Tuesday, July 23, 2013

The CAFC cites Ruschig in Novozymes case on written description.

Novozymes lost on written description at the CAFC.



Plaintiffs - Appellants Novozymes A/S and Novozymes
North America, Inc. (collectively, “Novozymes”) and
Defendants - Appellees DuPont Nutrition Biosciences APS,
Genencor International Wisconsin, Inc., Danisco US Inc.,
and Danisco USA Inc. (collectively, “DuPont”) are competitors
in the market for enzyme preparations used in a
variety of commercial applications, including ethanol
production.
On May 11, 2010, Novozymes brought suit
against DuPont in the Western District of Wisconsin,
alleging infringement of its U.S. Patent No
. 7,713,723 (the “’723 patent”)

. The ’723 patent claims particular modified
enzymes that exhibit improved function and stability
under certain conditions. DuPont defended on grounds of
noninfringement and invalidity and filed counterclaims
seeking a declaratory judgment that the claims of the ’723
patent are invalid for failing to satisfy the enablement
and written description requirements of 35 U.S.C. §
112.


and

The case then went to trial before a jury, which
concluded that the ’723 patent’s claims are not invalid on
enablement or written description grounds and which
awarded infringement damages to Novozymes exceeding
$18 million . The district court, however, granted
DuPont’s post - trial motion for judgment as a matter of
law that the claims of the ’723 patent are invalid under
§ 112 for failure to satisfy the written description requirement.
Novozymes now appeal
s from the district court’s final
judgment of invalidity. For the reasons set forth below,
we affirm.


Footnote 3 mentions the AIA:

Paragraph 1 of 35 U.S.C. § 112 was replaced with
newly designated § 112 (a) when § 4(c) of the Leahy -
Smith America Invents Act (“AIA”), Pub. L. No. 112 -
29, took effect on September 16, 2012. Because this case was filed
before that date, we will refer to the pre - AIA version of
§ 112.


An issue in the case:


Addressing the written description requirement, the
district court stated that “[t]he concern is that a patentee
may attempt to use later filed claims, relying on more
recently discovered data, to expand the scope of his invention
or to complete an idea.” Id. at 6 (citing Billups -
Rothenberg, Inc. v. Associated Reg’l & Univ. Pathologists,
Inc. , 642 F.3d 1031, 1036 (Fed. Cir. 2011)). Turning to
the ’723 patent, the court noted that the 2000 application
disclosed a potentially enormous number of alpha -
amylase variants, encompassing all possible combinations
among the seven disclosed parent enzymes, the thirty-
three disclosed positions for mutation, the numerous
different mutations possible at each position, and the
various possible combinations of individual mutations.
The court also noted that the 2000 application did not
point out the specific variants later claimed in the ’723
patent. Id. at 6 – 7.




and


In the district court’s view, the problem in either
situation was that “the specification failed to inform the
reader which member of that group was the right one
.”
Id. Accordingly, because “[t]he actual inventive work of
producing a [working variant] was left for subsequent
inventors to complete,” the district court held that the
2000 application provided insufficient
written description for the claims of the ’723 patent and that those claims
were therefore invalid under § 112. Id. at 17 – 18 (alterations in original) (quoting
Centocor , 636 F.3d at 1353) (internal quotation marks omitted).




The CAFC began with a reference to Ariad:

The written description requirement is set forth in the
first paragraph of 35 U.S.C. § 112. Ariad Pharm., Inc. v.
Eli Lilly & Co. , 598 F.3d 1336, 1343 – 45 (Fed. Cir. 2010)
(en banc).


and


To satisfy the written description requiremen
t, “the applicant must ‘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,’ and demonstrate
that by disclosure in the specification of the patent.”
Carnegie Mellon U niv. v. Hoffmann - La Roche Inc.
, 541 F.3d 1115, 1122 (Fed. Cir. 2008) (quoting
Vas - Cath Inc. v. Mahurkar , 935 F.2d 1555, 1563 –
64 (Fed. Cir. 1991)).
Accordingly, claims added during prosecution must find
support sufficient to satisfy § 112 in the written de
scrip- tion of the original priority application.
See, e.g. , Anascape, Ltd. v. Nintendo of Am., Inc.
, 601 F.3d 1333, 1335 (Fed. Cir. 2010). Assessing “possession as shown in
the disclosure” requires “an objective inquiry into the four
corners of the specification.” Ariad , 598 F.3d at 1351.
Ultimately, “the specification must describe an invention
understandable to [a] skilled artisan and show that the
inventor actually invented the invention claimed.”
Id. A “mere wish or plan” for obtaining the claimed
invention does not satisfy the written description requirement.

Regents of the Univ. of Cal. v. Eli Lilly & Co.
, 119 F.3d 1559, 1566 (Fed. Cir. 1997). The written description
inquiry presents an issue of fact. Ariad , 598 F.3d at 1351.



DuPont cited Ruschig:


Citing In re Ruschig , 379 F.2d 990 (CCPA 1967),
DuPont argues that where a patentee adds claims during
prosecution that, as here, were not included in the origi-
nal priority application, courts require a detailed description
and identification of the later - claimed invention in
the original disclosure, particularly where the specific
ation discloses numerous possibilities with scan
t guidance on which to select . In this case, DuPont points out
that the 2000 application fails to disclose a single alpha -
amylase variant substituted at position 239 that actually
exhibits increased thermostability, noting that the only
disclosed substitution at that position (S239W) disclosed
in the 2000 application does not work as required by the
’723 patent’s claims. DuPont also asserts that the 2000
application’s undifferentiated disclosure was no more
than an “invitation to experiment” that failed to provide
guidance toward the later-claimed solution.



There was a reference to "blaze marks":

We have often applied those fundamental concepts to
hold claims invalid in cases where a patent’s written
description disclosed certain subject matter in terms of a
broad genus but its claims specified a particular sub-
genus or species contained therein. For example, in
Ruschig , our predecessor court affirmed the holding of the
Patent Office Board of Appeals that a claim to a specific
drug molecule, added after filing, lacked sufficient description
in the underlying application, which disclosed
only a generic structure that could yield the claimed
molecule given the proper selections at several variable
positions. 379 F.2d at 993–94. In that
case, the application’s undifferentiated description was deficient because it
failed to provide sufficient “blaze marks” to guide a reader
through the forest of disclosed possibilities toward the
claimed compound, which resided among the myriad
others that also could have been made. Id. at 994 – 95.


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