Case: 21-1149 Document: 55 Page: 1 Filed: 02/03/2022
United States Court of Appeals
for the Federal Circuit
______________________
BLEPHEX, LLC,
Plaintiff-Appellee
v.
MYCO INDUSTRIES, INC., JOHN R. CHOATE,
Defendants-Appellants
______________________
2021-1149, 2021-1365
______________________
Appeals from the United States District Court for the
Eastern District of Michigan in No. 2:19-cv-13089-GAD-
EAS, Judge Gershwin A. Drain.
______________________
Decided: February 3, 2022
______________________
PETER J. ARMENIO, Quinn Emanuel Urquhart & Sulli-
van, LLP, New York, NY, argued for plaintiff-appellee.
Also represented by WILLIAM ADAMS, MATTHEW D. ROBSON;
ALEXANDER HALE LOOMIS, Boston, MA.
THOMAS A. LEWRY, Brooks Kushman PC, Southfield,
MI, argued for defendants-appellants. Also represented by
REBECCA JAMIE CANTOR, CHRISTOPHER C. SMITH.
______________________
Before MOORE, Chief Judge, SCHALL and O’MALLEY,
Circuit Judges.
Case: 21-1149 Document: 55 Page: 2 Filed: 02/03/2022
2 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
O’MALLEY, Circuit Judge.
In February 2019, Myco Industries, Inc. (“Myco”) began
marketing a product it called the AB Max at a trade show
in New Orleans. The AB Max is a device for treating bleph-
aritis. 1 A month later, BlephEx, LLC (“BlephEx”) filed an
application that would become United States Patent Num-
ber 10,449,087 (“the ’087 patent”). On October 22, 2019,
the United States Patent and Trademark Office issued the
’087 patent, entitled “Instrument for Treating an Ocular
Disorder.” The same day, BlephEx sued Myco and its
chairman, John R. Choate, in the Eastern District of Mich-
igan, alleging that the AB Max infringed claim 16 of the
’087 patent. 2 Soon thereafter, the district court granted a
preliminary injunction enjoining Myco and those acting on
its behalf from, inter alia, selling, distributing, or offering
to sell or distribute the AB Max product. See BlephEx, LLC
v. Myco Indus., Inc., No. 2:19-CV-13089,
2020 WL 5951504
(E.D. Mich. Oct. 8, 2020) (“Preliminary Injunction Deci-
sion”); BlephEx, LLC v. Myco Indus., Inc., No. 2:19-CV-
13089,
2020 WL 7134932 (E.D. Mich. Nov. 25, 2020) (“Re-
consideration Decision”). Myco appealed.
Because the district court did not abuse its discretion
in granting the preliminary injunction, clearly err in its un-
derlying factual findings, or abuse its discretion in setting
the scope of the preliminary injunction, we affirm.
1 Blepharitis is a chronic inflammatory disease of
the eyelids and eyelid margins that causes a buildup of
scurf or debris. See
U.S. Patent No. 10,449,087 col. 1 ll. 24–
25.
2 There is a history of enmity among the parties.
While the parties spill a fair amount of ink on that history,
we do not. It did not factor into the district court’s judg-
ment and is, thus, irrelevant to our conclusions.
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BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 3
I. BACKGROUND
A. The ’087 Patent
The ’087 patent discloses “[a]n instrument for remov-
ing debris from an eye during the treatment of an ocular
disorder.” ’087 Patent Abstract. The claimed device may
be used to treat blepharitis.
According to the ’087 patent, treatment of blepharitis
historically involved home treatment in which the patient
would physically scrub the eyelid margin with a cotton
swab, fingertip, or scrubbing pad to remove debris, oil, and
scurf. ’087 Patent col. 1 ll. 30–61. The ’087 patent claims
that “patients routinely fail to totally cleanse” the eyelid
margin with this home treatment method. ’087 Patent col.
2 ll. 12–14. To remedy this problem, the ’087 patent dis-
closes a swab attached to an electromechanical device for
eye care professionals to use to clean patients’ eyelid mar-
gins and eyelashes.
The ’087 patent has 20 method claims. BlephEx as-
serted claim 16, and it was on that claim that BlephEx
predicated its request for a preliminary injunction. Claim
16 recites:
16. A method of treating an eye for an ocular disor-
der with a swab operably connected to an electro-
mechanical device, wherein the eye has an eyelid
margin and includes a removable debris, the
method comprising:
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; and
while the swab is being moved by the elec-
tromechanical device, contacting a portion
of the eyelid margin that includes the re-
movable debris with the swab thereby
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4 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
impacting the debris with the swab to re-
move debris from the eye.
B. The Preliminary Injunction
As noted, BlephEx sought a preliminary injunction.
