Ex Parte Zhu et al

Board of Patent Appeals and Interferences

Jun 22, 2009

10769603 (B.P.A.I. Jun. 22, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PETER C. ZHU and CHARLES G. ROBERTS
__________

Appeal 2009-0020061
Application 10/769,603
Technology Center 1600
__________

Decided:2 June 22, 2009
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 The real party in interest in this appeal is Ethicon, Inc. (App. Br. 3).
2 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 2009-002006
Application 10/769,603

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
germicidal compositions. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Claims 1, 4, 5, 8-12, 15, 18-21, 23, 25-28, and 30-34 stand rejected
and are on appeal (see App. Br. 3).3 Claims 1, 15, and 21 are representative
and read as follows:
1. A germicidal composition comprising:
a diluent;
phthalaldehyde; and
an amount of isophthalaldehyde to enhance the germicidal
efficacy of the phthalaldehyde,
wherein a concentration of the phthalaldehyde is 1% or less,
and
wherein the amount of isophthalaldehyde is sufficient to give a
weight ratio of the isophthalaldehyde to the phthalaldehyde that
is 5:1 or less.

15. A germicidal composition comprising:
a diluent;
phthalaldehyde; and
a material that is selected from the group consisting of
isophthalaldehyde, terephthalaldehyde, and a combination of
isophthalaldehyde and terephthalaldehyde, to reduce a staining
property of the phthalaldehyde and enhance an efficacy of the
phthalaldehyde, wherein a concentration of the phthalaldehyde
is from 0.1% to 1%, and wherein a concentration of the material
is from 0.05 to 2%.

3 Although the Appeal Brief lists claims 2, 3, 13, 14, 16, 17, 22, and 24 as
appealed claims, those claims are not subject to any ground of rejection (see
Ans. 4-5).
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21. A germicidal composition comprising:
a diluent;
a germicidal compound; and
an amount of isophthalaldehyde to enhance the germicidal
efficacy of the germicidal compound.

The Examiner cites the following documents as evidence of
unpatentability:
Yagi et al. US 6,429,220 B1 Aug. 6, 2002
Bratescu et al. US 2004/0071653 A1 Apr. 15, 2004

