About bwheelock

Education J.D., Washington University in St. Louis B.S.E. in Mechanical Engineering, Duke University

Thank You Veterans

There is no shortage of patriotic subject matter in the U.S. patent collection, but those relating to Veteran’s day are a sobering reminder of the sacrifice that all of our veterans were willing to make, and why they deserve our appreciation on Veteran’s Day and every day:

U.S. Patent No. 7,934,690 products a Flag Holder (for a Veteran’s grave)
U.S. Patent No. 1466112 protects a grave marker for a Veteran’s grave
U.S. Patent No. D18517 protects a Veteran’s Grave Designator

Board Erred in Finding Reference Was Not Reasonably Pertinent to the Problem Facing the Inventor

In Airbus S.A.S. v. Firepass Corp., [2019-1803](November 8, 2019), the Court of Appeals for the Federal Circuit vacated the PTAB’s reversal of the Examiner’s rejection of new claims presented by patent owner Firepass Corporation in an inter partes reexamination of U.S. Pa-tent No. 6,418,752.

The ’752 patent discloses a fire prevention and suppression system that prevents and extinguishes fires using breathable air instead of water, foam, or toxic chemicals—each of which can present risks to personnel or electronic equipment.

The invention is based on the inventor’s alleged discovery that a low-oxygen (“hypoxic”) but normal pressure (“normbaric”) atmosphere inhibits fire ignition and combustion, yet remains breathable for humans. In rejection the claims the Examiner relied upon prior art including a patent to the same inventor on a generator for creating a hypoxic environment for athletic training or therapy. The Board reversed the rejection of the claims accepting the patent owners argument, raised for the first time on appeal, that the prior patent was not analogous art to the claimed invention of the ’752 patent, and is therefore not relevant prior art for the purposes of obviousness.

The Federal Circuit reiterated that a reference qualifies as prior art for an obviousness determination only when it is analogous to the claimed invention. The Court noted two tests separate tests defining the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved. The Federal Circuit held that the Board’s “field of endeavor” determination was supported by substantial evidence, but the Board erred in its “reasonably pertinent” determination because the Board declined to consider record evidence advanced by Airbus to demonstrate the knowledge and perspective of a person of ordinary skill in the art at the time of the invention.

With respect to the field of endeavor analysis, the Federal Circuit said that to determine the applicable field of endeavor, the fact finder must consider “explanations of the invention’s subject matter in the patent application, including the embodiments, function, and structure of the claimed invention. While the disclosure of the references is the primary focus, this court has also instructed that the fact finder must consider each reference’s disclosure in view of the reality of the circumstances and weigh those circumstances from the vantage point of the common sense likely to be exerted by one of ordinary skill in the art in assessing the scope of the endeavor. The Board could not say that the Board’s finding was unreasonable.

With respect to of the reasonably pertinent test, the Federal Circuit explained that outside of an inventor’s field of endeavor, it only presume knowledge from those arts reasonably pertinent to the particular problem with which the inventor was involved. This rule reflects the reality of the circumstances that an inventor could not possibly be aware of every teaching in every art. The pertinence of the reference as a source of solution to the inventor’s problem must be recognizable with the foresight of a person of ordinary skill, not with the hindsight of the inventor’s successful achievement. A reference outside an inventor’s field of endeavor is “reasonably pertinent” only if its subject matter logically would have commended itself to an inventor’s attention in considering his problem.

The Federal Circuit said that the Board accurately observed that the examiner’s rejection did not “provide or explain the requisite correlation” between the problems addressed by the reference and the patent, but expressly declined to consider multiple references in the record that Airbus asserted would establish the necessary link. The Federal Circuit held that the Board erred by refusing to consider the references in support of the reasonably pertinent test. Because a “reasonably pertinent” reference is one that an ordinarily skilled artisan would reasonably have consulted in seeking a solution to the problem that the inventor was attempting to solve, the reasonably pertinent inquiry is inextricably tied to the knowledge and perspective of a person of ordinary skill in the art at the time of the invention. In order to determine whether a reference is “reasonably pertinent,” a reasonable fact finder should consider record evidence cited by the parties to demonstrate the knowledge and perspective of a person of ordinary skill in the art at the time of the invention.

The Federal Circuit vacated the Board’s reversal of the examiner’s rejection and remanded for the Board to reconsider its analogous art determination.