The district court found that all relevant factors weighed
heavily in favor of a preliminary injunction and, thus,
granted BlephEx’s motion. The district court concluded
that (1) BlephEx had a strong likelihood of success on the
merits; (2) BlephEx would suffer irreparable harm in the
absence of preliminary relief; (3) preliminary relief would
not unduly harm others; and (4) an injunction would serve
the public interest.
The likelihood of success on the merits factor is at issue
in this appeal. The district court’s finding that BlephEx
established a strong likelihood of success had multiple
prongs, moreover, and Myco challenges only one. Specifi-
cally, the district court first found that BlephEx estab-
lished that it was likely to prove direct infringement by
Myco. Myco does not appeal this finding. The district court
also found that BlephEx was likely to prove that Myco and
Mr. Choate induced and contributed to infringement of
claim 16. Myco, again, does not appeal these findings. The
conclusion Myco challenges is that Myco failed to demon-
strate a substantial question of validity. The district court
was unconvinced by Myco’s argument that the ’087 patent
is likely invalid over U.S. Pat. Pub. No. 2013/0331768 (“Ni-
chamin”).
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BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 5
Nichamin is a published patent application entitled
“Eye Treatment.” It describes a “novel combination of mi-
crodermabrasive along with a therapeutically effective
amount of an isoprenoidal essential oil” useful for treat-
ment or prevention of ocular disorders, diseases, or syn-
dromes, such as blepharitis. J.A. 1446 (¶ 48). It also
discloses “kits and methods for treating and preventing”
various eye conditions and for cleaning healthy eyes. J.A.
1446 (¶ 50). Nichamin’s Figure 2 shows a wand being used
to remove debris from an eyelid margin:
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6 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
J.A. 1446–47 (¶ 54); J.A. 1438. And Nichamin’s Figure 3
depicts an electromechanical device used to apply the novel
composition:
J.A. 1448 (¶ 65); J.A. 1439.
Myco argued before the district court that these two
figures show different perspectives of the same embodi-
ment—an electromechanical device (depicted in Figure 3)
equipped with a swab (depicted in Figure 2) used to contact
the eyelid margin. The district court disagreed. It found
that Nichamin’s Figures 2 and 3 depict two different em-
bodiments and that nothing in Nichamin suggested com-
bining the two.
The district court thus found that Myco had not pre-
sented a substantial question of anticipation based on Ni-
chamin. The court noted that a prior art reference must
disclose all elements of a claim “arranged as in the claim”
to anticipate. Preliminary Injunction Decision,
2020 WL
5951504, at *6 (quoting Finistar Corp. v. DirecTV Grp.,
Inc.,
523 F.3d 1323, 1334–35 (Fed. Cir. 2008)). Because Ni-
chamin does not disclose combining the applicator device
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BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 7
of the embodiment depicted in Figure 3 with a swab, the
district court found that Nichamin fails to disclose the lim-
itation of a “swab [] being moved by the electromechanical
device,” and, thus, cannot anticipate claim 16.
Id.
The district court also noted that Nichamin was con-
sidered during examination of the ’087 patent application.
It rejected Myco’s argument that the examiner did not con-
sider Nichamin because he did not substantively discuss it.
See Preliminary Injunction Decision,
2020 WL 5951504, at
*6 (citing Tinnus Enters., LLC v. Telebrands Corp., 733 F.
App’x 1011, 1020 (Fed. Cir. 2018)) (noting that it is “pre-
sumed that public officials do their assigned jobs”).
The district court then found that Myco’s “obviousness
argument is unsupported with any expert evidence demon-
strating that it would have been obvious to one of ordinary
skill in the art to attach a swab to the end of Nichamin’s
hand-held device.”
Id. It found that Myco also failed “to
explain how one of ordinary skill in the art would have ad-
dressed the safety concerns of attaching a swab that is
soaked in an abrasive to the Nichamin hand-held device.”
Id. Without more, the district court concluded, it could not
find that Myco had raised a substantial question of obvi-
ousness.
Because it concluded that BlephEx established a
strong likelihood of proving its infringement claim, and
that Myco failed to present a substantial question of valid-
ity, the district court concluded that the likelihood of suc-
cess factor favored entry of a preliminary injunction. After
finding that the remaining three factors similarly militated
in favor of granting a preliminary injunction, the district
court granted BlephEx’s motion. It later denied Myco’s mo-
tion to reconsider.
The district court adopted BlephEx’s proposed prelimi-
nary injunction language and enjoined Myco from “using,
offering for sale, and/or selling in the United States any
ABMax™ device, including any disposable swab designed
Case: 21-1149 Document: 55 Page: 8 Filed: 02/03/2022
8 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
to be used with any ABMax™ device.” Reconsideration De-
cision,
2020 WL 7134932, at *4.
The district court rejected Myco’s argument that the
preliminary injunction was overbroad because the AB Max
has non-infringing uses. The district court found this ar-
gument both untimely and without merit. It found Myco’s
arguments and evidence presenting only hypothetical non-
infringing uses were outweighed by evidence that the only
actual use of the AB Max was to treat anterior blephari-
tis—a use that the district court found would likely infringe
claim 16. The district court thus concluded that its injunc-
tion was not overbroad.
