UNITED STATES DISTRICT COURT FOR THE
`EASTERN DISTRICT OF TENNESSEE
`AT GREENEVILLE
`
`DENTSPLY INTERNATIONAL, INC. and
`TULSA DENTAL PRODUCTS, LLC, d/b/a
`TULSA DENTAL SPECIALITIES,
`Plaintiffs,
`
`v. (cid:9)
`
`U S ENDODONTICS, LLC,
`Defendant.
`
`No. 2:14-CV-196
`
`ORDER DENYING MOTION FOR PRELIMINARY INJUNCTION
`
`This patent infringement case is before the Court on Dentsply International, Inc.'s
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`("Dentsply") motion for a preliminary injunction, [Docs. 26, 27, 59], prohibiting the defendant,
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`US Endodontics, LLC ("US Endo") "from manufacturing all post-heat-treated nickel-titanium
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`endodontic files" using a method that infringes two patents (United States Patent Nos. 8,727,773
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`[the "773 patent"] and 8,562,341 [the "341 patent"]) to which Dentsply asserts exclusive license:
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`US Endo has responded in opposition, [Doc. 65], and Dentsply has replied, [Doc. 77]. An
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`evidentiary hearing was conducted on November 25-26, 2014, [Docs. 161, 162]. The parties have
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`filed both pre-hearing, [Does. 102, 103, 113, 114], and post-hearing briefs, [Does. 177, 179]. The
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`matter is now ripe for disposition. For the reasons which follow, the motion for a preliminary
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`injunction is DENIED.
`
`I. (cid:9)
`
`Background
`
`On October 22, 2013, the United States Patent and Trademark Office ("USPTO") issued
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`the '341 patent to Gold Standard Products, Inc. ("Gold Standard") as assignee of the inventor, Dr.
`
`Neill H. Luebke ("Dr. Luebke"), a board certified endodontist. The USPTO issued the '773
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`Dentsply has now limited its request for a preliminary injunction to the '773 patent, [Doc. 77, at 2 fn. 1].
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`Case 2:14-cv-00196-JRG-MCLC Document 203 Filed 11/20/15 Page 1 of 23 PagelD #:
`659 (cid:9)
`1PR2015-00632 — Ex. 1032
`US ENDODONTICS, LLC, Petitioner
`
`

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`patent to Gold Standard as the assignee of Dr. Luebke on May 20, 2014. The '341 and '773
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`patents generally relate to a method of manufacturing or modifying heat-treated dental or
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`orthodontic instruments used to perform root canals. Dentsply, a manufacturer of dental products,
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`is the exclusive licensee for both the '341 and the '773 patents. The claims of these patents cover
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`a process for post-heat-treating endodontic nickel-titanium files at 400° C or higher. US Endo
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`also manufactures and sells post-heat-treated endodontic files.
`
`Dr. Luebke has decades of experience in root canal therapy and researching and
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`developing endodontic files in both academic and industrial settings. Stainless steel files,
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`traditionally used by dentists, were replaced by nickel-titanium files in the 1990's. These nickel-
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`titanium files were used by dentists to evacuate a tooth canal and were prone to fracture inside a
`
`patient's tooth. In 1995, Dr. Luebke began to research a way to address the fracture problem with
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`the nickel-titanium endodontic files. His research led to the invention of post-machining heat-
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`treated files which were more flexible but just as strong as the nickel-titanium files being used in
`
`the industry. This heat treatment process was the foundation for the '341 and '773 patents.
`
`US Endo, a New Mexico, LLC, is registered to do business in Tennessee and
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`manufactures nickel-titanium endodontic files marketed and sold by non-party Edge Endo to end
`
`users, i.e., dental practitioners. Edge Endo began offering the files for sale in April, 2013.
`
`Dentsply alleges that US Endo has been unlawfully manufacturing and selling endodontic files
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`which infringe the '773 patent. Specifically Dentsply asserts that US Endo infringes claim 1 of
`
`the '773 patent, which reads:
`
`I. A method for manufacturing or modifying an endodontic
`instrument for use in performing root canal therapy on a tooth, the
`method comprising:
`(a) providing an elongate shank having a cutting edge extending
`from a distal end of the shank along an axial length of the shank,
`the shank comprising a superelastic nickel titanium alloy, and
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`2
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`(b) after step (a), heat-treating the entire shank at a temperature
`from 400° C. up to but not equal to the melting point of the
`superelastic nickel titanium alloy,
`wherein the heat treated shank has an angle greater than 10
`degrees of permanent deformation after torque at 45 degrees of
`flexion when tested in accordance with ISO Standard 3630-1.
