Claim Term Analysis and Secondary Considerations in Inter Partes - - PDF document

SEPTEMBER/OCTOBER 2014

I P L i t i g a t o r

5

Andrew P. Ritter is an associate at Sughrue Mion, PLLC in Washington, DC. His practice focuses on patent prosecution, inter partes matters, and opinion preparation on matters relating to infringement and validity in litigation. Mr. Ritter focuses on such areas as computer systems, medical systems, medical devices, electrical and optical connectors, and

• ther mechanical and electrical devices. The views

expressed herein are solely those of the author. In a recent inter partes review (IPR), the Patent and Trial Appeals Board (PTAB), in addressing two impor- tant concepts in construing and validating patent claims, found that only some of the grounds of patentability were sufficient to meet the “preponderance of the evi- dence standard” for determining claims unpatentable. Specifically, the PTAB held that claim terms in an IPR are construed in a broad but reasonable manner and that secondary considerations, without any nexus between the evidence of the secondary considerations and the claimed invention, are not enough to save claims from a prima facie case of obviousness.1 As the two-year anniversary of the implementation

• f the IPR approaches, a brief overview of the IPR is

provided, while presenting an analysis of the claim term construction and the application of secondary consider- ations in IPR proceedings.

Inter Partes Review Background

Inter partes review proceedings became available on September 16, 2012, replacing the preexisting inter partes reexamination procedure. Under the American Invents Act (AIA), the change from inter partes reexamination to IPR “convert[ed] inter partes reexamination from an examination to an adjudicative proceeding,” while also elevating the threshold for initiating IPRs, institut- ing estoppel provisions, and allowing the petitioner to challenge any and all patents, among other changes.2 The burden on the petitioner to prove invalidity in an IPR, however, remains unchanged from inter partes reexamination procedures, in which the petitioner must prove “that a patent is invalid by a preponderance of the evidence.”3 In addition, to determine the validity of a patent dur- ing an IPR, claim terms are construed using a “broadest reasonable construction” in view of the specification.4 Furthermore, factors relating to the validity of the claimed invention under 35 U.S.C. §§ 102 and 103 also must be investigated.

The “Broad But Reasonable” Claim Term

The enactment of the AIA by Congress gave petition- ers the ability to request that the PTAB cancel one or more claims of a patent, by determining that the claim

• r claims are unpatentable under 35 U.S.C. §§ 102 or

103, based on prior art consisting of patents and printed publications.5 Unlike litigation in district courts, where claims are presumed valid and claims are construed based on the narrower Phillips standard,6 the PTAB uses the broadest reasonable construction standard during IPRs of unexpired patents.7 Thus, the petitioner in an IPR has a greater opportunity to prove invalidity of one

• r more claims than an accused infringer in district court

litigation. While IPR proceedings are still in their infancy, the PTAB has made clear that the broadest reason- able interpretation standard will be applied in IPR

• proceedings. For example, the PTAB has applied the

broadest reasonable interpretation standard in each of its decisions. The PTAB’s decision in Nuvasive, Inc. v. Warsaw Orthopedic, Inc. provides several examples of the PTAB’s claim construction using the “broad but reasonable” standard.

Nuvasive, Inc. v. Warsaw Orthopedic, Inc.

During the Nuvasive IPR, six grounds of unpatentabil- ity were asserted against the patent at issue based on six asserted prior art. In its decision, the PTAB reproduced claim 9 as illustrative of the claimed subject matter of the patent.8 Claim 9 is directed to methods of performing surgery along a lateral aspect of the spine by sequentially

Claim Term Analysis and Secondary Considerations in Inter Partes Review

Andrew P. Ritter

6

I P L i t i g a t o r

SEPTEMBER/OCTOBER 2014

advancing surgical instruments through a lateral aspect

• f the spine, using each preceding surgical instrument as

a guide, to place a spinal implant in a disc space of the spine.9 In its decision, the PTAB determined claims 17-23 were prima facie obvious under 35 U.S.C. § 103(a) over prior art references to Jacobson, Leu, and Brantigan, in view of a broad but reasonable construction of the claim terms.

What Is “Lateral”?

