Examining Art Units to Avoid Subject Matter Eligibility Challenges for Bioinformatics and AI-related Patents | Mintz – Intellectual Property Viewpoints

Codi Saxon

Overview of Issue Issue Eligibility Troubles Computer system-dependent innovations – especially in the equipment understanding (ML), bioinformatics, and synthetic intelligence (AI) fields – are susceptible to subject make any difference eligibility problems. Topic matter eligibility difficulties might avoid a patent application from becoming granted by the United States Patent and […]

Overview of Issue Issue Eligibility Troubles

Computer system-dependent innovations – especially in the equipment understanding (ML), bioinformatics, and synthetic intelligence (AI) fields – are susceptible to subject make any difference eligibility problems. Topic matter eligibility difficulties might avoid a patent application from becoming granted by the United States Patent and Trademark Business (USPTO) and may even be asserted to invalidate a patent publish-grant. Topic subject eligibility troubles consist of categorizing the computer system-linked creation as an summary plan, which involves mental procedures (concepts capable of being done on pen and paper), strategies of arranging human action (such as taking care of interactions concerning individuals), and mathematical concepts.

In latest many years, the Federal Circuit has carried out a multi-step take a look at to identify irrespective of whether patent claims would survive a matter make any difference eligibility problem. In some cases, the Federal Circuit has upheld the validity of claims reciting an summary strategy when the claims integrate the summary thought into a useful application or recite supplemental features that amount to appreciably more than the summary thought. Similarly, the USPTO implements a very similar multi-phase exam with a variety of pointers to decide no matter whether patent claims in an software will survive a issue issue eligibility rejection. Yet, 101 jurisprudence continues to be unsettled in regards to the important analyzing standards and is frequently evolving with new recommendations and rising case regulation. As a result, the fate of bioinformatics and equipment studying-dependent patents and patent applications remains uncertain.

As we formerly talked about in Patenting Criteria for Artificial Intelligence in Biotech and Artificial Biology Element 1, personal computer-primarily based apps for inventions masking a gamut of daily life science disciplines – from sequencing and functional genomics to drug style, discovery, and testing – have realized incredible rewards thanks to the use of machine finding out and AI. But the patent rights safeguarding these state-of-the-art inventions are inclined to the identical issue matter eligibility vulnerabilities mentioned previously mentioned.

Topic Subject Eligibility Troubles in AI and Bioinformatics

Several ML, bioinformatics, and AI patents facial area an uphill fight for patentability due to the use of laptop systems and algorithms, and the speedily evolving regulation surrounding subject matter matter eligibility. These computation-large places face matter make a difference eligibility issues, especially for their ML capabilities or proximity to mathematical calculations.

For illustration, the Federal Circuit issued a selection that manifests the troubling eligibility landscape in the fields of equipment 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 statements directed to computerized strategies to produce genetic details. In this article, Stanford sought to patent promises directed to a “computerized system for inferring haplotype phase in a assortment of unrelated individuals” that made “new data” with the use of precise regulations and machine understanding techniques. These machine mastering approaches included ways these types of as making a info framework describing a Hidden Markov Product, continuously randomly modifying at the very least a person of the imputed original haplotype phases, and instantly replacing an imputed haplotype section. Id. at 4-5.

The Federal Circuit held that the statements did not “involve sensible, technological advancements extending over and above increasing the accuracy of a mathematically calculated statistical prediction.” Id. at 10. Furthermore, the Federal Circuit located that “the recited measures of obtaining, extracting, and storing info amount to perfectly-identified, regime, and regular actions taken when executing a mathematical algorithm on a typical computer system,” and the statements recite generic pc parts that were in no way “specialized.” Id. at 12. As such, Stanford’s patent application for its computerized strategy for inferring haplotype stage did not get granted as a patent. At the time of publication, the courtroom proceedings have terminated for this patent software.

As formerly mentioned listed here and right here, there are a variety of methods to mitigate the chance of a subject make a difference eligibility rejection. For case in point, an successful drafting strategy features adding explicit descriptions in the specification that identifies certain industries or apps in which the AI may well be particularly beneficial and outlining AI’s advantages in excess of existing techniques and procedures.

In this article, we discuss a further strategy that contains drafting a patent software for placement into a unique art device, which is probably a single of the most essential drafting concerns that couple of patent practitioners consider about. This post gives insight to USPTO artwork models to reduce the probability of abstract idea assaults in the initially spot for your ML, bioinformatics, AI, and computational patent.

Art Units Covering Technologies Relevant to AI and Bioinformatics

The USPTO assigns every single U.S. patent software to a person of numerous art units, which are organizational units of engineering subclasses. Some art models at the USPTO might behave additional aggressively than other folks in asserting subject matter make a difference eligibility troubles. Let us look at art models 1631 and 2129 to review the aggressiveness of different art units and their assertiveness relating to subject issue eligibility worries.

