Ex Parte Rheinbaben et al

Board of Patent Appeals and Interferences

Jun 8, 2009

10168442 (B.P.A.I. Jun. 8, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/168,442 09/18/2002 Friedrich Von Rheinbaben 1675USWO 8460
43896 7590 06/09/2009
ECOLAB INC.
MAIL STOP ESC-F7, 655 LONE OAK DRIVE
EAGAN, MN 55121
EXAMINER
KRISHNAN, GANAPATHY
ART UNIT PAPER NUMBER
1623
MAIL DATE DELIVERY MODE
06/09/2009 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FRIEDRICH VON RHEINBABEN, HOLGER BIERING,
KLAUS-PETER BANSEMIR, and SABINE GLAESER
__________

Appeal 2009-0008371
Application 10/168,442
Technology Center 1600
__________

Decided:2 June 9, 2009
__________

Before DONALD E. ADAMS, ERIC GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 “ECOLAB GMBH & CO. OHG is the current owner and real party of
interest for this Appeal” (App. Br. 3 (filed March 10, 2008)).
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).

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DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of inactivating hepatitis A virus on the skin. The Examiner has rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Claims 11, 12, 14, 15, 23-26, and 28-34 stand rejected and are on
appeal. (App. Br. 5). Claims 11, 28, and 31, the appealed independent
claims, illustrate the appealed subject matter and read as follows:
11. A method for inactivating hepatitis A virus on skin
surfaces of hands comprising:
washing hands with an inactivating composition for a
length of time sufficient to provide 4 log reduction of the
hepatitis A virus, wherein:
the inactivating composition comprises 80 % to 97 % by
weight of ethanol, based on total composition, and water, the
composition being free of chlorine-containing and/or chlorine-
releasing active compounds, and the composition being
provided on a solid carrier.

28. A method for inactivating hepatitis A virus present in the
foodstuffs industry on skin surfaces of hands comprising:
washing hands that are at risk of coming in contact with
an infectious amount of hepatitis A virus with an inactivating
composition for a length of time sufficient to provide 4 log
reduction of the hepatitis A virus present in the foodstuffs
industry, wherein:
the inactivating composition comprises 80 % to 97 % by
weight of ethanol, based on total composition, and water, the
composition being free of chlorine-containing and/or chlorine-
releasing active compounds, and the composition being
provided on a solid carrier.

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31. A method for inactivating hepatitis A virus on skin
surfaces of hands comprising:
washing hands with an inactivating composition for a
length of time sufficient to provide 4 log reduction of the
hepatitis A virus, wherein:
the inactivating composition comprising 80% to 90% by
weight of ethanol, based on the total composition, alkyl
polyglycoside, and water, the composition being free of
chlorine-containing and/or chlorine-releasing active
compounds, and the composition being provided on a solid
carrier.

The Examiner cites the following documents as evidence of
unpatentability:
von Rheinbaben US 5,728,404 Mar. 17, 1998
Widulle (as translated) EP 0 848 907 A1 Jun. 24, 1998

PGC Scientifics 1995-1996 General Catalog of Laboratory Equipment
and Supplies, p. 85.

The following rejection is before us for review:
Claims 11, 12, 14, 15, 23-26, and 28-34 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Widulle, von Rheinbaben, and
the PGC Catalog (Ans. 3-6).3

