Prosecution Insights
Last updated: April 19, 2026
Application No. 18/449,654

METHOD FOR CALCULATING DRINKING TIME

Non-Final OA §101§103
Filed
Aug 14, 2023
Examiner
HUANG, MICKEY NMN
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Shanxi Medical University
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
3y 4m
To Grant
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
58 granted / 92 resolved
-2.0% vs TC avg
Strong +56% interview lift
Without
With
+55.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
38 currently pending
Career history
130
Total Applications
across all art units

Statute-Specific Performance

§101
7.1%
-32.9% vs TC avg
§103
37.4%
-2.6% vs TC avg
§102
21.7%
-18.3% vs TC avg
§112
26.0%
-14.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 92 resolved cases

Office Action

§101 §103
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 . Claim Objections Claim 1-2 is/are objected to because of the following informalities: In claims 1, applicant should define EtG and EtS before using abbreviation. In claim 2, mg/m should be mg/mL. Appropriate correction is required. Specification The disclosure is objected to because of the following informalities: In para. [0013], 0.22 to 0.66 mg/m should be 0.22 to 0.66 mg/mL. Appropriate correction is required. 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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to mathematical concept without significantly more. Regarding claim 1, the claim(s) recite(s) a “method for calculating drinking time; the method comprises the step of obtaining a quadratic regression equation: y = 1.646x2 - 0.9599x + 0.0878, R2 = 0.9904 by fitting using the average concentration ratio CEtG/CEtSas an abscissa and sampling time as an ordinate, wherein x represents the average concentration ratio CEtG/CEtS, and y represents the sampling time; and measuring CEtG/CEtSof blood samples under test, obtaining a relationship between the drinking time and the CEtG/CEtS based on the quadratic regression equation, and calculating the drinking time.” The limitation of obtaining a regression equation by fitting using the average concentration ratio…calculating the drinking time based on the quadratic regression equation, is a process that, under its broadest reasonable interpretation, covers an abstract idea in the form of mathematical concept. That is, other than reciting preparing and analyzing a blood sample, nothing in the claim element precludes the step from practically being performed with existing mathematical formula/relationship. One can manually deriving a regression model (with help of a calculator) based on data collected and manually solving the regression model to estimate drinking time based on concentration values collected. If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationship, then it falls within the “Mathematical Concept” grouping of abstract ideas. Accordingly, the claim recites an abstract idea (Step 2A, Prong 1). The judicial exception is not integrated into a practical application. After calculation is completed, nothing is done with the information. By definition, there is no integration of the determination into an application, let alone a practical one. Moreover, the fact that the judicial exception is performed by a computer (obtaining a regression model) does not constitute integration of the judicial exception into a practical application. MPEP §2106.05(f). The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Analyzing a sample for its concentration, other than the abstract idea appear to be routine and conventional ways of collecting data using analytical technique. Routine and conventional ways of collecting data/signal using analytical technique cannot provide an inventive concept. Claims 2-3 and 8 do not cure the deficiency above as the claims merely recite the concentrations of reagents or concentration of the alcohol detected. Claim 4 does not cure the deficiency above as the claim further recites conventional data gathering (setting up time interval for data collection). Claims 5-7 do not cure the deficiency above as the claims further specify how the concentrations of EtS and EtG are determined by pre-treating the samples and analyzing the treated sample using LC-MS, which is an insignificant extra-solution activity and conventional in preparing and analyzing concentration of unknown by chromatography-Mass spectrometry. 