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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/31/2026 has been entered and considered. Rejections and/or objections not reiterated from the previous Office action mailed 05/01/2026 are hereby withdrawn.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 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 are pending and under consideration in this action. Claims 11-16, 19-21, 23-27, 31, 33-34, and 38 were previously canceled.
Priority
The instant application is a 371 of PCT/IB2020/060331, filed 11/4/2020, which claims priority to Australian Application Number 2019904145, filed 11/4/2019, as reflected in the filing receipt mailed on 8/23/2022. 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 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 is 11/4/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/31/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner. A signed copy is included with this Office action.
Claim Objections
Claims 39 is objected to because of the following informalities:
Claim 39 recites the limitation “wherein the microscope-derived measurements comprises transmitted light measurements and/or fluorescence measurements”, which should be corrected to “wherein the microscope-derived measurements comprise transmitted light measurements and/or fluorescence measurements” to include appropriate grammar.
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 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 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 1 recites the limitations “predict the mode of action of the candidate compound based on the nature and/or magnitude of the phenotypic response” and “store, in a computer-readable memory, data representing the phenotypic profile and the determined mode of action and/or potency for the candidate compound” in steps (vii) and (viii) of the claim, respectively. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. Both the preamble (“a method of screening candidate compounds…”) and step (i) (“contacting a plurality of different candidate compounds…”) recite a plurality of candidate compounds. Steps (vii) and (viii) recite “the candidate compound”, indicating one of the plurality of compounds. However, steps (iii)-(vi) do not appear to limit the candidate compounds to just one of the plurality of compounds. This rejection can be overcome by amendment of claim 1 to clarify the selection of a single candidate compound recited in steps (vii) and (viii), or similarly amend steps (vii) and (viii) to recite “predict the mode of action of each candidate compound based on the nature and/or magnitude of the phenotypic response” and “store, in a computer-readable memory, data representing the phenotypic profile and the determined mode of action and/or potency for each candidate compound”, respectively. Claims 2-10, 17-18, 22, 28-30, 32, 35-37 and 39 are also rejected due to their dependency on claim 1.
Claim 17 recites the limitation “wherein step (ii) comprises comparing phenotypes of the test samples to phenotypes of positive control samples contacted with known herbicidal or plant growth regulator compounds and further comprises comparing phenotypes of the test samples to phenotypes of negative control samples not contacted with known herbicidal or plant growth regulator compounds”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. Step (ii) of claim 1, to which claim 17 depends, recites “obtaining, using an imagining system, image data comprising microscope-derived measurements and/or micrographs of test samples and control samples…”. Claim 1 also recites generating a phenotypic profile for each test sample in step (iv) and subsequent comparison of test sample phenotypic profiles with control sample phenotypic profiles in step (v). It appears that claim 17 further limits the phenotypic profile generation and comparison in steps (iv) and (v) of claim 1, and not the image data generated in step (ii); however, clarification is respectfully requested. This rejection can be overcome by amendment of claim 17 to clarify which step in claim 1 is limited by the recitations in claim 17. Claim 18 is also rejected due to its dependency on claim 1.
Claim 28 recites the limitation “wherein the method further comprises step (iii) of: (a)-(f)”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. Claim 1, to which claim 28 depends, already recites steps (i)-(viii). It is unclear whether step (iii), recited in claim 28, is intended to occur after steps (i)-(viii) of claim 1, or if step (iii) is intended to further limit one of steps (i)-(viii) recited in claim 1. Examiner also notes that steps (i) and (ii) in step (a) of claim 28 should also be renumbered accordingly. This rejection can be overcome by amendment of claim 28 to clarify the step numbering. Claims 29-30, 32, and 35-37 are also rejected due to their dependency on claim 28.
