Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 1 of 21
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`UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF TEXAS
`AUSTIN DIVISION
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`Civil Action No. 1:20-cv-00692-ADA
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`Plaintiff,
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`Defendants.
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`RAVGEN, INC.,
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`v.
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`NATERA, INC. AND NSTX, INC.,
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`DEFENDANTS NATERA, INC. AND NSTX, INC.’S RULE 50(b)
`RENEWED MOTION FOR JUDGMENT AS A MATTER OF LAW
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`

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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 2 of 21
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`TABLE OF CONTENTS
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`B.
`C.
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`D.
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`INTRODUCTION .............................................................................................................. 1
`BACKGROUND ................................................................................................................ 2
`A.
`The Asserted Claims Require Adding A “Cell Lysis Inhibitor” In Amounts
`Sufficient To Inhibit Cell Lysis. ............................................................................. 2
`Natera’s Noninfringement Evidence....................................................................... 4
`Ravgen’s Failure To Offer Evidence Sufficient To Prove Literal
`Infringement ............................................................................................................ 5
`Ravgen’s Failure To Offer Evidence Sufficient To Prove Infringement
`Under The Doctrine Of Equivalents ....................................................................... 6
`LEGAL STANDARD ......................................................................................................... 7
`NATERA IS ENTITLED TO JMOL OF NO INFRINGEMENT. ..................................... 8
`A.
`No Reasonable Jury Could Have Found That Ravgen Met Its Burden To
`Prove Literal Infringement. ..................................................................................... 9
`No Reasonable Jury Could Have Found That Ravgen Met Its Burden To
`Prove Infringement Under The Doctrine Of Equivalents. .................................... 12
`CONCLUSION ................................................................................................................. 14
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`B.
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`
`
`ii
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` I.
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`II.
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`III.
`IV.
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`V.
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 3 of 21
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Akzo Nobel Coatings, Inc. v. Dow Chemical Co.,
`811 F.3d 1334 (Fed. Cir. 2016)......................................................................................8, 13
`
`Brigham & Women’s Hospital, Inc. v. Perrigo Co.,
`761 F. App’x 995 (Fed. Cir. 2019) ............................................................................8, 9, 10
`
`Brooke Group Ltd. v. Brown & Williamson Tobacco Corp.,
`509 U.S. 209 (1993) .............................................................................................................8
`
`CommScope Technologies LLC v. Dali Wireless Inc.,
`10 F.4th 1289 (Fed. Cir. 2021) ..................................................................................8, 9, 11
`
`Edgewell Personal Care Brands, LLC v. Munchkin, Inc.,
`998 F.3d 917 (Fed. Cir. 2021)............................................................................................14
`
`Flowers v. Southern Regional Physician Services, Inc.,
`247 F.3d 229 (5th Cir. 2001) ...............................................................................................7
`
`Gemalto S.A. v. HTC Corp.,
`754 F.3d 1364 (Fed. Cir. 2014)............................................................................................8
`
`McClaren v. Morrison Management Specialists, Inc.,
`420 F.3d 457 (5th Cir. 2005) ...............................................................................................8
`
`Microsoft Corp. v. GeoTag, Inc.,
`817 F.3d 1305 (Fed. Cir. 2016)............................................................................................9
`
`Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
`843 F.3d 1315 (Fed. Cir. 2016)..........................................................................................14
`
`
`ViaTech Technologies Inc. v. Microsoft Corp.,
`733 F. App’x 542 (Fed. Cir. 2018) ....................................................................................13
`
`Vocalife LLC v. Amazon.com, Inc.,
`No. 2021-1937, 2022 WL 2986786 (Fed. Cir. July 28, 2022)
`(nonprecedential) ...............................................................................................................12
`
`Warner-Jenkinson Co. v. Hilton Davis Chem. Co.,
`520 U.S. 17 (1997) .............................................................................................................14
`
`
`Yoon Ja Kim v. ConAgra Foods, Inc.,
`465 F.3d 1312 (Fed. Cir. 2006)..........................................................................................12
`
`
`
`iii
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 4 of 21
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`STATUTES AND RULES
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`Fed. R. Civ. P. 50 .............................................................................................................................9
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`iv
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 5 of 21
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`I.
