reduction to practice Archives

Take That Conception Out of the Oven – It’s CRISPR Even If the Cook Doesn’t Know

by Connor M. Larson | May 22, 2025 | America Invents Act, Patents

Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception of an invention does not require that the inventor appreciated the invention at the time of conception. Knowledge that an invention is successful is only part of the case for reduction to practice. Regents of the Univ. of Cal. et al. v. Broad Inst. et al., Case No. 22-1594 (Fed. Cir. May 12, 2025) (Reyna, Hughes, Cunningham, JJ.)

The Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, Regents) and the Broad Institute, Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, Broad) were each separately involved in research concerning CRISPR systems that “are immune defense systems in prokaryotic cells that naturally edit DNA.” At issue was the invention of the use of CRISPR systems to modify the DNA in eukaryotic cells. Regents and Broad filed competing patent applications resulting in an interference proceeding under pre-AIA law at the US Patent & Trademark Office Board of Patent Appeals & Interferences to determine which applicant had priority to the invention.

The main issue before the Board was a priority dispute over who first conceived of the invention and sufficiently reduced it to practice under pre-AIA patent law. Regents submitted three provisional patent applications dated May 2012, October 2012, and January 2013 and moved to be accorded the benefit of the earliest filing date, May 2012, for the purpose of determining priority. Alternatively, Reagents sought to be accorded either October 2012 or January 2013 as its priority date. The Board found that Regents’ first and second provisional applications (filed in May and October 2012, respectively) were not a constructive reduction to practice because neither satisfied the written description requirement of 35 U.S.C. § 112. The third provisional application, filed in January 2013, was the first to amount to a constructive reduction to practice of the counts in interference. The Board then ruled that Broad was the senior party for the purposes of priority in the interference proceeding because Broad reduced the invention to practice by October 5, 2012, when a scientist submitted a manuscript to a journal publisher. The Board ruled that Regents failed to prove conception of the invention prior to Broad’s actual reduction to practice. Regents appealed.

Regents argued that in assessing conception, the Board “legally erred by requiring Regents’ scientist to know that their invention would work.” The Federal Circuit agreed and vacated the Board’s decision. As the Court explained, there are three stages to the inventive process: conception, reasonable diligence, and reduction to practice. At the conception stage, “an inventor need not know that his invention will work for conception to be complete.” Rather, knowledge that the invention will work, “necessarily, can rest only on an actual reduction to practice.” The Board therefore legally erred by requiring Regents to know its invention would work to prove [...]

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Uncle Sam Can March In: Government Licenses Under Bayh-Dole Aren’t Subject to “Strict Timing Requirements”

by Joshua Revilla | Feb 22, 2024 | Patents

In an appeal from the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit affirmed a determination that 35 U.S.C. § 202(c)(4), a provision of the Bayh-Dole Act, operates to provide a license to the government for federally funded research based on work that occurred prior to the effective date of a funding agreement. University of South Fl. Board of Trustees v. United States, Case No. 22-2248 (Fed. Cir. Feb. 9, 2024) (Reyna, Taranto, Stoll, JJ.)

University of South Florida (USF) owns a now-expired patent directed to transgenic mice expressing a certain gene causing an accelerated pathology for Alzheimer’s disease. The patent’s subject matter was conceived while the two named inventors worked at USF, but both inventors transitioned their work to the Mayo Clinic prior to the first actual reduction to practice of the claimed invention. The mice remained at USF, under the care of USF professors, while the named inventors continued to oversee the project from Mayo. The first actual reduction to practice occurred while the inventors were at Mayo.

While the named inventors were still at USF, one inventor submitted a grant application to the National Institutes of Health (NIH). The NIH awarded the inventors (while they were still at USF) a grant covering the mouse project. After the inventors moved to Mayo but prior to the award grant, the designated grantee changed from USF to Mayo. In November 1997, Mayo and USF entered into a subcontract whereby Mayo would pay USF for grant-covered work occurring at USF.

