PTAB

IPR2018-00981

Repro Med Systems Inc v. EMed Technologies Corp

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Devices and Methods for Protecting a User from a Sharp Tip of a Medical Needle
  • Brief Description: The ’576 patent discloses a safety device for medical needles featuring two wings that fold to enclose the needle after use. The device's asserted novelty resides in a mechanical fastener that consists of a lip extending along a portion of one wing’s perimeter and a corresponding mating portion on the other wing, which are configured to align and lock the wings in a closed position.

3. Grounds for Unpatentability

Ground 1: Anticipation over Harada - Claims 1 and 2 are anticipated by Harada.

  • Prior Art Relied Upon: Harada (Japanese Application # JPH0966106).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Harada, which teaches a needle cover with foldable wings, discloses every element of claims 1 and 2. Harada’s device includes a pair of wings (3a, 3b) attached to a central body (4) that fold to cover a needle (2). Critically, Harada discloses a mechanical fastener (7) with a male engaging means (7a) on one wing and a female engaging means (7b) on the other. Petitioner contended that the male portion (7a) is the claimed "lip" and the female portion (7b) is the "mating portion," both located along the perimeter of the wings, thus anticipating the claims.
    • Key Aspects: Petitioner noted that Harada was submitted in an Information Disclosure Statement (IDS) during prosecution but was never discussed or applied by the examiner.

Ground 2: Obviousness over Sasso in view of Harada - Claims 1-3 are obvious over Sasso and Harada.

  • Prior Art Relied Upon: Sasso (Patent 6,500,155) and Harada (Japanese Application # JPH0966106).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Sasso, a reference considered by the examiner, teaches all elements of claim 1 except for a mechanical fastener consisting of a lip extending along a perimeter of one wing and a mating portion on the other. Sasso discloses a winged needle shield (24) with a fastener using posts (44, 46) and apertures (50, 52). Petitioner argued that Harada remedies this deficiency by explicitly teaching a perimeter-based fastener with a male "lip" (7a) and female "mating portion" (7b). Dependent claims 2 (planarly extending wings) and 3 (wings as a handle) were argued to be disclosed by Sasso’s structure or to be obvious design choices.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Harada's perimeter-based fastener with Sasso’s device. Both references solve the same problem of preventing needle sticks using foldable wings. A POSITA would be motivated to use Harada's fastener to provide a more secure and better-aligned closure for the wings in Sasso’s device, which is a known design goal.
    • Expectation of Success: The combination involved applying a known type of fastener to a known type of needle shield. This integration of simple mechanical components would have been straightforward with a high expectation of success and predictable results.

Ground 3: Obviousness over Sasso in view of Norelli - Claims 1-3 are obvious over Sasso and Norelli.

  • Prior Art Relied Upon: Sasso (Patent 6,500,155) and Norelli (Patent 4,820,277).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground presented an alternative to Harada for supplying the missing fastener element in Sasso. Petitioner argued Norelli discloses a needle protector with a mechanical fastener consisting of projecting locking clips (68) on one jaw and receiving sockets (70) on the other. These elements, located at the wing perimeters, function as the claimed "lip" and "mating portion," respectively. Combining Norelli's fastener with Sasso's needle shield would result in the claimed invention.
    • Motivation to Combine: The motivation was identical to that for combining Sasso and Harada: to improve the fastening mechanism of a winged needle protector by incorporating a well-understood alternative fastener design from a device in the same field.
    • Expectation of Success: A POSITA would have reasonably expected success in substituting Norelli's clip-and-socket fastener for Sasso's post-and-aperture system, as both are simple mechanical locking mechanisms used for the same purpose.

  • Additional Grounds: Petitioner asserted additional anticipation challenges against claims 1-2 based on Cole (Patent 4,944,731) and Ishikawa (Patent 5,147,319) individually. Petitioner also asserted numerous other obviousness grounds, primarily combining Sasso, Raines (Patent 6,911,020), or Keaton (Application # 2008/0177234) with Harada, Cole, Ishikawa, or Norelli to teach the claimed perimeter-based mechanical fastener.

4. Key Claim Construction Positions

  • "Lip": Petitioner argued for the term's plain and ordinary meaning, consistent with a PTAB construction in a case involving the related ’476 patent, as "a rounded, raised, or extended piece along an edge." This broad interpretation was central to Petitioner's argument, as it encompassed the varied fastener structures found in the prior art, such as Harada’s male connector and Norelli’s locking clips.
  • "Mechanical fastener consisting of a lip...": Petitioner highlighted that the claims were amended during prosecution from "including a lip" (as in the related, invalidated ’476 patent) to "consisting of a lip." Petitioner argued this change was an immaterial and superficial attempt to overcome prior art, as the fastener in the prior art references could still be fairly characterized as consisting of the lip and its corresponding mating part.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-3 of Patent 9,808,576 as unpatentable.