Prosecution Insights
Last updated: August 18, 2026
Application No. 18/696,187

METHOD FOR DETECTING AND/OR QUANTIFYING MOOD DISORDER AND/OR IMPROVEMENTS OF THE MOOD DISORDER STATUS USING TRIGONELLINE AS BIOMARKER AND IMPROVED METHODS AND COMPOSITIONS THEREOF

Non-Final OA §101§103§112
Filed
Mar 27, 2024
Priority
Sep 28, 2021 — EU 21199430.6 +1 more
Examiner
FRITCHMAN, REBECCA M
Art Unit
Tech Center
Assignee
Nestlé S.A.
OA Round
1 (Non-Final)
46%
Grant Probability
Moderate
1-2
OA Rounds
1y 7m
Est. Remaining
82%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allowance Rate
302 granted / 661 resolved
-14.3% vs TC avg
Strong +36% interview lift
Without
With
+35.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
66 currently pending
Career history
748
Total Applications
across all art units

Statute-Specific Performance

§101
5.0%
-35.0% vs TC avg
§103
59.5%
+19.5% vs TC avg
§102
9.1%
-30.9% vs TC avg
§112
20.4%
-19.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 661 resolved cases

Office Action

§101 §103 §112
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 . Detailed Action Summary This is the Non-Final Office action based on the 18/696187 application filed 03/27/2024. Claims 3-17, & 19-22 are pending. Claims 1-2 & 18 are cancelled. 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 3-17, & 19-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and law of nature without significantly more. Step 1: Independent Claims 3 and 16 are directed towards methods. Step 2A, Prong One: Independent Claim 3 recites an abstract ideas which are “assessing,” and “comparing,” the level of trigonelline to the level in a reference sample. Assessing and comparing are mental processes which are abstract ideas. Further, there is a claimed natural correlation which is the level of trigonelline in comparison and its association with mood disorder, its status or emotional reaction. This is also a judicial exception and the claims follow a similar analysis to that of Example 29 of the USPTO subject matter eligibility examples, which was found ineligible. Further, the claimed comparison to a referenceis a mental process or at best, a mathematical comparison using an equation. Formulas or equations are mathematical concepts, which are an enumerated abstract idea (MPEP § 2106.04(a)). For Claim 16, all that is claimed is administering coffee beans and fenugreek and probiotics are found in yogurt and other fermented foods. Therefore, as broadly claimed, this can read on administering or eating/providing a naturally occurring food products, which are natural compounds. This is similar to USPTO subject matter eligibility example 2, Claim 1, drawn towards “a method of providing pomelo fruit,” which was found ineligible, since there is no difference in the substance of the probiotic or trigonelline from how they are found in nature. Therefore, the claimed composition and method does not involve anything which is markedly different from what is found in nature. Step 2A, Prong Two: The abstract idea and natural correlation in independent Claims 3 is not integrated into a practical application because upon or after the comparison, nothing further is done to practically apply. Also- there is no measurement or detection steps that are more than data-gathering. As claimed, the “assessing,” is just data gathering to perform the judicial exceptions. Data gathering is considered to be extra-solution activity, and does not practically apply the judicial exception. See MPEP 2106.05 (g). For Claim 16, no further steps are claimed, so nothing that practically applies or that makes the product markedly different from what is found in nature is added. Step 2B: There is nothing in independent Claim 3 which add something which is non routine and conventional or significantly more to the claimed abstract idea or natural correlation judicial exceptions. As claimed, “assessing,” and comparison to references, especially as generally claimed instantly claimed is well understood routine and conventional (WURC) in the art. This is evidenced by SLUPSKY in US 20120197539, which teaches of measuring the level of trigonelline (paragraph 0009, 0024, 0073, 0099, 0119), and comparing it to a reference profile (abstract) and further that if the level measured is increased or decreased in comparison to a control, and measuring specifically that the trigonelline is increased in comparison to a control (paragraph 0076, table 3).SLUPSKY teaches of measuring the metabolic profile using HPLC and TLC (paragraph 0177). See MPEP 2106.05(d)- “laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner.” For Claim 16, no further steps are claimed, so nothing that adds significantly more or that makes the product markedly different from what is found in nature, is added. The dependent claims are analyzed the same way as