WHITELEY CORPORATION PTY LTD

Patent Trials and Appeals Board

Apr 1, 2021

2020004217 (P.T.A.B. Apr. 1, 2021)

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.
15/035,633 05/10/2016 Trevor Glasbey 13124.00004(US
from PCT)
4908
67883 7590 04/01/2021
Pryor Cashman LLP
Patent Department
7 Times Square
NEW YORK, NY 10036-6569
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
04/01/2021 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 TREVOR GLASBEY

Appeal 2020-004217
Application 15/035,633
Technology Center 1600
Before ULRIKE W. JENKS, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.

Opinion for the Board filed by NEWMAN

Opinion Concurring-in-Part and Dissenting-in-Part filed by CHANG

NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3, 6–8, 11–15, and 18. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Whiteley
Corporation Pty Ltd. Appeal Br. 3. Herein, we refer to the Appeal Brief
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2
STATEMENT OF THE CASE
Organic peroxy acids, such as peracetic acid (PAA), have
numerous advantageous properties for use as disinfectants. In
particular peracetic acid displays a broad spectrum of biological
activity including bactericidal, fungicidal, biocidal, and
particularly sporicidal. Furthermore, peracetic acid is not
deactivated by catalase and peroxidase, the enzymes
responsible for breaking down hydrogen peroxide, and typically
found in the tissues of all animal and plant species, as well as
most aerobic bacteria.
Spec. 1:6–12.
However, the Specification states that peracetic acid is “typically
supplied as an equilibrium mixture, also containing the precursor materials
hydrogen peroxide and acetic acid,” and that peracetic acid generated by
direct reaction of these precursors has a “sharp, pungent odour (due to the
excess acetic acid) and [a] highly acidic pH [that] makes the solution
corrosive to many surfaces.” Id. at 1:23–27. In addition, the solution is
thermodynamically unstable. Id. at 1:29.
The Specification states that, to avoid the above problems, “systems
have been developed to generate . . . peracetic acid in situ from more stable
precursors by reacting suitable peroxide sources with an acetyl transfer agent
(activator)” such as tetraacetylethylenediamine (TAED). Id. at 2:1–3, 2:27–
28. According to the Specification, such formulations may be provided in
the form of a powdered blend “which, upon dissolution in water, react to
form the peroxy acid in situ.” Id. at 2:8–10. Further according to the
Specification, a disadvantage of such a formulation is that “peracetic acid is

filed March 26, 2020 (“Appeal Br.”), the Examiner’s Answer filed April 22,
2020, (“Ans.”), and the Reply Brief filed May 19, 2020 (“Reply Br.”)
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not generated instantaneously” and “[t]he requisite target peracetic acid
concentration may not therefore be reached until several minutes after full
dissolution of the precursor powder,” which in turn “poses real risk that the
end user may begin to use the disinfectant solution before an effective
amount of the active agent has been produced, leading to potentially
compromised disinfection.” Id. at 4:27–30, 5:4–8.
The Specification states that “it would be desirable to provide a means
to provide the user with an indication of when sufficient peracetic acid has
been generated and therefore when the disinfectant solution is ready for
use.” Id. at 5:10–12.

CLAIMED SUBJECT MATTER
The claims are directed to powder compositions for generating
peracetic acid. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A powder composition for generating and indicating an initial
achievement of a biocidally effective concentration of peracetic acid
upon dissolution in water, the powder composition consisting
essentially of:
(a) a hydrogen peroxide source;
(b) an acetyl source; and
(c) a peracetic acid bleachable dye,
wherein said composition is configured to generate and indicate an
initial achievement of a biocidally effective concentration of peracetic
acid upon dissolution in water, said indication being a substantial
removal of color generated by said peracetic acid bleachable dye.
Appeal Br. 21 (Claims App.).
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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Ramon T. Ignacio, et al. US 6,287,518 B1 September 11,2001
Patricia A. Antonoplos, et al. US 6,551,555 B2 April 22, 2003
Stanley William Huth US 2003/0096720A1 May 22, 2003
Ulrich Pegelow, et al. US 2007/0197416 Al August 23, 2007

