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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/14/23 is being considered by the examiner.
Claim Status
Claims 1-20 are pending and are examined.
Claim Objections
Claim 14 is objected to because of the following informalities: Add “cm” as the lower unit to “a circle with a diameter comprised between 3 cm and 10 cm.” Appropriate correction is required.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 6 is 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 6 recites the limitation "the reference pad". There is insufficient antecedent basis for this limitation in the claim.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 3, 8, 9, 11, 14, 15, 16, 17, 18, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McCord (WO 2020/018232; already of record on the IDS received 12/14/2023), in view of Sambath (“Potassium ion fluorescence probes: Structures, properties, and bioimaging.” ChemPhotoChem. 5, 317-325. 2021; already of record on the IDS received 12/14/2023) and Viro Research (“Manufacturing of Lateral Flow Assays (Part 1”). Nov. 2020.
Regarding Claim 1, McCord teaches a test strip (Fig. 7 test matrix 212, [0062]) for detecting an ion of interest present in urine for a urine optical analysis device cartridge,
the test strip (test matrix 212) comprising:
a sample pad configured to receive a urine sample ([0065] sample pad 711),
a test pad comprising a probe (colorimetric test pads in regions 702a through 702r)
and
a backing pad on which the sample pad and the test pad are arranged, the backing pad being configured to transport the ions of interest across the test strip from the sample pad towards the test pad (a backing; [0062] A test matrix may have multiple layers, including for example a backing, one or more layers for reagents, and a top laminate layer. Materials may be selected to absorb sufficient urine sample volume to perform the tests, and to release the volume to the regions with reagents to perform the desired assays.),
the backing pad being made of a porous plastic membrane ([0068] a transparent laminate backing 727. Urine may fill the test chamber 728 and flow through perforations on the exposure side 724 to reach the tests embedded in read side 723.).
McCord is silent to a probe made of a fluorophore conjugated with an ionophore, a fluorescence emission intensity of the fluorophore increasing when an ion of interest is binding with the ionophore, and that the porous membrane is plastic.
Sambath teaches in the related art of imaging. Fluoroionophores undergo transduction, producing fluorescence signals when interacting with e.g. potassium ions. See Abstract. The fluoroionophore’s constructs includes a receptor with an affinity towards K+ and a fluorophore to report the change. Design and synthesis of various fluorescence probes for K+ analysis under biological conditions. Fluoroionophores were divided into two categories based on the structure of the K+ receptor, namely, crown ethers and cryptands.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted a fluorophore conjugated with an ionophore, a fluorescence emission intensity of the fluorophore increasing when an ion of interest is binding with the ionophore, as taught by Sambath, with the colorimetric probe in the test matrix of McCord, allowing for K+ (potassium sensing) probes for very specific physiologically-relevant ranges of concentrations relating to biosensing and micro-organelle targeting ability, as taught by Sambath, in the Conclusion.
Modified McCord is silent as to the porous membrane is plastic.
Viro Research teaches in the related art of a test strip and lateral flow assay. The strips have five components which include: 1) plastic backing with adhesive and release liner, 2) sample pad, 3) conjugate pad, 4) nitrocellulose pad, and 5) cover layers over the composite device. The materials are supplied in a roll, sheet or strip formats. The membrane is already converted for lamination onto the plastic backing. See Introduction. Two pads are typically processed using impregnated sheet stock, followed by drying, cutting to width, and lamination to the backing card. See Conjugate and Sample Pads.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the porous membrane a plastic porous membrane, as taught by Viro Research, in the test strip, as taught by modified McCord, to allow for standard operating practice of making a lateral flow assay for rapid testing.
Regarding Claim 2, modified McCord teaches the test strip according to claim 1, wherein the ion of interest is chosen between: sodium, potassium, and magnesium (potassium ions. See Abstract.).
Regarding Claim 3, modified McCord teaches the test strip according to claim 1, wherein the test strip extends along a longitudinal direction, the test strip presenting a length less than 20 mm ([0062] 5 mm length), and/or a width less than 5 mm (the examiner notes that the limitation reciting “or” is not required).
