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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 02 March 2026.
Claims 1, 14, 21, 23-33, 36-37, 39-40, and 42-43 are pending.
Claims 2-13, 15-20, 22, 34-35, 38, and 41 are cancelled.
No claims are withdrawn.
Claim 43 is 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 limitations are:
Conveyance system operable to move…as in cl. 1.
Magnetics module configured to apply magnetic force…as in cl. 1.
Incubation module operable to maintain…as in cl. 14.
Waste module for cartridge disposal…as in cl. 15.
Analysis module operable to detect and quantify...as in cl. 1.
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.
At least one of “a conveyor or robotic arm”, and equivalents thereof --see [0194] of Applicant’s pre-grant publication US 2021/0349082.
At least one of “a permanent magnet or an electro-magnet to provide a magnetic field”, and equivalents thereof – see [0194] of Applicant’s pre-grant publication US 2021/0349082.
At least one of “a heating and/or cooling element and a thermostat to control that element to maintain the incubation area at a desired temperature”, and equivalents thereof – see [0195] of Applicant’s pre-grant publication US 2021/0349082.
A receptacle or removable bin and equivalents thereof (see par. [0206], for example).
***Unclear from disclosure, see the 35 USC 112 section below.***
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, 21, 23-33, 36-37, 39-40, and 42-43 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.
Independent Claims 1 and 39 are reliant on particular software for accomplishing the functionality of “detect and quantify the individual complexes deposited on the detection areas of the imaging wells”. However, the written description fails to disclose the algorithm(s) for performing the claimed specific computer functions of detection and quantification of individual complexes as in Claims 1 and 39.
See MPEP 2181(II)(B): For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). -- See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008).
See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) (“[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general-purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’”) (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)). In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general-purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function.
See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. For a computer-implemented means-plus-function claim limitation invoking 35 U.S.C. 112(f) the Federal Circuit has stated that “a microprocessor can serve as structure for a computer implemented function only where the claimed function is ‘coextensive’ with a microprocessor itself.”
See EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622, 114 USPQ2d 1711, 1714 (Fed. Cir. 2015), citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737, 1747 (Fed. Cir. 2011). “‘It is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed.’” EON Corp., 785 F.3d at 621, 114 USPQ2 at 1714, quoting Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365, 102 USPQ2d 1122, 1125 (Fed. Cir. 2012). “‘[S]pecial programming’ includes any functionality that is not ‘coextensive’ with a microprocessor or general-purpose computer.”
EON Corp., 785 F.3d at 623, 114 USPQ2d at 1715 (citations omitted). “Examples of such coextensive functions are ‘receiving’ data, ‘storing’ data, and ‘processing’ data—the only three functions on which the Katz court vacated the district court’s decision and remanded for the district court to determine whether disclosure of a microprocessor was sufficient.” 785 F.3d at 622, 114 USPQ2d at 1714. Thus, “[a] microprocessor or general-purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer implemented functions require disclosure of an algorithm.” Id., 114 USPQ2d at 1714.
To claim a means for performing a specific computer-implemented function and then to disclose only a general-purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999); Rain Computing, Inc. v. Samsung Electronics America Co., 989 F.3d 1002, 1007-8, 2021 USPQ2d 284 (Fed. Cir. 2021).
The corresponding structure is not simply a general-purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. Thus, the specification must sufficiently disclose an algorithm to transform a general-purpose microprocessor to the special purpose computer. See Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1241. (“Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy 35 U.S.C. §112 ¶ 6. It was required, however, to at least disclose the algorithm that transforms the general-purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.’” (quoting WMS Gaming, 184 F.3d at 1349, 51 USPQ2d at 1391.))
An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002. Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow char t, or “in any other manner that provides sufficient structure.”
Finisar, 523 F.3d at 1340, 86 USPQ2d at 1623; see also Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.
However, no specific algorithm(s) is/are defined and the functions therein Claims 1 and 39 go beyond a general-purpose computer and are not coextensive with the computer as defined in the MPEP passages cited above.
Therefore, the claim(s) is/are indefinite and rejected under 35 USC 112b/2nd. Applicant may provide a citation to the literature which introduces such software Applicant was in possession of coincident with the above discussion.
Discussion with respect to the software/algorithms as in Claims 1 and 39 is not found within the disclosure. The specification incorporates by reference the prior art of US Pat 9,643,180 and US Pat 8,021,848 as being used to quantify the microbes; however, the “11. Detection” section of US Pat 9,643,180 merely discusses imaging techniques and generic detection of the imaged particles and further merely generically discusses quantification without providing specific algorithmic detail thereto; and the US Pat 8,021,848 similarly merely discusses detection of targets via a CCD without specifying the particular algorithmic steps undertaken by the controller/processor to achieve the detection and subsequent quantification.
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, 14, 21, 23-25, 27-29, 31-33, 36-37, 39-40, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Walsh et al. (US 2012/0046203 A1), hereinafter “Walsh”, in view of Abrams et al. (US 2012/0149007 A1), hereinafter “Abrams”, and Davies et al. (US 2017/0080417 A1), hereinafter “Davies”.
