Associated Document (.pdf) - Schwegman, Lundberg & Woessner

Hot Topics
Janet E. Embretson, J.D., Ph.D.
Shareholder
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.

Hot Topics
• Improvements to Restriction Practice
(Group 1600)
• Revisions to PCT Practice (effective
January 1, 2004)
• Bayer AG v. Housey Pharmaceuticals, Inc.
• Jansen v. Rexall Sundown, Inc.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Group 1600 Action Plan
• Publish examples of claim sets that will be
examined together
• Reemphasize rejoinder practice (M.P.E.P.
821.04)
• Training
• Increased review
• Continuing reassessment
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Revisions to PCT Application
Procedures
• Filing Requirements, e.g., designation
• Chapter I
• Fees
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• Automatic all inclusive coverage of all
designations
• Need to name applicant inventors
• Need signature of at least one applicant in
request
• If >1 applicant, address, residence and
nationality need only be provided for an applicant
who is entitled to file with RO
• RO, ISA or IPEA can waive requirement for POA
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• Written Opinion in Chapter I
• ISA issues nonbinding Written Opinion (WO)
• Demand due within later of 3 months of ISR and
WO (or Article 17.2(a) Declaration) or 22 months
from priority date
• If Demand timely filed, WO by ISA is WO of IPEA
• Filing of a Demand constitutes election of all
designated states
• If Demand is not timely filed, WO by ISA
becomes IPRP (Public at 30 months from priority
date)
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• Fees
• Separate basic and designation fees eliminated in
favor of single international filing fee due at one time
(still pay for sheets >30)
• Search fee
• Cost reduction if prior U.S. 111(a) application filed (from $450
to $300) – but need to timely furnish information; otherwise
$1000 (used to be $700)
• For >1 invention search fee $1000/additional invention
• Examination fee
• If paid IPEA/US search fee $600 (used to be $490), otherwise
$750
• Examination fee $600/additional invention
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Bayer AG v. Housey Pharmaceuticals
(340 F.3d 1367(Fed. Cir. 2003))
• U.S. Patent Nos. 4,980,281, 5,266,464, 5,688,655 and
5,877,007
• A method of screening for substances which
specifically inhibit or activate a particular protein
affecting the cultural or morphological characteristics
of the cell expressing the protein
• Does 35 U.S.C. § 271(g) apply to:
1) Information imported into or used in the U.S. reflecting
identification and characterization of a drug acquired from
using the patented method
2) Sale in the U.S. of a drug determined to be an inhibitor or
activator of a target protein using the patented methods
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§ 271(g) provides:
• Whoever without authority imports into the United States
or offers to sell, sells, or uses within the United States a
product which is made by a process patented in the
United States shall be liable as an infringer, if the
importation, offer to sell, sale, or use of the product
occurs during the term of such process patent…A product
which is made by a patented process will, for purposes of
this title, not be considered to be so made after-
1) It is materially changed by subsequent processes; or
2) It becomes a trivial and nonessential component of another
product.
• “made”
• Looked to dictionaries
• Looked to other provisions of the statue
• Looked to legislative history
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• Reading the statute to cover processes other than manufacturing
processes could lead to anomalous results. The importation of
information in the abstract (here, the knowledge that a substance
possesses a particular quality) cannot be easily controlled. As Bayer
points out, a person possessing the allegedly infringing information
could, under Housey’s interpretation, possibly infringe by merely
entering the country.
• In order for a product to have been “made by a process patented in
the United States” it must have been a physical article that was
“manufactured” and that the production of information is not covered.
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• 35 U.S.C. § 271(g) does not specify what products will be considered
to have been ‘made by’ the patented process, apparently because
Congress wanted the courts to resolve this critical question of
proximity to the product of the patented process on a case-by-case
basis.
• In Bio-Technology we affirmed the district court’s ruling that a protein
made by a host organism expressing an inserted plasmid was a
product “made by” the patented process for creating the plasmid
itself. Here, unlike the process in Bio-Technology, the patented
process is not used in the actual synthesis of the drug product. We
agree with the district court’s conclusion that “processes of
identification and generation of data are not steps in the manufacture
of a final drug product.” Bayer AG, 169 F. Supp 2d. at 331.
• Thus, the process must be used directly in the manufacture of the
product, and not merely as a predicate process to identify the product
to be manufactured. A drug product, the characteristics of which
were studied using the claimed research processes, therefore, is not
a product “made by” those claimed processes.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Jansen v. Rexall Sundown, Inc.
(342 F.3d 1329 (Fed. Cir. 2003))
• U.S. Patent No. 4,945,083
• Methods of treating or preventing macrocyticmegaloblastic
anemia (aka pernicious anemia)
by administering a combination of folic acid and
vitamin B12 to a human in need thereof
• Claims amended from “treating or preventing
anemia in humans” to “treating or preventing
macrocytic-megaloblastic anemia” and “to a
human in need thereof,” added simultaneously
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• Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir.
2001)
• Preamble is statement of purpose and gives life
and meaning to the claim
• Did not decide whether either phrase alone in the
claim would lead to same conclusion
• Supported by PH-both phrases added
simultaneously to overcome same rejection, so
should be read together
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• “Need” must be recognized and appreciated
• Distinguished use of over-the-counter product
from use of a product prescribed by a doctor
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The Written Description Requirement
– Law, Policy and Practice in Flux
Warren D. Woessner, J.D., Ph.D. Shareholder
Robin A. Chadwick, J.D., Ph.D. Associate
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.

