UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`MINERVA SURGICAL, INC.,
`Petitioner,
`
`v.
`
`HOLOGIC, INC.,
`Patent Owner.
`
`_____________
`
`Case PGR2017-00002
`Patent 9,247,989
`_____________
`
`PATENT OWNER’S BRIEF CONCERNING EX PARTE TRUCKAI
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`MINERVA SURGICAL, INC.,
`Petitioner,
`
`v.
`
`HOLOGIC, INC.,
`Patent Owner.
`
`_____________
`
`Case PGR2017-00002
`Patent 9,247,989
`_____________
`
`PATENT OWNER’S BRIEF CONCERNING EX PARTE TRUCKAI
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Pursuant to the Board’s December 4, 2017 Order (Paper No. 21), Patent
`
`Owner Hologic, Inc. (“Hologic”) submits this brief to address the Board’s October
`
`18, 2017 decision in Ex Parte Truckai (Ex. 3001), which conclusively establishes
`
`that Minerva’s attacks on the ‘989 patent are contrary to the disclosures of the
`
`specification itself.
`
`I.
`
`The Board Found That The Specification At Issue Here Discloses Both
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`Mechanical And Inflation-Based Expansion.
`
`In Ex Parte Truckai, the Board heard the appeal of Petitioner Minerva
`
`Surgical, Inc. (“Minerva”) from an Examiner’s finding that a claim for an
`
`endometrial ablation method was anticipated. Ex. 3001, at 1-2 (citing US
`
`2002/0022870 A1 (published Feb. 21, 2002) (“Truckai”)). There, the sole
`
`independent claim comprised insertion of a probe with “an expandable-contractible
`
`frame that carries a compliant energy-delivery surface,” and two expansion means:
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`“actuating the frame to expand the energy-delivery surface in the uterine cavity,”
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`and further, “actuating an inflation source to further expand the energy-delivery
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`surface in the uterine cavity.” Id. at 2.
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`Examining the disclosures of Truckai, the Board made five detailed Findings
`
`of Fact (“FF”) about its First Exemplary Embodiment and illustrative figures. Ex.
`
`3001, at 3-6 (citing Truckai ¶¶11-22, 31, 56-89, 95 & Figs. 1-10 & 20). Relevant
`
`here, Truckai and the ‘989 patent share a common specification; all passages and
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`- 1 -
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`
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`figures discussed by the Board thus have identical counterparts in the ‘989 patent.
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`Compare id. with Ex. 2001, at 2:36-3:20, 3:45-59, 4:58-9:24, 9:53-62 & Figs. 1-10
`
`& 20.1
`
`As the Board noted, Truckai recites: “the electrode carrying means 12 may
`
`be provided to have additional components inside it that add structural integrity
`
`to the electrode carrying means when it is deployed within the body.” Ex. 3001,
`
`FF5 (citing Truckai ¶85 (emphasis by Board)). This verbiage follows a description
`
`of actuating internal springs to expand the electrode carrying means. Id. (citing
`
`Truckai ¶¶81-83). “Thus,” the Board found, “Truckai teaches that the balloons 52,
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`shown as expanding the electrode carrying means in Figure 10, can be an
`
`additional component relative to the springs 15 and 19 to hold the electrode
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`carrying means 12 in contact with the uterine tissue to be ablated.” Id. Because
`
`Truckai discloses both “actuating the frame to expand the energy-delivery surface
`
`in the uterine cavity,” and “actuating an inflation source to further expand the
`
`energy-delivery surface in the uterine cavity,” it anticipates Minerva’s sole
`
`independent claim. Id. at 7.
`
`1 The common specification is from provisional application No. 60/084,791, filed
`
`on May 8, 1998.
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`- 2 -
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`
`
`On appeal, Minerva raised the same argument that it advances here: that “the
`
`inflatable balloons 52 disclosed by Truckai cannot be used with these spring
`
`members 15 and 19, but can only be used as an alternative thereto.” Ex. 3001, at 8.
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`Rejecting this based on disclosures in the specification itself, the Board reasoned
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`that “[t]he balloons 52 are disclosed by Truckai as a potential addition to the
`
`structure” already described, “which includes the springs 15 and 19.” Id. at 9
`
`(emphases added). The balloons are therefore “‘additional components inside’ the
`
`electrode carrying means 12, which serve to ‘add structure integrity to the
`
`electrode carrying means.” Id. (citing FF4, FF5).
`
`II.
`
`The Board’s Reasoning Applies Here.
`
`The foregoing analysis is correct, and dispositive of Minerva’s core
`
`contention that mechanical and inflation expansion are solely “alternative” or
`
`incompatible means based on the ‘989 specification. Ex. 1001, at 51-66. The
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`Board rejected this as contrary to the plain text, where the specification expressly
`
`conveys that balloons are “a potential addition” to mechanical expansion. Ex.
`
`3001, at 9. This exegesis of what the specification objectively teaches applies with
`
`equal force here, and the ‘989 specification’s identical disclosures thus satisfy the
`
`written description requirement for the claimed invention utilizing both mechanical
`
`and inflation expansion. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
`
`1351 (Fed. Cir. 2010) (written description asks whether the specification
`
`- 3 -
`
`
`
`objectively shows “possession” of the claimed invention). In Ex. 3001, the Board
`
`needed only to review the plain language of Truckai to find that such an invention
`
`was disclosed. It should do the same here.
`
`The Board’s findings in Ex. 3001 likewise impel a finding of enablement.