Regarding Claim 1, Walsh teaches a system for specifically detecting and quantifying individual targets in a sample using non-magnified imaging ([0253]: “In most cases imaging is done without any magnification.”),
said targets comprising biological entities including molecules, viruses, or cells ([0028]: “By target is meant a cell, virus, molecule, or molecular complex that is potentially present in a sample and the presence of which is tested by the invention.”),
wherein the system comprises:
a cartridge (Fig. 17) comprising:
a pneumatic port (The port through which the plunger injects air into the cartridge via compression of the plunger – see paras. [0166-0167]);
a series of wells (Fig. 17 shows the cartridge having a sample well, growth wells, and imaging wells.),
the series of wells including:
an input well (“sample well”) for receiving the sample (Fig. 17 and [0355]: “…the sample is added to a sample well of the cartridge.”);
a plurality of division wells (“growth wells”) that are configured to receive aliquots of the sample (Fig. 17 and [0430]: “After the sample container barcode was scanned, the initiation of the sample into the growth wells occurred.”);
and a plurality of imaging wells (Fig. 17 and [0167]: “…the linear actuator depresses the plunger of the sample container further, mobilizing liquid in the growth wells to imaging wells…”), each imaging well having a detection area (“the bottom surface” as in [0258]: “…imaging occurred on the bottom surface of the imaging well.”);
wherein the cartridge comprises a plurality of reagents ([0354]: “The cartridge contains the reagents required to run a single assay or a series of parallel assays, and automatically initiates the assay when the sample is added.”,
the plurality of reagents comprising:
magnetic particles that are configured to bind to the targets ([0043]: “…magnetic selection of targets bound to magnetic particles…”);
photonic labels comprising binding moieties (antibodies) that bind specifically to the targets ([0041]: “A target that is bound to four types of antibodies, one of which is conjugated to a fluorescein molecule…”);
and dye-cushion reagents comprising a density agent and dye that is dried onto the detection surface of each imaging well of the plurality of imaging wells ([0473]: “The plunger mobilizes the liquid sample into imaging wells containing dried reagents.”),
wherein the reagents comprise all reagents for performing an analysis of the sample ([0354]: “The cartridge contains the reagents required to run a single assay or a series of parallel assays…);
and an analyzer configured to receive the cartridge ([0355]: “The cartridge is inserted into the analyzer…”),
the analyzer comprising:
a fluidics module comprising:
an actuator configured to move the valve body of the cartridge between the plurality of positions ([0473]: “…the actuator depresses a plunger feature on the container. The plunger mobilizes the liquid sample into imaging wells containing dried reagents.” – Given that the actuator pushes sample through backflow valves, effectively opening and closing them, the actuator is configured to move the valve body of the cartridge between the plurality of positions.);
and a pressure or vacuum source ([0166]: “Reagents could be mobilized by application of vacuum or pressure such as by a pumping action, such as with a syringe, peristaltic, impeller, or diaphragm pump.”)
configured to apply a pressure or vacuum to the pneumatic port of the cartridge ([0166]: “Reagents could be mobilized by application of vacuum or pressure such as by a pumping action, such as with a syringe, peristaltic, impeller, or diaphragm pump.”),
wherein the actuator and the pressure or vacuum source cooperate with the cartridge to move the sample between selected wells of the series of wells of the cartridge and to create a mixture containing complexes by exposing the sample to the plurality of reagents required to form the complexes ([0473]: “…the actuator depresses a plunger feature on the container. The plunger mobilizes the liquid sample into imaging wells containing dried reagents.” – [0450]: “The liquid in the sample rehydrates reagents located inside the sample container and starts the assay reaction.”),
each complex comprising individual targets bound to both magnetic particles and photonic labels ([0570]: “…fluorescent and magnetic particles to bind signaling moieties and selection moieties…”,
and to enable the mixture to contact and hydrate the dye-cushion reagents to form an opaque dye cushion layer separating labeled complexes from the detection area ([0450]: “The liquid in the sample rehydrates reagents located inside the sample container and starts the assay reaction.”);
a magnetics module configured to apply magnetic force to draw the complexes through the dye-cushion layer and deposit the complexes in the detection area of the detection area of the wells of the cartridge ([0265]: “The device may include of one or more subsystems for selection of labeled targets through the application of selection forces upon labeled target-selection moiety complexes in the sample. This example describes several methods used to apply magnetic force for selection. Magnetic selection of magnetically-responsive particles was accomplished by using magnet types and configurations that generate high magnetic gradients.”),
an imaging module comprising a digital array photodetector configured to obtain non-magnified images of individual complexes deposited on the detection areas of the imaging wells ([0320]: “...imaging module that uses non-magnified imaging to detect two different fluorescent signaling signatures within a single sample.”);
and a conveyance system (“gantry robot system” as in [0420]) operable to move the cartridge within the analyzer, wherein the conveyance system is operable to move the cartridge about and between the fluidics module, the magnetics module, and the imaging module ([0420]: “The gantry robot system carried the sample container from the conveyor belt through each station required for processing.”);
wherein the conveyance system is configured to position the pneumatic port of the cartridge in fluid communication with the pressure or vacuum source of the fluidics module of the analyzer (As discussed above, the robotic gantry carries the sample container to each station for processing. Para. [0166] recites “A mechanical actuator could interact with an interface on a sample container, such as the plunger in FIG. 17.” discussing actuation of a pressure source integrated as one with the cartridge via an arm depressing the cap with plunger, positioned thereto by the gantry robot. Given that Walsh additionally teaches non-integrated pressure sources (discussed in para. [0166]: “Reagents could be mobilized by application of vacuum or pressure such as by a pumping action, such as with a syringe, peristaltic, impeller, or diaphragm pump.”), the gantry robot must thereby necessarily position the cartridge such that it is in fluid communication with the pressure source, similarly to how it positions the cap with plunger and the actuator to engage one another, so as to achieve the sought movement of the cartridge through the device and the pressure-based microfluidic flow required for analyses performed on the cartridge.);
and an analysis module (“a general-purpose computer” as in [0246]) comprising at least one processor and image analysis software ([0015]: “…integrated image analysis software with object finding algorithms…”),
wherein the analysis module is operable to detect and quantify the individual complexes deposited on the detection areas of the imaging wells ([0224]: “The primary function of image analysis is to quantify the amount of signal present in the images produced by the imaging subsystem.”),
as in Claim 1.
