DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application, Pub. No. US 2022/0196639 A1, filed on 01/03/2022 is division of
U.S. Application No. 15/951,720, filed April 12, 2018, now U.S. Patent No. 11,215,610,
which is a continuation of U.S. Application No. 13/915,362, filed June 11, 2013, now U.S.
Patent No. 10,067,123, which is a continuation of U.S. Application No. 13/188,288, filed
July 21, 2011, now U.S. Patent No. 8,470,524, which is a continuation of U.S. Application
No. 11/549,558, filed October 13, 2006, now U.S. Patent No. 8,012,744. The effective filing date of this application is October 13, 2006.
Status of Claims
Claims 1-4 and 6-7 are currently pending. Claim 5 is canceled. Claims 1-4 and 6-7 are examined herein. Amendment to claim 1 appears to limit the species for quenching agent to “a quenching agent configured to inhibit an enzymatic reaction” and this species is searched and examined herein. Regarding claim 2, while Applicant labeled claim 2 as “Original,” claim 2 is an amended claim and is examined as such herein below.
Information Disclosure Statement
Six Information Disclosure Statements (IDS), filed 08/31/2022, 10/04/2022, 03/21/2023, 06/07/2023, 09/06/2023 and 11/20/2023, are in compliance with the provisions of 37 CFR 1.97, acknowledged, and considered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: "a quenching agent configured to inhibit an enzymatic reaction" in claim 1. The specification fails to define a specific and sufficient structure or material that would perform the recited function of “to inhibit an enzymatic reaction.” As such, herein, Examiner uses the broadest reasonable interpretation to define a material that is capable of performing the recited function when searching the prior art.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Montagu et al., (PGPub No. US 2006/0275852 A1), in view of Abraham-Fuchs (PGPub No. US 2002/0111741 A1), Huang et al., (Huang et al., A Resonance Energy Transfer between Chemiluminescent Donors and Luminescent Quantum-Dots as Acceptors (CRET), July 2006, Angew. Chem. Int. Ed. 2, 45, 5140 –5143), Bronstein et al.,(I. Bronstein et al., 1,2-Dioxetanes: Novel Chemiluminescent Enzyme Substrates. Applications to Immunoassay, 1989, Journal of Bioluminescence and Chemiluminescence, 4, 99-111), Belly et al., (PGPub NO. US 5,958,339), and Seargeant et al., (L. E. Seargeant et al., Inhibition of Human Alkaline Phosphatases by Vanadate, 1979, Biochem. J., 181, 247-250), as evidenced by Kingsmore (S. F. Kingsmore, Multiplexed protein measurement: technologies and applications of protein and antibody arrays, 2006, Nat Rev Drug Discov, 5,4, 310-320.
Throughout the disclosure, Montagu teaches a system comprising assay cassettes (i.e. biochips/fluidic device) and a control unit (i.e. a POC test device/reader assembly), wherein the cassettes comprises an identifier (e.g., bar code), a septum connected to a sample reservoir (US 2006/0275852 A1: Fig 5, reference numbers 32, 134; i.e. a sample collection unit), a reaction chamber (Fig 5, reference number133) comprising a ligand receptor array (US 2006/0275852 A1: Fig 5, reference number 20; i.e. an assay assembly), and a liquid waste chamber (US 2006/0275852 A1: Fig 5, reference number139; i.e. waste assembly), wherein the assay assembly comprises at least one reagent for generating a fluorescent signal indicative of the presence of the analyte in the sample of bodily fluid (US 2006/0275852 A1: paras 0016, 0076, 0084, 0094, 0127, 0132, 0137, 0159, 0163, 0177, 0204, and 0274). The control unit (i.e. reader assembly) comprises a bar code reader (US 2006/0275852 A1: Figs. 5-5A, reference number 154; i.e. an identification detector) configured to detect the bar code on the cassette, a controller for controlling operation of the rest of assay operation, and a reading system that captures an image of the reaction chamber for processing (US 2006/0275852 A1: para 0126 and 0275; Fig. 8, reference number 60; Fig. 8F, reference number 64); a detection assembly (paras 0126, 0249 [serum opto-sensor], 0273-0313; Fig. 6, components 150, 152). Montagu further teaches a method of conducting an assay employing the disclosed cassette (US 2006/0275852 A1: para 0026).
