Ex Parte Jackson et al

Board of Patent Appeals and Interferences

Feb 13, 2009

10119502 (B.P.A.I. Feb. 13, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOAN E. JACKSON, MAURICE M. IWU,
CHRISTOPHER O. OKUNJI, CYRUS BACCHI, JOHN D. TALLY, JR.,
and JOHNSON F. AYAFOR
__________

Appeal 2008-5247
Application 10/119,502
Technology Center 1600
__________

Decided: 1 February 13, 2009
__________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and FRANCISCO C.
PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2008-5247
Application 10/119,502

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for treating parasitic infections. The Examiner has rejected the claims as
lacking written description and enablement, and as being indefinite. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Claims 27-38 stand rejected and are on appeal (see App. Br. 8-9).2
Claim 27 is representative and reads as follows:
Claim 27. A method for treating parasitic infections in
individuals, comprising the steps of:
(a) identifying plant-cholesterol like molecules in plants having
activity against leishmania, trypanosomiasis and trichomoniasis
parasites;
(b) isolating chemical structure of said plants;
(c) determining a relationship between a sterol pathway of said
plants and compositions having similar structures to said plants;
(d) administering an effective amount of said compositions to
an individual to inhibit cholesterol synthesis for treatment of
said leishmania, trypanosomiasis and trichomoniasis parasites.

The following rejections are before us for review:
Claims 27-38 stand rejected under 35 U.S.C § 112, first paragraph, as
failing to comply with the written description requirement (Ans. 5-6).
Claims 27-38 stand rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement (Ans. 6-10).

2 Appeal Brief filed July 13, 2007.
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Claims 27-38 stand rejected under 35 U.S.C. § 112, second paragraph,
as being indefinite for failing to particularly point out and distinctly claim
the subject matter which applicant regards as the invention (Ans. 11-12).
WRITTEN DESCRIPTION
ISSUE
The Examiner urges that “an adequate written description requires a
precise definition, such as by structure, formula, chemical name, or physical
properties, ‘not a mere wish or plan for obtaining the claimed chemical
invention’” (Ans. 5 (quoting University of California v. Eli Lilly and Co.,
119 F.3d 1559, 1566 (Fed. Cir. 1997))). Thus, the Examiner contends, “the
written description requirement can be met by ‘showing that an invention is
complete by disclosure of sufficiently detailed, relevant identifying
characteristics,’ including, inter alia, ‘functional characteristics when
coupled with a known or disclosed correlation between function and
structure . . . .’” (Ans. 5 (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323
F.3d 956, 964 (Fed. Cir. 2002))).
Applying these concepts, the Examiner finds that independent claims
27, 29, 31, 33, and 35 “contain subject matter which was not described in the
specification in such a way as to reasonably convey to one skilled in the
relevant art that the inventor(s), at the time the application was filed, had
possession of the claimed invention” (Ans. 5). Specifically, the Examiner
finds that “the instant specification fails to provide an adequate written
description for identifying suitable plant cholesterol-like molecules in plants
having activity against leishmania, trypanosomiasis and trichomoniasis
parasites” (id. at 6).
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According to the Examiner, the Specification describes “only a
limited number of suitable plants, which are characterized [as] having a
sterol-like structure. See pages 11-12 of the specification. No other
detailed, relevant identifying characteristics are specified which would
adequately describe suitable plant cholesterol-like molecules in plants
having activity against leishmania, trypanosomiasis and trichomoniasis
parasites” (id.)
Appellants contend that the Specification “discloses a wide array of
known compounds that inhibit steroid metabolism that provide the
possessory link between the Applicant’s specification and recited claims”
required under the relevant case law (App. Br. 12). Appellants further argue
that the Examiner’s rejection is based solely on case law, which “is outside
of the scope of examination practices” (id. at 13).
Appellants contend that the Specification adequately discloses the
isolation strategy used to obtain the claimed compounds, as well as the
correlation between the chemical activity of a group of plants and its impact
on leishmaniasis, and that given the expertise of those in this field, a person
of ordinary skill would understand the claimed invention to be adequately
supported by the Specification (id. at 15-16). Moreover, Appellants argue,
“in absence of prior art, Applicant cannot be forced to limit claim recitation
to a specific group of plants or a specific methodology” (id. at 16).
Appellants do not argue the claims subject to this ground of rejection
separately. We select claim 27 as representative of the rejected claims. See
37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner erred in
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finding that the Specification fails to provide an adequate written description
for “plant cholesterol-like molecules” that have activity against leishmania,
trypanosomiasis and trichomoniasis parasites, and methods of isolating those
compounds from plants, as recited in claim 27.
FINDINGS OF FACT (“FF”)
1. Claim 27 recites a method for treating parasitic infections. The
method includes the step of identifying “plant-cholesterol like molecules in
plants having activity against leishmania, trypanosomiasis and
trichomoniasis parasites.” The method also includes the step of “isolating
chemical structure of said plants.”
2. The Specification does not define “plant-cholesterol like.” The
Specification’s sole recitation of that term appears in the following passage:
We observed that traditional medical herbal therapies,
containing plant sterols having the cholestane backbone but
with hydrophillic substitutent side chains, first destabilized then
killed parasites in vitro in a dose-dependent manner. Chemical
analyses of the structure of the antiparasitic active moieties
from these plants (>70 tested) most frequently revealed an
isoprenoid, terpenoid, or steroidal structure resembling but not
duplicating normal mammalian sterolgenic precursors. It is
known, as previously discussed, that Leishmania spp. and
African Trypanosoma spp. take up cholesterol and any
cholestane-backbone molecule . . . . We believe that substitute
“plant cholesterol-like” molecules serve to destabilize parasites’
membranes because of either addition of new hydrophillic
sidegroups; or replacement of typically hydrophobic side-
groups with more hydrophillic side-groups. These observations,
in addition to the knowledge of the importance of cholesterol
and cholesterol synthesis in the organism, appeared to validate
the use of these medicinal plants as herbal remedies for
treatment of protozoan parasitic infections.