`
`II. (cid:9)
`
`Legal Standard
`
`Rule 65 of the Federal Rules of Civil Procedure permits a party to seek injunctive relief if
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`he believes he will suffer irreparable harm or injury during the pendency of the action. Fed. R.
`
`Civ. P. 65. Similarly, 35 U.S.C. § 283 permits courts to issue "injunctions in accordance with the
`
`principles of equity to prevent the violation of any rights secured by patent, on such terms as the
`
`court deems reasonable." The patentee's entitlement to any injunction is a matter largely within
`
`the discretion of the trial court. Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed.
`
`Cir. 1997).
`
`"A preliminary injunction is 'an extraordinary remedy that may only be awarded upon a
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`clear showing that the plaintiff is entitled to such relief."' LifeScan Scotland, Ltd. v. Shasta
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`Techs., 734 F.3d 1361, 1366 (Fed. Cir. 2013) (quoting Winter v. Natural Resources Defense
`
`Counsel, Inc., 555 U.S. 7, 22 (2008)). In determining whether to exercise its discretionary
`
`authority to enter injunctive relief the court must consider four universally applicable factors: (1)
`
`Whether plaintiff is likely to succeed on the merits; (2) whether plaintiff is likely to suffer
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`irreparable harm in the absence of preliminary relief; (3) whether the balance of equities tips in
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`plaintiff's favor; and (4) whether an injunction is in the public interest. Winter, 555 U.S. at 20.
`
`"These factors, taken individually, are not dispositive; rather the district court must weigh
`
`and measure each factor against the other factors and against the form and magnitude of the relief
`
`requested." Amazon.com, Inc. v. BarnesandNoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir.
`
`2001) (quoting Hybritech, Inc. v. Abbott Labs., 849 F.2d 1446, 1451 (Fed. Cir. 1998)): It is the
`
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`3
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`movant's burden to prove each of the four elements, Reebok Int'l Ltd. v..1 Baker, Inc., 32 F.3d
`
`1552, 1555 (Fed. Cir. 1994). A preliminary injunction should not be granted "if the alleged
`
`infringer raises a substantial question regarding either infringement or validity" of the patent.
`
`AstraZeneca, LP v. Apotex, Inc., 633 F.3d 1042, 1050 (Fed. Cir. 2010).
`
`III. (cid:9)
`
`Analysis and Discussion
`
`In its post-hearing brief, Dentsply argues that the "evidence establishes that US Endo
`
`infringes claims 1, 2, 4 and 5 of the '773 patent"2 and that US Endo failed to present any evidence
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`of non-infringement. US Endo, on the other hand asks the Court to limit its non-infringement
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`analysis to claim 1 and, claims non-infringement on the basis that claim 1 of the '773 patent
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`"should be construed to require the heat-treating occurs in an atmosphere consisting of a gas
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`essentially unreactive with nickel titanium," and, "[kinder this construction, US Endo
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`indisputably does not infringe." 3
`
`US Endo further argues that the '773 patent is invalid if construed broadly as Dentsply
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`contends because the '773 patent is not entitled to a priority date earlier than April 25, 2012,
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`based on the prior art published before April, 2012. Alternatively, US Endo argues that, even if
`
`the '773 patent has a priority date of 2004, it is invalid over pre-2004 art. More specifically, US
`
`Endo asserts that the '773 patent is invalid as anticipated by and/or rendered obvious over the
`
`prior art, and for lacking an adequate written description. Dentsply responds that US Endo
`
`offered no proof of anticipation at the evidentiary hearing and disputes that US Endo has raised a
`
`substantial question that claim 1 is invalid under § 103 for obviousness.
`
`A. (cid:9)
`
`Likelihood of Success on the Merits
`
`In order to demonstrate a likelihood of success on the merits of its case, a plaintiff
`
`2 See Doc. 81-1 at 15
`3 US Endo initially raised two non-infringement arguments but appears to have abandoned its second argument.