Further regarding Claim 1, Walsh does not specifically teach the instrument discussed above further comprising a plurality of reagent wells configured to label the target for imaging, as in Claim 1.
However, Abrams teaches a respective cartridge embodiment of the cartridge of Walsh (See Walsh Fig. 17 and Abrams Fig. 42.) comprising reagent reservoirs containing reagent ([0021]: “Some or all of the reagents for the tests may be contained in...reagent reservoirs...” – See also paras. [0402, 0411] regarding antibody labeling for imaging.), configured to label the target for imaging (See para. [0401], for example.). Therein, this arrangement represents an obvious alternative arrangement to that of Walsh wherein lyophilized reagents are loaded into the imaging wells.
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 Walsh further comprising a plurality of reagent wells configured to label the target for imaging, such as suggested by Abrams, as a mere obvious alternative configuration for mixing the sample with reagent prior to imaging would have a reasonable expectation of success given Walsh and Abrams are drawn to embodiments of the same cartridge system (See Walsh Fig. 17 and Abrams Fig. 42.).
The prior art discloses combined reagent/imaging wells ([0440]) serving the functions of storing reagents and performing imaging. Merely separating these known elements into different wells, each performing the same function it was known to perform, is considered a predictable variation. The separation does not result in a new, unexpected function or solve a new problem not already addressed by the prior art. Each well performs its known function (storage and imaging) in the same way it would if the other element were absent or differently configured.
Further regarding Claim 1, Walsh does not specifically teach the instrument discussed above further comprising a valve body defining a plurality of connecting channel segments, wherein the valve body is disposed between the plurality of reagent wells and the plurality of division wells and is axially slidable about and between a plurality of positions to selectively position the connecting channel segments to provide fluid communication between selected wells of the series of wells of the cartridge, wherein in a first position of a valve body, the input well is in fluid communication with at least a portion of the plurality of division wells and in a second position of the valve body, the connecting channel segments provide fluid communication between at least a portion of the plurality of division wells and at least a portion of the plurality of reagent wells to thereby transfer the sample from the plurality of division wells to the plurality of reagent wells, as in Claim 1.
However, Davies teaches a respective cartridge comprising a sliding valve arrangement between layers A/B/C/D/E of a substrate defining a plurality of connecting channel segments 121300 (Fig. 23B and paras. [0012-0016]) such that relative motion between the substrates places at least some of a first population of input channels (interpreted as functionally equivalent to the “wells” of Walsh given their common functionality of holding and releasing fluid) in register with at least some of the second population of wells 125100 etc. to supply a solution via transfer of the sample from a plurality of first wells to a plurality of second wells ([0010]). Therein, this arrangement allows reagents to be mixed with multiple aliquots of sample simultaneously as the microchannels of the device can be moved at the same time ([0123]), reducing variation in sample reaction start times and errors drawn thereto, and further thereby offers higher throughput capabilities ([0004]).
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 Walsh further comprising a valve body defining a plurality of connecting channel segments, wherein the valve body is disposed between the plurality of reagent wells and the plurality of division wells and is axially slidable about and between a plurality of positions to selectively position the connecting channel segments to provide fluid communication between selected wells of the series of wells of the cartridge wherein in a respective position of the valve body is disposed between the plurality of reagent wells and the plurality of division wells and transfer the sample from the plurality of division wells to the plurality of reagent wells, such as suggested by Davies, so as to allow reagents to be mixed with multiple aliquots of sample simultaneously, reducing variation in sample reaction start times and errors drawn thereto.
Further, given that Davies teaches plural aliquots of sample mixed with plural aliquots of reagent, one skilled in the art would find it obvious to position the sliding valve arrangement at least between the division wells and imaging/reagent wells of Walsh (modified as separate wells in view of Abrams as discussed above) given that the sample is split into a plurality of sample aliquots via the division wells of Walsh.
Further, given that the sliding valve is claimed as between the division and reagent wells as in Claim 1, in a first position of the valve body, the input well of modified Walsh is interpreted as in fluid communication with at least a portion of the plurality of division wells, given that the valve body does not separate the input well from the plurality of division wells.