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(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakuma (US20090087913A1) in view of Lostia (Measurement of Ethyl Glucoronide, Ethyl Sulphate and Their Ratio in the Urine and Serum of Healthy Volunteers after Two Doses of Alcohol, 2013). Regarding claim 1, Sakuma discloses a method of indication of alcohol consumption by measuring quantity of ethyl glucuronide and ethyl sulfate in the urine (para. [0078]), comprising: drawing a plurality of urine samples within 0 to 120 h upon start of drinking (Urine samples were collected before and after consumption of alcohol beverage. Para. [0065]; times ranges from 0 to 100 hours after drinking, see para. [0046], [0055], [0068]; Fig. 10-16), testing concentrations of EtG and EtS in the urine sample (The method used for this example detected six chemical species in less than four minutes: (1) ethyl glucuronide and (2) ethyl sulphate…para. [0031]; Figs. 10-16); and obtaining normalized concentrations of EtG and EtS (These metabolite concentrations were normalized to 1 g creatinine/L urine; para. [0031]). Though the Examples provided by Sakuma are for testing in urine, Sakuma explicitly discloses the method can be modified to test for blood (para. [0020] and claim 5). Sakuma is silent of utilizing average concentration ratio of CEtG/CEtS of EtG to EtS, obtaining a quadratic regression equation by fitting using the average concentration ratio as an abscissa and sampling time as an ordinate, and measuring the ratio of blood samples under test, obtaining a relationship between the drinking time and the CEtG/CEtS based on the quadratic regression equation, and calculating the drinking time. Analogous art, Lostia discloses a study of measurement of EtG, EtS, and their Ratio in individuals over a period of 12 hours after consumption (Abstract). Losita specifically measure the EtG/EtS ratio over period of consumption time (Fig. 2). Even though the results of the study is limited and preliminary, Losita suggests drinking time can be estimated based on EtG/EtS drinking results (With the data obtained, we postulate that two or three consecutive urine or serum samples with increasing EtG/EtS might indicate recent drinking within the last 6–10 h depending on the biological specimen used for the investigation….In urine samples after 8 units, we found that the EtG/EtS ratio after 24 h returns to the original value after 1 h since alcohol was administered. Because until 6–10 h (depending on the biological specimen: serum or urine) EtG/EtS rises, two or three consecutive decreasing values might suggest drinking before the previous 10 or even more hours. Page 82, left column, para. 2). Losita further suggests refine data collection and further investigation (such as increasing more time-points sampled) allows one to derive a prediction model to determine the time of alcohol intake (Nevertheless, we suggest the monitoring of EtG/EtS in any future drinking experiment to evaluate its possible use in prediction models to determine the time of alcohol intake. Page 82, left column, para. 1). In addition, the results of Sakuma in Figure 10-13 suggest a parabolic relationship of EtG and EtS concentration and consumption times (initially increasing and decreasing after reaching local max). Therefore, it would have been obvious to one of ordinary skill in the art to have utilized the suggestions of Lostia and conceive the relationship of CEtG/CEtS and consumption time of data presented by Sakuma, fitting the relationship between the CEtG/CEtS and the time to obtain a regression equation, and when the alcohol drinking time needs to be calculated, first measuring the CEtG/CEtS in a blood sample, and then calculating the alcohol drinking time by means of the equation to derived the claimed invention since it would have been within the ambit of one of ordinary skill in the art to apply routine curve‑fitting and statistical regression techniques (e.g., quadratic regression) for data analysis. Regarding claims 2-3, Modified Sakuma discloses the claimed invention as discussed above in claim 1. Neither Sakuma nor Lostia explicitly discloses the blood alcohol concentration upon drinking is in the range of 0.22 to 0.66 mg/mL or alcohol intake is 0.72 g/kg. Alcohol intake is the amount of pure alcohol consumed per kg of the drinker. Similarly, Blood alcohol concentration is calculated using formula: B A C = A l c o h o l   c o n s u m e d   i n   g r a m s B o d y   w e i g h t   i n   g r a m s   x   D i s t r i b u t i o n   R a t i o   r * 100 Where r is 0.68 for men and 0.55 for women. A BAC of 0.08% means 0.08 g of alcohol per 100 mL or 0.8 mg/mL; the legal limit varies from 0.2 mg/mL (China) to 0.8 mg/mL (most U.S. jurisdiction). In addition, Sakuma discloses a list of volunteers for the alcohol consumption experiment. Each trial includes the gender of the volunteer, volumes of the alcohol consumed, alcohol content, the country of origin (para. [0048]-[0064]) and the appropriate standard drinks conversion (Fig. 8-9). For example, male volunteer who consumed 1L of Polish lager (Zywiec, 5.5%) (55 mL of pure alcohol in 1 L of lager) is estimated to have consumed 43 g of alcohol 55   m L   a l c o h o l * 10 g 12.7 m L = 43   g   a l c o h o l Sakuma is silent regard providing weight of each volunteer. It is the Examiner’s position that it would have been obvious to one of the ordinary skill in the art before the effective filing date to have derive the disclosed concentration range of blood alcohol concentration and alcohol intakeby routine experimentation based on factors such as type of alcoholic drinks (% alcohol content and the corresponding standard drink conversion), volume consumed, gender of the drinker, and the weight of the drinker. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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 MPEP 2144.05 and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Regarding claim 4, Modified Sakuma discloses the claimed invention as discussed above in claim 1. Neither Sakuma nor Lostia discloses the claimed sampling intervals at 0, 0.5, 2, 3, 5, 8, 12, 24, 36, 48, and 120 h; instead, Sakuma discloses taking sampling intervals at 0 hours and multiple smaller sampling intervals between 0 and 5 hours (as low as every 30 minutes to 1 hour), and larger intervals between 5 and 100 hours (in the interval of 10-24 hours)(Fig. 12). It would have been obvious to one of ordinary skill in the art to have modified the sampling intervals of Sakuma (taking samples in the interval of every 30 min to 1 hour for the first few hours after drinking; and 10-24 hours after 8th-12th hour after drinking) to derive the claimed sampling intervals of 0, 0.5, 2, 3, 5, 8, 12, 24, 36, 48, and 120 h. The data of Sakuma suggests the major increase in alcohol metabolites occur between first 5-8 hours after consumption before decreasing over time (Fig. 11-13). Therefore, one of skill in the art is motivated to take more sample within smaller sampling intervals in the first 10 hours similar to Sakuma before taking a longer sampling intervals after alcohol metabolites begin to decrease to better improve the curve fitting and regression models. Claim(s) 5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakuma in view of Lostia as applied to claim 1 above, and further in view of Sidqey (Quantitative Determination of Ethyl Glucuronide and Ethyl Sulfate in Postmortem and Antemortem Whole Blood Using Phospholipid Removal 96-Well Plate and UHPLC–MS-MS, 2020), Lee (Presoaking Dried Blood Spot with Water Improves Efficiency for Small-Molecule Analysis, 2019) and Want (Solvent -Dependent Metabolite Distribution, Clustering, and Protein Extraction for Serum Profiling with Mass Spectrometry, 2005). Regarding claim 5, Modified Sakuma discloses the claimed invention as discussed above in claim 1. Sakuma discloses the concentrations of EtG and EtS in the samples are tested by: S1. Pre-treating the samples (para. [0032]-[0033]) transferring the sample and added into internal standards EtG-D5 and EtS-D5 (According to various embodiments of the applicant's teachings, at least one internal standard can be added to the sample before analysis of the sample. Para. [0024]; The internal standard can comprise a chemical having a chemical structure that mimics that of a component in the sample…. Thus, the internal standards can comprise…deuterated ethyl glucuronide, and/or deuterated ethyl sulphate. Para. [0025]) and adding acetonitrile (Each urine sample (100 μL) was mixed with 200 μL of a solution (80% water+20% acetonitrile) para. [0033]); and S2. Measuring the concentration of EtG and EtS by liquid chromatography-tandem mass spectrometry for the blood samples under test in S1 (para. [0034-]-[0035]). Neither Sakuma nor Lostia explicitly discloses transferring the sample into centrifuge tubes, adding 80% acetonitrile in methanol, precipitating and centrifuging at 0 DEG C, transferring supernatant, drying, re-dissolving with 5% of acetonitrile in water, centrifuging again and taking the supernatant to obtain the sample under test In an analogous art, Sidqey discloses a sample pretreatment step for analyzing EtG and EtS in blood samples. In addition to mixing the blood samples with internal standards in plastic tubes/centrifuge tubes (The samples were added 50 µL of IS-solution and mixed. Sample Preparation), Sidqey discloses adding acetonitrile, precipitating (four hundred microliters of ice cold ACN was added to precipitate the proteins. Sample Preparation), centrifuging (Following centrifugation at 4,500 x g (4,500 rpm on Heraeus, Multifuge X3R centrifuge, Osterode, Germany) for 5 min. Sample Preparation), transferring supernatant, drying, re-dissolving with 0.2% acetonitrile in water (the supernatants were filtered through a 96-well phospholipid removal Phree plate, 30 mg/well and collected into a 96-well collection plate using AV vacuum manifold all from Phenomenex. The filtered samples were evaporated to dryness under a stream of nitrogen at 65°C using a Zymark TurboVap (Caliper life sciences, Hopkinton, MA, USA). The residue was dissolved in 150 µL water/ACN/FA (100/0.2/0.1, v/v) solution. Sample Preparation), centrifuging again, and taking the supernatant to obtain the blood samples under test (and shaken for 1 min before UHPLC–MS-MS analysis. Sample Preparation). It would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporate the pretreatment of Sidqey to the method of Sakuma to derive the claimed invention. Doing so remove phospholipid from blood samples which may interfere with the sensitive instrument (Sidqey, Discussion). While the proposed combination of Sakuma, Lostia, and Sidqey discloses a method of estimating drinking time with a pre-treatment step comprising: transferring blood samples into centrifuge tubes added with internal standards EtG-D5 and EtS-D5, adding acetonitrile, precipitating and centrifuging, transferring supernatant, drying, re-dissolving with 0.2% acetonitrile