During the IPR, the patent owner, Warsaw, argued that the feature “a path having an axis lying in a coronal plane,” as recited in Claim 17, must lie in a direct lateral path to the spine.10 However, the PTAB determined that Jacobson, which depicts passing a cannula laterally to an intervertebral space, was sufficient to teach this feature

• f Claim 17.11 In its argument, the patent owner alleged

that “lateral” as recited in Claim 17 actually meant a direct lateral approach to the spine (i.e., a 90 degree lat- eral approach), while the disclosure of Jacobson only disclosed a posterolateral approach.12 To rebut the patent

• wner’s argument, the petitioner, Nuvasive, presented

expert testimony that one of ordinary skill in the art would understand that “lateral” meant just that—a lat- eral approach to the spine.13 In agreeing with the petitioner, the PTAB stated that “[w]e credit [the expert’s] testimony that one of ordi- nary skill in the art would have understood the term “lateral … to mean ‘lateral’ … at least because it would have been reasonable for one of ordinary skill in the art to have construed [the] term with a common, accepted definition.”14 Furthermore, the PTAB also stated that the failure of Claim 17 to recite “direct lateral” supports that the determination that a person of ordinary skill in the art would not have construed the term lateral to mean “direct lateral.”15 In other words, the PTAB construed the term at its most common definition, which was the most reasonable interpretation of the term.

Defining an Implantable Space

The PTAB also determined whether the feature “implant being sized to occupy substantially the full transverse widths of the vertebral bodies,” as recited in claim 17, was prima facie obvious in view of Brantigan. In construing the above-recited feature of claim 17, the PTAB agreed with the petitioner that Brantigan discloses an “implant that is both shaped and sized with regard to the disc space.”16 However, the patent owner argued that Brantigan discloses an implant designed to sit within an apophyseal ring and to sit in a central region of adja- cent vertebral bodies.17 In other words, the patent owner asserted that Brantigan failed to disclose an implant that extended beyond a central region of the vertebral body

• r overlapped onto an apophyseal ring.18 However, the

PTAB found that Brantigan disclosed an implant “sized to conform with the disc spaced between adjoining vertebrae.”19 In construing the term “disc space,” as recited in claim 17, the PTAB determined that a broad but reasonable construction, in light of the specification, would “include a space between adjacent vertebral bodies.”20 However, the patent owner relied on expert testimony from the inventor of the patent at issue to provide an anatomical definition of a “vertebral body” as: [Containing] a vertebral endplate that “is typi- cally vascular,” an “apophyseal ring” “anatomically distinct from the vertebral endplate” and “almost entirely avascular” located “[t]oward the vertebral periphery,” and a “cortical rim” “distinct from the apophyseal ring” located “[a]t the very edge of the vertebral body.”21 The PTAB determined that, regardless of whether or not the expert’s anatomical definitions were correct, the patent owner did not provide sufficient evidence to show that the implant as claimed extended outside the disc space.22 Thus, in agreeing with the petitioner, the PTAB determined that an implant sized to conform to the “disc space,” which includes the space between adjacent verte- bral bodies, would have been obvious to one of ordinary skill in the art. For example, an “implant being sized to

• ccupy substantially the full transverse widths of the

vertebral bodies” would necessarily include an implant “sized to conform with the disc spaced between adjoin- ing vertebrae,” as disclosed by Brantigan.23 Accordingly, the PTAB determined that the feature of claim 17 was prima facie obvious in view of Brantigan’s disclosure and the broad but reasonable interpretation of the feature “disc space.”

Inclusion by Failing to Exclude

The patent owner also argued that the “graft con- glomerate” disclosed in Leu did not teach “an interbody intraspinal implant,” as recited in claim 17. The patent

• wner again provided expert testimony from the inventor

that the graft conglomerate of Leu contains “impacted bone” and “soft cancellous bone,” which the patent

• wner asserted a person of ordinary skill in the art would

understand is not provided in an interbody intraspinal implant.24 However, the patent owner failed to provide an explanation for restricting bone types and the speci- fication did not explicitly state that such bone type must not be present, i.e., be excluded, in an interbody intra- spinal implant. Thus, in broadly construing the feature

SEPTEMBER/OCTOBER 2014

I P L i t i g a t o r

7

• f claim 17, the PTAB found that it was reasonable for

the claimed interbody intraspinal implant to include impacted bone and soft cancellous bone.25 Accordingly, the PTAB found that, in view of the disclosure in Leu, claim 17 was prima facie obvious. The PTAB’s ruling in Nuvasive applies the well-known “broadest reasonable interpretation” standard in con- struing claims. While the PTAB seemed willing to review evidence that showed a claim term was different than its

• rdinary meaning, the PTAB made clear that, absent

specific evidence narrowing the scope of the term or giv- ing the term a different meaning, the claim term will be given a broad interpretation in view of the specification and the common usage of the term.

