Nau v. Ohuchida

THIS OPINION WAS WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today
is binding precedent of the Interference Trial Section of
the Board of Patent Appeals and Interferences. The opinion
is otherwise not binding precedent. The decision was entered
on 14 April 1999
Paper 57
Filed by: Trial Section Motions Panel
Box Interference
Washington, D.C. 20231
Tel: 703-308-9797
Fax: 703-305-0942
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_______________
HEINZ NAU and CIARAN M. REGAN,
Junior Party,
(Application 08/446,481),
v.
SHUICHI OHUCHIDA, KAZUO KISHIMOTO,
NARITO TATEISHI and HIROYUKI OHNO,
Senior Party
(Application 08/681,482).
_______________
Patent Interference No. 104,258
_______________
Before: McKELVEY, Senior Administrative Patent Judge	, and
SCHAFER, LEE and TORCZON,Administrative Patent Judges	.
McKELVEY, Senior Administrative Patent Judge	.
ORDER DECIDING NAU MISCELLANEOUS MOTION 2
A. Introduction
NAU MISCELLANEOUS MOTION 2 (Paper 51) requests that the
board return OHUCHIDA REPLY 1 (Paper 48) and an accompanying

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DECLARATION OF NARITO TATEISHI (Paper 49). Alternatively, Nau
asks for leave to file a reply to OHUCHIDA REPLY 1.
OHUCHIDA OPPOSITION 2 (Paper 54) opposing NAU MISCELLANEOUS
MOTION 2 and NAU REPLY 2 (Paper 56) have also been filed and
considered.
Issues raised by NAU MISCELLANEOUS MOTION 2 are important
with respect to the administration of justice before the board in
interferences. Hence, we take this opportunity as a Trial
Section to address those issues.
B. Findings of fact
Declaration of the interference
1. The interference was declared on November 30,
1998 (Paper 1) and involves a single count.
2. Nau is involved on the basis of its U.S.
application filed May 22, 1995.
3. Nau has been accorded the benefit for the purpose
of priority of an earlier U.S. application filed August 30, 1994.
4. Ohuchida is involved on the basis of its U.S.
application filed July 23, 1996.
5. Ohuchida has been accorded the benefit for the
purpose of priority an earlier U.S. application filed June 1,
1994.

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6. Since Ohuchida's priority benefit date is prior
to Nau's priority benefit date, Ohuchida is senior party. 37 CFR
§ 1.601(m).
Interfering subject matter
7. The sole count of the interference reads:
A method according to any of claims 16, 24 or 30
of the Nau application
or
a method according to claim 11 of the Ohuchida
application.
8. Ohuchida claim 11 reads:
A method for treating diseases induced by reactive
astrocytes, which comprises administering an effective
amount of a compound of the formula (X):
[formula (X) is then set out]
or non-toxic salts thereof or acid addition salts
thereof.
9. Ohuchida claim 23, which depends from Ohuchida
claim 11, and has been designated as corresponding to the count,
reads:
A method according to claim 11, wherein the disease is
Alzheimer's disease ***.
10. Ohuchida claim 24, which depends from Ohuchida
claim 11, and has been designated as corresponding to the count
reads:

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A method of claim 11, wherein said compound of the
formula (X) is 2-propylpentanoic acid.
Early proceedings in the interference
11. Ohuchida claims the benefit of three Japanese
patent applications, the earliest of which was filed on June 1,
1993 (Ohuchida Ex. 2002, second page--which is unnumbered).
12. At the time the interference was declared,
Ohuchida was not accorded priority benefit of any of the three
Japanese patent applications (Paper 1, page 41).
13. An early determination of Ohuchida's priority
benefit date would expedite proceedings in this interference.
Accordingly, an ORDER (Paper 2) was entered simultaneously with
the declaration of the interference which authorized Ohuchida to
file a preliminary motion before the normal times set for filing
preliminary motions.
Ohuchida Preliminary Motion 1
14. Ohuchida timely filed OHUCHIDA PRELIMINARY
MOTION 1 (Paper 31) in which benefit for the purpose of priority
was sought for each of the three Japanese patent applications.
15. In a "FACTS" section in its preliminary motion,
Ohuchida set out 21 allegations of fact.
16. According to a translation of the earliest
Japanese patent application (Ohuchida Ex. 2002, page 8):