Why the rejection?
• Claim: An isolated nucleic acid
comprising SEQ ID NO:1.
• The specification discloses the
nucleotide sequence for SEQ ID NO:1
and the fact that it is a cDNA that can
hybridize to infectious yeast.
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35 U.S.C. § 112 (2003) (emphasis added)
[1] The specification shall contain a written description
of the invention, and of the manner and process of
making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art
to which it pertains, or with which it is most nearly
connected, to make and use the same, and shall set
forth the best mode contemplated by the inventor of
carrying out his invention.
[2] The specification shall conclude with one or more
claims particularly pointing out and distinctly claiming
the subject matter which the applicant regards as his
invention.
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Early Written Description Cases
• In re Ruschig, 379 F.2d 990 (CCPA 1967)(Rich)
• Section 112(1) as a mechanism for policing priority -- support
required in originally-filed disclosure for later-presented or
amended claims
• Essentially interchangeable with new matter prohibition of 35
USC § 132.
• In re Rasmussen, 650 F2d 1212, 1214 (CCPA 1981)
(Markey)
• “Broadening a claim does not add new matter to the disclosure.
Disclosure is that which is taught, not that which is claimed. An
applicant is entitled to claims as broad as the prior art and his
disclosure will allow.”
• No literal support for the wording of claims is needed.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Univ. Cal. v. Eli Lilly, 119 F.3d
1559 (Fed. Cir. 1997)(Lourie, J.)
• “Precise definition” of protein and nucleotide
sequences required, “such as by structure,
formula, chemical name or physical
properties”…”relevant structural or physical
characteristics.
• Rationale: Tools of biotech are enabling of broad
genus claims to many species of nucleic acids or
proteins.
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Lourie hints - even actual “possession” may
not meet the Written Description Requirement
• “[W]e do not ‘elevate “possession” to the posture of a
statutory test for patentability.’ Rather the opinion refines
the ‘possession’ test for circumstances such as these in
which the inventors showed possession of a species of
the invention by reference to a deposit, but may not have
described what else within the scope of the claims they
had possession of.”
• Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ 1618 (Fed. Cir. 2002)(Lourie, J.,
concurring in denial of rehearing en banc). Judge Lourie, discussing Enzo v. Gen-
Probe, 296 F.3d 1316 (Fed. Cir. 2002)(revised panel opinion).
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Judge Lourie – Why a Strict
Written Description Requirement
• “[P]erceptions that patents are stronger
tempt patent owners to try to assert their
patents beyond the original intentions of the
inventors and their attorney…Claims are
now being asserted to cover what was not
reasonably described in the patent.”
• Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ 1618 (Fed.
Cir. 2002)(Lourie, J., concurring in denial of rehearing en
banc).
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Patent Office was quick to adopt
the Lilly tests
• “Synopsis of Application of Written Description
Requirement Guidelines” is on PTO Website.
• Synopsis essentially quotes Lilly language and
was cited by Judge Lourie in the revised Enzo
panel opinion. (296 F.3d at 1324).
• Original Guidelines are published at 66 Fed.
Reg. 1099 (2001).
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PTO finds WDR guidelines useful to
dispose of “reach-through claims”
• A reach through claim is directed to a molecule or other
substance that could be obtained by use of patentable
subject matter.
• For example: “Receptor agonist” claims – Receptor X is
defined but agonist Y is defined only as binding to receptor
X. No structure for the agonist Y is described.
• Another example: a method of treating disease Z by
administering agonist Y that can bind to receptor X. Again
Y is not defined structurally (only a research tool using
receptor X has been found).
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PTO Position
• Generic claim to “A receptor X agonist” or to “a
receptor X agonist identified by a screening
method” unlikely to meet WDR.
• No description of structure of representative
number of claimed compounds
• No description of chem./phys. characteristics OR
of function of representative number of claimed
compounds (other than binding)
• Lilly cited for assertion that “description of how to
obtain compounds not sufficient without
description of what the compounds are.”
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But Fed. Cir. is not united on WDR:
Moba, B.V. v. Diamond Automation, Inc. (2003)
• Per curiam opinion: Rader, Schall, Bryson
• Written Description Requirement is not a priority issue;
• Affirming DCt’s broad construction of claim to method of processing
eggs, and;
• Upholding jury verdict: claim not invalid under 112, 1 st .
• Rader concurrence:
• Lilly rule defies 30 years of case law and should be abolished by en
banc Federal Circuit opinion.
• Bryson concurrence:
• If a separate WDR exists in §112, 1, why limit it to priority cases?
