Ex Parte Chia et al

Patent Trial and Appeal Board

Jul 9, 2013

11978433 (P.T.A.B. Jul. 9, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LI-LIANG SHEN CHIA and TERRY MICHAEL WILLIAMS
__________

Appeal 2012-003608
Application 11/978,433
Technology Center 1600
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Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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Application 11/978,433

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STATEMENT OF CASE
Representative Claim

1. A synergistic microbicidal composition; said composition
comprising:
(a) a silver-containing copolymer comprising polymerized units of a
monomer X and a monomer Y;
wherein the copolymer comprises 5 wt% to 11.5 wt% silver, based on
total copolymer weight; and wherein monomer X is N-vinylimidazole and
monomer Y comprises at least one C2-C8 alkyl (meth)acrylate; and
(b) 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one, 2-n-octyl-4-
isothiazolin-3-one, a 3:1 mixture of 5-chloro-2-methyl-4-isothiazolin-3-one
and 2-methyl-4-isothiazolin-3-one, C12-C16 alkyl dimethylbenzylammonium
chloride, C9-C15 alkyltolylmethyl trimethylammonium chloride,
benzisothiazolin-3-one, hydrogen peroxide, sodium hypochlorite,
glutaraldehyde, 5-chloro-2-(2,4-dichlorophenoxy)phenol, 3-iodo-2-
propynylbutyl carbamate or a combination thereof;
wherein a ratio of silver to 4,5-dichloro-2-n-octyl-4-isothiazolin-3-one
is from 1:0.14 to 1:15, a ratio of silver to 2-n-octyl-4-isothiazolin-3-one is
from 1:0.039 to 1:8360, a ratio of silver to a 3:1 mixture of 5-chloro-2-
methyl-4-isothiazolin-3-one and 2- methyl-4-isothiazolin-3-one is from 1:
0.039 to 1:140, a weight ratio of silver to C12-C16 alkyl
dimethylbenzylammonium chloride is from 1:19.6 to 1:980, a weight ratio of
silver to C9-C15 alkyltolylmethyltrimethylammonium chloride is from 1:39.2
to 1:1152, a weight ratio of benzisothiazolin-3-one to silver is from 1:0.0002
to 1:1, a weight ratio of hydrogen peroxide to silver is from 1:0.000005 to
1:0.01, a weight ratio of sodium hypochlorite to silver is from 1:0.008 to
1:200, a weight ratio of glutaraldehyde to silver is from 1:0.00006 to
1:0.047, a weight ratio of 5-chloro-2-(2,4-dichlorophenoxy)phenol to silver
is from 1:0.00011 to 1:0.57 and a weight ratio of 3-iodo-2-propynylbutyl
carbamate to silver is from 1:0.000002 to 1:80.

Cited References

Costerton US 4,542,169 Sep. 17, 1985
Ghosh et al. US 2005/0227895 A1 Oct. 13, 2005

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Grounds of Rejection
Claims 1 and 3-7 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ghosh in view of Costerton.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 4-
6.

Discussion
ISSUE
The Examiner concludes that Ghosh teaches the silver containing
polymer (a) combination, however,
Ghosh fails to teach the composition as comprising 4,5-
dichloro-2-n-octyl-4-isothiazolin-3- one (DNOI) wherein the
ratio of silver to DNOI is from 1:0.14 to 1:15.
Costerton is directed to biomedical devices that control
bacterial growth. The invention provides a biomedical device
for controlling bacteria which comprises an elastomer and a 3-
isothiazolinone combined with a metal salt such as silver nitrate
(see column 3, lines 1-15 and claim 1). An exemplified and
preferred 3-isothiazolinone is DNOI (see column 4, line 50 and
Tables III and A). The amount of metal salt to the
isothiazolinone ranges from about 1 to 60 percent, based on
weight of isothiazolinone and metal salt (see column 2, lines
65-68).
Therefore, it would have been obvious to one of ordinary
skill in the art at the time the invention was made to combine
the teachings of Ghosh and Costerton with a reasonable
expectation for success in arriving at a synergistic microbicidal
composition comprising a silver containing copolymer, said
copolymer comprising vinylimidazole, butyl acrylate and
acrylic acid and further comprising DNOI wherein the ratio of
silver to DNOI is from 1:0.14 to 1:15. The composition of a
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copolymer comprising silver with another antimicrobial agent
such as a 3-isothiazolinone is well known, as demonstrated by
Ghosh. While the inclusion of DNOI is not taught by Ghosh,
its inclusion would have been obvious in view of the Costerton.
As Ghosh suggests including further antimicrobial agents such
as 3-isothiazolinones, one would have looked to the art for
various 3-isothiazolinones that have antibacterial activity to
include in the composition of Ghosh. Costerton teaches using
DNOI in combination with a silver salt such as silver nitrate in
order to stabilize the isothiazolinone. In addition to
antimicrobial activity, Costerton teaches that silver salts also
provide a stabilizing effect to the isothiazolinone. Thus, one
would have been motivated to use silver with DNOI with a
reasonable expectation for success in not only providing further
antibacterial effect but also a stabilizing benefit. Costerton
suggests employing silver salt in an amount of about 1-60% by
weight which obviates Applicants instantly claimed range.