Regarding Claim 14, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the instrument discussed above comprising an incubation module operable to maintain the cartridge contents at a desired incubation temperature when the cartridge is positioned therein ([0430]: “fixed temperature incubation” – [0430]: “The sample containers were incubated at 35° C. for four hours to allow bacterial cell growth.”), as in Claim 14.
Regarding Claim 21, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above, Walsh is modified to include a plurality of reagent wells via obvious combination with Abrams, teaching a commensurate cartridge having reagent wells. Therein Abrams, the reagent wells contain at least a portion of the plurality of reagents disposed within the plurality of reagent wells, as in Claim 21.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Walsh with the reagent wells of Abrams, to provide at least a portion of the plurality of reagents disposed within the plurality of reagent wells so as to achieve the reagent mixing in the reagent wells sought by Abrams.
Regarding Claim 23, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the analyzer comprises a cartridge disposal module, wherein the conveyance system is operable to move the cartridge to the cartridge disposal module ([0437]: “Once the analysis was completed, the imager gantry robot moved the sample container to the ejection system. The sample container was then pushed off the platform and into the biohazard waste container.”), as in Claim 23.
Regarding Claim 24, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the magnetic particles comprise binding moieties that bind specifically to the targets ([0043]: “…magnetic selection of targets bound to magnetic particles…”), as in Claim 24.
Regarding Claim 25, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the analyzer comprises an input mechanism, wherein the conveyance system of the analyzer comprises:
a carousel that comprises a plurality of slots sized to accommodate the cartridge (Fig. 58 and [0154]: “…a sample container is placed into a loading carousel by a user where it is then automatically taken into the analyzer and processed.”);
and a mechanical arm that is configured to move the cartridge from the input mechanism to the carousel transfer cartridges between the carousel and each of the fluidics module, the magnetics module, and the imaging module (([0015]: “…a robotic gantry that can move a sample container between locations on the analyzer…” Said locations include the carousel and the modules. A robotic gantry is interpreted as a robotic arm given that both achieve the desired function of moving sample containers between locations within the analyzer.), as in Claim 25.
Regarding Claim 27, the prior art meets the limitations of Claim 25 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the input mechanism is a loading tray that is configured to receive the cartridge, wherein the mechanical loading arm is configured to automatically load the cartridge to the carousel from the loading tray ([0156]: “There is a range of ways in which the analyzer might accept sample containers for test processing. Sample introduction can be as simple as a user directly placing a sample container onto an assay tray for immediate analysis”), as in Claim 27.
Regarding Claim 28, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the analyzer is configured to process in parallel multiple test cartridges for different diagnostics applications containing different types of patient samples ([0151]: “The analyzer can accommodate a variety of different types of samples… Samples may range in consistency from urine, feces, blood, serum, saliva, to mucus, food or water.”), wherein the analyzer permits access of the plurality of modules and the conveyance system in an order dictated by the control module ([0419]: “The analyzer… has custom software and hardware for sample container conveyance…”), as in Claim 28.
Regarding Claim 29, the prior art meets the limitations of Claim 25 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the analyzer is configured to load cartridges from the input mechanism onto the carousel ([0156]: “External automation units, not associated with the analyzer may also deliver sample containers to the analyzer for processing such as an automated track system, which might be part of an independent hospital sample tracking system.”) while, in parallel, processing of one or more additional cartridges received within the analyzer ([0157]: “The sample or sample container may be held temporarily in a queue to await processing or it may experience one or more pretreatments.”), as in Claim 29.
Regarding Claim 31, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the imaging module includes an XYZ stage operable to effect relative movement between the cartridge and the digital array photodetector in x, y, and z directions during imaging ([0397] and Fig. 14: “Motion in the analyzer was accomplished by two motorized stages (FIG. 14). Movement in the X (forward and backward) and Y (left and right) axis used accomplished using a two-directional motorized stage and was used to position the sample for imaging. Movement in the Z axis (up and down) was accomplished by a single motorized stage and was used for image focusing.”), as in Claim 31.
Regarding Claim 32, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the imaging module includes an optics assembly, wherein the optics assembly comprises the digital array photodetector ([0314]: “The imaging subsystem was built with a CCD camera…”), a light source ([0264]: “The light source could be a xenon bulb, or it could be a defocused laser source.”), and a lens ([0221]: “Lenses may focus or defocus the image so that when it arrives at the photodetector array it is less than 10-fold magnified from actual size.”), as in Claim 32.
Regarding Claim 33, the prior art meets the limitations of Claim 32 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the optics assembly further comprises a filter wheel ([0328]: “Emission filter exchange can be automated by use of a motor driven filter bar or wheel.”), as in Claim 33.
Regarding Claim 36, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the magnetics module comprises one or more magnets ([0218]: “Magnetic selection may utilize one or more electromagnets or solid state magnets in particular orientations.”), and wherein the analyzer is configured to position the cartridge so that the magnetics module is proximate to the detection surface of each of the plurality of imaging wells of the cartridge ([0362]: “…after the assay incubation is complete, the analyzer uses linear actuators to move magnets into position below the cartridge to perform magnetic selection of the reaction.”), as in Claim 36.
