Last The FederalCircuit - Finnegan · EDITED BY VINCE KOVALICK This publication brings you a...

EDITED BY VINCE KOVALICK

This publication brings you a synopsis of patent cases decided last month by the United States Court of Appeals for the Federal Circuit based on slip opinions received from the court. You can review anddownload the full text of each opinion by visiting our website at www.finnegan.com

REWRITING DEPENDENT CLAIMS IN INDEPENDENT FORM TRIGGERS ESTOPPELDependent claims that were redrafted into independent form did more than simply add an additional limitation; they further defined and circumscribed an existing limitation for the purpose of putting the claims in condition for allowance. RanbaxyPharms., Inc. v. Apotex, Inc., No. 02-1429 (Fed. Cir. Nov. 26, 2003) . . . . . . . . . . . . . . . .1

35 U.S.C. § 121'S SHIELD APPLIES TO FORMAL PTO RESTRICTIONREQUIREMENTSRestriction requirements must provide a clear demarcation between restricted subjectmatter to allow determination that claims in continuing applications are consonant and, therefore, deserving of § 121's protections. Geneva Pharms., Inc. v. GlaxoSmithKline PLC, No. 02-1439 (Fed. Cir. Nov. 21, 2003) . . . . . . . . . . . . . . . . . . . . .2

DISTRICT COURT DID NOT ABUSE ITS DISCRETION IN AWARDING RULE 11 SANCTIONS AGAINST PATENTEE'S COUNSELPrior Federal Circuit claim-construction rulings obviated basis for Phonometrics to pursue additional defendants. Phonometrics, Inc. v. Economy Inns of Am., No. 02-1502 (Fed. Cir. Nov. 21, 2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

CLAIM LANGUAGE REQUIRES ORDER FOR RECITED STEPSHad the district court relied exclusively on a dictionary definition or allowed it to overcome clear language in the patent itself, its methodology would have been clearlywrong. Combined Sys., Inc. v. Defense Tech. Corp. of Am., No. 03-1251 (Fed. Cir. Nov. 20, 2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

FACTS CONCERNING COMMERCIAL EMBODIMENT OF INVENTION DO NOT LEAD TO INVALIDITY OR UNENFORCEABILITYDistrict court misapplied both enablement and inequitable-conduct requirements by focusing on a commercially viable embodiment rather than a statutory claimed invention. CFMT, Inc. v. YieldUP Int'l Corp., No. 01-1452 (Fed. Cir. Nov. 12, 2003) . . . . .5

BOARD'S DECISION ON OBVIOUSNESS SUPPORTED BY SUBSTANTIAL EVIDENCEIf the evidence will support several reasonable but contradictory conclusions, the Federal Circuit will not find Board's decision unsupported by substantial evidence simply because it chose one conclusion over another plausible alternative. Velander v. Garner, No. 02-1366 (Fed. Cir. Nov. 5, 2003) . . . . . . . . . . . . . . . . . . . . . . .6

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Rewriting Dependent Claims inIndependent Form TriggersEstoppel

Lara C. Kelley

[Judges: Mayer (author), Clevenger, andBryson]

In Ranbaxy Pharmaceuticals, Inc. v. Apotex,Inc., No. 02-1429 (Fed. Cir. Nov. 26, 2003), theFederal Circuit affirmed a district court's denialof a preliminary injunction against RanbaxyPharmaceuticals, Inc. ("Ranbaxy").

Apotex, Inc. ("Apotex") and Ranbaxy aregeneric drug manufacturers, who both seek tomarket amorphous cefuroxime axetil, a broad-spectrum antibiotic. Apotex is the owner ofU.S. Patent No. 5,847,118 ("the '118 patent"),which is directed to a process for preparingamorphous cefuroxime axetil. Ranbaxy soughta DJ that it does not infringe the claims of the'118 patent. Apotex counterclaimed andmoved for a preliminary injunction, arguingthat Ranbaxy was infringing the claims of the'118 patent under the DOE. Apotex concededthat there was no literal infringement. Thus,the sole issue before the district court whenmaking its decision on the preliminary injunc-tion motion was Apotex's likelihood of successon its DOE theory. The district court concludedthat prosecution history estoppel precludedApotex's reliance on the DOE.