Myco appealed. We have jurisdiction under
28 U.S.C.
§ 1292(c)(1).
II. DISCUSSION
Myco makes three arguments on appeal. First, it ar-
gues that it presented a substantial question as to the va-
lidity of claim 16 of the ’087 patent on both anticipation and
obviousness grounds. Second, it argues that the prelimi-
nary injunction improperly upset the status quo. Third, it
argues that the preliminary injunction is overbroad. We
address each argument in turn.
A. Substantial Question of Validity
Myco argues that we should vacate the injunction be-
cause claim 16 of the ’087 patent is vulnerable to an inva-
lidity challenge based on Nichamin. Myco first argues that
it presented a substantial question of anticipation based on
Nichamin Figures 2 and 3, which it asserts depict only one
embodiment. It then argues that, even if Figures 2 and 3
depict different embodiments, a skilled artisan would com-
bine those embodiments to anticipate claim 16 because the
“applicator” depicted in Figure 3 can be a swab. Myco fur-
ther argues that the district court improperly deferred to
the patent examiner’s allowance of the ’087 patent over Ni-
chamin. Finally, Myco argues that, even if it has not shown
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BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 9
a substantial question of anticipation, “it is a small step to
obviousness”—that “it would have been common sense, and
therefore obvious, to use a swab with Nichamin’s Figure 3
device.” Appellant’s Br. 40–41. We do not find Myco’s ar-
guments persuasive. We address Myco’s anticipation and
obviousness arguments below. But, first, we address the
burdens of proof in the preliminary injunction inquiry and
the standard of review we apply to the district court’s find-
ing that Myco failed to raise a substantial question of va-
lidity.
1. Burdens of Proof
A party may obtain a preliminary injunction by show-
ing that (1) it is “likely to succeed on the merits,” (2) it is
“likely to suffer irreparable harm in the absence of prelim-
inary relief,” (3) the “balance of equities tips in [its] favor,”
and (4) “an injunction is in the public interest.” Winter v.
Nat. Res. Def. Council, Inc.,
555 U.S. 7, 20 (2008). The bur-
den is always on the movant to show that it is likely to suc-
ceed on the merits. And in the context of a patent
infringement suit, “[a] patent holder seeking a preliminary
injunction bears the burden of establishing a likelihood of
success on the merits with respect to the patent’s validity.”
Entegris, Inc. v. Pall Corp.,
490 F.3d 1340, 1351 (Fed. Cir.
2007) (citing Helifix Ltd. v. Blok-Lok, Ltd.,
208 F.3d 1339,
1351 (Fed. Cir. 2000)). Absent an invalidity defense, “the
very existence of the patent with its concomitant presump-
tion of validity satisfies the patentee’s burden of showing a
likelihood of success on the validity issue.” Titan Tire Corp.
v. Case New Holland, Inc.,
566 F.3d 1372, 1377 (Fed. Cir.
2009) (citations omitted). But if the accused infringer pre-
sents a substantial question of validity, “i.e., asserts an in-
validity defense that the patentee cannot prove ‘lacks
substantial merit,’ the preliminary injunction should not
issue.” Entegris,
490 F.3d at 1351 (quoting Genentech, Inc.
v. Novo Nordisk,
108 F.3d 1361, 1364 (Fed. Cir. 1997)).
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10 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
To show invalidity at trial, Myco will have “the ulti-
mate burden of persuasion to prove invalidity by clear and
convincing evidence, as well as the initial burden of going
forward with evidence to support its invalidity allegation.”
Titan Tire,
566 F.3d at 1376 (citing Tech. Licensing Corp.
v. Videotek, Inc.,
545 F.3d 1316, 1327 (Fed. Cir. 2008)). At
the preliminary injunction stage, however, those burdens
are “tailored to fit the preliminary injunction context.”
Id.
at 1377. If an alleged infringer attacks the validity of a
patent at the preliminary injunction stage, as Myco has, it
bears the initial burden “to come forward with evidence of
invalidity,” just as it would at trial.
Id. If the alleged in-
fringer comes forward with such evidence, the district court
should then consider “the evidence on both sides of the va-
lidity issue” to determine if the alleged infringer has raised
a substantial question of validity.
Id. at 1379 (citations
omitted).
Myco need not, to defeat a preliminary injunction,
prove invalidity by clear and convincing evidence, as it
must to succeed at trial.
Id. (citing Amazon.com, Inc. v.