REJECTIONS
1. Claims 1, 3, 6–8, 11–15, and 18 are rejected under 35 U.S.C. § 112(a)
as failing to comply with the written description requirement. Ans. 3.
2. Claims 1, 3, 6–8, 11–15, and 18 are rejected under 35 U.S.C. § 103 as
being unpatentable over Huth, Antonoplos, Ignacio, and Pegelow. Id.
at 5.
OPINION
A. Written Description
The Examiner finds that “Appellant’s disclosure as originally filed is
devoid of any mention whatsoever of a composition ‘consisting essentially
of’ a hydrogen peroxide source, an acetyl source, and a peracetic acid
bleachable dye.” Ans. 4. The Examiner concludes that the absence of direct
support in the Specification for the amendment, which replaced
“comprising” in sole independent claim 1 with “[the] powder compositions
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‘consisting essentially of,’” warrants a new matter rejection.2 Id. The
Examiner states that because “consisting essentially of” limits the scope of
each claim to the specified steps or materials claimed and any that “do not
materially affect the basic and novel characteristic(s)” of the claimed
invention, that, to support this claim structure, the Specification would need
to delineate “precisely which basic and novel characteristics the invention
provides which additional included agents must not materially affect.” Id.
The Examiner finds that Appellant instead provides “[a] litany of additional
components which are explicitly envisioned as suitably combined with the
three required elements of the composition claimed.” Id. Because the
Specification does not clearly identify the basic and novel characteristics of
the invention, the Examiner finds that the skilled artisan would not have had
“any guidance though the forest of potential additional composition
components known at the time.” Id. The Examiner concludes that the
claims are not supported by sufficient written description. Id. at 5.
Appellant argues that the Specification clearly articulates the
invention
the invention of independent claim 1 is directed to a powder
composition that, upon dissolution in water, provides dual
benefits: (1) The generation of a biocidally effective
concentration of peracetic acid (“PAA”), which may serve as,
e.g., a hospital disinfectant for surface cleaning; and (2) The
indication of an initial achievement, i.e., the temporal onset, of
a biocidally effective concentration of PAA.

2 Applicant’s claim amendments were submitted with its “Request for
Continuation Examination (RCE) and Amendment in Response to July 5,
2019 Final Office Action” on October 3, 2019.
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Appeal Br. 7 (citing claim 1 as originally filed and Specification 10:3–6).
Appellant argues that this description clearly describes the basic and novel
characteristics of the invention as required by 35 U.S.C. § 112, which
Appellant defines as:
For the first characteristic relating to PAA generation, the
claimed components/materials contributing to this aspect are
“(a) a hydrogen peroxide source” and “(b) an acetyl source”;
when (a) and (b) are dissolved in water, they produce PAA, a
known disinfectant. . . . For the second characteristic relating to
the onset or first indication of an efficacious concentration or
amount of PAA in water, the claimed component/material
contributing to this aspect is “(c) a peracetic acid bleachable
dye.”
Appeal Br. 8; Reply Br. 10. Appellant argues that additional materials like
“one or more of an acidifying agent, a wetting agent, a pH buffering agent, a
sequestering agent, a flow modifier, a perfume, other additives, or
combinations thereof” do not affect the basic and novel characteristics of the
claimed invention. Appeal Br. 10–11.
We agree with Appellant that the Examiner has not shown that the
Specification fails to adequately describe the claimed composition. A
description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must “clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed.” In other
words, the test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in
the art that the inventor had possession of the claimed subject
matter as of the filing date.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(citation omitted, alteration in original). “The descriptive text needed to
meet these requirements varies with the nature and scope of the invention at
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issue, and with the scientific and technologic knowledge already in
existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005).
The phrase “consisting essentially of” is a transition phrase that, when
used before a list of ingredients in a composition claim, indicates that “the
invention necessarily includes the listed ingredients [but] is open to unlisted
ingredients that do not materially affect the basic and novel properties of the
invention.” HZNP Medicines LLC v. Actavis Laboratories UT, Inc., 940
F.3d 680, 692–693 (Fed. Cir. 2019) (quoting AK Steel Corp. v. Sollac &
Ugine, 344 F.3d 1234, 1239 (Fed. Cir. 2003)). Thus, to satisfy the written
description requirement, Appellant’s disclosures must reasonably convey to
those skilled in the art that the inventor had possession of a powder
composition that (1) includes a hydrogen peroxide source, an acetyl source,
and a peracetic acid bleachable dye, and (2) does not include any ingredients
that would materially affect the basic and novel properties of a composition
of these listed ingredients.
The Specification describes a composition comprising a hydrogen
peroxide source, an acetyl source, and a peracetic acid bleachable dye.
Spec. 7:9–13. The composition, when dissolved in solution, generates color
via the peracetic acid bleachable dye at the point when the concentration of
peracetic acid is biocidally effective (ready for use as a disinfectant). Id. at
7:14–16. The composition is preferably provided in powder form. Id. at
10:11. The Specification further describes optionally added components:
“wetting agents, sequestering and chelating agents, and other ingredients,
such as bleach stable fragrances, corrosion inhibitors, powder flow
modifiers, rheology modifiers etc.” Id. at 11:7–9. Finally, as Appellant
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points out, Appeal Br. 9–10, the Specification at 16:14–24 identifies a
preferred embodiment that describes precisely the recited components and
their function in the composition. We find these disclosures to be sufficient,
in light of the scientific and technological knowledge in existence at the time
of the invention, to satisfy the written description requirement. Capon, 418
F.3d at 1357. In short, we agree with Appellant that the Specification shows
possession of a powder composition
consisting essentially of: (a) a hydrogen peroxide source; (b) an
acetyl source; and (c) a peracetic acid bleachable dye, wherein
said composition is configured to generate and indicate an
initial achievement of a biocidally effective concentration of
peracetic acid upon dissolution in water, said indication being a
substantial removal of color generated by said peracetic acid
bleachable dye
as recited in claim 1. The rejection under 35 U.S.C. § 112, first paragraph,3
is reversed.
B. Obviousness
The Examiner has rejected all of the claims on appeal as obvious
based on the disclosures of Huth, Ignacio, Antonoplos, and Pegelow. The
Examiner finds that Huth discloses “cleansing compositions which combine
a per-compound oxidant as a decontaminating agent and enzymes, along

