DCT

3:24-cv-00188

Podimetrics Inc v. Bluedrop Medical Ltd

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:24-cv-00188, S.D. Tex., 06/24/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the Southern District of Texas because Defendant maintains a regular and established place of business in Houston, from which it offers to sell and sells the accused products. The complaint identifies a Houston office address and Houston-based members of Defendant's leadership team.
  • Core Dispute: Plaintiff alleges that Defendant’s remote temperature monitoring system for diabetic foot care infringes four patents related to using thermometry to detect and predict the emergence of foot ulcers.
  • Technical Context: The technology involves at-home, automated monitoring of foot temperature to detect early signs of inflammation, a precursor to diabetic foot ulcers, which can lead to severe complications including amputation.
  • Key Procedural History: The complaint alleges that Defendant’s founders, former employees of Medtronic, Inc., started Bluedrop immediately after Medtronic had received confidential information about Plaintiff’s technology under a non-disclosure agreement. Plaintiff further alleges that Defendant’s current Chief Commercial Officer and Medical Director were also exposed to Plaintiff’s confidential business and technical information through prior interactions. The complaint details pre-suit correspondence in which Plaintiff provided notice of the patents-in-suit and Defendant disputed infringement based on its interpretation of the claim term "thermogram," a position Plaintiff alleges is incorrect.

Case Timeline

Date Event
2012-04-02 Priority Date for ’305, ’178, and ’672 Patents
2014-03-21 Priority Date for ’723 Patent
2015-04-XX Podimetrics allegedly shares confidential information with Medtronic under NDA
2015-04-XX Bluedrop's founders allegedly leave Medtronic and found Bluedrop
2015-08-04 U.S. Patent No. 9,095,305 Issues
2016-02-16 U.S. Patent No. 9,259,178 Issues
2016-03-01 U.S. Patent No. 9,271,672 Issues
2016-05-03 U.S. Patent No. 9,326,723 Issues
2022-03-31 Podimetrics sends letter to Bluedrop identifying Patents-in-Suit
2022-07-04 Bluedrop responds to Podimetrics, disputing infringement
2022-08-08 Podimetrics replies to Bluedrop, disputing Bluedrop's claim construction
2024-XX-XX Bluedrop allegedly registers with FDA to begin U.S. sales
2024-06-24 Complaint Filed

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

U.S. Patent No. 9,095,305 - "METHOD AND APPARATUS FOR INDICATING THE EMERGENCE OF A PRE-ULCER AND ITS PROGRESSION"

The Invention Explained

  • Problem Addressed: The patent describes existing methods for monitoring diabetic foot ulcers as often being "inconvenient to use, unreliable, or inaccurate," which leads to poor patient compliance and missed opportunities for early intervention (’305 Patent, col. 2:50-54).
  • The Patented Solution: The invention proposes a system where a patient steps onto an "open platform," like a floor mat, embedded with temperature sensors (’305 Patent, col. 5:1-5). These sensors generate discrete temperature data, which a processor uses to form a "thermogram"—a spatially continuous, two-dimensional map of temperature values across the sole of the foot (’305 Patent, col. 10:25-35). The system then analyzes this thermogram for "prescribed patterns" (e.g., localized hot spots) and produces an alert indicating the emergence or progression of a pre-ulcer (’305 Patent, Abstract).
  • Technical Importance: The technology aimed to replace sporadic, manual temperature checks with an automated, data-driven monitoring system that could be integrated into a patient's daily routine to improve compliance and enable early detection (Compl. ¶13).

