Case 1:20-cv-00925-JFB-SRF Document 119 Filed 03/30/21 Page 1 of 27 PageID #: 6613
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOLOGIC, INC., a Delaware corporation;
`and CYTYC SURGICAL PRODUCTS,
`LLC, a Massachusetts limited liability
`company,
`
`Plaintiffs,
`v.
`
`MINERVA SURGICAL, INC., a Delaware
`corporation.
`
`)
`)
`)
`)
`)
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`)
`
` C.A. No. 20-925-JFB-SRF
`
`JURY TRIAL DEMANDED
`
` REDACTED - PUBLIC VERSION
`
`DEFENDANT MINERVA SURGICAL, INC.’S OPENING BRIEF
`IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT OF
`NO INFRINGEMENT UNDER THE DOCTRINE OF EQUIVALENTS
`
`Ian R. Liston (#5507)
`Jennifer A. Ward (#6476)
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`222 Delaware Avenue, Suite 800
`Wilmington, DE 19801
`(302) 304-7600
`iliston@wsgr.com
`jward@wsgr.com
`
`Counsel for Defendant Minerva Surgical, Inc.
`
`Of Counsel:
`
`Vera M. Elson
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`650 Page Mill Road
`Palo Alto, CA 94304
`(650) 493-9300
`velson@wsgr.com
`
`Edward G. Poplawski
`Olivia M. Kim
`Erik J. Carlson
`WILSON SONSINI GOODRICH & ROSATI, P.C.
`633 West Fifth Street, 15th Floor
`Los Angeles, CA 90071
`(323) 210-2900
`epoplawski@wsgr.com
`okim@wsgr.com
`ecarlson@wsgr.com
`
`Dated: March 22, 2021
`
`

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`Case 1:20-cv-00925-JFB-SRF Document 119 Filed 03/30/21 Page 2 of 27 PageID #: 6614
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`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1
`
`PROSECUTION HISTORY ESTOPPEL BARS HOLOGIC’S DOE THEORY .............. 2
`
`A.
`
`B.
`
`Hologic Surrendered Its Right to the Territory Covering All Handles with
`a “Proximal Grip and a Distal Grip” During Prosecution....................................... 3
`
`The Festo Presumption Estops Hologic From Recapturing the Surrendered
`Territory Using DOE .............................................................................................. 6
`
`III.
`
`HOLOGIC’S DOE THEORY IS ALSO BARRED UNDER ENSNAREMENT .............. 9
`
`A.
`
`B.
`
`Hologic’s Hypothetical Limitation Fails To Broaden, And Improperly
`Narrows, The Scope Of The Actual Claim ........................................................... 11
`
`Hologic Hypothetical Claim Ensnares the Prior Art ............................................. 14
`
`IV.
`
`CONCLUSION ................................................................................................................. 20
`
`i
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`

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`
`TABLE OF AUTHORITIES
`
`CASES
`
` PAGE(S)
`
`Agrofresh Inc. v. Essentiv LLC,
`No. 16-662 (MN), 2020 U.S. Dist. LEXIS 222898 (D. Del. Nov. 30, 2020) ................9, 15
`
`Canton Bio Med., Inc. v. Integrated Liner Techs., Inc.,
`216 F.3d 1367 (Fed. Cir. 2000)............................................................................................8
`
`Deering Precision Instruments, L.L.C. v. Vector Distribution Sys., Inc.,
`347 F.3d 1314 (Fed. Cir. 2003)............................................................................................8
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) ................................................................................................... passim
`
`Hologic, Inc. v. Minerva Surgical, Inc.,
`325 F. Supp. 3d 507 (D. Del. 2018) .....................................................................................2
`
`Jang v. Bos. Sci. Corp.,
`872 F.3d 1275 (Fed. Cir. 2017).................................................................................. passim
`
`Norian Corp. v. Stryker Corp.,
`432 F.3d 1356 (Fed. Cir. 2005)............................................................................................9
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008)............................................................................................3
`
`Realtime Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019)..........................................................................................19
`
`Streamfeeder, LLC v. Sure-Feed Sys., Inc.,
`175 F.3d 974 (Fed. Cir. 1999).................................................................................... passim
`
`Talbert Fuel Sys. Pats. Co. v. Unocal Corp.,
`347 F.3d 1355 (Fed. Cir. 2003)............................................................................................8
`
`Ultra-Tex Surfaces, Inc. v. Hill Bros. Chem. Co.,
`204 F.3d 1360 (Fed. Cir. 2000)..........................................................................................11
`
`Wang Labs., Inc. v. Mitsubishi Elecs. Am., Inc.,
`103 F.3d 1571 (Fed. Cir. 1997)............................................................................................8
`
`Wilson Sporting Goods Co. v. David Geoffrey & Assocs.,
`904 F.2d 677 (Fed. Cir. 1990)............................................................................................15
`
`STATUTES
`
`35 U.S.C. §103 .................................................................................................................................4
`
`ii
`
`

