Public Use Bar Doesn’t Require Invention to Be Handled or Ready for Human Use/FDA Approval

Intellectual Property Law

In Minerva Surgical, Inc. v. Hologic, Inc.,1 the Federal Circuit held that an invention ready for patenting is in public use if it is shown to or used by an individual other than the inventor with no obligation of confidentiality. There is no requirement that the invention be physically handled by the public to implicate the public use bar to patentability. In addition, an invention can be reduced to practice and ready for patenting even if it is not ready for human use or Food and Drug Administration (FDA) approval.

The application for U.S. Patent No. 9,186,208 (the ’208 patent) was filed on November 2, 2012, and claimed a priority date of November 7, 2011. The ’208 patent was related to surgical devices for endometrial ablation, that stopped or lessened abnormal uterine bleeding. The surgical device had an energy-delivery surface that was inserted into a patient’s uterus to obliterate and remove the endometrial lining of the uterus. The device included a frame having inner and outer elements, also called flexures or struts. The inner and outer elements had substantially dissimilar material properties (SDMPs). Independent claim 13 recited:

A system for endometrial ablation comprising:

an elongated shaft with a working end having an axis and comprising a compliant energy-delivery surface actuatable by an interior expandable-contractable frame;

the surface expandable to a selected planar triangular shape configured for deployment to engage the walls of a patient’s uterine cavity;

wherein the frame has flexible outer elements in lateral contact with the compliant surface and flexible inner elements not in said lateral contact, wherein the inner and outer elements have substantially dissimilar material properties.2

Minerva sued Hologic, Inc., and Cytyc Surgical Products, LLC (collectively, Hologic) for infringing the ’208 patent. Hologic filed for summary judgment of invalidity, asserting that the ’208 patent claims were anticipated by the public use bar of 35 United States Code Section 102(b). Hologic argued that from November 16 to 19, 2009, more than a year before the ’208 patent’s priority date, Minerva brought its Aurora device to the 38th Global Congress of Minimally Invasive Gynecology, funded by the American Association of Gynecologic Laparoscopists (AAGL 2009). Hologic contended that the Aurora device contained the features of the ’208 claims, which were consequently invalid as a result of the public use.3

The district court awarded summary judgment that the ’208 patent claims were anticipated by the public use bar. The court determined that the exhibition of the Aurora device at AAGL 2009 established public use more than a year before the ’208 patent’s priority date and that the Aurora device included the features of claim 13 of the ’208 patent. In addition, the district court found that the Aurora device was ready for patenting at the time of AAGL 2009.4

Minerva appealed, and the Federal Circuit affirmed. On appeal, Minerva contended that the district court incorrectly awarded summary judgment of invalidity based on public use. The Federal Circuit disagreed. Under the public use bar, “[a] person shall be entitled [to] 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.”5 The public use bar applies when, prior to the critical date, the invention was (1) in public use and (2) ready for patenting.

The “in public use” requirement is satisfied if the invention “was accessible to the public or was commercially exploited” by the inventor.6 “An invention is in public use if it is shown to or used by an individual other than the inventor under no limitation, restriction, or obligation of confidentiality.”7 “Ready for patenting,” the second requirement, can generally be demonstrated by providing evidence of reduction to practice prior to the critical date—that is, by showing that one year before the priority date, also called the critical date, the inventor created drawings or other descriptions of the invention that enabled a person of ordinary skill to practice the invention.

Minerva contended on appeal that the Aurora device at AAGL 2009 was not in public use because Minerva only exhibited the device and that the invention was not ready for patenting because the technology was still being improved at the time of AAGL 2009.

The Federal Circuit disagreed and determined that the district court properly concluded that displaying the Aurora device at AAGL 2009 established that the invention was in public use under Section 102(b) because the invention was demonstrated to individuals other than the inventor with no obligation of confidentiality. The court reasoned that the unrestricted access to the Aurora device at AAGL 2009 showed public use. Specifically, AAGL 2009 was considered the “Super Bowl” of the gynecologic device industry, and Minerva publicly disclosed 15 devices over several days and displayed the devices at a booth, in meetings with interested groups and in a technical presentation. The court reasoned that presentations of the Aurora device at the exhibition booth included demonstrating the device on a transparent uterine model, which generated highly visible plasma only where saline touched the energy-delivery surface of the inventive device.8

Minerva asserted, however, that its simple display of the Aurora device at AAGL 2009 was not sufficient to be considered a public use. The court disagreed and explained that Minerva showed the Aurora device to numerous experienced industry participants who were permitted to inspect the Aurora device thoroughly and see how it functioned. The court explained:

Minerva also disputes the district court’s finding that attendees “observed or handled” the device because “there is no evidence even suggesting that Minerva had a prototype at its AAGL booth that could be handled.” . . . Regardless of whether the Aurora devices were closely observed or physically handled, our 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. . . . The inescapable conclusion of the detailed feedback Minerva received on the Aurora device is that Minerva allowed knowledgeable individuals to scrutinize the invention enough to recognize and understand the SDMP technology Minerva later sought to patent.9

The court also noted that there were no confidentiality obligations placed on the individuals who saw the Aurora device. Further, there was no disagreement that the Aurora devices demonstrated at AAGL 2009 divulged the SDMP technology. In addition, it was the device revealing the SDMP technology that Minerva brought to AAGL 2009.