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2-Propylpentanoic acid *** and non-toxic salts
thereof of the present invention are useful for
improvement of cerebral function, for [example] in
animals including human beings, especially human
beings, because they have an activity of functional
improvement of astrocyte and their toxicity is very
low. An object disease, for example ***, [is a]
Neurodegenerative disease (e.g., Alzheimer's disease
***).
17. Dosage amounts are described in the earliest
Japanese application at page 9.
18. According to Ohuchida, Example 1 of the earliest
Japanese application describes the effects of sodium valproate on
astrocyte functions (Ohuchida Ex. 2002, pages 11-12).
19. Sodium valproate is the sodium salt of valproic
acid. Valproic acid is another name for 2-propylpentanoic acid.
See Merck Compound 10049 in The Merck Index, page 1691 (12 ed.
1996).
20. Similar effects are described in Experiment 1
of the Ohuchida U.S. application involved in the interference
(pages 41-42).
21. Ohuchida reasons in its preliminary motion that it
is entitled to the benefit for the purpose of priority of the
Japanese patent application based on a description therein of a
method using valproic acid which Ohuchida maintains is within the
scope of the count.

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Nau opposition to Ohuchida's preliminary motion
22. In opposing Ohuchida's preliminary motion, Nau
admits or denies each of the 21 factual allegations which had
been set out by Ohuchida.
23. Nau also sets out additional facts in numbered
paragraphs 24 through 39.
24. On the merits, Nau argues that Ohuchida is not
entitled to priority benefit because the specification of the
Japanese patent application is not enabling within the meaning of
the first paragraph of 35 U.S.C. § 112.
25. In particular, Nau argues that the Japanese patent
applications do not describe an enabling embodiment within the
scope of the count.
26. In support of its position, Nau relies on a
DECLARATION OF DAVID E. PLEASURE, M.D. (Nau Ex. 1012) (Paper 44).
27. According to Dr. Pleasure, the Japanese patent
applications do not provide sufficient information to allow one
of ordinary skill in the art to conclude that the compounds of
formula (X) can be used in the method defined by the count (	see,
e.g., Nau Ex. 1012, page 2).
Ohuchida's reply
28. Ohuchida filed OHUCHIDA REPLY 1 (Paper 48) to
respond to Nau's opposition.

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29. In its reply, Ohuchida purports to respond to the
additional facts set out in paragraphs numbered 24 through 39 of
Nau's opposition.
30. For the most part, however, Ohuchida does not
admit or deny the additional facts set out by Nau. Rather,
Ohuchida maintains that the facts "are irrelevant."
31. For example, responding to Nau's additional
facts 24-26 and 33, Ohuchida states:
Nau's allegations *** with respect to "invented
compounds" are irrelevant, because the count is
directed to methods of therapy and use of the
compounds.
32. OHUCHIDA REPLY 1 was accompanied by a DECLARATION
OF NARITO TATEISHI (Paper 49).
33. In his declaration, Mr. Tateishi expresses
opinions which are contrary to those expressed by Dr. Pleasant on
behalf of Nau.
Additional observations
34. At this point in the proceedings, it will be
assumed that both Dr. Pleasant and Mr. Tateishi are qualified to
express the opinions set out in their respective declarations.
35. Neither Dr. Pleasant nor Mr. Tateishi have been
cross-examined. Hence, credibility cannot be realistically
assessed at this time.

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C. Discussion
1. Ohuchida's "irrelevant" responses to
Nau's additional facts
Procedures have been adopted by the Trial Section of the
Interference Division of the board to make resolution of
interferences just, speedy and inexpensive. 37 CFR § 1.601. One
of those procedures requires that an opponent in an opposition:
shall set out *** [w]hether each fact alleged by the
moving party is admitted, denied or that the opposing
party is unable to admit or deny the fact alleged.
See Paragraph 26(b)(2) of the NOTICE DECLARING INTERFERENCE
(Paper 1). There is a similar requirement for replies.See
Paragraph 26(c)(2) of the NOTICE DECLARING INTERFERENCE
(Paper 1).
An allegation that a fact set out in a motion or opposition
is "irrelevant" does not comply with the noted provisions of the
NOTICE DECLARING INTERFERENCE. What is required by the NOTICE
DECLARING INTERFERENCE is that the fact set out be admitted,
denied or that a party assert that it is unable to admit or deny
the fact alleged. It is in the argument portion of a motion that
a party may properly maintain that a fact is irrelevant.
OHUCHIDA REPLY 1 does not comply with Paragraph 26(c)(2) of
the NOTICE DECLARING INTERFERENCE. Rather, Ohuchida attempts to
avoid direct admissions or denials. Ohuchida's action makes it

