Ex Parte Kusama et al

Board of Patent Appeals and Interferences

Jun 8, 2009

10826119 (B.P.A.I. Jun. 8, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_________________

Ex parte TOYOKO KUSAMA, KOICHI KADOWAKI,
and TETSUYA NOMURA

Appellants
_________________

Appeal 2009-001929
Application 10/826,119
Technology Center 1600
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Decided1: June 9, 2009
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Before RICHARD TORCZON, SALLY GARDNER LANE and MICHAEL
P. TIERNEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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Application 10/826,119

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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134, is from a Final Rejection of claims
24, 25 and 35. Claims 1-23, 26-34, 36 and 37 have been withdrawn as being
drawn to non-elected subject matter. (App. Br. 2). We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
Appellants claim a primer pair and a kit comprising a primer pair for
the detection of a ruminant-specific DNA.
The Examiner relied on the following documents:
Saulle et al., Rapid Communication: Nucleotide Sequence of Chamois,
Alpine Ibex, and Red Deer tRNALys and ATPase8 Mitochondrial Genes, 77 J.
Animal Sci. 3398-99 (1999); and
Lowe et al., A Computer Program for Selection of Oligonucleotide
Primers for Polymerase Chain Reactions, 18 Nucleic Acids Res. 1757-61
(1990).
The Examiner rejected claims 24, 25 and 35 under 35 U.S.C.
§ 103(a) over Saulle and Lowe. We focus on claim 24 as a representative
claim. See 37 C.F.R. § 41.37(c)(1)(vii).
II. LEGAL PRINCIPLES
“If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S.
398, 417 (2007).
“When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the
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product not of innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might show that it
was obvious under § 103.” KSR, 550 U.S. at 421.
III. ISSUE
Would those of skill in the art have had a reason to select the
ruminant-specific DNA primers within the DNA sequence reported in
Saulle?
IV. FINDINGS OF FACT
1. Appellants’ claim 24 recites2:
A primer pair for detection of a ruminant-specific DNA,
the primer pair being
a combination of the DNA sequence of SEQ ID NO: 3
and the DNA sequence of SEQ ID NO: 4, or
a combination of the DNA sequence of SEQ ID NO: 5
and the DNA sequence of SEQ ID NO: 6.

(App. Br. 15, Claims App’x).
2. Appellants’ specification reports the results of PCR analysis
with primers of SEQ ID NO: 5 and SEQ ID NO: 6, demonstrating that
PCR products from DNAs derived from cattle, sheep, goat, and
deer which are ruminants, were more clearly observed (104 bp
band position). On the other hand, PCR products (DNA
fragments) could not be detected in the DNA samples of
animals that were not ruminants. . . . [T]he combination of Fpr-
F [SEQ ID NO: 5] and Fpr-R [SEQ ID NO: 6] is a primer pair
that specifically detects DNAs derived from animal species of
ruminant origin.

2 Claim 24 has been reformatted to add indentations. See 37 C.F.R. § 1.75(i).
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(Spec. 17-18).
3. Saulle teaches:
The considerable nucleotide variation of the tRNALys and
ATPase8 genes among species belonging to the Pecora
infraorder3 makes the tRNALys-ATPase8 coding region a very
informative target sequence in PCR-based assays for species
identification of meat and meat-derived products. By using an
appropriately designed species-specific primer pair within the
tRNALys-ATPase8-ATPase6 sequence, we developed a PCR-
based procedure for rapid detection and identification of bovine
mitochondrial DNA from animal feeds and complex food
matrices . . . .

(Saulle 3398, right col.).
4. Saulle teaches a genetic sequence, the tRNALys-ATPase8 of
alpine ibex, which contains within it the sequence of SEQ ID NO: 5 and
SEQ ID NO: 6 recited in Appellants’ claim 24. (Saulle 3399, left col.;
SCORE Search Results).
5. Saulle does not teach where the specific sequences of SEQ ID
NOS: 5, or 6 begin or end.
6. Those of skill in the art would have known how to obtain
primers from a genetic sequence using the algorithms taught in Lowe or
other similar algorithms.
V. ANALYSIS
Appellants’ claim 24 recites primer pairs with specific DNA
sequences. The primer pairs are used “for detection of a ruminant-specific
DNA . . . .” (FF 1). “A mere statement of a new use for an otherwise old or

