Wake Forest University Health Sciences ("Wake Forest") appeals the district court's grant of judgment as a matter of law ("JMOL") of invalidity for obviousness. In granting Smith & Nephew, Inc.'s ("S & N") motion for JMOL, the district court overturned the jury's determination that S & N had failed to prove that the asserted claims of the patents in suit were obvious. We conclude that, on the basis of the jury's factual findings, S & N failed to establish by clear and convincing evidence that the claims were obvious. Accordingly, we reverse and remand.
Kinetic Concepts, Inc., KCI Licensing, Inc., KCI USA, Inc., KCI Medical Resources, KCI Manufacturing, and Medical Holdings Limited (collectively "KCI") and Wake Forest brought suit against S & N, alleging infringement of U.S. Patent Nos. 7,216,651 ("'651 patent") and 5,645,081 ("'081 patent"). Wake Forest is the owner of the asserted patents, and KCI are the exclusive licensees of the patents. Both patents claim methods and apparatuses for treating difficult-to-heal wounds by applying suction or negative pressure, e.g., '651 patent Abstract; '081 patent Abstract. Wake Forest and KCI asserted that S & N infringes apparatus claims 2 and 5 of the '081 patent and induces infringement of method claims 42, 109, 116, and 121 of the '651 patent.
As described by the asserted patents, medical "treatment of open wounds that are too large to spontaneously close" is difficult. '081 patent col.1 ll.11-12; '651 patent col.1 ll.29-30. "Wound closure requires that epithelial and subcutaneous tissue migrate from the wound border toward the wound." '081 patent col.2 ll.49-50. To facilitate such migration, doctors commonly use mechanical closures, such as sutures or staples. Id. at col.1 ll.24-25. Such mechanical closures create tension on the skin, which encourages epithelial migration. Id. at col.1 ll.25-28. "While suturing and stapling of wounds is widely practiced, it has a major drawback: the tensile force required to achieve closure with sutures or staples causes very high localized stresses at the suture insertion points, resulting in the rupture of the tissue at these points." Id. at col.1 ll.28-33. This rupturing inhibits healing of the wound. Id. at col.1 ll.33-35. Additionally, it is not feasible to suture some large open wounds. Id. at col.1 ll.28-33.
To address these shortcomings, the invention applies "negative pressure to a wound over an area sufficient to promote migration of epithelial and subcutaneous tissue toward the wound, with the negative pressure being maintained for a time sufficient to facilitate closure of the wound." Id. at col.2 ll.45-49; '651 patent col.4 ll.18-23 ("[A] method of treating tissue damage is provided which comprises applying a negative or reduced pressure to a wound over an area sufficient to promote the migration of epithelial and subcutaneous tissue toward the wound and for a time period sufficient to facilitate closure of the wound."). Claim 2 of the '081 patent and claim 42 of the '651 patent are illustrative:
'081 patent col.9 ll.50-65.
'651 patent col.25 ll.31-48.
Figure 1 of the '651 patent discloses the key components of the claimed apparatus:
As depicted in this figure, the claimed apparatus includes: (1) a vacuum pump (30); (2) tubing (12); (3) an open-celled foam wound screen (10); and (4) an adhesive seal (18). '651 patent col.6 ll.31-61; see also '081 patent col.2 ll.30-35 ("FIG. 1 shows a cross-sectional view of a negative pressure device comprising a open-cell polymer screen, a flexible hose connecting the foam section to a suction pump, and a flexible polymer sheet overlying the foam-hose assembly to provide the necessary seal."). To utilize the apparatus, "[f]irst, the open cell foam is cut to fit the shape of the wound and placed inside the wound. Then the adhesive seal is placed over the foam that is inside the wound." Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102, slip op. at 2 (W.D.Tex. Oct. 10, 2010) (order granting defendant's motion for judgment as a matter of law of invalidity for obviousness) (ECF No. 605) ("JMOL Order"). Once the seal is in place, "[o]ne end of the tubing is placed through the seal into the foam and the other end is attached to the vacuum pump. The vacuum pump is turned on and, because of the tight seal around the wound, the edges of the wound immediately begin to move together." Id.
In the present litigation, S & N asserted prior art that generally falls into three primary categories: (1) the Bagautdinov references; (2) the Zamierowski reference; and (3) the Chariker-Jeter references. On appeal, there is no dispute that these references are all prior art.
The Bagautdinov references consist of two articles written by Dr. Bagautdinov.
Id. Bagautdinov I notes that use of this method "inevitably obtain[s] acceleration of the healing periods and rehabilitation of the patients." J.A. 10003. The second reference ("Bagautdinov II") was also published in 1986. J.A. 10026-27. Bagautdinov II describes application of a method similar to that described in Bagautdinov I to 170 patients. J.A. 10026. The method employed requires that,
J.A. 10026-27. As a result of this method, "[o]n average, the wound became clean by day 4-5, with the appearance of granulated tissue.... The average duration of inpatient treatment was 11.8 bed days, compared to 17.2 in the control group; 61.7% of the patients were released with healed wounds and did not require outpatient treatment." J.A. 10027.
The Zamierowski reference is a Patent Cooperation Treaty Application filed on April 3, 1990. J.A. 10057. The reference describes a "fluidic connection system ... for draining liquids from and introducing liquids to patients." J.A. 10059. As described by the reference, the system, which amounts to a wound dressing, consists of:
J.A. 10061-63. The reference indicates that this wound dressing "promotes healing." J.A. 10063.
The Chariker-Jeter references consist of two published articles ("Chariker-Jeter I" and "Chariker-Jeter II," respectively), J.A. 10044-47; J.A. 10050-56, and Dr. Chariker's 1989 public use of the system described in the articles on Gary Aderholt ("Chariker-Jeter public use"). Both Chariker-Jeter I and Chariker-Jeter II describe the same "closed wound drainage system." J.A. 10052. As described in Chariker-Jeter II, the drainage system is created by:
J.A. 10052 (footnote added). Chariker-Jeter II explains that "[o]ur clinical observations suggest that fistula effluent does inhibit wound healing.... By minimizing the inflammatory response [associated with the presence of effluent], fibroplasia is reduced. This, we believe, encourages rapid wound contraction and re-epithelialization." J.A. 10055.
Finally, with respect to the Chariker-Jeter public use, Dr. Chariker testified that he treated Mr. Aderholt in 1989 with his closed suction wound drainage system. "[Mr. Aderholt] was injured with a log chain that flew off another truck into his truck, entered his chest, his abdomen, ruptured his lung, his [diaphragm], his pancreas, his spleen, his stomach." J.A. 22032:8-11. With the aid of pictures of Mr. Aderholt's treatment, Dr. Chariker stated that his treatment was an example of the drainage system facilitating the healing of a wound on a patient without a fistula. J.A. 22035:6-38:11.
In 2003, Wake Forest and KCI sued Blue Sky Medical Group, Inc., ("Blue Sky") et al., alleging that its gauze based negative pressure wound therapy products infringed U.S. Patent No. 5,636,643
On appeal, this court affirmed the jury's finding that invalidity was not established and that the asserted claims were not infringed. Blue Sky, 554 F.3d at 1025-26. In reaching that conclusion, however, we determined that the district court committed harmless error by failing to construe the term "wound." Id. at 1019. While we did not provide a definitive construction of "wound," we concluded that construing "`wound' to include fistulae and `pus pockets' would [] expand the scope of the claims far beyond anything described in the specification." Id. Significantly, for the present appeal, we also concluded that "wound," "as used in the asserted patents, does not cover the fistulae described in the Chariker-Jeter publications...." Id. at 1018.
