Ex Parte Franciskovich et al

Patent Trial and Appeal Board

Oct 24, 2017

13480565 (P.T.A.B. Oct. 24, 2017)

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.
13/480,565 05/25/2012 Phillip P. Franciskovich STRSP0118USB 5380
23908 7590 10/26/2017
RENNER OTTO BOISSELLE & SKLAR, LLP
1621 EUCLID AVENUE
NINETEENTH FLOOR
CLEVELAND, OH 44115
EXAMINER
CHOI, FRANK I
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
10/26/2017 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):
ipdocket @ rennerotto. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILLIP P. FRANCISKOVICH, DONALD G. ROSENHAMER,
KATHLEEN A. FIX, and DANA HALL
Appeal 2016-008043
Application 13/480,5651
Technology Center 1600
Before ULRIKE W. JENKS, ELIZABETH A. LaVIER, and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving “a composition
suitable for sterilizing articles such as medical, dental, pharmaceutical,
veterinary or mortuary instruments, devices, and the like.” Specification 1.
The Examiner rejected the claims on appeal as obvious under 35 U.S.C.
§ 103(a) and provisionally on the ground of non-statutory obviousness-type
double patenting.
We affirm.
1 According to Appellants, the real party in interest is American Sterilizer
Company. App. Br. 3.
Appeal 2016-008043
Application 13/480,565
STATEMENT OF THE CASE
Claims 1—35 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A sterilizing apparatus comprising a sterilization
chamber and a sterilant introduction system, wherein the
sterilant introduction system separately supplies components
(A) and (B) to form an aqueous composition consisting
essentially of the components (A) and (B):
(A) an anti-microbial agent consisting essentially of
peracetic acid; and
(B) a reagent mixture consisting essentially of a buffer,
an anticorrosive agent and a chelator;
wherein the composition does not contain molybdate, and
wherein the components (A) and (B) in the sterilant
introduction system are in an initial weight ratio of (A) to (B)
from 0.45 to 1.3, component (A) comprises from 15% to 45%
by weight of peracetic acid, and component (B) comprises from
35% to 98% by weight of the buffer, from 0.5% to 35% by
weight of the anticorrosive agent, and from 0.3% to 60% by
weight of the chelator.
App. Br. 18.
The claims stand rejected as follows:
Claims 1—35 were rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Huth2 and Kralvoic.3
Claims 1—35 were provisionally rejected on the ground of non-
statutory obviousness-type double patenting over claims 20—22, and 24-46
of copending Application No. 13/440,405.4
2 Huth et al., US Patent No. 6,448,062 Bl, issued Sept. 10, 2002 (“Huth”).
3 Kralovic et al., US Patent No. 4,731,222, issued Mar. 15, 1988
(“Kralovic”).
4 Application No. 13/440,405 is involved in copending Appeal No. 2016-
008041. The appeal addressed almost identical issues and involved the same
2
Appeal 2016-008043
Application 13/480,565
OBVIOUSNESS
Appellants argue claims 1—35 together as a group. We designate
claim 1 as representative for the group.
The Examiner found that Huth disclosed a composition including all
of the elements of claim 1 and that the only differences between claim 1 and
Huth relate to using an apparatus where the article is placed in a sterilization
chamber and to certain of the dependent claims that Appellants do not
separately argue. Final Act. 2—10.5
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3—13; Final Act. 2—16) and agree
that the claims are obvious over the combination of Huth and Kralovic. We
address Appellants’ arguments below.
Appellants argue that Huth teaches that the composition relied upon
by the Examiner was intended to be combined with a cleaning composition
that includes an enzyme. Appellants explain:
While Huth et al. discloses a composition at col. 29, lines 10-20
that does not include an enzyme, this composition is disclosed
as the disinfecting portion of the disclosed combined cleaning/
disinfecting composition, and would not be capable of the
Huth-claimed simultaneous cleaning and disinfection.
Real Party in Interest. Indeed, the argument portion of the briefs submitted
in both cases is substantially identical. Notwithstanding the fact that
significant portions of the briefs submitted in the two appeals were
substantially identical, submitted on the same day, and signed by the same
person, Appellants failed to identify the related appeal as required by 37
C.F.R. § 41.37(c)(ii). Appellants also failed to identify this case as related to
Appeal No. 2016-000813, which involves similarly overlapping subject
matter and briefing.
