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 .
Prosecution History Summary
Claims 20-24 and 26-97 are cancelled.
Claims 9-19 and 25 are withdrawn.
Claim 100 is new.
Claim 1 is amended.
Claims 1-8 and 98-100 are pending.
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 and 98-100 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process (claims 1-8 and 98-100). Accordingly, claims 1-8 and 98-100 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A method of verifying eligibility of a subject for a treatment, the method comprising:
-receiving a vector of the subject comprising data representing a plurality of symptoms of the subject in a rating scale;
-computing an anomaly score based on the vector of the subject and a plurality of vectors representing rating scales of other subjects;
-based on the anomaly score, ranking the subject with a likelihood of contributing to a subgroup of patients having a common element structure of the rating scale; and
-enriching a study population in a clinical trial based on the anomaly score prior to randomization, the enriched study population having a reduced heterogeneity relative to information collected in the clinical trial;
-treating the subject based on anomaly score, wherein treating the subject comprises administering a drug or therapy of the disease or condition to the subject.
Examiner states submits that the foregoing underlined limitations constitute: “mathematical concepts” because analyzing the vectors to compute an anomaly score to enrich a study population are mathematical relationships.
Furthermore, the foregoing underlined limitation constitute: a “mental process” because analyzing the vectors to compute an anomaly score to enrich a study population can all be performed in the human mind.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether
the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP
§$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond
the abstract idea integrate the exception into a practical application in a manner that imposes a
meaningful limit on the judicial exception. The courts have indicated that additional elements
merely using a computer to implement an abstract idea, adding insignificant extra solution
activity, or generally linking use of a judicial exception to a particular technological environment
or field of use do not integrate a judicial exception into a “practical application.” MPEP
§2106.05(1(A).
In the present case, the additional limitations beyond the above-noted at least one abstract
idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A method of verifying eligibility of a subject for a treatment, the method comprising:
-receiving a vector of the subject comprising data representing a plurality of symptoms of the subject in a rating scale;
-computing an anomaly score based on the vector of the subject and a plurality of vectors representing rating scales of other subjects;
-based on the anomaly score, ranking the subject with a likelihood of contributing to a subgroup of patients having a common element structure of the rating scale; and
-enriching a study population in a clinical trial based on the anomaly score prior to randomization, the enriched study population having a reduced heterogeneity relative to information collected in the clinical trial;
-treating the subject based on anomaly score, wherein treating the subject comprises administering a drug or therapy of the disease or condition to the subject (extra-solution activity, see MPEP 2106.05(g)).
The remaining dependent claim limitations not addressed above fail to integrate the
abstract idea into a practical application as set forth below:
Claim 2: The claim specifies computing the anomaly score, which further narrows the abstract idea.
Claim 3: The claim specifies the nodes for computing the anomaly score, which further narrows the abstract idea.
Claim 4: The claim specifies the binary tree of the node, which further narrows the abstract idea.
Claim 5: The claim specifies further comprising improving a dataset, which further narrows the abstract idea.
Claim 6: The claim specifies enriching the study population by verifying a diagnosis, which further narrows the abstract idea.
Claim 7: The claim specifies enriching the study population to identify an outlier, which further narrows the abstract idea.
Claim 8: The claim specifies treating the subject based on anomaly score, which is insignificant extra-solution activity (see MPEP 2106.05(g)).
Claim 98: The claim specifies verifying the diagnosis, which further narrows the abstract idea.
Claim 99: The claim specifies determining the subject is not an outlier, which further narrows the abstract idea.
Claim 100: The claim specifies the disease or condition, which further narrows the abstract idea and treating the user, which is an extra-solution activity.
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as receiving a vector, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); computing an anomaly score, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); ranking the subject, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); enriching a study population, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2, 5, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 2 (computing an anomaly score), e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); claims 5 (improving clinical dataset), e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-8 and 98-100 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vairavan et al. (WO 2022/008523 A1).
As per claim 1, Vairavan teaches a method of verifying eligibility of a subject for a treatment, the method comprising:
-receiving a vector of the subject comprising data representing a plurality of symptoms of the subject in a rating scale (Vairavan: para. 51; Providing a quantitative test such as MADRS measuring severity of symptoms and scoring the 10 items.);
-computing an anomaly score based on the vector of the subject and a plurality of vectors representing rating scales of other subjects (Vairavan: para. 74; Analyze the test feature data to generate an anomaly score. The score compared to training data, which includes population data (para. 69));
-based on the anomaly score, ranking the subject with a likelihood of contributing to a subgroup of patients having a common element structure of the rating scale (Vairavan: para. 48; Quantifiable measure to a likelihood of depression.); and
-enriching a study population in a clinical trial based on the anomaly score prior to randomization, the enriched study population having a reduced heterogeneity relative to information collected in the clinical trial (Vairavan: para. 89-92; Analyze the data to determine onset of relapse of depression. Analyzing data from survey questions scoring.);
-treating the subject based on the anomaly score, wherein treating the subject comprises administering a drug or therapy of the disease or condition to the subject (Vairavan: para. 93; Following the determination from scoring, the processor determines treatment. Output a signal adjusting the treatment.).
