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`Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 1 of 42 PagelD #: 4199
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`
`
`
`EXHIBIT 3
`EXHIBIT 3
`
`

`

`
`
`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.84 Filed 11/07/19 Page 1 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 2 of 42 PageID #: 4200
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`
`
`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF MICHIGAN
`SOUTHERN DIVISION
`
`
`BlephEx, LLC,
`
`
`Plaintiff,
`
`v.
`
`Myco Industries, Inc. and John R.
`Choate
`
`
`Defendants.
`
`
`
`
`
`
`Civil Action No. 2:19-cv-13089
`
`Honorable Gershwin A. Drain
`and Magistrate Judge Elizabeth
`A. Stafford
`
`JURY TRIAL DEMANDED
`
`
`BLEPHEX, LLC’S MOTION FOR A
`PRELIMINARY INJUNCTION
`AND BRIEF IN SUPPORT
`
`
`
`

`

`
`
`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.85 Filed 11/07/19 Page 2 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 3 of 42 PageID #: 4201
`
`
`
`MOTION
`
`Pursuant to 35 U.S.C. § 283, Plaintiff BlephEx, LLC (“BlephEx”) hereby
`
`moves for a preliminary injunction to enjoin Defendants Myco Industries, Inc.
`
`(“Myco”) and John R. Choate (collectively, “Defendants”) from directly or
`
`indirectly infringing BlephEx’s United States Patent No. 10,449,087 (“the ‘087
`
`Patent”), which was issued by the United States Patent and Trademark Office
`
`(“USPTO”) on October 22, 2019. As detailed in the accompanying Brief below,
`
`Defendants’ AB Max device, when used as instructed by Defendants, infringes at
`
`least Claim 16 of the ‘087 Patent. BlephEx respectfully requests that the Court
`
`preliminarily enjoin Defendants, and their officers, agents, and those in active
`
`concert with any of them, from selling or offering for sale the AB Max device until
`
`a final judgment is entered in this action.
`
`Pursuant to Rule 7.1(a), BlephEx sought to ascertain whether this motion
`
`would be opposed by Defendants. On November 6, 2019, Defendants indicated they
`
`oppose this motion.
`
`
`
`
`
`
`
`i
`
`

`

`
`
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`
`
`BRIEF
`
`CONCISE STATEMENT OF ISSUES PRESENTED
`
`Should the Court issue a preliminary injunction prohibiting sales of the AB
`
`Max device where BlephEx has made a strong showing that the AB Max device,
`
`when used as instructed by Myco, infringes Claim 16 of BlephEx’s ‘087 Patent;
`
`BlephEx has been and will continue to be irreparably harmed absent an injunction;
`
`the balance of the hardships tips in BlephEx’s favor; and the public interest would
`
`be served by an injunction?
`
`
`
`
`
`
`
`ii
`
`

`

`
`
`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.87 Filed 11/07/19 Page 4 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 5 of 42 PageID #: 4203
`
`
`
`TABLE OF RELEVANT AUTHORITIES
`
`Cases
`
`Page(s)
`
`Aria Diagnostics, Inc. v. Sequenom, Inc.,
` 726 F.3d 1296 (Fed. Cir. 2013) .................................................................... 20, 21
`
`Atlas Powder Co. v. Ireco Chem.,
` 773 F.2d 1230 (Fed. Cir. 1985) ............................................................................. 9
`
`Brocade Comm. Sys., Inc. v. A10 Networks, Inc.,
` No. C 10-3428 PSG, 2013 WL 140039 (N.D. Cal. 2013) ..................................19
`
`Celgard, LLC v. LG Chem, Ltd.,
` 624 F. App’x 748 (Fed. Cir. 2015) ......................................................................19
`
`Cornucopia Prods., LLC v. Dyson, Inc.,
` No. 12-234, 2012 WL 3094955 (D. Ariz. July 27, 2012) ...................................25
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
` 717 F.3d 1336 (Fed. Cir. 2013) ...........................................................................25
`
`Dynacore Holdings Corp. v. U.S. Philips Corp.,
` 363 F.3d 1263 (Fed. Cir. 2004) ...........................................................................15
`
`Golden Blount, Inc. v. Robert H. Peterson Co.,
` 438 F.3d 1354 (Fed. Cir. 2006) ...........................................................................16
`
`Hoop v. Hoop,
` 279 F.3d 1004 (Fed. Cir. 2002) ............................................................................. 9
`
`Hybritech Inc. v. Abbott Labs.,
` 849 F.2d 1446 (Fed. Cir. 1988) .......................................................................9, 24
`
`Johns Hopkins Univ. v. Alcon Labs.,
` No. 15-525, 2018 U.S. Dist. LEXIS 70403 (D. Del. Mar. 1, 2018) ...................14
`
`Lucent Techs., Inc. v. Gateway, Inc.,
` 580 F.3d 1301 (Fed. Cir. 2009) ...........................................................................15
`
`Mentor Graphics Corp. v. Quickturn Design Sys., Inc.,
` 150 F.3d 1374 (Fed. Cir. 1998) ...........................................................................18
`
`
`
`iii
`
`

