Examining Bioinformatics and AI Art Units

Codi Saxon

Monday, November 22, 2021 Overview of Subject Matter Eligibility Issues Personal computer-dependent inventions – particularly in the device learning (ML), bioinformatics, and synthetic intelligence (AI) fields – are susceptible to matter make a difference eligibility issues. Matter make a difference eligibility issues may possibly avert a patent application from remaining […]

Overview of Subject Matter Eligibility Issues

Personal computer-dependent inventions – particularly in the device learning (ML), bioinformatics, and synthetic intelligence (AI) fields – are susceptible to matter make a difference eligibility issues. Matter make a difference eligibility issues may possibly avert a patent application from remaining granted by the United States Patent and Trademark Office environment (USPTO) and could even be asserted to invalidate a patent write-up-grant. Topic issue eligibility troubles involve categorizing the computer system-relevant invention as an summary concept, which incorporates psychological processes (concepts able of becoming done on pen and paper), procedures of arranging human exercise (these as taking care of interactions in between persons), and mathematical ideas.

In modern years, the Federal Circuit has implemented a multi-step check to establish regardless of whether patent statements would endure a topic make any difference eligibility challenge. In some conditions, the Federal Circuit has upheld the validity of statements reciting an summary strategy when the claims combine the summary idea into a simple software or recite supplemental features that total to significantly much more than the abstract notion. Equally, the USPTO implements a comparable multi-move test with various pointers to establish no matter if patent claims in an software will endure a matter issue eligibility rejection. Nonetheless, 101 jurisprudence continues to be unsettled in regards to the key determining conditions and is regularly evolving with new recommendations and emerging situation legislation. As a final result, the destiny of bioinformatics and device mastering-primarily based patents and patent programs remains unsure.

As we beforehand mentioned in Patenting Factors for Artificial Intelligence in Biotech and Artificial Biology Section 1, pc-centered programs for innovations covering a gamut of existence science disciplines – from sequencing and practical genomics to drug design and style, discovery, and screening – have realized great benefits because of to the use of equipment finding out and AI. But the patent legal rights protecting these innovative inventions are inclined to the similar issue make a difference eligibility vulnerabilities mentioned earlier mentioned.

Issue Matter Eligibility Worries in AI and Bioinformatics

Numerous ML, bioinformatics, and AI patents confront an uphill struggle for patentability because of to the use of laptop or computer programs and algorithms, and the speedily evolving regulation surrounding subject make any difference eligibility. These computation-hefty regions experience topic make a difference eligibility troubles, particularly for their ML options or proximity to mathematical calculations.

For case in point, the Federal Circuit issued a conclusion that manifests the troubling eligibility landscape in the fields of device learning and bioinformatics. In In re Board of Trustees of the Leland Stanford Junior Univ., No. 2020-1288 (Fed. Cir. Mar. 25, 2021), the Federal Circuit affirmed the rejection of the patentability of promises directed to computerized methods to create genetic facts. Listed here, Stanford sought to patent promises directed to a “computerized technique for inferring haplotype period in a collection of unrelated individuals” that produced “new data” with the use of precise rules and device discovering techniques. These machine finding out methods integrated measures these types of as making a info construction describing a Hidden Markov Model, consistently randomly modifying at minimum one of the imputed first haplotype phases, and mechanically replacing an imputed haplotype stage. Id. at 4-5.

The Federal Circuit held that the statements did not “involve realistic, technological improvements extending over and above improving upon the accuracy of a mathematically calculated statistical prediction.” Id. at 10. In addition, the Federal Circuit observed that “the recited techniques of obtaining, extracting, and storing data amount to very well-identified, regime, and common ways taken when executing a mathematical algorithm on a standard laptop or computer,” and the statements recite generic computer system elements that were being in no way “specialized.” Id. at 12. As this sort of, Stanford’s patent software for its computerized system for inferring haplotype phase did not get granted as a patent. At the time of publication, the courtroom proceedings have terminated for this patent software.

As beforehand discussed here and here, there are a quantity of techniques to mitigate the probability of a topic issue eligibility rejection. For illustration, an productive drafting approach features introducing explicit descriptions in the specification that identifies unique industries or purposes where by the AI could be significantly useful and explaining AI’s benefits about existing systems and processes.

In this posting, we focus on another technique that features drafting a patent application for placement into a distinct artwork device, which is possibly a single of the most vital drafting issues that several patent practitioners consider about. This article provides perception to USPTO art units to minimize the probability of summary concept assaults in the first spot for your ML, bioinformatics, AI, and computational patent.

Artwork Units Covering Systems Connected to AI and Bioinformatics

The USPTO assigns every U.S. patent software to 1 of many artwork models, which are organizational units of engineering subclasses. Some art models at the USPTO may behave extra aggressively than other people in asserting topic matter eligibility difficulties. Let’s glimpse at art models 1631 and 2129 to evaluate the aggressiveness of distinct art units and their assertiveness relating to subject matter subject eligibility problems.

