Ex Parte Arata

Patent Trial and Appeal Board

May 6, 2016

10928639 (P.T.A.B. May. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/928,639 08/27/2004
25225 7590 05/10/2016
MORRISON & FOERSTER LLP
12531 HIGH BLUFF DRIVE
SUITE 100
SAN DIEGO, CA 92130-2040
FIRST NAMED INVENTOR
Andrew B. Arata
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.
631342000500 2186
EXAMINER
CHOI, FRANK I
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
05/10/2016 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):
PatentDocket@mofo.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREW B. ARATA
Appeal2013-010374
Application 10/928,639
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
disinfectant composition. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellant identifies the Real Party in Interest as Pure Bioscience
(see App. Br. 1 ).
Appeal2013-010374
Application 10/928,639
Statement of the Case
Background
"Despite the antimicrobial efficacy of various known antimicrobial
compounds, there remains a need for antimicrobial compositions that are
effective at lower concentrations of antimicrobial agent" (Spec. i-f 15).
"There is also a need for antimicrobial compositions that provide the
advantages of quaternary amines, oxidizing agents and halogen compounds,
but in addition possess extended antimicrobial effect on solid surfaces and
other substrates" (id.).
The Claims
Claims 1, 4, and 7-18 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A composition consisting essentially of
(a) an aqueous solution of an antimicrobial amount of
silver dihydrogen citrate and citric acid (SDC/citric acid) and
(b) an oxidizing agent,
wherein the ECso of said composition is less than the sum
of the ECso of the solution of (a) plus the ECso of the agent of
(b).
The Issue
The Examiner rejected claims 1, 4, and 7-18 under 35 U.S.C. § 103(a)
as obvious over Arata,2 Elhaik,3 and Krause4 (Final Act. 2-5).
The Examiner finds that Arata teaches "an aqueous disinfectant ...
[that] comprises an aqueous solution of silver citrate ... [that] can be
2 Arata, US 6, 197 ,814 B 1, issued Mar. 6, 2001.
3 Elhaik et al., US 6,277,414 Bl, issued Aug. 21, 2001.
4 Krause, US 2,105,835, issued Jan. 18, 1938.
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Application 10/928,639
combined with a detergent such as sodium dodecyl sulfate" (Final Act. 2).
The Examiner finds that Elhaik teaches "an aqueous disinfecting
composition comprising hydrogen peroxide and Ag in the form of a salt or
complex" (id.). The Examiner finds that Krause teaches "that the process of
sterilization is accelerated to a surprising degree by combination of two
methods of sterilization, hydrogen peroxide and silver" (Final Act. 3).
The Examiner finds it obvious "to combine the prior art with the
expectation that the combination of silver dihydrogen citrate/citric acid and
oxidizing agent, including hydrogen peroxide, would have synergistic
effects and would be effective as a disinfectant for fabrics" (Final Act. 4).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner's conclusion
that Arata, Elhaik, and Krause render claim 1 obvious?
(ii) If so, has Appellant presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
Findings of Fact
1. Elhaik teaches
an aqueous decontaminating (i.e. disinfecting and/or
cleaning) composition comprising a mixture of H202,
RCQ3H (where R is ethyl or, preferably, methyl), RC02H
(where R is defined as indicated above), Ag (in the form of a
salt or complex as a source of Ag+ ions) and H3PQ4, in
which the four components hydrogen peroxide,
percarboxylic acid, carboxylic acid corresponding to said
percarboxylic acid and Ag+ have a synergistic effect in
respect of the disinfecting and cleaning properties.
(Elhaik, col. 4, 11. 37--46; emphasis added).
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Application 10/928,639
2. Elhaik teaches that a "stabilizer, which is present (i) to protect
the H202 and the Ag+ ions during the preparation of the aqueous
decontaminating composition ... is selected from the group consisting of
mineral and organic acids" (Elhaik, col. 7, 11. 14--21 ). Elhaik teaches "a
stabilizing organic acid (especially ... citric acid [)]" (Elhaik, col. 2, 11. 25-
26).
3. Elhaik teaches, in example 7, a stock cleaning composition
which comprised:
fl/\:
mixtwe ol' CHF:O)-I + c11,,e.·o,H
AgN03
H.-YO.,
~11rfod.aiit
II:.O to m~kc up to
'7):)~:.t.; by ~Â¥e.igh~
4 .. 7'}!h by ~~height
o.oogc;;:. hy wdgh.t
0 00,';% b~' weigh;
O.G·4-~:f. hy )~'eigh.~
100'};, by \vdght
The stock cleaning solution comprised hydrogen peroxide and silver nitrate
(Elhaik, col. 12, 11. 55--65).
