Category Archives: Obviousness

Motivation to Combine Prior Art Can Come from Knowledge of those Skilled in the art, the Art Itself, or the Nature of the Problem

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In Acoustic Technology, Inc. v. Itron Networked Solutions, Inc., [2019-1061] (February 19, 2020), the Federal Circuit affirmed the PTAB’s determination in IPR2017-01024 that the challenged claim of U.S. Patent No. 6,509,841 was unpatentable,

The patent owners first ground of attack was that nine days after institution of the IPR, Silver Spring agreed to merge with Itron, Inc., an entity undisputedly time-barred under 35 U.S.C. § 315(b). However, the Federal Circuit held that the patent owner waived this argument because it failed to present those arguments before the Board.

As the the merits of the anticipation finding, the patent owner complained that the petitioner’s expert improperly testified about what a person of ordinary skill in the art would “recognize” from the reference, — arguing that this might be appropriate for obviousness, but not anticipate. The Federal Circuit disagreed, noting that in an anticipation analysis, the dispositive question is whether a skilled artisan would “reasonably understand or infer” from a prior art reference that every claim limitation is disclosed in that single reference. Expert testimony may shed light on what a skilled artisan would reasonably understand or infer from a prior art reference. Moreover, expert testimony can constitute substantial evidence of anticipation when the expert explains in detail how each claim element is disclosed in the prior art reference.

The Federal Circuit examined the testimony of Petitioner’s expert and concluded that he conducted a detailed analysis and explained how a skilled artisan would reasonably understand the cited prior art. The Court thus concluded that the Board’s finding of anticipate was supported by substantial evidence.

The Federal Circuit also rejected the patent owner’s argument that the Board improperly relied on “the same structures to satisfy separate claim limitations.” The Federal Circuit explained that it was clear from the disclosure that the identified structure may have different functions in a given embodiment.

Finally with respect to the obviousness of the claimed invention, the Federal Circuit rejected patent owners argument that the Board erroneously mapped the prior art onto the elements of the claim and that the Board’s motivation-to-combine finding is not supported by substantial evidence. On this later point the Federal Circuit pointed out that the motivation to combine prior art references can come from the knowledge of those skilled in the art, from the prior art reference itself, or from the nature of the problem to be solved. The Board found that motivation was adequately explained by expert testimony which was not conclusory or otherwise defective, and thus the Board was within its discretion to rely upon it.

Only an Expert Can Testify about What Would Be Obvious to a Non-Expert

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In HVLPO2, LLC, v. Oxygen Frog, LLC, [2019-1649] (February 5, 2020), the Federal Circuit reversed and remanded the district court’s determination that U.S. Patent Nos. 8,876,941 and 9,372,488 directed to methods and devices for controlling an oxygen-generating system, would have been obvious, because the district court abused its discretion by admitting lay witness testimony regarding obviousness.

At trial, Oxygen Frog argued that the claims were obvious in view of a combination of two prior art references. The author of one of the references, Piebes, was not qualified as an expert witness, but did provide deposition testimony as a fact witness. HVO objected to Mr. Piebes’ testimony regarding obviousness as improper expert opinion testimony. The district court overruled the objection, and instead gave the jury a limiting instruction prior to playing Mr. Piebes’ deposition testimony.

The Federal Circuit found that under the circumstances here, the district court’s limiting instruction was insufficient to cure the substantial prejudice caused by Piebes’ testimony, and thus the district court abused its discretion by denying a motion for a new trial.

The Federal Circuit said that the admission of Piebes’ testimony opining that it would be “obvious” to modify a prior art system in a particular way that would match the claimed invention was improper. It noted that Federal Rule of Evidence 702 provides:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) the expert’s scientific, technical, or other spe-cialized knowledge will help the trier of fact to un-derstand the evidence or to determine a fact in issue; . . .

