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Federal Circuit 20042005

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Title: Federal Circuit 20042005


1
Federal Circuit 2004-2005
A Year in Review
June/July 2004 June/July 2005
  • Gale R. Peterson
  • Cox Smith Matthews
  • San Antonio, Texas

IPO Annual Meeting September 11-13, 2005,
Seattle, Washington
2
Novelty and the Loss of Rightto a Patent - 102
  • Highlights
  • Increased emphasis on claim construction
  • Disagreements re inherency resolved
  • Continuing struggle w/ on sale and in public
    use issues

3
Claim Construction-Anticipation
  • More than 9 new cases
  • Unitherm Food Sys. v. Swift-Eckrich, Inc., 340
    F.3d 1314 (Fed. Cir. 2004)(J. Bryson JJ. Lourie
    and Rader) p. 6
  • In re Crish, 393 F.3d 1253 (Fed. Cir. 2004) (J.
    Lourie Circuit Judge Mayer, J. Dyk) p. 8
  • Alza v. Mylan Labs., 391 F.3d 1365 (Fed. Cir.
    2004)(SJ. Archer J. Newman concurring-in-part,
    dissenting-in-part J. Dyk) p. 9
  • Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313
    (Fed. Cir. 2005)(J. Bryson SJ. Friedman and J.
    Radar) p. 12

4
Claim Construction-Anticipation
  • More than 9 new cases
  • Sentry Protective Products, Inc. v. Eagle
    Manufacturing Co., 400 F.3d 910 (Fed. Cir. 2005)
    - J. Prost JJ. Lourie and Schall p. 14
  • MercExchange, L.L.C. v. eBay, Inc., 401 F.3d 1323
    (Fed. Cir. 2005) J. Bryson - CJ Michel, J.
    Clevenger p. 16
  • ArthroCare Corp. v. Smith Nephew, Inc., 406
    F.3d 1365 (Fed. Cir. 2005) J. Bryson JJ. Mayer
    and Lourie p. 17
  • Prima Tek II, L.L.C. v. Polypap, S.A.R.L. (Prima
    Tek -2), ___ F.3d ____ (Fed. Cir. 2005) J. Dyk
    J. Gajarsa, SCJ. Plager p. 18
  • Northpoint Tech., Ltd. v. MDS-Am., Inc., ___ F.3d
    ___ (Fed. Cir. 2005)(J. Bryson J. Schall,
    concurring-in-part, dissenting-in-part J. Dyk)
    p. 22

5
Claim Construction-Anticipation
Unitherm Food Sys. v. Swift-Eckrich, Inc., 340
F.3d 1314 ( Fed. Cir. 2004)(J. Bryson JJ.
Lourie and Rader) p. 6
  • Numeric Ranges - Not Read Into Claims
  • Evid - Accused Infr Prior In Public Use
  • Method - browning of pre-cooked meat
  • ConAgra - ltr to industry will enforce patent
  • Unitherm d/j invalid Walker-Process Sherman
    2
  • Process - invented demonstrated to ConAgra critical date prior in public use
  • Golden Brown color not ltd by spec
  • Invalid

6
Claim Construction-Anticipation
Northpoint Tech., Ltd. v. MDS-Am., Inc., ___ F.3d
___ (Fed. Cir. 2005)(J. Bryson J. Schall,
concurring-in-part, dissenting-in-part J. Dyk)
p. 22
  • Claim Construction Results in Finding of
    Anticipation
  • transmitting terrestrial signals - common
    frequency w/ satellite
  • Northpoint - p/a did not teach antennas pointed
    opp directions
  • D. Ct. - directional reception range not ltd
    where receiving antenna pointed
  • Fed. Cir. - Affd

7
Inherency
  • Highlights
  • Whether one of ordinary skill in the art must
    have recognized the inherency now resolved?

8
Inherency
  • Generally
  • A prior art reference that does not explicitly
    disclose or teach a particular claim element may
    nevertheless anticipate a claim containing such
    an element if the prior art inherently discloses
    the element
  • In order to establish inherency, the extrinsic
    evidence must make clear that the missing
    descriptive matter is necessarily present in the
    thing described in the reference and that it
    would be so recognized by persons of ordinary
    skill.
  • Continental Can Co. USA v. Monsanto Co. (1991)
    J. Newman

9
Anticipation - Shown Through Inherency
  • Must one of ordinary skill in the art recognize
    what was asserted to be inherent?

Continental Can 1991 Yes MEHL/Biophile 1999
No Atlas Powder 1999 No EMI Group 2001 No
  • Elan Pharms., Inc. v. Mayo Found. For Med.
    Res., 304 F.3d 1221 (Fed. Cir. 2002) VACATED
    (en banc) Alzheimer Yes (J. Newman JJ.
    Gajarsa Dyk) p. 27
  • Majority (Newman) one of ordinary skill in
    the art would not have recognized the asserted
    inherency
  • Dissent (Dyk) it matters not that those of
    ordinary skill heretofore may not have recognized
    these inherent characteristics.
  • Replacement Opinion - 346 F.3d 1051 (Fed.
    Cir. 2003) Remanded to determine whether p/a
    was enabling

10
Anticipation - Shown Through Inherency
  • Schering Corp. v. Geneva Pharms., 339 F.3d 1373
    (Fed. Cir. 2003)(J. Rader SCJ Plager J.
    Bryson) p. 27
  • (1) An inherent feature of a p/a reference need
    not be perceived as such by a person of ordinary
    skill in the art before the critical date
  • (2) A p/a reference may inherently anticipate the
    entire claimed subject matter even though not
    mentioned
  • Patent 1 Loratadine CLARITIN
  • Patent 2 Metabolite of loratadine - DCL
  • Patent 1 p/a to Patent 2
  • DCL formed when patient ingested loratadine
  • this courts precedent does not require a
    skilled artisan to recognize the inherent
    characteristic in the p/a that anticipates the
    claimed invention.

11
Anticipation - Shown Through Inherency
  • Schering Corp. v. Geneva Pharms. (Schering II),
    348 F.3d 992 (Fed. Cir. 2003)(J. Rader w/ SCJ
    Plager and J. Bryson)
  • Pet. for panel rehg denied
  • Pet. for rehg en banc - denied
  • Dissents - Judges Newman and Lourie
  • Judge Gajarsa - would rehear en banc
  • Judge Schall - did not participate in the vote

12
Anticipation - Shown Through Inherency
  • Toro Co. v. Deere Co., 355 F.3d 1313 (Fed. Cir.
    2004)(J. Michel - JJ. Lourie and Linn) pg. 28
  • Schering is the law

13
Anticipation - Shown Through Inherency
  • Toro Co. v. Deere Co., - Contd
  • Simply put, the fact that a characteristic is a
    necessary feature or result of a prior-art
    embodiment (that is itself sufficiently described
    and enabled) is enough for inherent anticipation,
    even if that fact was unknown at the time of the
    prior invention.

