“AAGL 2009 was the industry’s ‘super bowl’ and was open to the public. It included key participants for Minerva’s budding business, such as potential investors and physicians, and Minerva had every incentive to introduce these participants to the Aurora device as much as possible. – CAFC Opinion
Image from CAFC Opinion
The U.S. Court of Appeals for the Federal Circuit (CAFC) set precedent Wednesday to clarify the requirements for disclosure of patent-ready technology to be considered “in public use” for prior purposes at a public event. issued an opinion. Public Use Prohibition of the American Invents Act (AIA) under 35 USC 102(b).
The appeal is Minerva Surgical, Inc.’s lawsuit against Hologic, Inc. and Cytyc Surgical Products, LLC for infringement of U.S. Patent No. 9,186,208 entitled “System for Endometrial Ablation.” The U.S. District Court for the District of Delaware ruled that Minerva brought a device called “Aurora” to the 38th World Congress so that related claims could be anticipated under his pre-AIA Section 102(b) public use ban. issued summary judgment to Hologic. Minimally Invasive Gynecology Sponsored by the American Association of Gynecological Laparoscopists (AAGL 2009) over a year before the priority date of the ‘208 patent. Hologic argued that the Aurora device disclosed all limitations of the asserted claims.
Under pre-AIA public use regulations,[a] A person shall have the right to a patent except in the following cases: . . the invention was. . . in public. . . in this country more than one year before the filing date of the patent application in the United States” and “before the reference date, the invention was [(1)] official and [(2)] Ready to get a patent. ”
On appeal, Minerva argued that its disclosure of the Aurora device at AAGL 2009 “merely exhibited” the device and therefore could not be considered “in public use.” Because the Aurora device lacked SDMP terminology at the time of AAGL, the claim term “the inner and outer elements have substantially different material properties” (“SDMP” terminology) of claim 13 at issue on appeal is It was not disclosed in 2009; at the time, Minerva was still improving its SDMP technology, so the invention was not ready to be patented.
In its discussion, the CAFC said Minerva’s display of the Aurora device at AAGL 2009 was “far more than just a visual view” of the device. The court explained:
“AAGL 2009 was the industry’s ‘super bowl’ and was open to the public. It included key participants for Minerva’s budding business, such as potential investors and physicians, and Minerva had every incentive to introduce these participants to the Aurora device as best it could. According to records, Minerva brought “15 of him with full stomachs.”[y] From “functional” Aurora devices to AAGL 2009…. Minerva’s unveiling of these 15 devices spanned several days, and Minerva showcased them at its booth, stakeholder meetings, and technical presentations. ” [citations omitted]
In addition, Minerva pitched the device to industry members who were able to study it closely. Minerva denied the device was physically handled, but the CAFC said it didn’t matter. “[O]Disclosure standards that rise to the level of public use are not based on devices being physically handled by the public. Public use can also occur if the device is used in a way that one member of the public understands the invention. Nor was the observer of the device bound to confidentiality through non-disclosure agreements or other informal agreements, the court said.
The CAFC also found that SDMP terminology was disclosed by the Aurora device presented at AAGL 2009. devices with SDMP technology,” the court said.
Turning to Minerva’s assertion that the invention was not ready for patenting at AAGL 2009, the CAFC argued that “(1) Minerva worked the invention; I did not agree on the grounds that I had a valid document describing the invention of
On the first point, the court found that despite Minerva’s allegations that it was still working to improve the Aurora device of the time, it substantiated claim 13 and functioned to perform endometrial ablation. Minerva’s creation of a working prototype showed the invention to be patent-ready, it said. unequivocally dismisses Minerva’s claim that it was never actually used. “Contrary to Minerva’s contention, our case law does not require us to impose a ‘living human’ requirement here,” the court wrote. “Minerva does not point to anything in the inherent records that indicates that the ‘208 patent is limited to devices usable only in living human tissue.” “It was just a ‘later improvement’ or ‘tweak,'” the court said.
Moreover, even if the court applied the enhanced requirements proposed by Minerva, it would be fair to say that if the relevant studies of record “Minerva’s device would be considered acceptable for clinical use in the pre-hysterectomy case.” means a clinical trial in live humans.
Finally, the invention was ready for patenting because of the document “sufficiently specific to enable a person skilled in the art to carry out the invention” in the SDMP terms of claim 13. Devices with SDMP terminology.
The Federal Circuit therefore affirms that the district court granted summary judgment against Hologic, and Hologic is entitled to judgment as a matter of law in anticipation of the ‘208 patent under § 102(b)’s prohibition ordinance. said there is.
Minerva and Hologic were also recently involved in a high-profile battle before the Supreme Court stemming from one of Hologic’s patents centered on assignee estoppel doctrine.
