Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 1 of 10 PageID #: 13865
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 20-cv-1646-RGA-JLH
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`JURY TRIAL DEMANDED
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`RAVGEN, INC.,
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`v.
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`ARIOSA DIAGNOSTICS, INC.,
`ROCHE SEQUENCING SOLUTIONS, INC.,
`ROCHE MOLECULAR SYSTEMS, INC., and
`FOUNDATION MEDICINE, INC.,
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`RAVGEN, INC.,
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`v.
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`MYRIAD GENETICS, INC., and
`MYRIAD WOMEN’S HEALTH, INC.,
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`RAVGEN, INC.,
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`v.
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`BIORA THERAPEUTICS, INC.,
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`Plaintiff,
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`Defendants.
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`Plaintiff,
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`Defendants.
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`Plaintiff,
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`Defendant.
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`C.A. No. 20-cv-1730-RGA-JLH
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`JURY TRIAL DEMANDED
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`C.A. No. 20-cv-1734-RGA-JLH
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`JURY TRIAL DEMANDED
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`RAVGEN’S OBJECTIONS TO REPORT AND RECOMMENDATION
`REGARDING CLAIM CONSTRUCTION
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 2 of 10 PageID #: 13866
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`TABLE OF CONTENTS
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`Page
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`INTRODUCTION ...............................................................................................................1 
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`THE AGENT TERMS .........................................................................................................1 
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`A. 
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`B. 
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`C. 
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`The Evidence Consistently Excludes Chelators Used As Anticoagulants
`From The Scope Of The Agent Terms. ...................................................................1 
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`The R&R Fails To Give Proper Weight To The Patentee’s Prosecution
`History Statements. ..................................................................................................5 
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`Numerous Prior Claim Construction Decisions Held That The Agent
`Terms Exclude Chelators Used As Anticoagulants. ................................................6 
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`CONCLUSION ....................................................................................................................6 
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` i
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`I. 
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`II. 
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`III. 
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 3 of 10 PageID #: 13867
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`Cases 
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`TABLE OF AUTHORITIES
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`Page(s)
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`Fenner Invs., Ltd. v. Cellco P’ship,
`778 F.3d 1320 (Fed. Cir. 2015)........................................................................................... 5
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`MBO Lab’ys, Inc. v. Becton, Dickinson & Co.,
`474 F.3d 1323 (Fed. Cir. 2007)....................................................................................... 4, 6
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`Omega Eng’g, Inc. v. Raytek Corp.,
`334 F.3d 1314 (Fed. Cir. 2003)........................................................................................... 2
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`Personalized Media Commc’ns, LLC v. Apple Inc.,
`952 F.3d 1336 (Fed. Cir. 2020)........................................................................................... 5
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`Shire Dev., LLC v. Watson Pharms., Inc.,
`787 F.3d 1359 (Fed. Cir. 2015)........................................................................................... 5
`
`St. Clair Intell. Prop. Consultants, Inc. v. Canon Inc.,
`412 F. App’x 270 (Fed. Cir. 2011) ..................................................................................... 4
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`Sunovion Pharms., Inc. v. Teva Pharms. USA, Inc.,
`731 F.3d 1271 (Fed. Cir. 2013)........................................................................................... 5
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`ii
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 4 of 10 PageID #: 13868
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`I.
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`INTRODUCTION
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`Plaintiff Ravgen, Inc. (“Ravgen”) respectfully submits these objections to the July 10, 2023
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`Report and Recommendation (“R&R”) regarding claim construction (C.A. No. 20-1646-RGA-
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`JLH, D.I. 205) for Ravgen’s U.S. Patent Nos. 7,332,277 (the “’277 Patent”) and 7,727,720 (the
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`“’720 Patent”). Ravgen objects to the R&R’s finding that only the anticoagulant chelator EDTA,
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`and not other chelators used as anticoagulants, is excluded from the scope of the Agent Terms.1
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`II.
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`THE AGENT TERMS
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`The R&R’s construction of the Agent Terms is correct in all aspects except one: the R&R
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`errs in finding that only EDTA—not all chelators used as anticoagulants—is excluded from the
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`Agent Terms. The R&R arrives at that finding by improperly dismissing relevant prosecution
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`history statements that inform claim construction. The Court should amend the R&R and construe
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`the Agent Terms as: “a substance that inhibits the lysis of cells that is selected from the group
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`consisting of membrane stabilizer, cross-linker, and cell lysis inhibitor, and does not include
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`EDTA chelators used as anticoagulants nor endogenous substances.”