Barnesandnoble.com, Inc.,
239 F.3d 1343, 1358 (Fed. Cir.
2001)). It need only present evidence showing that there is
a substantial question of validity despite the presumption
of patent validity and BlephEx’s arguments in favor of va-
lidity, such that BlephEx’s likelihood of success is in ques-
tion. Titan Tire,
566 F.3d at 1377–79. Again, the ultimate
burden is on BlephEx to show that it is likely to succeed on
the merits to obtain the extraordinary remedy of a prelim-
inary injunction, including “on the validity issue.” Titan,
566 F.3d at 1377. But the initial burden is on Myco to pro-
duce some evidence to raise a substantial question of valid-
ity.
Id. at 1377. To fulfill that burden, Myco need only
“assert[] a defense that [BlephEx] cannot show ‘lacks sub-
stantial merit.’” See Genentech,
108 F.3d at 1364.
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BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 11
2. Standard of Review
We review a district court’s grant of a preliminary in-
junction under the law of the regional circuit, in this case,
the Sixth Circuit. See Macom Tech. Sols. Holdings, Inc. v.
Infineon Techs. AG,
881 F.3d 1323, 1328 (Fed. Cir. 2018).
The Sixth Circuit reviews a district court’s decision to issue
a preliminary injunction under the “highly deferential”
abuse of discretion standard. DV Diamond Club of Flint,
LLC v. Small Bus. Admin.,
960 F.3d 743, 746 (6th Cir.
2020) (quoting Certified Restoration Dry Cleaning Net-
work, L.L.C. v. Tenke Corp.,
511 F.3d 535, 541 (6th Cir.
2007)). The Sixth Circuit will reverse a district court’s
grant of a preliminary injunction “only if the district court
‘relied upon clearly erroneous findings of fact, improperly
applied the governing law, or used an erroneous legal
standard.’”
Id. (quoting S. Glazer’s Distrib. of Ohio, LLC v.
Great Lakes Brewing Co.,
860 F.3d 844, 849 (6th Cir.
2017)).
Myco incorrectly asserts that we should review
whether it presented a substantial question of patent va-
lidity de novo. That is not the case. Although we review a
district court’s grant of a preliminary injunction under the
law of the regional circuit, “we give dominant effect to Fed-
eral Circuit precedent insofar as it reflects considerations
specific to patent issues.” See Macom Tech., 881 F.3d at
1328 (quoting Mikohn Gaming Corp. v. Acres Gaming, Inc.,
165 F.3d 891, 894 (Fed. Cir. 1998)). Whether a patentee
has shown a likelihood of success on the merits is one such
area where we apply our own law, as it is a question spe-
cific to patent law. See Revision Mil., Inc. v. Balboa Mfg.
Co.,
700 F.3d 524, 526 (Fed. Cir. 2012). In the context of a
preliminary injunction, we review the question of whether
a movant has shown a likelihood of success in showing pa-
tent validity for abuse of discretion. Titan Tire,
566 F.3d
at 1384 (“[W]e cannot say the trial court abused its discre-
tion in concluding that Titan was unlikely to withstand
Case’s challenge to the validity of the ’862 patent on
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12 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
obviousness grounds.”). We review the underlying issue of
whether the patent challenger’s asserted prior art raises a
substantial question of validity, a factual issue, for clear
error. Amazon.com,
239 F.3d at 1358 (“We review the dis-
trict court’s assessment of prior art references for clear er-
ror.”).
3. Anticipation
Myco’s primary anticipation argument is premised on
its assertion that Nichamin’s Figures 2 and 3 depict the
same embodiment—an electromechanical device with a
swab. We conclude that the district court did not clearly
err when it concluded that Figures 2 and 3 depict separate
embodiments.
Figure 2 shows a wand contacting a portion of the eye-
lid margin. J.A. 1446 (¶ 54). Figure 3 shows a hand-held
device with an applicator—which Myco admits is not a
swab 3—used to chafe the eyelid margin. J.A. 1448 (¶ 65).
Because neither figure shows “a swab operably connected
to an electromechanical device” where the swab contacts a
portion of the eyelid margin as required by claim 16, Myco’s
argument that Figures 2 and 3 depict the same anticipat-
ing embodiment fails to raise a substantial question of va-
lidity. “[I]t is not enough that the prior art reference . . .
includes multiple, distinct teachings that the artisan might
somehow combine to achieve the claimed invention” to
show anticipation. Net MoneyIN, Inc. v. VeriSign, Inc.,
545
F.3d 1359, 1371 (Fed. Cir. 2008) (citing In re Arkley,
455
F.2d 586, 587 (C.C.P.A. 1972)).
