Ex Parte Choi et al

Patent Trial and Appeal Board

Aug 31, 2016

11846019 (P.T.A.B. Aug. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111846,019 08/28/2007 Sungmee Choi
12596 7590 09/02/2016
LUCAS & MERCANTI, LLP
30 BROAD STREET
21st FLOOR
NEW YORK, NY 10004
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
419A-102793-US 9707
EXAMINER
CHONG,YONGSOO
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/02/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
info@lmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SUNGMEE CHOI, RADU CRACIUN,
GARETH WILLIAMS, and KATHERINE P. ROBERTS 1
Appeal2014-007589
Application 11/846,019
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to
antimicrobial compositions including an isothiazolin-3-one and an alkyl
amine. The claims are rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as ARCH WOOD
PROTECTION, INC. (App. Br. 1.)
Appeal2014-007589
Application 11/846,019
STATEMENT OF THE CASE
"This invention relates to a composition for use as a wood
preservative ... [and] [m]ore specifically, ... to a composition that includes
at least one alkyl amine and at least one isothiazolin-3-one." (Spec. i-f 2.)
According to the Specification, "[ o ]ne drawback heretofore associated with
wood preservative compositions containing isothiazolin-3-ones, such as OIT
[2-n-octyl-4-isothiazolin-3-one] or BBIT [N-n-butyl-1,2-benzisothiazolin-3-
one] ... is the preservative compositions are less efficacious at a cost
effective level in inhibiting mold growth." (Id. at i-f 4.) Appellants disclose
that "[t]he presence of the alkyl amine in these compositions permits usage
of lower amounts of the isothiazolin-3-one(s) to provide the desired
antimicrobial efficacy at a cost effective level." (Id. at i-f 15.)
Claims 1, 7-12, and 19-30 are on appeal. Claim 1 is illustrative:
1. An antimicrobial composition concentrate
compr1s1ng:
at least one isothiazolin-3-one in an amount of
between about 0.1 wt.% and about 40 wt.% based on the
weight of the antimicrobial composition concentrate,
wherein said isothiazolin-3-one is selected from the group
consisting of 2-n-octyl-4-isothiazolin-3-one, N-n-butyl-
1,2-benzisothiazolin-3-one and a combination thereof;
at least one alkyl amine in an amount of between
about 2 wt. % and about 80 wt.% based on the weight of
the antimicrobial composition concentrate, wherein said
alkyl amine comprises a tertiary amine having methyl or
ethyl-substituents together with a long chain substituent
having an average chain length of 12 carbons per molecule
of the tertiary amine;
at least one surfactant present in an amount of
between about 1 wt.% and about 50 wt.% based on the
weight of the antimicrobial composition concentrate; and
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Application 11/846,019
at least one solvent present in an amount of between
about 1 wt.% and about 30 wt.% based on the weight of
the antimicrobial composition concentrate, wherein when
the isothiazolin-3-one consists of 2-n-octyl-4-isothiazolin-
3-one, the weight ratio of the 2-n-octyl-4-isothiazolin-3-
one to the alkyl amine is between 1:5 and 1:20; when the
isothiazolin-3-one consists of N-n-butyl-1 [,]2-
benzisothiazolin-3-one, the weight ratio of the N-n-butyl-
1 [,]2-benzisothiazolin-3-one to the alkyl amine is between
1:6.25 and 1:25; when the alkyl amine is used in
combination with both 2-n-octyl-4-isothiazolin-3-one, and
N-n-butyl-1,2-benzisothiazolin-3-one, the weight ratio of
the sum of the 2-n-octyl-4-isothiazolin-3-one and the N-n-
butyl-1 [,]2-benzisothiazolin-3-one to the alkyl amine is
between about 1: 10 and about 1 :20, and the weight ratio
of the 2-n-octyl-4-isothiazolin-3-one to the N-n-butyl-1,2-
benzisothiazo lin-3-one is between 1 : 1 and 2: 1.
(App. Br. 9 (Claims App'x).)
Claims 1, 7-12, and 19-30 are rejected under 35 U.S.C. § 103(a) over
Crudden, 2 Walker, 3 and Imai. 4
DISCUSSION
Issue
Has the Examiner established by a preponderance of the evidence that
claims 1, 7-12, and 19-30 would have been obvious over Crudden, Walker,
and Imai?
