Thursday, November 06, 2008

In re Alonso: one species fails to support a genus claim

In In re Kenneth Alonso, patent applicant Alonso, represented by the law firm of Finnegan, Henderson, lost an appeal from the BPAI for failing to meet the written description requirement of 35 USC 112.

The claim at stake was number 92, directed to:

[a] method of treating neurofibrosarcoma in a human by administering an
effective amount of a monoclonal antibody idiotypic to the
neurofibrosarcoma of said human, wherein said monoclonal antibody is
secreted from a human-human hybridoma derived from the
neurofibrosarcoma cells.

The examiner (later affirmed by the BPAI) had rejected the genus claim because it was
supported by only one species:

Applicant is reminded that the disclosure only describes the preparation of
a single Mab produced by the hybridoma cell line HB983. However, the
claims are directed toward a much larger genus of molecules (i.e., Mabs
that bind to a neurofibrosarcoma), not a specific Mab identified by the
deposited hybridoma. . . . The crux of the rejection is whether or not
applicant has provided sufficient support for the broadly claimed genus of
therapeutic anitbodies. As set forth in the rejection, the skilled artisan
would reasonably conclude that applicant was clearly not in possession of
the claimed genus of compounds
. Applicant should direct the claim
language toward the only described embodiment (e.g., a Mab produced by
hybridoma HB983).

The CAFC, affirming the examiner and the BPAI, presented the law on written description in
the following way:

Whether an applicant has complied with the written description requirement is a
finding of fact, to be analyzed from the perspective of one of ordinary skill in the art as of
the date of the filing of the application. Regents of the Univ. of Cal. v. Eli Lilly & Co.,
119 F.3d 1559, 1566 (Fed. Cir. 1997); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563
(Fed. Cir. 1991).


The written description requirement of 35 U.S.C. ' 112, & 1, is straightforward:
AThe specification shall contain a written description of the invention . . . . To satisfy
this requirement, the specification must describe the invention in sufficient detail so “that
one skilled in the art can clearly conclude that the inventor invented the claimed
invention as of the filing date sought. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565,
1572 (Fed. Cir. 1997); see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d
1336, 1345 (Fed. Cir. 2005); Eiselstein v. Frank, 52 F.3d 1035, 1039 (Fed. Cir. 1995).
The requirement Aserves a teaching function, as a ‘quid pro quo’ in which the
public is given >meaningful disclosure in exchange for being excluded from practicing
the invention for a limited period of time.=@ Univ. of Rochester v. G.D. Searle & Co., Inc.,
358 F.3d 916, 922 (Fed. Cir. 2004) (quoting Enzo Biochem, Inc. v. GenProbe Inc., 323
F.3d 956, 970 (Fed. Cir. 2002)).3


The Board properly characterized the relevant genus as the Agenus of antibodies
specific to neurofibrosarcoma cells.@ Id. A genus can be described by disclosing: (1) a
representative number of species in that genus; or (2) its Arelevant identifying
characteristics,@ such as Acomplete or partial structure, other physical and/or chemical
properties, functional characteristics when coupled with a known or disclosed
correlation between function and structure, or some combination of such
characteristics.@ Enzo, 323 F.3d at 964.

OF SOME INTEREST, a paper of the inventor-applicant was cited against the inventor-applicant.
The CAFC referred to text of the BPAI:

[t]here is ample evidence of record that the specificities of antibodies
falling within the scope of the genus (and the structures of the antigens
they bind) would be expected to vary substantially. For example, Osband4
provides evidence of a recognition in the art that considerable antigenic
A heterogeneity of tumors both between patients and metastatic sites within
a single patient@ is to be expected. In addition, an article authored by
[Alonso]5 acknowledges that A[t]he efficacy of antibody therapy is thought
to be related to tumor burden as well as to idiotypic change in the original
tumor.” This acknowledged heterogeneity is reflected in the goal of the
claimed method - to raise customized antibodies to possibly unique
antigens on a particular patient=s tumor.