`
`INTRODUCTION
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`Because Ravgen did not meet its burden at trial to produce substantial evidence that
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`Natera’s Panorama test meets every limitation of each asserted claim, JMOL of no infringement is
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`required.
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`Specifically, asserted claims 125 and 132 of U.S. Patent No. 7,332,277 (“’277 patent”)
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`both require adding a “cell lysis inhibitor … selected from glutaraldehyde, formaldehyde and
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`formalin” in amounts sufficient to actually inhibit cell lysis. And though Ravgen presented
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`evidence purporting to show that formaldehyde exists in the Streck tubes, and that some cross-
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`linking occurs in the tubes, Ravgen indisputably did not offer:
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`(1)
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`any evidence proving the actual (or even approximate) amount of formaldehyde
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`in the tubes;
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`(2)
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`any evidence proving the actual (or even approximate) amount of purported
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`cross-linking in the tubes; or
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`(3)
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`any evidence that whatever amount of formaldehyde or cross-linking supposedly
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`exists in the tubes is enough to actually inhibit cell lysis.
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`Such evidence was necessary to prove infringement, but Ravgen indisputably failed to provide it.
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`That failure of proof requires JMOL of no infringement as to both asserted claims.
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`Ravgen cannot avoid that result by pivoting to its doctrine of equivalents theory because
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`there too it suffers from a failure of proof. At trial, Ravgen’s expert offered merely conclusory
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`testimony that the preservative used in Streck’s tubes (IDU) is “completely equivalent as a donor
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`of formaldehyde” and is no different than “adding formaldehyde with a syringe.” The Court
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`indicated at the close of the evidence that it would revisit the sufficiency of that barebones assertion
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`after the jury returned its verdict, and reconsideration of that testimony here confirms that JMOL
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`of no infringement under the doctrine of equivalents is required.
`1
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`Because no reasonable jury could have found for Ravgen on the issue of infringement
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`based on the record at trial, JMOL of no infringement should enter for both asserted claims.
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`II.
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`BACKGROUND
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`A.
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`The Asserted Claims Require Adding A “Cell Lysis Inhibitor” In Amounts
`Sufficient To Inhibit Cell Lysis.
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`At trial, named inventor Dr. Ravinder Dhallan testified that the “heart” of the ’277 patent’s
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`alleged invention is his idea to add formaldehyde to a maternal blood sample, which he asserts
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`will dramatically increase the relative amount of cell-free fetal DNA in the sample (even up to
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`100%) by preventing the mother’s blood cells from lysing (i.e., bursting). 1/8 Trial Tr. [Dhallan]
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`at 73:12-74:21; PTX-1 [’277 patent] at 32:33-39, 32:54-56. The only examples that the patent
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`reports in connection with that idea involved adding 4% formaldehyde to blood samples, PTX-1
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`[’277 patent] at 220:17-24, 229:62-230:23, 235:10-17, which is the same amount of formaldehyde
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`that Ravgen adds today to its commercial tests, 1/8 Trial Tr. [Dhallan] at 145:2-19, 146:13-20.
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`As detailed below, Dr. Dhallan’s idea to add formaldehyde in amounts sufficient to inhibit
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`cell lysis appears in claims 125 and 132 of the ’277 patent, which require adding “an agent that
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`inhibits cell lysis to inhibit the lysis of cells” (claim 125) or “an agent that inhibits lysis of cells”
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`(claim 132), and each claim further specifies that the added “agent” must be a “cell lysis inhibitor
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`… selected from glutaraldehyde, formaldehyde and formalin”:1
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`Requirements of Claim 125
`1. A method for detecting the presence or
`absence of a fetal chromosomal abnormality,
`said method comprising: quantitating a ratio of
`the relative amount of alleles at a heterozygous
`locus of interest in a mixture of template DNA,
`wherein said mixture comprises maternal
`DNA and fetal DNA, and wherein said mixture
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`1 Claim 125 depends from claims 10, 9, 8, 4, and 1, and claim 132 depends from claims 60, 59,
`and 55.
