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 remarks and amendments filed on 22 September 2025.
Claims 1-11,13-16, 23-27 and 30-37 are pending.
Claims 1-11 and 25-27 are withdrawn.
Claims 12, 17-22, and 28-29 are cancelled.
No claims are newly added.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an 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 variable pressure source...increasing/reducing a/the pressure in the main chamber...as in Claims 13 and 23.
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.
A syringe or step pump, as in Applicant’s instant specification para. [0068]...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 13-14, 23, 30, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2018/0106798 A1), hereinafter “Nelson”, in view of Van Der Zaag et al. (US 2018/0141038 A1), hereinafter “Vanderzaag”.
Regarding Claim 13, Nelson teaches a method of operating a liquid handling device wherein the liquid handling device comprises:
a main chamber 230 (Fig. 9 and [0041]: “In FIG. 9, an assay chamber 230 includes a plurality of capture agent spots, collectively referred to as 232 arranged along a surface of assay chamber 230.”),
a sample chamber 210 for receiving a sample (Fig. 9 and [0043]: “In FIG. 10, assay system 300 is shown in a “fill” state, in which first inlet valve 222 has been opened, releasing first fluid 212 into assay chamber 230, thereby placing first fluid 212 in contact with capture agent spots 232.”),
a variable pressure source ([0028], [0045]),
a sample chamber conduit 220 fluidically connecting the sample chamber 210 to the main chamber 230 (Fig. 9),
a sample chamber conduit valve 222 configured to open and close the sample chamber conduit 220 (Fig. 9),
a respective measurement chamber conduit 260 for each measurement chamber, the measurement chamber conduit fluidically connecting the measurement chamber to the main chamber 230 (Fig. 9 shows conduit 260 extending from the main chamber 230, wherein, as discussed below, this conduit is fully capable of extending to a measurement chamber and being duplicated with expected results for multiple measurement chambers.), and
a respective measurement chamber conduit valve 224 configured to open and close each respective measurement chamber conduit (Fig. 9: Herein, the valve 224 is fully capable of being used with a downstream measurement chambers, or being duplicated along with the conduit 260 to provide flow modulation to multiple measurement chambers.);
wherein the method comprises:
opening the sample chamber conduit valve ([0008]: “…the invention provides a pump system comprising: an inlet valve; an outlet valve; and a chamber between and in communication with each of the inlet valve and the outlet valve, the chamber being adapted to: receive, through the open inlet valve, a quantity of a compressible fluid at a first pressure…”);
reducing a pressure in the main chamber using the variable pressure source to cause the sample to flow from the sample chamber to the main chamber ([0045]: “In FIG. 12, assay system 300 is shown in an “empty” state, wherein outlet valve 224 is open and first fluid 212 is discharged from assay chamber 230 through outlet channel 260. In some embodiments of the invention, outlet channel 260 may include or be connected to a pumping device operable to exert a negative pressure on first fluid 212, in which case first fluid 212 may be actively drawn from assay chamber 230.”);
closing the sample chamber conduit valve ([0028]: “In other contexts, pumping system 100 may be used to pump different quantities of fluid 12 by holding inlet valve 22 open for differing periods.” – Further, the inlet valve of this embodiment would be understood by one of ordinary skill in the art to be applicable to the valves of Fig. 9.);
opening one of the respective measurement chamber conduit valves; and increasing the pressure in the main chamber via the variable pressure source to cause the sample to flow from the main chamber ([0008]: “…a compressible fluid at a first pressure; hold the quantity of the compressible fluid at a second pressure greater than the first pressure against the closed inlet valve and the closed outlet valve; and discharge the quantity of the compressible fluid through the open outlet valve.”),
as in Claim 13.
Further regarding Claim 13, Nelson does not specifically teach the method discussed above wherein the provided device comprises one or more measurement chambers for performing measurements on the sample, or a variable pressure source conduit connecting the main chamber to a variable pressure source, as in Claim 13 (given that the assay chamber 230 of Nelson is interpreted herein as the main chamber).
