PTAB

IPR2017-01438

Opus KSD Inc v. Incisive Surgical Inc

Key Events

Petition

petition

Title: Surgical Stapler and Method
Brief Description: The ’517 patent discloses a surgical stapler and method for delivering fasteners below the skin surface. The system involves positioning an insertion head at least partially below the skin to insert a rigid fastener into concealed dermal target tissue zones parallel to the skin surface.

Prior Art Relied Upon: ’889 Publication (Application # 2012/0325889).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that the ’517 patent is not entitled to its claimed priority date of June 25, 2002. The claims were allegedly copied from the ’889 Publication and first introduced into the application on March 12, 2013, but the ’517 patent’s specification fails to provide written description or enablement for them. Specifically, the claims recite everting skin to expose inner surfaces for fastener deployment from above, whereas the ’517 patent’s disclosure exclusively describes an insertion head placed beneath the skin to staple concealed tissue. Without priority, the ’889 Publication, published in 2012, qualifies as prior art. Petitioner contended the ’889 Publication discloses every limitation of claims 1-8, including a stapler with feet for retracting tissue, exposing the inner skin surfaces, and an insertion device that deploys a fastener from above and perpendicular to the skin.

Prior Art Relied Upon: ’889 Publication (Application # 2012/0325889) and admitted prior art described within the ’517 patent.
Core Argument for this Ground:
- Prior Art Mapping: As a secondary position, Petitioner argued that even if the ’889 Publication does not explicitly teach that its "feet" contact the skin without piercing it, this feature would have been obvious. The drawings of the ’889 Publication show feet that are free from any piercing structures.
- Motivation to Combine: The ’517 patent itself admits that a known goal in the art was to close wounds without piercing the epidermis to avoid scarring. This admission provides the rationale for modifying the stapler of the ’889 Publication to ensure its feet do not pierce the skin. A POSITA would combine the teachings to achieve the known benefit of improved cosmetic results.
- Expectation of Success: A POSITA would have a reasonable expectation of success in designing the feet of the ’889 device to be non-piercing, as it would involve a simple design choice to use smooth surfaces, a predictable and well-understood mechanical principle.

Prior Art Relied Upon: Textbook of Pediatric Emergency Procedures ("Pediatric Procedures") and Principles of Wound Management ("Wound Management").
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that method claims 4 and 8, which are broad enough to cover manual suturing, merely recite conventional surgical techniques. The prior art textbooks describe all the claimed steps: using bioabsorbable fasteners (sutures), everting wound edges with forceps to expose the dermal layer, inserting the needle/fastener from above and perpendicular to the skin into the exposed tissue, and leaving the fastener (suture knot) below the skin surface upon release.
- Motivation to Combine: The references are from the same field of wound closure and collectively represent the standard of care. A POSITA would naturally look to such authoritative texts and combine their fundamental techniques to perform a standard subcuticular wound closure.
- Expectation of Success: The techniques were well-established, routine surgical procedures, ensuring a high expectation of success.

Prior Art Relied Upon: Pediatric Procedures, Wound Management, and Tanner (Patent 3,716,058).
Core Argument for this Ground:
- Prior Art Mapping: This ground builds on Ground 3, addressing the possibility that the term "bioabsorbable fastener" might be construed to exclude traditional sutures. Tanner discloses a bioabsorbable barbed suture that functions as a self-anchoring fastener, eliminating the need for knots.
- Motivation to Combine: Petitioner argued that a known drawback of traditional suturing, as noted in the textbooks, is the difficulty and time-consumption of tying knots. Tanner was created specifically to improve the efficiency of suturing. A POSITA would combine the standard suturing techniques from the textbooks with Tanner’s improved barbed fastener to make the process faster and more reliable.
- Expectation of Success: Substituting Tanner’s barbed suture for a conventional suture is a simple substitution of one known component for another to achieve a predictable improvement.

Petitioner argued for construing claim terms according to their plain and ordinary meaning, which aligns with the disclosure of the ’889 Publication but conflicts with the ’517 patent’s specification.
“expose an inner surface” / “everted to expose the dermal layer”: Petitioner contended this means to lay the inner tissue layers open for direct visual inspection by the surgeon, as taught in the ’889 Publication. This construction is contrary to the ’517 patent’s method, which teaches compressing tissue into a capture zone, thereby concealing it.
“from above and generally perpendicular”: Petitioner argued this requires the fastener to be deployed from outside the incision downward into the tissue. This contradicts every embodiment in the ’517 patent, which shows a fastener deployed parallel to the skin from an insertion head placed beneath the skin.

The petition’s central technical contention was the irreconcilable conflict between the ’517 patent’s written description and its challenged claims. Petitioner asserted the ’517 patent’s sole inventive concept is a device that operates below the skin surface to staple concealed tissue. In contrast, the challenged claims (copied from the ’889 Publication) define a completely different device that operates above the skin surface to staple exposed tissue. Petitioner argued that the device described in the ’517 patent is physically incapable of performing the methods or embodying the apparatus recited in the claims, rendering the claims invalid for lack of written description and enablement.

Petitioner requests institution of an inter partes review and cancellation of claims 1-8 of the ’517 patent as unpatentable.