1631 Artwork Unit

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

At a look:

  • 59.7% allowance rate
  • 718 allowed patent apps in previous 5 a long time
  • 485 abandoned applications in previous 5 years
  • 80.7% of abandoned apps within just the past 5 a long time had a 101 rejection at the closing place of work action

Rejections in Closing Place of work Motion of Abandoned Apps in Artwork Unit 1631

Art Unit 2129 Abandoned Applications

2129 Artwork Unit

Area: Artificial Intelligence & Miscellaneous Laptop Programs

At a glance:

  • 82.5% allowance level
  • 832 permitted patent applications in previous 5 several years
  • 176 deserted programs in earlier 5 a long time
  • 39.8% of deserted applications inside the earlier 5 years had a 101 rejection at the ultimate workplace motion

Rejections in Last Business Motion of Abandoned Programs in Art Unit 2129

Art Unit 1631 Abandoned Applications

Artwork device 1631 tends to deal with technologies associated to molecular biology, bioinformatics, and gene regulation. Art device 2129 addresses synthetic intelligence and miscellaneous personal computer systems. As this kind of, it is possible that the greater selection of 101 rejections in the 1631 art unit is attributable to artwork unit 1631 encountering a lot of apps directed toward a obviously developing substance and/or a regulation of mother nature. Yet, comparing the aggressiveness of the two art models, artwork unit 1631 seems to be much more aggressive in asserting 101 rejections with 80.7% of abandoned apps in the earlier 5 years having a 101 rejection at the ultimate place of work action. In contrast, artwork unit 2129 tends to be a lot less aggressive at asserting 101 rejections with 39.8% of deserted applications in the previous 5 decades having a 101 rejection at the closing business office motion. Also, artwork device 2129 has a considerably increased allowance charge than art device 1631. The foregoing facts indicates a ML-centric or bioinformatics patent is a lot more possible to go deserted for issue issue ineligibility in artwork unit 1631 than art unit 2129.


The comparison in between artwork device 1631 and art device 2129 is salient to patent practitioners for a number of good reasons. Very first, the historical evaluation outcomes for these artwork units expose which just one is friendlier towards AI-based mostly programs. The quantity of applications in just about every art device that have been deserted owing to a 101 rejection is indicative of the problems of beating a 101 rejection in each and every artwork device. Next, prior to submitting a patent application, patent practitioners may possibly want to modify their declare phrase usage, title, and summary in the specification in an energy to immediate the patent software to a a lot more favorable art unit. While there is minimal transparency in how the USPTO types patent purposes into diverse art models, the specialized field, abstract, and declare language of a patent software are possible components viewed as all through this process. Preemptive endeavours to route a patent application to a additional favorable artwork device may be especially worthwhile because after a patent application is assigned to an art device, the USPTO offers no recourse for reassigning the application to a distinct artwork unit. As these kinds of, determining examination outcomes in each artwork device ahead of drafting a patent is knowledge to be leveraged as a practiced patent practitioner drafts a ML, bioinformatics, or AI-linked patent software.


Potentially the quite a few roadblocks Stanford’s patent software faced via prosecution may perhaps be tied to the application’s assignment to art unit 1631. In the case of Stanford’s patent software for its computerized strategy for generating genetic data, the application was likely to have been assigned to art device 1631 because of to language these kinds of as “the field of personal computer diagnostics” and “methods for examining a genome.” Furthermore, the USPTO may have taken into account language in the claims’ preambles such as “computerized technique for interpreting genetic data” and “processing unit to interpret genetic data” in its final decision to assign Stanford’s application to the 1631 artwork device. Moreover, the abstract is focused on how an algorithm performs optimization on haplotypes. As such, there were being numerous regions (e.g., the discipline of invention, promises, and abstract) that contained language for computational assessment as getting involved in analyzing genomes and genetic facts.


Matter matter eligibility difficulties are in this article to remain, especially for computer system-centered bioinformatics and AI-associated patent apps. The pitfalls of receiving topic issue eligibility problems can be mitigated by comparing assessment outcomes in every art unit and then drafting patent apps to concentrate on favorable art units. Drafting procedures contain modifying the claims, abstract, and title to target a favorable artwork device. Drafting an software for placement into a precise artwork unit can be an crucial consideration in patent planning. At the time an artwork unit is assigned to your patent application, you are not able to have the software reassigned to a distinctive art unit. Practitioners should hence be conscious whilst drafting the specification to contemplate an artwork unit to stay clear of prosecution landmines down the road, thus improving the probability of a patent grant.

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