`

`
`
`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.88 Filed 11/07/19 Page 5 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 6 of 42 PageID #: 4204
`
`
`
`
`Metalcraft of Mayville, Inc. v. The Toro Co.,
` 848 F.3d 1358 (Fed. Cir. 2017) .......................................................................9, 18
`
`Metalcraft of Mayville, Inc. v. Toro Co.,
` No. 16-C-544, 2016 WL 4076894 (E.D. Wis. Aug. 1, 2016) .............................22
`
`Metso Minerals, Inc. v. Powerscreen Intern. Distribution Ltd.,
` No. 06-cv-1446(ETB), 2011 WL 2149629 (E.D.N.Y. May 26, 2011) ...............19
`
`M-I LLC v. FPUSA, LLC,
` 626 F. App’x 995 (Fed. Cir. 2015) ......................................................................18
`
`Minn. Min. & Mfg. Co. v. Chemque, Inc.,
` 303 F.3d 1294 (Fed. Cir. 2002) ...........................................................................13
`
`Moleculon Research Corp. v. CBS, Inc.,
` 793 F.2d 1261 (Fed. Cir. 1986) ...........................................................................15
`
`PowerOasis, Inc. v. T–Mobile USA, Inc.,
` 522 F.3d 1299 (Fed. Cir. 2008) ...........................................................................17
`
`PPG Indus., Inc. v. Guardian Indus. Corp.,
` 75 F.3d 1558 (Fed. Cir. 1996) .............................................................................25
`
`Presidio Components, Inc. v. Am. Tech. Ceramics Corp.,
` 702 F.3d 1351 (Fed. Cir. 2012) ...........................................................................24
`
`Purdue Pharma L.P. v. Boehringer Ingelheim GMBH,
` 237 F.3d 1359 (Fed. Cir. 2001) ...........................................................................17
`
`Robert Bosch LLC v. Pylon Mfg. Corp.,
` 659 F.3d 1142 (Fed. Cir. 2011) .................................................................... 19, 23
`
`Sanofi-Synthelabo v. Apotex, Inc.,
` 470 F.3d 1368 (Fed. Cir. 2006) ...........................................................................21
`
`Tate Access Floors, Inc. v. Interface Architectural Res., Inc.,
` 279 F.3d 1357 (Fed. Cir. 2002) ............................................................................. 9
`
`Tinnus Enters., LLC v. Telebrands Corp.,
` 846 F.3d 1190 (Fed. Cir. 2017) .............................................................. 18, 20, 23
`
`
`
`iv
`
`

`

`
`
`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.89 Filed 11/07/19 Page 6 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 7 of 42 PageID #: 4205
`
`
`
`Toshiba Corp. v. Imation Corp.,
` 681 F.3d 1358 (Fed. Cir. 2012) ...........................................................................15
`
`Trebro Mfg., Inc. v. Firefly Equip., LLC,
` 748 F.3d 1159 (Fed. Cir. 2014) ...........................................................................18
`
`Statutory Authorities
`
`35 U.S.C. § 271(a) ...................................................................................................14
`
`35 U.S.C. § 271(b) ...................................................................................................14
`
`35 U.S.C. § 271(c) ............................................................................................ 14, 16
`
`35 U.S.C. § 281 ........................................................................................................14
`
`35 U.S.C. § 283 ....................................................................................................8, 14
`
`35 U.S.C. § 284 ........................................................................................................14
`
`35 U.S.C. § 285 ........................................................................................................14
`
`35 U.S.C. § 287(a) ....................................................................................................14
`
`35 U.S.C. § 287(c) ....................................................................................................14
`
`
`
`
`
`v
`
`