3 The Examiner asserts that “no indication of the basic and novel
characteristics of the invention can be discerned from the disclosure,
rendering it impossible for a skilled artisan to determine what potentially
includable components would interfere.” Ans. 11–12. However, whether
the Specification sufficiently identifies the basic and novel characteristics of
the invention where the transitional phrase “consisting essentially of” is
employed is an issue of definiteness resolved by the factfinder. See HZNP
Medicines, 940 F.3d at 694.
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with any of chelators, buffers, dyes, and combinations thereof.” Ans. 7. The
Examiner finds that Huth discloses all aspects of the composition except for
the color change (removal of color) indicating “an initial achievement of a
biocidally effective concentration of peracetic acid.” Id. at 8–9. The
Examiner finds that Ignacio and Antonoplos disclose that sterilization
monitors can “undergo distinct color changes in the presence of a peracetic
acid” in a manner in which the concentration of the dye reflects the rate of
removal of the oxidizing agent from the solution. Id. at 9–10. The
Examiner further finds that Pegelow teaches that Amaranth (CI 16185) is an
“exemplary dye capable of being oxidatively destroyed in the cleaning
process.” Id. at 10–11. In light of these combined teachings, the Examiner
concludes that the skilled artisan would have found the claimed subject
matter obvious. Id. at 11.
Appellant argues, among other things, that the claimed subject matter
is not obvious because the central reference Huth “necessarily includes at
least one enzyme and, yet, any inclusion of this enzyme component required
by the teachings of Huth in the composition of Applicant’s claimed
invention would materially affect its basic and novel characteristics.”
Appeal Br. 12. Appellant argues that the enzyme disclosed in Huth
acts to break down blood and other organic contaminants in or
on medical instruments; a second enzyme recited in Huth acts
to break down the decontaminating agent itself, e.g., PAA,
which is necessarily removed in order to reuse the medical
instrument after patient contact and disinfection.
Id. Appellant argues that Huth discloses that “inclusion of the enzyme
component necessarily affects and is necessarily affected by the inclusion of
the decontaminating agent(s), e.g., H2O2 and/or PAA,” requires inclusion of
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additional components such as buffers to “limit the effects that the enzyme
component and decontaminating agent(s) have on each other,” but that those
components work “entirely differently than the claimed invention.” Id. at
12–14.

Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, id. at 415, it also reaffirmed the importance of
determining “whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id. at 418 (emphasis
added).
Thus, as the Federal Circuit has since explained, “obviousness
concerns whether a skilled artisan not only could have made but would have
been motivated to make the combinations or modifications of prior art to
arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d
1064, 1073 (Fed. Cir. 2015).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, ‘the test is what the
combined teachings of the references would have suggested to those of
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ordinary skill in the art.’” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (citation omitted).
We agree with Appellant that a preponderance of the evidence does
not support the Examiner’s conclusion of obviousness. In particular, we are
not persuaded that the teachings of Huth would have suggested to the skilled
artisan that the chemical composition disclosed by Huth could be made
without an enzyme, or that inclusion of the enzyme as taught by Huth would
not affect the basic and novel characteristics of the claimed invention.
Huth discloses “[a] composition for simultaneous cleaning and
decontaminating a device. The composition is a per-compound oxidant in an
amount effective for decontaminating the device and an enzyme in an
amount effective for cleaning the device.” Huth Abstract (emphasis added).
The “composition is a per-compound oxidant, such as hydrogen peroxide
(H2O2) and/or peracetic acid (PAA) and an enzyme.” Id. ¶ 42. Huth
discloses that an advantage of the invention is that it combines the
“enzymatic detergent precleaning treatment with the decontaminating step
so that cleaning and decontaminating are performed simultaneously.” Id.
¶ 51. Huth refers to the invention as “the combination of enzyme plus
decontaminant.” Id. ¶ 54. In short, the invention of Huth requires the
enzyme component to perform the cleaning step.
Moreover, the amount of enzyme used in the solution must be
“effective and efficacious” as described:
An effective and efficacious amount is that which (1) removes,
in a reasonable time a substantial portion of the proteinaceous
or other deposits which occur during the use of the medical
device, (2) does not decrease the efficacy of the
decontaminating agent(s) when combined with the latter
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agent(s) in the working solution, and (3) allows the
decontaminating agent(s) to achieve the standards, e.g., high-
level disinfection and sterilization, required for the reprocessing
of the particular device or instrument.

