Opinion · Court of Appeals for the Federal Circuit

Minerva Surgical, Inc. v. Hologic, Inc.

59 F.4th 1371

Type
Opinion
Court
Court of Appeals for the Federal Circuit
Jurisdiction
Federal
Date
2023-02-15
Topic
general

Case: 21-2246 Document: 58 Page: 1 Filed: 02/15/2023 United States Court of Appeals for the Federal Circuit ______________________ MINERVA SURGICAL, INC., Plaintiff-Appellant v. HOLOGIC, INC., CYTYC SURGICAL PRODUCTS, LLC, Defendants-Appellees ______________________ 2021-2246 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-00217-JFB-SRF, Senior Judge Joseph F. Bataillon. ______________________ Decided: February 15, 2023 ______________________ ROBERT N. HOCHMAN, Sidley Austin LLP, Chicago, IL, argued for plaintiff-appellant. Also represented by JULIA G.

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Case: 21-2246     Document: 58    Page: 1   Filed: 02/15/2023




   United States Court of Appeals
       for the Federal Circuit
                  ______________________

                MINERVA SURGICAL, INC.,
                    Plaintiff-Appellant

                             v.

  HOLOGIC, INC., CYTYC SURGICAL PRODUCTS,
                      LLC,
              Defendants-Appellees
             ______________________

                        2021-2246
                  ______________________

     Appeal from the United States District Court for the
 District of Delaware in No. 1:18-cv-00217-JFB-SRF, Senior
 Judge Joseph F. Bataillon.
                  ______________________

                 Decided: February 15, 2023
                  ______________________

     ROBERT N. HOCHMAN, Sidley Austin LLP, Chicago, IL,
 argued for plaintiff-appellant. Also represented by JULIA
 G. TABAT, CAROLINE A. WONG; VERA ELSON, Wilson, Son-
 sini, Goodrich & Rosati, PC, Palo Alto, CA.; OLIVIA M. KIM,
 EDWARD        POPLAWSKI,        Los      Angeles,       CA.

     MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
 Washington, DC, argued for defendants-appellees. Also
 represented by MARC A. COHN, JENNIFER SKLENAR; AARON
 PATRICK BOWLING, Chicago, IL; RYAN CASAMIQUELA, San
 Francisco, CA; ASSAD H. RAJANI, Palo Alto, CA.
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 2                    MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



                  ______________________

     Before PROST, REYNA, and STOLL, Circuit Judges.
 REYNA, Circuit Judge.
     Minerva Surgical, Inc. sued Hologic, Inc. and Cytyc
 Surgical Products, LLC in the District of Delaware for in-
 fringement of 
U.S. Patent No. 9,186,208
. After discovery,
 the district court granted summary judgment that the as-
 serted claims are anticipated under the public use bar of
 pre-AIA 
35 U.S.C. § 102
(b). Minerva appeals.
      We affirm. First, the patented technology was “in pub-
 lic use” because, before the critical date, Minerva disclosed
 fifteen devices having the technology at an event—the in-
 dustry’s “Super Bowl.” Minerva’s disclosure of these de-
 vices spanned several days and included Minerva
 showcasing them at a booth, in meetings with interested
 parties, and in a technical presentation. Minerva did not
 disclose the devices under any confidentiality obligations,
 despite the commercial nature of the event.
     Second, at the time of the public use, the technology
 was “ready for patenting.” Specifically, Minerva had cre-
 ated working prototypes and enabling technical documents
 describing the claimed technology.
     The district court thus correctly granted summary
 judgment of invalidity because there are no genuine factual
 disputes, and defendants are entitled to judgment as a
 matter of law that the asserted claims are anticipated un-
 der the public use bar of § 102(b).
                      THE ’208 PATENT
     The application for 
U.S. Patent No. 9,186,208
 (the “’208
 patent”) was filed on November 2, 2012, and claims a pri-
 ority date of November 7, 2011. Minerva Surgical, Inc. v.
 Hologic, Inc., 
550 F. Supp. 3d 158
, 161 (D. Del. 2021).
 Csaba Truckai and Akos Toth are the listed inventors.
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                   3



