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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 12, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-16, 18-20, 22, and 24-30 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has provided extensive amendments to independent claims 10 and 22, and argued that the combination of Wu et al., in view of Lucas et al., do not teach the limitations of the amended claims.
Based on the amendments to independent claim 10, the Examiner now contends that the claim is directed to ineligible subject matter under 35 U.S.C. 101 as the claims are directed to a judicial exception without significantly more. The Examiner contends that the comparing and determining steps of claim 10 are abstract ideas in that they only require mental analysis of the data gathered in the preparing, adding, and measuring steps. The Examiner also notes that the claim does not recite a practical application as nothing is done after the concentration of the active substance is determined. As such, the Examiner contends that claim 10 is directed to ineligible subject matter.
With respect to the prior art rejections, Applicant has argued that the claims now recite a linear correlation between absorbance and concentration of the active substance that is not taught by reference to Lucas et al. After further consideration, the Examiner has found Applicant’s arguments with respect to Lucas et al., to be persuasive. However, after an updated search, the Examiner contends that the limitations of claims 10 and 22 are taught by the combination of Wu et al., in view of Keinan et al., (US 2011/0159596). Because reference to Keinan et al., is newly cited, the Examiner will not argue the merits of its teachings here, but will instead rely on the rejection detailed below. Therefore, based on the teachings of the prior art, and the arguments presented here, the Examiner contends that the limitations of the instant claims are directed to ineligible subject matter, and are taught by the prior art, thus the claims are not in condition for allowance.
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 10-16, 18-20, 22, and 24-30 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.
For claim 10, the phrase “about 550 nm” is unclear as the Examiner is unable to determine a deviation from 550 nm that encompasses “about” 550 nm. The specification does not state what the term “about” encompasses, thus the Examiner is unable to determine the metes and bounds of “about” 550 nm. Claims 11-16, 18-20, 22, and 24-30 depend directly or indirectly from claim 10 and are also indefinite.
For claim 15, the phrase “about 50°C” is indefinite as the Examiner is unable to determine a deviation from 50°C that is encompassed by the claimed “about” 50°C. As such, the metes and bounds of “about 50°C” cannot be determined.
For claim 22, the phrase “about 550 nm” is unclear as the Examiner is unable to determine a deviation from 550 nm that encompasses “about” 550 nm. The specification does not state what the term “about” encompasses, thus the Examiner is unable to determine the metes and bounds of “about” 550 nm.
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 10-16 and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) the abstract ideas of comparing a measured absorbance with a reference absorbance, and determining a concentration of an active substance based on the comparison. Independent claim 10 recites a method for detection and quantitative determination of an active substance comprising preparing a sample solution comprising at least one active substance by extracting the active substance in a solvent, adding at least one colored reagent to the solution, measuring an absorbance at a wavelength of about 500 nm, comparing the measured absorbance with a reference absorbance, and determining a concentration of the active substance based on the comparison. Comparing a measured absorbance and determining a concentration based on the comparison are abstract ideas in that they only require mental analysis of the data gathered from the measuring step (MPEP 2106.04(a)(2) III This judicial exception is not integrated into a practical application because nothing occurs in the claim after determining the concentration of the active substance. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of preparing a solution, adding at least one color reagent, and measuring an absorbance are well-understood, routine, and conventional activity known in the art. The steps of preparing a solution, adding a color reagent, and measuring an absorbance are well known and widely practiced for determining a concentration of a substance in a sample. As such, the additional elements of claim 10 do not amount to significantly more than the judicial exception. Given this view, the Examiner contends that independent claim 10 is directed to a judicial exception without significantly more, and therefore is ineligible subject matter under 35 U.S.C. 101.
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.
Claim(s) 10-13 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Keinan et al., (US 2011/0159596).