`

`
`
`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.90 Filed 11/07/19 Page 7 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 8 of 42 PageID #: 4206
`
`
`TABLE OF CONTENTS
`
`
`
`Page
`
`I.
`
`INTRODUCTION ......................................................................................... 1
`
`II.
`
`BACKGROUND ........................................................................................... 4
`
`A.
`
`Relevant Anatomy Of The Eye ........................................................... 4
`
`B.
`
`C.
`
`Anterior Blepharitis ............................................................................. 4
`
`Dr. Rynerson’s Novel Treatment For Eyelid Margin
`Diseases ............................................................................................... 5
`
`D.
`
`The ‘087 Patent ................................................................................... 6
`
`E.
`
`F.
`
`The Relationship Between The ‘087 Patent And
`The ‘718 Patent ................................................................................... 6
`
`Facts Regarding Mr. Choate And The Infringing
`AB Max ............................................................................................... 7
`
`III. LEGAL STANDARD ................................................................................... 8
`
`IV. ARGUMENT ................................................................................................. 9
`
`A.
`
`BlephEx Has A Strong Likelihood Of Success .................................. 9
`
`1.
`
`The AB Max Device, When Used As Directed By Myco,
`Infringes Claim 16 .................................................................. 10
`
`(a)
`
`The AB Max Satisfies the Preamble ..............................10
`
`(b) Myco Instructs Eye Care Professionals To Perform The
`First Step Of Claim 16 (Limitation 16.a) .......................11
`
`(c) Myco Instructs Eye Care Professionals To Perform The
`Second Step Of Claim 16 (Limitation 16.b) ...................12
`
`2. Myco Has Induced And Continues To Induce Infringement
`Under Section 271(B) ............................................................. 13
`
`
`
`vi
`
`

`

`
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`
`
`3. Myco Has Contributorily Infringed Claim 16 Of The ‘087
`Patent Under Section 271(c) ................................................... 15
`
`4. Myco Cannot Show The ‘087 Patent Is Invalid ...................... 17
`
`BlephEx Will Continue To Be Irreparably Harmed
`Absent A Preliminary Injunction ...................................................... 18
`
`The Balance Of Hardships Tips Decidedly In Favor
`Of BlephEx ........................................................................................ 24
`
`B.
`
`C.
`
`D. A Preliminary Injunction Would Serve The Public
`Interest ............................................................................................... 25
`
`V.
`
`CONCLUSION ............................................................................................ 25
`
`
`
`
`
`vii
`
`

`

`
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`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.92 Filed 11/07/19 Page 9 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 10 of 42 PageID #: 4208
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`
`
`I.
`
`INTRODUCTION
`
`On October 22, 2019, the USPTO issued the ‘087 Patent to BlephEx and, that
`
`same day, BlephEx filed the present action for patent infringement against
`
`Defendants. BlephEx brings this motion for preliminary injunction and respectfully
`
`asks this Court’s assistance to stop what is, as detailed below, a clear-cut case of
`
`infringement of BlephEx’s new patent.
`
`The ‘087 Patent’s Claim 16 is directed to an electromechanical device for
`
`cleaning debris from a patient’s eyelid margin. Claim 16 is recited in full below
`
`with portions particularly pertinent to this motion in bold italics:
`
`A method of treating an eye for an ocular disorder with a swab
`operably connected to an electromechanical device, wherein the
`eye has an eyelid margin and includes a removable debris, the
`method comprising:
`
`[16.a] effecting movement of the swab relative to the
`electromechanical device, the swab having at least a portion
`thereof configured to access a portion of the eyelid margin;
`
`[16.b] while the swab is being moved by the electromechanical
`device, contacting a portion of the eyelid margin that includes
`the removable debris with the swab thereby impacting the debris
`with
`the
`swab
`to
`remove debris
`from
`the
`eye.
`
`The accused AB Max device, when used as directed by Defendants, infringes
`
`Claim 16 under a straightforward analysis. It is configured to access “a portion of
`
`the eyelid margin” and in fact contacts “a portion of the eyelid margin,” namely the
`
`anterior portion of the eyelid margin to treat anterior blepharitis. Importantly, Myco
`
`
`
`1
`
`

