Filed May 23, 2018
`
`
`On behalf of Smith & Nephew, Inc.
`By: Christy G. Lea
`Joseph R. Re
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: 949-760-0404
`Fax: 949-760-9502
`Email: BoxSMNPHL.117LG@knobbe.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
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`MÖLNLYCKE HEALTH CARE AB,
`Petitioner,
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`v.
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`SMITH & NEPHEW, INC.,
`Patent Owner.
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`PGR2018-00035
`Patent 9,642,750
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`SMITH & NEPHEW PRELIMINARY RESPONSE TO PETITION
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`
`On behalf of Smith & Nephew, Inc.
`By: Christy G. Lea
`Joseph R. Re
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Tel.: 949-760-0404
`Fax: 949-760-9502
`Email: BoxSMNPHL.117LG@knobbe.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
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`MÖLNLYCKE HEALTH CARE AB,
`Petitioner,
`
`v.
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`SMITH & NEPHEW, INC.,
`Patent Owner.
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`
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`PGR2018-00035
`Patent 9,642,750
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`SMITH & NEPHEW PRELIMINARY RESPONSE TO PETITION
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`TABLE OF CONTENTS
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`Page No.
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`I.
`
`INTRODUCTION ......................................................................................... 1
`
`II. THE ’750 PATENT ....................................................................................... 3
`
`A.
`
`B.
`
`C.
`
`D.
`
`Background ......................................................................................... 3
`
`The Flexible Suction Adapter ............................................................. 4
`
`The Relevant Embodiments and Description .................................... 10
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`Prosecution History & Priority Claim ............................................... 11
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`III. LEVEL OF ORDINARY SKILL IN THE ART ......................................... 13
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`IV. CLAIM CONSTRUCTION ........................................................................ 14
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`V.
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`THE ’750 PATENT IS NOT ELIGIBLE FOR POST GRANT
`REVIEW ...................................................................................................... 15
`
`A.
`
`B.
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`The ’750 Patent Claims Are Entitled to a Pre-AIA Effective
`Filing Date of May 7, 2010 ............................................................... 16
`
`Petitioner Failed to Prove That the ’750 Patent Is Not
`Entitled to an Effective Filing Date Before March 16, 2013 ............ 17
`
`1.
`
`The ’440 Application Disclosed the Subject Matter of
`Claim 1 .................................................................................... 17
`
`a.
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`b.
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`c.
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`d.
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`“a suction adapter” ........................................................ 18
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`“an applicator . . . comprising at least one
`aperture” ....................................................................... 19
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`“a bridge portion . . . comprising . . . a first
`channel and a second channel” ..................................... 21
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`“a visualization window . . . that provides
`unobstructed visualization” .......................................... 26
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`-i-
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`
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`TABLE OF CONTENTS
`(cont’d)
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`Page No.
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`e.
`
`f.
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`“material extending downwardly from the
`upper surface of the bridge portion” ............................. 29
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`“an intermediate wall extending
`perpendicularly . . .” ..................................................... 31
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`The ’440 Application Disclosed the Subject Matter of
`Claims 2-17 ............................................................................. 34
`
`The ’440 Application Disclosed the Subject Matter of
`Claim 18 .................................................................................. 34
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`a.
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`b.
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`c.
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`d.
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`e.
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`f.
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`g.
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`“attachment portion” ..................................................... 36
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`“fluid inlet” ................................................................... 38
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`“fluid outlet” ................................................................. 40
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`“connection portion” ..................................................... 42
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`“inspection portion” ...................................................... 45
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`“duct wall” .................................................................... 48
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`“partition wall” ............................................................. 50
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`Petitioner’s Co-pending Application Is Irrelevant .................. 51
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`The ’440 Application Disclosed the Subject Matter of
`Claims 19-24 ........................................................................... 52
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`2.
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`3.
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`4.
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`5.
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`VI. CONCLUSION ............................................................................................ 52
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`-ii-
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`TABLE OF AUTHORITIES
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`Page No(s).
