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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, 8, 10, 13, and 15-16 in the reply filed on 06/22/2026 is acknowledged.
Claims 19, 26, and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/22/2026.
Information Disclosure Statement
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
Claim Objections
Claim 8 is objected to because of the following informalities: It is suggested to recite “the noble metal” as “the noble metal of the noble metal-containing compound” to improve antecedent basis of the terms. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-6, 8, 10, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin et al. (WO 2022056084 A1).
Regarding claim 1, Martin teaches a method (abstract; paragraph [0007]) for detecting noble metal-containing compound contamination of a surface (abstract and [0007] teaches methods of detecting analyte contamination of a surface; [0011] teaches the analyte is a platinum-based antineoplastic drug, i.e. noble metal containing compound; [0132] teaches the analyte includes palladium-based drugs, ruthenium-based drugs, and gold-containing drugs), the method comprising:
collecting a sample comprising a noble metal-containing compound from said surface ([0007] teaches obtaining or collecting a sample from a surface containing an antineoplastic agent; [0011] and [0132] teaches the antineoplastic drug includes platinum-based, ruthenium-based drugs, and gold-containing drugs);
contacting said sample with a dye and a reducing agent to form a test solution ([0009] teaches the fluid sample reacts with a reducing agent and detection dye in the presence of the analyte; therefore, the fluid sample contacts a dye and reducing agent to form a test solution since the fluid sample reacts with the dye and reducing agent); and
measuring an absorbance of the test solution ([0007] teaches the liquid sample is read by a user or test system to identify the presence and concentration of the analyte; [0018] teaches measuring a test signal at the test well; [0138] teaches measurements of the test well including measuring absorbance with a reader device).
Regarding claim 3, Martin further teaches wherein the dye is an azo dye ([0011], “azo dye”).
Regarding claim 4, Martin further teaches wherein the dye is Congo red or methyl orange ([0011], “methyl orange” and “Congo red”).
Regarding claim 5, Martin further teaches wherein the dye is methylene blue ([0011], “methylene blue”).
Regarding claim 6, Martin further teaches wherein the reducing agent is selected from the group consisting of: lithium borohydride, lithium aminoborohydride, sodium borohydride, and sodium cyanoborohydride ([0009], NaBH4, i.e. sodium borohydride).
Regarding claim 8, Martin further teaches wherein the noble metal is selected from the group consisting of ruthenium, rhodium, palladium, platinum, silver, gold, osmium, and iridium ([0011] teaches the analyte is a platinum-based antineoplastic drug, i.e. platinum; [0132] teaches the analyte includes palladium-based drugs, ruthenium-based drugs, and gold-containing drugs).
Regarding claim 10, Martin further teaches the method of Claim 8, wherein the noble metal-containing compound is selected from the group consisting of: cisplatin, oxaliplatin, nedaplatin, carboplatin, triplatin tetranitrate, phenanthriplatin, picoplatin, and satraplatin ([0011] teaches cisplatin, oxaliplatin, nedaplatin, carboplatin, triplatin tetranitrate, phenanthriplatin, picoplatin, and satraplatin).
Regarding claim 15, Martin further teaches the method of Claim 8, wherein the noble metal-containing compound is selected from the group consisting of: gold sodium thiosulfate, gold sodium thiomalate, disodium aurothiomalate, aurothioglucose, and auranofin ([0132] teaches gold containing drugs, including auranifin, aurothioglucose, sodium aurothiosulfate, disodium aurothiomalate, and sodium aurothiomalate).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Martin as applied to claim 1 above, and further in view of Budd et al. (US 20190195808 A1).
Regarding claim 2, Martin fails to teach: wherein the method further comprises measuring the rate of absorbance change.
Martin teaches rate of the dye reaction and the reducing agent with the fluid sample in the wells may be modified ([0118],[0131]).
Budd teaches techniques for optical analysis of fluid samples using sensors (abstract). Budd teaches a colorant, such as a dye, is added to the fluid sample for measuring at detection points ([0034]). Budd teaches experimental data for a target analyte that compares absorbance/transmittance measurement to the rate of change in the absorbance/transmittance measurement, wherein the rate of change measurement has a correlation to the concentration of the analyte as the absorbance measurement ([0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Martin to incorporate Budd’s teachings of measuring rate of change of absorbance ([0070]) to provide: wherein the method further comprises measuring the rate of absorbance change. Doing so would have a reasonable expectation of successfully improve analysis and characterization of the sample, such as allowing for concentration measurement of a target analyte as taught by Budd.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Martin as applied to claim 8 above, and further in view of Alessio et al. (Alessio et al., “NAMI-A and KP1019/1339, Two Iconic Ruthenium Anticancer Drug Candidates Face-to-Face: A Case Story in Medicinal Inorganic Chemistry”, Molecules 2019, 24, 1995).
Regarding claim 13, Martin fails to teach: the method of Claim 8, wherein the noble metal-containing compound is sodium trans-imidazoledimethylsulfoxidetetrachlororuthenate(III), imidazolium trans-imidazoledimethylsulfoxidetetrachlororuthenate(III),or sodium trans- [tetrachloridobis(1H- indazole)ruthenate(III)].
