Ex Parte Toland

Board of Patent Appeals and Interferences

Jul 13, 2007

10680676 (B.P.A.I. Jul. 13, 2007)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MITCHELL R. TOLAND
__________

Appeal 2007-2681
Application 10/680,676
Technology Center 1600
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Decided: July 13, 2007
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Before TONI R. SCHEINER, DONALD E. ADAMS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for sorting plant embryos. The Examiner has rejected the claims as
nonenabled and lacking adequate written description. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse the rejection for inadequate written
description but affirm the rejection for nonenablement.
Appeal 2007-2681
Application 10/680,676

BACKGROUND
“Reproduction of selected plant varieties by tissue culture has been a
commercial success for many years” (Specification 1). The predominant
approach to conifer tissue culture is somatic embryogenesis, a process in
which
an explant, usually a seed or seed embryo, is placed on an
initiation medium where it multiplies into a multitude of
genetically identical immature embryos. . . . [T]he immature
embryos are placed on a development or maturation medium
where they grow into somatic analogs of mature seed embryos.
These embryos are then individually selected and placed on a
germination medium for further development.
(Id.) “[T]he selection from the maturation medium of individual embryos
suitable for germination . . . is a skilled yet tedious job that is time
consuming and expensive” (id. at 2).
The Specification discloses a method for automated sorting of
embryos. Embryos are
classified by developing a single metric classification model by
acquiring raw digital image data of reference samples of whole
plant embryos . . . of known embryo quality. . . . The metric
values are [calculated and] divided into two sets. . . . A Lorenz
curve is calculated from each set of metric values. A threshold
value is determined from a point on the Lorenz curve which
serves as a single metric classification model to classify plant
embryos by embryo quality.
(Id. at 4.) The classification model developed based on embryos of known
quality is then “applied to the raw image data acquired from plant embryos
of unknown quality in order to classify the quality of the unknown plant
embryo” (id.).
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The Specification provides a more detailed description of the Lorenz
curve method (id. at 18-20) and working examples of using this method to
“classify[ ] embryos according to their morphological similarity to normal
zygotic embryos” (id. at 27-30) and likelihood to germinate (id. at 30-32).
DISCUSSION
1. CLAIMS
Claims 1-14 are pending and on appeal. The claims have not been
argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). We will focus on claims 1 and 14, which read as follows:
1. A method for classifying plant embryos according to their
quantifiable characteristics comprising:
(a) developing a single metric classification model by
(i) acquiring raw digital image data of reference
samples of whole plant embryos or any portion thereof of known
quantifiable characteristics;
(ii) calculating a metric value from the acquired raw
digital image data of each embryo of known quantifiable characteristics;
(iii) dividing the metric values obtained in step (a)(ii)
into two sets of metric values according to their known quantifiable
characteristics;
(iv) calculating a Lorenz curve from the two sets of
metric values;
(v) using any point on the Lorenz curve calculated in
step (a)(iv) as a threshold value to arrive at a single metric classification
model for classifying plant embryos by their quantifiable characteristics;
(b) acquiring raw digital image data of a whole plant embryo
or any portion thereof of unknown quantifiable characteristics; and
(c) applying the developed single metric classification model
to the raw digital image data of step (b) in order to classify the plant embryo
of unknown quantifiable characteristics according to its presumed
quantifiable characteristics.
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14. The method according to Claim 1 wherein the
quantifiable characteristics comprise conversion potential, resistance to
pathogens, drought resistance, heat resistance, cold resistance, salt tolerance,
preference for light quality, or suitability for long-term storage.