Regarding Claim 37, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh teaches the analysis system discussed above wherein the cartridge comprises an identifier, wherein the analyzer comprises a reader configured to read the identifier, and wherein the analyzer is configured to associate the cartridge with a set of instructions for processing within the analyzer based on the identifier read by the reader ([0364]: “Each cartridge is labeled with a 1D barcode that encodes the container's test type. This is read by the system processor using a barcode reader shown in FIG. 12. The system processor performs its analysis process based on the test type scanned.”), as in Claim 37.
Regarding Claim 39, Walsh teaches a system for specifically detecting and quantifying individual targets in a sample using non-magnified imaging ([0253]: “In most cases imaging is done without any magnification.”),
wherein the system comprises:
a cartridge (Fig. 17) comprising:
a pneumatic port (The port through which the plunger injects air into the cartridge via compression of the plunger – see paras. [0166-0167]);
a series of wells (Fig. 17 shows the cartridge having a sample well, growth wells, and imaging wells.),
the series of wells including:
an input well (“sample well”) for receiving the sample (Fig. 17 and [0355]: “…the sample is added to a sample well of the cartridge.”);
a plurality of division wells (“growth wells”) that are configured to receive aliquots of the sample (Fig. 17 and [0430]: “After the sample container barcode was scanned, the initiation of the sample into the growth wells occurred.”);
and a plurality of imaging wells (Fig. 17 and [0167]: “…the linear actuator depresses the plunger of the sample container further, mobilizing liquid in the growth wells to imaging wells…”), each imaging well having a detection area (“the bottom surface” as in [0258]: “…imaging occurred on the bottom surface of the imaging well.”);
wherein the cartridge comprises a plurality of reagents ([0354]: “The cartridge contains the reagents required to run a single assay or a series of parallel assays, and automatically initiates the assay when the sample is added.”,
the plurality of reagents comprising:
magnetic particles that are configured to bind to the targets ([0043]: “…magnetic selection of targets bound to magnetic particles…”);
photonic labels comprising binding moieties (antibodies) that bind specifically to the targets ([0041]: “A target that is bound to four types of antibodies, one of which is conjugated to a fluorescein molecule…”);
and dye-cushion reagents comprising a density agent and dye that is dried onto the detection surface of each imaging well of the plurality of imaging wells ([0473]: “The plunger mobilizes the liquid sample into imaging wells containing dried reagents.”),
wherein the reagents comprise all reagents for performing an analysis of the sample ([0354]: “The cartridge contains the reagents required to run a single assay or a series of parallel assays…);
and an analyzer configured receive the cartridge ([0355]: “The cartridge is inserted into the analyzer…”),
the analyzer comprising:
a fluidics module comprising:
an actuator configured to move the valve body of the cartridge between the plurality of positions ([0473]: “…the actuator depresses a plunger feature on the container. The plunger mobilizes the liquid sample into imaging wells containing dried reagents.” – Given that the actuator pushes sample through backflow valves, effectively opening and closing them, the actuator is configured to move the valve body of the cartridge between the plurality of positions.);
and a pressure or vacuum source ([0166]: “Reagents could be mobilized by application of vacuum or pressure such as by a pumping action, such as with a syringe, peristaltic, impeller, or diaphragm pump.”)
configured to apply a pressure or vacuum to the pneumatic port of the cartridge ([0166]: “Reagents could be mobilized by application of vacuum or pressure such as by a pumping action, such as with a syringe, peristaltic, impeller, or diaphragm pump.”),
wherein the actuator and the pressure or vacuum source cooperate with the cartridge to move the sample between selected wells of the series of wells of the cartridge and to create a mixture containing complexes by exposing the sample to the plurality of reagents required to form the complexes ([0473]: “…the actuator depresses a plunger feature on the container. The plunger mobilizes the liquid sample into imaging wells containing dried reagents.” – [0450]: “The liquid in the sample rehydrates reagents located inside the sample container and starts the assay reaction.”),
each complex comprising individual targets bound to both magnetic particles and photonic labels ([0570]: “…fluorescent and magnetic particles to bind signaling moieties and selection moieties…”,
and to enable the mixture to contact and hydrate the dye-cushion reagents to form an opaque dye cushion layer separating labeled complexes from the detection area ([0450]: “The liquid in the sample rehydrates reagents located inside the sample container and starts the assay reaction.”);
a magnetics module configured to apply magnetic force to draw the complexes through the dye-cushion layer and deposit the complexes in the detection area of the imaging area of the wells of the cartridge ([0265]: “The device may include of one or more subsystems for selection of labeled targets through the application of selection forces upon labeled target-selection moiety complexes in the sample. This example describes several methods used to apply magnetic force for selection. Magnetic selection of magnetically-responsive particles was accomplished by using magnet types and configurations that generate high magnetic gradients.”),
an imaging module comprising a digital array photodetector configured to obtain non-magnified images of individual complexes deposited on the detection areas of the imaging wells ([0320]: “...imaging module that uses non-magnified imaging to detect two different fluorescent signaling signatures within a single sample.”);
a cartridge disposal module configured to receive the cartridge for disposal after use ([0578]: “Finally, the container is ejected to an onboard waste container (FIG. 29) and the next cartridge in the loading carousel replaces it at the same position.”),
and a conveyance system (“gantry robot system” as in [0420]) operable to move the cartridge within the analyzer, wherein the conveyance system is operable to move the cartridge about and between the loading module, fluidics module, the magnetics module, the imaging module ([0420]: “The gantry robot system carried the sample container from the conveyor belt through each station required for processing.”);
and an analysis module (“a general-purpose computer” as in [0246]) comprising at least one processor and image analysis software ([0015]: “…integrated image analysis software with object finding algorithms…”),
wherein the system is operative to automatically perform the steps of labeling specific target cells in the specimen with the photonic labels, wherein the photonic labels are photonically labeled nucleic acid probes that can bind to complementary target-specific sequences on ribosomal RNA; incubating said target cells with the magnetic particles thereby forming the complexes, wherein reactions for labeling and binding magnetic particles to target cells occur concurrently in a reaction mixture; depositing said complexes on the detection surface of the imaging wells using magnetic force of the magnetics module; and counting the individual labeled target cell complexes in the imaging well using non-magnified digital imaging (These recitations are drawn to process recitations. As the claims are drawn to a device, such process recitations are not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Herein, the analysis system of Walsh is fully capable of performing the recited analysis steps given its commensurately structured cartridge, analysis apparatus, and image analysis software (paras. [0224-0238]). Applicant may wish to amend the recitations to be recited by way of “the processor configured to perform the steps of...” or “the processor programmed to perform the steps of...” so as to hold patentable weight – see Typhoon Touch Techs, Inc. v. Dell, Inc.), as in Claim 39.
