Ex Parte Hoffman et al

Patent Trial and Appeal Board

Sep 12, 2016

12633883 (P.T.A.B. Sep. 12, 2016)

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.
12/633,883 12/09/2009 Douglas R. Hoffman 64505128US01 6540
23556 7590 09/12/2016
KIMBERLY-CLARK WORLDWIDE, INC.
Patent Docketing
2300 Winchester Rd.
NEENAH, WI 54956
EXAMINER
BECKHARDT, LYNDSEY MARIE
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
09/12/2016 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 PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DOUGLAS R. HOFFMAN, AMIN HE, DAVID W. KOENIG,
ANDREA J. SMILTNEEK, DAEGUN, KIM, and YOUNGSOOK KIM
____________

Appeal 2015-000678
Application 12/633,8831
Technology Center 1600
____________

Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to “an article of manufacture.” Claims 1–4, 8, 10, 12, and 28
are on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Kimberly-Clark Worldwide, Inc. Br. 1.
Appeal 2015-000678
Application 12/633,883

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STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claim 1 is the sole independent claim, is representative, and
reads as follows:
1. A cleaning medium or formulation containing a sporicidal
composition comprising: about 0.1-20% weight/weight of a
germinant agent, about 62-75% w/w of an antimicrobial agent,
in terms of dry or wet total weight, and a surfactant, and all of
which is admixed with water to generate a solution with a pH of
3.5-9.5; wherein said sporicidal composition exhibits at least a
90% reduction of live Clostridium difficile spores within about
10 minutes of application of said cleaning medium to a spore-
contaminated surface.
Br. 8 (Claims App’x) (strikethrough original).
The following rejections are on appeal:
Claims 1, 3–4, 8, 10, and 12 rejected under 35 U.S.C. § 103(a) over
Wheeldon,2 Ginsburg,3 Boucher,4 and EMD.5 Final Action 3.

2 L.J. Wheeldon et al., Susceptibility of Germinating Clostridium difficil
Spores to 70% Ethanol, Poster Presentations, 64 J. HOSPITAL INFECTION S47
(2006) (hereinafter “Wheeldon”).
3 Isaac Ginsburg and Ron Kohen, Synergistic Effects Among Oxidants,
Membrane-Damaging Agents, Fatty Acids, Proteinases, and Xenobiotics:
Killing of Epithelial Cells and Release of Arachidonic Acid, 19
INFLAMMATION 101–18 (1995) (hereinafter “Ginsburg”).
4 U.S. Patent No. 3,968,248 (issued July 6, 1976 to Boucher) (hereinafter
“Boucher”).
5 Fluid Thioglycollate Medium G, EMD Catalog, available at
http://85.238.144.18/analytics/Micro_Manual/TEDISdata/prods/1_16761_05
00_5000.html (visited Apr. 25, 2012) (hereinafter “EMD”).
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Application 12/633,883

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Claim 2 rejected under 35 U.S.C. § 103(a) over Wheeldon, Ginsburg,
Boucher, EMD, and Sorg.6 Final Action 6.
Claims 1, 3–4, 8, 10, 12, and 28 rejected under 35 U.S.C. § 103(a)
over Wheeldon, Ginsburg, Williams,7 and EMD. Final Action 7.
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art. For emphasis we highlight the following:

FINDINGS OF FACT
FF1. Wheeldon disclosed:
Methods: A carrier test system was designed comprising
germination of C. difficile spores with 0.1% (w/v) sodium
taurocholate in thioglycolate medium for 30 minutes followed by
exposure to 70% (v/v) ethanol. Viability of C. difficile spores
was subsequently determined by culturing suspensions on
Fastidious Anaerobic agar. . . .
Results: A 2-log reduction in germinating C. difficile spores was
achieved within 60 minutes following exposure to 70% ethanol.
There was no reduction in the number of C. difficile spores in
control carrier test systems.
Discussion: These preliminary results suggest that germination
of C. difficile spores increases their susceptibility to 70% ethanol
and therefore potentially other disinfectants commonly used in
the clinical setting. A two-stage cleaning process comprising
germination followed by disinfection may offer an alternative

6 Joseph A. Sorg and Abraham L. Soneshein, Bile Salts and Glycine as
Cogerminants for Clostridium difficile Spores, 190 J. BACTERIOLOGY 2505–
12 (2008) (hereinafter “Sorg”).
7 U.S. Patent 5,783,146 (issued July 21, 1998 to Williams, Jr.) (hereinafter
“Williams”).
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Application 12/633,883