`

`
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`
`
`has already made admissions – and the Court has already made findings – regarding
`
`the AB Max device that show infringement. As the Court is aware, in the parties’
`
`co-pending litigation, Myco Industries v. BlephEx, LLC, No. 19-cv-10645 (E.D.
`
`Mich.) (“the 645 Litigation”), Myco moved for a preliminary injunction against
`
`BlephEx on the basis that the AB Max does not infringe the BlephEx patent at issue
`
`there, U.S. Patent No. 9,039,718 (“the ‘718 Patent”). In that motion, Myco argued
`
`that the AB Max device is for contacting the anterior portion of the eyelid margin,
`
`to treat anterior blepharitis. In granting Myco’s motion, this Court found that “Mr.
`
`Choate consistently state[d] that the AB Max is for debriding the anterior eyelid
`
`margin” and concluded “the AB Max is for treatment of anterior blepharitis.” Ex.
`
`71 at 12. BlephEx respectfully submits that these admissions and findings compel
`
`the conclusion that Defendants infringe Claim 16 of the ‘087 Patent.
`
`Notably, Claim 16 of the ‘087 Patent does not include the limitations referring
`
`to the “inner edge” of the eyelid margin that were the sole basis for Myco’s argument
`
`that it does not infringe the ‘718 Patent. The ‘718 Patent Claim 1 recites that the
`
`device has a swab “configured to access an inner edge portion of the eyelid margin”
`
`and performs the step of “contacting a portion of the eye between the eyelashes and
`
`the inner edge of the eyelid margin.” In the 645 Litigation, Myco advanced a claim
`
`
`1 All references to “Ex.” are to the exhibits to the Declaration of Matthew D.
`Robson, submitted herewith.
`
`
`
`2
`
`

`

`
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`
`
`construction argument in its motion for preliminary injunction that these limitations
`
`should be construed to limit the ‘718 Patent claims to covering treatment of only
`
`posterior blepharitis. While Myco has since abandoned that erroneous claim
`
`construction argument, and did not advance it in its claim construction briefs,
`
`Myco’s former “posterior blepharitis” argument is wholly inapplicable here.
`
`Defendants’ infringement is irreparably harming BlephEx. BlephEx is a small
`
`company whose core product is the patent-protected BlephEx device and method.
`
`BlephEx has been forced to compete with an infringing product that Myco, having
`
`not invested in the research and development of the invention, actively markets as
`
`being a third of the price of the BlephEx. As a result, BlephEx has suffered extensive
`
`price erosion and irreparable damage to its goodwill and reputation, as customers
`
`insist BlephEx match the price of the AB Max, and formerly loyal customers opt for
`
`the cheaper knock-off product. This is exactly the type of irreparable harm
`
`preliminary injunctions enjoining infringement are intended to prevent.
`
`The immense hardship on BlephEx is palpable, and the strong public policy
`
`favoring enforcement of patent rights supports entry of an injunction.
`
`For these reasons and as discussed in more detail below, BlephEx respectfully
`
`requests that the Court grant its motion for preliminary injunction.
`
`
`
`3
`
`

`

`
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`
`
`II. BACKGROUND
`
`A. Relevant Anatomy Of The Eye
`
`Claim 16 of the ‘087 Patent focuses on the “eyelid margin.” The parties’
`
`experts have already addressed in the 645 Litigation what a person of ordinary skill
`
`in the art (“POSA”) would understand the “eyelid margin” to be. BlephEx’s expert,
`
`Dr. Penny Asbell (“Dr. Asbell”), declared that a POSA would understand the “eyelid
`
`margin” to be “the edge of an eyelid, which is divided into an anterior portion and a
`
`posterior portion by the physiological feature of the gray line.” Ex. 10 ¶ 80; see also
`
`id. ¶¶ 70-79. Myco’s expert, Dr. Steve Silberberg (“Dr. Silberberg”), agrees with
`
`Dr. Asbell on this definition. Ex. 11 at 173:14-16.
`
`During his deposition, Dr. Silberberg identified the boundaries for the anterior
`
`and posterior portions of the eyelid margin. According to Dr. Silberberg, the anterior
`
`portion of the eyelid margin (or “outer eyelid margin”) includes at least the midpoint
`
`of the eyelashes and extends inwardly to the gray line. Ex. 11 at 46:6-47:1. Once
`
`across the gray line, one has left the anterior eyelid margin and is now on the
`
`posterior eyelid margin. Id. at 47:3-21.
`
`B. Anterior Blepharitis
`
`As the Court is aware, Myco advertises that the AB Max is for treatment of
`
`anterior blepharitis. Ex. 7 at 17 (the Court finding that “the AB Max is for treatment
`
`of anterior blepharitis”). As Myco’s expert admitted, anterior blepharitis is a
`
`
`
`4
`
`