Regarding claim 1, Montagu teaches a method of detecting an analyte in a sample of bodily fluid, the method comprising: providing the sample of bodily fluid into a fluidic device having a housing and being configured to run an assay for detecting the analyte in the sample (US 2006/0275852 A1: paras 0018, 0079, 00140; and Fig. 17), herein the fluidic device comprises a sample collection unit (para 0036, and Figs. 5-5A, component 134), an assay assembly (paras 0022 and 0062; Figs. 5-5A, component 133) wherein the sample of bodily fluid is allowed to react with a reactant immobilized in the assay assembly of the fluidic device (paras 0076, 0079, 0126, 0137, 0140, 00274 and Fig. 17), and a waste chamber (para 0039, Figs. 5-5A, component 139); inserting the fluidic device into a reader assembly (paras 0126, 0137, 0150, Figs. 8, 8A, 8F), wherein the reader assembly comprises an identification detector (paras 0126, 0137, 0249, 0273-0313) a communication assembly (paras 0276-0313), and a detection assembly (para 0306). Montagu does not teach detecting an identifier of the device, transmission of the identifier to an external device to and receiving a protocol to execute on the fluidic device.
Throughout the disclosure, Abrahams-Fuchs teaches a network and method for evaluating medical data using a disposable biochip that contains a patient’s sample and a biochip identifier that characterizes the biochip. Abrahams-Fuchs teaches the biochip is inserted into a point of care (POC) test device that reads the biochip identifier. Abrahams-Fuchs teaches the POC test device is in communication with an external device and then transmits the biochip data to the external device. Abrahams-Fuchs teaches a data bank that stores a large number of measurement protocols that are accessible to the external device. Abrahams-Fuchs further teaches the external device is capable of selecting a measurement protocol, based on the biochip identifier, for executing said protocol on the fluidic sample in the biochip that is inserted inside the POC device.
Abrahams-Fuchs teaches detecting an identifier of the fluidic device by the identification detector; transmitting, by the identification detector, the identifier to the communication assembly transmitting, by the communication assembly, the identifier to an external device; device, a protocol to execute on the fluidic device based on the identifier (US 2002/0111741 A1: Abstract). Montagu and Abraham-Fuchs do not teach wherein the assay assembly is configured to yield a luminescent signal amplified by fluorescence indicative of the presence of the analyte in the sample of bodily fluid and detecting, by the detection assembly, the analyte in the sample by detecting the luminescent signal amplified by fluorescence.
Throughout the article, Huang teaches method called chemiluminescence (CL) resonance energy transfer (CRET), comprising a resonance energy transfer between chemiluminescent donors and quantum dot fluorescent (QD) acceptors. CRET involves nonradiative (dipole–dipole) transfer of energy from a chemiluminescent donor to a suitable acceptor molecule. CRET occurs by the oxidation of a luminescent substrate without an excitation source. Huang teaches applying the CRET method to an immunoassay based on antigen(BSA)–antibody(anti-BSAIgG) interactions. Immunoglobulin antigen (BSA) was first conjugated to a quantum dot by electrostatic interaction, and a catalyst (HRP) covalently conjugated to the corresponding antibody. Huang teaches an efficient CRET between the chemiluminescent substrate (luminol) that emits energy (luminescent signal) that is transferred to an acceptor, which in this study are quantum dots (QDs), when the antigen and corresponding antibody are in close proximity. The enhanced fluorescence emitted by the QD is the detected signal (Huang et al., July 2006, Angew. Chem. Int. Ed. 2, 45, pgs. 5141-5142).
