Opinion ID: 806478
Heading Depth: 3
Heading Rank: 2

Heading: Level of Ordinary Skill in the Art

Text: 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. C. Differences Between the Claimed Invention and the Prior Art 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 41 KINETIC CONCEPTS v. SMITH & NEPHEW 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. Cir. 2008) (holding that post-KSR “some kind of motivation must be shown from some source, so that the jury can understand why a person of ordinary skill would have thought of either combining two or more references or modifying one to achieve the patented [invention].” (citation omitted)). Significantly, whether there is a reason to combine prior art references is a question of fact. Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296, 1303 (Fed. Cir. 2010) (citing McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1352 (Fed. Cir. KINETIC CONCEPTS v. SMITH & NEPHEW 42 2001)). Here, not only did S&N offer no evidence establishing a reason to combine, but Wake Forest offered substantial evidence that a person having ordinary skill in the art had no reason to combine the prior art references to arrive at the claimed invention. E.g., J.A. 22669:18–25; J.A. 22691:18–22; J.A. 22715:25–16:4; J.A. 22737:7–11; J.A. 22753:24–54:3. In light of the jury’s verdict, we must assume that it determined there was no reason to combine the prior art references, and we must defer to this factual finding because it is supported by substantial evidence. D. Objective Indicia of Nonobviousness 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 43 KINETIC CONCEPTS v. SMITH & NEPHEW 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.” J.A. 22831:1–3. Indeed, S&N’s own expert testified that the device was “a paradigm shift in wound healing” and that it “is so effective that it’s changed the way that [he] and [his] fellow surgeons treat serious wounds.” J.A. 22409:11–10:11. To date, the device has been used on more than three million patients. J.A. 21753:22–25. Indeed, Harvard Medical School called the device an “exciting novel therapeutic approach to wounds,” J.A. 20504:22–05:2, and the American Association of Plastic Surgeons recognized the device as the last decade’s “biggest advance in the plastic surgery field.” J.A. 22762:10–15. The effectiveness of the device and this KINETIC CONCEPTS v. SMITH & NEPHEW 44 praise has made it a commercial success with $1.4 billion in annual sales. J.A. 21771:12–13. 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-theshelf 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. E. The Ultimate Conclusion of Obviousness 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 45 KINETIC CONCEPTS v. SMITH & NEPHEW find that, on the basis of the jury’s factual findings, it erred by granting S&N’s Motion for JMOL. 10 While the Supreme Court made clear that a mechani- cal 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 ordinary skill in the art would combine the primary references to obtain the disclosed inventions. Although expert testimony regarding motivation to combine is not always required, the technology at issue here is not the type of technology where common sense would provide the motivation to combine these references. See Master Lock Co., 616 F.3d at 1240 n.5 (“However, as we [have] noted . . . ‘expert testimony regarding matters beyond the comprehension of laypersons is sometimes essential,’ particularly in cases involving complex technology. In such cases, expert testimony may be critical, for example, to establish . . . the existence (or lack thereof) of a motivation to combine references.” (internal citations omitted)). At a minimum, creation of the claimed apparatus or method requires combining the Zamierowski references, which disclose treating or healing of wounds, with the 10This conclusion is consistent with the PTO’s determination on reexamination that claims of the ’651 and ’081 patents were patentable in the face of some references at issue here. While this determination is not binding on this court, the jury was informed of the results of the reexamination and S&N does not dispute the admissibility of this evidence. KINETIC CONCEPTS v. SMITH & NEPHEW 46 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 47 KINETIC CONCEPTS v. SMITH & NEPHEW 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. Because none of the prior art references disclosed utilizing negative pressure to heal wounds, this is not even a case where the inventions at issue are merely composed of elements that were known in the art. Indeed, nearly seven years after the ’081 patent was filed, Dr. Attinger testified that he still did not believe the apparatus and method disclosed in the patents would work. J.A. 22827:3–29:2. 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 eviKINETIC CONCEPTS v. SMITH & NEPHEW 48 dence 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 49 KINETIC CONCEPTS v. SMITH & NEPHEW 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 regarding the credibility of that evidence. 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 con- vincing 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.