Huth ¶ 78 (emphasis added). The amount of enzyme required
depends on multiple factors, including:
enzyme activity and purity, the amount of proteinaceous and
other matter deposited, the desired soaking period and
temperature, the nature and concentration of the
decontaminating agent(s), the specific medical device or
instrument, the delivery form of the enzyme and its related shelf
stability, the presence of surfactants and other solution
components known to enhance the activity of the particular
enzyme.

Id. ¶ 79. The decontaminant concentration directly affects enzyme
concentration (see, e.g., Huth ¶ 81 “[e]nzyme activity loss from exposure to
the decontaminant is greater with longer regimen soak times. Thus, these
two effects need to be balanced in the final enzyme formula”; ¶¶ 82–86,
discussing pH, temperature, enzyme activity loss, and dilution
considerations in achieving correct concentration of enzyme and PAA); ¶
204, reflecting loss of PAA concentration over time in solution with enzyme
and organic matter. Because the enzyme must be balanced against PAA, the
solution must be stabilized to avoid PAA entirely dissolving the enzyme.
See, e.g., Huth
¶¶ 96–99 regarding balancing components to maximize concentration of
hydrogen peroxide and minimize concentration of acetic acid to produce
desired amount of peracetic acid for effective but minimally corrosive
solution. We, therefore, disagree with the Examiner’s strict interpretation of
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paragraphs 78 and 79 of Huth as generally teaching that, in the compositions
of Huth, “the enzyme does not interfere with the decontaminating agents
with which they are to be combined.” Ans. 16. A composition where the
enzyme does not interfere is only achieved where the composition has been
carefully balanced with formulation of pH, temperature, stabilizers and
enzyme dilution as described above, and that will permit the enzyme to
cleanse and the peracetic acid to decontaminate such that, “the combined
cleaning and decontaminating solutions of the present invention achieve
significantly greater cleaning per unit of enzyme than prior stand-alone
enzyme solutions,” which allows less enzyme to be used for cleansing. Id.
¶ 83. Some of these combinations are formulated as “single use” because
application will exhaust one or more components (see e.g., Huth ¶¶152–
155). Notably, there is no teaching in Huth to use peracetic acid and color
indicator dye without enzyme to perform decontamination. Rather, the
cleaning enzyme and decontaminating components are explicitly stated as
“[t]he two essential components.” Id. ¶ 136.
Appellant states that, to overcome the rejection based on Huth,
Appellant amended the claimed invention to recite “[a powdered
composition] ‘consisting essentially of’” the listed components that did not
include an enzyme. Appeal Br. 13–14. As noted by the Examiner and
Appellant, “the [transitional] phrase ‘consisting essentially of’ limits the
scope of a claim to the specified [materials or steps] ‘and those that do not
materially affect the basic and novel characteristic(s)’ [of the claimed
invention].” In re Herz, 537 F.2d 549, 551–52 (CCPA 1976). As described
above, Huth teaches a carefully balanced cleaning and decontaminating
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solution that is balanced to permit a greater total benefit than each individual
component. Therefore, we consider the enzyme (cleaning component), as an
“essential component” to materially affect the “basic and novel
characteristics” of the claimed composition. Because Appellant amended
the claim to recite the transitional phrase “consisting essentially of,” without
including an enzyme in the composition, and because Huth does not teach
use of the composition without an enzyme, we are not persuaded that the
skilled artisan would have found it obvious based on Huth to make the
composition of claim 1. None of Antonoplos, Ignacio, or Pegelow are cited
to teach use of the composition without an enzyme. We conclude that the
Examiner has not met the burden to present a prima facie case of
unpatentability, and we reverse the rejection of all claims. In re Oetiker at
1445.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 6–8, 11–
15, 18
112 Written description 1, 3, 6–8,
11–15, 18
1, 3, 6–8, 11–
15, 18
103 Huth, Antonoplos,
Ignacio, Pegelow
1, 3, 6–8,
11–15, 18
Overall
Outcome
1, 3, 6–8,
11–15, 18

REVERSED
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CHANG, Administrative Patent Judge, concurring-in-part and dissenting-
in-part

