conception 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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Wave Goodbye: Arguments Incorporated by Reference Are Waived

by Benjamin Ediger, Ph.D. | Nov 30, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s patentability determination, finding that the patent challenger waived an argument it attempted to incorporate by reference to another brief. Medtronic, Inc. v. Teleflex Life Scis. Ltd., Case No. 2022-1721 (Fed. Cir. Nov. 16, 2023) (Lourie, Prost, Chen, JJ.)

Teleflex owns a patent directed to a method for using a guide extension catheter with a guide catheter. Medtronic challenged the patent in two inter partes review (IPR) proceedings, arguing that certain claims were obvious in light of Ressemann and Itou and that another claim was obvious in light of Ressemann, Itou and Kataishi. Teleflex argued that Itou was not prior art because the claimed invention was conceived prior to Itou’s filing date and was either actually reduced to practice before the critical date or diligently pursued until its constructive reduction to practice date. Medtronic did not contest Teleflex’s demonstration of conception but instead challenged Teleflex’s alleged showings of both actual reduction to practice and diligence until constructive reduction to practice.

The Board ultimately found that Itou did not qualify as prior art and that Medtronic therefore had not shown that the challenged claims were unpatentable. One of the issues before the Board was whether in vivo testing was required for actual reduction to practice because the claims at issue were method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” The Board ultimately found that no such testing was required, explaining that Medtronic “was unable to identify any legal precedent requiring in vivo performance of a claimed in vivo method to show actual reduction to practice.” According to the Board, actual reduction to practice could “be verified using a physical model that replicates the anatomy in which the method would likewise be performed in vivo.” Medtronic appealed.

Medtronic challenged the Board’s determination regarding constructive reduction to practice, arguing as follows:

In addressing diligence, the Board simply adopted its earlier erroneous diligence analysis in IPR2020-00132. Appx61–62. Therefore, if this Court vacates the Board’s diligence holding in No. 21-2356, it should likewise vacate the Board’s decision here. Appellant’s Br. at 41.

The Federal Circuit explained that it did not vacate the diligence holding in the prior decision, so Medtronic’s condition precedent had not been met. Medtronic nevertheless urged the Court to decide the diligence question. The Court refused, finding that Medtronic improperly incorporated by reference an argument from another brief. The Court explained that it would be fundamentally unfair to allow Medtronic to use incorporation by reference to exceed the word limit on briefs. The Court observed that parties pursuing appeals must make certain strategic decisions concerning what material to include in their opening briefs, and here, Medtronic affirmatively chose not to include developed arguments on diligence. The Court therefore found that Medtronic waived its challenge to the Board’s diligence finding. With the diligence issue waived and conception stipulated, the Court affirmed [...]

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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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