Ex Parte Schlesser

Board of Patent Appeals and Interferences

May 6, 2010

11154914 (B.P.A.I. May. 6, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/154,914 06/16/2005 Jerry L. Schlesser JS001 2700
48536 7590 05/06/2010
BERT P. KRAGES II
ATTORNEY AT LAW
6665 SW HAMPTON ST
PORTLAND, OR 97223
EXAMINER
CLARK, AMY LYNN
ART UNIT PAPER NUMBER
1655
MAIL DATE DELIVERY MODE
05/06/2010 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JERRY L. SCHLESSER
__________

Appeal 2009-010283
Application 11/154,914
Technology Center 1600
__________

Decided: May 6, 2010
__________

Before ERIC GRIMES, TONI R. SCHEINER, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for improving the academic and behavioral performance of a human.
The Patent Examiner rejected the claims as lacking enablement. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
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STATEMENT OF THE CASE
The invention concerns a method for improving the academic and
behavioral performance of a human by administering a nutritional
supplement. The Specification states: “[i]t has been found that a nutritional
supplement consisting of flavonoid compound, lipoic-carotenoid
compounds, and a neurotransmitter amino acid such as taurine … is
particularly useful in improving the ability to learn in people, particularly
with respect to the academic, behavioral, and emotional functioning of
children in a school setting.” (Spec. 2).
Claims 11-15, 17, and 19 are on appeal. Claim 11 is representative
and reads as follows:
11. A method for improving the academic and behavioral performance of
a human comprising administering to said human a nutritional supplement
comprising an effective amount of flavonoid content extracted from plant
material containing the same; lipoic-carotenoid compounds; and at least one
amino acid or amino-acid derivative selected from the group consisting of
taurine, cysteine and derivatives, gamma-aminobutyric acid (GABA),
glutamic acid and derivatives, theanine, glutathione, methionine and
derivatives, serine and derivatives, tyrosine, tryptophan and derivatives,
lysine, glycine, and phenylalanine.

The Examiner rejected the claims under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.

ENABLEMENT
The Issue
The Examiner’s position is that the claims “contain subject matter
which was not described in the specification in such a way as to enable one
skilled in the art to which it pertains, or with which it is most nearly
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connected, to make and/or use the invention.” (Ans. 3-4). The Examiner
considered the Wands factors and discussed findings regarding the nature of
the invention, breadth of the claims, guidance of the specification, the
existence of working examples, the state and predictability of the art and the
amount of experimentation necessary. (See id. at 4-10). In particular, the
Examiner found that the nature of the invention is complex in that there are
several different factors that potentially affect the academic and behavioral
performance encompassed by the claims, i.e., mental disorder, genetics and
home environment, yet the claimed method is expected to improve such
performance regardless of these factors. (Id. at 5).
The Examiner also found that no working examples are provided that
demonstrate the efficacy of a nutritional supplement comprising an effective
amount of the flavonoid, lipoic-carotenoid compounds and at least one
amino acid, as recited in the claims, in improving academic and behavioral
performance. (Id. at 7). According to the Examiner, the example provided
in the Specification is inadequate because it does not provide evidence to
suggest that the improved performance observed was related to the claimed
method of administering the recited nutritional supplement. (Id.).
Specifically, the Examiner challenged the working example because the
performance of children administered the nutritional supplement of the
claims was compared to the performance of children who were in the class
the previous year. The Examiner found that the example results were
inconclusive because the study did not rule out extrinsic factors such as
genetics, home environment and mental disorder, that may have contributed
to the performance difference between the classes. (Id. at 8). Additionally,
the Examiner found that the example did not address potential classroom
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variables between the compared classes that may have influenced
performance, e.g., a different teacher, or different teaching or disciplinary
style. (Id. at 7-8).
The Examiner also found that at the time of the invention the state of
the art was “unpredictable and underdeveloped.” (Id. at 8). According to
the Examiner, Carlton1 disclosed that some researchers reported nutritional
treatment in learning-disabled children provided improvement in academic
performance, while others reported that such treatment had no effect on
performance. (Id. at 8-9). The Examiner found that Carlton concluded from
its study that the overall results only “tentatively” supported a conclusion
that learning disabilities “in some cases” may be nutrient-responsive. (Id. at
9).
Additionally, the Examiner found the quantity of experimentation
necessary to carry out the claimed invention to be high because the skilled
artisan would be unable to rely on the prior art or the instant Specification to
teach how to make and use a composition comprising an effective amount of
the recited components of the nutritional supplement. (Id. at 11).
Therefore, in view of the above factors and findings, the Examiner
concluded that “the skilled artisan would have required an undue amount of
experimentation to make and/or use the claimed invention.” (Id. at 11-12).
Appellant contends that the Examiner “has failed to meet the burden
to establish a reasonable basis to question the enablement provided for the
claimed invention.” (App. Br. 3). Specifically, Appellant asserts that the
Examiner has not provided specific reasons why a skilled artisan would