(Spec. 9-10 (emphasis added) (citations omitted).)
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3. The Specification states:
Forty-two medicinal plants were identified as having
antileishmanial properties from ethnomedical studies and either
antileishmanial/antifungal properties from ethnobotanical
research. Fifty percent (21/42) plants and 59/121 extracts tested
showed in vitro antileishmanial activity. The chemical isolation
strategy focused preferentially on isolation of di- and tri-
terpenes (sterol-like) compounds which seemed to contain
highly active (>90% cidal in vitro) antileishmanial compounds.

(Spec. 11.)
4. The Specification describes the structure of only one compound
obtained from a plant with antileishmanial activity where the compound is
also asserted to have a structure with “a resemblance to a sterol nuclei
structure” (Spec. 12). The compound is identified as “a spirostanol saponin,
Mannispirotan A, isolated from the fruit pulp of Dracaena manii” (id. at 11-
12). The spirostanol saponin is disclosed as having the following structure:

(Id. at 12).
The Specification does not list the specific steps performed in
obtaining the compound.
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5. The Specification does not explicitly state whether the spirostanol
saponin is a plant-cholesterol like compound.
6. In addition to the spirostanol saponin, the Specification states that
“[f]our additional highly active extracts have been purified and their
structures, which include more than 25 separate compounds, determined.
Most are compounds that have chemical congeners, isoprenoids, di- and
triterpenoids common to lipid metabolism; a few are berberine-like or
-dimers presented in patent 5,290,553, to Iwu” (Spec. 12).
The Specification does not provide the specific structures of the
compounds isolated by Appellants, nor does the Specification state how
those compounds were obtained, or what plant(s) they were obtained from.
The Specification does not state that any of the compounds are “plant-
cholesterol like.”
7. The Specification states that when “additional plant extracts were
examined, and additional active structures elucidated, namely, Sakuretin
from Eupatorium odoratum, Labdane-dial from Aframomum danielli, and
Afromomum aulocacarpus, unexpectedly, the structures of these compounds
did not resemble cholesterol, but instead resembled Vitamin D2 and possible
parts of a squalene isoprenoid structure as it is cyclized” (Spec. 12-13). The
Specification provides the following structures of the compounds that do not
resemble cholesterol:
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(Id. at 13). The Specification does not explicitly state whether Labdane or
Sakurentin is a plant-cholesterol like compound.
8. The Specification states that Appellants “have found that drugs known
to inhibit different parts of the cholesterol pathway can be, for the first time,
used as antiparasitic agents” (Spec. 14). The Specification lists a number of
known cholesterol pathway-affecting drugs that can be used in treating
parasitic infections (id. at 15-40).
The Specification does not state that any of the compounds listed are
“plant-cholesterol like.” Moreover, other than berberine “extracted from
Coptis chinensis” (id. at 33), and “tomato lycopene” (id. at 34), the
Specification does not state that any of the known cholesterol
pathway-affecting drugs are from plants.
9. The Specification identifies a number of plant extracts that have anti-
parasitic activity (see, e.g., Spec. 44-52). However, the Specification does
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not state whether these extracts contain “plant-cholesterol like” compounds.
The Specification does not provide the structure of any compounds
contained in these extracts. The Specification does not disclose the specific
steps used to prepare these extracts.
PRINCIPLES OF LAW
To meet the initial burden of establishing a prima facie case of
unpatentability based on the written description requirement, the Examiner
must “present[] evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). Thus, “[i]f . . .
the specification contains a description of the claimed invention, albeit not in
ipsis verbis (in the identical words), then the examiner . . ., in order to meet
the burden of proof, must provide reasons why one of ordinary skill in the
art would not consider the description sufficient.” Id.
To describe the full scope of a generically claimed invention
involving chemical materials, a Specification must allow one skilled in the
art to “visualize or recognize the identity of the members of the genus.” Eli
Lilly, 119 F.3d at 1568. This may be achieved by “set[ting] forth any
common features possessed by members of the genus that distinguish[] them
from others.” Enzo, 323 F.3d at 967.
For example, “generic formulae usually indicate with specificity what
the generic claims encompass. One skilled in the art can distinguish such a