The Federal Circuit said that this precisely described testimony which would pertain to an obviousness invalidity challenge in a patent trial. The Federal Circuit said that Issues of infringement and validity are analyzed in great part from the perspective of a person of ordinary skill in the art, such that a witness who is not ‘qualified as an expert by knowledge, skill, experience, training, or education’ in the pertinent art cannot assist the trier of fact to understand the evidence or to deter-mine a fact in issue. Thus, the Federal Circuit said. “it is an abuse of discretion to permit a witness to testify as an expert on the issues of non-infringement or invalidity unless that witness is qualified as an expert in the pertinent art.

The Federal Circuit said that the prohibition of unqualified witness testimony extends to the ultimate conclusions of infringement and validity as well as to the underlying technical questions. A witness not qualified in the pertinent art may not testify as an expert on obviousness, or any of the underlying technical questions, such as the nature of the claimed invention, the scope and content of the prior art, the differences between the claimed invention and the prior art, or the motivation of one of ordinary skill in the art to combine these references to achieve the claimed invention.

Because the district court abused its discretion by admitting lay witness testimony regarding obviousness, the Federal Circuit reversed and remanded for a new trial.

Federal Circuit Asks PTAB to Give it a Go and Decide Whether Indefinite Claims Were otherwise Patentable

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In Samsung Electronics America, Inc. v. Prisua Engineering Corp., 2019-1169, 2019-1260 (February 4, 2020) the Federal Circuit affirmed the PTAB determination that claim 11 of U.S. Patent No. 8,650,591 was invalid for obviosuness, but vacated the PTAB’s decision declining to decide whether claims 1-4 and 8 were patentable because these claims were indefinite.

The claims of the ‘591 patent are directed to methods and apparatuses for generating a displayable edited video data stream from an original video data stream. The Board determined that claim 1 (and claims 2-4 and 8) claimed both an apparatus and a method, and thus was indefinite under IPXL Holdings. Because the claims were indefinite, the Board declined to determine whether they otherwise defined patentable subject matter. The Board also found the claims indefinite because of the inclusion of “digital processing unit” which the Board found invoked 112(f), without identifying any corresponding stucture in the claims.

Samsung appealed arguing that the Board should have declared the claims in valid for indefiniteness. The Federal Circuit agreed with the Board that the Board did not have the authority to invalidate claims on that ground.

Samsung’s secondary argument was that the Board should have nonetheless assessed the patentability of claims 1 and 4–8 under sections 102 or 103. On this point, the Federal Circuit agreed.

The Federal Circuit noted that on the first ground of indefiniteness — mixed method and apparatus claiming, the indefiniteness problem was one of understanding when infringement occurred, and not necessarily what the claim actually means. Moreover, the Federal Circuit noted that the Board had previously held that IPXL-type indefiniteness does not prevent the Board from addressing patentability.

Thus the Federal Circuit remanded the case for the Board to attempt to apply 102 and 103 to the claims.

As to the second ground of indefiniteness, that “digital processing unit” invoked 112(f) without providing corresponding structure in the claims, the Federal Circuit disagreed. The Federal Circuit said that the question whether the term “digital processing unit” invokes section 112, paragraph 6, depends on whether persons skilled in the art would understand the claim language to refer to structure, assessed in light of the presumption that flows from the drafter’s choice not to employ the word “means. The Federal Circuit said that the Board pointed to no evidence that a person skilled in the relevant art would regard the term “digital processing unit” as purely functional. In fact, the patent owner argued to the Board, based on testimony from its expert (the inventor), that the digital processing unit recited in the claims is “an image processing device that people in the art are generally familiar with.” Moreover, the fact that claim 1 required the “digital processing unit” to be operably connected to a “data entry device” supports the structural nature of the term “digital processing unit,” as used in the claim.

The Federal Circuit rejected the Board’s conclusion that the term “digital processing unit,” as used in claim 1, invoked means-plus-function claiming,
and that for that reason claims 1 and 4–8 cannot be analyzed for anticipation or obviousness.