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ...................................................passim
`
`In re GPAC, Inc.,
`57 F.3d 1573 (Fed. Cir. 1995) ............................................................................ 13
`
`ICU Med., Inc. v. Alaris Med. Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .......................................................................... 16
`
`Mylan Pharms., Inc. v. Yeda Research & Dev. Co.,
`PGR2016-00010, Paper 9 (PTAB Aug. 15, 2016) ............................................. 15
`
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`PGR2015-00019, Paper 17 (PTAB Jan. 29, 2016) ............................................. 15
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .......................................................................... 16
`
`Wombat Security Techs. v. Phishme, Inc.,
`PGR2017-00009, Paper 7 (PTAB June 8, 2017) ................................................ 16
`
`OTHER AUTHORITIES
`
`35 U.S.C. § 100 ........................................................................................................ 15
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`35 U.S.C. § 112 .............................................................................................. 2, 12, 16
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`35 U.S.C. § 324 .......................................................................................................... 1
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`37 C.F.R. § 42.207 ..................................................................................................... 1
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`MPEP 2159.02 ......................................................................................................... 13
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`MPEP 2304.02 ......................................................................................................... 12
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`-iii-
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`Pursuant to 37 C.F.R. § 42.207, 35 U.S.C. § 324, and the Notice of filing
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`date accorded (Paper 4), Patent Owner Smith & Nephew, Inc., submits its
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`Preliminary Response to Mölnlycke Health Care AB’s (“Petitioner”) Petition for
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`Post-Grant Review of U.S. Patent No. 9,642,750 (“the ’750 Patent”).
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`I.
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`INTRODUCTION
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`The Board should not institute post-grant review of the ’750 Patent because
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`post-grant review is available only for patents subject to the first-inventor-to-file
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`(“FITF”) provisions of the America Invents Act (“AIA”). The ’750 Patent, which
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`issued from Application No. 15/018,724 (“the ’724 Application”), claimed priority
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`to a series of provisional applications filed in 2009 and 2010. The second of those
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`provisional applications, No. 61/332,440 (“the ’440 Application”), which was filed
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`on May 7, 2010, clearly and unambiguously disclosed the invention embodied in
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`all of the claims of the ’750 Patent. Because, under Ariad, the ’440 Application
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`need only reasonably convey to those skilled in the art that the inventors had
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`possession of the claimed invention, the ’750 Patent is entitled to an effective filing
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`date of May 7, 2010, and is therefore not eligible for post-grant review.
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`Petitioner fails to carry its burden to show otherwise. First, Petitioner argues
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`that claim 18 lacks written description support, in part, because it was copied from
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`a co-pending MHC patent application during prosecution of the ’724 Application.
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`But the fact that Smith & Nephew sought to provoke an interference is irrelevant to
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`1
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`Molnlycke v. Smith & Nephew
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`the question of whether the ’724 Application comports with the written description
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`requirement of 35 U.S.C. § 112(a). Moreover, Petitioner’s written description
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`analysis relies on a distorted, and overly narrow, interpretation of the relevant
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`figures and disclosure. Second, Petitioner argues that claim 1 lacks written
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`description support because two claim terms do not appear exactly in the
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`specification. Of course, such a precise correlation between the language of the
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`claims and specification is not required. Regardless, Petitioner’s arguments ignore
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`the clear import of relevant disclosures, and completely misconstrue the content of
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`relevant figures. Accordingly, Petitioner has failed to meet its burden to prove
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`standing, and thus the Board should deny the Petition in its entirety.
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`Finally, separate from the threshold eligibility issue, Petitioner has failed to
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`focus its unpatentability arguments. Indeed, it alleges twelve grounds of
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`unpatentability in a single petition, including seven distinct grounds against each of
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`claims 1-17. Because Petitioner has not met its burden on the eligibility question,
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`Smith & Nephew will not address the numerous grounds raised by Petitioner,
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`whose sheer volume warrants the Board to exercise its discretion to deny the
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`Petition.
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`II. THE ’750 PATENT
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`A. Background
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`The ’750 Patent is directed to “apparatuses and methods for negative
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`pressure wound therapy,” and discloses several embodiments of negative pressure
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`wound therapy (“NPWT”) systems. Ex. 1001 (’750 Patent). Smith & Nephew has
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`been making and selling NPWT devices since at least 2007. Typically, and at their
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`most basic level, NPWT devices include a source of negative pressure, such as a
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`vacuum pump, as well as a canister, tubing, a wound cover, and a way to seal the
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`wound cover to the patient’s skin. Ex. 1001, 1:29-39; Ex. 2001, ¶¶19-27. As
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`shown below, some NPWT devices are larger and intended for use in a medical
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`facility. Others are portable, allowing the patient to wear the device from place to
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`place. Others are single-use, disposable dressings that do not have separate
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`canisters.
