Case: 23-2393 Document: 46 Page: 1 Filed: 03/28/2024
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`
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`NOTE: This disposition is nonprecedential.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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`BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v.
` VIVITRO LABS, INC.
`
`Before LOURIE, DYK, and STARK, Circuit Judges.
`LOURIE, 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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`BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v.
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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.
`
`
`INC., OPERATING
`2 DYNATEK LABORATORIES,
`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 (transla-
`tion of Xi).
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`BIOMEDICAL DEVICE CONSULTANTS & LABORATORIES v.
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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 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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`
`
`
`
`