PTAB

IPR2019-00120

Becton Dickinson Co v. Baxter Corp Englewood

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Work Station for Medical Dose Preparation System
  • Brief Description: The ’273 patent relates to a work station for use in a medical dose preparation system. The invention describes an apparatus comprising a base with a support platform, a scale to output weight data, an imaging device to output image data of a medication receptacle on the platform, a processor, and a memory where the weight and image data are associatively stored.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1, 3-8, 10-11, and 16-21 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 liquid pharmaceuticals, taught every limitation of the independent claims. Fioravanti’s appliance was described as being set in a workstation and included an electronic precision balance with a scale (the claimed base and support platform), top and front cameras to acquire images of vials or syringes on the scale (the imaging device), a processing system (the processor), and a memory device. Petitioner asserted that Fioravanti’s system uses both weight and image data to verify the steps of medication preparation, which inherently requires the associative storage of that data in its memory database, thus meeting all limitations of claim 1.

Ground 2: Obviousness of Claims 1-14 and 16-21 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 asserted that Fioravanti taught most elements of the claims, with Alexander supplying the remaining teachings. Alexander discloses a system for remotely supervising and verifying pharmacy functions performed by a non-pharmacist. Petitioner argued Alexander’s teaching of an institutional pharmacy workstation, where images of the preparation process and related documentation are captured and transmitted to a remote pharmacist for verification, rendered obvious the limitations related to remote access and verification (claim 21). Alexander taught storing received images in a database as records for later access, which could be associated with a job or task identifier.
    • Motivation to Combine: A POSITA would combine Fioravanti and Alexander because both references address the same problem of reducing errors in pharmacy dose preparation using computer-assisted verification. Petitioner noted that Fioravanti’s system explicitly contemplated a “remote-surveillance station,” and Alexander provided a compatible and detailed example of such a remote verification system. A POSITA would have found it obvious to integrate Alexander’s robust remote verification methods into Fioravanti’s dose preparation appliance to achieve the shared goal of improved pharmacy safety and efficiency.
    • Expectation of Success: Petitioner argued the combination involved integrating known, compatible systems to yield predictable results.

Ground 3: Obviousness of Claims 1-14 and 16-21 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 supplemented the Fioravanti/Alexander combination with teachings from Eliuk, which discloses an automated Pharmacy Admixture System (APAS). Petitioner argued Eliuk provided further support for the claimed elements. Eliuk teaches a system with a "vial ID station" that uses a camera system and a rotating platform to identify vials, a separate station with a scale to weigh items like IV bags before and after reconstitution, and a database that stores drug order records. Critically, Eliuk taught that each dose ID may be associated with process measurements, including weights at different stages and captured images or video clips.
    • Motivation to Combine: A POSITA would combine Eliuk with the teachings of Fioravanti and Alexander because all three concern computer-aided pharmaceutical preparation and verification using imaging and weight measurement. The principles and verification techniques in Eliuk's automated system were argued to be equally applicable to the manual or semi-automated systems of Fioravanti and Alexander. Combining the references would simplify workflow and enhance error checking, a well-known goal in the art.
    • Expectation of Success: Petitioner contended that a POSITA would have reasonably expected success in combining these similar systems for pharmacy automation and verification.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including adding Claypool (Application # 2009/0205877) for its teaching of a digital scale with a detachable platform to address claim 2, and Bear (Application # 2008/0119958) for its teaching of a medication dispenser with integrated lighting to address claims 13-15.

4. Key Claim Construction Positions

  • "Work Station": Petitioner argued for a broad construction of "a location in a pharmacy where some operation related to medical dose order management is performed," contending the term is not limited to the specific combination of claimed components but refers to the area of use.
  • "At Substantially the Same Time": To address potential indefiniteness for this term in claim 5, Petitioner proposed the construction "sufficiently close in time that the medication dose preparation image has not changed since the time the weight was recorded."
  • "Metadata": Petitioner asserted this term in claim 19 should be given its plain meaning of "data regarding a medical dose order," arguing the patent uses the term to encompass the weight and image data being stored in association with a specific prescription order.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review (IPR) and the cancellation of claims 1-21 of the ’273 patent as unpatentable.