Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 1 of 37 PagelD #: 1285
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`DNA GENOTEK lNC.,
`
`Plaintiff,
`
`V.
`
`SPECTRUM DNA, SPECTRUM SOLUTIONS
`L.L.C., and SPECTRUM PACKAGING L.L.C.,
`
`Defendant.
`
`\./V—/\/\J%\J\/\/\/\/
`
`C.A. No. 15-661 —SLR
`
`JURY TRIAL DEMANDED
`
`PUBLIC VERSION
`
`DEFENDANTS’ BRIEF IN OPPOSITION T0
`
`DNA GENOTEK’S MOTION FOR PRELIMINARY INJUNCTION
`
`OF COUNSEL:
`
`Michael Sacksteder
`FENWICK & WEST LLP
`
`555 California Street, 12th Floor
`San Francisco, CA 94104
`Tel: (415) 875-2300
`
`Melanie Mayer
`FENWICK & WEST LLP
`
`1 191 Second Avenue
`
`Seattle, WA 94104
`Tel: (206) 389-4510
`
`Dated: October 2, 2015
`PUBLIC VERSION
`Dated: October 9, 2015
`1206160/42724
`
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Stephanie E. O’Byme (#4446)
`POTTER ANDERSON & CORROON LLP
`Hercules Plaza, 6”‘ Floor
`1313 N. Market Street
`
`Wilmington, DE 19801
`Tel: (302) 984-6000
`dmoore@potteranderson.com
`b ala
`otterandersoncom
`
`s0b3@e@,potteranderson.com
`
`Attorneysfor Defendants Spectrum DNA,
`Spectrum Solutions L.L. C., and Spectrum
`Packaging L. L. C.
`
`ANCESTRY EX. 1 O1 6
`
`

`
`Case 1:15—cv-00661-SLR Document 41 Filed 10/09/15 Page 2 of 37 PageID #: 1286
`
`TABLE OF CONTENTS
`
`222.9
`
`I.
`
`II.
`
`INTRODUCTION ............................................................................................................ .. 1
`
`NATURE AND STAGE OF THE PROCEEDINGS ....................................................... .. 2
`
`III.
`
`STATEMENT OF ADDITIONAL FACTS ..................................................................... .. 3
`
`A.
`
`B
`
`C.
`
`D
`
`Spectrum ................................................................................................................. 3
`
`Relevant Aspects of the ’38l Patent ................................................................. .. 3
`
`Relevant Aspects of the Spectrum Product....... .. .................................................. .. 5
`
`Prior Art to the ’38l Patent.......................
`
`........................................................... 6
`
`1.
`
`2.
`
`United States Patent No. 7,645,424 ............................................................ 6
`
`PCT Publication WO 98/03265 ................................................................ .. 7
`
`IV.
`
`ARGUMENT .................................................................................................................... .. 8
`
`A.
`
`B.
`
`This Court Lacks Jurisdiction to Decide Genotek’s Motion. ............................... .. 8
`
`Genotek Is Highly Unlikely to Succeed on the Merits. .........
`
`............................. .. 9
`
`1.
`
`2.
`
`The Spectrum Product Does Not Infringe the ’381 Patent Because
`It Does Not Include a “Vial Comprising .
`.
`. a Piercing Member.” .......... .. 9
`
`The Spectrum Product Does Not Infringe the ’381 Patent Because
`It Does Not Include a Piercing Member with a “First Pointed
`Comer.” .................................................................................................... .. 14
`
`3.
`
`Claim 1 of the ’381 Patent Is Invalid in Light of the Prior Art............... .. 15
`
`C.
`
`Genotek Has Failed to Demonstrate Irreparable Harm........................................ .. 21
`
`1.
`
`2.
`
`3.
`
`Price erosion does not necessarily cause irreparable harm, and even
`if it did, no evidencesupports Genotek’s price erosion theories. ........... .. 22
`
`No evidence supports Genotek’s argument that Spectrum is
`harming its reputation with its current and potential customers. ............ .. 24
`
`No evidence supports Genotek’s argument that Spectrum is
`harming its business operations. ............................................................. .. 26
`
`into
`
`

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`Case 1:15-cv—O0661—SLR Document 41 Filed 10/09/15 Page 3 of 37 Page|D #: 1287
`
`4.
`
`5.
