October 9, 2015
Bloomberg BNA
By Thomas L. Irving; *Stacy D. Lewis
Patent Owners often submit objective evidence of nonobviousness in inter partes reviews (IPRs). But Patent Owners have not always succeeded in persuading the Patent Trial and Appeal Board (PTAB) that such objective evidence tips the balance in favor of nonobviousness. A problem for Patent Owners has been when the PTAB decides that Patent Owners have not shown sufficient nexus between the objective evidence of nonobviousness and the claimed invention.1
Objective evidence of nonobviousness such as commercial success, long-felt and unmet need, failure/skepticism of others, industry acclaim, unexpected results and copying may be the "most probative and cogent evidence of nonobviousness in the record."2 The nexus required for objective evidence of nonobviousness is not a new concept. CCPA, Federal Circuit and PTAB case law, as well as the Manual of Patent Examining Procedure (MPEP) have long recited the requirement since the U.S. Supreme Court set forth the modern obviousness inquiry in Graham v. John Deere Co.3
The PTAB is relying on this same Federal Circuit case law:
[W]e note that it is not sufficient that a product or its use merely be within the scope of a claim in order for objective evidence of nonobviousness tied to that product to be given substantial weight. There must also be a causal relationship, termed a "nexus," between the evidence and the claimed invention. Merck & Co., Inc. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1376[, 73 U.S.P.Q.2d 1641] (Fed. Cir. 2005) [(69 PTCJ 316, 2/4/05)]. A nexus is required in order to establish that the evidence relied upon traces its basis to a novel element in the claim, not to something in the prior art. Institut Pasteur & Universite Pierre et Marie Curie v. Focarino, 738 F.3d 1337, 1347[, 109 U.S.P.Q.2d 1134] (Fed. Cir. 2013) [(87 PTCJ 433, 1/3/14)]. Objective evidence that results from something that is not "both claimed and novel in the claim," lacks a nexus to the merits of the invention. In re Kao, 639 F.3d 1057, 1068[, 98 U.S.P.Q.2d 1799] (Fed. Cir. 2011) [(82 PTCJ 76, 5/20/11)].
All types of objective evidence of nonobviousness must be shown to have nexus. In re GPAC Inc., 57 F.3d at 1580 (nexus generally); see also Rambus Inc. v. Rea, 731 F.3d 1248, 1256[, 108 U.S.P.Q.2d 1400] (Fed. Cir. 2013) [(86 PTCJ 1074, 9/27/13)] (long-felt need); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364[, 103 U.S.P.Q.2d 1130] (Fed. Cir. 2012) [(84 PTCJ 353, 6/29/12)] (copying); In re Huang, 100 F.3d 135, 140[, 40 U.S.P.Q.2d 1685] (Fed. Cir. 1996) (commercial success).
The stronger the showing of nexus, the greater the weight accorded the showing of nexus, the greater the weight accorded the objective evidence of nonobviousness. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 306, 227 U.S.P.Q. 657 (Fed. Cir. 1985).4
This is familiar territory for patent practitioners. Why then are Patent Owners having such a hard time establishing nexus between the claimed invention and the objective evidence of nonobviousness? Is the PTAB applying the "nexus" test more strictly than the courts or the examiners? Is the level of factual analysis that often comes with objective evidence just too big of an imposition on the tight timeline of the IPRs? Is the prohibition on "new testimony" in Patent Owner's Preliminary Response (POPR)5 a deal-breaker?
This article will examine such attempts, successful and not, to rely on objective evidence of nonobviousness and will discuss how the necessary link between the evidence and the merits of the claimed invention may be made. The article will also look at the issue whether evidence proffered is commensurate in scope with the breadth of the claimed invention. Finally, the article will discuss the strategic use of prosecution declarations in the POPR supporting positions of nonobviousness under the current rules, which may be helpful in convincing the PTAB to deny the institution of an IPR.
CustomPlay, LLC v. ClearPlay, Inc., IPR2014-00339, provides an example of the PTAB finding Patent Owner's objective evidence of nonobviousness insufficient.6 In particular, statements about gross sales were not sufficiently tied to the merits of the claimed invention so as to constitute evidence of commercial success. The PTAB held all the instituted claims unpatentable, and rejected Patent Owner's argument of objective evidence of nonobviousness:
Patent Owner argues, without citation of any supporting evidence, that "secondary considerations [of commercial success] support the validity of the claims." . . . The objective indicia, however, must establish a nexus with the claimed subject matter. Here, Patent Owner provides argument, but no evidence, of the alleged commercial success. See, e.g., PO Resp. 54 ("Since 2001, [Patent Owner] has had gross sales of $21 million."). Patent Owner also fails to provide any evidence that the alleged commercial success is due to the patented invention rather than other factors.7
In Qualtrics Labs, Inc. v. OpinionLab, Inc., IPR2014-00421, the PTAB described the level of detail required to show sufficient nexus between commercial success and the claimed invention:
To show how commercial success supports non-obviousness, however, Patent Owner must prove that the sales were a direct result of the unique characteristics of the invention, and not a result of economic and commercial factors unrelated to the quality of the patented subject matter. Patent Owner has not so shown. Even if Patent Owner's product includes the limitations of claim 1, there is no explanation as to how these limitations are related to the alleged commercial success other than simply alleging that the limitations are present in its product. Patent Owner provides examples of the database and reporting module features of its product and discusses use of various features by its customers, but does not attempt to tie any of these features to the alleged commercial success. Patent Owner's specific discussion of "commercial success" does not cure this deficiency. See id. at 49–52 (alleging that "OpinionLab's page-specific user feedback solution embodying the claimed invention is utilized by an extensive list of customers" and that "OpinionLab's customer list has continued to grow" without tying this alleged commercial success to the unique characteristics of the claims).8
In other words, the PTAB is looking for causation of the commercial success by the merits of the claimed invention. A mere correlation between commercial success and elements of the claimed invention may not carry Patent Owner to victory.
