Court Opinion

ID: 9955333
Source: CourtListenerOpinion
Date Created: 2024-03-28 14:01:06.208832+00
Date Added: 2024-06-11T08:15:33.881459
License: Public Domain

Case: 23-2393    Document: 46     Page: 1   Filed: 03/28/2024

        NOTE: This disposition is nonprecedential.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.
                 ______________________
Case: 23-2393      Document: 46    Page: 2    Filed: 03/28/2024

 2        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 compliance 1 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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                                         VIVITRO LABS, INC.

 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 Dynatek 2 anticipates claims 1, 2, 8, and 13
 of the ’935 patent and that the combination of Dynatek and
 Xi 3 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    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 (transla-

 tion of Xi).
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                                         VIVITRO LABS, INC.

 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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                                         VIVITRO LABS, INC.

 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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                                         VIVITRO LABS, INC.

 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 Lu 4 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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                                         VIVITRO LABS, INC.

 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