Biomedical Device Consultants & Laboratories of Colorado, LLC v. Vivitro Labs, Inc.

N OTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
BIOMEDICAL DEVICE CONSULTANTS &
LABORATORIES OF COLORADO, LLC,
Plaintiff-Appellant
v.
VIVITRO LABS, INC.,
Defendant-Appellee
______________________
2023-2393
______________________
Appeal from the United States District Court for the
Central District of California in No. 2:23-cv-04291-HDV-E,
Judge Hernan D. Vera.
______________________
Decided: March 28, 2024
______________________
G REGORY S. T AMKIN, Dorsey & Whitney LLP, Denver,
CO, argued for plaintiff-appellant. Also represented by
SHANNON L. BJORKLUND, Minneapolis, MN.
WARREN J AMES T HOMAS , Meunier Carlin & Curfman
LLC, Atlanta, GA, argued for defendant-appellee. Also
represented by J OHN W. HARBIN.
______________________
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Before L OURIE, D YK, and STARK, Circuit Judges.
L OURIE, Circuit Judge.
Biomedical Device Consultants & Laboratories of Col-
orado, LLC (“BDC”) appeals from the decision of the United
States District Court for the Central District of California
denying its motion for a preliminary injunction. See Bio-
medical Device Consultants & Lab’ys of Colo., LLC v.
Vivitro Labs, Inc., No. 2:23-CV-04291-HDV, 2023 WL
6783296 (C.D. Cal. Aug. 29, 2023) (“Decision”). We affirm.
BACKGROUND
BDC and ViVitro Labs, Inc. (“ViVitro”) manufacture
and sell competing heart valve durability testing devices.
Decision at *1. BDC sued ViVitro in district court accusing
ViVitro’s “AD[C] Heart Valve Durability Tester” of infring-
ing U.S. Patent 9,237,935 (“the ’935 patent”) and moved for
a preliminary injunction. Id. The ’935 patent is directed
toward accelerated rate fatigue testing devices for pros-
thetic valves. ’935 patent, abstract, col. 17 ll. 29–50. BDC
asserted eight claims of the ’935 patent with claim 1 as the
only independent claim. Relevant to this appeal is the “ex-
cess volume area” limitation of claim 1. Claim 1 recites, in
part:
1. A device for accelerated cyclic testing of a valved
prosthetic device comprising . . .
an excess volume area capable of operating
at the accelerated pulsed rate, wherein the
excess volume area is in fluid communica-
tion with the fluid return chamber provid-
ing a volume for storing a volume of a test
system fluid when the test system fluid is
under compression.
Id. col. 17 ll. 29–50.
All three properties of an excess volume area described
in that limitation are in dispute: (1) that it is “capable of
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operating at the accelerated pulsed rate,” (2) that it is “in
fluid communication with the fluid return chamber,” and
(3) that it “provid[es] a volume for storing a volume of a test
system fluid when the test system fluid is under compres-
sion.” Id.
The specification describes the excess volume area in
terms of its relationship to a compliance1 chamber.
The compliance chambers 135 provide excess volume
area for fluid to move into when the piston 114 per-
forms a compression stroke. As the pressure of the
gas in the compliance chamber 135 increases, the
volume occupied by the gas decreases to provide ad-
ditional volume for displacement of the liquid work-
ing fluid within the test chamber 106.
Id. col. 12 ll. 4–9 (emphasis added).
The specification does not provide a more detailed de-
scription of the excess volume area; however, Figure 3 pro-
vides a cross-sectional view showing the return chamber
136, the compliance chamber 135, test valve sample 130,
and the fluid flow path as described in an embodiment of
the invention. Id. col. 9 ll. 5–9.
1 “Compliance” is a term of art that is also expressly
defined in the ’935 patent. ’935 patent, col. 9 ll. 11–16
(“‘compliance’ refers to the ability of the cavities forming
the compliance chambers 135 to absorb some of the pres-
sure placed upon the fluid in the test chamber 106 and fur-
ther to control recoil toward the original volume
dimensions upon removal of the compressive force.”).
ViVitro agrees that this definition is consistent with the
understanding of the term by a person of ordinary skill in
the art. J.A. 1177–78.
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Id. at Fig. 3.
The district court denied BDC’s request for a prelimi-
nary injunction, finding that it failed to establish a likeli-
hood of success on the merits for two independent reasons.
