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 .
Response to Arguments
Applicant's arguments filed December 22, 2025 have been fully considered but they are not persuasive. Applicant has cancelled previously examined claims 1-9, and added new claims 10-29. Applicant has argued that new claims 10-29 are not taught by the prior art cited in the previous Office Action. Specifically, Applicant has argued that the claims recite a linear relationship between color intensity and active ingredient concentration which is not taught by the prior art. The Examiner contends that Applicant’s arguments are not commensurate with the scope of the claims as the claims do not recite a linear relationship between color intensity and the claimed active ingredient. Claim 10 step d) recites “the concentration of the derivative of arylalkylamine, pyrrole, indole, opiate, or tropane alkaloid in step a) is chosen such that a quantitative and linear color reaction occurs in step b)” which the Examiner contends does not recite a linear relationship between color intensity and active ingredient concentration. First, the Examiner notes that step d) of claim 10 is unclear as it appears that the concentration of the active ingredient is “chosen” compared to analyzing a sample having an unknown concentration. Second, step d) recites “a quantitative and linear color reaction” which does not indicate a linear relationship between color intensity and active ingredient concentration. Independent claim 10 does not recite a linear relationship between color intensity and active ingredient concentration, thus the Examiner contends that Applicant’s arguments are not commensurate with the scope of the claims. As detailed below, Independent claim 10 now stands rejected under 35 U.S.C. 103 as being unpatentable over the combination of Wu et al., (US 2015/0017732) in view of Lucas et al., (WO 2014/131114). While both references were cited in the previous Office Action, the Examiner notes that the order in which the references were relied upon has changed as the Examiner now contends reference to Wu et al., to be the closest prior art. Therefore, reference to Wu et al., is now cited as the primary reference. As such, the Examiner contends that the limitations of the instant claims are taught by the prior art, thus the claims are not in condition for allowance.
With respect to the rejections under 35 U.S.C. 112(b), the Examiner notes that new claims 10-29 contain numerous limitations that are indefinite. As such, claims 10-29 are rejected under 35 U.S.C. 112(b) as the Examiner is unable to determine the metes and bounds of the claims.
Claim Objections
Claims 18 is objected to because of the following informalities: at lines 1 and 2, the names for MDMA and DMT should be spelled out in its entirety prior to using abbreviations. Also, the phrases “DMT or psilocybin, cocaine, heroin or morphine” should be amended to recite --DMT, psilocybin, cocaine, heroin, or morphine-- Appropriate correction is required.
Claim 25 is objected to because of the following informalities: at line 2, the name for LSD should be spelled out in its entirety prior to using an abbreviation. Appropriate correction is required.
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 10-29 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.
Claim 10 recites the limitation "the quantitative determination" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the concentration" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the respective active substance" in line 6. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that it is unclear which of the active substances, “the respective active substance” references.
Claim 10 recites the limitation "the removal" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the active substance" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. The Examiner notes that it is unclear which of the active substances “the active substance” references.
For claim 10, the phrase “performance of an analytical step” is unclear as the Examiner is unable to determine what step Applicant regards as the analytical step. The Examiner notes that the instant specification does not mention or describe an “analytical step,” thus it is unclear what Applicant regards as the claimed analytical step.
Claim 10 recites the limitation "the color values" in line 15. There is insufficient antecedent basis for this limitation in the claim.
For claim 10, the phrase “collection of individual measurements” is unclear as the claim does not recite any individual measurements, or a step of collecting any individual measurements. Also, it is unclear as to what the term “measurements” references as the claim does not recite any individual measurements.
For claim 10, the phrase “is chosen such that a quantitative and linear color reaction occurs” is unclear as the Examiner is unable to determine what “chosen” references. Specifically, it is unclear if the concentration of the active substances is being chosen, or if the concentration of the calibration solution, color scale, or individual measurements are being claimed as chosen.
For claim 11, it is unclear how the claimed “synthetic products” are also biological materials. The instant specification states the method can be used with “synthetic products of any origin” which entails any and all artificial substances. As such, the Examiner is unable to determine the metes and bounds of the claimed synthetic products.
Claim 15 recites the limitation "the temperature" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the ambient temperature" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the colored phase" in line 6. There is insufficient antecedent basis for this limitation in the claim.
For claim 16, the phrase “an analytical solution is added” is unclear as the Examiner is unable to determine what step Applicant regards as the analytical solution. The Examiner notes that the instant specification does not mention or describe an “analytical solution,” thus it is unclear what Applicant regards as the claimed analytical solution.