Further regarding Claim 39, Walsh does not specifically teach the instrument discussed above further comprising a plurality of reagent wells configured to label the target for imaging, as in Claim 39.
However, Abrams teaches a respective cartridge embodiment of the cartridge of Walsh (See Walsh Fig. 17 and Abrams Fig. 42.) comprising reagent reservoirs containing reagent ([0021]: “Some or all of the reagents for the tests may be contained in...reagent reservoirs...” – See also paras. [0402, 0411] regarding antibody labeling for imaging.), configured to label the target for imaging (See para. [0401], for example.). Therein, this arrangement represents an obvious alternative arrangement to that of Walsh wherein lyophilized reagents are loaded into the imaging wells.
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 Walsh further comprising a plurality of reagent wells configured to label the target for imaging, such as suggested by Abrams, as a mere obvious alternative configuration for mixing the sample with reagent prior to imaging would have a reasonable expectation of success given Walsh and Abrams are drawn to embodiments of the same cartridge system (See Walsh Fig. 17 and Abrams Fig. 42.).
The prior art discloses combined reagent/imaging wells ([0440]) serving the functions of storing reagents and performing imaging. Merely separating these known elements into different wells, each performing the same function it was known to perform, is considered a predictable variation. The separation does not result in a new, unexpected function or solve a new problem not already addressed by the prior art. Each well performs its known function (storage and imaging) in the same way it would if the other element were absent or differently configured.
Further regarding Claim 39, Walsh does not specifically teach the instrument discussed above further comprising a valve body defining a plurality of connecting channel segments, wherein the valve body is disposed between the plurality of reagent wells and the plurality of division wells and is axially slidable about and between a plurality of positions to selectively position the connecting channel segments to provide fluid communication between selected wells of the series of wells of the cartridge, wherein in a first position of a valve body, the input well is in fluid communication with at least a portion of the plurality of division wells and in a second position of the valve body, the connecting channel segments provide fluid communication between at least a portion of the plurality of division wells and at least a portion of the plurality of reagent wells to thereby transfer the sample from the plurality of division wells to the plurality of reagent wells, as in Claim 39.
However, Davies teaches a respective cartridge comprising a sliding valve arrangement between layers A/B/C/D/E of a substrate defining a plurality of connecting channel segments 121300 (Fig. 23B and paras. [0012-0016]) such that relative motion between the substrates places at least some of a first population of input channels (interpreted as functionally equivalent to the “wells” of Walsh given their common functionality of holding and releasing fluid) in register with at least some of the second population of wells 125100 etc. to supply a solution via transfer of the sample from a plurality of first wells to a plurality of second wells ([0010]). Therein, this arrangement allows reagents to be mixed with multiple aliquots of sample simultaneously as the microchannels of the device can be moved at the same time ([0123]), reducing variation in sample reaction start times and errors drawn thereto, and further thereby offers higher throughput capabilities ([0004]).
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 Walsh further comprising a valve body defining a plurality of connecting channel segments, wherein the valve body is disposed between the plurality of reagent wells and the plurality of division wells and is axially slidable about and between a plurality of positions to selectively position the connecting channel segments to provide fluid communication between selected wells of the series of wells of the cartridge wherein in a respective position of the valve body, the connecting channel segments provide fluid communication between at least a portion of the plurality of division wells and at least a portion of the plurality of reagent wells to thereby transfer the sample from the plurality of division wells to the plurality of reagent wells, such as suggested by Davies, so as to allow reagents to be mixed with multiple aliquots of sample simultaneously, reducing variation in sample reaction start times and errors drawn thereto.
Further, given that Davies teaches aliquots of sample mixed with aliquots of reagent ([0140]), one skilled in the art would find it obvious to position the sliding valve arrangement at least between the division wells and imaging/reagent wells of Walsh (modified as separate wells in view of Abrams as discussed above) given that the sample is split into a plurality of sample aliquots via the division wells of Walsh.