14
Anticipation - Shown Through Inherency
SmithKline Beecham Corp. v. Apotex Corp.
(SmithKline III)., 403 F.3d 1331 (Fed. Cir.
2005)(J. Rader - J. Bryson, concurring opinion J
Gajarsa) p. 29
  • When a Product is Naturally Produced by
    Practicing the Prior Art, There is Inherent
    Anticipation
  • Claim Crystalline paroxetine hydrochloride
    PHC hemihydrate.
  • Paroxetine cmpd known from 70s
  • Ferrosan now expired 196 patent PHC
    anhydrate antidepressant licensed to SKB
  • Late 1980s SKB scientist in UK develops
    crystalline form more stable FDA approval
    PAXIL? - 1993
  • Apotex ANDA PHC anhydrate
  • SKB infringes disappearing polymorph once
    crystalline form made environment is seeded
    cannot produce pure form of PHC anhydrate w/o
    some crystalline form

15
Anticipation - Shown Through Inherency
SmithKline III - Contd
  • D Ct CJ Posner ltd claim to commercially
    significant amts of crystalline
  • Fed Cir error nothing in claim so requires
  • D Ct no infg equity SK created the problem
  • Fed Cir unnecessary to address potential
    merit
  • Fed Cir (First Opinion) crystalline form idd
    in 1985 in UK
  • U.S. clinical tests 1985
  • UK appl 1985
  • US appl 1986 1 yr after US clinical trials
  • SK experimental testing
  • Fed Cir NO
  • Everybody petitions for rehearing rehearing
    en banc

16
Anticipation - Shown Through Inherency
SmithKline III - Contd
  • Fed Cir (Second Opinion) inherent anticipation
    by 196 patent under Schering rationale
  • Problems
  • D Ct rejected inherent anticipation Apotex
    did not appeal
  • SKB pet rehrg did not use 196 process
    cannot be inherent anticipation
  • Pet rehrg rehrg en banc denied
  • Judge Gajarsa concurring
  • B/C claim to cmpd invalid under 101 as
    naturally occurring.

17
Anticipation - Anticipation of Quantitative Claim
Terms Cannot Be Shown by Relying on Prior Art
Patent Drawings Alone
  • Nystrom v. TREX Co., Inc., 374 F.3d 1105 (Fed.
    Cir. 2004)(J. Linn - CJ Mayer J. Gajarsa) - p.
    37

Claim defining a difference in thickness
between the longitudinal centerline and the
opposite side edges, with the ratio of said
difference in thickness to the width of the board
being about 140
18
Anticipation
  • Nystrom v. TREX Co.- Contd
  • TREX invalid computer modeling p/a dwg
  • D Ct s/j invalid
  • Fed Cir - REVD
  • Under the principles set forth in our prior
    cases, the speculative modeling premised on
    unstated assumptions in prior art patent drawings
    cannot be the basis for challenging the validity
    of claims reciting specific dimensions not
    disclosed directly in such prior art.

19
Anticipation - Summary Judgment is Not
Appropriate Where the Opposing Party Offers
Specific Facts That Call into Question the
Credibility of the Movants Witnesses
  • TypeRight Keyboard Corp. v. Microsoft Corp., 374
    F.3d 1151 (Fed. Cir. 2004)(JJ. Dyke - Lourie and
    Shall) - p. 40
  • TypeRight owner 2 patents V-shaped keybrds
    critical date 2/21/90
  • MS invalid Marquardt doc undated showed
    unlabeled pix of V-shaped keybrds
  • Fed Cir MS - several consultants who were paid
    for the time they spent testifying.
  • Dr. Cakir fd doc in his file from 1990 but
    thought he had recd doc at trade show in 1986
  • Dr. Hirsch recalled seeing similar pix in
    1986
  • No one ever contacted Marquardt GmbH
  • Fed Cir summary judgment is not appropriate
    where the opposing party offers specific facts
    that call into question the credibility of the
    movants witnesses.

20
Anticipation - Testimony
  • Schumer v. Lab. Computer Sys., Inc. (2002)
  • Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d
    1142 (Fed. Cir. 2004)(J. Gajarsa JJ. Bryson and
    Dyk) - p. 42
  • Testimony Concerning Anticipation Must (1) Be
    From One Skilled in the Art, (2) Identify Each
    Claim Element, (3) State the Witnesses
    Interpretation of the Claim Element, and (4)
    Explain in Detail How Each Claim element is
    Disclosed in the Prior Art
  • Turn-Keys patent cross-laminating layers of
    plastic
  • Koito d/j invalid jury agreed
  • Turn-Key JMOL
  • D Ct DENIED relied on single p/a ref Koito
    introduced into evid but w/o testimony
  • Fed Cir ERROR In order to prove anticipation
    testimony of the type described in Schumer is
    reqd

21
Anticipation Enabling Disclosure
  • In re Elsner, 381 F.3d 1125 (Fed. Cir. 2004)(JJ.
    Lourie - Clevenger and Bryson)(companion case w/
    similar facts) p. 43
  • Evidence of a Foreign Sale of a Claimed
    Reproducible Plant Variety May Enable an
    Otherwise Non-Enabled Printed Publication
    Disclosing That Plant and Thereby Creating a
    102(b) Bar
  • Elsner plant breeder Germany new geranium
    Pendec
  • 1997 filed Community Plant Variety Rts cert. in
    Germany
  • Published w/ name address of breeder
  • 1998 Pendec sold in Germany
  • 1999 Elsner w/drew application
  • 2000 filed plant patent appl. in U.S.
  • PTO rejd CPVO pub and sale placed skilled
    artisan in possession of the invention
  • LeGrice CCPA 1962 - 162 plant patent
    appls need not comply w/ 112 BUT reference
    must be enabling

22
Anticipation Enabling Disclosure
  • In re Elsner Contd
  • PTO LeGrice did not decide - foreign sale
    could enable
  • Fed Cir agreed issue whether evidence of
    the foreign sale of a claimed reproducible plant
    variety may enable an otherwise non-enabled
    printed publication disclosing that plant,
    thereby creating a 102(b) bar. YES
  • Fed Cir When a publication identifies the
    plant that is invented or discovered and a
    foreign sale occurs that puts one of ordinary
    skill in the art in possession of the plant
    itself, which, based on the level of ordinary
    skill in the art, permits asexual reproduction
    without undue experimentation, that combination
    of facts and events so directly conveys the
    essential knowledge of the invention that the
    sale combines with the publication to erect a
    statutory bar.