Key Claims at a Glance

  • The complaint asserts independent Claim 1 (Compl. ¶22).
  • The essential elements of Claim 1 are:
    • Providing one or more processors.
    • Providing an open platform with a plurality of temperature sensors for receiving a foot.
    • Generating a plurality of discrete temperature data values from the sensors.
    • Forming at least one thermogram of the sole of the foot from the data, where the thermogram is a "spatially continuous data set of two-dimensional temperature values."
    • Determining whether the thermogram presents at least one of a plurality of "prescribed patterns."
    • Producing output information indicating the emergence or progression of a pre-ulcer, where the production is a function of the pattern determination.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,259,178 - "METHOD AND APPARATUS FOR INDICATING THE RISK OF AN EMERGING ULCER"

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the ’305 Patent: the need for a more reliable and convenient method for monitoring foot ulcers to improve patient compliance and prevent serious health complications (’178 Patent, col. 2:48-52).
  • The Patented Solution: The technology described is substantively identical to that of the ’305 Patent. It involves an open platform with temperature sensors that collect data from a patient's foot, which is then used to form a thermogram (’178 Patent, Abstract). This thermogram is analyzed for prescribed patterns to generate an output, in this case indicating "a risk of an ulcer emerging" (’178 Patent, col. 16:47-56). The patent specification describes this process as allowing for earlier intervention by caregivers (’178 Patent, col. 4:18-20).
  • Technical Importance: As with the ’305 Patent, this technology represents a shift toward automated, routine-integrated, and data-centric monitoring for preventative diabetic care (Compl. ¶13).

Key Claims at a Glance

  • The complaint asserts independent Claim 1 (Compl. ¶25).
  • The essential elements of Claim 1 are nearly identical to Claim 1 of the ’305 Patent, comprising steps for providing processors and a sensor platform, generating data, forming a thermogram as a "spatially continuous data set," determining the presence of "prescribed patterns," and producing output information indicating "a risk of an ulcer emerging."
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,271,672 - "METHOD AND APPARATUS FOR INDICATING THE EMERGENCE OF AN ULCER"

  • Patent Identification: U.S. Patent No. 9,271,672, “METHOD AND APPARATUS FOR INDICATING THE EMERGENCE OF AN ULCER,” issued March 1, 2016 (Compl. ¶26).
  • Technology Synopsis: This patent builds upon the core technology by adding a temporal analysis component. The method involves not only analyzing a single thermogram for prescribed patterns but also explicitly "comparing the at least one thermogram against a prior thermogram of the same foot" (’672 Patent, col. 16:32-35). This allows the system to detect changes or trends over time, such as the development or worsening of a hot spot, providing a more dynamic risk assessment.
  • Asserted Claims: Independent Claim 1 (Compl. ¶28).
  • Accused Features: The complaint alleges that Defendant’s system performs this claimed comparison by tracking "hot spots" over multiple scans, determining a hot spot is "non-urgent" if new but "urgent" if it persists in "two or more consecutive scans" (Compl. ¶109).

U.S. Patent No. 9,326,723 - "METHOD AND APPARATUS MONITORING FOOT INFLAMMATION"

  • Patent Identification: U.S. Patent No. 9,326,723, “METHOD AND APPARATUS MONITORING FOOT INFLAMMATION,” issued May 3, 2016 (Compl. ¶29).
  • Technology Synopsis: This patent introduces methods for comparing two separate thermograms, such as a left foot versus a right foot (contralateral analysis) or a foot against its own prior scan (temporal analysis). A key element is "to apply at least one transformation to one or both of the first and second thermograms to align the first features... with corresponding second features" (’723 Patent, col. 19:1-7). This alignment step enables a more accurate, apples-to-apples comparison by accounting for variations in foot placement.
  • Asserted Claims: Independent Claim 1 (Compl. ¶31).
  • Accused Features: The complaint alleges that Defendant’s system compares "six areas of one foot to the corresponding six areas of the second foot" and that the device "performs a transformation so as to be able to compare the same six areas of each foot" (Compl. ¶126). The complaint includes an image from Defendant's user guide showing that feet can be placed variably within a larger sensing area, suggesting a transformation may be needed for accurate comparison (Compl. ¶57).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the "Bluedrop Foot Scanner," which collectively refers to the Bluedrop OneStep Foot Scanner and/or Bluedrop Delta Foot Scanner hardware and the accompanying EveryStep Monitoring Service (Compl. ¶53).