The following rejections are before us for review:
Claims 1, 4, 5, 9-11, 18-21, 23, 28, and 30-34 stand rejected under
35 U.S.C. § 103(a) as being obvious over Yagi (Ans. 3-5).
Claims 8, 12, 15, and 25-27 stand rejected under 35 U.S.C. § 103(a)
as being obvious over Yagi and Bratescu (Ans. 5-6).
OBVIOUSNESS -- YAGI
ISSUE
The Examiner cites Yagi as “teach[ing] an antibacterial composition
comprising a variety of antimicrobial agents such as phthalaldehyde,
isophthalaldehyde, and terephthalaldehyde . . . in water or a hydrophilic
organic solvent” (Ans. 4 (citations omitted)). The Examiner concedes that
Yagi “fail[s] to disclose these components in a single example” but reasons
that an ordinary artisan “would have been motivated to combine
phthalaldehyde, isophthalaldehyde, and terephthalaldehyde in a single
composition because of the reasonable expectancy of successfully producing
an antibacterial composition since each compound is well known to be
useful as [an] antimicrobial agent[]” (id. at 5).
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Regarding the limitations directed to weight ratios of the ingredients,
the Examiner urges that Yagi discloses that “[e]ach antimicrobial agent can
be employed from 0 to 30% by weight,” and reasons that the ingredient
ratios would have been “obvious to one of ordinary skill in the art to
optimize for the antibacterial composition. Generally, mere optimization of
ranges will not support the patentability of subject matter encompassed by
the prior art unless there is evidence indicating such concentration or
temperature is critical” (Ans. 4).
Appellants do not dispute whether the Examiner made a prima facie
case of obviousness. Instead, “Appellants . . . respectfully rebut this
rejection by submitting herewith a declaration pursuant to 37 C.F.R. § 1.132
signed by Harriet Chan-Myers” (App. Br. 12). Appellants argue that “the
amount of synergism [shown] in the declaration by Ms. Chan-Myers is
significant, is sufficiently greater than what would have been expected based
on the prior art, and is due to more than statistical variability” (id.).
Appellants also argue that “[t]o the extent the Declaration is not
commensurate with a portion of the scope of the claims, Appellants
respectfully submit that the nonobviousness of the entire claimed range is
supported by the data in the declaration showing unexpected results over a
narrower claimed range pursuant to MPEP 716.02(d)(I)” (id. at 13 (emphasis
removed)). Specifically, “Appellants respectfully submit that it is difficult
to perform experiments to demonstrate synergism at OPA [(phthalaldehyde)]
concentrations higher than 0.5%” because of the very fast bacterial kill rate
of OPA (id. at 13-14). Thus, it is urged, “[f]orcing the Appellants to limit
their claims to 0.5% merely because it is very difficult to collect
experimental data at concentrations higher than 0.5% would unfairly
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prejudice Appellants, since higher than 0.5% concentrations may easily be
used and will likely also exhibit the unexpected results that Appellants have
observed” (id. at 14).
Appellants further argue that “it is difficult to demonstrate unexpected
results at concentrations of isophthalaldehyde (IPA) greater than about
0.25%. The solubility of IPA in water is about 0.25%. In practice, a solvent
may readily be added to increase the solubility of the IPA” (id.). However,
Appellants urge, adding a solvent to the compositions “would make it
difficult to meaningfully interpret the experiments and to compare the results
to those where the solvent was not used, since the solvent itself may tend to
kill bacteria and/or alter the effect of the phthalaldehyde on the bacteria
(e.g., alter the bacteria’s barrier)” (id.).
Moreover, Appellants argue, “there is no known reason to believe,
and the Examiner has not indicated why there would be a reason to believe,
that the synergistic effects of a combined solution of OPA and IPA would
stop abruptly at the solubility limit of 0.25% IPA” (id. at 14-15). Rather, it
is urged:
Forcing the Appellants to limit their claims to 0.25% IPA
merely because it is a solubility limit and it is difficult to
demonstrate unexpected results are due to the IPA instead of
due to the solvent would unfairly prejudice Appellants, since
higher than 0.25% concentrations may easily be used by
addition of a solvent and will likely also exhibit the unexpected
results that Appellants have observed.

(Id. at 15.)
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether Appellants have shown that
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the Examiner erred in finding that Appellants’ evidence of unexpected
results was not sufficiently commensurate in scope with the claimed subject
matter so as to rebut the prima facie case of obviousness.
FINDINGS OF FACT (“FF”)
1. Yagi discloses “an antimicrobial composition which comprises an
isothiazolone compound” (Yagi, col. 1, ll. 12-16).
2. Yagi discloses that “[t]he antimicrobial composition . . . may further
comprise corrosion inhibitors, scale inhibitors, antimicrobial agents other
than the isothiazolone compounds, defoaming agents, surfactants and
algicides where necessary” (Yagi, col. 6, ll. 19-32).
3. Yagi discloses that “[e]xamples of the antimicrobial agent other than
the isothiazolone compounds include . . . aldehyde compounds such as
glutaraldehyde, phthalaldehyde, isophthalaldehyde and terephthalaldehyde”
(Yagi, col. 6, ll. 52-65).
4. Yagi discloses that its compositions may contain “0 to 30% by weight
of [the non-isothiazolinone] antimicrobial agents . . . and 30 to 99% by
weight of water or a hydrophilic organic solvent” (Yagi, col. 7, ll. 13-16).
5. Harriet Chan-Myers declares that she “designed and supervised the
performance of additional experiments to investigate the germicidal efficacy
of solutions including OPA alone, IPA alone, and OPA plus IPA. Various
different concentrations of each of OPA and IPA were used” (App. Br. 26
(Evidence Appendix, Chan-Myers Declaration)).
6. The Chan-Myers Declaration states:
The additional experiments were performed generally as
described in Section VII entitled Suspension Test of the present
patent application (see e.g., paragraphs [0071]-[0073]), with the
following exceptions: (1) a higher initial titer of 8x106/mL of
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Mycobacterium terrae, instead of 1x106, was used to create a
more challenging condition for the test solutions; and (2) at
each of the appropriate time intervals, in order to have a more
accurate determination of the survivors, serial dilutions were
performed with the neutralized 1mL aliquots germicide-cell
suspension, and the dilutions were filtered to test for survivors.

