Dickinson Wright
Part 3
This post is the third in a three-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment.
Example 49. Fibrosis Treatment
Key takeaway for Claim 1.
Example 29, Claim 1, includes a split-actor problem, because the entities that collect the sample, identify the high risk/weighted scores, and administer the treatment aren’t necessarily the same. Although the comparison between Claim 1 and Claim 2 clearly shows the feature that would make the claim patent-eligible, Example 49 may not have much value in real-world patent applications.Claim 1. A post-surgical fibrosis treatment method comprising:
(a) collecting and genotyping a sample from a glaucoma patient to a provide a genotype dataset;
(b) identifying the glaucoma patient as at high risk of post-implantation inflammation (PI) based on a weighted polygenic risk score that is generated from informative single-nucleotide polymorphisms (SNPs) in the genotype dataset by an ezAI model that uses multiplication to weight corresponding alleles in the dataset by their effect sizes and addition to sum the weighted values to provide the score; and
(c) administering an appropriate treatment to the glaucoma patient at high risk of PI after microstent implant surgery.
Background for Claim 1:
Glaucoma is a medical condition that is caused by poor drainage of aqueous humor from the eye. Treatment options vary depending on the severity of the condition and the timing at which it was diagnosed. They can include lifestyle changes, pharmaceutical eye drops or laser eye surgery. Although newer drainage devices such as microstents are more comfortable, scarring and inflammation caused by fibrosis still remain a problem. The disclosed invention comprises a machine-learning model (ezAI) that is trained using genome-wide associations studies and single-nucleotide-polymorphisms to generate a polygenic risk score. When compared to reference PRS values, the patient at high-risk of PI will have a weighted score that is in the top quartile. Based on this output/ranking, the treatment of PI is customized for the patient to lead to better prognosis after implant surgery.
SME Holding for Claim 1:
Claim 1 is ineligible.Step 1: Under MPEP SS 2106.03, the analysis determines whether the claim falls within any statutory category, including processes, machines, manufactures, and compositions of matter. The claim cites steps to determine the patient’s risks for a condition. Therefore, claim 1 is a procedure. Step 2A, Prong 1: Under MPEP 2106.04(II), a claim “recites a judicial exemption” when the exception is “set forth” (described) in the claim. Claim Element b) cites a “mental procedure” of comparing a score of a patient with known top-quartile values, a ‘law of nature’ because it describes a naturally occurring relationship between a person’s genotype and phenotype, and also a’mathematical calculation’ to generate a ‘weighted risk score’ (multiplication of alleles to weight them by their effect sizes, and addition to add the weighted value sum). Claim Element b contains multiple abstract ideas. (Step 1A: YES).
Step 2, Prong 2: Under MPEP SS 210604(d), it is determined whether the claim as an entire integrates the judicial exemption into a practical application or whether the claims are “directed at” the exception. Here, Claim Element a) cites the additional elements “collecting” a sample from an glaucoma patients to provide a “genotype dataset,” which are minor extra-solution activities that are merely data gathering incidental of limitation (b). The “genotyping element” is also a mere data gathering activity (a set genotypes derived from the collected samples) because all uses for the judicial exemption require genotyping of the collected samples. Claim Element c) cites the additional element “administering a suitable treatment to a glaucoma patients at high risk of PI”, but does not specify how the patient will be treated, or what treatment they are to receive. Instead, it covers any treatment that a doctor decides to give to the patient. There are no meaningful restrictions on the administering steps such that a particular treatment or prophylaxis would apply, because it does not limit the treatment to a particular type or manner. MPEP 2106.04(d). The focus on the treatment application as a practical application could be misplaced. That is, and as discussed in the background for claim one, the specification appears to explicitly note that “determining patient risk using a weighted PRS as disclosed and accordingly customizing treatment lends to better prognosis after implant surgery.” Thus, Claim Element (b)’s recitation of “identifying the glaucoma patient as at high risk of post-implantation inflammation” is arguably a practical application.