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`Often, patients who use NPWT devices are bedridden with their wounds
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`under their bodies. At least as early as 2009, Smith & Nephew recognized a need
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`for a flexible, soft suction adapter that would be comfortable for patients to wear
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`and lay on over time. Smith & Nephew also recognized the benefit of including a
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`window to allow a user to see the wound and to help the user properly position the
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`suction adapter. Ex. 1001, 2:34-44, 25:35-38.
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`B.
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`The Flexible Suction Adapter
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`Several of the ’750 patent embodiments relate to a “flexible suction adapter”
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`that comprises two primary elements: an applicator and a bridge. Ex. 2001, ¶28.
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`Figures 15A-D illustrate one such embodiment, as described below.
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`Bridge (1502)
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`Applicator (1520)
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`Ex. 1001, Fig. 15A, 22:1-10; Ex. 2001, ¶28.1 As shown in Figure 55 below, the
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`applicator attaches to a wound cover over a wound and the bridge connects the
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`applicator to a source of negative pressure.
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`Applicator
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`Wound Cover
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`Negative Pressure Source
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`Bridge
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`Tube Set
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`
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`Ex. 1001, Fig. 55B, 22:1-7; see also id., Fig. 7C; Ex. 2001, ¶29. To facilitate
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`attachment to a wound cover, the applicator may comprise several layers, including
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`several adhesive and removable protective layers, as shown in Figure 15D below.
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`Ex. 2001, ¶30. It also may comprise an aperture through which suction may flow
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`1 The parties agree that the specification of the ’750 Patent contains all of the
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`disclosures originally submitted in connection with the ’440 Application. For ease
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`of reference, all citations to relevant patent disclosures contained herein reflect the
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`column and line numbers of the ’750 Patent (Ex. 1001).
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`to the wound and through which fluid, e.g. wound exudate, may flow away from
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`the wound to promote healing. Id.
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`Viewing
`Window
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`Apertures
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`Applicator
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`Ex. 1001, Fig. 15D, 24:56-62; Ex. 2001, ¶30. The apertures may also be used in
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`connection with a viewing window in the bridge to allow monitoring of the wound
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`during the course of treatment. Ex. 1001, 24:63-25:2.
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`The bridge comprises three layers: an “upper layer 1510” (shown in blue),
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`an “intermediate layer 1514” (shown in red), and a “bottom layer 1518” (shown in
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`purple).
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`Upper Layer
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`Intermediate
`Layer
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`Bottom Layer
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`
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`Ex. 1001, Fig. 15B, 22:7-14; Ex. 2001, ¶31. Between the layers are two elongate
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`channels: an “upper channel layer 1512” (shown in green) and a “lower channel
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`layer 1516” (shown in yellow).
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`Upper
`Channel
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`Lower
`Channel
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`Ex. 1001, Fig. 15B, 22:7-17; Ex. 2001, ¶32. The channels facilitate fluid flow
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`between the distal and proximal ends of the bridge. Ex. 2001, ¶33. Each layer of
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`the bridge includes an aperture at the distal end that allows air to pass through the
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`upper channel layer into the apertures. Ex. 1001, 25:49-56. The negative pressure
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`draws air passing though the upper channel layer and apertures into the lower
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`channel layer back toward a pump. Id. The negative pressure draws the wound
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`exudate from the wound into the lower channel layer. Id. In addition, the upper
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`layer of the bridge includes a “viewing window 1522” that enables a practitioner to
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`see through the window and the distal apertures, and into the wound to aid both
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`placement of the system and ongoing monitoring of the wound:
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`With continued reference to FIGS. 15A-B, certain embodiments may
`also provide for a viewing window 1522 that permits targeting and
`visualization of the wound site prior to placement of the system 1501
`as well as ongoing monitoring of the wound site during the course of
`treatment. Preferably, a set of apertures are created or formed through
`the distal portions of layers 1510, 1512, 1514, 1516, and 1518 in
`alignment with aperture 1526 through the applicator 1520.
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` *
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` * *
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`Preferably, a viewing window 1522 which is at least partially
`transparent is provided to cover the first aperture through the top layer
`1510 to shield the wound from contamination.
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`Ex. 1001, 24:65-25:12.
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`Viewing
`Window
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`Upper Layer
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`Apertures
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`Ex. 1001, Fig. 15B; Ex. 2001, ¶33.
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`C. The Relevant Embodiments and Description
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`The ’750 patent describes various embodiments of the flexible suction
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`adapter, including in its detailed description of Figures 15A-D and Figures 55A-J.