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`TABLE OF ABBREVIATIONS
`
`’348 or ’348 patent:
`
`U.S. Patent No. 9,095,348 (asserted patent)
`
`DOE:
`
`First Action:
`
`Doctrine of Equivalents
`
`Hologic, Inc. et al. v. Minerva Surgical, Inc., Civ. No. 15-1031
`(D. Del.)
`
`Hologic:
`
`Plaintiffs Hologic, Inc. and Cytyc Surgical Products, LLC
`
`Hypothetical Limitation:
`
`The limitation of Hologic’s hypothetical claim that requires
`grips “attached to one another at a fixed or compound joint
`about which the two members hinge or rotate relative to one
`another”
`
`Mr. Leinsing:
`
`Minerva:
`
`NovaSure:
`
`Mr. Karl Leinsing (Hologic’s technical expert)
`
`Defendant Minerva Surgical, Inc.
`
`Hologic’s NovaSure Endometrial Ablation System
`
`Original device:
`
`Minerva’s Original device at issue in the First Action
`
`PHE:
`
`Prosecution History Estoppel
`
`“pivot point” limitation:
`
`The limitation of claim 1 of the ’348’s requiring grips: “pivotally
`attached to one another at a pivot point”
`
`POSITA:
`
`PTO:
`
`Person of Ordinary Skill In The Art (hypothetical as of the date
`of invention)
`
`U.S. Patent and Trademark Office
`
`Spring Handle device:
`
`Minerva’s Spring Handle device accused in this case.
`
`Dr. Tucker:
`
`Dr. Robert Tucker (Minerva’s technical expert)
`
`iii
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`

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`I.
`
`INTRODUCTION1
`
`Hologic’s theory of infringement under the doctrine of equivalents (“DOE”) is barred by
`
`two legal restrictions on DOE.2 First, prosecution history estoppel (“PHE”) bars Hologic’s DOE
`
`theory. Initially, the Examiner rejected Hologic’s claims finding that every single element of the
`
`claims, including a handle with “grips,” was obvious in light of the prior art. Both prior art
`
`references that formed the basis of the Examiner’s rejection included handles with grips that slid
`
`toward each other and were not “pivotally attached to one another at a pivot point.” Thus, to
`
`overcome the Examiner’s rejection and gain allowance of its claims, Hologic opted to amend
`
`(and thereby narrow) the literal scope of its claims to grips that are “pivotally attached to one
`
`another at a pivot point.” Yet now Hologic impermissibly seeks to recapture in litigation the
`
`very scope it surrendered to gain allowance of its claims, namely grips that slide together. These
`
`are the quintessential circumstances under which the U.S. Supreme Court’s seminal precedent in
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002) bars a patent owner
`
`from later recapturing in litigation a broader scope of equivalents under the DOE. Hologic
`
`should be barred as a matter of law from reneging on its representations to the Examiner and
`
`recapturing grips that slide under a DOE theory.
`
`Second, Hologic’s DOE theory independently fails as a matter of law under ensnarement.
`
`Hologic has proposed a hypothetical claim that is improper for two reasons: (1) it fails to
`
`broaden, and indeed improperly narrows the actual claim; and (2) Hologic fails to show that its
`
`hypothetical claim is patentable over the prior art. Either restriction alone is enough to dispose
`
`1 Unless stated otherwise, all emphasis in quotes is added.
`2 Minerva maintains that there is no infringement under DOE on the merits as well.
`
`