3 The Examiner’s statement of the rejection does not list claims 32-34
(Ans. 3). However, the appealed rejection lists those claims as being
rejected (Non-Final Rejection 1, 7 (mailed July 18, 2007)).
Moreover, Appellants contend that those claims are subject to the
appealed rejection (App. Br. 10), and the Examiner’s Answer states that
Appellants’ statement of the grounds of rejection to be reviewed is correct
(Ans. 2). We therefore consider the omission of claims 32-34 from the
statement of the rejection to be a typographical error.
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OBVIOUSNESS
ISSUE
The Examiner cites Widulle as disclosing a spray disinfectant
containing 30-70% ethanol, fragrance, and surfactants, the reference
teaching that the composition is “used for the inactivation of viruses
including the hepatitis A virus and also teach[ing] that the normal waiting
time for the inactivation on surfaces is reduced” (Ans. 3). The Examiner
contends that Widulle differs from the claims in that the composition “is
intended for inactivation of the hepatitis A virus on inanimate surfaces and
not on the skin and do[es] not teach the[] composition being provided on a
solid carrier” (id.).
To address Widulle’s shortcomings, the Examiner cites von
Rheinbaben as disclosing “methods of virucidal disinfection with aqueous
compositions comprising 40 to 90% of alcohol, ethanol in particular and
Lewis acids like zinc chloride for the disinfection of viruses on skin” (id.).
The Examiner concedes that von Rheinbaben does not explicitly describe
“inactivation of the hepatitis A virus and also do not teach their composition
[as] being provided on a solid carrier. But the teaching of von Rheinbaben
et al suggests that a composition comprising a very high percentage of
alcohol can be used on the surface of the skin” (id. at 4).
The Examiner relies on the PGC Catalog as disclosing a “a sterile pad
(solid carrier) that is saturated with 70% isopropyl alcohol, which is large
and easy to handle and are for the purpose of cleaning” (id.).
Based on the references’ teachings, the Examiner finds:
One of ordinary skill in the art would be motivated to use
a composition comprising 80- 97% ethanol in a method for
inactivating hepatitis A virus on the skin surface of hands as
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instantly claimed since Widulle’s teaching shows that a rapid
inactivation of hepatitis virus takes place even at 60% ethanol
concentration. Hence increasing the percentage of ethanol
would result in a higher log reduction of the hepatitis A virus.
Using high concentrations of ethanol on the surface of the skin
is safe according to the teaching of Rheinbaben.

(Id. at 5.)
The Examiner further finds that a person of ordinary skill in the art
would have been “motivated to provide the instant composition on a solid
carrier like paper or cloth fabric since providing the said composition on a
solid carrier is easy to handle, as taught by PGC Scientific” (id.).
Appellants contend that the “Examiner fails to establish a prima facie
case of obviousness by combining Widulle with von Rheinbaben et al. and
the catalog” (App. Br. 17). Specifically, Appellants argue that “the
combined references fail to teach or suggest Applicants’ claim limitations,”
and that “there is no motivation provided by the references themselves, nor
in the knowledge of the ordinary skilled artisan, to modify the references or
combine the reference teachings in a manner to result in the method of
Applicants[’] invention. The references as a whole teach away from the
claimed invention” (id.).
Moreover, Appellants argue, “there was . . . no reasonable expectation
of success, prior to Applicants’ invention, of using the claimed method to
inactivate hepatitis A viruses based on either the teachings of the cited
references or the knowledge of the ordinary skilled artisan” (id.). Therefore,
Appellants conclude, “[t]he inevitable conclusion of the reasoning set forth
above is that the Examiner used impermissible hindsight in rejecting the
claimed invention as obvious” (id.).
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In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether the Examiner erred in
concluding that the cited references would have rendered the claimed
processes prima facie obvious to a person of ordinary skill in the art.
FINDINGS OF FACT
1. Von Rheinbaben discloses that “important viruses of relevance in
human medicine such as, for example, entero, polio, hepatitis A, ECHO,
Coxsackie, corona, calici or rhino viruses cannot be adequately eliminated
by known hand disinfectants” (von Rheinbaben, col. 1, ll. 29-33).
Thus, “[t]his fact can lead to the transmission of virus infections,
particularly in hospitals, through contamination of the hands of patients and
staff and the instruments used by them. There is also a danger of infection
from contaminated surfaces” (id. at col. 1, ll. 33-37).
2. To address the shortcomings of previous hand disinfectants, von
Rheinbaben discloses “a virucidal disinfectant which c[an] be used
universally, but especially for hands” (von Rheinbaben, col. 1, ll. 39-40).
3. Hepatitis A virus is an uncoated, or unenveloped, hydrophilic virus
(Spec. 1).
4. Von Rheinbaben discloses that “pure methanol, ethanol, n-propanol,
isopropanol or butanol have a distinct but limited virucidal effect in very
high concentrations of around 80% or more. Against envelope-free
hydrophilic viruses, this virucidal effect decreases with increasing chain
length or decreasing hydrophilicity of the alcohols” (von Rheinbaben, col. 1,
ll. 41-46).
5. Von Rheinbaben discloses that “[l]ower concentrations of these
alcohols are not sufficiently effective. Individually, pure propanol,
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isopropanol or butanol is definitely not sufficiently active against envelope-
free hydrophilic viruses. Known mixtures of ethanol and isopropanol with a
total active-substance content of 20 to 40% show no virucidal activity
either” (von Rheinbaben, col. 1, ll. 48-54).
6. Von Rheinbaben discloses:

[T]he virucidal activity of alcohols or alcohol/water mixtures
with a total alcohol concentration of 40 to 90% and preferably
50 to 80% can be considerably increased by addition of base- or
acid-hydrolyzed salts of metal ions of the earth metal and meta
metal group of the periodic system of elements in quantities of
0.1 to 1% by weight and preferably in quantities of 0.2 to 0.6%
by weight.

(Von Rheinbaben, col. 2, ll. 6-13.)
7. Von Rheinbaben discloses that “[s]uitable alcohols are methanol,
ethanol, n-propanol, isopropanol, butanol. Their concentration in aqueous
solution is from 40% to 90% and preferably from 50% to 80%. Mixtures of
ethyl alcohol and isopropyl alcohol in a ratio by weight of 8:1 to 1:1 are
particularly effective” (von Rheinbaben, col. 2, ll. 21-25).
8. Von Rheinbaben discloses that its disinfectants “contain metals salts
as an important component” and that “salts of lanthanum, silver, zinc,
cerium and aluminium are particularly preferred” (von Rheinbaben, col. 2,
ll. 26-36).
Von Rheinbaben discloses that “salts of inorganic acids, for example
chlorides, sulfates or nitrates, may be used” (von Rheinbaben, col. 2, ll. 39-
40).
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9. Von Rheinbaben discloses that its compositions can “contain small
quantities of substances for improving compatibility with the skin, wetting
agents and corrosion inhibitors” (von Rheinbaben, col. 2, ll. 18-20).
Also, the disinfectants can be in the form of sprayable solutions, and
“may also be made up in the form of gels or the like” (id. at col. 2, ll. 51-54).
10. Von Rheinbaben’s examples used, by weight, 50% ethanol, 30%
isopropanol, and 1% zinc chloride, with the remainder being water
(Example 1), 70% ethanol and 1% zinc chloride (remainder water) (Example
2), 60% ethanol, 20% isopropanol, and 0.5% zinc chloride (remainder water)
(Example 3), and 50% ethanol, 30% isopropanol, and 0.5% zinc sulfate (or
lanthanum nitrate hexahydrate, cerium chloride hexahydrate, aluminium
lactate, silver lactate) (remainder water) (Example 4) (von Rheinbaben, col.
3, ll. 1-26).
11. Von Rheinbaben evaluated the exemplary compositions in a
suspension test against “against polio, adeno, vaccinia and SV40 tumor
virus” (von Rheinbaben, col. 3, l. 27).
12. Testing of alcohol-based disinfectants, apparently lacking the metal
salts, did not achieve adequate activity:
Where 40 to 80% by weight ethanol, n- and isopropanol
or butanol were used, it was not possible in the virus suspension
test under the DVV guidelines to achieve adequate
effectiveness against any of the four test viruses. A general
reduction in the virus titer by >4 powers of ten was not
obtained.
Ethanol/propanol mixtures (n and iso) showed equally
poor activity in the DVV virus suspension test: against polio
virus, the reduction in the virus titer produced by a mixture of
60% by weight of ethanol and 20% by weight of isopropanol,
remainder water, after a contact time of 5 minutes was at most
2.3 powers of ten.
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(Von Rheinbaben, col. 3, l. 41, through col. 4, l. 3.)
13. “Although poliovirus is . . . an uncoated particle, the sensitivity of the
poliovirus to disinfectant recipes [based on ethanol] is regarded as an
exception among experts. It is therefore required as standard for the testing
of the virucidicity of hand disinfectants that they are tested against the
uncoated simian virus 40” (Spec. 1-2).
14. Regarding its disclosure, Widulle states:
The invention concerns an aqueous-alcoholic spray
disinfectant preparation for the inactivation of enveloped[] and
nonenveloped viruses on inanimate surfaces. The preparation
can be used simultaneously to clean these surfaces.
The inactivation of nonenveloped viruses with chemical
disinfectants is difficult. The poliovirus serves as a[n] [sic,
example?] of . . . nonenveloped viruses. The hepatitis A virus
is also in this virus group, however.