4. Table IX of Elhaik is reproduced below:
T/\Jff.E IX
Prt.~du~~ts: s A. H c ''l h ·y,) """"'-'
y c
Ex. ·~ .... Al, ill ?r~2 7.6U 7.&J S2.34 0.~F! 0.9~~ ~0.29 0.96
er :--"I:· n.2s h)
Ex. '} i't2, B2 7.84 7.76 ?.8:! 3.3(i 1198 0.99 U.42 U.97 _,
(T ..,. 0.25 h)
E:i.:. ·~ A3, B2 7.S3 3.2"'/ 5.{1{) ~~2.34 0.41 G.71 ~~0;:'.!.9 CL?D ._. ~ '
(I' - 1 )1)
Lx. 4, A4,, .B4 7.81 7.20 6.50 ~~22.34 0.91 0.83 ~~~:n.29 0.76
er ~.,... o.s hJ
Ex. 5-, A\ H:-i 7 . .8J 7JJ9 6.41 ;:;2.34 0.90 OJU ~~n.29 0.72
(T = D.5 h)
In Table IX, the "interaction of the combination of H202 + silver component
+ CH3C02H/CH3CQ3H mixture was assessed ... Table IX shows that, at a
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Appeal2013-010374
Application 10/928,639
final dilution of 1/10, the mixture of essential constituents of Ex. 1-Ex. 5 has
a synergistic effect relative to [prior art formulations] Al-A5 ... towards
the viral strain of orthopoxvirus since YAB is less than or equal to Y c"
(Elhaik, col. 24, 11. 30-68). The formulations of Examples 1-5 include both
H202 and AgN03; the formulations Al-A5 are missing the silver component
(Elhaik, col. 11, 1. 55 to col. 12, 1. 30).
5. Arata teaches that "silver ions within an aqueous solution have
only a limited stable ionic life" (Arata, col. 5, 11. 18-19).
6. Arata teaches an "improved aqueous disinfectant [that]
comprises an aqueous solution of silver citrate wherein the silver is
electrolytically generated in a solution of citric acid and water. The
electrolytically generated silver forms an organic metal complex with the
citric acid such as a chelated organic metal complex with the citric acid"
(Arata, col. 6, 11. 38--43).
7. Arata teaches that the "present invention provides an aqueous
disinfectant solution having a stable ionic form having an extended useful
shelf-life" (Arata, col. 5, 11. 29-31 ).
8. Arata teaches that the "aqueous disinfectant may be combined
with an alcohol such as ethyl alcohol (ETOH) and/or a detergent such as
sodium dodecyl sulfate" (Arata, col. 6, 11. 55-57).
9. Krause teaches that the "sterilizing action of hydrogen peroxide
and its derivatives is known ... sterilization of liquids is likewise known
whereby certain metals, particularly silver and copper are caused to act on
the liquid" (Krause 1, col. 1, 11. 4--16).
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10. Krause teaches that the "process of sterilization is accelerated to
a surprising degree by combining the two methods of sterilization. Thus,
according to the invention, hydrogen peroxide as well as metal are caused to
act on the liquid to be sterilized" (Krause 1, col. 1, 11. 24--29).
11. Krause teaches that the "simultaneous action of substances
yielding oxygen on the one hand and of active metals or metallic compounds
on the other hand according to the invention, has not only the advantage of
intensifying the sterilizing action, but also the further advantage that the
liquid once sterilized remains sterile" (Krause 2, col. 2, 11. 45-51 ).
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).
"[E]vidence rising out of the so-called 'secondary considerations'
must always when present be considered en route to a determination of
obviousness." Stratojlex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed.
Cir. 1983). "Synergism is one factor to be considered in the ultimate
determination of obviousness of the composition. However, we attribute no
magic status to synergism per se since it may be expected or unexpected."
In re Huellmantel, 324 F.2d 998, 1003 (CCPA 1963).
"Although secondary considerations must be taken into account, they
do not necessarily control the obviousness conclusion." Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007).
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Application 10/928,639
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2-5; FF 1-11) and agree that
the claims are rendered obvious by Arata, Elhaik, and Krause.
Prima F acie Case
Elhaik teaches a disinfectant composition comprising an aqueous
solution of an antimicrobial amount of silver ions and the oxidizing agent
hydrogen peroxide (FF 1 ). Elhaik teaches that the disinfectant composition
may include stabilizers such as citric acid (FF 2). Elhaik teaches that the
disinfectant composition "has a synergistic effect" (FF 4).