Claim 37 recites “the method according to claim 28, wherein step (iii) is implemented using a computer”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. First, as indicated for claim 28 above, it is unclear when step (iii) of claim 28 occurs in the method of claim 1. Additionally, claim 1 requires steps (iii)-(viii) to be implemented on a computer. Since it is unclear where step (iii) of claim 28 falls in the method of claim 1, it is therefore unclear whether the method of claim 28 is already computer-implemented. This rejection can be overcome by amendment of claim 37 to clarify step (iii) of claim 28 and its required computer-implementation.
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 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Framework with which to evaluate Subject Matter Eligibility as outlined in MPEP § 2106:
Step 1: Are the claims directed to a process, machine, manufacture or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework as it pertains to the instant claims:
Step 1:
In the instant application, claims 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 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 mental process (i.e., an evaluation of the image to extract measurements/features) in “(iii) extract, by a processor, a plurality of measurements and/or features from the image data”; a mental process (i.e., an evaluation of the features to generate a phenotypic profile) in “(iv) generate, by the processor, a phenotypic profile for each test sample from the extracted measurements or features, the phenotypic profile including a plurality of morphological and physiological characteristics of the test sample”; a mental process (i.e., a comparison of phenotypic profile data to a control) in “(v) compare the phenotypic profile of each test sample with a phenotypic profile generated from the control samples”; mental process (i.e., an evaluation of comparison data to determine type/magnitude of phenotypic response) in “(vi) determine, based on the comparison, the nature and/or magnitude of the phenotypic response, wherein the nature and/or magnitude of the phenotypic response is indicative of a mode of action and/or potency of herbicidal activity and/or herbicidal or plant growth regulating activity”; a mental process (i.e., an evaluation of the nature/magnitude of the phenotypic response) in “predict the mode of action of the candidate compound based on the nature and/or magnitude of the phenotypic response”; and a mental process (i.e., an observation of the types of test or control samples) in “wherein the test samples and the control samples comprise whole-plants, spores, sporelings, explants, protoplasts or vegetative propagules”.
Claim 2 recites a mental process (i.e., an evaluation of the candidate compounds) in “wherein the candidate compounds are candidate compounds for herbicidal activity”.
Claim 3 recites a mental process (i.e., an observation of the type of non-vascular plant) in “wherein the nonvascular plant is a moss, hornwort or liverwort”.
Claim 4 recites a mental process (i.e., an observation of the types of samples) in “wherein the test samples and control samples are sporelings”.
Claim 5 recites a mental process (i.e., an evaluation of the species of the sporeling samples) in “wherein the test samples and control samples originate from spores of a same species of non-vascular plant”.
Claim 6 recites a mental process (i.e., an observation of the type of sporeling) in “wherein the test samples comprise are moss sporelings, liverwort sporelings, hornwort sporelings, or any combination thereof”.
Claim 9 recites a mental process (i.e., an observation of the type of test/control samples) in “wherein the test samples and control samples are leafy liverwort sporelings, simple thalloid liverwort sporelings, complex thalloid liverwort sporelings, or any combination thereof”.
Claim 10 recites a mental process (i.e., an observation of the type of test/control samples) in “wherein the test samples and control samples are selected from the group consisting of: Marchantia alpestris sporelings … Marchantia nepalensis, and any combination thereof”.
Claim 17 recites a mental process (i.e., an evaluation/comparison of phenotypes with positive and negative controls) in “wherein step (ii) comprises comparing phenotypes of the test samples to phenotypes of positive control samples contacted with known herbicidal or plant growth regulator compounds and further comprises comparing phenotypes of the test samples to phenotypes of negative control samples not contacted with known herbicidal or plant growth regulator compounds”.
Claim 18 recites a mental process (i.e., an evaluation/comparison of phenotypes and comparison to compounds with a known mode of action) in “wherein the known herbicidal compounds have a known mode of action, and said comparing of test sample phenotypes to positive control sample phenotypes is used to predict the mode of action of a candidate compound identified to have herbicidal or plant growth regulating activity”.
