G.N. v. S.W

The opinion in support of the decision being
entered today is binding precedent of the Trial Section
Paper 39
Filed by: Trial Section Motions Panel
Box Interference Entered
Washington, D.C. 20231 27 September 2000
Tel: 703-308-9797
Fax: 703-305-0942
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_______________
GN,
Junior Party
(Patent 5,xxx,xxx),
v.
SW,
Senior Party,
(Application 08/yyy,yyy).
_______________
Patent Interference No. 104,vvv
_______________
Before: McKELVEY, Senior Administrative Patent Judge, and
SCHAFER, LEE, TORCZON, GARDNER-LANE and MEDLEY,Administrative
Patent Judges.
McKELVEY, Senior Administrative Patent Judge
ORDER DENYING GN PRELIMINARY MOTION 1

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A. Introduction
GN Preliminary Motion 1 (Paper 38) seeks to substitute
proposed Count A (Paper 38, Appendix A) for Count 1 (Paper 1,
page 46), the interference otherwise having been
settled. According to GN, the preliminary motion will not be
opposed by SW (Paper 38, page 2). In support of the preliminary
motion, GN relies, inter alia, on a declaration of Dr. RS (Ex
2008) and a portion of the prosecution history of the SW
application (Ex 2002 through Ex 2007) involved in the
interference.
B. Findings of fact
The record supports the following findings by a
preponderance of the evidence.
1. The interference was declared on 10 September 1999
(Paper 1, page 1) with a single count (Paper 1, page 46).
2. Count 1 reads as follows:
Count 1
A method according to claims 1 or 12 of U.S. Patent
5,xxx,xxx (GN),
or
a method according to claims 14 or 16 of application
08/yyy,yyy (SW),
or

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a composition of matter according to claims 20 or 32 of
GN,
or
a composition of matter according to claims 13 or 15 of
SW.
3. Claim 1 of the GN patent (Ex 2001) involved in the
interference reads ( bold added):
GN claim 1
A method *** comprising *** providing *** a first
virion-free nucleic acid construct *** and *** a second
virion-free nucleic acid construct ***.
4. GN dependent claims 3 and 4 read (bold added):
GN claim 3
The method of claim 1, wherein said first nucleic acid
construct and said second nucleic acid construct are present
on the same vector.
GN claim 4
The method of claim 1, wherein said first nucleic acid
construct and said second nucleic acid construct are present
on different vectors.
5. Claim 20 of the GN patent involved in the
interference reads ( bold added):
GN claim 20

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A [composition of matter] *** comprising a virion-free
first nucleic acid construct *** and *** a virion-free
second nucleic acid construct ***.
6. GN dependent claims 22 and 23 read ( bold added):
GN claim 22
The mammalian cell of claim 20, wherein said first
nucleic acid construct and said second nucleic acid
construct are present on the same vector.
GN claim 23
The mammalian cell of claim 20, wherein said first
nucleic acid construct and said second nucleic acid
construct are present on different vectors.
7. According to the preliminary motion, the invention
claimed by SW is directed only to compositions and methods
wherein a first nucleic acid construct and a second nucleic acid
construct are present on different vectors.
8. The preliminary motion refers to compositions
wherein the first nucleic acid construct and the second nucleic
acid construct are present on different vectors as a "two-
component system." These compositions can also be referred to as
a two-vector system.
9. Compositions wherein the first nucleic acid
construct and the second nucleic acid construct are present on

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the same vector are referred to in the preliminary motion as a
"one-component system." These compositions can also be referred
to as a one-vector system.
10. According to the preliminary motion, "the only
common subject matter claimed" by both parties is the two-vector
system.
11. Further according to the preliminary motion,
the subject matter of the GN one-vector claims 3 and 22 is
directed to an invention which is said to be separately
patentable from the subject matter of the SW two-vector claims.
12. GN therefore moves to have proposed Count A
substituted for Count 1.
13. Proposed Count A reads (new material in bold
and deleted material in brackets and strikeout):
Proposed count A
A method according to claims 4 [1] or 12 of U.S. Patent
5,xxx,xxx (GN),
or
a method according to claims 14 or 16 of application
08/yyy,yyy (SW),
or
a composition of matter according to claims 23 [20] or
32 of GN,
or