For the first time in its reply brief, Myco argues that,
under our precedent in Blue Calypso, LLC v. Groupon, Inc.,
815 F.3d 1331 (Fed. Cir. 2016), a prior art reference that
3 See Oral Arg. at 5:45–6:00, available at
https://oralarguments.cafc.uscourts.gov/dfault.aspx?fl=21-
1149_06092021.mp3.
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BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 13
lacks “an express discussion of the actual combination”
“may still anticipate if that reference teaches that the dis-
closed components or functionalities may be combined and
one of skill in the art would be able to implement the com-
bination.”
Id. at 1344 (citing Kennametal, Inc. v. Ingersoll
Cutting Tool Co.,
780 F.3d 1376, 1383 (Fed. Cir. 2015)). As
this argument was not presented to the district court, Myco
has failed to preserve it. Even if we were to consider it,
moreover, we would be unpersuaded.
Myco argues that the level of skill in the relevant art is
extremely high, agreeing with BlephEx that “an ordinary
artisan ‘would have highly advanced skill—at least a doc-
torate degree (a Doctor of Medicine (MD) or Doctor of Op-
tometry (DO) degree) with at least two to five years of
experience treating eyelid margin disease including bleph-
aritis.” Appellant’s Reply Br. 13–14. Myco argues that the
“highly skilled ordinary artisan here would ‘at once envis-
age’ the claimed combination from Nichamin’s teachings.”
Appellant’s Reply Br. 11 (quoting Chamberlain Grp., Inc.
v. Techtronic Indus. Co.,
935 F.3d 1341, 1350 (Fed. Cir.
2019)). But Myco offers nothing other than attorney argu-
ment as to what the highly skilled artisan would do. Alt-
hough Myco need not present the kind of evidence that
would be required at trial, a substantial question of valid-
ity cannot be manufactured through mere supposition
about what an artisan with highly advanced skill in the
medical field might do.
Myco next argues that the “applicator” of Nichamin’s
Figure 3 can be a swab. Appellant’s Br. 33. None of Myco’s
arguments are convincing. Myco first points us to Figure 3
for this contention. But, as explained above, the district
court did not clearly err in finding that Figure 3 merely de-
picts a hand-held device dispensing a mixture from an ap-
plicator; it does not depict a swab. J.A. 1448 (¶ 65).
Myco next points to Nichamin’s paragraph 66, which
explains that a composition “may be dispensed in any way
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14 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
(e.g., from an applicator/device/wand . . .)” and “may be dis-
pensed to any appropriate material, such as an applica-
tor/device/wand” or “directly to a tissue, such as an eye area
tissue, from a dispenser.” J.A. 1448 (¶ 66). But nowhere
in paragraph 66 does it say that the “applicator/de-
vice/wand” used to dispense the composition is a swab con-
nected to an electromechanical device used to contact the
eyelid margin. It is not enough for anticipation purposes
to say that an “applicator/device/wand” may dispense a
composition “directly to . . . an eye area tissue, from a dis-
penser” where the claims require a swab connected to an
electromechanical device used to contact the eyelid margin.
Myco goes on to cite paragraph 75, which states that,
“[i]n other embodiments, the composition may be applied
to the eyelid and/or eyelash using part of the body, such as
a knuckle or finger, or a material (e.g., a pad, sponge,
brush, sponge [sic], or swab containing an applicator such
as cotton, polyester, rayon, or other material).” J.A. 1448
(¶ 75). According to Myco, paragraph 75 discloses using a
swab with the electromechanical device embodiment de-
picted in Figure 3. But, as the district court found, para-
graph 75 expressly refers to “other embodiments,”
indicating that paragraph 75 describes options for embodi-
ments other than that depicted in Figure 3—the only em-
bodiment that includes an electromechanical device. J.A.
1448; Reconsideration Decision,
2020 WL 7134932, at *2.
We also are not persuaded by Myco’s reference to Ni-
chamin’s paragraphs 79 and 87. Paragraph 79 states that
“[a]ny of these methods of applying the compound may be
combined with any other method.” J.A. 1448 (¶ 79). Para-
graph 87 provides that “it is contemplated that any op-
tional feature of the inventive variations described may be
set forth and claimed independently, or in combination
with any one or more of the features described herein.” J.A.
1449 (¶ 87). These generic statements do not establish that
one of skill in the art would “at once envisage” the specific
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BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 15
combination Myco urges. Chamberlain Grp., 935 F.3d at
1350.
Finally, Myco points us to Figure 6 of Nichamin (shown
below), which depicts a kit including “an applicator (e.g.,
pad or swab).” J.A. 1449 (¶ 83). Myco argues that Figure
3’s applicator may be a swab because Figure 6’s applicator
may be a “pad or swab.” Again, we are unpersuaded. No-
where in Figure 6 is there any indication that the swab
should be connected to the electromechanical device of Fig-
ure 3 and used to contact the eyelid margin. Rather, the
swab of Figure 6 appears to be the handheld swab also
shown in Figure 1. Paragraph 83 also discloses optional
inclusion of a microdermabrasive device in the kit depicted
in Figure 6. It does not, however, disclose connecting the
swab to that device.