Further, given that the sliding valve is claimed as between the division and reagent wells as in Claim 39, in a first position of the valve body, the input well of modified Walsh is interpreted as in fluid communication with at least a portion of the plurality of division wells, given that the valve body does not separate the input well from the plurality of division wells.
Regarding Claim 40, the prior art meets the limitations of Claim 39 as discussed above. Further, the claim is drawn to further process recitations performed by the system of Claim 39. As discussed above, as the claims are drawn to a device, such process recitations are not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Herein, the analysis system of Walsh is fully capable of performing the recited analysis steps given its commensurately structured cartridge, analysis apparatus, and image analysis software (paras. [0224-0238]). Applicant may wish to amend the recitations to be recited by way of “the processor configured to perform the steps of...” or “the processor programmed to perform the steps of...” so as to hold patentable weight – see Typhoon Touch Techs, Inc. v. Dell, Inc.
Examiner additionally notes that Walsh teaches a cartridge pre-loaded with reagent commensurately as claimed ([0430]: “the liquid sample was mobilized from the sample input reservoir to the growth chambers were growth reagents were lyophilized”).
Regarding Claim 42, the prior art meets the limitations of Claim 1 as discussed above. Further, modified Walsh does not specifically teach the system discussed above wherein the plurality of division wells are disposed on a first side of the valve body, and the plurality of reagent wells are disposed on a second side of the valve body, the second side being opposite the first side, as in Claim 42.
However, as discussed above regarding Claim 1, Walsh is modified with a sliding valve body by obvious combination with Davies. Therein, the wells and channels of Davies are provided in a first side/second side arrangement as elements of the top and bottom substrates being opposite one another (Fig. 2B), thereby providing the sliding valve through the sliding and mating of the top and bottom substrates and intermediates thereof.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify Walsh wherein the plurality of division wells are disposed above the valve body, and the plurality of reagent wells are disposed below the valve body, such as suggested by Davies, so as to enable the sliding valve arrangement between top and bottom substrates.
Further, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of wells would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the wells. Whether the wells are located opposite one another or in some other spatial arrangement is immaterial because the valve function of opening and closing fluid communication between two spaces remains the same.
Regarding Claim 43, the prior art meets the limitations of Claim 1 as discussed above. Further, walsh teaches the system discussed above wherein the dye is selected to absorb excitation light and emitted light associated with the photonic labels, and the opaque dye cushion layer optically sequesters unbound photonic labels from the detection area by absorbing the excitation light and the emitted light ([0026, 0439]), as in Claim 43.
Examiner further notes that the recitation “the opaque dye cushion layer optically sequesters unbound photonic labels from the detection area by absorbing the excitation light and the emitted light” is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Walsh in view of Abrams and Davies, as applied to Claims 1, 14, 21, 23-25, 27-29, 31-33, 36-37, 39-40, and 42-43 above, and in further view of Tan et al. (US 2017/0043338 A1), hereinafter “Tan”.
Regarding Claim 30, the prior art meets the limitations of Claim 1 as discussed above. Further, Walsh does not specifically teach the analysis system discussed above wherein the analyzer does not contain any reagents outside of any cartridges therein, as in Claim 30.
However, Tan teaches a respective cartridge-based analysis system wherein the cartridge comprises a plurality of reagent wells ([0043]) which contain all the reagents for the assay (no reagents are supplied by the reader/analyzer), and wherein supplying reagents for analysis via reagent wells of the cartridge instead of via the analyzer/reader provides for reduction in human error and operation costs ([0003]: “All-in-one reagent cartridge and an automatic system conducting an immunoassay test on the cartridge is desired for minimal human input error, cost saving, and prompt results.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the analysis system of Walsh with a cartridge comprising a plurality of reagent wells and reagents contained therein and no reagents provided outside the cartridge, such as suggested by Tan, so as to reduce human error and operating costs; and would have a reasonable expectation of success therein.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Walsh in view of Abrams and Davies, as applied to Claims 1, 14, 21, 23-25, 27-29, 31-33, 36-37, 39-40, and 42-43 above, and in further view of Reymond et al. (US 2008/0317630 A1), referred to herein as “Reymond”.
Regarding Claim 26, the prior art meets the limitations of Claim 25 as discussed above. Further, Walsh does not specifically teach the analysis system discussed above wherein the carousel is configured to align a slot of the plurality of slots with one of the fluidics module, the magnetics module, or the imaging module, wherein the mechanical arm is operable to push the cartridge between the carousel and the module slot, as in Claim 26.
However, Reymond teaches an automated extraction and analysis system ([0001] and [0051]) wherein a centrifuge (interpreted as the “reaction carousel”) aligns a slot of the centrifuge to a module slot (Final measurement system 30 is interpreted as having a slot for receiving the microholder 12, given that [0053] teaches “…the robotic push-rod being capable of momentarily pushing each microholder so as to bring its upper part into a shield for the counter…”), and wherein robotic push-rod 31 (interpreted as the mechanical arm) is operable to push the cartridge between the centrifuge carousel and the module slot ([0164] and Fig. 7: push-rod 31 moves along path D to push sample microholder 12 into the shield of final measurement system 30.).