in water, centrifuging again, and taking the supernatant to obtain the blood samples under test, the combined method does not disclose using 80% acetonitrile in methanol, centrifuging at 0 Degree C, and re-dissolving/reconstituting with 5% of acetonitrile in water. Regarding the limitation of “adding 80% acetonitrile in methanol”, Sidqey discloses utilizing an “ice cold acetonitrile” (Sample Preparation), which is presumed to be pure acetonitrile. Even though Sidqey discloses methanol as one of the reagents used in the experiment, the methanol is mainly used as mobile phases or as solution to prepare EtG-d5 and EtS-d5 stock solution (Para. 2, Preparation of Solutions), and there is no disclosure or suggestion of mixture of acetonitrile and methanol being used for preparing the sample. In an analogous art, Want discloses a list of solvent of protein extraction for serum profiling with Mass Spectrometry (Abstract). Furthermore, Want discloses 70:30 ACN/MeOH composition precipitates more protein compared to using pure acetonitrile or methanol (Figure 5). And the addition of methanol to acetonitrile improves detection of metabolites features in LC/MS. (The addition of methanol to acetonitrile increased the number of detected reproducible features by up to 25%...although varying the percentage of methanol between 30 and 70% did not have a significant effect. Number of Reproducible Features, para.2, page 747-748). It would have been obvious to one of ordinary skill in the art before the effective filing date to have experiment with mixing acetonitrile with methanol and optimizing the composition of the solvent of Sidqey to 80:20 ACN/MeOH based on the disclosure of Want. Using a mixture of ACN/MeOH at an optimal composition improves protein precipitation and metabolites detection in LC/MS. Regarding the limitation of “centrifuging at 0 DEG C”, Sidqey discloses the sample must be prepared with “ice cold acetonitrile” (an indication of low temperature preparation environment) but falls short explicitly stating centrifuging the resulting solution 0 DEG C or a temperature close to 0 DEG C. However, Sidqey discloses the samples, QC, calibrator and stock solutions are stored at 4 DEG C (Collected samples were store at 4 DEG C prior to processing; Biological Samples; IS solution was prepared by dilution…and stored at 4 DEG C; Preparation of Solutions), which is close to the disclosed value of 0 DEG C. Even without explicit disclosure, based on usage of “ice cold” acetonitrile, storing samples and solution at 4 DEG C, and protein’s fundamental property of denature at low temperature, a thermodynamically driven process where proteins lose their native structure and aggregate due to the weakening of the hydrophobic effect and changes in solvent properties at reduced temperatures, it would have been obvious to one of ordinary skill in the art to have kept the temperature of the solution low at 0 DEG C during centrifugation to derive the claimed temperature. Doing so allows proteins to aggregated and precipitated out. Regarding the limitation of re-dissolving with 5% of acetonitrile in water, Sidqey discloses the sample is re-dissolved/reconstituted in 0.2% of acetonitrile in water. Analogous art Lee discloses for the purpose of analyzing dried blood spots/sample in LC-MS, reconstituting the sample in water improves efficiency (Method Summary, para. 4). Lee reconstitutes such sample in an acetonitrile-water solution (5:95) in HPLC vial (Dried samples were dissolved in 30 μl of acetonitrile-water-formic acid (5:95:0.1, v/v) and transferred into an HPLC vial. Sample preparation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to reconstituting dried blood sample of Modified Sakuma in solution comprising 5% acetonitrile in water as taught by Lee to derive the claimed invention. While water serves as ideal solvent for the dried blood according to Lee, the addition of small volume of acetonitrile better prepares the mixture for LC-MS analysis, allowing for better resolution. Overall, it is the Examiner’s position that the disclosed concentration range and temperature are optimum or workable ranges by routine experimentation. Generally, differences in concentration and temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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 MPEP 2144.05 and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Regarding claim 8, Modified Sakuma discloses the claimed invention as discussed above in claim 5. Sakuma discloses the concentration of 1mg/mL is used for internal standard EtG-D5 and EtS-D5 are used (para. [0037]). Furthermore, Sidqey (after incorporation into Sakuma) discloses the internal standard stock solution of EtG-D5 and EtS-D5 at 1 mg/mL (Internal standard (IS) stock solutions of EtG-d5 and EtS-d5 (1 mg/mL) were prepared; Preparation of Solutions) are further diluted to 2.3 and 7.8 μ g/mL respectively (From the stock solutions, a IS solution was prepared by dilution with Type-1 water to a final concentration of 2.3 mg/L (18 μM) EtS and 7.8 mg/L (35 μM) EtG; Preparation of Solutions), which is close to the claimed range 1 μ g/mL. The ranges are close enough that one skilled in the art would have reasonable expectations that the compositions would have the same properties. The claimed concentration is 1 μ g/mL, which is only a 1.3 and 6.8 μ g/mL difference from the 2.3 and 7.8 μ g/mL disclosed by Sdiqey. One skilled in the art would reasonably expect that an internal standard solution with concentration of 2.3 and 7.8 μ g/mL versus 1 μ g/mL would still allow for proper sample mixing for analyzing the ethanol metabolites. Therefore, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Without showing unexpected results, the claimed range and range disclosed by Yamanaka are close enough that one skilled in the art would have a reasonable expectation of success. Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakuma, Lostia, and Sidqey, Lee, and Want as applied to claim 5 above, and further in view of Steimling (Definitive EtG/EtS LC-MS/MS Analysis, 2019). Regarding claim 6, Modified Sakuma discloses the claimed invention as discussed above in claim 5. Sakuma discloses in S2, a separation condition for liquid chromatography comprises the following parameters: Chromatographic column: Waters Atlantis ® HILIC, 3.0 x 100 mm, silica 3 micron; and column temperature at 50 DEG C (para. [0040]); and In an elution system, mobile phase A: a small amount formic acid in water, mobile phase B: a small amount of formic acid in acetonitrile; flow rate 0.35 mL/min (Mobile phases A, B, C, D, and Rinse 3 solution comprised 70% acetonitrile+30% water+10 mM ammonium formate, pH adjusted to 5.0 with a small amount of formic acid at a flow rate of 0.35 mL/min (isocratic). Para. [0040]). The recited ranges are close to values “2.1 mm x 100 mm, column temperature 35 DEG C” and 0.1% of formic acid and flow rate of 0.2 mL/min. It would have been obvious to one of ordinary skill in the art before the effective filing date to have adapted Inertsil ODS-3 column with 2.1 mm x 100 mm, 3 micron and column temperature 35 DEG C instead of Waters Atlantis’s column and a column temperature of 50 DEG C. It is the Examiner’s position that the disclosed values are close enough that one of ordinary skill in the art before the effective filing date of the invention would have expected the same properties. Case law holds that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Neither Sakuma, Lostia, nor Sidqey discloses the claimed gradient time. Analogous art Steimling discloses EtS/EtG analysis by mass spectrometry using following mobile phases and gradient time (Page 5): PNG media_image1.png 371 832 media_image1.png Greyscale Therefore, it would have been obvious to one of ordinary skill in the art to have routinely experiment and optimize elution time and mobile phases volume ratio based on teaching from Steimling to the method of Modified Sakuma to derive the claimed invention. Doing so minimizes the matrix suppression effect (Steimling, Matrix Effect, Page 6). Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakuma, Lostia, and Sidqey, Lee, and Want as applied to claim 5 above, and further in view of Sharma (Automated Sample Preparation for the Monitoring of Ethanol Metabolites in Urine by LC-MS/MS, 2015). Regarding claim 7, Modified Sakuma discloses the claimed invention as discussed above in claim 5. Sidqey, (after incorporation with Sakuma) discloses the concentrations were determined using electrospray ionization source using negative mode (Negative ESI-MS-MS-detection in multiple reaction monitoring (MRM) mode with two transitions for EtG and EtS and one transition for the ISs was performed. Ms-MS conditions) at a temperature of 500 DEG C (…delivered at a temperature of 500°C. Ms-Ms conditions). However, Sidqey is silent regarding the voltage of ion spray is at -4000 V. Analogous art Sharma discloses using LC-MS/MS for analyzing EtS and EtG in urine (Abstract). Sharma discloses the LC-MS/MS analysis was performed in negative ionization mode with ion spray voltage at -4500 V (Page 2, right column, para. 3) at a temperature of 600 DEG C (Page 2, right column, para. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date to have use the ion spray parameter of Sharma or a similar value such as -4000 V to the method of Modified Sakuma and have a reasonable expectation of success and achieving similar result since both Sidqey and Sakuma are method of analyzing EtS and EtG metabolites in human fluid using a negative ionization mode at a temperature close to each other (500 DEG C vs 600 DEG C). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET. 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, Maris Kessel can be reached at 5712707698. 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. /M.H./ Examiner, Art Unit 1758 /MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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Prosecution Timeline

Aug 14, 2023
Application Filed
Feb 26, 2026
Non-Final Rejection — §101, §103 (current)

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1-2
Expected OA Rounds
63%
Grant Probability
99%
With Interview (+55.8%)
3y 4m
Median Time to Grant
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