J.A. 1442.
The district court did not clearly err in finding that
“[n]owhere in the text of Nichamin is it suggested the hand-
held device in Figure 3 includes a swab.” Reconsideration
Decision,
2020 WL 7134932, at *2. None of the paragraphs
Case: 21-1149 Document: 55 Page: 16 Filed: 02/03/2022
16 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
identified by Myco on appeal describe a swab that is both
operably connected to an electromechanical device and
used to contact the eyelid margin, as required by claim 16.
Myco argues that the district court improperly deferred
to the patent examiner when it noted that the examiner
considered Nichamin during examination and, neverthe-
less, allowed the ’087 patent to issue. That is not the case.
To the extent Myco is suggesting that the examiner did not
substantively consider Nichamin during prosecution of the
’087 patent, and that this alleged failure to consider Ni-
chamin should have some effect on the burdens borne by
the respective parties in this case, that argument is una-
vailing. “[W]hen prior art ‘is listed on the face’ of a patent,
‘the examiner is presumed to have considered it.’” Stone
Basket Innovations, LLC v. Cook Med. LLC,
892 F.3d 1175,
1179 (Fed. Cir. 2018) (quoting Shire LLC v. Amneal
Pharms., LLC,
802 F.3d 1301, 1307 (Fed. Cir. 2015)). Be-
cause Nichamin is cited on the face of the ’087 patent, the
patent examiner is presumed to have considered it and the
district court did not err in noting that Nichamin was be-
fore the examiner. To the extent Myco contends that the
district court relied solely on the presumption of validity, it
is clear that the district court considered the substantive
anticipation arguments presented by Myco and found them
unavailing. The district court did not improperly defer to
the patent examiner, as Myco claims.
4. Obviousness
Myco’s obviousness argument before the district court
consisted of only a single sentence appended to its antici-
pation argument: “In addition, based on Nichamin’s de-
scription, it would have been obvious to one of ordinary
skill in the art to attach a swab to the end of Nichamin’s
hand-held device.” J.A. 1405. Myco offered no evidence in
support of this assertion and no additional argument ex-
plaining it. In other words, Myco put all of its eggs in the
anticipation basket at the preliminary injunction stage.
Case: 21-1149 Document: 55 Page: 17 Filed: 02/03/2022
BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 17
Having failed to convince the district court that Nichamin
anticipates claim 16, Myco now claims it did not need to
present any evidence beyond the Nichamin reference itself
in support of its obviousness defense.
Specifically, Myco argues that “it would have been com-
mon sense” to “use a swab with Nichamin’s Figure 3 de-
vice,” and, thus, that it had no need to present any evidence
beyond the reference itself, expert or otherwise, to show a
substantial question of obviousness. Appellant’s Br. 41.
And Myco argues that the district court improperly relied
on unsubstantiated safety concerns associated with chaf-
ing sensitive eye tissue when it found insufficient evidence
of a motivation to combine Nichamin’s electro-mechanical
device with a swab. We are unpersuaded by Myco’s argu-
ments.
As to Myco’s first argument, we conclude that the dis-
trict court did not clearly err in finding that Myco’s conclu-
sory obviousness argument did not pose a substantial
question of validity. It is true that “[t]he burden on the
accused infringer to show a substantial question of invalid-
ity at [the preliminary injunction] stage is lower than what
is required to prove invalidity at trial.” Altana Pharma AG
v. Teva Pharms. USA, Inc.,
566 F.3d 999, 1006 (Fed. Cir.
2009). But Myco failed to present any evidence regarding
the factual considerations underlying the obviousness in-
quiry, including whether a skilled artisan would have been
motivated to modify the device of Figure 3 to use a swab.
Generally, expert testimony is not required at the pre-
liminary injunction stage given the lower burden and be-
cause the timing of a preliminary injunction may foreclose
the possibility of developing “a fully comprehensive presen-
tation of [an accused infringer’s] defenses,” New England
Braiding Co. v. A.W. Chesterton Co.,
970 F.2d 878, 883
(Fed. Cir. 1992). And, some cases, even beyond the prelim-
inary injunction stage, “involve technologies and prior art
that are simple enough that no expert testimony is
Case: 21-1149 Document: 55 Page: 18 Filed: 02/03/2022
18 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
needed.” Intercontinental Great Brands LLC v. Kellogg N.
Am. Co.,
869 F.3d 1336, 1348 (Fed. Cir. 2017).
But this is not a case involving simple technology.