However, Vanderzaag teaches a respective liquid handling device comprising a first measurement chamber 22 for performing a first measurement on the sample and a second measurement chamber 32-1 for performing a second measurement on the sample ([0066-0067]), thereby providing one or more measurement chambers commensurately as claimed, wherein Vanderzaag further teaches a variable pressure source conduit connected to a variable pressure source (a pump) for driving sample in the direction it is intended to be transported ([0081]). Further, this arrangement allows for measurements to be performed on a processed sample, thereby allowing users to determine a relevant result from the sample.
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 method of Nelson so as to provide the device as having one or more measurement chambers in addition to the main chamber (which itself is also be capable of performing measurements in Nelson) for performing further measurements on the sample, so as to improve measurement accuracy and precision through multiple rounds of data collection redundancy, and a variable pressure source conduit connecting the main chamber to a variable pressure source, such as suggested by Vanderzaag, so as to provide a structure/methodology for performing relevant measurements of a sample, and to drive a sample through the device in the intended direction, thereby reducing error related to improper flow; and would have a reasonable expectation of success therein.
Regarding Claim 14, the prior art meets the limitations of Claim 13 as discussed above. Further, Nelson teaches the method discussed above further comprising:
opening the reagent chamber conduit valve corresponding to one of the one or more reagent chambers (See Fig. 14 -- the reagent chamber valve 252 is open and all other valves are closed.);
reducing the pressure in the main chamber via the variable pressure source using the variable pressure source to cause the sample to flow from the main chamber to the respective measurement chamber ([0045]: “In FIG. 12, assay system 300 is shown in an “empty” state, wherein outlet valve 224 is open and first fluid 212 is discharged from assay chamber 230 through outlet channel 260. In some embodiments of the invention, outlet channel 260 may include or be connected to a pumping device operable to exert a negative pressure on first fluid 212, in which case first fluid 212 may be actively drawn from assay chamber 230.”); and
closing the reagent chamber conduit valve ([0028]: “In other contexts, pumping system 100 may be used to pump different quantities of fluid 12 by holding inlet valve 22 open for differing periods.” – Further, the inlet valve of this embodiment would be understood by one of ordinary skill in the art to be applicable to the valves of Figs. 10 and 14.),
as in Claim 14.
Further regarding Claim 14, the connection between the variable pressure source and the main chamber via a variable pressure source conduit is provided for by the obvious combination of Nelson and Vanderzaag as discussed above regarding Claim 1.
Regarding Claim 23, Nelson teaches a method of operating a liquid handling device, wherein the liquid handling device comprises:
a main chamber 230 (Fig. 9 and [0041]: “In FIG. 9, an assay chamber 230 includes a plurality of capture agent spots, collectively referred to as 232 arranged along a surface of assay chamber 230.”),
one or more auxiliary chambers 210/240 (Fig. 9 shows the auxiliary chambers 210 and 240 for holding fluids 212 and 242 respectively and as discussed in paras. [0043-0046].);
a respective auxiliary chamber conduit 220/250 for each auxiliary chamber 210/240, wherein each auxiliary chamber conduit fluidically connects the respective auxiliary chamber 210/240 to the main chamber 230 (Fig. 9 shows the conduits 220 and 250 connecting the auxiliary chambers 210 and 240 to the main chamber 230 respectively.); and
a respective auxiliary chamber conduit valve 222/252 for opening and closing each respective auxiliary chamber conduit 220/250 (Fig. 9 and [0043, 0046]),
the method comprises:
opening one of the auxiliary chamber conduit valves 222/252 ([0008]: “…the invention provides a pump system comprising: an inlet valve; an outlet valve; and a chamber between and in communication with each of the inlet valve and the outlet valve, the chamber being adapted to: receive, through the open inlet valve, a quantity of a compressible fluid at a first pressure…”);
and increasing or reducing the pressure in the main chamber using the variable pressure source by a predetermined amount, thereby enabling transfer of a metered volume of a liquid between the main chamber 230 and the respective auxiliary chamber 210/240 wherein increasing the pressure in the main chamber transfers the metered volume of the liquid from the main chamber to the respective auxiliary chamber, and decreasing the pressure in the main chamber transfers the metered volume of the liquid from the respective auxiliary chamber to the main chamber. ([0008]: “In another embodiment, the invention provides a pump system comprising: an inlet valve; an outlet valve; and a chamber between and in communication with each of the inlet valve and the outlet valve, the chamber being adapted to: receive, through the open inlet valve, a quantity of a compressible fluid at a first pressure; hold the quantity of the compressible fluid at a second pressure greater than the first pressure against the closed inlet valve and the closed outlet valve; and discharge the quantity of the compressible fluid through the open outlet valve.” – see also [0044].),
as in Claim 23.