`

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`of Hologic’s DOE theory as a matter of law.3
`
`II.
`
`PROSECUTION HISTORY ESTOPPEL BARS HOLOGIC’S DOE THEORY4
`
`This case presents the classic situation that gives rise to PHE under the Supreme Court’s
`
`seminal Festo decision. The Examiner rejected Hologic’s attempt to broadly claim a handle with
`
`grips, as obvious over prior art that taught grips that slide together. In response, Hologic
`
`narrowed its claims to grips that were attached in a specific way by a specific structure
`
`(“pivotally attached to one another at a pivot point”). Hologic further argued that this narrowing
`
`amendment distinguished the prior art, which the Examiner had found disclosed every other
`
`element of the amended claim, including a handle with grips. In so narrowing its claims,
`
`Hologic surrendered all equivalents in “the territory between the original claim and
`
`the amended claim.” Festo, 535 U.S. at 740. In other words, by electing to narrow its claims in
`
`order to gain allowance, Hologic did not merely surrender equivalents that encompass the
`
`specific prior art handles upon which the Examiner’s rejection was based, but presumptively
`
`surrendered all equivalents in between its broader original claim and its amended claim.
`
`Fundamentally, Hologic should be restricted to the scope of its claim as amended and
`
`allowed, and should be estopped from attempting to recapture the surrendered territory under a
`
`DOE theory. Id. at 733-34 (“When, however, the patentee originally claimed the subject matter
`
`3 Hologic’s theory of literal infringement also fails as a matter of law for the reasons set forth in
`Minerva’s concurrently-filed Motion for Partial Summary Judgment of No Literal Infringement.
`Minerva’s brief in support of that motion contains a statement of the nature and stage of the
`proceedings, a statement of facts, and legal standard, which are not repeated here.
`4 In the First Action, Minerva moved for Summary Judgment on a similar issue related to a prototype
`spring handle design. The Court did not decide the issue because the Court agreed “with Hologic’s
`position that a ruling on the purported handle redesign would be an improper advisory opinion since
`the product [was] not being marketed and [was] not alleged to be infringing Hologic’s patent. The
`court [did not need to] address whether Minerva's ‘new’ handle design would infringe Hologic's ’348
`Patent because that design [was] not at issue.” Hologic, Inc. v. Minerva Surgical, Inc., 325 F. Supp.
`3d 507, 529 (D. Del. 2018). Thus, PHE is now ripe for the Court do decide.
`
`2
`
`

`

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`alleged to infringe but then narrowed the claim in response to a rejection, he may not argue that
`
`the surrendered territory comprised unforeseen subject matter that should be deemed equivalent
`
`to the literal claims of the issued patent.”); see also O2 Micro Int’l Ltd. v. Beyond Innovation
`
`Tech. Co., 521 F.3d 1351, 1366 (Fed. Cir. 2008) (“district court erred in allowing the jury to find
`
`infringement under the doctrine of equivalents” because PHE applied). Hologic cannot
`
`overcome the presumption of surrender because the reason for the narrowing amendment was to
`
`overcome a prior art rejection by narrowing the claimed invention to grips that are both attached
`
`at and that rotate about the same “pivot point.” Hologic thereby surrendered not just the
`
`slidably-attached grips in the prior art, but also the “territory between” the original claims that
`
`covered “grips” attached in any way, and the narrower amended claims that specify how the
`
`grips must be attached using “a pivot point.” (i.e., Hologic cannot now attempt to reclaim this
`
`territory under some theory that the claims are broad enough to cover grips that rotate and/or
`
`slide). Consequently, Hologic is estopped from arguing that Minerva’s Spring Handle device
`
`infringes under the DOE.
`
`A.
`
`Hologic Surrendered Its Right to the Territory Covering All Handles with a
`“Proximal Grip and a Distal Grip” During Prosecution
`
`Hologic filed the application for the ’348 patent on August 8, 2013. Ex.5 5 (Tucker Rbtl.
`
`Rpt.) ¶ 83; Ex. 19 (’348 patent) at cover page; Ex. 17 (’348 patent file history) at 145561. Claim
`
`1, the only asserted independent claim here, was originally numbered prosecution claim 19.6 Ex.
`
`5 (Tucker Rbtl. Rpt.) ¶¶ 84-85; Ex. 17 (’348 patent file history) at 145914. Prosecution claim 19
`
`originally included a “handle limitation” that broadly recited “a handle coupled to the proximal
`
`5 All exhibits are attached to Declaration of Erik J. Carlson filed concurrently herewith.
`6 To find in Minerva’s favor on all asserted claims of the ’348 patent, the Court need only analyze
`prosecution claim 19, which issued as claim 1, because all other asserted claims are dependent
`claims, and thus inherit the “pivot point” limitation from claim 1.
`
`3
`
`