     The ’208 patent is directed to surgical devices for a pro-
 cedure called “endometrial ablation,” which stops or re-
 duces abnormal uterine bleeding. ’208 patent at Abstract.
 The procedure generally involves inserting a device having
 an energy-delivery surface into a patient’s uterus, expand-
 ing the surface, energizing the surface to “ablate” or de-
 stroy the endometrial lining of the patient’s uterus, and
 removing the surface. See 
id.
 at 1:31–2:67, 6:12–60.
     The patented device contains a frame having “inner”
 and “outer” elements, also called flexures or struts, as seen
 in the following figure:
 Op. Br. at 11 (annotating Fig. 9 of the ’208 patent). The
 elements expand to bring the energy-delivery surface into
 contact with the walls of the uterine cavity. Minerva Sur-




 gical, 550 F. Supp. 3d at 161. Once in place, the energy-
 delivery surface is used to apply energy sufficient to de-
 stroy the uterine lining. Id.
     Independent claim 13, representative for the purposes
 of this appeal, recites:
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 4                    MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



     A system for endometrial ablation comprising:
         an elongated shaft with a working end hav-
         ing an axis and comprising a compliant en-
         ergy-delivery surface actuatable by an
         interior expandable-contractable frame;
         the surface expandable to a selected planar
         triangular shape configured for deploy-
         ment to engage the walls of a patient’s uter-
         ine cavity;
         wherein the frame has flexible outer ele-
         ments in lateral contact with the compliant
         surface and flexible inner elements not in
         said lateral contact, wherein the inner and
         outer elements have substantially dissimi-
         lar material properties.
 ’208 patent at 22:34–45 (emphasis added).
     This appeal focuses on the claim term, “the inner and
 outer elements have substantially dissimilar material
 properties,” (“SDMP” term) which was construed by the
 court to mean that the “inner and outer frame elements
 have different thickness and different composition.” Mi-
 nerva Surgical, 550 F. Supp. 3d at 162. The parties do not
 appeal that construction. The parties also do not dispute
 that the SDMP frame is intended to result in: (1) An in-
 crease to the device’s flexibility—facilitating the device’s
 ability to contact the uterine lining; (2) An increase to the
 device’s durability—preventing deformation while the de-
 vice is being used and removed; and (3) A reduction in the
 device’s diameter. See id. at 164–65; Op. Br. at 3–4, 15;
 Resp. Br. at 8–10; J.A. 6334.
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                  5



                DISTRICT COURT PROCEEDINGS
      In 2017, Minerva accused Hologic, Inc. and Cytyc Sur-
 gical Products, LLC (collectively “Hologic”) of infringing
 the ’208 patent. J.A. 116. After discovery, Hologic moved
 for summary judgment of invalidity, arguing that the as-
 serted ’208 patent claims were anticipated under the public
 use bar of pre-AIA 
35 U.S.C. § 102
(b). 1 Minerva Surgical,
 550 F. Supp. 3d at 160. According to Hologic, on November
 16–19, 2009—more than a year before the ’208 patent’s pri-
 ority date—Minerva brought a device called “Aurora” to
 the 38th Global Congress of Minimally Invasive Gynecology
 sponsored by the American Association of Gynecologic Lap-
 aroscopists (“AAGL 2009”). Hologic asserted that the Au-
 rora device disclosed every limitation of the asserted claims
 and that the asserted claims were therefore invalid as an-
 ticipated by Minerva’s own device.
     The story of the Aurora device starts in 2008, when Mi-
 nerva began its development. Op. Br. at 9. By early 2009,
 Minerva had begun developing prototypes, but these
 lacked a frame, an “inner flexure,” “lateral symmetry,” and
 the SDMP technology. J.A. 6644–45. Minerva was, how-
 ever, searching for the “right combination of parameters to
 be able to open the device wide enough and cover a large
 enough surface area, deliver energy and then be able to col-
 lapse” so the device could be withdrawn, i.e. problems the
 SDMP technology resolved. Id.
     By mid-2009, Minerva had prototypes that could be in-
 serted into uteri, could deliver energy necessary to perform
 the surgery, and could be withdrawn after the procedure,
 but the prototypes’ frames were “deforming too much.”