2 Crudden, US 2008/0057134 Al, published Mar. 6, 2008 ("Crudden").
3 Walker et al., US 6,485,790 B2, issued Nov. 26, 2002 ("Walker").
4 Imai, US 6,726,937 B2, issued Apr. 27, 2004 ("Imai").
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Application 11/846,019
Findings of Fact (FF)
FF 1. The Examiner's findings of fact and statement of the rejection
of claims 1, 7-12, and 19-30 may be found at pages 3-9 of the Final
Rejection dated September 6, 2013. (See also, Ans. 3-10.) We adopt the
Examiner's findings and provide the following for emphasis.
FF 2. Crudden teaches "efficacious compositions ... comprising a
mixture of a traditional fungicide and an ion-exchange type antimicrobial
agent." (Crudden Abstract.) Crudden teaches the "us[e] of such
compositions ... in preventing the growth of molds and, more specifically,
in conjunction therewith, the preservation of wood and wood products." (Id.
at i-f 2.) Crudden further teaches that "[p]referred classes of fungicides
include the azoles, ... isothiazolones, strobilurins, and the like." (Id. at
i-f 20; see also, id. at i-f 21 and claim 9.) According to Crudden, "[t]he
isothiazolone fungicides are also an important class of suitable fungicides.
These include octhilinone; ... 5-chloro-2-methyl-4-isothi[a]zolin-3-one; 1,
2-benzisothiazolin-3-one; 2-butyl-,2-benzisothiazolin-3-one ... and the
like." (Id. at ,-r 23.)
FF 3. Walker teaches "preservative composition[s] compris[ing] a
wood distribution and penetration enhancing agent, which includes an amine
oxide, and the wood preservatives." (Walker Abstract.) Walker teaches the
"wood preservative [is] selected from quartemary ammonium compounds,
amines, and salts thereof." (Id. at col. 1, 11. 15-17.) Walker teaches that "an
amine contemplated for use ... [is] N-dodecyl-N, N-dimethylamine, which
is available as Earlene® 12S from Lonza Inc." (Id. at col. 5, 11. 49-53.)
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FF 4. The Specification discloses that an "example of a suitable alkyl
amine is a dodecyl alkyl amine, sold under the name of Earlene 12S,
supplied by Lonza Group, Switzerland." (Spec. i-f 22.)
FF 5. Imai teaches "a composition containing 2-n-octyl-4-
isothiazolin-3-one [OIT] and N-n-butyl-1,2-benzoisothiazolin-3-one [BBIT]
for providing antifungal efficacy to a wood preservative .... " (Imai
Abstract; see also, id. at col. 1, 11. 41-53.) Imai teaches "addition ofOIT
and BBIT to a wood preservative gives high antifungal activity with good
operability and without [being] corrosive to metal when the mixture can be
used as a pressure process type wood preservative product." (Id. at col. 1, 11.
54--58.) Imai further teaches that compositions including OIT and BBIT
solve problems arising with "the conventional fungicides, 4-chloro-2-
methylisothiazolin-3-one (hereinafter, referred [to] as[] CMIT)." (Id. at col.
1, 11. 27-39.) According to Imai, "compositions containing OIT and BBIT ..
. [are] extremely less corrosive to metal than CMIT, and show[] long[ er]
residual activity than CMIT. So, the composition is easy to be handled and
is very economical." (Id. at col. 2, 11. 38--44.) Imai teaches the compositions
preferably further include inert carriers or auxiliaries, such as solvents and
surfactants. (Id. at col. 2, 11. 19-59.)
Principles of Law
"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'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
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Analysis
Appellants argue the patentability of claims 1, 7-12, and 19-30 as a
group. We select claim 1 as representative.
The Examiner finds Crudden teaches antifungal compositions for
preventing mold growth on wood products. (Ans. 4.) The Examiner finds
Crudden identifies isothiazolones as a preferred fungicide. (Id.)
According to the Examiner, Crudden does not specifically disclose the
tertiary alkyl amine or the particular antifungal agents of claim 1 - OIT and
EEIT. The Examiner thus turns to Walker and Imai. The Examiner finds
Walker teaches compositions for enhancing penetration and preservation of
wood that include an amine preservative, in particular a "preferred amine
[that] is N-dodecyl-N,N-dimethylamine, which is available as Earlene 12S."