formula from others and can identify many of the species that the claims
encompass. Accordingly, such a formula is normally an adequate
description of the claimed genus.” Lilly, 119 F.3d at 1568.
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The Specification may also describe a genus by disclosing species
which “are representative of the scope of the genus claims, i.e., if they
indicate that the [Appellants have] invented species sufficient to constitute
the genera, they may be representative of the scope of those claims.” Enzo,
323 F.3d at 967. Thus, the Specification must “describe a sufficient number
of species within the very broad genus to indicate that the inventors had
made a generic invention, i.e., that they had possession of the breadth of the
genus, as opposed to merely one or two such species.” Id.
Claims may also meet the written description requirement where a
claimed functional characteristic is “coupled with a disclosed correlation
between that function and a structure that is sufficiently known or
disclosed.” Id. at 964.
Thus, determining whether a disclosure adequately describes a generic
claim involving biological subject matter “depends on a variety of factors,
such as the existing knowledge in the particular field, the extent and content
of the prior art, the maturity of the science or technology, the predictability
of the aspect at issue, and other considerations appropriate to the subject
matter.” Capon v. Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
Ultimately, however, while there is some flexibility in how applicants
may comply with the written description requirement, “the patent
specification [must] set forth enough detail to allow a person of ordinary
skill in the art to understand what is claimed and to recognize that the
inventor invented what is claimed.” University Of Rochester v. G.D. Searle
& Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004).
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ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
finding that the Specification fails to provide an adequate written description
of “plant cholesterol-like molecules” that have activity against leishmania,
trypanosomiasis and trichomoniasis parasites, and methods of isolating those
compounds from plants, as recited in claim 27.
Appellants argue that the Specification’s disclosure of a diverse
variety of known cholesterol pathway-affecting drugs demonstrates
possession of the claimed invention (App. Br. 11-12). We are not persuaded
by this argument.
Claim 27 requires the isolated compounds to be both “plant-
cholesterol like,” and have activity against leishmania, trypanosomiasis and
trichomoniasis parasites. While the Specification identifies a number of
known cholesterol pathway-affecting drugs that may be active against the
claim-recited parasites (FF 8), the Specification does not state that any of
these compounds are “plant-cholesterol like.” Moreover, it appears that only
two of the known cholesterol pathway-affecting drugs listed in the
Specification are actually obtained from plants (see id.), as apparently
required by claim 27 (FF1).
Thus, the Specification does not identify any of the known cholesterol
pathway-affecting drugs as being members of the genus recited in claim 27.
We therefore do not agree with Appellants that, by listing those drugs, the
Specification has disclosed a representative number of species adequate to
describe the claimed genus.
We also do not agree with Appellants that the Examiner’s rejection is
based only on case law. The Examiner, having obviously reviewed the
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Specification, points out that it does not provide “detailed, relevant
identifying characteristics . . . which would adequately describe suitable
plant cholesterol-like molecules in plants having activity against leishmania,
trypanosomiasis and trichomoniasis parasites” (Ans. 6).
We agree. The Specification does not provide a definition for the
term “plant-cholesterol like” (FF 2). While the Specification uses the term
in a passage that also discusses isoprenoid, terpenoid, steroidal, and
cholestane-backbone structures, the Specification does not identify which
structures are intended to be “plant-cholesterol like” nor does it provide a
specific formula or structure that would allow a skilled artisan to identify the
features that distinguish members of the genus from non-members.
Moreover, claim 27 requires that members of the genus not only be
“plant-cholesterol like,” but also have activity against leishmania,
trypanosomiasis and trichomoniasis parasites. The Specification identifies
the plant-derived spirostanol saponin, Mannispirotan A, as having
antileishmanial activity (FF 4). However, rather than explicitly stating that
the compound is “plant-cholesterol like,” the Specification only implies it,
stating that the compound’s structure has “a resemblance to a sterol nuclei
structure” (Spec. 12 (FF 4)).