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`See Ex. 1001, 22:1-26:2, 41:57-47:19. In its description of those Figures, the
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`patentee explained that the “system may be combined with other components as
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`described elsewhere in this application.” Id., 22:3-4. The patentee also repeatedly
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`described non-limiting examples and options for the embodiments. See, e.g., id.,
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`22:18-36 (use of alternative materials), 22:39-45 (use of alternative methods of
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`adhesion), 23:47-50 (inclusion of a filter), 25:29-48 (alternative methods of use).
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`The patentee further explained that Figures 55A-J illustrate embodiments similar to
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`the embodiments illustrated in Figure 15A. Id., 41:57-59. Figures 15B and 55D,
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`shown below, clearly depict the similarities between these embodiments.
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`Id., Figs. 15B, 55D; Ex. 2001, ¶34.
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`Because the Figure 15 and Figure 55 embodiments share common
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`disclosures in the specification (compare Ex. 1001, 22:1-26:2 with id., 41:57-48:8),
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`the description of Figure 55 provides additional context for nearly all of the
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`elements of the Figure 15 embodiment. Ex. 2001, ¶35. Where appropriate, Smith
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`& Nephew’s written description analysis identifies relevant disclosures relating to
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`Figure 55.
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`D.
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`Prosecution History & Priority Claim
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`The ’750 Patent issued on May 9, 2017 from the ’724 Application, which
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`was filed on February 8, 2016. Ex. 1001 at page 1. The ’724 Application is a
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`continuation of Application No. 14/267,636, filed May 1, 2014, which is a
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`continuation of Application No. 13/381,885, filed December 30, 2011, which is the
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`U.S. National Phase of International Application No. PCT/US2010/061938 (“the
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`PCT Application”), filed December 22, 2010. Id. at 1:7-18. The PCT application
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`combined the disclosures of the three provisional applications, added disclosures
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`relating to the embodiments depicted in Figures 32-57, and claimed priority to a
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`group of provisional applications filed in 2009 and 2010. Id.; Ex. 2001, ¶37.
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`Other than the priority claim, the specification and claims filed by Smith &
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`Nephew in the ’724 Application on February 8, 2016 were identical to the
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`specification and claims of the PCT Application filed December 22, 2010. Ex.
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`2001, ¶37. The disclosures that support the issued claims of the ’750 Patent were
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`PGR2018-00035
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`submitted at least as early as May 7, 2010, in connection with provisional
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`application No. 61/332,440 (“the ’440 Application”). See Ex. 1006; see also Ex.
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`2001, ¶37.
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`On February 14, 2016, Smith & Nephew submitted a preliminary
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`amendment in the ’724 Application that cancelled all of the original claims and
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`added claims 54-77. See Ex. 1002 at PDF page 108. Pursuant to its duty of
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`disclosure to the Patent Office, Smith & Nephew directed the Examiner to consider
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`“the possible correspondence between the claims of the present application and the
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`claims of U.S. Patent Application No. 14/761,335, as Claims 71, and 74-77 of the
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`instant application are substantial copies of Claims 1, 9, and 11-13 of U.S. Patent
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`Application No. 14/761,335 respectively.” Ex. 1002 at PDF page 112. U.S. Patent
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`Application No. 14/761,335 is assigned to Petitioner (“the MHC application”).
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`Accordingly, Smith & Nephew added claims 71 and 74-77 to potentially provoke
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`an interference with the MHC application, as is explicitly permitted according to
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`MPEP 2304.02. The MHC application, however, was not in condition for
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`allowance, and the Examiner allowed all of the claims of Smith & Nephew’s ’724
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`Application in the first office action on March 9, 2017. Ex. 1002 at PDF page 13.
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`The ’750 Patent issued two months later.
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`In allowing the claims, the Examiner never raised any issue whether the
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`claims lacked written description support under 35 U.S.C. § 112(a). See Ex. 1002.
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`12
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`Thus, the Examiner necessarily found that the specification adequately supported
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`the newly added claims. See MPEP 2159.02. Petitioner has fallen woefully short
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`to cause this Board to question the Examiner’s sound judgment and to revisit the
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`written description question.
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`III. LEVEL OF ORDINARY SKILL IN THE ART
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`Petitioner correctly characterizes the ’750 Patent claims as directed to
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`suction devices and kits for a negative pressure wound therapy system and,
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`therefore, relating to the field of negative pressure wound therapy. Pet. at 13.