(Widulle 1.)
15. Widulle discloses that “[a]ccording to the state of the art, agents based
on ethanol are preferred for the inactivation of polioviruses. Such agents,
however, are not effective against SV-40 viruses, even if the ethanol content
is 90 wt%” (Widulle 2).
16. Widulle discloses, however, that DE-A-44 24 325 “describes an
alcoholic disinfectant preparation for the disinfection of the hands and the
skin which is effective against nonenveloped viruses such as polioviruses
within a short time. The disinfectant preparation comprises at least 80 wt%
ethanol and/or methanol and contains at least 0.3 wt% butanone (methyl
ethyl ketone)” (Widulle 2).
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17. Widulle discloses antiviral spray disinfectant compositions
“compatible with surfaces made of plastic, silicone, ceramic, glass, and
metal, in particular, stainless steel, aluminum, chromium, nickel, and noble
metals, and synthetic leather and rubber. Moreover, the preparation should
be compatible with highly polished or satin-etched, lacquered hard surfaces,
for example, laboratory furniture” (Widulle 3).
18. Widulle discloses that prior art disinfectants are not sufficiently
effective or “dry too quickly because of the high alcohol content, or are
corrosive on stainless steel and aluminum surfaces, because of their acid
content (Lewis acids, Borenstedt [sic, Brønsted] acids), or base content.
Furthermore, they are unsuitable for use on surfaces other than skin, because
of the fraction of skin-care additives” (Widulle 3).
19. Widulle’s compositions contain
(a) 30 to 70 wt% ethanol;
(b) 0.02 to 1 wt% of at least one amino component of the
following formulas:
H[HNCH2CH2CH2]n-NR[CH2CH2CH2NH]pH (I)
and/or
H[HNCH2CH2CH2]q-NH-CH2CH2CH2NHR (II)

wherein n, p, and q can be 1, 2, or 3, independent of one
another, and the substituent R can be a straight-chain or
branched, saturated or unsaturated, or cyclic alkyl radical with 6
to 18 carbon atoms, or their mixtures;
(c) 0.2 to 2 wt% of at least one terpene hydrocarbon, relative to
the total quantity of the aqueous preparation.

(Widulle 3-4.)
20. Widulle discloses that its compositions “can also contain 0.01 to 2
wt%, preferably 0.2 to 0.5 wt% nonionic surfactants. . . . The preparation
according to the invention can, moreover, contain small molar quantities of
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anionic surfactants, with respect to the molar quantity of the amine
component” (Widulle 6).
21. The PGC Scientifics 1995-1996 General Catalog of Laboratory
Equipment and Supplies discloses an alcohol swab described as a “large,
easy to handle sterile pad. Ideal for preparing injection site or cleaning
minor scrapes or abrasions. Absorbent, non-woven, textured material
virtually eliminates linting and provides good scrubbing action. Sterile;
individually packaged in hermetically sealed foil packets. Each pad is
saturated with 1.3 cc of 70% isopropyl alcohol” (PGC Catalog 85).
PRINCIPLES OF LAW
“During examination, the examiner bears the initial burden of
establishing a prima facie case of obviousness.” In re Kumar, 418 F.3d
1361, 1366 (Fed. Cir. 2005).
As the Supreme Court pointed out in KSR Int' l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” Rather, the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
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Accordingly, as the Court of Appeals for the Federal Circuit has
stated, “obviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Int’l. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
While holding that some rationale must be supplied for a conclusion
of obviousness, the Supreme Court nonetheless rejected a “rigid approach”
to the obviousness question, and instead emphasized that “[t]hroughout this
Court’s engagement with the question of obviousness, our cases have set
forth an expansive and flexible approach . . . .” KSR, 550 U.S. at 415. The
Court also rejected the use of “rigid and mandatory formulas” as being
“incompatible with our precedents.” Id. at 419; see also id. at 421 (“Rigid
preventative rules that deny factfinders recourse to common sense, however,
are neither necessary under our case law nor consistent with it.”).
The Court thus reasoned that the analysis under 35 U.S.C. § 103 “need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” Id. at 418; see
also id. at 421 (“A person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.”).
The Court further reasoned that it is obvious to choose from among
known solutions to prior art problems:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
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instance the fact that a combination was obvious to try might
show that is was obvious under § 103.