Apotex's original independent claim was fora process of making amorphous cefuroximeaxetil using "a highly polar organic solvent,"which dependent claims further limited to sul-foxide, formic acid, or an amide. During prose-cution, the independent claim was rejectedunder 35 U.S.C. § 112, ¶ 2, the Examinerasserting that the term "highly polar organicsolvent" was indefinite. Additionally, the inde-pendent claim was rejected under 35 U.S.C.§ 103(a) as obvious over a prior art process ofmaking the drug using acetone, which theExaminer assumed was a highly polar organicsolvent. The dependent claims specifying par-ticular solvents were objected to and indicatedas being allowable if rewritten in independentform. In response, Apotex canceled the pend-ing claims and replaced them with all newclaims; the only independent claim presentedultimately became claim 1 of the '118 patentand was limited to the particular solvents recit-

ed in the previously objected-to dependentclaims.

Ranbaxy's alleged infringing process usesacetic acid rather than the specifically recitedsolvents, and so Apotex moved for a prelimi-nary injunction alleging infringement under theDOE. The district court found that prosecutionhistory estoppel precluded Apotex's reliance onthe DOE because: (1) Apotex had submitted anarrowing amendment for reasons related topatentability, and (2) Apotex had surrenderedsolvents of the same polarity as acetone, name-ly, acetic acid.

On appeal, the Federal Circuit addressed theissue of whether rewriting a dependent claim inindependent form triggers prosecution historyestoppel by first distinguishing its Bose Corp. v.JBL, Inc., 274 F.3d 1354 (Fed. Cir. 2001), deci-sion. The Court observed that Bose had heldthat rewriting a claim to explicitly recite a previ-ously inherent feature did not trigger estoppel,but that it had not addressed the issue ofrewriting a dependent claim in independentform. The Federal Circuit stated that the cor-rect focus for determining whether a narrowingamendment has been made is on whether sub-ject matter that was originally claimed was sur-rendered for reasons related to patentability.The Court found that rewriting the dependentclaims that recited specific highly polar organicsolvents in independent form further definedand circumscribed the existing limitation of"highly polar organic solvent" for the purposeof putting the claims in condition forallowance.

In addressing whether Apotex could over-come the presumption of surrender, the FederalCircuit rejected Apotex's argument that it couldnot have foreseen that reciting particular sol-vents would constitute a surrender of an obvi-ous structural equivalent of those solvents, par-ticularly in light of Apotex's arguments thatacetic acid was a known equivalent. However,the Federal Circuit observed that, before thedistrict court, there was a dispute among theexperts on the issue of the proper method ofdetermining polarity. As such, the FederalCircuit noted that Apotex may be able to pres-ent sufficient evidence to rebut the presump-tion of surrender, and if so, the trier of factmust determine the proper method of deter-mining polarity and whether acetic acid andacetone have the same polarity.

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35 U.S.C. § 121's Shield Appliesto Formal PTO RestrictionRequirements

Michael J. Leib

[Judges: Rader (author), Mayer, and Bryson]

In Geneva Pharmaceuticals, Inc. v.GlaxoSmithKline PLC, No. 02-1439 (Fed. Cir.Nov. 21, 2003), the Federal Circuit affirmed adistrict court's judgment invalidating the claimsof several patents for nonstatutory doublepatenting.

GlaxoSmithKline, PLC et al. ("GSK") own theeight patents-in-suit, which all originate fromthe same parent application, U.S. PatentApplication No. 05/569,007 ("the '007 applica-tion"). The eight patents-in-suit can be dividedinto two groups: those patents that issued in2000-2001 ("the 2000/01 patents"), and thosepatents that issued in 1985 ("the 1985patents"), which include U.S. Patent Nos.4,525,352 ("the '352 patent"); 4,529,720 ("the'720 patent"); and 4,560,552 ("the '552patent").

