ColoPlast AS v. PaMaRope Pty Ltd

1. Case Identification

• Case #: IPR2021-01437
• Patent #: 10,925,715
• Filed: August 31, 2021
• Petitioner(s): Coloplast A/S and Coloplast Corp.
• Patent Owner(s): Peter Emmanuel Petros
• Challenged Claims: 1-4, 6-7, 9-14, 16-17, 19-20

2. Patent Overview

• Title: Anchoring Device and its Implementation
• Brief Description: The ’715 patent describes a method for providing ligament-like support between two locations in a patient's body. The method involves using a pair of anchors to fix a filamentary element to provide support, for example, to treat female urinary incontinence. Petitioner asserted that the challenged claims are overly broad because they omit a key "locking member" feature that was present in all claims of earlier patents in the same family.

3. Grounds for Unpatentability

Ground 1: Obviousness over Neisz and Benderev

• Prior Art Relied Upon: Neisz (Application # 2002/0161382) and Benderev (Patent 6,500,194).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Neisz, a prior art application for treating female urinary incontinence, taught nearly all limitations of the challenged claims. Neisz disclosed an implantable sling system comprising a ribbon-like mesh, deployable anchors, and associated sutures. The method involved placing the implant to support the urethra by anchoring it to endopelvic fascia on opposite sides. Neisz also showed a suture passing loosely through an aperture in its anchor. Petitioner contended that to the extent Neisz did not explicitly teach adjusting sling tension by pulling the suture through the anchor aperture, Benderev supplied this teaching. Benderev described a surgical technique for treating incontinence by applying traction to suspending sutures to achieve a "gentle elevation and cradle-like support" for the urethra. The combination also met the limitation of the filamentary element becoming "embodied with fascia," as Neisz taught using a synthetic mesh with holes sized to "afford tissue ingrowth."
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Benderev's well-known suture tensioning technique with Neisz's implant system for several reasons. Primarily, it would ensure sufficient tension was applied to the sling to properly support the urethra. Additionally, applying traction as taught by Benderev would ensure adequate anchor fixation and remove unnecessary slack from the sutures post-implantation. This combination represented the application of a known technique to a known system to achieve predictable results.
  • Expectation of Success: A POSITA would have had a high expectation of success, as applying Benderev’s simple and reproducible tensioning method to Neisz’s analogous sling system would predictably improve its function without altering its fundamental operation.

Ground 2: Obviousness over Brenneman and Kovac

• Prior Art Relied Upon: Brenneman (WO 98/19606) and Kovac (Patent 6,039,686).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued Brenneman taught a general method for treating urinary incontinence using anchors implanted on each side of the urethra to suspend a sling with sutures. Brenneman disclosed that the "tension on the sling provided by the sutures is adjusted to provide the appropriate biasing force." Petitioner asserted that Kovac provided the specific details of the sling itself. Kovac taught a urethra support system using a rectangular, "ribbon-like" surgical mesh sling. The combination of Brenneman's method with Kovac's specific sling allegedly met all limitations of the independent claims, including providing a ribbon-like filamentary element, attaching anchors to tissue lateral to the urethra, introducing the element into fascial tissue, and adjusting tension. The "embodied with fascia" limitation was met because Kovac recommended using Mersilene® mesh, a material well-known at the time to allow for "excellent tissue ingrowth."
  • Motivation to Combine: A POSITA implementing Brenneman’s method, which generally called for a "sling" without specifying its design, would have been motivated to look to the known art for a suitable example. Kovac, which disclosed a system with similar components (anchors, sutures, sling) and surgical techniques for the same purpose, provided an obvious and suitable ribbon-like sling design. The clear similarities between the systems would have prompted a POSITA to incorporate Kovac's sling into Brenneman's method to achieve the desired urethral support.
  • Expectation of Success: A POSITA would have expected success in combining the references. Incorporating a known type of surgical mesh sling (Kovac) into a compatible anchoring and tensioning system (Brenneman) was a straightforward design choice that would predictably result in an effective incontinence treatment.

4. Key Claim Construction Positions

• "the filamentary element will become embodied with fascia in the fascial tissue" (claims 1, 11): Petitioner proposed this term means "fascial tissue grows into the filamentary element during healing." This construction was argued to be consistent with the ’715 patent’s specification, which described the element being adapted to "facilitate the growth of tissue" and becoming embodied with fascia "with the healing of the incisions."
• "lateral" (claims 1, 11): Petitioner proposed this term means "to one side of." This construction was supported by the specification’s description of anchors being embedded in ligaments "on each side of the vagina."

6. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial would be inappropriate.
  • Regarding §314(a) (Fintiv): Petitioner asserted that the co-pending district court litigation was in its infancy, with no trial date set and minimal investment by the parties or the court. Therefore, the Board's Final Written Decision would likely issue well before any potential trial, weighing heavily in favor of institution.
  • Regarding §325(d): Petitioner contended that denial under §325(d) was unwarranted because none of the primary prior art references (Neisz, Benderev, Brenneman, Kovac) or the specific combinations argued in the petition were considered by the Examiner during the prosecution of the ’715 patent.

7. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-4, 6-7, 9-14, 16-17, and 19-20 of the ’715 patent as unpatentable.