Ex Parte Samuelson et al

Board of Patent Appeals and Interferences

Feb 10, 2009

10958452 (B.P.A.I. Feb. 10, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LYNNE A. SAMUELSON,
FERDINANDO BRUNO, SUKANT K. TRIPATHY,
SUSAN TRIPATHY, RAMASWAMY NAGARAJAN,
JAYANT KUMAR, and WEI LIU
__________

Appeal 2008-5927
Application 10/958,452
Technology Center 1600
__________

Decided:1 February 10, 2009
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

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).

Appeal 2008-5927
Application 10/958,452

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of modulating the conformation of DNA, which the Examiner has rejected
as failing the enablement requirement. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.

Statement of the Case
The Claims
Claims 16 and 21-27 are on appeal. We will focus on claim 16, which
is representative and reads as follows:
16. A method of modulating the conformation of DNA
(deoxyribonucleotides) double helix which is bound to
polyaniline in a complex, comprising changing the oxidation
state of the polyaniline.

The Examiner rejected claims 16 and 21-27 under 35 U.S.C. § 112,
first paragraph as failing to comply with the enablement requirement (Ans.
3-9).
The Examiner reasons that
the specification does not provide any example or other form
of enabling guidance as to how the changes in oxidation
state of polyaniline-dsDNA is to be used in a method that
has utility, and no declaration has been filed which would
show that appellants have been able to use the invention in
the manner disclosed, using the guidance provided. This
lack of showing, and the teachings of Zhang et al., some 9
years post effective filing date, all point to the instant
disclosure as not being enabling for the claimed invention.

(Ans. 11.)
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Appellants contend that the “claimed invention is described in detail
throughout the specification, including the manner and process of making
and using the invention, in clear and exact terms” (App. Br. 3). Appellants
specifically contend that “[p]age 21, Example 3, teaches the making of a
DNA-polyaniline complex in substantial detail, and describes, through page
25, the materials, the sources of the materials, and the purity, weight, and
sterilization of such materials” (App. Br. 5).
In view of these conflicting positions, we frame the enablement issue
before us as follows:
Did the Examiner err in finding that it would have required undue
experimentation on how to use the method of modulation of a DNA double
helix bound to polyaniline in a complex?
Findings of Fact (FF)
Breadth of the Claims
1. The Examiner finds that the claims encompass the
“manipulation of the state of oxidation of polyaniline, which has formed on
a dsDNA molecule, and as such, the change in the oxidation state of the
polyaniline will have an effect of the conformation of the dsDNA that has
served as a scaffold for the formation of polyaniline” (Ans. 8).
Presence of Working Examples
2. The Specification teaches “formation of a polyelectrolyte
complex of DNA-polyaniline” (Spec. 25, l. 6).
3. The Specification teaches that the “secondary structure of DNA
was readily controlled by . . . changing the extent of oxidation of polyaniline
. . . . The neutralization of polyaniline minimized the electrostatic interaction
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between the DNA and polyaniline resulting in the uncoiling of DNA, back to
its native state” (Spec. 26, ll. 3-9).
Amount of Direction or Guidance Presented
4. The Specification teaches that “the chirality and electrical
properties of polyaniline combined with the selectivity of DNA may be
useful in the design of highly specific biosensors” (Spec. 25, ll. 26-28).
5. Figure 8 of the Specification is reproduced below:

“Fig. 8 is a schematic representation of polyaniline bound to a DNA double
helix” (Spec. 5, l. 12).
6. The Specification teaches one use of the DNA/polyaniline
complex is for “a method of identifying a target polynucleotide by
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contacting the target polynucleotide with a probe which includes a
polynucleotide/conductive polymer complex that can bind to a target
polynucleotide by hybridization” (Spec. 15, ll. 22-25).
7. The Specification teaches that the polynucleotide binding
incorporates “noncanonical base-pairing schemes such as triple helix
formation . . . and quadruplex formation” (Spec. 18, ll. 9-12).
8. The Specification teaches that “changing the oxidation state of
polyaniline bound to a DNA duplex changes the linear length of a helical
turn and, therefore, could be used to study the binding properties of DNA
regulatory proteins” (Spec. 4, ll. 14-16).
State of the Art and Unpredictability of the Art
9. The Examiner finds that “the example does not disclose any
nucleic acid hybridization event, or the application of any change in [the]
oxidation state of polyaniline of dsDNA” (Ans. 6).
10. Zhang teaches
Although kinds of synthesizing methods have been
established, preparation of one-dimensional nano-structured
PANI with controllable morphologies and sizes, especially
well oriented arrays on a large scale is still a major
challenge. Furthermore, the exact formation mechanisms of
the nanostructures need to be elucidated from a scientific
point of view, which will be of great importance in
morphological control of PANI and other polymers prepared
by precipitation polymerization.