     1   “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.” Pre-AIA 
35 U.S.C. § 102
(b).
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 6                    MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



 J.A. 6645. By July or August 2009, Minerva had recog-
 nized that the deformation was caused by the prototypes
 having “a very simple frame structure . . . [with] the same
 properties.” J.A. 6646; see also J.A. 6621 (Inventor Truckai
 testifying that conception of the SDMP term occurred
 “somewhere between” July 23, 2009, and November 25,
 2009).
     In July 2009, Minerva began testing the Aurora device
 on extirpated (surgically-removed) human uteri. Op. Br. at
 55–56. A report analyzing tests conducted on October 1,
 2009, and November 14, 2009, describes that “[a]ll Minerva
 devices (n=13) were successfully deployed and conformed
 to the uterus,” and “[a]ll devices were removed successfully
 post-ablation.” J.A. 12175–76. These results align with
 the benefits that the SDMP technology is intended to
 achieve. The report concludes that “the Minerva device
 would be considered acceptable for clinical use in pre-hys-
 terectomy cases”—i.e., in live patients. J.A. 12176.
     Undated pages from a lab notebook show the Aurora
 device having a frame with an inner element using 440A
 stainless steel and an outer element using 17-4 PH stain-
 less steel. J.A. 12227. These two steels have different
 thicknesses and compositions, and thus disclose the SDMP
 term. Minerva Surgical, 550 F. Supp. 3d at 163. While
 these pages are undated, subsequent pages are dated No-
 vember 25, 2009. J.A. 12250.
     The undated lab notebook pages include two CAD
 drawings dated August 2009 that also disclose the SDMP
 term. J.A. 12234; Minerva Surgical, 550 F. Supp. 3d at
 163. The first CAD drawing shows an outer element made
 of 0.010” thick 17-4 PH stainless steel. Id. The second
 drawing shows an inner element made of 0.018” thick 420
 stainless steel. Id. Inventor Toth testified that prototypes
 using 420 stainless steel “were performing quite fine” but
 “Minerva didn’t stop developing the [Aurora] device even
 though the frame was like perfect.” J.A. 6668. He
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                   7



 explained that Minerva later found materials that were “a
 little better.” J.A. 6669.
     On October 23, 2009, Minerva pitched the Aurora de-
 vice to a potential acquiror. J.A. 11883, 12090. The presen-
 tation slide deck includes several photos of the device and
 touts that the Aurora device had a “small insertion diame-
 ter” and improved “[f]lexibility to conform” to the uterus—
 the benefits of the SDMP technology. J.A. 11899–900.
     By October 2009, Minerva was preparing for AAGL
 2009, an industry related event dubbed “the Super Bowl of
 [the] industry” by Inventor Truckai. J.A. 9128. AAGL
 2009 attendees were from various industry groups,
 competitors, investors, and phyisicians. J.A. 11294 (slide
 deck describing that around 70 device companies had
 exhibits at AAGL 2009), 11914, 12090–91.
      Inventor Truckai—who was Minerva’s CEO at the
 time—asked Minerva’s research and development team to
 have “15 full[y] functional” devices ready to bring to AAGL
 2009. J.A. 14643; Minerva Surgical, 550 F. Supp. 3d at
 164.    Minerva obtained a booth at AAGL 2009 to
 demonstrate the Aurora devices. J.A. 12115, 11298–99. A
 Minerva employee manning the booth reported in an email
 that the “[b]ooth has been busy. Lots of interested [doctors]
 including several potential investigators. . . . Devices have
 been working well. One frame broke but I swapped it out
 undetected.”       J.A. 12189.       A Minerva document
 summarizes “comments from AAGL . . . meetings” and
 provides feedback that Minerva received on its Aurora
 device from sophisticated attendees, such as phyisicians.
 J.A. 11914. One comment states that the Aurora device’s
 “[f]rame flexibility lends possibility of better conformity to
 varying architectures of the uterine cavity,” which, again,
 is a purpose of the SDMP technology. Id.
     On November 19, 2009, Dr. Andrew Brill, the
 Chairman of Minerva’s Medical Advisory Board, gave a
 presentation at AAGL 2009 discussing the Aurora device.
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 8                    MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