1 Carlton, et al., “Rational Dosages of Nutrients Have a Prolonged Effect on
Learning Disabilities”, 6 ALT. THERAPIES 85-91 (2000).
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require undue experimentation to formulate and administer the supplement
of the invention when both aspects are explicitly described in the
Specification. (Id.). Moreover, Appellant asserts that the Examiner has not
rebutted the declaratory evidence2 that a skilled artisan “would be able to
select amounts of constituents disclosed in the specification and prepare a
formulation that could be tested for effectiveness using methodologies such
as those set forth in the specification or disclosed by other researchers.” (Id.
at 9). Regarding the Specification example, Appellant asserts that
controlling factors such as the teacher, home environment, and genetics are
not required to practice the invention as described in the claims. (Id. at 6).
The issue is whether the Examiner established a reasonable basis to
question the enablement of the claimed method for improving academic and
behavioral performance of a human comprising administering to said human
a nutritional supplement, as recited in the claims.

Findings of Fact
1. The Specification stated that “[i]t is well known that nutrition plays an
important role in academic performance and several studies have
observed significant links between the consumption of nutrients ….
and classroom achievement, conduct, and basic intelligence.” (Spec.
1).
2. The Specification also stated, “It has been found that a nutritional
supplement consisting of flavonoid compounds, lipoic-carotenoid
compounds, and a neurotransmitter amino acid such as taurine, taken

2 Declarations of Jerry L. Schlesser, dated Nov. 30, 2006 and May 20, 2008.
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at a frequency of once per day is particularly useful in improving the
ability to learn in people, particularly with respect to the academic,
behavioral, and emotional functioning of children in a school setting.”
(Id. at 2).
3. The Specification described a preferred formulation of the supplement
of the invention detailing the component ingredients with their
respective quantities, i.e., dose per tablet. (Id. at 8).
4. The Specification described a study involving the administration of a
nutritional supplement in accordance to the instant claims to about 70
percent of the 328 students enrolled in an elementary school during
the 2003-04 school year. (Id. at 6).
5. The Specification study assessed Grade 5 reading skills, Grade 4 math
skills, and behavior of the students in the 2003-04 class and compared
the results with those of the prior year class. (Id. at 6-7).
6. The Specification disclosed that the percentage of students classified
as proficient or better in reading skills increased from 56.1 percent
during the 2002-03 school year to 65.5 percent during the 2003-04
school year; math skills increased from 46.7 percent to 92.5 percent;
and serious incidents of student misbehavior decreased by more than
two-thirds during the year that the supplement was administered. (Id.
at 7).
7. The Specification study did not address any extrinsic factors or
variables potentially distinguishing the students assessed in the 2002-
03 school year from those assessed in the 2003-04 school year. (See
id. at 6-7).
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8. Carlton is a journal article that analyzed the effects of nutrients on
twenty learning-disabled children. (Carlton, 85).
9. Carlton concluded that “[t]he overall results of this study tentatively
support the concept that learning disabilities may in some cases be a
nutrient-responsive disorder.” (Id.)
10. Carlton noted that some researchers had previously reported
nutritional treatment in learning-disabled children provided
improvement in academic performance, while others had reported that
such treatment had no effect on performance. (Id.)
11. Carlton summarized the results as follows: “[t]he nutrients
administered in this small study significantly raised the academic
performance of the children . . . . Discontinuation of nutrients was
followed by a significant fall in academic performance . . . .” (Id. at
90.)
12. The Declaration of Jerry L. Schlesser affirmed that a person of
ordinary skill in the field of formulating nutritional supplements
would have been familiar with the component ingredients in the
nutritional supplement of the invention and would have recognized
how to prepare the formulation from the instant Specification. (Decl.
of Schlesser, May 20, 2008 at 1, ¶ 3; 2, ¶ 4).
13. The Declaration of Jerry L. Schlesser also affirmed that the
effectiveness of the formulations could be assessed in accordance with
known methodologies and that developing similar methods to
determine effectiveness would be “well within the abilities of a
practitioner of ordinary skill in the field of nutritional science.” (Id.).