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`A.
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`The Evidence Consistently Excludes Chelators Used As Anticoagulants From
`The Scope Of The Agent Terms.
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`The specifications, prosecution histories, and extrinsic evidence consistently and
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`repeatedly indicate that chelators used as anticoagulants, including both EDTA and ACD, are not
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`within the scope of the Agent Terms.
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`First, the patent specifications demonstrate that anticoagulant chelators are excluded from
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`the Agent Terms by distinguishing anticoagulant chelators from the claimed agents. For example,
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`the specifications describe an experiment using blood collection tubes with only the anticoagulant
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`1 The Agent Terms recite an “agent that [inhibits/impedes] cell lysis” in certain claims of the
`asserted Ravgen patents, as defined in the Joint Claim Construction Brief (“Joint Brief”). See C.A.
`No. 20-1646-RGA-JLH, D.I. 150 at 2.
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`1
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`

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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 5 of 10 PageID #: 13869
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`chelator EDTA as the control condition demonstrating “absence… of inhibitors of cell lysis.” ’277
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`Patent at 89:11-13; ՚720 Patent at 89:35-37. As another example, the specifications describe
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`collecting blood in tubes containing an anticoagulant, using EDTA as an example (’277 Patent at
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`31:52-54), and separately describe blood samples that include the claimed agents, with lists of
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`exemplary cell lysis inhibitors (id. at 31:57-32:3), membrane stabilizers (id. at 32:4-21), and
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`crosslinkers (id. at 226:28-229:20), none of which include anticoagulant chelators. Ex. P3 ¶ 31.2
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`Second, the patentee’s repeated statements during prosecution establish that chelators used
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`as anticoagulants, such as EDTA and ACD, are excluded from the Agent Terms. Indeed, the
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`examiner acknowledged those positions and, consistent with the patentee’s statements, found that
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`prior art disclosure of chelators used as anticoagulants, including both EDTA and ACD, did not
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`meet the Agent Terms. The Court should likewise find that the patentee’s clear and unambiguous
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`representations regarding the scope of the Agent Terms act as an express disavowal of
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`anticoagulant chelators. Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1324-26 (Fed. Cir.
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`2003). And even if they are not found to rise to the level of express disavowal, the patentee’s
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`repeated and consistent representations regarding claim scope during prosecution are at minimum
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`definitional, establishing that anticoagulant chelators are not within the scope of the Agent Terms.
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`During prosecution of the ’277 Patent, the patentee explained that anticoagulant chelators
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`do not meet the Agent Terms. In particular, the examiner rejected claims based on an interpretation
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`of the agent terms as covering anticoagulant chelators, such as EDTA, in prior art. Ex. P6 at 5. The
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`patentee overcame that rejection, unequivocally stating:
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`[T]he assertion by the office that EDTA is a cell lysis inhibitor is
`simply incorrect. Applicant asserts that EDTA is not an ‘agent that
`inhibits cell lysis.’ Rather, EDTA is a well-known chelator of
`calcium and magnesium. EDTA is routinely added to blood during
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`2 All exhibit citations herein are to the parties’ exhibits submitted with the Joint Brief.
`2
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 6 of 10 PageID #: 13870
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`the blood collection process as an anticoagulant due to its ability
`to chelate calcium.
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`Ex. P7 at 33. The patentee further pointed out that “EDTA is clearly referred to as a chelator in
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`Applicant’s specification, not as a cell lysis inhibitor[,] whereas multiple examples of agents that
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`inhibit cell lysis are provided separately[.]” Id.; Ex. P3 ¶¶ 32-33. The patentee repeated the same
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`explanation—distinguishing EDTA as “simply an anticoagulant” not within the scope of the
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`Agent Terms—in an interview with the examiner. Ex. P8 at 2. And in a later response addressing
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`the Holodniy reference that disclosed the anticoagulant chelator ACD, the patentee indicated that
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`its explanation that EDTA does not meet the Agent Terms also applies to ACD. The patentee
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`confirmed that the claimed agent does not encompass ACD by unequivocally stating that
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`Holodniy—despite its teaching of ACD—“fail[s] to teach... wherein an agent that impedes cell
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`lysis has been added.” Ex. P54 at 18.