23
Anticipation Enabling Disclosure
  • In re Elsner Contd
  • REMANDED to consider how readily one skilled
    in the art could have learned of the foreign
    sales from the printed PBR applications.
  • it is unclear whether a skilled artisan
    would have known of the foreign sales. The
    foreign sale must not be an obscure, solitary
    occurrence that would go unnoticed by those
    skilled in the art. Its availability must have
    been known in the art, just as a printed
    publication must be publicly available.

24
Anticipation Rule 105
  • Star Fruits v. United States., 343 F.3d 1277
    (Fed. Cir. 2005)(J. Clevenger J. Dyk,
    dissenting J. Newman) p. 49
  • Failure to Respond to a Request for Information
    Under Rule 105 May Lead to Abandonment of the
    Application Rule 105 is Enforceable
  • Rule 105 exr may require submission of
    information as may be reasonably necessary to
    properly examine or treat the matter
  • Peach tree
  • Exr Any info re sale/public distribution of
    plant variety anywhere in the world
  • Star Fruits refd Rule 56
  • PTO - abnd
  • Fed Cir Affd abandonment

25
Anticipation Enabling Disclosure
  • Rasmusson v. SmithKline Beecham Corp., ___ F.3d
    ___ (Fed. Cir. 2004)(J. Bryson SJ. Plager and
    J. Prost) p. 56
  • A Reference Must Be Enabling to Anticipate, But
    That is Different from the Enablement Requirement
    of 112(1)
  • Method treating prostate cancer - finasteride
  • Bd - publd app could not anticipate b/c app
    failed to demonstrate finasteride effective in
    treating prostate cancer, plus app provided no
    reasonable expectation of success
  • Fed. Cir. REVD REMANDED the standard for
    proper enablement of a prior art reference
    for    anticipation under section 102
    differs from the enablement standard under
    section 112. Prior art reference need not
    demonstrate utility in order to serve as an
    anticipating reference under section 102.

26
Loss of Rights - 102(b) Patented or Described
in a Printed Publication - Public Accessibility
  • In re Klopfenstein, 380 F.3d 1345 (Fed. Cir.
    2004)(J. Prost, JJ Michel and Schall) p. 67
  • Poster Presentation May Qualify as a Printed
    Pub
  • Method - preparing food using extruded soy fiber
  • Fed Cir Factors - poster presentation printed
    pub
  • the length of time the display was exhibited,
  • the expertise of the target audience,
  • the existence (or lack thereof) of reasonable
    expectations that the material displayed would
    not be copied, and
  • the simplicity or ease with which the material
    displayed could have been copied.
  • Fed Cir key ? Is whether ref is publicly
    available
  • 14 slides displayed on poster for 2 ½ days
    publicly available

27
Loss of Rights - 102(b) On Sale
  • UMC Electronics Co. v. United States, 816 F.2d
    647 (Fed. Cir. 1987) ARTP not a prerequisite
  • Pfaff v. Wells Electronics, 525 U.S. 55 (1998)
    (1) First, the product must be the subject of a
    commercial offer for sale and (2) Second, the
    invention must be ready for patenting.
  • Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d
    1041 (Fed. Cir. 2001) (1) a commercial offer
    for sale requires an offer that meets the level
    of an offer for sale in the contract sense, (2)
    decided per Federal Circuit law will look to
    UCC, Restatement (2d) of Contracts, among other
    sources
  • Linear Technology Corp. v. Micrel, Inc., 275 F.3d
    1040 (Fed. Cir. 2001) UCC varies will look
    for common denominator

28
Loss of Rights - 102(b) On Sale
  • Sparton Corp. v. United States, 399 F.3d 1324
    (Fed. Cir. 2005)(SJ. Archer - CJ. Michel and J.
    Schall) p. 74
  • With No Conception of an Invention, There Cannot
    Be An Offer for Sale or Sale of That Invention
  • Alleged sale - 1971 ECP to Navy - dual depth -
    sonobuoys
  • ECP did not propose patented invention
  • Invention later developed included in actual
    buoys
  • Govt Claims Ct U.C.C. 2-106, 2-311
    Sparton could substitute conforming goods
    therefore sale.
  • FED CIR under the Claims Courts analysis,
    the patented single part release plate was the
    subject of an offer for sale before it was even
    conceived. Such a result is illogical.

29
Loss of Rights - 102(b) On Sale
  • in public use and on sale bars diff
    rationales
  • experimental use negation of in public use
  • EZ Dock, Inc. v. Schafer Systems, Inc., 276 F.3d
    1347, 61 USPQ2d 1289 (Fed. Cir. 2002) J. Rader,
    CJ Mayer, additional views J. Linn
  • the question posed by the experimental use
    doctrine, assessed under the first prong of the
    two-part on-sale bar test is whether the
    primary purpose of the inventor at the time of
    the sale, as determined from an objective
    evaluation of the facts surrounding the
    transaction, was to conduct experimentation.
  • Suggests 13 factors - Baker Oil Tools - 1987

30
Loss of Rights - 102(b) On Sale
  • Allen Engineering Corp. v. Bartell Industries,
    Inc., 299 F.3d 1336 (Fed. Cir. 2002) J. Linn,
    JJ. Gajarsa and Prost
  • First prong Pfaff analysis -
  • Whether product was (1) the subject of a
    commercial offer for sale not primarily for
    purposes of experimentation   .
  • Instructions to D. Ct.
  • Must determine whether a commercial offer for
    sale has occurred, applying traditional contract
    law principles, and also whether the
    circumstances surrounding the transaction show
    that the transaction was not primarily for
    purposes of experimentation.
  • Use 13 factors - EZ Dock

31
Loss of Rights - 102(b) On Sale
  • - Customer Awareness and Control by the Inventor
    Are Critical to a Finding of Experimental
    Negation of on sale Activity Analysis is First
    to Determine Whether Any Pre-Critical Date
    Sales As Contemplated by 102(b) Were Made and
    Then to Determine Whether Such Sales Were
    Negated By Experimentation
  • Electromotive Division of General Motors Corp. v.
    Transportation Systems Division of General
    Electric Co., ___ F.3d ____, ____ USPQ2d ____
    (Fed. Cir. 2005) C.J. Michel, SCJ Plager, J.
    Linn NEW
  • Bearings locomotive turbochargers
  • EMD in-house testing field durability testing
  • Substituted bearings preordered locomotives
  • Sales no customer awareness no control