`
`Genotek has not shown a causal nexus between its alleged harm
`and Spectrum’ s. alleged infiingement. ...................................................... 27
`
`Genotek is not facing any imminent harm.............................................. .. 28
`
`D.
`
`E.
`
`F.
`
`In the Unlikely Event that Spectrum Is Found to Infringe, It Could Easily
`Pay a Damages Award. ....................................................................................... .. 29
`
`The Balance of Hardships Favors Spectrum......................................................... 29
`
`The Public Interest Weighs Against an Injunction. ............................................ .. 30
`
`V.
`
`CONCLUSION ............................................................................................................... .. 30
`
`ii
`
`09
`
`

`
`Case 1:15—cv-00661-SLR Document 41 Filed 10/09/15 Page 4 of 37 PageID #: 1288
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`3M Unitek Corp. v. Ormco Co.,
`96 F. Supp. 2d 1042 (C.D. Cal. 2000) ................................................................................... ..25
`
`Altana Pharma AG v. Teva Pharms. USA, Inc. ,
`566 F.3d 999 (Fed. Cir. 2009)............................................................................................ ..1, 16
`
`Am. Calcar, Inc. v. Am. Honda Motor Co.,
`651 F.3d 1318. (Fed. Cir. 2011).............................................................................................. ..15
`
`Apple Inc. v. Samsung Elecs. Co.,
`735 F.3d 1352 (Fed. Cir. 2013).................................................................................. ..22, 25, 27
`
`Belden Techs, Inc. v. Superior Essex Commc ’ns. LP,
`802 F. Supp. 2d 555 (D. Del. 2011) ....................................................................................... ..23
`
`Bio-Tech. Gen. Corp. v. Genentech, Inc.,
`80 F .3d 1553 (Fed. Cir. 1996) .......................................................................................... ..26, 27
`
`Celgard, LLC v. LG Chem., Ltd,
`No. 2014-1675, 2015 U.S. App. LEXIS 14079 (Fed. Cir. Aug. 12, 2015) ............................. ..8
`
`Corning Glass Works V. Sumitomo Elec. I/'.S.A., Inc.,
`868 F.2d 1251 (Fed. Cir. 1-989).............................................................................................. ..12
`
`Demarini Sports, Inc. v. Worth, Inc.,
`239 F.3d 1314 (Fed. Cir. 2001).............................................................................................. ..12
`
`Douglas Dynamics, LLC v. Buyers Prods. Co. ,
`717 F.3d 1336 (Fed. Cir. 2013) .................................................................................. ..24, 25, 26
`
`eBay Inc. v. MercExchange, L.L.C.,
`547 U.S. 388 (2006) .................................................................................................................22
`
`Extrel FT116', Inc. v. Bruker Instruments, Inc,
`No. 91-1216, 1992 U.S. App. LEXIS 1038 (Fed. Cir. Jan. 24, 1992) ................................... ..13
`
`Freedman Seating Co. v. Am. Seating Co. ,
`420 F.3d 1350 (Fed. Cir. 2005).............................................................................................. ..13
`
`Gemalto S.A. v. HTC Corp.,
`754 F.3d 1364 (Fed. Cir. 2014).............................................................................................. ..13
`
`-h
`
`

`
`Case 1:15-cv-0O661—SLR Document 41 Filed 10/09/15 Page 5 of 37 PageID #: 1289
`
`1CUMed., Inc. v. Alaris Med. Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009)............................................................................................... ..21
`
`IPXL Holdings, L.L. C. v. Amazon. com, Inc.,
`430 F.3d 1377 (Fed. Cir. 2005).............................................................................................. ..10
`
`LizardTech, Inc. v. Earth Resource Mapping, Inc.,
`424 F.3d 1336 (Fed. Cir. 2005).............................................................................................. ..21
`
`Marquip, Inc. v. FosberAm., Inc.,
`198 F.3d 1363 (Fed. Cir. 1999).......................................................................................
`
`..... ..12
`
`.
`Moore U.S.A., Inc. v. Standard Register Co.,
`229 F.3d 1091 (Fed. Cir. 2000) .............................................................................................. ..12
`
`'
`.