Thus, claim 1 is directed to an automated method for classifying plant
embryos. Digital images of plant embryos having known characteristics are
analyzed and used to develop a “single metric classification model” for
classifying other plant embryos. That is, the known samples are used to
determine a “metric value” of known characteristics. The metric values are
then used to calculate a Lorenz curve, which is used to determine a threshold
value “to arrive at a single metric classification model.”
After a single metric classification model has been generated, it is
applied to digital images of a plant embryo of unknown characteristics, in
order to classify the unknown embryo “according to its presumed
quantifiable characteristics”; i.e., the unknown embryo is classified as
similar to or dissimilar from the embryos in the training set. (Spec. 8: 17-18
(“Unclassified embryos are classified as acceptable or not based on how
close images of the unclassified embryos fit to the classification model
developed from the training set groups.”)).
Claim 14 specifies that the “quantifiable characteristics” can be
conversion potential (i.e., likelihood to germinate; Spec. 7: 13-15);
resistance to pathogens, drought, heat, or cold; salt tolerance; preference for
light quality; or suitability to long-term storage (i.e., storage of the embryos
themselves; Spec. 7: 18). These characteristics are referred to generically as
“plant embryo quality” in the Specification (id. at 7: 15-18).
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2. PRIOR ART
The Examiner does not rely on any references.
3. WRITTEN DESCRIPTION
Claims 1-14 stand rejected under 35 U.S.C. § 112, first paragraph, as
lacking an adequate written description in the Specification. The Examiner
acknowledges that the Specification describes the claimed method as applied
to selecting embryos for their germination potential, but not with respect to
other quantifiable characteristics:
Appellant has demonstrated that one can take embryos which
are visually determined to be good (an old and well known
process), capture digital image data, and then take that data and
apply well known data processing algorithms to interpret the
data and produce a “classification model.” It is not in the
creation of a such a model that appellant has failed to
adequately describe or enable in their claimed invention but in
the application of said model. As such, the invention as a
whole has not been adequately described or enabled.
(Answer 5.) By “good” embryos, we understand the Examiner to mean
embryos having a morphology that indicates they are more likely to
germinate. (See id.: “Using morphology as a basis for selecting embryos is
old and well known – embryos of a certain morphology tend to germinate
better than others.”).
The Examiner argues that the Specification does not adequately
describe the genus of “quantifiable characteristics” that could be selected for
using the claimed method (id. at 5-6). The Examiner also argues that the
Specification does not adequately describe “how one could practice this
invention wherein a digital image of only ‘any portion thereof’ is captured
and a model is made” (id. at 5). Finally, the Examiner argues that the
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description is inadequate because “there is nothing to convey to one of skill
in the art that the properties in claim 14 could be reasonably predicted using
a digital image classification model” (id. at 6).
We will reverse the rejection for lack of written description. “The
‘written description’ requirement . . . serves both to satisfy the inventor’s
obligation to disclose the technologic knowledge upon which the patent is
based, and to demonstrate that the patentee was in possession of the
invention that is claimed. . . . The descriptive text needed to meet these
requirements varies with the nature and scope of the invention at issue, and
with the scientific and technologic knowledge already in existence.” Capon
v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005).
Here, the Examiner argues that the Specification does not adequately
describe the “quantifiable characteristics” to be selected for using the
claimed method, relying on the test defined by University of California v. Eli
Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997), and cases
applying it. That test, however, does not apply to every generic term recited
in a claim: it applies only to a chemical genus encompassing compounds
that are not defined by structure. See Amgen, Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1332, 65 USPQ2d 1385, 1398 (Fed. Cir.
2003): “Both Eli Lilly and Enzo Biochem are inapposite to this case because
the claim terms at issue here are not new or unknown biological materials
that ordinarily skilled artisans would easily miscomprehend.”
Like the “vertebrate cells” and “mammalian cells” recited in the
claims at issue in Amgen, the term “quantifiable characteristics” recited in
the instant claims is not a “new or unknown biological material[ ] that
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ordinarily skilled artisans would easily miscomprehend.” As in Amgen, the
Eli Lilly/Enzo Biochem test that the Examiner relies on is inapposite here.
The Examiner also argues that the claims lack adequate descriptive
support because the Specification does not describe how to use images only
of a “portions” of embryos to practice the claimed method or how to classify
embryos according to the properties recited in claim 14 using digital image
classification (Answer 5, 6).
In a nutshell, the Examiner’s reasoning seems to be that the
Specification does not describe these aspects of the claims because it does
not provide any working examples showing classification based on embryo
organs or classification with respect to the properties recited in claim 14.
Lack of working examples, however, is not an adequate basis for a written
description rejection. See Falkner v. Inglis, 448 F.3d 1357, 1366,
79 USPQ2d 1001, 1007 (Fed. Cir. 2006) (“[E]xamples are not necessary to
support the adequacy of a written description[;] . . . the written description
standard may be met . . . even when actual reduction to practice of an
invention is absent.”).
The instant Specification describes the claimed method in general
terms (e.g., Specification 4 and 18-20) and provides a working example of
using the method to classify embryos based on similarity to normal zygotic
embryos (id. at 27-32). The Specification also states that the method can be
used to classify embryos based on any quality susceptible to quantification
(id. at 8: 28-29), and that images of embryo organs (i.e., portions of
embryos) can be used instead of images of whole embryos (id. at 7: 28-35).
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We reverse the rejection of claims 1-14 for lack of adequate written
description because the Examiner has not adequately explained why the
Specification’s disclosure does not satisfy that requirement of 35 U.S.C.
§ 112, first paragraph. Whether it satisfies the enablement requirement of
that paragraph is a separate issue, to which we now turn.
4. ENABLEMENT
Claims 1-14 also stand rejected under 35 U.S.C. § 112, first
paragraph, as nonenabled. The Examiner relies in part on the same
reasoning used to support the written description rejection – after explaining
the rejection for lack of adequate description, the Examiner concludes that
[i]t follows logically that the entire claimed invention has not
been enabled by the instant specification because applicant has