Therefore, the Federal Circuit agreed with the district court that the invention was in public use before the critical date of the ’208 patent. The court also determined that the Aurora device was ready for patenting because Minerva reduced the invention to practice and created documentation that described the invention. Specifically, Minerva reduced the invention to practice by producing working prototypes that encompassed the claims and worked for executing endometrial ablations. Minerva contended, however, that it was still working to refine the Aurora device at the time of AAGL 2009. Minerva maintained that the Aurora device did not operate for its planned purpose of executing ablations on live human uteri. The court disagreed and noted: “This argument is unsupported by law and the evidence in this case.”10 The court explained:

Contrary to Minerva’s argument, our case law does not require imposing the “live human” requirement here. Minerva points to nothing in the intrinsic record indicating that the ’208 patent is limited to devices only usable on live human tissue. . . . Further, that Minerva was ultimately able to find materials that were “a little better” for the SDMP term does not preclude a reduction to practice finding. . . . This instead amounts to mere “later refinements” or “fine- tuning,” which are more than reduction to practice requires. . . . Likewise, Minerva’s contention fails because it is essentially that the disclosed Aurora device was not ready for FDA approval, which is also beyond that required.11

 In addition, the invention was ready for patenting because Minerva created drawings and detailed descriptions in lab notebook pages disclosing a device with the SDMP term before the critical date. The court accordingly held that the invention was ready for patenting prior to the critical date of the ’208 patent.

Therefore, the Federal Circuit held that the district court properly held that Minerva’s demonstration of the Aurora device established that the invention was in public use and ready for patenting. The court affirmed the district court’s award of summary judgment to Hologic and held that the ’208 patent was anticipated under the public use bar of Section 102(b).

Practical considerations and action items

This decision is a reminder to prospective patent applicants to avoid revealing the details of an invention before filing a patent application, but if a disclosure is necessary, to make such disclosure in a confidential manner and preferably using a written confidentiality agreement. In situations where disclosure under confidentiality is not possible, such as disclosure of a prototype at a trade show, even if the prototype is not yet complete, the one-year grace period can start to file a patent application. Prospective applicants need to calendar this important date and ensure that any patent application on the disclosed invention or related improvements are filed within the year.

Keep in mind that it is the claimed invention that is the focus with regard to a public use or disclosure. That is, the scope of the claims defines what might be anticipated/invalidated by a public use/disclosure. Therefore, when dealing with potential public uses/disclosures, it is advisable to have a variety of claims, ranging from broad to very narrow, to increase the likelihood that the patent will survive such challenges. At the same time, patent litigants can still challenge the narrower claims that might not be anticipated based on obviousness, which would combine the public use/disclosure with other prior art.

Finally, patent owners that plan on asserting that the public use/disclosure was not enabling or was insufficient should remember to limit what information is publicly disclosed, limit what specific knowledge the public can collect, maintain specific records documenting what was disclosed and what was not disclosed and could not be understood, and if at all possible, limit who is provided the information and enter into confidentiality agreements with those limited individuals.

Irah Donner is a partner in Manatt’s Intellectual Property practice and is the author of Patent Prosecution: Law, Practice, and Procedure, 2023 Edition, and Constructing and Deconstructing Patents, Second Edition, both published by Bloomberg Law.

1Minerva Surgical, Inc. v. Hologic, Inc., 59 F.4th 1371, 2023 USPQ2d 194, 2023 WL 1999900 (Fed. Cir. 2023).

2 Id., 59 F.4th at 1374.

3 Id., 59 F.4th at 1376.

4 Id., 59 F.4th at 1377.

5 Id., 59 F.4th at 1377 (quoting 35 U.S.C. § 102(b)).

6 Id., 59 F.4th at 1377 (quotations and citations omitted).

7 Id., 59 F.4th at 1377 (quoting Am. Seating Co. v. USSC Grp., Inc., 514 F.3d 1262, 1267 (Fed. Cir. 2008)).

8 Id., 59 F.4th at 1378.

9 Id., 59 F.4th at 1379.

10 Id., 59 F.4th at 1381.

11 Id., 59 F.4th at 1381.



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