Pb, and Pc are disposed such that each section of flow path (202) between the valves Pa, Pb, Pc, is partitioned upon closing of valves Pa, Pb, Pc to form a pumping chamber.
Kobayashi further teaches the limitation “wherein the pumping branch is configured to be coupled fluidically to the channel inlet via a first connection of the first channel-crossover element which is different from a second connection of the first channel-crossover element for the at least one filtering branch” (Para [0128]; shared flow path 202; see Fig. 6), and
Kobayashi further teaches the limitation “the pumping branch is configured to be coupled fluidically to the channel outlet via a first connection of the second channel-crossover element which is different from a second connection of the second channel-crossover element for the at least one filtering branch” (Para [0128]; shared flow path 202; see Fig. 6).
Regarding claim 2, Kobayashi teaches all of claim 1 in addition to “the at least one pumping chamber includes at least two first pumping chambers arranged or connected in a row adjacent to one another.” (Paras [0111] and [0132] and Fig. 6 and Fig. 2, pump valves Pa, Pb, and Pc. When the valve is disposed in the shared flow path, since it can be used as the metering valve and/or the pump valve in both the first circulation flow path 10 and the second circulation flow path 20, the constitution of the fluidic device can be simplified.). Therefore “P” is located within flow paths 10 and 20 which the pump valves along flow paths 10 and 20 can be used as either a metering valve or a pump valve. Fig 6 shows that “P” is valves Pa, Pb, and Pc. Therefore the metering valves hold a volume of liquid and teach to the pumping chamber.
Regarding claim 8, Kobayashi teaches all of claim 1 in addition to “wherein the at least one pumping chamber comprises a single pumping chamber and the at least one pumping valve comprises at least three pumping valves.” (Paras [0111] and [0132] and Fig. 6 and Fig. 2, pump valves Pa, Pb, and Pc. When the valve is disposed in the shared flow path, since it can be used as the metering valve and/or the pump valve in both the first circulation flow path 10 and the second circulation flow path 20, the constitution of the fluidic device can be simplified.). Therefore “P” is located within flow paths 10 and 20 which the pump valves along flow paths 10 and 20 can be used as either a metering valve or a pump valve. Fig 6 shows that “P” is valves Pa, Pb, and Pc. Therefore the metering valves hold a volume of liquid and teach to the pumping chamber.
Regarding claim 9, Kobayashi teaches all of claim 1 in addition to “wherein an inlet valve is arranged between the channel inlet and the first channel-crossover element, and/or an outlet valve is arranged between the channel outlet and the second channel-crossover element.” (Para [0139], Fig. 6, An introduction flow path valve 12 for opening and closing the introduction flow path is provided in the introduction flow path 213).
Regarding claim 16, Kobayashi teaches all of claim 1 in addition to “wherein the first and second channel-crossover elements are T-shaped.” (Fig. 6 between W3 and W1 and between W4 and W2).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et. al. (US 20190111429 A1) as applied to claim 2.
Regarding claim 17, modified Kobayashi teaches all of claim 2 but does not explicitly teach “wherein the at least two first pumping chambers includes three pumping chambers arranged or connected in series in the row.” which is duplication of apparatus parts. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the apparatus. It has been held that a mere duplication of working parts of a device involves only routine skill in the art, MPEP 2144.04 (VI)(B). One would have been motivated to duplicate the apparatus for the purposes of controlling the flow and direction of flow within the device. In addition Kobayashi already reaches duplication of pumping parts within (Fig. 6, Pa, Pb, and Pc).
Claims 3-7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et. al. (US 20190111429 A1) as applied to claims 1 and 2 above, and in view of Stern et. al. (US 20150258544 A1).