More importantly, the Specification discloses that a number of tested
plant extracts had anti-parasitic activity (see FF 3, 6, 7, 9), but does not
disclose any active compounds obtained from these extracts. The
Specification does disclose three specific structures (FF 6, 7), but it is
unclear which are “plant-cholesterol like.” Thus, we agree with the
Examiner that the Specification does not link the claimed anti-parasitic
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function with any specific structural attributes of any of the disclosed
compounds.
Also, because it discloses only one compound with a resemblance to a
sterol nuclei structure, and two others which are specifically characterized as
not resembling cholesterol, despite having tested at least 42 different plant
extracts (see FF 3, 4, 7-9), the Specification suggests that obtaining members
of the claimed genus is an unpredictable undertaking. This is further
evidence that Appellants were not in possession of the claimed genus at the
time the application was filed.
In sum, given the absence of a definition or generic formula for the
claimed category of compounds, the failure to link the claimed anti-parasitic
function to specific structural attributes in the disclosed compounds, the
dearth of specific examples of members of the claimed genus, along with the
disclosed unpredictability in obtaining members of the genus, we agree with
the Examiner that the Specification does not provide an adequate written
description of “plant cholesterol-like molecules” that have the claimed anti-
parasite activity, and methods of isolating those compounds from plants, as
recited in claim 27.
We therefore affirm the Examiner’s rejection of claim 27 as lacking
written description under 35 U.S.C. § 112, first, paragraph. Claims 28-38
fall with claim 27. See 37 C.F.R. § 41.37(c)(1)(vii).
ENABLEMENT
ISSUE
Applying the oft-cited factors set forth in In re Wands, 858 F.2d 731,
737 (Fed. Cir. 1988), the Examiner concludes that the Specification fails to
provide sufficient specific disclosure that would enable a person skilled in
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the art to practice the subject matter recited in claims 27-38 without undue
experimentation (Ans. 7-10).
Appellants contend that, given the disclosure in Figure 1 of eleven
types of inhibitors of lipid metabolism with anti-parasitic properties, as well
as the disclosure of a significant number of specific compounds having those
activities, the Specification has “indeed met enablement requirements by
clearly and precisely identifying the_nature of the invention; (c) the state of
the prior art; (d) the level of one of ordinary skill; and (e) the level of
predictability in the art” (App. Br. 19). Appellants further argue that the
“multiple examples and a discussion of their results provides one of ordinary
skill with sufficient direction to make and use the invention without undue
experimentation, particularly if the skill is one of a PhD candidate or PhD, as
the Examiner contends” (id. at 19-20). Thus, Appellants argue, given the
demonstrated high level of skill in the art and the detailed disclosure in the
Specification, “the Examiner failed to meet the burden under this test” (id. at
21).
Appellants do not argue the claims subject to this ground of rejection
separately. We select claim 27 as representative of the rejected claims. See
37 C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner erred in
concluding that the Specification fails to provide an enabling disclosure for
“plant-cholesterol like molecules” that have activity against leishmania,
trypanosomiasis and trichomoniasis parasites, and methods of isolating those
compounds from plants, as recited in claim 27.
PRINCIPLES OF LAW
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The Examiner bears the burden of establishing that practicing the full
scope of the claimed subject matter would have required undue
experimentation. In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993)
(“[T]he PTO bears an initial burden of setting forth a reasonable explanation
as to why it believes that the scope of protection provided by that claim is
not adequately enabled by the description of the invention provided in the
specification of the application.”).
While the Specification must enable the skilled artisan to practice the
full scope of the claimed subject matter, “[i]t is well settled that patent
applicants are not required to disclose every species encompassed by their
claims, even in an unpredictable art.” In re Vaeck, 947 F.2d 488, 496 (Fed.
Cir. 1991). Nonetheless,
[T]here must be sufficient disclosure, either through illustrative
examples or terminology, to teach those of ordinary skill how to
make and how to use the invention as broadly as it is claimed.
This means that the disclosure must adequately guide the art
worker to determine, without undue experimentation, which
species among all those encompassed by the claimed genus
possess the disclosed utility.