Claim 28 recites a mental process (i.e., an evaluation of the differences in the two sets of mismatches) in “filtering the first set of mismatches with respect to the second set of mismatches to identify a first subset of mismatches that are unique to the first set of mismatches, wherein the first subset of mismatches are candidate mutations that may confer resistance to herbicides or to plant growth regulators”; and a mental process (i.e., an observation of the contact results of comparison sample, and an evaluation of the genus for the samples) in “wherein the first comparison sample is from an independent sample that does not survive contacting with the candidate compound or which exhibits growth abnormalities after contacting the candidate compound, and is of the same genus as the resistant mutagenized sample, and wherein the reference DNA sequence is a known reference sequence of a plant of said genus”.
Claim 29 recites a mental process (i.e., an evaluation of the differences in two sets of mismatches) in “filtering the first set of mismatches with respect to the third set of mismatches to facilitate identification of a second subset of mismatches that are unique to the first set of mismatches, and generating a third subset of mismatches by filtering the first subset of mismatches with respect to the second subset of mismatches, wherein the first and second subsets of mismatches are candidate mutations that may confer resistance to herbicides or resistance to plant growth regulators”; and a mental process (i.e., an observation of the contact results of comparison sample, and an evaluation of the genus for the samples) in “wherein the second comparison sample is from an independent sample that does not survive contacting with the candidate compound or which exhibits growth abnormalities after contacting the candidate compound, and is of the same genus as the mutagenized samples”.
Claim 30 recites a mental process (i.e., an observation of the mutagenized sample types) in “wherein the mutagenized samples are the same plant population (M1 samples)”.
Claim 32 recites a mental process (i.e., an observation/evaluation of the method steps) in “wherein the method does not comprise a step of segregation analysis, complex segregation analysis or bulk segregation analysis”.
Claim 35 recites a mental process (i.e., an evaluation of the samples) in “wherein the mutagenized samples are haploid”.
Claim 36 recites a mental process (i.e., an evaluation of the mutation and comparison to compounds with herbicidal or plant growth regulating activity) in “wherein the candidate mutations are in a gene encoding a protein that is targeted by the candidate compound identified to have herbicidal or plant growth regulating activity”.
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)), and 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)) that the courts have identified as concepts that can be practically performed in the human mind.
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.
Specifically, claim 1 involves nothing more than extracting features from an image, generating a phenotypic profile with morphological and physiological characteristics, comparing phenotypic profiles with control samples, determining the nature and/or magnitude of the phenotypic response, and predicting the mode of action. Since there are no specifics in the methodology, the steps reciting extracting features from an image, generating a phenotypic profile with morphological and physiological characteristics, comparing phenotypic profiles with control samples, determining the nature and/or magnitude of the phenotypic response, and predicting the mode of action are something that, under the BRI, one could perform mentally. Therefore, the claimed steps are not further defined beyond something that reads on 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 1 recites “contacting a plurality of different candidate compounds with a plurality of test samples from non-vascular plants”; “obtaining, using an imaging system, image data comprising microscope-derived measurements and/or micrographs of the test samples and of control samples from non-vascular plants not contacted with candidate compounds”; “a computer with a processor and memory”; and “store, in a computer-readable memory, data representing the phenotypic profile and the determined mode of action and/or potency for the candidate compound”.
Regarding the above cited limitation in claim 1 of (i) a computer with a processor and memory. This limitation requires only a generic computer component, which does not improve computer technology. Therefore, this limitation equates to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding the above cited limitations in claim 1 of (ii) contacting a plurality of different candidate compounds with a plurality of test samples from non-vascular plants; and (iii) obtaining, using an imaging system, image data comprising microscope-derived measurements and/or micrographs of the test samples and of control samples from non-vascular plants not contacted with candidate compounds. These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before the recited judicial exceptions of extracting features from an image, generating a phenotypic profile with morphological and physiological characteristics, comparing phenotypic profiles with control samples, determining the nature and/or magnitude of the phenotypic response, and predicting the mode of action (see MPEP § 2106.04(d)).