Perhaps entire Ruschig line of cases was wrong.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Fed. Cir. Commentary
on the Lilly Rule
Judge Rader: “[T]he Lilly rule is not just a mere one-time mistake. It
defies over thirty years of case law. It finds no specific support in
any statutory language. It creates a technology-specific rule in a
technology-neutral statute. It distorts the statute's rules for
adequate disclosure of inventions. It complicates biotechnology
patent drafting to the point of near impossibility and invites
invalidating mistakes. It prices non-corporate inventors out of
some biotechnological invention markets. Last, but not least, it
burdens both trial and appellate courts with unnecessary and
confusing procedures in otherwise simple cases like this one.”
Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1326-27
(Fed. Cir. Apr. 1, 2003) (Rader, J., concurring).
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Fed. Cir. Commentary
on the Lilly Rule
Judge Michel: “More recently, in Enzo Biochem, we clarified
that Eli Lilly did not hold that all functional descriptions of
genetic material necessarily fail as a matter of law to meet the
written description requirement; rather, the requirement may
be satisfied if in the knowledge of the art the disclosed
function is sufficiently correlated to a particular, known
structure. See Enzo Biochem, 296 F.3d at 1324 . . . .” Amgen
Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1332
(Fed. Cir. Jan. 6, 2003) (Michel, J.).
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Fed. Cir. Commentary
on the Lilly Rule
Judge Dyk: “Eli Lilly, in departing from the general rule that an
applicant satisfies the written description requirement by
‘conveying with reasonable clarity to those skilled in the art
that, as of the filing date sought, he or she was in possession
of the invention,’ Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555,
1563-64 (Fed. Cir. 1991), and imposing a unique written
description requirement in the field of biotechnology, is open
to serious question.” Enzo Biochem, Inc. v. Gen-Probe, Inc.,
285 F.3d 1013, 1024 (Fed. Cir. Apr. 2, 2002) (Dyk, J.,
dissenting), vacated on reh’g, 296 F.3d 1316 (Fed. Cir. July
15, 2002).
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Federal Circuit Views on WDR
E x p a n s ive A p plic atio n o f W D R : L im it W D R to P r io r ity :
L o urie (L illy, G entry, Enzo I, II & den reh’g) Rader (Enzo den reh’g,
M o ba concur)
Newman (Enzo den reh’g)
B ryso n (Lilly, Moba concur, C o rd is) L in n (Enzo den reh’g)
C lev eng er (Amgen dissent) G ajarsa
Questions/Limits Lilly to its facts
M ic he l (Am gen)
D yk (Enzo I dissent; Enzo den reh’g)
Undeclared:
M ayer?
Prost?
Schall?
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Varying Perspectives
Enablement
Best Mode
Written Description of the
Invention (a la Ruschig)
Claim Definiteness
Claim Interpretation
Person skilled in the art
Person skilled in the art
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
Contemplated by the inventor
Does specification reasonably
convey to person skilled in the art
that inventor possessed laterclaimed
invention as of filing date?
Customary and ordinary meaning
to person skilled in the art (unless
applicant was own lexicographer)
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Is The Lilly Prong of WDR Distinguishable
from § 112, 2 Claim Indefiniteness?
• All Dental Prodx, LLC v. Advantage Dental Prods, Inc., 309 F.3d 774, 779 (Fed. Cir. Oct. 25,
2002) (Newman/Freidman/Lourie) (“While the contested language [claim limitation] is not a
model of clarity, it is also fairly simple and intelligible, capable of being understood in the
context of the patent specification. It is thus reasonably clear what the invention is and that
the patent specification conveys that meaning. . . . It is also clear what the invention is not.”)
• Enzo Biochem, Inc. v. Gen-Probe Inc., 2002 U.S. App. LEXIS 14412 (Fed. Cir. July 15,
2002) (Lourie, J., concurring in denial of reh’g en banc) (“It is incorrect that the mere
appearance of vague claim language in an original claim or as part of the specification
necessarily satisfies the written description requirement or shows possession of a generic
invention.”)
• Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316, 1328 (Fed. Cir. July 15, 2002)
(revised panel opinion) (Lourie, Dyk, Prost) (“Even if a claim is supported by the
specification, the language of the specification, to the extent possible, must describe the
claimed invention so that one skilled in the art can recognize what is claimed. The
appearance of mere indistinct words in a specification or a claim, even an original claim,
does not necessarily satisfy that requirement.”).
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Contrasting Recent Appeals from
WDR Jury Verdicts
Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, *33 (Fed. Cir. July 10, 2003) (sustaining jury
verdict of WDR validity) (Mayer/Michel/Dyk):
An expert witness for Abbott testified that in his opinion the claims of both patents were properly fully
supported. (Tr. at II-156-57.) That testimony, while brief, did provide substantial evidence supporting
the jury verdict. See Union Oil Co. v. Atl. Richfield Co., 208 F.3d 989, 999 (Fed. Cir. 2000).
PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1248 (Fed. Cir. Sept. 4, 2002) (reversing jury verdict
that had upheld WDR validity) (Mayer, Lourie, Linn):
[N]othing in the specification indicates that the invention is anything other than a mixture of two
chemicals. [Patentee] added claim 33 to its pending patent application to encompass separate
applications of the ingredients . . . . The specification describes only three methods . . .: application of
a substituted napthlene alone . . ., application of CIPC alone . . ., and application of a mixture of both
chemicals. None of these methods is the same as the spaced, sequential application of the two
chemicals . . . . New claim 33 is directed to new subject matter, and we hold that no reasonable juror
could conclude otherwise. We therefore reverse the judgment that claim 33 satisfies the written
description requirement . . . .
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Amgen, Inc. v. Hoechst Marion Roussel,
Inc. 314 F3d 1313, -1218 (Fed. Cir. 2003)
• “EPO Wars”
• Appeal of District Court decision mostly
favorable to Amgen (57 USPQ2d 1449).
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• Lin (U.S.Pat. No. 5,955,422): Claim 1
• A pharmaceutical composition comprising a
therapeutically effective amount of human [EPO]
and a pharmaceutically acceptable diluent,
adjuvant or carrier, wherein said [EPO] is purified
from mammalian cells grown in culture.
• Hoechst: Claim fails to meet WDR:
• 1. Only two kinds of mammalian cells exemplified -
not enough (citing UC v. Lilly)
• 2. Cells transformed only with exogenous DNA, so
process limitation should be narrowed.
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• District Court disagreed
• Federal Circuit (Judge Michel writing)
agreed with district court:
• 1. Two cell types are enough to support “mammalian
cells” or “vertebrate cells.”
• 2. Although Amgen only disclosed one way to transform
the mammalian cells, panel held:
• “We cannot invalidate a patent for failure to describe a method
of producing the claimed compositions that is not itself
claimed.”
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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• Estoppel did not narrow the claim
• 3. Amgen had said that the invention is “uniquely
characterized” by one type of DNA expression,
AND process steps are an element of the claim.
• 4. CONCLUDE: The process steps of a productby-process
claim are not the best point from which
to launch a WDR attack
• Suggested by UC v. Lilly
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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BIOGEN v. BERLEX LABORATORIES, INC.
318 F3d 1132 (Fed. Cir. January 31, 2003)
• Berlex asserted infringment of U.S. Pat No. 5,376,567:
• Claim 42. Method to produce IF in CHO cell
• Claim 66. Transformed cell
• Claim 70. Method of making IF by growing cell transformed by IF
gene and marker gene
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• Biogen got summary judgment of
noninfringement from district court.
• Berlex appealed.
• Claims 42 and 66
•No method limitations
• Claim 70
•Does not mention linked co-transformation
•Specification has general language that
other methods were known
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• Biogen argues
• Broad reading of claims is not supported by the
specification, and that Berlex’s interpretation would
render claims invalid for lack of adequate written
description.
• Judge Newman (writing for the panel) agreed
with Biogen.
• This limited the “product-by-process” element
of the method claim 70 to linked cotransformation.
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• The panel cited Modine Mfg Co. v ITC, 75
F3d 1545 (Fed. Cir. 1996)
• (“when the preferred embodiment is described in
the specification as the invention itself, the claims
are not necessarily entitled to a scope broader
than that embodiment.”) BUT was Amgen’s
description of the transformation with exogenous
DNA any less the “invention itself”?
• Patentee’s ability to keep a preferred
embodiment out of a claim seems to depend
on the panel
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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“Essential Element” Test for WDR
Debunked by Gentry Author
Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc., 291 F.3d 1317, 1323 (Fed. Cir. May 2002) (Mayer/Lourie/Schall)
(emphasis added):
We are not persuaded by Kvaerner's arguments, relying on Gentry, that it is essential to the invention for the workover
port to enter the assembly "between the two plugs" and that claims reciting a location other than "between the two
plugs" are therefore invalid for inadequate description. In Gentry, the original disclosure identified the console of a
sectional sofa as the only possible location for the controls. 134 F.3d at 1479, 45 USPQ2d at 1503. We held that the
asserted claims were invalid because the location of the recliner controls in the claims was not limited to the console.
134 F.3d at 1479-80, 45 USPQ2d at 1503-04. In reaching that conclusion, we stated: "It is clear that [the inventor]
considered the location of the recliner controls on the console to be an essential element of his invention. Accordingly,