The patents-in-suit relate to the antibioticclavulanic acid and its salts. Clavulanic acidretains an ability to protect a variety of antibi-otics against a number of enzymes produced bybacteria, such as ß-lactamase, that renderantibiotics useless. Specifically, the patents-in-suit claim clavulanic acid in combination withantibiotics like amoxicillin or penicillin, andmethods of using clavulanic acid and its salts toinhibit ß-lactamase.

Geneva Pharmaceuticals, Inc. filed DJ suitsagainst GSK challenging the validity of the2000/01 and 1985 patents. Upon motions forSJ, the district court held the 2000/01 patentsinvalid for nonstatutory double patenting overthe '720 patent. The district court ruled that35 U.S.C. § 121 did not shield the 2000/01patents against invalidity over the '720 patent.Subsequently, after a bench trial, the districtcourt invalidated the 1985 patents on nonstatu-tory double-patenting grounds over twoexpired GSK patents, the Crowley patent andthe Fleming patent.

On appeal, the Federal Circuit affirmed thedistrict court and held that § 121 did not shieldthe 2000/01 patents from double-patenting

invalidity over the '720 patent for two reasons.First, the Court determined that the 2000/01patents and the '720 patents did not trace theirlineage back to a common parent, a require-ment to obtain § 121 protection, because themethod of use claims, which appear in the '720patent, were never pending in the original '007application. To protect a patent from a double-patenting rejection, § 121 requires that theclaims later sought to be shielded must appearin a parent application before a restrictionrequirement is issued. According to the Court,section 121 does not shield claims merelybecause the parent application provides somesupport for claims that are first entered in sub-sequent related applications. In this case, the'720 patent's claims never appeared in the origi-nal '007 application. Because of this, the '720patent could not have been a formal divisionalof the '007 application so that § 121 would pre-vent the '720 patent from erecting a nonstatu-tory double-patenting bar against the 2000/01patents.

Second, even assuming nonpending claimscould be restricted, the Court ruled that theprosecution history in this case did not clearlydocument a restriction requirement, anotherprerequisite for § 121's statutory shield. TheCourt noted that the Examiner issued no docu-ment referring anywhere to "restriction." GSKargued that an interview summary evidenced aproper restriction requirement. The Court,however, found that the interview summary didnot clearly set forth the subject matter and thespecific claims that the PTO consideredpatentably distinct. Section 121 only shieldsclaims against a double-patenting challenge if itclearly sets forth the line of demarcationbetween the independent and distinct inven-tions that prompted the restriction requirement.Because the interview summary did not clearlyrefer to groups of claims that the Examiner con-sidered patentably distinct, GSK did not meetits burden in showing that the record provideda clear demarcation of the allegedly restrictedsubject matter.

The Court also affirmed the district court'sjudgment invalidating on nonstatutory double-patenting grounds two of the 1985 patents, the'352 and '552 patents, in light of the Crowleypatent. The Court noted that the '352 and '552patent claims recite limitations that are eitherbroader than or obvious variants of correspon-

ding limitations in the Crowley claim. TheCrowley patent claims pharmaceutical composi-tions containing "20 mg to 500 mg of potassi-um clavulanate [a salt of clavulanic acid]" incombination with amoxicillin, whereas the '352and '552 patents claim pharmaceutical compo-sitions containing a "synergistically effectiveamount" of clavulanic acid in combination withamoxicillin and penicillin, respectively. GSKargued that the claim limitation "synergisticallyeffective amount" was a point of patentable dis-tinction between the '352 and '552 patents andthe Crowley patent. The Court, however, dis-agreed and construed the term "synergisticallyeffective amount" to mean any amount that issynergistic against any bacteria. Because thisamount encompassed a substantial part of thesubject matter of the Crowley claim—namely,the "20 mg to 500 mg" range—the Courtfound the '352 and '552 patent claimspatentably indistinct from Crowley and, thus,invalid.

Finally, the Court affirmed the district court'sjudgment invalidating GSK's remaining 1985patent, the '720 patent, on nonstatutory double-patenting grounds over the Flemingpatent. The Fleming patent claims a com-pound, potassium clavulanate, for which thewritten description discloses the single use ofinhibiting ß-lactamase. The '720 patent claimsthat use as a method. The Court held that theFleming and '720 patents are not patentablydistinct because a method of using a composi-tion is not patentably distinct from an earlierclaim to the identical composition in a patentdisclosing the identical use.