`Neology, Inc. v. Fed. Signal Corp.,
`C.A. No. 11-672-LPS/MPT, 2012 U.S. Dist. LEXIS 83984 (D. Del. June 18,
`2012) .......................................................................................................................... ..21-22, 24
`
`Nutrition 21 v. United States,
`930‘F.2d 867 (Fed. Cir. 1991)................................................................................................ ..29
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`No. 08-309—LPS, 2014 U.S. Dist. LEXIS 88488 (D. Del. June 30, 2014) ............................ ..25
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`No. C 09-5235 MMC, 2015 U.S. Dist. LEXIS 17492 (N .D. Cal. Feb. 12,
`2015) ...................................................................................................................................... ..2S
`
`Quest Integrity USA, LLC v. Clean Harbors Indus. Servs., Inc. ,
`C.A. No. 14-1482-SLR, 2015 US. Dist. LEXIS 76696 (D. Del. June 12,
`2015) ...................................................................................................................................... ..23
`
`Reebok Int 7, Ltd v. 1 Baker; Inc.,
`32 F.3d 1552 (Fed. Cir. 1994)................................................................................................ ..30
`
`Rhine v. Casio, Inc.,
`183 F.3d 1342 (Fed. Cir. 1999) .............................................................................................. ..11
`
`Riverbed Tech, Inc. v. Silver Peak Sys., Inc.,
`C.A. No. 11-484—RGA, 2014 U.S. Dist. LEXIS 127651 (D. Del. Sept. 12,
`2014) ................................................................................................................................ ..27, 28
`
`Sage Prods. Inc. v. Devon Indus., Inc.,
`126 F.3d 1420 (Fed. Cir. 1997).................................................................................... .. 1, 11—12
`
`Sanofi—Synthelab0 v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006).............................................................................................. ..27
`
`iv
`
`

`
`Case 1:15-cv-0O661—SLR Document 41 Filed 10/09/15 Page 6 of 37 PageID #: 1290
`
`Titan Tire Corp. v. Case New Holland, Inc.,
`566 F.3d 1372 (Fed. Cir. 2009).............................................................................................. ..1.6
`
`Univ. of Utah Research Found. v. Ambry Genetics Corp. ,
`3 F. Supp. 3d 1213, 1253 (D. Utah 2014) .............................................................................. ..25
`
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (U.S. 1997) ......................................................................................................... ..13
`
`Wavetronix LLC V. Iteris, Inc.,
`No. A-14-CA—970—SS, 2015 U.S. Dist. LEXIS 6993 (W.D. Tex. Jan. 21,
`2015) ...................................................................................................................................... ..25
`
`Windsurfing Int’l, Inc. v. AMF, Inc.,
`782 F.2d 1995 (Fed. Cir. 1.986).................................................................
`
`........................... ..29
`
`Winter v. Natural Res. Def Council, Inc.,
`555 U.S. 7, 129 S. Ct. 365 (2008) .......................................................................................... ..28
`
`Zodiac Pool Care, Inc. v. Hoflinger Indus, Inc.,
`206 F.3d 1408 (Fed. Cir. 2000).............................................................................................. ..12
`
`STATUTES
`
`35 U.S.C. § 102 ........................................................................................................................... ..11
`
`35 U.S.C. § 102(b) .......................................................................................................................... ..7
`
`35 U.S.C. § 102(¢) .......................................................................................
`
`..................................6
`
`35 U.S.C. § 112 ..................................................................................................................... ..11,21
`
`v
`
`

`
`Case 1:15-cv-0O661—SLR Document 41 Filed 10/09/15 Page 7 of 37 PagelD #: 1291
`
`I.
`
`INTRODUCTION
`
`DNA Genotek Inc.’s (“Genotel<’s”) request for the extraordinary remedy of a preliminary
`
`injunction should be denied. First, Genotek fails to prove a likelihood of success on the merits.
`
`To start, Spectrum’s product does not infringe claim 1 of U.S. Patent 8,221,381 (“the ’381
`
`_patent”). Claim 1 is directed to a container system with “a vial comprising .
`
`.
`
`. a piercing
`
`member.” The Spectrum product has a piercing insert in the cap, not the vial. Furthermore, the
`
`Spectrum product does not include a piercing member with a “first pointed corner” as required
`
`by claim 1.