his original disclosure serves to limit the permissible breadth of his after-drafted claims." Id. In so stating, we did not
announce a new "essential element" test mandating an inquiry into what an inventor considers to be essential to his
invention and requiring that the claims incorporate those elements. Use of particular language explaining a decision
does not necessarily create a new legal test. Rather, in Gentry, we applied and merely expounded upon the
unremarkable proposition that broad claim is invalid when the entirety of the specification clearly indicates that the
invention is of a much narrower scope. Id. ("Claims may be no broader than the supporting disclosure."). There was no
description or support whatever in the Gentry patent of the controls being other than on the console. In contrast, in this
case, Cooper's claims to the location of the workover port in the '119 patent are supported by the figures showing that
the workover port is in fact above the tubing hanger and below the BOP bore. See, e.g., '119 patent, Figure 7.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Competent Expert Testimony on
WDR Can Save the Day
ICN Photonics, Ltd. v. Cynosure, Inc., 2003 U.S. App. LEXIS 14512, *14-*15 (Fed. Cir. July 16, 2003) (non-precedential)
(reversing summary judgment of WDR invalidity) (Lourie/Linn/Prost):
“Unlike the inadequate expert testimony in New Railhead Mfg. v. Vermeer Mfg., 298 F.3d 1290, 1295-96 (Fed. Cir. 2002),
which was entirely subjective and erroneously conflated the written description requirement with the enablement
requirement, Rapaport's affidavit properly focused on the written description issue and testified as to what an objective
dermatologist would understand from reading the '900 patent application when it was filed in 1997. Furthermore, unlike
the inadequate expert testimony in Lockwood, 107 F.3d at 1572, which opined as to what were obvious variants of the
disclosure, Rapaport's opinion is confined to what the '900 patent actually teaches. Finally, unlike the inadequate expert
testimony in Augustine, 181 F.3d at 1303, which was not anchored to any application language pertaining to the
limitations at issue, Rapaport cited specific passages in the '900 specification and explained that a dermatologist in 1997
would have interpreted them to mean that coagulation does not occur. That is sufficient to create a genuine issue of
material fact. Further probing of his basis for the opinion is, again, a topic for later exploration as the case proceeds.”
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Competent Expert Testimony on
WDR Can Save the Day
Abbott Labs. v. Syntron Bioresearch, Inc., 334
F.3d 1343 (Fed. Cir. July 10, 2003) (sustaining
jury verdict of WDR validity) (Mayer/Michel/Dyk)
“An expert witness for Abbott testified that in his
opinion the claims of both patents were properly
fully supported. (Tr. at II-156-57.) That
testimony, while brief, did provide substantial
evidence supporting the jury verdict. See Union
Oil Co. v. Atl. Richfield Co., 208 F.3d 989, 999
(Fed. Cir. 2000).”
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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A non-enablement rejection is also better
than a WDR rejection at the PTO
• If applicant can argue Wands factors, there is a
lot to work with – state of the art; examples;
overall guidance in specification, etc.
• But if you get a WDR rejection, it may be very
difficult to show what the Examiner says is
missing is really there.
• Unless rejection is based on missing material
that is well known in the art.
• Can use declarations, including expert
declarations, in prosecution as well. See In re
Alton, 76 F3d 1168 (Fed. Cir. 1996)
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Prosecution in View of the PTO
WDR Guidelines
• “Make It Or Fake It”
• The Three-pronged test for adequate written description
is actually two-pronged.
1. Actual reduction to practice
2. Detailed drawings or complete structure
3. Distinguishing disclosed identifying characteristics
Partial structure
Physical and/or Chem. Properties
Functional characteristics
Correlation between structure and function
Method-of-making
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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1. Actual Reduction to Practice
• Shown by structure – The embodiment that
meets all the limitations of the claim:
PhC=CHCONHMe
OR
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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Shown by Properties
• “Sufficient Relevant Identifying
Characteristics”
• Have “functional properties” or “correlation
between structure and function” ever
worked per se? (except for Ab fiction)
• How about actual method of making?
• You still have to have it.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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U. S. Pat. No. 5843462
• A vaccine comprising an immunogenic amount
of at least one diphtheria toxin specific peptide
containing an immunodominant region
sequence, where the peptide is combined with a
physiologically acceptable vehicle, which
amount is effect to immunize a susceptible
mammal against Corynebacterium diphtheria,
wherein the peptide has at least 7 and at most
40 amino acid residues.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
48