Further regarding Claim 23, Nelson does not specifically teach the method discussed above wherein the provided device comprises a variable pressure source conduit connecting the main chamber to a variable pressure source, as in Claim 23 (given that the assay chamber 230 of Nelson is interpreted herein as the main chamber).
However, Vanderzaag teaches a respective liquid handling device comprising a a variable pressure source conduit connected to a variable pressure source (a pump) for driving sample in the direction it is intended to be transported ([0081]). Further, this arrangement allows for measurements to be performed on a processed sample, thereby allowing users to determine a relevant result from the sample.
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 method of Nelson so as to provide the device as having a variable pressure source conduit connecting the main chamber to a variable pressure source, such as suggested by Vanderzaag, so as to drive a sample through the device in the intended direction, thereby reducing error related to improper flow; and would have a reasonable expectation of success therein.
Regarding Claim 30, the prior art meets the limitations of Claim 13 as discussed above. Further, Nelson teaches the method discussed above wherein the liquid handling device further comprises:
one or more reagent chambers 240 (Fig. 9);
a respective reagent chamber conduit 250 for each reagent chamber, the reagent chamber conduit fluidically connecting the reagent chamber 240 to the main chamber 230 (Fig. 9 shows the conduit 250 connecting the chamber 240 to the main chamber 230.); and
a respective reagent chamber conduit valve 252 configured to open and close each respective reagent chamber conduit 250 (Fig. 9 shows valve 252 for opening and closing the conduit 250.),
as in Claim 30.
Regarding Claim 32, the prior art meets the limitations of Claim 30 as discussed above. Further, Nelson does not specifically teach the method discussed above wherein the one or more measurement chambers comprise a first measurement chamber configured to perform a first measurement on the sample and a second measurement chamber configured to perform a second measurement on the sample, wherein the liquid handling device further comprises:
a first measurement chamber conduit fluidically connecting the first measurement chamber to the main chamber;
a second measurement chamber conduit fluidically connecting the second measurement chamber to the main chamber;
a first measurement chamber conduit valve configured to open and close the first measurement chamber conduit; and
a second measurement chamber conduit valve configured to open and close the second measurement chamber conduit,
as in Claim 32.
However, Vanderzaag teaches a respective microfluidic liquid handling device comprising a first measurement chamber 22 for performing a first measurement on the sample and a second measurement chamber 32-1 for performing a second measurement on the sample ([0066-0067]), wherein the liquid handling device further comprises:
a first measurement chamber conduit fluidically connecting the first measurement chamber 22 to the main chamber 32-2 (Fig. 1 shows the first measurement chamber 22 fluidically connected to the main chamber 32-2 via a conduit having a flow from the first to the second measurement chamber, wherein fluidically connecting the two chambers merely requires providing a path between the two chambers so as to aid in “fluid connection” – wherein the flow path ends at the valve.);
a second measurement chamber conduit fluidically connecting the second measurement chamber 32-1 to the main chamber 32-2 (Fig. 1 shows a conduit directly connecting the second measurement chamber 32-1 to a main chamber 32-2.);
a first measurement chamber conduit valve configured to open and close the first measurement chamber conduit (Fig. 1 shows an actuatable valve arranged in line with the first measurement chamber conduit.); and
a second measurement chamber conduit valve configured to open and close the second measurement chamber conduit (Fig. 1 shows an actuatable valve second measurement chamber conduit proximal to the main chamber 32-2 and configured to open/close the second chamber conduit.).
Therein, this arrangement provides a structure capable of analyzing multiple analytes ([0006]), wherein the specific channel and valve structure allows for precise control over fluid movement within the microfluidic device, thereby promoting better accuracy ([0017, 0078-0082]).