(App. Br. 26.)
7. The Chan-Myers Declaration states:
Solutions of OPA alone with concentrations ranging from
0.1% to 0.5%, solutions of IPA alone with concentrations
ranging from 0.1% to 0.25% IPA, and combined solutions of
OPA and IPA with OPA concentrations ranging from 0.1% to
0.5% and IPA concentrations ranging from 0.1% to 0.25% IPA,
were each tested for their effectiveness at killing 6.89 logs of
Mycobacterium terrae. Table 1 lists results for a first set of
experiments performed at an exposure time of 3 min and a
temperature of 20°C. Table 2 lists results for a second set of
experiments performed at an exposure time of 5 min and a
temperature of 15°C. The results are presented in terms of log
reductions/mL.

(App. Br. 26-27.)
8. Tables 1 and 2 of the Chan-Myers Declaration are reproduced below:

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(App. Br. 27.)
9. With respect to Table 1, the Chan-Myers Declaration states:
[A]s shown the log reductions observed for combined
OPA and IPA solutions were greater than the sum of the log
reductions observed for solutions including OPA alone and IPA
alone at the same OPA and IPA concentrations. Let’s consider
one detailed example. A 0.1% OPA alone solution had a log
reduction of only 0.93. Likewise, a 0.25% IPA alone solution
had a log reduction of only 0.27. However, a combined
solution of 0.1% OPA plus 0.25% IPA had a significantly and
unexpectedly greater log reduction of 4.53. Note that this log
reduction of 4.53 is significantly greater than 1.2 (=0.93+0.27),
which is the sum of the log reductions observed for the OPA
alone and IPA alone solutions. Accordingly, a synergistic
effect also apparently exists at relatively lower concentrations
of 0.1% OPA.

(App. Br. 27.)
10. With respect to Table 2, the Chan-Myers Declaration states:
Table 2 similarly generally shows that the log reductions
observed for combined OPA and IPA solutions were greater
than the sum of the log reductions observed for solutions
including OPA alone and IPA alone at the same OPA and IPA
concentrations. A 0.5% OPA alone solution had a log
reduction of only 3.16. Likewise, a 0.25% IPA alone solution
had a log reduction of only 0.35. However, a combined
solution of 0.5% OPA plus 0.25% IPA had a significantly and
unexpectedly greater log reduction of 6.89 (representing a total
kill). Note that this log reduction of 6.89 is significantly greater
than 3.51 (=3.16+0.35), which is the sum of the log reductions
observed for the OPA alone and IPA alone solutions.
Accordingly, a synergistic effect also apparently exists at
relatively higher concentrations of 0.5% OPA.

(App. Br. 27.)
11. The Chan-Myers Declaration concludes:
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I believe that these experimental results clearly
demonstrate that a combined solution of OPA plus IPA has a
synergistically enhanced germicidal efficacy relative to OPA
alone and IPA alone solutions. I further believe that the
synergistically enhanced germicidal efficacy is demonstrated
over a range of different OPA and IPA concentrations. Further,
I have no reason to believe that the synergistic enhancement
would stop abruptly at a concentration of 0.5% OPA. I find
these results surprising and unexpected, and I believe others
skilled in the art would also find these results to be surprising
and unexpected.

(App. Br. 28.)
12. The Specification discloses in Example 9 that a number of germicidal
solutions were tested for their capacity to stain skin from a pig’s ear (Spec.
[0048]). The results are shown in Table 12:

13. The Specification states that “[t]he results show that, under the test
conditions, the OPA solution was dark staining, the IPA solution was non-
staining, and the OPA plus IPA solution was nearly non-staining. These
results show that the IPA reduces the staining property of the OPA” (Spec.
[0049]).
According to the Specification, “the inventors have observed that . . .
TPA [(terephthalaldehyde)] further reduces the staining caused by the OPA
over a mixture of OPA plus IPA. This is due to more than just ‘dilution’ of
the staining properties of the OPA” (id. at [0050]).
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14. The Specification discloses in Example 10 that a number of
germicidal solutions were “tested to determine their effectiveness in killing
at least l x 106/mL of Mycobacterium terrae bacteria using a bacterial
suspension test. Germicidal solutions containing TPA or mixtures of TPA
with OPA, IPA, or both, were tested at an exposure time of 5 minutes and a
temperature of 20°C” (Spec. [0051]).
15. Table 13 presents the results of Example 10’s experiments:
16. The Specification interprets the data obtained in Example 10 as
follows:
The results show that, under the test conditions,
germicidal compositions including about 0.1% TPA, plus 0.2%
IPA, plus 0.1% OPA, or higher concentrations, are effective to
achieve a total kill of the bacteria within 5 minutes at a
temperature of 20°C. The results also show that a mixture of
TPA and IPA enhances the germicidal efficacy of OPA or that
there is a germicidal synergy. That is, the composition
including TPA, IPA, and OPA has unexpectedly enhanced
germicidal efficacy over a composition including only OPA.
Note from Example 8 that a 0.1% OPA concentration was not
effective to achieve a total kill. Note also that a mixture of 0.1%
TPA plus 0.2% IPA didn’t have a significant kill (confluent).
This enhancement or germicidal synergy is unexpected and
significant.

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(Spec. [0052].)
17. Example 10 also included an analysis of the staining properties of the
tested compounds. The data is presented in Table 14, reproduced below:

