Arthrex, Inc. v. Smith & Nephew, Inc.
Opinion
*1322
In an inter partes review, the Patent Trial and Appeal Board ruled claims 10 and 11 of Arthrex, Inc.'s
BACKGROUND
I
The '541 patent describes a surgical suture anchor used to reattach soft tissue to bone. '541 patent col. 1 ll. 25-35. The disclosed "fully threaded suture anchor" includes "an eyelet shield that is molded into the distal part of the biodegradable suture anchor."
Figure 5 of the '541 patent illustrates the helical threading on body 3 and the integral rigid support (eyelet shield 9) of the suture anchor 1:
*1323 Independent claims 10 and 11 are at issue here. They recite:
10. A suture anchor assembly comprising:
an anchor body including a longitudinal axis, a proximal end, a distal end, and a central passage extending along the longitudinal axis from an opening at the proximal end of the anchor body through a portion of a length of the anchor body, wherein the opening is a first suture opening, the anchor body including a second suture opening disposed distal of the first suture opening, and a third suture opening disposed distal of the second suture opening, wherein a helical thread defines a perimeter at least around the proximal end of the anchor body;
a rigid support extending across the central passage, the rigid support having a first portion and a second portion spaced from the first portion, the first portion branching from a first wall portion of the anchor body and the second portion branching from a second wall portion of the anchor body, wherein the third suture opening is disposed distal of the rigid support;
at least one suture strand having a suture length threaded into the central passage, supported by the rigid support, and threaded past the proximal end of the anchor body, wherein at least a portion of the at least one suture strand is disposed in the central passage between the rigid support and the opening at the proximal end, and the at least one suture strand is disposed in the first suture opening, the second suture opening, and the third suture opening; and
a driver including a shaft having a shaft length, wherein the shaft engages the anchor body, and the suture length of the at least one suture strand is greater than the shaft length of the shaft.
11. A suture anchor assembly comprising:
an anchor body including a distal end, a proximal end having an opening, a central longitudinal axis, a first wall portion, a second wall portion spaced opposite to the first wall portion, and a suture passage beginning at the proximal end of the anchor body, wherein the suture passage extends about the central longitudinal axis, and the suture passage extends from the opening located at the proximal end of the anchor body and at least partially along a length of the anchor body, wherein the opening is a first suture opening that is encircled by a *1324 perimeter of the anchor body, a second suture opening extends through a portion of the anchor body, and a third suture opening extends through the anchor body, wherein the third suture opening is disposed distal of the second suture opening;
a rigid support integral with the anchor body to define a single-piece component , wherein the rigid support extends across the suture passage and has a first portion and a second portion spaced from the first portion, the first portion branching from the first wall portion of the anchor body and the second portion branching from the second wall portion of the anchor body, and the rigid support is spaced axially away from the opening at the proximal end along the central longitudinal axis; and
at least one suture strand threaded into the suture passage, supported by the rigid support, and having ends that extend past the proximal end of the anchor body, and the at least one suture strand is disposed in the first suture opening, the second suture opening, and the third suture opening.
II
Smith & Nephew sought IPR of claims 10 and 11 of the '541 patent. It challenged both claims as obvious over U.S. Pub. No. 2006/0271060 ("Gordon") and
Gordon discloses a bone anchor in which a suture loops about a pulley 182 positioned within the anchor body. J.A. 1758, ¶¶ [0084]-[0086]. Figure 23 illustrates the pulley 182 held in place in holes 184a, b.
*1325 J.A. 1747. Smith & Nephew asserted that Gordon disclosed nearly all of the claimed features, including the rigid support, which Smith & Nephew identified as pulley 182. As relevant here, however, Smith & Nephew acknowledged that Gordon did not expressly disclose that the pulley was "integral with the anchor body to define a single-piece component," as required by claim 11. J.A. 228. For that feature, Smith & Nephew relied on West.
West also describes a bone anchor 10, as shown in Figure 1, reproduced below.
J.A. 1762. In West's anchor, "[o]ne or more pins [23a and 23b] are fixed within the bore of the anchor body [12]. One or more sutures can be looped on the pins [23a and 23b]." J.A. 1760, Abstract. West explains that to manufacture the bone anchor, "anchor body 12 and posts 23 can be cast and formed in a die. Alternatively anchor body 12 can be cast or formed and posts 23a and 23b inserted later." J.A. 1768 at col. 7 ll. 41-44; see also J.A. 1767 at col. 5 ll. 58-60. Smith & Nephew argued that this disclosure would have motivated one of ordinary skill to manufacture the Gordon anchor using a casting process, creating a "rigid support integral with the anchor body to define a single-piece component," as recited in claim 11. J.A. 217-19. Relying on its expert's testimony, Smith & Nephew asserted that using the West casting process would minimize the materials used in the anchor, thus facilitating regulatory approval, and would reduce the likelihood of the pulley separating from the anchor body. J.A. 218-19. It also asserted that the casting process was "a well-known and accepted technique for creating medical implants" and "would have been a simple design choice." J.A. 218.
