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Dec 3, 2012 (4 years and 8 months ago)

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Draft Written Description Article 11/24/05


Many people have maintained that there are really two patent laws; one for chemistry and
biotechnology and one for mechanical and electrical. It’s not true, it can’t be true. I have looked
a million times and I

don’t see anything in 35 U.S.C. § 112 that says there is one law for
chemical and one law for mechanical. It simply does not say that. So since when do we have all
of these exceptions for biotech written description and enablement requirements?


There
has always been confusion concerning the extent to which the “written description”
requirement is separate and distinct from the enablement requirement. In
In re Wilder,
the Court
of Appeals for the Federal Circuit stated outright that the written descrip
tion requirement in 35
U.S.C. § 112 is separate from the enablement requirement of the same provision.
1

However,
four years later in
Kennecott Corp. v. Kyocera Int’l, Inc.
, the same Court stated “The purpose of
the written description requirement [of sect
ion 112, 1
st

paragraph] is to state what is needed to
fulfill the enablement criteria. These requirements may be viewed separately, but they are
intertwined.”
2



In
Vas
-
Cath Inc. v. Mahurkar
, Judge Rich wrote the opinion of the court reaffirming the holdi
ng
in
Wilder

that “35 U.S.C. § 112, first paragraph, requires a ‘written description of the invention’
which is separate and distinct from the enablement requirement.”
3

Judge Rich further expanded
“The purpose of the “written description” requirement is b
roader than to merely explain how to
“make and use”; the applicant must also convey 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
.”
4

Judge Rich
further defined
the inve
ntion

for purposes of the “written description” inquiry, whatever is “now
claimed.”
5


Then came
In re Bell
and
In re Deuel
.
6

The courts in
Bell

and
Deuel

said ‘oh, I’m sorry. You
can’t be obvious unless you render obvious the precise structure. You have

to have the precise
structure and if there is no teaching of the precise structure then its not described and cannot be
obvious.’
7

Well, since when does it have to be described to be obvious? If its enabled it is
supposed to be obvious. In fact, the argu
ment was made at the time if you take the material off
the shelf and it’s within the ordinary skill of the artisan to sequence it and determine what the
material is, that’s enough. The court in
Bell

and

Deuel

said ‘No. That’s not enough.’
8


Then came

Enzo

Biochem Inc. v. Gen
-
Probe Inc.
(
Enzo I
) and somebody said ‘Wait a minute;
we’ve got a deposit.
9

Since we have a deposit, that satisfies 112, 1
st

paragraph.’
10

Well, how can



1

736 F.2d 1516, 1520, 222 USPQ 269, 372 (Fed. Cir. 1984), cert. denied, 469 U.S. 1209 (1985).

2

835
F.2d 1419, 1421, 5 USPQ2d 1194, 1197 (Fed. Cir. 1987), cert. denied, 486 U.S. 1008 (1998).

3

Vas
-
Cath Inc. v. Mahurkar, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991).


4

Id
.

5

Id
.

6

In re Bell
,
991 F.2d 781
, 785,
26 USPQ2d 1529
,

1532

(Fed.Cir. 1993);

In re Deuel
,
51 F.3d 1552
, 1558,
34
USPQ2d 1210
,

1215

(1995).

7

In re Bell
,
26 USPQ2d at 15
36 (Fed.Cir. 1993);
In re Deuel
,
34 USPQ2d 121
6 (1995).

8

Id
.

9

62 USPQ2d 1289 (Fed. Cir. 2002).

10

Id

at 1291.

that be? ‘You don’t have a description of the sequence but you have a deposit whi
ch enable’s a
person having ordinary skill in the art to get the sequence.’
11

But if that were right then
Bell

and
Deuel

would have gone in the other direction.
12

So
Enzo

was withdrawn, and
Enzo II

came back
and said ‘Well, because there is a deposit, we’l
l say that it satisfies the written description
requirement of 112 and the enablement requirement.’
13

That makes no sense at all. That’s a
joke. It’s a sham. Its fiction. Its not there, but well say it is.


The
Capon v. Eshhar

panel tried to back up fro
m the extremes of the Court’s earlier requirement
of a written description requirement separate from enablement.
14

In
Capon
, the panel found
structure and operability in a link defined by its desired function alone.
15

Even though there was
no written disclo
sure of a linker,
Capon

held that linkers are known and it is within the ordinary
skill of the artisan to figure out which linkers will work, hence the linkers were enabled.
16

So the
patent bar, the examiners, everybody who dealt with the case said “Ah! Fi
nally, they are cutting
us a break!”