Nexus between Secondary Considerations of Non-Obviousness and Claimed Invention

In addition to construing claims during an IPR, the PTAB determines whether the patented claims are unpat- entable under 35 U.S.C. §§ 102 or 103, based on prior art consisting of patents and printed publications.26 If it is determined that a prima facie case of obviousness exists under 35 U.S.C. § 103, the patent owner may produce evidence to rebut the prima facie case of obviousness.27 One such way of rebutting a prima facie case of obvi-

• usness is by presenting evidence of secondary consid-
• erations. “Such secondary considerations as commercial

success, long felt but unsolved needs, [and] failure of

• thers might be utilized … [a]s indicia of obviousness
• r nonobviousness.”28 However, “[a] nexus between the

merits of the claimed invention and evidence of second- ary considerations is required in order for the evidence to be given substantial weight in an obviousness deci- sion.”29 Accordingly, if a prima facie case of obviousness is established and the patent owner is unable to show a nexus between the asserted one or more secondary con- siderations, then the claims will be deemed unpatentable as obvious.

History of Secondary Considerations

The concept of using secondary considerations was developed most notably in Graham v. John Deere Co., where the Supreme Court recognized that secondary considerations, such as commercial success or long felt but unsolved needs, might provide indicia of nonobvi-

• usness to “permit a more practical test of patentabil-

ity.”30 For example, the technical facts present in most patent litigation make it difficult for all but the most skilled in the technical art at issue to understand whether a claim should be unpatentable as obvious over prior art references. Thus, the focus on secondary consider- ations may provide the judiciary with additional tools with which to assess a claimed invention and determine whether the claimed invention was nonobvious, in an effort to avoid a hindsight analysis of the claimed inven- tion.31 Furthermore, while secondary considerations are intended to be a tool to be used to help determine whether a claimed invention is obvious under 35 U.S.C. § 103, a court is required to consider evidence of second- ary considerations when making a determination of

• bviousness under 35 U.S.C. § 103.32

For example, in Simmons Fastener Corp. v. Illinois Tool Works, Inc., the district court found that a patent with claims directed to an industrial fastener for refrigerator manufacturers, which was assigned to Illinois Tool Works and which was asserted against Simmons, was invalid as

• bvious.33 The patent in this case had claims directed to a

screw anchor for use on the inside of a refrigerator cabi- net, which allowed shelving to be assembled within the refrigerator cabinet without cracking the fragile plastic walls and limiting foam from leaking through fastener holes during assembly, which were problems known to the refrigerator industry.34 While the parties stipulated to several facts that were undisputed, including that Illinois Tool Works had sold millions of products covered by the claims to refrig- erator manufactures, to the extent that “[t]he [Illinois Tool Works] patented product has been a substantial commercial success,” the district court did not consider this or other secondary considerations.35 In fact, the district court stated that secondary considerations do not support a claimed invention if the claimed invention does not pass test for non-obviousness under 35 U.S.C. § 103.36 Furthermore, the district court found that “[c]ommercial success ‘cannot breathe life into a patent

• therwise invalid because of obviousness.’ ”37 Correctly,

the Court of Appeal for the Federal Circuit (CAFC)

• verturned the district court’s decision.38

In its holding, the CAFC states that “the trial court erred as a matter of law in refusing to consider the evi- dence of secondary consideration (objective evidence) mandated by Graham v. John Deere Co., in arriving at its decision on obviousness.”39 Specifically, the CAFC found that the four part inquiry in Graham includes not only the scope and content of the prior art, the differences between the claimed invention and the prior art, and the level of skill in the relevant art, but also evidence of secondary considerations, when present.40 Furthermore, while certain elements of the four-part Graham test may be given more or less weight depending on the evidence, all evidence on the issue of these four elements always must be considered.41 Thus, in determining obviousness

8

I P L i t i g a t o r

SEPTEMBER/OCTOBER 2014

under 35 U.S.C. § 103 in district court litigation, each element of the four-part Graham test, including the sec-

• ndary consideration, must be considered when relevant

evidence is present.