Finally, as discussed above, for purposes of satisfying the written
description requirement, it is not enough merely to disclose a method of
making and identifying compounds capable of being used to practice the
claimed invention. That is, it is not enough to describe[] the procedure for
making a human-human hybridoma from neurofibrosarcoma, and teach
how to determine whether a given antibody, specific to a patient=s
neurofibrosarcoma, will function in the claimed method. We find that the
single antibody described in the Specification is insufficiently
representative to provide adequate written descriptive support for the
genus of antibodies required to practice the claimed invention.

Alonso's OWN WRITING undermined his case for the genus claim.

Oddly, the CAFC discussed the University of Rochester case, even though the Rochester
case differs from the Alonso case in that the University of Rochester did not have even ONE SPECIES
to support its claim:

it is clear from reading the patent that one critical aspect of the method - a
compound that selectively inhibits [COX-2] activity - was hypothetical, for it
is clear that the inventors had neither possession nor knowledge of such a
. . . [T]he claimed method depends upon finding a compound
that selectively inhibits [COX-2] activity. Without such a compound, it is
impossible to practice the claimed method of treatment.

The CAFC stated: Moreover, while it is true that Rochester
disclosed no compounds that worked with the claimed method, the one compound
disclosed by Alonso cannot be said to be representative of a densely populated genus.

Thus, the Alonso decision gets into the troubling area that one embodiment may be no better than
no embodiments. Footnote 6 delved into a different argument by Alonso concerning enablement and written
description: we have been
clear that “[a]lthough the legal criteria of enablement and written description are related
and are often met by the same disclosure, they serve discrete legal requirements.”
Capon v. Eshhar, 418 F.3d 1349, 1360 (Fed. Cir. 2005). “[A]n invention may be
enabled even though it has not been described.” Rochester, 358 F.3d at 921.

The Carnegie-Mellon case was also discussed: Even more recently, we
held that the written disclosure requirement was not met where the claims at issue
covered a broad “genus of recombinant plasmids that contain coding sequences for
DNA polymerase . . . from any bacterial source, [but] the narrow specifications of the
[relevant patents] only disclose[d] the . . . gene coding sequence from one bacterial
source . . . .” Carnegie Mellon Univ. v. Hoffman-LaRoche Inc., 541 F.3d 1115, 1125
(Fed. Cir. 2008)
The relevance of the older Eli Lilly case was mentioned:
Aa description of rat insulin
cDNA is not a description of the broad classes of vertebrate or mammalian insulin
cDNA.@ Id. at 1568. As in Eli Lilly, the specification of the ’749 Application contains
information about only one compound.

The CAFC noted that enumeration of species is not the only pathway to secure written description
support: we have found adequate written descriptive support for a claimed invention where the
disclosure specifies Arelevant identifying characteristics,such as A complete or partial
structure, other physical and/or chemical properties, functional characteristics when
coupled with a known or disclosed correlation between function and structure, or some
combination of such characteristics. Enzo, 323 F.3d at 964

Alonso had tried a structure-function correlation argument at the CAFC (but not the BPAI), and the argument
was NOT considered under the rule expressed in Boston Scientific Scimed, Inc. v. Medtronic Vascular, Inc., 497 F.3d 1293,
1298 (Fed. Cir. 2007). [Failure to advance legal theories before the [B]oard
constitutes a failure to >make a complete presentation of the issues, ]

***See also

***Separately, in Ex parte Nomura, well-done figures overcame a written description rejection. The BPAI wrote:

We cannot sustain the Examiner’s § 112, 1st paragraph, written
description rejection concerning the claim phrase “is thinner than the inner layer” for the reasons below.

Generally, features clearly shown by patent drawings cannot be
disregarded. In re Mraz, 455 F.2d 1069, 1072, 173 USPQ 25, 27 (CCPA
1972). In addition, when assessing whether a drawing provides descriptive
support for a claim feature the “legitimate enquiry in each case . . . is what
the drawing in fact discloses to one skilled in the art.” In re Wolfensperger,
302 F.2d 950, 955, 133 USPQ 537, 542 (CCPA 1962). Figures that
consistently show the same relative proportions cannot be ignored.
Wolfensperger, 302 F.2d at 959, 133 USPQ at 545.


Post a Comment

<< Home