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`However, Petitioner ignores that field and broadens the relevant field of art to
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`“wound care” generally when defining the level of ordinary skill in the art.
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`Petitioner presumably did so because its expert, Michael Helmus, apparently has
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`no experience in the NPWT field. See Ex. Ex. 1010, Appendix A. But negative
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`pressure wound therapy is a specialized subfield of wound care that requires
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`knowledge of that NPWT field. Ex. 2001, ¶15. Indeed, experience in the NPWT
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`field is far more important than having an advanced engineering degree when
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`designing an NPWT device. Id. Such experience would ensure that a POSITA
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`would have understood the problems generally associated with NPWT systems, the
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`existing solutions to those problems, and the speed with which new NPWT
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`products come to market. See In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir.
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`1995) (listing factors to consider when determining the level of skill in the art).
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`13
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`PGR2018-00035
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`Thus, Smith & Nephew disagrees with Petitioner’s level of skill and submits that a
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`POSITA would have been someone having an engineering degree, with at least 3
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`to 5 years of experience in designing, developing, or manufacturing negative
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`pressure wound therapy devices. Ex. 2001, ¶15.
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`IV. CLAIM CONSTRUCTION
`
`Petitioner offers constructions for
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`three claim
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`terms: “unobstructed
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`visualization,” “duct wall,” and “partition wall.” Pet. at 12-13. The Board need
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`not construe any of these terms, however, because, under any conceivable
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`construction, the specification fully discloses the claimed inventions.
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` With regard to Petitioner’s first construction, claim 1 recites “a visualization
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`window . . . that provides unobstructed visualization from outside of the suction
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`adapter, through the visualization window and through the aperture in the
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`applicator.” Ex. 1001, 52:17-22 (emphasis added). Petitioner asks the Board to
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`construe “unobstructed visualization” to mean “an unblocked view of the wound
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`site.” Pet. at 12. But Petitioner’s construction is unhelpful and disingenuous.
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`Indeed, Petitioner argues for a more detailed definition in another section of its
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`Petition.
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`In its indefiniteness section, Petitioner further argues that “unobstructed
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`visualization” means “an unblocked view of the wound site with no intermediate
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`elements present below the visualization window to through the aperture in the
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`PGR2018-00035
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`applicator.” Pet. at 117-118. Petitioner contends that this unobstructed view
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`requires that “[t]here is no further element or material present in the apertures or
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`between the apertures; that is, the view from the visualization window to through
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`the aperture in the applicator does not pass through anything but empty space.” Id.
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`at 118.
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` Under Petitioner’s more detailed definition of “unobstructed
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`visualization,” the specification would still disclose the claimed invention.2
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`V. THE ’750 PATENT IS NOT ELIGIBLE FOR POST GRANT REVIEW
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`Post-grant review is “available only for patents that issue from applications
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`that, at one point, contained at least one claim with an ‘effective filing date,’ as
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`defined by 35 U.S.C. § 100(i), on or after March 16, 2013.” Mylan Pharms., Inc.
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`v. Yeda Research & Dev. Co., PGR2016-00010, Paper 9 at 5 (PTAB Aug. 15,
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`2016). Because Petitioner bears the burden of setting forth grounds for standing,
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`Petitioner bears the “burden to show that the patent is subject to the first-inventor-
`
`to-file provisions of the AIA.” US Endodontics, LLC v. Gold Standard
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`Instruments, LLC, PGR2015-00019, Paper 17 at 11-12 (PTAB Jan. 29, 2016).
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`“Entitlement to the benefit of an earlier filing date under §§ 119, 120, 121,
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`and 365 is premised on disclosure of the claimed invention ‘in the manner
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`2 Though Smith & Nephew may disagree with Petitioner’s more detailed definition,
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`any explanation of such disagreement would be unhelpful here because the
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`definition does not affect the written description analysis.
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`PGR2018-00035
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`provided by § 112(a) (other than the requirement to disclose the best mode)’ in the
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`earlier application.” Wombat Security Techs. v. Phishme, Inc., PGR2017-00009,
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`Paper 7 at 7-8 (PTAB June 8, 2017) (citing 35 U.S.C. §§ 119(e), 120). To satisfy
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`the written description requirement under 35 U.S.C. § 112(a), the specification
`
`must “reasonably convey[] to those skilled in the art that the inventor had
`
`possession” of the claimed invention as of the filing date. Ariad Pharms., Inc. v.