above. Claims 4 & 17 recite the disorder is mild to severe which is part of the natural correlation judicial exception itself. This is part of the judicial exception so does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B. Claim 5 recites what the sample is from the subject for the sample and the reference, however this does not change the fact that all is done is the judicial exceptions and data gathering, and therefore does to practically apply at step 2A/2, nor to add significantly more at step 2B. Claims 6 and 8-10 recite what the reference value is, however this is still part of the comparison and does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B. Claim 7 recites what the assessing is done by mass spectrometry, however this is still part of the data gathering and does nothing to practically apply at step 2A/2. Further, using mass spectrometry is WURC so it also does not add significantly more at step 2B. Claims 11 recite what the sample is a natural sample of the ones claims, however this is still part of the natural correlation and does nothing to practically apply at step 2A/2. Further using blood, urine, and feces samples are WURC so do not add significantly more at step 2B. Claim 12 states the purpose of the invention, but does not add any more method steps and particularly does not add anything which practically applies at step 2A/2, nor to add significantly more at step 2B. Claim 13 specifies that another biomarker is assessed the same way as trigonelline. However, this is treated the same way as the trigonelline in Claim 3 and does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B. Claim 14--- there is an antecedent basis issue which makes it unclear what is going on with this claim and therefore hard to make and assessment with respect to 101. Since probiotics are naturally occurring, for the time being--- the claimed probiotic is considered to be a product of nature with nothing claimed that makes it markedly different from what is found in nature, nor which practically applies at step 2A/2, nor to adds significantly more at step 2B. Claims 15 & 22 specify that the subject the sample is taken from is a human or human companion. The sample is still assessed just for data gathering, and nothing is claimed which practically apply at step 2A/2, nor which adds significantly more at step 2B. Claim 19-20 claim that the probiotic trigonelline composition can be administered orally (as in eating food or beverage). However, no further steps are claimed, so nothing that adds significantly more or that makes the product markedly different from what is found in nature, is added, nor which practically applies is added. Claim 21 adds that the probiotic administered is bifidobacterium longum NCC3001, which is a product of nature. Therefore, the claimed probiotic is considered to be a product of nature with nothing claimed that makes it markedly different from what is found in nature, nor which practically applies at step 2A/2, nor to adds significantly more at step 2B. 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 3-17, & 19-22 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. With respect to Claim 3, “excessive,” and mood “disorder,” are relative terms, which are not defined by the claim. It is unclear what in the claim what would exactly be considered a “disorder,” of mood or “excessive,” and differently people would take these things to be drastically different things. Therefore, the claim is not clear. This also applies to all dependent claims these phrases and terms are used in. Further with respect to Claim 3, claiming that and “increased,” level in the sample compared to a predetermined reference value indicates that “improvement,” has occurred, but since what the predetermined reference value is pulled from is not defined, it is unclear how this could be true. Maybe the reference value is from a person who is cherry with no emotional stress. In that case, is what is claimed really true or “improvement?” Therefore, the claim is unclear. This is also unclear in Claim 13. With respect to Claim 4, “mild,” and “severe,” are relative terms, which are not defined by the claim. It is unclear what in the claim what would exactly be considered a “mild,” and “severe,” and different people would take these things to be drastically different things. Therefore, the claim is not clear. With respect to Claim 5, it is unclear what “previously,” means in the claim. Is “previously,” in reference to the “assessing… level of trigonelline,” in Claim 3. Correction is required as this is unclear. With respect to Claim 6, it is unclear what “the same,” means. It is assumed applicant means that the same type of body fluid is used for both the control as assessed sample, but as this is not clearly claimed, it is unclear. With respect to Claim 7, “the biomarkers,” fails