During the appeal in the prior litigation, S & N acquired Blue Sky. In December 2008, S & N announced it was launching a new foam-based negative pressure wound treatment product. Responding to this announcement, Wake Forest and KCI filed this suit, asserting that S & N's Renasys product infringed the asserted patents.
After conducting a Markman hearing, the district court construed various terms recited in the claims. For this appeal, the court's construction of only the term "wound" is relevant; it construed this term to mean: "tissue damage to the surface of the body, including the epithelial and subcutaneous layers, and excluding fistulae and pus pockets." Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102, slip op. at 8 (W.D.Tex. Nov. 12, 2009) (claim construction order) (ECF No. 280) ("Claim Construction Order"); see also JMOL Order at 4.
Before the case was given to the jury for determination, the parties disagreed about the form and content of the jury instructions. Wake Forest and KCI had demanded a trial by jury. In response, S & N moved the district court to strike the jury demand with respect to questions of law, including the ultimate question of obviousness. Def.'s Mot. to Strike Pls.' Jury Demand on Questions of Law at 5-9, Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., 08-cv-102 (W.D.Tex. Jan. 21, 2010) (ECF No. 397) ("Motion to Strike"). Prior to ruling on the merits of the motion to strike, the district court conducted an on-the-record pre-trial hearing. During the hearing, S & N made clear that it wanted the jury to make findings with respect to the factors under Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966), and reserve the ultimate question of obviousness for the judge. Pre-Trial Conference Tr. at 16-22, Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102 (W.D.Tex. Jan. 25, 2010) ("Pre-Trial Conference Transcript"). To facilitate this division of responsibility, S & N proposed a special interrogatory verdict form:
Wake Forest and KCI expressed the belief that this proposal was "one of the worst ideas of all time" because it would make the process so complicated that the jury could not get it right, thereby "taking away from the jury the power they have been given by the constitution." Id. at 23. Highlighting their concern with S & N's proposed verdict form, Wake Forest and KCI explained that: "It's not two pages, but actually five pages of questions. Two pages that look like this of detailed questions about whether the prior art discloses teeny tiny aspects of the patent, and two questions that call for a narrative answer from the jury." Id. at 26. Responding to this criticism, the trial judge indicated that he was "very reluctant ... to give juries questions requiring narrative answers." Id. at 27.
The trial judge summarized the parties' arguments as both saying essentially the same thing: "[N]o matter how I present this to the jury I have to make a separate determination as to obviousness. Even if I were to submit this to the jury in a broad form submission — just is it obvious — regardless of what the jury said, my analysis would have to require that I do my own look at the matter from a legal point of view...." Id. at 30. The trial judge concluded the discussion of the Motion to Strike by indicating that he would read the materials presented by the parties and consider using special interrogatories. He cautioned, however, that, "while I'm open to a special interrogatory presentation, I'm not open to a special interrogatory presentation that goes on and on and on." Id. at 30-31.
Four days after conducting the pre-trial hearing, the district court denied S & N's request that it not submit the ultimate question of obviousness to the jury. Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102, slip op. at 4-5 (W.D.Tex. Jan. 29, 2010) (order granting in part and denying in part defendant's motion to strike plaintiff's jury demand on questions of law) (ECF No. 407). It concluded that "[t]he jury instructions shall explain the underlying factual issues that the jury must resolve as well as the legal standard for determining obviousness. Additionally, the jury verdict form shall specifically ask the jury to determine the underlying Graham factors, and make a final determination of obviousness that the court will consider as advisory." Id. at 5.
In accordance with this ruling, the parties began developing proposed joint jury instructions and a special verdict form. At the close of the presentation of evidence, the parties were still developing the instructions and the verdict form. Jury Trial Tr. Day 10 at 2806, Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102 (W.D.Tex. Feb. 23, 2010) ("Day 10 Trial Transcript"). Because the jury instructions and verdict form were not complete and there was some disagreement over the exact form the documents should take, the district court held a charge conference to resolve any remaining disputes, and finalize the instructions and the verdict form. At this stage in the proceeding, the obviousness verdict form proffered by S & N was eighteen pages in length, and Wake Forest and KCI's was slightly more than seven pages in length. Id. at 2969-70. Each of the proposed verdict forms contained specific questions addressing the differences, if any, between the asserted claims and the three categories of prior art discussed above. After reviewing the proposals,
The judge explained his belief that, if the verdict form only posed the ultimate question to the jury, the court would be left with little guidance regarding the factual predicate for the jury's resolution of that issue. Id. at 2990-91. The district court, therefore, expressed its preference to ask the jury specific questions about the various Graham factors, in addition to asking the jury its view on the ultimate conclusion of obviousness. Id. at 2992-94.
After discussing the various options with the parties, the judge decided that the best option was to allow the parties to draft a 300-word description of what the parties asserted were the differences between the three main categories of prior art and each of the asserted claims. These "jury contentions" would be included in the jury instructions. Then the jury verdict form would ask what differences, if any, the jury found between the given claim and the three main categories of prior art, providing space for the jury to list the differences in a narrative. Id. at 2997-3006.
With these guidelines, the judge dismissed the parties to finish drafting the jury instructions and verdict form, explaining that that they would meet that evening when the instructions and verdict form were complete. Id. at 3003-04. The judge advised the parties, however, that "if you've got any better idea on obviousness that you can agree to, I'll be glad to do it, but what you've come up with so far we're not going to do. And so, if you can't come up with anything, then you just have to do it the way I said, which I think is not optimal." Id. at 3062.
When the parties met that night with the judge, a court reporter was not present, so there is no record of the discussion. It is clear from looking at the jury instructions and the verdict form as presented to the jury, however, that the parties and the judge agreed to use a different format than suggested by the judge at the close of the charge conference. Although the jury instructions contain a discussion of the parties' contentions regarding the differences between the prior art and the claims, Jury Trial Tr. Day 11 at 3098-3102, Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102 (W.D.Tex. Feb. 24, 2010) ("Day 11 Trial Transcript"), the verdict form did not allow the jury to provide a narrative about which differences they found to exist, nor did it pose questions regarding all of the Graham factors. J.A. 65-89. Instead, in questions 5(A)-(C), the jury was asked whether several enumerated differences between the prior art and the asserted claims were the only differences that existed. The jury was simply instructed to answer yes or no. In addition, in question 5(D), the verdict form contained a chart that allowed the jury to indicate whether they found certain objective indicia of nonobviousness to be present with respect to each of the asserted claims. J.A. 70. Finally, in question 6, the verdict form asked the jury to decide whether S & N had proven that the asserted claims were obvious. J.A. 71.
The jury determined that the claims and the prior art exhibited differences in addition to those listed, J.A. 64-69, that most of the objective considerations favoring nonobviousness were present with respect to each claim, that infringement was proven, and that obviousness was not established. J.A. 62-63; 71. After the verdict was read to the parties, the district court indicated that the parties should prepare post-trial motions if they wished to challenge the jury's verdict. Jury Verdict Tr.
Pursuant to Rule 50(b) of the Federal Rules of Civil Procedure, S & N moved for JMOL, arguing that all of the asserted claims of the '081 and '651 patents were obvious. In its motion, S & N asserted that substantial evidence did not support the jury's explicit findings that (1) additional differences between the prior art and the asserted claims existed, and (2) that multiple objective indicia of nonobviousness were present.