Regarding Claim 8, modified McCord teaches the test strip according to claim 1, wherein the sample pad comprises a buffer able to keep the pH of the sample pad between pH 6.5 and 7.5 for a urine sample of pH 5 to 8 ([0065] Liquid sample and buffer 710 are dispensed onto a sample pad 711.).
Regarding Claim 9, modified McCord teaches the test strip according to claim 1, wherein the test pad is made of cellulose ([0065] The sample and conjugate then flow into nitrocellulose membrane 714.).
Regarding Claim 11, modified McCord teaches the test strip according to claim 1, wherein the ion of interest is sodium and the probe is made of a crown ether linked to a fluorophore (See page 317, 2nd column, 2. Crown ethers. Probe 2 in 2nd paragraph in column 1 on page 318 and probe 6 in 2nd paragraph in column 2 on page 318 describe fluorescent crown ether).
Regarding Claim 14, McCord teaches a cartridge for a urine optical analysis device, the cartridge comprising a plurality of chambers arranged next to one another in a right circular cylinder shape of at least 80% of a circle wherein at least one of the plurality of chambers comprises a test strip according to claim 1 ([0074] One or more embodiments may alternatively store test matrices in a circular cartridge, and may for example spool a reel of test matrices between a storage cartridge and a waste cartridge.)
McCord is silent to a circle with a diameter comprised between 3 and 10 cm.
Regarding a circle with a diameter size between 3 and 10 cm, a particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (see MPEP 2144.05.II.B.). There is no evidence indicating that the diameter is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the device such that the diameter is between 3 and 10 cm for the arrangement of the plurality of chamber right circular cylinder shape, allowing for standard and optimal sizing for a point of care diagnostic device.
Regarding Claim 15, modified McCord teaches the cartridge according to claim 14.
Modified McCord is silent to the cartridge further comprises a pH measuring strip arranged in at least one of the plurality of chambers.
Buffers and reagents need to be at a certain pH for lateral flow assay to work properly. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a pH measuring strip, to the device of modified McCord, to monitor the pH during testing.
Regarding Claim 16, McCord teaches a urine optical analysis device (Urine analysis system that couples or integrates with a toilet. See Abstract) comprising: the cartridge according to claim 14, a station, configured to be positioned on a wall of a toilet bowl ([0074] One or more embodiments may alternatively store test matrices in a circular cartridge) Figure 8A shows an illustrative embodiment of a system that employs a reel to reel system for test matrix storage and transport. [0057] urine analysis system mounted to toilet 110.), the station comprising: a case comprising an annular housing in which the cartridge is at least partially received and is rotatably mounted therein around a rotation axis ([0074] may for example spool a reel of test matrices between a storage cartridge and a waste cartridge), an injector ([0040] tool, and then dispense this sample into the standalone urine analysis system.), configured to inject urine on the test strip, an analyzer with a light source and a light sensor ([0075] One or more embodiments may illuminate the test matrix with selected wavelengths of light to maximize the sensitivity of one or more urine analysis tests. Different tests may respond to different wavelengths; therefore, one or more embodiments may provide several different wavelengths for illumination of the test matrix. Figure 9 illustrates an example of selecting an optimal wavelength for a specific test. [0076] Sensors 224), configured to emit and receive light, and to detect a change of fluorescence of the test strip ([0076] Images of the test matrix may be analyzed to determine the results of the urine tests embedded in the test matrix. An image or other signals to be analyzed may be any data captured by any sensor or sensors of the urine analysis system. Analysis of images or other signals may be performed local to the urine analysis system, remote from the system, or via a combination of local and remote analysis. Figure 10 shows several illustrative alternatives for the organization of data analysis. One or more images 100 la or other signal data are obtained by sensors 224.).
