Ex Parte Birkmayer

Board of Patent Appeals and Interferences

Aug 12, 2004

09896209 (B.P.A.I. Aug. 12, 2004)

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The opinion in support of the decision being entered today
was not written for publication and is not binding
precedent of the Board.
Paper No.13
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
Ex parte Joerg G. Birkmayer
Appeal No. 2003-1804
Application No. 09/896,209
ON BRIEF
Before McKELVEY, Senior Administrative Patent Judge, and SCHAFER
and GRON, Administrative Patent Judges.
GRON, Administrative Patent Judge.
DECISION ON APPEAL UNDER 35 U.S.C. § 134
This is an appeal under 35 U.S.C. § 134 from an examiner’s
final rejection of Claims 1-33 which are all the claims pending
in U.S. Application No.09/896,209, filed June 29, 2001.
Appeal No. 2003-1804
Application No. 09/896,209
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Introduction
Claims 1-33 stand finally rejected under 35 U.S.C. § 103(a)
as being unpatentable in view of the combined teachings of
Birkmayer (Birkmayer I), U.S. Patent No. 5,712,259, issued on
January 27, 1998; Prof. Georg Birkmayer, M.D., Ph.D, NADH The
Energizing Coenzyme, Good Health Guide (Keats Publishing, Inc.,
New Canaan, Connecticut 1998)(Birkmayer II); Langsjoen et al.
(Langsjoen), U.S. Patent No. 5,011,858, issued on April 30, 1991;
and the website, BioActive Nutrients, ”C2 Chromium Picolinate and
L-Carnitine,” http://www.bioactivenutrients.com/c2.html, 1999
(Bioactive Nutrients). Independent Claims 1, 12, and 23 read as
follows:
1. A method for alleviating the effects of sleep
deprivation in a human being, comprising administering to
a human being exhibiting the effects of sleep deprivation an
amount of NADH or NADPH or a physiologically compatible salt
of NADH or NADPH which is effective to reduce or eliminate
said effects of sleep deprivation.
12. A method for alleviating the effects of jet lag in
a human being, comprising administering to a human being
exhibiting the effects of jet lag an amount of NADH or NADPH
or a physiologically compatible salt of NADH or NADPH which
is effective to reduce or eliminate said effects of jet
lag.
23. A method for enhancing attentiveness or reaction
time in a human being, comprising administering to a human
being an amount of NADH or NADPH or a physiologically
compatible salt of NADH or NADPH which is effective to
improve attentiveness or reaction time.
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Application No. 09/896,209
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We have considered the applicant’s specification and claims,
the applied prior art, and the positions of the examiner and
appellant set forth in the examiner’s answer and appellant’s
brief respectively. The examiner also rejected the appellant’s
claims under 35 U.S.C. § 102, 35 U.S.C. § 103(a), and for double
patenting, over Birkmayer I alone. However, we need not reach
these rejections because we conclude that the combined prior art
teaching establishes the prima facie obviousness under 35 U.S.C.
§ 103(a) of the invention defined by Claims 1-33. Appellant has
presented no objective evidence of nonobviousness. Accordingly,
we affirm the examiner’s final rejection of all pending claims
under 35 U.S.C. § 103(a) in view of the combined prior art
teachings.
Discussion
“The PTO has the burden under section 103 to establish a
prima facie case of obviousness.” In re Fine, 837 F.2d 1071,
1073, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988). Claims 1, 12, and 23
comprise administering to a human being an effective amount of
NADH or NADPH or a physiologically acceptable compatible salt of
NADH or NADPH. The Claim 1 method is effective for alleviating
the effects of sleep deprivation. The Claim 12 method is
effective for alleviating the effects of jet lag. The Claim 23
method is effective for enhancing attentiveness or reaction time.
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Application No. 09/896,209
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Applicant’s specification describes sleep deprivation as
follows (applicant’s specification, page 1, lines 17-25):
Sleep deprivation is the condition of being deprived of
this needed sleep, resulting in adverse effects on an
individual, such as for example, decreased attentiveness,
decreased ability to concentrate, decreased reaction time,
decreased alertness, and decreased productivity and
efficiency. Sleep deprivation can be caused by, for
example, sleep disorders, such as insomnia or obstructive
sleep apnea, medical illnesses, shifting work schedules,
depression, or flying across time zones.
