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 .
Status of Claims
Claims 1-19 are pending and examined herein.
Claim Objections
Claims 1, 6, 15, and 17 are objected to because:
Claim 1 recites “a biosensing test of the substrate solution”, should be “a biosensing test on the substrate solution”.
Claim 6 recites “the capillary pump,,”, should be “the capillary pump, [[,]]”.
Claims 15 and 17 contain abbreviation ELONA. These should be completely spelled out in its first occurrence.
Appropriate correction is required.
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.
Claim 3 recites the reaction chamber is configured to incubate a solution, which is not modified by sufficient structure, material, or acts for performing the claimed function. This limitation is interpreted in view of the specification pg. 6, last paragraph disclosing that a further retention valve can temporarily retain the flow. Thus, the solution present in the reaction chamber will be incubated for the duration of the flow retention.
Claim 14 recites the test strip of claim 1, configured to measure levels of the analyte, wherein the analyte is a hormone and claim 15 recites the test strip of claim 1, configured to perform an ELISA or ELONA test, which are not modified by sufficient structure, material, or acts for performing the claimed function. These limitations are interpreted in view of Fig. 8a-d illustrating a generic ELISA test with immobilized antibodies.
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 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “to perform at least part of a biosensing test of the substrate solution” (step (iv)). It is unclear why the biosensing test is performed on the substrate solution instead of the fluid sample or a target analyte.
Additionally, claim 1 fails to recite all essential connections between the test strip elements i-v.
Claims 2-19 are rejected because they depend from rejected claim 1.
Claim 2 recites a branched flow path. It is unclear where along the path the branch point is located and what test strip elements are located in different sections of the flow path.
Claim 3 recites “the reaction chamber is configured to incubate a solution”. Parent claim 1 recites “a series of solutions, said solutions comprising at least a fluid sample and a substrate solution.” It is unclear if claim 3 is referring to one of the solutions of claim 1 or a solution in addition to the solutions of claim 1.
Claim 5 recites “a substantially diamond-shaped cross section”. The terms “substantially diamond-shaped” and “diamond-shaped” are indefinite because the specification lacks some standard for measuring the shapes and the terms are not defined in the art.
Claim 17 recites “use of the test strip of claim 1 or the test system of claim 16” without setting forth any steps involved in the process. Therefore, claim 17 is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced (MPEP 2173.05(q)).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because a “use” is not a process, a machine, a manufacture, or a composition of matter. A “use” is not one of the statutory categories of invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (PGPub 20120040470), in view of Olanrewaju et al. (Lab Chip. 2018 Aug 7;18(16):2323-2347), Zhong et al. (Transactions on Biomedical Circuits and Systems, 2019), and as evidenced by Trantidou et al. (Microsyst Nanoeng. 2017 Apr 24; 3:16091).
Regarding claim 1, Dorn teaches a microfluidic test cartridge comprising:
an inlet for receiving solutions, such as, a sample fluid containing the analyte ([0069]).
Recitation of “an inlet for receiving a series of solutions, said solutions comprising at least a fluid sample and a substrate solution” is an intended use of the inlet. The substrate solution is not structurally claimed as an active component of the test strip so the inlet only needs to be capable of receiving it. So long as the inlet in the cartridge of Dorn is capable of receiving a sample fluid containing the analyte and substrate solution , it reads on the claim.
