101 rejections at the USPTO plummeted in computational biology in 2023!
We analyzed office actions since 2008 related to bioinformatics/computer[1] technologies.
3 Interesting Takeaways re: Patent Eligibility[2] (See Graph):
After 2014 (Alice S. Ct. decision), percent of 101 rejections increased substantially in these computer-related art units.
From ~10-40% in 2013 to 70-80% by 2019.
The increase occurred at different times/rates for different art units.
Since 2019 (2019 USPTO Guidelines (PEG 2019)[3]), percent of 101 rejections trend down.
From 70-80% to ~10% to ~45%.
The decrease occurred at different times/rates for different art units.
101 rejections in the computational biology art unit (1631) plummeted from 50% in 2022 to 10% in 2023.
There was no change (AU 2857) and an increase (AU 2129) from 2022 to 2023 in the other computer-related art units we analyzed.
Maybe the substantial decrease in AU 1631 is the cumulative effect of the 2019 PEG as well as additional activities of the USPTO to attempt to clarify subject matter eligibility (Section 101).
However, applicants in other art units (e.g., AU 2129) may not be benefiting from these more recent USPTO activities.
Chart 1. Percentage of Office Actions Containing a 101 Rejection Since 2008:
Brief Background:
Two prominent Supreme Court decisions regarding patent eligibility (35 U.S.C. § 101) were Mayo Collaborative Services Inc. v. Prometheus Laboratories Inc. (Mayo 2012) and Alice Corp. v. CLS Bank International (Alice 2014). In both instances, the Supreme Court held that the claims at issue in the case did not meet the patent-eligible subject matter requirements of 35 U.S.C. § 101.
The Supreme Court decisions above established the two-part Alice/Mayo test for patentable subject matter.
Alice/Mayo Test
Step 1) Is the claim to a process, machine, manufacture or composition of matter?
Step 2A) Is the claim directed to an ineligible concept (i.e., a law of nature, a natural phenomenon, or an abstract idea)?
Step 2B) Does the claim recite additional elements that are "significantly more" than the judicial exception?
Chart 2. Alice/Mayo 2-Step Test Flowchart[4]
2019 USPTO Guidelines
In January 2019, and later updated in October 2019, the USPTO issued the 2019 Revised Subject Matter Eligibility Guidance (2019 PEG), which updated the test to be used by USPTO personnel in evaluating subject matter eligibility under 35 U.S.C. § 101. This was in response to concerns that the Office was inconsistently applying the eligibility criteria set forth in Mayo, Alice, and other court decisions.
The 2019 PEG adds a Prong 2 to Step 2A of the original Alice/Mayo test. Step 2A is a two-prong check:
Prong 1) Does the claim recite a judicial exception? (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Prong 2) If so, does the claim recite additional elements that integrate the exception into a practical application?
The below flowchart includes these expanded steps.
Chart 3. Expanded Step 2A Flowchart:
It is noteworthy that the 2019 PEG clarified that a claim meets the requirements of Section 101 if it recites additional elements that integrate the judicial exception into a practical application. The USPTO cited numerous cases in support of the addition of PRONG 2 to Step 2A, including the Alice decision itself[5]. The 2019 PEG appeared to reduce the number of 1st office action patent-ineligible subject matter rejections by 25%[6].
The USPTO has continued to attempt to clarify the patent eligibility requirements of section 101 since the 2019 Guidelines were issued as they recently described in their 2024 Guidance Update on Patent Subject Matter Eligibility, including on Artificial Intelligence (2024 Guidance)[7]. Some of these USPTO activities related specifically to biotech inventions, and most general 101 Guidance is relevant to biotech inventions, which often are considered laws of nature and/or abstract ideas. It is not clear to the authors if any one of these more recent USPTO activities resulted in the significant decrease in 101 subject matter eligibility rejections in the computational biology art unit in 2023, if it was the cumulative effect of these various USPTO activities, or if there is another reason for the increase (e.g., further developments in biotech Section 101 case law, or a significant change in the types of applications/claims that were pending in AU 1631 despite the fact that the description of the art unit has not changed). One lesson for practitioners, since attempts to direct applications to certain art units to increase the chance of a more reasonable examination have become more widespread, is that art units that may have been more favorable with respect to 101 rejections a few years ago, may now be less favorable (e.g., Art Unit 2129 vs. Art Unit 1631).
The computational biology and software-enabled technology landscape moves fast, especially as AI continues to become more widespread and robust in its applications. It will be interesting to keep a pulse on the developments around 101 subject matter eligibility requirements. From looking at the data we analyzed, the percentage of 101 rejections out of total office actions has been trending down since 2019 for the computer-related art units we analyzed, especially last year in the computational biology art unit. This trend bodes well for companies that innovate in computer-related biotechnologies, offering a potentially better environment for patenting these inventions. It will be interesting to see whether these newly issued computational biology patents are upheld by the courts, since USPTO Guidelines do not have the force and effect of law[8].
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Post History:
9/18/24 (EJV, DV)
This blog post is not legal advice and does not necessarily represent the viewpoint of any of the clients of Double Helix Law. Please seek the guidance of a registered and licensed patent attorney or patent agent for any patent-related questions you have. Please note, especially regarding statements made for jurisdictions outside the U.S., that the authors of this article are U.S. patent practitioners.
Footnotes:
[1] We focused on three art units that deal with computer related technologies:
1631: Data processing: measuring, calibrating, or testing. Data processing: structural design, modeling, simulation, and emulation. (src). (Tech Center 1600: Biotechnology and organic chemistry (src))
2857: Semiconductors, memory, circuits and related. Data processing: measuring, calibrating, or testing. (src)
2129: Artificial intelligence (AI) and computer applications. Data processing: artificial intelligence. (src)
[2] Percentages are based on number of office actions containing this rejection type in that AU, out of the total number of OA's for given AU. Data from USPTO. (src)
[3] PEG 2019: Patent Eligibility Guidance update from the USPTO made several changes to the process for determining if a patent subject matter is eligible. (src)
[4] The flow charts diagrams and tests are based on MPEP 2106 Patent Subject Matter Eligibility. (src)
[5] See Footnotes 16 to 18 of the PEG 2019. (src)
[6] Adjusting to Alice USPTO patent examination outcomes after Alice Corp. V. CLS Bank International. (src)
[7] 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence. (src)
[8] 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence. (src)
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