Arata teaches that silver ions have limited stability (FF 5) but that
replacing silver ions with silver citrate (FF 6) provides "a stable ionic form
having an extended useful shelf-life" (FF 7).
Krause teaches that hydrogen peroxide and silver are known
disinfecting agents (FF 9), that the "process of sterilization is accelerated to
a surprising degree by combining" these two agents (FF 10) and that their
combined use has "the advantage of intensifying the sterilizing action" (FF
11).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the ordinary artisan would have had reason to replace the
silver ion disinfectants in Elhaik with the silver citrate disinfectant in Arata
because the substitution would have been expected to provide "a stable ionic
form having an extended useful shelf-life" (FF 7). We also agree with the
Examiner that Krause teaches "sterilization is accelerated to a surprising
degree by combination of two methods of sterilization, hydrogen peroxide
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and silver" providing an "expectation that the combination of silver
dihydrogen citrate/citric acid and oxidizing agent, including hydrogen
peroxide, would have synergistic effects" (Final Act. 4; cf FF 9-11).
Secondary Considerations
Appellant contends that the "issue with regard to patentability is,
therefore, whether appellant has demonstrated synergy adequately, and
whether synergy would have been expected" (App. Br. 3). Appellant
contends that there "is no explicit statement in Elhaik that their compositions
provide synergy as defined in the present claims - that is that the combined
effect of the silver ion and the oxidizing agent is greater than the sum of the
individual components (SDC/citric acid and an oxidizing agent) each taken
alone" (id.). Appellant contends that the Jonte Declaration5 "did compare
compositions containing oxidizing agent alone and compositions containing
only SDC/citric acid with the claimed combination. As demonstrated, the
claimed combination reduced the CPU/ml of endospores of representative
bacteria by almost 6 logs after only 10 minutes, whereas oxidizing agent
alone required 6 hours of contact time" (App. Br. 5).
The Examiner finds that "the declaration makes no comparison with
the closest prior art as it only compares a composition containing SDC/citric
acid, hydrogen peroxide and peracetic acid with hydrogen peroxide/peracetic
acid alone or SDC/citric acid alone" (Ans. 6).
Appellant acknowledges that "Appellant is not attempting to show
superior results to Elhaik. Appellant is simply showing that the claimed
combination is synergistic" (Reply Br. 6).
5 Declaration of Dolana Blount Jonte, dated June 22, 2012.
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We find that the Examiner has the better position. Elhaik and Krause
both suggest that the combination of hydrogen peroxide with silver results in
synergistic disinfection (FF 4, 10, 11 ), with Elhaik expressly teaching that
the mixture "has a synergistic effect" (FF 4). Therefore, synergism of these
two components is an expected result, not an unexpected result. See In re
Skoner, 517 F .2d 94 7, 950 (CCP A 197 5) ("Expected beneficial results are
evidence of obviousness of a claimed invention. Just as unexpected
beneficial results are evidence of unobviousness. ")
Even if we credit the results in the Jonte Declaration, results not
disclosed in the Specification, as demonstrating unexpectedly better
disinfection for the combination of silver citrate and hydrogen peroxide
relative to hydrogen peroxide alone or silver citrate alone, the Examiner
correctly points out that the results were not compared to the closest prior art
of Elhaik. Elhaik teaches an example disinfectant that comprises silver
nitrate and hydrogen peroxide (FF 3). Elhaik's disinfecting composition is
the closest prior art, not the Oxonia Active® composition comprising
hydrogen peroxide alone or the SDC/citric acid composition comprising
silver alone that were tested in the Jonte Declaration (Jonte Deel. i-fi-12-3).
Therefore, the Jonte Declaration failed to compare the claimed invention
with the closest prior art composition of Elhaik that comprised both silver
and hydrogen peroxide (FF 3). See In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991) ("when unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.").
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This reasoning is particularly appropriate here where the prior art of
Krause provides a direct expectation of synergism for the combination of
silver and hydrogen peroxide (FF 10-11 ), thereby rendering separate
comparisons to silver alone or hydrogen peroxide alone insufficient evidence
to rebut the strong prima facie case of obviousness suggesting replacing the
silver nitrate in Elhaik' s silver nitrate/hydrogen peroxide disinfectant with
Arata's silver citrate for improved stability and Krause's intensified
sterilizing action (FF 1-11 ).
Conclusions of Law
(i) The evidence of record supports the Examiner's conclusion that
Arata, Elhaik, and Krause render claim 1 obvious.
(ii) Appellant has not presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Arata, Elhaik, and Krause. Claims 4 and 7-18 fall
with claim 1.
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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