`
`Genotek’s attempt to expand the scope of claim 1 under the Doctrine of Equivalents
`
`(“DOE”) must also be rejected. First, Genotek’s DoE argument attempts to capture a completely
`
`different arrangement of structural elements than recited in claim 1. This is contrary to Federal
`
`Circuit precedent. See Sage Prods. Inc. v. Devon Indus, Inc., 126 F.3d 1420, 1425 (Fed. Cir.
`
`1997). Second, Genotek’s attempt to expand claim 1 under DoE would imperrnissibly cover the
`
`prior art. Finally, in applying the function/way/result test, Genotek incorrectly focuses just on
`
`the piercing member. When the function/way/result test is properly focused onthe correct
`
`element, Spectrum’s product does not infringe under DoE because the piercing insert in the cap
`
`does not perform substantially the same way as a “vial comprising .
`
`.
`
`. a piercing member.”
`
`Genotek also fails to show that it will succeed on the merits because claim 1 of the ’381
`
`patent is invalid under pre-AIA §§ 102, 103 and 112. Spectrum need only “raise[] a ‘substantial
`
`question’ of invalidity” to defeat Genotek’s preliminary injunction motion. Altana Pharma AG
`
`v. Teva Pharms. USA, Inc., 566 F.3d 999, 1005-06 (Fed. Cir. 2009). As described in detail
`
`below, two separate prior art references disclose every element of claim 1, rendering this claim
`
`invalid as anticipated and/or obvious. In addition, if claim 1 is construed to cover devices with a
`
`

`
`Case 1:15-cv—O0661-SLR Document 41 Filed 10/09/15 Page 8 of 37 PageID #: 1292
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`piercing member in the lid (as Genotek argues), this claim is invalid for lack of written
`
`description, since it would encompass embodiments not disclosed in the ’38l patent.
`
`Genotek also fails to meet its burden of showing irreparable harm. Even though the
`
`evidence relevant to Genotek’s alleged harm is within Genotek’s control, it provides no actual
`
`evidence of any such harm. Instead, Genotek relies on speculation and conclusory statements,
`
`primarily from its expert, Dr. McDuff. However, during his deposition, Dr. McDuff admitted
`
`that he only spent a total of 6.6 hours on this matter, did not speak to anyone at Genotek in
`
`arriving at the opinions expressed in his declaration, and did not even read the declaration of
`
`Genotek President Ian Curry until the day he signed his own. Declaration of Melanie Mayer in
`
`Support of Defendants’ Opposition to Genotek’s Motion for Preliminary Injunction (“Mayer
`
`Decl.”), Ex. G (McDuff Depo. Tr.) at 11:25-12:2; 27:21-24; 54:4-9; 91 :8-13; see also
`
`‘Declaration of Thomas R. Varner, Ph.D. in Support of Defendants’ Opposition to DNA
`
`Genotek’s Motion for Preliminary Injunction (“Varner Dec1.”) 1111 at 67-78.
`
`In addition, Dr.
`
`McDuff provides no opinion that Genotek would suffer irreparable harm. Genotek’s request for
`
`the extraordinary remedy of a preliminary injunction should be denied.
`
`II.
`
`NATURE AND STAGE OF THE PROCEEDINGS
`
`Genotek filed this action on July 30, 2015, alleging that Spectrum’s DNA saliva
`
`collection kit infringes the ’381 patent. D.I. 1. On August 24, 2015, the parties stipulated to an
`
`extension of time for Spectrum to answer the Complaint. D.I. 7. On the same day, Genotek
`
`moved for a preliminary injunction barring Spectrum from further alleged infringement of the
`
`’38l patent. See D.I. 8, 9. On September 4, 2015 , Spectrum filed a motion to dismiss for lack of
`
`personal jurisdiction. D.I. 19, 20. On September 30, 2015, Genotek filed a response to
`
`Spectrurn’s motion to dismiss. D.I. 30, 31.
`
`

`
`. Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 9 of 37 PageID #: 1293
`
`III.
`
`STATEMENT OF ADDITIONAL FACTS
`
`A.
`
`Spectrum
`
`Contrary to Genotek’s efforts to portray Spectrum as a “secretive” company that
`
`“recently launched a website offering infringing product to customers other than Ancestry,”
`
`Genotek itself admits that Spectrum has been in operation and searchable on the Internet since
`
`2005 (D.I. 13, 1] 5). Spectrum is a privately held company based in Utah, and is primarily
`
`involved with the design, development, and manufacture of packaging for a number of industries
`
`including cosmetics, bottling, and plastics. Declaration of Gregg Williams in Support of
`
`Defendants’ Opposition to Genotek’s Motion for Preliminary Injunction (“Williams Decl.”), 1] 2.