2. “Detailed Drawings”
• Also = Structure in Chem/Biotech Claims
• (X)(Y)ArC=C(R1)CON(R2)(R3)
• But does not require actual possession of
all the claimed species.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
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A Tale of Two Applications
• 10/1234: Inventor isolates novel substance from
blood. It completely inhibits cancer cell growth.
Files before any physical or chemical
characterization (beyond slimy goop).
• 10/1235: Inventor computer-generates a new
genus of anti-bacterials from a single known
compound. Structures completely defined, no
compounds made or tested.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
50

Q: Who gets the patent?
• Inventor who cures cancer might get
product-by-process claim, and method of
treatment claim with process limitations
• Computational chemist has no legal
barriers to a very broad generic claim to
prophetic genus of compounds, and to
method of use
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
51

”The absence of definitions or details for wellestablished
terms or procedures should not be
the basis for a rejection for lack of written
description”
• Surfactants in a paint remover
• Known DNA sequence encoding interferon in a plant
• Use declarations to establish level of skill in the art
and that elements of the invention were well-known
prior to your filing date, or just send in references
with the response.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
52

Work hard to genericize biological
species
• Subunits of sequences
• % Sequence Identity
• Hybridizing sequences
• Specified variants
• Specified derivatives
• PLUS FUNCTION (acceptable limit of
bioactivity and how to measure it)
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
53

Conclusions/Comments
• WDR of §112, 1 in flux
• Movement to limit/abolish Lilly rule
• Gentry limited to its facts
• Implications for PTO WDR examination
guidelines
• Test cases
• Heightened Supreme Court interest in
intra-Federal Circuit splits
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
54

Significant Federal Circuit WDR Cases 2002-2003
Cordis Corp. v. Medtronic
AVE, Inc., 2003 U.S. App.
LEXIS 16521 (Fed. Cir. Aug.
2003)
Moba, B.V. v. Diamond
Automation, Inc., 325 F.3d
1306 (Fed. Cir. Apr. 2003)
PIN/NIP, Inc. v. Platte Chem.
Co., 304 F.3d 1235 (Fed. Cir.
Sept. 2002)
Abbott Labs. v. Syntron
Bioresearch, Inc., 334 F.3d
1343 (Fed. Cir. July 2003)
Amgen, Inc. v. Hoechst
Marion Roussel, Inc., 314
F.3d 1313 (Fed. Cir. Jan.
2003)
Enzo Biochem, Inc. v. Gen-
Probe Inc., 296 F.3d 1316
(Fed. Cir. July 2002) (revised
panel opinion); 2002 U.S.
Ap. LEXIS 14412 (Fed. Cir.
July 2002) (denying
rehearing en banc)
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
ICN Photonics, Ltd. v.
Cynosure, Inc., 2003 U.S.
App. LEXIS 14512 (Fed. Cir.
July 2003) (nonprecedential)
All Dental Prodx,LLC v.
Advantage Dental Prods.,
Inc., 309 F.3d 774 (Fed. Cir.
Oct. 2002)
Cooper Cameron Corp. v.
Kvaerner Oilfield Prods., Inc.,
291 F.3d 1317 (Fed. Cir. May
2002)
55