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`Requirements of Claim 132
`55. A method comprising determining the
`sequence of a locus of interest on free fetal
`DNA isolated from a sample obtained from a
`pregnant
`female, wherein
`said
`sample
`comprises free fetal DNA and an agent that
`inhibits lysis of cells, if cells are present,
`wherein said agent is selected from the group
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`
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`2
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 7 of 21
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`Requirements of Claim 125
`of maternal DNA and fetal DNA has been
`obtained from a sample from a pregnant
`female, and further wherein said heterozygous
`locus of interest has been identified by
`determining the sequence of alleles at the locus
`of interest, and wherein said ratio indicates the
`presence or absence of a fetal chromosomal
`abnormality.
`4. The method of claim 1, wherein the template
`DNA is obtained from a sample selected from
`the group consisting of: a blood, serum,
`plasma, saliva, urine, tear, vaginal secretion,
`lymph fluid, cerebrospinal fluid, mucosa
`secretion, peritoneal fluid, ascitic fluid, fecal
`matter, and body exudates.
`8. The method of claim 4, wherein said sample
`is mixed with an agent that inhibits cell lysis
`to inhibit the lysis of cells, if cells are present,
`wherein the agent is selected from the group
`consisting of membrane stabilizer, cross-
`linker, and cell lysis inhibitor.
`9. The method of claim 8 wherein said agent
`is a cell lysis inhibitor.
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`10. The method of claim 9, wherein said cell
`lysis inhibitor is selected from the group
`consisting of glutaraldehyde, derivatives of
`glutaraldehyde, formaldehyde, formalin, and
`derivatives of formaldehyde.
`125. The method of claim 10, wherein said cell
`lysis inhibitor is selected from glutaraldehyde,
`formaldehyde and formalin.
`
`PTX-1 [’277 patent] at 469:9-478:35.2
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`Requirements of Claim 132
`consisting of membrane stabilizer, cross-
`linker, and cell lysis inhibitor.
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`59. The method of claim 55, wherein said
`agent is a cell lysis inhibitor.
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`60. The method of claim 59, wherein said cell
`lysis inhibitor is selected from the group
`consisting of: glutaraldehyde, derivatives of
`glutaraldehyde, formaldehyde, derivatives of
`formaldehyde, and formalin.
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`132. The method of claim 60, wherein said cell
`lysis inhibitor is selected from glutaraldehyde,
`formaldehyde and formalin.
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`
`
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`The Court made clear at Markman that the “cell lysis inhibitor” limitations require adding
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`amounts of the cell lysis inhibitor sufficient to “inhibit[] the rupture of cells.” Dkt. 289 [Markman
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`Order] at 2. And consistent with that ruling, Ravgen’s expert, Dr. Brian Van Ness, conceded at
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`2 All bold/italics emphasis in this brief is added.
`3
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 8 of 21
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`trial that (1) the claimed “cell lysis inhibitor” has to be added to a sample, and also that (2) “[i]t’s
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`not enough just to have some formaldehyde in the tube [because] [i]t has to be there in sufficient
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`quantities to actually inhibit cell lysis.” 1/9 Trial Tr. [Van Ness] at 483:10-14; id. at 482:18-21
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`(“Q. To meet the claims, the cell lysis inhibitor has to be added to a sample in order to inhibit cell
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`lysis, right? A. I think that’s fair.”). The need to show not only the existence of added
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`formaldehyde, but also that such amount is sufficient to inhibit cell lysis in a blood sample makes
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`sense given the undisputed evidence that formaldehyde occurs naturally in many things, including
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`in human blood. 1/8 Trial Tr. [Dhallan] at 166:22-167:2; 1/9 Trial Tr. [Van Ness] at 496:24-497:1;
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`1/10 Trial Tr. [Hunsley] at 938:10-20; 1/11 Trial Tr. [Acker] at 1162:20-25.
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`B.