Similarly, the PTAB rejected Patent Owner's evidence of industry praise for failure to establish sufficient nexus with the claimed invention:
As with commercial success . . . evidence of industry praise is only relevant when it is directed to the merits of the invention claimed. Patent Owner identifies various documents discussing features of its product . . . . Notably, these materials quoted in the Patent Owner Response praise [Patent Owner's] product in general. Patent Owner does not identify any praise due to specific features that are present in the claims. Patent Owner has not established a sufficient nexus with the claimed invention.9
Again, correlation between the praise and the claimed invention was not enough. The PTAB was looking for proof, not present, that the merits of the claimed invention elicited the industry praise.
The PTAB also rejected Patent Owner's evidence of copying for merely showing "similarities between its products and those offered by Petitioner" without "any analysis or explanation of how other companies, such as Petitioner, allegedly copied its product that allegedly includes the features of the claimed invention."10 In other words, Patent Owner failed to analyze and/or explain why the copying was driven by the merits of the claimed invention.
The PTAB held all instituted claims unpatentable.11
In Intri–Plex Technologies, Inc. v. Saint–Gobain Performance Plastics Rencol Ltd., IPR2014–00309, Patent Owner submitted objective evidence of nonobviousness (commercial success and copying) via a declaration supporting the Patent Owner Response.12 The PTAB found that the objective evidence of nonobviousness had sufficient nexus and was strong enough to tip the balance in favor of Patent Owner:
[W]e determine that the first three Graham factors favor a determination that the challenged claims are obvious.
However, a proper obviousness determination requires a consideration of all factors, and we determine that Saint-Gobain's case for nonobviousness based on secondary considerations is particularly strong, and outweighs the other three factors. In particular, we are persuaded that our finding of commercial success is particularly strong . . . . Indeed, we determine that commercial success alone sufficiently outweighs the other three factors, and that our finding of copying merely strengthens further our finding that secondary considerations weigh in favor of Saint-Gobain.13
In Medtronic, Inc. v. Nuvasive, Inc., IPR2014-00074, Patent Owner raised objective evidence of nonobviousness in its POPR.14 In particular, it faulted Petitioner's experts' declarations for not taking into account the documentation of industry praise and success in Petitioner's possession due to earlier district court litigation between the parties.15 Patent Owner also directed the PTAB's attention to Petitioner's internal documents indicating its knowledge of Patent Owner's commercial success, initial skepticism, industry praise and copying.16
The PTAB, seeing no evidence of the requisite nexus, was not persuaded by any of Patent Owner's evidence, and dealt with it in a single paragraph decision instituting IPR on most of the challenged claims:
We have reviewed the evidence presented by Patent Owner. Although Patent Owner asserts that the "XLIF" system ("eXtreme Lateral Interbody Fusion") is a commercial embodiment protected by the '356 patent, on the current record, Patent Owner has not advanced any clear or specific evidence explaining what the XLIF system is precisely, such that it is clear which features, if any, of the challenged claims, are part of the XLIF system. It is, therefore, not clear, on the current record, that any of the alleged secondary indicia of non-obviousness relate to the surgical system recited in the challenged claims.17
Patent Owner's failure to tie its objective evidence to the claimed invention doomed its objective evidence argument.
It is quite evident that Patent Owner failed on a threshold issue of explaining how any secondary indicia even relate to the product of the claimed invention, let alone provide a causal nexus to the objective evidence.
It is worth noting that in Medtronic, the expert declarations did not violate the prohibition on "new" testimonial evidence with the POPR because they were prepared prior to the filing of the IPR petition and not for the purposes of the IPR.18 In contrast, expert declarations prepared for related litigation but executed after the filing of the Petition have been rejected as inappropriate by the PTAB.19
Patent Owner raised objective evidence of nonobviousness submitted during prosecution in its POPR in Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676.20 Patent Owner extensively detailed objective evidence of unexpected results, industry praise, long-felt need and commercial success, presented in two expert declarations during prosecution, and Patent Owner criticized the petition for not addressing this evidence.21
The PTAB was not persuaded, however, and instituted the IPR, partly because the references on which the IPR obviousness grounds were based were different than those in prosecution. In addition, Patent Owner failed to establish (1) the objective evidence was reasonably commensurate in scope with the challenged claims, (2) the requisite nexus, and (3) even whether the results in fact were unexpected:
Patent Owner's Preliminary Response and evidence of record at this time do not address adequately considerations such as whether evidence of objective indicia are reasonably commensurate with the scope of the challenged claims, whether a sufficient nexus exists between such evidence and the merits of the claimed invention, or whether evidence of unexpected results establishes a difference between the results obtained and those of the closest prior art.22
Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, provides an example of a case where Patent Owner raised objective evidence of nonobviousness presented during a reexamination23 and used that evidence to defeat a prima facie case of obviousness made out by Petitioner. The PTAB analyzed the objective evidence, balanced it against the evidence of prima facie obviousness, and concluded that the objective evidence of nonobviousness carried the day, leading to denial of institution.24
In its Petition, Petitioner noted that Patent Owner submitted objective evidence of nonobviousness in the reexamination of the patent, but argued that Patent Owner "will be unable to overcome the strong showing of obviousness set forth in this Petition."25
Patent Owner filed a POPR and attached the expert declarations from the reexamination prosecution containing objective evidence of nonobviousness that Patent Owner linked to the claimed invention.26 The objective evidence included commercial success, long-felt but unmet need, failure of others and unexpected results. Patent Owner's evidence of commercial success was a brochure featuring the invention and trial testimony from earlier litigation that the product was successful due to the patented features.