Another teaching of Dorn provides means for temporal retaining of the assay solutions – “a precisely defined volume of liquid is delayed in the chambers for a particular period of time and transported further after this time” ([0057]); therefore, this feature performs the recited function of the retention valve and sealed/unsealed configurations of the vent hole;
a reaction chamber functionalized with one or more bioreceptors for binding to a target analyte – specifically, Dorn teaches the reagent chamber with reagents stored on in the form of a reagent pad into which reagents have been taken up (adsorbed onto, fixed onto, dispersed into, dried into) ([0070]). The reagents can be antibodies, antibody fragments, and anticalins ([0074]), and enzyme substrates ([0075]). The reagents are dissolved and react with the analytes or are perfectly mixed with the sample fluid ([0082]). Therefore, Dorn teaches bioreceptors for binding to a target analyte and a substrate solution;
a pump - specifically, “the means for transporting the sample fluid, for example a pressure surge, a syringe, a plunger, or a pump” ([0127]);
a test chamber to receive the substrate solution from the reaction chamber – specifically, the sample volume with the dissolved reagents is transported further via a channel into the detection chamber ([0084]). The detection chamber comprises a biochip ([0187]);
a vent hole coupled to the test chamber to allow a flow of solution from the reaction chamber into the test chamber - ventilation of the complete channel system takes place via ventilation hole(s) ([0195] and holes (20) in Fig. 1, 4, or 5). Additionally, Dorn teaches that the body of the test cassette can consist of various polymeric materials, such as, for example, polystyrene (PS), polypropylene (PP), polycyclic olefins, polyethylene (PE), polyethylene terephthalate (PET), Teflon or analogues ([0048]). The listed polymers are hydrophobic in nature, therefore a vent hole formed in one of these polymers inherently becomes a hydrophobic vent hole.
Dorn does not specifically teach the limitation of claim 1 “when the vent hole is unsealed and to allow a flow of solution from the reaction chamber to the capillary pump when the vent hole is sealed.” However, such limitation is drawn to intended use of the device and therefore the prior art only needs to be capable of performing the recited intended use. So long as the vent hole (20) in the cartridge of Dorn is capable to allow a flow of solution from the reaction chamber to the pump, it reads on the claims.
The test cartridge of Dorn is equivalent to the test strip of instant invention because Fig. 2 of the disclosure labels reference item (206) as a cartridge.
Dorn fails to teach an inlet comprising a retention valve, a capillary pump and a plurality of test electrodes.
Regarding claim 1, Olanrewaju teaches “Capillary microfluidics in microchannels: from microfluidic networks to capillaric circuits” (Title). Olanrewaju also teaches a capillary pump for moving liquid in microfluidic devices from the inlet to the reaction chamber (Fig. 1B).
Additionally, Olanrewaju teaches a retention valve between the inlet (loading pad) and the reaction chamber (Fig. 1B).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the pump of Dorn with the capillary pump as taught by Olanrewaju, to provide a microfluidic test cartridge with means for directional fluid flow, as an obvious matter of simple substitution of one known element for another to obtain predictable results.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because both references are drawn to microfluidic devices designed for performing immunoassays; and the capillary pump of Olanrewaju is capable of providing the same directional fluid flow as the pump of Dorn.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because both references are drawn to microfluidic devices designed for performing immunoassays; and the capillary pump of Olanrewaju is capable of providing the same directional fluid flow as the pump of Dorn.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the test cartridge of Dorn with the retention valve as taught by Olanrewaju, to provide the test cartridge with means for preventing complete drainage, entry of air, and drying of the reaction chamber downstream (pg. 2335, col. 2, par. 3).
One having ordinary skill in the art would have been motivated to incorporate the retention valve into the test cartridge provide the advantage of improved liquid flow control as mentioned above. This combination would have been desirable to those of ordinary skill in the art for the reasons mentioned above.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because both Dorn and Olanrewaju are similarly drawn to test cartridges/strips, and Olanrewaju teaches the retention valve as an improvement in liquid flow control.
Dorn and Olanrewaju fail to teach a plurality of test electrodes.
Regarding claim 1, Zhong teaches micro-electrode-dot-array digital microfluidic biochips (Title). Zhong also teaches a plurality of test electrodes as a means of assay detection.
Specifically, Zhong teaches microfluidic biochips used for immunoassays comprising thousands of microelectrodes on a single biochip (Abstract and Fig. 3a and 3b).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dorn and Olanrewaju for the microfluidic test cartridge with the plurality of test electrodes as taught by Zhong, to provide a microfluidic test cartridge with electrode-based analyte detection, as an obvious matter of simple substitution of one known element for another to obtain predictable results.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because both references are drawn to microfluidic devices designed for performing immunoassays.
Regarding claim 2, Dorn in view of Olanrewaju teaches a branched flow path to guide solution though the assay cartridge. Specifically, Olanrewaju teaches capillary channels throughput the publication. The capillary pump inherently comprises at least one capillary channel (e.g., Fig. 7A).