`
`4
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`in an infringement suit is required to show that (1) the plaintiff will likely prove that defendant is
`
`infringing its patent; and (2) that the plaintiff's infringement claim will likely withstand
`
`challenges to validity and enforceability of the patent. Amazon.com, 239 F.3d at 1350 (citing
`
`Genentec, 108 F.3d at 1364). If a defendant "raises a substantial question concerning either
`
`infringement or validity, i.e., asserts an infringement or invalidity defense that the [plaintiff]
`
`cannot prove 'lacks substantial merit,' plaintiff is not entitled to the requested relief. Id.
`
`The standard for assessing likelihood of success on the merits has engendered some
`
`confusion over the meaning of the terms "raises a substantial question" and "lacks substantial
`
`merit." See Avery Dennison Corp. v. Alien Technology Corp., 626 F. Supp. 2d 693 (N.D. Ohio
`
`2009) (discussing Enrico Int'l Corp. V. Vutec Corp., 516 F.3d 1350, 1354 (Fed. Cir. 2008)
`
`(holding that a substantial question with respect to the validity of the patent is sufficient to support
`
`a denial of a motion for preliminary injunction) and Abbott Laboratories v. Sandoz, Inc., 544 F.3d
`
`1341 (Fed. Cir. 2008) (appearing to reject the "substantial question" formulation of the alleged
`
`infringer's burden)). The Federal Circuit, however, clarified the requirements for a preliminary
`
`injunction in Titan Tire Corp. v. Case New Holland, Inc., and it may be useful to quote the
`
`Federal Circuit verbatim on the standard:
`
`In assessing whether the patentee is entitled to the injunction, the
`court views the matter in light of the burdens and presumptions
`that will inhere at trial. See Gonzales v. 0 Centro Espirita
`Beneficence Uniao do Vegetal, 546 U.S. 418, 429, 126 S.Ct. 1211,
`163 L.Ed.2d 1017 (2006) ("[T]he burdens at the preliminary
`injunction stage track the burdens at trial.").
`
`At trial, as we explained in our recent case of Technology
`Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327
`(Fed.Cir.2008), an issued patent comes with a statutory
`presumption of validity under 35 U.S.C. § 282. Because of this
`presumption, an alleged infringer who raises invalidity as an
`affirmative defense has the ultimate burden of persuasion to prove
`invalidity by clear and convincing evidence, as well as the initial
`
`5
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`burden of going forward with evidence to support its invalidity
`allegation. Tech. Licensing, 545 F.3d at 1327. Once the challenger
`presents initially persuasive evidence of invalidity, the burden of
`going forward shifts to the patentee to present contrary evidence
`and argument. Id. Ultimately, the outcome of the trial on this point
`will depend on whether, in light of all the evidence, the party
`challenging the patent's validity has carried its burden of
`persuasion to prove by clear and convincing evidence that the
`patent is invalid. Id. at 1328.
`
`Before trial, when the question of validity arises at the preliminary
`injunction stage, the application of these burdens and presumptions
`is tailored to fit the preliminary injunction context. To begin, the
`patent enjoys the same presumption of validity during preliminary
`injunction proceedings as at other stages of litigation. Canon
`Computer Sys., Inc. v. Nu—Kote Intl, Inc., 134 F.3d 1085, 1088
`(Fed.Cir.1998). Thus, if a patentee moves for a preliminary
`injunction and the alleged infringer does not challenge validity, the
`very existence of the patent with its concomitant presumption of
`validity satisfies the patentee's burden of showing a likelihood of
`success on the validity issue. See Purdue Pharma L.P. v.
`Boehringer Ingelheim GmbH, 237 F.3d 1359, 1365 (Fed.Cir.2001);
`Canon, 134 F.3d at 1088.
`
`If, instead, the alleged infringer responds to the preliminary
`injunction motion by launching an attack on the validity of the
`patent, the burden is on the challenger to come forward with
`evidence of invalidity, just as it would be at trial. The patentee, to
`avoid a conclusion that it is unable to show a likelihood of success,
`then has the burden of responding with contrary evidence, which
`of course may include analysis and argument.