`
`Spectrum began selling saliva collection kits to Ancestry.com DNA, LLC (“AncestryDNA”) in
`
`.
`
` . Id., 1] 3. Genotek has made clear that its “motion does not seek
`
`to enjoin Spectrum from continuing to supply Ancestry.” D.I. 8 at 1. Instead, Genotek’s motion
`
`is directed to the less than- of Spectrum’s sales of saliva collection kits invoiced to non-
`
`Ancestry firms. To date, those sales total less than
`
`Williams Decl., 114.
`
`B.
`
`Relevant Aspects of the ’381 Patent
`
`The relevant portion of the ’38l patent discloses———and the asserted claim recites-two
`
`distinct components: a “via ” and a “lid.” See Declaration of Terry Layton, Ph.D. in Support of
`
`Defendants’ Opposition to Genotek’s Motion for Preliminary Injunction (“Layton Decl.”), Ex. B
`
`(‘"381 patent”), 4:21-22,12:6l-13:4, Figs. 1-1 1, 22-24. Claim 1 recites that the vial “comprises,”
`
`among other sub-components, a “piercing member.” Id., 12:61-63. In every disclosed
`
`embodiment of claim 1, the piercing member is physically integrated into the vial. Figures 10
`
`and 23 of the patent show this physical integration.
`
`

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`Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 10 of 37 PagelD #: 1294
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`
`
`
`
`FIG. 23
`
`The photographs in Genotek’s brief of its practicing product also show this integration. D.I. 9 at
`
`3. Nowhere in the ’381 patent is the piercing member described or shown as being located in the
`
`lid or as being a separate component from the Via1.1
`
`Claim 1 further requires the recited piercing member to comprise “a side wall, [and] a
`
`first cutting edge extending from afirst pointed corner to .a second corner that defines the
`
`intersection between said cutting edge and said side wall.” ’381 patent, 12:63-67 (emphasis
`
`added). Genotek inserted this limitation during prosecution to distinguish cited prior art. Mayer
`
`Dec1., Ex. A. The specification discloses that the piercing member can be approximately
`
`trapezoidal and “includes first cutting edge 33 having pointed end 30 at one corner of the
`
`trapezoid and a second end at a second comer of the trapezoid where cutting edge 32 intersects
`
`side wall 34.” ’381 patent, 6:33-38 (emphasis added). Figure 3 shows this configuration.
`
`1 In one embodiment, the piercing member is integrated into a separate funnel. That
`embodiment corresponds to independent claim 21, which is not asserted in this action.
`
`

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`Case 1:15—cv-00661-SLR Document 41 Filed 10/09/15 Page 11 of 37 PageID #: 1295
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`first pointed corner
`
`FIG. 3
`
`C.
`
`Relevant Aspects of the Spectrum Product
`
`The Spectrum product includes a collection tube (1), a funnel (2), and a cap (3).
`
`3
`
`1
`
`2
`
`Unlike the devices disclosed in the ’381 patent, the piercing insert in the Spectrum product is
`
`located in the cap, not the collection tube. See Layton Decl., ‘W 15-17, 24-26, 28. When a user
`
`screws the cap onto the collection tube, the top of the tube pushes the insert farther up into the
`
`cap as the cap is tightened, ultimately breaking the foil that holds in the liquid. Id., 111] 15-17, 33.
`
`Although photographs in Genotek’s brief and expert declaration show the piercing insert
`separated from the cap, the insert remains inside the cap during the entire operation ofthe
`
`Spectrum device. In fact, the insert is difficult to pry out of the cap. Genotek’s technical expert
`
`testified that when he disassembled the Spectrum device and a substantially identical Ancestry
`
`device, he used pliers to remove the insert from the cap. Mayer Decl., Ex. B at 12:25-13:1;
`
`52:12-17. He declined during his deposition to attempt to remove the insert without pliers,
`
`saying, among other things, “I would not attempt to break my fingers.” Id. at 48:15-22.