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 device of Nelson wherein one or more measurement chambers comprise a first measurement chamber for performing a first measurement on the sample and a second measurement chamber for performing a second measurement on the sample, wherein the liquid handling device further comprises: a first measurement chamber conduit fluidically connecting the first measurement chamber to the main chamber; a second measurement chamber conduit fluidically connecting the second measurement chamber to the main chamber; a first measurement chamber conduit valve configured to open and close the first measurement chamber conduit; and a second measurement chamber conduit valve configured to open and close the second measurement chamber conduit, such as suggested by Vanderzaag, so as to provide a structure capable of multiplexed analysis and precise control over fluid movement within the device; and would have a reasonable expectation of success therein.
Regarding Claim 33, the prior art meets the limitations of Claim 32 as discussed above. Further, Nelson does not specifically teach the method discussed above wherein the one or more reagent chambers comprise one or more first dedicated reagent chambers for reagents to be used only in a diagnostic test to be performed in the first measurement chamber, one or more second dedicated reagent chambers for reagents to be used only in a diagnostic test to be performed in the second measurement chamber, and one or more shared reagent chambers for reagents to be used in the diagnostic tests to be measured in both the first and second measurement chambers, as in Claim 33.
However, Vanderzaag teaches a respective microfluidic device wherein the one or more reagent chambers comprise one or more first dedicated reagent chambers 28/38-1 for reagents to be used only in a diagnostic test to be performed in the first measurement chamber 22, one or more second dedicated reagent chambers for reagents to be used only in a diagnostic test to be performed in the second measurement chamber 32-1, and one or more shared reagent chambers 38-2 for reagents to be used in the diagnostic tests to be measured in both the first and second measurement chambers 22/32-1 (Fig. 1 and [0066]: “The first cartridge portion 20 may comprise a liquid reservoir 28, for example a pouch, with certain reagents needed for the analysis or the processing of the sample, coupled to the first measurement chamber 22 via a fluidic switch 27.”), wherein this arrangement allows different assays requiring different reagents to be performed on a multiplexed chip structure.
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 device of Nelson wherein the one or more reagent chambers comprise one or more first dedicated reagent chambers for reagents to be used only in a diagnostic test to be performed in the first measurement chamber, one or more second dedicated reagent chambers for reagents to be used only in a diagnostic test to be performed in the second measurement chamber, and one or more shared reagent chambers for reagents to be used in the diagnostic tests to be measured in both the first and second measurement chambers, such as suggested by Vanderzaag, so as to allow different assays requiring different reagents to be performed on a multiplexed chip structure; and would have a reasonable expectation of success therein.
Claims 15-16 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Vanderzaag, as applied to Claims 13-14, 23, 30, and 32-33 above, and in further view of Kellogg et al. (US PAT 6,632,399 B1), hereinafter “Kellogg”.
Regarding Claim 15 the prior art meets the limitations of Claim 14 as discussed above. Further, Nelson/Vanderzaag does not specifically teach the method discussed above further comprising:
opening the mixing chamber conduit valve;
increasing the pressure in the main chamber via the using the variable pressure source to cause the sample to flow from the main chamber to the mixing chamber to form a mixture of the sample and the reagent therein;
reducing the pressure in the main chamber via the variable pressure source conduit using the variable pressure source to cause the mixture to flow from the mixing chamber to the main chamber; and
closing the mixing chamber conduit valve, as in Claim 15.
However, Kellogg teaches a respective microfluidic device comprising a sample chamber 502, mixing chambers 252 and 540, and an assay chamber 537 (Fig. 7D and [col. 12, line 10; col 8, line 8; col. 47, line 63]), wherein the inclusion of a mixing chamber permits sample to be better homogenized with the reagent as it enters the assay chamber, reducing error due to unmixed samples.
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 method of Nelson/Vanderzaag so as to include a mixing chamber as discussed by Kellogg, and operating the mixing chamber comprises opening the mixing chamber conduit valve; increasing a pressure in the main chamber using the variable pressure source; reducing a pressure in the main chamber using the variable pressure source; and closing the mixing chamber conduit valve, wherein this method of operation is a limitation provided for by Nelson and the mixing chamber is provided by Kellogg merely as an additional chamber, so as to permit sample to be better homogenized with the reagent as it enters the assay chamber, reducing error due to unmixed samples; and would have a reasonable expectation of success therein.