While I agree with the Majority that a preponderance of evidence of
record does not support the Examiner’s written description rejection, I
respectfully dissent from the Majority’s opinion with respect to the reversal
of the Examiner’s rejection under 35 U.S.C. § 103.
A. Issue
The Examiner rejects claims 1, 3, 6–8, 11–15, and 18 as obvious over
Huth, Antonoplos, Ignacio, and Pegelow. Ans. 5.
The Examiner finds that Huth teaches all of the limitations of claim 1,
except that it does not explicitly disclose a composition “configured to
generate and indicate an initial achievement of a biocidally effective
concentration of peracetic acid upon dissolution in water” through the
“substantial removal of color generated by said peracetic acid bleachable
dye,” as required in claim 1. Ans. 7–8. Citing Ignacio and Antonoplos,
however, the Examiner finds that this limitation merely describes “a
difference in the amount of bleachable dye present in the composition
relative to the quantity of peracetic acid to be generated from the peroxide
and acetyl sources.” Id. at 8–10. The Examiner concludes that a skilled
artisan would have found it obvious to modify the relative concentration of
bleachable dye to oxidizing agent in Huth’s composition to arrive at the
claimed composition, because “difference in concentration . . . will not
support the patentability of subject matter encompassed by the prior art
unless there is evidence indicating such concentration . . . is critical,” and “it
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is not inventive to discover the optimum or workable ranges by routine
experimentation” where “general conditions of a claim are disclosed in the
prior art.” Id. at 10.4
Appellant contends that the prior art does not suggest a composition
consisting essentially of the explicitly recited components, as required by
claim 1. Appeal Br. 11–15. Appellant further contends that the cited prior
art combination does not suggest the limitation of a composition “configured
to . . . indicate an initial achievement of a biocidally effective concentration
of peracetic acid upon dissolution in water, said indication being a
substantial removal of color generated by said peracetic acid bleachable
dye.” Id. at 15–17.
Appellant does not separately argue the claims. I therefore focus my
analysis on claim 1 as representative. The issues with respect to this
rejection are (1) whether a preponderance of the evidence of record supports
the Examiner’s finding that the prior art combination suggests a composition
consisting essentially of the explicitly recited components of claim 1, and (2)
whether a preponderance of evidence of record supports the Examiner’s
finding that the prior art combination suggests a composition “configured to
. . . indicate an initial achievement of a biocidally effective concentration of
peracetic acid.”

4 The Examiner further cites Pegelow for the specific hydrogen peroxide
source and dye recited in certain dependent claims. Ans. 10–11.
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B. Analysis
1. “consisting essentially of: (a) a hydrogen peroxide source; (b)
an acetyl source; and (c) a peracetic acid bleachable dye”
As the Majority explained in its opinion, the phrase “consisting
essentially of” is a transition phrase that, when used before a list of
ingredients in a composition claim, indicates that “the invention necessarily
includes the listed ingredients [but] is open to unlisted ingredients that do
not materially affect the basic and novel properties of the invention.”
HZNP, 940 F.3d at 692–693. Furthermore, Appellant has the burden of
showing that the additional ingredient taught by the prior art reference
materially affects the basic and novel characteristics of the claimed
invention. See In re De Lajarte, 337 F.2d 870, 874 (CCPA 1964).
Appellant asserts that the “basic and novel properties” of its invention
are “(1) The generation of a biocidally effective concentration of peracetic
acid (‘PAA’) . . . ; and (2) The indication of an initial achievement, i.e., the
temporal onset, of a biocidally effective concentration of PAA.” Appeal Br.
7; see also Reply Br. 3, 7–8. Accordingly, based on Appellant’s own
identification of the “basic and novel properties” of its invention, the
dispositive question with respect to the obviousness rejection is whether
Appellant has shown that the composition suggested by the cited prior art
combination includes ingredients that materially affect either the generation
of a biocidally effective concentration of PAA or the indication of the initial
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achievement of a biocidally effective concentration of PAA. I agree with the
Examiner that Appellant has not met this burden. Ans. 15.
Appellant contends that Huth is “directed to a . . . composition [that]
includes a per-compound oxidant (such as H2O2 and/or PAA) and an
enzyme” and/or “a multi-component composition including at least one
enzyme, a chelating agent, and a buffer.” Appeal Br. 11–12, 13. Appellant
contends that “any inclusion of this enzyme component required by the
teachings of Huth in the composition of Applicant’s claimed invention
would materially affect its basic and novel characteristics.” Id. at 12; see id.
at 13 (asserting that “the enzyme of Huth works in a contrary manner to the
use of PAA as a surface decontaminant”).
Assuming for the sake of argument that Huth does not suggest a
claimed composition without inclusion of an enzyme,5 I am not persuaded
that the enzyme in Huth materially affects either the generation of a
biocidally effective concentration of PAA or the indication of the initial
achievement of such a concentration. As an initial matter, Appellant does
not appear to suggest in the Appeal Brief that the enzyme would interfere
with the function of a dye or other similar indicators. Thus, I understand