`

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`
`
`condition of the eyelid margin. Ex. 11 at 28:10-16. And the parties’ experts agree
`
`that “Anterior Blepharitis describes an inflammation of the lid margin anterior to the
`
`gray line and concentrated around the lashes.” Ex. 11 at 192:10-193:5; Ex. 12 at
`
`1932; Ex. 10 ¶¶ 132-33.
`
`C. Dr. Rynerson’s Novel Treatment For Eyelid Margin Diseases
`
`Prior to Dr. Rynerson’s novel treatment for eyelid margin diseases such as
`
`blepharitis, meibomitis, and dry eye syndrome, patients were generally prescribed a
`
`hygienic home treatment procedure. This required them to try to remove debris from
`
`the eyelid margin with a cotton swab, fingertip, or scrub. Unfortunately, such home
`
`treatment generally achieved limited success due to the practical difficulties of
`
`cleaning one’s own eyelid and eyelid margin. Ex. 1 at 1:50-2:21.
`
`Seeking to address the problems with prior treatments, Dr. Rynerson,
`
`developed a unique
`
`treatment for cleaning
`
`the eyelid margin using an
`
`electromechanical device. Dr. Rynerson’s invention has revolutionized the
`
`treatment of eyelid margin disorders. Within two years of its introduction to the
`
`market in 2013, it had already been adopted by over 1,000 ophthalmic practices and
`
`to date over 5,000 have been sold worldwide. Declaration of Dr. James Rynerson
`
`(“Rynerson Decl.”) ¶ 7. The BlephEx device has received widespread recognition
`
`and industry praise. For example, the Association of Optometrists selected the
`
`BlephEx device as a finalist for 2017 “Product of the Year.” Ex. 29.
`
`
`
`5
`
`

`

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`
`
`D. The ‘087 Patent
`
`On October 22, 2019, the USPTO issued the ’087 Patent to BlephEx. As
`
`discussed in the ’087 Patent specification, the ‘087 Patent invention is directed to
`
`solving problems with patient home treatment because patients “routinely fail to
`
`totally cleanse the margin of the eyelid, the base of the eyelashes, and the meibomian
`
`glands.” Ex. 1 at 2:10-14. The inventive method of the ’087 Patent addresses these
`
`problems with a device for cleaning the eyelid margin and eyelashes. “The
`
`electromechanical device 10 operably drives the swab 14 to break the debris free
`
`from either of the upper or lower eyelid margins 60, 62.” Id. at 7:62-64.
`
`E.
`
`The Relationship Between The ‘087 Patent And The ‘718 Patent
`
`The recently issued ‘087 Patent is a different patent from the ‘718 Patent at
`
`issue in the 645 Litigation, though the patents are related. In the 645 Litigation,
`
`Myco moved for a preliminary injunction, arguing that it was likely to prove non-
`
`infringement of the ‘718 Patent. Myco’s sole non-infringement position was based
`
`on its claim construction argument that the ‘718 Patent is not infringed by methods
`
`of treating anterior blepharitis on the anterior portion of the eyelid margin. Myco
`
`contended this was because “[e]very claim includes the limitation that treatment
`
`must occur ‘between the eyelashes and the inner edge of the eyelid margin’ or ‘an
`
`inner edge portion of the eyelid margin,’” which, according to Myco, limited the
`
`‘718 Patent claims to covering treatment of only posterior blepharitis. Ex. 6 at 15.
`
`
`
`6
`
`

`

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`
`
`Myco has since abandoned this claim construction argument, having not advanced
`
`it in its claim construction briefing. Ex. 8. And Myco’s former claim construction
`
`position is erroneous for the reasons recited in BlephEx’s claim construction brief.
`
`Ex. 9. However, before Myco abandoned its “posterior blepharitis” argument, it
`
`secured a preliminary injunction based thereon (“PI Order”). Ex. 7.2
`
`The ’087 Patent includes claims that do not recite the “inner edge” limitations
`
`that were Myco’s sole basis for alleged non-infringement. For example, Claim 16
`
`of the ’087 Patent does not recite any limitations directed to an “inner edge” of the
`
`eyelid margin. Thus, Myco’s (now abandoned) “posterior blepharitis” argument
`
`advanced in the 645 Litigation is inapplicable to Claim 16 of the ‘087 Patent.
`
`F.
`
`Facts Regarding Mr. Choate And The Infringing AB Max
`
`Mr. Choate is a former employee of BlephEx’s predecessor company. Ex. 18
`
`¶ 36. Dr. Rynerson invented the novel treatment method discussed above and filed
`
`the ultimate parent application for the ‘087 Patent on July 24, 2012, before any
`
`communication with Mr. Choate. Rynerson Decl. ¶ 5.
`
`In February 2019, Mr. Choate and Myco launched the AB Max product. The
`
`patented BlephEx product and infringing AB Max product are shown below:
`
`
`2 BlephEx submitted the Court’s PI Order to the USPTO Examiner, who
`confirmed he reviewed it before allowing the ‘087 Patent’s claims. Ex. 2. at
`September 3, 2019 Information Disclosure Statement.
`
`
`
`
`7
`
`