Examiner further notes that mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, the mixing chamber is not claimed as requiring specific structural features so as to discriminate from the main and sample chambers except by nominal designation which does not limit the recitation. Thus, one of ordinary skill in the art would find it obvious to provide an additional chamber so as to provide a mixing effect prior to an assay/measurement chamber, as this concept has been explored in the prior art as discussed above.
Further regarding Claim 15, the connection between the variable pressure source and the main chamber via a variable pressure source conduit is provided for by the obvious combination of Nelson and Vanderzaag as discussed above regarding Claim 1.
Regarding Claim 16, the prior art meets the limitations of Claim 15 as discussed above. Further, Nelson/Vanderzaag teaches the method discussed above further comprising repeating increasing the pressure in the main chamber and reducing the pressure in the main chamber one or more times ([0025-0026]), as in Claim 16.
Regarding the mixing chamber, as discussed above, this limitation is provided for by the reference of Kellogg so as to permit better homogenization of sample and reagent to reduce error related to unmixed samples. Herein, one of ordinary skill in the art would find it obvious that the process of repeatedly actuating valves to deliver sample to the device would include the mixing chamber provided by Kellogg, wherein this combination provides precise control over fluid actuation and mixing.
Regarding Claim 31, the prior art meets the limitations of Claim 30 as discussed above. Further, Nelson/Vanderzaag does not specifically teach the device discussed above further comprising a mixing chamber configured to mix the sample with a reagent from one of the one or more reagent chambers; a mixing chamber conduit fluidically connecting the mixing chamber to the main chamber; and a mixing chamber conduit valve configured to open and close the mixing chamber conduit, as in Claim 31.
However, Kellogg teaches a respective microfluidic device comprising a sample chamber 502, mixing chambers 252 and 540, and an assay chamber 537 (Fig. 7D and [col. 12, line 10; col 8, line 8; col. 47, line 63]), wherein the inclusion of a mixing chamber permits sample to be better homogenized with the reagent as it enters the assay chamber, reducing error due to unmixed samples.
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 method of Nelson/Vanderzaag so as to include a mixing chamber for mixing the sample with a reagent from one of the one or more reagent chambers; a mixing chamber conduit fluidically connecting the mixing chamber to the main chamber; and a mixing chamber conduit valve configured to open and close the mixing chamber conduit, such as suggested by Kellogg, wherein the actuatable valves are provided for by Nelson and similarly contemplated in Kellogg, so as to permit sample to be better homogenized with the reagent as it enters the assay chamber, reducing error due to unmixed samples; and would have a reasonable expectation of success therein.
Examiner further notes that mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, the mixing chamber is not claimed as requiring specific structural features so as to discriminate from the main and sample chambers except by nominal designation which does not limit the recitation. Thus, one of ordinary skill in the art would find it obvious to provide an additional chamber so as to provide a mixing effect prior to an assay/measurement chamber, as this concept has been explored in the prior art as discussed above.
Claims 24 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Vanderzaag, as applied to Claims 13-14, 23, 30, and 32-33 above, and in further view of Di Tullio et al. (US 2016/0091511 A1), hereinafter “DiTullio”.
Regarding Claim 24, the prior art meets the limitations of Claim 23 as discussed above. Further, Nelson/Vanderzaag does not specifically teach the method discussed above wherein the liquid handling device further comprises:
a waste chamber; a waste chamber conduit, wherein the waste chamber conduit fluidically connects the waste chamber to the main chamber; and a waste chamber conduit valve for opening and closing the waste chamber conduit,
the method further comprises: closing the respective auxiliary chamber conduit valve; opening the waste chamber conduit valve; and increasing a pressure in the main chamber using the variable pressure source thereby transferring the liquid in the main chamber to the waste chamber, as in Claim 24.