District Court Did Not Abuse ItsDiscretion in Awarding Rule 11Sanctions Against Patentee'sCounsel

Steven L. Park

[Judges: Michel (author), Rader, andNewman (dissenting)]

In Phonometrics, Inc. v. Economy Inns ofAmerica, No. 02-1502 (Fed. Cir. Nov. 21, 2003),the Federal Circuit affirmed a sanction underFed. R. Civ. P. 11 against a patentee's counselfor continuing to pursue infringement claims

after he should have known the claims weregroundless.

During the mid to late 1990s, Phonometrics,Inc. ("the patentee") sued numerous hotel com-panies, including Economy Inns of America(collectively "Defendants"), for infringement ofU.S. Patent No. 3,769,463 ("the '463 patent").The '463 patent relates to telephone equipmentfor calculating and displaying the cost of long-distance telephone calls.

The suits were stayed during the pendencyof two appeals to the Federal Circuit regardingthe same patent and patentee. Both appealsresulted in claim-construction rulings adverse tothe patentee, the latter ruling being provided inan unpublished decision.

Based on these opinions, fourteen of theDefendants served Phonometrics with a copy oftheir joint (unfiled) motion for Rule 11 sanc-tions and a "safe-harbor" letter demanding dis-missal of Phonometrics's infringement actions.In response, the patentee's counsel refused towithdraw its infringement claims and subse-quently opposed the Rule 11 motion as well asthe Defendants' ensuing motion for SJ. The dis-trict court granted the Rule 11 motion, person-ally imposing on the patentee's counsel a sanc-tion to pay the Defendants' attorney's fees asso-ciated with bringing the sanctions motion. Thedistrict court noted that a litigant's Rule 11 obli-gations include a duty to refrain from continu-ing to advocate a position once it becomesuntenable, and the patentee's continued pursuitof its claims after the Federal Circuit opinionsviolated that duty.

The Federal Circuit affirmed, holding that thedistrict court did not abuse its discretion inawarding sanctions. The Court noted that eachdecision was on the merits since the FederalCircuit's precedential claim-construction rulingconsistently applied and was resolved by thatconstruction. The Court further noted that thepatentee's counsel, who represented the pat-entee in virtually all the previous suits regardingthe '463 patent, was very familiar with its histo-ry. Noting that the issue before the Court wasnot whether the Federal Circuit would awardsanctions, but whether the district court abusedits discretion, in view of these facts, the Courtfound there was ample basis for the districtcourt's decision to impose sanctions.

Judge Newman dissented, arguing that theissue of whether the precedential claim-construction ruling applied to the Defendants

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was not settled until the Federal Circuit's subse-quent unpublished decision. It would be aleap, opined Judge Newman, to award Rule 11sanctions for declining to withdraw other litiga-tion against other parties whose infringementstatus was still being explored based on a non-precedential opinion.

Similarly, in Phonometrics, Inc. v. Westin HotelCo., No. 02-1501 (Fed. Cir. Nov. 26, 2003), theFederal Circuit affirmed-in-part an award ofattorney's fees, but vacated part of the orderand remanded for a redetermination of theamount.

Westin Hotel Company is another one of sev-eral hotel companies sued by Phonometrics. Inthis case, however, the grounds for the fees andcosts award, in the amount of just over$24,000, were based on 35 U.S.C. § 285 and28 U.S.C. § 1927, whereas in the above case,the fee award was based on a Rule 11 sanction.

Claim Language Requires Orderfor Recited Steps

Kenneth M. Lesch

[Judges: Michel (author), Mayer, andBryson]

In Combined Systems, Inc. v. DefenseTechnology Corp. of America, No. 03-1251 (Fed.Cir. Nov. 20, 2003), the Federal Circuit affirmedthe district court's SJ of noninfringement thatDefense Technology Corporation of Americaand Federal Laboratories, Inc. (collectively"DTCA") did not infringe U.S. Patent No.6,202,562 ("the '562 patent") assigned toCombined Systems, Inc. ("CSI") after finding noerror in the district court's claim construction.