(Id. at 4--5.) The Examiner finds Imai teaches compositions that include
OIT and EEIT "for providing antifungal efficacy to a wood preservative."
(Id. at 5; see also, Adv. Act. at 2 ("Imai is used to show specific isothiazoles,
which are within the scope of the genus, set by Crudden, are also used for
the same purpose [ antifungal agents].") The Examiner also finds that both
Crudden and Imai disclose compositions that comprise, in addition to the
antifungal agents, surfactants and solvents as in claim 1. (Ans. 4--5.)
The Examiner concludes the skilled artisan would have predictably
designed an antifungal composition, as generally taught in Crudden,
comprising the antifungal agent OIT and/or EEIT as taught in Imai, along
with the alkyl amine preservative (Earlene® 12S) taught in Walker. (Ans.
6.) The Examiner reasons that the skilled person would have been motivated
to make this combination because:
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(1) Crudden, Walker, and Imai are analogous art since all three
are concerned with wood preservation; (2) both Crudden and
Walker teach, in general, amine active agents, for example,
Crudden teaches broadly aliphatic nitrogen fungicides and
Walker teaches N-dodecyl-N,N-dimethylamine (Earlene 12S)
specifically; (3) both Crudden and Imai disclose the use of
isothiazoles as preferred antifungal agents; ( 4) and because of the
functional equivalency of the isothiazoles disclosed by Crudden
and the combination of the specific isothiazoles, OIT and BBIT,
as disclosed by Imai.
(Id.) Also, the Examiner finds "Imai clearly teaches that the added
advantage of using the specific antifungal composition of OIT and BBIT to a
wood preservative is for its high antifungal activity with good operability
and without being corrosive to metals" especially compared with
"conventional [isothiazolone] fungicide, CMIT." (Id. at 8.)
Appellants raise several counterarguments. First, Appellants argue "if
the Examiner cannot identify a 'lead or reference composition' in Crudden
for one skilled in the art to modify, then a primafacie case of obviousness
has not been set forth." (App. Br. 4.) Second, Appellants argue the
"Examiner is erroneously applying a 'double standard' regarding the
Examiner's statements of fact on the equivalency of isothiazolones." (Id. at
5.) Third, Appellants argue they provided sufficient "indirect evidence" of
unexpected results to show the claims are nonobvious. (Id. at 5---6.) Finally,
Appellants argue the Examiner erred by allegedly requiring "clear and
convincing evidence" to show unexpected results. (Id. at 7.)
As discussed below, Appellants' arguments are unpersuasive.
Insofar as Appellants argue the Examiner must identify a particular
lead composition to make out a prima facie case, we are not persuaded.
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Application 11/846,019
(App. Br. 3.) An obviousness analysis is an "expansive and flexible"
inquiry. KSR, 550 U.S. at 415. The inquiry may sometimes proceed by
identifying a lead compound or reference composition. But not always, and
the authority cited by Appellants is not to the contrary. Unigene Labs., Inc.
v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011) ("A prima facie case of
obviousness in the chemical arts is often based on a known compound,
called a 'lead compound,' which serves as a starting point for a person of
ordinary skill developing the claimed invention") (emphasis added). 5
Consistent with the flexible framework set forth in KSR, we agree
with the Examiner's findings and rationale for combining Crudden, Walker,
and Imai. KSR, 550 U.S. at 420 ("in many cases a person of ordinary skill
will be able to fit the teachings of multiple patents together like pieces of a
puzzle.") All three references relate to compositions for wood preservation.
(FF 2-3, 5.) Crudden teaches use of isothiazolones as antifungal agents.
(FF 2.) Imai does likewise, but is specific to OIT and BBIT and teaches
those antifungal agents are highly advantageous, including compared to a
conventional isothiazolone such as CMIT. (FF 5.) Imai expressly teaches
"addition of OIT and BBIT to a wood preservative gives high antifungal
activity" and other advantages. (Id.) The Examiner thus reasonably
concluded it would have been obvious to the skilled artisan to combine OIT
5 Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999, 1008 (Fed.