 A brochure, distributed at AAGL 2009, explains that the
 presentation would include discussion of “[t]he disposable
 device’s ability to conform to the uterus [to] enable
 treatment of uterine cavities with deformities and variable
 volumes.” J.A. 13444.
      An “Investigator’s Brochure” dated November 20,
 2009—a day after AAGL 2009—provided a detailed de-
 scription of the Aurora device and identified that its frame
 elements were made of “Stainless steel (420 and 17-4),”
 which is consistent with the August 2009 CAD drawings.
 J.A. 12169. Similarly, a Bill of Materials from November
 24, 2009, lists the same frame elements. Resp. Br. at 18
 (citing J.A. 11917); Op. Br. at 18–19 (conceding that the
 Bill of Materials “sets forth the specifications for a frame
 with flexures having different thicknesses and different
 compositions of steel”). These documents, therefore, all dis-
 close the SDMP term. Inventor Toth testified that the de-
 vice referenced in the Bill of Materials was “[l]ikely” the
 Aurora device shown at AAGL 2009. J.A. 6689.
     In view of the forgoing record, the district court granted
 summary judgment that the asserted claims are antici-
 pated under the public use bar. Minerva Surgical, 550 F.
 Supp. 3d at 169–70. The court found no genuine dispute
 that the display and demonstration of the Aurora device at
 AAGL 2009 constituted public use more than a year before
 the ’208 patent’s priority date and that those devices dis-
 closed embodied claim 13 of the ’208 patent. Id. The court
 also explained that the prototypes and technical documents
 showed that the invention of the ’208 patent was ready for
 patenting at the time of AAGL 2009. Id.
     Minerva timely appeals, and we have jurisdiction un-
 der 
28 U.S.C. § 1295
(a)(1).
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                      9



                     STANDARD OF REVIEW
     We review a district court’s grant of summary judg-
 ment under the law of the regional circuit, in this case the
 Third Circuit. Teva Pharm. Indus. Ltd. v. AstraZeneca
 Pharm. LP, 
661 F.3d 1378, 1381
 (Fed. Cir. 2011). The
 Third Circuit reviews a grant of summary judgment de
 novo. 
Id.
 Summary judgment is appropriate when, draw-
 ing all justifiable inferences in the nonmovant’s favor,
 there exists no genuine issue of material fact and the mo-
 vant is entitled to judgment as a matter of law. Fed. R. Civ.
 P. 56(a); Anderson v. Liberty Lobby, Inc., 
477 U.S. 242, 255
 (1986). “Whether a patent is invalid for public use is a
 question of law based on underlying facts.” Am. Seating
 Co. v. USSC Grp., Inc., 
514 F.3d 1262, 1267
 (Fed. Cir.
 2008).
                          DISCUSSION
    Minerva argues that the court erred in granting sum-
 mary judgment of invalidity based on the public use bar.
 We disagree.
                  Pre-AIA 
35 U.S.C. § 102
(b)
     Under the 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.” Pre-AIA 
35 U.S.C. § 102
(b). “The public use bar is triggered ‘where,
 before the critical date, the invention is [(1)] in public use
 and [(2)] ready for patenting.’” 2 Polara Eng’g Inc. v. Camp-
 bell Co., 
894 F.3d 1339, 1348
 (Fed. Cir. 2018) (citing Invi-
 trogen Corp. v. Biocrest Mfg., L.P., 
424 F.3d 1374, 1379
 (Fed. Cir. 2005)).