`
`Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc); see also Vas-Cath
`
`Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991) (patent application
`
`must “convey with reasonable clarity to those skilled in the art that, as of the filing
`
`date sought, he or she was in possession of the invention”). This test requires “an
`
`objective inquiry into the four corners of the specification” from the perspective of
`
`a POSITA. Ariad, 598 F.3d at 1351. “Such description need not recite the claimed
`
`invention in haec verba but must do more than merely disclose that which would
`
`render the claimed invention obvious.” ICU Med., Inc. v. Alaris Med. Sys., Inc.,
`
`558 F.3d 1368, 1377 (Fed. Cir. 2009).
`
`A. The ’750 Patent Claims Are Entitled to a Pre-AIA Effective Filing
`Date of May 7, 2010
`
`Although filed after March 16, 2013, the ’724 Application claimed priority
`
`through a series of continuation applications to a group of three provisional
`
`applications filed in 2009 and 2010. Ex. 1001 at page 1. The disclosures that
`
`support the claims of the ’750 patent, including Figs. 15A-D, were submitted at
`
`16
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`
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`least as early as May 7, 2010, in connection with the ’440 Application. Ex. 2001,
`
`¶37. These same disclosures were included in the PCT Application filed
`
`December 22, 2010 and every intervening application between the PCT and the
`
`’724 Application. Id. As detailed below, because each of the claims of the ’750
`
`Patent finds ample written description support in the ’440 Application, the claims
`
`are entitled to an effective filing date of May 7, 2010.3
`
`B.
`
`Petitioner Failed to Prove That the ’750 Patent Is Not Entitled to
`an Effective Filing Date Before March 16, 2013
`
`1.
`
`The ’440 Application Disclosed the Subject Matter of
`Claim 1
`
`Petitioner appears to concede that the specification provides support for
`
`nearly all of the limitations of claim 1. Pet. at 42. Petitioner argues that only two
`
`limitations lack written description support: (a) “a visualization window . . . that
`
`provides unobstructed visualization,” and (b) “an intermediate wall extending
`
`perpendicularly from the downwardly extending material to partition the first
`
`channel from the second channel.” Id. As detailed below, however, Figs. 15A-D
`
`and related disclosures provide ample support for these two limitations.
`
`3 Even if the disclosures relating to Figure 55 were necessary to satisfy the written
`
`description requirement, the issued claims would nonetheless be entitled to a pre-
`
`AIA effective filing date because such disclosures were first submitted to the PTO
`
`in connection with the PCT Application on December 22, 2010.
`
`17
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`Accordingly, Petitioner has not shown that the specification, as originally filed,
`
`fails to reasonably convey to a POSITA that the inventors had possession of the
`
`claimed invention. See Ariad, 598 F.3d at 1351.
`
`Below Smith & Nephew sets forth how the written description supports each
`
`limitation of claim 1. Though such an analysis goes well beyond the two
`
`limitations disputed by Petitioner, it is helpful for several reasons. First, it
`
`provides context for the entirety of claim 1. Second, it shows the support for claim
`
`1 regardless of who bears the burden of proof. Third, it provides a foundation for
`
`understanding the disputed limitations in claim 18, the only other independent
`
`claim at issue.
`
`a.
`
`“a suction adapter”
`
`Claim 1 recites “a suction adapter configured to be sealed to a wound cover
`
`covering a wound site.” Ex. 1001, 52:4-5. Petitioner does not dispute that the
`
`specification provides written description support for this limitation. Pet. at 42.
`
`Indeed,
`
`the specification discloses
`
`that “Figs. 15A-D
`
`illustrate an
`
`embodiment of a negative pressure wound treatment system 1501 comprising a
`
`flexible suction adapter” that “may be combined with other components as
`
`described elsewhere” in the specification. Ex. 1001, 22:1-4 (emphasis added).
`
`Elsewhere,
`
`the specification states
`
`that
`
`the disclosed “suction adapter
`
`embodiments” may be used with negative pressure wound treatment systems
`
`18
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`“comprising a flexible drape configured to be positioned over a wound and sealed
`
`to the skin surrounding the wound,” wherein the “suction adapter is configured to
`
`be attached to the drape so as to surround at least one aperture formed in the
`
`drape.” Ex. 1001, 3:58-64 (emphasis added). A POSITA would have understood
`
`“drape” to be an example of a “wound cover.” Ex. 2001, ¶41. Thus, a POSITA
`
`would have understood the “flexible suction adapter” of Figure 15 to be
`
`“configured to be sealed to a wound cover covering a wound site,” as claimed. Ex.