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`Natera’s Noninfringement Evidence.
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`Ravgen accused Natera of infringing claims 125 and 132 of the ’277 patent based on Streck
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`blood collection tubes that are used in connection with Natera’s Panorama prenatal test. Although
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`Natera did not have the burden of proof with respect to Ravgen’s infringement allegations, it
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`offered unrefuted evidence at trial that: (1) Streck does not add formaldehyde to its tubes; (2)
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`Streck instead chose to add imidazolidinyl urea (IDU) to its tubes, precisely to avoid the many
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`downsides of formaldehyde; and (3) because IDU can release trace amounts of formaldehyde as it
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`degrades, Streck adds glycine to eliminate the released formaldehyde. 1/10 Trial Tr. [Hunsley] at
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`939:6-940:13, 944:23-946:8, 940:14-944:8, 954:25-957:19, 965:4-19; 1/11 Trial Tr. [Acker] at
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`1148:19-1151:5, 1156:19-1158:22; 1/9 Trial Tr. [Van Ness] at 437:12-16, 490:14-491:7, 492:12-
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`493:17, 497:11-17, 538:23-539:2; DTX-888; PTX-1356.0041-42.
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`Natera’s technical expert, Dr. Jason Acker, also offered unrebutted evidence that the most
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`formaldehyde ever detected in a Streck tube (before blood was added) was just 0.009% (reported
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`4
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 9 of 21
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`in a 2018 study),3 and offered testing he directed showing that this trace amount (which Streck
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`views as a contaminant and adds glycine to remove) is not nearly enough to inhibit cell lysis. 1/11
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`Trial Tr. [Acker] at 1161:3-1167:10; DTX-1037; DTX-1038. In fact, it is such a low concentration
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`that, after a blood sample is collected in a Streck tube, the concentration of formaldehyde
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`attributable to the Streck tube chemicals is even lower than the concentration of formaldehyde
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`found naturally in human blood. 1/10 Trial Tr. [Hunsley] at 944:9-19, 951:20-954:12, 959:21-
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`964:21; 1/11 Trial Tr. [Acker] at 1162:4-25.
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`Dr. Acker also presented other unrebutted testing evidence showing that, rather than use
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`formaldehyde to inhibit cell lysis, Streck uses a compound called “allantoin” (a preservative
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`present in IDU and commonly used in skin care/cosmetic products) to preserve cells in an entirely
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`different way: i.e., his testing showed that allantoin extends cell life for samples in the Streck
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`tubes by blocking programmed cell death, also referred to as “apoptosis.” 1/11 Trial Tr. [Acker]
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`at 1151:11-1155:21; DTX-1040; DTX-1041.
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`C.
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`Ravgen’s Failure To Offer Evidence Sufficient To Prove Literal Infringement.
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`At trial, Ravgen and Dr. Van Ness: (1) argued that Streck’s tubes contain formaldehyde—
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`but without offering any testing or other evidence to establish the actual amount of formaldehyde
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`found in the tubes; (2) argued that formaldehyde generally causes proteins to “cross-link” and can
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`“stabilize” cell membranes, and that testing purported to show that some cross-linking occurs in
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`the Streck tubes—without offering any testing or other evidence to show the purported amount of
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`cross-linking that occurs; and (3) argued that the “cell lysis inhibitor” requirement of the asserted
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`claims was met—but without offering any testing or other evidence to prove that whatever trace
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`3 The 4% formaldehyde used by the examples in the ’277 patent and by Ravgen’s commercial
`tests, see supra at 2, is 444 times greater than 0.009%—the most formaldehyde ever detected in
`the Streck tube. 1/8 Trial Tr. [Dhallan] at 168:17-20.