Further, one of ordinary skill in the art would find it an obvious engineering choice to design the instrument to insert the sample-containing microholder into the measurement module for the purpose of aligning the optical source(s) and/or detector(s) of the final measurement system (given that [0051] teaches a fluorescence counter embodiment for the final measurement system) more precisely with the container’s surface, minimizing errors due to misalignment or refraction variations at the interface and ensuring accurate and consistent measurements of the sample’s physical properties.
By this, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the analysis instrument taught by Walsh with the push-bar measurement system taught by Reymond to ensure accurate and consistent measurements of a sample’s physical properties.
Response to Arguments
35 USC 112(b)
Applicant’s amendments sufficiently overcome the rejection set forth over Claim 42 under 35 USC 112(b) for the use of relative terms rendering the scope of the claim indefinite. As such, the rejection of Claim 42 as indefinite under 35 USC 112(b) is hereby withdrawn.
35 USC 103
Applicant’s arguments are on the alleged grounds that Walsh relies on applying pressure through backflow valves to actuate fluid, lacking the sliding valve arrangement, and that Examiner’s use of Ismagilov to provide the sliding valve arrangement does not meet the requirements of the amended Claims 1 and 39 requiring that the connecting channel segments provide fluid communication between at least a portion of the plurality of division wells and at least a portion of the plurality of reagent wells.
However, Applicant’s arguments are moot as Ismagilov is no longer relied upon herein to account for any aspect of the claimed invention, instead being replaced by the prior art of Davies for providing the sliding valve arrangement (Represented as layer B in Fig. 23B.) comprising connecting channel segments particularly providing fluid communication between wells/channels/chambers/etc., as necessitated by Applicant’s amendments thereto.
Davies teaches a respective cartridge comprising a sliding valve arrangement between layers A/B/C/D/E of a substrate defining a plurality of connecting channel segments 121300 (Fig. 23B and paras. [0012-0016]) such that relative motion between the substrates places at least some of a first population of input channels (interpreted as functionally equivalent to the “wells” of Walsh given their common functionality of holding and releasing fluid) in register with at least some of the second population of wells 125100 etc. to supply a solution via transfer of the sample from a plurality of first wells to a plurality of second wells ([0010]). Therein, this arrangement allows reagents to be mixed with multiple aliquots of sample simultaneously as the microchannels of the device can be moved at the same time ([0123]), reducing variation in sample reaction start times and errors drawn thereto, and further thereby offers higher throughput capabilities ([0004]).
Thus, Examiner sets forth the rejection of Claims 1, 14, 21, 23-25, 27-29, 31-33, 36-37, 39-40, and 42-43, and further dependents thereof, as being unpatentable under 35 USC 103 over at least Walsh in view of Abrams and Davies, as necessitated by Applicant’s amendments specifying the channels providing fluid communication between the wells.
Applicant further argues that Abrams fails to cure the alleged sliding valve body deficiency in Walsh. However, as discussed above, the alleged deficiency in Walsh is cured via obvious combination with the prior art of Davies so as to improve accuracy and increase throughput. Thus, Applicant’s arguments are moot as Abrams is not relied upon herein for curing the alleged sliding valve body deficiency of Walsh.
Applicant further alleges that the claimed configuration produces unexpected technical effects in that the sliding valve arrangement allows for simultaneous fluid actuation for synchronous reaction monitoring. However, Applicant’s arguments are not persuasive because the prior art of Davies relied upon for providing the sliding valve arrangement specifically discusses the advantages of programmed alignment of components at specific time points to reduce human error ([0013]), and establishes that multiple channels can be moved at the same time ([0123]). Applicant has merely stated an advantage/mode of operation of the design of the sliding valve arrangement not amounting to results that would be unexpected to one skilled in the art.
Applicant further argues on the alleged grounds that the claimed sliding valve body cooperates with a rotary disk and a motion module so as to achieve precise positioning and repeatable valve actuation for consistent runs. However, the “rotary disk” and “motion module” do not appear in Applicant’s disclosure, rendering Applicant’s arguments moot. Further, Davies discusses automation of the valve arrangement ([0013]) so as to reduce human error and achieve better accuracy and consistency between runs.
Applicant further alleges that as Claim 1 is patentable, dependents thereof are further patentable by virtue of dependency. However, as discussed above, Claim 1 is rejected under 35 USC 103 as unpatentable over Walsh in view of Abrams and Davies. Thus Applicant’s argument is moot.
New Claim 43
Applicant alleges that new Claim 43 is patentable because the prior art of Walsh does not provide for the opacity of the claimed dye to excitation and emission light. However, as discussed above in the body of the action, Walsh discusses the opacity of its dye cushion layer in paras. [0025]: “For devices that include fluorescent signaling moieties, dyes can absorb light of the fluorescent excitation frequencies, the fluorescent emission frequencies, or both.” and [0026]: “By dyed cushion is meant a cushion that includes dye. The dyed cushion simultaneously provides a physical exclusion of the bulk reaction from the detection zone (as a function of the density of the dyed cushion) while preventing or reducing the transmission of signal from the overlying reaction to the detector (as a function of the dye included in the dense layer).”
Thus, Examiner sets forth the rejection of Claim 43 as unpatentable under 35 USC 103 over Walsh in view of Abrams and Davies.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798