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a composition of matter according to claims 13 or 15 of
SW.
14. If GN preliminary motion 1 were to be granted, GN
claims 3 and 22 would be designated as not corresponding to Count
A.
15. In support of the preliminary motion, GN has filed
a declaration of Dr. RS (Ex 2008).
16. Dr. RS is an employee of *** [the] assignee of the
GN patent (Ex 2008, ¶ 1).
17. He holds a Ph.D. in biochemistry, cell and
molecular biology from *** University (Ex 2008, ¶ 2).
18. Dr. RS is not a named inventor (Ex 2008, ¶ 4).
19. Dr. RS states that he has reviewed both the GN
patent and the SW application involved in the interference (Ex
2008, ¶ 4).
20. According to Dr. RS, the GN patent describes both
a one- and two-vector system, while the SW application describes
only a two-vector system (Ex 2008, ¶ 5).
21. Dr. RS tells us (Ex 2008, ¶ 6):
One advantage of the one-vector system, is the need to
prepare only one vector. However, a major advantage of the
two-vector system is that the rep sequences is [sic--are?]
separated from the provirus, thereby minimizing the
possibility of integration of the rep gene into the host
genome.

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22. Dr. RS states the following opinion (Ex 2008, ¶
7):
I have been asked to consider whether one of ordinary
skill in the art, given the one-vector system described [by
GN], would be taught that a two vector system would be
practicable with a reasonable expectation of success, as of
about 1994-1995. At that time, my conclusion is [that] he
would not. The proper incorporation, transfection and
expression of all necessary information provided in a one
vector system could not be reasonably predicted, at that
time, to be successfully completed in a two vector system,
without experimentation to determine the success of the
same. The outcome of those experiments, including
determination of whether a suitable two vector system could
be prepared, could effectively be used to transfect a
eukaryotic host, and then whether the transformat would
properly express the heterologous genetic information, could
not have been predicted with any reasonable degree of
confidence as of 1994.
23. In forwarding the involved GN patent and the SW
application files to the board for a determination of whether an
interference should be declared, the examiner prepared a
statement under 37 CFR § 1.609(b) [Rule 609(b)].
24. In the Rule 609(b) statement, the examiner notes
(pages 4-5):
Dependent claims 3, 4, 22, and 23, which recite that the
first nucleic acid construct and the second nucleic acid

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construct are constructed either on the same vector or on
two different vectors, are directed to the same patentable
invention disclosed in claims 1-8, and 14-16 of SW et al.
because claims 2-8, and 13-16 of SW et al. encompass the
presence of two different vectors in the claimed process
and/or compositions, e.g., see Example 1 at page 11 of SW
et al. Furthermore, it would have been prima facie
obvious for one of ordinary skill in the art to have
employed one vector comprising two nucleic acid constructs
which are ligated directly together, wherein therep gene
product is produced in trans from one nucleic acid construct
with respect to the other nucleic acid construct, with a
reasonable expectation of success, particularly since
nucleic acid vectors that accommodate a large number of
inserts or separate nucleic acid constructs that are ligated
directly together via appropriate restriction sites are
routinely employed in the art,e.g., Berkner, Bio
Techniques, Vol. 6, 7, pp. 616-628, 1988, especially
column 3 at page 620. Note also that Samulski et al.
(WO 94/13788, copy attached) teach that a rep coding
sequence can be included in the same plasmid vector that
comprises a separate construct expressing an exogenous gene
product, e.g., page 12, lines 25-31, Fig. 8).
25. Dr. RS, while mentioning the phrase "one of
ordinary skill in the art," fails to state his understanding of
the meaning of the phrase.
26. Dr. RS, while testifying that "given the one
vector system" one would not be taught that "a two vector system
would be practicable with a reasonable expectation of success",

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fails to address any other prior art, including, for example, the
prior art mentioned in the examiner's Rule 609(b) statement.
27. Dr. RS, while testifying that the "success" of the
two-vector system "could not have been predicted with any
reasonable degree of confidence as of 1994" does not address
(1) the examiner's contrary conclusion or (2) the prior art
relied upon by the examiner in support of his conclusion.
C. Discussion
1.
A party filing a motion in an interference, including a
preliminary motion, has the burden of proof to show that it is
entitled to the relief sought in the motion. 37 CFR § 1.637(a).
The burden exists even when the motion is not opposed and the
interference otherwise may have been settled. As applied to the
facts of this case, GN was under a burden to establish by a
preponderance of the evidence that the one-vector invention of GN
claims 3 and 22 is directed to an invention which is separately
patentable from the two-vector invention claimed by SW. The mere
fact that a one-vector system and a two-vector system may not
overlap in scope does not per se establish that a one-vector
system does not interfere-in-fact with a two-vector system.
Aelony v. Arni, 547 F.2d 566, 192 USPQ 486 (CCPA 1977) (an
interference-in-fact held to exist between a claim to a method of