The PTAB denied institution on all challenged claims.27 The PTAB found Petitioner had established a prima facie case of obviousness. The PTAB then turned to the objective evidence of nonobviousness, reviewed the examiner's findings with respect to it, and agreed that "patent owner's evidence of secondary considerations is persuasive."28 The evidence of significant commercial success in particular overcame the prima facie case of obviousness.29 Patent Owner presented evidence that the claimed invention was successful, including sales growth and evidence of the growth of a product later judged infringing.30
The Omron decision offers guidance on the issue of nexus to the merits of the claimed invention and a shift of the evidentiary burden to Petitioner if a prima facie nexus is established:
A prima facie case of nexus is established when the patentee shows both that there is commercial success, and that the product that is commercially successful is the invention disclosed and claimed in the patent. Once the patentee demonstrates a prima facie nexus, the burden of coming forward with evidence in rebuttal shifts to the challenger.31
The PTAB found that "[b]ased on the record cited above, we determine that Patent Owner has presented sufficient evidence to establish a prima facie case of nexus."32
Hence, Petitioner miscalculated by not carrying out a balanced analysis and coming forward with evidence to support unpatentability. In denying Petitioner's request for rehearing of the institution decision,33 the PTAB noted that Petitioner knew of the evidence presented in the reexamination, and could have addressed it in the Petition, but did not.34 Addressing the objective evidence in the rehearing request was too late: "we are not persuaded by Petitioner's new arguments regarding the merits or admissibility of the evidence of secondary considerations."35
In Lupin Ltd. v. Vertex Pharmaceuticals Inc., IPR2015-00405, the PTAB instituted the IPR on fewer than all challenged claims and fewer than all asserted grounds after Patent Owner submitted objective evidence of nonobviousness in its POPR.36 The objective evidence came from a variety of articles, FDA documents, pre-existing sales data and deposition testimony of Petitioner's expert from another IPR.37 The PTAB found the objective evidence of nonobviousness persuasive with respect to certain claims directed to specific compounds and compositions. In particular, scientific literature supporting Patent Owner's nonobviousness arguments had sufficient nexus to the claimed invention:
Patent Owner's evidence related to fosamprenavir [is] persuasive. The evidence shows, for example, that fosamprenavir, and in particular fosamprenavir calcium, has improved pharmacokinetics, reduced gastrointestinal side effects, and different resistance profile as compared to its parent drug, amprenavir. The evidence presented by Patent Owner further suggests that the development of HIV protease inhibitors prodrugs was not at all predictable, but produced compounds with varying degree of effectiveness.38
The PTAB determined, however, that the evidence was not "commensurate in scope" with the patent's broader claims. Noting that "commensurate in scope" did not require "that the proffered evidence must reach every embodiment within the scope of the claims," in this case the objective evidence only related to fosamprenavir while the scope of claim 1 was broader than just fosamprenavir.39 The PTAB accepted Patent Owner's evidence of nonobviousness only for the subject matter of claims 2 and 3, directed only to the common salts of fosamprenavir.40
The PTAB granted the petition only with respect to the broader claims.41 That was a victory for Vertex because the narrower claims, highly useful in Hatch Waxman litigation, were not thrown into the IPR.
Sufficient nexus to a request for additional discovery of objective evidence was shown in John's Lone Star Distribution, Inc. v. Thermolife International, LLC, IPR2014-01201.42 Patent Owner requested additional discovery of documents relating to evidence of commercial success. The PTAB partially granted the request, finding sufficient nexus between the request for certain sales information and the claim limitations:
Patent Owner points us to evidence indicating that potentially relevant products have enjoyed at least some commercial success, after being advertised as containing components recited in challenged claims.
. . . Here, prior to filing its Response, Patent Owner seeks discovery on the issue of commercial sales of three products by a competitor, most likely to bolster evidence Patent Owner may already have in its possession relating to the issue of commercial success generally.
In view of contentions of both parties, as well as evidence before us, we are persuaded that Patent Owner has set forth a threshold amount of evidence sufficient to deem that the discovery of certain requested documents is necessary in the interest of justice.
