Minerva Surgical, Inc. v. Hologic, Inc.

• Decision Date: 23 July 2021
• Docket Number: C.A. No. 18-00217-JFB-SRF
• Parties: MINERVA SURGICAL, INC. Plaintiff and Counterdefendant, v. HOLOGIC, INC. and Cytyc Surgical Products, LLC, Defendants and Counterclaimants.
• Court: U.S. District Court — District of Delaware

550 F.Supp.3d 158

MINERVA SURGICAL, INC. Plaintiff and Counterdefendant,

v.HOLOGIC, INC. and Cytyc Surgical Products, LLC, Defendants and Counterclaimants.

C.A. No. 18-00217-JFB-SRF

United States District Court, D. Delaware.

Signed July 23, 2021

Ian Robert Liston, Jennifer A. Ward, Wilson Sonsini Goodrich & Rosati PC, Wilmington, DE, Christopher D. Mays, Pro Hac Vice, Dale R. Bish, Pro Hac Vice, Edward G. Poplawski, Pro Hac Vice, Erik J. Carlson, Pro Hac Vice, Neil N. Desai, Pro Hac Vice, Olivia M. Kim, Pro Hac Vice, Ty W. Callahan, Pro Hac Vice, Vera M. Elson, Pro Hac Vice, for Plaintiff and Counterdefendant.

Karen L. Pascale, Young, Conaway, Stargatt & Taylor LLP, Wilmington, DE, Assad Rajani, Pro Hac Vice, Jonathan Swisher, Pro Hac Vice, Marc A. Cohn, Pro Hac Vice, Masanori (Marty) Koresawa, Pro Hac Vice, Matthew M. Wolf, Pro Hac Vice, Ryan J. Casamiquela, Pro Hac Vice, William O. Young, Jr., Pro Hac Vice, for Defendants and Counterclaimants.

MEMORANDUM AND ORDER

Joseph F. Bataillon, Senior United States District Judge

This matter is before the Court on the parties’ cross-motions for summary judgment on the issue of invalidity. D.I. 208 and D.I. 210. Plaintiff Minerva Surgical Inc. ("Minerva") seeks a summary judgment of validity of U.S. Patent No. 9,186,208 ("the ’208 patent") and defendants Cytyc Surgical Products, LLC's and Hologic, Inc. (collectively, "Hologic") seek a declaration that the asserted claims of the ’208 patent are invalid under 25 U.S.C. § 102(b).¹ This is an action for patent infringement under 35 U.S.C. § 271 et seq. The parties’ motions on invalidity are dispositive of the action herein.

Hologic argues that the asserted claims of the ’208 patent are invalid under the public display or on-sale bar of § 102(b) because Minerva displayed an embodiment of the purported invention, its "Aurora" endometrial ablation

device prototype at the 38th Global Congress of Minimally Invasive Gynecology sponsored by the American Association of Gynecologic Laparoscopists on November 16-19, 2009 ("AAGL 2009"). Minerva counters that Hologic's evidence does not show that any device at Minerva's trade-show booth embodied the asserted claims. Minerva argues that the evidence on which Hologic relies does not amount to clear and convincing evidence of public use and contends the ’208 patent was not ready for patenting at the time of the AAGL Conference in 2009. It proposes a timeline wherein the accused product was conceived less than a week after the conference and diligently reduced to practice.

Conversely, Minerva moves for a summary judgment declaring that the ’208 patent is valid.² Specifically, Minerva seeks a declaration that no Minerva prototype was "in public use" as of November 2009 and cannot be used to invalidate the ’208 Patent under 35 U.S.C. § 102(b).³

I. FACTS

The following facts are gleaned from the Court's earlier orders and from the parties’ agreed facts. See D.I. 80; D.I. 130, Orders; D.I. 335, Proposed Pretrial Order, D.I. 335-1, Ex.1, Statement of Uncontested Facts. Minerva and Hologic are competing suppliers of endometrial ablation

devices to treat Menorrhagia, also known as Abnormal Uterine Bleeding or AUB, which is menstrual bleeding that is abnormally heavy in amount and/or duration. Id. Endometrial ablation is a transcervical surgical technique in which the lining of the uterus is destroyed with the goal of preventing further bleeding. D.I. 335-1, Ex. 1 at 4. Hologic's NovaSure ADVANCED, NovaSure CLASSIC, and Minerva's Endometrial Ablation System are indicated for use on pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes of whom childbearing is complete. D.I. 335-1, Ex. 1 at 3-5, Statement of Uncontested Facts.

These devices are designed to insert an expandable and contractible frame into the patient's uterus through the cervical canal. D.I. 80 at 1. The frame consists of "inner" and "outer" elements, also called flexures or struts, that expand to bring a membrane into contact with the uterine cavity. Id. Once in place, the membrane is used to apply energy sufficient to destroy the uterine lining. Id.