     2   The parties agree that the critical date for the ’208
 patent is November 7, 2010.
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 10                    MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



      The “in public use” element of the bar is met if the in-
 vention “was accessible to the public or was commercially
 exploited” 3 by the inventor. Delano Farms Co. v. California
 Table Grape Comm’n, 
778 F.3d 1243, 1247
 (Fed. Cir. 2015)
 (citation omitted); see also Dey, L.P. v. Sunovion Pharms.,
 Inc., 
715 F.3d 1351, 1355
 (Fed. Cir. 2013) (same with minor
 modifications). “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.”
 Am. Seating, 
514 F.3d at 1267
. To determine whether this
 occurred, the court considers, “inter alia, the nature of and
 public access to activities involving the invention [and] con-
 fidentiality obligations imposed upon observers.” Id.;
 Delano Farms, 
778 F.3d at 1247
.
      “Ready for patenting”—the second element of the pub-
 lic use bar—may be shown in at least two ways. Pfaff v.
 Wells Elecs., Inc., 
525 U.S. 55
, 67–68 (1998). The first way
 is “by proof of reduction to practice before the critical date.”
 
Id.
 “Reduction to practice occurs if the claimant had pos-
 session of the subject matter of the [claim] and . . . it was
 shown or known to work for its intended purpose.” Helsinn
 Healthcare S.A. v. Teva Pharm. USA, Inc., 
855 F.3d 1356, 1372
 (Fed. Cir. 2017) (citation omitted). “Possession” of the
 subject matter may be shown by the existence of a working
 prototype. Hamilton Beach Brands, Inc. v. Sunbeam
 Prods., Inc., 
726 F.3d 1370, 1379
 (Fed. Cir. 2013). The “in-
 tended purpose” of an invention should be considered in
 light of the claims and specification. Manning v. Paradis,
 
296 F.3d 1098
, 1102–04 (Fed. Cir. 2002).
     The second way the “ready for patenting” element may
 be shown is “by proof that prior to the critical date the in-
 ventor had prepared drawings or other descriptions of the


      3  Because we find that the invention “was accessible
 to the public,” we do not resolve whether it was also “com-
 mercially exploited.” Delano Farms, 
778 F.3d at 1247
.
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                  11



 invention that were sufficiently specific to enable a person
 skilled in the art to practice the invention.” Pfaff, 525 U.S.
 at 67–68. For example, we have found “CAD drawings” and
 related descriptions sufficiently enabling. Hamilton Beach
 Brands, 
726 F.3d at 1378
.
      Minerva has three main arguments. First, Minerva as-
 serts that disclosure of the Aurora device at AAGL 2009
 was not “in public use” because Minerva “merely displayed”
 the device. Op. Br. at 59–65. Second, Minerva argues that
 there was no disclosure of the “invention” of claim 13 of the
 ’208 patent because the Aurora device disclosed at AAGL
 2009 lacked the SDMP term. 
Id.
 at 42–53. Third, Minerva
 argues that the invention was not “ready for patenting” be-
 cause Minerva was still improving the SDMP technology at
 the time of AAGL 2009, so the device did not function for
 its intended purpose of ablating “live human” tissue. 
Id.
 at
 53–59. We address each of these arguments in turn.
                          In Public Use
     The district court correctly determined that disclosing
 the Aurora device at AAGL 2009 constituted the invention
 being “in public use” for the purposes of § 102(b) because
 the invention was “shown to . . . individual[s] other than
 the inventor under no limitation, restriction, or obligation
 of confidentiality.” Am. Seating, 
514 F.3d at 1267
.
      First, “the nature of and public access to activities in-
 volving” the Aurora device at AAGL 2009 indicate public
 use. 
Id.
 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 incen-
 tive 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. J.A.
 14643. 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
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 12                   MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