`
`2001, ¶42.
`
`b.
`
`“an applicator . . . comprising at least one aperture”
`
`Claim 1 recites “an applicator configured to be positioned over an opening
`
`in the wound cover, the applicator comprising at least one aperture.” Ex. 1001,
`
`52:6-8. Petitioner does not dispute that the specification provides written
`
`description support for this limitation. Pet. at 42. Indeed, the specification
`
`discloses an “applicator 1520” in connection with the embodiment of Figs. 15A-D.
`
`Ex. 2001, ¶43.
`
`As shown in Fig. 15D below, the specification discloses that “the system
`
`1501 also comprises an applicator 1520 designed for placement over a wound
`
`site.” Ex. 1001, 24:36-38; see also id., 2:39-41, 22:7-10. The applicator further
`
`comprises several layers that, collectively, enable the applicator to be positioned
`
`over and secured to the wound site. See Ex. 1001, 24:36-64; Ex. 2001, ¶44. As
`
`19
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`shown below, the applicator includes “at least one aperture 1526 through itself”
`
`that “can serve to fluidically connect the wound site” to the remaining elements of
`
`the system. Ex. 1001, 24:56-62; see also id., 25:3-6 (“a set of apertures are created
`
`or formed through the distal portions of layers 1510, 1512, 1514, 1516, and 1518
`
`in alignment with aperture 1526 through the applicator 1520”).
`
`Viewing
`Window
`
`Ex. 1001, Fig. 15D; Ex. 2001, ¶45.
`
`Apertures
`
`Applicator
`
`20
`
`
`
`
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`The specification also discloses an applicator with reference to Figure 55D: “the
`
`applicator 5520 is placed over an aperture 5535 formed in a drape 5531 that is
`
`placed over a suitably-prepared wound 5530.” Ex. 1001, 42:14-16.
`
`Apertures
`
`Applicator
`
`
`
`Ex. 1001, Fig. 55D; Ex. 2001, ¶46.
`
`c.
`
`“a bridge portion . . . comprising . . . a first channel
`and a second channel”
`
`Claim 1 recites “a bridge portion connected to the applicator and comprising
`
`at least a first channel and a second channel extending parallel to an upper surface
`
`of the applicator, wherein at least one of the first channel and second channel is
`
`configured to provide suction to the wound site through the aperture in the
`
`21
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`applicator from a source of negative pressure.” Ex. 1001, 52:9-16. Petitioner does
`
`not dispute that the specification provides written description support for this
`
`limitation. Pet. at 42.
`
`As detailed below, a POSITA would have understood the claimed “bridge
`
`portion,” “first channel,” and “second channel” to be supported by the disclosed
`
`“bridge 1502,” “upper channel layer 1512,” and “lower channel layer 1516,”
`
`respectively. Ex. 2001, ¶47. The specification discloses:
`
`the system 1501 may comprise a bridge 1502 having a proximal end
`1503 and a distal end 1505 and an applicator 1520 at the distal end
`1505 of the bridge 1502. In some embodiments, the bridge 1502 may
`comprise an upper channel layer 1512 sandwiched between an upper
`layer 1510 and an intermediate layer 1514, with a lower channel layer
`1516 sandwiched between the intermediate layer 1514 and a bottom
`layer 1518.
`
`Ex. 1001, 22:7-14 (emphasis added). As shown by the arrows in Figure 15B
`
`below, the upper and lower channels (1512 and 1516) have “elongate portions
`
`extending between proximal and distal ends” of the bridge (Ex. 1001, 22:15-16),
`
`parallel to the upper surface layer of the applicator (1520). Ex. 2001, ¶48.
`
`22
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`
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`Molnlycke v. Smith & Nephew
`PGR2018-00035
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`Upper
`Channel
`
`Lower
`Channel
`
`
`
`Ex. 1001, Fig. 15B; Ex. 2001, ¶48. Thus, a POSITA would have understood both
`
`the first channel (i.e. upper channel) and second channel (i.e. lower channel) to
`
`extend parallel to the upper surface of the applicator, as claimed. Ex. 2001, ¶48.
`
`Moreover, as noted above with respect to the “applicator” limitation, the
`
`“ap
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