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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered and considered. Rejections and/or objections not reiterated from the previous office action mailed 01/13/2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Status of the Claims
Claims 3-8, 10, and 13 are pending and under consideration in this action. Claims 1-2, 9, and 11-12 were previously canceled.
Terminal Disclaimer
The terminal disclaimer filed on 04/13/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,038,420 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer overcomes the outstanding rejection of claims 3-5, 7-8, and 10 on the grounds of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,038,420 B2.
Priority
This application claims foreign priority from Chinese Application No. CN202011106439.4, filed 10/15/2020, as reflected in the filing receipt mailed 10/27/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claims to the benefit of priority are acknowledged and the effective filing date of claims 3-8, 10, and 13 is 10/15/2020.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites the limitation “wherein main secondary mass spectrometry ion peaks… risk warning molecule versicolorin B (Ver B) comprise 311.0542Da, 311.0187Da, and 283.0238Da”, which is missing an “and” before the “wherein…” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3-8, 10, and 13 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 3 recites the limitation “wherein main secondary mass spectrometry ion peaks of the aflatoxin contamination risk warning molecule 5-methoxysterigmatocystin (5-MST) and C19H14O7 comprise 350.0809Da, 340.0571Da, 322.04675Da, 311.05469Da and 285.0098Da” in lines 35-38 of the claim. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. The molecular formula C19H14O7 appears to correspond to the 5-MST warning molecule (see at least Specification, Para. [0023], Table 1). However, that molecular formula could also correspond to numerous other compounds not recited in the instant claim. This rejection can be overcome by amendment of claim 3 to remove the molecular formula, recite “wherein main secondary mass spectrometry ion peaks of the aflatoxin contamination risk warning molecule 5-methoxysterigmatocystin (5-MST, C19H14O7) comprise 350.0809Da, 340.0571Da, 322.04675Da, 311.05469Da and 285.0098Da”, or similar clarification that the molecular formula is only for the 5-MST warning molecule. Claims 4-8, 10, and 13 are also rejected due to their dependency from claim 3.
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 3-8, 10, and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite both (1) mathematical concepts (mathematical relationships, formulas or equations, or mathematical calculations) and (2) mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Step 1:
In the instant application, claims 3-8, 10, and 13 are directed towards a method, which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong One). The following instant claims recite limitations that equate to one or more categories of judicial exceptions:
Claim 1 recites a mathematical concept in “performing modeling with a chemometrics method by using the content of one or more of the aflatoxin contamination risk warning molecules as a variable to obtain a classification prediction model, inputting the quantitative result of the aflatoxin contamination risk warning molecule, and outputting a risk assessment result based on the classification prediction model to warn aflatoxin contamination of the sample”; a mental process (i.e., an evaluation of the risk warning molecule) in “wherein the aflatoxin contamination risk warning molecule is 5-methoxysterigmatocystin (5-MST) or a combination of the 5-methoxysterigmatocystin (5-MST) and one or more than one of versiconol (VOH) and versicolorin B (Ver B)”; a mental process (i.e., an evaluation of mass deviation and a comparison of ion peaks) in “wherein the qualitative analysis of the aflatoxin contamination risk warning molecule comprises: determining a mass deviation within 5 ppm according to an accurate mass number of a primary mass spectrometry of the aflatoxin contamination risk warning molecule, and then comparing main characteristic ion peaks of a secondary mass spectrometry in combination with a secondary mass spectrogram to perform the qualitative analysis, wherein main secondary mass spectrometry ion peaks of the aflatoxin contamination risk warning molecule 5-methoxysterigmatocystin (5-MST) and C19H14O7 comprise 350.0809Da, 340.0571Da, 322.04675Da, 311.05469Da and 285.0098Da; secondary mass spectrometry ion peaks of the aflatoxin contamination risk warning molecule versiconol (VOH) comprise: 329.06546Da, 341.09506Da, and 359.07596Da; and the main secondary mass spectrometry ion peaks of the aflatoxin contamination risk warning molecule versicolorin B (Ver B) comprise 311.0542Da, 311.0187Da, and 283.0238Da”; and a mental process (i.e., an evaluation of data based on a standard curve) in “wherein the quantitative analysis of the aflatoxin contamination risk warning molecule comprises: in combination with an internal standard substance, performing the quantitative analysis based on a standard curve of each aflatoxin contamination risk warning molecule of a ratio of a chromatographic peak area to a peak area of an internal standard-warning molecule concentration”.