(Zhang 17, col. 2.)
11. The Examiner finds that the “dsDNA was encased within a
shell of polyaniline. Applicant has not disclosed how one is to use dsDNA
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to detect anything of interest when the polynucleotide is encased in
polyaniline” (Ans. 10).
Quantity of Experimentation necessary
12. The Examiner finds that the “quantity of experimentation
necessary is great . . . and then with little if any reasonable expectation of
successfully enabling the full scope of the claims” (Ans. 4).
13. The Examiner finds that “[a]s for using polyaniline on dsDNA
for some form of ‘biosensing,’ such methodology is for the public to identify
and enable, as there is no guidance as to how any form of biosensing is to be
practiced” (Ans. 10).
Principles of Law
“In order to satisfy the enablement requirement of section 112, an
applicant must describe the manner of making and using the invention ‘in
such full, clear, concise, and exact terms as to enable any person skilled in
the art ... to make and use the same ....’ 35 U.S.C. § 112, para. 1.”
Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1322 (Fed. Cir.
2005).
The Court has explained that “‘the how to use prong of section 112
incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the
specification disclose as a matter of fact a practical utility for the
invention.’” In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999), quoting
In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir. 1993). “Patent protection is
granted in return for an enabling disclosure . . . , not for vague intimations of
general ideas that may or may not be workable.” Genentech Inc. v. Novo
Nordisk, A/AS, 108 F.3d 1361, 1365 (Fed. Cir. 1997). “Tossing out the mere
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Application 10/958,452

germ of an idea does not constitute enabling disclosure. While every aspect
of a generic claim certainly need not have been carried out by an inventor, or
exemplified in the specification, reasonable detail must be provided in order
to enable members of the public [skilled in the art] to understand and carry
out the invention.” Id. at 1366 (emphasis added).
Factors to be considered in determining whether a
disclosure would require undue experimentation . . . include
(1) the quantity of experimentation necessary, (2) the
amount of direction or guidance presented, (3) the presence
or absence of working examples, (4) the nature of the
invention, (5) the state of the prior art, (6) the relative skill
of those in the art, (7) the predictability or unpredictability
of the art, and (8) the breadth of the claims.

In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
The Examiner has the initial burden to establish a reasonable basis to
question the enablement provided for the claimed invention. See In re
Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993) (Examiner must provide a
reasonable explanation as to why the scope of protection provided by a
claim is not adequately enabled by the disclosure).
Analysis
The Specification provides substantial teachings regarding methods of
making polyaniline-DNA complexes, including working examples (FF 2-3).
The Examiner’s rejection is focused not on the “how to make” prong of
enablement, but on the “how to use” prong (see Ans. 10).
Claim 16 is drawn to a method of “modulating the conformation of
DNA (deoxyribonucleotides) double helix which is bound to polyaniline in a
complex” (Claim 16). Claims 16 and 21-27 do not identify any specific use
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which results from modulation of the DNA conformation (see Claims 16 and
21-27).
The Specification does identify two specific uses for a
polyaniline/DNA complex; first as a biosensor for hybridization and second
as a biosensor for binding to proteins (FF 4-8). However, the Specification
does not explain or exemplify how DNA which is bound to polyaniline can
function as a biosensor (see FF 5, where figure 8 of the Specification shows
the double stranded DNA surrounded by the polyaniline). The Specification
does not provide a use for a method of simply modulating the conformation
of DNA bound to polyaniline in a complex as required by claim 16.
The Examiner cites Zhang, who generically discusses challenges in
polyaniline formation and use (FF 10). The Examiner then provides specific
scientific reasoning regarding the inability of a polyaniline-DNA complex to
bind to either regulatory proteins or other DNA molecules (FF 9, 11). In
view of the disclosed arrangement of polyaniline on the DNA molecule (FF
5), the Examiner reasonably concludes that it is unpredictable whether the
encased polyaniline-DNA complex would permit hybridization or protein
binding. The Examiner also reasonably finds that in the absence of any
teaching of specific protocols or methods on how to use the DNA-
polyaniline complex in the Specification, the quantity of experimentation
would be large (FF 12-13).
Consequently, if the two specific uses of modulating the conformation
of a polyaniline-DNA complex in the Specification require undue
experimentation to satisfy the “how to use” prong of enablement, then the
method of modulating the DNA conformation of claim 16 also requires
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undue experimentation since the method will not satisfy the “how to use”
prong of the enablement inquiry.
Balancing the Wands factors, we agree with the Examiner that undue
experimentation would have been required to use the claimed invention.
With a Specification that only teaches methods of making the DNA-
polyaniline complex (FF 2-8), with no guidance as to how modulating the
DNA-polyaniline complexes results in a practical, real world use, such as
use as a biosensor (FF 9-11), the significant experimentation required for use
the polyaniline-DNA complex in the claimed method, and the
unpredictibilty of the prior art, we conclude that it would require an undue
amount of experimentation to use the polyaniline-DNA complex in a method
of modulating conformation as set forth in the claim 16.
We are not persuaded by Appellants’ argument that the Specification
describes how “to combine the recognition capabilities of DNA with the
doping dependent electrical properties of polyaniline for developing
methods for highly selective DNA detection and biosensing” (App. Br. 7).
While Appellants contend that the DNA-polyaniline complex can be used as
a biosensor (FF 2), the Specification does not teach any specifics on how to
use the DNA-polyaniline as a biosensor (FF 9-11). Nor does the
Specification provide any specific teachings which overcome the issues
raised by the Examiner regarding how to bind probes or regulatory proteins
to DNA which is encased in polyaniline (FF 9, 11).
Appellants have provided no specific evidence regarding methods of
using the DNA-polyaniline complex for hybridization or protein binding. At
best, Appellants argue that the methods may be used. See In re Pearson,
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494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot
take the place of evidence.”).
Conclusions of Law
The Examiner did not err in finding that it would have required undue
experimentation on how to use the method of modulation of a DNA double
helix bound to polyaniline in a complex.
SUMMARY
In summary, we affirm the rejection of claim 16 under 35 U.S.C. §
112, first paragraph enablement. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 21-27 as these
claims were not argued separately.
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)(2006).
AFFIRMED

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