Additionally, Olanrewaju teaches that the cross-sectional area of the retention valve constriction has to be of smaller dimension than the capillary pump, thus limiting the range of capillary pressure of the pump and the capillaric circuits (pg. 2335, col. 2, par. 3).
In Fig. 5 Olanrewaju teaches a more elaborate structure for a microfluidic circuit than in previously mentioned example illustrated in Fig. 1B. This improved version comprises a branched flow path with one branch connecting an inlet located on the left-hand side of the horizontal flow path with a vent, labeled as inlet/vent on top of retention burst valve 2. The hydrophobic nature of the vent is addressed above in “Regarding claim 1, Dorn step v”. The other branch of the branched flow path connects the same inlet located on the left-hand side of the horizontal flow path with the capillary pump (#3 in Fig. 5), meeting the limitation of claim 2 reciting a branched flow path to guide solution from the inlet to the hydrophobic vent hole and from the inlet to the capillary pump.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the test cartridge of Dorn with the branched flow path as taught by Olanrewaju, to provide the test cartridge with means to connect additional reservoirs for storage of assay fluids prior to the assay. One having ordinary skill in the art would have been motivated to incorporate the branched flow path with reservoirs into the test cartridge to provide the test cartridge with all required assay fluids ahead of time to simplify the assay run. This combination would have been desirable to those of ordinary skill in the art for the reasons mentioned above.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because both Dorn and Olanrewaju are similarly drawn to test cartridges/strips, and Olanrewaju teaches the branched flow path with reservoirs as an improvement in functionality of the test cartridge of Dorn.
Regarding claim 3, Dorn teaches the reaction chamber is configured to incubate a solution and the test strip comprises a further retention valve for temporarily retaining a said incubated solution.
Specifically, Dorn teaches the reagent chamber with reagents stored on in the form of a reagent pad into which reagents have been taken up (adsorbed onto, fixed onto, dispersed into, dried into) ([0070]) and the reagent chamber configured to incubate a solution - “[a]fter the reagent pad has been wetted, a defined period of time (preincubation time) can be allowed to elapse, for example until a biochemical reaction has ended or until a certain reaction temperature has been reached” ([0083]).
Dorn fails to teach a further retention valve. However, the further retention valve of claim 3 is a duplication of parts previously known in the art - Olanrewaju teaches a retention valve between the inlet (loading pad) and the reaction chamber (Fig. 1B). Olanrewaju teaches the benefit of the retention valve – “retention valve prevents complete drainage, entry of air, and drying of the reaction chamber downstream” (pg. 2335, col. 2, par. 3). As such, the retention valve temporarily retains a solution.
The duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04). In the instant case Applicant fails to disclose any particular purpose or any known problem for which two retention valves should be used and fails to demonstrate the criticality of this specific limitation. A single retention valve is sufficient to prevent complete drainage, entry of air, and drying. Therefore, the duplication of the retention valve is obvious in view of MPEP 2144.04.
Regarding claim 4, Dorn in view of Olanrewaju teaches the capillary pump comprises at least one capillary channel defined by an array of micropillars. Specifically, Fig. 7Bi demonstrates a simple capillary pump with “posts”, which are equivalent to the micropillars of claim 4.
Regarding claim 5, Dorn in view of Olanrewaju teaches a variety of different shapes of micropillars for use in the capillary pump: posts, hexagons, a tree of lines, symmetric, asymmetric, and balled lines (Fig. 7B). Since Applicant has not disclosed that the micropillars with diamond-shaped cross section are for any particular purpose or solve any stated problem and the prior art of Olanrewaju teaches that the micropillars shapes can vary, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimal micropillar shape.
Regarding claim 6 limitation of wherein the capillary pump comprises a bypass channel along at least part of a perimeter of the capillary pump, wherein a smallest cross-sectional width of the bypass channel is greater than a smallest separation of between adjacent said micropillars.
The bypass channel of instant invention is not an isolated structural feature of the pump, instead, it is an integral part of the capillary pump – a mere spacing, separating the array of micropillars from the pump wall. Therefore, the bypass channel is taught by Fig. 7B as shown by the perimeter channel (e.g., Olanrewaju Fig. 7B).
