Written Description II
Prof Merges
Sept. 7, 2010
Casebook p. 305
“In this case, the original disclosure clearly
identifies the console as the only possible
location for the controls. It provides for
only the most minor variation in the
location of the controls, noting that the
control “may be mounted on top or side
surfaces of the console rather than on the
front wall . . . Without departing from this
invention.”
Univ of Rochester v. Searle
Univ. of Rochester v. GD Searle & Co.,
358 F.3d 916 (Fed. Cir. 2004)
Traditional non-steroidal anti-inflammatory
drugs ("NSAIDs") such as aspirin [and]
ibuprofen . . . are believed to function by
inhibiting the activity of enzymes called
cyclooxygenases. Cyclooxygenases
catalyze the production of a molecule
called prostaglandin H[2], which is a
precursor for other prostaglandins that
perform various functions in the human
body
Patent in suit, owned by
University of Rochester, was for
a method of treating
inflammation using inhibitors of
prostaglandin H synthase-2
(PGHS-2) enzyme activity, also
known as “COX-2”
Dr Donald Young, Dr Virginia
Winn, and Dr Kerry O'Banion
Claim 1: ‘850 Patent
1. A method for selectively
inhibiting PGHS-2 activity in a
human host, comprising
administering a non-steroidal
compound that selectively inhibits
activity of the PGHS-2 gene
product to a human host in need
of such treatment.
Claimed method of using a compound
acting upon a polypeptide did not
comply with the written description
requirement where such a compound
was not disclosed.
• Spec. did not disclose which, if any,
compounds selectively inhibit PGHS-2
Cyclo-oxygenase Enzyme
Traditional Painkillers: block Cox
enzyme from producing
prostaglandins
SLIDE NAME
Rochester discovery: selective
Cox 1 inhibition
Selective antagonist
Cox-2 Inhibitors
Celebrex
COX-2 Inhibitors: $13 billion
mkt!
‘850 Patent Spec
“The present invention provides a
simple in vitro system for the
screening of drug actions on both the
constitutive and the inflammatory
cyclooxygenase, which will be useful
for the development of drugs that
selectively inhibit inflammation
without producing the side effects
due to inhibition of constitutive
prostaglandin production.”
High-Throughput Screening: Finding Hits
District court opinion
The '850 patent neither discloses any actual
Cox-2 inhibiting compound nor provides any
suggestion as to how such a compound
could be made or otherwise obtained other
than by trial-and-error research. Indeed, the
court found no evidence in the '850 patent
that the inventors themselves knew of any
such compound at the time their patent
application was filed.
Federal Circuit opinion
• Enablement and WD – separate
requirements
• Relationship? – confused!!
Bottom line: holding
“Without such disclosure [of
specific peptides, etc.
selectively inhibit Cox 2] the
claimed methods cannot be
said to have been
described.”
Example: Selective Serotonin
Re-uptake Inhibitors, e.g. Prozac
Up to the minute on written
description . . .
Goeddel vs. Sugano
Interference appeal decided
• No. 2009-1156,-1157
• Avail. at
http://www.cafc.uscourts.gov/images/st
ories/opinions-orders/09-1156-1157.pdf
Note dates
• Sugano priority filing:
Issue
• Human fibroblast in-terferon (“hFIF”),
also called interferon beta or β-IF
• “Mature” vs. initial forms
• Recombinant mature form in dispute
here
That a modified gene encoding the 166 amino
acid protein could have been “envisioned”
does not establish [priority]. The question is
not whether one skilled in this field might
have been able to produce mature hFIF by
building upon the teachings of the Japanese
Application, but rather whether that
application “convey[ed] to those skilled in
the art that the inventor had possession of
the claimed subject matter as of the filing
date.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) – p. 13
In University of Rochester the court held
that the description of the COX-2
enzyme did not also serve to describe
all unknown compounds capable of
inhibiting the enzyme. University of
Rochester, 358 F.3d at 926-27.
Precedent in evolving science is
attuned to the state of the science, but
remains bound by the requirement of
showing “that the inventor actually
invented the invention claimed.” – p. 14
Lizardtech v. ERM
424 F.2d 1336 (Fed. Cir. 2005)
• Data compression technology
• Mathematical “transforms” used to convert
and compress data, stored as arrays
• If the correct transform is chosen, the
majority of the information is stored in a
relatively small portion of the array.