The court first found a substantial question concerning in-
fringement. To reach this conclusion, it adopted a prelim-
inary construction of the term excess volume area. While
at one point the court said it was adopting the plain and
ordinary meaning of the phrase, at another point it seemed
to give weight to the preferred embodiments and state-
ments from an inter partes review proceeding for a related
patent. Decision at *4–5 (“BDC’s prior position in the IPR
proceeding supports this view, as ‘material deformation’
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does not meet the excess volume area limitation”); Id. at *5
(“The plain and ordinary meaning of ‘excess volume area,’
as used in Claim 1 and as supported by the teachings of the
specification, is a compliance chamber that is separate and
needs to be fluidly connected.”). It then applied that limited
preliminary construction and determined that ViVitro’s ac-
cused product lacked the claimed excess volume area. Id.
at *5.
The district court also found that “Vivitro has pre-
sented evidence of invalidity, and BDC has not demon-
strated at this point that Vivitro’s assertions lack
substantial merit.” Id. at *6. Using the expert declaration
of Lakshmi Dasi (“the Dasi declaration”), ViVitro presented
arguments that Dynatek2 anticipates claims 1, 2, 8, and 13
of the ’935 patent and that the combination of Dynatek and
Xi3 renders obvious all asserted claims of the ’935 patent.
Dynatek is a user manual for Dynatek Laboratories, Inc.’s,
M6 accelerated rate heart valve durability testing device.
J.A. 1014. That manual describes a device containing a
partially air-filled capacitance tank connected to a test
chamber. Id. at 1018. It uses a rotating swashplate and
bellows as a drive mechanism. Id. Xi is a Chinese patent
that discloses an accelerated rate heart valve durability
testing device that contains a partially air-filled compli-
ance chamber within a test chamber. Id. at 988–89. It uses
a reciprocating shaft to drive a sample valve through test
fluid. Id. at 986. The district court determined that Dyna-
tek’s annotated Figure 1A disclosed the “excess volume
area” as a capacitance tank. Decision at *6.
2 D YNATEK L ABORATORIES , I NC., O PERATING
I NSTRUCTIONS M6 SIX -P OSITION HEART VALVE D URABILITY
T ESTING D EVICE. J.A. 1014, 1018, 1020, 1022–29, 1032,
1036, 1039 (excerpts of Dynatek).
3 Chinese Patent CN 1035153C. J.A. 981–96 (transla-
tion of Xi).
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J.A. 1020.
It also determined that the Dasi declaration “supports
the view that Dynatek discloses every element of Claim 1
and thus anticipates Claim 1” and three dependent claims.
Decision at *6. For the remainder of the asserted claims,
it determined that the Dasi declaration raised questions
regarding the obviousness of all the asserted claims over
Dynatek and Xi and that BDC’s argument attempting to
distinguish those references lacked merit. Id.
In view of the resulting lack of a likelihood of success
on the merits, the district court denied BDC’s motion for a
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preliminary injunction. BDC timely appealed, and we have
jurisdiction to review the district court’s order under
28 U.S.C. § 1292(c)(1).
D ISCUSSION
The grant or denial of a preliminary injunction is
within the sound discretion of a district court, and we will
not reverse its judgment absent an abuse of that discretion.
Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d
1343, 1350 (Fed. Cir. 2001). Accordingly, we will only over-
turn a preliminary injunction decision on appeal if “the
court made a clear error of judgment in weighing relevant
factors or exercised its discretion based upon an error of
law or clearly erroneous factual findings.” Id.
A movant seeking a preliminary injunction must estab-
lish 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.’” BlephEx,
LLC v. Myco Indus., Inc., 24 F.4th 1391, 1398 (Fed. Cir.
2022) (quoting Winter v. Nat. Res. Def. Council, Inc., 555
U.S. 7, 20 (2008)). The burden is on the patent owner to
show that it is likely to succeed on the merits with respect
to infringement and validity. Id. at 1398–99; Amazon.com,
239 F.3d at 1350. If the accused infringer “raises a sub-
stantial question concerning either infringement or valid-
ity, i.e., asserts an infringement or invalidity defense that
the patentee cannot prove ‘lacks substantial merit,’ the
preliminary injunction should not issue.” Amazon.com,
239 F.3d at 1350–51 (quoting Genentech, Inc. v. Novo
Nordisk, A/S, 108 F.3d 1361, 1364, (Fed. Cir. 1997)).
