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

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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Interference Analysis Is a Two-Way Street

On appeal from an interference proceeding, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board decision that found the claims of the senior party’s patent were not invalid as time-barred under 35 U.S.C. § 135(b)(1). The Federal Circuit concluded that the “two-way test” requires looking to see if either set of pre-critical and post-critical date claims contains a material limitation not found in the other and not just looking to see if the post-critical date claims have additional material limitations. Speck et al. v. Bates et al., Case No. 22-1905 (Fed. Cir. May 23, 2024) (Dyk, Bryson, Stoll, JJ.)

35 U.S.C. § 135(b)(1), pre-AIA, provides that “a claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted.” This has been described as a statute of repose that places a time limit on a patentee’s exposure to an interference, the deadline for which is referred to as the “critical date.” At issue in this appeal was the “long-standing” exception to § 135(b)(1) for instances where the applicant files its claim after the critical period but has already been claiming substantially the same invention as the patentee during the critical period.

This case involves drug-coated balloon catheter technology. Bates is the senior party that filed a patent application, and Speck is the junior party that owns an issued patent. Speck’s patent issued on September 4, 2012, whereas Bates filed his application on August 29, 2013, six days before the critical date of Speck’s patent (i.e., one year after the filing date). Bates amended the application on August 30, 2013 (still before the critical date), and canceled all of the original claims and replaced them with new claims. Bates later amended the claims after the critical date to add a requirement that the device be “free of a containment material atop the drug layer.” The amendment was made to overcome a rejection from the examiner during prosecution.

Speck filed a motion to terminate the interference on the ground that the claims of Bates’s application were time-barred under § 135(b)(1) because Bates amended the claims more than one year after Speck’s patent issued. Speck also moved the Board to find that the claims of Bates’s application were unpatentable for lack of written description.

The Board denied Speck’s motion to terminate under § 135(b)(1), finding that the later-amended claims did not differ materially from the claims in other patents and patent applications Bates owned that were filed prior to the critical date, because “Speck ha[d] not directed [the Board] to a material limitation of the Bates involved claims that is not present in the earlier Bates claims.” Speck filed a motion for rehearing, which the Board denied. The Board also denied Speck’s motion to find that Bates’s claims lacked [...]

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

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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Post-AIA Patents Are Not Shielded from Interferences

Addressing the applicability of interference proceedings to patent applications filed after the Leahy-Smith America Invents Act (AIA) was enacted, the Patent Trial & Appeal Board (Board) found it proper to declare an interference between a patent application with a priority date before March 16, 2013, the AIA implementation date, and a patent with a priority date after March 16, 2013. SNIPR Technologies Limited v. The Rockefeller University, Pat. Interf. No. 106,123 (DK) (PTAB Nov. 19, 2021) (Katz, APJ).

The AIA switched the US patent system from a “first to invent” to a “first inventor to file” system. In line with this change, the AIA eliminated the patentability requirement under 35 U.S.C. § 102(g), regarding whether another inventor made the invention first, and the interference proceeding under 35 U.S.C. §135 for determining who invented the claimed invention first. Section 3(n)(2) of the AIA provides a timing provision relating to this change. Under this section, the interference proceeding “shall apply to each claim of an application for patent, and any patent issued thereon, for which the amendments made by this section also apply, if such application or patent contains or contained at any time, a claim [having a priority date before March 16, 2013].”

The US Patent & Trademark Office (PTO) declared an interference between several patents owned by SNIPR and a pending application to The Rockefeller University. The claims involved were drawn to a method of killing or modifying specific bacteria in a mixed population of bacteria with different species using the CRISPR-mediated gene editing technology. The Rockefeller application asserted a priority date of February 7, 2013 (i.e., pre-AIA), while the SNIPR patents asserted the priority date of May 3, 2016 (i.e., post-AIA). SNIPR argued that the interference proceeding was improper since all involved patents were filed after the AIA was enacted.

The Board rejected SNIPR’s argument, explaining that Section 3(n)(2) provides for continuation of interference under certain circumstances. The Board noted that the patentability requirement under 35 U.S.C. §102(g) and interference still apply to each claim having a priority date before March 16, 2013, such as the claims of Rockefeller’s involved application. Accordingly, when the Rockefeller claims would otherwise be allowable, except for the existence of an interference with other claims such as SNIPR’s claims, Section 3(n)(2) necessarily calls for an interference proceeding between the Rockefeller application and the SNIPR patents. Otherwise, the PTO would not be able to determine whether Rockefeller was entitled to a patent under 35 U.S.C. §102(g).

The Board further reasoned that, instead of ending all interferences at the implementation of the AIA, US Congress enacted Section 3(n)(2) to continue the interference proceeding as applicable to certain cases after AIA. Congress also did not explicitly require that cases involved in interferences must all have priority dates before March 16, 2013. Therefore, the Board found that Congress contemplated interferences between pre-AIA and post-AIA applications and patents. Accordingly, the Board ruled in Rockefeller’s favor, finding it was the first to invent the claimed technology.




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