ENABLEMENT / WRITTEN
DESCRIPTION PATENT
PROSECUTION PRACTICE
Presented at: Webb & Co.
Rehovot, Israel
Date: February 21, 2013
Presented by: Roy D. Gross
Associate
St. Onge Steward Johnston & Reens LLC
Stamford, Connecticut, U.S.
rgross@ssjr.com
35 U.S.C. § 112, First Paragraph
• 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…
• Note: the written description requirement and the enablement
requirement are separate requirements. Vas-Cath, Inc. v. Mahurkar,
935 F.2d 1555 (Fed. Cir. 1991)
Written Description Requirement
• is an inquiry/analysis of whether the applicant was in
possession of the invention he/she seeks to patent.
• “[T]he description must ‘clearly allow persons of ordinary skill in
the art to recognize that [the inventor] invented what is claimed.’”
Ariad Pharm v. Eli Lilly, 2010 WL 1007369, *13-14 (Fed. Cir. 2010,
citing Vas Cath, 935 F.2d at 1563) (emphasis added). MPEP
§2163
• ensures that the inventor had possession, as of the filing date
of the application, of the specific subject matter claimed.
• “The test for sufficiency is whether the disclosure of the application
relied upon reasonably coveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the
filing date.” Ariad, at, *14 (emphasis added). “[I]t is the
specification itself that must demonstrate possession.” Id., at *14.
Written Description Requirement
(continued)
Key Points to Remember
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Written Description Requirement is a Question of Fact.
Requires possession of the claimed subject matter as of the filing date.
Specification itself must demonstrate possession.
Determining whether a patent complies with the written description
requirement will necessarily vary depending on the context.
Why is there a Written Description Requirement?
• Ensures that the scope of the right to exclude, as set forth in the
claims, does not overreach the scope of the inventor’s contribution to
the field of art as described in the patent specification.
• Ensures that the public receives a meaningful disclosure in exchange
for being excluded from practicing an invention for a period of time.
Possession of Subject Matter for Claims
Drawn to a Single Embodiment or Species
• Possession is shown by describing the invention, with all its
claimed limitations. Possession may be shown by:
• Description of an actual reduction to practice.
• Showing that the invention was “ready for patenting” such as by
the disclosure of drawings or structural chemical formulas that
show that the invention was complete.
• Describing distinguishing identifying characteristics sufficient to
show that the applicant was in possession of the claimed
invention.
• Note: Applicant does not have to describe exactly the subject
matter claimed in the specification.
Typical Disclosure to Satisfy Written
Description Requirement
The Written Description Requirement is typically satisfied by the
disclosure of such descriptive means as:
• Formulas
• Words
• Structures
• Figures
• Diagrams
• Functional characteristics when coupled with a known or disclosed
correlation between function and structure that fully set forth the claimed
invention
Possession of Subject Matter for Genus
Claims
General Rule:
• Disclosure of a single species may be sufficient written
description to support for a later claimed genus (generic claim)
including that species. Bilstad v. Wakalopulos, 386 F.3d 1116,
1124 (Fed. Cir. 2004).
Exception:
• In applications directed to inventions in arts where the results
are unpredictable, the disclosure of a single species usually
does not provide an adequate basis to support generic claims.
In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938).
If the art is unpredictable, then disclosure of more species is
necessary to adequately show possession of the entire genus.
Unpredictable Arts
• Unpredictable Arts include arts which involve the chemical industry,
the experimental sciences, and other such arts where the results
are not easily predictable. In re Fisher, 427 F.2d 833, 839, (CCPA
1970) (contrasting mechanical and electrical elements with chemical
reactions and physiological activity). MPEP § 2164.03.
• The pharmaceutical industry is the prototypical example of a highly
unpredictable field. Pfizer v. Teva Pharm., 482 F.Supp.2d 390, 413
(D.N.J. 2007); 2 Chisum on Patents § 5.04.
Genus Claims in the Unpredictable Arts
• Need adequate description of species – general detail of genus may
not be adequate.
• “Merely drawing a fence around the outer limits of a purported genus is
not an adequate substitute for describing a variety of materials
constituting the genus and showing that one has invented a genus and
not a species.” Ariad, at *13.
• Must show sufficient species to support genus.
• “The specification must demonstrate that the applicant has made a
generic invention that achieves the claimed result, and do so by
showing that the applicant has invented species sufficient to support a
claim to the functionally-defined genus.” Ariad, at *12.
Ariad Pharm v. Eli Lilly, 598 F.3d 1336,
1341 (Fed. Cir. 2010) (en banc)
Exemplary Asserted Claim (rewritten to include claims from which it depends)
• 80. [A method for modifying effects of external influences on a eukaryotic
cell, which external influences induce NF-κB-mediated intracellular
signaling, the method comprising altering NF-κB activity in the cells such
that NF-κB-mediated effects of external influences are modified, wherein
NF-κB activity in the cell is reduced] wherein reducing NF-κB activity
comprises reducing binding of NF-κB to NF-κB recognition sites on genes
which are transcriptionally regulated by NF-κB.