to have proper antecedent basis and “biomarkers,” were not mentioned in the claims prior to this. Further for Claim 7, it is unclear what “mass spectrometry according to by ultra-performance liquid of gas chromatography couple to tandem mass spectrometry,” means. With respect to this, it seems applicant is claiming a broad limitation of “mass spectrometry,” followed by a narrower limitation. This is unclear since it is not clear what applicant intends the claim to be actually limited to. With respect to Claim 8, “the… body fluid,” fails to have proper antecedent basis as only “body sample,” was claimed prior to this and not “body fluid.” With respect to Claim 10, applicant claims, “during an intervention,” and also, “but at least one week, for example at least four weeks before,” Again, it seems applicant is claiming a broad limitation and also a narrower limitation which makes the claim unclear. Further, however it is unclear exactly what applicant is claiming since applicant seems to be claiming that the sample is taken both before and after treatment, but “but,” is used. Further with respect to Claim 10, “ameliorate,” is a relative term which is not defined by the claim since a definition of it is to “make better or more tolerable.” Therefore, this is unclear. With respect to Claim 14, “the probiotic,” fails to have proper antecedent basis and probiotic was not mentioned in this claim or one prior to it that it depends from. Therefore, it is unclear in the claim. With respect to Claim 15, “companion,” is a relative term that is not defined by the claim and therefore is unclear as different people would interpret this drastically differently. Further with respect to Claim 16, claiming that and “improved,” is a relative term that is not defined by the claim. It is unclear if any improvement would actually occur or not since improvement is relative person to person. Therefore, the claim is unclear. Further with respect to Claim 16, “ameliorate,” is a relative term which is not defined by the claim since a definition of it is to “make better or more tolerable.” Therefore, this is unclear. Further with respect to Claim 16, “excessive,” and mood “disorder,” are relative terms, which are not defined by the claim. It is unclear what in the claim what would exactly be considered a “disorder,” of mood or “excessive,” and differently people would take these things to be drastically different things. Therefore, the claim is not clear. This also applies to all dependent claims these phrases and terms are used in. Even further with respect to Claim 16, it is unclear what an “Effective,” amount of a composition “combining a probiotic with trigonelline or a derivative thereof,” would be as it is not claimed how or if it is determined if something is effective. Since the only claimed steps is “administering,” this “Effective,” amount, “effective,” is a relative term not defined by the claim. Further, it is certainly relative to whatever probiotic or trigonielle derivative is used. Therefore, it is unclear what is meant by effective in the claim. With respect to Claim 17, “mild,” and “severe,” are relative terms, which are not defined by the claim. It is unclear what in the claim what would exactly be considered a “mild,” and “severe,” and different people would take these things to be drastically different things. Therefore, the claim is not clear. With respect to Claim 22, “companion,” is a relative term that is not defined by the claim and therefore is unclear as different people would interpret this drastically differently. Claims 4-17, & 19-22 are also rejected by virtue of their dependency on Claim 3. 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 non-obviousness. 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 3-17, & 19-22 are rejected under U.S.C. 103 as being obvious by SLUPSKY in US 20120197539 in view of POULSEN in The use of metabolomics for studying the effects of pre and probiotics. With respect to Claim 3, SLUPSKY teaches of a method for assessing patient health using metabolomics. The method comprises providing a bodily fluid or tissue sample from a subject, collecting a metabolic profile from the bodily fluid or tissue sample and comparing the metabolic profile to a reference profile, wherein the preferred bodily fluid is urine to determine if the subject is metabolically stressed or not (paragraph 0014, 0045, 0066, 0068, 0104, 0122, 0129). Reference profiles are also provided (abstract). More specifically, SLUPSKY teaches of measuring the level of trigonelline (paragraph 0009, 0024, 0073, 0099, 0119), and comparing it to a reference profile (abstract) and further that if the level measured is increased or decreased in comparison to a control, and measuring specifically that the trigonelline is increased in comparison to a control (paragraph 