Enablement and Written
Description
Prof. Robert Merges
1.29.08
Disclosure/Enablement, § 112
¶ 1 Written Description of Claimed Invention
¶ 1 Enablement of one skilled in the art
without undue experimentation of:
• how to make
• how to use
¶ 1 Best Mode contemplated by inventor
¶ 2,6 Claims - definiteness
Disclosure/Enablement, § 112
U.S.C. § 112: ¶ 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.
U.S.C. § 112: ¶ 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.
U.S.C. § 112: ¶ 3
A claim may be written in independent or, if
the nature of the case admits, in dependent
or multiple dependent form.
U.S.C. § 112: ¶ 4
Subject to the following paragraph, a claim in
dependent form shall contain a reference to a claim
previously set forth and then specify a further
limitation of the subject matter claimed. A claim in
dependent form shall be construed to incorporate
by reference all the limitations of the claim to which
it refers.
U.S.C. § 112: ¶ 5
A claim in multiple dependent form shall contain a
reference, in the alternative only, to more than one
claim previously set forth and then specify a further
limitation of the subject matter claimed. A multiple
dependent claim shall not serve as a basis for any
other multiple dependent claim. A multiple claim
shall be construed to incorporate by reference all the
limitations of the particular claim in relation to
which it is being considered.
U.S.C. § 112: ¶ 6
An element in a claim for a combination may be
expressed as a means or step for performing a specified
function without the recital of structure, material, or
acts in support thereof, and such claim shall be
construed to cover the corresponding structure,
material, or acts described in the specification and
equivalents thereof.
Updating Incandescent Lamp
• Federal Circuit:
– Enablement is an issue of fact
• Standard has not changed
Patents are required to "teach those skilled in the art
how to make and use the full scope of the claimed
invention without 'undue experimentation.' "
Genentech Inc. v. Novo Nordisk A/S, 108 F.3d
1361, 1365 (Fed.Cir.1997).
Contrasting Recent Cases
• Koito Manufacturing Co., Ltd. v. Turn Key
Tech, 2004 WL 1872719 C.A.Fed. (Cal.),
Aug. 23, 2004.
– Enablement satisfied
• AK Steel Corp. v. Sollac and Ugine, 344
F.3d 1234, C.A.Fed. (Ohio), 2003.
– Invalid, lack of enablement
The technology
• Bristol-Myers Squibb (BMS) was the first
company to develop and patent a liquid
pharmaceutical composition of megestrol
acetate. BMS' U.S. Patent No. 5,338,732 (the
Atzinger patent) teaches that stable
suspensions of megestrol acetate can be created
but that the type and concentration of the
surfactant in solution is critical to creating a
stable flocculated suspension.
Tech (cont’d)
• Megestrol acetate
• A synthetic progestational hormone
C24H32O4
Surfactants
Surfactants (“surface active agents”) are
artificially manufactured molecules whose
jobs are to suspend substances in water. They
can do this because of their unique molecular
structure. One end of the surfactant molecule
is hydrophilic -- it likes water. The other end
is lipophilic -- it likes fats. The lipophilic end
is also referred to as being hydrophobi.c
Development of the invention
When [patentee] Par formulated a generic
version of BMS's patented product, it
sought to design around the Atzinger
patent claims by utilizing other surfactants
and wetting agents. In developing its own
product, Par discovered that flocculated
suspensions of megestrol acetate could be
formed using a much wider range of
ingredients and concentrations than taught
in the Atzinger patent.
The claims in Atzinger, prior art
1. An oral pharmaceutical composition
comprising [a] micronized megestrol
acetate at a concentration of 15 to 150
mg/mL [b] in combination with polysorbate
[surfactant] at a concentration of 0.005% to
0.015% weight/volume and [c] polyethylene
glycol at a concentration of greater than
5% weight/volume [d] which composition
forms a stable flocculated suspension in
water.
Claimed invention: Patentee’s ‘318
patent
1. A method of treating a neoplastic
condition comprising administering to a
subject suffering from said condition an
oral pharmaceutical composition in the
form of a stable flocculated suspension in
water capable of being redispersed after
being allowed to settle at 40.degree. C.
and 75% relative humidity for a period
of three months,
Claimed invention: Patentee’s ‘318
patent
said composition comprising: (a) micronized
megestrol acetate; (b) about 10 to 40% by
weight of at least one compound selected
from the group consisting of polyethylene
glycol, propylene glycol, glycerol, and
sorbitol; and (c) about 0.0001 to 0.03% by
weight of a surfactant, wherein polysorbate
and polyethylene glycol are not
simultaneously present in said composition.
The litigation
Par brought the present suit in 2003,
asserting that Roxane infringes certain
claims in the ′318 and ′320 patents. Roxane
denies infringement and asserts that the
claims of the ′318 and ′320 patents are
invalid and unenforceable. Roxane moved
for summary judgment of invalidity,
arguing, inter alia, that the asserted claims
in the ′ 318 and ′320 patents are invalid for
lack of enablement.
The opinion: Pharm. Res. v. Roxane
• “In this case, Par sought extremely
broad claims in a field of art that it
acknowledged was highly unpredictable,
therefore, Par has set a high burden that
its patent disclosure must meet to satisfy
the requisite quid pro quo of patent
enablement.” -- 2007 WL 3151692, at 2.