For claim 17, the phrase “the analytical solution” is unclear as the Examiner is unable to determine what step Applicant regards as the analytical solution. The Examiner notes that the instant specification does not mention or describe an “analytical solution,” thus it is unclear what Applicant regards as the claimed analytical solution.
Claim 19 recites the limitation "the enzyme" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 depends from claim 10, but instead of determining the active substances recited in claim 10, claim 19 is directed to determining concentration of bacterial cultures or other organisms. As such, it is unclear how claim 19 can properly depend from claim 10 as claim 19 is not directed to determining the active substances recited in claim 10. Also, for claim 19, the phrase “thereby enabling conclusions to be drawn” is unclear as claim 10, from which claim 19 depends is directed to a quantitative determination of the concentration of active substances.
For claim 19, the phrase “these bacteria” is inconsistent with “bacterial cultures” recited at line 2. As such, it is unclear which of the bacterial cultures the phrase “these bacteria” references.
The term “similar” in claim 20 is a relative term which renders the claim indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the term “similar” cannot be determined as the specification does not recite parameters by which one can determine if a compound is similar to primary aromatic amines. As such, the term “similar” is a relative term of degree.
The term “rapid” in claim 22 is a relative term which renders the claim indefinite. The term “rapid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not provide a parameter by which one can determine what is, or is not rapid, thus the term “rapid” is a relative term of degree.
Claim 22 recites the limitation "the subsequent determination of concentration" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the release" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the subsequent incubation" in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the color intensity" in lines 16-17. There is insufficient antecedent basis for this limitation in the claim.
For claim 22, the phrase “wherein a color change occurs in the test kit” is indefinite as the Examiner is unable to determine if the reaction takes place in the kit, or if Applicant intends to recite utilizing the components of the kit to perform the colorimetric reaction.
For claim 22, the claim recites a process limitation in a claim directed to a device, and therefore is indefinite. Claim 22 recites “a quantitative determination of concentration is carried out by comparing the color intensity of the test substance with the curve of measures values obtained through calibration” which the Examiner contends is a process limitation. As such, it is unclear if infringement occurs when one performs the quantitative determination step, or if infringement occurs when the claimed kit is made or formed (MPEP 2173.05(p) II).
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 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Lucas et al., (WO 2014/131114).
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 (paragraphs 0007, 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 explicitly teach a quantitative and linear color reaction.
Lucas et al., teach a method for cannabinoid quantification wherein a visualization reagent produces a color response in a linear range (page 8 first full paragraph). Lucas et al., teach that it is advantageous to utilize a visualization reagent in a linear range as a means of quantifying analytes in a sample (page 8 first full 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., wherein a visualization reagent that reacts in a linear range is utilized in order to quantify the amount of an analyte in a sample as taught by Lucas 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 16, Wu et al., teach a container having an aqueous top layer and an organic bottom layer wherein the sample is added to the container (paragraph 0029). The Examiner notes that claim 16 is being read in light of the rejection under 35 U.S.C. 112(b) in which the claimed analytical solution is unclear.
Regarding claim 17, Wu et al., teach chloroform as the organic layer (paragraph 0029). The Examiner notes that claim 17 is being read in light of the rejection under 35 U.S.C. 112(b) in which the claimed analytical solution is unclear.
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).
Regarding claim 21, Wu et al., do not teach optical detection performed by spectrophotometric analysis.
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., 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) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Lucas et al., (WO 2014/131114) as applied to claim 10 above, and further in view of Lim et al., (US 2018/0231513).
Regarding claims 14 and 15, Wu et al., in view of Lucas et al., do not teach an incubation period above ambient temperature.
Lim et al., teach a colorimetric sensor array wherein a sample container is maintained at a constant temperature by an incubator (paragraph 0109). 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) 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., (US 2015/0017732) in view of Huff et al., (US 2018/0275088).
Regarding claims 22 and 23, 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). The Examiner notes that the claim is being read in light of the rejection under 35 U.S.C. 112(b) in which the phrase “color change occurs in the test kit” is indefinite. 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.
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 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 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 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 Huff et al., (US 2018/0275088) in view of Dennis et al., (US 2007/0224128) as applied to claim 27 above, and further in view of Egan et al., (US 2010/0304359).
Regarding claim 28, Wu et al., in view of Huff et al., in view of Dennis 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 Huff et al., in view of Dennis 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
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.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797