Id.
The Court also reaffirmed, however, that claims are likely to be
unobvious when “when the prior art teaches away” from their practice.
KSR, 550 U.S. at 416. The Court noted that it had held claims to be
unobvious where the prior art warned of risks involved in using the claimed
elements. Id. (citing United States v. Adams, 383 U.S. 39, 51-52 (1966)).
Similarly, as stated by our reviewing court, “[a] reference may be said
to teach away when a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant.” In re Kahn, 441 F. 3d 977, 990 (Fed. Cir. 2006) (quoting In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994)).
When evaluating claims for obviousness, “the prior art as a whole
must be considered. The teachings are to be viewed as they would have
been viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041
(Fed. Cir. 1986). Accordingly, “‘[i]t is impermissible within the framework
of section 103 to pick and choose from any one reference only so much of it
as will support a given position, to the exclusion of other parts necessary to
the full appreciation of what such reference fairly suggests to one of
ordinary skill in the art.’” Id. (quoting In re Wesslau, 353 F.2d 238, 241
(CCPA 1965)).
Thus, “in a section 103 inquiry, ‘the fact that a specific [embodiment]
is taught to be preferred is not controlling, since all disclosures of the prior
art, including unpreferred embodiments, must be considered.’” Merck &
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Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)); see also In re
Mills, 470 F.2d 649, 651 (CCPA 1972) (“All the disclosures in a reference
must be evaluated, including nonpreferred embodiments, and a reference is
not limited to the disclosure of specific working examples.” (citations
omitted)).
Moreover, it is well settled that “[o]bviousness does not require
absolute predictability of success. . . . For obviousness under § 103, all that
is required is a reasonable expectation of success.” In re O’Farrell, 853
F.2d 894, 903-04 (Fed. Cir. 1988).
It is also well settled that “the discovery of an optimum value of a
variable in a known process is usually obvious.” Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for determining the
optimal parameters for prior art result effective variables “flows from the
‘normal desire of scientists or artisans to improve upon what is already
generally known.’” Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed.
Cir. 2003)).
The Federal Circuit has also stated that, “[i]n cases involving
overlapping ranges, we and our predecessor court have consistently held that
even a slight overlap in range establishes a prima facie case of obviousness.”
Peterson, 315 F.3d at 1329. Moreover, “a prima facie case of obviousness
exists when the claimed range and the prior art range do not overlap but are
close enough such that one skilled in the art would have expected them to
have the same properties.” Id.
It is also well settled that evidence of unexpected results may rebut an
examiner’s prima facie case of obviousness. See In re Rouffet, 149 F.3d
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1350, 1355 (Fed. Cir. 1998); see also KSR, 550 U.S. at 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)).
However, to establish that claimed subject matter yields an
unexpected result, the claimed subject matter must be compared to the
closest prior art. In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir.
1991) (“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.”); see also In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (“When
an article is said to achieve unexpected (i.e. superior) results, those results
must logically be shown as superior compared to the results achieved with
other articles.”).
ANALYSIS
Appellants’ arguments do not persuade us that the Examiner erred in
concluding that that the cited references would have rendered the processes
recited in claims 11 and 28, and their dependent claims, prima facie obvious
to a person of ordinary skill in the art. We do agree, however, that the
Examiner did not make a prima facie case of obviousness with respect to
claim 31.
Claim 11 recites a method for inactivating hepatitis A virus on hands
by washing with an inactivating composition for a length of time sufficient
to provide 4 log reduction of the hepatitis A virus. Claim 11 requires the
inactivating composition to contain 80 to 97% by weight of ethanol. The
composition must be free of chlorine-containing and/or chlorine-releasing
active compounds, and be provided on a solid carrier.
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Claim 28 recites a similar method for inactivating hepatitis A virus
present in the foodstuffs industry by washing hands in a virus-inactivating
composition. Like claim 11, the inactivating composition must contain
water, 80 to 97% by weight ethanol, be free of chlorine-containing and/or
chlorine-releasing active compounds, and be provided on a solid carrier.