Regarding the above cited limitation in claim 1 of (iv) store, in a computer-readable memory, data representing the phenotypic profile and the determined mode of action and/or potency for the candidate compound. This limitation equates to an extra-solution step of generally outputting a result by storing the data in computer memory, which is incidental to the primary process of generating a phenotypic profile with morphological and physiological characteristics, comparing phenotypic profiles with control samples, determining the nature and/or magnitude of the phenotypic response, and predicting the mode of action for each candidate compound (see MPEP § 2106.05(g)).
Additionally, none of the recited dependent claims recite additional elements which would integrate the judicial exception into a practical application. Specifically, claims 7 and 8 further limit the contacting procedure for the candidate compounds; claim 22 further limits the determination of the phenotypic response by obtaining measurements; claims 28 and 29 further recite steps for extracting, sequencing, and aligning DNA for mutagenized samples, equating to data gathering steps; claim 37 recites generic computer components that equate to mere instructions to implement an abstract idea on a generic computer; and claim 39 further limits the microscope-derived measurements. As such, claims 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 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 claims recite the same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitation in claim 1 of (i) a computer with a processor and memory. This limitation equates to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept (see MPEP § 2106.05(d) and MPEP § 2106.05(f)).
Regarding the above cited limitations in claim 1 of (ii) contacting a plurality of different candidate compounds with a plurality of test samples from non-vascular plants; and (iii) obtaining, using an imaging system, image data comprising microscope-derived measurements and/or micrographs of the test samples and of control samples from non-vascular plants not contacted with candidate compounds. These limitations are considered to be insignificant extra-solution activity of mere data gathering. These steps are incidental to the primary process of generating a phenotypic profile with morphological and physiological characteristics, comparing phenotypic profiles with control samples, determining the nature and/or magnitude of the phenotypic response, and predicting the mode of action for each candidate compound. These limitations are similar to the data gathering recited in In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989) of performing clinical tests on individuals to obtain input for an equation and in In re Meyers, 688 F.2d 789, 794; 215 USPQ 193, 196-97 (CCPA 1982) of testing a system for a response, the response being used to determine system malfunction (see MPEP § 2106.05(g)).
Regarding the above cited limitation in claim 1 of (iv) store, in a computer-readable memory, data representing the phenotypic profile and the determined mode of action and/or potency for the candidate compound. This limitation equates to an extra-solution step of generally outputting a result but storing data in computer memory, which is incidental to the primary process of generating a phenotypic profile with morphological and physiological characteristics, comparing phenotypic profiles with control samples, determining the nature and/or magnitude of the phenotypic response, and predicting the mode of action for each candidate compound. This post solution activity is analogous to the additional element of measuring metabolites of a drug administered to a patient in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012); the post-solution activity of adjusting an alarm limit variable to a figure computed according to a mathematical formula in Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978); and the insignificant application of printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55 (see MPEP § 2106.05(g)).
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 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 are not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 07/31/2026 have been fully considered but they are not persuasive.
1. Applicant argues that under Step 2A, Prong 1, claim 1 is not directed to an abstract idea. The Examiner alleges that claim 1 merely recites a mental process, namely an evaluation/comparison of phenotypes with a control (e.g., see page 6 of the Office Action). Amended claim 1 is directed to a computer-implemented, image-based phenotyping system for high-throughput screening of candidate herbicidal compounds, wherein image data is acquired using an imaging system. The image data includes fluorescence, light-emission data, and/or micrographs. Computational feature extraction is performed by a processor on digital image data. Phenotypic profiles are generated as structured computational representations. The phenotypic profiles are compared using computerized processing. Accordingly, the claim is directed to a specific technological workflow for processing biological imaging data, not to a generalized comparison or mental evaluation (Applicants Remarks, Pg. 9).
