Ethicon Endo-Surgery, Inc. v. Covidien LP

812 F.3d 1023

ETHICON ENDO–SURGERY, INC., Appellant

v.COVIDIEN LP, Appellee.

No. 2014–1771.

United States Court of Appeals, Federal Circuit.

Jan. 13, 2016.

Philip Staton Johnson, Johnson & Johnson, New Brunswick, NJ, argued for appellant. Also represented by Steven D. Maslowski, Ruben H. Munoz, Jason Weil, Akin, Gump, Strauss, Hauer & Feld, LLP, Philadelphia, PA; Pratik A. Shah, Hyland Hunt, Washington, DC.

Kathleen Daley, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, argued for appellee. Also represented by J. Michael Jakes ; J. Derek McCorquindale, Reston, VA.

Katherine Twomey Allen, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, argued for intervenor Michelle K. Lee. Also represented by Benjamin C. Mizer, Mark R. Freeman; Nathan K. Kelley, Scott Weidenfeller, Stacy Beth Margolies, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

Before NEWMAN, DYK, and TARANTO, Circuit Judges.

Opinion for the court filed by Circuit Judge DYK. Dissenting opinion filed by Circuit Judge NEWMAN.

DYK, Circuit Judge.

Ethicon Endo–Surgery, Inc. ("Ethicon") owns U.S. Patent No. 8,317,070 ("the '070 patent"). Covidien LP ("Covidien") petitioned the United States Patent and Trademark Office ("PTO") for inter partes review of claims 1–14 of the '070 patent. The PTO, through a panel of the Patent Trial and Appeals Board ("PTAB" or "Board"), granted the petition. On the merits, the same Board panel found all challenged claims invalid as obvious over the prior art. Ethicon appeals, asserting that the Board's final decision is invalid because the same Board panel made both the decision to institute and the final decision. Ethicon also asserts that the Board erred in finding the claims obvious.

We first hold that 35 U.S.C. § 314(d) does not preclude us from hearing Ethicon's challenge to the authority of the Board to render a final decision. On the merits we hold that neither the statute nor the Constitution precludes the same panel of the Board that made the decision to institute inter partes review from making the final determination. We also find no error in the Board's determination that the '070 patent claims would have been obvious over the prior art. Accordingly, we affirm.

BACKGROUND

The claims of the '070 patent are directed to a surgical device used to staple, secure, and seal tissue that has been incised. As the specification describes, a typical embodiment can both make the incision and simultaneously apply lines of staples on opposing sides of the incision. '070 Patent col. 7 ll. 5–31. As is commonly done during endoscopic procedures, a surgeon will insert the device into the patient and will pull a trigger to latch onto a desired tissue. Once attached, the surgeon will then pull another trigger, which causes a blade to move, cutting the desired tissue. Simultaneously, rows of staples on either side of the cutting blade are actuated against a staple forming surface, both securing and sealing the newly-cut tissue.

Claim 1 is representative of the claimed invention:

A surgical stapling device comprising an end effector that comprises:

a circular anvil having a staple forming surface;

a plurality of staples facing the staple forming surface of the anvil, each staple comprising a main portion and two prongs, wherein the two prongs each comprise a first and a second end, wherein the first ends are connected to opposite ends of the main portion, and wherein the two prongs extend non-parallelly from the main portion; and

a staple driver assembly comprising a plurality of staple drivers, wherein each staple driver supports one of the plurality of staples and is configured such that, when the staple driver assembly is actuated, each staple driver drives the staple into the staple forming surface of the anvil, wherein a first quantity of the staples have a first pre-deformation height, measured from a lower surface of the main portion to the second end of the first prong, and a second quantity of the staples having a second pre-deformation height, measured from a lower surface of the main portion to the second end of the first prong, wherein the first height is less than the second height, such that when the staple driver assembly is actuated, the first quantity of staples have a different formed staple length than the second quantity of staples.

(emphases added).

Surgical staplers were not new at the time of the '070 patent. As the patent specification itself describes, these types of devices were well known and had been commonly used. '070 Patent col. 1 ll. 45–47. The '070 patent claims two primary aspects of stapler design: the use of staples of different pre-formed and formed heights (i.e., heights before and after stapling) and the use of staples with nonparallel legs. It is undisputed that both of these improvements, separately, were also well-known in the prior art. Thus, the purported inventive aspect of the '070 patent is the combination of these two features in a surgical stapler. The patent discloses no particular synergy resulting from the combination.