Accordingly, we find that persons with sleep deprivation or jet
lag show similar symptoms which both include decreased
attentiveness, decreased ability to concentrate, and decreased
reaction time. Moreover, we note that appellant states all
claims stand or fall together. (Appeal Brief, page 5, Grouping
of claims).
The examiner relies on the combined teachings of Birkmayer
I, Birkmayer II, Langsjoen, and Bioactive Nutrients as evidence
that the claimed inventions would have been obvious to one of
ordinary skill in the art at the time the inventions were made.
Birkmayer I describes a “method for treating Chronic Fatigue
Syndrome(CFS) or alleviating symptoms thereof wherein the reduced
form of nicotinamide adenine dinucleotide(NADH) or the reduced
form of nicotinamide adenine dinucleotide phosphate(NADPH) or
physiologically compatible salts or derivatives of NADH and/or
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NADPH are administered to a person suffering from the syndrome or
its symptoms.” (Birkmayer I, abstract).
Although Birkmayer I is directed to a method of treating
Chronic Fatigue Syndrome (CFS), persons with CFS show similar
symptoms to persons with jet lag or sleep deprivation.
Birkmayer I teaches that “in patients suffering from Chronic
Fatigue Syndrome, a clear alleviation of their symptoms,
including but not limited to fatigue, headaches, depression and
muscle pain and weakness, is achieved.” (Birkmayer I, column 2,
lines 43-48). Additionally, in Example II of Birkmayer I, a
patient “showed symptoms of fatigue for at least 6 months, sore
throat, painful lymph nodes, muscle weakness, muscle pains,
headache, short term memory problems, forgetfulness and inability
to concentrate.” (Birkmayer I, column 7, lines 38-41). After
being treated with NADH, the “patient’s symptoms were
alleviated.” (Birkmayer I, column 7, lines 46-48). “The patient
reported an improvement in the energy level as reflected by
increased exercise programs and shorter lasting fatigue after
exercise.” (Birkmayer I, column 7, lines 48-50). Thus, symptoms
of Chronic Fatigue Syndrome are also common to jet lag and sleep
deprivation. Accordingly, it would have been obvious to a person
having ordinary skill in the art at the time the invention was
made that a prior art method for treating symptoms of Chronic
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Application No. 09/896,209
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Fatigue Syndrome likely would have been effective for treating
symptoms of jet lag and/or sleep deprivation.
Moreover, Birkmayer II also suggests applicant’s claimed
inventions. Birkmayer II teaches that NADH (ENADA) can be
administered to improve the energy level and well-being of heathy
individuals and individuals with health problems. (Birkmayer II,
page 23, fourth paragraph). Birkmayer II states (Birkmayer II,
page 23, fourth paragraph):
ENADA is a natural approach to energy, drive and
health. ENADA (NADH) energizes both body and brain
activity, improves alertness, concentration, emotion, drive,
hormone secretion and overall mood enhancement. It helps
improve brain cell performance and helps keep cells alive
for a longer period of time. The more ENADA (NADH) a cell
has available, the more energy it can produce to perform its
process efficiently. ENADA (NADH) is available to everyone
whose lifestyle demands increased energy, vitality and
mental activity.
Birkmayer II discloses that effects observed after administering
NADH “included increased oxygen capacity, decreased reaction
time and greater mental acuity and alertness.” (Birkmayer II,
page 25, first paragraph).
Additionally, Birkmayer II teaches that NADH is useful for
treating persons suffering from fatigue. Birkmayer II reports
recipients stating (Birkmayer II, page 41):
On many mornings, I found it difficult to get up; my
body felt heavy and couldn’t wake up. It was difficult
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to get through the long hours that I keep to get
through my training.... From the first day that I took
ENADA, I noticed a difference immediately. I all of the
sudden had mental clarity with a sharp state of mind, was
able to think clearly, and felt more energetic....My muscles
seem to have an endless supply of energy to keep going
(I would get very fatigued very quickly before).
