Ex Parte Snow et al

Board of Patent Appeals and Interferences

Sep 22, 2008

10384172 (B.P.A.I. Sep. 22, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ALAN D. SNOW, KEN-ICHIRO FUKUCHI, and
JOHN HASSELL
__________

Appeal 2008-2531
Application 10/384,172
Technology Center 1600
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Decided: September 22, 2008
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Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for making a transgenic mouse. The Examiner has rejected the claims as
nonenabled and indefinite. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Appeal 2008-2531
Application 10/384,172

INTRODUCTION
Claims 1 and 3 are pending and on appeal. Claims 1 and 3 read as
follows:
1. A method for making a transgenic mouse, the method
comprising the steps of first; selecting appropriate restriction sites for
ligation of cDNA clones, and ligating together 7 overlapping cDNA clones
to produce a ligated cDNA clone that encodes for perlecan’s ∼400 kilodalton
core protein, second; microinjecting this cDNA construct into a fertilized
egg, then third; transplanting the embryo formed after the microinjection
into a foster mother to produce a neonate mouse whose genome and somatic
cells express the perlecan’s transgene.
3. The method of Claim 1 further comprising the following steps
within the first step:
a) constructing a plasmid (pFrontEnd) from clone 19-J (-XbaI),
clone 54 and clone DIII, by isolating the 3.3 kilobase SalI/XbaI fragment
isolated from clone DIII, isolating the 1.4 kilobase Not I/Bcl I DNA
fragment from clone 19-J (XbaI) and cloning it into the NotI and Bcl sites of
clone 54 to produce clone 19-J/54, isolating the 1.8 kilobase NotI/Sal I DNA
fragment from clone 19-J/54 and ligating it onto the Sal I site of the
3.3 kilobase SalI/XbaI fragment isolated from clone DIII, and cloning a
resulting 5.1 kilobase Not I/Xba I fragment into the Not I and Xba I site of
pBluescript I to produce clone pFrontEnd;
b) constructing a plasmid (pBackEnd) from clone DV and
clone 12, to introduce a Hind III site into clone DV by replacing the XhoI
site in clone DV with a Hind III site using Hind III linkers to produce
clone DV with a Hind III site, and isolating the 3.2 kilobase Xba I/Cla I
fragment from clone 12 and cloning it into the Xba I/Cla I sites of clone DV
with a Hind III site from which a smaller Xba I/Cla I fragment is previously
removed to produce clone pBackEnd;
c) constructing a clone pF+ B by connecting together the
p Front End and p Back End plasmids from step a) and step b), and cloning
the 5.1 kilobase NotI/Xba I fragment from step a) into the same restriction
enzyme sites of p Back End;
d) constructing a plasmid (p Missing Link) from clone 72 and
clone 7 by isolating a 1.5 kilobase NotI/Hind III fragment isolated from
clone 72 and a 2.2 kilobase Hind III/Bam HI fragment from clone 7 and
cloning them respectively into the NotI and Bam HI sites of pBluescript I to
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Application 10/384,172

produce clone 72/7, and isolating a 190 base pair Ppu MI fragment from
clone 7 and inserting it into a restriction enzyme site in clone 72/7 from
which smaller Ppu MI fragments have been previously removed;
e) inserting the cDNA of p Missing Ling into pF+ B, isolating
a 2.8 kilobase Nru I/Bss HII fragment from p Missing Link and cloning it
into the NFu I and Bss HII sites of pF+ B from which a small Nru I/Bss HII
fragment has been removed to produce plasmid pBS DI-V.
ENABLEMENT
Claims 1 and 3 stand rejected under 35 U.S.C. § 112, first paragraph,
“as failing to comply with the enablement requirement” (Ans. 4). The
claims have not been argued separately and therefore stand or fall together.
37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds:
to practice the invention as claimed, one skilled in the art would
require[] the possession of at least 14 structurally distinct
cDNA clones, which are i) not well known and ii) are not
readily available from publically accessible mouse cDNA
libraries . . . or iii) could not be readily made in a repeatable
fashion in accordance with the teachings of the instant
specification especially using figures 2A-2G of the drawings.
(Ans. 7-8.) Specifically, the Examiner finds that the following clones are
required: clone 19-J, clone 54, clone DIII, clone 54, clone 19-J/54, clone
pFront End, clone DV, clone 12, clone p back end, clone pF+ B, p Missing
link, clone 72, clone 7, clone 72/7, plasmid pBS DI-V (id. at 4). The
Examiner also finds that, because the “elements required for practicing the
instant invention are not known and readily available to the public or
obtainable by a repeatable method set forth in the instant specification[,] . . .
it would require an undue experimentation to practice the invention as
claimed” (id. at 8).
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Application 10/384,172