It may be true that the PGC Catalog discloses using 70% isopropanol
on a solid carrier for disinfecting injection sites, minor scrapes, and
abrasions (FF 21), and that Widulle uses ethanol concentrations of 30 to
70% to disinfect solid surfaces (FF 19). However, Von Rheinbaben
discloses virucidal compositions useful for washing hands (FF 2), the
compositions containing 40 to 90% alcohol in water (FF 6), ethanol being
disclosed among suitable alcohols (FF 7).
Thus, von Rheinbaben discloses that compositions with ethanol
concentrations overlapping those encompassed by claims 11 and 28 are
suitable virucidal hand disinfectants. In view of the PGC Catalog’s
disclosure that solid carriers were useful vehicles for applying alcohol
disinfectants to skin, we agree with the Examiner that a person of ordinary
skill in the art would have reasoned that it would be desirable to use
compositions with the claimed ethanol concentrations on a solid carrier like
that disclosed by the PGC Catalog to disinfect hands.
We note that von Rheinbaben discloses using metal salts in its
compositions (FF 6, 8), and that Widulle’s virucidal compositions contain
amino compounds and terpenes as well as ethanol (FF 19). Claims 11 and
28, however, use the transitional term “compris[ing]” to describe both the
overall method and the inactivating composition itself.
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Thus, except for the explicitly excluded chlorine-containing or
chlorine-releasing compounds (which Appellants do not argue as being
taught by the cited references), claims 11 and 28 encompass compositions
containing ingredients in addition to those explicitly recited, including the
additional ingredients described by von Rheinbaben and Widulle. See
Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997)
(“‘Comprising’ is a term of art used in claim language which means that the
named elements are essential, but other elements may be added and still
form a construct within the scope of the claim.”).
We note that neither von Rheinbaben nor Widulle actually
exemplifies inactivating hepatitis A virus with compositions containing the
claimed ethanol concentrations. However, von Rheinbaben discloses that its
hand disinfectants are useful in activating non-enveloped viruses such as SV
40 (FF 11), a virus acknowledged by Appellants as being an acceptable test
of virucidal activity, in contrast to the polio virus (FF 13).
Von Rheinbaben also discloses that hepatitis A virus is among the
viruses of medical concern in its disinfectant methods (FF 1), and that non-
enveloped viruses are of particular importance (FF 4). Thus, in view of the
teachings of von Rheinbaben combined with the PGC Catalog, we agree
with the Examiner that the cited prior art would have provided a person of
ordinary skill with the impetus and reasonable expectation for inactivating
non-enveloped viruses, such as hepatitis A virus, with ethanol-based
compositions on solid carriers such as that disclosed by the PGC Catalog.
As noted above, it is well settled that “[o]bviousness does not require
absolute predictability of success.” In re O’Farrell, 853 F.2d at 903-04.
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In sum, Appellants’ arguments do not persuade us that the Examiner
failed to make a prima facie case of obviousness with respect to claims 11
and 28. While Appellants state that the results of the claimed methods are
“surprising given both the cited art and the knowledge of artisans of ordinary
skill” (App. Br. 11), Appellants do not point to direct comparative evidence
sufficient to rebut the Examiner’s prima facie case.
We therefore affirm the Examiner’s obviousness rejections of claims
11 and 28, and their dependent claims 14, 15, 25, 26, 29, 30, 32, and 33,
which were not argued separately. See 37 C.F.R. § 41.37(c)(1)(vii).
Nor are we persuaded that the Examiner failed to make a prima facie
case of obviousness with respect to claim 12.
Regarding claim 12, Appellants argue, “[w]hile a metal ion salt may
be a Lewis acid, the combination of references would still require 0.1-
1.0 wt% of the metal ion salt. In contrast, no amount of Lewis acid or
phenol is specified in Applicants’ method” (App. Br. 19).
Claim 12 recites “[t]he method of claim 11, wherein the composition
further comprises at least one of Lewis acids, or phenols.” Claim 12
therefore encompasses any amount of Lewis acids or phenols.
Von Rheinbaben discloses that, in addition to as much as 90%
ethanol, its hand disinfectant should contain metal salts, such as zinc
chloride or zinc sulfate (FF 8, 10). The Examiner points out (Ans. 3), and
Appellants do not dispute, that those salts are Lewis acids. We therefore
agree with the Examiner that Rheinbaben suggests practicing the subject
matter recited in claim 12, and affirm the Examiner’s rejection of that claim.
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Application 10/168,442