However, DiTullio teaches a respective microfluidic device comprising a waste chamber; a waste chamber conduit fluidically connecting the waste chamber to the main chamber; and a waste chamber conduit valve configured to open and close the waste chamber conduit ([0153]: “As shown in FIG. 25, some embodiments of the present invention pertain to a ground sensor first configuration for a cartridge 700 in which a conduit 705 splits at a junction 707 into a first conduit 710 and a second conduit 715 prior to or upstream of a ground chip 720. The second conduit 715 may comprise a constriction or capillary stop 725 and is configured to pass over a lower region of the sensor chip 730 comprising at least one analyte detection electrode (as described with respect to FIGS. 15 and 16). The first conduit 710 is configured to pass over the ground chip 720 (e.g., ground chip with reference sensor as described with respect to FIG. 17) and the upper region of the sensor chip 730 comprising at least one analyte detection electrode (as described with respect to FIGS. 15 and 16). The cartridge 700 may further comprise at least one fluidic lock mechanism 735 (e.g., a membrane sponge valve, a microchannel capillary, or a micro-array valve) positioned within the first conduit 710, and one or more conduits 740 (e.g., vents), which lead from the first conduit 710 and the second conduit 715 to the cavity 747. In this embodiment, the cavity 747 is configured as a waste chamber (as discussed with respect to FIG. 24). However, it should be understood by those of skill in the art that the one or more conduits 740 may be configured to lead to a waste conduit (as discussed with respect to FIG. 24).”).
Therein, this arrangement allows for movement of a sample to a waste reservoir when the sample is completed, further containing the sample so as to prevent hazardous exposure and preventing damage to re-usable chips by preventing fluid from sitting on components of the device for extended periods.
Further, specifically regarding increasing a pressure in the main chamber thereby enabling transfer of liquid in the main chamber to the waste chamber, DiTullio discusses increasing pressure in the device to drive sample between chambers ([0145]), wherein this concept is similarly contemplated in Nelson where pressure increase/decrease in the main chamber 230 drives flow in the device.
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 device of Nelson/Vanderzaag wherein the liquid handling device further comprises: a waste chamber; a waste chamber conduit, wherein the waste chamber conduit fluidically connects the waste chamber to the main chamber; and a waste chamber conduit valve for opening and closing the waste chamber conduit, such as suggested by DiTullio, and wherein the method further comprises: closing the respective auxiliary chamber conduit valve; opening the waste chamber conduit valve; and increasing a pressure in the main chamber thereby enabling transfer of liquid in the main chamber to the waste chamber, such as suggested by DiTullio and similarly contemplated by Nalson/Vanderzaag, so as to allow for movement of a sample to a waste reservoir when the sample is completed, further containing the sample so as to prevent hazardous exposure and preventing damage to re-usable chips by preventing fluid from sitting on components of the device for extended periods; and would have a reasonable expectation of success therein.
Regarding Claim 34, the prior art meets the limitations of Claim 13 as discussed above. Further, Nelson/Vanderzaag does not specifically teach the device discussed above further comprising: a waste chamber; a waste chamber conduit fluidically connecting the waste chamber to the main chamber; and a waste chamber conduit valve configured to open and close the waste chamber conduit, as in Claim 34.
However, DiTullio teaches a respective microfluidic device comprising a waste chamber; a waste chamber conduit fluidically connecting the waste chamber to the main chamber; and a waste chamber conduit valve configured to open and close the waste chamber conduit ([0153]: “As shown in FIG. 25, some embodiments of the present invention pertain to a ground sensor first configuration for a cartridge 700 in which a conduit 705 splits at a junction 707 into a first conduit 710 and a second conduit 715 prior to or upstream of a ground chip 720. The second conduit 715 may comprise a constriction or capillary stop 725 and is configured to pass over a lower region of the sensor chip 730 comprising at least one analyte detection electrode (as described with respect to FIGS. 15 and 16). The first conduit 710 is configured to pass over the ground chip 720 (e.g., ground chip with reference sensor as described with respect to FIG. 17) and the upper region of the sensor chip 730 comprising at least one analyte detection electrode (as described with respect to FIGS. 15 and 16). The cartridge 700 may further comprise at least one fluidic lock mechanism 735 (e.g., a membrane sponge valve, a microchannel capillary, or a micro-array valve) positioned within the first conduit 710, and one or more conduits 740 (e.g., vents), which lead from the first conduit 710 and the second conduit 715 to the cavity 747. In this embodiment, the cavity 747 is configured as a waste chamber (as discussed with respect to FIG. 24). However, it should be understood by those of skill in the art that the one or more conduits 740 may be configured to lead to a waste conduit (as discussed with respect to FIG. 24).”).