The '562 patent relates to a "tubular sock-like" shotgun projectile full of lead shotdesigned to incapacitate individuals withoutcausing serious injury. The only limitations atissue in claim 1 were "forming folds in saidtubular sock-like projectile body immediatelyforward of said rear opening" and "insertingsaid formed folds . . . into said projectile com-partment front opening." The district court rea-

soned that the dictionary definition of "fold,"namely, "to bend over or double up so that onepart lies on another part," when combined withthe gerund "forming," requires the "deliberate"and "systematic" creation of folds. The deliber-ate creation of folds excluded incidental gathersin the material that occur when a string ispulled to close the projectile body or when theshot is secured in the projectile compartment.Additionally, the district court held that thefolds must be formed prior to, not during,insertion of the projectile into the projectilecompartment.

On appeal, CSI argued that "forming folds"should be construed to mean forming any foldsby closing the sock-like projectile body, includ-ing forming folds in the tail before, during, orafter insertion of the projectile body into theprojectile compartment. Examining the claimlanguage first, the Federal Circuit agreed withthe district court that the affirmative recitationof "forming folds" requires the "deliberate"forming of folds. The Federal Circuit also deter-mined that as a matter of grammar, the recita-tion of "inserting said formed folds . . . into saidprojectile compartment" forecloses, in theabsence of compelling intrinsic evidence to thecontrary, a construction permitting the folds tobe formed after or during insertion of the pro-jectile into the projectile compartment.

The Federal Circuit then looked to the writ-ten description and drawings to determine ifthe presumption of ordinary and customarymeaning was rebutted and to aid it in theclaim-construction analysis. The writtendescription and drawings, the Federal Circuitnoted, are consistent with requiring the deliber-ate forming of folds and do not provide anydescription of incidental folds, bends, or creas-es. Thus, after considering the intrinsic evi-dence, the Federal Circuit agreed with the dis-trict court's construction requiring the deliber-ate forming of folds in the tail of the projectile.

CSI did not challenge the district court's con-clusion that, as a matter of law, DTCA did notinfringe claim 1 as construed literally or underthe DOE. As a result, the Federal Circuitaffirmed the district court's SJ of noninfringe-ment.

Facts Concerning CommercialEmbodiment of Invention Do NotLead to Invalidity orUnenforceability

Won S. Lee

[Judges: Rader (author), Friedman, and Linn]

In CFMT, Inc. v. YieldUP International Corp.,No. 01-1452 (Fed. Cir. Nov. 12, 2003), theFederal Circuit reversed the district court's deci-sion on inequitable conduct, vacated its SJ ofinvalidity for nonenablement regardingU.S. Patent Nos. 4,778,532 ("the '532 patent")and 4,917,123 ("the '123 patent"), and remand-ed the case for further proceedings.

The '532 and '123 patents are directed toimprovements in cleaning systems for semicon-ductor wafers. CFMT, Inc. ("CFMT") suedYieldUP International Corporation ("YieldUP") forinfringement of the '532 and '123 patents, and,in response, YieldUP asserted that the twopatents were invalid for lack of enablement andunenforceable for inequitable conduct.

YieldUP's nonenablement argument wasbased on problems CFMT encountered in set-ting up an installation for Texas Instruments("TI"). In its initial runs, the machine did notmeet TI's standards for wafer cleanliness.CFMT's inventors adjusted the machine andexperimented for months before meeting TI'sstandards. Eventually, the inventors obtained athird patent claiming the improvements in theirinitial machine. The district court grantedYieldUP's motion for SJ that the '532 and '123patents were invalid for nonenablement becausethe TI system had not cleaned wafers properly,the inventors had experimented with the systemfor more than six months, and the requiredexperimentation had not been routine based onthe fact that the solution to the problems hadeventually resulted in the third patent.

