Ex Parte Hageman

Patent Trials and Appeals Board

Jul 24, 2013

10793871 - (D) (P.T.A.B. Jul. 24, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ROBERT JOHAN JOSEPH HAGEMAN
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Appeal 2011-011733
Application 10/793,871
Technology Center 1600
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Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
GEORGIANNA W. BRADEN, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 from the final rejection of
claims 1-10, directed to a method for maintaining a positive nitrogen balance
in a mammal undergoing metabolic stress. The Examiner has rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellant identifies the Real Party-In-Interest as N.V. Nutricia of
Zoetermeer, The Netherlands. (App. Br. 1).
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Application 10/793,871

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STATEMENT OF THE CASE
Claims 1-10 are pending and on appeal. Claims 11-30 are also
pending, but have been withdrawn from consideration (App. Br. 2). Claim 1
is representative of the invention and reproduced below:
1. A method for maintaining a positive nitrogen balance in a mammal
undergoing metabolic stress, which method comprises administering to the
mammal a composition containing methyl donors selected from the group
consisting of L-serine, methionine, choline, phosphatidyl choline, betaine,
dimethylglycine, sarcosine, methylated folates, S-adenosyl methionine,
thymidine triphosphate, adenosine triphosphate and methyl acceptors
selected from the group consisting of L-glycine, enthanolamine,
Phosphatidyl ethanolamine, folate, and ribose, wherein the total molar
amount of methyl donors delivered by the method exceeds the total molar
amount of methyl acceptors delivered by the method by at least 0.18 mmol
per kg of body weight per day so that a positive nitrogen balance is
maintained in the mammal undergoing metabolic stress.
Claims 1-10 stand rejected under 35 U.S.C. § 103(a), as unpatentable
over Smythies and Ashby.
FINDINGS OF FACT
The following findings of fact are supported by a preponderance of
the evidence.
1. Smythies teaches that orally ingested L-methionine “acts in
some manner in some schizophrenics to worsen symptoms” (Smythies, col.
1, ll. 18-20), but these symptoms can be alleviated by orally administering
L-serine, mixed with food or in capsules, in an amount which “generally
ranges between about 1 and about 25 grams per day” (id. at col. 2, ll. 5-11).
2. Ashby teaches that free amino acids are unpalatable, and
therefore, are usually provided in capsules, or sprinkled on food, or
formulated as flavored drinks (Ashby 2: 10-17). Ashby further teaches that
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essential amino acids are rapidly destroyed when cooked in the presence of
sugars, and discloses palatable free amino acid-containing confectionary
compositions which do not require cooking (id. at 2: 28-35).
3. Ashby discloses phenylalanine-depleted apricot-flavored bars
suitable for children with phenylketonuria comprising 14.16 % of a mixture
of amino acids and 1.87 % of a vitamin mineral pre-mix. The vitamin
mineral premix includes folic acid (folate) (Ashby 3: 6-9; Example 1).
4. A logical inference is that Ashby’s confectionary compositions
contain all the L-amino acids normally found in proteins (whether non-
essential, conditional, and essential), with the exception of phenylalanine,
since the composition is designed for phenylketonurics.
5. L-glycine is a conditional amino acid normally found in
proteins, while L-methionine is an essential amino acid.2
DISCUSSION
The claims require, in relevant part, that “the total molar amount of
methyl donors delivered by the method exceeds the total molar amount of
methyl acceptors delivered by the method by at least 0.18 mmol per kg of
body weight per day so that a positive nitrogen balance is maintained” (see
e.g., claims 1, 6, 31). That is, the claims require that the amount of the
enumerated methyl donors (e.g., L-serine) exceed the amount of enumerated
methyl acceptors (e.g., folate) by at least 0.18 mmol per kg of body weight
per day so that a positive nitrogen balance is maintained.
The Examiner finds that Smythies teaches administering L-serine with
food at a dosage of 1-25 gm/day to alleviate the symptoms of schizophrenia

2 http://www.nlm.nih.gov/medlineplus/ency/article/002222.htm
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(Ans. 4), while Ashby discloses administering free amino acids in fruit-
based, vitamin enriched compositions to improve the palatability of the free
amino acids (id.), where folate is present “in at most about 0.187g” (id. at 5).
The Examiner does not dispute Appellant’s contention that neither
Smythies nor Ashby discusses “administering a total molar amount of
methyl donors that exceeds the total molar amount of methyl acceptors by at
least 0.18 mmol per kg of body weight per day” (App. Br. 9). However, the
Examiner concludes that “[i]t would have been obvious . . . to administer L-
serine to a patient with schizophrenia . . . using the free amino [acid-
containing] palatable food disclosed by [Ashby]” (Ans. 5), thereby
administering a composition “which appears to read on [an excess of methyl
donors of] at least 0.18 mmol per kg of body weight per day, where L-serine
is a methyl donor and folic acid (i.e., folate) is a methyl acceptor” (id.).
Appellant contends, in relevant part, that the Examiner has not
established that one of ordinary skill in the art would have had a reason to
combine the teachings of Smythies and Ashby because Smythies teaches
that methionine exacerbates the symptoms of schizophrenia, while Ashby’s
compositions “include essential amino acids, such as methionine, which
SMYTHIES sets out to avoid” (App. Br. 9).
Appellant further contends that “one cannot conclude that the addition
of the active [i.e., L-serine] of SMYTHIES to the food disclosed by ASHBY
would have automatically resulted in a positive nitrogen balance being
maintained” (id.), since Ashby’s amino acid mixture contains folic acid and
an indeterminate amount of a second methyl acceptor, the amino acid L-
glycine (id. at 10).
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Appellant’s arguments are persuasive. We agree with Appellant that
the Examiner has not established that one of ordinary skill in the art would
have had reason to add Smythies’ L-serine to Ashby’s composition as
Ashby’s composition contains a mixture of amino acids, including
methionine, which, according to Smythies, exacerbates the symptoms of
schizophrenia (FFs 1, 4, 5). Moreover, we agree with Appellant that even if
one were to combine Smythies’ L-serine with Ashby’s composition, the
Examiner has not established that the resultant composition would have the
ratio of methyl donors to acceptors required by the claims since Ashby’s
composition contains indeterminate amounts of at least two methyl
acceptors: folic acid and the free amino acid L-glycine (FFs 2, 4).
SUMMARY
The rejection of claims 1-10 as unpatentable over Smythies and
Ashby is reversed.

REVERSED

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