`

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`portion” along with all the other elements of asserted claim 1. Ex. 5 (Tucker Rbtl. Rpt.) ¶ 85;
`
`Ex. 17 (’348 patent file history) at 145794.
`
`Prosecution claim 26, a claim dependent on prosecution claim 19, recited “wherein the
`
`handle comprises a proximal grip and a distal grip operably coupled to the applicator head so
`
`that when the proximal grip and the distal grip are moved closer together, the applicator head
`
`transitions from the contracted state to the expanded state.” Ex. 5 (Tucker Rbtl. Rpt.) ¶ 86; Ex.
`
`17 (’348 patent file history) at 145795. This shows that during prosecution, Hologic initially
`
`attempted to claim the territory covering any handles with a proximal grip and a distal grip
`
`(which would have covered Minerva’s Spring Handle design, among others). Where a claim
`
`originally encompassed the asserted equivalent, “prosecution history has established that the
`
`inventor turned his attention to the subject matter in question, knew the words for both the
`
`broader and narrower claim, and affirmatively chose the latter.” Festo, 535 U.S. at 734-35.
`
`On March 6, 2015, the Examiner rejected Hologic’s attempt to claim the territory
`
`covering all handles with grips. Specifically, the Examiner rejected all pending claims
`
`(including prosecution claims 19 and 26) as obvious under 35 U.S.C. §103, and therefore invalid
`
`over the prior art Truckai ’880 patent (Ex. 28, U.S. Patent No. 5,769,880) in view of King (Ex.
`
`29, U.S. Patent No. 4,016,867). Ex. 5 (Tucker Rbtl. Rpt.) ¶ 87; Ex. 17 (’348 patent file history)
`
`at 145814-818. In other words, the Examiner found that all of the limitations of prosecution
`
`claim 19 and prosecution claim 26 were obvious in view of the combination of Truckai ’880 and
`
`King. Id. Relevant to this motion, the Examiner also rejected prosecution claim 26 as obvious
`
`because both Truckai ’880 and King disclosed: “wherein the handle comprises a proximal grip
`
`and a distal grip operably coupled to the applicator head so that when the proximal grip and the
`
`distal grip are moved closer together, the applicator head transitions from the contracted state to
`
`4
`
`