Smith & Nephew further argued that claim 11 was anticipated by
Among other things, Arthrex disputed whether a person of ordinary skill would *1326 have been motivated to modify Gordon in view of West to achieve the invention of claim 11, and it asserted that the Curtis ground did not include the "helical thread" of claim 10 under the correct construction of that term. In its final written decision, the Board disagreed and ruled that Smith & Nephew had shown both claims unpatentable on both the Gordon and West and the Curtis grounds. Arthrex appeals.
DISCUSSION
On review of the Board's final written decisions, we evaluate whether the Board's factual findings are supported by substantial evidence.
See
Belden Inc. v. Berk-Tek LLC
,
Arthrex challenges the Board's determination that Smith & Nephew proved claims 11 and 10 unpatentable, and it attacks the constitutionality of IPRs as applied to its patent. We address each argument in turn.
I
We begin with claim 11. The Board determined that one of ordinary skill would have found the claimed invention obvious over Gordon and West, a conclusion Arthrex attacks both procedurally and substantively. Because the Board did not violate Arthrex's procedural rights, and because substantial evidence supports the Board's conclusion that a person of ordinary skill would have been motivated to combine the teachings of Gordon and West to achieve the claimed invention, we affirm. Because we affirm the Board's finding of unpatentability based on Gordon in view of West, we do not reach Arthrex's challenges to the Board's finding that claim 11 is anticipated by Curtis.
A
Arthrex first contends that the Board impermissibly relied on a new theory of motivation to combine in its final written decision. As we have often explained, IPR proceedings are formal administrative adjudications subject to the procedural requirements of the APA.
See, e.g.
,
Dell Inc. v. Acceleron, LLC
,
Arthrex argues that by describing West's casting method as "preferred," a characterization not found in Smith & Nephew's petition, the Board crafted a new reason for combining Gordon and West and violated its procedural rights. We disagree. Though the Board used different *1327 language than the petition in its discussion of whether one of ordinary skill would have been motivated to combine Gordon and West, it did not introduce new issues or theories into the proceeding. Rather, the Board properly resolved the parties' dispute about the scope and content of West's disclosure in order to evaluate the theory of obviousness raised in Smith & Nephew's petition.
West describes that an "anchor body 12 and posts 23 can be cast and formed in a die. Alternatively anchor body 12 can be cast or formed and posts 23a and 23b inserted later." J.A. 1768 at col. 7 ll. 41-47 (emphasis added). Pointing to this statement, the petition proposed that a person of ordinary skill would have had "several reasons" to combine West and Gordon, including that the casting process disclosed by West was a "well-known technique [whose use] would have been a simple design choice." J.A. 218. Smith & Nephew's expert relied on the same passage as support for his opinion that a person of ordinary skill would have found it obvious to implement Gordon's anchor using West's casting method. See J.A. 1648-50. Throughout the proceeding, the parties disputed how a person of ordinary skill would have understood that specific portion of West's disclosure and whether that disclosure would have motivated a person of ordinary skill to combine West and Gordon as Smith & Nephew proposed. Arthrex had-and took-the opportunity to argue these issues, asserting that West's casting method would be inherently problematic. J.A. 402-05, 421-30.
In the final written decision, the Board examined the parties' arguments and the portion of West's disclosure cited in the petition. In considering that disclosure, the Board noted that West's presentation of two manufacturing options suggests that the first option, casting, is "primary" and "preferred."
See
Smith & Nephew, Inc. v. Arthrex, Inc.
, No. IPR2016-00918,
Arthrex is correct that the Board's use of "preferred" differs from the petition's characterization of West's casting as "well-known," "accepted," and "simple." J.A. 218. But in finding motivation to combine, the Board relied on the same few lines of West as the petition. It considered the same proposed combination of West's casting technique and Gordon's anchor. And it ruled on the same theory of obviousness presented in the petition-that one of ordinary skill would have recognized that using West's casting with Gordon's anchor was a "simple design choice."
See
id.
;
Smith & Nephew
,
In these circumstances, the mere fact that the Board did not use the exact language of the petition in the final written decision does not mean it changed theories in a manner inconsistent with the APA and our case law. In
Sirona Dental Systems GmbH v. Institut Straumann AG
, for example, we affirmed the Board even though it characterized a reference as providing "geometry data" rather than as providing 3-D plaster model data, as the petition had.