Cir. 2009) ("[T]o the extent Altana suggests the prior art must point to only a
single lead compound for further development efforts, that restrictive view
of the lead compound test would present a rigid test similar to the teaching-
suggestion-moti vation test that the Supreme Court explicitly rejected in
KSR.")
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Application 11/846,019
and BBIT with a preferred wood preservative disclosed in Walker - the
alkyl amine Earlene® 12S, which is the same preferred alkyl amine
disclosed in the present Specification. (FF 3--4.) The various agents making
up the modified composition here are simply operating according to their
known and established functions - as antifungal agents and preservatives
for the treatment of wood. KSR, 550 U.S. at 417. ("[W]hen the question is
whether a patent claiming the combination of elements of prior art is
obvious," the answer depends on "whether the improvement is more than the
predictable use of prior art elements according to their established
functions.")
Although Appellants argue that identification of a lead composition is
necessary because "Crudden teaches 36 generic classes of fungicides" and
so "encompass thousands upon thousands of potential anti-fungal agents,"
this argument elides the more precise teachings of Crudden and Imai. (App.
Br. 4.) Crudden identifies isothiazalones as "important" and among fewer
than ten preferred fungicides. (FF 2.) And Imai focuses on the benefits of
the isothiazolones OIT and BBIT alone. (FF 5.) When we consider these
teachings, we are not persuaded the number of combinations is so great that
it casts doubt on the obviousness of the particular combination proposed by
the Examiner. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) ("[D]isclos[ing] a multitude of effective combinations does
not render any particular formulation less obvious. This is especially true
because the claimed composition is used for the identical purpose taught by
the prior art.")
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Based on the teachings of the prior art and the Examiner's reasoning
of record, we conclude the Examiner has established a prima facie case that
claim 1 would have been obvious.
As to Appellants' second argument, we are not persuaded the
Examiner is applying a "double standard." (App. Br. 5; Reply Br. 3.) We
understand the Examiner's finding concerning "functional equivalency" in
support of the obviousness rejection to be that the isothiazolones disclosed in
Crudden and in Imai are interchangeable and will each provide antifungal
activity. (See Ans. 6-7.) Appellants, however, seek to extend the
Examiner's findings further to fill gaps in Appellants' evidence of
unexpected results. Because Appellants lack evidence showing the
antifungal effects in a composition with 40 ppm ofBBIT or 50 ppm of OIT,
Appellants identify a composition having a mixture of BBIT and OIT
totaling 50 ppm of antifungal agent. (App. Br. 5---6.) Appellants argue this
evidence concerning the mixture should be sufficient indirect proof of the
antifungal activity of compositions of unmixed OIT and BBIT in view of the
Examiner's statement regarding "functional equivalency." (App. Br. 5.) We
do not, however, understand the Examiner to have found that all
isothiazolones - much less OIT and BBIT - will exhibit the same level of
antifungal activity. Appellants' apparent contention that an OIT/BBIT
mixture totaling 50 ppm is indistinguishable, for purposes of showing
unexpected results, from a composition including 50 ppm of OIT alone is
thus not sufficiently supported by the Examiner's findings or other
persuasive evidence presented here.
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We tum now to Appellants' argument that evidence of unexpected
results demonstrates the nonobviousness of the claims. According to
Appellants, the combination of OIT and/or BBIT along with a tertiary alkyl
amine like Earlene® 12S provides "unexpected synergy" - improved
antifungal effect is provided when, for example, the composition includes
both OIT and a tertiary alkyl amine compared to either agent alone. (App.
Br. 5---6.) Appellants point to data, which is provided in Tables 3 and 4 of
the Specification, in support. (Id. (citing Responses dated July 23, 2013 and
November 5, 2013).)
The Examiner finds that Appellants' argument related to unexpected
results is not persuasive. Among other things, the Examiner finds any
"synergism should be sufficient to overcome the obviousness, but also must
be commensurate with the scope of the claims." (Ans. at 10.) The Examiner
further finds the data is not sufficient to allow a direct comparison, and thus
does not persuasively show the alleged synergy. (Ans. 9-10.) According to
the Examiner, "in order to provide a showing [of] an unexpected synergy,
one must compare A + B with A alone and B alone, at all the claimed
concentrations." (Id.) The Examiner finds such a comparison is not
possible because Appellants' data does not include measurements of
antifungal effect of OIT, BBIT, and alkyl amine alone at the concentrations
used in the comparative examples. (Id.) In other words, for example, "it is
impossible to compare [] the combination of 50 ppm of OIT and 250 ppm of
C12-alkyl amine" because the data includes no measurements for 50 ppm of
OIT or 250 ppm of alkyl amine alone. (Id.)