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`the expanded state.” Ex. 5 (Tucker Rbtl. Rpt.) ¶ 93; Ex. 17 (’348 patent file history) at 145817;
`
`see also id. at 145795. Both Truckai ’880 and King taught the use of a proximal grip and a distal
`
`grip that “moved closer together” via a sliding motion in order to deploy an applicator head. Ex.
`
`5 (Tucker Rbtl. Rpt.) ¶ 87; Ex. 17 (’348 patent file history) at 145814-818.
`
`Hologic had the option of trying to contest the Examiner’s rejection. But instead, in a
`
`March 19, 2015 response to the Examiner’s rejection, Hologic chose to amend prosecution claim
`
`19. Hologic combined the limitations of prosecution claims 19 and 26 (i.e., re-wrote prosecution
`
`claim 26 as a stand-alone claim), and then—importantly for purposes of PHE—added a new and
`
`very specific way of attaching the grips; namely, specifying grips “pivotally attached to one
`
`another at a pivot point.” Hologic thereby surrendered its claim to any “handle coupled to the
`
`proximal portion” from pending claim 19 and replaced it with the narrower handle limitation.
`
`Festo, 535 U.S. at 734 (“While the patentee has the right to appeal [a rejection], his decision to
`
`forgo an appeal and submit an amended claim is taken as a concession that the invention as
`
`patented does not reach as far as the original claim.”). In short, by narrowing the claim, Hologic
`
`elected to limit the scope of its claims to a structure wherein the grips must be “pivotally
`
`attached to one another at a pivot point,” presumptively surrendering any future range of
`
`equivalents. Ex. 5 (Tucker Rbtl. Rpt.) ¶ 94; Ex. 17 (’348 patent file history) at 145866. Below is
`
`a color-coded version of the narrowed handle limitation showing language that was previously
`
`included in original prosecution claim 19 (in blue) and language that was previously included in
`
`prosecution claim 26 (shown in purple):
`
`a handle coupled to the proximal portion of the elongate member, wherein the
`handle comprises a proximal grip and a distal grip pivotally attached to one
`another at a pivot point and operably coupled to the applicator head so that when
`the proximal grip and the distal grip are moved closer together, the applicator
`head transitions from the contracted state to the expanded state;
`
`Ex. 5 (Tucker Rbtl. Rpt.) ¶ 97. As shown above, the only new requirement that was not already
`
`5
`
`

`

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`in either rejected prosecution claim 19 or 26 was the specific attachment requirement of
`
`“pivotally attached to one another at a pivot point.” Ex. 5 (Tucker Rbtl. Rpt.) ¶ 98. Importantly,
`
`the examiner had already found all requirements of the handle limitation except for “pivotally
`
`attached to one another at a pivot point” in the prior art combination of Truckai ’880 and King.
`
`As the Supreme Court stated in Festo:
`
`A patentee who narrows a claim as a condition for obtaining a patent disavows his
`claim to the broader subject matter. . . . We must regard the patentee as having
`conceded an inability to claim the broader subject matter or at least as having
`abandoned his right to appeal a rejection.
`
`535 U.S. at 737.
`
`Hologic confirmed its surrender in remarks accompanying the narrowing amendment.
`
`Hologic argued to the Examiner that “[n]either Truckai nor King show or suggest a proximal
`
`grip and a distal grip pivotally attached, as recited in claim 19.” Ex. 5 (Tucker Rbtl. Rpt.) ¶ 96;
`
`Ex. 17 (’348 patent file history) at 145872. Based on Hologic’s amendment and argument
`
`regarding the “pivot point” limitation, on April 27, 2015, the Examiner allowed prosecution
`
`claim 19 as amended. Ex. 5 (Tucker Rbtl. Rpt.) ¶ 100; Ex. 17 (’348 patent file history) at
`
`145903-909. Amended prosecution claim 19 issued as asserted claim 1. Ex. 5 (Tucker Rbtl.
`
`Rpt.) ¶¶ 84-85; Ex. 17 (’348 patent file history) at 145914. In short, on March 19, 2015, Hologic
`
`struck a bargain with the Examiner that in exchange for narrowing its claims by adding the
`
`“pivotally attached to one another at a pivot point” requirement, it would surrender all claim
`
`scope (i.e., territory) beyond the “pivotally attached at a pivot point”-style grips of the handle
`
`element. The doctrine of prosecution history estoppel bars a patentee from later reneging on its
`
`bargain and attempting to recapture claim scope surrendered during prosecution under the DOE.
`
`B.
`
`The Festo Presumption Estops Hologic From Recapturing the Surrendered
`Territory Using DOE
`
`Hologic narrowed the scope of independent claim 1 of the ’348 patent during prosecution
`
`6
`
`