not taught how to apply the instant invention such that one of
skill in the art could predict using applicant’s classification
model . . . whether or not any embryo would germinate or have
one of the other “characteristics” as in claim 14.
(Answer 8.) The Examiner also argues that the “specification has not
enabled the use of ‘any portion thereof’ an embryo as the means for creating
a classification model” (id.).
Although we have some quibbles, we agree with the thrust of the
Examiner’s reasoning and his conclusion that the Specification does not
enable practice of the full scope of the claimed method without undue
experimentation.
First, the quibbles: the Examiner has not adequately supported his
conclusion that more than routine experimentation would be required to use
the claimed method to classify embryos on the basis of germination
potential. The Examiner has acknowledged that “[u]sing morphology as a
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basis for selecting embryos is old and well known – embryos of a certain
morphology tend to germinate better than others” (Answer 5).
The Specification states that embryos “that are most likely to
successfully germinate into normal plants are preferentially selected using a
number of visually evaluated screening criteria . . . [including] axial
symmetry, cotyledon development, surface texture, [and] color” (Spec.
2: 6-9). The Specification also provides working examples of the claimed
method to classify embryos according to their “morphological similarity to
normal zygotic embryos” (id. at 27: 29-30) and germination rate (id. at
30: 5-7).
Thus, the evidence of record appears to show that the morphological
properties associated with embryos most likely to germinate into plants were
well-known in the art and routinely applied by technicians in hand-sorting
embryos. In light of the state of the art and the guidance and working
examples presented in the Specification, the Examiner has not adequately
explained why undue experimentation would be required to use the claimed
method to classify embryos according to their germination potential.
We also conclude that the Examiner has not adequately explained why
the claimed method could not be practiced, without undue experimentation,
using digital images of portions of embryos rather than complete embryos.
As shown in the application’s Figure 1, the portions of a plant embryo
include the cotyledon, hypocotyl, and radical. Some of the morphological
properties commonly used to sort embryos are those of the embryo organs
(e.g., cotyledon development; Spec. 2: 8). The Specification provides a
working example of the claimed method in which the observed features used
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as inputs included the “area of the cotyledons from the embryo end view,
and mean area of the cotyledons touching the bounding convex hull of the
embryo end view” (id. at 29: top line of the table).
Thus, the evidence of record appears to show that the morphological
features of portions of the embryo, and not just those of the embryo overall,
are important indicators of which embryos are likely to germinate. Granted,
the claimed method may not be as accurate if only the features of portions of
the embryo were used as inputs, but the claims do not require any particular
level of accuracy. The Examiner has not adequately explained why even the
claimed method could not be practiced without undue experimentation using
digital images of portions of plant embryos.
That said, we agree with the Examiner’s conclusion that the claims are
nonenabled because the Specification provides inadequate guidance with
respect to classifying embryos on the basis of characteristics other than
germination potential using the claimed method. (See, e.g., Answer 6, 8-9.)
Claim 14, for example, makes clear that the “quantifiable characteristics”
recited in claim 1 include “resistance to pathogens, drought resistance, heat
resistance, cold resistance, salt tolerance, preference for light quality, [and]
suitability for long-term storage.”
The Specification provides no guidance regarding what features of a
digital image of embryos or embryo organs are associated with any of these
characteristics. Nor does the Specification provide any working examples
that show the use of embryo images to classify plant embryos according to
any of characteristic other than likelihood to germinate. In fact, the evidence
of record does not show there exist any features of plant embryo images that
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can be used to classify embryos as resistant to pathogens, drought, etc.
Therefore, we agree with the Examiner that using the claimed method to
classify plant embryos according to characteristics other than likelihood to
germinate would likely require undue experimentation on the part of those
skilled in the art.
Appellants argue that “the present invention is not directed to
requiring to first identify a particular set of parameters or data that can be
always used as indicative of specific quantifiable characteristics of plant
embryos” (Br. 9). Appellants argue that “the specification clearly describes
how a single metric classification model is developed based on data acquired
from reference embryos of known quantifiable characteristics, and then is
used to classify embryos of unknown quantifiable characteristics according
to their presumed quantifiable characteristics” (id. at 12).
We do not find this argument persuasive. Since the Specification does
not disclose which morphological characteristics are associated with
pathogen resistance, drought resistance, etc., Appellants’ argument,
essentially, is that disclosing a method of training a computer to recognize
images of embryos that are most likely to germinate entitles them to a patent
on training a computer to recognize any subset of plant embryos. Then, if it
turns out that there are visually recognizable characteristics of embryos that
are pathogen resistant, drought resistant, etc., Appellants’ patent would
cover teaching computers to recognize them, too, even though Appellants
haven’t disclosed (presumably because they don’t know) what to train the
computer to look for.
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This result does not comport with the quid pro quo underlying the
patent system. “Patent protection is granted in return for an enabling
disclosure of an invention, not for vague intimations of general ideas that
may or may not be workable. . . . Tossing out the mere germ of an idea does
not constitute enabling disclosure.” Genentech Inc. v. Novo Nordisk A/S,
108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997).
Here, Appellants have disclosed a method for using digital image data
to classify plant embryos according to their likelihood to germinate. They
have not, however, disclosed a method for using digital image data to
classify plant embryos according to any other quantifiable characteristics.
With respect to classifying embryos according to pathogen resistance,
drought resistance, etc., the specification discloses nothing more than a
general idea that may or may not be workable. That does not constitute an
enabling disclosure and we affirm the rejection of claims 1-14 for lack of
enablement.
SUMMARY
We reverse the rejection for lack of written description but affirm the
rejection of claims 1-14 for lack of enablement.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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WEYERHAEUSER COMPANY
INTELLECTUAL PROPERTY DEPT., CH 1J27
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