The district court found that ViVitro raised a substan-
tial question with respect to both validity and infringe-
ment. If BDC cannot show that the district court abused
its discretion with regard to both of those findings, we must
affirm the denial of the preliminary injunction. See id. As
we affirm the district court in finding a substantial
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question of validity, we need not consider infringement.
We will therefore begin and end with the court’s finding of
a substantial question of validity.
At the preliminary injunction stage, a defendant may
raise a substantial question of validity “on evidence that
would not suffice to support a judgment of invalidity at
trial.” Amazon.com, 239 F.3d at 1358. The question here
is one of “vulnerability,” which “requires less proof than the
clear and convincing showing necessary to establish inva-
lidity itself.” Id. Furthermore, the district court’s assess-
ment of prior art references is an issue of fact reviewed for
clear error. Id.; BlephEx, 24 F.4th at 1400 (“We review the
underlying issue of whether the patent challenger’s as-
serted prior art raises a substantial question of validity, a
factual issue, for clear error.”).
I
BDC argues that Dynatek does not anticipate any
claims of the ’935 patent for three reasons: (1) its capaci-
tance tank is in fluid communication with the distribution
chamber, not the return chamber, (2) its capacitance tank
cannot store test fluid when “the test system fluid is under
compression” because the test system as a whole is not un-
der compression, and (3) its capacitance tank is not physi-
cally capable of “operating at the accelerated pulsed rate.”
App. Br. at 44–49. However, as we explain below, none of
those arguments demonstrates clear error by the district
court in evaluating Dynatek and the evidence presented in
the Dasi declaration. BDC therefore fails to demonstrate
that the district court abused its discretion by finding a
substantial question of validity with respect to anticipa-
tion.
BDC makes the assertion that Dynatek’s capacitance
tank is not in fluid communication with the return cham-
ber because “it is connected to the wrong side of the valve.”
App. Br. at 46. But BDC did not explain why the test valve,
sitting in between the distribution chamber and the return
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chamber, would cut off fluid communication between the
capacitance tank and the return chamber other than to say
that the district court abused its discretion by not consid-
ering that argument.
The Dasi declaration states that a person of skill in the
art would understand “fluid communication” to only re-
quire that “fluid can move from a point inside a first volume
to a point inside a second volume.” J.A. 1195. It also ex-
plains that fluid flows from Dynatek’s distribution cham-
ber through the test valve, into the return chamber, and
then back to the distribution chamber through the central
return reservoir. J.A. 1188 (Dynatek Fig. 1A annotated).
The ’935 patent specification supports Dasi’s under-
standing of fluid communication—that intermediate struc-
tures do not prevent two components from being in fluid
communication. For example, the specification describes
the pressure source as in fluid communication with the dis-
tribution chamber. ’935 patent col. 3 ll. 3–5. Yet, all the
cross-sectional drawings in the ’935 specification show a
number of structures in between the pressure source and
the distribution chamber. See e.g., ’935 patent Fig. 3, col.
6 l. 61–col. 7 l. 50 (showing at least an adapter 117 and a
plenum 118 as intermediate structures between the pres-
sure source and the distribution chamber 126). Neither the
Dasi declaration, relied on by the district court, nor the
specification supports BDC’s argument that two compo-
nents must be directly connected to be in fluid communica-
tion.
BDC alleges that Dynatek does not disclose “an excess
volume area . . . providing a volume for storing a volume of
test system fluid when the test system fluid is under com-
pression” because Dynatek’s “test system is never ‘under
compression.’” App. Br. at 47–48. That assertion fails be-
cause it does not conform with the language of the claim.
The plain language of the claim merely requires that “the
test system fluid is under compression,” not that the test
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system is under compression. ’935 patent col. 17 ll. 45–50.
That is an important distinction because BDC admits that
Dynatek’s drive mechanism subjects at least a portion of
the test fluid to compression. App. Br. at 48 (“fluid in the
test chamber on the upper end of the swashplate is subject
to some positive force”). The Dasi declaration also explains
that Dynatek’s bellows compress the fluid to actuate the
test value. J.A. 1187.