`

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`
`Dr. Rynerson’s BlephEx
`
`
`Myco’s AB Max
`
`
`
`
`
`
`
`
`Just like the BlephEx, the AB Max device uses a rotating swab to clean a
`
`patient’s eyelid margin. Ex. 20, Step 18. The swabs of the devices are also the same
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`for purposes of infringement, as shown in the below side-by-side comparison:
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`BlephEx’s Swab
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`Myco’s Swab
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`And the copying does not stop there. As shown in Appendix A, Myco’s
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`instruction manual is largely a copy of the BlephEx’s. Indeed, Myco has copied
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`even BlephEx’s eyelid model, eyelash mite model, and order form. App’x A.
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`III. LEGAL STANDARD
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`35 U.S.C. § 283 provides that district courts “may grant injunctions in
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`accordance with the principles of equity to prevent the violation of any right secured
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`8
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`by patent.” Under § 283, “a district court has discretion to grant a preliminary
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`injunction it deems reasonable.” Hoop v. Hoop, 279 F.3d 1004, 1006 (Fed. Cir.
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`2002). In the context of a preliminary injunction against infringement, “a
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`preliminary injunction preserves the status quo if it prevents future trespasses” of the
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`patent. Atlas Powder Co. v. Ireco Chem., 773 F.2d 1230, 1232 (Fed. Cir. 1985).
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`A patentee is entitled to a preliminary injunction if it shows: 1) “that [it] is
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`likely to succeed on the merits,” 2) “that [it] is likely to suffer irreparable harm in
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`the absence of preliminary relief,” 3) “that the balance of equities tips in [its] favor,”
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`and 4) “that an injunction is in the public interest.” Metalcraft of Mayville, Inc. v.
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`The Toro Co., 848 F.3d 1358, 1363 (Fed. Cir. 2017); see also Hybritech Inc. v.
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`Abbott Labs., 849 F.2d 1446, 1451 n.12 (Fed. Cir. 1988). “Individually, no factor is
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`dispositive; the district court must weigh the factors against each other and against
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`the form and magnitude of requested relief.” Tate Access Floors, Inc. v. Interface
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`Architectural Res., Inc., 279 F.3d 1357, 1365 (Fed. Cir. 2002).
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`IV. ARGUMENT
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`A. BlephEx Has A Strong Likelihood Of Success
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`The first factor strongly supports entry of a preliminary injunction because the
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`AB Max clearly infringes when used as directed by Myco. This is not a close case.
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`Claim 16 requires that the claimed device perform the step of “contacting a portion
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`of the eyelid margin that includes the removable debris.” Myco unequivocally
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`9
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`instructs eye care professionals to use the AB Max to contact a portion of the eyelid
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`margin, namely the anterior or outer portion, to remove debris associated with
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`anterior blepharitis, as this Court already found in the PI Order. Ex. 7 at 17.
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`1.
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`The AB Max Device, When Used As Directed By Myco,
`Infringes Claim 16
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`(a) The AB Max Satisfies the Preamble
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`The preamble to Claim 16 recites “[a] method of treating an eye for an ocular
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`disorder with a swab operably connected to an electromechanical device, wherein
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`the eye has an eyelid margin and includes a removable debris.” The AB Max
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`satisfies the preamble. Declaration of Dr. Penny Asbell (“Asbell Decl.”) ¶¶ 77-80.
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`Myco instructs eye care professionals to use the AB Max to “treat[] an ocular
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`disorder,” namely anterior blepharitis. Myco’s website touts the AB Max as an
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`“Advanced Doctor Treatment for Anterior Blepharitis.” Ex. 23. The AB Max
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`instruction manual further shows that Defendants instruct practitioners to use the AB
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`Max to treat anterior blepharitis. Ex. 20. Moreover, as this Court has already noted,
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`in the AB Max Demonstration Video, Mr. Choate “consistently states that the device
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`is for … ‘anterior blepharitis’.” Ex. 7 at 12.
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`The AB Max further includes “a swab operably connected to an
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`electromechanical device” as shown in the images of the device supra Section II.F.