• Inventors were the first to identify NF-κB and to uncover the mechanism by
which NF-κB activates gene expression underlying the body’s immune
responses to infection.
• The Federal Circuit found that the claims are genus claims, encompassing
the use of all substances that achieve the desired result of reducing the
binding of NF-κB to NF-κB recognition sites
Ariad (continued)
Holding
• The Federal Circuit held that Ariad’s broad claims were invalid for
lack of written description. Although the claims covered all methods
of inhibiting NF-κB regulation, the specification only used broad
functional language to disclose only hypothetical methods. In other
words, Ariad’s patent described a problem—not a solution.
Teaching
• The decision in Ariad v. Lilly encourages practitioners to carefully
consider the support for broad genus claims when drafting the
specification. Depending on the technology involved and the
breadth of the claims sought, more detail may be necessary to show
sufficient possession to satisfy the written description requirement.
Prosecution Tips for Satisfying the Written
Description Requirement
Suggestions
• Provide as many figures and examples in specification as possible. Show
that the inventor ‘invented’ the claimed subject matter.
• Add tables of data for various ranges in the specification so that data points
in the upper, middle and lower limits of the ranges are shown.
• When claiming a genus, show a “representative number of species” in the
specification. Provide adequate details of species that are representative of
the entire genus. When there is substantial variation within the genus,
describe a sufficient variety of species to reflect the variation.
• Claim both genus and species. Claim species in dependent claims.
• Do not claim results in claims, claim the structure. If art is unpredictable,
add additional detail and examples.
Enablement Requirement
• is an inquiry/analysis of whether the specification teaches how
to make and use the claimed invention.
• To be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the
claimed invention without ‘undue experimentation.’” Alza Corp. v.
Andrx Pharma, LLC, 2010 WL 1644060 (Fed. Cir. April 26,
2010)(Emphasis Added).
Key Points to Remember
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Enablement is a Question of Law.
Determined as of the effective filing date of the application;
Must be enabling to persons of skill in the art.
Full Scope of Claim must be enabled.
Scope of the Claims ≤ Scope of the
Enablement
• “The scope of the claims must be less than or equal to the
scope of the enablement. The scope of enablement, in turn, is
that which is disclosed in the specification plus the scope of
what would be known to one of ordinary skill in the art
without undue experimentation.” Nat’l Recovery Techs. V.
Magnetic, 166 F.3d 1190, 1195-1196 (Fed. Cir. 1999).
• A patent need not teach, and preferably omits, what is well known
in the art. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331,
1332 (Fed. Cir. 1991);
• “The specification must teach those of skill in the art how to make and
how to use the invention as broadly as it is claimed.” In re Goodman,
11 F.3d 1046, 1049 (Fed. Cir. 1993) (Emphasis Added)
Wands Factors -> determining whether
experimentation is “undue”
• The claimed invention must be enabled so that any person skilled in
the art can make and use the invention without undue experimentation.
In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988)
• Wands Factors:
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(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention
based on the content of the disclosure.
• Claim construction is important in determining whether experimentation
is undue!
Predictability in the Art
• The amount of guidance or direction needed to enable the invention is
inversely related to the amount of knowledge in the state of the art as
well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166
USPQ 18, 24 (CCPA 1970).
• Even in unpredictable arts, a disclosure of every operable species is
not required.
• A single embodiment may provide broad enablement in cases involving
predictable factors, such as mechanical or electrical elements. In re
Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944).
Full Scope of Claims must be Enabled
• Plant Genetic Sys. v. Dekalb Genetics Corp., 315 F.3d 1335
(Fed. Cir. 2003)
• Claims at issue were directed to a “plant cell” integrating DNA into
its genome. The specification of the patent in Plant Genetic only
taught integrating DNA stably into dicot plants. The alleged
infringing product made and sold by defendants, however, was a
monocot plant. It was disputed whether the claims directed to a
“plant cell” were enabled for monocots, and what kind plant cells
were covered by the claims.
• The Plant Genetic Court found that the claims were directed to
both monocot and dicot plants. The Court held that these
claims were invalid for lack of enablement because practicing
stable gene transformation for monocot cells in 1987 required
undue experimentation, as the specification did not show or
teach one of skill in the art how to do this.
Full Scope of Claims must be Enabled
• In re Vaeck, 947 F.2d 448 (Fed. Cir. 1991) (claims directed to
cyanobacteria where only one species of cyanobacteria was
employed in the working examples of specification. The Court
took into account the relatively incomplete understanding of
biology of cyanobacteria, and upheld the PTO’s enablement
rejection to the broad claims).
• Libel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371 (Fed. Cir.
