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 .
Applicant’s filing of claims 1-20 on 5/29/23 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/29/23 was acknowledged. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. In claim 1, for example, the claim language, “determining a concentration of an analyte in the samples using the measured transmission and scattering intensity of the light and calibration curves created from multiple calibration samples having known varying amounts of the analyte and the reagents” is an abstract idea because it is a mathematical concept and/or mental process. Performing the measured transmission and scattering intensity is performed on a generic computer, a sensor, which may include a photodetector (see claim 5 and [0047] of PG Pub.). Performing the calibration curves also appear to be a known/generic computer because one example is described in PG Pub. [0067] made by ThermoFisher Scientific. This judicial exception is not integrated into a practical application because once the “determining a concentration” step is done, then no action is done. The “measuring” step, “using the measured transmission and scattering intensity” step, and “calibration curves” are used to gather data to determine the concentration of the analyte. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the samples, and instruments used to perform the illuminating, measuring, and determining steps as described in PG Pub. [0047], [0067] and claim 5 are routine and conventional within the art, and thus, does not qualify as significantly more than the abstract idea.
Dependent claims 2-10 all further refine the method steps and were considered, however, the subject matter does not affect the result established above.
Furthermore, claim 11, for example, recites, “determining a color of the liquid sample using It (λ) ; and determining a turbidity of the liquid sample using Is (λ). The claim language is an abstract idea because it is a mathematical concept and/or mental process. Determining the color and turbidity is performed on a generic computer, a sensor, which may include a photodetector (see claim 5 and [0046-0047] of PG Pub.). This judicial exception is not integrated into a practical application because once the determining a color and turbidity steps are done, then no action is done. The “measuring an intensity” step, is used to gather data. Data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the samples, and instruments used to perform the illuminating, measuring, and determining steps as described in PG Pub. [0046-0047] and claim 5 are routine and conventional within the art, and thus, does not qualify as significantly more than the abstract idea.
Dependent claims 12-19 all further refine the method steps and were considered, however, the subject matter does not affect the result established above.
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 1-20 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.
Claims 1, 2, 7, 8, 10, 11, 17, 18 and 19 are rejected for indefiniteness because each claim merely recites a use, e.g., “using,” without any active, positive steps delimiting how this use is actually practiced. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brueckner et al. (“Brueckner,” US Pub. No. 2015/0046114).
As to claim 1, Brueckner teaches a method for quantitative measurement of an analyte (see e.g., abstract), comprising: illuminating samples with different colors of light (e.g., [0008] et seq. discloses light of selected color range), wherein the samples comprise a first sample from which reagents are absent (e.g., blank sample), and a second sample containing the reagents (sample and the assay reagents in [0115] et seq.); measuring transmission and scattering intensity of the light through the samples ([0023] et seq. describes turbidimetry and nephelometry, which involves transmission and scattering of light); and determining a concentration of an analyte in the samples using the measured transmission and scattering intensity of the light ([0056] et seq. describes turbidimetry and nephelometry, which measures the concentration of an analyte is measured) and calibration curves created from multiple calibration samples having known varying amounts of the analyte and the reagents (e.g., [0037] et seq., at least two calibration curves are generated).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner 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 2-6 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Brueckner in view of Wietzorrek (US Pub. No. 2018/0172600).
See Brueckner above.
As to claims 2-6 and 11-15, while Brueckner teaches in [0115] et seq. a Roche COBAS C 311 analyzer (e.g., “optical detector”; see also analyzers in [0069]), which contains vessels (“cuvettes”) containing samples that are inserted into the optical detector for detection, a light source (e.g., [0013] et seq.) and multiple sensors (e.g., photodiode array); illuminating the samples with the different colors of light using the light source (e.g., [0056] et seq.); and measuring the transmission and scattering intensity of the light through the samples using the first sensor and the second sensor (e.g., [0056] et seq.), Bruecker does not specifically teach the structural arrangement of the lights sources and detectors. Wietzorrek teaches a light source and detectors in a perpendicular (90 degrees) structural relationship to each other in fig. 2 and [0098] et seq., and optical windows (e.g., [0004] et seq.). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the structural relationship because it provides the capability to directly inspect an image of the light source to be characterized (e.g., [0100] of Wietzorrek). Furthermore, as to claim 11, Brueckner teaches determining a color of the liquid sample using I.sub.t (λ) ; and determining a turbidity of the liquid sample using I.sub.s (λ) in e.g., [0023] et seq.
As to claim 16, Brueckner teaches illuminating the liquid sample comprises: cycling the light source through different colors of light in e.g., [0013] et seq.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Brueckner in view of Tokhtuev et al. (“Tokhtuev,” US Pub. No. 2009/0098022) and Coates (US Pub. No. 2008/0265146).
See Brueckner above.