`
`While the evidentiary burdens at the preliminary injunction stage
`track the burdens at trial, importantly the ultimate question before
`the trial court is different. As this court explained in New England
`Braiding Co. v. A.W. Chesterton Co., the trial court "does not
`resolve the validity question, but rather must ... make an
`assessment of the persuasiveness of the challenger's evidence,
`recognizing that it is doing so without all evidence that may come
`out at trial." 970 F.2d 878, 882-83 (Fed.Cir.1992). Instead of the
`alleged infringer having to persuade the trial court that the patent is
`invalid, at this stage it is the patentee, the movant, who must
`persuade the court that, despite the challenge presented to validity,
`the patentee nevertheless is likely to succeed at trial on the validity
`issue.
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`566 F.3d 1372,1376-77 (Fed. Cir. 2009)
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`The Federal Circuit explicitly addressed the meaning of the term "raises a substantial
`
`question" and the petitioner's burden to show that an infringer's defense "lacks substantial merit,"
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`noting that the confusion can be traced to New England Braiding Co. v. A. W. Chesterton Co., 970
`
`F.2d 878, 883 (Fed. Cir. 1992).
`
`The precise meaning of the emphasized language, referring, first,
`to evidence presented by the alleged infringer to support an
`invalidity defense that "raises a substantial question," and, second,
`to the patentee's obligation to show that the alleged infringer's
`defense "lacks substantial merit," is less than entirely clear, and
`leaves room for different interpretations. There are several possible
`ways a trial court could understand that language. To begin, the
`trial court might assume that only the evidence the challenger
`presents is relevant to the question of whether the challenger
`succeeds in raising a "substantial question" of invalidity, and that
`that evidence alone could be the basis for the trial court to deny the
`injunction.
`
`Alternatively, the trial court could understand its task to involve
`not only examining the alleged infringer's evidence of invalidity,
`but also considering rebuttal evidence presented by the patentee
`and determining whether the patentee can show that the invalidity
`defense "lacks substantial merit." This latter understanding more
`properly acknowledges both parts of the above quote from New
`England Braiding, and our cases have made clear that the
`patentee's rebuttal of the challenger's invalidity evidence is an
`important part of the court's overall evaluation of the evidence.
`See, e.g., Genentech, 108 F.3d at 1364 ("In other words, if Novo
`raises a 'substantial question' concerning validity ... (i.e., asserts a
`defense that Genentech cannot show 'lacks substantial merit') the
`preliminary injunction should not issue" (citing New England
`Braiding, 970 F.2d at 882-83)). A few cases have focused the
`discussion on whether the challenger succeeded in establishing a
`substantial question of invalidity without emphasizing that the
`patentee must be given the opportunity to show that the invalidity
`defense "lacks substantial merit." However, the extensive
`assessment of the evidence on both sides in those cases
`demonstrates that what underlies those decisions is the necessary
`balancing of all the evidence before the court. See, e.g., E.I. duPont
`de Nemours & Co. v. MacDermid Printing Solutions L.L.C., 525
`F.3d 1353,1358-63 (Fed.Cir.2008).
`
`7
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`Accepting, then, that the trial court looks at both sides of the
`evidence, the evidence presented by the patentee as well as by the
`alleged infringer, there remains still a question as to exactly how
`the trial court is to understand what is meant by saying the
`challenger's evidence "raises a substantial question" of invalidity.
`On the one hand, a trial court could understand that phrase to
`describe a procedural step involving assessment of evidence that
`the challenger has put forward initially. If the trial court determines
`that the challenger's evidence is sufficient to raise "a substantial
`question" of invalidity, the trial court must then afford the patentee
`the opportunity to show that the invalidity defense "lacks
`substantial merit." In other words, the trial court's determination
`that a "substantial question" has been raised by the alleged
`infringer could be considered a trigger for the patentee's
`opportunity to respond to the evidence presented by the challenger.
`
`An alternative to that way of understanding the phrase "raises a
`substantial question" is to see it as a description of the question a
`trial court must resolve regarding the evidence of invalidity at the
`preliminary injunction stage, after necessarily taking into account
`the patentee's responses. That is, it refers to the net of the evidence
`after the trial court considers all evidence on both sides of the
`validity issue available at this early stage of the litigation. Under
`this view, a finding of a "substantial question" of invalidity is a
`substantive conclusion by the trial court, a conclusion that the
`patentee is unlikely to succeed on the merits of the validity issue
`because the patentee is unable to establish that the alleged
`infringer's invalidity defense "lacks substantial merit."