As per claim 5, the method of claim 1 is as described. Vairavan teaches further comprising: improving a clinical dataset by employing the enriched study population.
As per claim 6, the method of claim 1 is as described. Vairavan teaches wherein enriching the study population includes verifying a diagnosis of the subject based on the anomaly score (Vairavan: para. 89-92; Analyze the data to determine onset of relapse of depression. Analyzing data from survey questions scoring.).
As per claim 7, the method of claim 1 is as described. Vairavan teaches wherein enriching the study population includes identifying the subject as an outlier compared to the subgroup of patients based on the anomaly score (Vairavan: para. 48; para. 72-74; para. 77; Detect anomaly.).
As per claim 8, the method of claim 1 is as described. Vairavan teaches wherein the plurality of symptoms is of a disease or condition, the method further comprising: treating the subject having the disease or condition based on the anomaly score (Vairavan: para. 93).
98. (Previously presented) The method of Claim 6, wherein verifying the diagnosis of the subject based on the anomaly score comprises in response to determining that the anomaly score is within a tolerable range, confirming the diagnosis (Vairavan: para. 91-92).
99. (Previously presented) The method of Claim 7, wherein determining the subject is not an outlier compared to the subgroup of patients based on the anomaly score comprises in response to determining that the anomaly score is within a tolerable range, determining the subject is not an outlier compared to the subgroup of patients based on the anomaly score (Vairavan: para. 111).
100. (New) The method of Claim 1, wherein the disease or condition comprises at least one of bipolar disorder, depression, or schizophrenia (Vairavan: abstract), and treating the subject comprises administering a therapeutically effective amount of a therapeutic agent to the subject to treat the at least one of bipolar disorder, depression, or schizophrenia (Vairavan: para. 93; Following the determination from scoring, the processor determines treatment. Output a signal adjusting the treatment.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Vairavan et al. (WO 2022/008523 A1) in view of Matyska et al. (EP 3451219 A1).
As per claim 2, the method of claim 1 is as described. Vairavan does not explicitly teach the following, however, Matyska teaches wherein computing the anomaly score is based on determining a path length from a starting node to an ending node of a binary tree grown generated from the vector of the subject and the plurality of vectors of the other subjects (Matyska: para. 55; Determining the path length by counting the number of edges from the root to the leaf node on a tree.).
One of ordinary skill in the art would have recognized that applying the known technique of Matyska would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Matyska to the teachings of Vairavan would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying specific determination for anomaly score to Vairavan teaching another way of calculating an anomaly score would have been recognized by those of ordinary skill in the art as resulting in an improved system that would provide a more accurate way of determining clinical trial subjects (Matyska: para. 8).
As per claim 3, the method of claim 2 is as described. Vairavan does not explicitly teach the following, however, Matyska teaches wherein the starting node is a root node and the ending node is a terminal external node (Matyska: para. 55; Determining the path length by counting the number of edges from the root to the leaf node on a tree.).
The motivation to combine is same as claim 2.
As per claim 4, the method of claim 3 is as described. Vairavan does not explicitly teach the following, however, Matyska teaches wherein the binary tree is an element of an isolation forest (Matyska: para. 55; para. 22).
The motivation to combine is same as claim 2.
Response to Arguments
Applicant's arguments filed 2/2/2026 for claims 1-8 and 98-100 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues that treating the subject based on the anomaly score cannot be performed mentally. When considering if a particular treatment and prophylaxis is considered a practical application under Step 2A Prong Two, Examiner considered the factors presented in MPEP § 2106.04(d)(2).• Factor A. The treatment plan determined from the abstract idea is not "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). Here, the treatment delivered is not specified. The determined treatment that is delivered is never specifically provided with dosage, frequency, etc., and the treatment device (not claimed) is never automatically started (only configured to deliver a treatment). • Factor B. The treatment limitation does not have a significant relationship to the judicial exception – that is it does not integrate the law of nature into a practical application. As stated above, because the delivered treatment type is not defined, any possible treatment could not reasonably be considered known in the art as a treatment. • Factor C. The treatment or prophylaxis limitation does not impose meaningful limits on the judicial exception and is only extra-solution activity or a field-of-use (see MPEP § 2106.05(g))). The administering step according to a generated treatment plan is well known, nominally related to the inventive concept of creating the treatment plan, and amount to necessary data output similar to that of In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016). The step does not add a meaningful limitation to the process of determining a treatment plan for a patient.Therefore, the claims only recite the prophylactic step as a tool which only serves to as insignificant post solution activity (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception.
In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration.
Applicant's arguments filed for claims 1-8 and 98-100 under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues that Vairavan teaches that the trained anomaly detector is personalized to each individual patient and does not teach computing an anomaly score based on comparison between the vector of the subject and plurality of vectors representing rating scales of other subjects. Examiner disagrees with the interpretation of Vairavan by the Applicant and emphasizes that Vairavan teaches in para. 52 evaluating a patient using CGI-S scale for rating the patient’s illness relative to patients who have the same diagnosis and treatment, therefore, teaching a plurality of vectors representing rating scales of other subjects.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kozloski et al. – U.S. Publication No. 2019/0362817 – Teaches a system for determining participation of an entity within a clinical trial.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3681