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very difficult for the board to determine what facts are or are
not dispute.
Since OHUCHIDA REPLY 1 does not comply with the NOTICE
DECLARING INTERFERENCE, it will be returned. Ohuchida shall be
given an opportunity to present a reply which meets the letter
and spirit of the procedures designed by the Trial Section.
Parties in interferences are put on notice that, in the
future, a response which maintains that an allegation of fact is
irrelevant will be taken as an admission that the fact is true
and correct. A party will not be able to later maintain that the
fact is not correct. Compare Marshall v. Sedlock and Francisco,
Inc., 83 Lab. Cas. (CCH) P33,641, 1978 U.S. Dist. LEXIS 18964
(E.D. Mich 1978) (copy attached) andDunlop v. Quality Spring
Products, Inc., 20 Fed. R. Serv. 2d (Callaghan) 561, 1975 U.S.
Dist. LEXIS 12010 (W.D. Mich 1975) (copy attached) (both holding
that an averment in a pleading that a fact is immaterial is
insufficient to constitute a denial of the fact alleged).See
also Reed v. Hickey, 2 F.R.D. 92, 1941 U.S. Dist. LEXIS 2101
(E.D. Pa. 1941) (copy attached) (holding that when an allegation
of fact is neither admitted nor denied, "but proof there is
demanded if material" is not a denial).
2. The Tateishi declaration
a.
It has long been the perception of most, if not all, of the
administrative patent judges of this board that counsel routinely

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raise new arguments and present new evidence with replies.
Presentation of new arguments and evidence with replies raise
several concerns which the Trial Section had hoped to eliminate
through requirements in the NOTICE DECLARING INTERFERENCE.
One concern is whether a good faith effort was made in the
first instance in filing a motion, including a preliminary
motion. To this end, it is the practice of the Trial Section to
consider a motion. If it finds that the motion fails to make out
a prima facie case for relief, the motion may be denied without
consideration of any opposition or reply. The Trial Section does
not deem it fair to an opponent when a party "gets its licks in"
for the first time at the reply stage after the opponent can no
longer submit evidence and/or argument. In short, the Trial
Section hopes to eliminate the unfair tactical advantage which
can be gained through improper replies.
Another concern is that improper replies make the decision-
making process difficult. It is time-consuming to read a motion
only to discover that the issue to be resolved is joined at the
reply stage. Hence, new arguments and new evidence at the reply
stage generally result in inefficient administration of justice
inefficient, all contrary to the philosophy set out in 37 CFR
§ 1.601.
The Trial Section's concern with replies is not a new
development. At the time the "new" interferences rules were
being considered, it was proposed to allow replies only for

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certain motions. Notice of Proposed Rulemaking, Patent
Interference Proceedings, 49 Fed. Reg. 3766, 3776 (col. 3), 3793
(col. 2) (Jan. 30, 1984). As a result of comments received
following the notice of proposed rulemaking, it was decided to
permit replies in all instances. However, the following
observation can be found in the Notice of Final Rule (emphasis
added):
Another comment made at the hearing suggested
that a reply to an opposition to a motion should
be permitted as a matter of course. Upon
consideration of the comment, it has been decided
to authorize the filing of replies to opposition
to all motions. Presently, replies are permitted
as a matter of course only for oppositions to
motions under 37 CFR 1.231 [1984]. Section
1.638(b), as changed, would permit the reply in
every instance. The PTO over the years has
received complaints concerning the inability of a
party to file replies. The change being made in
§ 1.638(b) will be reviewed sometime in the future
to determine whether authorizing replies is
helpful to the Board and/or whether undue delay in
resolving interference occurs because replies are
filed. Moreover, the PTO will make a judgment on
whether "new issues" are being raised as a matter
of course in replies. It can thus be seen that
the change in authorizing replies may be
considered experimental and could be changed in
the future if found to be counter-productive or

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inconsistent with the objective of resolving
interferences in a relatively prompt manner	.
Notice of Final Rule, Patent Interference Proceedings, 49 Fed.
Reg. 48416, 48442 (col. 3) (Dec. 12, 1984). The Trial Section
has gone out of its way to eliminate the raising of new arguments
in replies. See Paragraph 31 of the NOTICE DECLARING
INTERFERENCE. If the interference bars wishes to retain its
option of being able to file replies, then it should make every
effort to avoid raising improper new arguments and presenting
improper new evidence with replies. Quite frankly, if the
efforts of the Trial Section are not successful, we see the next
step as a proposal to amend the rules to permit a reply only with
leave of an administrative patent judge.
b.
In light of the comments made in subpart "a" above, the
presentation of the Tateishi declaration with Ohuchida's reply,
as opposed to with the preliminary motion, gave us pause.
However, what appears at first blush to be an unfair advantage
gained by Ohuchida, upon mature reflection, turns out not to be
the case. Nevertheless, Nau has been placed in an untenable
position, but not because Ohuchida filed new arguments and new
evidence with its reply. Rather, it is the circumstances of this
case which place Nau behind the eight ball.