0076, table 3). SLUPSKY teaches of measuring/assessing the metabolic profile using HPLC and TLC (paragraph 0177). SLUPSKY teach of the trigonelline measurements are associated with metabolic stress (which can be considered a mood disorder or mood through broadest reasonable interpretation) and that specifically a metabolic profile for stress is obtained (paragraph 0150), which includes conditions like anorexic, bulemia, cachexia, diabetes, having myocardial infarction, having congestive heart failure and trauma which can all be considered mood disorders through broadest reasonable interpretation. In case it is not apparent that the trigonelline is elevated in comparison to normal in SLUPSKY, POULSEN is used to remedy this. POULSEN teaches of methods of measuring pre and probiotics in patients (Page 2). POULSEN further teaches that the trigonelline levels are measured higher/elevated in one subject in comparison to another subject, which can be considered a measured value compared to a reference value (Page 27, paragraph 2 and Figure 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect elevated levels of trigonelline as is done in POULSEN in the method of SLUPSKY due to effect trigonelline has on metabolism of other compounds and on oxidative stress (POULSEN, page 39, paragraphs 1-3). With respect to Claim 4, SLUPSKY teaches of the trigonelline measurements are associated with metabolic stress (which can be considered a mood disorder or mood through broadest reasonable interpretation) and that specifically a metabolic profile for stress is obtained, which includes conditions like anorexic, bulemia, cachexia, diabetes , which can be considered mild to serve as claimed through broadest reasonable interpretation (paragraph 0150). With respect to Claim 5, SLUPSKY teaches that the reference samples or subject can be from the same subject tested in (paragraph 0012). With respect to Claim 6, SLUPSKY teaches of measuring trigonelline as shown above, but does not teach specifically of detecting the average amount. POULSEN is used to remedy this and teaches of detecting average concentration of the biomarkers including trigonelline (Page 61, A9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect average values as is one in POULSEN in the method of SLUPSKY due to the advantage this give in being able to determine intra-individual differences (Page 19, paragraph 3). With respect to Claim 7, SLUPSKY teaches of detection by mass spectrometry (paragraph 0061, 0177) and of using gas chromatography (paragraph 0061). With respect to Claim 8, SLUPSKY teaches of monitoring by repeatedly comparing over time the metabolic profile (paragraph 0013), and therefore this reads on making repeated measurements and comparing of those measurements to each other and comparison over time of measurements in which the earlier measurements can be considered to the predetermined reference measurements (paragraph 0048). With respect to Claim 9, SLUPSKY teaches of monitoring by repeatedly comparing over time the metabolic profile (paragraph 0013), and therefore this reads on making repeated measurements and comparing of those measurements to each other and comparison over time of measurements in which the earlier measurements can be considered to the predetermined reference measurements (paragraph 0048). SLUPSKY teaches of treating the subject at least one of before and after providing at least one bodily fluid sample from the subject; and comparing the metabolic profile to a reference profile to assess the efficacy or toxicity of the treatment in treating the subject (paragraph 0015). This makes the claimed predetermined reference before treatment obvious. With respect to Claim 10, SLUPSKY teaches of monitoring by repeatedly comparing over time the metabolic profile (paragraph 0013), and therefore this reads on making repeated measurements and comparing of those measurements to each other and comparison over time of measurements in which the earlier measurements can be considered to the predetermined reference measurements (paragraph 0048). SLUPSKY teaches of treating the subject at least one of before and after providing at least one bodily fluid sample from the subject; and comparing the metabolic profile to a reference profile to assess the efficacy or toxicity of the treatment in treating the subject (paragraph 0015). This reads on the claimed collecting of samples during intervention to treat. With respect to Claim 11, SLUPSKY teaches that the preferred bodily fluid is urine to determine if the subject is metabolically stressed or not (paragraph 0014, 0045, 0066, 0068, 0104, 0122, 0129). With respect to Claim 12, SLUPSKY teaches of treating the subject at least one of before and after providing at least one bodily fluid sample from the subject; and comparing the metabolic profile to a reference profile