It is respectfully submitted that this is not persuasive for the following reasons:
As indicated in Step 2A, Prong One above, several limitations in claim 1 recite mental processes. These mental processes include steps (iii), (iv), (v), (vi), and (vii). Each of steps (iii) through (vii) recites a limitation, that under the broadest reasonable interpretation (BRI), recites a mental process. For example, step (v) of compare the phenotypic profile of each test sample with a phenotypic profile generated from the control samples, equates to a comparison / evaluation of two phenotypic profiles, which is capable of being performed in the human mind, or using a computer as a tool. Step (v) does not include any specifics, for example, that indicate that the comparison of the two phenotypic profiles is not capable of being reasonably performed in the human mind.
Additionally, Applicant indicates that the phenotypic profiles are generated as structured computational representations. However, step (iv) requires the generation of a phenotypic profile with morphological and physiological characteristics, but does not require any specific structured representation of that phenotypic profile. Analogous to the example provided for step (v) above, step (iv) also recites an abstract idea because, under the BRI, the limitation equates to evaluation of extracted features (including the morphological and physiological data), which is a process capable of being performed in the human mind, or using a computer as a tool.
Therefore, claim 1 recites abstract ideas, requiring further analysis under Step 2A, Prong One and Step 2B, and this argument is not persuasive.
2. Applicant also argues that under Step 2A, Prong 2, claim 1 is integrated into a practical application. Here, the Applicant's Specification identifies a particular problem in the technical field of agriculture and herbicide discovery (see Specification, line 34 of page 3 to line 18 of page 4). As such, the Applicant's specification clearly identifies a particular problem in the technical field of agriculture and herbicide discovery. The method uses non-vascular plants, as a miniaturized screening platform, to develop a high-throughput screening method for the identifying candidate compounds for herbicidal activity or plant growth regulating activity. Claim 1 requires the acquisition of image data and the use of an imaging system to generate raw digital biological image datasets. These features tie the claimed method to a specific technological environment as opposed to a generic data analysis context. Further, the claim recites a defined computation workflow including the extraction of measurements or features from image data by a processor, generation of phenotypic profiles and computational comparison of phenotypic profiles between treated and control samples. The Specification describes acquiring data relating to multiple phenotypic variables (sample length, width, shape, pigmentation, chlorophyll concentration, cell count, etc.) and statistical/multivariate analysis (e.g., principal component analysis, clustering) to identify "hits." The method is explicitly described in the Specification as providing a "high-throughput method, which enables rapid, cost-effective, consistent and reproducible screening of a chemical substance under laboratory conditions." The method therefore constitutes a technical image processing pipeline that cannot be considered to be a mental process. The claimed method transforms acquired raw imaging data into structured phenotypic profiles that are representative of characteristics of a biological response. The transformation step of raw image-derived data into structured analytical outputs is reflective of a practical technological application. Claim 1 also requires the storage of the phenotypic profiles and the determined mode of action and/or potency outputs. This further supports the integration of the method into a practical application (Applicant’s Remarks, Pg. 9-12).
It is respectfully submitted that this is not persuasive for the following reasons:
With regards to the acquisition of image data and use of an imaging system to generate raw digital biological image datasets, limitation (ii) is considered to be an insignificant extra-solution activity of mere data gathering under Step 2A, Prong Two, because the gathered image data is used in the computational pipeline to determine phenotypic profiles and predict the mode of action of each candidate compound. Under Step 2B, limitation (ii) is incidental to the primary process of computational pipeline to determine phenotypic profiles and predict the mode of action of each candidate compound. This is analogous to data gathering that the courts have found to be insignificant extra-solution activity (see MPEP § 2106.05(g)). For example, the mere data gathering of performing clinical tests on individuals to obtain input for an equation in In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989) or the data gathering of determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis). As such limitation (ii), reciting the acquisition of image data, does not integrate the method into a practical application.
With regards to the defined computational workflow including the extraction of measurements or features from image data by a processor, generation of phenotypic profiles and computational comparison of phenotypic profiles between treated and control samples (limitations (iii), (iv), and (v)). None of the phenotypic variables, indicated by Applicant on Pg. 11 of Applicant’s Remarks, nor the statistical/multivariate analysis is required by limitations (iii)-(v).
MPEP § 2106.04(d)(II) recites:
The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).