General Knowledge is Available in Obviousness Inquiry Even Though IPRs are Limited to Documentary Prior Art

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In Koninklijke Philips N.V. v. Google, [2019-1177] (January 30, 2020), the Federal Circuit affirmed the PTAB determination that claims 1-11 of U.S. Patent No. 7,529,806 were unpatentable as obvious.

Philips presetnted three arguments on appeal. First, that the Board erred by instituting inter partes review on the ground that the claims would have been obvious over SMIL 1.0 in light of Hua because Google did not advance that specific combination in its petition. Second, that the Board erred in finding that the claims would have been obvious in view of SMIL 1.0 because the Board impermissibly relied on “general knowledge” to supply a missing claim limitation. Third, that the Board’s obviousness findings are nevertheless unsupported by substantial evidence.

On Philips’ first point, the Federal Circuit agreed, holding that the Board erred by instituting inter partes review based on a combination of prior art references not advanced in Google’s petition. 35 U.S.C. § 311(a) does not contemplate a petition that asks the Director to initiate whatever kind of inter partes review he might choose.

On Philips’ second point, the Federal Circuit disagreed with Philips’ argument that because 35 U.S.C. § 311(b) expressly limits inter partes reviews to “prior art consisting of patents or printed publications,” and because general knowledge is neither of those, § 311(b) prohibits use of general knowledge to supply a missing claim limitation in an inter partes review. The Federal Circuit explained that although the prior art that can be considered in inter partes reviews is limited to patents and printed publications, it does not follow that we ignore the skilled artisan’s knowledge when determining whether it would have been obvious to modify the prior art.

The Federal Circuit also disagreed with Philips that the Board’s reliance on “general knowledge” violated Arendi. The Federal Circuit explained that in Arendi it cautioned that although “common sense and common knowledge have their proper place in the obviousness inquiry,” (a) invoking “common sense . . . to supply a limitation that was admittedly missing from the prior art” should generally only be done when “the [missing] limitation in question [is] unusually simple and the technology particularly straightforward;” and (b) references to common sense “cannot be used as a whole-sale substitute for reasoned analysis and evidentiary support.” The Federal Circuit said that in Arendi, the Board relied on nothing more than “conclusory statements and unspecific expert testimony” in finding that it would have been “common sense . . . to supply a limitation that was admittedly missing from the prior art.” Conversely, in the present case, the Federal Circuit found that the Board relied on expert evidence, which was corroborated by Hua, in concluding that pipelining was not only in the prior art, but also within the general knowledge of a skilled artisan.

Finally, the Federal Circuit disagreed with Philips third point, that the finding of obvious was not supported by substantial evidence. The Federal Circuit noted that the Board thoroughly explained why the modified prior art disclosed all the limitations of claim 1, The Federal Circuit said that relying on an expert declaration and reference as evidence of a skilled artisan’s general knowledge, the Board found that a skilled artisan “would have been motivated to modify the prior art. The Board also determined that there would have been a reasonable expectation of success. The Federal Circuit concluded concluded that the Board’s findings are supported by substantial evidence.

Lack of Showing of Criticality Dooms Claims with Ranges Overlapping the Prior Art

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Genentech, Inc., v. Hospira, Inc., [2018-1933] (January 10, 2020), the Federal Circuit affirmed the PTAB holding claims 1–3 and 5–11 of U.S. Patent 7,807,799 directed to methods of purifying certain antibodies and other proteins unpatentable as anticipated or obvious.

Important to the invention was operating at a low temperature to eliminate the need for subsequent purification steps, the claims specified a range of “about 10°C to about 18°C”, which the Federal Circuit found overlapped the prior art range of “18–25°C,” regardless of the construction of “about 18°C.” The Federal Circuited noted that the patentee own proposed construction for “about 18°C” embraces temperatures up to 19°C, which further reinforces the overlap with the prior art’s disclosed temperature range.

