Ex Parte Edwards

Board of Patent Appeals and Interferences

Mar 30, 2006

10034981 (B.P.A.I. Mar. 30, 2006)

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for publication and is not binding precedent of the Board.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 KEITH R. EDWARDS
__________

Appeal No. 2006-0392
Application No. 10/034,981
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ON BRIEF
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Before ADAMS, MILLS, and GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
An oral hearing in this case was scheduled for March 21, 2006. Upon
reviewing the case, however, we have determined that an oral hearing will not be
necessary and we render the following decision based on the record. See 37
CFR § 41.47(f).
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1-14. Claim 1 is representative of the subject matter on
appeal, and reads as follows:

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Application No. 10/034,981

1. A method for the abortive treatment of acute migraine headache in a
subject comprising administering to the subject an effective dose of intravenous
valproate such that acute migraine headache is lessened or reduced in said
subject.1

Claims 1-14 stand rejected under 35 U.S.C. § 103(a) as being obvious
over Welch2 and Walser.3 After careful review of the record and consideration of
the issue before us, we reverse.
DISCUSSION
According to the rejection:
Welch teaches the administration of 800mg valproate daily
for migraine headache therapy (pp. 1476-1483). The instant claims
administer valproate in amounts ranging from 100 mg to 2000 mg.
The 800 mg of valproate administered by the prior art lies within the
range of 100 mg to 2000 mg of the instant claims.
Welch clearly teaches treating migraine headache with
valproate but does not teach administering valproate by injection
and effective amount in instant claim 1 can be any amount.
But Walser teaches that valproate can be administered by
intravenous injection in 800 mg dosage (column 4, lines 48-53).
Walser is dependent [sic, depended] upon for intravenous
administration of same quantity of valproate, 800 mg, administered
by Welch to treat migraine.
Therefore, it would have been obvious to one of ordinary skill
in the art at the time the invention was made to intravenously
administer 800 mg of valproate to treat migraine because Walser

1 According to the examiner, the copy of claim 1 contained in the appendix to the Appeal Brief is
incorrect, as the amendment after final dated November 19, 2003, was not entered. See
Examiner’s Answer, page 3. Thus, the claim should read as amended on February 27, 2003,
and that is the version set forth above. See id.
2 Welch, “Drug Therapy of Migraine,” The New England Journal Of Medicine, Vol. 329, No. 20,
pp. 1476-1483 (1993)
3 U.S. Patent No. 5,432,176, issued July 11, 1995.

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Application No. 10/034,981

intravenously administers 800 mg of valproate. One having
ordinary skill in the art would have been motivated to intravenously
administer valproate since medications intravenously administered
gets to the blood stream faster.

Final Rejection, mailed May 19, 2003, pages 2-3.
Appellant argues that the examiner has failed to establish a prima facie
case of obviousness. See Appeal Brief, page 5. We agree, and the rejection is
reversed.
The burden is on the examiner to set forth a prima facie case of
obviousness. See In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598-99
(Fed. Cir. 1988). “A rejection based on section 103 clearly must rest on a factual
basis, and these facts must be interpreted without hindsight reconstruction of the
invention from the prior art. In making this evaluation, all facts must be
considered. The Patent Office has the initial duty of supplying the factual basis
for its rejection. It may not, because it may doubt that the invention is patentable,
resort to speculation, unfounded assumptions or hindsight reconstruction to
supply deficiencies in its factual basis. To the extent the Patent Office rulings are
so supported, there is no basis for resolving doubts against their correctness.
Likewise, we may not resolve doubts in favor of the Patent Office determination
when there are deficiencies in the record as to the necessary factual bases
supporting its legal conclusion of obviousness.” In re Warner, 379 F.2d 1011,
1017, 154 USPQ 173, 178 (CCPA 1967), cert. Denied, 389 U.S. 1057 (1968)
(emphasis in original).

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Application No. 10/034,981

Claim 1 is drawn to “[a] method for the abortive treatment of acute
migraine headache in a subject comprising administering to the subject an
effective doe of intravenous valproate such that acute migraine headache is
lessened or reduced in said subject.” As noted by the appellant, however, the
Welch reference teaches that there is a distinction between the prophylactic
treatment of migraine headaches and the acute treatment of migraine
headaches. See Appeal Brief, page 5. Welch teaches that valproic acid is useful
for the prevention of migraine headaches, but does not teach or suggest its use
for the symptomatic treatment of acute migraine headaches.
The examiner argues that Welch teaches that valproate sodium is
moderately effective in preventing migraine and reducing the frequency, severity
and duration of severe attack as compared with placebo, and that Welch does
not restrict when the valproate may be administered, which we infer to mean that
the preventative treatment of the administration of valproate sodium may be
administered while the patient has a migraine headache. The examiner does not
address, however, why one of ordinary skill in the art would take an oral
preventative treatment, given daily, and administer it intravenously. The rationale
given in the rejection, i.e., since medications intravenously administered get to
the blood stream faster, applies to the symptomatic treatment required by claim 1
and not to the preventative treatment taught by Welch. Thus, it appears that the
examiner has impermissibly used hindsight to combine the references to arrive at
the claimed invention. Moreover, as further noted by the appellant, Walser is
drawn to the intravenous administration of valproate in the treatment of chronic

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Application No. 10/034,981

renal failure, but does not teach or suggest its use for other indications. See
Appeal Brief, page 8.
CONCLUSION
Because the examiner has failed to set forth a prima facie case of
obviousness, the rejection under 35 U.S.C. § 103(a) is reversed.
REVERSED

Donald E. Adams )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

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Application No. 10/034,981

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