Additionally, as described in Step 2A, Prong One and argument (1) above, limitations (iii), (iv), and (v) have been identified as judicial exceptions (mental processes). The integration of a judicial exception into a practical application can only be achieved by additional elements, not by a limitation that recites a judicial exception. Thus, the recited limitations are not considered as an improvement in the technical image processing pipeline for non-vascular plants using a miniaturized screening platform.
With regards to the transformation of acquired raw imaging data into structured phenotypic profiles that are representative of characteristics of a biological response. Analogous to argument (1) above, none of steps (iii) through (viii) require a specific “structured phenotypic profile”, as indicated by Applicant on Pg. 11 of Applicant’s Remarks.
MPEP § 2106.05(c) recites:
An "article" includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified. "Transformation" of an article means that the "article" has changed to a different state or thing. Changing to a different state or thing usually means more than simply using an article or changing the location of an article. A new or different function or use can be evidence that an article has been transformed. Purely mental processes in which thoughts or human based actions are "changed" are not considered an eligible transformation. For data, mere "manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been deemed a transformation. CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360, 31 USPQ2d 1754, 1755, 1759 (Fed. Cir. 1994)).
Additionally, the acquired image data is not a particular transformation to a different state or thing. The acquired image data is analyzed in a series of steps (i.e., limitations (iii)-(vii)) that equate to mental processes (see argument (1) above). Steps that recite mental processes are not considered an eligible transformation (see MPEP § 2106.05(c)). As such, the phenotypic profile is not reflective of a practical application.
With regards to the storage of phenotypic profiles and determined mode of action and/or potency outputs (limitation (viii)). Under Step 2A, Prong Two, this limitation equates to an extra-solution step of generally outputting a result by storing the data in computer memory. Under Step 2B, limitation (viii) equates to a post solution activity analogous to the additional element of measuring metabolites of a drug administered to a patient in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012); and the insignificant application of printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55 (see MPEP § 2106.05(g)).
MPEP 2106.05(a)(I) recites:
"In computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016). In Enfish, the court evaluated the patent eligibility of claims related to a self-referential database. Id. The court concluded the claims were not directed to an abstract idea, but rather an improvement to computer functionality. Id. It was the specification's discussion of the prior art and how the invention improved the way the computer stores and retrieves data in memory in combination with the specific data structure recited in the claims that demonstrated eligibility. 822 F.3d at 1339, 118 USPQ2d at 1691. The claim was not simply the addition of general purpose computers added post-hoc to an abstract idea, but a specific implementation of a solution to a problem in the software arts. 822 F.3d at 1339, 118 USPQ2d at 1691."
Furthermore, no evidence has been presented to suggest that the computer itself has been altered in any way, i.e., by changing the functioning of a processor or by changing the way in which it stores or accesses memory. Nothing about the physical components of the computer nor the way the computer operates is changed by the limitations in claim 1. Therefore, the use of a computer to store phenotypic profiles and the determined mode of action and/or potency outputs invokes a computer as a tool (see MPEP 2106.05(a)(I)).
Therefore, the additional elements in claim 1 do not integrate the judicial exceptions into a practical application. This argument is thus not persuasive.
3. Applicant also argues that the claim includes an inventive concept under Step 2B. The claimed method does not merely observe plant phenotypes. Instead, it employs automated extraction of image-derived features and generation of phenotypic profiles from imaging data. The claim also requires the computational comparison of profile-level representations across test and control samples. This methodology is distinct from conventional manual scoring or visual inspection techniques used in prior herbicidal screening methods. The technology also provides an improvement in how biological image data is processed by converting raw imaging signals into structured phenotypic profiles, and enabling computational comparison at the profile level rather than subjective visual interpretation. This constitutes an improvement to computer-implemented image analysis technology, not merely an abstract idea implemented on a computer (Applicant’s Remarks, Pg. 12).