5 Office Action mailed July 22, 2015 (“Final Act.”).
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Appeal 2016-008043
Application 13/480,565
App. Br. 10. Appellants then argue that the present claims are
distinguishable over Huth because the claims are limited by the transitional
phrase “consisting essentially of’ and the addition of an enzyme would
materially change the basic and novel characteristics of composition used in
connection with the claimed apparatus. Id. at 11—15. We are not persuaded.
Claim 1 identifies the claim as being directed to “a sterilizing
apparatus” comprising “sterilant introduction system” for an “aqueous
composition.” The Specification defines the term “sterilizing” as follows:
The term “sterilization” refers to rendering a substance
incapable of reproduction, metabolism and/or growth. The term
“sterilization” includes microbial deactivation. While
sterilization is often taken to refer to a total absence of living
organisms, the term may be used herein to refer to a substance
free from living organisms to a degree agreed to be acceptable.
Unless otherwise indicated, the term “sterilization” may be used
herein to also refer to processes less rigorous than sterilization,
for example, disinfection, sanitization, decontamination,
cleaning, and the like. Variations of the term “sterilization,”
such as sterilant, sterilizing, etc., may also be used herein to
refer to and encompass related variants associated with
sterilization processes as well as processes less rigorous than
sterilization (e.g., disinfectant, disinfecting, etc.).
Spec. 3.
Huth discloses the following composition, described as an “[ajqueous
solution of disinfecting agent.”
Kuaeiiofi&l CoKiponeM Haw Materia* Concerttratio n ^?NV ,v
Dislatecuag agest hydrogen peroxide 6,0-b,0
Disinfecting agent peracetic acid aos-o.20
Chel&dag age sit Na.EDTA 0.05-0.35
11,0, Stabi lizer Dequest 2010 0.10-1,0
Bitfl'et/H-,O, st a bi. lizer boric add (1006-0,60
Anticorrosive 3,2.3 - b enzo ttia zol e 0.10-1.0
Diluent water q.s. to volume-
4
Appeal 2016-008043
Application 13/480,565
Huth col. 29,11. 8—20. Huth uses the term “disinfection” to refer to “the
removal of hazardous or unwanted materials such as bacteria, mold spores or
other pathogenic forms and the like” and distinguishes between “high-level
disinfection,” “intermediate-level disinfection,” and “low-level
disinfection,” each of which provides different levels of decontamination.
Huth col. 1,11. 28—33 and 41—45, and col. 2,11. 29—31 and 39-42. Huth’s
disinfecting composition is, by itself, a “sterilizing” composition as that term
is defined in the Specification.
While it is true that Huth contemplates that its disinfecting
composition will ultimately be used together with a cleaning composition,
the disinfecting composition is separately disclosed. Id. at col. 29,11. 8—20.
In addition, as the Examiner points out, Huth discloses examples in which
the antimicrobial efficacy of peracetic acid compositions was tested without
an enzyme. Ans. 5 (citing Huth Examples 12 and 13, col. 43,1. 63 — col. 46,
1. 26). Because Huth’s disinfecting composition can be used without an
enzyme, Huth’s disclosure of an enzyme that may be used with its
disinfecting composition does not distinguish that disinfecting composition
from the composition recited in connection with the claimed sterilizing
apparatus.
Our finding that Huth discloses a disinfecting composition that can be
used without an enzyme renders moot Appellants’ argument that the
transitional phrase “consisting essentially of’ precludes the presence of an
enzyme. Nonetheless, we note that we agree with the Examiner that the
basic and novel properties of the claimed composition relate to the activity
of the composition as a sterilizer, not to the advantages — including number
ingredients, complexity of formulation, and/or cost of the ingredients — that
5
Appeal 2016-008043
Application 13/480,565
one embodiment of the claimed composition enjoys as compared to a single
selected prior art composition. See Ans. 5—6.
We further note that Appellants have not persuaded us that the
presence of an enzyme would materially affect the sterilizing properties of
Huth’s disinfecting composition. We acknowledge the declaratory
testimony offered by Appellants that the presence of an enzyme reduces the
amount of peracetic acid available for sterilization. See Kaiser Deck614.
