DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1 is amended.
Claims 2, 4, and 9-20 are canceled.
Claims 1, 3, 5-8, and 21 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-8, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “destroying the raw milk sample in order to avoid human consumption of the raw milk sample”, however the applicant does not cite support for said amendment and upon review of applicant’s specification, no support for said destruction could be found.
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, 3, 5-8, and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Under step 1, claim 1 belongs to a statutory category of a method.
Under Step 2A prong 1, the claims as a whole are identified as being directed to a judicial exception as claim 1 recite(s) “testing a raw milk sample to determine whether the raw milk sample is abnormal and processing the raw milk sample when the raw milk sample is determined to be abnormal”, “converting the first set of chemical fingerprints into a cluster of data points in a multi-dimensional principal component analysis (PCA) plot, wherein each dimension of the multi-dimensional PCA plot is based on a principal component (PC), each PC corresponding to one physiochemical property in the plurality of physiochemical properties; constructing a profile pattern of the cluster of data points, wherein the constructing of the profile pattern comprises: for each of respective data points in the cluster, calculating a square root of sum of all squared PCs: ranking the respective data points into a predetermined set of intervals according to respective values of the calculated square root of sum of all squared PCs as obtained for the respective data points: and obtaining the profile pattern in the PCA plot by removing, from the cluster, data points that fall into one or more intervals in the predetermined set of intervals, wherein each of the one or more intervals has a number of data points exceeding a predetermined number of data points; setting up a prediction model configured to identify a new milk sample having a new data point in the PCA plot to be abnormal if a squared Mahalanobis distance (MD) score between the new data point and a centroid of the profile pattern exceeds a threshold squared MD score, wherein the threshold squared MD score is determined by a first process comprising:”, “converting the second set of chemical fingerprints into a plurality of second data points in the PCA plot, whereby an individual testing sample in the set of testing samples has a corresponding second data point in the plurality of second data points; for the individual testing sample, calculating a squared MD score between the corresponding second data point and the centroid of the profile pattern in the PCA plot; and determining the threshold squared MD score for distinguishing the plurality of normal testing samples and the plurality of abnormal testing samples in the set of testing samples, wherein the threshold squared MD score is determined according to respective squared MD scores calculated for the set of testing samples;”, and “converting the chemical fingerprint of the raw milk sample into a third data point in the PCA plot; and using the prediction model to determine whether the raw milk sample is abnormal according to the third data point” which are directed to mathematical concepts and/or mental processes based on applicant’s specification for example see Par. 52-53, 63-64, 66-70, 72-74, also see MPEP 2106.04(a)(2)(I)(A)(iv) “organizing information and manipulating information through mathematical correlations”.
Under Step 2A prong 2, evaluating whether the claim as a whole integrates the exception into a practical application of that exception, the judicial exception is not integrated into a practical application because “obtaining a first set of chemical fingerprints, wherein each chemical fingerprint of the first set of chemical fingerprints is indicative of a plurality of physiochemical properties of a corresponding sample in a set of normal milk samples;”, “obtaining a second set of chemical fingerprints, wherein each chemical fingerprint in the second set of chemical fingerprints is indicative of the plurality of physiochemical properties of a corresponding testing sample in a set of testing samples, the set of testing samples including a plurality of normal testing samples of milk and a plurality of abnormal testing samples of milk;”, and “obtaining a chemical fingerprint of the raw milk sample;” are considered to be data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The elements of “responsive to determining that the raw milk sample is abnormal, destroying the raw milk sample in order to avoid human consumption of the raw milk sample” are recited at a high level of generality without describing how the operation is performed, which amounts to no more than mere instructions to apply the abstract idea.
Under Step 2B, evaluating additional elements to determine whether they amount to an inventive concept both individually and in combination, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “obtaining a first set of chemical fingerprints, wherein each chemical fingerprint of the first set of chemical fingerprints is indicative of a plurality of physiochemical properties of a corresponding sample in a set of normal milk samples;”, “obtaining a second set of chemical fingerprints, wherein each chemical fingerprint in the second set of chemical fingerprints is indicative of the plurality of physiochemical properties of a corresponding testing sample in a set of testing samples, the set of testing samples including a plurality of normal testing samples of milk and a plurality of abnormal testing samples of milk;”, and “obtaining a chemical fingerprint of the raw milk sample;” are considered to be data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity are considered to be insignificant extra-solution activity similar to MPEP 2106.05(g) (see Mere Data Gathering (ii) and Selecting a particular data source or type of data to be manipulated (iii)) and a field of use similar to MPEP 2106.05(h)(vi) as they describe gathering data and what that data is but no additional elements that could be considered a particular configuration or steps to obtain said data. The elements of “responsive to determining that the raw milk sample is abnormal, destroying the raw milk sample in order to avoid human consumption of the raw milk sample” are considered to be merely instructions to apply the judicial exception, thus do not amount to significantly more than the exception itself per MPEP 2106.05(f) and are well-understood, routine, and conventional activities/elements previously known to the industry per MPEP 2106.05(d) (as any person would recognize abnormal milk should be disposed of, i.e. “destroyed”).