But the Court would not give in. The court had to find a way to justify the earlier opinion. They
were going to hold strong, so the exercise of good sense and judgment
Capon

presented was
discarded and dismissed in
Ca
rnegie Mellon University v. Hoffmann
-
La Roche Inc
. and
Impax
Laboratories Inc. v. Aventis Pharmaceuticals Inc
.
17

Resurrecting
Eli Lilly

and
Enzo I

rationale,
the Court reverted back through

Carnegie Mellon

and
Aventis

and said ‘Oh, no, you’ve got to
have s
tructure; it may not be as much structure as we had before but you still have to have that
structure. If there had been a deposit and no structure,
Enzo 2

would have said you don’t need
any structure.’
18

Carnegie Mellon

decided that the holding in

Capon

w
as limited to the specific
facts of that case.
19


So then what happened? Then the Court gets
In re Kubin
, which is
Bell

and
Deuel
a third time.
20

Now, in a new atmosphere with a lot more knowledge what does the court say? The court says
‘In these times, wit
h all this new learning and this new experience, now we’ll go the other way.
We’ll say now, on the facts at the present time
Bell

and
Deuel
would have gone the other way,
but at that time we’ll let it go.’
21

So what happens? Basically
Kubin

says ‘we are
going to go the
other way from
Bell
and
Deuel
. You don’t have to have it described, its enough to be enabled.’
22

Well, great! That decision jives with
Enzo II
. We don’t really need structure, enablement is
enough.





11

Id.

12

Id
at 1295.

13

Enzo Biochem Inc. v. Gen
-
Probe
Inc.
, 63 USPQ2d 1609, 1618 (Fed. Cir. 2002).

14

Capon v. Eshhar
, 76 USPQ2d 1078 (Fed. Cir. 2005).

15

Id
at 1087.

16

Id
at 1086.

17

Carnegie Mellon University v. Hoffmann
-
La Roche Inc
., 88 USPQ2d 1233 (Fed. Cir. 2008);

Impax Laboratories
Inc. v. Aventis Pharmac
euticals Inc.
, 88 USPQ2d 1381 (Fed. Cir. 2008).

18

Carnegie Mellon University v. Hoffmann
-
La Roche Inc
., 88 USPQ2d at 1240 (Fed. Cir. 2008);
Impax
Laboratories Inc. v. Aventis Pharmaceuticals Inc.
, 88 USPQ2d
138
4 (Fed. Cir. 2008).

19

Carnegie Mellon Universi
ty v. Hoffmann
-
La Roche Inc
., 88 USPQ2d at 1241 (Fed. Cir. 2008).

20

90 USPQ2d 1417 (Fed. Cir. 2009).

21

Id
at 1422
-
23.

22

Id
at 1424
-
25.

In
Capon
, the Court found structure w
here there wasn’t any structure. Everyone who read the
decision knew it was a sham, but became satisfied because following
Capon
a lot of structure
was no longer required. Then
Kubin

came and the Courts further recognized that
Bell

and
Deuel

cannot be su
stained. They were holding new ground. We don’t really need structure, enablement
is enough.


Well how can it be that you don’t need any structure? How can you not have structure in one
case that then you have to have structure in another case? The jus
tification sometimes is ‘It’s
biotechnology, and with biotechnology you have special exceptions.’ Really? Section 112 is
supposed to apply to everything. It’s either enabled and described or its not.


If the deposit in fact satisfies 112 1
st
written d
escription requirement, then it
-

and were going to
say it satisfies the description requirement
-

then there can’t be both a written description
requirement and an enablement requirement in 112 1
st
. It is not the fault of practitioners,
scientists, or ex
aminers, that the results in

Bell

and
Duel
cannot be justified unless the written
description requirement of 112, 1
st

P has sufficient structure. It has to be one requirement.
Describe so as to enable. If you say it describes so as to enable, then
Bell

w
as wrong;
Deuel

was
wrong;
Kubin

was right, which is exactly the way the court went. Then
Capon

is absolutely right
because even though the linker wasn’t described, it’s enabled. Then, if you have a deposit that’s
sufficient to satisfy 112 1
st

because it

describes, it is enabled. You can get the material and
reproduce whatever it is that the material encodes.


If the courts are going to create written description exceptions, they have to apply these
exceptions to all inventions. The Courts can not say t
hat we have two requirements for
mechanical and electrical, and one requirement for biotech and chemistry. It does not work that
way. 112 does not provide for it. So, if you maintain the fact that there are two requirements
under the first paragraph of 1
12, you have to acknowledge that it’s a joke, it’s a sham, but we’re
going to do it anyway.


Hopefully, the courts in reconsidering
Ariad Pharmaceuticals Inc. v. Eli Lilly and Co.

will take
this issue seriously and come to the conclusion, the correct concl
usion that seems to jive with all
the results in all of these cases, that there is only one 112 requirement for all inventions.
23

You
describe so as to enable. That is the approach the court must take in
Ariad
. All of Judge Rich’s
background and experience

cannot justify separate written description and enablement
requirements for 112, 1
st
.
24

Please
-

we are tired of this sham, take this case seriously.






23

(Withdrawn)
Ariad Pharmaceuticals Inc. v. Eli Lilly and Co
., 90 USPQ2d 1549 (Fed. Cir. 2009)
.

24

Vas
-
Cath Inc. v. Mahurkar
, 19 USPQ2d 1111 (Fed. Cir. 1991).