Petitioner Allowed to Supplement Evidence that Reference was Available

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.

OK, Campers, Here’s How to Make Your Claim Preamble a Limitation

In In re Fought and Clanton, [2019-1127](November 4, 2019) the Federal Circuit reversed the PTAB decision that the claims 1 and 2 in U.S. Application Serial No. 13/507,528 were anticipated.

The claims were directed to travel trailer with a movable garage wall. Claim 1 read:

Claim 1 form U.S. Application 13/507528
Figs. 1 and 2 of Application 13/507528

The Examiner rejected both claims 1 and 2 as anticipated. The Board affirmed the examiner’s rejection, concluding the preamble term “travel trailer” is a mere statement of intended use that does not limit the claim.

The Federal Circuit rejected appellants first argument that “A travel trailer having” was not a preamble, noting though this claim does not use the typical claim language (comprising) which denotes the transition be-tween the preamble and the body, the word “having” performs the same role.

Appellants next argument was that even if “travel trailer” is part of the preamble, it is limiting because limitations in the body of the claims rely on “travel trailer” for antecedent basis and for structural limitations. On this point, the Federal Circuit agreed, noting that it has repeatedly held a preamble limiting when it serves as antecedent basis for a term appearing in the body of a claim. Appellants provided extrinsic evidence to support their assertion that “travel trailer” is a specific type of recreational vehicle that includes a living quarters. The Federal Circuit said:

Based on the extrinsic evidence, we conclude that a “travel trailer” is a specific type of recreational vehicle and that this term is a structural limitation of the claims. There is no dispute that if “travel trailer” is a limitation, Dietrich and McDougal, which disclose cargo trailers and shipping compartments, do not anticipate. Just as one would not confuse a house with a warehouse, no one would confuse a travel trailer with a truck trailer.

The Federal Circuit rejected appellant’s argument that the Patent Office had an obligation to identify the level of ordinary skill in the art — at least where the applicant had not put it in issue.

Whether a preamble is a limitation is a two-edged sword for applicants, one the one hand if the preamble is a limitation, it can make the claim patentable, but on the other hand it can also make the claims harder to infringe, Where the applicant wants the preamble to be a limitation, purposely using the words in the body of the claim will achieve that goal, however idly parroting the words of the preamble in the body can unintentionally limit the claims for purposes of infringement.

Federal Circuit Gives the PTAB an Inferiority Complex

In Arthrex, Inc. v. Smith & Nephew, Inc., [2018-2140](October 31, 2019), the Federal Circuit vacated and remanded the Final Written Decision of the PTAB in IPR2017-00275 because the decision was issued while there was an Appointments Clause Violation.

The Board held that claims 1, 4, 8, 10–12, 16, 18, and 25–28 of Arthrex’s U.S. Patent No. 9,179,907 were unpatentable as anticipated. Arthrex appealed, contending that the appointment of the Board’s Administrative Patent Judges (“APJs”) by the Secretary of Commerce, as currently set forth in Title 35, violates the Appointments Clause of the constitution (Art. II, § 2, cl. 2). The Federal Circuit agreed concluding that the statute as currently constructed improperly makes the APJs principal officers.

More specifically, Arthrex argued that the APJs who presided over its inter partes review were not constitutionally appointed; they were principal officers who must be, but were not, appointed by the President with the advice and consent of the Senate. The issue was whether the APJs were in fact “Officers of the United States” and if so, whether they are inferior officers or principal officers. The Federal Circuit held that in light of the rights and responsibilities in Title 35, APJs were principal officers.

The Federal Circuit, under cover of Free Enterprise Fund v. Public Company Accounting Oversight Board, 561 U.S. 477 (2010) determined that the solution was to sever the problematic portions of the patent act, while leaving remaining provisions intact. The Federal Circuit thus severed the portion of the Patent Act restricting removal of the APJs, thereby rendering the APJs inferior officers and solving the constitutional appointment problem.

Poof. Fixed.

Synthesizing and Screening Thousands of Candidate Compounds Constitutes Undue Experimentation

In Idenix Pharmaceuticals LLC. v. Gilead Sciences Inc., [2018-1691] (October 30, 2019), the Federal Circuit affirmed that U.S. Patent No. 7,608,597
was invalid for lack of enablement, and further held that it was invalid for lack of written description as well. A jury found that patent not invalid, and awarded damages. Gilead’s motion for JMOL was granted as to enablement, but denied as to written description.