to assess the efficacy or toxicity of the treatment in treating the subject (paragraph 0015). SLUPSKY does not teach of the treatment being a probiotic. POULSEN is used to remedy this and teaches of measuring pre and probiotics in patients and associated other compounds (Page 2). POULSEN further teaches that the trigonelline levels are measured higher/elevated in one subject in comparison to another subject, which can be considered a measured value compared to a reference value (Page 27, paragraph 2 and Figure 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect elevated levels of trigonelline and associated pre and probiotics as is done in POULSEN in the method of SLUPSKY due to effect trigonelline has on metabolism of other compounds and on oxidative stress (POULSEN, page 39, paragraphs 1-3) and due to the advantage probiotics are supposed for have for potential health benefits (Page 2, “purpose” section). With respect to Claim 13, SLUPSKU teaches of the above, but does not teach of measuring 4-cresol sulfate as claimed. POULSEN remedies this and teaches of measuring 4-cresol sulfate(Table 2, last row). It would have been obvious to one of ordinary skill in the art to measure 4-cresol sulfate as is done in POULSEN in the method of SLUPSKY due to its known prevalence in human urine and due to the known effect it has on colonic nitrogen protein metabolism (Table 2, title, Table 3, page 36-row 4, column 2). With respect to Claim 14, SLUPSKY teaches of the above, but does not teach of measuring BC NCC301 as claimed. POULSEN remedies this and teaches of measuring bifidobacterium longum(Table 3, page 36-row 5, column 1). It would have been obvious to one of ordinary skill in the art to measure bifidobacterium longum as is done in POULSEN in the method of SLUPSKY due to its known association with improvement of symptoms associated with IBD (which can cause bad mood)(Page 10, row 2, columns 1, 2, 3). With respect to Claim 15, SLUPSKY teaches of the subject being a human subject (Table 7). With respect to Claim 16, SLUPSKY teaches of a method for assessing patient health using metabolomics. The method comprises providing a bodily fluid or tissue sample from a subject, collecting a metabolic profile from the bodily fluid or tissue sample and comparing the metabolic profile to a reference profile, wherein the preferred bodily fluid is urine to determine if the subject is metabolically stressed or not (paragraph 0014, 0045, 0066, 0068, 0104, 0122, 0129). Reference profiles are also provided (abstract). More specifically, SLUPSKY teaches of measuring the level of trigonelline (paragraph 0009, 0024, 0073, 0099, 0119), and comparing it to a reference profile (abstract) and further that if the level measured is increased or decreased in comparison to a control, and measuring specifically that the trigonelline is increased in comparison to a control (paragraph 0076, table 3). SLUPSKY teaches of measuring/assessing the metabolic profile using HPLC and TLC (paragraph 0177). SLUPSKY teach of the trigonelline measurements are associated with metabolic stress (which can be considered a mood disorder or mood through broadest reasonable interpretation) and that specifically a metabolic profile for stress is obtained (paragraph 0150), which includes conditions like anorexic, bulemia, cachexia, diabetes, having myocardial infarction, having congestive heart failure and trauma which can all be considered mood disorders through broadest reasonable interpretation. SLUPSKY does not teach of specifically administering trigonelline and probiotic. POULSEN is used to remedy this. POULSEN teaches of methods of using and measuring pre and probiotics in patients (Page 2). POULSEN further teaches that the trigonelline levels are measured higher/elevated in one subject in comparison to another subject, which can be considered a measured value compared to a reference value (Page 27, paragraph 2 and Figure 7) and the levels are a result of administration or drinking of coffee (Page 38, last paragraph). POULSEN also teaches of administration of probiotic intake, and that this intake changes the excretion of other compounds ()Page 34, last paragraph and Page 35, first paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to administer and detect levels of probiotic and of trigonelline as is done in POULSEN in the method of SLUPSKY due to effect trigonelline has on metabolism of other compounds and on oxidative stress and due to the effect probiotics have on the excretion of other compounds (POULSEN, page 39, paragraphs 1-3, Page 35, paragraph 1). With respect to Claim 17, SLUPSKY teaches of the trigonelline measurements are associated with metabolic stress (which can be considered a mood disorder or mood through broadest reasonable interpretation) and that specifically a metabolic profile for stress is