The limitation “a smallest cross-sectional width of the bypass channel is greater than a smallest separation of between adjacent said micropillars” simply turns the inherently present spacing between the array of micropillars and the pump wall (bypass channel) into another channel with a reduced aspiration action running along the periphery of the capillary pump’s micropillars. The functionality of the capillary pump is not modified or affected in any way by such bypass channel.
Additionally, Applicant fails to disclose any known problem which is solved by introduction of the bypass channel with the specified cross-sectional width.
Regarding claim 7 limitation of “wherein a smallest separation between adjacent said micropillars is less than a smallest width of a solution flow path from the reaction chamber to the capillary pump”.
Dorn in view of Olanrewaju teaches that liquid flow in capillaric circuits is driven by capillary pressure (Olanrewaju, pg. 2326, col. 1, last par.) and the capillary pressure is roughly scaled proportionally to the inverse of the smallest dimension (Olanrewaju, pg. 2326, col. 2, par. 2). In order to ensure proper liquid flow in the assay cartridge, the capillary pressure in the capillary pump channels has to be greater than the capillary pressure in the other parts of the cartridge. Therefore, the smallest separation between adjacent said micropillars has to be less than a smallest width of a solution flow path from the reaction chamber to the capillary pump. This is an inherent property of capillary flow dynamics; therefore, it is obvious.
Regarding claim 8 limitation of “the capillary pump has an inlet comprising a constriction”.
Dorn in view of Olanrewaju teaches a retention valve between the inlet (loading pad) and the reaction chamber (Olanrewaju, Fig. 1B) and the benefit of the retention valve – “retention valve prevents complete drainage, entry of air, and drying of the reaction chamber downstream” (Olanrewaju, pg. 2335, col. 2, par. 3). Therefore, the valve of Olanrewaju is interpreted as the constriction.
Although, Olanrewaju does not specifically teach the capillary pump having an inlet comprising a constriction, such limitation is drawn to intended use of the device and therefore the prior art only needs to be capable of performing the recited intended use. So long as the retention valve of Olanrewaju (Fig. 1B) is capable of delivering the functionality of an inlet comprising a constriction it reads on the claims.
Regarding claim 9, Dorn teaches vent holes (20) fluidically connected to the reagent chamber (7) (Fig. 1). Therefore, the vent holes (20) can reduce pressure in the reagent chamber by allowing any air to escape.
Regarding claims 10 and 11, Dorn teaches that the body of the test cassette (2) can consist of polydimethylsiloxane ([0048] and Fig. 4). Polydimethylsiloxane is a biocompatible polymer widely used in microfluidic chips, that can be modified to have hydrophilic surface, as evidenced by Trantidou (Abstract). Therefore, all recited components of the test strip: the test chamber, the channel, the inlet, the capillary pump, and the vent hole can be formed in a hydrophilic polymer layer.
Regarding claim 12, Dorn in view of Olanrewaju teaches a retention valve between the inlet (loading pad) and the reaction chamber (Fig. 1B), as a passive stop valve that prevents complete drainage, entry of air, and drying” (Olanrewaju, pg. 2335, col. 2, par. 3).
Olanrewaju does not specifically teach that the retention valve is used to at least reduce a flow rate of solution into the test chamber, but when the retention valve prevents complete drainage, it at least reduces a flow rate of solution to a downstream chamber. Such limitation is drawn to intended use of the device and therefore the prior art only needs to be capable of performing the recited intended use. The retention valve taught by Olanrewaju is capable of at least reducing the flow rate; therefore, it reads on the claims.
Regarding claim 16, Dorn in view of Olanrewaju teaches an apparatus for operating the test cassette according to the invention (Dorn, [0066]). The apparatus of Dorn corresponds to the system of claim 16. Additionally, the reference teaches that “[t]he sample fluid to be analyzed is introduced into the test cassette through the inlet” (Dorn, [0069]). Olanrewaju teaches that inlets are easy to fill in a laboratory setting using a pipette. The pipette meets the limitation of claim 16 reciting a fluid sample collector device for collecting the fluid sample and inputting the fluid sample into the inlet
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dorn, Olanrewaju and Zhong for the microfluidic test cartridge with a disposable tip or a similar collector/transfer device for collecting the fluid sample and introducing it to the test strip inlet, as done routinely for many assays.