32
Obviousness - 103 Claim Construction
  • Merck Co. v. Teva Pharms., 395 F.3d 1364 (Fed.
    Cir. 2005)(J. Gajarsa J. Prost, dissenting J.
    Radar) p. 90
  • The Term about Means approximately When a
    Patentee Redefines a Term in the Specification,
    He Must Clearly do so Circuit Judge Rader
    Dissenting Court has a Truth in Advertising
    Problem
  • Cmpds treat osteoporosis but adverse
    gastrointestinal side effects administered in
    small daily doses
  • Invention - Once weekly higher doses
  • Claim - about 70/35 mg once weekly
  • Spec defined about equivalent to 70 or 35
    mg
  • P/a - intermittent treatment program once
    weekly dosage schedule of 40mg OR 80mg
  • D. Ct. - about means exactly 70/35 mg - not
    obvious
  • Fed. Cir. REVD about means approximately
  • J. Radar spec defined about

33
Obviousness
  • In re Bigio, 381 F.3d 1320 (Fed. Cir. 2004) (J.
    Rader J. Schall, dissent by J. Newman) p. 94
  • Claims Are Given Their Broadest Reasonable
    Interpretation During Ex Parte Prosecution -
    Hair Brush Not Limited to One For Brushing
    Scalp Hair
  • Claims hair brush
  • P/A toothbrushes
  • Fed. Cir. majority tooth brushes could be used
    for brushing hair, ie, facial hair
  • J. Newman dissented noting a brush for hair has
    no more relation to a brush for teeth than does
    hair resemble teeth

34
Obviousness Range Cases
  • Iron Grip Barbell Co. v. USA Sports, Inc., 392
    F.3d 1317 (Fed. Cir. 2004)(J. Dyk J. Newman and
    SJ. Archer) p. 103
  • Where There is a Range Disclosed in the Prior
    Art, and the Claimed Invention Falls Within That
    Range, There is a Presumption of Obviousness
  • Invention weight plate w/ 3 handle openings
  • p/a weight plates w/ 1, 2 and 4 grips
  • Fed Cir where there is a range disclosed in
    the p/a, and the claimed invention falls within
    that range, there is a presumption of
    obviousness that may rebutted by showing (1)
    teaching away, or (2) unexpected results.

Patent-in-Suit Three-Grip Plate
Prior art
Invention
35
Obviousness Range Cases
In re Harris, ____ F.3d ____ (Fed. Cir. 2005)(J.
Rader J. Clevenger and SJ. Friedman) p. 111
  • Where Claimed Range Is Completely Covered by P/A,
    Prima Facie Obvious Even More Compelling
  • Nickel-based superalloy for turbine engine blades
    12 elements
  • P/A Overlapped all 12 elements completely
    overlapped 11 elements
  • No teaching away No unexpected results
  • PTO rejection AFFD
  • Fed. Cir. where the claimed ranges are
    completely encompassed by the prior art, the
    conclusion that the claims are prima facie
    obvious is even more compelling than in cases of
    mere overlap. 

36
ObviousnessCommercial Success
Merck Co. v. Teva Pharms., Inc., 395 F.3d 1364
(Fed. Cir. 2005)(J. Gajarsa - J. Prost,
dissenting J. Rader) p. 115
  • Commercial Success is Not a Factor Where Market
    Entry by Others is Barred by FDA Developing
    Split
  • Method treating osteporosis administering
    once-weekly doses cmpd
  • Teva obvious Lunar News articles suggesting
    once-weekly doses close to claimed doses
  • Fed Cir about means approximately invalid
  • D Ct Evid of commercial success
  • Fed Cir majority Not a factor
  • Merck had another patent that precluded
    practicing the Lunar News method FDA procedure
    gave Merck exclusive rts.

37
ObviousnessCommercial Success
Merck Co. v. Teva Pharms., Inc. Contd
  • Financial success is not significantly probative
    of that question obviousness in this case
    because others were legally barred from
    commercially testing the Lunar News ideas.
  • because market entry by others was precluded
    on those bases, the inference of non-obviousness
    of weekly-dosing, from evidence of commercial
    success, is weak. Although commercial success may
    have probative value for finding non-obviousness
    of Mercks weekly-dosing regimen in some context,
    it is not enough to show the claims at bar are
    patentably distinct from the weekly-dosing ideas
    in the Lunar News articles.

38
ObviousnessCommercial Success
Merck Co. v. Teva Pharms., Inc. Contd
  • Denied petitions for rehrng rehring en banc
  • J. Lourie dissented joined by J. Newman C.J.
    Michel
  • J. Lourie commercial success is a fact
    question, and, once it is established, as found
    here by the trial court, the only other question
    is whether the success is attributable to the
    claimed invention (nexus), rather than to other
    factors such as market power, advertising, demand
    for all products of a given type, a rising
    economy that lifts all boats, etc.

39
ObviousnessCommercial Success
Syntex (U.S.A.) LLC v. Apotex, 407 F.3d 1371
(Fed. Cir. 2005)(J. Gajarsa - J. Clevenger,
concurring J. Prost) 118
  • Evidence of Commercial Success is a Weak Factor
    Where Market Entry by Others is Barred by Other
    Patents Disagreement Between Examiners May Be
    Evidence of Obviousness
  • Ophthalmic formulation non-steriodal
    anti-inflammatory drug preservative
    surfactant (octoxynol 40 known, but not in
    ophthalmic formulations)
  • Problem preservatives didnt mix well w/ NASIDs
  • Surfactant used to make insoluble chems soluble
  • Parent rejd art taught NASIDs preservative
    surfactant (but not octoxynol 40)
  • Syntex declaration unexpected results
  • Exr not persuaded

40
ObviousnessCommercial Success
Syntex (U.S.A.) LLC v. Apotex Contd
  • Continuation new exr
  • Same rejection
  • Syntex had shown in parent unexpected results
  • Exr allowed
  • Fed Cir inconsistency between exrs significant
  • Apotex ANDA
  • D Ct infringed not invalid
  • Fed Cir REVD D Ct had not properly
    considered evid of obviousness especially views
    of first exr
  • Coml success D Ct should re-evaluate in view
    of Merck Assuming that the active ingredient
    in the formulation was previously patented, the
    coml success of ACULAR may heavily derive from
    subject matter that does not on the whole
    contribute to the patentable distinctiveness of
    these claims.

41
Enablement-Written Description-Best Mode
  • Highlights
  • Divisions within court on the test for compliance
    with the written description requirement
  • Best mode analysis tied to claimed invention

42
Enablement-Written Description-Best ModeWritten
Description
  • Test for Compliance
  • Vas-Cath, Inc. v. Mahurkar (1991)
  • Although the applicant does not have to describe
    exactly the subject matter claimed, the
    description must clearly allow persons of
    ordinary skill in the art to recognize that he or
    she invented what is claimed. The test for
    sufficiency of support is whether the
    disclosure of the application reasonably conveys
    to the artisan that the inventor had possession
    at that time of the later claimed matter.
  • Possession of the invention currently under
    attack by some on the court.