After a bench trial, the district court enteredjudgment that the '532 and '123 patents wereunenforceable due to inequitable conductbecause: (1) CFMT did not disclose to the PTOthe initial TI test results ("the TI data"), and(2) CFMT stated multiple advantages of theinvention to traverse an obviousness rejection.The district court concluded that the undis-

closed TI data were material because a reason-able examiner would have considered the datarebutting the invention's advantages in decidingwhether to allow the two patents. The districtcourt inferred that CFMT intended to deceivethe PTO because it considered the TI data highlymaterial.

Concerning enablement, the Federal Circuitfocused on two issues: (1) whether the claims'preamble terms requiring "removal of contami-nants" needed a specific level of contaminantremoval that the disclosure did not enable, and(2) whether the improvements leading to thethird patent showed that the '532 and '123patents had not enabled the scope of theclaimed inventions. With regard to the firstissue, the Federal Circuit stated that the districtcourt had erred in setting the enablement bartoo high because enablement did not require aninventor to meet lofty standards for success inthe commercial marketplace. The FederalCircuit explained that the patent statute did notrequire that a patent disclosure enable one ofordinary skill in the art to make and use a per-fected, commercially viable embodiment absenta claim limitation to that effect.

In the absence of any standard of cleaning inthe claims, the Federal Circuit found that "clean-ing" in the context of CFMT's invention meantgenerally removing any contaminants from thewafer surface. The Federal Circuit noted thatthe CFMT inventors' prototype had removedgrease stains. It also pointed out that there wasno evidence that a person of ordinary skill wouldhave had to undertake undue experimentationto build a similar prototype and carry out theclaimed invention to remove the contaminants,i.e., the grease stains.

The Federal Circuit noted that the lengthyexperiments at TI did not show nonenablementbecause the CFMT inventors undertook thatwork to satisfy TI's particular commercialrequirements, not to show enablement of thescope of the claimed inventions.

As to the district court's decision that thethird CFMT patent evinced the inventors hadengaged in undue experimentation to cleansemiconductor wafers, the Federal Circuit statedthat additional inventive work, such as animprovement invention, did not alone shownonenablement. The Federal Circuit pointedout that the district court's reasoning incorrectly

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presumed that development of the third patentimplied extensive experimentation becausepatent acquisition did not require any thresholdlevel of effort or ingenuity.

The Federal Circuit rejected the districtcourt's finding that the CFMT inventors' state-ments in response to the obviousness rejectionwithout disclosing the TI data were inaccurateand constituted misrepresentations, becausethe statements listing multiple advantages ofthe invention were not material. The FederalCircuit noted that the statements were notinaccurate because a closed cleaning systemprovided an inherent advantage of less contam-ination by airborne particles. Since the advan-tages advocated in the statements recited onlythe natural, expected results of a closed systemor at most overemphasized the benefits of theinvention, the Federal Circuit concluded thatthis kind of advocacy did not rise to the level ofmisrepresentation. The Federal Circuit furthernoted that the Examiner had not expresslyresorted to secondary considerations, such asthe unexpected results and advantages in theCFMT inventors' statements, during prosecu-tion. The Federal Circuit concluded that a rea-sonable Examiner would not have found thestated advantages important in decidingwhether to allow the application because theywere merely conclusory arguments withoutobjective evidentiary support.

Since the TI data reflected a commercial, notstatutory, standard for enablement, the FederalCircuit found that the data were only marginal-ly relevant to the enablement issue. Contraryto the district court's finding, the Federal Circuitstated that the materiality of the undisclosed TIdata was low and, therefore, the district courthad little basis for inferring intent.

Since the district court erred in granting a SJof nonenablement, the Federal Circuit vacatedand remanded for the district court to reconsid-er whether a person of ordinary skill in the artcould achieve any level of cleaning with theclaimed invention without undue experimenta-tion. Further, the Federal Circuit reversed thedistrict court's decision on inequitable conductbecause the district court had abused its discre-tion in view of the low materiality of the undis-closed subject matter and no evidence ofintent.

Board's Decision on ObviousnessSupported by Substantial Evidence

Vince Kovalick

[Judges: Schall (author), Prost, and Gajarsa(dissenting)]

In Velander v. Garner, No. 02-1366 (Fed. Cir.Nov. 5, 2003), the Federal Circuit affirmed theBoard's decision that all allowed claims of thepatent application in question wereunpatentable as obvious over the prior art.