2007) (claims directed to a method of loading a tubular
replacement syringe with and without a pressure jacket. The
Court held that the claims were invalid because the specification
only taught the embodiment without the pressure jacket).
Full Scope of Claims must be Enabled
• AK Steel v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) (claims
directed to a ferrous base ferritic strip made from both Type 1
and Type 2 aluminum. The Court held that that since the
specification only taught Type 2 aluminum, the claims were not
enabled);
• Monsanto Co. v. Syngenta Seeds, 503 F.3d 1352 (Fed. Cir.
2007) (claims directed to a chimeric plant gene. The Court held
that the patent claims extended to the cells of all flowering
plants and the patent was filed before transformation of
monocot cells was possible. Therefore, those skilled in the art
could not determine whether the plant gene could carry out the
claimed functions and the full scope of the claims were not
enabled);
Enablement Tips
• Suggestions
• Cleary define claim terms, so as to support the interpretation in the
specification that you desire. Applicants can be their own
lexicographer.
• Provide as many figures and examples in specification as possible.
Add tables of data for various ranges in the specification so that data
points in the upper, middle and lower limits of the ranges are shown.
• When claiming a genus, show a “representative number of species” in
the specification. Provide adequate details of species that are
representative of the entire genus. When there is substantial variation
within the genus, describe a sufficient variety of species to reflect the
variation.
• Claim both genus and species. Claim species in dependent claims.
• Do not claim results in claims, claim the structure.
Enablement Example - U.S. Patent
6,598,603
(EEFD Dec. 31, 1997)
•
Exemplary Claim 1
• A method of treating a patient suffering from a respiratory disease, the
method comprising administering to the patient a nebulized dose of a
budesonide composition in a continuing regimen at a frequency of not
more than once per day.
• Key term: budesonide composition
• Specification discloses examples of a budesonide suspension. The
specification does not disclose a budesonide solution.
• Question: Is the full scope Claim 1 enabled?
Prior Art Enablement
• An anticipating reference must be enabled.
• An anticipating reference must enable the claimed invention.
Impax Labs, Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314
(Fed. Cir. 2008). Under 35 U.S.C. § 102, “[a]n ‘anticipating’
reference must describe all of the elements and limitations of the
claim in a single reference, and enable one of skill in the field of
the invention to make and use the claimed invention.” Merck &
Co., Inc. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1372 (Fed.
Cir. 2003) (citations omitted).
• For prior art to enable the claimed invention, the description of the prior
art must be such that “a person of ordinary skill in the field of the
invention can practice the subject matter based on the reference,
without undue experimentation.” Sanofi-Synthelabo v. Apotex, Inc.,
550 F.3d 1075, 1082 (Fed. Cir. 2008).
Prior Art Enablement
• Prior Art Enablement is similar to enablement under § 112, but
no utility requirement.
• A reference need not demonstrate utility or efficacy to be enabling
in the context of § 102. In re Gleave, 560 F.3d 1331, 1335–36
(Fed. Cir. 2009). No “actual creation or reduction to practice” is
required for enablement of a prior art reference. In re Gleave, 560
F.3d at 1134.
• Further, “[i]t is not, however, necessary that an invention disclosed
in a publication shall have actually been made in order to satisfy
the enablement requirement.” In re Donohue, 766 F.2d 531, 533
(Fed. Cir. 1985).
• Patents are presumed to be enabled because they are presumed
valid. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d
1313, 1354-1355 (Fed. Cir. 2003) (holding that “a presumption
arises that both the claimed and unclaimed disclosures in a prior
art patent are enabled.”)
Prior Art Enablement Example (U.S. Patent
No. 6,598,603)
Exemplary Claim 1
• A method of treating a patient suffering from a respiratory disease, the
method comprising administering to the patient a nebulized dose of a
budesonide composition in a continuing regimen at a frequency of not
more than once per day.
• Key term: budesonide composition
• Specification discloses examples of a budesonide suspension.
Specification states that:
• The therapeutic suspensions can also contain one or more excipients.
Excipients are well known in the art and include buffers (e.g., citrate buffer,
phosphate buffer, acetate buffer and bicarbonate buffer), amino acids,
urea, alcohols, ascorbic acid, phospholipids, proteins (e.g., serum
albumin), EDTA, sodium chloride, liposomes, mannitol, sorbitol, and
glycerol. Solutions or suspensions can be encapsulated in liposomes or
biodegradable microspheres.
Real Life Enablement Example (U.S.
Patent No. 6,598,603)
• Prior art (U.S. Patent No. 5,192,528) discloses a suspension of
budesonide composition that discloses budesonide suspended in a
liposome.
• Prior art discloses method of making a liposome suspension of
beclomethasone and lists budesonide as an exemplary corticosteroids
taught by the patent.
• Patentee argues that prior art is not fully enabled because budesonide
suspension not explicitly taught.
• Question: Is the prior art ‘528 reference enabled?
The End