Claim 4 recites a mathematical concept in “wherein the chemometrics method is a multivariate statistical analysis method including hierarchical cluster analysis, least partial square orthogonal projection or random forest”.
Claim 5 recites a mathematical concept in “a quantitative value of the aflatoxin contamination risk warning molecule is directly input into the classification prediction model to predict the aflatoxin contamination risk”.
Claim 6 recites a mental process (i.e., an evaluation of values compared to threshold values to classify risk) in “if the content of 5-methoxysterigmatocystin is greater than a threshold value of 34.7 µg/kg, whether the content of VerB is greater than 96.35 µg/kg is further used to determine the contamination risk of the sample, if the content of VerB is greater than 96.35 µg/kg, the sample is a high-risk aflatoxin contamination sample, and if the content of VerB is less than or equal to 96.35 µg/kg, the sample is a medium-risk aflatoxin contamination sample; and then the medium-risk sample is further input into the accurate classification prediction model for verification”.
Claims 7 and 13 recite a mental process (i.e., an evaluation of content over the national limit) in “wherein a sample with the aflatoxin content higher than a national limit standard is directly identified as a high-risk sample, which is the suspected sample”.
These recitations are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Specifically, claim 3 involves nothing more than performing modeling using a chemometrics method, performing qualitative analysis by comparing ion peaks to determine mass deviation, and performing quantitative analyzing a standard curve for the risk warning molecules. The step reciting “performing modeling using a chemometrics method” is, under the BRI, performed using mathematical operations. The instant Specification (see Para. [0008]) discloses that the chemometrics method is a multivariate statistical analysis method such as hierarchical cluster analysis, least partial square orthogonal projection, and random forest. Additionally, since there are no specifics in the methodology, the steps reciting performing qualitative analysis by comparing ion peaks to determine mass deviation, and performing quantitative analyzing a standard curve for the risk warning molecules, are something that under BRI, one could perform mentally. Therefore, the claimed steps are not further defined beyond something that reads on performing a calculation using a computer as a tool, and merely looking at data and making a determination. As such, said steps are directed to judicial exceptions. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application (Step 2A, Prong One: YES).
Step 2A, Prong Two:
In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP § 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP § 2106.04(d)(I)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP § 2106.04(d)(III)). The following independent claims recite limitations that equate to additional elements:
Claim 3 recites “weighing a quantitative sample, extracting the aflatoxin contamination risk warning molecule to obtain a sample extract, and detecting and analyzing the sample extract to obtain a quantitative result of the aflatoxin contamination risk warning molecule, wherein detecting the sample extract comprises: subjecting the sample to detection and analysis by liquid chromatography-high resolution mass spectrometry”; and “utilizing the risk assessment result to determine a contamination by toxigenic Aspergillus flavus and/or a contamination by aflatoxin in the sample”.
Regarding the above cited limitation in claim 3 of (i) weighing a quantitative sample, extracting the aflatoxin contamination risk warning molecule to obtain a sample extract, and detecting and analyzing the sample extract to obtain a quantitative result of the aflatoxin contamination risk warning molecule, wherein detecting the sample extract comprises: subjecting the sample to detection and analysis by liquid chromatography-high resolution mass spectrometry. This limitation equates to insignificant, extra-solution activity of mere data gathering because this limitation gathers data before the recited judicial exception of performing modeling with a chemometrics method with the aflatoxin risk warning molecule data as an input variable (see MPEP § 2106.04(d)).
Regarding the above cited limitation in claim 3 of (ii) utilizing the risk assessment result to determine a contamination by toxigenic Aspergillus flavus and/or a contamination by aflatoxin in the sample. This limitation equates to an extra-solution “apply it” step, because the limitation is used to determine the contamination in a sample without providing any details of how the risk assessment result is used to determine the contamination for any sample containing an aflatoxin (see MPEP § 2106.05(f)).
