PTAB

IPR2019-00121

Becton Dickinson Co v. Baxter Corp Englewood

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Work Station for Medical Dose Preparation System
  • Brief Description: The ’693 patent describes a work station used in a medical dose preparation system. The station includes a base with a staging region, an imaging device, and a scale, all connected to a processor and memory. The core inventive concept asserted during prosecution was the capability to record a weight from the scale and capture an image of the medication at "substantially the same time" upon a user's input, and then associatively store both data points in memory.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-3, 5-7, 15, and 17 under 35 U.S.C. §102 over Fioravanti

  • Prior Art Relied Upon: Fioravanti (Application # 2011/0191121).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Fioravanti, which discloses a "digital assistant appliance" for preparing pharmaceutical compositions, teaches every element of the challenged claims. Fioravanti’s system includes an electronic precision balance with a scale (the claimed scale and base), a top videocamera (the imaging device), and a processing system with memory. Petitioner asserted that Fioravanti’s flowchart, which shows a single process step for "Identification Of Vial With Artificial Vision/Gravimetric Electronic System," discloses the simultaneous capture of image and weight data. Furthermore, Fioravanti teaches storing sample images and weight data for each drug in a database, which Petitioner contended meets the "associatively stored" limitation.
    • Key Aspects: This ground asserted that the very feature used to overcome prior art during prosecution—the simultaneous and associative recording of weight and image data—was explicitly disclosed in Fioravanti’s integrated system design.

Ground 2: Obviousness of Claims 1-12 and 15-19 under 35 U.S.C. §103 over Fioravanti in view of Alexander

  • Prior Art Relied Upon: Fioravanti (Application # 2011/0191121) and Alexander (Patent 8,374,887).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground relied on Fioravanti to teach the primary components of the work station, as detailed in Ground 1. Petitioner argued that Alexander, which describes a system for remote supervision and verification of pharmacy functions, provides additional context and motivation. Alexander discloses an "institutional pharmacy workstation" with an image capture device linked to a computer system for remote review. Petitioner contended Alexander explicitly teaches associating captured images with a job or task identifier in a database, strengthening the argument for the "associatively stored" limitation.
    • Motivation to Combine: A POSITA would combine these references to enhance the error-reduction capabilities of Fioravanti's local workstation with the remote oversight and verification features taught by Alexander. Petitioner noted that Fioravanti itself suggests a "remote-surveillance station," making the combination with a dedicated remote verification system like Alexander's a natural and predictable design choice to achieve the shared goal of improving pharmacy safety.
    • Expectation of Success: The combination involved integrating compatible computer-based systems to achieve predictable results in pharmacy management.

Ground 3: Obviousness of Claims 1-12 and 15-19 under §103 over Fioravanti in view of Alexander and Eliuk

  • Prior Art Relied Upon: Fioravanti (Application # 2011/0191121), Alexander (Patent 8,374,887), and Eliuk (Patent 7,783,383).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground built upon the combination of Fioravanti and Alexander by adding the teachings of Eliuk. Eliuk discloses an automated Pharmacy Admixture System (APAS) that transports vials to a camera station for imaging and then to a scale for weighing. Critically, Eliuk teaches that a "drug order record" stored in its database may be associated with "process measurements, such as measurements of weights at different processing stages, [and] captured images."
    • Motivation to Combine: A POSITA would combine Eliuk's data association methods with the manual workstation of Fioravanti and the remote verification of Alexander. All three references address the same problem of ensuring correct dose preparation through imaging and weight verification. A POSITA would have found it obvious to apply the explicit data association techniques from the automated system (Eliuk) to a manual or remote-verification system to improve data integrity and workflow, thereby simplifying the overall process and reducing errors.
    • Expectation of Success: Combining known data management techniques from related pharmacy systems was argued to be a straightforward application of existing technology.

  • Additional Grounds: Petitioner asserted additional obviousness challenges to address specific dependent claims, including combinations with:

    • Burns (Patent 7,986,369) for its disclosure of a web cam stand with an integrated power and data "umbilical" (Claim 10).
    • Bear (Application # 2008/0119958) for its teaching of selectively lighting medication compartments for image capture (Claims 11-14).
    • Claypool (Application # 2009/0205877) for its disclosure of a digital scale with a removable platform for cleaning (Claim 16).
    • Angel (Patent 4,993,506) for its teachings on using multiple load cells in a scale design (Claims 18-19).

4. Key Claim Construction Positions

  • Petitioner argued for the broadest reasonable interpretation of key terms. The most contested term, central to the patent’s allowance, was "at substantially the same time." Petitioner contended this term should be interpreted to mean "sufficiently close in time that the medication dose preparation image has not changed since the time the weight was recorded." This construction was proposed to prevent Patent Owner from arguing that the prior art's sequential-but-rapid data capture fails to meet the limitation, when for all practical purposes the captured data represents the same moment in the preparation process.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-19 of the ’693 patent as unpatentable.