43
Enablement-Written Description-Best ModeWritten
Description
  • Test for Compliance
  • Regents v. Eli Lilly (1997)(J. Lourie JJ.
    Newman Bryson)
  • Gene material identified only by a statement of
    function or result did not adequately describe
    the claimed invention
  • Written description of genetic material requires
    a precise definition, such as by structure,
    formula, chemical name, or physical properties.

44
Enablement-Written Description-Best ModeWritten
Description
  • In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004)(J.
    Lourie - JJ Mayer and Gajarsa) 130
  • Failure to Disclose Less Than a Complete DNA
    Sequence May Not Satisfy the Written Description
    Requirement
  • Discovery 2 specific proteins isolated from
    human urine selectively inhibited cytotoxic
    effect of tumor necrosis factor- TBP-I and TBP-II
  • Disclosed partial DNA sequences molecular
    weight
  • Claimed DNA molecules encoding those proteins
  • Brd insufficient written description
  • Fed Cir Affd Appellants concede that it is
    now known that urinary TBP-II has a sequence of
    185-192 amino acids. Without the approximately
    95 of the amino acid sequence that Appellants
    did not disclose, we cannot say that the DNA
    molecules claimed in the 129 application have
    been described.
  • Fed Cir - until Appellants obtained the
    complete amino acid sequence of TBP-II, they had
    no more than a wish to know the identity of the
    DNA encoding it.

45
Enablement-Written Description-Best ModeWritten
Description
  • Capon v. Eshhar, ___ F.3d ____ (Fed. Cir. 2005)
    J. Newman, JJ. Mayer and Gajarsa - New
  • Whether the Written Description Requirement is
    Satisfied Must Take Into Account the State of
    Scientific Knowledge
  • patent-application interference
  • chimeric gene - combined DNA segments - enhanced
    immune response
  • Brd w/o complete sequence Lilly et al. no
    written description support
  • Fed Cir Revd depends on tech.

46
Enablement-Written Description-Best ModeWritten
Description
  • Northpoint Tech., Inc. v. MDS-America, Inc., ___
    F.3d ___ (Fed. Cir. 2005)(J. Bryson J. Schall,
    concurring-in-part, dissenting-in-part J. Dyk)
    137
  • Expert Testimony That Elaborate Measures, Not
    Described in the Patent, Were Required to Make
    the Claimed Invention Work Supports Conclusion
    That Claims are Invalid Due to Lack of Enabling
    Support
  • Method and apparatus for transmitting terrestrial
    signals on a common frequency with satellite
    transmissions
  • Jury - MDS infringed, but claims invalid as
    anticipated and non enabled
  • Panel AFFD expert testimony
  • J. Dyk dissenting experimentation not undue

47
Enablement-Written Description-Best ModeBest Mode
  • Best Mode
  • Unintentional omission of information known in
    the art is not deliberate concealment
  • Best Mode analyzed in terms of claimed invention

48
Enablement-Written Description-Best ModeBest Mode
  • The Best Mode Requirement Is Not Violated by
    Unintentional Omission of Information That Would
    be Readily Known to Persons in the Field of the
    Invention
  • High Concrete Structures v. New Enterprise, 377
    F.3d 1379 (Fed. Cir. 2004)(J. Newman - CJ. Mayer
    and J. Clevenger) p. 142
  • Tilt carrying heavy concrete structures
  • Spec can be rotated manually
  • Inventors depo helps to use a crane
  • No concealment of best mode

49
Enablement-Written Description-Best ModeBest Mode
  • Cardiac Pacemakers v. St. Jude, 381 F.3d 1374
    (Fed. Cir. 2004)(J. Newman SJ. Friedman and J.
    Rader) p. 143
  • The Best Mode Requirement Relates to Invention
    Disclosed and Claimed
  • Implantable cardiac defibrillators could detect
    type of arrhythmia
  • Asked Honeywell to develop new battery it did
  • Battery not disclosed or claimed other
    batteries could be used
  • Persons knowledgeable in the field would know
    where to get batteries

50
Particularly Point Out and Distinctly ClaimWhat
the Applicant Regards as His Invention
  • 112(2) Particularly Point Out and Distinctly
    Claim
  • Judged from perspective of one of ordinary skill
    in the art
  • Not invalid unless insolubly ambiguous

51
Particularly Point Out and Distinctly ClaimWhat
the Applicant Regards as His Invention
  • Bancorp v. Hartford Life, 359 F.3d 1367 (Fed.
    Cir. 2004)(J. Bryson JJ. Rader and Prost) p.
    146
  • If Claim is Not Insolubly Ambiguous, It is Not
    Invalid for Indefiniteness
  • System for tracking value of life insurance
    policies in separate accounts
  • surrender value protected investment credits
    not defined in patent not a term of art
  • D Ct invalid indefinite
  • Fed. Cir. REVD components of the term have
    well-recognized meanings, which allow the reader
    to infer the meaning of the entire phrase with
    reasonable confidence.

52
Particularly Point Out and Distinctly ClaimWhat
the Applicant Regards as His Invention
  • Howmedica Osteonics Corp. v. Tranquil Prospects,
    Ltd., 401 F.3d 1367 (Fed. Cir. 2005)(J. Rader -
    JJ. Dyk and Prost) p. 147
  • A Claim is Definite if Its Legal Scope is Clear
    Enough That a Person of Ordinary Skill in The Art
    Could Determine Whether a Particular Product or
    Process Infringes or Not
  • intramedullary prosthesis and method of
    implanting hip joint
  • Claim 70 of transverse sectional dimensions
    of long bone
  • ? dimensions refer to 1-D or 2-D
  • D Ct indefinite Fed Cir REVD one of
    ordinary skill in the art would understand from
    spec that dimensions referred to 2-D

53
Particularly Point Out and Distinctly ClaimWhat
the Applicant Regards as His Invention
  • Marley Mouldings Ltd. v. Mikron Indus., Inc., ___
    F.3d ____ (Fed. Cir. 2005) J. Newman JJ. Schall
    and Dyk
  • Claims Are Not Indefinite Even Though Tests Do
    Not Definitively Show Infringement or
    Non-Infringement
  • Composite frame molding
  • Claims wood flour in parts (volume)
  • Equations relating weigh volume depends on
    density
  • Marley inf tests using lowest density spec
    sheet range
  • Mikron non-inf tests using avg density
  • Fed Cir not indefinite not insolubly ambiguous