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`The accused method further treats an eye “ha[ving] an eyelid margin and includes a
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`removable debris.” The AB Max manual expressly instructs contacting the “outer
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`10
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`eyelid margin of the chosen lid and lash line” in order to “remove the scurf, debris,
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`dead skin etc.” Ex. 20, Step 18.
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`(b) Myco Instructs Eye Care Professionals To Perform The
`First Step Of Claim 16 (Limitation 16.a)
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`Myco instructs eye care professionals to perform the step of “effecting
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`movement of the swab relative to the electromechanical device, the swab having at
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`least a portion thereof configured to access a portion of the eyelid margin.” Asbell
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`Decl. ¶¶ 81-87. The AB Max instruction manual instructs the user to “[p]ress and
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`hold the power button for three (3) seconds to start the AB Max device in forward
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`mode.” Ex. 20, Step 15. The swab of the device then starts spinning.
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`The AB Max swab has “at least a portion thereof configured to access a
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`portion of the eyelid margin” as claimed – namely it is configured to access at least
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`the anterior or outer portion of the eyelid margin. As this Court has already found,
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`“Mr. Choate consistently states that the AB Max is for debriding the anterior eyelid
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`margin.” Ex. 7 at 12. Confirming that the swab of the AB Max is configured to
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`access the anterior or outer portion of the eyelid margin, the AB Max manual
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`instructs eye care professionals to “apply the spinning AB Max microsponge to the
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`outer eyelid margin of the chosen lid and lash line in a swirling and scrubbing
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`motion.” Ex. 20, Step 18. The AB Max’s FDA product code further confirms
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`infringement because it states that the swab is “applied to the lower and upper eyelid
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`11
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`margins and eyelashes to remove debris.” Ex. 22. And the Myco website instructs
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`that the swab is for “massaging the anterior eyelid margins.” Ex. 24.
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`It is self-evident that the “anterior” or “outer” eyelid margin is a portion of the
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`eyelid margin. Confirming this, Myco’s expert testified in the 645 Litigation that
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`the “anterior eyelid margin” is the portion of the eyelid margin extending from the
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`gray line to at least the midpoint of the eyelashes. Ex. 11 at 46:6-47:2.
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`As still more evidence the AB Max swabs are configured to access the anterior
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`portion of the eyelid margin, Myco states that its swab is specifically designed to
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`treat anterior blepharitis: “proprietary tips specifically designed to treat Anterior
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`Blepharitis.” Ex. 24. As Myco’s expert admitted, anterior blepharitis is a condition
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`of the eyelid margin. Ex. 11 at 28:10-16.
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`(c) Myco Instructs Eye Care Professionals To Perform The
`Second Step Of Claim 16 (Limitation 16.b)
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` Myco instructs eye care professionals to perform the step of “while the swab
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`is being moved by the electromechanical device, contacting a portion of the eyelid
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`margin that includes the removable debris with the swab thereby impacting the
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`debris with the swab to remove debris from the eye.” Asbell Decl. ¶¶ 88-94.
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`The AB Max manual instructs eye care professionals to “apply the spinning
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`AB Max microsponge to the outer eyelid margin of the chosen lid and lash line in a
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`swirling and scrubbing motion”:
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`12
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`Case 2:19-cv-13089-GAD-EAS ECF No. 10, PageID.104 Filed 11/07/19 Page 21 of 41Case 1:23-cv-00089-TSK Document 100-3 Filed 02/14/24 Page 22 of 42 PageID #: 4220
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`Ex. 20, Step 18. The AB Max further “impact[s] the debris with the swab to remove
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`debris from the eye” as claimed because, as shown above, Myco instructs users to
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`“remove the scurf, debris, dead skin etc.” Id. Moreover, as this Court has already
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`found, Mr. Choate has “consistently state[d] that the AB Max is for debriding the
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`anterior eyelid margin.” Ex. 7 at 12; see also id. at 11. The AB Max’s FDA product
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`code also confirms infringement as it states