“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993). With regard to a method claim, “the application must be
adequate to teach how to practice the claimed method. If such practice
requires particular [material], . . . it is axiomatic that the application must
therefore provide a sufficient disclosure of that [material] if such is not
already available.” In re Ghiron, 442 F.2d 985, 991 (CCPA 1971).
It is undisputed that practicing the claimed method requires at least
the following seven clones: clone 19-J, clone 54, clone DIII, clone DV,
clone 12, clone 72, and clone 7 (claim 3; Ans. 4 & 8). Appellants assert that
“[a]ll the clones are either publically available from supply houses, or are
created as part of the overall ligation process, and the disclosure readily
teaches how this may be done” (Br. 3).
In particular, Appellants generally refer to Specification Figures 2A-
2G as illustrating the clones (Br. 4). “Figures 2A-2G are schematics
showing the construction strategy of the full-length cDNA for perlecan core
protein using plasmid clones containing cDNAs for overlapping parts of
perlecan” (Spec. 9). Figures 2A-2G do not appear to describe how to make
clones 19-J, 54, DIII, DV, 12, 72, and 7, which are starting materials in the
construction strategy depicted in these figures. Thus, Appellants have not
shown that the Specification teaches how to make these seven clones.
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In support of their position that the clones are publically available,
Appellants refer to Noonan1 (Br. 4). Noonan identifies clones 12, 54, and
72 (see, e.g., Fig. 2). However, Appellants have not pointed to, nor did we
find, any disclosure in Noonan that these clones are publically available. In
addition, we find no disclosure of clones 19-J, DIII, DV, or 7, which are
required to practice the claimed invention, in the Noonan reference.
Therefore, we agree with the Examiner that Appellants have not
provided sufficient evidence that these seven clones are publically available.
We therefore affirm the enablement rejection.
INDEFINITENESS
Claim 3 stands rejected under 35 U.S.C. § 112, second paragraph, “as
being indefinite” (Ans. 6). The Examiner finds that the scope of claim 3,
which “contains the trademark/trade name pBluescript I,” is uncertain
because “a trademark or trade name is used to identify a source of good, and
not the goods themselves. Thus, a trademark or trade name does not identify
or describe the goods associated with the trademark or trade name.” (Id.)
The Examiner also finds that “the relationship between a trademark and the
product it identifies is sometimes indefinite, uncertain, and arbitrary. The
formula or characteristics of the product may change from time to time and
yet it may continue to be sold under the same trademark.” (Id. at 10
(emphasis omitted).) In addition, the Examiner finds that “pBluescript I has
been not associ[at]ed with any particular structure” (id.).

1 Douglas M. Noonan et al., The Complete Sequence of Perlecan, a
Basement Membrane Heparan Sulfate Proteoglycan, Reveals Extensive
Similarity with Laminin A Chain, Low Density Lipoprotein-Receptor, and
the Neural Cell Adhesion Molecule, 266 JOURNAL OF BIOLOGICAL
CHEMISTRY 22939-22947 (1991).
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Application 10/384,172

Appellants assert that “‘pBluescript I’ is both a source identifier AND
a proper identifier of particular goods” (Br. 4). In particular, Appellants
argue:
The pBluescript I component is made by and available from
Stratagene Cloning Systems, as is made clear in the
specification; it is known to those skilled in the art by this
name, and known to identify a particular composition of
definite structure, which has been publically available from
Stratagene. Under such circumstances, “pBluescript” does not
just identify the source, it does in fact, at least to those in the
know, also identify the particular composition called out in the
specification and claims.
(Id. at 4-5.)
“A claim is indefinite if its legal scope is not clear enough that a
person of ordinary skill in the art could determine whether a particular
composition infringes or not.” Geneva Pharms., Inc. v. GlaxoSmithKline
PLC, 349 F.3d 1373, 1384 (Fed. Cir. 2003). Claim 3 requires cloning a
fragment into pBluescript I. It is undisputed that “pBluescript” is a
trademark (Ans. 9). It is also undisputed that a “formula or characteristics of
[a] product may change from time to time and yet it may continue to be sold
under the same trademark” (id. at 10 (emphasis omitted)).
The Specification states that pBluescript I vector is a product of
Stratagene (Spec. 49) and illustrates two restriction sites of the vector in
Figure 2C. We find Appellants’ description of the vector to be an
insufficient characterization of the vector recited in the claims. In view of
the limited information provided and the fact that a product may change and
continue to be sold under the same trademark, we agree with the Examiner
that claim 3 is indefinite. See Ex parte Simpson, 218 USPQ 1020 (BPAI
1982). We therefore affirm the indefiniteness rejection.
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Application 10/384,172

CONCLUSION
The Examiner’s position is supported by the preponderance of the
evidence of record. We therefore affirm the rejection of claims 1 and 3
under 35 U.S.C. § 112, first paragraph, and the rejection of claim 3 under
35 U.S.C. § 112, second paragraph.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED

LP

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