Responding to S & N's motion, Wake Forest and KCI argued that, in addition to the explicit jury findings, the jury's implicit findings necessary to determine the ultimate question of obviousness should be presumed to have been found in Wake Forest and KCI's favor. Furthermore, these findings, both explicit and implicit, should not be disturbed by the trial court unless they are not supported by substantial evidence. In light of this standard, Wake Forest and KCI asserted that substantial evidence supported the jury's factual determinations: (1) that additional differences existed between the prior art and the asserted claims; (2) that objective indicia of nonobviousness were present; and (3) that teaching away was demonstrated with respect to the Bagautdinov and Chariker-Jeter references. On the basis of these findings, Wake Forest and KCI asserted that S & N's motion should be denied because it failed to establish that the asserted claims were obvious as a matter of law.
Replying to Wake Forest and KCI, S & N highlighted that the jury's verdict of nonobviousness was advisory only. Accordingly, it argued that there were no implicit factual findings in support of the advisory verdict on nonobviousness to which the court should defer. Instead, S & N asserted that "as the ultimate decision-maker on obviousness, th[e] [district] [c]ourt has the responsibility to make its own findings, based upon the current record, necessary to support its own legal conclusion regarding obviousness." Def.'s Reply in Supp. of its Renewed Mot. for J. as a Matter of Law of Invalidity for Obviousness and Mot. for New Trial at 1, Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102 (W.D.Tex. May 12, 2010) (ECF No. 548). Based upon this understanding of how the jury's verdict should be reviewed by the district court, S & N argued that the asserted claims were obvious as a matter of law.
Prior to ruling on the merits of S & N's motion, the court conducted a hearing. S & N began by arguing that, because the jury's verdict on the ultimate question of obviousness was advisory, it is inappropriate to "just assume every finding of fact in favor of" the jury's nonobviousness verdict. Post-Trial Hr'g Tr. at 133, Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08-cv-102 (W.D.Tex. May 17, 2010) ("Post-Trial Hearing Transcript"). Indeed, S & N argued that implied findings of fact only arose with respect to questions 5(A)-(C), regarding additional differences, and 5(D), regarding the existence of objective indicia of nonobviousness. Id. at 133-34, 36. "It is not simply enough to say the jury found obviousness, implied every finding of fact in our favor, which is what KCI is arguing, and therefore the verdict should be upheld. Not true. They are only entitled to implied findings to the extent they are encompassed by the Verdict Question 5, not 6." Id. at 136. S & N argued that substantial evidence did not support the jury's factual finding that additional
Wake Forest and KCI, on the other hand, argued that the jury's verdict on the ultimate question of obviousness is always advisory because, as a question of law, it must be determined by the court. See id. at 153. Nonetheless, "the case law is absolutely clear that ... [w]hen the jury finds that [the claims] are not obvious, you have to assume that they find the right underlying facts, and then the test is substantial evidence" for the underlying factual findings. Id. at 155. Under this standard, Wake Forest and KCI argued that substantial evidence supported the jury's explicit and implicit factual findings, and that S & N's motion should have been denied.
Ultimately, the district court indicated that it would "review[] the jury's conclusions on obviousness, a question of law, without deference, and the underlying findings of fact, whether explicit or implicit within the verdict, for substantial evidence." JMOL Order at 8. After thoroughly summarizing the relevant prior art, the district court concluded that, contrary to the jury's explicit findings, "the differences between the claimed invention and the prior art, if any, are minimal." Id. at 18. Indeed, the district court concluded that the differences were so minor that "such minimal variations would have been apparent to one having ordinary skill in the art...." Id. at 34. The court concluded, therefore, that "the evidence is clear and convincing that there is no legally sufficient basis on the record to conclude that all asserted claims of the patents in suit were not obvious." Id. The fact that the jury also found that several objective indicia of nonobviousness were present did not alter the district court's conclusion because, it said, "the Court is not convinced that they overcome the strong case of obviousness established by the teaching in the prior art." Id. at 35. Accordingly, the court granted S & N's motion and entered judgment in its favor. Id. at 37.
Wake Forest timely appealed.
We review a district court's grant of JMOL de novo, applying the law from the regional circuit, the Fifth Circuit in this case. Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1248 (Fed.Cir.2005). In the Fifth Circuit, JMOL may be granted by the trial court only if "the facts and inferences point so strongly and overwhelmingly in favor of one party that the Court believes that reasonable men could not arrive at a contrary verdict.... On the other hand, if there is substantial evidence opposed to the [grant of JMOL] ... [it] should be denied." Broussard v. State Farm Fire & Cas. Co., 523 F.3d 618, 624 (5th Cir.2008) (quoting Brown v. Bryan Cnty., 219 F.3d 450, 456 (5th Cir.2000)). When evaluating the district court's grant of JMOL, consideration is given to "all of the evidence, drawing all reasonable inferences and resolving all credibility determinations in the light most favorable to the non-moving party." Id. (quoting Brown, 219 F.3d at 456). Because obviousness is a mixed question of law and fact, "[w]e first presume that the jury resolved the underlying factual disputes in favor of the verdict [] and leave those presumed findings
In the face of what amounts to well settled law, S & N argues that, because the jury's verdict in this case was "advisory," "no factual findings implied within the advisory verdict are binding...." Appellee's Br. at 39. S & N asserts, therefore, that we should review only the jury's explicit factual findings with respect to questions 5(A)-(D) for substantial evidence. Because the jury's advisory verdict on the ultimate question of obviousness gave rise to no implied factual findings, S & N contends the district court was free to make its own findings of fact with respect to all issues not submitted to the jury. Id. at 39-40. According to S & N, we should review these factual findings for clear error. Finally, S & N argues that the district court's ultimate conclusion regarding obviousness should be reviewed de novo in light of the factual findings we find to be supported by the evidence. We disagree.
Although S & N is correct that the district court repeatedly referred to the jury in this case as "advisory," S & N is wrong about the implications use of that term carries. We first address the ways in which the phrase "advisory jury" is used by trial courts.
The term is sometimes used to refer to Rule 39(c)(1) juries. Fed.R.Civ.P. 39(c)(1) ("In an action not triable of right by a jury, the court, on motion or on its own: may try any issue with an advisory jury...."). Under Rule 39(c)(1), when an "advisory jury" is used, no jury findings — either explicit or implicit — are binding on the trial court and the court is obligated to make independent findings of fact and conclusions of law on the issue presented to the jury. S & N first claims that the district court submitted the matter to the jury under Rule 39(c)(1) and that accordingly, neither the trial court nor we are bound by the jury's factual findings. We disagree.
We do not believe that the district court intended to invoke Rule 39(c)(1) when it referred to an "advisory jury." First, a Rule 39(c)(1) advisory jury is available only in an action not triable by right to a jury. Id. But, patent infringement actions must be tried to a jury if demanded by a party. Markman v. Westview Instruments, Inc., 517 U.S. 370, 377, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Second, S & N did not ask and the district court did not make special findings that Rule 52 requires in all actions tried "with an advisory jury." Fed.R.Civ.P. 52 ("[T]he court must find the facts specially and state its conclusions of law separately."); see also Transmatic, Inc. v. Gulton Indus., Inc., 53 F.3d 1270, 1275 (Fed.Cir.1995) ("When, as here, trial is held before the district court with an advisory jury, the court must find the facts specially just as it would when conducting a bench trial without an advisory jury." (citing In re Incident Aboard the D/B Ocean King, 758 F.2d 1063, 1072 (5th Cir.1985))). And, rather than filing a motion to have the judgment amended under Rule 52(b),
As a consequence, all of the cases cited by S & N for the proposition that there are "no factual findings implied within the advisory verdict [that] are binding on the district court" are irrelevant because all of the cases involved actions that are not triable to a jury by right and all addressed Rule 39(c)(1) advisory juries. E.g., Am. Calcar, Inc. v. Am. Honda Motor Co., 651 F.3d 1318, 1333 (Fed.Cir.2011) ("Inequitable conduct is equitable in nature, with no right to a jury, and the trial court has the obligation to resolve the underlying facts of materiality and intent." (citation omitted)); Sheila's Shine Prods., Inc. v. Sheila Shine, Inc., 486 F.2d 114, 122 (5th Cir. 1973). Whether the jury's verdict on obviousness gave rise to implied factual findings is not, therefore, controlled by these cases.