`
`The teeth of the Spectrum insert also embody a key distinction from the “piercing
`
`

`
`Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 12 of 37 Page|D #: 1296
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`member” disclosed and claimed in the ’38l patent. The surfaces of the Spectrum insert teeth—~
`
`including the corncrs—are squared off, rather than tapered to a point like the “pointed en ” of
`
`the first comer in the ’38 l_ patent.
`
`squared-off
`
`edges
`
`D.
`
`Prior Art to the ’381 Patent
`
`1.
`
`United States Patent No. 7,645,424
`
`The ’424 patent claims priority to a provisional patent application filed November 19,
`
`2003, and a published PCT application filed November 18, 2004. Both filings pre-date the
`
` - See Mayer Deck, Ex. E
`
`(Curry Depo. Tr.) at 55:1-16 (named inventor and Genotek President Ian Curry estimating that
`
`—). Accordingly, the ’424 patent constitutes prior art to the ’381 patent
`
`under pre—AIA 35 U.S.C. § 102(e).
`
`The ’424 patent, entitled “Reagent Cuvette,” discloses a molded plastic, two-
`
`compartment container for adding a chemical “starter reagent” to a previously formed mixture of
`
`blood and a “buffer reagent.” Layton Decl., Ex. F (“’424 patent”) at 2:40-45, 3:10-16. The
`
`mixture is formed when a user adds a blood sample through the open end of a “first chamber,”
`
`labeled “2” in Figure 1 (see below). Id. at 3:10-16. A “second chamber,” located in the lid and
`
`labeled “3,” contains the starter reagent. Id. at 3:4-5. A foil membrane seals the starter reagent
`
`into the chamber 3. Id. Chamber 2, in the body of the device, incorporates “piercing members.”
`
`Id. at 2:60-67. In the embodiment of Figure 3, the piercing members are four trapezoid-shaped
`
`

`
`Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 13 of 37 PageID #: 1297
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`“spikes,” with upward—facing acute-angle corners. Id. at 2:60-67 & Figs. 3, 4. In another
`
`embodiment, the piercing member “takes the form ofa blade to out along a longer length of the
`
`membrane.” Id at 3:51-53.
`
`
`
` ¢:=V\\\\\\~\
`.“-$1
`
`
`
`.‘\\: ..«-
`
`
`
`
`
`
`
`H9,
`
`_
`
`Fig.3
`
`The user inserts the reagent—containing lid, with the lid’s membrane-sealed opening
`
`facing down, into the socket 6 at the top of chamber 2 “by gently pressing it down so that its foil
`
`membrane is broken by the spikes.” Id. at 3:17-20. The membrane “is both pierced and torn by
`
`the spikes 20 so that the full quantity of starter reagent drops into the inspection part 5” of the
`
`chamber 2. Id. at 3:20-24. The lid snaps into place with a “friction fit” so the “chambers 2 and 3
`
`are effectively a single chamber.” Id. at 3228-30.
`
`2.
`
`PCT Publication WO 98/03265
`
`The ’265 publication was published January 29, 1998. It constitutes prior art to the ’381
`
`patent under pre-AIA 35 U.S.C. § 102(b). As illustrated in Figure 1, reproduced below, the ’265
`
`publication discloses a “cap-shape[d] reagent container” for performing water-quality analysis.
`
`Mayer Decl., Ex. F (’265 publication) at Abstract. The user injects a water sample into the
`
`

`
`Case 1:15—cv—0O661-SLR Document 41 Filed 10/09/15 Page 14 of 37 Page|D #: 1298
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`“container body” or “main vessel” 15 through the open end at the top. Id. at 16. The cap 3
`
`contains a “reagent storage container” or “film vessel” 5 that holds a liquid reagent. Id. at 10.
`
`The cap also contains a “cutter” 8A, positioned below the reagent storage container 5.
`
`
`
`When the user begins to screw on the cap, “the cutter 8A is pushed into the cap‘-body 3.”
`
`Id. As the cap is tightened, the edge ofthe cutter 8A “breaks through the film vessel 5.” Id. at
`
`14. The reagent “leaks out outside of film vessel 5,” through slits in the cutter structure,
`
`discharging the reagent into the container body» Id. at 10. The user ultimately completely
`
`tightens the cap to allow the container body to be “churned,” thoroughly mixing the sample and
`
`the reagents. Id. at 12.
`
`IV.
`
`ARGUMENT
`
`A.