Regarding Claim 17, modified McCord teaches a method to manufacture a test strip according to claim 1 ([0065], Fig. 7), comprising:
providing a probe (Fig. 7A [0065] First the sample liquid flows to conjugate pad 712, into which a detection conjugate 713 is embedded.)
providing a sample pad (sample pad 711), and
Modified McCord is silent to a paper substrate, a backing pad made of a porous plastic membrane, diluting the probe in a solvent to form a stock solution, soaking the paper substrate into the stock solution with shaking, drying the probe on the paper substrate by heating it to form a test pad, and fixing the sample pad and the test pad on the backing pad with an adhesive layer.
Viro Research teaches in the related art of a test strip and lateral flow assay. The strips have five components which include: 1) plastic backing with adhesive and release liner, 2) sample pad, 3) conjugate pad, 4) nitrocellulose pad, and 5) cover layers over the composite device. The materials are supplied in a roll, sheet or strip formats. The membrane is already converted for lamination onto the plastic backing. See Introduction. Two pads are typically processed using impregnated sheet stock, followed by drying, cutting to width, and lamination to the backing card. See Conjugate and Sample Pads.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the elements and method steps of a paper substrate, a backing pad made of a porous plastic membrane, diluting the probe in a solvent to form a stock solution, soaking the paper substrate into the stock solution with shaking, drying the probe on the paper substrate by heating it to form a test pad, and fixing the sample pad and the test pad on the backing pad with an adhesive layer, as taught by Viro Research, in the device and manufacturing of the device, as taught by modified McCord, to allow for standard operating practice of making a lateral flow assay for rapid testing.
Regarding Claim 18, 19, and 20, modified McCord teaches the method according to claim 17.
Modified McCord is silent to the solvent is methanol, before fixing the sample pad on the backing pad, the method further comprises: soaking the sample pad in a buffer solution, and heating the sample pad, the sample pad is heated at a temperature between 35oC and 60oC.
To manufacture a lateral flow assay for use with a sample, it would be reasonable to clean the elements in the lateral flow assay. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed the method steps of using methanol as a solvent, before fixing the sample pad on the backing pad, the method further comprises: soaking the sample pad in a buffer solution, and heating the sample pad, the sample pad is heated at a temperature between 35oC and 60oC, to clean the elements of the lateral flow assay and avoid contamination from the elements in the lateral flow assay.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over McCord (WO 2020/018232; already of record on the IDS received 12/14/2023), in view of Sambath (“Potassium ion fluorescence probes: Structures, properties, and bioimaging.” ChemPhotoChem. 5, 317-325. 2021; already of record on the IDS received 12/14/2023) and Viro Research (“Manufacturing of Lateral Flow Assays (Part 1”). Nov. 2020, and further in view of Bentsen (US Patent 5,958,782).
Regarding Claim 4, modified McCord teaches the test strip according to claim 1.
Modified McCord is silent to the test pad and the sample pad are fixed to the backing pad with at least an adhesive tape.
Bentsen teaches A dye-coupled Cuprophan.TM. sheet (from Example 14) was laminated to a thin (0.175 mm) polycarbonate sheet (Bayer AG; Leverkusen, Germany) using a 2-part polyurethane adhesive such as Flexobond.TM. 430 (Bacon Industries, Inc.; Irvine, Calif.). On the polycarbonate side, a CW14.TM. pressure sensitive adhesive sheet (RSW Inc., Specialty Tape Div.; Racine, Wis.) was attached. Col. 30, lines 62-67. In Figs. 4a and 4b, The sensors were mounted on an S400 flowthrough cassette (CDI/3M Health Care) using Type 924 transfer tape adhesive (3M Company) and were hydrated overnight. Col. 33, lines 15-19.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used adhesive tape, as taught by Bentsen, to attach the test pad and the sample pad to the backing pad in the device of McCord to allow for a commercially available and cost-effective material for attachment of structural elements on the device.
Claims 5, 6, 7, 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over McCord (WO 2020/018232; already of record on the IDS received 12/14/2023), in view of Sambath (“Potassium ion fluorescence probes: Structures, properties, and bioimaging.” ChemPhotoChem. 5, 317-325. 2021.; already of record on the IDS received 12/14/2023) and Viro Research (“Manufacturing of Lateral Flow Assays (Part 1”). Nov. 2020, and further in view of Kumar (US Pub 2019/0187154).