Huang teaches an assay configured to yield a luminescent signal amplified by fluorescence, which a skilled artisan could easily adapt to indicate the presence of an analyte and thus the assay taught by Huang is capable of detecting an analyte in a sample by detecting a luminescent signal amplified by fluorescence (Huang et al., 2006, Angew. Chem. Int. Ed. 2, 45, pgs. 5140-5142 and Figs. 1-3). Huang does not teach the elected species dioxetane-phosphate as a marker and alkaline phosphatase as an enzyme in a chemiluminescent assay.
Throughout the article, Bronstein teaches the method of synthesizing two dioxetane-phosphate-based chemiluminescent enzyme substrates with one that can be activated to chemiluminescence by alkaline phosphate. Bronstein further teaches that alkaline phosphate-catalyzed chemiluminescence from one of the dioxetane-phosphate substrates is constant for a long period of time, allowing for detection of attomole quantities of analyte. Bronstein teaches that a chemiluminescent (CL) method using a dioxetane-phosphate-based marker and alkaline phosphate enzyme is an alternative to colorimetric and fluorescent detection methods for immunoassays because this CL method is simple with enhanced detection sensitivity, which enables development of rapid clinical assays.
Bronstein teaches a chemiluminescent immunoassay comprising a dioxetane-phosphate marker and alkaline phosphatase enzyme (Bronstein et al., 1989, Journal of Bioluminescence and Chemiluminescence, 4, Abstract). Montagu, Huang, and Bronstein do not teach wherein the waste chamber comprises a quenching site.
Throughout the disclosure, Belly teaches a method of detecting an analyte in a sample, comprising allowing a sample suspected to contain the analyte to react with a reactant contained in a fluidic device that comprises an assay assembly configured to yield an optical signal that is indicative of the presence of the analyte (Figs 1-4, col. 4, lines 12-63); moving unreacted reactant from the assay assembly to an quencher assembly operable to be in fluidic communication with, but spaced apart from said assay assembly (light absorbing means comprised as an integral part of at least a portion of the absorbent material, figs. 1-4, col. 4, lines 12-63, col. 8, lines 30-47), wherein said quencher assembly is adapted to reduce interference of said optical signal (figs. 1-4, col. 4, lines 24-32); and detecting said optical signal thereby detecting the analyte in the sample (col. 9, lines 35-50). Belly et al. teach reagent chambers such as dispensing devices for dispensing reagents (col. 8, lines 30-47) and a reaction site comprising a reactant that binds the analyte (col. 4, lines 34-50). Belly et al. teach that the quencher assembly comprises an absorbent material (col. 4, lines 20-32). Belly et al. teach that quenching agents such as black or pigmented polyvinyl alcohol or chemical agents or any material able to absorb or block signal generated by the washed label or other interferents (col. 9, lines 1-15) that is comprised as an integral part of the absorbent material (col. 4, lines 13-32). Belly et al. teach that the absorbent material can be comprised of materials such as glass microfibers, paper, sponge, fabric, plastic or the like, so long as the material is capable of absorbing liquids (col. 8, lines 50-60).
Belly teaches an absorbent material that “takes up (absorbs) wash fluid” and may be positioned adjacent to the wash application (US 5,958,339: col. 8, lines 48-56) or to the “read area” (col. 4, lines 13-27), which indicates that the absorbent material absorbs waste fluid and may be a site separated from other chambers and thus, using the broadest reasonable interpretation, reads on the instant limitation of a waste chamber. Further, Belly teaches that “light absorbing means can be comprised as an integral part of at least a portion of the absorbent material” (col. 4, lines 24-26), thus using the broadest reasonable interpretation, Belly teaches the waste chamber comprises a quenching site. Belly does not teach a quenching agent configured to inhibit an enzymatic reaction between a first reagent and a second reagent, hereby reducing interference of the luminescent signal amplified by fluorescence hereby reducing interference of the luminescent signal amplified by fluorescence.
Throughout the article, Seargeant teaches orthovanadate is a potent inhibitor of alkaline phosphatase enzyme, which takes part in the enzymatic reaction in a chemiluminescent reaction to produce a luminescent signal.