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Principles of Law
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk, A/S,
108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557,
1561 (Fed. Cir. 1993)). The Examiner has the initial burden to establish a
reasonable basis to question the enablement provided for the claimed
invention. Wright, 999 F.2d at 1562.
“Factors to be considered in determining whether a disclosure would
require undue experimentation . . . . 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 731, 737 (Fed. Cir. 1988).

Analysis
We have considered the evidence proffered by the Examiner, but do
not find that the Examiner met the burden of establishing that undue
experimentation would have been required to practice the claimed invention.
While the prior art indicates some unpredictability regarding the
effectiveness of nutritional supplementation for improving academic and
behavioral performance (see FF-10), and while the design of the study
described in the Specification example did not control for all parameters
(FF-7), we conclude that on balance the record evidence establishes that a
person of ordinary skill in the art would have been able to practice the
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claimed method without undue experimentation. See Wands, 858 F.2d at
737.
The Specification expressly described how to make the supplement of
the invention method and provided a preferred formulation which lists the
exact quantities of each of the recited supplement components. (FF-3). The
Specification expressly described how to use the supplement by providing
clear instructions to administer the formulated tablet once daily. (FF-2).
Moreover, Appellant’s declaratory evidence affirmed that a person of
ordinary skill in the art of formulating nutritional supplements would have
been familiar with the component ingredients of the nutritional supplement
of the invention and would have understood from the Specification how to
prepare the formulation. (FF-12). The declaratory evidence also affirmed
that the skilled artisan would have understood from the Specification and
prior art how to assess the effectiveness of supplementation in human
subjects with regard to improving academic and behavioral performance.
(FF-13). Further, the declaratory evidence states that it would be “well
within the abilities of a practitioner of ordinary skill in the field of nutritional
science” to develop similar methods to determine the effectiveness of
administering the nutritional supplement of the invention. (Id.). The
Examiner’s findings have not established otherwise. See Wright, 999 F.2d at
1562; Genentech, Inc, 108 F.3d at 1365.
The Specification states “[i]t is well known that nutrition plays an
important role in academic performance.” (FF-1.) That statement of fact is
undisputed, and we must weigh it as evidence of the state of the art. We
agree with the Examiner that Carlton addressed inconsistent reports in the
art. (FF-10.) However, Carlton reported that the nutrients administered in
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their own study “significantly raised academic performance,” and
discontinuing the nutrients was followed by a significant fall. (FF-11.) We
balance that evidence of the state of the art against doubt related to the
Specification’s failure to control all variables. Given the existing knowledge
in the art that nutrition was known to play a role in academic performance,
and Carlton’s demonstration of significant effects achieved with a nutritional
supplement, we are not persuaded that a person of ordinary skill in the art
would have concluded that Appellant’s failure to control all variables
(i) outweighed what that person already knew of this art, and (ii) left that
person without sufficient guidance to practice the claimed method.

CONCLUSION OF LAW
The evidence does not weigh in favor of concluding that undue
experimentation would have been required to practice the claimed method.

SUMMARY
We reverse the rejection of claims 11-15, 17, and 19 under 35 U.S.C.
112, first paragraph.

REVERSED

lp

Appeal 2009-010283
Application 11/154,914

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BERT P. KRAGES II
ATTORNEY AT LAW
6665 SW HAMPTON ST
PORTLAND OR 97223