54
Particularly Point Out and Distinctly ClaimWhat
the Applicant Regards as His Invention
  • Datamize, L.L.C. v. Plumtree Software, Inc., ___
    F.3d ____ (Fed. Cir. 2005) J. Prost, JJ.
    Clevenger and Bryson - NEW
  • aesthetically pleasing Renders Claims
    Indefinite Some Objective Standard Must Appear
    in the Claims, Specification or Prosecution
    History
  • software - authoring user interfaces - electronic
    kiosks
  • Claims aesthetically pleasing look and feel
    for said interface screens
  • Fed Cir indefinite - simply put, the
    definition of aesthetically pleasing cannot
    depend on an undefined standard.
  • Look to claims spec prosecution history

55
Inventorship
  • Eli Lilly v. Aradigm, 376 F.3d 1352 (Fed. Cir.
    2004)(J. Clevenger J. Gajarsa, concurring J.
    Lourie) p. 153
  • One Claiming To Have Been Improperly Omitted As A
    Joint Inventor Must Show A Contribution To
    Conception Of The Claimed Invention, And That
    Showing Must Meet A Clear And Convincing Level
    Of Proof
  • Methods of aerosolized administration of insulin
    analogs
  • Fed. Cir. pty claiming nonjoinder/misjoinder
    must meet heavy burden by clear and convincing
    evidence and must provide evidence to
    corroborate the alleged joint inventors
    conception   .
  • Caterpillar, Inc. v. Sturman Indus., Inc., 387
    F.3d 1358 (Fed. Cir. 2005)(J. Prost JJ. Newman
    and Dyk) p. 155
  • There Is a Presumption That Patents Name Correct
    Inventors

56
Legal Ethics Inequitable Conduct
  • WATCH OUT FOR
  • Changing standard of materiality

57
Legal Ethics Inequitable Conduct
  • The Elements
  • Materiality
  • Intent

58
Legal Ethics Inequitable Conduct
  • Materiality Evolving Standard
  • Pre-1977 74 OG Guidelines Rule 56 (appl.
    stricken if fraud) Case law (generally
    related to patentability)
  • 1977 reasonable examiner standard paraphrased
    from SEC disclosure standard for unsophisticated
    investors
  • 1982 Claims may be rejected appeal to Brd
  • 1983 Renamed P/A Statement to IDS
  • 1987 AIPLA Blue Ribbon Committee
  • 1988 PTO Proposed Rule 57 but for standard
  • 1988 Kingsdown Harita PTO disbands fraud
    squad will not investigate or reject
  • 1989 Revised Rule 57 proposed Commr Quigg
    resigns
  • 1990 Commr Manbeck formally w/draws Rule 57
  • 1991 Draft new Rule 56 announced
  • 1992 New Rule 56 eff. March 16, 1992
  • 2000 Duty to disclose new art in CIP

59
Legal Ethics Inequitable Conduct
  • New Rule 56
  • Applies to applications reexams pending filed
    aft. 3/16/92
  • Duty of disclosure applies to pending claims
  • Duty satisfied if material art is cited by PTO or
    submitted to PTO
  • Materiality
  • Cumulative art not material
  • Prima Facie Standard
  • Claim not patentable
  • Refutes/inconsistent w/ argument or position
  • Preponderance of the evidence standard
  • Terms given broadest reasonable construction
  • Before considering contrary evidence
  • January 11, 2005 - CAFC panel adopts new Rule
    56
  • Does not reconcile prior cases strongly
    suggesting materiality standard of new Rule 56
    does not apply to IE

60
Legal Ethics Inequitable Conduct
  • J.P. Stevens I (1984)
  • Inequitable conduct requires clear convincing
    proof
  • Non-disclosed or false info must meet a
    threshold degree of materiality
  • Hoffman-La Roche (2003)
  • Interpreted New Rule 56 as not a significant
    break in the previous reasonable examiner
    standard
  • Dayco Products II (2003)
  • Final disposition the same under either
    materiality standard - pass on disposing of the
    issue but also suggests new Rule 56 is not
    the standard

61
Inequitable ConductWhich Standard Controls?
  • Bruno Indep. Living Aids, Inc. v. Acorn Mobility
    Servs. Ltd., 394 F.3d 1348 (Fed. Cir. 2005)(J.
    Lourie JJ. Gajarsa and Linn) p. 160
  • A Panel of the Court Adopts the Materiality
    Standard of New Rule 56
  • Stairlift
  • P/A Wecolator similar stairlift mfd by 3/P
  • Urged stairlift was Substantial Equivalent to
    Wecolator when seeking FDA approval
  • Did not disclose Wecolator to PTO
  • D. Ct. invalid for IE case exceptional for
    atty fees
  • Fed. Cir. AFFD Adopted new Rule 56 - Bruno
    knew or should have known of materiality
  • If Wecolator had been disclosed, Bruno could not
    have made argument during prosecution

62
Inequitable Conduct
  • Purdue Pharma L.P. v. Endo Pharms., Inc., 394
    F.3d 1348 (Fed. Cir. 2005)(SJ. Plager JJ.
    Gajarsa and Linn) p. 168
  • Repeated Assertions of a Surprising Discovery
    May Constitute Inequitable Conduct When Not Based
    on Scientific Proof
  • Controlled release of oxycodone formulations
  • Purdue relied on surprising discovery to
    overcome 103 rejections
  • Inventor testified it was insight, rather than
    scientific proof, that formed basis of assertion
  • D. Ct. p-i-s infringed, but unenforceable due
    to inequitable conduct
  • Fed. Cir. absent statement re origin of
    surprising discovery, arguments enough of a
    suggestion that clinical trials had been
    performed   .
  • Fed. Cir. - Purdue made a deliberate decision to
    withhold and thus misrepresent the origin of its
    discovery to the PTO.
  • AFFD

63
Inequitable Conduct Intent
  • Bruno Indep. Living Aids, Inc. v. Acorn Mobility
    Servs. Ltd., 394 F.3d 1348 (Fed. Cir. 2005)(J.
    Lourie JJ. Gajarsa and Linn) p. 171
  • Inferred Failure to Provide a Good Faith Reason
    for Nondisclosure May lead to an Inference of
    Intent to Deceive
  • Fed. Cir. Intent need not, and rarely can, be
    proven by direct evidence.
  • Rather, in the absence of a credible
    explanation, intent to deceive is generally
    inferred from the facts and circumstances
    surrounding a knowing failure to disclose
    material information.