`5
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 10 of 21
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`amount of formaldehyde exists in the tubes and whatever amount of cross-linking supposedly
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`occurs actually inhibits cell lysis, or even could inhibit cell lysis (including no evidence showing
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`that the highest amount of formaldehyde ever detected in the Streck tubes—0.009%—can inhibit
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`cell lysis in a sample). 1/9 Trial Tr. [Van Ness] at 441:13-20 (Dr. Van Ness admitting he “never
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`tested the contents of the Streck tubes” or “directed anyone” to do so); id. at 507:1-22 (Dr. Van
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`Ness admitting that Dr. Chalmers, who performed the testing that Dr. Van Ness relied upon for his
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`cross-linking analysis, “did not do any testing to determine whether there was enough
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`formaldehyde in Streck’s tubes to inhibit cell lysis”); id. at 511:4-8 (Dr. Van Ness admitting the
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`Dr. Chalmers cross-linking testing he relied on at trial “didn’t analyze cell lysis”).4
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`Thus, Ravgen offered no evidence directed to whether Natera’s accused Panorama test
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`literally meets the requirement of claims 125 and 132—the “heart” of Dr. Dhallan’s formaldehyde
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`idea—to add a “cell lysis inhibitor” “in sufficient quantities to actually inhibit cell lysis.” 1/9
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`Trial Tr. [Van Ness] at 483:10-14.
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`D.
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`Ravgen’s Failure To Offer Evidence Sufficient To Prove Infringement Under
`The Doctrine Of Equivalents.
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`Dr. Van Ness also offered an opinion at trial that the “cell lysis inhibitor” limitation is met
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`under the doctrine of equivalents. But the entirety of that testimony consisted of three conclusory
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`4 Dr. Van Ness speculated that “more” formaldehyde exists in the Streck tubes based on his theory
`that IDU continually releases formaldehyde, including when blood is added to the tube, and that
`any released formaldehyde will preferentially react with amino acids on blood cells, which
`prevents the added glycine from effectively extinguishing formaldehyde. 1/8 Trial Tr. [Van Ness]
`at 365:3-367:17; 1/9 Trial Tr. [Van Ness] at 500:3-502:8, 522:8-14, 523:1-6. But even under those
`unsupported theories—which Natera’s expert disputed—Dr. Van Ness never attempted to quantify
`the supposed additional amounts of formaldehyde or demonstrate that the resulting amounts would
`have been sufficient to inhibit cell lysis. Similarly, Dr. Van Ness pointed to Streck and third-party
`documents, and a test conducted by a different expert (who did not appear at trial), to suggest that
`formaldehyde causes cross-linking in Streck’s tubes. 1/8 Trial Tr. [Van Ness] at 376:1-377:9,
`379:9-21; 1/9 Trial Tr. [Van Ness] at 393:3-5, 393:11-17, 393:23-394:22, 520:7-15, 537:8-539:1;
`PTX-1171; PTX-1172. However, he never attempted to quantify the amount of any such purported
`cross-linking or to demonstrate that any such cross-linking inhibits cell lysis.
`6
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 11 of 21
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`answers from Dr. Van Ness in which he failed to provide any particularized testimony or linking
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`argument about supposed insubstantial differences between the addition of formaldehyde (required
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`by the claims) and IDU (what Streck adds to the tubes), or to prove that IDU or trace formaldehyde
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`that may be released from IDU (with 0.009% being the most ever detected in the Streck tube
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`chemicals) otherwise meets the requirement to inhibit cell lysis under the doctrine of equivalents.
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`1/9 Trial Tr. [Van Ness] at 402:1-20, 403:24-404:4.
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`At the close of evidence, the Court indicated that it was “concerned whether or not the
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`plaintiff put on sufficient evidence with regard to the doctrine of equivalents,” and explained that
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`“if it comes back that they [the jury] find doctrine of equivalents, I’ll take a look at the record to
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`see if there was sufficient evidence to support it at that time.” 1/11 Trial Tr. at 1319:22-1320:5.
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`* * *
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`In sum, Ravgen cannot point to anything in the trial record where it even attempted to
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`prove that the Streck tubes contain formaldehyde in an amount sufficient to inhibit cell lysis,
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`either literally or under the doctrine of equivalents. Although Ravgen attempted to prove its case
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`through circumstantial evidence that trace amounts of formaldehyde, as well as some amount of
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`cross-linking, are detectable in Streck tubes, it never provided any evidence that these phenomena
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`actually inhibit cell lysis in the Streck tubes, as required by both asserted claims. That complete
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`lack of evidence on a key claim limitation requires JMOL of no infringement.