5 I note that Huth teaches that “dyes may be added to either the separate
cleaning formula, a separate decontaminant formula, both separate formulas
or to a combined cleaning plus decontaminant formula to differentiate the
formula from water or other reprocessing solutions.” Huth ¶ 129. Thus,
Huth appears to at least suggest a composition comprising a dye and a
decontaminant formula without the inclusion of an enzyme.
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Appellant’s argument to be focused on the characteristic of “the generation
of a biocidally effective concentration of PAA.”6
Appellant first contends that “[o]ne enzyme recited in Huth acts to
break down blood and other organic contaminants in or on medical
instruments; a second enzyme recited in Huth acts to break down the
decontaminating agent itself, e.g., PAA, which is necessarily removed in
order to reuse the medical instrument after patient contact and disinfection.”
Appeal Br. 12; see also id. at 13–14 (asserting that, “[b]ased on the full
disclosure of Huth, there is no doubt that, in order to be employed
effectively and according to its intended purpose, the composition of Huth
requires at least one, likely two, enzymes in addition to a chelating agent and
a buffer so that the PAA decontaminating agent may also be included”)
(emphasis added). Appellant contends that “breaking down the PAA by

6 In the Reply Brief, Appellant contends for the first time that “Huth requires
stated enzymes to function . . . and those enzymes described by Huth
counteract the disinfectant and color changing aspects of the disclosed
invention.” Reply Br. 9 (emphasis added). Appellant provides no argument
or support as to how the enzymes in Huth counteract the “color changing
aspects of the disclosed invention.” Moreover, Appellant has not explained
why such an argument could not have been raised in the Appeal Brief.
Hence, the argument has been waived. See Ex parte Nakashima, 93
USPQ2d 1834 (BPA1 2010) (informative) (arguments and evidence not
timely presented in the Principal Brief will not be considered when filed in a
Reply Brief, absent a showing of good cause explaining why the argument
could not have been presented in the Principal Brief); Ex parte Borden, 93
USPQ2d 1473, 1477 (BPA1 2010) (informative) (explaining that “the Rules
do not require the Board to take up a belated argument that has not been
addressed by the Examiner, absent a showing of good cause”).
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Huth is directly contrary to the present invention, which decontaminates by
using PAA as the agent for the same on surfaces.” Id. at 12.
I am not persuaded. Appellant does not cite to any portion of Huth
that supports its contention that Huth requires an enzyme that breaks down
the PAA. “Attorneys’ argument is no substitute for evidence.” Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). In fact, Huth teaches
“unique device reprocessing steps employing a bulk soil removal rinsing
step, followed by a simultaneous cleaning and decontaminating step
employing a per-compound oxidant and an enzyme, and a last rinsing step
to remove the oxidant and enzyme solution from the device.” Huth ¶ 52.
Thus, contrary to Appellant’s assertion, the decontaminating agent in Huth
appears to be removed by rinsing rather than enzymatic breakdown.
Appellant does cite to paragraphs 78–79 of Huth for the proposition
that “inclusion of the enzyme component necessarily affects and is
necessarily affected by the inclusion of the decontaminating agent(s), e.g.,
H2O2 and/or PAA and, thus, additional components are required to limit the
effects that the enzyme component and decontaminating agent(s) have on
each other.” Appeal Br. 12; see also Reply Br. 10–11 (alleging that Huth
paragraphs 78–79 teaches the “negative impact of enzyme and
decontaminating agent, e.g., PAA, on each other”).
The cited paragraphs do not support Appellant’s argument. While
paragraph 79 of Huth does teach that “[t]he precise amount of enzyme
required . . . will depend on several factors including . . . the nature and
concentration of the decontaminating agent(s),” this general teaching does
not suggest that the enzyme will interfere with or materially affect the
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generation of a biocidally effective concentration of a decontaminating
agent. Indeed, paragraph 78 teaches the opposite – that Huth’s invention
generally employs “an effective and efficacious amount of enzyme to clean
the device or instrument” and that this amount is “that which . . . does not
decrease the efficacy of the decontaminating agent(s) when combined with
the latter agent(s) in the working solution[] and . . . allows the
decontaminating agent(s) to achieve the standards, e.g., high-level
disinfection and sterilization[] required for the reprocessing of the particular
device or instrument.” In short, these paragraphs teach that the amount of
enzyme in Huth’s composition is one that will not materially affect “the
generation of a biocidally effective concentration” of decontaminating
agents such as PAA.
Appellant further cites to paragraph 48 of Huth as describing the
inactivation of enzymes by PAA and paragraph 52 of Huth as describing
“destabilization of the decontaminating agent by contact with blood and
trace metals,” which Appellant contends to be the intended purpose of Huth.
Appeal Br. 12–13; see also Reply Br. 10. Citing these paragraphs,
Appellant contends that, “[i]n order to permit the competing
decontaminating agent and enzyme of Huth to effectively coexist in the
composition, Huth requires the additional inclusion of ‘a unique chelating
agent and/or buffer,” where “[t]he chelating agent in the proper
concentration prevents destabilization of the decontaminant due to contact
with blood and trace metals” and “the buffer ‘provides adequate buffering
capacity for a large volume of decontaminant during multiple device
processing cycles.’” Appeal Br. 13; see also Reply Br. 10–11.
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I am not persuaded. While paragraph 48 may suggest that PAA may
inactivate certain cleaning enzymes, it does not suggest the opposite.
Because it is the generation of a biocidally effective concentration of PAA
rather than the enzyme that is the alleged basic and novel property of the
invention, the cited paragraph does not preclude the prior art composition
suggested by Huth and other cited prior art from reading on claim 1.
Appellant’s citation to paragraph 52 is similarly inapposite. That
paragraph lists as an advantage of Huth’s composition that it is reusable
because of “the incorporation of a combination of enzyme plus
decontaminant plus a unique chelating agent and/or buffer.” Huth teaches
that the buffer “provides adequate buffering capacity for a large volume of
decontaminant during multiple device processing cycles.” Huth ¶ 52. It also
teaches that “[t]he chelating agent in the proper concentration prevents
destabilization of the decontaminant due to contact with blood and trace
metals.” Id.
While Appellant is correct that paragraph 52 teaches that the
decontaminant in Huth’s composition may be destabilized due to contact
with blood and trace metals when used to clean medical instruments such as
endoscopes, Appeal Br. 12–13, and not withstanding Appellant’s emphasis
that such use is the “intended purpose” of Huth’s composition, id., this is
irrelevant to whether the composition taught by Huth includes any ingredient
that materially affects the basic and novel properties of the invention,
because blood and trace metals are not part of Huth’s composition.7