Specifically, we authorize additional discovery from Petitioner in relation Patent Owner's Request (2) . . . .43
In Kingston Technology Co. v. CATR Co., IPR2015-00149, post-institution decision, Patent Owner requested authorization to file "a motion for additional discovery of the financial performance of Petitioner's allegedly infringing products and industry praise of such products."44 Patent Owner had not raised objective evidence of nonobviousness in its POPR,45 possibly partly because Patent Owner did not make a product meeting the instituted claims and therefore had no commercial success evidence. The PTAB authorized the motion.46
In deciding Patent Owner's motion for additional discovery, the PTAB noted that it generally applies the five factors ("the Garmin factors") set forth in Garmin Int'l, Inc. v. Cuozzo Speed Techs. LLC.47 "The first Garmin factor . . . whether there exists more than a ‘mere possibility’ or ‘mere allegation that something useful [to the proceeding] will be found,’" is relevant to nexus.48
The PTAB granted Patent Owner's motion with respect to two of its document requests, but not two others.49 Patent Owner's first request related to financial results pertaining to Petitioner's product. Patent Owner's second request related to consumer feedback on Petitioner's product, and the third request related to other feedback on Petitioner's product "(e.g., industry press)."50 The fourth document request sought documents showing Petitioner's "initial decision to commercialize a product" that allegedly met the instituted claims.51
Patent Owner submitted a claim chart to support its argument that Petitioner's product practiced the challenged claims, and argued that the chart showed "that Petitioner's product is ‘coextensive with the claim language, triggering a presumption of nexus.’"52 Patent Owner further argued that "even if there were no presumption of nexus, consumers have singled out the patented features . . . for praise in consumer reviews."53 The chart and the praise showed that there was "more than a mere possibility that something useful, e.g., that Petitioner's product is commercially successful, will be found."54
The PTAB agreed that Patent Owner's claim chart supported Patent Owner's first document request, and that the second request related to records a typical business may have.
Petitioner opposed the fourth request because Patent Owner failed to identify a product produced by Patent Owner that Petitioner could have copied. Patent Owner responded that Petitioner could have copied other copyists. The PTAB rejected Patent Owner's argument because "without more, [it] is precisely the type of allegation sought to be avoided by the requirement that there be more than a mere possibility or allegation that something useful will be found."55 With respect to the third request, the PTAB found that this information was likely available to Patent Owner, and therefore failed the third Garmin factor, inability to "generate equivalent information by other means."56
Patent Owner was able to use the discovery obtained in its Patent Owner Response.57
The PTAB acknowledged that it will strictly apply the nexus requirement to a request for additional discovery:
As Patent Owner recognizes, the nexus requirement for proving commercial success is well-established by the case law and is strictly observed.
. . . The interest of justice standard for granting additional discovery and its legislative history require that a showing of relevance be made by the party seeking additional discovery before the request is granted.58
Moreover, the PTAB acknowledged that this is a heavy burden:
As the cases surveyed demonstrate, this puts a heavy burden on Patent Owner. The Board will not allow Patent Owner additional discovery with no indication that the information sought will be relevant.59
In Microsoft v. Proxyconn, the PTAB denied Patent Owner's motion for additional discovery related to objective evidence due to failure of Patent Owner to demonstrate nexus.60
In MasterImage 3D Asia, LLC v. RealD, Inc., IPR2015-00035, Patent Owner sought authorization to file a motion for additional discovery of documents relevant to objective evidence of copying and commercial success.61 The documents had been produced by Petitioner in an ITC proceeding, but the rules of the ITC precluded use of such documents in another proceeding, such as the PTAB. The PTAB denied the request on the grounds that Patent Owner had not satisfied the Garmin factors.62
According to the PTAB, Patent Owner had only made allegations without any support that there was more than a "mere possibility" of evidence of copying in the documents.63 Furthermore, the PTAB held that "Patent Owner has not presented a threshold showing of nexus" between the documents allegedly containing evidence of commercial success and the claims.64
The PTAB authorized Patent Owner to file a motion for additional discovery relating to objective evidence of copying in Kamada, Ltd.v. Grifols Therapeutics Inc., IPR2014-00899.65 However, the PTAB denied the subsequent motion, finding that Patent Owner had not "presented a threshold amount of evidence or reasoning tending to show beyond speculation that something useful will be uncovered."66 The PTAB continued, explaining that evidence of nexus was also lacking. Specifically, "Patent Owner . . . failed to present any evidence or reasoning tending to show beyond speculation that, even if there were evidence of copying, a nexus exists between Petitioner's alleged copying and the claimed invention of the ’180 patent."67
Lupin Ltd. v. Vertex Pharmaceuticals Inc., IPR2015-00405, discussed in detail above, provides an example of a case where the PTAB determined that Patent Owner's objective evidence of nonobviousness was only commensurate in scope with the patent's narrower claims. The PTAB therefore accepted Patent Owner's evidence of nonobviousness only for the subject matter of the narrower claims68 and granted the petition with respect to the broader claims.69 As noted above, that was a victory for Vertex because the narrower claims, highly useful in Hatch-Waxman litigation, were not thrown into the IPR.