The Nexus Test

Although secondary considerations are important and, as discussed supra, required in determining obviousness under 35 U.S.C. § 103, evidence of secondary consider- ations cannot be applied in a vacuum. Instead, a nexus must exist between the claimed invention and the com- mercial success, showing that the commercial success is related, or has a nexus, to the claimed invention, as

• pposed to the commercial success being a result of the

prior art or other unrelated market factors.42

When No Nexus Exists

Evidence with respect to secondary considerations must be taken as a whole. As shown in Tokai Corp. v. Easton Enterprises, Inc., merely reciting sales of a prod- uct, without relating the increased sales (i.e., commercial success) to the claimed invention, is insufficient to estab- lish a nexus, and the evidence cannot be relied on for

• vercoming a prima facie case of obviousness.43

The patent at issue in Tokai includes claims directed to a safety utility lighter having extended lighting rods including, inter alia, an operation member and a safety device having a locking member and an urging member.44 One issue was whether the district court properly held that Tokai, the assignee of the asserted patent, erred in invalidating the asserted claims as obvious, in view of the evidence of commercial success of the lighter.45 The CAFC held that the district court properly determined the first three Graham factual inquiries, e.g., the scope and content of the prior art, the differences between the claimed invention and the prior art, and the level of skill in the relevant art, finding a prima facie case of obvious- ness in view of the cited references.46 Regarding the secondary indicia of nonobviousness, the CAFC also found that the district court properly determined that there was an insufficient nexus between the commercial success of the lighters and the claimed

• invention. Specifically, Tokai not only admitted that

child-safety utility lighters were available in the prior art, but also conceded that all lighters sold are required by law to have a safety device.47 Furthermore, when Tokai’s rep- resentatives presented the sales data of Tokai’s lighters, at no point did the representatives refer to the claimed locking feature, which was the asserted distinguishing feature from the prior art utility lighters.48 Accordingly, the CAFC upheld the district court’s finding that Tokai failed to establish a nexus between the claimed locking feature and the alleged commercial success evidence, because “Tokai proffered no evidence from which one could reasonably infer a nexus between its sales data and its utility lighters’ automatic-locking features.”49 As shown by the CAFC’s decision in Tokai, evidence from which a reasonable inference of a nexus between the claimed invention and the secondary considerations, e.g., commercial success, must be established to successfully assert secondary factors to overcome a prima facie case

• f obviousness.

Finding a Nexus Between Secondary Considerations and Claimed Invention

Unlike the evidence presented in Tokai, the patent

• wner in In re Cyclobenzaprine Hydrochloride Extended-

Release Capsule Patent Litigation provided a sufficient nexus between the evidence of secondary considerations and the claimed invention.50 The patent owner, Aptalis Pharmatech, Inc., owned the patents at issue, which cover a modified-release dosage

• f skeletal muscle relaxants and the method of relieving

muscle spasms using the claimed muscle relaxants. The CAFC noted that the district court improperly held that “bioequivalence alone was sufficient to render the claims at issue obvious.”51 However, even in view of this error, the CAFC determined that the secondary considerations

• vercame any obviousness findings.52

The CAFC points to the patent owner’s assertion that another pharmaceutical company had attempted but failed to develop an extended-release of the muscle

• relaxant. While the district court discounted this evi-

dence, the CAFC noted that this was “clear error” and that evidence of others failure “may carry sig- nificant weight in an obviousness inquiry.”53 The evi- dence provided by the patent owner showed that other pharmaceutical companies were unable to develop the modified-release muscle relaxants when these pharma- ceutical companies development was different from that

• f the patent owner.54

The CAFC noted that both the patent owner and the competing pharmaceutical companies had a com- mon goal to create a therapeutically effective product. However, these competing pharmaceutical companies were unable to develop the claimed invention, which the patent owner developed using a different method. Thus, the CAFC determined that this evidence that others failed while the patent owner succeeded was sufficient to support a nonobviousness finding.55 In other words, there was a sufficient nexus between the evidence that

• thers failed when the patent owner succeeded and the

claimed invention, because the fact that only the patent

• wner succeeded led to the claimed invention.