3 We understand the “Pecora infraorder” to include most ruminants.
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obvious composition cannot render a claim to the composition patentable.”
In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Thus, if it would have
been obvious for those of skill in the art to determine the sequence of the
claimed primer pairs, Appellants’ claims are not patentable under 35 U.S.C.
§ 103(a).
Saulle teaches that the ATPase8 gene sequence is informative for
species identification in meat products, specifically detection of bovine
DNA. (FF 3). Saulle teaches a DNA sequence, from alpine ibex, which
includes within it the sequence of SEQ ID NOs: 5 and 6 (FF 4), but does not
identify where the sequences of SEQ ID NOs: 5 or 6 begin or end. (FF 5).
Lowe indicates that those of skill in the art knew how to derive operable
primers from larger DNA sequences. (FF 6).
Those of skill in the art would have had reason to identify and isolate
ruminant-specific primers in the alpine ibex APTase8 gene sequence because
Saulle teaches that these primers are useful for detection of bovine DNA.
Lowe teaches that those skilled in the art would have been able to identify
and isolate primers with the alpine ibex ATPase8 gene sequence. Thus, it
would have been obvious to use the method of Lowe to produce substitute
primers for detection of ruminant-specific DNA. See KSR, 550 U.S. at 417,
421.
Appellants agree that “Saulle et al discloses the complete nucleic acid
sequence to be detected,” (App. Br. 5), but argue that
[a]s long as the target sequence to be amplified cannot be
selected appropriately, even if the known nucleic acid sequence
of Saulle et al is combined with the step of generating and
designing primers as taught by Lowe et al, the specific
combination of primers of the claimed invention could not be
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obtained by those skilled in the art. In other words, one skilled
in the art would not have expected to obtain primers capable of
discriminating between homologous sequences without
extensive experimentation to determine which primers actually
perform as desired in PCR. This is because Saulle et al does
NOT teach or suggest whether or not the ruminant DNA can be
actually detected without detecting DNAs other than the
ruminant DNA.

(App. Br. 5). We disagree with Appellants that Saulle does not teach
detection of ruminant DNA because it expressly states that the ATPase8
gene is “a very informative target sequence in PCR-based assays for species
identification of meat and meat-derived products.” (FF 3). Furthermore,
Saulle teaches that primer pairs have been developed from that gene for
detecting bovine DNA. (Id.). The Examiner found, relying upon Lowe, that
one skilled in the art would have been able to identify and isolate primers
within the sequence taught by Saulle. We accept this finding since the
record indicates that those of skill in the art would have been able to conduct
PCR experiments, such as those referred to in Saulle, to determine if a
primer pair could differentiate ruminant species. (See FF 2). Appellants
have argued, but not directed us to evidence showing, that it would have
required “extensive experimentation” to determine other primer pairs from
the alpine ibex ATPase8 gene, including those claimed. Appellants have not
shown that the identification of the primers would have been unexpected.
Unexpected results must be established with factual evidence, not attorney
arguments or conclusory statements. See In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997).
Appellants also argue that “while one skilled in the art might
conceivably expect Saulle et al to be useful in generating primers capable of
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amplifying an ATPase8 target, none of the optimization steps of Lowe et al
indicates that such primers can discriminate between two homologous
ATPase8 targets.” (App. Br. 6). The Examiner did not rely upon Lowe as
teaching the ability of primers from the ATPase8 sequence to discriminate
between homologous targets. This is taught by Saulle. Thus, we are not
persuaded that because Lowe lacks specific steps to compare sequences or
determine discriminatory primers, the claimed primer pairs would not have
been obvious.
Appellants argue that
a close reading of Lowe et al suggests that the program will not
produce the claimed primers. On page 1758, column 1, first
paragraph of Lowe et al, Lowe et al teaches that “[a]ll primers
should contain a GC-type sequence pair (i.e., either a CC, GG,
GC, or CG) at their 3’ end.” . . . None of the claimed primer
sequences have a GC-type sequence pair at their 3’ end.
Therefore, the program of Lowe et al will not produce any of
the claim[ed] primers regardless of any sequence entered into
the program.

(Reply Br. 4). Lowe supports the Examiner’s finding that at the time of
Appellants invention those ordinarily skilled in the art would have been able
to determine primer sequences from a larger genetic sequence. While some
of the specific rules of Lowe might not apply in identifying and isolating the
primers within the Saulle sequence, Appellants have not argued, nor directed
us to evidence showing, that one skilled in the art would have been unable to
identify primers within a larger sequence.
Finally, Appellants argue that “[t]hose having ordinary skill in the art
are normally motivated to select primers that flank the coding region for a
gene, since under such conditions the entire gene i[s] amplified by PCR for
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purposes of sequencing, cloning, or sub-cloning” (Reply Br. 5-6), but that
the claimed primer pairs are found “well within the coding region of the . . .
gene . . . .” (Reply Br. 6). While Appellants’ argument demonstrates that
those of skill in the art were capable of deriving primer sequences,
Appellants have not supported this specific argument with evidence that
those of skill in the art would not have looked to sequences within the
coding region to derive the claimed primers. “Argument of counsel cannot
take the place of evidence lacking in the record.” Meitzner v. Mindick, 549
F.2d 775, 782 (CCPA 1977). Accordingly, we are not persuaded by
Appellants’ argument.
VI. CONCLUSIONS OF LAW
Those of skill in the art have had a reason to search for ruminant-
specific DNA primers in the DNA sequence reported in Saulle.
VII. ORDER
Upon consideration of the record and for the reasons given, the
rejection of claims 24, 25, and 35 under 35 U.S.C. § 103(a) over Saulle and
Lowe is AFFIRMED.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED
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Application 10/826,119

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Gregory Turocy
Amin & Turocy, LLP
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