Federal Circuit Clarifies Public Use Bar Requirements in Win for Hologic Against Minerva

“AAGL 2009 was the ‘Super Bowl’ of the industry and was open to the public. It included attendees who were critical to Minerva’s budding business—such as potential investors and physicians—and Minerva had every incentive to showcase the Aurora devices to these attendees as best as it could.” – CAFC opinion

public use bar

Image from CAFC opinion

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday issued a precedential opinion clarifying the requirements for the disclosure of technology that is ready for patenting at a public event to qualify as being “in public use” for purposes of the pre-America Invents Act (AIA) public use bar under 35 USC 102(b).

The appeal stems from Minerva Surgical, Inc.’s suit against Hologic, Inc. and Cytyc Surgical Products, LLC for infringement of U.S. Patent No. 9,186,208, titled “Systems for endometrial ablation.” The U.S. District Court for the District of Delaware granted summary judgment for Hologic that the relevant claims were anticipated under the public use bar of the pre-AIA Section 102(b) because Minerva brought a device called “Aurora” to the 38th Global Congress of Minimally Invasive Gynecology sponsored by the American Association of Gynecologic Laparoscopists (AAGL 2009) more than one year before the ‘208 patent’s priority date. Hologic argued that the Aurora device disclosed every limitation of the asserted claims.

Under the pre-AIA public use bar, “[a] person shall be entitled a patent unless . . . the invention was . . . in public use . . . in this country, more than one year prior to the date of the application for patent in the United States” and it is triggered “where, before the critical date, the invention is [(1)] in public use and [(2)] ready for patenting.”

Minerva argued on appeal that the disclosure of the Aurora device at AAGL 2009 did not qualify as being “in public use” because it “merely displayed” the device; that the claim term of claim 13, which was at issue on appeal, “the inner and outer elements have substantially dissimilar material properties,” (“SDMP” term) was not disclosed because the Aurora device lacked the SDMP term at the time of AAGL 2009; and that the invention was not ready for patenting because Minerva was still improving the SDMP technology at the time.

In its discussion, the CAFC said that Minerva’s display of the Aurora device at AAGL 2009 went “well beyond” a mere visual view of the device. The court explained:

“AAGL 2009 was the ‘Super Bowl’ of the industry and was open to the public. It included attendees who were critical to Minerva’s budding business—such as potential investors and physicians—and Minerva had every incentive to showcase the Aurora devices to these attendees as best as it could. The record shows that Minerva brought “15 full[y] functional” Aurora devices to AAGL 2009…. And Minerva’s disclosure of these fifteen devices spanned several days and included Minerva showcasing them at a booth, in meetings with interested parties, and in a technical presentation.” [citations omitted]

Furthermore, Minerva pitched the device to industry members who were able to closely study the device. While Minerva denied that the devices were physically handled, the CAFC said that doesn’t matter. “[O]ur standard for disclosure rising to the level of public use is not predicated on a device being physically handled by the public…. Rather, public use may also occur where, as here, the inventor used the device such that at least one member of the public without any secrecy obligations understood the invention.” There also were no confidentiality obligations imposed on observers of the device via non-disclosure or other informal agreements, said the court.

The CAFC also found that the SDMP term was disclosed by the Aurora devices shown at AAGL 2009. “Minerva’s documentation about the Aurora device from before and shortly after the event expressly discloses the Aurora device having the SDMP term or touts benefits that are derived from the device having the SDMP technology,” noted the court.

Turning to Minerva’s arguments that the invention was not ready for patenting at AAGL 2009, the CAFC disagreed because “(1) Minerva reduced the invention to practice and (2) Minerva had enabling documentation describing the invention of claim 13.”

On the first point, the court said that Minerva’s creation of working prototypes that embodied claim 13 and that worked for performing endometrial ablations showed that the invention was ready for patenting, despite Minerva’s assertions that it was still working to improve the Aurora device at the time of AAGL 2009. The court specifically rejected Minerva’s contention that since the device did not function to perform ablations on “live human” uteri it was not reduced to practice. “Contrary to Minerva’s argument, our case law does not require imposing the ‘live human’ requirement here,” wrote the court. “Minerva points to nothing in the intrinsic record indicating that the ’208 patent is limited to devices only usable on live human tissue.” Minerva’s later improvements to the invention amounted to “mere ‘later refinements’ or ‘fine tuning,’” said the court.

Additionally, even if the court did apply the heightened requirement proposed by Minerva, it would not preclude a reduction to practice finding, said the CAFC, because the relevant studies in the record showed that that “the Minerva device would be considered acceptable for clinical use in pre-hysterectomy cases,” meaning in clinical trials on live humans.

Finally, the invention was also ready for patenting because there was documentation “sufficiently specific to enable a person skilled in the art to practice the invention” of the SDMP term of claim 13, including “drawings and detailed descriptions in the 2009 lab notebook pages disclosing a device with the SDMP term.”

The CAFC thus affirmed the district court’s grant of summary judgment for Hologic and said that Hologic is entitled to judgment as a matter of law that the ’208 patent is anticipated under the public use bar of § 102(b).

Minerva and Hologic were also recently engaged in a high-profile battle stemming from one of Hologic’s patents that centered on the doctrine of assignor estoppel and went up to the Supreme Court.

 

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