Thus, when a patent owner is presented with a prima facie case of obviousness, to successfully assert a second- ary consideration to overcome the prima facie case, a

SEPTEMBER/OCTOBER 2014

I P L i t i g a t o r

9

sufficient nexus must be shown between the secondary consideration evidence and the claimed invention.

The Nexus Test in Inter Partes Review

As discussed in above, the PTAB determines the valid- ity of one or more claims of a patent during an inter partes review under 35 U.S.C. §§ 102 and 103. While the standard for proving invalidity of patent claims in an IPR is by a preponderance of the evidence, which is different from district court litigation,56 the analy- sis for determining whether a claim is unpatentable as obvious under 35 U.S.C. § 103 does not change. Furthermore, while the PTAB did not address second- ary considerations in detail, the PTAB did discuss in its first inter partes review decision that the assignee of the patent at issue did not provide a sufficient showing of nexus between the asserted secondary considerations

• f nonobviousness and the claimed invention to war-

rant discovery for commercial success evidence.57 As the analysis for determining the patentability of a claim is the same in both district court ligation and IPRs, including the four-part Graham test, the PTAB logically has ensured that a nexus exists between secondary con- siderations and the claimed invention in order for the secondary considerations to be relevant to the obvious- ness analysis.

Failing the Nexus Test

In most IPRs in which secondary considerations have been raised, the PTAB has determined that no nexus existed between the secondary considerations and the claimed invention.58 As discussed in Nuvasive, Inc. v. Warsaw Orthopedic, Inc., when asserting evidence regard- ing any secondary consideration, a nexus must exist between the claimed invention and the evidence.59 Commercial Success. The patent owner in Nuvasive, Warsaw Orthopedic, asserted that both Nuvasive’s and Warsaw’s spinal implants had “tremendous commer- cial success,” and that the sales of Nuvasive’s product totaled $250 million over a six-year period, while sales

• f Warsaw’s product totaled $50 million over the same

period.60 However, the PTAB noted that, whether or not the sales figures were correct, Warsaw did not demon- strate a sufficient nexus between the sales figures and the claimed invention. Specifically, the patent owner relied on certain features of Nuvasive’s device to show that surgeons chose this device.61 However, the features

• f Nuvasive’s device were not recited in the claims.62

Furthermore, the PTAB found that even if the features

• n which the patent owner relied were in the claims,

Nuvasive’s device included additional benefits not relied on by the patent owner.63 Accordingly, the PTAB determined that the patent owner had not provided a sufficient nexus between the claimed invention and the proffered evidence to establish commercial success of the claimed invention.64 Industry Praise. The patent owner in Nuvasive also argued that the claims of the patent were non-obvious based on industry praise of the claimed invention. The patent owner cited to a Web site operated by a physician, which stated that the patent owner’s product, which is inserted from a “direct lateral approach,” was a benefit

• f the product.65 Even if Warsaw had been successful in

arguing that the term “lateral,” as recited in Claim 17, meant a “direct lateral” approach (see discussion regard- ing “lateral approach,” supra), Nuvasive demonstrated that the “direct lateral” approach was present in the prior art.66 Citing Tokai Corp., the PTAB notes that if “evidence of secondary considerations stems from what was known in the prior art … there can be no nexus.”67 In other words, the evidence of secondary considerations must be from what is new in the claimed invention for a nexus to exist. The patent owner also provided additional evidence of benefits noted by doctors and others in the spinal sta- bilization industry. However, several of the documents cited as “industry praise” related to features that were well known in the art.68 Furthermore, even when the industry praise was not related to features well known in the art, the patent owner never sufficiently showed that the industry praise had any nexus to the claimed features of the patent at issue, and thus, no sufficient nexus was found between the claimed invention and the asserted industry praise to overcome the prima facie case

• f obviousness.69
• Copying. The third secondary consideration patent
• wner argued in Nuvasive was that the claims of the

patent were non-obvious based on petitioner’s alleged copying of the claims.70 While copying of the claimed invention may provide objective proof of the nonob- viousness, the evidence is generally given little weight unless the alleged copy does not embody each and every feature of the claimed invention.71 The patent owner in Nuvasive argued that the peti- tioner worked on early prototypes of a device that alleg- edly included the features of the claimed invention.72 However, the patent owner did not show that any of the claims of the patent at issue recited the specific length of the petitioner’s implant device.73 Accordingly, the PTAB held that the patent owner did not provide sufficient evidence to show a nexus between the claimed invention and the petitioner’s device to prove non-obviousness by copying.74 As discussed by the PTAB in Nuvasive, when a patent