(Spec. [0058].)
18. Regarding Table 14, “[a]s shown, OPA has good germicidal
efficacies, but tends to stain certain surfaces. IPA and TPA do not stain but
have much poorer germicidal efficacies. The inventors have discovered that
compositions including OPA plus IPA, or OPA plus IPA plus TPA, have
good germicidal efficacies and reduced staining” (Spec. [0058]).
PRINCIPLES OF LAW
It is well settled that evidence of unexpected results may rebut an
Examiner’s prima facie case of obviousness. See In re Rouffet, 149 F.3d
1350, 1355 (Fed. Cir. 1998); see also KSR Int' l Co. v. Teleflex Inc., 550
U.S. 398, 416 (“The fact that the elements worked together in an unexpected
and fruitful manner supported the conclusion that Adams’s design was not
obvious to those skilled in the art.”) (discussing United States v. Adams, 383
U.S. 39 (1966)).
It is also well settled that “the applicant’s showing of unexpected
results must be commensurate in scope with the claimed range.” In re
Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). For example, in Peterson
our reviewing court declined to reverse an obviousness rejection of claims
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directed to a metal alloy where the data showing unexpected results did not
extend to the entire claimed range of a critical ingredient. Id. at 1331.
Thus, in rebutting a prima facie case of obviousness, where the claims
recite a composition that includes a range of ingredient amounts, Appellants
bear the burden of showing that the unexpected results extend to the entire
claimed range. See id.; see also In re Geisler, 116 F.3d 1465, 1469 (Fed.
Cir. 1997) (“[W]e agree with the Commissioner that Geisler has failed to
satisfy his burden to show that the claimed protective layer exhibits
unexpected properties in the 50 to 100 Angstrom thickness range.”).
ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
finding that Appellants’ evidence of unexpected results was not sufficiently
commensurate in scope with the claimed subject matter so as to rebut the
Examiner’s prima facie case of obviousness.
The thrust of Appellants’ arguments is that, although the Chan-Myers
Declaration presents data only showing IPA’s (isophthaladehyde’s)
synergistically potentiating effect on OPA (phthalaldehyde) at OPA
concentrations up to 0.5%, and IPA concentrations up to 0.25%, that data is
sufficient to show that the entire range of OPA and IPA concentrations
encompassed by claim 1 would achieve this synergistic potentiation.
We first note, however, that claim 21 is also subject to this ground of
rejection. Unlike claim 1, claim 21 does not recite any specific
concentration of either IPA or OPA.
Rather, claim 21 simply recites IPA in combination with a diluent and
“a germicidal compound,” without restriction on the amount of any
ingredient, except that the IPA is present in an amount “to enhance the
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germicidal efficacy of the germicidal compound.” Given the unlimited
identities and amounts of the germicidal compound, contrasted with the
proffered data limited to combinations of IPA with OPA in a few specified
amounts (see FF 7-12), we simply cannot agree with Appellants that the
showing of unexpected results is sufficiently commensurate with the scope
of claim 21 so as to demonstrate that claim’s unobviousness.
Regarding claim 1, we note that, under certain experimental
conditions, the Chan-Myers Declaration appears to show synergistic results
at OPA concentrations within the claimed range of 1% or less. For example,
in Table 1, 0.1% and 0.2% IPA, amounts which provide zero reduction of
bacteria after 3 minutes of treatment at 20°C, are shown to significantly
potentiate the bacterial killing effect of 0.1, 0.2, and 0.5% OPA (FF 8).
However, as the Examiner points out, this is only half of the range of
OPA concentrations recited in claim 1 (1% or less), and a significantly
smaller portion of the IPA concentrations encompassed by claim 1 (up to
five times the OPA concentration). As noted above, to demonstrate
unexpected results for a multi-ingredient composition, Appellants must show
that the entire range of ingredient amounts claimed confers the unexpected
properties. See In re Peterson, 315 F.3d at 1330-31.
Also, as seen in Table 1, 0.25% IPA provides essentially the same
effect on 0.5% OPA as 0.1% and 0.2% IPA (FF 8). Further, while 0.25%
IPA increases the kill rate of 0.5% OPA by 0.30 logs/mL (from 6.59
logs/mL to 6.89), the 0.25% IPA solution by itself provides a 0.27 logs/mL
kill rate, only slightly less than its potentiating effect (id.). These results
suggest that the potentiating effect of IPA on OPA actually declines as the
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concentrations of either of the two compounds increases beyond the data
presented.
Moreover, as seen in Table 2 of the Chan-Myers Declaration, after 5
minutes of treatment at 15°C, 0.1% IPA is shown to only increase the kill
rate of 0.1% OPA from 0.43 logs/mL to 0.48 logs/mL, despite the fact that
0.1% IPA by itself provides a kill rate of 0.25 logs/mL under the conditions
of Table 2 (id.). Similarly, 0.2 and 0.25% IPA increase the kill rate of 0.1%
OPA less than their respective kill rates alone would suggest (see id.). Thus,
rather than showing unequivocal evidence of unexpected results across the
claimed ranges, Table 2 shows that, under certain conditions, concentrations
of IPA and OPA within the range recited in claim 1 fail to provide an
unexpected improvement when compared to their use alone.
In sum, the evidence of record suggests that the potentiating effect of
IPA on OPA decreases as the concentrations of those compounds increase.
Also, claim 1 encompasses concentrations of OPA and IPA that, in certain
conditions, do not provide an unexpected improvement over the compounds’
use by themselves. We are therefore not persuaded that a person of ordinary
skill in the art would have expected the proffered data to representatively
demonstrate unexpected properties for all of the compositions encompassed
by claim 1.
Rather, given that Appellants’ proffered data extends at best to half of
the concentrations of OPA and IPA encompassed by claim 1, and given that,
in certain conditions, concentrations of OPA and IPA encompassed by claim
1 do not provide an unexpected improvement over the compounds’ use by
themselves, the preponderance of the evidence supports the Examiner’s
finding that Appellants’ showing of unexpected results is not sufficiently
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commensurate in scope with claim 1 to overcome the prima facie case of
obviousness. We therefore affirm the Examiner’s rejection of claim 1 as
obvious over Yagi.
Because they were not argued separately, claims 4, 5, 9-11, 21, 23,
and 32 fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellants present separate arguments of unobviousness for each of
claims 30, 31, and 34 (App. Br. 16-17). Claims 30, 31, and 34 read as
follows:
30. The germicidal composition of claim 1, wherein the
concentration of phthalaldehyde is 0.28% or less, and wherein the
concentration of isophthalaldehyde is 0.3% or less.

31. The germicidal composition of claim 1, wherein the
concentration of phthalaldehyde is 0.5% or less, and wherein a
concentration of the isophthalaldehyde is 0.3% or less.

34. The germicidal composition of claim 1, wherein the amount of
isophthalaldehyde is sufficient to give a weight ratio of the
isophthalaldehyde to the phthalaldehyde that is 2:1 or less.