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using cyclopentadiene and a claim to a method using butadiene,
isoprene, dimethylbutadiene, piperylene, anthracene, perylene,
furan and sorbic acid; the claims were held to be directed to the
same patentable invention even though they did not overlap in
scope).
Among other things, GN was under a burden to establish
(1) the scope and content of the relevant prior art, (2) any
difference between the subject matter of claims 3 and 22 and the
prior art and (3) the level of skill in the art.Graham v. John
Deere Co., 383 U.S. 1, 17 (1966). For the purpose of the
preliminary motion, the SW two-vector system is presumed to be
prior art. The presumption is based on the assumption that SW
prevails on priority. If SW prevails on priority, then GN would
be entitled to claims 3 and 22 only if those claims define an
invention which is separately patentable from the subject matter
claimed by SW. If GN prevails on priority, it does not matter
whether GN one-vector claims 3 and 22 are patentably distinct
from any GN two-vector claims, because the GN two-vector claims
cannot be prior art vis-a-vis the GN one-vector claims.
In addition, GN was under a burden to establish that given a
two-vector system, a person having ordinary skill in the art
would not have found the one-vector system to have been prima
facie obvious. As part of its case, GN undertook to establish
that a person having ordinary skill in the art reasonably would

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not have expected success. In re O'Farrell, 853 F.2d 894, 903, 7
USPQ2d 1673, 1681 (Fed. Cir. 1988) (absolute predictability not
required for obviousness--reasonable expectation of success is
sufficient).
In ¶ 42 of the NOTICE DECLARING INTERFERENCE (Paper 1,
page 32), the parties were instructed as follows:
Affidavits expressing an opinion of an expert must
disclose the underlying facts or data upon which the
opinion is based. See Fed. R. Evid. 705 and 37 CFR
§§ 1.639(b) and 1.671(b).
Opinions expressed without disclosing the
underlying facts or data may be given little, or no,
weight. See Rohm and Haas Co. v. Brotech Corp.	, 127
F.3d 1089, 1092, 44 USPQ2d 1459, 1462 (Fed. Cir. 1997)
(nothing in the Federal Rules of Evidence or Federal
Circuit jurisprudence requires the fact finder to credit
the unsupported assertions of an expert witness).
Based on his testimony, we cannot reasonably be sure if
Dr. RS understands the meaning of "one of ordinary skill in the
art." We generally give no weight to expert testimony on the
ultimate issue of obviousness. However, the level of skill in
the art is a factual matter and is properly the subject matter of
expert testimony. But, unless we know the expert's understanding
of the meaning of the phrase "one of ordinary skill in the art,"
we are not in a very good position to give much weight to the
expert's "level of skill in the art" testimony. We need to have

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some idea of "What does a person having ordinary skill in the art
know?" A carpenter knows how to use a hammer and a saw. What
does a person having ordinary skill in the one-vector and two-
vector systems know? Dr. RS does not tell us.
Further based on his testimony, we cannot reasonably be
sure that Dr. RS was aware of, or considered, any prior art--
other than the SW two-vector system--in rendering his opinion.
The only prior art which we find discussed in his testimony is
the SW two-vector system. Facially, on this record, there
is other relevant prior art--that discussed in the examiner's
Rule 609(b) statement. On this record, a complete analysis of
whether success would have been expected necessarily must be
based on all relevant prior art. Since Dr. RS does not mention
the prior art cited by the examiner in the Rule 609(b) statement,
we decline to credit his testimony with respect to whether one
skilled in the art would or would not have expected success.
Moreover, we will not undertake to evaluate Dr. RS's opinion vis-
a-vis that of the examiner without an analysis by GN.
Dr. RS's testimony does not demonstrate that he was
instructed by counsel with respect to the factual standards which
are to be used in resolving obviousness issues. For example, we
have not been pointed to any evidence that Dr. RS was aware of
the prior art cited by the examiner. While a difference between
a one-vector system (GN claims 3 and 22) and a two-vector system