1631 Art Unit

Discipline: Molecular Biology, Bioinformatics, Nucleic Acids, Recombinant DNA and RNA, Gene Regulation

At a glance:

  • 59.7% allowance amount

  • 718 authorized patent applications in previous 5 many years

  • 485 deserted applications in previous 5 yrs

  • 80.7% of abandoned purposes within the past 5 decades experienced a 101 rejection at the last workplace action

Rejections in Ultimate Office Motion of Deserted Purposes in Artwork Device 1631

Art Unit 2129 Abandoned Applications

2129 Artwork Unit

Subject: Synthetic Intelligence & Miscellaneous Laptop or computer Purposes

At a glance:

  • 82.5% allowance price

  • 832 allowed patent programs in previous 5 many years

  • 176 abandoned purposes in previous 5 a long time

  • 39.8% of abandoned applications within the earlier 5 decades experienced a 101 rejection at the ultimate office environment motion

Rejections in Last Office Action of Abandoned Apps in Art Unit 2129

Art Unit 1631 Abandoned Applications

Art device 1631 tends to cover systems relevant to molecular biology, bioinformatics, and gene regulation. Art device 2129 covers artificial intelligence and miscellaneous laptop or computer technologies. As these types of, it is attainable that the bigger amount of 101 rejections in the 1631 art unit is attributable to art unit 1631 encountering several apps directed towards a in a natural way developing compound and/or a regulation of mother nature. Nonetheless, comparing the aggressiveness of the two art units, artwork device 1631 appears to be far more aggressive in asserting 101 rejections with 80.7% of deserted programs within just the previous five yrs obtaining a 101 rejection at the closing office environment motion. In contrast, art device 2129 tends to be a lot less intense at asserting 101 rejections with 39.8% of deserted apps inside of the past five several years possessing a 101 rejection at the remaining business motion. Moreover, artwork unit 2129 has a a great deal increased allowance charge than art device 1631. The foregoing info suggests a ML-centric or bioinformatics patent is additional likely to go deserted for subject make any difference ineligibility in art unit 1631 than art device 2129.

The comparison among artwork device 1631 and art device 2129 is salient to patent practitioners for a selection of motives. 1st, the historical examination outcomes for these art units reveal which one is friendlier to AI-dependent programs. The variety of purposes in every artwork device that were abandoned because of to a 101 rejection is indicative of the issues of beating a 101 rejection in every single artwork device. 2nd, prior to filing a patent application, patent practitioners may possibly wish to alter their declare phrase use, title, and abstract in the specification in an hard work to immediate the patent application to a much more favorable art unit. Despite the fact that there is minimal transparency in how the USPTO types patent purposes into unique artwork units, the specialized discipline, abstract, and assert language of a patent application are probably things regarded in the course of this system. Preemptive endeavours to route a patent application to a far more favorable art unit may be especially worthwhile mainly because after a patent application is assigned to an artwork unit, the USPTO offers no recourse for reassigning the software to a unique art device. As this sort of, figuring out assessment outcomes in every single artwork unit prior to drafting a patent is know-how to be leveraged as a practiced patent practitioner drafts a ML, bioinformatics, or AI-linked patent software.

Potentially the lots of roadblocks Stanford’s patent software confronted by way of prosecution may perhaps be tied to the application’s assignment to artwork device 1631. In the circumstance of Stanford’s patent software for its computerized system for generating genetic facts, the software was possible to have been assigned to artwork unit 1631 owing to language such as “the subject of computer diagnostics” and “methods for examining a genome.” Additionally, the USPTO could have taken into account language in the claims’ preambles such as “computerized technique for decoding genetic data” and “processing device to interpret genetic data” in its final decision to assign Stanford’s software to the 1631 artwork unit. On top of that, the abstract is centered on how an algorithm performs optimization on haplotypes. As this sort of, there had been multiple places (e.g., the subject of invention, promises, and abstract) that contained language for computational assessment as staying involved in analyzing genomes and genetic information.


Subject matter matter eligibility worries are right here to keep, particularly for personal computer-centered bioinformatics and AI-similar patent purposes. The hazards of receiving subject matter make a difference eligibility problems can be mitigated by evaluating evaluation results in every art unit and then drafting patent purposes to concentrate on favorable artwork units. Drafting tactics incorporate modifying the promises, abstract, and title to focus on a favorable art unit. Drafting an software for placement into a specific artwork unit can be an crucial thought in patent planning. After an art device is assigned to your patent software, you can not have the software reassigned to a diverse artwork unit. Practitioners ought to for that reason be mindful when drafting the specification to think about an art device to keep away from prosecution landmines down the road, thus maximizing the likelihood of a patent grant.

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Nationwide Regulation Evaluate, Volume XI, Range 326

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