`
`While our cases since New England Braiding have not always been
`explicit as to which of these two meanings of "raises a substantial
`question" was intended, our precedents establish that the phrase
`refers to a conclusion reached by the trial court after considering
`the evidence on both sides of the validity issue. Thus the trial court
`first must weigh the evidence both for and against validity that is
`available at this preliminary stage in the proceedings. Then, as
`explained in New England Braiding, if the trial court concludes
`there is a "substantial question" concerning the validity of the
`patent, meaning that the alleged infringer has presented an
`invalidity defense that the patentee has not shown lacks substantial
`merit, it necessarily follows that the patentee has not succeeded in
`showing it is likely to succeed at trial on the merits of the validity
`issue. 970 F.2d at 883.
`
`Id. at 1377-79
`
`8
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`1. (cid:9)
`
`Patent Infringement
`
`A patent is infringed when a person "without authority makes, uses or sells
`
`any potential invention, within the United States . . . during the term of the patent." 35 U.S.C. §
`
`271(a). Patent infringement analysis involves two steps. A court first "determines the scope and
`
`meaning to the patent claims asserted." Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448,
`
`1454 (Fed. Cir. 1998); see also Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en
`
`banc) ("[T]he claims of a patent define the invention to which the patentee is entitled the right to
`
`exclude."). (quotation marks omitted)). Then "the properly construed claims are compared to the
`
`allegedly infringing device." Cybor, 138 F.3d at 1454. Step one-claim construction--is a question
`
`of law for the court. Amazon.com, 239 F.3d at 1351. To ascertain the meaning of claims, courts
`
`rely on the claims, the specification, and the prosecution history. Markman v. Westview
`
`Instruments, 52 F.3d 967, 979 (Fed. Cir. 1995). In addition to this intrinsic evidence, the court
`
`may also consider extrinsic evidence, such as expert testimony, including how those skilled in the
`
`art would interpret the claims, as guides to aid the court in ascertaining the meaning of technical
`
`or scientific terms or terms of art. Id.
`
`a. Claim Construction
`
`Dentsply has not specifically addressed the meaning and scope of
`
`the claims nor has it addressed specifically, at least in its opening brief,4 the proper construction
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`of any claim's term; however, US Endo suggests in its initial brief, that there are at least two
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`terms that will require construction: (1) "heat treating" and (2) "permanent deformation." [See
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`Doc. 65 at 6-7]. US Endo does not further pursue its argument that it is necessary for the Court to
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`4 US Endo suggests that Dentsply's failure to address claim construction in its opening brief should result in a
`finding that Dentsply has not shown a likelihood of success on the merits, citing Millipole Corp. v. W. L. Gore &
`Assoc., 2011 WL 5513193 (D. N.J. Nov. 9, 2011). Such a failure might warrant that finding where the court decides
`the motion on the pleadings but does not in this case, where the court has a full evidentiary record.
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`construe the claim term "permanent deformation," and it likewise does not appear so to the Court.
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`Dentsply argues that claim construction is not necessary for the court to decide the preliminary
`
`injunction motion, [see Doc. 77 at 2 fn 2]; however, it does appear to the Court that is necessary
`
`to construe the term "heat treating," because its meaning is central to the determination of
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`Dentsply's claim of infringement.
`
`In undertaking claim construction at the preliminary injunction
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`stage, "a district court does not have to conduct a comprehensive and final construction." Shuffle
`
`Master, Inc. v. VendingData, Corp., 163 Fed. App'x 864, 867 (Fed. Cir. 2005). Instead,
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`"[d]istrict courts may engage in a rolling claim construction, in which the court revisits and alters
`
`its interpretation of the claim terms as its understanding of the technology evolves." Jack
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`Guttman, Inc. v. KopyKake Enter., Inc., 302 F.3d 1352, 1361 (Fed. Cir. 2002). "A district court
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`therefore is at liberty to change the construction of a claim term as the record in a case evolves
`
`...." Transonic Sys., Inc. v. Non-Invasive Med. Tech. Corp., 75 Fed. App'x 765, 774, 2003 WL
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`2201733 (Fed. Cir. Aug. 26, 2003). Because a court must determine whether the movant is likely
`
`to prevail on the merits, however, "if that question turns on a contested issue of claim
`
`construction, the court must give the claim construction issue the attention necessary to determine
`
`the likelihood of success." Shuffle Master, 163 Fed. App'x at 868.