Seargeant teaches a quenching agent configured to inhibit an enzymatic reaction between a first reagent and a second reagent and is thus capable of reducing interference from the luminescent signal (Seargeant et al., 1979, Biochem. J., 181, pgs. 247-248 and pg. 249, last para).
It would have been prima facie obvious, at the time of filing, to combine the teachings of Montagu with the teachings of Abraham-Fuchs in order modify and improve the method of detecting an analyte in a biological sample using a fluidic device, as taught by Montagu, with the network and method comprising a biological sample identifier with a biochip device in communication with an external device with remotely accessible protocols, as taught by Abraham-Fuchs. In the art, it is well known that a single marker is not always sufficient to definitively diagnose a disease. Instead, a proper diagnosis is made by an evaluation protocol requiring several combined markers where development of markers for such diagnostic tests is very cost intensive and time intensive. Further, developing “expert rules” for required tests is both cost and time intensive (see Abraham-Fuchs, para 0004). Thus, a skilled artisan would have been motivated to combine these teachings to modify and improve the method of detecting an analyte using a fluidic device taught by Montagu with the network and automated biochip method taught by Abraham-Fuchs because it would enable multiple measurements of multiple markers and enable the use of robots for detecting multiple analytes simultaneously without the need of much human interaction. At the time of filing, a skilled artisan would have been further motivated to combine these teachings because it would expand patient access to diagnostic tests since the automated feature taught by Abraham-Fuchs allows for rapid diagnostic testing at a POC site, including a hospital bedside or a patient's home (see Abraham-Fuchs, para 0005). At the time of filing, the use of fluidic devises for analyte detection and a network and automated biochip POC device with stored protocols accessible remotely were known, taught, and used successfully by Montagu and Abrahams-Fuchs, respectively. Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings to modify the method of detecting an analyte using a fluidic device, as taught by Montagu, with the automated biochip and network taught by Abraham-Fuchs amounts to combining known elements to a known method to yield expected and predictable results.
It would have been prima facie obvious, at the time of filing, to combine the teachings of Montagu, in view of Abraham-Fuchs, with Huang in order to modify the method of detecting an analyte in a biological sample with an automated biochip fluidic device using a fluorescent detection system, as taught by Montagu in view of Abraham-Fuchs, with the CRET signaling method taught by Huang. In the art, is known that multiplexing, in the context of diagnostics, improves efficiency and conserves sample volumes (see Kingsmore, 2006, Nat Rev Drug Discov, 5,4, pg. 10 and Huang et al., pg. 5142, last para ). Thus, a skilled artisan would have been motivated to modify and improve the detection system taught by Montagu with the CRET signaling system taught by Huang because it would enable a skilled artisan to apply different fluorescence acceptors with different emission wavelengths to allow multiplexing and detection of more than one analyte. A skilled artisan would have been further motivated to make this modification because it would simplify the detection system by eliminating the need for an excitation source (see Huang et al., pg. 5140, last para). At the time of filing, using a bio-chip fluidic device comprising different chambers and using a luminescent signaling system for the detection of an analyte was well-known and conventional. Further, at the time of filing, Huang had already taught and suggested CRET as an advantageous signaling method for immunoassays as it does not require an excitation source and allows for multiplexing. Thus, at the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining and modifying the teachings of Montagu with Huang to improve Montagu’s detection system to simplify and allow for multiplexing of the signaling method amounts to applying a known improvement on a known technique or base device to yield expected and predictable results.
Further, it would have been prima facie obvious, at the time of filing, to combine the teachings of Huang and Bronstein in order to modify the chemiluminescent reaction taught by Huang with the dioxetane-phosphate marker/substrate and alkaline phosphatase enzyme taught by Bronstein. A skilled artisan would have been motivated to make this combination and modification because it would enhance the detection sensitivity for an analyte, allowing for small amounts of analyte to be detected. At the time of filing, chemiluminescence as a detection system for immunoassays was well-known in the art and Bronstein’s teachings for synthesizing and using dioxetane-phosphate marker/substrate and alkaline phosphatase enzyme to enhance the detection sensitivity in an immunoassay using chemiluminescence were already known in the art. Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining the known teachings to modify the signaling system of an immunoassay, where each element performs the same function when separated, amounts to combining known methods and techniques to yield predictable results.