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`by adding the “pivot point” limitation in order to overcome prior art handles with grips. Ex. 5
`
`(Tucker Rbtl. Rpt.) ¶¶ 240-248. But now, Hologic seeks to use the DOE to renege on that
`
`bargain and recapture the territory it surrendered. Specifically, Hologic attempts to venture out
`
`from the specific type of attachment (“pivotally attached to one another at a pivot point”) to
`
`recapture a different structure; namely, grips that are slidably engaged, or that slide and rotate
`
`(Hologic’s “compound movement” theory). Minerva’s Spring Handle design would have fallen
`
`within the scope of the original handle limitation that covered grips irrespective of the way in
`
`which they were attached. But particularly in light of the fact that the prior art Truckai ’880 and
`
`King references both teach grips that slide, Hologic cannot now credibly argue that it “lacked the
`
`words” to describe either grips that slide, or grips that both slide and rotate (Hologic’s alleged
`
`“compound movement”). Festo, 535 U.S. at 734 (“Where the original application once
`
`embraced the purported equivalent but the patentee narrowed his claims to obtain the patent or to
`
`protect its validity, the patentee cannot assert that he lacked the words to describe the subject
`
`matter in question.”).
`
`The way in which the grips are attached was at issue during prosecution, and directly
`
`related to the reason for Hologic’s narrowing amendments. Therefore, PHE forecloses Hologic
`
`from now relying on the DOE in litigation to allege infringement. Id. at 740. This is the
`
`quintessential case for the application of PHE because Hologic not only added the “pivot point”
`
`limitation to overcome the Examiner’s prior art rejection, but also represented to the Examiner
`
`that the “pivot point” limitation distinguished the prior art. Id. at 737-38 (the purpose of PHE is
`
`“to hold the inventor to the representations made during the application process and to the
`
`inferences that may reasonably be drawn from the amendment.”); see also, e.g., Canton Bio
`
`Med., Inc. v. Integrated Liner Techs., Inc., 216 F.3d 1367, 1371 (Fed. Cir. 2000) (patentees’
`
`7
`
`

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`successful argument distinguishing prior art gives rise to estoppel because the “prosecution
`
`record shows that patentability was premised in significant part on [a specific claim requirement]
`
`and its distinction from the [prior art] cited references.”); Wang Labs., Inc. v. Mitsubishi Elecs.
`
`Am., Inc., 103 F.3d 1571, 1578 (Fed. Cir. 1997) (“Wang’s actions before the PTO trigger
`
`prosecution history estoppel. The PTO rejected claims as obvious in light of prior art; the
`
`patentee amended, adding limitations arguing distinctions from the prior art which persuaded the
`
`PTO to allow the amended claim.”). Thus, Hologic “clearly disclaimed the territory between the
`
`original claim 1 and new claim 1 as issued.” Deering Precision Instruments, L.L.C. v. Vector
`
`Distribution Sys., Inc., 347 F.3d 1314, 1325 (Fed. Cir. 2003).
`
`Talbert Fuel Sys. Pats. Co. v. Unocal Corp., 347 F.3d 1355 (Fed. Cir. 2003) is instructive
`
`as to the scope of surrender here. In Talbert Fuel, the patentee’s claims to a gasoline fuel were
`
`originally rejected by the examiner over a prior art reference that disclosed fuel with a boiling
`
`point in “the range of 390°F-420°F.” Id. at 1358. The patentee limited the claims by adding “a
`
`boiling range of 121°F-345°F.” Id. The Federal Circuit held: “the amendment of the
`
`[patentee’s] claims to a boiling point upper limit of 345°F, in light of the [prior art] reference
`
`showing gasolines with boiling endpoints of 390°F-420°F, is a presumptive surrender of
`
`gasolines boiling in the range between [patentee’s] amended endpoint of 345°F and [the prior
`
`art’s] endpoints.” Id. at 1359. In other words, the amendment to distinguish the prior art boiling
`
`point range did not only surrender what was actually in the prior art (390°F-420°F) but
`
`everything in between the amended claim and the prior art (345°F-390°F).
`
`Here, as in Talbert Fuel, Hologic has not only surrendered grips that only slide together
`
`like in Truckai ’880 and King, but any style of grips attached in other ways (e.g., grips that slide
`
`and rotate under Mr. Leinsing’s “compound movement” theory) because such grips fall within
`
`8
`
`