We are not persuaded that Appellants’ evidence of unexpected results
is sufficiently commensurate in scope with the subject matter encompassed
by these claims to overcome the Examiner’s prima facie case of
obviousness. With respect to claims 30 and 31, we note that the OPA
concentrations of 0.28% or less, and 0.5% or less are within the ranges of
concentrations (0.1%, 0.2%, and 0.5%) used in the experiments described in
the Chan-Myers Declaration (see FF 8).
However, the ranges encompassed by claims 30 and 31 include OPA
and IPA concentrations which, under certain conditions, produce less than
an additive, much less synergistic, effect. For example, as pointed out
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above, Table 2 of the Chan-Myers Declaration shows that after 5 minutes of
treatment at 15°C, 0.1% IPA only increases the log reduction of 0.1% OPA
from 0.43 logs/mL to 0.48 logs/mL, despite the fact that 0.1% IPA by itself
provides a reduction of 0.25 logs/mL under the conditions of Table 2 (id.).
Similarly, 0.2 and 0.25% IPA increase the log reduction of 0.1% OPA less
than their respective kill rates alone would suggest (see id.).
Claim 34 simply limits the ratio of IPA to OPA to 2:1 or less, and
therefore encompasses the 1% OPA concentration recited in claim 1, as well
as encompassing the lower concentrations that provide less than a
synergistic effect. In view of these facts, a preponderance of the evidence
supports the Examiner’s finding that Appellants’ showing of unexpected
results is not commensurate in scope with the subject matter encompassed
by claims 30, 31, and 34. We therefore affirm the Examiner’s rejection of
claims 30, 31, and 34 as obvious over Yagi.
Appellants also separately argue that claim 33 is unobvious over Yagi
in view of the evidence presented in the Chan-Myers Declaration (App. Br.
17).
Claim 33 depends from claim 15. Claims 15 and 33 read as follows:
15. A germicidal composition comprising:
a diluent;
phthalaldehyde; and
a material that is selected from the group consisting of
isophthalaldehyde, terephthalaldehyde, and a combination of
isophthalaldehyde and terephthalaldehyde, to reduce a staining
property of the phthalaldehyde and enhance an efficacy of the
phthalaldehyde, wherein a concentration of the phthalaldehyde
is from 0.1% to 1%, and wherein a concentration of the material
is from 0.05 to 2%.

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33. The germicidal composition of claim 15, wherein the
concentration of phthalaldehyde is about 0.5% or less, and
wherein a concentration of the isophthalaldehyde is 0.3% or less.