The term "advisory jury" can also be used to denote a jury's resolution of a legal issue that the court can permissibly give to the jury to decide, but whose ultimate determination is reserved for the court. See e.g., Spectralytics, Inc. v. Cordis Corp., 649 F.3d 1336, 1341-42 (Fed.Cir. 2011); R.R. Dynamics, Inc. v. A. Stucki Co., 727 F.2d 1506, 1515 (Fed.Cir.1984). As we have explained:
R.R. Dynamics, 727 F.2d at 1515. This appears to be the manner in which the district court used the term "advisory jury." Pre-Trial Conference Transcript at 16-22 ("[N]o matter how I present this to the jury I have to make a separate determination as to obviousness."). This conclusion is buttressed by the fact that the Patent Case Management Judicial Guide, which the district court explained it reviewed with respect to this issue, suggests this use of the term "advisory jury." Peter S. Menell et al., Patent Case Management Judicial Guide 8-32 (2009) ("[T]he court can submit only the relevant Graham factors to the jury for its determination through special interrogatories, with or without an advisory verdict on the legal question of obviousness, and then determine the ultimate question of obviousness itself based on the jury's factual determinations.").
With this understanding of the district court's use of the term "advisory jury," we now address S & N's remaining argument regarding the standard of review. S & N asserts that the district court utilized a Rule 49(a) special interrogatory verdict form. Based on this contention, S & N asserts that there are no implied factual findings to which deference is due because a party waives its right to a jury trial on factual issues for which the party did not demand a special interrogatory and "factual issues not submitted to the jury as special interrogatories are deemed decided by the district court in accordance with the court's judgment." Appellee Br. at 40.
S & N is incorrect. First, a court employing a Fed.R.Civ.P. 49 special verdict form can only require the jury to return such findings as to "each issue of fact." Rule 49(a)(1). Because the ultimate conclusion of obviousness is a legal question, there is strength to the argument that by including that question on its verdict form the court chose to employ a general verdict with answers to written questions governed by Rule 49(b). It is clear that factual findings in support of the general verdict are implied when a verdict form under Rule 49(b) is used. See Quaker City Gear Works, Inc. v. Skil Corp., 747 F.2d 1446, 1453 (Fed.Cir.1984) (explaining that when a Rule 49(a) verdict form includes a legal question, "since the answer to the legal question necessarily resolves any disputed underlying factual issues, we have undertaken to review the factual findings on which the legal conclusion is based, applying the substantial evidence standard." (citation omitted)). Furthermore, we have indicated that, while it is not error to submit legal questions to the jury as part of a Rule 49(a) special verdict form, "since the answer to the legal question necessarily resolves any disputed underlying factual issues," the court must accept implicit factual findings upon which the legal conclusion is based when they are supported by substantial evidence. Id. (citing Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1550 (Fed.Cir.1983)); see also Gaia Techs. Inc. v. Recycled Prods. Corp., 175 F.3d 365, 371 (5th Cir.1999) ("Rule 49(a) does not permit a district court to make findings contrary to the jury verdict."). In essence, because the district
Accordingly, we review all of the jury's explicit and implicit factual findings for substantial evidence. We then examine the legal conclusion of obviousness de novo to determine whether it is correct in light of the factual findings that we find adequately supported. Jurgens, 927 F.2d at 1557.
A patent is obvious, and, therefore, invalid "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains." 35 U.S.C. § 103(a). Obviousness is a question of law based on underlying factual findings: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the art; and (4) objective indicia of nonobviousness. Graham, 383 U.S. at 17-18, 86 S.Ct. 684. A party seeking to invalidate a patent on the basis of obviousness must "demonstrate `by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.'" Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed.Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed.Cir.2007)). While an analysis of any teaching, suggestion, or motivation to combine elements from different prior art references is useful in an obviousness analysis, the overall inquiry must be expansive and flexible. KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 415, 419, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007).
This court has explained, moreover, that the obviousness inquiry requires examination of all four Graham factors. E.g., Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1375 (Fed.Cir.2012). Indeed, courts must consider all of the Graham factors prior to reaching a conclusion with respect to obviousness. In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1076-77 (Fed.Cir.2012) (collecting cases). At all times, the burden is on the defendant to establish by clear and convincing evidence that the patent is obvious. Id. at 1077-78.
Because Wake Forest asserts that the district court erred by granting judgment as a matter of law overturning the jury's verdict, we must determine which of the jury's explicit and implicit factual findings with respect to the Graham factors are supported by substantial evidence. Each of the Graham factors is addressed in turn below.
The parties agree on which references are prior art. On appeal, S & N
The Bagautdinov references disclose a device for draining fluid from purulent wounds. The device involves placement of a polyurethane foam in the purulent wound, attaching the foam to a pump, and covering the apparatus and the wound with a polyethylene film secured to the skin with vaseline oil. J.A. 10002.
The jury was presented with conflicting evidence regarding whether the references treated wounds as construed by the district court, and if they did, whether they treated wounds with negative pressure. S & N's experts contended that the references disclosed the treatment of wounds within the meaning of the asserted claims. See J.A. 22345:13-17 (testimony of Dr. Gordon, S & N's expert, stating that Bagautdinov I disclosed the use of negative pressure to treat a wound). In addition, Dr. Bagautdinov displayed the method disclosed in the references to the jurors with the aid of a manikin. J.A. 22204-05.
Wake Forest presented conflicting testimony, however. It proffered expert testimony that the purulent wounds described in the Bagautdinov references are in fact abscess or pus pockets not within the district court's construction of the term "wound." J.A. 22871:19-21 ("Dr. Bagautdinov is using a variant, or modification of a technique, to aspirate, or to suck out, pus from a purulent wound, which is a pus pocket."); J.A. 21431:15-23 (discussing how Bagautdinov treated pus pockets by lancing and then draining them with the disclosed method). In addition, Wake Forest's expert testified that the Bagautdinov references indicate that use of the device is discontinued when the purulent wound has been cleaned of infection, whereas the patented method and apparatus are utilized only after a wound has been cleaned of infection. J.A. 22878:7-80:16. S & N's expert conceded, moreover, that the Bagautdinov articles were "particularly concerned about the problems related to putting negative pressure on the area of skin surrounding the wound and the risk of spreading infection, causing tissue damage...." J.A. 22343:5-8. In
Finally, Wake Forest presented testimony that the method disclosed in the Bagautdinov references could not create an adequate seal, J.A. 21437:25-38:2; J.A. 21433:2-15, and did not treat wounds through negative pressure because the pressure was not sustained for a long enough period of time. J.A. 21433:18-34:11; J.A. 21437:19-38:2. Indeed, Dr. Bagautdinov admitted that he only used his device to treat "infected wounds," J.A. 22312:15-22, and that he "never considered using [his] technique to treat wounds until closure." J.A. 22310:17-21.