Id. (footnote omitted).
“The scope of enablement . . . is that which is disclosed in the
specification plus the scope of what would be known to one of ordinary skill
in the art without undue experimentation.” National Recovery Technols,.
Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999).
However, “[t]ossing out the mere germ of an idea does not constitute
enabling disclosure.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361,
1366 (Fed. Cir. 1997). Instead, “[w]hile every aspect of a generic claim
certainly need not have been carried out by an inventor, or exemplified in
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the specification, reasonable detail must be provided in order to enable
members of the public to understand and carry out the invention.” Id.
Lastly, it is well settled that factors to be considered in evaluating
whether experimentation would be undue include:
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth
of the claims.

In re Wands, 858 F.2d at 737.
ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that the Specification fails to provide an enabling disclosure for
“plant cholesterol-like molecules” that have activity against leishmania,
trypanosomiasis and trichomoniasis parasites, and methods of isolating those
compounds from plants, as recited in claim 27.
We note that the Specification discloses general categories of
inhibitors, as well as a significant number of known cholesterol pathway-
affecting compounds, that may be useful against the claim-recited parasites
(see, e.g. FF 8). However, claim 27 requires the compounds to be “plant-
cholesterol like,” and Appellants point to no disclosure in the Specification
suggesting that any of the known cholesterol pathway-affecting drugs meets
that limitation. Rather, the only compound which is even suggested as
meeting that limitation is Mannispirotan A, which is disclosed as having “a
resemblance to a sterol nuclei structure” (Spec. 12 (FF 4)). We are therefore
not persuaded that the Specification’s disclosure of known cholesterol
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pathway-affecting compounds provides, through multiple examples,
sufficient disclosure that would allow a person skilled in the art to make the
compounds recited in claim 27 without undue experimentation.
While the Specification identifies the source plant for Mannispirotan
A, the Specification does not disclose any of the specific steps used to obtain
the compound (id.). Also, while the Specification discloses that a number of
other extracts were found to contain active compounds (see FF 6, 9), the
Specification does not disclose the specific structures of those compounds,
or the specific steps used to prepare the extracts or isolate the compounds.
We also note the Specification’s disclosure that a significant number
of plant extracts were tested, and that a number of them had activities that
“warrant further study” (Spec. 47 (see also FF 9)). However, the
Specification only discloses the structure of three compounds and it is
unclear whether all three, or only Mannispirotan A, are intended to be
members of the claimed genus. We do not see, and Appellants do not point
to, any explicit disclosure of compounds that are both “plant-cholesterol
like” and have activity against leishmania, trypanosomiasis and
trichomoniasis parasites. Given that at least 42 different extracts were tested
(FF 3; see also FF 6, 7, 9), and the limited disclosure of compounds which
possibly meet the limitations of claim 27, Appellants’ disclosure supports,
rather than undermines, the unpredictability inherent in practicing the
invention recited in claim 27.
In sum, given the lack of specific examples of compounds meeting the
limitations of claim 27, the absence of specific disclosures of the steps
involved in obtaining such compounds, along with the disclosed
unpredictability in obtaining the claimed compounds, we agree with the
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Examiner that the Specification does not provide an enabling disclosure for
“plant-cholesterol like molecules” that have activity against leishmania,
trypanosomiasis and trichomoniasis parasites, and methods of isolating those
compounds from plants, as recited in claim 27.
We therefore affirm the Examiner’s rejection of claim 27 for lack of
enablement under 35 U.S.C. § 112, first, paragraph. Claims 28-38 fall with
claim 27. See 37 C.F.R. § 41.37(c)(1)(vii).