It may suffice for Patent Owners to simply cite Federal Circuit case law about a presumption of nexus when the marketed product is the claimed invention. For example, in FLIR Systems, Inc. v. Leak Surveys, Inc., IPR2014-00608, Patent Owner cited Demaco Corp. v. F. Von Langsdorff Licensing Ltd. to support a presumption of nexus "[w]here the marketed product embodies the claimed features, and is coextensive with them."70
But, in light of the trend to date of the PTAB decisions mostly rejecting Patent Owners' attempts to use objective evidence, it may be more prudent for Patent Owner to provide detailed explanation linking the objective evidence with the claimed invention.71
If objective evidence of nonobviousness arises late in the IPR proceeding, it may still be possible for Patent Owner to get that evidence before the PTAB. In Shire Development LLC v. LCS Group, LLC, IPR2014-00739, the PTAB granted Patent Owner's motion to submit supplemental information with respect to a news release announcing FDA approval.72 This was after the Patent Owner Response had been filed, but the PTAB noted "the document may be relevant to objective indicia of non-obviousness . . . [and] the information could not have been earlier submitted because the press release was issued by the FDA after the filing of the Patent Owner Response."73
Currently, in the POPR, Patent Owner cannot "present new testimony evidence beyond that already of record."74 This may change in the future.75 But for now, to defeat institution, Patent Owner should be able, in the POPR, to rely on declarations setting forth objective evidence of nonobviousness originating from the prosecution or even from other publicly available documents, such as from reexamination and litigation76 that are not "new testimony evidence."77
The best case scenario for a Patent Owner is to have the petition denied and avoid an IPR, particularly since denial cannot be judicially reviewed.78 Even if this is not achieved, the POPR may lead to the trial being instituted on fewer grounds and/or fewer claims than challenged in the petition.79 This is still a positive development for a Patent Owner now faced with a trial narrower in scope.
So a Patent Owner should consider loading evidence into her prosecution, along with crisp and compelling arguments to show no prima facie case of obviousness, at least in applications likely to end up in litigation or a post-grant proceedings, such as IPR, enabled by the America Invents Act (AIA). Solid evidentiary showings and/or possibly declarations, in addition to on-point legal arguments,80 may help to develop strong patentability records. Prudently establishing such records during prosecution could support Patent Owner's efforts to persuade the PTAB that Petitioner does not have a "reasonable likelihood" of success and thus achieve denial of institution.
Submission of this evidence during prosecution requires careful thought and planning. Evidence or a declaration thrown together in haste, or otherwise considered defective, may even be harmful rather than helpful.81 Additionally, inequitable conduct is still alive and well post-Therasense.82 To be sure, inequitable conduct cannot be raised during an IPR or post-grant review. But there is no apparent estoppel precluding a losing IPR or PGR petitioner from raising inequitable conduct in a subsequent litigation. That lack of estoppel reinforces the importance of avoiding inequitable conduct issues related to declaration testimony presented either during prosecution or in an AIA post-grant proceeding.
When IPR proceedings were first introduced, there was some concern that filing a POPR was too much "showing your hand" to Petitioner. This concern is receding in view of the high petition grant rate and the high claim cancellation rate. The PTAB desires to have cases front-loaded to make the most efficient use of the its resources by allowing it to make the institution decision based on the most information possible.
If Patent Owner has relevant and compelling information in the prosecution history, or in related proceedings, such as reexamination or litigation, that could well help Patent Owner convince the PTAB to deny the petition. In particular, in the POPR, Patent Owner can tell the PTAB in a concise, compelling argument why the petition should be denied. This is helpful to the PTAB judges, who do not have an infinite amount of time to figure out the parties' arguments. Such concise and compelling arguments can help the PTAB achieve both the policy objective that IPR proceedings be "just, speedy, and inexpensive" and the statutory objective of resolution 12-18 months from institution.
This article examined attempts, successful and not, to rely on objective evidence of nonobviousness in the POPR and the Patent Owner Response. Where Patent Owners were unsuccessful, it can be because the PTAB concludes there is an insufficient showing of nexus between the objective evidence and the claimed invention. If, as a Patent Owner, you are fortunate to have good objective evidence of nonobviousness, then it is worth the effort in the POPR or Patent Owner Response to explain the nexus between that evidence and the merits of the claimed invention to the PTAB in detail. PTAB panels should be given more than a sentence or two about the nexus being "presumed." In establishing the prima facie nexus, Patent Owners should favor detailed explanation and analysis on the nexus issue. Why leave such an important point in doubt?
Perhaps the PTO will change the rules and allow "new" testimony with the POPR, and then we may see more Patent Owner success with objective evidence, although it is not evident why such changes at the PTAB in any way diminish the need to establish the requisite nexus. In the meantime, every Patent Owner, whether in the POPR or the Patent Owner Response, should put her best foot forward to link through analysis and explanation any objective evidence to the merits of the claimed invention.
Endnotes
1See, e.g., Tandus Flooring, Inc. v. Interface, Inc., IPR2013-00527, Paper 48, at 46 (P.T.A.B. Feb. 12, 2015); Cardiocom, LLC v. Robert Bosch Healthcare Sys., Inc., IPR2013-00468, Paper 72, at 34 (P.T.A.B. Jan. 27, 2015); Smith & Nephew, Inc. v. Convatec Tech., Inc., IPR2013-00102, Paper 87, at 45 (P.T.A.B. May 29, 2014).
2 Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538, 218 U.S.P.Q. 871 (Fed. Cir. 1983).