• wner is attempting to overcome a prima facie case of
• bviousness, whether by evidence of commercial success,

10

I P L i t i g a t o r

SEPTEMBER/OCTOBER 2014

industry praise, or copying, a sufficient nexus must be shown between the evidence of the secondary consider- ation and the claimed invention to show nonobviousness.

Find a Nexus in Inter Partes Review

Unlike in Nuvasive, the PTAB in Omron Oilfield & Marine Inc. v. MD/Totco, a Division of Varco, L.P., determined that the patent owner (MD/Totco) provided a sufficient nexus between the evidence of at least one secondary consideration and the claimed invention to

• vercome the prima facie case of obviousness.

The patent at issue in Omron Oilfield “relates to an automatic drilling system that regulates the release of a drill string in a drilling rig in response to, among other things, drilling fluid pressure and bit weight.”75 The PTAB found that, taking the prior art alone and with-

• ut considering the other Graham factors, that a person
• f ordinary skill in the art would have combined the

prior art references to obviate the claimed invention.76 However, as discussed supra, the analysis does not end there, and the PTAB properly reviewed the secondary considerations, specifically evidence of commercial suc- cess of the patent owner’s product, which embodied the claimed invention. In considering the commercial success of the patent

• wner’s drilling system, the PTAB noted “that advertis-

ing the benefits of the claimed invention links the inven- tion to commercial success.”77 The PTAB considered the patent owner’s brochure, which showed the inventive features of using weight on a bit with drilling pressure to automatically control the drill string, along with testimony that the pump pressure was critical to custom- ers’ use of the product.78 In addition, the patent owner presented evidence showing that, over a one year period, the use of the claimed drilling system increased in land based oil rigs, which were adjudged to infringe the patent at issue, by 20 percent in Canada and 44 percent in the United States.79 Accordingly, the PTAB held that, in view

• f this evidence, the patent owner sufficiently established

a nexus between the evidence of commercial success and the claimed invention to overcome the prima facie case

• f obviousness.80

In view of the PTAB’s decision in Omron Oilfield, it appears that the PTAB has followed the precedent from district court litigation and will require specific evidence tying the commercial success of a product to the claimed

• invention. For instance, as shown in Omron Oilfield,

an advertisement specifically stating the benefits of the product, where the benefits are the new features of the claimed invention, and testimony showing that users preferred or chose the product embodying the claimed invention for those benefits, is one way to provide a suf- ficient nexus between the secondary consideration and the claimed invention.

Conclusion

Unsurprisingly, the PTAB has indicated that, as in dis- trict court litigation, without any nexus between the evi- dence of the secondary considerations and the claimed invention, patent claims will not be saved a prima facie case of obviousness. While the PTAB is willing to review evidence of a nexus, it is clear that such evidence must make a strong link between the asserted secondary con- siderations and the claimed invention. Furthermore, it is clear that the PTAB will construe claim terms in a broad but reasonable manner and, unless the specification or claims narrowly define a term, claim terms likely will be interpreted as broadly as the common and accepted definition of the term allows.

• 1. Nuvasive, Inc. v. Warsaw Orthopedic, Inc., IPR2013-00206, Paper No. 65

(Patent Tr. & App. Bd. 2014).

• 2. H.R. Rep. No. 112-98 at 45-46 (2011).
• 3. Id. at 47.
• 4. See 37 C.F.R. § 42.100(b) (2012).
• 5. Leahy-Smith America Invents Act § 311(b), 125 Stat 284, 299 (2011).
• 6. 35 U.S.C. § 282; see Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
• 7. 37 C.F.R. § 42.100(b).
• 8. Nuvasive at 3.
• 9. Id. at 3-4.
• 10. Id. at 7.
• 11. Id. at 8.
• 12. Id.
• 13. Id.
• 14. Id. at 8.
• 15. Id. at 9.
• 16. Id. at 16.
• 17. Id.
• 18. Id. at 17.
• 19. Id.
• 20. Id.
• 21. Id.
• 22. Id. at 18.
• 23. Id. at 17-18.
• 24. Id. at 21.
• 25. Id. at 21-22.
• 26. Leahy-Smith America Invents Act § 311(b), at 299.
• 27. In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990).
• 28. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966).
• 29. Muniauction, Inc. v. Thomson Corp., 532 F.2d 1318, 1327 (Fed. Cir. 2008);

internal citations omitted.