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`III. LEGAL STANDARD
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`“A motion for judgment as a matter of law ... in an action tried by jury is a challenge to the
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`legal sufficiency of the evidence supporting the jury’s verdict.” Flowers v. S. Reg’l Physician
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`Servs., Inc., 247 F.3d 229, 235 (5th Cir. 2001). After a jury verdict, “judgment as a matter [of]
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`law should be granted only where ‘there is no legally sufficient evidentiary basis for a reasonable
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`
`
`7
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 12 of 21
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`jury to find for that party on that issue.’” McClaren v. Morrison Mgmt. Specialists, Inc., 420 F.3d
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`457, 461 (5th Cir. 2005) (quoting Fed. R. Civ. P. 50(a)); Fed. R. Civ. P. 50(b).
`
`In a patent infringement case, JMOL of no infringement is required where the plaintiff fails
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`to offer substantial evidence that the accused product meets a limitation of an asserted claim—
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`especially where the accused infringer offered contrary evidence that the limitation-at-issue was
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`not met. See Brigham & Women’s Hosp., Inc. v. Perrigo Co., 761 F. App’x 995, 1003-05 (Fed.
`
`Cir. 2019) (affirming JMOL of no infringement where plaintiff failed to offer proof of claim
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`limitation requiring “immediate relief” within a certain time period); CommScope Techs. LLC v.
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`Dali Wireless Inc., 10 F.4th 1289, 1297-98 (Fed. Cir. 2021) (reversing district court’s denial of
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`JMOL of no infringement because “[n]ot only was there a lack of evidence to show that the accused
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`product met [a claim limitation requiring a component to be put in a “nonoperating state”], there
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`is unrebutted evidence showing the opposite” where the accused infringer’s expert offered
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`evidence to show that the accused components “are continuously operating” and the plaintiff “did
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`not contest” that evidence); see also Brooke Grp. Ltd. v. Brown & Williamson Tobacco Corp., 509
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`U.S. 209, 242 (1993) (“When an expert opinion is not supported by sufficient facts to validate it
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`in the eyes of the law, or when indisputable record facts contradict or otherwise render the opinion
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`unreasonable, it cannot support a jury’s verdict.”).
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`Likewise, JMOL of no infringement under the doctrine of equivalents should enter where
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`a plaintiff’s equivalents arguments rest on nothing more than conclusory assertions and/or would
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`require vitiating a claim element. See Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d
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`1334, 1342 (Fed. Cir. 2016); Gemalto S.A. v. HTC Corp., 754 F.3d 1364, 1374 (Fed. Cir. 2014).
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`IV. NATERA IS ENTITLED TO JMOL OF NO INFRINGEMENT
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`At trial, Ravgen did not even attempt to prove the amount of formaldehyde that exists in
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`the Streck tubes used for Natera’s Panorama test, the amount of cross-linking that supposedly
`8
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 13 of 21
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`occurs in the tubes, or that whatever amount of formaldehyde exists or cross-linking supposedly
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`occurs actually inhibits cell lysis—as required by both asserted claims. Given that failure of proof,
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`JMOL of no infringement is required.
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`A.
`
`No Reasonable Jury Could Have Found That Ravgen Met Its Burden To Prove
`Literal Infringement.
`
`“To establish literal infringement, every limitation set forth in a claim must be found in an
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`accused product, exactly.” Microsoft Corp. v. GeoTag, Inc., 817 F.3d 1305, 1313 (Fed. Cir. 2016).
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`Therefore, where a plaintiff fails to offer substantial evidence demonstrating that a claim limitation
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`is met, JMOL of no literal infringement is required. See Fed. R. Civ. P. 50.