Myco repeatedly argues that the level of skill in the art is
very high, even going so far as to argue that its burden to
show obviousness at trial and at the preliminary injunction
stage is lessened because such a high level of skill is re-
quired to comprehend the art. Yet Myco presents no evi-
dence of what this highly skilled artisan would be
motivated to do beyond conclusory attorney argument.
Myco cannot have it both ways. Although Myco need not
have presented expert testimony, it needed to provide
something on which the district court could base a finding
that there is a substantial question of validity. In this case,
where the level of skill in the art is so high, conclusory at-
torney argument is not enough. 4
As to Myco’s second argument, the district court did not
clearly err in finding that Myco failed to explain how a
skilled artisan would have addressed the safety concerns of
its proposed modification. While Myco claims BlephEx
overstates the safety concerns that the combination would
present, Myco’s failure to present evidence of a motivation
to modify and failure to rebut BlephEx’s evidence of a mo-
tivation not to modify demonstrates that Myco did not
carry its initial burden of showing a substantial question
of validity. See Metalcraft of Mayville, Inc. v. The Toro Co.,
4 The obviousness argument before the district court
was so sparse that we might be justified in finding that
Myco forfeited the argument. But we need not rely on for-
feiture. The inadequacy of the record leads us to the same
judgment. Of course, findings of fact and legal conclusions
predicated on the record developed at the preliminary in-
junction stage are not binding on the court at trial. Outside
the Box Innovations, LLC v. Travel Caddy, Inc.,
695 F.3d
1285, 1302 (Fed. Cir. 2012).
Case: 21-1149 Document: 55 Page: 19 Filed: 02/03/2022
BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 19
848 F.3d 1358, 1367 (Fed. Cir. 2017) (finding that the dis-
trict court did not abuse its discretion in rejecting the obvi-
ousness argument of a party seeking to avoid a preliminary
injunction where the party did not provide any evidence as
to a motivation to combine prior art references).
For the foregoing reasons, we see no clear error in the
district court’s determination that Myco failed to show a
substantial question of validity and that BlephEx showed
a strong likelihood of success on the merits.
B. Status Quo
Myco next argues that the purpose of a preliminary in-
junction is to preserve the status quo and that, here, the
preliminary injunction upset the status quo. Myco also
maintains that the district court never addressed its argu-
ments concerning preservation of the status quo. We disa-
gree.
At the outset, we note that Myco misidentifies the “sta-
tus quo” in this case. Myco posits that the “status quo” is
the last uncontested status preceding the start of the par-
ties’ controversy. It asserts that, in this case, the “status
quo” is the state of the world before the ’087 patent issued,
i.e., “a market where both BlephEx and Myco competed and
sold their products” and in which BlephEx could not assert
infringement of claim 16, as it had not yet been granted.
Appellant’s Br. 26–27. Although the ’087 patent was
granted after Myco began selling the AB Max, it was
granted before BlephEx filed suit against Myco, even if
only shortly before. Thus, the status quo when the prelim-
inary injunction was filed was a state in which the ’087 pa-
tent had been granted and could be asserted.
Contrary to Myco’s arguments, moreover, preservation
of the status quo is not the sole objective of preliminary in-
junctions. Preliminary injunctions also serve to prevent
ongoing trespasses during the pendency of an infringement
case. See Atlas Powder Co. v. Ireco Chems.,
773 F.2d 1230,
Case: 21-1149 Document: 55 Page: 20 Filed: 02/03/2022
20 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
1232 (Fed. Cir. 1985) (“[A] preliminary injunction pre-
serves the status quo if it prevents future trespasses.”).
Even where a patent is applied for and granted after the
allegedly infringing product enters the market, a prelimi-
nary injunction may still be used to prevent future tres-
passes on the patent, so long as the district court correctly
applies the relevant factors. After all, “there is nothing im-
proper, illegal, or inequitable in filing a patent application
for the purpose of obtaining a right to exclude a known com-
petitor’s product from the market.” Kingsdown Med. Con-
sultants, Ltd. v. Hollister Inc.,
863 F.2d 867, 874 (Fed. Cir.
1988). Any such application, “must comply with all stat-
utes and regulations, of course, but, if it does, its genesis in
the marketplace is simply irrelevant and cannot of itself
evidence deceitful intent.”
Id. (citing State Indus., Inc. v.
A.O. Smith Corp.,
751 F.2d 1226, 1235 (Fed. Cir. 1985)). 5
And patents so obtained are generally entitled to all the
same enforcement rights as every other patent.
Just as preservation of the status quo is not the sole
aim of preliminary injunctions, it is not an overriding con-
cern that trumps consideration of the four preliminary in-
junction factors. Rather, it is inherent in the four
preliminary injunction factors—particularly in the “irrep-
arable harm” and “balance of hardships” factors. In some
cases, a preliminary injunction may rightly disturb the sta-
tus quo.