Though Arthrex argues otherwise, this case is unlike those in which we have found an APA issue. In
Magnum Oil Tools
, we found an APA violation where the Board mixed arguments raised in two different grounds of obviousness in the petition to craft its own new theory of unpatentability.
Nor is this, as Arthrex elsewhere suggests, a case in which the Board's decision is so divorced from the arguments presented by the petitioner as to impair appellate review.
See
Rovalma, S.A. v. Bohler-Edelstahl GmbH & Co. KG
,
B
Arthrex also contends that even if the Board's decision was procedurally proper, the Board erred in finding Smith & Nephew had shown a motivation to combine Gordon and West by a preponderance of the evidence. We review this question of fact for substantial evidence.
In re Kahn
,
Substantial evidence supports the Board's determination that a person of ordinary skill would have been motivated to apply West's casting method to Gordon's anchor. The Board correctly found that West expressly identifies two possible methods for making a rigid support.
See
Smith & Nephew
,
Additional record evidence supports this result. Smith & Nephew's expert, Mr. Mark Ritchart, offered detailed testimony explaining that using a casting process would result in a stronger anchor more likely to receive regulatory approval. J.A. 1649-50. Professor Alexander Slocum testified similarly, stating that the design would also "decrease ... manufacturing costs," "prevent the suture anchor from appearing in and obscuring the bone in x-rays," and "reduce[ ] ... stress concentrations" on the anchor. J.A. 2869-70.
Arthrex correctly notes that some evidence arguably cuts against the Board's conclusion. Mr. Ritchart acknowledged potential complexities of casting, J.A. 3839, and Arthrex's expert, Dr. Kenneth Gall, argued at length that a person of ordinary skill would not have applied West to Gordon as Smith & Nephew argued,
see, e.g.
, J.A. 3747-49. But the presence of evidence supporting the opposite outcome does not preclude substantial evidence from supporting the Board's fact finding.
See, e.g.
,
Falkner v. Inglis
,
II
We next address claim 10. Arthrex challenges the Board's construction of "helical thread," asserting that this term should have been construed to require that the helical thread "facilitates rotary insertion of the anchor into bone." Appellant's Br. 55. Because the Board correctly construed the term and Arthrex does not otherwise challenge the Board's finding that the Curtis ground renders claim 10 unpatentable, we affirm without considering *1330 whether claim 10 is also unpatentable based on Gordon and West.
We review the Board's ultimate claim constructions de novo,
In re Man Mach. Interface Techs. LLC
,
Here, the Board correctly construed "helical thread" as "a helical ridge or raised surface that serves to retain the anchor in bone" without limiting the term to threads used to facilitate rotary insertion.
Smith & Nephew
,
The prosecution history further supports the Board's decision not to limit the claimed "helical thread[s]" to those used for rotational insertion. As Arthrex concedes, Appellant's Br. 60-61 & n.10, three references cited during prosecution describe threaded anchors that are not rotated into the bone. As we have explained, art "cited in the prosecution history of the patent constitutes intrinsic evidence."
V-Formation, Inc. v. Benetton Grp. SpA
,
III
Finally, we address Arthrex's challenge to the constitutionality of certain IPRs. Arthrex notes that the Supreme Court has not addressed the constitutionality of IPR as applied to patents issued prior to the America Invents Act (AIA), which created IPRs.
See
Oil States Energy Servs., LLC v. Greene's Energy Grp., LLC
, --- U.S. ----,
We exercise our discretion and reach Arthrex's argument rather than finding that Arthrex waived this issue by failing to present it to the Board.
See e.g.
,
In re DBC
,
In any event, even if Arthrex's patent had issued prior to the passage of the AIA, our court recently rejected arguments similar to Arthrex's in
Celgene Corp. v. Peter
. No. 18-1167,
CONCLUSION
We have reviewed the parties' remaining arguments and find them unpersuasive. We therefore affirm the Board.
AFFIRMED
Per recent regulation, the Board applies the
Phillips
claim construction standard to petitions filed on or after November 13, 2018.
See
Changes to the Claim Construction Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial and Appeal Board
,
To the extent Arthrex intends to raise a general due process challenge unrelated to retroactivity, the single paragraph of conclusory assertions presented in its opening brief is "insufficient to preserve the issue for appeal."
See
Trading Techs. Int'l, Inc. v. IBG LLC
,
Reference
- Full Case Name
- ARTHREX, INC., Appellant v. SMITH & NEPHEW, INC., Arthrocare Corp., Appellees United States, Intervenor
- Cited By
- 15 cases
- Status
- Published