Because of this conflicting expert testimony, the jury was free to "make credibility determinations and believe the witness it considers more trustworthy." Streber v. Hunter, 221 F.3d 701, 726 (5th Cir.2000) (quotations omitted). In light of the jury's determination that S & N failed to prove obviousness, we must infer that the jury found Wake Forest's experts to be credible and persuasive on this point. Broussard, 523 F.3d at 624; Jurgens, 927 F.2d at 1557. Crediting their testimony over that of S & N's expert, there is substantial evidence supporting the factual finding that the Bagautdinov references do not disclose: (1) the treatment of "wounds" as described in patents; or (2) use of negative pressure to treat wounds. There is also substantial evidence to support the finding that the references teach away from maintaining negative pressure on a wound for extended periods of time because of the perceived problems associated with doing so.
The parties agree that the Zamierowski reference's method is utilized on "wounds" within the district court's construction, and discloses placing a screen means into a wound, sealing the wound by placing a membrane with an adhesive coating over the wound, and connecting a tube from under the membrane to a vacuum source. J.A. 28. This system can then be used to either drain from or inject fluid into the wound. J.A. 10063. S & N argues, and the district court found, that the Zamierowski reference also disclosed treating wounds with negative pressure. JMOL Order at 27-28.
During trial, Wake Forest argued that this reference does not disclose healing wounds with negative pressure because it neither disclosed a seal capable of maintaining negative pressure on a wound, nor disclosed treating the wound towards a selected stage of healing as required by the asserted method claims.
The district court concluded that Wake Forest's first argument was incorrect because it found that the patent claims do not require healing to be accomplished by negative pressure. Id. at 27. In the alternative, the district court concluded that the Zamierowski reference met this requirement because fluid is removed from the wound with negative pressure and removal
The district court was incorrect with respect to its determination that the claims of the asserted patents do not require wounds to be healed by negative pressure. First, in the Blue Sky appeal, we concluded that all of the claims of the '081 patent asserted in the present litigation require the use of negative pressure to treat a "wound." 554 F.3d at 1015 ("[E]ach of the asserted claims in both the '081 and '643 patents requires using `reduced' or `negative' pressure to `treat a wound' or `facilitate the healing of a wound....'"). Thus, we have already construed the claims to include this limitation and that legal conclusion was binding on the district court and is binding on this panel. The specifications of both the '081 and '651 patents support our conclusion in Blue Sky, moreover. E.g., '081 patent col.2 ll.45-49 ("The present invention includes... applying a negative pressure to a wound over an area sufficient to promote migration of epithelial and subcutaneous tissue toward the wound, with the negative pressure being maintained for a time sufficient to facilitate closure of the wound."); '651 patent col.2 ll.61-64 ("[A] wound treatment apparatus is provided for treating a wound by applying reduced pressure... to the wound...."). And, before the PTO, the patentees distinguished their claims from the prior art by asserting that references "do not disclose or suggest `an appliance for administering a reduced pressure treatment to a wound'; `an apparatus/method for treating a wound' with reduced pressure." J.A. 5501 ('651 patent); see also J.A. 5502 ('651 patent); J.A. 8267 ('081 patent) (Unlike the prior art, "[the] claimed invention is directed to a device configured to create and maintain negative pressure on a wound site ... for the purpose of administering a negative pressure treatment to the wound."). Finally, S & N never argued before the district court that the asserted claims did not require this limitation. In light of our prior holding in Blue Sky, the language of the specification, and the patentee's statements made during reexamination, we find that each of the asserted claims requires the use of negative pressure to heal or treat wounds.
With respect to the district court's alternative holding, whether the prior art discloses the limitations of a particular claim is a question of fact to be determined by the jury, and Wake Forest presented ample evidence that the Zamierowski reference does not disclose the use of negative pressure to heal wounds. J.A. 21453:19-25; J.A. 22667:24-70:10; J.A. 22866:19-68:12.
In support of its argument that the Zamierowski reference does not disclose a seal capable of maintaining negative pressure, Wake Forest presented testimony that the reference does not create a seal within the meaning of the patent because it uses only a tight liquid seal that has air gaps. J.A. 21472:19-73:11; J.A. 22668:25-69:4. This testimony is consistent with the reference, which indicates that the dressing material is "breathable semipermeable" and the seal is "relatively liquid-tight." J.A. 10068; J.A. 10070. With respect to the contention that "healing" is not accomplished as contemplated by the patents, Wake Forest's expert testified that the Zamierowski reference failed to disclose maintaining negative pressure until the wound has progressed to a selected stage of healing. J.A. 22456:24-58:1; J.A. 22669:5-8. Zamierowski, instead, uses a
Because the jury concluded that S & N failed to establish that the patents were obvious, we must assume that the jury found Wake Forest's expert to be credible and persuasive on this point. In light of this assumption, there is substantial evidence to support the factual finding that the Zamierowski reference does not disclose a sealing means capable of maintaining negative pressure, or maintenance of pressure until the wound has progressed toward a selected stage of healing.
The Chariker-Jeter references, as explained above, disclose a system for treating wounds that are complicated by a fistula. J.A. 10043. The parties dispute whether these references disclose the treatment of a wound within the meaning of the patents, and if it does disclose treatment of such wounds, whether the disclosed device used negative pressure to treat the wounds. With the exception of the Chariker-Jeter public use, the two Chariker-Jeter publications indisputably deal only with the treatment of "[p]atients with draining wounds and fistulae." J.A. 10050.
In Blue Sky, we held that the term wound, as used in these patents "does not cover the fistulae described in the [Chariker-Jeter] publications...." 554 F.3d at 1018. Despite our conclusion that the injuries treated in the Chariker-Jeter publications are not "wounds" within the meaning of these patents, S & N presented testimony attempting to establish that the references disclosed such treatment. J.A. 22348:1-49:12; J.A. 22028:7-30:6. Regarding the Chariker-Jeter public use, which was not addressed in Blue Sky, S & N proffered the testimony of Dr. Chariker who, while he was a resident, helped treat Mr. Aderholt with the system disclosed in the Chariker-Jeter publications. In this testimony, Dr. Chariker testified that he used the system to heal Mr. Aderholt with negative pressure. J.A. 22032:2-38:11.
Wake Forest presented testimony to contradict S & N's evidence. Its expert testified that all of the patients mentioned in the Chariker-Jeter publications had fistulae, and therefore, that the publications do not disclose the treatment of wounds within the district court's construction. J.A. 21441:1-7; J.A. 22672:11-23. In fact, on cross examination Dr. Chariker admitted that neither of the Chariker-Jeter publications discloses wounds not involving a fistula. J.A. 22045:15-25. Wake Forest's experts testified, moreover, that the device disclosed in the Chariker-Jeter references did not use negative pressure to treat wounds. J.A. 22671:12-91:24; J.A.
Significantly, Dr. Chariker conceded that he "didn't publish anything about negative pressure wound therapy regarding fistulas or nonfistulas." J.A. 22046:8-9. Similarly, Dr. Jeter admitted on cross examination that she never suggested using the disclosed device if there was nothing to drain. J.A. 22147:8-11.