Martin teaches the analytes of interest can include ruthenium-based drugs ([0132]).
Alessio teaches promising anticancer drug candidates includes ruthenium(III) coordination compounds such as imidazolium trans-imidazoledimethylsulfoxidetetrachlororuthenate(III) or sodium trans- [tetrachloridobis(1H- indazole)ruthenate(III)] (abstract teaches NAMI-A and KP1339).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the noble metal-containing compound of Martin to incorporate Martin’s teachings of analytes including ruthenium-based drugs ([0132]) and Alessio’s teachings of ruthenium-based drugs including imidazolium trans-imidazoledimethylsulfoxidetetrachlororuthenate(III) or sodium trans- [tetrachloridobis(1H- indazole)ruthenate(III)] (abstract teaches NAMI-A and KP1339) to provide: the method of Claim 8, wherein the noble metal-containing compound is imidazolium trans-imidazoledimethylsulfoxidetetrachlororuthenate(III) or sodium trans- [tetrachloridobis(1H- indazole)ruthenate(III)]. Doing so would have a reasonable expectation of successfully improving detection of known ruthenium-based drugs as taught by Alessio.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Martin as applied to claim 1 above, and further in view of Berezhna et al. (US 20170176325 A1).
Regarding claim 16, Martin fails to explicitly teach: wherein the absorbance is measured at 490 nm to 510 nm, 460 nm to 480 nm, or 660 nm to 680 nm.
Martin teaches measuring absorbance ([0138]). Martin teaches dyes including methylene blue, methyl orange, and Congo red ([0160]). Martin teaches a light detector that defines wavelength ranges of the captured light to detect light of a certain wavelength ([0160]).
Berezhna teaches spectrophotometric methods for assessing biological stains used in a histology analyzer (abstract). Berezhna teaches methylene blue is a due that produces a 664 nm blue color ([0008]). Berezhna teaches the methods measures absorbance spectrum of stains over a predefined range ([0010]), wherein the range is or is within 200 nm to 800 nm, 500 nm to 700 nm, 600 nm to 700 nm, 640 nm to 670 nm, 500 nm to 550 nm or 200 nm to 400 nm ([0047]). Berezhna teaches absorbance ranges measured can include 400-500nm, 640-700nm, 640-670nm, and the like ([0100]). Berezhna teaches a predetermined specific wavelength, e.g., based on a known wavelength where discriminating spectral characteristics are expected, may be used to obtain absorbance data useful in making an assessment as described herein ([0102]). Berezhna teaches stains and dyes include Congo red, methylene blue, and methyl orange ([0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of measuring absorbance of Martin to incorporate Martin’s teachings of measuring absorbance of dyes, such as methylene blue, methyl orange, and Congo red, at defined wavelength ranges ([0138],[0160]) and Berezhna’s teachings of measuring absorbance ranges, such as 200-800nm, 400-500nm, 640-700nm, and methylene blue producing a 664 nm blue color ([0008],[0047],[0100]) to provide: wherein the absorbance is measured at 490 nm to 510 nm, 460 nm to 480 nm, or 660 nm to 680 nm. Doing so would have a reasonable expectation of successfully improving and optimizing the measured wavelength ranges of desired dyes, such as methylene blue, methyl orange, and Congo red. Additionally, doing so would have been an obvious matter of routine optimization in view of Martin’s teachings of measuring absorbance of dyes, such as methylene blue, methyl orange, and Congo red, at defined wavelength ranges ([0138],[0160]) and Berezhna’s teachings of known measuring absorbance ranges, such as 200-800nm, 400-500nm, 640-700nm, and methylene blue producing a 664 nm blue color ([0008],[0047],[0100]), wherein it would have been routine optimization to arrive at the claimed invention to improve and optimize the measured wavelength ranges of desired dyes, such as methylene blue, methyl orange, and Congo red (MPEP 2144.05(II)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harding et al. (US 20190120727 A1) teaches methods for testing surfaces for the presence of hazardous contaminants, while minimizing user exposure to these contaminants, including trace amounts of antineoplastic agents, in healthcare settings at the site of contamination (abstract).
Isaacson et al. (US 20190086431 A1) teaches lateral flow assays for indicating concentration of hazardous contaminant in a test sample (abstract). Isaacson teaches assays for detecting antineoplastic drugs ([0008]-[0009]).
Yonehara et al. (US 20100112622 A1) teaches a color measuring method (abstract). Yonehara teaches the maximum absorption wavelength of methylene blue is typically approximately 660 to 670 nm (e.g., approximately 666 nm), and conventional methods merely can measure the light absorbance, for example, at a wavelength of 600 to 680 nm; and the detection wavelength of methylene blue in the present invention is, for example, 610 to 730 nm, preferably 650 to 715 nm, and more preferably 660 to 700 nm ([0070]).
Snowden et al. (US 4203725 A) teaches methods for on-site determination of the presence and concentration of contaminant materials (abstract). Snowden teaches methyl orange and absorbance ranges of colors, such as 490-500 for red, 480-490 for orange (column 8, Table 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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