The Federal Circuit said a prior art reference that discloses an overlapping but different range than the claimed range can be anticipatory, even where the prior art range only partially or slightly overlaps with the claimed range.  Once a patent challenger has established, through overlapping ranges, its prima facie case of anticipation, the court must evaluate whether the patentee has established that the claimed range is critical to the operability of the claimed invention.  The Federal Circuit found that the the patentee failed to show criticality of the range.

As to obviousness, the Federal Circuit noted that even a slight overlap in range establishes a prima facie case of obviousness, and that the burden of production falls upon the patentee to come forward with pertinent evidence that the overlapping range would not have been obvious in light of the prior art.  One way in which the patentee may rebut the presumption of obviousness is by showing that there is some-thing special or critical about the claimed range.  The Federal Circuit found that presumption of obviousness applies here, and the Board found that Genentech failed to establish criticality for the claimed temperature range, which Genentech did not appeal. The Federal Circuit said that another way in which the presumption can be rebutted is by showing that a process parameter, such as temperature, was not recognized as “result-effective.”  However, Federal Circuit said that the Board reasonably found that a skilled artisan would have been motivated to optimize the temperature given the teachings of the prior art, and that given the ease with which temperature can be varied, finding an optimal temperature range would have been nothing more than routine experimentation.

Inherency Supplied Missing Claim Limitation in Obviousness Analysis

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In Persion Pharmaceuticals LLC v. Alvogen Malta Operations LTD., [2018-2361] (December 27, 2019) the Federal Circuit affirmed the district court’s determination that the asserted claims of U.S. Patent No. 9,265,760 and 9,339,499 entitled “Treating Pain in Patients with Hepatic Impairment” were obvious.

Persion raised four primary challenges to the district court’s obviousness conclusion. First, Persion contended that the district court improperly relied on inherency to conclude that the prior art discloses the pharmacokinetic limitations of the asserted claims.  It is long settled that in the context of obviousness, the mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art.  The Federal Circuit noted that the Supreme Court explained long ago that it is not invention to perceive that the product which others had discovered had qualities they failed to detect.

However, inherency is a high standard, that is carefully circumscribed in the context of obviousness.  Inherency may not be established by probabilities or possibilities, and the mere fact that a certain thing may result from a given set of circumstances is not sufficient.  Inherency renders a claimed limitation obvious only if the limitation is “necessarily present,” or is “the natural result of the combination of elements explicitly disclosed by the prior art.”  The Federal Circuit said “inherency may supply a missing claim limitation in an obviousness analysis” where the limitation at issue is “the natural result of the combination of prior art elements,” and found that was the case here.

Second, Persion argued that the district court improperly relied on pharmacokinetic profiles from drugs other than extended-release single-active-ingredient hydrocodone formulations and from patients other than those with hepatic impairment in reaching its obviousness conclusion.  The Federal Circuit found that the district court provided several reasons for its conclusion that a person of ordinary skill in the art would have considered other types of drug products in developing a hydrocodone-only extended-release formulation.  In light of the record as a whole, we find no clear error in the district court’s findings on the relevance of combination product data to a person of ordinary skill considering the administration of a hydrocodone-only product.

Third, Persion contended that the district court erred by finding the asserted claims obvious before considering the objective indicia factors.  The Federal Circuit found that the district court considered Persion’s evidence of objective indicia together with the other evidence presented at trial on the issue of obviousness.  While the district court’s discussion of objective indicia followed its discussion of the asserted prior art, the Federal Circuit found that the substance of the court’s analysis makes clear that it properly considered the totality of the obviousness evidence in reaching its conclusion and did not treat the objective indicia as a mere “afterthought” relegated to rebutting a prima facie case.  Overall, the Federal Circuit found no clear error with the district court’s assessment of the objective indicia evidence. Fourth, Persion argued that the district court’s factual findings concerning obviousness are inconsistent with its findings concerning the lack of written description support.  The Federal Circuit found no such inconsistency, noting that Persion’s entire argument with respect to this issue is based on incomplete quotations from the district court’s opinion.