7 In this regard, I note that claim 1 is to a composition rather than a method
of use. For this reason, I am similarly unpersuaded Appellant’s arguments
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Finally, Appellant does not point to any specific teaching in
paragraphs 48 and 52, or elsewhere in Huth, that the chelating agent and/or
buffer is required “[i]n order to permit the competing decontaminating agent
and enzyme of Huth to effectively coexist in the composition.” Appeal Br.
13. As discussed above, the purpose of the chelating agent in Huth is to
prevent destabilization of the decontaminant due to contact with blood and
trace metals. Likewise, paragraphs 48 and 52 of Huth both suggest that the
purpose of the “unique chelating agent and/or buffer” is to create a reusable
decontaminating and cleaning solution. Huth, however, also clearly teaches
a single-use solution. Huth ¶ 48; see also id. at Abstract (“The composition
may additionally contain a corrosion inhibitor . . . , a chelator, a buffer, a dye
and combinations thereof.”) (emphasis added).8
Appellant appears to contend that the Examiner engaged in
“impermissible hindsight to pick and choose only one or two of the
components of Huth relevant to the claimed invention for purposes of . . . the
present prior art rejection.” Appeal Br. 13; see also id. at 14 (“The

to the extent they are based on a particular use of the claimed composition.
See, e.g., Appeal Br. 13 (arguing that “the enzyme of Huth works in a
contrary manner to the use of PAA as a surface contaminant”) (emphasis
added); 14 (arguing that the “consisting essentially of” language “captures
the truly critical components of the claimed composition and associated
impact on the use of PAA in a surface disinfecting composition) (emphasis
added).
8 Assuming that the chelating agent and/or buffer is required in Huth’s
composition, Appellant appears to agree that the chelating agents and
buffers, in and of themselves, do not “interfere with the basic and novel
characteristics of the invention claimed.” Reply Br. 11.