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approach to reducing C. difficile spores. Additional studies are
required to further investigate these initial findings.
Wheeldon S47 (P9.01 at left col.); see also Final Action 3–4 and Ans. 11–14
(discussing Wheeldon).
FF2. Ginsburg disclosed, “while neither [taurocholate], ethanol,
[glucose oxidase], nor trypsin when tested alone had any toxic effects on the
cells, the combination of [taurocholate] with ethanol, peroxide, and trypsin
were highly cytolytic,” confirming that combining the germinant
taurocholate and the antimicrobial ethanol would not degrade each other.
Ginsburg 111; see also Final Action 4–5 and Ans. 11–14 (discussing
Ginsburg).
FF3. Boucher disclosed disinfecting with sporidical compositions
“based upon the synergistic effects observed when combining nonionic and
anionic surfactants with aqueous or alcoholic glutaraldehyde solutions.”
Boucher Abstract; see also Final Action 4–5 and Ans. 12 (discussing
Boucher).
FF4. Williams, similar to Boucher, disclosed “[c]ompositions,
devices, and methods are disclosed for achieving rapid cleaning,
disinfection, and sterilization in aqueous solution. . . . An ethoxylated
aliphatic amine is disclosed as the cationic surfactant of choice, preferably
with a liquid soluble germicide simultaneously present in aqueous solution
to accelerate sterilization” and also “[t]he resulting sporicidal composition is
able to rapidly reduce the contact time needed for sporicidal kill from hours
to minutes, and from minutes to seconds.” Williams Abstract and col. 2, ll.
43–46; see also Final Action 8–10 and Ans. 13 (discussing Williams).
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FF5. EMD discloses “Thioglycollate Medium” using “synthetic
agar-agar” has a “pH [of] 7.1 ± 0.2 at 25º C,” confirming the pH of the
germination solution disclosed by Wheeldon. EMD 5th paragraph; see also
Final Action 4 (discussing EMD).

DISCUSSION
We consider and address all obviousness rejections together because
the same determinative evidence and arguments apply to each. The
Examiner has established a prima facie case that the claims would have been
obvious over the cited prior art combinations. Final Action 3, 6, and 7.
Appellants contend, even though Wheeldon “teaches a two-step
process for disinfecting a surface,” where “[o]ne step is the germination of
C. difficile spores with a 0.1% wt/vol sodium taurocholate in thioglycolate
medium,” which “is followed by exposure to 70% ethanol, wherein the
results suggest that germination of C. difficile spores increases their
susceptibility to 70% ethanol,” it would not have rendered the respective
germinant agent and antimicrobial agent elements of the claims obvious
because “Wheeldon nevertheless fails to provide any motivation for
combining sodium taurocholate [and] ethanol into a single composition.”
Br. 4; see also FF1 (quoting relevant portion of Wheeldon). Appellants’
case for non-obviousness hinges on this argument, but it is unpersuasive.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[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
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than the predictable use of prior art elements according to their established
functions.” Id. at 417. “It is prima facie obvious to combine two
compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition which is to be used for
the very same purpose. . . . [T]he idea of combining them flows logically
from their having been individually taught in the prior art.” In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Here, we are presented with a claim to two combined components
(two primary components; there are others) to create a sporicidal
composition, and also prior art disclosing the same components applied
sequentially, but mixed on a surface to be cleaned to create a sporicidal
composition on that surface. There is no identified unexpected result
attributable to the recited pre-combined germicide, antimicrobial, and
surfactant components (at the recited pH range) that is not also suggested by
the results achieved by the prior art. See FF1 (results of combining
germinant and antimicrobial); FF3 (synergistic sporicidal effects of
combining surfactants with alcohol); FF4 (rapid disinfection results by
combining surfactant and germicide). Also, the prior art indicates that there
would be no disruption in the cell-killing characteristic in combining
Wheeldon’s taurocholate and ethanol in a single composition. See FF2.
Therefore, the cited prior art combination(s) would have rendered the claims
obvious.
Appellants also argue that the recited “time-to-kill feature in claim 1”
was not taught or suggested by the cited prior art combination and, so, the
claims would not have been obvious. Br. 5. This is also not persuasive.
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“From the standpoint of patent law, a compound and all of its
properties are inseparable; they are one and the same thing.” In re Papesch,
315 F.2d 381, 391 (CCPA 1963). The same is true for a composition. Here,
the recited composition would have been obvious over the cited prior art
combination. The “discovery that a claimed composition possesses a
property not disclosed for the prior art subject matter, does not by itself
defeat a prima facie case.” In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990).
Here, there is no persuasive evidence on record that the recited time-to-kill
property would have been unexpected. See, e.g., Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1371 (Fed. Cir. 2007) (affirming obviousness determination
absent sufficient evidence of unexpected results).
For the above reasons, we find that the evidence of record supports
the Examiner’s determination that claim 1 would have been obvious over the
cited prior art combination. The claims subject to each of the grounds of
rejection were not separately argued by Appellants and fall with
representative claim 1. 37 C.F.R. § 41.37(c)(1)(iv). As to the rejection of
claim 2, Appellants relied on their prior arguments (Br. 6), which, as
discussed above, we do not find persuasive.

SUMMARY
The rejection of claims 1, 3–4, 8, 10, and 12 under 35 U.S.C. § 103(a)
over Wheeldon, Ginsburg, Boucher, and EMD is affirmed.
The rejection of claim 2 under 35 U.S.C. § 103(a) over Wheeldon,
Ginsburg, Boucher, EMD, and Sorg is affirmed.
The rejection of claims 1, 3–4, 8, 10, 12, and 28 under 35 U.S.C.
§ 103(a) over Wheeldon, Ginsburg, Williams, and EMD is affirmed.
Appeal 2015-000678
Application 12/633,883

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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