3 383 U.S. 1, 148 U.S.P.Q. 459 (1966). See, e.g., In re Caveney, 386 F.2d 917, 923, 155 U.S.P.Q. 681 (C.C.P.A. 1967) and In re Jella, Appeal No. 2008-1619, at 6 (B.P.A.I. Nov. 3, 2008) (precedential); Manual of Patent Examining Procedure §716.01(b) (9th ed. Nov. 2013) ("Note the great reliance apparently placed on [evidence of secondary considerations] by the Supreme Court in upholding the patent in United States v. Adams, 383 U.S. 39, 148 U.S.P.Q. 479 (1966) [the companion case to Graham v. John Deere Co.]… . The term ‘nexus' designates a factually and legally sufficient connection between the objective evidence of nonobviousness and the claimed invention so that the evidence is of probative value in the determination of nonobviousness.").
4 Tandus, IPR2013-00527, Paper 48, at 46. See also, Gnosis S.p.A. v. Merck & Cie, IPR2013-00117, Paper 71, at 31-32 (P.T.A.B. June 20, 2014).
5 See 37 C.F.R. §42.107(c) (2014) ("No new testimonial evidence. The preliminary response shall not present new testimony evidence beyond that already of record, except as authorized by the Board.").
6 CustomPlay, LLC v. ClearPlay, Inc., IPR2014-00339, Paper 27, at 29-30 (P.T.A.B. July 21, 2015).
7 Id. (alteration in original) (footnote omitted) (citations omitted).
8 Qualtrics Labs, Inc. v. OpinionLab, Inc., IPR2014-00421, Paper 41, at 30-31 (P.T.A.B. July 24, 2015) (citations omitted).
9 Id. at 31-32 (citations omitted).
10 Id. at 32-33.
11 Id. at 33. See also, LKQ Corporation v. Clearlamp, LLC, IPR2013-00020, Paper 73, at 28 (P.T.A.B. March 27, 2014) ("Neither is it apparent from the record that there is sufficient evidence that LKQ undertook to replicate the particular process of Mr. Paperi. Indeed, even assuming that LKQ does produce a product encompassed by the patent, . . . the record suitably establishes that one of ordinary skill in the art would have been cognizant from the prior art of all the steps associated with those claims and which operate for their intended function. In that regard, Clearlamp has not shown persuasively that LKQ's refurbishing process is due only to an act of copying of the particular process practiced by Dr. Paperi, rather than simply through practice of the teachings of the prior art.").
12 Intri–Plex Techs., Inc. v. Saint–Gobain Performance Plastics Rencol Ltd., IPR2014–00309, Paper 22, at 11-13 (P.T.A.B. Aug. 11, 2014).
13 Intri–Plex Techs., Inc. v. Saint–Gobain Performance Plastics Rencol Ltd., IPR2014–00309, Paper 83, at 45-46 (P.T.A.B. Mar. 23, 2014).
14 Medtronic, Inc. v. Nuvasive, Inc., IPR2014-00074, Paper 10, at 10-11 (P.T.A.B. Jan. 31, 2014).
15 Id.
16 Id. at 32-37, 54-56.
17 Medtronic, Inc. v. Nuvasive, Inc., IPR2014-00074, Paper 15, at 21 (P.T.A.B. Apr. 8, 2014) (citation omitted).
18 See 37 C.F.R. §42.107(c) (2014), supra note 5.
19 See also FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-00608, Paper 6, at 48 (P.T.A.B. July 15, 2014) (involving Patent Owner raising objective evidence of nonobviousness from related litigation); FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-00608, Paper 10, at 33-34 (P.T.A.B. Sept. 5, 2014) (determining that arguments relying on objective evidence of nonobviousness from related litigation were "best addressed in a trial phase where both parties have an opportunity to cross-examine witnesses and where the Board can evaluate credibility of witnesses" and noting that the POPR improperly relied upon "declaration testimony presented to the Northern District of Texas in connection with its consideration of a motion for a stay. The declaration testimony, prepared and filed in the district court after the petitions were filed, addresses not only why a stay should be denied in the civil action, but also substantively why Petitioner is not likely to succeed in the IPRs. The declaration testimony relied upon by Patent Owner is consequently not pre-existing declaration testimony; rather it is ‘new testimony evidence beyond that already of record’ within the meaning of §42.108(c). Declaration testimony of the kind presented by the Patent Owner is not entitled to consideration at this stage of the proceeding. 37 C.F.R. §2.107(c)."). See also, C&D Zodiac, Inc. v. B/E Aerospace, Inc., IPR2014-00727, Paper 15, at 18 (P.T.A.B. Oct. 29, 2014) ("The declarations are new testimony prohibited at this stage of the proceeding, as they were executed for filing in U.S. District Court for the Eastern Division of Texas after the Petition was filed[.]").
20 Phigenix, Inc. v, Immunogen, Inc., IPR2014-00676, Paper 10, at 11-30 (P.T.A.B. July 30, 2014).
21 Id.
22 Phigenix, Inc. v, Immunogen, Inc., IPR2014-00676, Paper 11, at 22 (P.T.A.B. Oct. 29, 2014).
23 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 10, at 42-46, 52 (P.T.A.B. Aug. 6, 2013).
24 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 14, at 3-5 (P.T.A.B. Feb. 13, 2014).
25 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 1, at 10 (P.T.A.B. May 3, 2013).
26 Omron, Paper 10, at 42 n. 12.
27 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 11, at 21 (P.T.A.B. Oct. 31, 2013).
28 Id. at 12-13.
29 Id. at 16.
30 Id. at 15.
31 Id. at 14 (citation omitted).
32 Id. at 14-15.
33 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 14, at 2 (P.T.A.B. Feb. 13, 2014).