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Examiner turns a blind eye toward the teachings of Huth in order to cherry-
pick out only the PAA-producing components, willfully ignoring the vital
presence and role of the enzymes, the chelating agent, and the buffer”),
Reply Br. 12. Appellant also contends in the Reply Brief that the
obviousness rejection should be reversed because the Examiner explicitly
and improperly construed “consisting essentially of” as equivalent to
“comprising.” Reply Br. 10.
I am not persuaded because the Examiner provided an alternative
basis for the rejection, namely that “even if Appellant’s disclosure would
support such an intermediate interpretation of claim scope—i.e., “consisting
essentially of” construed as excluding ingredients that materially affect the
basic and novel properties of the invention—“nothing in Huth would in fact
interfere with either the generation of peracetic acid or of the peracetic acid
bleaching of oxidizable dye combined with the peracid-generating
components.” Ans. 15. As discussed above, I agree that Appellant has not
shown that the enzyme, chelator, and/or buffer materially affect these
alleged basic and novel properties of the claimed invention.
2. “configured to . . . indicate an initial achievement of a
biocidally effective concentration of peracetic acid”
Appellant contends that the cited combination of prior art does not
suggest a composition “configured to . . . indicate an initial achievement of a
biocidally effective concentration of peracetic acid.” In particular, Appellant
contends that “[i]n Huth, the indicator signals the end of the disinfection
period, and not the initial presence of a biocidally effective concetration of
PAA, as in Applicant’s invention.” Appeal Br. 15. Appellant contends that
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both Antonoplos and Ignacio likewise teach “indicators designed to indicate
that the disinfection conditions were met, rather than showing an initial
concentration has been reached” and are further “directed towards specific
indicator systems or devices that are external to the composition, rather than
integral with the composition, as in Applicant’s invention.” Id.
I am not persuaded. Although Huth teaches using indicator dyes to
“serve as an indicator of completion of the required decontamination soak
time,” Huth also teaches that colorants may also be incorporated into Huth’s
formulations to “indicate the presence or absence of H2O2 or PAA or other
peroxides.” Huth ¶ 130. Furthermore, Ignacio teaches that, “[d]uring a
typical sterilization cycle, the instruments being sterilized are exposed to a
sterilization solution containing, for example about 200 ppm or 2500 ppm of
peracetic acid.” Ignacio 1:15–18. Ignacio further teaches “a method of
determining whether a solution including peracid has a concentration of
peracetic acid of about 2500 ppm,” i.e., a biocidally effective concentration
of peracetic acid, wherein “[a] monitor composition is exposed to the
peracetic acid solution under conditions that will cause the monitor
composition to undergo a color change at about 2500 ppm of peracetic acid.”
Id. at 2:1–6. In light of these teachings, I agree with the Examiner that a
skilled artisan would have had a reason to incorporate into Huth a dye that
indicates the presence of a biocidally effectively concentration of HAA. For
these reasons, I am also not persuaded by Appellant’s argument that Ignacio
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does not teach indicators designed to indicate “an initial achievement of a
biocidally effective concentration of peracetic acid.”
Finally, I am unpersuaded by Appellant’s criticism that Antonoplos
and Ignacio do not teach an indicator integral with the composition. “Non-
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references. . . . [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole.” In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Furthermore, “[t]he test for
obviousness is not whether the features of one reference may be bodily
incorporated into another reference. Rather, we look to see whether
combined Teachings render the claimed subject matter obvious.”
Application of Wood, 599 F.2d 1032, 1037 (CCPA 1979). In this case, Huth
teaches an indicator integral with the composition, and the combination the
cited prior art renders claim 1 obvious for the reasons discussed above.
Appellant contends in the Reply Brief that “it is factually incorrect to
assert that Huth teaches or suggests the presence of a bleachable dye in a
composition in which a quantity of peracetic acid is generated from a
hydrogen peroxide source and an acetyl source, with the dye color
dissipating upon the initial presence of a sufficient PAA concentration for
use as an effective disinfectant.” Reply Br. 12–13. Appellant does not
provide any explanation as to how, much less why, the statement is factually
incorrect. In the Reply Brief, and in the context of responding to the
Examiner’s written description rejection, Appellant further argues that “the
indicator dye mechanism of Huth is distinct in composition and function
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from that of the claimed invention and, if anything, is completely opposite in
its operation” for a variety of reasons. Reply Br. 5–7.
To the extent Appellant’s argument is that the prior art only teaches
“indicators designed to indicate that the disinfection conditions were met”
rather than “the initial presence of a biocidally effective concentration of
PAA,” I am not persuaded for the reasons already discussed. Appellant has
waived additional arguments on this issue with respect to the obviousness
rejection, because they were not raised in the Appeal Brief, and Appellant
has not shown good cause why such arguments could not have been raised
therein. See Ex parte Nakashima, 93 USPQ2d 1834; Ex parte Borden, 93
USPQ2d at 1477.
Finally, Appellant contends that, “[a]s further evidence of the
inventiveness and/or nonobviousness of Applicant’s claimed composition,
Applicant notes that counterpart foreign applications have been allowed
around the world, with broader independent claims and having considered
the same art as before the USPTO, particularly Huth and Pegelow.” Appeal
Br. 17–18; see also Reply Br. 13. The decisions of foreign patent offices,
however, are not binding on the Board, and, as discussed above, I do not
find Appellant’s arguments on this record persuasive.
Accordingly, for the reasons discussed above, I would affirm the
Examiner’s rejection under 35 U.S.C. § 103.