Part 3
This is the third post in a 3-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 49, Claim 1 includes a likely split-actor issue, because the entities collecting the sample, identifying the high risk/weighted score, and administering the treatment are not 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. Depending on the condition’s severity and the timing of the diagnosis, treatment can include lifestyle adjustments, pharmaceutical eye drops, laser eye surgery, or drainage device implants to facilitate healthy drainage. While newer drainage devices, such as microstents, are more comfortable than earlier drainage devices, post-surgery scarring and inflammation due to fibrosis remain issues. Commonly prescribed anti-fibrotic drugs, such as drug A, can reduce scarring but do so non-specifically while causing more inflammation (“post-implantation inflammation” or “PI”) that further damages the eye.
The disclosed invention comprises a machine learning model (ezAI model) that is trained on genome-wide association studies and single-nucleotide polymorphisms (SNPs) to generate a weighted polygenic risk score (PRS). The patient at high risk of PI has a weighted PRS in the top quartile of PRS values when ranked against reference PRS values. 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 § 2106.03, the analysis determines whether the claim falls within any statutory category, including processes, machines, manufactures, and compositions of matter. Here, the claim recites steps of determining the patient’s risk for a condition, and thus claim 1 is a process. (Step 1: YES).
Step 2A, Prong One: Under MPEP § 2106.04(II), the claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Here, Claim Element (b) recites a “mental process” of comparing a patient’s score against known top-quartile scores, a “law of nature” because it describes the naturally occurring relationship between a patient’s genotype (a particular combination of genes giving rise to PI) and phenotype (risk for PI), and also a “mathematical calculation” to generate a weighted risk score (multiplication to weight alleles by their effect sizes and addition to sum the weighted values). Claim Element (b) recites multiple abstract ideas. (Step 2A Prong One: YES).
Step 2A, Prong Two: Under MPEP § 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. Here, Claim Element (a) recites the additional elements of “collecting” and of “genotyping a sample from a glaucoma patient to provide a genotype dataset,” which are insignificant extra-solution activities that amount to mere data gathering incidental to limitation (b). The additional element of “genotyping” also represents mere data gathering (a set of genotypes from the collected sample) because all uses of the judicial exception require genotyping the collected sample. Claim Element (c) recites the additional element of “administering an appropriate treatment to the glaucoma patient at high risk of PI” but does not provide any information as to how the patient is to be treated or what the treatment is, but instead covers any possible treatment that a medical professional decides to administer to the patient. As such, there are no meaningful constraints on the administering step such that the particular treatment or prophylaxis consideration would apply because it is not limited to any particular manner or type of treatment. See MPEP 2106.04(d)(2). Step 2A Prong Two also fails.
Then again, the focus on treatment application as the practical application may 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 § 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. Generally, as a practice tip takeaway, if the claim cannot provide a “practical application” of the abstract idea, it cannot provide “significantly more” than the abstract idea. Indeed, most of the claim features are examples of an “insignificant extra-solution activity” in Step 2A, Prong Two, thus, the analysis for eligibility also fails in Step 2B. (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. Also, when initially drafting the application, ensure that the technical improvement of the invention is described in the specification and explicitly recited in the claim.[1] As noted above, there may be an argument that the recited judicial exception is integrated into a practical application if the characterization that Claim Element (b) recites a mental process can be overcome.
Key Takeaway for Claim 2: Example 49, Claim 2 is eligible by adding a “wherein” clause that limits the “appropriate treatment” to a particular compound. The same potential split-actor issues are present, as discussed in Claim 1.
Claim 2. The method of claim 1, wherein the appropriate treatment is Compound X eye drops.
Background for Claim 2:
See claim 1.
SME Holding for Claim 2:
Claim 2 is eligible. See the analysis above for Step 1 and Step 2A, Prong One.