`
`When construing a claim's terms, the words of a claim are
`
`generally afforded their ordinary and customary meaning, that is, "the meaning that the term
`
`would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as
`
`of the effective filing date of the patent application." Phillips, 415 F.3d at 1313. When the
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`meaning of a claim term as understood by persons of skill in the art is not immediately apparent,
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`courts look to 'those single courses available to the public that show what a person of skill in the
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`art would have understood disputed claim language to mean.' Id. at 1315 (quoting Innova/Pure
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`Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)).
`
`Such sources include "the words of the claims themselves, the
`
`remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant
`
`scientific principles, the meaning of technical terms, and the state of the art." Id. (quotation
`
`omitted). As part of a "fully integrated instrument," however, claims must be read in view of the
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`specification set forth in the patent, which is often 'the best guide to the meaning of a disputed
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`terms.' Id. at 1315; see, e.g., Multiform Desiccants, Inc. v. Medzam Ltd., 133 F.3d 1473, 1478
`
`(1998) (stating that "[t]he best source for understanding a technical term is the specification from
`
`which it arose, informed, as needed, by the prosecution history.").
`
`Claim 1 of the '773 patent provides in step (b) for "heat treating" of
`
`the patented device. US Endo urges the Court to construe the claim to require the "heat-treating"
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`to occur "in an inert gas atmosphere that is unreactive with the nickel titanium alloy," [Doc. 65 at
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`6], while Dentsply argues the heat treating may be done in any atmosphere. If construed as uged
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`by US Endo, the allegedly infringing products do not infringe since US Endo's EdgeFiles are
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`treated in air. [Goldberg Declaration, Doc. 53 at ¶ 13].
`
`US Endo argues that the intrinsic evidence "compels [its] construction" on
`
`the basis that the '773 patent specification does not describe the step of heat-treating "occurring in
`
`any atmosphere other than one that is reactive with nickel titanium." [Doc. 103 at 8]. US Endo
`
`points to several references and statements made by Dr. Luebke during the prosecution of the
`
`patent application in support of its position. The complete record, including the testimony at the
`
`evidentiary hearing, however, convinces the Court that Dentsply's construction of the term is the
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`proper one.
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`Although the specification of the '773 patent does make the references
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`noted by US Endo, the claim itself has no requirement as to the atmosphere in which the heat-
`
`treating must occur. US Endo's construction, however, directly contradicts the language of
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`dependent claims 4-6 of the '773 patent. Dependent claim 4 expressly recites that step (b), i.e.,
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`the heat-treating, "is performed in any atmosphere." Claims 5 and 6 state that "the method of
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`claim 4, wherein the atmosphere is unreactive, ambient or any other acceptable heat treatment
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`process." Under US Endo's claim construction, dependent claim 4 would be broader than the
`
`claim upon which it depends, resulting in an impermissible reading. See 35 U.S.C. § 112; Robotic
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`Vision Sys. Inc. v. View Eng'g, Inc., 189 F.3d 1370 (Fed. Cir. 1999).
`
`The testimony of Dr. Goldberg, US Endo's expert, at the evidentiary
`
`hearing confirms the Court's conclusion. Dr. Goldberg testified that the ordinary meaning,
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`"outside the context of a patent claim," of the term "heat-treating" does not include the limitation
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`read into it by Dr. Goldberg, i.e., that the heat-treating must be done in an atmosphere unreactive
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`with nickel-titanium. [Doc. 162 at 73]. In addition, Dr. Goldberg's opinion has been offered in
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`somewhat of a vacuum due to the limitation placed on him by US Endo. Dr. Goldberg
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`acknowledged that he had not considered dependent claims 4 and 5 because "he was not asked
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`[by US Endo] to consider any claims other than claim 1 in doing [his] analysis." [Id. at 74]. Dr.
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`Goldberg also acknowledged that a dependent claim may not be any broader than the claim upon
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`which it depends and that "under [his] proposed construction of claim 1, claims 4 and 5 would he
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`broader than claim 1," [Id. at 75], and "would be in conflict." [Id. at 77].
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`US Endo has asserted in various pleadings that there are other claim terms
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`that need to be construed by the Court, including "permanent deformation" and "Martensitic."
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`US Endo has either abandoned or otherwise failed to pursue these arguments for the purpose of
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`the pending motion for preliminary injunction and the Court will not address them.
