“Understanding the University of Minnesota v. Gilead Case: The Complexities of Patent Claims and Provisional Applications”
University of Minnesota v. Gilead: A Case of Patent Priority
In a recent Federal Circuit decision, the University of Minnesota found itself in a precarious position. The university was essentially precluded from claiming priority to a provisional patent application. The reason? The provisional failed to provide adequate written description support for a later claimed invention. This case, University of Minnesota v. Gilead, is a stark reminder of the importance of thoroughness and precision in patent applications.
The Provisional Patent Application
A provisional patent application is not required to include any patent claims. Its purpose is to provide an earlier effective filing date for a later-filed non-provisional patent application, assuming certain requirements are met. In this case, the University of Minnesota’s provisional application included 63 claims, 49 of which were directed toward a compound of a specific formula.
Claim 1, the only independent claim, defined a genus of astronomical proportions. As Judge Lourie puts it, “the listings of possibilities are so long, and so interwoven, that it is quite unclear how many compounds actually fall within the described genera and subgenera.”
Multiple Dependent Claims
Claims 2-48 lie between these two extremes, defining a huge number of subgenuses of the genus of compounds defined by Claim 1 – by my count over 500,000. This was achieved through the use of multiple dependent claims that depend upon other multiple dependent claims, a practice that is not permitted under U.S. patent law.
The Manual of Patent Examiner Procedure (MPEP) defines a multiple dependent claim as “a dependent claim which refers back in the alternative to more than one preceding independent or dependent claim.” It also cites 37 C.F.R. 1.75 for the proposition that “[a] multiple dependent claim shall not serve as a basis for any other multiple dependent claim.”
The Issue of Subgenus Claims
The problem arises when claim 47, which encompasses 250,880 other unique claims, each defining its own subgenus. The huge number results from the multiplicative effect of five iterations of multiple dependent claims. One can readily understand why the PTO does not allow multiple dependent claims that depend on other multiple dependent claims. But since this was only a provisional application, the claims were never examined, and are simply serving as a vehicle for disclosing a huge number of subgenuses. By my count, the provisional includes a total of 584,431 subgenus claims.
The Court’s Decision
The Board concluded that the claims in the provisional did not provide ipsis verbis support for the later claimed subgenus, albeit without providing much in the way of explanation, and the Federal Circuit affirmed. The problem is that the later claimed subgenus is buried in an astronomical number of other subgenuses.
The courts have long used the terminology of “blaze marks” when assessing written description support for a later claimed chemical compound or genus. The term refers to the practice of marking a trail through the forest by slashing the bark of trees. In this case, even if there are blaze marks defining a trail to the waterfall, as a practical matter it would be very difficult to find the correct trail if there are too many other blaze marks defining a huge number of trails that do not lead to the waterfall.
Final Thoughts
Returning to the case at hand, I do not think the result would have changed if somehow the university could have, perhaps with the help of AI, drafted 584,331 discrete dependent claims that would have been the functional equivalent of the multiple dependent claims that it did file in its provisional application. At some point, the disclosure of too many alternative possibilities can, as a practical matter, negate the disclosure of one specific subgenus. This is the basis for the Board’s determination that there was not ipsis verbis support for the later claimed subgenus, nor were there sufficient blaze marks pointing the way.
And given the standard of review, it is not surprising to me that the Federal Circuit affirmed. As stated in its opinion, “the primary considerations in a written description analysis are factual and must be assessed on a case-by-case basis. We thus review the Board’s decision regarding written description for substantial evidence.”
This case serves as a reminder of the importance of precision and thoroughness in patent applications. It also highlights the complexities of patent law and the challenges faced by those seeking to protect their inventions.