Finally, BDC alleges that Dynatek’s capacitance tank
cannot operate at the accelerated pulsed rate. Specifically,
it alleges that the capacitance tank is designed to address
only small variations in volume over longer periods of time
and that the tube connecting the capacitance tank to the
test system is, “as a matter of ordinary physics,” too narrow
to allow fluid to transfer back and forth at an accelerated
rate. App. Br. at 48–49. However, the claim does not re-
quire fluid to transfer to and from the excess volume area
at an accelerated rate; it requires that the excess volume
area is “capable of operating at the accelerated pulsed
rate.” ’935 patent col. 17 ll. 29–50. BDC does not dispute
that Dynatek discloses a system capable of operating at an
accelerated rate, App. Br. at 45 (Dynatek discloses “an ac-
celerated tester”) and that the capacitance tank is con-
nected to the test system, id. at 46 (“the Dynatek
capacitance tank is in fluid communication with the distri-
bution chamber”). The claim language and BDC’s own ad-
missions rebut its allegations with respect to the
capacitance tank being “capable of operating at the accel-
erated pulsed rate.”
For the foregoing reasons, the district court did not
make a clear error in its assessment of the prior art. It
therefore did not abuse its discretion in finding that BDC
failed to demonstrate that ViVitro’s anticipation defense
lacked substantial merit. See Titan Tire Corp. v. Case New
Holland, Inc., 566 F.3d 1372, 1377 (Fed. Cir. 2009) (“[I]t is
the patentee, the movant, who must persuade the court
that, despite the challenge presented to validity, the
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patentee nevertheless is likely to succeed at trial on the va-
lidity issue.”).
II
BDC also argues that the district court’s ruling on an-
ticipation is not adequate to deny the preliminary injunc-
tion because it addresses only four of the eight asserted
claims. It argues that the district court did not find a sub-
stantial question of obviousness because the decision states
that “the Court will benefit from further briefing to deter-
mine whether the teachings of Xi, Dynatek and Lu4 could
have been combined.” App. Br. at 50 (quoting Decision at
*6). That argument fails because the district court ex-
pressly recognized ViVitro’s argument that the asserted
claims were “all obvious variations of Dynatek and Xi.” De-
cision at *6. It rejected BDC’s attempt to distinguish Dy-
natek and Xi based on their drive mechanisms, noting that
“the ’935 patent does not specify the ‘pressure source’ that
moves the fluid,” and stated that “[s]imilar doubts remain
for the concept of obviousness.” Id. It is clear from those
statements that the district court found a substantial ques-
tion of obviousness with respect to Dynatek and Xi. The
court’s statement that it would benefit from future “brief-
ing to determine whether the teachings of Xi, Dynatek, and
Lu could have been combined,” does nothing more than
acknowledge that it will benefit from additional briefing
when it needs to evaluate obviousness under the more rig-
orous clear and convincing standard.
BDC goes on to argue that to the extent that the dis-
trict court’s ruling can be interpreted as finding a substan-
tial question of obviousness, it was an abuse of discretion.
4 Lu is a publication that the Dasi declaration alleges
describes the system of Xi but was not relied on by ViVitro
as a basis for its invalidity arguments. See J.A. 1184,
1255–1261.
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BDC argues that the combination of Dynatek and Xi fails
to establish obviousness for three reasons: (1) neither Dy-
natek nor Xi discloses an “excess volume area,” (2) ViVitro
failed to articulate why a person of ordinary skill in the art
would have been motivated to combine Dynatek and Xi,
and (3) ViVitro and the district court failed to address sec-
ondary considerations. Again, none of those arguments
demonstrates that the district court abused its discretion
by finding a substantial question of validity with respect to
obviousness based on the Dasi declaration.
For example, BDC repeats the allegation that the air
chamber of Xi fails to meet the excess volume area limita-
tion because “it is connected on the wrong side of the valve.”
App. Br. at 51. That allegation fails for at least similar
reasons as the Dynatek argument discussed above. See
also J.A. 1195 (The Dasi declaration explaining that “fluid
can flow from either side of the valve (i.e., any of the return
chamber, distribution chamber, or return conduit) in Xi’s
system into any of the air chambers of Xi, the air chambers
of Xi are in fluid communication with both the fluid return
chamber and fluid distribution chamber of Xi.”).