Recent WDR Scholarship Cited by the Federal Circuit
Chambers, Scott A., "Written Description" and Patent Examination Under the U.S. Patent and Trademark Office Guidelines, IP Litigator, Sept.-Oct. 2000, at 9, 10
("Thus, the Federal Circuit's present interpretation of the written description requirement maintains the vitality of the U.S. patent system and provides
disclosures that others can build on. By suggesting that disclosure of the structure or actual sequence of complex chemical entities may sometimes be
required, the Federal Circuit may have advanced the goal of the patent system to actually put the claimed invention into the hands of the public.");
"Conflicts in Federal Circuit Patent Law Decisions," The Federal Circuit Bar Journal, Vol. 11, no. 3, p. 723, chronicles this circuit's primary conflicts. Listed first as the
leading conflict is "I. The Written Description Requirement of § 112, First Paragraph." Id. at 725-34. The article notes: "The Federal Circuit has not provided
clear and consistent rules for determining precisely what type of disclosure is sufficient to comply with the § 112 written description requirement." Id. at 725.
Janis, Mark D., "On Courts Herding Cats: Contending with the 'Written Description' Requirement (and Other Unruly Patent Disclosure Doctrines)" 2 Wash. U. J. L. &
Pol'y 55, 60, 70, 83 (2000) (“Today, however the written description requirement enjoys a prominence wholly out of proportion to its humble origins.. . . Recent
efforts to elaborate the 'possession' standard both confirm the substantial redundancy of the enablement and written description requirements . . . .The written
description requirement is a threat to the coherence of disclosure doctrines . . . .)
Mueller, Janice M., "The Evolving Application of the Written Description Requirement to Biotechnological Inventions" 13 Berkeley Tech. L.J. 615, 617 (Spring 1998)
("The Lilly decision establishes uniquely rigorous rules for the description of biotechnological subject matter that significantly contort written description
doctrine away from its historic origins and policy grounding. The Lilly court elevates written description to an effective 'super enablement' standard . . ..").
Rai, Arti, "Intellectual Property Rights in Biotechnology: Addressing New Technology" 34 Wake Forest L. Rev. 827, 834-35 (Fall, 1999) ("Thus in [ Lilly ] . . . the
CAFC broke new ground by applying the written description requirement not only to later-filed claims but also to claims filed in the original patent. . . . The Lilly
court used the written description requirement as a type of elevated enablement requirement.");
Sampson, Margaret, The Evolution of the Enablement and Written Description Requirements under 35 U.S.C. § 112 in the Area of Biotechnology, 15 Berkeley Tech.
L. J. 1233, 1260-61 (2000) ("Without a heightened written description requirement, inventors could receive patent rights to sequences of which they have no
knowledge, in organisms with which they have never worked. . . . Therefore, the Federal Circuit's approach to the written description requirement in the area of
biotechnology has prevented nucleotide sequence claims from becoming a Pandora's box that the patent law is unable to control.").
Wegner, Harold C., "An Enzo White Paper: A New Judicial Standard for a Biotechnology 'Written Description' Under 35 U.S.C. § 112, P 1" 1 J. Marshall Rev. Intell.
Prop. L. 254, 263 (2002) (recognizing "there may very well be problems with the scope of enablement in the facts of the Enzo case," but written description
would not apply to "original claims.").
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
56

…And our thanks to:
Prof. Janice Mueller
John Marshall Law School
315 S. Plymouth Court
Chicago, IL 60607
Tel. 312/427-2737 x531
Email: 7mueller@jmls.edu
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
57

Written Description Requirement:
An International View
Ann S. Viksnins, B.A., M.S., J.D.
Shareholder
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.

