Cybergenetics Corp. v. Inst. of Envtl. Sci. & Research
| Decision Date | 29 September 2020 |
| Docket Number | Case No. 5:19-cv-1197 |
| Citation | 490 F.Supp.3d 1237 |
| Parties | CYBERGENETICS CORP., Plaintiff, v. INSTITUTE OF ENVIRONMENTAL SCIENCE AND RESEARCH, et al., Defendants. |
| Court | U.S. District Court — Northern District of Ohio |
Mark M. Supko, Siri M. Rao, Crowell & Moring, Washington, DC, Pilar R. Stillwater, Crowell & Moring, San Francisco, CA, Michael J. Garvin, Vorys, Sater, Seymour & Pease, Cleveland, OH, for Plaintiff.
John M. Skeriotis, Jon A. Troyer, Sergey V. Vernyuk, Emerson Thomson Bennett, Akron, OH, for Defendant Institute of Environmental Science and Research.
Jessica A. Lopez, Ronald S. Kopp, Roetzel & Andress, John M. Skeriotis, Jon A. Troyer, Sergey V. Vernyuk, Emerson Thomson Bennett, Akron, OH, for Defendant NicheVision, Inc.
Plaintiff Cybergenetics Corp. ("plaintiff") brought this action on May 24, 2019, alleging that defendants, Institute of Environmental Science and Research and NicheVision Inc. (collectively, "defendants"), infringe U.S. Patent No. 8,898,021 (" ‘021 patent") (Doc. No. 21-1) and U.S. Patent No. 9,708,642 (" ‘642 patent") (Doc. No. 21-2). (See Doc. No. 1 (Complaint).) Plaintiff subsequently filed an amended complaint on October 16, 2019. (Doc. No. 21 ["Am. Compl."].)
Now pending before the Court is a motion to dismiss filed by defendants. (Doc. No. 24 ["Mot."].) Defendants argue that the asserted claims in the ‘021 patent and the ‘642 patent are not patent eligible under 35 U.S.C. § 101. (Mot. at 5821 .) Plaintiff opposes the motion (Doc. No. 29 ["Opp'n"]), and defendants filed a reply. (Doc. No. 30 ["Reply"].)
Because the asserted claims of the ‘021 patent and ‘642 patent are ineligible under § 101, as discussed below, defendants’ motion to dismiss is granted.
The basics of DNA testing, as relevant to this motion, are set forth in the amended complaint. First, a laboratory conducts "PCR amplification" to copy a single DNA sample and produce billions of similar molecules. (Am. Compl. ¶ 27.) Because PCR amplification "generates a different chain reaction each time DNA copes [sic] are synthesized ... repeated amplification of the same [DNA] ... will produce different peak heights and patterns compared to the original, naturally occurring DNA fragment." (Id. ¶ 42.) In short, PCR amplification copies a DNA sample but introduces variation in the copies. (See id. ¶ 43.)
Second, a laboratory conducts capillary electrophoresis
"to separate the [copied] DNA molecules according to their length" and prevalence in the sample. (Id. ¶¶ 30–31.) This quantifies the DNA sample to transform it into data. (Id. ¶ 31.) Third, under the traditional approach, the laboratory would then set a threshold to "eliminat[e] consideration of possible artifacts and low template DNA" to "simplify the DNA for visual human review[.]" (Id. ¶ 38.)
If there is only one person in the DNA sample, the result of the electrophoresis will easily reveal the genotype of that person. (Id. ¶ 34.) But when there are multiple people in the DNA sample, the analysis becomes more difficult. (Id. ¶ 35.) And when there are multiple unknown contributors in the DNA sample, it becomes even harder. (See id. ¶ 36.)
The ‘021 and ‘642 patents ("Patents-in-Suit") are owned by plaintiff and titled "Method and System for DNA Mixture Analysis." (Id. ¶¶ 12–13.) The Patents-in-Suit recite "computer-based systems and methods for analyzing a DNA sample comprising a mixture of DNA from multiple sources in order to determine a likelihood that a particular person's DNA is, or is not, contained within the mixture." (Id. ¶ 14.) The claimed methods use DNA data produced from PCR amplification and electrophoresis, but then "analyze [the data] to determine information about the composition of the mixed DNA sample." (Id. ¶ 15.)
These methods replace Step 3 of the traditional approach.
