NOTE: This disposition is nonprecedential.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

______________________ 

GREGORY S. TAMKIN, Dorsey & Whitney LLP, Denver, 

CO, argued for plaintiff-appellant. Also represented by 

SHANNON L. BJORKLUND, Minneapolis, MN. 

 WARREN JAMES THOMAS, Meunier Carlin & Curfman 

LLC, Atlanta, GA, argued for defendant-appellee. Also 

represented by JOHN W. HARBIN. 

 ______________________ 

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Before LOURIE, DYK, and STARK, Circuit Judges.

LOURIE, Circuit Judge. 

Biomedical Device Consultants & Laboratories of Colorado, 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 Biomedical 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 infringing 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 prosthetic 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 “excess 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 communication with the fluid return chamber providing 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 compression.” 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 performs a compression stroke. As the pressure of the 

gas in the compliance chamber 135 increases, the 

volume occupied by the gas decreases to provide additional volume for displacement of the liquid working fluid within the test chamber 106.

Id. col. 12 ll. 4–9 (emphasis added). 

The specification does not provide a more detailed description of the excess volume area; however, Figure 3 provides 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 pressure placed upon the fluid in the test chamber 106 and further 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 preliminary injunction, finding that it failed to establish a likelihood of success on the merits for two independent reasons. 

The court first found a substantial question concerning infringement. To reach this conclusion, it adopted a preliminary 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 statements 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 accused product lacked the claimed excess volume area. Id.

at *5.

The district court also found that “Vivitro has presented evidence of invalidity, and BDC has not demonstrated 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 compliance 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 Dynatek’s annotated Figure 1A disclosed the “excess volume 

area” as a capacitance tank. Decision at *6.

2 DYNATEK LABORATORIES, INC., OPERATING 

INSTRUCTIONS M6 SIX-POSITION HEART VALVE DURABILITY 

TESTING DEVICE. J.A. 1014, 1018, 1020, 1022–29, 1032, 

1036, 1039 (excerpts of Dynatek). 3 Chinese Patent CN 1035153C. J.A. 981–96 (translation 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). 

DISCUSSION

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 overturn 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 establish that “(1) it is ‘likely to succeed on the merits,’ (2) it is 

‘likely to suffer irreparable harm in the absence of preliminary 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 substantial question concerning either infringement or validity, 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 substantial question with respect to both validity and infringement. 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 invalidity itself.” Id. Furthermore, the district court’s assessment 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 asserted 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 capacitance 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 under compression, and (3) its capacitance tank is not physically 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 anticipation. 

BDC makes the assertion that Dynatek’s capacitance 

tank is not in fluid communication with the return chamber 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 considering that argument.

The Dasi declaration states that a person of skill in the 

art would understand “fluid communication” to only require that “fluid can move from a point inside a first volume 

to a point inside a second volume.” J.A. 1195. It also explains that fluid flows from Dynatek’s distribution chamber 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 understanding of fluid communication—that intermediate structures do not prevent two components from being in fluid 

communication. For example, the specification describes 

the pressure source as in fluid communication with the distribution 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 pressure 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 components must be directly connected to be in fluid communication.

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 compression” because Dynatek’s “test system is never ‘under 

compression.’” App. Br. at 47–48. That assertion fails because 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 require 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 accelerated tester”) and that the capacitance tank is connected to the test system, id. at 46 (“the Dynatek 

capacitance tank is in fluid communication with the distribution chamber”). The claim language and BDC’s own admissions rebut its allegations with respect to the 

capacitance tank being “capable of operating at the accelerated 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 validity issue.”).

II

BDC also argues that the district court’s ruling on anticipation is not adequate to deny the preliminary injunction because it addresses only four of the eight asserted 

claims. It argues that the district court did not find a substantial question of obviousness because the decision states 

that “the Court will benefit from further briefing to determine 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 expressly recognized ViVitro’s argument that the asserted 

claims were “all obvious variations of Dynatek and Xi.” Decision at *6. It rejected BDC’s attempt to distinguish Dynatek 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 question of obviousness with respect to Dynatek and Xi. The 

court’s statement that it would benefit from future “briefing 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 rigorous clear and convincing standard. 

BDC goes on to argue that to the extent that the district court’s ruling can be interpreted as finding a substantial 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 Dynatek 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 secondary 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 limitation 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 motivated 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 context of distinguishing Dynatek and Xi from the claimed invention. Decision at *6. And the Dasi declaration explains 

that a skilled artisan would have understood that the different 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 [Dynatek’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 Dynatek 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 easier for an end user to assemble, setup, and transport.”). 

These arguments fail to demonstrate that ViVitro’s obviousness defense lacks substantial merit. 

BDC’s remaining arguments do not disturb that conclusion. 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 omitted). 

Finally, BDC argues that both ViVitro and the district 

court failed to address secondary considerations of non-obviousness. 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 commercial success’ with its new tester.” App. Br. at 55. At 

the preliminary injunction stage, after the accused infringer successfully raises a substantial question of invalidity, the burden shifts to the patentee to demonstrate 

that the accused infringers’ invalidity defenses lack substantial 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 reply memorandum. As ViVitro explained at oral arguments 

before this court, its first opportunity to rebut BDC’s secondary consideration arguments was therefore at the preliminary injunction hearing. Oral Arg. at 16:15–17:55, 

available at https://oralarguments.cafc.uscourts.gov/default.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 considerations 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 preliminary injunction. However, that does not resolve the ultimate 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 construction 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 affirm. 

 AFFIRMED

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