The patented technology relates to the pro-duction of nonhuman mammals that have beengenetically altered so that they produce theenzyme fibrinogen in its biologically activestate. The enzyme is recovered from the milkof the mammal. In an interference proceedinginvolving U.S. Patent Application No.08/443,184 ("the '184 application"), the Boarddetermined that the allowed claims wereunpatentable as obvious over the prior art. Theinterference involved competing claims to atransgenic animal (and methods to make suchan animal) that produces fibrinogen andsecretes it into its milk.

After the interference was declared betweenthe '184 application and U.S. Patent No.5,639,940 ("the '940 patent"), Ian Garner andothers (collectively "Garner") moved to have theclaims in question declared unpatentable.Garner identified the elements of the claims inthe prior art and contended that the motivationto combine these elements could be found in apublication by Dr. Lothar Hennighausen ("theHennighausen review") and in U.S. Patent No.4,873,316 ("the Meade patent"). Garner con-tended that the Meade patent disclosed amethod for the production of heterologousproteins in the milk of transgenic animals, whilethe Hennighausen review suggested the pro-duction of commercial quantities of plasma pro-teins in transgenic animals, and, therefore, fib-rinogen was an obvious target for expression intransgenic animals.

Applicant, Velander, did not dispute that theelements of the claims were in the prior art northat the prior art contained some motivation tocombine those elements. Rather, he arguedthat, given the variables that affect proteinexpression levels, as of the critical date, one ofordinary skill in the art would not have had a

reasonable expectation of success in practicingthe invention claimed. Velander asserted thatthe Board improperly placed on him the bur-den of proving an expectation of failure in theprior art rather than requiring Garner to prove areasonable expectation of success to substanti-ate obviousness. The Federal Circuit dismissedthis argument, however, observing that theBoard clearly understood the burdens andapplied them appropriately.

The Federal Circuit reviewed the conflictingexpert testimony submitted by declarationsfrom both parties and concluded that, althoughthis was a close case, substantial evidence sup-ported the Board's decision. The Court summa-rized the case as boiling down to the questionof whether, as of the critical date, one of ordi-nary skill in the art would have had a reason-able expectation of success in producing arecoverable amount of biologically active fib-rinogen from a transgenic, nonhuman femalemammal that produces recoverable amounts ofbiologically active human fibrinogen in its milk.Given all the evidence, the Court could not saythat Velander had established that the Board'sdecision was not supported by substantial evi-

dence. Although other evidence in the recordsupported Velander's argument, the FederalCircuit ruled that if the evidence supports sever-al reasonable but contradictory conclusions, itwill not find the Board's decision unsupportedby substantial evidence simply because theBoard chose one conclusion over another plau-sible alternative.

Judge Gajarsa dissented, concluding thatthere was no reasonable basis for the Board'sdecision and that the finding of obviousnesslacked substantial evidence.


DISCLAIMER:The case summaries reflect the understanding ofthe authors only and are not meant to conveylegal opinions or advice of any kind. The firm dis-claims any liability for any errors or omissions inthese summaries. This promotional newsletterdoes not establish any form of attorney-clientrelationship with our firm or with any of ourattorneys.

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In Last month at The Federal Circuit, certain terms, titles, and names of fed-eral agencies that are frequently referred to in text, appear in abbreviatedforms or as acronyms. These abbreviated forms and acronyms are listed below.

ALJ Administrative Law Judge ANDA Abbreviated New Drug ApplicationAPA Administrative Procedures ActAPJ Administrative Patent Judge Board Board of Patent Appeals and InterferencesCommissioner Commissioner of Patents and Trademarks CIP Continuation-in-PartDJ Declaratory Judgment DOE Doctrine of EquivalentsFDA Food & Drug AdministrationIDS Information Disclosure StatementIP Intellectual PropertyITC International Trade CommissionJMOL Judgment as a Matter of Law MPEP Manual of Patent Examining ProcedurePCT Patent Cooperation TreatyPTO United States Patent and Trademark Office SEC Securities and Exchange CommissionSJ Summary JudgmentSM Special Master

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