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`For example, in CommScope Technologies, the asserted claim included a limitation
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`requiring, among other things, “switching a controller to a nonoperating state.” CommScope, 10
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`F.4th at 1295. At trial, the plaintiff’s expert testified that the requirement was met where
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`components turned a signal “on and off,” but he never explained how that operation constituted
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`the claimed “nonoperating state”; by contrast, the defendant’s expert offered evidence
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`demonstrating that the same components “are continuously operating,” and the plaintiff “did not
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`contest” that evidence. Id. at 1296-98. On appeal, the Federal Circuit held that the district court
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`had erred in failing to grant JMOL of no infringement because the plaintiff “point[ed] to no
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`evidence showing that any of the [identified components] are put in a ‘nonoperating state’ in the
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`accused [product],” especially where the defendant had offered “unrebutted evidence showing the
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`opposite.” Id. at 1297, 1299.
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`Similarly, in Brigham & Women’s Hospital, Inc. v. Perrigo Co., the claim required using
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`an antacid to provide “immediate relief” from heartburn within 5 to 10 minutes, and the plaintiff’s
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`expert alleged that the limitation was met based on studies that had measured relief from heartburn
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`caused by the accused product within 15 minutes, coupled with the expert’s testimony that such
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`9
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 14 of 21
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`relief would have been found at 5 to 10 minutes if measured because the accused product “worked
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`as quickly as an antacid.” 761 F. App’x at 1004-1005. On appeal, the Federal Circuit affirmed
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`the district court’s grant of JMOL of no infringement because the cited studies “[a]t most”
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`suggested that the accused product “might provide immediate and sustained relief [within 5 to 10
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`minutes]” and that “such speculative data, however, cannot sustain [the plaintiff’s] burden of
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`proof.” Id. at 1003-1005 (“As [the studies] did not measure the result that [plaintiff] claimed in
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`the ’137 patent, we agree with the district court that they do not support the jury verdict.”; “[A]t
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`most, [the expert’s] testimony only indicated that the measured parameter would ‘correlate to’ the
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`claimed result.”).
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`CommScope and Brigham & Women’s compel a similar outcome here. Ravgen alleged at
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`trial that formaldehyde in the Streck tubes meets the “cell lysis inhibitor” requirement of claims
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`125 and 132. But as Dr. Van Ness admitted on cross-examination (consistent with the Court’s
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`construction), to meet that claim limitation “[i]t’s not enough just to have some formaldehyde in
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`the tube [because] [i]t has to be there in sufficient quantities to actually inhibit cell lysis.” 1/9
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`Trial Tr. [Van Ness] at 483:10-14; Dkt. 289 [Markman Order] at 2 (holding claimed “cell lysis
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`inhibitor” must “inhibit[] the rupture of cells”).
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`Yet, similar to the plaintiff’s experts in CommScope and Brigham & Women’s, Dr. Van
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`Ness failed to offer substantial evidence directed to that claim limitation. Instead, he merely
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`testified that Streck’s tubes contain some amount of formaldehyde and that some amount of cross-
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`linking occurs in the tubes—without offering any evidence showing (1) the actual amount of
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`formaldehyde in the tubes, (2) the actual purported amount of cross-linking that occurs in the tubes,
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`or (3) that the unspecified amounts of formaldehyde and/or purported cross-linking in the tubes is
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`sufficient to meet the claim requirement to actually inhibit cell lysis. 1/9 Trial Tr. [Van Ness] at
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`10
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 15 of 21
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`511:4-8 (admitting the cross-linking testing he relied on at trial “didn’t analyze cell lysis”); id. at
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`402:22-403:14 (similar); id. at 483:12-14, 507:14-18 (admitting there must be “sufficient
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`quantities” of formaldehyde “to actually inhibit cell lysis”); id. at 507:1-9 (admitting Dr. Chalmers
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`“did not do any testing to determine whether there was enough formaldehyde in Streck’s tubes to
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`inhibit cell lysis”); id. at 540:22-541:2 (admitting he did not “perform any further tests on [his]
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`own”). That lack of substantial evidence requires JMOL of no literal infringement.