According to the prior art disclosures and the specification, the use of staples of different pre-formed and formed heights is beneficial in a number of ways. For example, "rows of inside staples [can] serve to provide a hemostatic barrier, while the outside rows of staples with larger formed heights [can] provide a cinching effect where the tissue transitions from the tightly compressed hemostatic section to the non-compressed adjacent section." '070 Patent col. 2 ll. 8–12. This is beneficial because these staples of different sizes "decrease[ ] leakage rates ... and provide[ ] short and long-term tissue strength" after incision. J.A. 290. The use of these different sized staples thus allows this type of device to be used on a broader range of tissue thicknesses. As is uncontested, these staples of varying pre-formed and formed heights were first disclosed 25 years ago by prior art references Tyco Healthcare International Publication No. WO 2003/094747 and U.S. Patent No. 4,941,623.

The primary benefit of using non-parallel legs on staples is that the staple legs press against the side of the staple cartridge and stay in the cartridge without falling out. J.A. 454. As is also uncontested, the use and benefit of these staples was previously disclosed in a 1970 U.S. Patent, No. 3,494,533, and were well known by those in the field, even according to Ethicon's own expert, who testified that he used nonparallel staples "maybe 50 or 75 percent of the time" in his practice.

In 2010, Covidien began selling surgical staplers that, Ethicon contends, embody the claimed invention of the '070 patent. The brochures for these staplers, featuring what Covidien called "Tri–Staple technology," tout "progressive staple heights" that allow "consistent performance over a broader range of tissue thickness." J.A. 1101, J.A. 1126. Notably absent from these brochures, though, was any mention of non-parallel legs on the staples. The staplers using this technology were very successful, achieving over $1 billion in product sales within the first three years of their introduction to the market. According to Covidien, the Tri–Staple devices are likely to be one of their most successful product lines ever.

Covidien filed a petition with the PTO on March 25, 2013, requesting inter partes review of claims 1–14 of the '070 patent on the ground that the claims would have been obvious over the prior art. The Board granted the petition on August 26, 2013.

In its June 9, 2014, final decision, the same panel of the Board that instituted the inter partes review rejected all of Ethicon's arguments and found all challenged claims of the '070 patent obvious under 35 U.S.C. § 103. It noted that Ethicon admitted that all of the recited elements of the patent claims were found in the prior art. Relying on Covidien's expert testimony, the Board concluded that one of skill in the art would have been motivated to combine the prior art staplers disclosing staples of varying heights with staples of non-parallel legs to securely hold the staples in the cartridge because the benefits of both were well known at the time of the invention. Further, the Board found no suggestion in the prior art teaching away from combining these elements. The Board alternatively found that it would have been obvious to try to combine non-parallel staples with the prior art devices disclosing staples of varying heights because of the "limited choice" of staple designs. J.A. 15.

Finally, it found that Ethicon's evidence of secondary considerations did "not overcome the strong case of obviousness." J.A. 19.

Ethicon appeals. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A). We review the Board's factual findings for substantial evidence and its legal conclusions de novo. In re Baxter Int'l, Inc., 678 F.3d 1357, 1361 (Fed.Cir.2012).

DISCUSSION

I

Ethicon challenges the final decision of the Board, arguing that the final decision should be set aside because it was made by the same panel that made the decision to institute inter partes review.

The America Invents Act¹ ("AIA") gives the Director the authority to determine whether an inter partes review should be initiated, and the Director has delegated this authority to the Board.² The statute specifically gives the Board the power to decide the ultimate question of patent validity. See 35 U.S.C. § 318 (requiring that "the Patent Trial and Appeal Board shall issue a final written decision with respect to the patentability of any patent claim challenged by the petitioner"). The PTO has determined that, in the interest of efficiency, the decision to institute and the final decision should be made by the same Board panel, in line with the purposes of the AIA, which requires the Director consider the "efficient administration of the [PTO], and the ability of the [PTO] to timely complete proceedings" in promulgating regulations....