Pharm. Res. v. Roxane
“The language of the claims and the
specification both suggest that the
claims encompass hundreds of
possible surfactants.” -- 2007 WL
3151692, at 4
Inoperative species
• Par now suggests that an ordinarily skilled
artisan would know that surfactant
concentrations over 0.030% weight-pervolume would not work, it follows that a large
part of the asserted claims' scope is directed
toward inoperative embodiments. The number
of inoperative combinations is significant when
assessing the experimentation that an
ordinarily skilled artisan would need to
practice the claimed invention. Atlas Powder
Co. v. E.I. Du Pont De Nemours & Co., 750
F.2d 1569, 1576 (Fed.Cir.1984).
“Par's specification discloses only three
working examples, utilizing only one new
surfactant. Given the highly
unpredictable nature of the invention and
the extremely broad scope of the claims,
these three working examples do not
provide an enabling disclosure
commensurate with the entire scope of
the claims.” – p. 4.
Contrasting case
• Koito Manufacturing Co., Ltd. v. Turn Key
Tech, 2004 WL 1872719 C.A.Fed. (Cal.),
Aug. 23, 2004.
– Enablement satisfied
• United States Patent 5,045,268 Sorensen September 3, 1991 Crosslamination injection molding
• Abstract
• A plastic product having a cross-laminated section including a first
plastic layer and a second plastic layer is injection molded in a mold
system that includes a first mold cavity with a first-layer-definingmold-cavity-section and a second mold cavity with a second-layerdefining-mold-cavity-section that has a second-cavity-section-wall.
The product is molded by injecting a quantity of first plastic into the
first mold cavity so that first plastic flows from a flow channel into the
first-layer-defining-mold-cavity-section in a first predetermined
general direction that is different than the direction of the flow
channel; solidifying at least partly the flowed first plastic in the firstlayer-defining-mold-cavity-section to thereby form said first plastic
layer having a first-direction-flow-record; adjusting the mold system
to provide the second mold cavity, with the second-cavity-sectionwall including the first plastic layer; injecting a quantity of second
plastic into the second mold cavity
“Koito also argues on appeal that certain
details used by Turn-Key, such as injection
parameters and gate size, were necessary for
one of skill in the art to practice the claimed
invention without undue experimentation.
We again find that Koito failed to put forth
clear and convincing evidence at trial that
knowledge of such production details was
necessary to practice the claimed invention
without undue experimentation.”
“In contrast to the absence of evidence by
Koito, Turn-Key presented evidence by the
inventor of the '268 patent that these details
were omitted from the patent because they
are "standard in the industry." This Court
has repeatedly explained that a patent
applicant does not need to include in the
specification that which is already known to
and available to one of ordinary skill in the
art.” -- 2004 WL 1872719, at 10.
“We thus have noted that "[n]ot every last
detail is to be described, else patent
specifications would turn into production
specifications, which they were never
intended to be ." In re Gay, 50 C.C.P.A.
725, 309 F.2d 769, 774 (CCPA 1962).
Unless there is evidence to the contrary,
therefore, the lack of certain production
details does not indicate failure of
enablement.” – Id.
The Written Description Requirement
Scope of enablement vs. scope of that which you have
“described”
Gentry Gallery, Inc. v. Berkline Corp.,
134 F.3d 1473 (Fed. Cir. 1998).
Original Claim
Language:
Prosecution
History:
Amended Claim
Language:
Gentry was granted a patent for a sectional sofa comprised of a pair of
reclining seats that faced the same direction. Claim 1, the broadest claim,
identifies a “fixed console” between the pair of seats. Claims 9, 10, 12-15,
and 19-21 are directed to a sectional sofa in which the control means are
specifically located on the console.
The term “console” does not cover a sofa section having a seat back that folds
down to serve as a table top. (This was to distinguish Gentry’s sofa from prior
art.)
The Federal Circuit limits the scope of the claim to cover sofas in which the
recliner control is located on the console and invalidates 12 claims in the
patent under § 112. The court affirmed that Berkline had not infringed on
Gentry’s patent by constructing reclining chairs separated by a center seat
whose back cushion pivoted to form a table.
Gentry Gallery, cont’d
Canon 1: Claims should be interpreted such that the
preferred embodiment falls within their scope.
Gentry Gallery, Inc. v. Berkline Corp., 134
F.3d 1473 (Fed. Cir. 1998).
Original Claim
Language:
Prosecution
History:
Amended Claim
Language:
Gentry was granted a patent for a sectional sofa comprised of a pair of
reclining seats that faced the same direction. Claim 1, the broadest claim,
identifies a “fixed console” between the pair of seats. Claims 9, 10, 12-15,
and 19-21 are directed to a sectional sofa in which the control means are
specifically located on the console.
The term “console” does not cover a sofa section having a seat back that folds
down to serve as a table top. (This was to distinguish Gentry’s sofa from prior
art.)
The Federal Circuit limits the scope of the claim to cover sofas in which the
recliner control is located on the console and invalidates 12 claims in the
patent under § 112. The court affirmed that Berkline had not infringed on
Gentry’s patent by constructing reclining chairs separated by a center seat
whose back cushion pivoted to form a table.
In re Curtis, 69 USPQ2d 1274 (CA FC 2004)
69 USPQ2D 1274
In re Curtis
U.S. Court of Appeals Federal Circuit
No. 03-1215
Decided January 6, 2004
In re Curtis, cont’d
• The Board determined that Curtis could not
traverse the examiner’s rejections by claiming the
benefit of an earlier patent application because the
disclosure therein failed to adequately describe the
subject matter encompassed by the rejected claims
under 35 U.S.C. §112, ¶ 1. Because the Board’s
decision is supported by substantial evidence and
otherwise is in accordance with law, we affirm.