N OTE : This disposition is nonprecedential.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 S HANNON L. B JORKLUND , Minneapolis, MN.

W ARREN J AMES T HOMAS , Meunier Carlin & Curfman LLC, Atlanta, GA, arg ued for defendant

- appellee. Also represented by J OHN W. H ARBIN

.

______________________ Case: 23-2393 Document: 46 Page: 1 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

. 2

Before L OURIE , D YK , and S TARK , Circuit Judges

. L OURIE , 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

. B ACKGROUND
BDC and ViVitro Lab s, 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 p atent”) and moved for a preliminary injunction

. Id. The ’ 935 patent is directed toward accelerated rate fatigue test ing 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

ex cess 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 de scribed in that limitation are in dispute : (1) that it is “capable of Case: 23-2393 Document: 46 Page: 2 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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 syst em fluid when the test system fluid is under compression .” Id

. The specification describes the excess volume area in terms of its relationship to a compliance 1 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, thevolume occupied by the gas decreases to provide additional volume for displacement of the liquid working flui d 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; how ever , Figure 3 provides a cross -section al 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 formingthe compliance chambers 135 to absorb some of the pressure plac ed 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 ord inary skill in the art . J.A. 1177

– 78. Case: 23-2393 Document: 46 Page: 3 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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, i t 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 a n 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’ Case: 23-2393 Document: 46 Page: 4 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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 cons truction 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 Dynatek 2 anticipates claim s 1, 2, 8, and 13 of the ’935 patent and that the combination of Dynatek and Xi 3 render s 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. Th at manual describes a device contain ing a partially air

- filled ca pacitance tank connect ed 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 F igure 1A disclose d th e “ excess volume

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

2 D YNATEK L ABORATORIES , I NC

. , O PERATING I NSTRUCTIONS M6 S IX -P OSITION H EART V ALVE D URABILITY T ESTING D EVICE . J.A. 1014 , 1018, 1020, 1022

– 29, 1032, 1036, 10 39 (excerpts of Dynatek)

. 3 Chinese Patent CN 1035153C

. J.A. 981

– 96 (translation of Xi). Case: 23-2393 Document: 46 Page: 5 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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 th o se references lacked merit. Id

. In v iew of the resulting lack of a likelihood of success on the merits, the district court denied BDC’s motion for a Case: 23-2393 Document: 46 Page: 6 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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 134 3, 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 [it s] favor,’ and (4) ‘an injunction is in the public interest.’” BlephEx, LLC v. Myco Indus., Inc. , 24 F.4th 1391, 1 398 (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. 1 997)).

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 Case: 23-2393 Document: 46 Page: 7 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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 theclear and convincing showing necessary to establish invalidity itself.” Id. Furthermore, the district court’s assessment of prior art refer ences 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 “th e test system fluid is undercompression” 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 demonstrate s 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 que stion of validity with respect to anticipatio n. BDC makes the assertion that Dynatek’s capacitancetank 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 Case: 23-2393 Document: 46 Page: 8 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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 discretio n by not considering th at 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 th r ough 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 )

. T he ’935 pate nt specification supports Dasi’s understanding of fluid communication

— that intermediate structures do not prevent two components from being in fluid communication. For example, t he 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 aplenum 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 support s BDC’s ar gument 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 oftest system fluid when the test system fluid is under compression” because Dynatek’s “ test system is never ‘ under compression. ’ ” App. Br. at 4 7– 48. Th at 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 un der compression,” not that the test Case: 23-2393 Document: 46 Page: 9 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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system is under compression

. ’935 patent col. 17 ll. 45

– 50. Th at is an important distinction because BDC admits that Dynatek’s drive mechanism subjects a t 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”)

. T he Dasi declaration also explains that Dynatek’s bellows compress the fluid to actuate the test value . J.A. 1187

. Finally, BDC alleges tha t Dynatek’s capacitance tank
cannot operat e at the accelerated pulsed rate

. Specifically, i t alleges that the capacitan ce 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

, “a s a matter of ordinary physics ,” too narrow to allow fluid to transfer back and forth at an accelerated
rate

. Ap p. 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 p atent 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 thecapacitance tank being “capable of operating at the accelerated pulsed rate .”
For the forego ing 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 Tir e 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 Case: 23-2393 Document: 46 Page: 10 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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 anti cipation 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 Lu 4 could have been combined.” App. Br. at 50 (quoting Decision at *6). Th at argument fails because the district court expressly recognized ViVitro ’s argument that the a ssert ed 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 th o se statements that the district court found a substantial question of obviousness with respect to Dynatek and Xi. The court’s statemen t that it wou ld 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 rigo rous 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. S ee J.A. 1184, 1255

– 1261. Case: 23-2393 Document: 46 Page: 11 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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BDC argues that the combination of Dynatek and Xi fails to establish obviousness for three reasons: (1) neither Dynatek n or Xi disclose s 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, n one of those arguments demonstrate s 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 fa ils to meet the excess volume area limitation because “it is connected on the wrong side of the valve.” App. Br. at 51. Th at 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 an d 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 allege s 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 t he Dasi declaration explains that a skill ed artisan would have understood that the different disclosed drive mechanism s 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,
t he declaration contains a variety of other reasons why a Case: 23-2393 Document: 46 Page: 12 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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.”); i d. ( A person of ordinary skill in the art “would be
mot ivated to use Xi’s air chambers in place of Dynatek’s capacitance tank and tygon tube. This simple substitutionwould result in a tester with fewer parts that would be easier for an end user to assemble, setup, and transport.”). These arguments fail to de monstrate that ViVitro’s obviousness defense lacks substantial merit

. BDC’s remaining arguments do not disturb th at conclusion. For example, i t 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. B ut 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 th at 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 s uccess’ 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 ’ invalid ity defenses lack substantial merit

. Altana Pharma AG v. Teva Pharms. USA, Inc. , 566 F.3d 999, 1006 (Fed. Cir. 2009)

. Th at single Case: 23-2393 Document: 46 Page: 13 Filed: 03/28/2024BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v. VIVITRO LABS , INC

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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

. BDCfirst raised its secondary considerations argument in its reply memorandum. As ViVitro explained a t 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?f l=23

- 2393_02072024.mp3 . At the hearing, ViVitro address ed secondary considerations by argu ing 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 argumentthat 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 abuse d its discretion in finding a substantial question of validity and in denying BDC’s request for a preliminary injunction

. However, th at does not resolve the ultimate question of in validity, which the district court will need to determine und er the higher clear and convincing standard rather than the substantial questions standard applicable to a preliminary injunction. See A mazon.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 narrow er one applied by the court. H owever, 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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C ONCLUSION
We have considered BDC ’s remaining arguments and find them unpersuasive. For the foregoing reasons, we affirm

. AFFIRMED Case: 23-2393 Document: 46 Page: 15 Filed: 03/28/2024