Introduction
• Six countries/regions will be compared to
the U.S. Written Description Requirement
• European Patent Office, Japan, Mexico,
Canada, Australia, South Korea
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
59

Issues
1) How must the invention be described in
the specification?
2) In what field does a fictional third party
inventor practice?
3) Scope of description?
4) Best Mode Requirement?
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
60

1. Description of invention in the
specification
• US and CA – full, clear, concise and exact in its
terms
• KR –stated in such a manner as to enable
persons to ‘easily’ carry out the invention
• EP, JP and MX – sufficiently clear and complete.
• AU – described fully; it must be clear and
intelligible.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
61

2. In what field does a fictional third
party inventor practice?
• EP, MX, AU and KR – person of skill in the
field of which the invention pertains
• CA and US – the person of ordinary skill
may have that skill in a field that is closely
connected to that of the invention, but need
not be in that exact field.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
62

3. Scope of description
• JP, EP and KR – the invention be able to be
carried out
• CA – be able to be made, constructed,
compounded or used
• US – be made or used
• MX – be able to be made
• AU – be able to be performed
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
63

4. Best Mode Requirement?
• EP, JP and KR – no best mode requirement
• CA – no best mode requirement, but does
require that the use as contemplated by the
inventor be disclosed
• US – best mode as contemplated by the inventor
is required
• AU – best mode as known by the inventor is
required
• MX – best mode must be disclosed where such
best mode is not clear from the description itself.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
64

Specific Country Laws
• United States
• Australia
• Canada
• European Patent Office
• Japan
• Mexico
• South Korea
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
65

United States (US)
• 35 USC 112
• The specification shall contain a written
description of the invention, and of the
manner and process of making and using it, in
such full, clear, concise, and exact terms as to
enable any person skilled in the art to which it
pertains, or with which it is most nearly
connected, to make and use the same, and
shall set forth the best mode contemplated by
the inventor of carrying out his invention.
66
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.

Australia (AU)
• Patents Act 1990, Section 40(2)(a)
• (a) describe the invention fully, including the best method known
to the applicant of performing the invention;
• Section 40(2)(a) is discussed at further length in the Australian
Patent Office Manual of Practice and Procedure, Volume 2, Part
10.
• Historically the expression used by the Australian courts has
been a requirement for sufficiency as discussed in Universal Oil
Products v. Monsanto, (1973) 46 ALJR 658, stating that “The
specification is sufficient if the patentee makes the nature of his
invention, and how to perform it, clear and intelligible to
personas having a reasonably competent knowledge of what
was known before on the subject to which the patent relates, and
having reasonable competent skill in the practical mode of doing
what was then known.”
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
67

Canada (CA)
• Patent Act Section 27(3)
• (3) The specification of an invention must
• (a) correctly and fully describe the invention and its
operation or use as contemplated by the inventor;
• (b) set out clearly the various steps in a process, or
the method of constructing, making, compounding or
using a machine, manufacture or composition of
matter, in such full, clear, concise and exact terms as
to enable any person skilled in the art or science to
which it pertains, or with which it is most closely
connected, to make, construct, compound or use it
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
68

European Patent Office (EP)
• European Patent Convention Article 83
• The European patent application must
disclose the invention in a manner
sufficiently clear and complete for it to be
carried out by a person skilled in the art.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
69

Japan (JP)
• Patent Law Section 36(4)
• (4) The detailed explanation of the invention under
the preceding Subsection (iii) shall state the invention,
as provided for in an ordinance of the Ministry of
Economy, Trade and Industry, in a manner sufficiently
clear and complete for the invention to be carried out
by a person having ordinary skill in the art to which
the invention pertains.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
70

Mexico (MX)
• Industrial Property Law, Article 47
• Art. 47. The patent application shall be accompanied by:
• I. a description of the invention, which shall be
sufficiently clear and complete to be fully understood and
where appropriate to serve as a guide for a person with
average skill in the art to make it; it shall also mention
the best method known to the applicant of carrying out
the invention when this is not clear from the description
thereof.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
71

South Korea (KR)
• Article 42(3)
• (3) The detailed description of the invention
under paragraph (2)(iii) shall state the
purpose, construction, and effect of the
invention in such a manner that it may easily
be carried out by a person having ordinary
skill in the art to which the invention pertains.
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.
72

Thank You!
If you have further questions or would like more
information about the firm, please contact Catherine
Klima at 612-359-3276 or cklima@slwk.com
©2003 Schwegman, Lundberg, Woessner & Kluth, P.A.