Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Guardant Health, Inc. v. Foundation Medicine, Inc.

United States District Court, D. Delaware

October 11, 2019

GUARD ANT HEALTH, INC., Plaintiff,
v.
FOUNDATION MEDICINE, INC., Defendant. GUARD ANT HEALTH, INC., Plaintiff,
v.
PERSONAL GENOME DIAGNOSTICS, INC., Defendant.

          REPORT AND RECOMMENDATION

          CHRISTOPHER J. BURKE, UNITED STATES MAGISTRATE JUDGE

         In these two related actions filed by Plaintiff Guardant Health, Inc. ("Guardant" or "Plaintiff) against Defendants Foundation Medicine, Inc. ("FMI") and Personal Genome Diagnostics, Inc. ("PGDx" and collectively with FMI, "Defendants"), Guardant alleges infringement of United States Patent Nos. 9, 598, 731 (the "'731 patent"), 9, 834, 822 (the '"822 patent"), 9, 840, 743 (the "743 patent") and 9, 902, 992 (the "'992 patent" and collectively with the other patents, "the asserted patents"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions as set forth below.

         I. BACKGROUND AND STANDARD OF REVIEW

         The Court hereby incorporates by reference the summary of the background of this matter set out in its September 6, 2019 Report and Recommendation ("September 6 R&R"). (D.I. 354 at 2-3)[1] It additionally incorporates by reference the legal principles regarding claim construction set out in the September 6 R&R. (Id. at 3-5) Because Defendants contend that the disputed claim terms addressed herein are indefinite, (see, e.g., D.I. 68 at 15-20), the Court further includes below the applicable standard for definiteness.

         The primary purpose of the definiteness requirement is to ensure that patent claims are written in such a way that they give notice to the public of what is claimed, thus enabling interested members of the public (e.g., competitors of the patent owner) to determine whether they infringe. All Dental Prodx, LLC v. Advantage Dental Prods., Inc., 309 F.3d 774, 779-80 (Fed. Cir. 2002). Put another way, "[a] patent holder should know what he owns, and the public should know what he does not." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 731 (2002). Even so, the Supreme Court of the United States has recognized that "absolute precision is unattainable" and not required. Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910(2014).

         "[A] patent is invalid for indefmiteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention." Id., at 901. Definiteness is to be evaluated from the perspective of a person of ordinary skill in the art ("POSA") at the time the patent was filed. Id. at 908.

         Like claim construction, definiteness is a question of law for the court. H-W Tech., L. C. v. Overstock.com, Inc., 758 F.3d 1329, 1332 (Fed. Cir. 2014); Pi-Net Int'l Inc. v. JPMorgan Chase & Co., 42 F.Supp.3d 579, 586 (D. Del. 2014). The United States Court of Appeals for the Federal Circuit has stated that "[a]ny fact critical to a holding on indefiniteness ... must be proven by the challenger by clear and convincing evidence." Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366 (Fed. Cir. 2003); see also Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338 (Fed. Cir.2008).[2]

         II. DISCUSSION

         The parties had claim construction disputes regarding 13 terms or sets of terms (hereinafter, "terms" or "term sets"). The Court has addressed five of these terms/term sets in previously-issued Report and Recommendations. (D.I. 354; D.I. 359) In this Report and Recommendation, the Court addresses two additional term sets. The Court will address the remaining terms/term sets in one or more subsequently-issued Report and Recommendation(s).

         A. "detecting, at one or more loci, at least one single nucleotide variant, at least one gene fusion and at least one copy number variant" / "detecting, at one or more genetic loci, a plurality of genetic aberrations, wherein the plurality of genetic aberrations comprises two or more different members selected from the group of members consisting of a single base substitution, a copy number variation (CNV), an insertion or deletion (indel), and a gene fusion"

         The claim term "detecting, at one or more loci, at least one single nucleotide variant, at least one gene fusion and at least one copy number variant" is found in claim 2 of the '822 patent, and the claim term "detecting, at one or more genetic loci, a plurality of genetic aberrations, wherein the plurality of genetic aberrations comprises two or more different members selected from the group of members consisting of a single base substitution, a copy number variation (CNV), an insertion or deletion (indel), and a gene fusion" is found in claim 1 of the '992 patent. Accordingly, these claims (along with claim 1 of the '822 patent, from which claim 2 depends) are reproduced below, with the disputed terms highlighted:

1. A method, comprising:
a) providing a population of cell free DNA ("cfDNA") molecules obtained from a bodily sample from a subject;
b) converting the population of cfDNA molecules into a population of non-uniquely tagged parent polynucleotides, wherein each of the non-uniquely tagged parent polynucleotides comprises (i) a sequence from a cfDNA molecule of the population of cfDNA molecules, and (ii) an identifier sequence comprising one or more polynucleotide barcodes;
c) amplifying the population of non-uniquely tagged parent polynucleotides to produce a corresponding population of amplified progeny polynucleotides;
d) sequencing the population of amplified progeny polynucleotides to produce a set of sequence reads;
e) mapping sequence reads of the set of sequence reads to one or more reference sequences from a human genome;
f) grouping the sequence reads into families, each of the families comprising sequence reads comprising the same identifier sequence and having the same start and stop positions, whereby each of the families comprises sequence reads amplified from the same tagged parent polynucleotide;
g) at each genetic locus of a plurality of genetic loci in the one or more reference sequences, collapsing sequence reads in each family to yield a base call for each family at the genetic locus; and
h) determining a frequency of one or more bases called at the locus from among the families.

('822 patent, col. 62:18-48)

2. The method of claim 1, further comprising detecting, at one or more loci, at least one single nucleotide variant, at least one gene fusion and at least one copy number variant.

(Id., col. 62:49-51 (emphasis added))

1. A method for detecting genetic aberrations in cell-free DNA ("cfDNA") molecules from a subject, comprising:
a) providing cfDNA molecules obtained from a bodily sample of the subject;
b) attaching tags comprising barcodes having a plurality of different barcode sequences to the cfDNA molecules to tag at least 20% of the cfDNA molecules, which attaching comprises ligating adaptors comprising the barcodes to both ends of the cfDNA molecules, wherein ligating comprises using more than 10x molar excess of the adaptors as compared to the cfDNA molecules, thereby generating tagged parent polynucleotides;
c) amplifying the tagged parent polynucleotides to produce amplified tagged progeny polynucleotides;
d) sequencing the amplified tagged progeny polynucleotides to produce a plurality of sequence reads from each of the tagged parent polynucleotides, wherein each sequence read of the plurality of sequence reads comprises a barcode sequence and a sequence derived from a cfDNA molecule of the cfDNA molecules;
e) mapping sequence reads of the plurality of sequence reads to one or more reference sequences from a human genome;
f) grouping the sequence reads mapped in
e) into families based at least on barcode sequences of the sequence reads, each of the families comprising sequence reads comprising the same barcode sequence, whereby each of the families comprises sequence reads amplified from the same tagged parent polynucleotide;
g) at each of a plurality of genetic loci in the one or more reference sequences, collapsing sequence reads in each family to yield a base call for each family at the genetic locus; and h) detecting, at one or more genetic loci, a plurality of genetic aberrations, wherein the plurality of genetic aberrations comprises two or more different members selected from the group of membersconsisting of a single ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.