With respect to the Chariker-Jeter public use, Wake Forest offered testimony that Mr. Aderholt's wound involved a fistula, so it was not a wound within the meaning of the patents. J.A. 22696:4-13; J.A. 22698:22-99:5; J.A. 22898:22-99:8. On cross examination, moreover, Dr. Chariker refused to say that Mr. Aderholt did not have a fistula; he only stated that one was never diagnosed. J.A. 22057:23; J.A. 22058:4; J.A. 22085:2-6. In addition, Wake Forest's expert testified that, based on his reading of Mr. Aderholt's operative notes and pictures of his treatment, the system used on Mr. Aderholt was not the system disclosed in the Chariker-Jeter publications. J.A. 22714:25-15:9. Wake Forest's expert also testified that the Chariker-Jeter public use did not have a seal capable of maintaining negative pressure because Mr. Aderholt's skin had several sump drains that freely let air flow. J.A. 2900:14-02:14. In other words, his wound was not healed with negative pressure. J.A. 2712:13-14:19.
Finally, Wake Forest's experts testified that use of the drainage system disclosed in the Chariker-Jeter publications was discontinued when the fistula closed or substantial drainage from the fistula stopped, irrespective of the state of any wound healing. J.A. 22869:20-70:12; J.A. 21438:13-39:18; J.A. 22672:24-74:4; J.A. 22870:3-5 ("In every single case, every single case that they show in the book chapter and in the article, the minute the fistula stopped draining, they got rid of their device."). Dr. Chariker conceded this fact on cross examination. J.A. 22062:17-20. This, again, reasonably could be deemed a teaching away from continued long-term use of the device, as directed by the '081 and '651 patents.
Again, because of the procedural posture of this case, we must assume that the jury found Wake Forest's experts credible and persuasive. Rather than credit this testimony, however, the district court impermissibly re-weighed witness credibility, concluding that Wake Forest's expert's testimony that Mr. Aderholt had a fistula was "completely unsupported by the evidence." JMOL Order at 32. This was error. See Blue Sky, 554 F.3d at 1020. On the basis of this credited testimony, there is substantial evidence to support the finding that: (1) none of the Chariker-Jeter references discloses treatment of a wound within the meaning of the patents (as distinct from a fistula or pus pocket); (2) the Chariker-Jeter references do not disclose use of negative pressure to heal or treat wounds
Although the parties did not stipulate the level of ordinary skill in the art, S & N's expert testified that the level of ordinary skill in the art "would include health care professionals, for example physicians or nurses, but it could be a podiatrist or somebody else, who has additional training or knowledge about wound care. It could also be engineers with experience operating or designing equipment used in conjunction with wound care." J.A. 22340:8-13. According to the district court, Wake Forest asserted that the level of skill was higher. J.A. 393. Because it is generally easier to establish obviousness under a higher level of ordinary skill in the art, Innovention Toys, LLC v. MGA Entm't, Inc., 637 F.3d 1314, 1323 (Fed.Cir. 2011) ("A less sophisticated level of skill generally favors a determination of nonobviousness, and thus the patentee, while a higher level of skill favors the reverse." (citation omitted)), we must assume that, in light of the jury's verdict, it adopted the lower level of skill proposed by S & N.
The jury explicitly found that the prior art and the asserted claims exhibited several differences, which S & N conceded existed. J.A. 65-69. In addition, the jury stated that each of the prior art references exhibited additional differences from those explicitly mentioned on the verdict form, although they were not asked to and, thus, did not identify those additional differences.
Although there are many differences between the primary prior art references and the asserted claims, for the purpose of this appeal, we need only focus on three. As discussed above, substantial evidence supports the finding that none of the references discloses treating wounds with negative pressure as required by the patents. Nor do the Bagautdinov and Chariker-Jeter references relate to the treatment of wounds described in the patents, as construed by this court in Blue Sky and the district court here. Finally, the Bagautdinov references and the Zamierowski reference do not disclose a seal capable of maintaining negative pressure. Accordingly, none of the references discloses healing or treatment with negative pressure. Only the Zamierowski reference discloses treating or healing wounds and only the Chariker-Jeter printed publications disclose a seal that is capable of maintaining pressure.
Even if the references disclosed all of the limitations of the asserted claims, which they do not, S & N still needed to proffer evidence indicating why a person having ordinary skill in the art would combine the references to arrive at the claimed invention. Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 (Fed.
With respect to the '081 asserted claims, the jury found the following indicia of nonobviousness: (1) commercial success; (2) long felt need; (3) copying; (4) unexpected results; (5) acceptance by others; and (6) initial skepticism. With respect to the '651 asserted claims, the jury found that for claims 109 and 116 on the basis of performing the method of claim 42, and claim 121 on the basis of performing the method of claim 42, the same indicia of nonobvious were present. Regarding claim 116, on the basis of performing the method of claim 20, and claim 121, on the basis of performing the method of claim 20, the jury concluded that only copying existed.
Wake Forest presented testimony regarding each of the objective indicia found by the jury. J.A. 22827:3-32:10; J.A. 217771:11-23; J.A. 21077:19-79:15. Wake Forest offered evidence that leading experts in the field were skeptical that the "counterintuitive" device could work. J.A. 22827:3-12, J.A. 22828:21-29:23, J.A. 21078:4-79:5. One expert testified that he "didn't know how you could put this [negative] pressure on a wound and not cut off the blood supply, not cause infection, etc." J.A. 22827:3-9. Indeed, Dr. Argenta, an inventor of the patents, testified that the hospital where he worked was concerned about allowing him to try his device on a patient with a serious wound, which could not be healed with conventional methods, but the "decision [was] do you let [the patient] die or do you try something." J.A. 20446:3-23. To everyone's surprise, the device completely healed this patient. J.A. 20446:21-47:6. The medical community was so skeptical of the device, moreover, that the patents' inventors had difficultly publishing their findings in peer-reviewed journals, J.A. 20501:1-19 (Reviewers from the journal Plastic and Reconstructive Surgery stated that "there was no way that this was possible, that this device could do this"), and they were turned away by conference organizers when they attempted to present the discovery. J.A. 20502:10-15; J.A. 20501:3.
Despite this initial skepticism, over time the device was widely adopted and praised. J.A. 22830:6-31:8, J.A. 21079:10-12. Wake Forest presented testimony from experts that the patented device "changed the way we do surgery," J.A. 21079:11-12, and "changed the way ... we've been treating wounds for the last twenty, thirty years."
Finally, Wake Forest proffered testimony that the device has been copied. For example, in internal documents and marketing materials, S & N repeatedly compares its products to the V.A.C., the commercial embodiment of the patents. J.A. 22760:11-61:23; J.A. 20537:17-39:18; J.A. 20999:1-21. Indeed, S & N's expert admitted that he authored an article explaining how to create "an off-the-shelf or makeshift V.A.C." J.A. 22410:18-12:6.
In the face of this evidence, S & N offered no rebuttal evidence. S & N's own invalidity expert even admitted that he did not consider the objective indicia of nonobviousness in reaching his conclusions regarding the invalidity of the patents. J.A. 22396:20-97:8; J.A. 22415:24-16:15. Significantly, the district court concluded that Wake Forest "present[ed] ample evidence of success of V.A.C. product and the other secondary considerations tending to show non-obviousness." J.A. 37. On the basis of this record, there is more than substantial evidence supporting the jury's findings of commercial success, long-felt need, copying, unexpected and superior results, wide spread acceptance in the field, and initial skepticism.