Further, it would have been prima facie obvious, at the time of filing, to combine Montagu with Belly and modify the waste chamber for the method of detecting an analyte in a biological fluid using a fluidic devise taught by Montagu, in view of Huang and Bronstein, with a quenching site in the waste chamber, as taught by Belly. A skilled artisan would have been motivated to combine and modify the waste chamber taught by Montagu, in view of Huang and Bronstein, with the waste chamber comprising a quenching site taught by Belly because it would allow for reduction of optical interference from interferents present in the waste chamber, thus enhancing the luminescent signal. It would have been prima facie obvious, at the time of filing, to further combine and improve the quenching site with the quenching agent configured to inhibit a chemiluminescent enzymatic reaction, as taught by Seargeant. A skilled artisan would have been motivated to combine and modify the quenching site taught by Belly with the quenching agent taught by Seargeant to enhance detection sensitivity of the immunoassay for detecting an analyte. At the time of filing, biochip fluidic devices for detecting an analyte and comprising several chambers including a waste chamber were well-known and conventional in the art. Further, at the time of filing, a quenching agent to improve luminescent signals and an immunoassay device with a waste chamber capable of comprising said quenching agents that reduce optical interference to enhance the detected luminescent signal, were all taught and known in the art. A person having ordinary skill in the art would have a reasonable expectation of success because combining these teachings would amount to applying known improvements (quenching site and inhibitor that enhances chemiluminescence) to a base device or technique (waste chamber and chemiluminescent reaction) to yield expected and predictable results (reduced optical interference and improved detection sensitivity).
Regarding claim 2, Montagu, Abraham-Fuchs, Huang, Bronstein, Belly, and Seargeant teach all of the limitations in claim 1. Montagu further teaches detecting a concentration of the analyte in the sample (paras 0079, 0140, 0167, and claim 73). Montagu teaches detecting a concentration of the analyte based on a fluorescent signal with the detection assembly (paras 0079, 0140, and 0314), but Montagu does not teach detecting said concentration based on the luminescent signal amplified by fluorescence.
As discussed above, Huang, in the same field of endeavor, teaches a method for detecting a chemiluminescent signal amplified by fluorescence, which a skilled artisan may adapt for indicating presence and quantity of an analyte (Huang et al., 2006, Angew. Chem. Int. Ed. 2, 45, pgs. 5140-5142 and Figs. 1-3).
It would have been prima facie obvious, at the time of filing, to substitute the fluorescent detection method for detecting a concentration of an analyte, as taught by Montagu, with the CRET detection assay of Huang. A skilled artisan would have been motivated to make this substitution because it would enable a skilled artisan to apply different fluorescence acceptors with different emission wavelengths to detect the concentration of more than one analyte, allowing for multiplexing. Additionally, a skilled artisan would be further motivated to make this substitution because it would simplify the detection assay by eliminating the need for an external excitation light source for the fluorescence signal. Fluorescence, chemiluminescence, and CRET, which involves energy transfer from a chemiluminescent reaction to an acceptor that emits the detected fluorescence, are all well-known techniques in the art that can be adapted in an immunoassay to detect and quantify an analyte in a biological sample. Thus, a person having ordinary skill in the art would have a reasonable expectation of success because substituting a conventional florescence detection method with a well-known CRET detection assay for detecting a concentration of an analyte would yield expected and predictable results.
Regarding claim 3, Montagu, Abraham-Fuchs, Huang, Bronstein, Belly, and Seargeant teach all of the limitations of claim 1. Montagu further teaches wherein the detection assembly comprises one of a digital camera with a charge coupled device [CCD] (US 2006/0275852 A1: Fig. 8F).