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`Following the patentee’s explanations that anticoagulant chelators are not within the scope
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`of the Agent Terms, both the patentee and the examiner consistently understood the Agent Terms
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`to exclude anticoagulant chelators—including EDTA and other anticoagulants, specifically
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`ACD. For example, in a subsequent action in the ’277 Patent prosecution, the examiner applied
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`the Amicucci reference, which discloses the anticoagulant chelator EDTA (see Ex. P27 at 301),
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`and agreed that the Amicucci authors “do not teach adding an agent that inhibits cell lysis to their
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`maternal samples.” Ex. P9 at 50. The same examiner applied that same interpretation during the
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`later prosecution of the ’720 Patent by using prior art disclosing anticoagulants EDTA and ACD,
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`but consistently agreeing that such prior art did not disclose the Agent Terms. Compare Ex. P10
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`at 3 (agreeing Amicucci reference does not disclose the claimed agent despite disclosure of
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`EDTA), 5-6 (same for Holodniy reference despite disclosure of ACD), 7 (same for Stuber
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`reference despite disclosure of EDTA) and Ex. P40 at 14 (same for Adams reference despite
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`3
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 7 of 10 PageID #: 13871
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`disclosure of ACD), with Ex. P27 at 301 (Amicucci disclosing an “EDTA-containing tube”), Ex.
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`P28 at 3511 (Holodniy disclosing “blood collection tubes that contained acid citrate dextrose
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`[ACD]”), Ex. P29 at 15:39-41 (Stuber disclosing “whole blood is collected in an EDTA whole-
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`blood tube”), Ex. P30 at 21:51-52 (Adams disclosing “[w]hole blood (WB) was extracted into
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`Acid-Citrate-Dextrose (ACD) tubes”); Ex. P3 ¶ 35.
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`The examiner’s agreement with the patentee’s arguments regarding ACD-disclosing art
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`lacking the claimed “agent” are instructive and indicate that a POSA would have understood the
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`patentee’s EDTA-excluding statements to apply equally to ACD. St. Clair Intell. Prop.
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`Consultants, Inc. v. Canon Inc., 412 F. App’x 270, 276 (Fed. Cir. 2011) (Examiner “can be
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`considered one of ordinary skill in the art” and thus “his construction of the asserted claims carries
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`significant weight”). Notably, the examiner’s agreement is consistent with the distinction in the
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`specification and the unequivocal statements by the patentee that anticoagulant chelators are not
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`the claimed agent as discussed above. The patentee’s clear and unambiguous statements made
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`throughout the prosecution to overcome the prior art dictate that—as the examiner agreed—the
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`Agent Terms do not include chelators used as anticoagulants, including both the EDTA and ACD
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`anticoagulants specifically addressed and distinguished from the claimed invention by the
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`patentee. MBO Lab’ys, Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1330 (Fed. Cir. 2007)
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`(“Prosecution arguments like this one which draw distinctions between the patented invention and
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`the prior art are useful for determining whether the patentee intended to surrender territory, since
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`they indicate in the inventor’s own words what the invention is not.”).
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`Third, the extrinsic evidence is consistent with the interpretations applied in the
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`prosecution histories and specifications. For example, extrinsic evidence establishes that
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`anticoagulant chelators are not within the scope of the Agent Terms because such compounds are
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`4
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 8 of 10 PageID #: 13872
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`commonly categorized as anticoagulants—not cross-linkers, membrane stabilizers, or cell lysis
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`inhibitors. Ex. P3 ¶ 36; Ex. P31 at 1; Ex. P32 at 965 (“Many different anticoagulants can be used
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`in
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`the preparation of plasma, such as heparin, acid citrate dextrose (ACD) and
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`ethylenediaminetetraacetic acid (EDTA).”). Thus, the intrinsic record and extrinsic evidence
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`establish that the Agent Terms do not include chelators used as anticoagulants.
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`B.
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`The R&R Fails To Give Proper Weight To The Patentee’s Prosecution History
`Statements.
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`The R&R found that the patentee’s prosecution history statements did not rise the level of
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`disclaimer or disavowal of anticoagulant chelators other than EDTA. R&R at 13. Ravgen disagrees
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`with that conclusion. But even if the statements did not rise to the level of disavowal, the R&R
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`fails to appreciate that the prosecution statements still define the Agent Terms. Even when
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`“prosecution history statements do not rise to the level of unmistakable disavowal, they do inform
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`the claim construction.” Shire Dev., LLC v. Watson Pharms., Inc., 787 F.3d 1359, 1366 (Fed.