19
We also agree with the Examiner that the cited references would have
rendered claims 23 and 24 obvious to a person of ordinary skill in the art.
Claims 23 and 24 read as follows:
23. The method of claim 11, wherein the length of [washing]
time [sufficient to provide 4 log reduction of the hepatitis A virus] is
less than 120 seconds.
24. The method of claim 11, wherein the length of time is
less than 60 seconds.

As noted above, “the discovery of an optimum value of a variable in a
known process is usually obvious.” Pfizer v. Apotex, 480 F.3d at 1368.
In the instant case von Rheinbaben explicitly discloses that its
composition is useful as a virucidal disinfectant for hands. Because a person
of ordinary skill in the art would have reasonably inferred that the washing
time and amount of virus present would affect the degree of disinfection, we
agree with the Examiner that the ordinary artisan would have been prompted
to determine the optimal duration of hand washing. We are therefore not
persuaded that the Examiner has failed to make a prima facie case of
obviousness with respect to claims 23 and 24, and affirm the Examiner’s
rejection of those claims.
Regarding claim 31, Appellants argue that the “combination of
Widulle, von R[h]einbaben et al., and the catalog do not disclose the
combination of an alkyl polylglycoside [sic, polyglycoside], water, and 80-
97 wt% ethanol to inactivate hepatitis A virus. The Examiner has failed to
set forth any combination of references that would result in the method of
claim 31” (App. Br. 21).
We agree with Appellants that the Examiner has not made a prima
facie case of obviousness with respect to claim 31. Claim 31 requires the
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Application 10/168,442

20
hand washing composition to contain water, 80 to 90% by weight ethanol,
and an alkyl polyglycoside.
In setting forth the prima facie case, the Examiner does not clearly
explain where the alkyl polyglycoside of claim 31 is either explicitly taught,
or reasonably suggested, by any of the cited references. Moreover, in
responding to Appellants’ arguments, the Examiner fails to adequately
explain how or why the cited references suggest that an alkyl polyglycoside
should be in a virucidal disinfectant composition as recited in claim 31. We
therefore reverse the Examiner’s obviousness rejection of claim 31 and its
dependent claim 34.
SUMMARY
We affirm the Examiner’s rejection of claims 11, 12, 14, 15, 23-26,
28-30, 32, and 33 under 35 U.S.C. § 103(a) as being unpatentable over
Widulle, von Rheinbaben, and the PGC Catalog.
However, we reverse the Examiner’s obviousness rejection of claims
31 and 34 over those references.

TIME PERIOD
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-IN-PART

lp
Appeal 2009-000837
Application 10/168,442

21

ECOLAB INC.
MAIL STOP ESC-F7, 655 LONE OAK DRIVE
EAGAN MN 55121