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(SW claims) is identified by Dr. RS, the prior art cited by the
examiner and the level of skill is not discussed.
In the preliminary motion, GN makes reference to, and relies
on, part of the prosecution history of the SW application (Ex
2002 through Ex 2007). According to GN, "when arguments were
presented [by SW during the SW application prosecution] to the
Examiner that one component systems and two component systems
were patentably distinct, the present two component SW claims
were allowed over prior art which was directed to a single
component system" (Paper 38, page 12, ¶ 29). Our principal
difficulty with the prosecution history argument is that the
argument does not take into account (1) the seemingly contrary
position expressed by the examiner in the Rule 609(b) statement
which (2) necessarily is based on (a) the presumed prior art as
represented by SW's claimed subject matter and (b) other prior
art cited in the Rule 609(b) statement.
In effect what GN has asked us to do is accept Dr. RS's
conclusions, without a sufficient underlying factual basis. For
reasons given above, we decline to give much, if any, weight to
Dr. RS's opinions, even though there was no cross-examination and
even though the preliminary motion is not opposed.
Alternatively, GN asks us to scour the record to see if somehow
the position urged by GN may be supported. We likewise decline
to dig into the record to see if we might be able to somehow make

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out a case for GN; we will not take on the role of an advocate
for GN.
2.
While not necessarily applicable to the case before us, we
take this opportunity to make the follow observations with the
hope that they may be of help to parties involved in
interferences, as well as patent practitioners who represent
those parties.
The board's ex parte and interference backlogs are
considerable. The board, as a whole, has had some success this
past year in reducing both backlogs. However, as a matter of
policy, we cannot, and should not, undertake in interference
cases to fill gaps in proofs which are otherwise manifestly
insufficient. In an interference, the burden is on a party--not
the board--to establish its case. The Trial Section recently has
experienced numerous--far too many--situations where a party in
an interference, in essence, says:
Here is the evidence. I do not have time to discuss the
evidence in detail, but if you look through it, you will see
the merit of my case.
To the extent that there are parties, or patent practitioners
representing those parties, who have a notion that we are going
to do their job, now would be a good time for those parties and
counsel to disabuse themselves of that notion. We simply are not

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going to expend board resources to try to "bail out" those who
ask us to search a record to prove (or disprove) their case.
DeSilva v. DiLeonardi, 181 F.3d 865, 866-67 (7th Cir 1999) ("A
brief must make all arguments accessible to the judges, rather
than ask them to play archaeologist with the record.").
The time it would take us to "bail out" those who file sloppy
motions is much better spent on attending to cases, both ex parte
and interferences, where parties and their attorneys have
presented proper motions based on proper records. There is no
substitute for a properly filed motion which is fully supported
by citations to a properly filed record coupled with a concise
argument in support of a position.
The Trial Section recently has had considerable experience
with preliminary motions filed following a settlement.
Understandably, such preliminary motions are often unopposed.
The fact that a motion is not opposed does not operate to relieve
a party from the burden of proof imposed on all parties filing
motions by 37 CFR § 1.637(a).
We are under an impression--perhaps incorrectly--that
parties filing an unopposed motion after "settlement" seem to
believe that the board will, or should, "automatically" grant the
motion. Many unopposed motions make only a minimal, often
insufficient, effort to factually or legally support a position
urged.

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In a contested motion, the board can expect opposing parties
to present both evidence and argument in favor of and against a
particular position. Once there is a settlement, the
interference at least in some respects ceases to be an
adversarial proceeding. We encourage settlement and assume that
all settlment efforts are good faith efforts. However, the fact
that an interference may have been settled, pending resolution of
certain patentability issues, should not be taken as a license to
authorize a party to file a profunctory motion that the party
feels we will, or have to, "automatically" grant. Moreover,
settlement does not invest a party with authority to engage in
shenanigans in an attempt to bamboozle the board into a certain
result. The public interest associated with the grant of a
patent for a patentable invention and patent practitioner's
ethical obligation for candor before this tribunal simply demand
more.

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D. Order
Upon consideration of GN Preliminary Motion 1, and for the
reasons given, it is
ORDERED that the motion is denied.
______________________________)
FRED E. McKELVEY, Senior )
Administrative Patent Judge )
)
)
______________________________)
RICHARD E. SCHAFER )
Administrative Patent Judge )
)
)
______________________________)
JAMESON LEE ) TRIAL SECTION
Administrative Patent Judge )
) BOARD OF PATENT
) APPEALS AND
______________________________ ) INTERFERENCES
RICHARD TORCZON )
Administrative Patent Judge )
)
)
______________________________)
SALLY GARDNER-LANE )
Administrative Patent Judge )
)
)
______________________________)
SALLY C. MEDLEY )
Administrative Patent Judge )