Regarding claim 10, Wu et al., teach a colorimetric method to detect illicit drugs (Table 4) comprising adding a sample to am ampoule of reagents (paragraphs0007, 0021), wherein the reagents include various dyes and an organic solvent (paragraphs 0007, 0022, 0029). The Examiner notes that the order in which the sample and reagents are added in reference to Wu et al., is different compared to the instant claims; however, the Examiner notes that any order of mixing ingredients is prima facie obvious (MPEP 2144.04 IV C). As such, reference to Wu et al., reads on claim 10 despite a different order of mixing the sample and reagents. Wu et al., also teach a color reaction between the sample and the reagents (paragraph 0021) wherein a color chart is utilized to determine an amount of illicit drugs in the sample (paragraph 0004). Wu et al., do not teach measuring an absorbance at about 550 nm, comparing the measured absorbance to a reference absorbance, and determining a concentration of an active substance based on a linear correlation between the measured and reference absorbances.
Keinan et al., teach a substance detector wherein a color sensor measures an absorbance at about 550 nm (paragraph 0215), comparing the absorbance measurements to reference absorbance measurements (paragraph 0217, 0249), and determining a concentration of a substance bases on a linear correlation between the measured and reference absorbance values (paragraphs 0240). Keinan et al., teach that it is advantageous to define a linear correlation as a means of measuring light absorption over a greater area of space without a lens for light focusing or distribution for the detector (paragraph 0215).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., wherein a linear correlation is defined between the reference and measured absorbance measurements in order to define a linear correlation over a greater area of space without a lens for light focusing or distribution as taught by Keinan et al.
Regarding claim 11, Wu et al., teach testing leaf samples (paragraph 0036) which reads on the claimed plants recited in the claim.
Regarding claim 12, Wu et al., teach the sample comprising indole (paragraphs 0003, 0026).
Regarding claim 13, Wu et al., teach Marquis reagent, Mecke reagent, Simon's reagent, Liebermann reagent, and Scott reagent as suitable reagents (paragraph 0007).
Regarding claim 18, Wu et al., teach detecting MDMA, psilocybin, cocaine, heroin (paragraphs 0021, 0024, Table 4).
Regarding claim 19, Wu et al., teach testing leaf samples (paragraph 0036) which reads on the claimed "other organisms." Additionally, the Examiner notes that tryptophanase is an enzyme found in plants, thus the teachings of Wu et al., reads on claim 19.
Regarding claim 20, Wu et al., teach detection of primary amines (paragraph 0029).
Claim(s) 14, 15, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Keinan et al., (US 2011/0159596) as applied to claim 10 above, and further in view of Lim et al., (US 2018/0231513).
Regarding claims 14, 15, and 30, Wu et al., in view of Keinan et al., do not teach an incubation period wherein the temperature is raised from ambient temperature to about 50°C.
Lim et al., teach a colorimetric sensor array wherein a sample container is maintained at a constant temperature by an incubator (paragraph 0109) wherein the incubation temperature is lower than 70°C (paragraph 0087) for up to 24 hours which encompasses the claimed up to 15 minutes. The Examiner contends that the temperature being lower than 70°C meets the limitation of claim 15 in that the phrase “about 50°C” is indefinite. The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art (MPEP 2141 III A). Referenced to Lim et al., teach a colorimetric sensor wherein the sample is incubated, thus one of ordinary skill in the art would have found it obvious to include an incubation period above ambient temperature. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., in view of Lucas et al., wherein the sample is incubated as taught by Lim et al., as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Keinan et al., (US 2011/0159596) as applied to claim 10 above, and further in view of Lucas et al., (US WO 2014/131114).
Regarding claim 16, Wu et al., in view of Keinan et al., do not teach determining concentration with a spectrophotometer.
Lucas et al., teach a method for cannabinoid quantification wherein a colorimetric reaction can be analyzed with a spectrometer(page 10 last paragraph). Lucas et al., teach that it is advantageous to utilize a spectrometer as a means of determining a specific absorbance shift (page 10 last paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., in view of Keinan et al., wherein a spectrometer is utilized to analyze the colorimetric reaction in order to determine a specific absorbance shift as taught by Lucas et al.
Claim(s) 22, 24-26 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Keinan et al., (US 2011/0159596) as applied to claim 10 above, and further in view of Huff et al., (US 2018/0275088).