34 Id. at 3.
35 Id. at 4.
36 Lupin Ltd. v. Vertex Pharms. Inc., IPR2015-00405, Paper 13, at 26-27 (P.T.A.B. July 9, 2015).
37 Lupin Ltd. v. Vertex Pharms. Inc., IPR2015-00405, Paper 11, at 32-39 (P.T.A.B. Apr. 13, 2015).
38 Lupin, Paper 13, at 21-22 (citations omitted).
39 Id. at 22.
40 Id. at 22-23.
41 Id. at 26-27. But see, e.g., In re Hollingsworth, 253 F.2d 238, 117 U.S.P.Q. 182 (C.C.P.A. 1958), In re Glatt, 630 F.3d 1026, 97 U.S.P.Q.2d 1661 (Fed. Cir. 2011) (81 PTCJ 311, 1/14/11), and Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563, 40 U.S.P.Q.2d 1481 (Fed. Cir. 1996), for Federal Circuit case law support for the position that objective evidence may establish the patentability of a claim broader in scope than the single embodiment shown within the claim.
42 John's Lone Star Distrib., Inc. v. Thermolife Int'l, LLC, IPR2014-01201, Paper 30, at 4-6 (P.T.A.B. May 13, 2015) (discussing the Garmin factors relevant to determining whether an additional discovery request is in the interest of justice (citing Garmin Int'l, Inc. v. Cuozzo Speed Techs., LLC, IPR2012-00001, Paper 26, at 6–7 (P.T.A.B. Mar. 5, 2013))).
43 Id. at 4-5.
44 Kingston Tech. Co. v. CATR Co., IPR2015-00149, Paper 17, at 2 (P.T.A.B. May 26, 2015).
45 See generally Kingston Tech. Co. v. CATR Co., IPR2015-00149, Paper 8 (P.T.A.B. Jan. 21, 2015).
46 Kingston, Paper 17, at 3.
47Kingston Tech. Co. v. CATR Co., IPR2015-00149, Paper 24, at 2-3 (P.T.A.B. June 10, 2015) (citing Garmin Int'l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-0001, Paper 26, at 6-7 (P.T.A.B. Mar. 5, 2013)).
48 Id. at 3 (alteration in original) (quoting Garmin Int'l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-0001, Paper 26, at 6 (P.T.A.B. Mar. 5, 2013)).
49 Id. at 8.
50 Id. at 3-4.
51 Id. at 5 (quoting Kingston Tech. Co. v. CATR Co., IPR2015-00149, Ex. 2001, at 1 (P.T.A.B. May 21, 2015)).
52 Id. at 3 (quoting Kingston Tech. Co. v. CATR Co., IPR2015-00149, Paper 16, at 3 (P.T.A.B. May 21, 2015)).
53 Id. (citing Kingston Tech. Co. v. CATR Co., IPR2015-00149, Paper 16, at 3 (P.T.A.B. May 21, 2015)).
54 Id.
55 Id. at 5.
56 Id. at 6.
57 Kingston Tech. Co. v. CATR Co., IPR2015-00149, Paper 33, at 43-45 (P.T.A.B. July 16, 2015) ("Amazon® customer reviews for the Kingston DT101 G2 device were submitted as Exhibit 2005. These reviews provide nearly universal praise . . . with 87.4% of the responses being 4 or 5 stars. Less than 5% are a 1-star rating . . . . The DT101 G2 was a commercially successful product. As ordered by the Board on June 10, 2015, the Petitioner provided to the Patent Owner sales data related to the DT101 G2. Ex. 2017.").
58 Microsoft Corp. v. Proxyconn, Inc., IPR2012-00026, Paper 32, at 4-5 (P.T.A.B. March 8, 2013).
59 Id. at 6.
60 Id. at 5 ("Patent Owner failed to provide a sufficient showing that might establish the relevance of the additional discovery requested, much less demonstrating that the interest of justice standard has been met.").
61 MasterImage 3D Asia, LLC v. RealD, Inc., IPR2015-00035, Paper 28, at 2 (P.T.A.B. June 23, 2015).
62 Id. at 2-3 (citing Garmin Int'l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 26, at 5–7 (P.T.A.B. Mar. 5, 2013)).
63 Id. at 3 (quoting Garmin Int'l, Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 26, at 6 (P.T.A.B. Mar. 5, 2013)). See also Google Inc. and Apple Inc. v. Jongerius Panoramic Technologies, LLC, IPR2013-00191, Paper 27, at 8 (P.T.A.B. Sept. 30, 2013) ("The evidence and arguments presented by Patent Owner amount to only a mere allegation and speculation that Petitioners copied the claimed invention from Patent Owner.").
64 Id.
65 Kamada, Ltd. v. Grifols Therapeutics Inc., IPR2014-00899, Paper 18, at 3 (P.T.A.B. Feb. 20, 2015).
66 Kamada, Ltd. v. Grifols Therapeutics Inc., IPR2014-00899, Paper 22, at 4 (P.T.A.B. Mar. 4, 2015).
67 Id.
68 Lupin Ltd. v. Vertex Pharm. Inc., IPR2015-00405, Paper 13, at 22-23 (P.T.A.B. July 9, 2015).
69 Id. at 26-27. For Federal Circuit case law, see supra note 41.
70 FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-00608, Paper 6, at 48-49 (P.T.A.B. July 15, 2014) (citing Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392-93, 7 U.S.P.Q.2d 1222 (Fed. Cir. 1988)). See also Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 11, at 14 (P.T.A.B. Oct. 31, 2013) ("A prima facie case of nexus is established when the patentee shows both that there is commercial success, and that the product that is commercially successful is the invention disclosed and claimed in the patent. See In re GPAC Inc., 57 F.3d 1573, 1580, 35 U.S.P.Q.2d 1116 (Fed. Cir. 1995).").