Additionally, none of the recited dependent claims recite additional elements which would integrate the judicial exception into a practical application. Specifically, claims 5-7 and 13 further limit the extraction and detection of the risk warning molecule; and claim 10 further limits the detection and analysis using liquid chromatography-high resolution mass spectrometry. As such, claims 3-8, 10, and 13 are directed to an abstract idea (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant independent claim recites the same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitation in claim 3 of (i) weighing a quantitative sample, extracting the aflatoxin contamination risk warning molecule to obtain a sample extract, and detecting and analyzing the sample extract to obtain a quantitative result of the aflatoxin contamination risk warning molecule, wherein detecting the sample extract comprises: subjecting the sample to detection and analysis by liquid chromatography-high resolution mass spectrometry, this limitation is a well-understood, routine, and conventional laboratory technique. The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)): determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)); and detecting DNA or enzymes in a sample (Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017)).
Additionally, regarding the above cited limitations in claim 3 of (i) weighing a quantitative sample, extracting the aflatoxin contamination risk warning molecule to obtain a sample extract, and detecting and analyzing the sample extract to obtain a quantitative result of the aflatoxin contamination risk warning molecule, wherein detecting the sample extract comprises: subjecting the sample to detection and analysis by liquid chromatography-high resolution mass spectrometry; and (ii) utilizing the risk assessment result to determine a contamination by toxigenic Aspergillus flavus and/or a contamination by aflatoxin in the sample. These limitations when viewed individually and in combination, are well-understood, routine, and conventional (WURC) limitations as taught by Jiang et al. (Predictive model of aflatoxin contamination risk associated with granary-stored corn with versicolorin A monitoring and logistic regression. Food Additives & Contaminants: Part A, 2019, 36(2), 308-319; cited in the Office action dated 05/07/2025) and Zhang et al. (A Review: Sample Preparation and Chromatographic Technologies for Detection of Aflatoxins in Foods. Toxins. 12(9): 539, 39 pages (2020); cited in the Office action dated 05/07/2025). Jiang et al. discloses a predictive model establishing an early warning system for aflatoxin contamination (Title, Abstract). Preparation of the samples includes steps of weighing 10-kg corn samples (Pg. 309, Col. 2, Para. 3), and extracting versicolorin A (the warning molecule) from corn, which involves crushing the sample, dissolving, filtering, and evaporating (Pg. 311, Col. 2, Para. 2). The extracted versicolorin A was detected and analyzed using HPLC (Pg. 312, Col. 1, Para. 2) (limitation (i)). Jiang et al. further discloses the development of a binary logistic regression model for early assessment of the risk of aflatoxin contamination of post-harvest corn before storage in a granary. For those samples deemed to be at high risk, a precise model was developed to predict the safer storage period, which can be useful for a decision-making for the stakeholders in food and feed supply chain (Abstract and Pg. 317, Col. 2, Para. 1) (limitation (ii)). Additionally, Zhang et al. discloses a review of sample preparation and chromatographic methods for detection of aflatoxins in food (Title). Zhang et al. further discloses the use of liquid chromatography-high resolution mass spectrometry (LC-MS) for quantitative analysis (Pg, 18, Section 3.3 and Pg. 19, Section 3.3.2) (limitation (i)).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 3-8, 10, and 13 are not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 04/13/2026 have been fully considered but they are not persuasive.
1. Applicant argues that the added technical feature of “utilizing the risk assessment result to determine a contamination by toxigenic Aspergillus flavus and/or a contamination by aflatoxin in the sample” renders the claim eligible under 101. According to paragraphs [0002]-[0004] of the description, Aspergillus flavus is widely distributed in the world, and is a major causative factor of regional liver cancer in China. The newly added limitation enables early identification of the toxigenicity of Aspergillus flavus in agricultural products or soil. In detail, according to paragraphs [0074]-[0079] and Fig. 9, the samples could be divided into the high risk samples, the medium risk samples, and the low risk samples by using the method limited in the amended claim 3 of the present application, and the high risk samples would be processed by toxin abatement or be directly destroyed as stated in the amended claim 6, so that the quality and safety of agricultural products could be ensured. Therefore, the added limitation integrates the judicial exceptions into a practical application (Applicant’s Remarks, Pg. 9-11).