(Ans. 5-6.)

Appellants argue that no synergistic interactions are disclosed or
suggested in Ghosh or Coserton. (App. Br. 11.) Appellants argue that a
Declaration has attested to the fact that both the existence of biocide synergy
and the particular ratios over which a pair of biocides exhibit synergy cannot
be predicted. However, the final Office Action does not acknowledge the
declaration in any way. (id.)
The issue is: Does the cited prior art support the Examiner’s
conclusion that the claimed subject matter is obvious? Have Appellants
rebutted the Examiner’s prima facie case of obviousness with Declaration
evidence?

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PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“After a prima facie case of obviousness has been established, the
burden of going forward shifts to the applicant. Rebuttal is merely „a
showing of facts supporting the opposite conclusion,‟ and may relate to any
of the Graham factors including so-called secondary considerations.” In re
Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984) (citations omitted).
See also, Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir.
2007), holding secondary considerations may not be sufficient to overcome a
prima facie case. (“[W]e hold that even if Pfizer showed that amlodipine
besylate exhibits unexpectedly superior results, this secondary consideration
does not overcome the strong showing of obviousness in this case.
Although secondary considerations must be taken into account, they do not
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necessarily control the obviousness conclusion. Newell Cos., Inc. v. Kenney
Mfg. Co., 864 F.2d 757, 768 (Fed.Cir.1988)”).
“It is well established that the objective evidence of nonobviousness
must be commensurate in scope with the claims.” In re Lindner, 457 F.2d
506, 508 (CCPA 1972).
“[C]ommensurate in scope” means that the evidence provides a
reasonable basis for concluding that the untested embodiments encompassed
by the claims would behave in the same manner as the tested
embodiment(s). See In re Lindner, 457 F.2d at 508.
“Selecting a narrow range from within a somewhat broader range
disclosed in a prior art reference is no less obvious than identifying a range
that simply overlaps a disclosed range. In fact, when . . . the claimed ranges
are completely encompassed by the prior art, the conclusion is even more
compelling than in cases of mere overlap. The normal desire of scientists or
artisans to improve upon what is already generally known provides the
motivation to determine where in a disclosed set of percentage ranges is the
optimum combination of percentages.” In re Peterson, 315 F.3d 1325,
1329-1330 (Fed. Cir. 2003).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellants’ arguments as set forth in the Answer. We find
that the Examiner has provided adequate evidence to support a prima facie
case of obviousness. We provide the following additional comment.
We agree that the Answer sets forth a prima facie case of obviousness
at pages 4-6. The Examiner‟s rationale for combining the cited references
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does not have to be the same as Appellants. In re Kemps, 97 F.3d 1427,
1430 (Fed. Cir. 1996). Thus, the Examiner need only provide a rationale
why one of ordinary skill in the art would have combined the same elements
in a similar manner. Synergy need not be the motivation found by the
Examiner as long as a rationale or motivation is provided by the Examiner.
In the present case, the Examiner reasonably found that
it would have been obvious to one of ordinary skill in the art at
the time the invention was made to combine the teachings of Ghosh
and Costerton with a reasonable expectation for success in arriving at a
synergistic microbicidal composition comprising a silver containing
copolymer, said copolymer comprising vinylimidazole, butyl acrylate
and acrylic acid and further comprising DNOI wherein the ratio of
silver to DNOI is from 1:0.14 to 1:15. The composition of a copolymer
comprising silver with another antimicrobial agent such as a 3-
isothiazolinone is well known, as demonstrated by Ghosh. While the
inclusion of DNOI is not taught by Ghosh, its inclusion would have
been obvious in view of the Costerton. As Ghosh suggests including
further antimicrobial agents such as 3-isothiazolinones, one would have
looked to the art for various 3-isothiazolinones that have antibacterial
activity to include in the composition of Ghosh. Costerton teaches
using DNOI in combination with a silver salt such as silver nitrate in
order to stabilize the isothiazolinone. In addition to antimicrobial
activity, Costerton teaches that silver salts also provide a stabilizing
effect to the isothiazolinone.