As the Examiner points out, however, Huth includes examples in which
peracetic acid compositions including an enzyme retained antimicrobial
activity. Ans. 5 (citing Huth Examples 12 and 13, col. 43,1. 63 — col. 46,
1. 26). Thus, even if we were to accept Appellants’ argument that, for
purposes of assessing obviousness, Huth’s disinfecting composition can only
be considered in connection with an enzyme, we find that the presence of the
enzyme does not materially affect the basic and novel characteristics of the
disinfecting composition.7
Appellants argue that claim 1 is not obvious over Huth because
Huth’s disinfecting composition includes at least a H2O2 stabilizer, Dequest
2010®, the active ingredient of which (hydroxyethylidenediphosphonic
acid) is excluded from the claims by the transitional phrase “consisting
essentially of.” App. Br. 15—17. We are not persuaded.
The Dequest 2010® component of Huth’s disinfecting composition is
identified as a hydrogen peroxide stabilizer. Huth col. 29,11. 8—20. While
6 Declaration of Nancy Kaiser under 37 C.F.R. § 1.132, signed March 23,
2015 (“Kaiser Decl.”).
7 Appellants’ arguments regarding the effect of peracetic acid on the
properties of the enzyme are not relevant because it is the sterilizing
composition that is claimed, not the enzyme.
6
Appeal 2016-008043
Application 13/480,565
Huth does teach a need for a hydrogen peroxide stabilizer and exemplify a
composition including Dequest 2010® as such a stabilizer {id.), Huth
expressly states: “destabilization can be prevented with sequestrants such as
hydroxy-ethylidene diphosphonic acid (Dequest 2010™, Monsanto Co.), or
with the use of conventional chelating agents.’ '’ Id. at col. 22,11. 31—35
(emphasis added). In view of this statement, a person of ordinary skill in the
art would have recognized Dequest 2010® as interchangeable with
conventional chelating agents and it would have been obvious to substitute a
“conventional chelating agent” for Dequest 2010® in Huth’s disinfecting
composition. See KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
(“[W]hen a patent claims a structure already known in the prior art that is
altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.”). As
claim 1 expressly includes a “chelator” as part of the claimed composition,
the use of a conventional chelating agent does not render the claimed
composition nonobvious over Huth.
Our finding that Huth’s disinfecting composition may use a
“conventional chelating agent,” renders moot Appellants’ argument that the
transitional phrase “consisting essentially of’ precludes the presence of a
peroxide stabilizer. Nonetheless, we note that Huth uses Dequest 2010®
and/or conventional chelating agents to stabilize its composition. Huth col.
22,11. 21—39. We recognize the testimony of Mr. Rosenhamer that because
the use of a stabilizer “would affect the stability and activity of the
[composition], it must necessarily affect the ‘basic and novel characteristics’
7
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Application 13/480,565
of any . . . composition to which it is added.” See Rosenhamer Decl.814.
However, we are not persuaded because we do not consider stability to be a
basic and novel characteristic of the claimed compound.
Accordingly, we affirm the Examiner’s decision to reject claims 20—
22 and 24-46 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Huth and Kralvoic.
DOUBLE PATENTING
Appellants do not address the Examiner’s provisional obviousness-
type double patenting rejection. We therefore summarily affirm this
rejection. See Manual of Patent Examining Procedure § 1205.02 (“If a
ground of rejection stated by the examiner is not addressed in the appellant’s
brief, that ground of rejection will be summarily sustained by the Board.”).
SUMMARY
For these reasons and those set forth in the Examiner’s Answer, and
the Final Office Action, we affirm the Examiner’s rejection of claims 1—35
under 35 U.S.C. § 103(a) as unpatentable over the combination of Huth and
Kralvoic and the Examiner’s provisional rejection of claims 1—35 on the
ground of nonstatutory obviousness-type double patenting over claims 20—
22 and 24-46 of copending Application No. 13/440,405.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED
8 Declaration of Donald G. Rosenhamer under 37 C.F.R. § 1.132, signed
July 22, 2013 (“Rosenhamer Decl.”).
8