However, as noted above in the analysis of Step 2A, Prong One, Claim Element (b) is characterized as reciting a “mental process.” As such, one would have to argue against the characterization of Claim Element (b) as reciting a “mental process” before relying on the claim element as a practical application. For example, while the background does not provide details, arguments that the operations of “identifying the glaucoma patient as at high risk of post-implantation inflammation” cannot practically be performed by the human mind may overcome the characterization.
Step 2B: Under MPEP SS 2106.05, the analysis evaluates whether the claim as a whole amounts to “significantly more” than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. As a general practice tip, if a claim cannot provide a “practical application” of an abstract idea, then it cannot provide “significantly more” than the abstract concept. (Step 2B: NO).
Applicant’s Sample Response to a Section 101 Rejection of Claim 1:
Respond to the rejection with claim amendments that add the feature from Example 49, Claim 2. (Step 2B: NO).
Applicant’s Sample Response to a Section 101 Rejection of Claim 1:
Respond to the rejection with claim amendments that add the feature from Example 49, Claim 2. Claim 2: The key takeaway is that Example 49, Claim 2 can be made eligible by adding an “wherein” clause which limits the “appropriate treatments” to a specific compound. Claim 2 has the same split-actor potential issues as Claim 1.
. The method of claim 1, wherein the appropriate treatment is Compound X eye drops.
Background for Claim 2:[1]See claim 1.
SME Holding for Claim 2:Claim 2 is eligible. The analysis for Step 1 and 2A, prong one is shown above. Here, claim 2 cites the additional element “the appropriate treatment is compound X eyedrops” for Claim Element c. This is a “practical implementation” of the abstract ideas. The claim may limit the patient to a certain patient population, for example, glaucoma sufferers at high-risk of PI, and then prescribe a treatment (Compound X drops instead of any anti-fibrotic drug, such as Drug A, after microstent surgery) that is specific to this specific patient group (glaucoma sufferers at high-risk of PI). MPEP 2106.04 (d)(2). (Step 2A: Prong Two is YES). The claim is therefore not directed at a judicial exemption. (Step 2A: NO). The claim is eligible.
Applicant’s Sample Response to a Section 101 Rejection of Claim 3:
Step 1: Under MPEP SS 2106.03, the analysis determines whether the claim falls within any statutory category, including processes, machines, manufactures, and compositions of matter. The claim cites a “post surgical fibrosis” treatment method and is, therefore, a process. The claim “recites a judicial exemption” when the judicial exclusion is “set forth” in the claim. The Office Action claims that the claim cites a mental process or a law of the nature and/or a mathematic calculation. Claim 2 is not abstract, contrary to the Office Action. It is a claim that relates to a non-abstract step performed on a particular computing device. However, even if the Office holds that the claims fall within an abstract idea, as discussed below regarding Step 2A, Prong Two, the claim integrates the recited judicial exception into a practical application.
Step 2A, Prong Two: Under MPEP SS 2106.04(d), the analysis determines whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is “directed to” the judicial exception. In this case, claim 2 states that “the appropriate treatment for Claim Element c) of claim 1 is compound X eyedrops”. This is a “practical implementation” of the abstract concept(s). The claim may limit the patient to a certain patient population, for example, glaucoma sufferers at high-risk of PI, and then prescribe a treatment (Compound X drops instead of standard antifibrotic treatments, such as Drug A, after microstent surgery) that is specific to this patient population. These steps reflect the background improvement. The claim as a unit integrates the judicial exemption into a practical application, such that it is not directed at the judicial (Step 2A Prong Two: Yes). The claim is eligible for Step 2A, Prong Two. The analysis does not continue to Step 2B. The SME Holding on Claim 1 seems to contradict how examiners are supposed to determine whether a claim recites a mathematical concept and may misinterpret Claim 1’s application. MPEP SS 210604(a)(2) states that “… Examiners should determine whether the claim recites a mathematical idea or merely limitations based on or involving a mathematical idea. If a claim is based on a mathematical idea or involves one, it does not recite that mathematical concept. See, for example, Thales Visionix Inc. v. United States 850 F.3d 1303, 1348-49, and 121 USPQ2d 1902-03(Fed. Cir. 2017 )….” Although the mathematical concepts of addition and multiplication are recited, it may be argued that Claim 1 is based on/involves a mathematical concept.
