DatRec LLC v. Progeny Genetics LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: DatRec, LLC (Texas)
  • Defendant: Progeny Genetics, LLC (Florida)
  • Plaintiff’s Counsel: Law Office of Victoria E. Brieant, P.A.; Ramey & Schwaller, LLP
• Case Identification: 9:20-cv-81913, S.D. Fla., 10/14/2020
• Venue Allegations: Venue is alleged to be proper based on Defendant having a regular and established place of business in the district, conducting substantial business in the forum, and committing acts of infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s Progeny Clinical software, a platform for managing genetic and clinical data, infringes a patent related to methods for constructing and using a verified database of personal data records for medical applications.
• Technical Context: The technology concerns the creation and management of authenticated databases of personal and medical information, enabling applications such as personalized medicine and genealogical analysis.
• Key Procedural History: The complaint does not mention any prior litigation, Inter Partes Review (IPR) proceedings, or licensing history related to the patent-in-suit.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,156,158 - "Method and System for Use of a Database of Personal Data Records"

• Patent Identification: U.S. Patent No. 8,156,158, "Method and System for Use of a Database of Personal Data Records," issued April 10, 2012 (’158 Patent).

The Invention Explained

• Problem Addressed: The patent’s background section identifies the difficulty of verifying the identity of individuals online as a "serious issue" that limits the utility of the internet for applications requiring authenticated personal data, such as forming trusted communities or performing reliable transactions (’158 Patent, col. 2:28-38).
• The Patented Solution: The invention proposes a method and system for creating a "verified database" of identified individuals. This is achieved by permitting users to enter "individual-associated data bits" (IDBs), which include personal and relationship information. These IDBs are then processed to generate more reliable "individual-identifier data sets" (IDSs), which form the basis of the verified database. This database can then be processed for specific applications, such as providing personalized medicine services (’158 Patent, Abstract; col. 2:63-3:6). Figure 1 illustrates this flow from obtaining IDBs (110) to processing them (120) to generate IDSs (130) that populate a database (140).
• Technical Importance: The invention aims to provide a reliable foundation for personalized medicine services by creating a system for building and maintaining authenticated medical and personal data records for individuals and their families (’158 Patent, col. 1:50-59).

Key Claims at a Glance

• The complaint asserts claims 1-23, with a preliminary analysis focused on claim 1 (Compl. ¶9).
• Independent claim 1 is a method claim comprising the essential elements of:
  • Providing a verified database of identified individuals, where the database comprises individual-identifier data sets (IDSs) and relationship data.
  • Processing the verified database according to selected parameters (including at least one medical application) to create a sub-group database.
  • Using the sub-group database to collect and deliver data to users and to provide a "personalized medicine service."
  • The "providing" step itself requires: permitting users to enter individual-associated data bits (IDBs) into a system; processing the entered IDBs to generate an IDS for each individual; and constructing the verified database from these IDSs.
• The complaint does not explicitly reserve the right to assert dependent claims, but the general assertion of claims 1-23 suggests this possibility (Compl. ¶9).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is Defendant's "Progeny Clinical" software, described as "Powerful Risk Assessment and Pedigree Software" and offered through the website www.progenygenetics.com (Compl. pp. 4, 9).

Functionality and Market Context

The complaint alleges that Progeny Clinical is a software tool used to "track all your family history and clinical data" (Compl. p. 4). A screenshot from Defendant's website describes the "MANAGE CLINICAL DATA" feature, which allows users to track family history and clinical data in a database (Compl. p. 4). Its functionality includes collecting data directly from patients via questionnaires, allowing clinicians to review and edit that data, and using the database to track hereditary cancer data (Compl. pp. 4, 6). The complaint alleges that users can design custom data entry screens and that the collected data is "immediately available in the database" (Compl. p. 6).

IV. Analysis of Infringement Allegations

'158 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: A central question may be the definition of a "verified database." The ’158 patent specification describes verification as a process of comparing data from multiple sources and ascribing reliability scores (’158 Patent, col. 11:57-12:35). The complaint alleges infringement based on features allowing clinicians to "review" and "edit" patient-entered data (Compl. p. 6). This raises the question of whether a clinician’s review constitutes "verification" as taught by the patent, or if the patent requires a more automated, multi-source comparison.
  • Technical Questions: The infringement analysis may turn on whether the accused software's function of allowing clinicians to "review... and edit or add data" (Compl. p. 6) performs the specific step of "processing the entered IDBs to generate the IDS" as required by the claim. The court may need to determine if this alleged functionality is equivalent to the patent's more detailed description of processing raw data bits (IDBs) to construct a refined data set (IDS) (’158 Patent, col. 9:12-41).

V. Key Claim Terms for Construction

• The Term: "verified database"

• Context and Importance: This term appears in the preamble and body of claim 1 and is fundamental to the invention. The entire claimed method operates on this specific type of database. Whether the accused Progeny Clinical database meets this definition will be a critical point of dispute.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The term is not explicitly defined in a glossary. A party might argue that any database where data is checked for accuracy, for example by a clinician reviewing a patient's submission, qualifies as "verified." The patent refers to creating a "verified database of IDSs of identified individuals" after processing IDBs, which could be interpreted broadly as creating a confirmed record (’158 Patent, col. 3:1-6).
  • Evidence for a Narrower Interpretation: The detailed description suggests a specific technical process for verification. Figure 5 and the accompanying text describe comparing data bits from different IDBs and assigning a score (’158 Patent, Fig. 5; col. 21:3-48). The specification also discusses ascribing a "reliability score" based on the "extent of data verification" from different individuals, implying a multi-source, cross-referential process that goes beyond simple manual review (’158 Patent, col. 12:5-14).

• The Term: "personalized medicine service"

• Context and Importance: This term defines the ultimate output of the claimed method. The parties will likely dispute whether the "Powerful Risk Assessment and Pedigree Software" offered by the defendant constitutes providing such a service. Practitioners may focus on this term because its scope will determine whether the accused product's general risk assessment function satisfies this specific claim limitation.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent states that "'Personalized medicine' is understood to broadly pertain to providing a medical service to an individual, matched to his genetic makeup and to providing a tailored medical treatment" (’158 Patent, col. 1:53-58). This broad description could encompass the hereditary cancer risk assessment allegedly performed by the accused software.
  • Evidence for a Narrower Interpretation: The specification provides specific examples of personalized medicine, such as providing an "optimal dosage/dosage regimen of a drug," a "forward prediction of a disease or disorder," and a "personalized preventative program" (’158 Patent, Figs. 11-13; col. 7:18-27). A party could argue the term is limited to these more specific applications of diagnosis, treatment, and prevention, rather than general data management or risk stratification.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement. The allegations are based on Progeny allegedly encouraging and instructing its customers on how to use the Progeny Clinical software in a way that directly infringes the ’158 patent (Compl. ¶¶ 11, 12).
• Willful Infringement: The complaint alleges that Progeny has "known of the ’158 patent and the technology underlying it from at least the date of issuance of the patent," which forms the basis of the willfulness claim (Compl. ¶¶ 11, 12).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of definitional scope: can the term "verified database", which the patent specification links to a specific technical process of multi-source data comparison and reliability scoring, be construed to cover a clinical database where patient-submitted data is simply reviewed and edited by a clinician?
• A key evidentiary question will be one of functional mapping: does the accused software's functionality for managing clinical data, tracking family history, and assessing risk perform the specific, multi-step method of the patent—including "processing" raw data bits (IDBs) to "generate" a distinct data set (IDS) and then using that to provide a "personalized medicine service"—or is there a mismatch in the technical operation?