obtained, which includes conditions like anorexic, bulemia, cachexia, diabetes , which can be considered mild to serve as claimed through broadest reasonable interpretation (paragraph 0150). With respect to Claim 19, SLUPSKY teaches of the invention as shown above, but does not teach of specifically administering trigonelline and probiotic. POULSEN is used to remedy this. POULSEN teaches of methods of using and measuring pre and probiotics in patients (Page 2) and specifically of delivery through coffee, which is ingested orally and is a beverage(Page 38, last paragraph). POULSEN further teaches that the trigonelline levels are measured higher/elevated in one subject in comparison to another subject, which can be considered a measured value compared to a reference value (Page 27, paragraph 2 and Figure 7) and the levels are a result of administration or drinking of coffee (Page 38, last paragraph). POULSEN also teaches of administration of probiotic intake, and that this intake changes the excretion of other compounds ()Page 34, last paragraph and Page 35, first paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to administer and detect levels of probiotic and of trigonelline as is done in POULSEN in the method of SLUPSKY due to effect trigonelline has on metabolism of other compounds and on oxidative stress and due to the effect probiotics have on the excretion of other compounds (POULSEN, page 39, paragraphs 1-3, Page 35, paragraph 1). With respect to Claim 20, SLUPSKY teaches of the invention as shown above, but does not teach of specifically administering trigonelline and probiotic. POULSEN is used to remedy this. POULSEN teaches of methods of using and measuring pre and probiotics in patients (Page 2) and specifically of delivery through coffee, which is ingested orally and is a beverage(Page 38, last paragraph). POULSEN further teaches that the trigonelline levels are measured higher/elevated in one subject in comparison to another subject, which can be considered a measured value compared to a reference value (Page 27, paragraph 2 and Figure 7) and the levels are a result of administration or drinking of coffee (Page 38, last paragraph). POULSEN also teaches of administration of probiotic intake, and that this intake changes the excretion of other compounds ()Page 34, last paragraph and Page 35, first paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to administer and detect levels of probiotic and of trigonelline as is done in POULSEN in the method of SLUPSKY due to effect trigonelline has on metabolism of other compounds and on oxidative stress and due to the effect probiotics have on the excretion of other compounds (POULSEN, page 39, paragraphs 1-3, Page 35, paragraph 1). With respect to Claim 21, SLUPSKY teaches of the above, but does not teach of measuring BC NCC301 as claimed. POULSEN remedies this and teaches of measuring bifidobacterium longum, which is BCNCC301 (Table 3, page 36-row 5, column 1). It would have been obvious to one of ordinary skill in the art to measure bifidobacterium longum as is done in POULSEN in the method of SLUPSKY due to its known association with improvement of symptoms associated with IBD (which can cause bad mood)(Page 10, row 2, columns 1, 2, 3). With respect to Claim 22, SLUPSKY teaches of the subject being a human subject (Table 7). Conclusion Prior art which is relevant to the disclosure, but not relied upon in the office action: CHOPRA in Quantitative Determination and Stress Degradation Studies on a Biomarker Trigonelline by a Validated Stability-Indicating HPTLC Method (as cited on IDS dated 03/27/2024). CHOPRA is used to remedy this and teaches of a method of high-performance thin-layer chromatographic (HPTLC)method for analysis of trigonelline (abstract) and of analysis correlated with stress (abstract). Specifically, CHOPRA teaches of analysis for the determination of stress conditions (abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use HTLC for the analysis of trigonelline as is done in CHOPRA in the method of SLUPSKY due to the advantage the method of CHOPRA has in that it is reproducible and selective (abstract). Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday. 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 on 571-270-7698. 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. /REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Read full office action

Prosecution Timeline

Mar 27, 2024
Application Filed
Jul 13, 2026
Non-Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
46%
Grant Probability
82%
With Interview (+35.8%)
4y 0m (~1y 7m remaining)
Median Time to Grant
Low
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Based on 661 resolved cases by this examiner. Grant probability derived from career allowance rate.

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