Contrary to Myco’s assertion that the district court ig-
nored the status quo, the district court considered the sta-
tus quo in its analysis of the irreparable harm factor. We
do not discern clear error in that analysis. Nor do we be-
lieve that the district court gave short shrift to its consid-
eration of the status quo. The district court directly
5 Of course, an applicant also must comply with 35
U.S.C § 115, which requires a declaration that the individ-
ual believes him or herself to be the original inventor.
Case: 21-1149 Document: 55 Page: 21 Filed: 02/03/2022
BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 21
addressed Myco’s claim that the allegedly infringing sales
of the AB Max had occurred before issuance of the ’087 pa-
tent. It found that the record showed that Myco and
BlephEx are direct competitors, that BlephEx had suffered
price erosion, loss of goodwill, and damage to its reputa-
tion, and that BlephEx is threatened with extinction by
continued sales of the AB Max. In response to Myco’s as-
sertion that all evidence of confusion, price erosion, and
loss of goodwill predated issuance of the ’087 patent, the
district court pointed to Myco’s continued efforts to market
and sell the AB Max after the patent issued. The district
court also identified an email from after the patent issued
in which a BlephEx customer complained that they did not
want to pay double for the same product. The district court
did not clearly err in finding that these facts were “suffi-
cient evidence to establish ongoing irreparable harm” to
BlephEx “when considered in conjunction with the signifi-
cant evidence of pre-issuance loss of goodwill and sales
along with price erosion.” Preliminary Injunction Decision,
2020 WL 5951504, at *7. Thus, the district court appropri-
ately considered the status quo in its analysis.
C. Scope of the Preliminary Injunction
Myco argues that the preliminary injunction is over-
broad because it enjoins all domestic sales of the AB Max
product even though BlephEx’s patent only covers a single
method of use. Myco argues that the injunction should only
bar “Myco from instructing or encouraging users to use the
AB Max to contact the eyelid margin to remove debris.” Ap-
pellant’s Br. 50. In furtherance of this argument, Myco as-
serts that it presented evidence of potentially non-
infringing uses of the AB Max. Finally, Myco argues that
the district court erred in placing the burden on Myco to
identify potentially non-infringing uses of the AB Max
when the burden should have been on BlephEx to argue
that the AB Max had no non-infringing use.
Case: 21-1149 Document: 55 Page: 22 Filed: 02/03/2022
22 BLEPHEX, LLC v. MYCO INDUSTRIES, INC.
We review challenges to the scope of a preliminary in-
junction under the standard of review used in the regional
circuit. Allergan, Inc. v. Athena Cosms., Inc.,
738 F.3d
1350, 1354 (Fed. Cir. 2013). The Sixth Circuit reviews the
scope of an injunction for an abuse of discretion. Audi AG
v. D’Amato,
469 F.3d 534, 550 (6th Cir. 2006).
The district court did not abuse its discretion when it
barred all domestic sales of the AB Max. Ample evidence
supports a finding that an injunction against all sales of
the AB Max product is necessary to avoid future infringe-
ment. The two expert declarations that Myco avers present
evidence of potentially non-infringing uses of the AB Max
do not indicate that the device has ever actually been so
used. And, as the district court found, those declarations
are contradicted by other expert testimony. For example,
Myco’s expert’s statement that the AB Max could be used
without contacting the eyelid margin was contradicted by
testimony from BlephEx’s expert that, due to the size of the
AB Max swab, the device could not practically be used to
contact only eyelashes without also contacting the eyelid
margin. And Myco’s expert’s statement that the AB Max
could be used in a non-infringing manner to treat conjunc-
tiva was contradicted by another of Myco’s experts, who
had previously indicated that use of the AB Max to contact
conjunctiva would cause harm. On top of these contradic-
tions, as the district court noted, the AB Max is registered
with the FDA as a device that “cleanses the eyelid mar-
gins.” Reconsideration Decision,
2020 WL 7134932, at *4.
And “AB” in AB Max stands for “anterior blepharitis,” in-
dicating that the device is designed for a use that the dis-
trict court found likely to infringe—treating anterior
blepharitis—rather than other, potentially non-infringing,
uses.
Id. Taken together, nothing in the district court’s
analysis indicates an abuse of discretion.
We find Myco’s assertion that the district court placed
the burden on Myco to show non-infringing uses similarly
unavailing. The district court did not place the burden on
Case: 21-1149 Document: 55 Page: 23 Filed: 02/03/2022
BLEPHEX, LLC v. MYCO INDUSTRIES, INC. 23
Myco to show non-infringing uses. Rather, it weighed the
evidence presented by both sides, including evidence belat-
edly produced by Myco, and determined that its prelimi-
nary injunction was not overbroad.
III. CONCLUSION
For the foregoing reasons, we affirm.
AFFIRMED