As to claims 7-10, while Brueckner teaches illuminating of the samples with the different colors of the light in e.g., [0069] et seq., Brueckner does not specifically teach cycling through red, green, blue and white (RGBW) wavelengths of light; calculating a normalized detection reagent transmission and scattering intensity for the RGBW wavelengths of light; calculating the concentration of the analyte in the samples using the normalized detection reagent transmission and scattering intensity and the calibration curves; and using a normalized scattering of the samples to determine the concentration of the analyte in the samples for diagnostic purposes. Tokhtuev teaches cycling through red, green and blue (RGB) wavelengths of light in [0043] et seq.; calculating a normalized detection reagent transmission and scattering intensity for the RGB wavelengths of light; calculating the concentration of the analyte in the samples using the normalized detection reagent transmission and scattering intensity and the calibration curves; and using a normalized scattering of the samples to determine the concentration of the analyte in the samples for diagnostic purposes in e.g., [0057] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the transmission and scattering intensity data normalized because it would ensure consistent readings (e.g., [0077] of Tokhtuev). Furthermore, Brueckner does not specifically teach cycling through red, green, blue and white (RGBW) wavelengths of light. Coates teaches in [0038] et seq., a matrix-based spectral sensor 16 is provided in FIGS. 2 and 3. The version shown is a 4-channel RGBW (Red-Green-Blue-White) sensing device, and is capable of handling a wide range of color-based applications. Custom versions of this sensor, featuring more than 4-optically selective channels can be used. New technologies, involving the deposition of the wavelength selective devices on the surface of the detector elements can be used to make application specific detection devices. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have 4-channel RGBW (Red-Green-Blue-White) sensing device because it would be advantageous to have a sensing device capable of handling a wide range of color-based applications (e.g., [0038] of Coates).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Brueckner in view of Wietzorrek, as applied to claim 11 above, and further in view of Coates.
See Brueckner, Wietzorrek and Coates above.
As to claim 17, the combination Brueckner, Wietzorrek and Coates teach placing the vessel into the optical detector, wherein the vessel is either empty or contains a clear liquid (e.g., water-blank in [0115] et seq. of Brueckner); illuminating the vessel using the light source by cycling the light source through red, green, blue and white (RGBW) wavelengths of light (e.g., RGBW in [0038] et seq. of Coates); measuring the intensity of transmitted light I.sub.t (λ) at the RGBW wavelengths of light, I.sub.t,R(Cal), I.sub.t,G(Cal), I.sub.t,B(Cal) and I.sub.t,w(Cal), using the first sensor (see [0056] et seq. of Bruecker and [0038] of Coates), as well as a dark reading I.sub.t(Off). (see inner measurement area being encased within a black and/or optically opaque external shell in e.g., [0013] et seq. of Coates), placing the liquid sample in the vessel (e.g., [0056] et seq. of Bruecker); illuminating the liquid sample using the light source by cycling the light source through the RGBW wavelengths of light (see [0056] et seq. of Bruecker and [0038] of Coates); and measuring the intensity of transmitted light I.sub.t (λ) at the RGBW wavelengths of light, I.sub.t,R(S), I.sub.t,.sub.G(S), I.sub.t,.sub.B(S) and It,w(S), using the first sensor (see [0056] et seq. of Bruecker and [0038] of Coates). For motivation statement, see above.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Brueckner in view of Wietzorrek, as applied to claim 11 above, and further in view of Coates and Tokhtuev.
See Brueckner, Wietzorrek, Coates and Tokhtuev above.
As to claims 18 and 19, the combination of Brueckner, Wietzorrek, Coates and Tokhtuev teach placing the vessel into the optical detector, wherein the vessel is either empty or contains a clear liquid (e.g., water-blank in [0115] et seq. of Brueckner); illuminating the vessel using the light source by cycling the light source through RGBW wavelengths of light (e.g., RGBW in [0038] et seq. of Coates); measuring the intensity of scattered light I.sub.s (λ) at the RGBW wavelengths of light, I.sub.s,R(Cal), I.sub.s,.sub.G(Cal), I.sub.s,.sub.B(Cal) and I.sub.s,w(Cal), using the second sensor (see [0056] et seq. of Bruecker), as well as a dark reading I.sub.s(Off) (see inner measurement area being encased within a black and/or optically opaque external shell in e.g., [0013] et seq. of Coates); placing the liquid sample in the vessel (e.g., [0056] et seq. of Bruecker); illuminating the liquid sample using the light source by cycling the light source through the RGBW wavelengths of light (e.g., RGBW in [0038] et seq. of Coates); measuring the intensity of scattered light I.sub.s (λ) at the RGBW wavelengths of light, I.sub.s,R(S), I.sub.s,G(S), Is,s(S) and Is,w(S), using the second sensor (see Bruecker and Coates above); and calculating at least one of a normalized scattering intensity and a net scattering intensity for the liquid sample, wherein the normalized scattering intensity is calculated for the liquid sample as I.sub.s,i (N) = [I.sub.s,.sub.i(S) - I.sub.s(Cal)]/I.sub.t,i (Cal), wherein i = R,G,B,W, and wherein the net scattering intensity for the liquid sample is calculated as I.sub.s,i = I.sub.s,i(S) - I.sub.s,i(Cal), wherein i = R,G,B,W. See Bruecker and Coates above. As for the normalized scattering intensity, see Tokhtuev above.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Brueckner in view of Wietzorrek, as applied to claim 11 above, and further in view of Self et al. (“Self,” US Pub. No. 2010/0126286).
See Brueckner and Wietzorrek above.
As to claim 20, Brueckner does not specifically teach preloading at least one detection reagent into the vessel under a vacuum; and sealing the vessel to preserve the vacuum within the vessel, wherein the vessel is sealed with a rubber cap. Self teaches a capper adapted to replace the lid on the at least one sample container (e.g., [0057] et seq., and applying a vacuum in [0079] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include applying a vacuum to preload the reagent into the vessel, and sealing the vessel with a rubber cap because it would maintain the integrity of the contents inside the vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
1/10/2026