The only independent claim of the ’597 patent recites:

  1. A method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine β-D-2′-methylribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.

The district court construed the structural limitation “β-D-2′-methyl-ribofuranosyl nucleoside” to require “a methyl group in the 2′ up position
and non-hydrogen substituents at the 2′ down and 3′ down positions,” while construing the preamble “[a] method for the treatment of a hepatitis C virus infection,” as a narrowing functional limitation, limiting the scope to the set of compounds that are effective for treatment of HCV.

The Federal Circuit observed that while the claim requires methyl at the 2′-up position, it allows nearly any imaginable substituent at the 2′-down position. It was undisputed that there are billions of potential 2′-methyl-up nucleosides. The key enablement question was whether a person of ordinary skill in the art would know, without undue experimentation, which 2′-methyl-up nucleosides would be effective for treating HCV. The Federal Circuit concluded they would not.

The Federal Circuit agreed with the district court that the quantity of experimentation required to determine which 2′-methyl-up nucleosides meet claim 1 was very high, favoring a finding of non-enablement. Even taking into account that a person of ordinary skill would know to eliminate certain substitutes, there was still a large number of possibilities. Even just testing the compounds expressly listed in the specification would require considerable effort.

The Federal Circuit further found that there was insufficient guidance in the specification as to which the 2′-methyl-up nucleosides will effectively treat HCV, stating that without specific guidance on that point, the specification provides “only a starting point, a direction for further research.” It is not enough to identify a “target” to be the subject of future testing. A specification that re-quires a POSA to “engage in an iterative, trial-and-error process to practice the claimed invention” does not provide an enabling disclosure.

The unpredictability of the art, and the broad scope of the claims weighed in favor of non-enablement.

Weighing each of the Wands factors, the Federal Circuit concluded as a matter of law that the ’597 patent is invalid for lack of enablement. Having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation.

On the issue of written description, the Federal Circuit, the Federal Circuit said that to fulfill the written description requirement, a patent owner must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’ and demonstrate that by disclosure in the specification of the patent. In the context of the this case, this meant that the patent must demonstrate that the inventor was in possession of those 2′-methyl-up nucleosides that fall within the boundaries of the claim (i.e., are effective against HCV), but are not en-compassed by the explicit formulas or examples provided in the specification.

A genus can be sufficiently disclosed by features common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus, which the Federal Circuit has described as “looking for blaze marks which single out particular trees” in a forest, rather than simply “pointing to trees.”

In particular the Federal Circuit noted the conspicuous absence of any disclosure of the accused compound, saying that a POSA would not “visualize or recognize the members of the genus” as including the accused compound, and thus the specification could not demonstrate to a POSA that the inventor had possession of that embodiment at the time of filing.

Federal Circuit Loosens the Iron Grip on Evidence of Copying

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.

Setting the Standard for Claim Drafting

Claims often reference government or industry standards. However standards can change over time, which has the potential to change the scope of the claim, unless it is understood that the meaning is fixed as of the filing date, and that is what the BPAI does.

In Ex parte McClary, Appeal 2009-001300, Application 11/101,897 (May 17, 2010), the Board reversed the Examiner’s 112 rejection that reference to the ARINC 615 protocol (an industry standard in the field of avionics) was indefinite because it was subject to being changed in the future. The Board said:

Compliance with the provisions of 35 U.S.C. § 112 is determined as
of the filing date of the application. W.L. Gore & Assoc., Inc. v. Garlock,
Inc., 721 F.2d 1540, 1556 (Fed. Cir. 1983). There does not appear to be any
dispute here that a particular version of the ARINC 615 protocol was in
existence as of Appellant’s filing date. Thus, one of ordinary skill in the
art, with reference to the standard in effect as of the filing date of
Appellant’s application, would readily be able to determine the metes and bounds of this element found in claims 10 and 12. Accordingly, we will not sustain the rejection of claims 10 and 12 under 35 U.S.C. § 112, second paragraph, as being indefinite.

Some drafters affirmatively control the meaning of their claims by expressly referencing the standard or protocol “in effect on the filing date.

Claim 11 of U.S. Patent No. 9,945,005 provides:

11. The method according to claim 1 wherein the material is leached for a sufficient period of time that the residue after leaching meets the EPA TCLP limits according to EPA Test Method 1311 procedure in effect on the filing date of this application.