Regarding claims 4 and 7, Montagu, Abraham-Fuchs, Huang, Bronstein, Belly, and Seargeant teach all of the limitations in claim 1. Regarding instant claim 4, Montagu further teaches wherein the assay assembly further comprises a reagent chamber, a reaction site, and a fluidic channel that connects the reagent chamber with the reaction site, wherein the reactant is immobilized in the reaction site of the assay assembly (US 2006/0275852 A1: paras 00076, 0079, 094, 0126, 0137, 0140, 00274; and Fig. 17). Regarding instant claim 7, Montagu further teaches further comprising: controlling movements of the sample within the fluidic device by an actuating element in the reader assembly, wherein the actuating element includes one of a pump and a value (US 2006/0275852 A1: Abstract; paras 0173-0184; and Figs. 5A, components 30, 37, 137A, 137B, 137C ) and further teaches the elected species of blood for a fluidic sample and the elected species of nucleic acids for the analyte (US 2006/0275852 A1: paras 0127, 0138-0139).
Regarding claim 6, Montagu, Abraham-Fuchs, Huang, Bronstein, Belly, and Seargeant teach all of the limitations in claim 1. Belly further teaches an absorbent material that “takes up (absorbs) wash fluid” (US 5,958,339 A: col. 8, lines 48-56 and col. 4, lines 13-27) and further teaches “light absorbing means can be comprised as an integral part of at least a portion of the absorbent material” (US 5,958,339 A: col. 4, lines 24-26), thus using the broadest reasonable interpretation, Belly teaches wherein the quenching site further comprises an absorbent material saturated with the quenching agent (US 5,958,339 A: col. 8, lines 30-50; Fig. 4; col. 4, lines 24-26; Fig. 1, component 16). Further, Belly teaches the adsorbent material can be [silica-based] glass fibers, which reads on the elected species of silica for the adsorbent material (US 5,958,339 A: col. 8, lines 56-59).
It would have been prima facie obvious, at the time of filing, to combine the teachings of Montagu, in view of Abraham-Fuchs, Huang, and Bronstein, with the teachings of Belly in order to modify the method and waste chamber of the fluidic device taught by Montagu with the quenching site and absorbent material taught by Belly. A skilled artisan would have been motivated to combine these teaching to modify the waste chamber taught by Montagu with the silica-based absorbent quenching site saturated with a quenching agent, as taught by Belly, because the absorbent material at the waste chamber would enable the retention of most or all of the waste fluid, preventing leaks and cross contamination into other chambers, while simultaneously removing optical signal interferants present in the waste fluid to improve signal detection sensitivity (see US 5,958,339 A: col. 8, lines 34-37 and 40-50). At the time of filing, a waste chamber in fluidic devices was well-known in the art. Further, at the time of filing, Belly taught a waste chamber comprising a silica-based absorbent material saturated with a quenching agent. Thus, at the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining well-known methods and further combining with well-known elements, which perform the same function separately as in combination, would yield expected and predicable improvements and results.
Response to Applicant Arguments/Remarks
Applicant’s response to Objection to the Specification is acknowledged and accepted.
Applicant’s arguments with respect to 35 U.S.C. 112(a) rejection of claims 1-7 are acknowledged and accepted. Thus, the 35 U.S.C. 112(a) rejection of claims 1-7 is withdrawn.
Applicant’s response with respect to 35 U.S.C. 112(b) rejections of claims 5-6 are acknowledged and accepted.
With respect to the 35 U.S.C. 103 rejection of claim 1, Applicant’s arguments have been considered but are moot because new grounds of rejection are necessary due to the amendment of claim 1.
With respect to the 35 U.S.C. 103 rejection of claim 5, Applicant’s arguments have been considered but are moot because claim 5 is canceled.
With respect to the 35 U.S.C. 103 rejection of dependent claims 2-4 and 6-7, Applicant’s arguments have been considered but are moot because new grounds of rejections are necessary due to the amendments of independent claim 1 and dependent claims 2 and 6.
Conclusion
All claims (1-4 and 6-7) are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA L LIRIANO whose telephone number is (571)272-0085. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at (571)272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA LIZETTE LIRIANO/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 14, 2026
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