 in a technical presentation. J.A. 9091, 11296, 12115, 12189
 (describing the booth as being “busy,” with “[l]ots of inter-
 ested [doctors,] including several potential investigators,”
 stopping by). Demonstrations of the Aurora device at the
 exhibition booth involved using the device on a “transpar-
 ent uterine model with saline” and resulted in “[h]ighly vis-
 ible plasma [being] generated only where saline contacted”
 the energy-delivery surface of the device. J.A. 11299. On
 the last day of the show, Minerva sponsored a presentation
 by Dr. Andrew Brill, Chairman of Minerva’s Medical Advi-
 sory Board, who among other things highlighted the Au-
 rora device’s “ability to conform to the uterus [that] may
 enable treatment of uterine cavities with deformities and
 variable volumes.” J.A. 9096–97; see also J.A. 9018, 9073,
 9096–97, 12035.
     Citing Motionless Keyboard, Minerva argues that its
 “mere display” of the Aurora device at AAGL 2009 does not
 rise to the level of “public use.” Op. Br. at 60–61 (citing
 Motionless Keyboard Co. v. Microsoft Corp., 
486 F.3d 1376
 (Fed. Cir. 2007)). We disagree.
     In Motionless Keyboard, the inventor disclosed his pa-
 tented keyboard to various third parties. Motionless Key-
 board, 
486 F.3d at 1385
. But these disclosures “only
 provided a visual view of the new keyboard design without
 any disclosure of the” claimed technology, which involved
 “enter[ing] data into a system.” 
Id.
     Minerva’s disclosure at AAGL 2009 went well beyond
 that at issue in Motionless Keyboard. At AAGL 2009, as
 evidenced by the records of the event (such as the feedback
 Minerva documented), Minerva pitched the Aurora device
 to various sophisticated industry members, who were al-
 lowed to scrutinize the Aurora device closely and see how
 it operated. For example, the “Product Comments” Mi-
 nerva received from the “AAGL & MAB [Medical Advisory
 Board] Meetings November 16–19, 2009” praised the “er-
 gonomic design of the handle” as “comfortable and easy to
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                   13



 use” for physicians and highlighted the “[f]rame flexibility”
 and “[f]lexibility of [the] shaft” as beneficial for patients.
 J.A. 11914; see also J.A. 11907–09, 12116. See generally 3
 Matthews Annotated Patent Digest § 17:145 (collecting
 cases) (“Displaying a product at a trade show by demon-
 strating to observers the product in its normal operation,
 or a simulation thereof, generally constitutes a ‘public use’
 of the displayed product.”); Art+Com Innovationpool
 GmbH, v. Google LLC, 
712 F. App’x 976, 984
 (Fed. Cir.
 2017) (invalidity finding where evidence showed that the
 “system was publicly demonstrated at two technical confer-
 ences to attendees with knowledge of the art and without
 any restriction or effort to maintain confidentiality”);
 Netscape Commc’ns Corp. v. Konrad, 
295 F.3d 1315
, 1319–
 21 (Fed. Cir. 2002) (affirming a district court’s conclusion
 that the inventor’s “demonstration of the claimed inven-
 tion” to two experts “without any obligation of confidenti-
 ality was a public use”). Minerva’s own employee reported
 that the Aurora devices were “working well” but were
 showcased so thoroughly that “[o]ne frame broke.” J.A.
 12189.
     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 proto-
 type at its AAGL booth that could be handled.” Op. Br. at
 63–64 (citing Minerva Surgical, 550 F. Supp. 3d at 169).
 Regardless of whether the Aurora devices were closely ob-
 served 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. See Am. Seating,
 
514 F.3d at 1267
. 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 un-
 derstood the invention. See Netscape, 295 F.3d at 1321.
 The inescapable conclusion of the detailed feedback Mi-
 nerva received on the Aurora device is that Minerva al-
 lowed knowledgeable individuals to scrutinize the
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 14                   MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