It is respectfully submitted that this is not persuasive for the following reasons:
MPEP 2106.05(a) recites:
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., thereby increasing the bandwidth of the channel"). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim "as a whole," in other words, the claim should be evaluated "as an ordered combination, without ignoring the requirements of the individual steps." When performing this evaluation, examiners should be "careful to avoid oversimplifying the claims" by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.
Under the BRI, the newly added limitation of “utilizing the risk assessment result to determine a contamination by toxigenic Aspergillus flavus and/or a contamination by aflatoxin in the sample” is used to determine the contamination in a sample without providing any steps as to how the contamination is determined. As indicated by Applicant, and recited in Specification Para. [0077]-[0078] and Fig. 10, the contamination is determined by comparing the content of the warning molecules in the sample to a threshold value, thereby assigning a risk category for the sample. Since there are no specific steps or parameters as to how the contamination is determined, this limitation is an extra-solution step, as indicated in Step 2A, Prong One above.
Additionally, the alleged improvements indicated by Applicant are not commensurate in scope with the claimed invention. Applicant appears to assert that the claimed features may be used to determine the contamination in a suspected sample by identifying low, medium, and high risk samples, and subsequently destroying high risk samples (Applicant’s Remarks, Pg. 10-11). However, independent claim 3 does not provide any indication of the identification of risk categories for contamination, nor subsequent destruction of high risk samples. Therefore, it appears the alleged improvements are not commensurate in scope with the claimed invention. This argument is thus not persuasive.
2. Applicant also argues that the newly added limitation in amended claim 3 could ensure the quality and safety of agricultural products by early warning of toxigenic Aspergillus flavus in agricultural products, as stated above. In summary, the method limited in the amended claim 3 is eligible as improvements to technology instead of being directed to abstract ideas and satisfied the requirement of Step 2B (Applicant’s Remarks, Pg. 11).
It is respectfully submitted that this is not persuasive for the following reasons:
As discussed in the rejection and arguments directly above, under the BRI, the newly added limitation of “utilizing the risk assessment result to determine a contamination by toxigenic Aspergillus flavus and/or a contamination by aflatoxin in the sample” is an extra-solution step under Step 2A, Prong One. Further analysis of this limitation under Step 2B, shows that this limitation, as currently recited, is well-understood, routine, conventional. Jiang et al. discloses a model to assess of the early risk of aflatoxin contamination in corn samples (see Step 2B above). Therefore, this limitation does not amount to significantly more than the judicial exception to ensure the quality and safety of agricultural products, and this argument is thus not persuasive.
Conclusion
No claims allowed.
Claims 3-8, 10, and 13 appear to be free of the prior art because the prior art does not fairly suggest or teach a prediction model using 5-methoxysterigmatocystin (5-MST) or a combination of 5-MST and one or more of versiconol or versicolorin B as a risk warning model for aflatoxin contamination, or specific secondary mass spectrometry ion peaks for 5-MST recited in instant claim 3. The closest prior art is Jiang et al. (Predictive model of aflatoxin contamination risk associated with granary-stored corn with versicolorin A monitoring and logistic regression. Food Additives & Contaminants: Part A, 36(2), 308-319 (2019); cited in the Office action dated 05/07/2025). Jiang et al. discloses the generation of an aflatoxin risk probabilistic model for positive and negative contamination cases using versicolorin A, a precursor to aflatoxin B1. However, Jiang et al. does not teach that the model uses 5-MST, versiconol, or versicolor B as the risk warning molecules, or the analysis of the molecules by LC/MS with specified secondary mass spectrometry peaks, as disclosed in instant claim 3. Claims 4-8, 10, and 13 appear to be free from the prior art due to their dependency on claim 3.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA P SANFORD whose telephone number is (571)272-6504. The examiner can normally be reached Mon-Fri 8am-5pm EST.
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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687
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