`
`This Court Lacks Jurisdiction to Decide Genotek’s Motion.
`
`A court “cannot enjoin a party if it does not have jurisdiction over that party.” Celgard,
`
`LLC v. LG Chem, Ltd., No. 2014-1675, 2015 U.S. App. LEXIS 14079, at *6 (Fed. Cir. Aug. 12,
`
`2015). Indeed, when a party contests personal jurisdiction, it is legal error to issue a preliminary
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`injunction without first making findings with respect to jurisdiction. Id. at *8. In this case,
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`Spectrum has contested personal jurisdiction in a Motion to Dismiss. D.I. 19. Accordingly, this
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`Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 15 of 37 Page|D #: 1299
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`Courtshould consider the jurisdictional’ issue first, and ifjurisdiction is found to be lacking, no
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`injunction can issue.
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`B.
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`Genotek Is Highly Unlikely to Succeed on the Merits.
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`Genotek is highly unlikely to succeed on the merits, both because the Spectrum product
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`does not infringe claim I of the ’381 patent, either literally or under the doctrine of equivalents,
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`and because claim 1 of the ’381 patent is invalid in View of the prior art.
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`1.
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`The Spectrum Product Does Not Infringe the ’381 Patent Because It
`Does Not Include a “Vial” Comprising . . . a Piercing Member.”
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`Genotek’s literal infringement argument asks the Court to accept that a component which
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`remains within the cap of Spectrum’s device at all times is somehow instead part of the claimed
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`vial. Claim 1 of the ’381 patent recites “a vial comprising. . .a piercing member.” Read in view
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`of the specification, a “vial comprising .
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`.
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`. a piercing member” means that the piercing member
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`is an integrated component of the vial. Layton Dec1., 1] 21-22, 29. The collection tube of the
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`Spectrum product, which Genotek identifies as the recited vial, has no piercing member. See
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`Layton Dec1., 111] 15-17, 23, 28. Instead, the piercing insert of the Spectrum product is located in
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`the lid of the Spectrum product, not in the vial. Id. at 1H] 15-17, 24-26, 28. Genotek’s expert
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`agrees that the piercing insert remains in the lid the entire time that the Spectrum product is in
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`use. Mayer Decl., Ex. B (Lasheras Depo. TL), 36:9—37:2; 45:20-46:10.
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`Neither Genotek, nor its expert, bothers to construe the term “vial comprising .
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`.
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`. a
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`piercing member.” Genotek nonetheless asserts that, when in use, the piercing insert of the
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`Spectrum product becomes “wedged” in the top of the collection tube such that the vial
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`comprises a piercing member. D.I. 9 at 7. Genotek is incorrect for several reasons. First,
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`Genotek provides no evidence that the piercing insert of Spectrum’s product becomes “wedged”
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`in the tube. Second, even if it did, this would not change the fact that the insert is a component
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`Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 16 of 37 Page|D #: 1300
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`of the -cap, and is not part of the tube. Layton Decl., ‘W 28-29. In addition, when the cap is
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`placed on the collection tube (the configuration in which Genotek argues the piercing insert is
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`“wedged” in the tube), the tube fails to satisfy other elements of claim 1, including the
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`requirement that the tube have a “first open end for receiving a sample.” Id. at ‘ll 30. Genotek
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`attempts to evade this problem by arguing that the end of the tube is open at some times during
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`the product’s operation, but not at others. However, when the tube is open, z'.e., when the cap is
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`not on the tube, it is impossible for the piercing insert to be “wedged” in the tube. Id. at W 17,
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`25, 28. Thus, Spectrum’s product does not infringe the claim in either the open or closed
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`position because its tube does not include “a vial comprising .
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`.
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`. a piercing member” when the
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`product is open and its tube does not include “a first open end for receiving the sample” when the
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`product is closed.
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`Id. at ‘W 28, 80-31.