Functionality and Market Context

The Bluedrop Foot Scanner is described as a device "akin to a scale" that uses temperature monitoring to detect areas of a diabetic patient's foot at risk of ulceration (Compl. ¶54). The complaint presents Bluedrop's marketing materials, which state the device "resembles a common home weighing scale" and works by having the patient stand on it for approximately 30 seconds (Compl. p. 21). The device is alleged to have an "array of temperature sensors" that collect "thermal information" to identify "hot spots" (Compl. ¶¶67-68, 21). This information is sent to a remote server for analysis, after which Bluedrop "engages with patients and prescribers as needed" (Compl. ¶54, p. 21). The complaint further alleges that the system compares temperatures at six points on each foot and defines a "hot spot" as a 2.2°C temperature difference between corresponding points on opposite feet (Compl. ¶59).

IV. Analysis of Infringement Allegations

9,095,305 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
providing an open platform for receiving at least one foot, the open platform having a plurality of temperature sensors; The Bluedrop Foot Scanner is a scale-like device with an "array of temperature sensors" on which a patient stands. ¶67 col. 5:1-5
generating, using the plurality of temperature sensors, a plurality of discrete temperature data values after receipt of the at least one foot; The scanner's array of temperature sensors collects "thermal information" over the soles of the feet. ¶68 col. 5:56-62
forming... at least one thermogram... comprising a spatially continuous data set of two-dimensional temperature values across the sole; The scanner allegedly uses the discrete temperature data from its sensors to create a thermogram, which the patent defines as a "data record" of continuous temperature data. ¶¶69, 71 col. 10:25-35
determining... whether the thermogram presents at least one of a plurality of prescribed patterns; The scanner compares data from six areas of each foot to determine a "hot spot," which the complaint alleges is a "prescribed pattern." ¶73 col. 12:7-12
producing... output information indicating an emergence of a pre-ulcer or progression of a known pre-ulcer... The system determines the presence of "hot spots" which are alleged to be "indicative of an emergence of a pre-ulcer or progression of a known pre-ulcer." ¶74 col. 3:0-2

9,259,178 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
providing an open platform for receiving at least one foot, the open platform having a plurality of temperature sensors; The Bluedrop Foot Scanner is a scale-like device with an "array of temperature sensors" on which a patient stands. ¶85 col. 5:1-5
generating, using the plurality of temperature sensors, a plurality of discrete temperature data values after receipt of the at least one foot; The device’s sensor array collects discrete temperature data values from the user’s feet. ¶82 col. 5:56-62
forming, by at least one of the one or more processors, at least one thermogram... comprising a spatially continuous data set... The scanner allegedly uses the collected discrete data to form a thermogram, defined in the patent as a "data record" or visual display of continuous temperature data. ¶¶86, 88 col. 10:15-25
determining... whether the at least one thermogram presents at least one of a plurality of prescribed patterns; The scanner compares six areas of each foot to identify a "hot spot," which constitutes a "prescribed pattern." ¶90 col. 11:61-66
producing... output information indicating a risk of an ulcer emerging on the at least one foot... The device uses the thermogram to determine the presence of "hot spots," which are alleged to be "indicative of an emergence of an ulcer." ¶91 col. 2:3-8

Identified Points of Contention

  • Scope Questions: The primary point of contention, identified in pre-suit letters, concerns the definition of "thermogram." Defendant argued its U.S. products would not infringe because they would not include a "display of thermal data," suggesting "thermogram" requires a visual output (Compl. ¶48). The complaint counters that the patent specification defines a thermogram as a "data record... or a visual display," raising the question of whether an internal data structure, without being displayed, satisfies this limitation (Compl. ¶¶50, 70; ’305 Patent, col. 10:25-27).
  • Technical Questions: A key technical question is whether the accused system, which allegedly measures temperature at discrete points (e.g., "six points are assessed on each foot"), actually performs the claimed step of "forming... a spatially continuous data set" (’305 Patent, Claim 1; Compl. ¶59). The infringement allegation may depend on whether the accused software interpolates data between sensor points to create a continuous map, as described in the patent, or if it merely analyzes a set of discrete data points. The complaint alleges the former occurs but notes that full details will require discovery of non-public software (Compl. ¶72). The complaint also highlights Defendant’s public presentations, which show graphical thermal images, suggesting the creation of such a data set (Compl. p. 18).