Thus, claim 33 encompasses compositions having 0.5% or less OPA
and 0.3% IPA. Because of its dependency on claim 15, however, claim 33
requires those concentrations to be effective to reduce a staining property of
OPA as well enhancing an efficacy of the OPA.
We affirm this rejection as well. Claim 33 recites the same
concentrations of OPA and IPA as claim 31. Thus, for the reasons discussed
above with respect to claim 31, we find that the showing of unexpected
results is not commensurate in scope with the claimed subject matter.
As to the reduction in staining by OPA recited in claim 33 through its
dependence on claim 15, we note that the Specification discloses improved
staining properties for compositions containing 0.14% OPA and 0.2% IPA
(FF 12, 13) and compositions containing 0.1% TPA, 0.2% IPA, and 0.1%
OPA (see FF 17, 18). Again, however, claim 33 encompasses
concentrations of OPA and IPA significantly higher and lower than the
concentrations for which reduced staining has been shown.
Claims 18-20 were also rejected as being over Yagi by itself. Claims
18-20 all depend ultimately from claim 15. Claim 18 recites “[t]he
composition of claim 15, wherein the material comprises
isophthalaldehyde.” Thus, because of its dependence on claim 15, claim 18
encompasses compositions having 0.1% to 1% OPA, and 0.05% to 2% IPA.
As discussed above, Table 2 of the Chan-Myers Declaration shows
that these ranges encompass concentrations of OPA and IPA which, when
combined, do not even produce an additive germicidal effect, much less a
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synergistic effect (FF 8). A preponderance of the evidence therefore
supports the Examiner’s finding that Appellants’ showing of unexpected
results is not commensurate in scope with claim 18.
Accordingly, we affirm the Examiner’s rejection of claim 18, as well
as claims 19 and 20, which were not argued separately. See 37 C.F.R.
§ 41.37(c)(1)(vii).
We recognize that our affirmance of claims 18-20 and 33 effectively
constitutes an affirmance of claim 15 as being obvious over Yagi by itself, a
rejection the Examiner did not actually make. We therefore designate our
affirmance of claims 15, 18-20 and 33 as being obvious over Yagi by itself a
new ground of rejection under 37 C.F.R. § 41.50(b).
OBVIOUSNESS -- YAGI AND BRATESCU
ISSUE
Claims 8, 12, 15, and 25-27 stand rejected under 35 U.S.C. § 103(a)
as being obvious over Yagi and Bratescu (Ans. 5-6).
The Examiner finds that Yagi “fail[s] to disclose a buffer and a
chelating agent in the composition,” but reasons that a “person of ordinary
skill in the art would have been motivated to combine [Bratescu’s] chelating
agents and buffers in the antimicrobial agents [of Yagi] because of the
reasonable expectancy of successfully producing an antibacterial
composition since each compound is well known to be useful in such
compositions” (id. at 6).
Appellants do not contest whether the Examiner made a prima facie
case of obviousness, but instead “respectfully rebut this rejection by
submitting herewith a declaration pursuant to 37 C.P.R. § 1.132 signed by
Harriet Chan-Myers” (App. Br. 18). Moreover, Appellants argue, “to the
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extent the Declaration is not commensurate with a portion of the scope of the
claims, Appellants respectfully submit that the nonobviousness of the entire
claimed range is supported by the data in the declaration showing
unexpected results over a narrower claimed range pursuant to MPEP
716.02(d)(I)” (id.). Furthermore, Appellants urge, “the patent application
includes data demonstrating unexpected results for OPA, IPA, and TPA. See
e.g., Example 10” (id.).
We affirm this rejection as well. We note that the Specification
shows, in Example 10, that a composition containing 0.1% TPA, 0.2% IPA,
and 0.1% OPA appears to exhibit synergistic germicidal activity (see FF 14-
16). We also note that those compositions are disclosed as having an
unexpected reduction in staining by OPA (FF 17, 18). However, claim 15
encompasses combinations of ingredients other than TPA, IPA, and OPA, as
well as encompassing concentrations of those ingredients significantly
higher and lower than the results presented in Example 10.
Moreover, as discussed above, claim 15 encompasses concentrations
of OPA and IPA which Table 2 of the Chan-Myers Declaration shows do not
even produce an additive germicidal effect, much less a synergistic effect
(FF 8). As also discussed above, the data in Table 1 of the Declaration
suggest that the potentiation effect of IPA on OPA appears to lessen as the
IPA concentration increases to 0.25% (see combination of 0.25% IPA plus
0.5% OPA (FF 8)), thus suggesting that higher concentrations of IPA
encompassed by claim 15 would not provide the same potentiating effect as
lower concentrations.
In sum, given the breadth of claim 15, and the fact that it encompasses
concentrations of IPA and OPA shown as not producing a synergistic effect,
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Appeal 2009-002006
Application 10/769,603

a preponderance of the evidence supports the Examiner’s finding that
Appellant’s showing of unexpected results is not commensurate in scope
with the subject matter recited in claim 15. We therefore affirm the
Examiner’s rejection of claim 15 as being obvious over Yagi and Bratescu.
Claims 8, 12, and 25-27 were not argued separately and therefore fall
with claim 15. See 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm the Examiner’s rejection of claims 1, 4, 5, 9-11, 21, 23, 28,
30-32, and 34 under 35 U.S.C. § 103(a) as being obvious over Yagi.
We affirm the Examiner’s rejection of claims 8, 12, 15, and 25-27
under 35 U.S.C. § 103(a) as being obvious over Yagi and Bratescu.
We also affirm the Examiner’s rejection of claims 15, 18-20 and 33 as
being obvious over Yagi by itself. However, as the Examiner did not
explicitly make a rejection of claim 15 over Yagi by itself, we designate that
affirmance a new ground of rejection under 37 C.F.R. § 41.50(b).

Time Period for Response
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.
37 C.F.R. § 41.50(b) also provides that the appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
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Appeal 2009-002006
Application 10/769,603

(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
will be remanded to the Examiner . . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record . . . .

AFFIRMED, 37 C.F.R. § 41.50(b)

cdc

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