PTAB

IPR2019-00119

Becton Dickinson Co v. Baxter Corp Englewood

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Management, Reporting and Benchmarking of Medication Preparation
  • Brief Description: The ’579 patent discloses methods and systems for telepharmacy, focusing on the remote management and verification of medication preparation. The core technology involves capturing and storing images corresponding to discrete, individual steps of a drug preparation recipe, allowing a remote pharmacist to later retrieve and inspect the images to verify proper completion of each step before approving the dose.

3. Grounds for Unpatentability

Ground 1: Claims 1-12 and 22 are obvious over Alexander in view of Liff.

  • Prior Art Relied Upon: Alexander (8,374,887) and Liff (6,581,798).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Alexander taught the core telepharmacy method of claim 1, including a system for a remote pharmacist to supervise and verify pharmacy functions performed by a technician. Alexander disclosed using an image capture device to capture images of the work at various stages, transmitting them to the remote pharmacist, and storing them for later review and approval. However, Petitioner contended Alexander lacked a detailed, interactive user interface. Liff allegedly supplied this element, disclosing an automated drug dispensing system with a sophisticated computer interface that guides an operator through filling a prescription with prompts, selectable menus, and areas for data input. The combination of Alexander’s remote verification via image capture with Liff’s interactive recipe display and user guidance was argued to render the claims obvious.
    • Motivation to Combine: Petitioner asserted that a Person of Ordinary Skill in the Art (POSITA) would combine these references as they both address the same problem: providing safe and efficient telepharmacy services in locations with insufficient licensed pharmacists. A POSITA would have been motivated to integrate Liff’s user-friendly interface into Alexander’s remote supervision system to improve workflow, reduce errors, and lower costs by using shared hardware and a consistent user experience.
    • Expectation of Success: Combining a known user interface (Liff) with a known remote verification system (Alexander) was a straightforward application of known techniques to improve a device in a predictable way.

Ground 2: Claims 1-12 and 22 are obvious over Alexander, Liff, and Morrison.

  • Prior Art Relied Upon: Alexander (Patent 8,374,887), Liff (Patent 6,581,798), and Morrison (2005/0080651).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground relied on the teachings of Alexander and Liff as established in Ground 1, with Morrison added to provide further teachings on managing a large-scale telepharmacy operation. Morrison disclosed a system for remote pharmacy order processing that explicitly taught features like a central server for receiving orders from a plurality of hospitals, organizing orders into queues, and displaying metrics such as order volume and processing time. Petitioner argued Morrison reinforced the motivation to create a comprehensive telepharmacy system and provided specific teachings for an interactive screen that displays electronic order images and provides fields for input, as recited in the claims.
    • Motivation to Combine: Petitioner argued that a POSITA seeking to build a robust telepharmacy system as suggested by Alexander and Liff would look to a reference like Morrison for managing order flow from multiple sources. A POSITA would combine Morrison’s server architecture and queue management with the Alexander/Liff system to create a more efficient, scalable, and commercially viable telepharmacy platform that could service multiple institutions from a central location.

Ground 3: Claims 3, 6, and 11-13 are obvious over Alexander, Liff, Morrison, and Peoples.

  • Prior Art Relied Upon: Alexander (Patent 8,374,887), Liff (Patent 6,581,798), Morrison (Application # 2005/0080651), and Peoples (6,098,892).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground targeted dependent claims requiring specific functionalities related to barcode scanning and the use of National Drug Codes (NDCs). Petitioner asserted that while the primary combination disclosed the overall system, it was Peoples that explicitly taught the claimed NDC-related features. Peoples disclosed a method and device for converting product-specific identification numbers on pharmaceutical products, read via a barcode scanner, into an industry-standard format, such as converting a 10-digit NDC to a standardized 11-digit format. This teaching directly mapped onto limitations in claims requiring scanning labels and processing NDC information.
    • Motivation to Combine: Petitioner contended that the use of NDCs and barcodes for drug identification was a mandatory and ubiquitous industry standard. Therefore, a POSITA implementing the telepharmacy system of Alexander, Liff, and Morrison would have been necessarily motivated to incorporate a known method, such as that taught by Peoples, to handle the required barcode scanning and NDC data processing to ensure accuracy and regulatory compliance.

4. Key Claim Construction Positions

  • "Medication/Dose Preparation Station": Petitioner proposed this term be construed as "an automated or manual workstation at which a dose of medication is prepared." This construction was argued to be consistent with the specification’s generic use of the term to refer to the location where preparation occurs.
  • "Hands-Free Device": Petitioner proposed this term be construed as "a device that operators can interact with using something other than their hands." This was based on the specification's limited disclosure, which only mentioned a foot-pedal, barcode scanner, and audible cues as examples.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-13 and 22 of the ’579 patent as unpatentable.