Therein, this arrangement allows for movement of a sample to a waste reservoir when the sample is completed, further containing the sample so as to prevent hazardous exposure and preventing damage to re-usable chips by preventing fluid from sitting on components of the device for extended periods.
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 method of Nelson/Vanderzaag so as to include a waste chamber; a waste chamber conduit fluidically connecting the waste chamber to the main chamber; and a waste chamber conduit valve configured to open and close the waste chamber conduit, such as suggested by DiTullio, so as to prevent hazardous exposure and preventing damage to re-usable chips by preventing fluid from sitting on components of the device for extended periods; and would have a reasonable expectation of success therein.
Regarding Claim 35, the prior art meets the limitations of Claim 34 as discussed above. Further, Nelson/Vanderzaag does not specifically teach the method discussed above wherein the waste chamber conduit fluidically connects the waste chamber to the main chamber via the measurement chamber, as in Claim 35.
However, DiTullio teaches the respective microfluidic device discussed above wherein the waste chamber is fluidically connected with a sample chamber/main chamber 590 (Fig. 24 shows the waste chamber 620 as fluidically connected via the waste chamber conduit 630 to the sample chamber/main chamber 590), wherein this arrangement provides a structure capable of accepting waste from any chambers of the device after processing.
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 method of Nelson/Vanderzaag wherein the waste chamber conduit fluidically connects the waste chamber to the main chamber via the measurement chamber, such as suggested by DiTullio, so as to provide a structure capable of accepting waste from any chambers of the device after processing; and would have a reasonable expectation of success therein.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Vanderzaag, as applied to Claims 13-14, 23, 30, and 32-33 above, and in further view of Marchand et al. (US 2019/0242807 A1), hereinafter “Marchand”.
Regarding Claim 36, the prior art meets the limitations of Claim 13 as discussed above. Further, Nelson/Vanderzaag does not specifically teach the method discussed above wherein at least one of the one or more measurement chambers comprises a plurality of electrodes, as in Claim 36.
However, Marchand teaches a measurement chamber having a plurality of electrodes, wherein said electrodes are for performing a biological measurement assay on a biological sample ([0022]), wherein the use of electrodes for biological measurement is well-known in the art was a reliable, rapid, and real-time measurement tool in microfluidic devices.
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 method of Nelson/Vanderzaag wherein at least one of the one or more measurement chambers comprises a plurality of electrodes, such as suggested by Marchand, so as to provide a structure capable of performing computer-implemented biological measurements, and wherein the use of electrodes for performing measurements in microfluidic devices is highly routine; and would have a reasonable expectation of success therein.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Vanderzaag, as applied to Claims 13-14, 23, 30, and 32-33 above, and in further view of Browne et al. (Browne, Andrew W. et al. “A PDMS pinch-valve module embedded in rigid polymer lab chips for on-chip flow regulation.” Journal of Micromechanics and Microengineering 19 (2009): 115012.), hereinafter “Browne”.
Regarding Claim 37, the prior art meets the limitations of Claim 13 as discussed above. Further, Nelson/Vanderzaag does not specifically teach the method discussed above wherein the sample chamber conduit valve and the one or more measurement chamber conduit valve are pinch valves, as in Claim 37.
However, Browne teaches the benefits of pinch valves in microfluidic systems, wherein they require less maintenance compared to valves with more moving parts, can be quickly actuated to allow for precise delivery of specific fluid volumes, and are easily integrated into microfluidic devices as the simple structure of a pinch valve is easily fabricated on a small scale (I: introduction).
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 method of Nelson/Vanderzaag wherein the sample chamber conduit valve and the one or more measurement chamber conduit valve are pinch valves, such as suggested by Browne, so as to achieve the benefits in a microfluidic device as discussed above; and would have a reasonable expectation of success therein.