The Patents-in-Suit call this analysis "deconvolution," or separating a multi-person DNA sample to identify the individuals in that sample. (Opp'n at 911.) Deconvolution involves calculating the variance of the DNA data produced by PCR amplification and accounting for that variance in subsequent probability calculations. (Am. Compl. ¶¶ 43–47; Opp'n at 911, 914.) Those probability calculations, in turn, predict the identity of an individual in the sample and calculate the likelihood that the prediction is correct. (Am. Compl. ¶ 44.)
A complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief[.]" Fed. R. Civ. P. 8(a)(2). Although this pleading standard does not require a great deal of detail, the factual allegations in the complaint "must be enough to raise a right to relief above the speculative level." Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) (citing authorities). In other words, " Rule 8(a)(2) still requires a ‘showing,’ rather than a blanket assertion, of entitlement to relief." Id. at 556 n.3, 127 S.Ct. 1955 ().
"To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ " Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009) (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ). Rule 8 does not "unlock the doors of discovery for a plaintiff armed with nothing more than conclusions." Id. at 678–79, 129 S. Ct. 1937. Id. at 679, 129 S. Ct. 1937. "The court need not, however, accept unwarranted factual inferences." Total Benefits Planning Agency Inc. v. Anthem Blue Cross & Blue Shield, 552 F.3d 430, 434 (6th Cir. 2008) (citing Morgan v. Church's Fried Chicken , 829 F.2d 10, 12 (6th Cir. 1987) ).
"Patent eligibility under § 101 is an issue of law," Intellectual Ventures I LLC v. Capital One Bank (USA) , 792 F.3d 1363, 1366 (Fed. Cir. 2015) (citing In re BRCA1– & BRCA2–Based Hereditary Cancer Test Patent Litig., 774 F.3d 755, 758 (Fed. Cir. 2014) ), and can be resolved at the motion to dismiss stage, SAP Am., Inc. v. InvestPic, LLC , 898 F.3d 1161, 1169 (Fed. Cir. 2018), cert. denied, ––– U.S. ––––, 139 S. Ct. 2747, 204 L. Ed. 2d 1134 (2019) ; Genetic Techs. Ltd. v. Merial L.L.C. , 818 F.3d 1369, 1373 (Fed. Cir. 2016) ; Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'l Ass'n , 776 F.3d 1343, 1346, 1351 (Fed. Cir. 2014), cert denied, 577 U.S. 914, 136 S. Ct. 119, 193 L. Ed. 2d 208 (2015), so long as "there are no factual allegations that, taken as true, prevent resolving the eligibility question as a matter of law." Aatrix Software, Inc. v. Green Shades Software, Inc. , 882 F.3d 1121, 1125 (Fed. Cir. 2018).
Important to the Court's analysis of patent eligibility under § 101 is the Supreme Court's decision in Alice Corp. Pty. Ltd. v. CLS Bank Int'l. , 573 U.S. 208, 134 S. Ct. 2347, 189 L. Ed. 2d 296 (2014).
Title 35 U.S.C. § 101 provides that:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
There are three exceptions to § 101 ’s broad description of patent eligible subject matter: laws of nature, natural phenomena, and abstract ideas. Alice, 573 U.S. at 216, 134 S.Ct. 2347 () (quoting Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 133 S. Ct. 2107, 186 L. Ed. 2d 124 (2013) ); Bilski v. Kappos, 561 U.S. 593, 601, 130 S. Ct. 3218, 177 L. Ed. 2d 792 (2010). The purpose of the exceptions is to prevent monopolization of the "basic tools of scientific and technological work" that would impede further innovation. Mayo Collaborative Servs. v. Prometheus Labs., Inc. , 566 U.S. 66, 71, 132 S. Ct. 1289, 1293, 182 L. Ed. 2d 321 (2012).
Alice, 573 U.S. at 217, 134 S.Ct. 2347 (alterations in original); see also Diehr , 450 U.S. at 187, 101 S.Ct. 1048 () (emphasis in original, citation omitted).
In Alice , the Supreme Court utilized the two-part framework set forth in Mayo for distinguishing patents that claim laws of nature, natural phenomena, or abstract ideas from patent eligible claims. Alice, 573 U.S. at 217–18, 134 S.Ct. 2347. The first step is to "determine whether the claims at issue are directed to one of those patent-ineligible concepts." Id. at 217, 134 S. Ct. 2347. If the claim is not directed to one of the three patent ineligible concepts, no further analysis is required—the claim is patent eligible under § 101. Id. But if the claim is directed to an abstract...
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