Regarding claim 3, modified Kobayashi teaches all of claim 2 but does not teach “wherein the at least one pumping chamber further includes a second pumping chamber configured to be separated from the at least two first pumping chambers by the at least one pumping valve.”. However, Stern teaches (Para [0093] and Fig. 1, valving and pumping schemes of a microfluidic device. Flow is controlled by valves 1100, which valves permit or cut-off flow as described above). It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Kobayashi by having the at least one pumping chamber further includes a second pumping chamber configured to be separated from the at least two first pumping chambers by the at least one pumping valve, since Stern teaches a valve and pump system and flow controlled based on valves being and they can cut off flow. In addition it would have been a matter of an obvious engineering choice, as it allows control of flow into different chambers allowing for different chambers to act as different storage or reaction chambers due to the isolation.
Regarding claim 4, modified Kobayashi teaches all of claim 3 as above in addition Kobayashi teaches “wherein each of the at least two first pumping chambers and the second pumping chamber have respective volumes that are substantially the same size.” (Para [0132] and Fig. 6, pump valves Pa, Pb, and Pc).
Regarding claim 5, modified Kobayashi teaches all of claim 2. The recitation “wherein at least two of the at least two first pumping chambers are configured to be temperature- controlled independently of one another.” is capability of the at least two first pumping chambers however taught within (Para [0108], Referring to FIG. 13, reactions occupying one or two pump volumes can be rapidly thermocycled between two temperatures for multiple-step nucleic acid amplification (e.g., two-step PCR) by holding, for example, temperature zone one ("Temp Zone 1) at an annealing temperature (e.g., approximately 65.degree. C.); holding temperature zone three ("Temp Zone 3") at a denaturation temperature (e.g., approximately 95.degree. C.); and transferring the reaction between P1 or P2 (or both) and P5 and P6 (or both).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kobayashi XYZ to incorporate the teachings of Stern wherein the at least two of the at least two first pumping chambers are configured to be temperature- controlled independently of one another. Doing so would provide for a device with extreme flexibility and increase accuracy and speed for reactions.
Regarding claim 18, modified Kobayashi teaches all of claim 2 but does not teach “wherein: the at least two first pumping chambers are arranged in series and are configured to be independently temperature controlled.” However already taught above in claims 4 and 5 see Paras (Para [0132 Para [0108]).
Regarding claim 6, modified Kobayashi teaches all of claim 2 but does not teach “further comprising: a channel system expansion module configured to be fluidically coupled to the pumping branch, the channel system expansion module comprising at least one upstream arrangement chamber configured for upstream arrangement of reagents and/or at least one evaluation chamber having evaluation cavities configured for evaluating sample constituents of the sample liquid.”
Stern teaches “further comprising: a channel system expansion module” and “the channel system expansion module comprising at least one upstream arrangement chamber” (Paras [0070], [0144], claims 6, 7, and Fig. 15) The present disclosure provides microfluidic devices that may be employed for use in biological sample preparation and/or analysis. Systems of the present disclosure may be used upstream of a biological and/or chemical sensing system, such as a sensor chip as described elsewhere herein. As a compliment or alternative to semi-permanently closed valves, dry reagents can be used in which enzyme solutions are lyophilized/freeze-dried in reagent reservoirs. The end-user then rehydrates the enzymes by adding water (or TE or ethanol wash solutions). Rehydration can be promoted by reciprocal pumping of added water into and out of reservoirs by high volume pump array (e.g., P7 array shown in FIG. 15). Therefore the microfluidic device systems teach to the channel system expansion module and the part of the disclosure that teaches to upstream chemical sensing system teaches to the upstream arrangement chamber.
The recitations channel system expansion module “configured to be fluidically coupled to the pumping branch” and the upstream arrangement chamber “configured for upstream arrangement of reagents and/or at least one evaluation chamber having evaluation cavities configured for evaluating sample constituents of the sample liquid.” are capability of the channel system expansion module and the upstream arrangement chamber. Modified Kobayashi discloses the positively claimed structural elements of the channel system expansion module and the upstream arrangement chamber as claimed, such channel system expansion module and the upstream arrangement chamber are said to be fully capable of the recited adaption in as much as recited and required herein. In addition, the capability of the upstream arrangement chamber is taught within the upstream chemical sensing as a chemical sensing is able to evaluate the sample constituents.