INDEFINITENESS
In rejecting claims 27-38 as indefinite under 35 U.S.C. § 112, second
paragraph, the Examiner reasons that the term “plant cholesterol-like
molecules” in independent claims 27, 29, 31, 33, and 35 is “a relative term,
which . . . is not defined by the claim[;] the specification does not provide a
reasonable standard for ascertaining the requisite degree, and thus one of
ordinary skill in the art would not be reasonably apprised of the scope of the
invention” (Ans. 11). The Examiner finds that “no guidance is provided as
to how ‘uncholesterol-like’ a given plant [molecule] can be and still fall
within the scope of the instantly claimed subject matter as circumscribed by
the term ‘plant cholesterol-like molecules’” (id.). Therefore, the Examiner
concludes, “the metes and bounds of the term are not clear, making it
impossible to ascertain with reasonable precision when that term is infringed
and when it is not” (id.).
The Examiner also finds that the recitation “’activity against’
leishmania, trypanosomiasis and trichomoniasis parasites’” is a relative
term, because the Specification does not provide guidance as to “how
‘inactive’ a given plant can be and still fall within the scope of the instantly
claimed subject matter” (id. at 11-12)(emphasis added).
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Appellants contend that the “term ‘plant-cholesterol like molecules’ is
clearly defined in the specification on page 9,” and that the Specification
provides standards of activity that define activity “with respect to the
parasites in question” (App. Br. 21-22). Appellants do not argue the claims
subject to this ground of rejection separately.
We select claim 27 as representative of the rejected claims. See 37
C.F.R. § 41.37(c)(1)(vii).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner erred in
concluding that a person skilled in the art, viewing claim 27 in light of the
Specification, would be unable to distinguish between claim-encompassed
subject matter and non-claim-encompassed subject matter.
PRINCIPLES OF LAW
The second paragraph of 35 U.S.C. § 112 requires only that one of
skill in the art, reading the claims in light of the specification, be able to
clearly distinguish between subject matter encompassed by the claims, and
subject matter not encompassed by the claims. See Miles Laboratories, Inc.
v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir. 1993) (“The test for
definiteness is whether one skilled in the art would understand the bounds of
the claim when read in light of the specification.”).
Thus, “[t]he purpose of claims is not to explain the technology or how
it works, but to state the legal boundaries of the patent grant. A claim is not
‘indefinite’ simply because it is hard to understand when viewed without
benefit of the specification.” S3 Inc. v. NVIDIA Corp., 259 F.3d 1364, 1369
(Fed. Cir. 2001).
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When assessing whether a term of degree is definite, one must
determine whether the Specification “provides some standard for measuring
that degree.” Seattle Box Co., v. Indus. Crating & Packaging, Inc., 731 F.2d
818, 826 (Fed. Cir. 1984).
During examination, the PTO must interpret terms in a claim using
“the broadest reasonable meaning of the words in their ordinary usage as
they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
However, “breadth is not to be equated with indefiniteness.” In re
Miller, 441 F.2d 689, 693 (CCPA 1971).
ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that a person skilled in the art, viewing claim 27 in light of the
Specification, would be unable to distinguish between claim-encompassed
subject matter and non-claim-encompassed subject matter.
We note that page 9 of the Specification uses the term “plant-
cholesterol like molecules” in a passage suggesting, at best, that sterols with
a cholestane backbone and variations in hydrophilic or hydrophobic groups
might be encompassed by the term (FF 2). However, the passage cited by
Appellants does not provide any specific formulae or name any specific
substituents that would meet the claimed genus.
Moreover, Appellants do not point to, nor do we see, any disclosure in
the Specification explaining the degrees of difference from cholesterol that
are encompassed, or not encompassed, by the molecules recited in claim 27.
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Appeal 2008-5247
Application 10/119,502