Birkmayer II teaches that NADH helps a person wake up, think
clearly, and have more energy. Decreased attentiveness,
decreased ability to concentrate, and decreased reaction time are
common symptoms of sleep deprivation and jet lag. One of
ordinary skill in the art at the time the invention was made
would have understood from Birkmayer II that administering NADH
likely would have been useful for alleviating symptoms of jet
lag, alleviating symptoms of sleep deprivation, and enhancing
attentiveness or reaction time.
Langsjoen and Bioactive Nutrients teach the use of coenzyme
Q10, L-Cartinine or L-glutathion to treat symptoms associated
with sleep deprivation, treat symptoms associated with jet lag,
or improve attentiveness or reaction time. Langsjoen teaches
that Q10 is used to alleviate symptoms of AIDS, such as fatigue
and malaise. (Langsjoen, column 3, lines 1-3). Bioactive
Nutrients teaches that a deficiency of Cartinine can cause
fatigue, muscle weakness, and brain degeneration. (Bioactive
Nutrients).
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In our view, persons having ordinary skill in the art would
have understood from Birkmayer I and Birkmayer II that NADH would
alleviate symptoms related to fatigue, sleep deprivation, and jet
lag. One of ordinary skill in the art at the time the invention
was made would have understood that Birkmayer II also suggests
administering NADH to any person to improve attentiveness and
reaction time. Therefore, it would have been prima facie obvious
at the time the claimed invention was made to alleviate the
effects of sleep deprivation, alleviate the effects of jet lag,
and/or enhance attentiveness or reaction time by administering
NADH.
Appellant’s arguments do not undermine the established prima
facie case of obviousness. Appellant argues that Birkmayer I
“fails to teach or suggest that the primarily mental symptoms of
jet lag and/or sleep deprivation, such as decreased attentiveness
or reaction time, could be successfully alleviated by the method
disclosed in the Birkmayer ’259 patent.” (Appeal brief, page 10,
second full paragraph). Appellant’s argument is unpersuasive.
Appellant’s claims do not require alleviation and treatment of
all effects of sleep deprivation or jet lag. Moreover,
Birkmayer I teaches alleviation of symptoms such as inability to
concentrate. (Birkmayer I, column 7, lines 38-48).
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Appellant further argues that “neither the Langsjoen patent
nor the Bioactive Nutrients website even mention NADH or NADPH,
they thus provide no teaching, suggestion nor [sic] motivation
for one of ordinary skill in the art to practice the method
of the Birkmayer ’259 patent to alleviate effects of sleep
deprivation and jet lag, or to enhance attentiveness and/or
reaction time in an individual.” (Appeal Brief, page 10, third
full paragraph). Bioactive Nutrients teaches that lack of
L-Carnitine causes fatigue. (Bioactive Nutrients). Langsjoen
teaches that Q10 is used to alleviate fatigue and malaise.
(Langsjoen, column 3, lines 1-3). Birkmayer I and Birkmayer II
teach that NADH gives energy and alleviates fatigue. It would
have been prima facie obvious to one skilled in the art at the
time the invention was made to combine compositions useful for
the same purpose to alleviate common symptoms.
Finally, appellant argues that “the enhanced attentiveness
was not taught nor [sic] suggested in the prior art, and thus
the method of the present invention has lead to ‘surprising
beneficial results.’” (Appeal Brief, page 11, first paragraph).
The record suggests the opposite. Birkmayer II teaches that NADH
“energizes both body and brain activity, improves alertness,
concentration, emotion, drive, hormone secretion and overall mood
enhancement.” (Birkmayer II, page 23, fourth paragraph).
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Therefore, improved attentiveness would not have been a
“surprising beneficial result” to a person having ordinary skill
in light of the prior art teaching.
Conclusion
For the reasons stated above, we affirm the examiner’s final
rejections of Claims 1-33 of Application No. 09/896,209 under
35 U.S.C. § 103(a) in view of the combined prior art. We need
not reach the rejections of appellant’s claims over Birkmayer I
alone.
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136 (a).
AFFIRMED
FRED E. McKELVEY )
Senior Administrative Patent Judge )
)
)
) BOARD OF PATENT
RICHARD E. SCHAFER ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
TEDDY S. GRON )
Administrative Patent Judge )
Appeal No. 2003-1804
Application No. 09/896,209
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