Claim 27 of U.S. Patent No. 7,043,402 provides:

27. The system of claim 20, wherein said electrical indication means is comprised of at least one of: (a) a serial communications port; (b) a bi-directional serial data bus chosen from among standards SAE/TMC J1708/J1587 protocol in effect on the filing date hereof, or SAE J1939 communications protocol in effect on the filing date hereof; (c) a CAN data bus; (d) a RF device; and/or (e) an IR device.

Claim 16 of U.S. Patent No. 6,889,385 provides:

16. The apparatus of claim 8 wherein said DOCSIS cable modem is compatible with any DOCSIS national standard for cable modems as of the filing date of the parent patent application of this patent application.

While claims referencing standards are not indefinite merely because the standard could be changed in the future, claim drafters still have to account for how infringement can be proved if the standard is in fact changed.

Marking Your Territory in Patent Claims

The use of trademarks in patent claims was previously discussed here. Trademarks continue to be used in patent claims, despite the potential for problems, not doubt because the trademark was seen as the best way to properly claim the invention. There is of course the concern that a trademark is indefinite, because the product can be changed at any time by the trademark owner. However changing meaning is a condition that can afflict any word in a claim, not just trademarks, granted changing meaning it is more likely with a trademark because it requires the action of a single person or entity, while changing the meaning of the work requires consensus.

Here are examples of trademarks recently used in patent claims:

AEROSIL– 10,154,954 (claim 2)

Android – 10,417,998 (claim 6), 10,417,008 (claim 6), 10,331,433 (claim 4).

ARSENSA – 10,154,954  (Claim 2)

Bluetooth – 10,420,011 (claim 9), 10,419,592 (claim 1), 10,365,866 (claim 10), 10,341,313 (claim 4), 10,321,516 (claim 6), 10,285,041 (claim 2), 10,027,169 (claim 7), 10,026,018 (claim 5), 9,998,996 (claim 7, 14), 9,955,515 (claim 8), 9,930,669 (claim 1), 9,912,794 (claim 1), 10,129,431 (claim 7, 16), 10,123,333 (claim 3, 14, 28), 10,019,852 (claims 2, 9,16), 9,980,059 (claims 1, 12, 23).

EPO-TEK – 10,330,233 (claim 17)

ETHERNET – 10,303,160 (claim 3,8)

Felica – 10,126,703 (claim 13)

Inconel – 10,392,728 (claim 10)

JAVA – 9,930,201 (claim 1)

JavaScript – 10,365,868 (claim 7)

Java Virtual Machine – 9,727,374 (claim 6)

Kahoot! 10,026,331 (claim 1)

KOVAR – 10,139,700 (claim 3)

Linux – 10,417,998 (claim 5), 10,417,008 (claim 5).

MIFARE – 10,126,703 (claim 13)

Monel – 10,392,728 (claim 10)

TRITON X – 10,254,276 (claim 5)

TWEEN – 10,254,276 (claim 5)

PARLEAM – 10,154,954 (claim 2)

QR Code – 10,223,625 (claim 5), 9,940,565 (claims 7, 10).

RLSA – 10,190,217 (claim 3), 10,017,853 (claim 7, 8)

SOFTISAN – 10,154,954 (claim 2)

VELCRO – 10,151,558  (claims 4, 7)

Vespel – 10,047,863 (claim 20)

VITRALI – 10,330,233 (claim 16)

Wi-Fi – 10,244,055 (claim 11), 10,044,903 (claims 6, 18), 10,129,431 (claims 6, 8, 17).

Wi-Fi Direct – 10,416,941 (claim 8), 10,342,071 (claim 12), 9,942,759 (claim 6).

Windows – 10,275,192 (claim 9).

ZIRCON – 10,240,814 (claims 1, 2, 9)

ZYLON – 10,201,999 (claim 8, 18)

Additional examples are relatively easy to find by search for the word trademark in the text of the claims, or searching for the R-in-the-circle symbol “.RTM.”

Although the meaning of a trademark can change over time, this is apparently understood by those of ordinary skill in the art, and rarely if ever is it necessary to specify that the meaning is determined “as of the filing date.”

Hope is not Enough to Create a Reasonable Expectation of Success

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.”