71 See, e.g., Medtronic, Inc. v. Nuvasive, Inc., IPR2014-00074, Paper 10, at 32-37, 54-56 (P.T.A.B. Jan. 31, 2014); Phigenix, Inc. v, Immunogen, Inc., IPR2014-00676, Paper 10, at 11-30 (P.T.A.B. July 30, 2014).
72 Shire Dev. LLC v. LCS Grp., LLC, IPR2014-00739, Paper 23, at 8 (P.T.A.B. Mar. 12, 2015).
73 Id. at 3.
74 37 C.F.R. §42.107(c).
75 Michelle K. Lee, PTAB'S Quick-Fixes for AIA Rules Are to Be Implemented Immediately, Post to Director's Blog, USPTO (Mar. 27, 2015, 10:18 AM), http://www.uspto.gov/blog/director/entry/ptab_s_quick_fixes_for. ("[W]e are considering proposing a number of other revisions to rules including . . . adjustments to the evidence that can be provided in the patent owner preliminary response . . . [and] adjustments to the scope of additional discovery.").
76 See Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 10, at 42, n. 12 (P.T.A.B. Aug. 6, 2013). But note that even if the declarations are prepared for related litigation, they must still be executed prior to the filing of the IPR petition, otherwise they are not "new." See FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-00608, Paper 10, at 33-34 (P.T.A.B. Sept. 5, 2014), and C&D Zodiac, Inc. v. B/E Aerospace, Inc., IPR2014-00727, Paper 15, at 18 (P.T.A.B. Oct. 29, 2014).
77 Anova Food, LLC. v. Sandau, IPR2013-00114, Paper 11, at 3 (P.T.A.B. June 25, 2014) ("37 C.F.R. §42.107(c) applies only to ‘new’ testimony that was taken specifically for the purpose of the inter partes review proceeding at issue, as supported by the discussion and the comments that accompanied the rule. For example, a party submitting the prosecution history for the challenged patent may include a copy of the declarations contained therein. The Declaration of Milton M. Yasunaga represents new testimonial evidence as it was created specifically for this proceeding, and authorization from the Board was not obtained before its filing. Accordingly, it will be not be relied upon for purposes of institution. The evidence on which it relies, however, such as the Declaration of Darren Zobrist that was filed in the United States District Court for the District of Hawaii in Civil No. CV 11 00795 (Ex. 2009), is not ‘new’ testimonial evidence relied upon by the Patent Owner to support the contentions in the preliminary response, and thus can be appropriately submitted with the response.").
78 In re Cuozzo Speed Techs., LLC, 778 F.3d 1271, 1276, 113 U.S.P.Q.2d 1613 (Fed. Cir. 2015) (89 PTCJ 877, 2/6/15).
79 See, e.g., Lupin Ltd. v. Vertex Pharm. Inc., IPR2015-00405, Paper 13, at 26-27 (P.T.A.B. July 9, 2015).
80 While an examiner during prosecution may or may not be an attorney, all members of PTAB are attorneys. Thus, while writing arguments in responses, it is important to provide citations to both the MPEP, which the examiner will be familiar with, as well as case law, which bind PTAB.
81 See, e.g., K-40 Electronics, LLC v. Escort, Inc., IPR2013-00203, Paper 6, at 6 (P.T.A.B. Aug. 29, 2013) (instituting IPR based on defective declaration submitted during prosecution).
82See, e.g., Aventis Pharma Socie´te´ Anonyme [S.A.] v. Hospira, Inc., 675 F.3d 1324, 102 U.S.P.Q.2d 1445 (Fed. Cir. 2012) (83 PTCJ 868, 4/13/12); Apotex Inc. v. Cephalon, Inc., No. 06-cv-2768, 2011 BL 285593 (E.D. Pa. Nov. 7, 2011), aff'd without opinion, No. 2012-1417 (Fed. Cir. Apr. 8, 2013); Intellect Wireless, Inc. v. HTC Corp., 732 F.3d 1339, 108 U.S.P.Q.2d 1563 (Fed. Cir. 2013) (86 PTCJ 1227, 10/18/13); Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 108 U.S.P.Q.2d 1745 (Fed. Cir. 2013) (87 PTCJ 171, 11/22/13); Apotex, Inc. v. UCB, Inc., 763 F.3d 1354, 112 U.S.P.Q.2d 1081 (Fed. Cir. 2014) (88 PTCJ 1043, 8/22/14); Am. Calcar, Inc. v. Am. Honda Motor Co., 768 F.3d 1185, 112 U.S.P.Q.2d 1353 (Fed. Cir. 2014) (88 PTCJ 1393, 10/3/14).
*Stacy Lewis is a law clerk at Finnegan.
©Bloomberg BNA 2015. Originally published by Bloomberg BNA on October 9, 2015. Reprinted by permission. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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