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We assess the persuasiveness of Appellants' arguments and evidence
of unexpected results against the strength of the Examiner's prima facie
case. And, for the reasons discussed above, that case is strong. Pfizer Inc. v.
Apotex Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) ("[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 necessarily control the obviousness
conclusion.")
Appellants' arguments regarding unexpected results are not
sufficiently persuasive to overcome the Examiner's prima facie
determination that claim 1 would have been obvious. It may well be that
some unexpected antifungal synergism occurs when OIT and/or BBIT is
combined with a tertiary alkyl amine, but we are not persuaded upon the
present record. Although Appellants' data does appear to provide an
improved effect in instances at certain concentrations (e.g., combination of
75 ppm OIT with 375 ppm ofBarlene® 12S (C12-alkyl amine)), other data
does not sufficiently reveal improved effect and synergism (see, e.g.,
combination of 50 ppm OIT with either 250 or 500 ppm of alkyl amine).
(Spec. i-f 56, Table 3.) Appellants have also not persuasively shown that, in
many instances of improvement, the change is not merely additive as the
Examiner found. (cf Ans. 9.)
Moreover, data showing improved effect, as well as data that does not,
reflect compositions within the scope of claim 1. As the Examiner noted,
Appellants must show unexpected results commensurate in scope with the
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claims. (Id. at 10.) Yet the record lacks sufficient evidence or explanation
for data concerning otherwise claimed compositions at claimed
concentrations that show no apparent synergistic improvement. 6 Thus, to
the extent unexpected synergism may occur when OIT and/or BBIT is
combined with a tertiary alkyl amine, such synergism may exist only with
compositions that are narrower than the present claims.
We also agree with the Examiner that Appellants' should have
provided further evidence under these circumstances, allowing for a direct
comparison across a range of concentrations. Because the data provided in
Table 3 includes the antifungal effects of OIT and BBIT at only 100 ppm
and 80 ppm respectively, and of the tertiary alkyl amine at only 1000 ppm,
the ability to make direct comparisons across the range of concentrations in
Table 3 is limited, if not impossible. (Ans. 9.) Moreover, for the reasons
discussed above, we are unpersuaded that Appellants can mix and match
examples from Table 3 and Table 4 to make up for the lack of direct,
comparative evidence. Given the strength of the prima facie case and lack
of clarity in the data presented, it was reasonable for the Examiner to seek
further direct evidence and a more persuasive showing of unexpected results
here.
6 The concentrate composition in this testing used 6.3 wt% OIT or 6.3 wt%
BBIT (Spec. i-fi-1 43, 46), yet claim 1 recites a range of "isothiazolin-3-one
[OIT and/or BBIT] in an amount between about 0.1 wt.% and about 40
wt.%". See In re Peterson, 315 F.3d 1325, 1330-31 (Fed. Cir. 2003)
("[T]he applicant's showing of unexpected results must be commensurate in
scope with the claimed range.")
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Application 11/846,019
Finally, we are not persuaded the Examiner's statement that "[i]t is
applicant's burden to present clear and convincing factual evidence of
nonobviousness or unexpected results" rises to the level of reversible error.
(See Adv. Act. 2.) In its full context, we understand the Examiner was
seeking clearer and more persuasive evidence of unexpected results from
Appellants based on the absence of sufficient comparative evidence, such as
discussed above. (Ans. 7-10.) In any event, we have considered the
arguments and evidence of record, both for and against the patentability of
Appellants' claims, applying the preponderance of the evidence standard.
See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Conclusion of Law
We conclude that the Examiner established by a preponderance of the
evidence of record that claim 1 would have been obvious over Crudden,
Walker, and Imai. Claims 7-12 and 19-30 have not been argued separately
and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1, 7-12, and 19-30 as unpatentable
under 35 U.S.C. § 103(a) over Crudden, Walker, and Imai.
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TIME PERIOD FOR RESPONSE
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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