Regarding Claims 5 and 6, modified McCord teaches the test strip according to claim 1.
Modified McCord is silent to the test strip further comprises an excitation optical filter, arranged at a bottom of the test strip, the excitation optical filter being configured to selectively transmit a main excitation wavelength of the fluorophore, the test strip further comprises an emission optical filter, arranged on top of the test pad and the reference pad, the emission optical filter being configured to selectively transmit a main emission wavelength of the fluorophore.
Kumar teaches in the related art of test strips. [0034] FIG. 5A is a cross-sectional view of a first schematic of optical components of an analyzer component with an optional optical filter according to an embodiment of the invention. [0035] FIG. 5B is a cross-sectional view of a second schematic of optical components of an analyzer component with an optional optical filter according to another embodiment of the present invention. [0071] In one embodiment, reflectors are used to direct light and are made of a UV reflective material with >80% reflectivity from 350-400 nm. One such material is an aluminum film coating. A photodetector with organic pigment filter for color selection or a photodetector with Gaussian filters integrated onto the chip provide optical sensing with wavelength selectivity. Optionally, an additional optical filter, such as a glass filter or gel filter, can be added to the optical path to selectively transmit light in the emission peak of the fluorescent particle.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an excitation optical filter, arranged at a bottom of the test strip, to selectively transmit a main excitation wavelength of the fluorophore, and added an emission optical filter, arranged on top of the test pad and the reference pad, to selectively transmit a main emission wavelength of the fluorophore, as taught by Kumar, in the device of modified McCord, to allow for the test strip to be paired with a compact optoelectronic reader and fully enable point-of-care and home testing, as taught by Kumar in [0071].
Regarding Claims 7 and 10, modified McCord teaches the test strip according to claim 1.
Modified McCord is silent to the sample pad is made of a porous plastic membrane and wherein the backing pad is made of a PE and/or PP hydrophilic membrane.
Kumar teaches [0049] A top layer, cover film 112 backed with adhesive layer 114b, is coupled to sample pad 110 and provides coverage of sample pad 110, conjugate absorbent pad 7, and part of membrane 104, while leaving test line 116 exposed. Top film layer 112 can be formed from a plastic or polymeric material that exhibits a balance between a moderate flexural modulus (e.g. from about 100,000 to about 600,000 psi), and good tensile strength (e.g. from about 3000 to about 15000 psi). This allows for ease in manufacturing, yet is still rigid enough for performing the assay. Suitable materials include, for example, acetal copolymer, acrylic, nylon (porous), polyester, polypropylene, polyphenylene sulfide, polyetheretherketone, or combinations thereof.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected a porous plastic membrane for the sample pad and wherein the backing pad is made of a polypropylene membrane, as taught by Kumar, in the device of modified McCord, to allow for materials for good tensile strength and rigid enough for performing the assay, as taught by Kumar, in [0049].
Regarding Claim 12, modified McCord teaches the test strip according to claim 11.
Modified McCord is silent to the fluorophore is fluorescein.
Kumar teaches in the related art of test strips. [0062] In one embodiment, the test line solution may also be mixed with a fluorescent reference material, such as fluorescein.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added fluorescein, as taught by Kumar, as the fluorophore in the device of modified McCord, allowing for a standard fluorescent molecule to be used for detecting.
Regarding Claim 13, modified McCord teaches the test strip according to claim 1.
Modified McCord is silent to the test strip further comprises a reference pad arranged on the backing pad, the reference pad comprising the fluorophore without the ionophore.
Kumar teaches in the related art of test strips. [0062] In one embodiment, the test line solution may also be mixed with a fluorescent reference material, such as fluorescein.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a reference pad with fluorescein, as taught by Kumar, in the device of modified McCord, allowing for a molecule with a known fluorescence signal (fluorescein) to be used as the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/JOHN MCGUIRK/Examiner, Art Unit 1798
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