Claims 13-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Dorn, in view of Olanrewaju and Zhong, as applied to claim 1 above, and further in view of Pinto et al. (Biosens Bioelectron. 2017 Apr 15; 90:308-313), and as evidenced by Trantidou et al. (Microsyst Nanoeng. 2017 Apr 24; 3:16091).
Regarding claims 13-15 and 17-19, Dorn, in view of Olanrewaju, Zhong, and Trantidou fails to teach the fluid sample comprises saliva, blood, blood serum, blood plasma, urine, nasal fluid or solutions thereof; the test strip of claim 1, configured to measure levels of the analyte, wherein the analyte is a hormone; and the test strip of claim 1, configured to perform an ELISA or ELONA test.
Regarding claims 13-15 and 17-19, Pinto teaches a microfluidic immunosensor for rapid and highly-sensitive salivary cortisol quantification (Title).
Specifically, Pinto teaches detection of cortisol (a hormone) in saliva using an ELISA test with HRP-labeled cortisol (Abstract), meeting the limitations of claims 13-15 and 17-19.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dorn, Olanrewaju, and Zhong to analyze cortisol levels in saliva as taught by Pinto because Dorn, Olanrewaju, and Zhong is generic with respect to the types of analytes and samples that can be used on the test strip and one skilled in the art would have been motivated to use the appropriate sample and analyte based on the desired test to be conducted. Pinto teaches motivation for measuring cortisol “A common feature of maladaptive response to chronic stress is the increased cortisol levels in specific periods or abnormal circadian cycle. Therefore, it is of utmost importance to monitor the cortisol concentration in the human body along the day” (pg. 308, col. 1, par. 1).
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because the prior art references are similarly drawn to microfluidic devices designed for performing immunoassays, and Pinto teaches successful detection of cortisol in saliva samples using a microfluidic device.
Regarding claim 18, Dorn teaches a disposable test cassette having at least one inlet for introducing a sample fluid (Abstract). Introducing the sample fluid into the inlet is the same as receiving the fluid sample in the inlet, as recited in claim 18.
Regarding claim 19, Pinto teaches “the washing solution of PBS-Tween20 was pumped with a flow rate of 4 µL/min during 1 min” (pg. 312, col. 1, last par.). Receiving wash-buffer solutions in the inlet is a required step in performing an ELISA test in the microfluidic immunosensor of Pinto. Unbound assay components, such as HRP-labeled molecules must be washed-out from the assay prior to detection.
Double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/624,333 in view of Olanrewaju.
Claim 1 of ‘333 recites a saliva test system for performing an ELISA or ELONA test, the system comprising:
a saliva receiver having an inlet channel for collecting from a user saliva comprising analyte, the saliva receiver to guide the collected saliva to an incubation chamber;
the incubation chamber having bioreceptors for binding to the analyte and reagent, and for providing an incubated solution;
the incubation chamber to incubate a substrate, the incubation to allow the substrate to react with a said bound reagent and thereby provide the incubated solution;
a test chamber arranged to receive a said incubated solution from the incubation chamber, the test chamber having biosensing test electrodes to perform on the incubated solution a biosensing test;
a narrowing, such as a constriction, of the inlet channel, the narrowing for limiting a volume of the collected saliva; and
a vent hole to assist flow of the collected saliva through the saliva receiver toward said incubation chamber, the vent hole coupled downstream of the narrowing and/or the incubation chamber and openable to enable flow of the collected saliva through the narrowing toward the incubation chamber.
‘333 does not teach a capillary pump of instant claim 1.
Olanrewaju teaches “Capillary microfluidics in microchannels: from microfluidic networks to capillaric circuits” (Title). Olanrewaju also teaches a capillary pump for moving liquid in microfluidic devices from the inlet to the reaction chamber (Fig. 1B).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the test system of ‘333 with the capillary pump as taught by Olanrewaju, in order to provide the test system with means for directional fluid flow, as an obvious matter of simple substitution of one known element for another to obtain predictable results.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ALEXANDER ALEXANDROVIC VOLKOV/
Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677