Response to Arguments
35 USC 112(f)
Applicant’s amendments specifying the variable pressure source as the element increasing/decreasing pressure in the main chamber introduces function to the previously presented generic placeholder of “a variable pressure source”, thereby necessitating interpretation under 35 USC 112(f) as in Claims 13 and 23 and as discussed above in the body of the action.
35 USC 103
Regarding Claim 13, Applicant’s arguments are on the grounds that allegedly the prior office action relies on Vanderzaag for teaching a variable pressure source, wherein the pump of Vanderzaag is only capable of producing an under/negative pressure.
Applicant’s arguments are not persuasive because Vanderzaag is relied upon merely for providing the variable pressure source conduit not specifically taught by Nelson, wherein Nelson is utilized for its teaching of a variable pressure source ([0045] discusses negative pressure, [0008] discusses positive pressure, wherein the two pressure sources taken together comprise the variable pressure source). Further, even if Nelson only relied upon a singular pump as in Vanderzaag, the singular pump remains interpreted as a variable pressure source for providing at least two pressures (the pump on-state and off-state). Therein, even the singular pump of Nelson, as well as the vacuum pump of Vanderzaag, provide for the decrease and increase in pressure commensurately as claimed.
Further regarding Claim 13, Applicant further argues that allegedly the outlet channel 260 of Nelson cannot act as both the measurement chamber conduit and at the same time as a pressure conduit to achieve the pressure increase/decrease operations recited by the claim.
This is not persuasive because the outlet channel 260 of Nelson is not relied upon for providing a pressure channel connecting the variable pressure source to the main chamber, wherein this deficiency in Nelson is cured by obvious combination with the pump and pressure-channel arrangement of Vanderzaag. Therein, the combined arrangement is fully capable of performing the pressure operations recited by the claim given the combination of a positive/negative pressure source in Nelson (as discussed above) with the pressure source connection to the main chamber in Vanderzaag providing a device commensurate with the instant Claim 13.
Thus, Examiner respectfully maintains the rejection of Claim 13 under 35 USC 103 as unpatentable over Nelson in view of Vanderzaag.
Regarding Claim 23, Applicant’s arguments are on the grounds that the sample chamber conduits of Nelson provide only positive pressure and do not facilitate decreasing pressure in the main chamber.
This is not persuasive because Claim 23 recites “increasing OR reducing the pressure in the main chamber” wherein the claim thus does not specifically require reducing the pressure, and the previous office action examines the former option of “increasing” the pressure. Thus, Applicant’s arguments are moot as they address matter not positively required by the claim, wherein the device of Nelson teaches a commensurate method of “increasing OR decreasing”.
Further regarding Claim 23, Applicant further argues that, similarly as above, the outlet channel of Nelson cannot serve as both the auxiliary chamber conduit and the pressure source conduit.
This is not persuasive because the outlet channel 260 of Nelson is not relied upon for providing a pressure channel connecting the variable pressure source to the main chamber, wherein this deficiency in Nelson is cured by obvious combination with the pump and pressure-channel arrangement of Vanderzaag. Therein, the combined arrangement is fully capable of performing the pressure operations recited by the claim given the combination of a positive/negative pressure source in Nelson (as discussed above) with the pressure source connection to the main chamber in Vanderzaag providing a device commensurate with the instant Claim 23.
Applicant’s amendments to Claim 23 to further specify the effect of pressure changes in the main chamber necessitated an updated interpretation and application of the Nelson reference. These features are taught by Nelson via its valve system, and compressible main chamber as discussed above in the body of the action. Thus, Examiner respectfully sets forth the rejection of Claim 23 under 35 USC 103 as unpatentable over Nelson in view of Vanderzaag as necessitated by Applicant’s amendment.
Dependent Claims
Applicant argues that Claims 14-16, 24, and 30-37 are patentable for their dependence on and incorporation of the subject matter of Claims 13 and 23. However, as discussed above, Claims 13 and 23 are rejected under 35 USC 103 as unpatentable over Nelson in view of Vanderzaag. Thus, Claims 14-16, 24, and 30-37 are not patentable merely for their dependence on Claims 13 and 23.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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