Life Sciences Advisory Bulletin
Expert Declarations Merit Special Consideration
In Patent Prosecution Says Federal Circuit
By Jane
E.R. Potter
[September 2007]
Experts, get your pens ready. The United States Court of Appeals
for the Federal Circuit has confirmed the importance of rebuttal
evidence, such as expert declarations, during patent prosecution.
In In
re Sullivan, __F.3d__, 2007 WL 2433841 (Fed. Cir. 2007),
the court directed the Board of Patent Appeals and Interferences
to consider on remand expert declarations that the applicant had
submitted.
The technology at issue in Sullivan relates to snake antivenom,
but the decision is broadly relevant beyond the specific technology.
Applicants Sullivan and Russell were pursuing claims to an antivenom
composition comprising fragments of antibodies. The examiner rejected
the claims as being obvious over publications of the inventors and
others. On appeal, the board agreed with the examiner that all the
claim limitations were found in a combination of publications.
With the case back in the examiner’s hands, the applicants
amended their broadest claim, and the examiner again rejected the
claims over the previous combination of references. Applicants appealed
to the board once again, but the board upheld the rejection. The
board stated that three expert declarations already of record related
only to the intended use of the composition as an antivenom
and therefore did not consider them on the issue of obviousness.
In their appeal, applicants argued that the three expert declarations
described how the prior art taught away from using the claimed antibody
fragments to neutralize rattlesnake venom. The Director of the Patent
and Trademark Office argued that the examiner correctly gave the
declarations no weight because they only related to the use of the
claimed composition.
The court reviewed the substance of the declarations. The first
one was filed in response to the first Office Action. This declaration
was submitted by an expert in developing snake antivenoms, and it
explained why a person skilled in the art would not have expected
fragments such as those claimed to effectively neutralize venom.
The court held that this declaration was relevant because it stated
that the prior art taught away from the claimed invention. Teaching
away is an important consideration for rebutting an obviousness
rejection.
The second declaration was by one of the inventors, Sullivan.
It explained in detail the properties of whole antibodies and fragments
of antibodies, and stated that experts believed that the claimed
fragments would not be effective against the toxic effects
of venom. The court held that Sullivan’s declaration was relevant
because it described an unexpected property or result from using
the claimed antibody fragment as an antivenom. Unexpected property
can be evidence of non-obviousness.
The third declaration was by the other inventor, Russell, and
provided further discussion of why those of ordinary skill in the
art expected antivenoms such as those claimed to fail.
The court found that the board was mistaken in asserting that
the declarations only related to the use of the claimed
compositions. The court found that the declarations did more. Specifically,
they (a) purported to show an unexpected result from use
of the claimed composition; (b) explained how the prior art taught
away from the composition; and (c) demonstrated a long-felt
need for the new antivenom composition. The board also made
clear that an unexpected property of a new composition is distinguishable
from a new use of a known composition. Declaration evidence of secondary
considerations, such as those discussed above, are relevant to overcome
an obviousness rejection.
The lesson from this case is more of a reminder: declarations
from experts and from the inventors may be filed during prosecution
and must be given weight by the examiner. This is particularly true
in a complex field such as antibodies. The inventors’ own
explanations of how the new antivenom differed from existing antibodies
provided technical details that are more appropriately supplied
by the inventors than by attorney or agent argument alone. Thus,
while attorney or agent arguments may parallel and repeat arguments
made in a declaration, the examiner and the board must give the
arguments in the declaration special consideration.
It can be helpful early in patent prosecution to begin identifying
potential experts and to contact them and determine their willingness
to help. Once an Office Action has been received, there is usually
a three-month deadline for replying, with an additional three months
available for a fee. Taking such extensions, however, may reduce
the ultimate patent term. Involving an expert early can translate
to more time for drafting a suitable declaration, identifying relevant
data, and preparing arguments before the three month deadline.
Finally, expert testimony need not be limited to written declarations.
A personal interview with the examiner, and the supervisory examiner
if appropriate, can include one or more inventors, representatives
of the applicant, and experts. Telephone conferences with the examiner
can also be held. Both approaches may help resolve issues of complex
technology more efficiently, and can supplement the written arguments.
For further information, please contact:
This Life Sciences Advisory Bulletin is a publication of the Life
Sciences Group of Davis Wright Tremaine LLP. Our purpose in publishing
this Advisory Bulletin is to inform our clients and friends of developments
in life sciences law. It is not intended, nor should it be used,
as a substitute for specific legal advice as legal counsel may be
given only in response to inquiries regarding particular situations.
Attorney advertising. Prior results do not guarantee a similar outcome.
Copyright © 2007, Davis
Wright Tremaine LLP.
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