(Ans. 5-6.) We find this rationale sufficient to support a prima facie case of
obviousness.
In rebuttal, the Appellants put forth the Declaration of Dr. Terry M.
Williams, dated Sept. 2, 2009. Appellants argue that, “The declarant has
attested to the fact that both the existence of biocide synergy and the
particular ratios over which a pair of biocides exhibit synergy cannot be
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predicted. However, the final Office Action does not acknowledge the
declaration in any way.” (App. Br. 11.)
In response to Appellants‟ Declaration, the Examiner argues that,
“Appellant does not show/exemplify the criticality of their instantly claimed
ranges, especially in view of the prior art references.” (Ans. 7.) The
Examiner further argues that, “Appellant has not provided even one piece of
data in their declaration to illustrate such synergistic benefit, but rather
expects the Office to believe the assertion that synergism exists over the
entire range being claimed.” (Id. at 7-8.)
We too, are not persuaded by Appellants‟ Declaration or the
synergistic data set forth in the Specification at pages 9-26. In particular, we
have reviewed the data from the Specification and the Declaration.
According to the Specification, paragraph [0040], describing and
interpreting the data from the Specification indicates, “When the sum of
Ca/CA and Cb/CB is greater than one, antagonism is indicated. When the sum
is equal to one, additivity is indicated, and when less than one, synergism is
demonstrated. The lower the SI, the greater the synergy shown by that
particular mixture.”
Reviewing Appellants data for E.coli and C. albicans in Table 1
(Spec. p. 9), for example, the data shows instances of antagonism, additivity
and synergism within the claimed ratios, in accordance with Appellants
definitions and data interpretation in para. [0040]. “[O]bjective evidence of
non-obviousness must be commensurate in scope with the claims which the
evidence is offered to support.” In re Greenfield, 571 F.2d 1185, 1189
(CCPA 1978) (quotations omitted). Moreover, nowhere in the Declaration
or Specification are elements of the data explained in a manner to support
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synergy for the full scope of the claims. That is, even limiting the inquiry to
the microbes and ratios shown by Appellants in their data tables, the data
itself does not show synergistic results for a large proportion of the tests. In
addition, there is no discussion in the Specification or Declaration
identifying a threshold value of synergism which would have been
unexpected, relative to a de minimis amount of synergism, so the scope of
data cannot be clearly evaluated (see, e.g. Spec. 14, table 6, where S. aureus
shows a “SI” of 0.97 at 24 hour contact time and ratio of 1:192 and a “SI” of
1.01 at 48 hour contact time and ratio of 1:192, where one is deemed
synergistic and the other antagonistic by the definition in the Specification
discussed above). Although secondary considerations must be taken into
account, they do not necessarily control the obviousness conclusion. Newell
Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988).
In the present case, we find that the Declaration evidence is
insufficient to overcome the Examiner‟s prima facie case of obviousness, as
it is not commensurate in scope with the pending claims and fails to rebut
the prior art suggestion of similar components in similar amounts. The
obviousness rejection is affirmed for the reasons of record. Arguments not
made by Appellants are waived.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection,
which is not rebutted by Appellants with sufficient evidence.

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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

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