64
Inequitable Conduct Intent
  • Frazier v. Roessel Cine Photo Tech, Inc., ___
    F.3d ____ (Fed. Cir. 2005) J. Linn J. Dyk,
    concurring-in-part and dissenting-in-part J.
    Bryson - NEW
  • Inferred Allowing a Video to be Submitted to
    the PTO in Order to Represent the Capabilities of
    a Lens, Knowing That The Video Was Shot With a
    Different Lens is Sufficient to Infer Intent to
    Deceive
  • D Ct Frazier not credible changed story
  • Fed Cir the district courts unchallenged
    findings establish that Frazier allowed a video
    to be submitted to the PTO in order to represent
    the capabilities of the claimed lens, knowing
    that portions of the video were shot with a
    different lens. The district courts finding of
    intent is not clearly erroneous on these facts.

65
Inequitable Conduct Intent
  • Pharmacia Corp. v. Par Pharma., Inc., ___ F.3d
    ____ (Fed. Cir. 2005) J. Rader, JJ. Schall
    Linn- NEW
  • A Terminal Disclaimer Does Not Cause Inequitable
    Conduct in One Patent to Infect Another Patent A
    High Degree of Materiality, in The Absence of a
    Credible Explanation, May Support an Inference of
    Intent to Deceive
  • Patent A Ineq. Cond. Declaration inconsistent
    w/ prior article by declarant not disclosed
  • Patent B ineq. cond. Not inferred b/c of term
    discl.

66
Inequitable Conduct Intent
  • A Plausible, Good Faith Explanation of Why
    Information Was Not Cited May Avoid a Finding of
    Intent to Deceive
  • Warner-Lambert Co. v. Teva Pharma. USA, Inc., ___
    F.3d ____ (Fed. Cir. 2005) J. Schall, JJ. Linn
    Prost New Non-disclosed prior tests of
    competitive product
  • TAP Pharma. Products, Inc. v. OWL Pharma.,
    L.L.C., ___ F.3d ____ (Fed. Cir. 2005) J.
    Bryson, JJ. Newman Gajarsa New Prior art
    Foreign search report

67
Legal Ethics Inequitable Conduct
  • Unitherm Food Sys. v. Swift-Eckrich, Inc., 375
    F.3d 1341 (Fed. Cir. 2004)(J. Gajarsa - JJ.
    Schall and Linn) p. 172
  • A Walker Process -Type Antitrust Claim Requires
    Proof Not Only Of Fraud On the PTO, But The Other
    Elements Of A Sherman Act 2 Claim As Well
  • Federal Circuit antitrust law centers on a single
    question What behavior by the patentee in
    procuring or enforcing a patent can strip the
    patentee of antitrust immunity?
  • Found elements of Walker Process -type AT
    satisfied, but other elements product market
    for Sherman 2 claim not satisfied

68
Reissue - Reexamination
  • N. Am. Container, Inc. v. Plastipak Packaging,
    Inc., ___ F.3d ___ (Fed. Cir. 2005)(J. Lourie -
    JJ. Bryson and Linn) p. 177
  • Recapture Estoppel Applied
  • Blow-molded bottles
  • Prosecution added generally convex - overcome
    103 rejections
  • Reissue app deleted inner wall portions are
    generally convex
  • Protests - recapture - exr not critical
  • D. Ct. claims invalid violated recapture rule
  • Fed. Cir. AFFD exrs denial of protests
    demonstrates his inattention to the rule
    against recapture.

69
Claim Construction
  • Highlights
  • Division among judges re strict application of
    the ordinary meaning of claim terms
  • Refusal to limit claims to disclosed
    embodiment(s), unless clear statements that
    invention is so limited
  • May be ltd to spec when claim is ambiguous
  • BUT some judges rebelling claims should be ltd
    to actual invention
  • Phillips v. AWH anti-climatic but does case
    signal narrower construction?

70
Claim Construction
  • Johnson Worldwide v. Zebco 1999
  • Renishaw v. Marposs 1998
  • Focus on ordinary meaning of the claims
  • Trend 1997 most of 2001 limit claims b/c of
    written description
  • Wang Labs. v. AOL
  • SciMed v. Advanced Cardiovascular Systems
  • Netword v. Centraal Corp.
  • Toro v. White Consolidated
  • Bell Atlantic v. Conrad
  • Trend 2002-2003 refocus on ordinary meaning
  • CCS Fitness, Inc. v. Brunswick Corp.
  • Teleflex, Inc. v. Ficosa North America Corp.
  • Texas Digital v. Telegenix
  • 2003-2005 Some Judges what is the invention?
  • 2005 - Phillips v. AWH ?

71
Claim Construction
  • Cases generally emphasizing claim language not
    ltd by specification

72
Claim Construction
  • Nystrom v. TREX, 374 F.3d 1105 (Fed. Cir.
    2004)(J. Linn and CJ. Mayer, dissent J. Gajarsa)
    p. 187
  • a board
  • D Ct wood
  • Dictionary defs wood or other rigid material
  • Maj not ltd to wood
  • J. Gajarsa when multiple definitions are
    conflicting look to intrinsic evid Novartis
    v. Eon
  • Maj Construction should add all definitions
    found support in spec although tenuous
    Novartis cannot override earlier panel opinions

73
Claim Construction
  • Numeric Ranges From Specification Examples Do Not
    Represent a Disavowal of the Common Meaning of
    the Term
  • Unitherm Food Sys. v. Swift-Eckrich, Inc., 375
    F.3d 1341 (Fed. Cir. 2004)(J. Gajarsa JJ.
    Schall and Linn) p. 190
  • ConAgra urged that Unitherm process not the same
    b/c it did not produce golden-brown color
  • D. Ct. concluded that patentee did not act his on
    lexicographer
  • Reference to Hunter-Lab Color Meter
    measurements to describe color merely examples
  • No disavowal of common meaning

74
Claim Construction
  • W.E. Hall v. Atlanta Corrugating, 370 F.3d 1343
    (Fed. Cir. 2004) (J. Gajarsa JJ. Linn and
    Prost) p. 191
  • If the Written Description or Prosecution History
    are Ambiguous as to Whether a Patentee Used a
    Term Consistent with the Ordinary and Custom
    Meaning, the Ordinary and Customary Meaning
    Prevails
  • ribs defining a plurality of open channels

75
Claim Construction
  • W.E. Hall v. Atlanta Corrugating Contd
  • Argued over p/a Nyssen pipes didnt need
    element 30

76
Claim Construction
  • W.E. Hall v. Atlanta Corrugating Contd
  • Arguments during prosecution clear meaning of
    open

77
Claim Construction - Summary
  • Housey Pharms. v. Astrazeneca, 366 F.3d 1348
    (Fed. Cir. 2004)(J. Clevenger - CJ. Mayer,
    dissenting J. Newman) p. 194
  • The plain meaning of claim terms control even
    though the result is that the claims concededly
    are invalid and non-infringed
  • Split plain meaning v. read in the context of
    the spec
  • Vanderlande Ind. V. U.S. ITC, 366 F.3d 1311 (Fed.
    Cir. 2004) (J. Michel JJ. Gajarsa and Linn)
    p. 195
  • General-usage dictionaries are irrelevant where
    there is evidence that artisans in the field
    would attach a special meaning to a claim term,
    or no meaning at all

