Ex Parte Widegren et al

Board of Patent Appeals and Interferences

Apr 4, 2011

10206557 (B.P.A.I. Apr. 4, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte BENGT WIDEGREN, BERTIL PERSSON, and
LEIF G. SALFORD

Appellants.
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Appeal 2010-004932
Application 10/206,557
Technology Center 1600
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Before RICHARD TORCZON, SALLY GARDNER LANE, and
MICHAEL P. TIERNEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.
DECISION ON APPEAL
The appeal, under 35 U.S.C. § 134, is from a Final Rejection of claims
74-96. Appellants canceled claims 1-73. (App. Br. 2.) We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
Appellants’ specification is directed to methylation-resistant nucleic
acid vectors that are useful in regulating gene expression. Appellants’ claim
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74 recites a vector that “compris[es] at least one CpG motif in the nucleotide
sequence, wherein one or two cytosines in the at least one CpG motif has
been replaced with a methylation-resistant cytosine analogue . . . .” (App.
Br. 14, Claims App’x.) The methylation-resistant cytosine analogue is
further limited to
5-azadeoxycytidine or a cytosine modified at the 5-position of
the pyrimidine ring by replacement of C with O or C-X,
wherein X is a nonelectrophilic or low electrophilic group and
the analogue can be integrated into the nucleotide sequence of
the vector, said 5-position being as shown in Fig. 2, which is
herein incorporated by reference.

(Id.)1
The Examiner rejected all of Appellants’ claims under 35 U.S.C.
§ 103(a) over Di Ianni2 and Jones3, although the rejections were presented
for groups of claims separately. (See Ans. 3-9.) We consider these rejections

1 Figure 2 of Appellants’ specification is reproduced below.

Figure 2 depicts an example of a general structure of a cytidine derivative.
(Spec., p. 4, l. 23.)
2 Di Ianni et al., “In Vivo Demethylation of a MoMuLV Retroviral Vector
Expressing the Herpes Simplex Thymidine Kinase Suicide Gene by 5'
Azacytidine,” 18 Stem Cells 415-21 (2000).
3 Jones and Taylor, “Cellular Differentiation, Cytidine Analogs and DNA
Methylation,” 20 Cell 85-93 (1980).
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to be based on the same grounds. Appellants do not make separate
arguments for the limitations recited in these groups of claims, asserting
only that the limitations are not taught by the prior art cited. Thus, we focus
on claim 74. See 37 C.F.R. § 41.37(c)(1)(vii) (“When multiple claims
subject to the same ground of rejection are argued as a group by appellant,
the Board may select a single claim from the group of claims that are argued
together to decide the appeal with respect to the group of claims as the
ground of rejection on the basis of the selected claim alone. . . . A statement
which merely points out what a claim recites will not be considered an
argument for separate patentability of the claim.”). We accept the
Examiner’s findings of fact regarding the rejections of the other claims.
The Examiner finds that Di Ianni inherently teaches a vector
comprising CpG motifs modified as claimed because it teaches incubating
cells that contain the MoMuLV vector with 5'-azacytidine. (Ans. 5-6 and
10-11; see Di Ianni, p. 416.) As evidence that the treatments taught in Di
Ianni necessarily create modified CpG motifs, the Examiner cites to
Example 1 of Appellants’ specification, which demonstrates a method
similar to that used in Di Ianni. Specifically, Example 1 recites producing
methylation-resistant plasmid DNA in bacteria by incubating cells
containing a plasmid of interest with medium containing 5'-deoxy-
azacytidine or another deoxy-cytosine analogue. (Spec. 21-22; see also
Spec. 22-23, Example 2.) Because Di Ianni does not teach vectors with CpG
motifs modified by the addition of 5-deoxyazacytidine, the Examiner cites
Jones, which teaches that 5-azadeoxycytidine can modify cytosine residues
to inhibit DNA methylation and is the functional equivalent of 5'-
azacytidine. (Ans. 5; Jones Abstract.) Thus, the Examiner rejected
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Appellants’ claims because those in the art would have considered it obvious
to substitute 5'-azacytidine of Di Ianni with the 5'-deoxyazacytidine of Jones
to modify the cytosines of CpG motifs in order to resist DNA methylation,
for regulation of gene expression. (Ans. 5; see also Di Ianni, p. 415, Jones,
p. 85.)
Appellants argue that the methods reported in Di Ianni are not the
same as those recited in Appellants’ specification (Reply Br. 4-5), but they
do not identify differences between the steps they used to produce the
claimed vectors and the steps taught by Di Ianni. Instead, Appellants argue
that the reason Di Ianni teaches these steps (to see the impact of transgene
silencing) is different from the reason Appellants performed these steps (to
produce a vector). (Reply Br. 5.) Even if a process is carried out for a
different reason, if it is the same process, the same product is necessarily
produced. Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366
(Fed. Cir. 1999).
Appellants also argue that the methods differ because Di Ianni teaches
affecting every cell in the culture medium, which Appellants assert is
inferior to the methods exemplified in their specification. (App. Br. 8-9;
Reply Br. 5-6.) Appellants’ claims do not include limitations for efficiency.
Appellants have not shown that the vectors taught by Di Ianni are distinct
from those claimed.
Appellants have failed to show that there are specific differences
between the steps taught by Di Ianni and those Appellants performed such
that the claimed vectors would not have been produced by Di Ianni when
using the 5'-deoxyazacytidine taught by Jones.
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Appellants argue that Di Ianni does not teach “replac[ing]” cytosines
in a CpG motif with 5'-azacytidine, but only teaches applying the modified
residue to vectors in culture. (App. Br. 8.) According to Appellants, the
MoMuLV vector does not correspond to the claimed vector, even though it
includes CpG motifs, because it was transferred into the host cell before
treatment began. (Reply Br. 4.) We are not persuaded by this argument
because the Examiner did not rely on the vector transferred into the host cell
as rendering the claimed vector obvious, but instead on the vectors produced
by the cells after treatment with 5'-azacytidine. Appellants produced
modified vectors using the same procedure. (Ans. 6 and 10.) Appellants fail
to explain how the claim term “replaced” distinguishes the vectors produced
by the steps taught in Di Ianni from the vectors produced by the steps used
in Appellants’ Examples 1 and 2.
We are also not persuaded by Appellants’ argument that the Examiner
impermissibly relied on methods disclosed in Appellants’ specification
(Reply Br. 4, n. 3). It is proper for the Examiner to rely upon the
specification to understand the claimed subject matter so that it can be
compared to the prior art.
ORDER
Upon consideration of the record and for the reasons given, the
rejection of claims 74-96 under 35 U.S.C. § 102(e) over Di Ianni and Jones
is AFFIRMED.

AFFIRMED

KMF