 invention enough to recognize and understand the SDMP
 technology Minerva later sought to patent. See, e.g., Dey,
 715 F.3d at 1355–56 (collecting cases) (“Even limited dis-
 closure to those who are skilled enough to know, under-
 stand, and easily demonstrate the invention to others, may
 mean that there was no reasonable expectation of secrecy
 and that the invention was therefore in public use.”).
      Second, the record shows that there were no “confiden-
 tiality obligations imposed upon” those who observed the
 Aurora device. Am. Seating, 
514 F.3d at 1267
. Minerva
 does not dispute the district court’s determination that the
 attendees were not required to sign non-disclosure agree-
 ments. J.A. 6689 (Inventor Toth stating his belief that
 AAGL 2009 participants were not required to sign NDAs).
 Nor does Minerva allege that AAGL 2009 implemented the
 type of informal confidentiality obligations we have recog-
 nized in prior cases. See, e.g., Bernhardt, L.L.C. v.
 Collezione Europa USA, Inc., 
386 F.3d 1371
, 1380–81 (Fed.
 Cir. 2004) (vacating a district court decision finding an in-
 validating public use where the district court failed to con-
 sider that “access was tightly controlled,” “there was an
 industry-wide understanding [of confidentiality],” “a
 breach of confidence could have serious consequences for
 an attendee,” and “there was no effective means for the at-
 tendees to divulge the designs they viewed at [the event]
 because no photographs or sketches . . . were permitted”).
 Instead, Minerva asserts that its “company policy is not to
 disclose proprietary information to people until Minerva
 files for a patent.” Op. Br. at 64 (cleaned up). While that
 may be true, the record establishes that Minerva did not
 follow this policy at AAGL 2009. 4



      4  Minerva also cites Delano Farms and Dey for its ar-
 gument that the AAGL 2009 disclosure was not “in public
 use.” See Op. Br. at 59–65. But there was evidence in those
 cases that the disclosure was confidential, unlike in this
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                 15



     Third, we agree with the district court that there is no
 genuine factual dispute that the Aurora devices shown at
 AAGL 2009 disclosed the SDMP term of claim 13. Minerva
 Surgical, 550 F. Supp. 3d at 169. The inventors conceived
 the SDMP technology before AAGL 2009. See, e.g., J.A.
 6646; see also J.A. 12234. 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. This includes Minerva’s
 July 2009 extirpated uteri studies, the lab notebook with
 August 2009 CAD drawings, the October 23, 2009 acquiror
 presentation, the November 20, 2009 Investigator
 Brochure, and the November 24, 2009 Bill of Materials.
     Further, the record establishes that it was this device
 disclosing the SDMP technology that Minerva brought to
 AAGL 2009. As discussed, Minerva brought “full[y]
 functional” devices to AAGL 2009. J.A. 14643. The
 feedback Minerva received at AAGL 2009 described
 features Minerva attributes to the SDMP term. J.A. 11914.
 Even Inventor Toth could not dispute that the device
 disclosed at AAGL 2009 “[l]ikely” had the SDMP term
 when confronted with the evidence. J.A. 6689.
    We therefore agree with the district court there was no
 genuine issue of material fact that the invention of claim




 case. See Delano Farms, 
778 F.3d at 1248
 (“When Jim
 Ludy gave [his cousin] the plants, Jim Ludy explicitly told
 his cousin to ‘keep [knowledge of the plants] to ourselves’
 and expected the fact of their possession of the plants to
 remain private.”); see also Dey, 
715 F.3d at 1356
 (material
 dispute existed where there was evidence of “precautions
 [that] were taken to exclude members of the public from
 obtaining information about the” at-issue drug).
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 16                   MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



 13 was “in public use” prior to the critical date of the ’208
 patent.
                     Ready for Patenting
     We conclude that the district court correctly deter-
 mined that the Aurora device was ready for patenting. The
 Aurora device was ready for patenting for two reasons: (1)
 Minerva reduced the invention to practice and (2) Minerva
 had enabling documentation describing the invention of
 claim 13.
     First, the record shows that the invention was ready
 for patenting because Minerva reduced the invention to
 practice by creating working prototypes that embodied
 claim 13 and worked for the intended purpose of perform-
 ing endometrial ablations. See Hamilton Beach Brands,
 
