Title: Federal Circuit 20042005
1Federal 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
2Novelty 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
3Claim 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
4Claim 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
5Claim 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
6Claim 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
7Inherency
- Highlights
- Whether one of ordinary skill in the art must
have recognized the inherency now resolved?
8Inherency
- 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
9Anticipation - 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
10Anticipation - 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.
11Anticipation - 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
12Anticipation - 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
13Anticipation - 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.
14Anticipation - 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
15Anticipation - 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
16Anticipation - 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.
17Anticipation - 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
18Anticipation
- 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.
19Anticipation - 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.
20Anticipation - 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
21Anticipation 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
22Anticipation 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.
23Anticipation 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.
24Anticipation 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
25Anticipation 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.
26Loss 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
27Loss 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
28Loss 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.
29Loss 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
30Loss 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
31Loss 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
32Obviousness - 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
33Obviousness
- 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
34Obviousness 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
35Obviousness 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.
36ObviousnessCommercial 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.
37ObviousnessCommercial 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.
38ObviousnessCommercial 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.
39ObviousnessCommercial 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
40ObviousnessCommercial 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.
41Enablement-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
42Enablement-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.
43Enablement-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.
44Enablement-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.
45Enablement-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.
46Enablement-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
47Enablement-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
48Enablement-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
49Enablement-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
50Particularly 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
51Particularly 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.
52Particularly 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
53Particularly 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
54Particularly 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
55Inventorship
- 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
56Legal Ethics Inequitable Conduct
- WATCH OUT FOR
- Changing standard of materiality
57Legal Ethics Inequitable Conduct
- The Elements
- Materiality
- Intent
58Legal 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
59Legal 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
60Legal 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
61Inequitable 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
62Inequitable 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
63Inequitable 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.
64Inequitable 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.
65Inequitable 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.
66Inequitable 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
67Legal 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
68Reissue - 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.
69Claim 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?
70Claim 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 ?
71Claim Construction
- Cases generally emphasizing claim language not
ltd by specification
72Claim 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
73Claim 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
74Claim 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
75Claim Construction
- W.E. Hall v. Atlanta Corrugating Contd
- Argued over p/a Nyssen pipes didnt need
element 30
76Claim Construction
- W.E. Hall v. Atlanta Corrugating Contd
- Arguments during prosecution clear meaning of
open
77Claim 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
78Claim 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
79Claim 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
80Claim 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
81Claim 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
82Claim 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
83Claim 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
84Claim Construction
- Cases generally emphasizing specification
85Claim 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.
86Claim 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.
87Claim 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
88Claim ConstructionLimited by Specification