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`b. Comparison of Claims to Allegedly Infringing Device
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`US Endo appears to make two arguments as to why it's allegedly
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`infringing products do not infringe. First, US Endo argues that it "indisputably does not infringe
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`because its heat-treating process occurs in air, which is reactive with nickel-titanium," [Doc. 177
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`at 7], an argument premised upon this Court's acceptance of US Endo's proposed construction of
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`the claim term "heat-treating." Second, US Endo argues that Dentsply has not shown "that US
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`Endo's EdgeFile Xl, X5 and X7 files are, before being heat-treated, `superelastic' as required by
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`each claim of the '773 patent." [Id. at 20].
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`Based on the Court's construction of the term "heat-treating" above, the
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`first of US Endo's arguments is easily disposed of. As for the second argument, Dr. Sinclair
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`testified without challenge that the accused files are likely superelastic prior to heat-treating.5 Id.
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`at 1377-79.
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`In addition, US Endo has never disputed that nickel-titanium is a superelastic
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`material. In Bennett's declaration, he acknowledges that the nickel-titanium EdgeFiles Xl, X3
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`(except for one file size having 12 degrees of taper), X-5, and X7 blades are heat treated. [Doc.
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`52 at 11¶ 6, 7, 12 and 13).
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`2. (cid:9)
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`Validity
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`As the Court noted at the outset of its analysis, a patentee seeking a
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`preliminary injunction must not only show a likelihood of success as to infringement but must
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`also show "that it will likely withstand challenges, if any, to the validity of the patent . . . in light
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`5 US Endo characterizes Dr. Sinclair's testimony as speculative because he did not do actual testing of the US Endo
`Xl, X5, and X7 files. It is true no actual testing was done; however, US Endo's argument disingenuously ignores Dr.
`Sinclair's actual testimony. Dr. Sinclair testified that his opinion that the elongated shank with the cutting edge
`comprises a superelastic nickel-titanium alloy has three bases: (1) all the files came from the same manufacturer, (2)
`the XR file, which was not heat-treated, has been tested and is superelastic, and (3) all the heat-treated files "show the
`same transformation temperature."
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`of the burdens and presumptions that will inhere at trial." Titan Tire Corp., 566 F.3d at 1376. At
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`the preliminary injunction stage, the patent is entitled to the same "presumption of validity" that
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`would inhere at trial. Id. at 1377 (citing Canon Computer Sys., Inc. v. Nu-Kote Intl, Inc., 134
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`F.3d 1085, 1088 (Fed. Cir. 1998)). If "the alleged infringer responds to the preliminary injunction
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`by launching an attack on the validity of the patent, the burden is on the challenger to come
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`forward with evidence of invalidity, just as it would be at trial." Id. The patentee must then
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`respond with evidence to show that, "despite the challenge presented to validity, the patentee
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`nevertheless is likely to succeed at trial on the validity issue." Id. In Titan, the Federal Circuit
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`characterized the question before the court as "whether it is more likely than not that the
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`challenger will be able to prove at trial, by clear and convincing evidence, that the patent is valid."
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`Id. at 1379.
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`a. Priority Date
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`As a preliminary matter, however, US Endo argues that the '773 patent is
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`not entitled to its earliest potential priority date of June 8, 2004, the filing date of the parent
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`application of the '773 patent. US Endo claims that the earlier-filed 2004 and 2005 applications
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`do not contain disclosure of heat-treating in any atmosphere other than one unreactive to nickel-
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`titanium. Instead, US Endo asserts that the first disclosure of heat-treating in a reactive
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`atmosphere was in the application of April 25, 2012, which led to the issuance of the '773 patent.
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`See Research Corp. Techs v. Microsoft Corp., 627 F.3d 859, 869-70 (Fed. Cir. 2010) (to be
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`entitled to an earlier priority date, "the claims of the later-filed application must be supported by
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`the written description in the [earlier] parent [application] 'in sufficient detail that one skilled in
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`the art can clearly conclude that the inventor invented the claimed invention as of the filing date
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`sought."). The holder or assignee of the patent has the burden of showing entitlement to an
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`earlier priority date. Id. at 871. US Endo argues that Dentsply has not met its burden. Dentsply,
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`not surprisingly, disagrees.
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`Because the Court finds, as discussed below, that Dentsply is unable to
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`establish that