Lizardtech
• Once we have chosen DWT as the
transform, how do we implement DWT
quickly and efficiently?
• DWT works by splitting the image data
using two filters. The low pass filter
retains the low frequency data, such as
broad areas of color. The high pass
filter retains the high frequency data,
such as edges and textures.
The prior art centers the filter on each
element in the tile. The Lizardtech
method also centers the filter on
elements outside the tile that have been
set to 0. This is a means of calculating
not only the coefficients for the tile
loaded into memory, but also the effect
of that tile on later calculated
coefficients. In effect, the sums are
broken up and calculated in pieces.
This results in a seamless transform
that is exactly the same as if DWT had
been run on the entire, unbroken
image.
ERM Uses a Continuous Sliding Window
Approach: This technique never breaks up
or tiles the image. so it does not introduce
any edge artifacts. Instead, it relies on the
critical observation that contrary to what
was previously thought, the DWT process
does not need to generate the entire
intermediate images before generating the
output sub-band images. The newlypatented ERM method uses this observation
to perform a standard prior art DWT
technique, but does so by structuring the
data flow to ensure that only the minimum
amount of data required is stored in memory
at any one time.
The problem is that the specification
provides only one method for creating
a seamless DWT, which is to "maintain
updated sums" of DWT coefficients.
That is the procedure recited by claim
1. Yet claim 21 is broader than claim 1
because it lacks the "maintain updated
sums" limitation. Thus, a person of
ordinary skill in the art would
understand that claim 21 is directed to
a seamless DWT. But because there are
no limitations in claim 21 as to how the
seamless DWT is accomplished, claim
21 refers to taking a seamless DWT
generically.
The trouble with allowing claim 21 to
cover all ways of performing DWTbased compression processes that
lead to a seamless DWT is that there is
no support for such a broad claim in
the specification. The specification
provides only a single way of creating a
seamless DWT, which is by maintaining
updated sums of DWT coefficients.
There is no evidence that the
specification contemplates a more
generic way of creating a seamless
array of DWT coefficients. . . . P. 324
Yingbin-Nature (Guangdong)
Wood Industry Co. v.
International Trade
Commission
U.S. Court of Appeals
Federal Circuit
535 F.3d 1322 (Fed. Cir. 2008)
The tongue is shaped such that, upon
insertion into the groove, the lower lip of the
groove is displaced a small distance from its
original position. The lower lip has an
“elastically yieldable or bendable portion,”
whereby the lower lip tends to return to its
original position when displaced.Thus, when
the tongue and the groove are coupled
together, the lower lip of the tongue exerts a
force against the groove … which draws
adjacent floor panels toward each other.
“Clearance” claims
According to Power Dekor, the
disclosure of the original ′044
application does not convey with
reasonable clarity to those skilled in
the art that the inventor possessed the
invention—i.e., the concept of
clearances—later claimed in claims 5
and 17. Power Dekor contends that the
later-claimed concept of “clearances”
was not discussed in the original
specification; . . .
[R]ather, it was introduced as
new matter in the application
leading to the ′779 patent
through alterations to fourteen
paragraphs, the introduction of
new reference numbers in
certain figures, and the
addition of two completely new
paragraphs.
[T]he ′779 patent's claims cover the very
internal voids that were shown and
described in the original disclosure. In
addition, they contend that merely adding
the generic word “clearance” to describe
those spaces did not constitute new matter.
Finally, Unilin and the Commission argue
that there is nothing improper about using
the term “clearance” in two different ways
within the ′779 patent—in one way to
describe the “recess” of an uncoupled
panel and in another to describe different
voids formed between two coupled panels.
The internal voids recited in claims 5 and 17
of the ′779 patent are all shown and
described in the disclosure accompanying
the original ′044 application. “[O]pen
spaces” are depicted in at least Figures 7
and 23 of the original disclosure. The
spaces were originally described as “dust
chambers,” whereas the ′779 patent
application was amended to refer to the
spaces as “dust chambers or clearances.”
[T]he spaces were described as having “the
advantage that [they] do not exert an
adverse influence upon good engagement.”
• No written description
problem with these
claims.