Regarding claim 7, “modified Kobayashi teaches all of claim 6. The recitation “wherein: the at least one upstream arrangement chamber is configured to be fluidically coupled to the pumping branch by a channel connecting element that is closed with an upstream arrangement valve; and the at least one evaluation chamber is configured to be fluidically coupled to the pumping branch by a further channel connecting element that is closed with an evaluation valve.” is capability of the upstream arrangement chamber and the evaluation chamber. Modified Kobayashi discloses the positively claimed structural elements of the upstream arrangement chamber and the evaluation chamber as claimed, such the upstream arrangement chamber and the evaluation chamber are said to be fully capable of the recited adaption in as much as recited and required herein.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered.
Applicant states claim 1 requires a pumping valve and a pumping chamber and Kobayashi does not disclose pump chambers. Applicant states the specification discloses a "pump valve" can act as a peristaltic pump, (para 42) and a "pumping chamber" [Para 008], "By contrast to valves, a pumping chamber, for example, can have a larger volume than a valve and can be used, for example, to temporarily hold defined liquid volumes." Applicant further states that claim 1 requires a pump chamber which has an increased volume. Applicant further states the pump valves Pa, Pb, and Pc of Kobayashi do not either have different volumes, or volumes sufficient to temporarily hold a defined volume of liquid.
In response, the Examiner respectfully disagrees. The examiner has clarified their position above and particularly points out which components of pump device “P” are considered to correspond to the claimed pumping valve and pumping chamber (see Action above). The term “pumping” in the limitation “pumping chamber” under broadest reasonable interpretation does not require the claimed chamber to actually apply pressure to the liquid.
Applicant’s specification discloses (Para [0008] “microfluidic valves and pumping chambers, which can cause a respective displacement of liquids from a designated portion of liquid-bearing structures of the treatment apparatus. For example, the valves and pumping chambers can be pneumatically actuated by a dedicated processing unit, so that a fully automated microfluidic processing of the liquids in the polymeric cartridge can be”….“By contrast to valves, a pumping chamber, for example, can have a larger volume than a valve and can be used, for example, to temporarily hold defined liquid volumes, in particular to hold a significant portion or nearly the total volume of a liquid to be processed in a step of microfluidic discharge.”
In this case, the liquids surrounding the valves and pumping chambers are understood to be displaced by a designated portion of liquid-bearing structures of applicant’s treatment apparatus. Other features such as pumping chambers having larger volumes than the valves, or pumping chambers having pneumatically-actuated flexible membranes, are not required by claim 16. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant states that with regard to claim 16 examiner states that the area between W4 and W2 of Kobayashi is "T" shaped. Applicant states that the area is “X” shaped looking at Fig. 6 and an “X” shape is not a “T” shape.
Examiner disagrees that the area is a X but rather maintains a T shape. Examiner’s rejection is based on the junction above W4 near W2 (see screenshot below). The area below O3 not denoted with the red arrows is not part of the second channel-crossover element.
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Applicant states with respect to claims 3-5 and 8, the Examiner cites Stern as teaching the use of valves to permit or cut-off flow. (Office Action at page 8). The valves of Stern are not, however, disclosed as being pumping valves. Accordingly, even if Kobayashi is modified to incorporate valves to permit or cut-off flow, such modification fails to provide two pumping chambers separated by a pumping valve.
Claim 3 recites “second pumping chamber configured to be separated from the at least two first pumping chambers by the at least one pumping valve” modified Kobayashi has corresponding limitations of having the second pumping chamber configured in this way as Stern teaches a valve and pump system and flow controlled based on valves which can cut off flow. Therefore, having the metering valves which control flow and can cut off flow teaches to the second pumping chamber configured to be separated from the at least two first pumping chambers.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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