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`the territory between the original claim (a handle with grips) and the claim amendment (grips
`
`“pivotally attached to one another at a pivot point”). See Norian Corp. v. Stryker Corp., 432
`
`F.3d 1356, 1361 (Fed. Cir. 2005) (“[T]here is no principle of patent law that the scope of a
`
`surrender of subject matter during prosecution is limited to what is absolutely necessary to avoid
`
`a prior art reference that was the basis for an examiner's rejection.”). Thus, any argument by
`
`Hologic that it only surrendered the particular grips of the Truckai ’880 or King references
`
`should be rejected.
`
`In sum, Hologic is estopped from asserting any scope beyond the literal scope of its
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`claims in light of its amendment and argument to overcome the Examiner’s prior art rejection.
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`See, e.g., Norian , 432 F.3d at 1361-62 (holding patentees are restricted by prosecution history
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`estoppel to “the scope of what they ultimately claim”).
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`III.
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`HOLOGIC’S DOE THEORY IS ALSO BARRED UNDER ENSNAREMENT
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`Under the ensnarement doctrine, the burden is squarely on the patentee to craft a
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`hypothetical claim that more broadly covers the full range of equivalents it alleges infringes
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`under its DOE theory. The patentee must then show that the broadened claim captures the
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`allegedly infringing equivalent (i.e., Minerva’s Spring Handle design), but does not also capture
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`the prior art. Jang v. Bos. Sci. Corp., 872 F.3d 1275, 1285–1287 (Fed. Cir. 2017); Streamfeeder,
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`LLC v. Sure-Feed Sys., Inc., 175 F.3d 974, 983-984 (Fed. Cir. 1999); Agrofresh Inc. v. Essentiv
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`LLC, No. 16-662 (MN), 2020 U.S. Dist. LEXIS 222898, at *48–*54 (D. Del. Nov. 30, 2020). If
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`the hypothetical claim captures the prior art, then the patentee has failed to establish that its
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`hypothetical claim would have been patentable, and its DOE theory should be barred. Given this
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`framework, in crafting its hypothetical claim the patentee may not add narrowing limitations.
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`Jang, 872 F.3d at 1286; Streamfeeder, 175 F.3d at 983. Nor is it permissible to simply maintain
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`the same literal scope as the actual claim, since the idea is to broaden the claim to capture the
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`9
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`

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`Case 1:20-cv-00925-JFB-SRF Document 119 Filed 03/30/21 Page 14 of 27 PageID #: 6626
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`alleged infringing equivalent, without also capturing the prior art. Jang., 872 F.3d at 1287;
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`Streamfeeder, 175 F.3d at 983.
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`In this case, Hologic’s DOE theory should be barred for two independent reasons;
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`namely, Hologic’s hypothetical claim: (1) fails to broaden, and indeed improperly narrows, the
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`scope of the actual claim; and (2) improperly ensnares the prior art. As stated by the Federal
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`Circuit, “[a] doctrine of equivalents theory cannot be asserted if it will encompass or ensnare the
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`prior art.” Jang, 872 F.3d at 1285 (internal quotation marks omitted). Ensnarement, like
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`prosecution history estoppel, is a question of law, which can be determined by the Court on
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`summary judgment. See id. at 1288. Hologic has elected to use a hypothetical claim analysis for
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`ensnarement. Ex. 9 (Leinsing Reply Rpt.) ¶ 58 (proposing a hypothetical claim).
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`The hypothetical claim proposed by Hologic’s expert “would be identical to claim 1
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`except the limitation requiring ‘a proximal grip and a distal grip pivotally attached to one another
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`at a pivot point’ would be replaced with a limitation requiring ‘a proximal grip and a distal grip
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`attached to one another at a fixed or compound joint about which the two members hinge or
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`rotate relative to one another.’” Ex. 9 (Leinsing Reply Rpt.) ¶ 58. Thus, as illustrated below,
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`Hologic’s hypothetical claim consists of only a single change to claim 1 of the ’348 patent;
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`namely, a change to the “pivotally attached to one another at a pivot point” limitation of the
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`handle as indicated below in bold italics (i.e., Hologic’s “Hypothetical Limitation”):
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`Claim 1 of the ’348 Patent
`a handle coupled to the proximal portion of the
`elongate member, wherein the handle
`comprises a frame, a proximal grip and a distal
`grip
`
`Handle Limitation
`Hologic’s Hypothetical Claim
`a handle coupled to the proximal portion of the
`elongate member, wherein the handle
`comprises a frame, a proximal grip and a distal
`grip
`
`pivotally attached to one another at a pivot
`point
`
`attached to one another at a fixed or
`compound joint about which the two members
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`10
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`