Having determined that the jury's explicit and several implicit factual findings are supported by substantial evidence, "we examine the [ultimate] legal conclusion [of obviousness] de novo to see whether it is correct in light of" these factual findings. Jurgens, 927 F.2d at 1557 (internal citations omitted); see also Wyers v. Master Lock Co., 616 F.3d 1231, 1248 (Fed.Cir. 2010) (Linn, J., concurring). Despite the district court's detailed analysis, we find that, on the basis of the jury's factual findings, it erred by granting S & N's Motion for JMOL.
While the Supreme Court made clear that a mechanical application of the teaching-suggestion-motivation test, requiring an explicit teaching in the prior art, is inappropriate, "[w]e must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention." Innogenetics, 512 F.3d at 1374 n. 3.
As noted above, S & N never offered evidence articulating why a person having
At a minimum, creation of the claimed apparatus or method requires combining the Zamierowski references, which disclose treating or healing of wounds, with the Chariker-Jeter publications that disclose a seal capable of maintaining negative pressure. The record is devoid of any reason someone would combine these references, however. Indeed, Wake Forest's experts testified that there was no reason to combine them. J.A. 22865:15-66:17; J.A. 22868:13-69:19; J.A. 22870:22-71:12. In addition, both of these references independently accomplish similar functions, namely, draining fluids. Because each device independently operates effectively, a person having ordinary skill in the art, who was merely seeking to create a better device to drain fluids from a wound, would have no reason to combine the features of both devices into a single device. Nor do the Bagautdinov references provide such motivation to combine the Zamierowski references and the Chariker-Jeter publications to arrive at the method and apparatus claimed in the patents in suit. Again, the Bagautdinov references disclose only the draining of purulent wounds; it says nothing about treating wounds within the district court's construction, much less the healing of such wounds with negative pressure.
As Dr. Argenta noted, moreover, if any of the doctors who created the devices disclosed in the prior art thought that negative pressure actually healed wounds, they would have left the devices in place until the wounds were fully healed. J.A. 22870. All of the doctors removed the devices after the wounds were drained, but before healing with negative pressure began. This indicates that the doctors were not using the disclosed devices and methods to heal wounds with negative pressure because they did not believe that these devices were capable of such healing. In fact, several of the primary references disclosed methods that purposefully minimize granulization while the devices were in place because of the perceived dangers associated with negative pressure. This amounts to significant evidence of teaching away. On the basis of this evidence, hindsight provides the only discernable reason to combine the prior art references. Unless one knew that negative pressure could be used to treat wounds, there would be no reason to combine the prior art to arrive at the claimed device and methods.
It is clear, moreover, that the district court concluded that the invention was obvious because it believed the claims contained elements that were not new. This reasoning is incorrect: "a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art." KSR, 550 U.S. at 418, 127 S.Ct. 1727. Because none of the prior art references disclosed utilizing negative pressure to heal wounds, this is not even a
Finally, the significant objective indicia of nonobviousness strongly weigh against a finding of obviousness. Mintz, 679 F.3d at 1378 (Evidence of objective indicia of nonobviousness "may often establish that an invention appearing to have been obvious in light of the prior art was not." (citation omitted)); In re Cyclobenzaprine, 676 F.3d at 1075-76 (same); see also Crocs, Inc. v. Int'l Trade Comm'n, 598 F.3d 1294, 1310 (Fed.Cir.2010) ("Secondary considerations `can be the most probative evidence of nonobviousness in the record, and enables the... court to avert the trap of hindsight.'") (quoting Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 960 (Fed.Cir.1986)); Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1365 (Fed.Cir.2008) ("Objective indicia may often be the most probative and cogent evidence of nonobviousness in the record.") (quoting Catalina Lighting, Inc. v. Lamps Plus, Inc., 295 F.3d 1277, 1288 (Fed.Cir.2002) (citation omitted)). We require analysis of the objective indicia because they "provide objective evidence of how the patented device is viewed in the marketplace, by those directly interested in the product." Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1391 (Fed.Cir.1988). As discussed above, the medical community scoffed at this device when it was initially introduced. The industry was skeptical that the device worked even after reading studies that established that it did in fact work. J.A. 21078:19-21079:5. After the system was disseminated, moreover, everyone began using it, and the method and apparatus were copied. This evidence provides a key objective insight into how the medical community viewed the patented device.
Significantly, this is not a case where the jury found the presence of only one or two objective indicia of nonobviousness. Nor is it a case where S & N seriously disputes those findings. Rather, the evidence strongly establishes the existence of nearly every objective indicia of nonobviousness, namely commercial success, long-felt need, copying, unexpected and superior results, wide spread acceptance in the field, and initial skepticism. See Allen Archery, Inc. v. Browning Mfg. Co., 819 F.2d 1087, 1092 (Fed.Cir.1987) ("[P]raise from a competitor tends to indicat[e] that the invention was not obvious." (alteration in original) (internal quotation omitted)); Gambro Lundia AB v. Baxter Healthcare Corp., 110 F.3d 1573, 1579 (Fed.Cir.1997) (acknowledging that the accused infringer's "recognition of the importance of this advance is relevant to a determination of nonobviousness."). We recently warned about the dangers of ignoring objective indicia of nonobviousness in Mintz, where we said: "[s]imply because the technology can be easily understood does not mean that it will satisfy the legal standard of obviousness. In fact, objective consideration of simple technology is often the most difficult because, once the problem and solution appear together in the patent disclosure, the advance seems self-evident." 679 F.3d at 1379. The objective indicia of nonobviousness serve a particularly important role in a case, like this one, where there is a battle of scientific experts regarding the obviousness of the invention. In such a case, the objective indicia provide an unbiased indication
Here, the objective evidence strongly supports the jury's findings under the first three Graham factors and cuts against the view that the claimed inventions were an obvious combination of known elements from the prior art.
On this record, S & N has not proven by clear and convincing evidence that the asserted claims are obvious. The district court committed error by failing to defer to the jury's factual findings and granting JMOL on obviousness. Because the district court concluded that the other issues raised in S & N's motion for JMOL were moot in light of its decision to grant JMOL on obviousness, we reverse and remand, so the district court can consider those arguments in the first instance.
Each party shall bear its own costs.
DYK, Circuit Judge, concurring.
I agree with the majority that deference is owed to the jury's implied findings in support of its nonobviousness verdict for the reasons ably set forth in the majority opinion. However, I write separately because, in my view, the majority errs in its construction of the "healing" limitations of these claims. Because the jury was not properly instructed on claim construction, it is impossible to determine what findings the jury made. At the same time, because the accused infringer did not seek a construction of the "healing" limitations, we should assume the jury used the correct construction. Under this construction, there was not substantial evidence that the claim limitations were absent from the prior art (though not in a single reference) or that secondary considerations supported a finding of non-obviousness, but there was substantial evidence for the jury to have found insufficient motivation to combine. On this ground, I agree with the majority that the accused infringer has not established invalidity for obviousness as a matter of law.
As the majority describes, the asserted claims cover an apparatus and method for treating wounds by applying suction, or "negative pressure," and Bagautdinov, Chariker-Jeter, and Zamierowski are three groups of prior art that disclose similar suction treatment systems. The jury found that none of the asserted claims would have been obvious over this prior art, but the district court granted judgment as a matter of law ("JMOL") that all of the asserted claims were invalid for obviousness.