726 F.3d at 1379
. The evidence establishing this includes
 inventor testimony explaining the prototypes and their im-
 plementation of the SDMP technology, the extirpated uteri
 studies, and the documents describing the prototypes.
     Minerva asserts that there is a factual dispute as to re-
 duction to practice because Minerva was still working to
 improve the Aurora device at the time of AAGL 2009. Mi-
 nerva insists that the Aurora device did not function for its
 intended purpose of performing ablations on “live human”
 uteri. Op. Br. at 55. This argument is unsupported by law
 and the evidence in this case.
      Contrary to Minerva’s argument, our case law does not
 require imposing the “live human” requirement here. Mi-
 nerva points to nothing in the intrinsic record indicating
 that the ’208 patent is limited to devices only usable on live
 human tissue. See, e.g., Op. Br. at 54–55, 58; Reply Br. at
 5–12; see Manning, 296 F.3d at 1102–04. Further, that Mi-
 nerva was ultimately able to find materials that were “a
 little better” for the SDMP term does not preclude a reduc-
 tion to practice finding. J.A. 6668. This instead amounts
 to mere “later refinements” or “fine tuning,” which are
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 MINERVA SURGICAL, INC.   v. HOLOGIC, INC.                 17



 more than reduction to practice requires. See Atlanta At-
 tachment Co. v. Leggett & Platt, Inc., 
516 F.3d 1361, 1367
 (Fed. Cir. 2008) (“[I]t is improper to conclude that an in-
 vention is not reduced to practice merely because further
 testing is being conducted.”); Hamilton Beach Brands, 
726 F.3d at 1379
 (“‘Fine-tuning’ of an invention after the criti-
 cal date does not mean that the invention was not ready for
 patenting.”). 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 re-
 quired. Helsinn Healthcare, 855 F.3d at 1372–73 (explain-
 ing that FDA approval is much stricter than the “ready for
 patenting” standard); see Op. Br. at 56–57 (arguing that
 the inventors did not know whether the Aurora device
 would have a failure rate lower than the five or ten percent
 required for a successful commercial device).
     Even if we applied Minerva’s heightened “live human”
 requirement, however, this would not preclude a reduction
 to practice finding. As discussed, the extirpated uteri
 studies concluded that “the Minerva device would be con-
 sidered acceptable for clinical use in pre-hysterectomy
 cases,” in other words that the Aurora device would be
 considered acceptable for use in clinical trials on live
 humans. J.A. 12176. And Inventor Toth similarly testified
 that the disclosed versions of the Aurora device were nearly
 “perfect.” J.A. 6668.
     Aside from being reduced to practice, the invention was
 ready for patenting for a second reason: there was docu-
 mentation “sufficiently specific to enable a person skilled
 in the art to practice the invention” of the disputed SDMP
 term of claim 13. Pfaff, 525 U.S. at 67–68. This documen-
 tation includes the drawings and detailed descriptions in
 the 2009 lab notebook pages disclosing a device with the
 SDMP term. See J.A. 12227, 12234; see also J.A. 11899–
 900 (the October 23, 2009, acquiror presentation having
 images and details of the device); Hamilton Beach Brands,
 
726 F.3d at 1378
 (explaining that “CAD drawings and
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 18                   MINERVA SURGICAL, INC.   v. HOLOGIC, INC.



 descriptions . . . [were] more than enough to enable a per-
 son of ordinary skill in the art to practice the claimed in-
 vention”).
     We thus agree with the district court there was no gen-
 uine issue of material fact that the invention of claim 13
 was “ready for patenting” before the critical date of the ’208
 patent. 5
                         CONCLUSION
     The district court correctly determined that Minerva’s
 disclosure of the Aurora device constituted the invention
 being “in public use” and that the device was “ready for pa-
 tenting.” We therefore affirm the district court’s grant of
 summary judgment because there are no genuine factual
 disputes, and Hologic is entitled to judgment as a matter of
 law that the ’208 patent is anticipated under the public use
 bar of § 102(b). We have considered Minerva’s remaining
 arguments and do not find them persuasive.
                         AFFIRMED
                            COSTS
 No costs.




      5  Minerva also appeals the district court’s exclusion
 of Minerva’s expert testimony on the doctrine of equiva-
 lence. Because the asserted claims are invalid as antici-
 pated, we do not reach this moot issue.