`
`“A prior art reference cannot anticipate a claimed invention if the allegedly
`
`anticipatory disclosures cited as prior art are not enabled.” In re Antor Media
`
`Corp., 689 F.3d 1282, 1287 (Fed. Cir. 2012) (citation omitted). To challenge
`
`anticipation, Minerva could have asserted—as it has here—that the operative
`
`language in Truckai is non-enabling, and offered evidence to rebut the presumption
`
`of enablement. See id. at 1288; 37 C.F.R. § 41.33(d). Minerva instead repeated its
`
`argument that mechanical and inflation expansion are alternate or incompatible
`
`approaches.
`
`Here, too, Minerva cannot plausibly argue that the Board erred, or that a
`
`different result should obtain. Minerva may argue that the record in this
`
`proceeding contains expert testimony, but such extrinsic matter cannot undermine
`
`an unambiguous finding that the disclosures in the specification alone anticipate.
`
`And, Minerva declined in Ex Parte Truckai to present evidence to challenge the
`
`presumption of enablement, instead offering attorney argument that the Board
`
`rejected as contrary to the specification.
`
`- 4 -
`
`
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`Moreover, Minerva’s expert “evidence” here should carry no weight, and
`
`cannot overcome the relevant presumptions. Minerva’s expert Dr. Pearce did not
`
`examine the state of the art at the relevant time; he did not cite even one piece of
`
`prior art bearing on how a POSA would read the language in question. See Patent
`
`Owner Response at 13-17. Dr. Pearce is not a POSA, and his conclusory
`
`testimony parrots the same attorney-made assertions the Board rejected. Id.2
`
`Perhaps Minerva offered no testimony in Ex Parte Truckai to avoid a finding that
`
`opinions of the kind made by Dr. Pearce are conclusory and plainly contrary to the
`
`objective teachings of the specification. Regardless, Minerva had a full and fair
`
`opportunity to present the arguments and evidence it thought germane to these
`
`issues, and lost.
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`Furthermore, Hologic had no opportunity to participate in Ex Parte Truckai,
`
`and the Board had neither Dr. Grundfest’s testimony (Ex. 2005), nor Hologic’s
`
`arguments in opposition before it. While Minerva has either ignored or attempted
`
`to chip away at the edges of parts of Dr. Grundfest’s testimony, Minerva offered
`
`no rebuttal testimony, and instead repeated unsubstantiated attorney arguments—
`
`2 The Board should also accord no weight here to Mr. Truckai’s testimony (Ex.
`
`1014), which offers biased and legally irrelevant assertions about the ostensible
`
`purpose of the invention. See Patent Owner Response, at 47-51.
`
`- 5 -
`
`
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`now rejected by the Board—about what the “four corners” of the specification
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`recite and disclose. See Petitioner Reply at 10-21. Dr. Grundfest’s unrebutted
`
`testimony thus confirms that in Ex. 3001, the Board reached the only reasonable
`
`conclusion concerning these issues: that the common specification discloses a
`
`method for endometrial ablation with both mechanical and inflation expansion.
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`There is no basis to repudiate these reasoned findings and issue a diametrically
`
`opposite set of findings here.
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`For these reasons, Hologic respectfully requests that the Board uphold its
`
`findings in Ex Parte Truckai, and enter a decision that claims 1-19 of the ‘989
`
`patent are not invalid for lack of adequate written description or lack of
`
`enablement.
`
`Dated: December 12, 2017
`
`Respectfully submitted,
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu, Ph.D. (Reg. No. 45,380)
`ARNOLD & PORTER KAYE
`SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`Attorneys for Patent Owner Hologic, Inc.
`
`- 6 -
`
`
`
`CERTIFICATE OF COMPLIANCE
`
`The undersigned certifies that this brief complies with the word-count
`
`limitations set forth in the Board’s Order on the Conduct of the Proceeding (Paper
`
`No. 21). This brief contains 1,191 words as calculated by the “Word Count”
`
`feature of Microsoft Word 2010, the word processing program used to create it,
`
`consistent with the requirements and provisions of 37 C.F.R. § 42.24.
`
`The undersigned further certifies that this preliminary response complies
`
`with the typeface requirements of 37 C.F.R. § 42.6(a)(2)(ii) and typestyle
`
`requirements of 37 C.F.R. § 42.6(a)(2)(iii). This preliminary response has been
`
`prepared in a proportionally spaced typeface using Microsoft Word 2010 in Times
`
`New Roman 14 point font.
`
`Dated: December 12, 2017
`
`Respectfully submitted,
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`Wallace Wu, Ph.D. (Reg. No. 45,380)
`ARNOLD & PORTER KAYE SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`- 7 -
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
`BRIEF CONCERNING EX PARTE TRUCKAI was served on December 12, 2017
`to the following Counsel for Petitioner via e-mail:
`
`Michael T. Rosato, Lead Counsel
`Matthew A. Argenti
`Steven W. Parmelee
`WILSON SONSINI GOODRICH & ROSATI
`701 5th Avenue, Suite 5100
`Seattle, WA 98104-7036
`mrosato@wsgr.com
`margenti@wsgr.com
`sparmelee@wsgr.com
`
`Attorneys for Petitioner Minerva Surgical, Inc.
`
`/Jennifer A. Sklenar/
`Jennifer A. Sklenar (Reg. No. 40,205)
`ARNOLD & PORTER KAYE SCHOLER LLP
`777 S. Figueroa Street, 44th Floor
`Los Angeles, CA 90017-5844
`Tel:
`(213) 243-4000
`Fax: (213) 243-4199
`
`- 8 -
`
`
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