It is respectfully submitted that this is not persuasive for the following reasons:
As described in argument (1) above, the automated extraction of image-derived features and generation of phenotypic profiles from imaging data (limitations (iii) and (iv)) recite abstract ideas. Similarly, the computational comparison of profile-level representations across test and control samples (limitation (v)) also recites an abstract idea. While the methodology may be distinct from conventional approaches used in prior herbicidal screening methods, only additional elements are considered for recitation of an inventive concept that provides significantly more than the judicial exceptions (mental processes).
Additionally, with regards to how biological image data is processed by converting raw imaging signals into structured phenotypic profiles, and enabling computational comparison at the profile level rather than subjective visual interpretation. As described in arguments (1) and (2) above, the claim does not require a structured phenotypic profile, instead only requiring the generation of a phenotypic profile. Additionally, the image data conversion and computational comparison (limitations (iii) and (iv)) recite abstract ideas, and are therefore not considered improvement to computer-implemented image analysis technology. Therefore, claim 1 does not recite additional elements that comprise an inventive concept to transform the claimed judicial exceptions into a patent-eligible application. This argument is thus not persuasive.
Conclusion
No claims allowed.
Claims 1-10, 17-18, 22, 28-30, 32, 35-37, and 39 appear to be free from the prior art because the prior art does not fairly suggest or teach the analysis of image data to determine a phenotypic profile including both morphological and physiological characteristics for prediction of a mode of action of a candidate compound. The closest prior art is as follows:
Hester et al. (IR-4 Ornamental Horticulture Program Liverwort Efficacy Study. Rutgers University, New Brunswick, NJ, USA. Retrieved from: https://www.ir4project.org/ehc/liverwort-efficacy-summary-2012/; published 3/28/2012; previously cited). Hester et al. teaches a method to evaluate several treatments for post-emergent control of liverworts (non-vascular plants) including contacting compounds with foliage to evaluate treatment efficacy and phenotypic responses based on a visual evaluation (Abstract; Pg. 6, Para. 1; Pg. 7, Para. 1 and Pg. 7, Table 1; Pg. 7, Para. 2; Pg. 21, Para. 1; and Pg. 29, Table 30). However, Hester et al. does not teach the extraction of features from image data and subsequent analysis to determine a mode of action, as disclosed in instant claim 1.
Kaiser et al. (Chlorophyll fluorescence imaging: a new method for rapid detection of herbicide resistance in Alopecurus myosuroides. Weed Research. 53(6): 399-406 (2013); published 8/26/2013; previously cited). Kaiser et al. teaches the use of fluorescence imaging with different herbicides and dosages to determine modes of action in Alopecurus myosuroides (a vascular plant) as well as the comparison to untreated control samples (Abstract; Pg. 400, Col. 2, Para. 1; and Pg. 401, Col. 1, Para. 2). Kaiser et al. further teaches the analysis of the images includes generation of dose-response curves (i.e., a physiological characteristic), thereby determining a mode of action (Abstract). However, Kaiser et al. does not teach the analysis of non-vascular plants nor that the phenotypic profile extracted from the image data includes both morphological and physiological characteristics of the test sample.
Rodriguez-Furlan et al. (High throughput selection of novel plant growth regulators: Assessing the translatability of small bioactive molecules from Arabidopsis to crops. Plant Science. 245: 50-60 (2016); published 04/2016; newly recited). Rodriguez-Furlan et al. discloses a high throughput screening approach using Arabidopsis (a vascular plant) as a model system for screening 10,000 diverse compounds as plant growth regulators (Abstract). The screening process includes microscope-well imaging to analyze morphological features compared to controls to analyze growth phenotypes (Pg. 52, Fig. 1 and Pg. 53, Fig. 2). However, Rodriguez-Furlan et al. does not teach the analysis of non-vascular plants nor that the phenotypic profile extracted from the image data also includes physiological characteristics to predict the mode of action of a candidate compound.
Claims 2-10, 17-18, 22, 28-30, 32, 35-37, and 39 appear to be free from the prior art due to their dependency on claim 1.
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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687
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