BDC also argues that ViVitro failed to explain why a
person of ordinary skill in the art would have been moti-
vated to combine Dynatek and Xi. It alleges that the two
systems “operate in completely different ways,” and thus,
that there would have been no motivation to combine the
two references’ teachings. App. Br. at 53. However, the
district court expressly rejected that argument in the con-
text of distinguishing Dynatek and Xi from the claimed in-
vention. Decision at *6. And the Dasi declaration explains
that a skilled artisan would have understood that the dif-
ferent disclosed drive mechanisms would have required
only a simple substation. J.A. 1202 (a person of ordinary
skill in the art “would know that [Xi’s] linear motor would
move a bellows up and down in the same way as [Dyna-
tek’s] rotating motor with a swashplate.”). Additionally,
the declaration contains a variety of other reasons why a
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skilled artisan would have been motivated to combine Dy-
natek and Xi. See, e.g., J.A. 1200 (“Both Xi and Dynatek
disclose accelerated testing systems for implantable
valves.”); id. (A person of ordinary skill in the art “would be
motivated to use Xi’s air chambers in place of Dynatek’s
capacitance tank and tygon tube. This simple substitution
would result in a tester with fewer parts that would be eas-
ier for an end user to assemble, setup, and transport.”).
These arguments fail to demonstrate that ViVitro’s obvi-
ousness defense lacks substantial merit.
BDC’s remaining arguments do not disturb that con-
clusion. For example, it alleges that Dynatek teaches away
from combining these references because it “repeatedly
warns users that all air must be removed from the test
chamber.” App. Br. at 53. But Dynatek also teaches users
to add air to the system to pressurize the capacitance tank.
See, e.g., J.A. 1028 (“Open the stopcock, add air and close
the stopcock to refill the syringe with air.”). A reference
does not teach away if it “does not ‘criticize, discredit, or
otherwise discourage’ investigation into the invention
claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek,
Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (citation omit-
ted).
Finally, BDC argues that both ViVitro and the district
court failed to address secondary considerations of non-ob-
viousness. App. Br. at 54. It claims that its evidence of
non-obviousness “is substantial and compelling,” yet, in
making that argument, the only evidence that BDC points
to in support of that assertion is a single statement by
ViVitro’s President that “BDC achieved ‘substantial com-
mercial success’ with its new tester.” App. Br. at 55. At
the preliminary injunction stage, after the accused in-
fringer successfully raises a substantial question of inva-
lidity, the burden shifts to the patentee to demonstrate
that the accused infringers’ invalidity defenses lack sub-
stantial merit. Altana Pharma AG v. Teva Pharms. USA,
Inc., 566 F.3d 999, 1006 (Fed. Cir. 2009). That single
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statement fails to demonstrate that the district court
abused its discretion by finding that BDC failed to meet its
burden.
Furthermore, BDC’s argument is incomplete because
ViVitro did address secondary considerations below. BDC
first raised its secondary considerations argument in its re-
ply memorandum. As ViVitro explained at oral arguments
before this court, its first opportunity to rebut BDC’s sec-
ondary consideration arguments was therefore at the pre-
liminary injunction hearing. Oral Arg. at 16:15–17:55,
available at https://oralarguments.cafc.uscourts.gov/de-
fault.aspx?fl=23-2393_02072024.mp3. At the hearing,
ViVitro addressed secondary considerations by arguing
that BDC failed to establish a nexus between the success
of its product and the features claimed in the ’935 patent.
Hearing Transcript 115–17, ECF No. 92. BDC’s argument
that the court erred by not considering secondary consider-
ations is therefore uncompelling.
In view of the arguments before us and the evidence
presented to the district court, we cannot conclude that the
district court abused its discretion in finding a substantial
question of validity and in denying BDC’s request for a pre-
liminary injunction. However, that does not resolve the ul-
timate question of invalidity, which the district court will
need to determine under the higher clear and convincing
standard rather than the substantial questions standard
applicable to a preliminary injunction. See Amazon.com,
239 F.3d at 1358–59.
We need not consider the district court’s claim con-
struction because its determinations on invalidity are
equally applicable to a broader construction of an “excess
volume area” or the narrower one applied by the court.
However, we caution that claim terms are generally not
limited to the preferred embodiments. See Laryngeal Mask
Co. v. Ambu, 618 F.3d 1367, 1372 (Fed. Cir. 2010).
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CONCLUSION
We have considered BDC’s remaining arguments and
find them unpersuasive. For the foregoing reasons, we af-
firm.
AFFIRMED
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