USF sued the United States alleging infringement of the mouse patent by a third party with the government’s authorization and consent. The third party was producing and using mice covered by the patent for the government. The US asserted a license defense under the Bayh-Dole Act, which gives the government a license to practice certain federally funded inventions. The Claims Court granted judgment to the US under its license defense, determining that USF operated pursuant to an implied contract with Mayo based on the understanding that Mayo would use funding from the NIH grant to pay USF for work done there. The Claims Court therefore determined that USF was a contactor with an implied subcontract that was a funding agreement under Bayh-Dole. Since the invention was therefore invented by a government contractor operating under a funding agreement, it was a “subject invention” that was first actually reduced to practice under a government contract. Therefore, under Bayh-Dole, the government was entitled to a license. USF appealed, arguing that the invention was not a “subject invention” within the meaning of § 202(c)(4) of Bayh-Dole.

USF argued that to trigger § 202(c)(4), a funding agreement must be in place at the time of the relevant work and there was no implied agreement in April 1997, the time the work that led to the reduction to practice commenced. The Federal Circuit determined that the November 1997 subcontract was adequate to support entitlement to claim a government license under § [...]

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Swing and a Miss: Failed Interferences Don’t Affect Later Ones

by Mike Baldwin | Jan 19, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s (Board) interference decision finding that priority belonged to the junior party based on sufficiently corroborated reduction to practice. Dionex Softron GmbH v. Agilent Technologies Inc., Case No. 21-2372 (Fed. Cir. Jan. 6, 2023) (Reyna, Chen, Stark, JJ.)

Both parties attempted to instigate an interference by copying each other’s claims regarding a method of operating a liquid chromatography system. Agilent first substantially copied Dionex’s claims but failed to secure declaration of an interference and subsequently amended its claims. Dionex then copied verbatim Agilent’s amended claims, successfully provoking an interference. The Board identified Dionex as the senior party and Agilent as the junior, placing the burden for priority on Agilent.

At the interference, Dionex moved for judgment based on lack of written description for the relevant count language (emphasis added):

. . . determining a movement amount of the piston within the chamber from a first position to a second position to increase a pressure in the sample loop from an essentially atmospheric pressure to the pump pressure, based on the pump pressure […] wherein decreasing the volume includes forwarding the piston within the chamber by the determined movement amount from the first position to the second position.

Dionex contended that Agilent’s specification lacked written description for “determining a movement amount” and subsequently “forwarding the piston,” wherein the order of those two separate operations was important and lacking support. Dionex also contended that while the relevant specification was Dionex’s patent for a majority of count terms, some terms, such as “determining,” should be viewed in light of Agilent’s application. The Board disagreed and found that Agilent’s specification was controlling and contained adequate written description to support the count.

In finding Agilent’s written description adequate, the Board rejected Dionex’s contention that the claims required a determination of movement amount before forwarding the piston. Applying the broadest reasonable interpretation standard, the Board found that the count language permitted determination of movement amount while forwarding the piston and that consequently there was adequate support in the specification.

Both parties moved for judgment on priority. The Board granted Agilent’s motion, finding that even as the junior party, Agilent proved conception and reduction to practice before Dionex’s earliest conception date. Applying the rule of reason, the Board found that the testimony of one of Agilent’s co-inventors was sufficiently corroborated by two coworkers to show successful reduction to practice by the critical date. The Board also credited Agilent’s coworker testimony in denying Dionex’s contention that Agilent’s reduction to practice lacked a pressure senor and credited testimony stating that a high-pressure pump with a built-in pressure system was used. The Board also declined Dionex’s request to draw a negative inference from the lack of testimony of the other co-inventor, crediting Agilent’s explanation that the testimony would have been cumulative. Dionex appealed.

On appeal, the Federal Circuit found that the Board had correctly treated Agilent’s specification as the “originating specification” because it was Dionex’s [...]

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