The ’208 patent is entitled "Systems for Endometrial Ablation

." D.I. 335-1, Ex. 1, Statement of Uncontested Facts at 1. The ’208 patent was issued by the United States Patent and Trademark Office on November 17, 2015. Id. Csaba Truckai and Akos Toth are listed as inventors on the ’208 patent. Id. Minerva is listed on the ’208 patent as the Assignee. Id. The ’208 patent expires on August 23, 2029. Id. at 2. The ’208 patent issued from U.S. Patent Application No. 13/667,774 ("the ’774 application"), which was filed on November 2, 2012. Id. The ’774 application is a continuation-in part of U.S. Patent Application No. 13/267,258, filed on October 6, 2011, which claims the benefit of Provisional Application No. 61/394,693, filed on October 19, 2010, and Provisional Application No. 61/556,675, filed on November 7, 2011. Id. The application relevant to the present motion is Provisional Application No. 61/556,675, filed on November 7, 2011.

Hologic started selling NovaSure ADVANCED in February 2017 in the United States.⁴ Id. Hologic markets and sells NovaSure ADVANCED throughout the United States. Id. at 3. Hologic markets and sells NovaSure CLASSIC throughout the United States. Id. at 21. Minerva markets and sells its Endometrial Ablation System throughout the United States. Id.

Minerva alleges that Hologic infringes independent Claim 13 and dependent claims 14-15, 17-18, and 20-23 (the "Asserted Claims") of the ’208 Patent. Independent claim 13 of the ’208 patent reads as follows:

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.

D.I. 1-2, Ex. B at 35, ’208 Patent, Claim 13 (emphasis added). The other asserted claims are dependent on claim 13. Id. Because Hologic does not dispute that all other requirements of the single asserted independent claim are literally present in the accused product, the focus of this case is on the ’208 patent ’s requirement that the inner and outer elements have "substantially dissimilar material properties" ("SDMP"). D.I. 247, Minerva's Answering Brief at 1 n.3; D.I. 279, Reply Brief at 13. The record shows, and the parties agree, that the priority date for the SMDP claim of the patent is November 7, 2011, which is the date patent application No. 61/556,675—the first application containing the SMDP limitation—was filed. D.I. 224, Declaration of Marc Cohn ("Cohn Decl.") Vol. I, D.I. 224-3, Ex. 32, Dr. Briant Report at 74.

After a hearing on disputed terms of the patent hearing under Markman v. Westview Instruments, Inc. , 52 F.3d 967, 977-78 (Fed. Cir. 1995), aff'd , 517 U.S. 370, 388-90, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), the Court construed SMDP to mean that the "inner and outer frame elements have different thickness and different composition." D.I. 130, R&R D.I. 194, Order adopting R&R. In recommending that construction of the term, the Magistrate Judge rejected Minerva's proposal that the claim term should be construed as "different thickness or width and different composition or treatment that provide different spring characteristics to influence the expandable planar triangular shape of the energy delivery surface." D.I. 130, R&R at 5-6. This Court subsequently overruled both parties’ objections to the R&R and adopted the Magistrate Judge's claim construction in its entirety. D.I. 194.

Minerva concedes that its plasma delivery system had been reduced to practice by the start of the AAGL Conference and acknowledges that some preliminary safety tests of that system had been completed.⁵ D.I. 279, Minerva Brief at 7; D.I. 248, Answering Brief at 5; D.I. 216, Declaration of Neil N. Desai ("Desai Decl."); D.I. 216-2, Ex. 11, Deposition of Akos Toth dated September 28, 2017 ("Toth Dep. I"); D.I. 216-2, Ex. 13, Deposition of Akos Toth dated May 31, 2019 ("Toth Dep. II"). Named inventor Akos Toth testified that Minerva had the frame design well established by late 2009. D.I. 216-2, Ex. 13, Toth Dep. II at 483. Co-inventor Csaba Truckai stated that the dissimilar properties limitation was conceived between July 23, 2009 and November 25, 2009. Id. , Ex. 12, Deposition of Csaba Truckai dated October 3, 2017 ("Truckai Dep. I"), at 448. Toth narrowed the timeframe for frame limitation to early- to mid-2009. D.I. 216-2, Ex. 13, Toth Dep. II at 475-76, 481-82, and 484-87.

Minerva's expert, Dr. Paul Briant, stated in his expert report that, based on his review of the record, the invention at issue was conceived no later than November 25, 2009. D.I. 224, Cohn Decl. Vol. II; D.I. 224-3, Ex. 32, Expert Invalidity Rebuttal Report of Dr. Paul L. Briant at 331. Dr. Briant identified and relied on lab notes dated July 23, 2009, to support his opinion on conception. The evidence shows that lab notes were made and kept in chronological order. D.I. 224-3 at 151; see D.I. 225-1, Ex. 46, Akos Toth Deposition at 498. Undated pages of a lab notebook that precede a page dated November 25, 2009 shows drawings of inner frame elements with 0.018? thickness and outer frame elements with 0.010? thickness and drawings of inner frame elements with 440A stainless steel and outer frame elements made of 17-4 PH, which have different compositions. D.I. 224-3, Ex. 31, Dr. Briant Rebuttal Report at 156 and 160.

There is no dispute that Minerva attended the trade show from November 16-19, 2009 and displayed a device then known as the Minerva "Aurora" there....