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c.
We start our analysis with the interference as declared.
The examiner held that the specification of the involved Ohuchida
application describes the invention of Ohuchida claim 11 in the
manner required by the first paragraph of 35 U.S.C. § 112. If
the examiner had felt otherwise, Ohuchida claim 11 would have
been rejected ex parte and the Ohuchida and Nau files would not
have been forwarded to the board for declaration of an
interference.
Ohuchida was not accorded the benefit for the purpose of
priority of its Japanese patent applications at the time the
interference was declared. Hence, Ohuchida had to file a
preliminary motion for priority benefit. 37 CFR § 1.633(f). The
party moving for benefit bears the burden of proof. 37 CFR
§ 1.637(a). See also Kubota v. Shibuya, 999 F.2d 517, 27 USPQ2d
1418 (Fed. Cir. 1993) (agreeing with the Commissioner that the
moving party had burden of proof on motions filed prior to
amendment of Rule 637(a); 58 Fed. Reg. 49432, 49434 (Sept. 23,
1993)).
In this case, however, the specification of the involved
Ohuchida application and the specification of the Japanese patent
application appear to be similar--at least where it counts.
Given the examiner's treatment of the involved Ohuchida U.S.
application, it does not logically follow that Ohuchida would be
expected to imagine and respond to all possible arguments which

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might be made by Nau in an opposition. Rather, in this case, the
issue of non-compliance with the first paragraph of 35 U.S.C.
§ 112 surfaces--properly--for the first time upon the filing of
Nau's opposition. The issue of non-compliance is joined--again
properly--when Ohuchida filed its reply. Thus, despite the
burden of proof provisions of 37 CFR § 1.637(a), this is a case
where a benefit application contains a statement of utility which
appears sufficient on its face. An issue of its insufficiency
arises only after an opposition is filed.
In view of the circumstances of this case, it might be said
that a de facto shift in the burden of proof to Nau has occurred
even though the de jure burden of proof remains on Ohuchida.
Ohuchida had a reasonable expectation that the PTO would find its
Japanese application sufficient given the examiner's treatment of
its involved U.S. application. On the other hand, Nau had no
input during the ex parte prosecution of the Ohuchida application
prior to the interference. We simply do not know whether the
examiner would have rejected Ohuchida's claims for failure to
comply with the first paragraph of 35 U.S.C. § 112 had the
examiner had the benefit of the Pleasant declaration.
For the reasons given, we cannot say that Ohuchida's
presentation of what might be regarded as "new" argument in, and
"new" evidence with, its reply in this case was improper.
Rather, Ohuchida's new argument and new evidence appear to be a
legitimate response to a proper first instance attack on the

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sufficiency of the specifications of its Japanese patent
applications made by Nau in a legitimate opposition to Ohuchida's
preliminary motion. Thus, this is arare case where the general
rule against raising new arguments and presenting new evidence in
a reply does not work.
The proper course of action in this case is to put the
parties back to the time when Nau filed its opposition.
Ohuchida, if it be so advised, may cross-examine Dr. Pleasant.
If after cross-examination, Ohuchida persists in its effort to
obtain benefit for the purpose of priority of its Japanese
applications, it may file a reply (with or without the Tateishi
declaration). If Ohuchida files a reply and relies on the
Tateishi declaration, Nau may cross-examine and file a further
reply. In this manner, Nau will have the last word with respect
to what might be its de facto burden of establishing the
insufficiency of the specifications of the Japanese patent
applications.
D. Order
Upon consideration of NAU MISCELLANEOUS MOTION 2 (Paper 51),
and for the reasons given, it is
ORDERED that the motion isgranted to the extent that
the Ohuchida reply and the Tateishi declaration shall be returned
to Ohuchida without prejudice to further proceedings consistent
with the terms of this order.

FURTHER ORDERED that this ORDER shall be published on
the PTO Web Page.
______________________________
FRED E. McKELVEY, Senior )
Administrative Patent Judge )
)
)
______________________________)
RICHARD E. SCHAFER )
Administrative Patent Judge )
)
) BOARD OF PATENT
______________________________) APPEALS AND
JAMESON LEE ) INTERFERENCES
Administrative Patent Judge )
)
)
______________________________)
RICHARD TORCZON )
Administrative Patent Judge )