Step 2A, Prong Two: Under MPEP § 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. Here, claim 2 recites the additional element of “the appropriate treatment is Compound X eye drops” for Claim Element (c). This qualifies as a “practical application” of the abstract idea(s). For example, the claim limits the patient as belonging to a specific patient population (glaucoma patients at high risk of PI), and the patient is then administered a treatment (Compound X eye drops instead of any common anti-fibrotic treatment, such as drug A, after microstent implant surgery) that is particular to that specific patient population (glaucoma patients at high risk of PI). MPEP 2106.04(d)(2). (Step 2A, Prong Two: YES). Therefore, the claim is not directed to a judicial exception. (Step 2A: NO). The claim is eligible.
Applicant’s Sample Response to a Section 101 Rejection of Claim 3:
Step 1: Under MPEP § 2106.03, the analysis determines whether the claim falls within any statutory category, including processes, machines, manufactures, and compositions of matter. Here, the claim recites a “post-surgical fibrosis treatment method” and, therefore, is a process.
Step 2A, Prong One: Under MPEP § 2106.04(II), the analysis determines whether the claim recites a judicial exception. The claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Here, the Office Action alleges that the claim recites a mental process, a law of nature, and/or a mathematical calculation. In contrast to the Office Action’s assertion, claim 2 is directed to non-abstract steps performed on a specific 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 § 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. Here, claim 2 recites administering “the appropriate treatment is Compound X eye drops” for Claim Element (c) of claim 1. This qualifies as a “practical application” of the abstract idea(s). For example, the claim limits the patient as belonging to a specific patient population (glaucoma patients at high risk of PI), and the patient is then administered a treatment (Compound X eye drops instead of any standard anti-fibrotic treatment, such as drug A, after microstent implant surgery) that is particular to that specific patient population (glaucoma patients at high risk of PI). These steps reflect the improvement described in the background. Thus, the claim as a whole integrates the judicial exception into a practical application such that the claim is not directed to the judicial exception (Step 2A, Prong Two: YES). The claim is eligible under Step 2A Prong Two and the analysis does not proceed to Step 2B.
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About the Authors:
Melissa Patterson focuses on the preparation and prosecution of patent applications, licensing, and litigation, particularly in innovative technologies such as software, computer and mechanical devices, AR/VR headsets, mobile communications, artificial intelligence, robotics, blockchain, insurance, healthcare records management, geophysical management, automotive technologies, and financial networks. She has successfully prosecuted over 1,000 U.S. and international patent matters, collaborating extensively with foreign counsel.
Hector Agdeppa focuses his practice on intellectual property law, particularly preparing and prosecuting patent applications. With extensive experience in electrical, mechanical, and computer software arts, as well as medical device innovation, He leverages his industry knowledge to guide clients through patent portfolio management and, when desired, monetization strategies.
Mark Catanese is a patent prosecution attorney in Dickinson Wright San Diego office. His practice focuses on the preparation and prosecution of patent applications for a diverse clientele, ranging from startups to Fortune 500 companies. His experience spans consumer electronics, wireless communications, satellite technologies, computer hardware and software, machine learning and artificial intelligence, robotic systems, LED and LCDs display technologies, augmented and virtual reality, optical systems, semiconductor devices, medical devices, and automotive systems.
[1] There may be an argument against a mental concept ground of rejection. The SME Holding for Claim 1 appears to contradict how examiners should consider whether a claim recites a mathematical concept, and possibly misconstrues Claim 1’s practical application. MPEP § 2106.04(a)(2) indicates that “… examiners should consider whether the claim recites a mathematical concept or merely limitations that are based on or involve a mathematical concept. A claim does not recite a mathematical concept (i.e., the claim limitations do not fall within the mathematical concept grouping), if it is only based on or involves a mathematical concept. See, e.g., Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902-03 (Fed. Cir. 2017)….” Here, although the mathematical concepts of multiplication and addition are recited in the claim, there may be an argument that Claim 1, nevertheless, merely involves/is based on a mathematical concept.