Patent Owner’s Praise for Other Inventions Destroyed Presumption of Nexus between Commercial Product and Claims

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In Fox Factory , Inc. v. SRAM, LLC, [2018-2024, 2018-2025] (December 18, 2019), the Federal Circuit vacated and remanded that the district court’s determination that claims 1–6 and 13–19 of U.S. Patent No. 9,182,027 was not obvious based on its analysis of secondary considerations. The independent claims of the ’027 patent—claims 1, 7, 13, and 20—recite a bicycle chainring with alternating narrow and wide tooth tips and teeth offset from the center of the chainring.

The Board determined that SRAM was entitled to a presumption of nexus between the challenged outboard offset claims and secondary considerations evidence pertaining to SRAM’s X-Sync products, subject to two limitations. First, the Board stated that evidence of secondary considerations “specifically directed” to either an inboard or outboard offset X-Sync product is only entitled to a presumption of nexus with the claims reciting the same type of offset. Second, the Board explained that the presumption of nexus only applies when a product is “coextensive” with a patent claim.

On appeal, FOX contended that the Board applied the wrong standard for determining whether SRAM was entitled to a presumption of nexus between the challenged claims and SRAM’s evidence of secondary considerations, and the Federal Circuit agreed.

In order to accord substantial weight to secondary considerations in an obviousness analysis, the evidence of secondary considerations must have a “nexus” to the claims, i.e., there must be a legally and factually sufficient connection’ between the evidence and the patented invention. The Federal Circuit noted that the patentee bears the burden of showing that a nexus exists. To determine whether the patentee has met that burden, the consideration is the correspondence between the objective evidence and the claim scope.

A patentee is entitled to a rebuttable presumption of nexus between the asserted evidence of secondary considerations and a patent claim if the patentee shows that the asserted evidence is tied to a specific product and that the product is the invention disclosed and claimed. Conversely, when the thing that is commercially successful is not coextensive with the patented invention—for example, if the patented invention is only a component of a commercially successful machine or process, the patentee is not entitled to a presumption of nexus.

The existence of one or more unclaimed features, standing alone, does not mean that nexus may not be presumed. There is rarely a perfect correspondence between the claimed invention and the product. The purpose of the coextensiveness requirement is to ensure that nexus is only presumed when the product tied to the evidence of secondary considerations is the invention disclosed and claimed. If the unclaimed features amount to nothing more than additional insignificant features, presuming nexus may nevertheless be appropriate.

The Federal Circuit explained that the degree of correspondence between a product and a patent claim falls along a spectrum. At one end of the spectrum lies perfect or near perfect correspondence. At the other end lies no or very little correspondence, such as where the patented invention is only a component of a commercially successful machine or process.

In the instant case the Federal Circuit concluded that no reasonable fact finder could conclude, under the proper standard, that the X-Sync chainrings are coextensive with the ‘027 patent claims. The Federal Circuit noted that the chainrings include unclaimed features that the patentee describes as “critical” to the product’s ability to “better retain the chain under many conditions” and that go to the “heart” of another one of Patent Owner’s patents. The Federal Circuit said that In light of the patentee’s own assertions about the significance of the unclaimed features, no reasonable fact finder could conclude that these features are insignificant.

Because it could not say that the X-Sync chainrings are the invention claimed by the independent claims, the Board erred in presuming nexus between the independent claims of the ’027 patent and secondary considerations evidence pertaining to the X-Sync chainrings. Because the Board erroneously presumed nexus between the evidence of secondary considerations and the independent claims, the Federal Circuit vacated the Board’s non-obviousness determination and remanded for further proceedings. On remand, the Federal Circuit said that the Patent Owner will have the opportunity to prove the nexus between the challenged independent claims and the evidence of secondary considerations.