"It is elementary in patent law that, in determining whether a patent is valid ... the first step is to determine the meaning and scope of each claim in suit." Nat'l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1334 (Fed.Cir.2004) (quoting Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed.Cir. 2001)); see also TI Grp. Auto. Sys. (N. Am.), Inc. v. VDO N. Am., L.L.C., 375 F.3d 1126, 1139 (Fed.Cir.2004) ("Our validity analysis is a two-step procedure: `The first step involves the proper interpretation of the claims.'") (quoting Beachcombers, Int'l, Inc. v. WildeWood Creative Prods., Inc., 31 F.3d 1154, 1160 (Fed.Cir. 1994)). The meaning of a claim is a purely
The majority excuses its failure to do so on the ground that these claim construction issues "were neither raised nor discussed before the district court, and were not argued in this appeal." Maj. Op. at 1346 n. 1. I agree with the majority that the parties have failed to address the claim construction issues directly, and have chosen instead to address the issues without the benefit of a proper claim construction. Nonetheless, defendant-appellee Smith & Nephew does contest the extent to which "healing" is required by the claims, arguing that "Wake Forest attempted to redefine its claimed invention throughout this litigation and continues to do so on appeal" by "mischaracterize[ing] the claims as requiring `active' treatment of `clean' wounds for `extended' periods of time in order to heal the wounds," even though "none of those limitations is in the claims." Def.-Appellee's Br. 41.
The asserted claims are claims 2 and 5 of U.S. Patent No. 5,645,081 ("the '081 patent") and claims 42, 109, 116, and 121 of U.S. Patent No. 7,216,651 ("the '651 patent"). The '081 claims both require the apparatus to create negative pressure "for facilitating the healing of wounds"
In my view, the "healing" limitations are properly construed as requiring only some progress toward healing — for example, the formation of some new tissue or skin — and not complete healing or wound closure. The language of the "selected stage of healing" limitation itself clearly indicates that only some progress toward healing is required. Additionally, claim 20 of the '651 patent (upon which claims 109, 116, and 121 depend) refers to "maintaining
There is also no indication in the specifications that "healing" or "selected stage of healing" refers to any particular stage of healing; the '651 patent simply notes that "[a]n initial stage of wound healing is characterized by the formation of granulation tissue" and that "[a] selected state of improved condition may include" a number of conditions, including any "stages of improvement or healing appropriate to a given type of wound or wound complex." '651 Patent col. 1 ll. 40-41, col. 12 ll. 59-66. The '081 patent does not define "facilitating... healing" (as used in the claim preambles), but it notes that the invention may be used to "promote the migration of... tissue," "reduce bacterial density in a wound," or "prevent[] the infection [in a burn wound] from becoming [too] severe," "facilitating ... healing." '081 Patent col. 1 ll. 57-58, col. 2 ll. 1-2, col. 3 l. 67-col. 4 l. 1.
Although the majority opinion does not explicitly construe the "healing" limitations, it seems to make three assumptions as to the meaning of these limitations. First, the majority suggests that the claims require application of negative pressure for a particular extended length of time. For example, the majority explains that Bagautdinov did not sustain pressure "for a long enough period of time" and taught away from applying negative pressure "for extended periods"; and that Chariker-Jeter taught "away from continued long-term use of the device, as directed by the '081 and '651 patents." Maj. Op. at 1362, 1365. But as discussed above, the district court correctly determined that the claims do not have a minimum time limitation, and that construction is not challenged on appeal.
Second, to some extent, the majority suggests that the claims require more than some progress toward healing, such as complete healing or closure. For example,
Third, the majority seems to suggest that the prior art was different from the claimed invention because the purpose of the prior art was drainage and cleaning, rather than healing. The majority explains that Bagautdinov was "for draining fluid" and was "discontinued when the purulent wound has been cleaned"; that Zamierowski is "used to either drain from or inject fluid into the wound" and was not used "for wound therapy"; and that Chariker-Jeter was a "drainage system" that was "discontinued when the fistula closed or substantial drainage from the fistula stopped." Maj. Op. 1362, 1364, 1365. However, the claims do not contain a purpose requirement — it is enough that healing is disclosed by the prior art, even if this was not the intention of the prior art inventors. As the Supreme Court explained, "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 419, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007); see also Nat'l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319, 1339 (Fed.Cir. 2004) ("A finding that two inventions were designed to resolve different problems ... is insufficient to demonstrate that one invention teaches away from another."); In re Beattie, 974 F.2d 1309, 1312 (Fed.Cir. 1992) ("[T]he law does not require that the references be combined for the reasons contemplated by the inventor."). It is irrelevant that the prior art had the purpose of drainage as long as it used negative pressure to heal wounds within the meaning of the claims.
As discussed below, the majority's erroneous claim construction leads it to incorrectly conclude that the claim limitations are not found in the prior art and that secondary considerations supported a finding of non-obviousness.
Under the correct claim construction, contrary to the majority, the claim limitations are disclosed in the prior art. Because the jury received no instruction on the meaning of the "healing" limitations, it is impossible to determine whether the jury's findings in support of its nonobviousness verdict were based on the correct construction.
Under the proper construction, the Bagautdinov, Chariker-Jeter, and Zamierowski groups of prior art all meet the limitations of "maintaining" negative pressure "for ... healing" or until a "selected stage of healing" because they explicitly disclose the re-growth of tissue and skin (i.e., the formation of granulation tissue and re-epithelialization). The Bagautdinov method "accelerates ... sealing of purulent wounds," and "the appearance of granulated tissue" was seen around the fourth or fifth day of vacuum treatment. J.A. 10003, 10027. One of the Chariker-Jeter publications states that "an increased rate of granulation and re-epithelialization is seen with the closed suction wound drainage system." J.A. 10051. And Zamierowski states that it "promotes healing" and that "the present invention is particularly well adapted for the ... regeneration of skin graft donor sites." J.A. 10063, 10067.
The majority also errs, in my view, in finding that the jury could properly rely on secondary considerations to find the claims non-obvious. The failure to construe the "healing" limitations affects not only the prima facie case of obviousness, but also the analysis of secondary considerations, as we cannot determine whether the jury's findings of secondary considerations were based on a proper understanding of claim scope. "Evidence of secondary considerations must be reasonably commensurate with the scope of the claims." In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed.Cir.2011). Secondary considerations related to a patentee's commercial product is not probative of nonobviousness if the asserted claims are far broader than that commercial embodiment. Here, as the majority notes, there was substantial evidence that the patentee's product (1) was a commercial success; (2) was responsive to a long-felt need; (3) was copied by others; (4) had unexpected results; (5) was accepted by others; and (6) faced initial skepticism. Maj. Op. at 1367. These secondary considerations, however, were related to the use of the commercial device utilizing the patent for extended periods to close and completely heal wounds.
As the majority describes, there is, however, substantial evidence that Bagautdinov and Chariker-Jeter treat pus pockets and fistulae, respectively, rather than "wounds," and that Bagautdinov, Zamierowski, and the Chariker-Jeter public use do not disclose an adequate seal. Thus, at the very least, to find obviousness, a person of ordinary skill would have needed a motivation to combine the treatment of "wounds" by Zamierowski with the seal from the Chariker-Jeter publications. While motivation to combine may be addressed on summary judgment or JMOL in appropriate circumstances, see Wyers v. Master Lock Co., 616 F.3d 1231, 1240 (Fed.Cir.2010), it is still a question of fact, and the accused infringers have failed to show that there was not substantial evidence to support a finding of insufficient motivation to combine. In other words, under the assumption that the jury used the correct construction of the "healing" limitations, there is substantial evidence for the jury to have at least found the asserted claims non-obvious due to insufficient motivation to combine. Thus, I agree with the majority's ultimate conclusion that the district court erred in granting JMOL of obviousness.