Claims 3, and 5-8 are considered to further describe the abstract ideas above without adding any additional elements.
Claim 21 recites the additional element(s) of using generic AI/ML technology, i.e. before the prediction model is used to determine whether the raw milk sample is normal or abnormal, training the prediction model to optimize an overall accuracy based on Extratree or XGBoost learning of the plurality of physiochemical properties of the set of testing samples so as to cause the prediction model to learn that certain physiochemical properties are more indicative of the profile pattern than other physiochemical properties”, to perform data evaluations or calculations, as identified under Prong 1 above. The claims do not recite any details regarding how the AI/ML algorithm or model functions or is trained. Instead, the claims are found to utilize the AI/ML algorithm as a tool that provides nothing more than mere instructions to implement the abstract idea on a general-purpose computer. See MPEP 2106.05(f). Additionally, the use of the before the prediction model is used to determine whether the raw milk sample is normal or abnormal, training the prediction model to optimize an overall accuracy based on Extratree or XGBoost learning of the plurality of physiochemical properties of the set of testing samples so as to cause the prediction model to learn that certain physiochemical properties are more indicative of the profile pattern than other physiochemical properties” merely indicates a field of use or technological environment in which the judicial exception is performed. See MPEP 2106.05(h). Therefore, the use of before the prediction model is used to determine whether the raw milk sample is normal or abnormal, training the prediction model to optimize an overall accuracy based on Extratree or XGBoost learning of the plurality of physiochemical properties of the set of testing samples so as to cause the prediction model to learn that certain physiochemical properties are more indicative of the profile pattern than other physiochemical properties” to perform steps that are otherwise abstract does not integrate the abstract idea into a practical application. See the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence; and Example 47, ineligible claim 2.
Examiner Note with regards to Prior Art of Record
Claims 1, 3, 5-8, and 21 are distinguished over the prior art of record based on the reasons below.
In claim 1, the claim differs from the closest prior arts of record, Satomaa (US 20090324617 A1), (WO 2023021262 A1), and HOU (CN 104777115 A) in that it fails to anticipate or render obvious “ranking the respective data points into a predetermined set of intervals according to respective values of the calculated square root of sum of all squared PCs as obtained for the respective data points: and obtaining the profile pattern in the PCA plot by removing, from the cluster, data points that fall into one or more intervals in the predetermined set of intervals, wherein each of the one or more intervals has a number of data points exceeding a predetermined number of data points; setting up a prediction model configured to identify a new milk sample having a new data point in the PCA plot to be abnormal if a squared Mahalanobis distance (MD) score between the new data point and a centroid of the profile pattern exceeds a threshold squared MD score, wherein the threshold squared MD score is determined by a first process comprising” and “calculating a squared MD score between the corresponding second data point and the centroid of the profile pattern in the PCA plot; and determining the threshold squared MD score for distinguishing the plurality of normal testing samples and the plurality of abnormal testing samples in the set of testing samples, wherein the threshold squared MD score is determined according to respective squared MD scores calculated for the set of testing samples;” in combination with all the other limitations in the claim as claimed and defined by the applicant.
Response to Arguments
Applicant's arguments filed 03/06/2026 have been fully considered but they are not persuasive. Regarding applicant’s 101 arguments, the amended claim language is not significantly more or a practical application per MPEP 2106.05(f) as cited above. Notably “The claim simply stated a judicial exception (e.g., law of nature or abstract idea) while effectively adding words that “apply it””.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20130070240 A1, APPARATUS AND METHOD FOR INSPECTING THE INNER SURFACE OF A TUBULAR STRUCTURE FOR CONTAMINATION; US 20100007889 A1, SAMPLE CONCENTRATION DETECTOR WITH TEMPERATURE COMPENSATION.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.J.B/Examiner, Art Unit 2857
/SHELBY A TURNER/Supervisory Patent Examiner, Art Unit 2857
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