We therefore agree with the Examiner that the term “plant-cholesterol like
molecules” renders claim 27 indefinite.
However, we agree with Appellants that the Examiner erred in finding
the recitation “activity against leishmania, trypanosomiasis and
trichomoniasis parasites” indefinite. As Appellants point out, the
Specification provides assays which can be used to assess the activity of
compounds against the designated parasites (see, e.g., FF 9).
Thus, giving the claims their broadest reasonable interpretation
consistent with the Specification, in the instant case, the term “activity
against” the designated parasites encompasses any compound that has any
degree of deleterious effect on the designated parasites. Thus, while the
term may be quite broad, we do not agree with the Examiner that a person
skilled in the art viewing the claims in light of the Specification would be
unable to discern the metes and bounds of the subject matter described by
the term “activity against.”
In sum, we agree with the Examiner that the term “plant-cholesterol
like molecules” renders claim 27 indefinite. We therefore affirm the
Examiner’s rejection of claim 27 under 35 U.S.C. § 112, second paragraph.
Claims 28-38 fall with claim 27. See 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm the Examiner’s rejection of claims 27-38 under 35 U.S.C §
112, first paragraph, as failing to comply with the written description
requirement.
We affirm the Examiner’s rejection of claims 27-38 under 35 U.S.C. §
112, first paragraph, as failing to comply with the enablement requirement.
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Appeal 2008-5247
Application 10/119,502

We affirm the Examiner’s rejection of claims 27-38 under 35 U.S.C. §
112, second paragraph, as being indefinite for failing to particularly point
out and distinctly claim the subject matter which applicant regards as the
invention.
TIME PERIOD
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

cdc

Attn: MCMR-JA (Ms. Arwine)
Elizabeth Arwine, Esq.
US Army Medical Research & Material Command
504 Scott Street
Fort Detrick MD 21701-5012
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