V. Key Claim Terms for Construction

"thermogram"

  • Context and Importance: The construction of this term appears to be the central dispute identified by the parties pre-suit. Whether it requires a visual display to a user, or can be satisfied by an internal "data record" processed by the system, may be dispositive for infringement. Practitioners may focus on this term because Defendant has already signaled its non-infringement theory relies on a narrow interpretation requiring a visual display (Compl. ¶48).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification of the ’305 Patent states, "a thermogram is a data record made by a thermograph, or a visual display of that data record" (’305 Patent, col. 10:25-27). The use of the disjunctive "or" suggests that a "data record" is an independent, sufficient alternative to a "visual display."
    • Evidence for a Narrower Interpretation: The term itself ("-gram") suggests a graphical output. The specification also refers to a thermogram as a "visual representation" and a "data set/map," and all illustrative figures (e.g., Figs. 9B-9D) depict visual thermal images (’305 Patent, col. 10:30-35). Defendant may argue that, when read in context, the term implies more than just raw numerical data.

"forming... a spatially continuous data set"

  • Context and Importance: The claims require this step, but the accused product is alleged to collect data at discrete points. Infringement will depend on whether the accused system's processing of these discrete points amounts to "forming" a "continuous" set.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification explicitly contemplates this process, stating the method may "form the thermogram by interpolating temperature data between at least two of the plurality of temperature sensors" (’305 Patent, col. 2:18-21). This suggests that any form of interpolation or data processing that fills the gaps between discrete sensor readings would meet the claim limitation.
    • Evidence for a Narrower Interpretation: Defendant could argue that its process of comparing a limited number of discrete points (e.g., "six points") does not create a "data set" that is "spatially continuous" across the entire sole, but rather is just a comparison of a sparse collection of values. The dispute may turn on the degree of completeness and continuity required by the claim.

VI. Other Allegations

Indirect Infringement

The complaint alleges inducement of infringement, stating that Defendant disseminates product descriptions, operating manuals, and instructions that lead end-users to configure and use the Bluedrop Foot Scanner in an infringing manner (Compl. ¶¶77, 94).

Willful Infringement

Willfulness is alleged based on Defendant’s actual knowledge of the patents-in-suit since at least March 31, 2022, from a letter sent by Plaintiff (Compl. ¶¶75, 92). The complaint further supports this allegation with extensive factual assertions suggesting deliberate copying, including that Defendant’s founders started the company after allegedly being exposed to Plaintiff’s confidential technology and business plans under an NDA with a third party, and that Defendant’s marketing materials mimic Plaintiff's (Compl. ¶¶33-41). The complaint includes a side-by-side visual comparison of a "feedback loop" diagram from Plaintiff's confidential presentation and a similar diagram from Defendant's public materials to support this narrative (Compl. ¶¶36, 41).

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

  • A core issue will be one of claim construction: does the term "thermogram," as used in the patents, require a visual thermal image to be displayed to a user, or can the limitation be met by the internal creation and processing of a "data record" representing a continuous temperature map? The outcome of this definitional dispute, foreshadowed in pre-suit communications, will significantly impact the infringement analysis.
  • A central evidentiary question will be one of technical operation: what processing does the accused Bluedrop software perform on the discrete temperature measurements it collects? Discovery will be necessary to determine if the system merely analyzes a collection of separate data points or if it performs an interpolation or similar step to "form a spatially continuous data set" as required by the asserted claims.
  • A key question for damages will be willfulness: given the detailed allegations of access to confidential information, hiring of personnel exposed to Plaintiff's technology, and imitation of marketing materials, the court will need to evaluate whether infringement, if found, was egregious and warrants enhanced damages.