• 30. Graham at 17-18.
• 31. Id. at 36.
• 32. Simmons Fastener Corp. v. Illinois Tool Works, Inc., 739 F.2d 1573, 1575-

1576 (Fed. Cir. 1984).

• 33. Id. at 1573.
• 34. Id. at 1573-1574.
• 35. Id. at 1574.
• 36. Simmons Fastener Corp. v. Illinois Tool Works, Inc., 560 F. Supp. 1277, 1293

(N.D.N.Y . 1983) rev’d, 739 F.2d 1573 (Fed. Cir. 1984).

• 37. Id.; internal citations omitted.
• 38. Simmons Fastener Corp., 793 F.2d at 1573.
• 39. Id. at 1574-1575; emphasis added.
• 40. Id. at 1575.
• 41. Id.
• 42. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311-1312 (Fed. Cir. 2006).
• 43. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1370 (Fed. Cir. 2011).
• 44. Id. at 1362.
• 45. Id. at 1366.
• 46. Id. 1367-1369.

SEPTEMBER/OCTOBER 2014

I P L i t i g a t o r

11

• 47. Id. at 1370.
• 48. Id.
• 49. Id., emphasis added.
• 50. In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent

Litig., 676 F.3d 1063, 1066 (Fed. Cir. 2012) cert. denied, 133 S. Ct. 933 (U.S. 2013).

• 51. Id. at 1069.
• 52. Id. at 1083.
• 53. Id at 1081.
• 54. Id. at 1082.
• 55. Id. at 1083.
• 56. See e.g., Microsoft Corp. v. i4i Limited Partnership, 563 U.S. __ (2011) (stan-

dard of proof for all invalidity claims is by “clear and convincing evidence”).

• 57. Garmin International Inc. v. Cuozzo Speed Technologies LLC, IPR2012-

00001, Paper No. 26 (Patent Tr. & App. Bd. 2013), 8.

• 58. See e.g., Micro Motion, Inc. et al. v. Invensys Sys., Inc. et al., IPR2014-00170

(Patent Tr. & App. Bd. 2014), 6 (no nexus between claimed invention and secondary considerations where patent owner merely made statement that publications provide nexus to secondary considerations); see also Illumina,

• Inc. v. The Trustees of Columbia Univ. in the City of New York, IPR2012-

00007 (Patent Tr. & App. Bd. 2012), 24 (no nexus where commercial success evidence was for product that did not include the claimed base compound).

• 59. Nuvasive at 25, citing Strtoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530,1539

(Fed. Cir. 1983).

• 60. Nuvasive at 26.
• 61. Id.
• 62. Id.
• 63. Id.
• 64. Id. at 26.
• 65. Id.
• 66. Id.
• 67. Id., citing Tokai Corp. at 1369.
• 68. Nuvasive at 28.
• 69. Id. at 29.
• 70. Id.
• 71. Id. at 30, citing Wyers v. Master Lock Co., 616 F.3d 1231,1246 (Fed. Cir.

2010); Pentec, Inc. v. Graphic Controls, Corp., 776 F.2d 309, 317 (Fed.

• Cir. 1985); see also Pharmatech Solutions, Inc., v. Lifescan Scotland Ltd.,

IPR2013-00247 (Patent Tr. & App. Bd. 2013), 21 (no nexus where petitioner copied medical test strips to make strips compatible with testing system).

• 72. Id. at 30.
• 73. Id. at 31.
• 74. Id. at 31.
• 75. Omron Oilfield & Marine, Inc. v. MD/Totco, a Division of Varco, L.P.,

IPR2013-00265, Paper No. 11 (Patent Tr. & App. Bd. 2013), 2.

• 76. Id. at 7.
• 77. Id. at 9, internal citations omitted.
• 78. Id.
• 79. Id.
• 80. Id.

As originally published in The IP Litigator September/October 2014 issue