Petitioner Allowed to Supplement Evidence that Reference was Available

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In Telefonaktiebolaget LM Ericsson v. TCL Corp., [2017-2381, 2017-2385] (November 7, 2019) the Federal Circuit affirmed the Board’s decision that the specified publication is an available reference, and based on this publication in combination with other prior art it affirmed the Board’s decision of invalidity of the challenged claims.

Ericsson argued that the Jentschel article is not prior art because it was not publicly available more than one year before Ericsson’s earliest asserted filing date, and thus is subject to antedating by Ericsson’s invention date. During the trial TCL sought to provide evidence of the date of availability of this journal issue in university libraries in Germany.

TCL first submitted to the PTAB a letter from a librarian from the “Periodicals Team” at the Technische Informationsbibliothek and Universitätsbibliothek in Hannover, Germany. Ericsson objected to the letter as inadmissible hearsay, and the statement was withdrawn when the librarian declined to provide a sworn statement and declined to testify in the United States. TCL then moved to submit the sworn Declaration of Doris Michel, a librarian at the Technische Universität Darmstadt in Germany. Ericsson again objected, stating that the submission was not in compliance with the Board’s Rules, which required a petitioner to present sufficient evidence, at the petition stage, and requires that a party who seeks to submit new or supplemental information more than one month after the date an IPR is instituted must show why the supplemental information rea-sonably could not have been obtained earlier, and that consideration of the supplemental information would be in the interests-of-justice.

TCL responds that Regulation § 42.123(b) gives the Board discretion to accept a tardy submission and to consider the interest of justice. TCL argues that the Jentschel article is very close prior art and that Ericsson was allowed to file supplemental briefing and to depose Ms. Michel.

The Federal Circuit concluded that the Board did not abuse its discretion in admitting the Michel Declaration, for when the challenged evidence is reasonably viewed as material, and the opponent has adequate opportunity to respond and to produce contrary evidence, the interest of justice weighs on the side of admitting the evidence.

Ericsson argues that the date of availability to the public of the Jentschel reference was not established by the Michel Declaration, even if that Declaration were deemed admissible. The Federal Circuit explained that a reference is deemed publicly available if it has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it. The Federal Circuit noted that Ericsson provided no evidence to counter the Michel Declaration, the date on the face of the journal, and the Library’s records showing receipt of the journal and its shelving. The Federal Circuit found that substantial evidence supports the Board’s ruling that Jentschel was accessible to the public in the May/June 1996 period, and that the Board did not abuse its discretion in receiving the Jentschel article as a reference.

The Federal Circuit further concluded that substantial evidence supports the Board’s finding that Jentschel renders obvious the claims.

Federal Circuit Loosens the Iron Grip on Evidence of Copying

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In Liqwd v L’Oreal USA Inc., [2018-2152](October 17/30, 2019), the Federal Circuit vacated and remanded the PTAB’s final written decision that cetain claims of U.S. Patent No. 9,498,419 directed to forulations and methods of keratin treatment are unpatentable as obvious.

During the PGR Liqwd presented evidence that L’Oreal had used Liqwd’s confidential information and copied Liqwd’s patented invention as an objective indicia of non-obviousness. However, the Board concluded that the copying involved was legally irrelevant, because it was not evidence of copying a specific product, citing Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004), and thus was not “copying of the type that is relevant to the question of obviousness.”

Objective indicia are essential safeguards that protect against hindsight bias, and thus are a fundamental part of the overall § 103 obviousness inquiry. The Federal Circuit said that It is well established that copying by a competitor is a relevant consideration in the objective indicia analysis, as such copying may be evidence that the patented invention is nonobvious. However copying requires duplication of features of the patentee’s work based on access to that work, lest all infringement be mistakenly treated as copying. Evidence of copying may include internal documents, direct evidence such as photos of patented features or disassembly of products, or access and similarity to a patented product.