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`Moreover, by arguing that infijngement depends on the user performing certain steps,
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`Genotek treats its apparatus claim as though it were a method claim, rendering claim 1 an
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`unpatentable “hybrid” claim. IPXL Holdings, L.L. C. v. Amazon. com, Inc., 430 F.3d 1377, 1384
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`(Fed. Cir. 2005) (“reciting both an apparatus and a method of using that apparatus renders a
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`claim indefinite”). In an apparent effort to advance its “use” argument while avoiding IPXL’s
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`holding, Genotek has previously argued that patent infringement is assessed when a product is
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`being used as intended, citing Cyrix Corp. v. Intel Corp., 846 F. Supp. 522, 536 (E.D. Tex. 1994)
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`for the proposition that “[i]nfringement of an apparatus claim occurs ‘when the claimed
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`combination has been assembled and is used or is available for use.”’ Id. But neither»Cyrz'x nor
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`16
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`Case 1:15—cv-00661-SLR Document 41 Filed 10/09/15 Page 17 of 37 PageID #: 1301
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`the authority from which it is derived support Genotek’s argument that infringement of an
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`apparatus claim is evaluated based on a showing of “intended use.”2
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`The Court should also reject Genotek’s infringement argument because it relies on a
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`claim construction that would render the claim invalid for both anticipation and lack of written
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`description. See Rhine v. Casio, Inc, 183 F.3d 1342, 1345 (Fed. Cir. 1999) (“claims should be
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`so construed, if possible, as to sustain their validity.”). As discussed below, Genotek’s
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`infringement argument expands the scope of claim 1 to cover both the prior art ’265 publication
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`and embodiments not described in the specification, rendering it invalid under pre-AIA
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`35 U.S.C. §§102 and 112 1|l. See infia, IV.B.3.b, c. Such a construction therefore should not be
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`adopted.
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`Geno.tek’s attempt to distort this limitation, via the Doctrine of Equivalents (“DOE”), to
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`cover the Spectrum device also fails for at least three reasons. First, such an attempt
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`impermissibly reads a structural limitation out of the claim. A patentee may not rely on the DOE
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`to eliminate a “clear structural limitation.” Sage Prods, Inc. v. Devon Indus, Inc, 126 F.3d
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`1420, 1425—26 (Fed. Cir. 1997). The public “has a right to rely” on such limitations “in
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`2 Although Cyrix relied on Lemelsorz v. United States, see 752 F.2d 1538, 1548 (Fed. Cir.
`1985), the cited language was used to defeat the patentee’s argument that infringement can be
`proved by showing delivered parts “are capable of being configured in an infringing manner.”
`Lemelson, 752 F.2d at 1548. In Lemelson, the patentee failed to meet his burden “not because he
`failed to prove that the government ‘used’ the accused devices,” but because—like Genotek
`here—he failed to prove that the accused devices “embodied the claimed invention.” Id. at
`1548-1549. And Decca, Ltd. v. United States—which Lemelson cites also does not support
`Genotek’s hybrid “intended use” standard. See 640 F.2d 1156, 1168 (Ct. C1. 1980). Decca
`simply held that two unpatented sub-parts of a patent system do not infringe a patent unless they
`are used or available for use in the patented form. Like in Lemelson and Decca, the issue here is
`whether the accused device “embodies the invention”—and not whether a user uses it as
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`intended. Genotek cannot rely on “intended use” to skirt IPXL’s prohibition on hybrid
`apparatus—method claims.
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`17
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`Case 1:15-cv-00661-SLR Document 41 Filed 10/09/15 Page 18 of 37 PageID #: 1302
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`conducting its business activities.” Id. To do otherwise “would reduce the claims to nothing
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`more than ‘fimctionai abstracts, devoid of meaningful structural limitations, on which the public
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`could rely.’” Zodiac Pool Care, Inc. v. Hoflinger Indus, Inc., 206 F.3d 1408, 1416 (Fed. Cir.
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`2000). This restriction on the DoE applies where the patentee seeks to cover a “structural
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`rearrangement” of claim limitations that fails to maintain the “functional relationship” of those
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`limitations. Demarini Sports, Inc. v. Worth, Inc, 239 F.3d 1314, 1333 (Fed. Cir. 2001); see also
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`Moore U.S.A., Inc. v. Standard Iiegister Co., 229 F.3d 1091 (Fed. Cir. 2000).
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`The Federal Circuit draws a bright line between “reciprocal changes” that maintain
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`claimed structure and changes that seek to rearrange claimed structure; the former is
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`permissible, the latter is not. [d3 Herc, Claim 1 requires the “piercing member” to be part of the
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`vial, not a separate component of the lid. Genotek’s attempt to expand claim 1 under the DoE to
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`read on devices with a piercing member in the lid impe