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`Cir. 2015). “Any explanation, elaboration, or qualification presented by the inventor during patent
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`examination is relevant, for the role of claim construction is to ‘capture the scope of the actual
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`invention’ that is disclosed, described, and patented.” Fenner Invs., Ltd. v. Cellco P’ship, 778 F.3d
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`1320, 1323 (Fed. Cir. 2015). “[A]n applicant’s repeated and consistent remarks during
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`prosecution can define a claim term by demonstrating how the inventor understood the
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`invention.” Personalized Media Commc’ns, LLC v. Apple Inc., 952 F.3d 1336, 1340 (Fed. Cir.
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`2020); Sunovion Pharms., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271, 1276 (Fed. Cir. 2013)
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`(prosecution history is “critical in interpreting disputed claim terms because it ‘contains . . . any
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`express representations made by the applicant regarding the scope of the claims.’”). Here, the
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`patentee’s repeated statements during prosecution, described in Section II.A above, repeatedly
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`5
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 9 of 10 PageID #: 13873
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`drew distinctions between the patented inventions and in doing so defined what the invention is
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`not. MBO Laby’s, 474 F.3d at 1330.
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`C.
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`Numerous Prior Claim Construction Decisions Held That The Agent Terms
`Exclude Chelators Used As Anticoagulants.
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`The R&R’s limited exclusion of just EDTA is also contrary to prior constructions of the
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`Agent Terms at the PTAB and in other district courts. The PTAB agreed with Ravgen’s position
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`four times, construing “the phrase ‘agent that impedes cell lysis’ to exclude chelators used as
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`anticoagulants” in four different Final Written Decisions. See C.A. No. 20-1646-RGA-JLH, D.I.
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`169 at 2. And the same construction has been adopted in multiple decisions in the Western District
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`of Texas where the court found, consistent with Ravgen’s claim construction positions here, that
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`the “clear and unambiguous prosecution statements that EDTA is not a cell lysis inhibitor acts as
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`a disavowal that EDTA and other chelators used as anticoagulants are not ‘cell lysis inhibitors’
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`as the term is used in the Asserted Patents.” Ex. P5 at 5; see also C.A. No. 20-1646-RGA-JLH,
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`D.I. 169 at 2. The Court should adopt that same construction here because it is supported by the
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`evidence for the reasons discussed above and because it will provide consistency with the multiple
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`prior decisions construing the Agent Terms.
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`III. CONCLUSION
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`For the foregoing reasons, the Court should construe the Agent Terms as “a substance that
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`inhibits the lysis of cells that is selected from the group consisting of membrane stabilizer, cross-
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`linker, and cell lysis inhibitor, and does not include chelators used as anticoagulants nor
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`endogenous substances.”
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`6
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`Case 1:20-cv-01734-JLH Document 168 Filed 07/31/23 Page 10 of 10 PageID #: 13874
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`Dated: July 31, 2023
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`Respectfully submitted,
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`FARNAN LLP
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`
`
`/s/ Brian E. Farnan
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`919 N. Market St., 12th Floor
`Wilmington, DE 19801
`Telephone: (302) 777-0300
`Facsimile: (302) 777-0301
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
`
`John M. Desmarais (pro hac vice)
`Kerri-Ann Limbeek (pro hac vice)
`Brian D. Matty (pro hac vice)
`Jamie L. Kringstein (pro hac vice)
`Kyle G. Petrie (pro hac vice)
`Joze Welsh (pro hac vice)
`Jun Tong (pro hac vice)
`Deborah J. Mariottini (pro hac vice)
`Peter Zhu (pro hac vice)
`Benjamin N. Luehrs (pro hac vice)
`Frederick J. Ding (pro hac vice)
`Julianne M. Thomsen (pro hac vice)
`William Benjamin Nichols (pro hac vice)
`DESMARAIS LLP
`230 Park Avenue New York, NY 10169
`Telephone: 212-351-3400
`Facsimile: 212-351-3401
`jdesmarais@desmaraisllp.com
`klimbeek@desmaraisllp.com
`bmatty@desmaraisllp.com
`jkringstein@desmaraisllp.com
`kpetrie@desmaraisllp.com
`jwelsh@desmaraisllp.com
`jtong@desmaraisllp.com
`dmariottini@desmaraisllp.com
`pzhu@desmaraisllp.com
`bluehrs@desmaraisllp.com
`fding@desmaraisllp.com
`jthomsen@desmaraisllp.com
`wnichols@desmaraisllp.com
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`Attorneys for Plaintiff Ravgen, Inc.
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`7
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