78
Claim Construction - Summary
  • TI Group v. Automotive, 375 F.3d 1126 (Fed. Cir.
    2004)(J. Prost J. Gajarsa, dissent J. Bryson)
    p. 198
  • The plain meaning of reservoir and within
    avoids infringement
  • Mars, Inc. v. H.J. Heinz, 377 F.3d 1369 (Fed.
    Cir. 2004)(J. Dyk JJ. Schall and Prost) p.
    200
  • Containing and Mixture are open-ended terms
    that do not exclude the presence of unlisted
    ingredients

79
Claim Construction - Summary
  • Innova/Pure Water v. Safari Water, 381 F.3d 1111
    (Fed. Cir. 2004)(J. Clevenger JJ. Rader and
    Linn) p. 202
  • It is a bedrock principle of patent law that the
    claims of a patent define the invention to which
    the patentee is entitled the right to exclude
  • Home Diagnostics v. LifeScan, 381 F.3d 1352 (Fed.
    Cir. 2004) (J. Rader JJ. Dyk and Prost) p.
    206
  • Preferred embodiment does not alone undermine
    customary meaning and scope of the claim language

80
Claim Construction
  • Eolas Techs. v. Microsoft, 399 F.3d 1325 (Fed.
    Cir. 2005)(J. Rader JJ. Friedman and Plager)
    p. 208
  • Absent a Disclaimer, Claims Are Not Limited to
    the Embodiment Disclosed in the Specification
  • Drawn to a distributed hypermedia method -
    allowed a user to operate a web browser in an
    interactive environment
  • Claims executable application
  • D Ct any computer code that is launched
    includes DLLs
  • Microsoft - spec described only standalone
    programs
  • Fed. Cir. no clear disclaimer embodiments in
    spec do not limit broader claim language

81
Claim Construction
  • Gemstar-TV Guide Intl v. ITC, 383 F.3d 1352
    (Fed. Cir. 2004)(J. Linn and J. Clevenger) p.
    210
  • Statement in Specification that innovative
    cursor is required Does Not Limit Claim to
    Such a Cursor
  • Interactive program guides
  • Claims visual identification
  • Spec an innovative cursor is required
    .
  • ITC - innovative cursor was required ltd
    visual identification to that cursor
  • Fed. Cir. - error Spec simply described
    advantages of innovative cursor

82
Claim Construction
  • NTP, Inc. v. Research In Motion, Ltd., ___ F.3d
    ___ (Fed. Cir. 2005)(J. Linn JJ. Michel and
    Schall) p. 211 (new opinion this portion
    unchanged)
  • Statement in Specification that electronic mail
    system is basically a Wireline System Together
    With Drawing Figure Illustrating Wireless Link
    Indicates System May Be Wireless
  • Claims electronic mail system
  • D. Ct. - willful infringement
  • RIM - electronic mail system should be limited
    to wireline sys
  • Fed. Cir. disagreed
  • Spec basically a wireline system dwg showed
    wireless link
  • Fed Cir basically means could include wireless

83
Claim Construction
  • Playtex Prods., Inc. v. Proctor Gamble Co., 400
    F.3d 901 (Fed. Cir. 2005)(J. Gajarsa JJ. Lourie
    and Linn) p. 213
  • Substantially is a Descriptive Term Commonly
    Used in Patent Claims to Avoid a Strict Numerical
    Boundary to the Specified Parameter
  • Asyst Techs. v. Emtrak, Inc., 402 F.3d 1188 (Fed.
    Cir. 2005)(J. Bryson CJ. Michel and J. Newman)
    p. 215
  • The Phrase mounted on Given its Ordinary
    Meaning a Conclusory Expert Opinion Does not
    Override Ordinary Meaning

84
Claim Construction
  • Cases generally emphasizing specification

85
Claim ConstructionLimited by Specification
  • Metabolite Labs, Inc. v. Lab. Corp. of Am.
    Holdings, 370 F.3d 1354 (Fed. Cir. 2004)(J. Rader
    SJ. Friedman, dissenting-in-part
    concurring-in-part J. Schall) p. 252
  • Reading Claim in the context of the
    Specification May Result in a Broader
    Construction Than Warranted by the Claim Language
  • Methods of detecting B vitamin deficiency
  • correlating an elevated level of   
    homocysteine    with deficiency of cobalamin
    or folate.
  • Panel Majority correlating means relating
    homocysteine levels to presence or absence of a
    vitamin deficiency
  • J. Schall dissenting panels construction
    expands the scope of claim 13 beyond the actual
    words of the claim.
  • Claim limited to elevated levels 80-84 of
    tests shows unelevated levels damages should
    be reassessed.

86
Claim ConstructionLimited by Specification
  • Irdeto Access v. Echostar, 383 F.3d 1295 (Fed.
    Cir. 2005)(J. Michel JJ. Newman and Bryson)
    p. 254
  • Where a Disputed Term Lacks an Accepted Meaning
    in the Art, There is no Heavy Presumption of
    Ordinary Meaning
  • Method of controlling broadcast of enciphered
    info using service keys group keys box
    keys
  • ? whether group keys included less than all
    subscribers
  • Terms had no accepted meaning in the art
  • Having conceded that the key modifiers have no
    accepted meaning in the art, the applicant
    expressly directed the public to the
    specification to discern that meaning and thus
    measure the scope of the claimed invention. And
    while the specification does not contain any
    statements of explicit disavowal or words of
    manifest exclusion, it repeatedly, consistently,
    and exclusively uses group to denote fewer than
    all subscribers, manifesting the patentees clear
    intent to so limit the term.

87
Claim ConstructionLimited by Specification
  • AstraZeneca AB v. Mutual Pharms. Co., 384 F.3d
    1333 (Fed. Cir. 2004)(J. Michel SJ. Archer and
    J. Bryson) p. 258
  • Specification May Always be Consulted to Confirm
    Construction
  • AZ 2 patents - felodipine - PLENDIL - treating
    hypertension
  • Mutual ANDA generic felodipine
  • a solution or dispersion of an effective amount
    of the active compound in a semi-solid or liquid
    nonionic solubilizer
  • Artisans - understand - solubilizer - 3 types
    of chemicals (1) surface active agents (also
    known as surfactants), (2) co-solvents, and (3)
    complexation agents.
  • Mutual - solubilizer per spec - only surfactants

88
Claim ConstructionLimited by Specification
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