The Federal Circuit conceded that in Iron Grip Barbell, it stated that “copying requires the replication of a specific product,” but explained that it was simply stating that something more than showing similarity between the accused product and the patent was needed. The Federal Circuit pointed that that access to the patent, or access to articles about a patented invention have been sufficient to establish copying, in the absence of a specific product to be copied. What the Federal Circuit meant was “copying requires duplication of features of the patentee’s work based on access to that work, lest all infringement be mistakenly treated as copying” and that the relevant inquiry was whether there was evidence of copying efforts.

The Federal Circuit concluded that the evidence presented by Liqwd shows more than merely a competing product that arguably falls within the scope of a patent. Determining that this evidence is relevant does not implicate the concern with avoiding every infringement suit turning into a confirmation of the nonobviousness of a patent. The Federal Circuit said that because this evidence of actual copying efforts was relevant, the Board erred by disregarding it. The Federal Circuit vacated the Board’s obviousness determination and remanded the case for the Board to consider this evidence in its obviousness analysis.

Hope is not Enough to Create a Reasonable Expectation of Success

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In OSI Pharmaceuticals, LLC v. Apotex Inc., [2018-1925] (October 4, 2019), the Federal Circuit reversed the PTAB’s determination that claims 44-46 and 53 of U.S. Patent No. 6,900,221 on the use of erlotinib on non smallcell lung cancer (NSCLC) would have been obvious because the Board’s finding of a reasonable expectation for success was not supported by substantial evidence.

The Board found that the disclosures in OSI’s own 10-K that erlotinib targeted a variety of cancers including NSCLC, and that erlotinib had entered Phase II clinical trials, would have provided a person of ordinary skill with a reasonable expectation of success in light of the other prior art references. The Board concluded that an ordinary artisan would under-stand from the commencement of Phase I studies referenced in the 10-K that “pre-clinical animal efficacy data” had been submitted to the FDA.

The Federal Circuit said that an obviousness determination requires finding that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so. The Federal Cicuit said that when the references are properly read, the Board’s finding that the asserted references provide a reasonable expectation of success also is not supported by substantial evidence.

The Federal Circuit noted that the record does not contain any clinical (human) data or pre-clinical (animal) data. It did not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. The Federal Circuit added that at the same time, it is undisputed that NSCLC treatment was highly unpredictable with an over 99.5% rate of failure for drugs entering Phase II clinical studies. On this record, the Federal Circuit was not persuaded that a reasonable fact finder could conclude that a person of ordinary skill would have reasonably expected success based on the combination of the references and OSI’s 10-K.

The Federal Circuit examined one reference (Gibbs) that said “these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer. The Federal Circuit consulted the footnotes and conclude that the reference as a whole would not be understood by a person of ordinary skill in the art to refer to erlotinib, because the supporting article did not refer to erlotinib. The Federal Circuit said that the Board’s finding that there is a “clear inference” in Gibbs that “erlotinib has anti-cancer activity against non-small cell lung cancer” is thus not supported by substantial evidence.

On the specific issue of reasonable expectation of success the Federal Circuit found that the asserted references do not disclose any information about erlotinib’s efficacy in treating NSCLC in a mammal (in Scnhur and Gibbs). These references contained no data or other promising information regarding erlotinib’s efficacy in treating NSCLC, just cancer generally and this was not enough “because of the highly unpredictable nature of treating NSCLC.” With respet to OSI’s own 10-K the Board emphasized the 10-K’s statement that erlotinib had completed Phase I clinical trials, which require preclinical animal efficacy data. However, the Federal Circuit noted, there was nothing in OSI’s 10-K suggesting the existence of erlotinib preclinical efficacy data that is specific to NSCLC.

The Federal Circuit concluded that “[t]hese references provide no more than hope—and hope that a potentially promising drug will treat a particular cancer is not enough to create a reasonable expectation of success in a highly unpredictable art such as this.”