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`Indeed, that result is particularly warranted here because, just like the defendant in
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`CommScope, Natera offered unrebutted expert evidence demonstrating that the claim limitation is
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`not met. Specifically, Dr. Acker explained to the jury that the most formaldehyde ever detected
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`in a Streck tube (before blood is added) was just 0.009%, and he offered unrebutted testing
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`demonstrating (1) that such trace amounts do not inhibit cell lysis, and (2) that, rather than use
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`formaldehyde to inhibit cell lysis, Streck’s tubes use allantoin to preserve cells in an entirely
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`different way by blocking apoptosis. 1/11 Trial Tr. [Acker] at 1151:11-1155:21; DTX-1040;
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`DTX-1041. See CommScope Techs., 10 F.4th at 1297, 1299 (citing defendant’s expert’s
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`“unrebutted evidence showing the opposite” of what the claim requires as supporting JMOL of no
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`infringement).
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`At bottom, Ravgen and its multiple experts failed to even measure the amount of
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`formaldehyde and/or cross-linking purportedly in the Streck tubes, failed to present any testing to
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`show that the amount of formaldehyde or cross-linking in the Streck tubes actually inhibits cell
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`lysis, and failed to present any testing (or even cross-examination) to rebut Dr. Acker’s testing
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`evidence showing that the highest amount of formaldehyde ever detected in the tubes—0.009%—
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`does not inhibit cell lysis. As a result, the jury lacked a legally sufficient evidentiary basis to find
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`that Natera’s Panorama test satisfies the “cell lysis inhibitor” requirement of each asserted claim.
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`
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`11
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 16 of 21
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`Accordingly, JMOL of no literal infringement should enter. See Brigham & Women’s
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`Hosp., 761 F. App’x at 1004 (“Although a jury is entitled to draw reasonable inferences from
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`circumstantial evidence, reasonable inferences themselves must be more than speculation and
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`conjecture.” (citations omitted)); see also Vocalife LLC v. Amazon.com, Inc., 2022 WL 2986786,
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`at *2-3 (Fed. Cir. July 28, 2022) (nonprecedential) (reversing denial of JMOL where plaintiff’s
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`expert alleged that the “plurality of configurations” claim requirement was met, but offered “no
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`evidence” to support that opinion beyond “conclusory, unsupported testimony”); Yoon Ja Kim v.
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`ConAgra Foods, Inc., 465 F.3d 1312, 1320 (Fed. Cir. 2006) (affirming JMOL of no infringement,
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`even where it was undisputed that the accused bread products included the claimed ingredients in
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`the claimed proportions, because the claim also required the plaintiff to prove that other unclaimed
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`ingredients in the products did not materially affect the characteristics of the bread, and on that
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`issue the plaintiff’s expert merely offered “conclusory testimony … [and] did not support this
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`determination with any examinations or tests of the actual accused products”).
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`B.
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`No Reasonable Jury Could Have Found That Ravgen Met Its Burden To Prove
`Infringement Under The Doctrine Of Equivalents.
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`Raven alleged at trial that the “cell lysis inhibitor” limitation is alternatively met under the
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`doctrine of equivalents. But in support of that argument, Ravgen merely offered Dr. Van Ness’s
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`conclusory testimony that “IDU is a formaldehyde releaser” and “the formaldehyde reacts with the
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`proteins and cross-links in the membrane. So it’s completely equivalent as a donor of
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`formaldehyde.” 1/9 Trial Tr. [Van Ness] at 402:1-403:9. The Court understandably expressed
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`that it was “concerned” about the sufficiency of this conclusory disclosure at the close of evidence,
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`and indicated its intent to revisit the issue in post-trial motions. 1/11 Trial Tr. at 1319:22-1320:5.
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`Review of that purely conclusory testimony here confirms that JMOL is required because
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`a reasonable jury would have no legally sufficient evidentiary basis to find in Ravgen’s favor under
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`12
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`Case 1:20-cv-00692-ADA Document 514 Filed 02/22/24 Page 17 of 21
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`the doctrine of equivalents. See Virnetx, Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1323 (Fed. Cir.
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`2014) (reversing denial of JMOL of no infringement under doctrin