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`Case 1:20-cv-00925-JFB-SRF Document 119 Filed 03/30/21 Page 15 of 27 PageID #: 6627
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`hinge or rotate relative to one another
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`and operably coupled to the applicator head so
`that when the proximal grip and the distal grip
`are moved closer together, the applicator head
`transitions from the contracted state to the
`expanded state
`
`and operably coupled to the applicator head so
`that when the proximal grip and the distal grip
`are moved closer together, the applicator head
`transitions from the contracted state to the
`expanded state
`
`A.
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`Hologic’s Hypothetical Limitation Fails To Broaden, And Improperly
`Narrows, The Scope Of The Actual Claim
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`A hypothetical claim analysis is a practical method to determine whether an equivalent
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`would impermissibly ensnare the prior art. See Ultra-Tex Surfaces, Inc. v. Hill Bros. Chem. Co.,
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`204 F.3d 1360, 1364 (Fed. Cir. 2000). The Federal Circuit’s precedent has been clear “that a
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`patentee’s hypothetical claim may not add any narrowing limitations.” Jang, 872 F.3d at 1286
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`(citing Streamfeeder, 175 F.3d at 983). “While use of a hypothetical claim may permit a minor
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`extension of a claim to cover subject matter that is substantially equivalent to that literally
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`claimed, one cannot, in the course of litigation and outside of the PTO, cut and trim,
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`expanding here, and narrowing there, to arrive at a claim that encompasses an accused device,
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`but avoids the prior art. Slight broadening is permitted at that point, but not narrowing.”
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`Streamfeeder, 175 F.3d at 983. To assess whether a hypothetical claim contains a narrowing
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`limitation, the literal scope of the actual claim should be compared to the literal scope of the
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`hypothetical claim. Jang, 872 F.3d at 1286-287.
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`Here, Hologic’s Hypothetical Limitation requires one of two things in the alternative:
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`1. grips “attached to one another at a fixed . . . joint about which the two members
`hinge or rotate relative to one another”; or
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`2. grips “attached to one another at a . . . compound joint about which the two
`members hinge or rotate relative to one another.”
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`Ex. 9 (Leinsing Reply Rpt.) ¶ 58. Each alternative is a narrowing amendment rendering the
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`hypothetical claim improper as summarized in the chart below and discussed thereafter:
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`11
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`Case 1:20-cv-00925-JFB-SRF Document 119 Filed 03/30/21 Page 16 of 27 PageID #: 6628
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`Hologic’s Alleged Scope of
`Actual Limitation
`
`Hologic’s Alleged Scope of
`Hypothetical Limitation
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`More broadly allows for “linear sliding
`movement”
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`“fixed…joint”: limited to rotation and “no
`linear movement.”
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`More broadly covers a “pivot point” that only
`rotates.
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`“compound joint”: limited to a joint that must
`rotate and slide.
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`(1) Fixed Joint. Starting with a “fixed…joint,” that term narrows the scope of the actual
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`claim. Hologic’s expert has opined that the actual claim is broad enough to literally cover an
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`attachment mechanism with some linear movement. Ex. 9 (Leinsing Reply Rpt.) ¶ 30 (opining
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`that the literal scope of the claimed “pivot point” can “allow for linear sliding movement”), ¶ 59
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`(opining that the literal scope of the claim is not l