Regarding claim 22, Wu et al., teach a kit (paragraph 0007) comprising a receptacle containing an acidic buffer (paragraph 0004), a separate receptacle containing the colorimetric reagents (paragraph 0007) wherein the colorimetric reagents can be Marquis reagent, Mecke reagent, Simon's reagent, Liebermann reagent, and/or Scott reagent (paragraph 0007). Wu et al., teach the kit comprising instructions and a color chart, but do not teach the instructions including a calibration curve of measured values.
Keinan et al., teach a substance detector wherein a color sensor measures an absorbance at about 550 nm (paragraph 0215), comparing the absorbance measurements to reference absorbance measurements (paragraph 0217, 0249), and determining a concentration of a substance bases on a linear correlation between the measured and reference absorbance values (paragraphs 0240). Keinan et al., teach that it is advantageous to define a linear correlation as a means of measuring light absorption over a greater area of space without a lens for light focusing or distribution for the detector (paragraph 0215).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., wherein a linear correlation is defined between the reference and measured absorbance measurements in order to define a linear correlation over a greater area of space without a lens for light focusing or distribution as taught by Keinan et al. Wu et al., in view of Keinan et al., do not teach instructions including a calibration curve of measured values.
Huff et al., a kit for sample analysis wherein the kit comprises instructions for generating a standard curve (paragraph 0429). Huff et al., also teach quantifying an analyte based on the standard curve (paragraph 0398). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. One of ordinary skill in the art would have recognized that standard curves are often utilized to determine an unknown concentration of an analyte in a sample. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., in view of Huff et al., wherein the kit comprises instructions for generating a standard curve as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claims 24 and 25, the Examiner notes that the indole and arylalkylamine derivatives are not elements of the kit, but instead represent the material worked upon by the claimed kit (MPEP 2115).
Regarding claim 26, Wu et al., do not teach a kit comprising a syringe.
Huff et al., teach a kit for sample analysis wherein the kit can comprise a syringe (paragraph 0435). Huff et al., teach that it is advantageous to provide a syringe as a means of including instruments for assisting with obtaining test samples (paragraph 0435).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., wherein the kit includes a syringe in order to provide instruments for obtaining test samples as taught by Huff et al.
Regarding claim 29, Wu et al., teach an extraction solution and color reagent forming two phases (paragraph 0029).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Keinan et al., (US 2011/0159596) in view of Huff et al., (US 2018/0275088) as applied to claim 22 above, and further in view of Dennis et al., (US 2007/0224128).
Regarding claim 27, Wu et al., in view of Keinan et al., in view of Huff et al., do not teach a kit comprising 4-(N,N-dimethylamino)benzaldehyde.
Dennis et al., teach a drug adherence monitoring system wherein 4-(N,N dimethylamino)benzaldehyde is taught as a suitable drug marker (paragraph 0134). Dennis et al., teach that it is advantageous to utilize drug markers as a means of providing an indication of presence and/or concentration of drugs in a subject (paragraph 0134).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., in view of Keinan et al., in view of Huff et al., wherein 4-(N,N dimethylamino)benzaldehyde is a component of the kit in order to provide a marker that gives an indication of presence and/or concentration of drugs in a subject as taught by Dennis et al.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Keinan et al., (US 2011/0159596) in view of Huff et al., (US 2018/0275088) as applied to claim 22 above, and further in view of Egan et al., (US 2010/0304359).
Regarding claim 28, Wu et al., in view of Keinan et al., in view of Huff et al., do not teach a kit comprising metal ions.
Egan et al., teach a multianalyte assay wherein a signal producing system for the assay includes all the reagents required to produce a measurable signal wherein metal ions are listed as a suitable reagent (paragraph 0167). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Egan et al., teach that metal ions are suitable reagents for signal producing systems, thus one of ordinary skill in the art would have recognized that metal ions can be utilized in an assay in which a signal producing system is utilized. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Wu et al., in view of Keinan et al., in view of Huff et al., to utilize the metal ions of Egan et al., as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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, Lyle Alexander can be reached at (571) 272-1254. 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.
/DWAN A GERIDO/Examiner, Art Unit 1797
/BRIAN R GORDON/Primary Examiner, Art Unit 1798
Prosecution Insights