Ex Parte Wooley

Patent Trial and Appeal Board

Oct 4, 2017

12503643 (P.T.A.B. Oct. 4, 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.
12/503,643 07/15/2009 Debbie Wooley A0294 8534
99653 7590 10/06/2017
Moser TahnaHa / An sell T imiterl
EXAMINER
1030 Broad Street AKHOON, KAUSER M
Suite 203
Shrewsbury, NJ 07702 ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
10/06/2017 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):
docketing@mtiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DEBBIE WOOLEY
Appeal 2016-007316
Application 12/503,6431
Technology Center 1600
Before FRANCISCO C. PRATS, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a multilayer
anti-infective protector useful for protecting against transmission of infective
agents from patients to equipment in a healthcare setting. The Examiner
rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 1, 2, 6—8, 10, and 21, under 35 U.S.C. § 103(a), for obviousness over
Wooley2 and Mauriello.3 Ans. 3—5.4
1 Appellant states that the “real party in interest is Ansell Healthcare
Products, LLC, located in Iselin, New Jersey.” Appeal Br. 3.
Appeal 2016-007316
Application 12/503,643
Claim 1, the sole independent claim on appeal, illustrates the appealed
subject matter and reads as follows (Appeal Br. 21 (some spacing and
indentation added)):
1. A multilayer anti-infective protector comprising:
a. an anti-infective agent;
b. a liquid permeable upper portion having a first
exposed surface and a first interior surface; and
c. a liquid impervious lower portion having a second
exposed surface and a second interior surface, the liquid
impervious lower portion adapted to contact a surface to be
protected at the second exposed surface;
wherein the anti-infective agent is at least one of a noble
metal-ion, chlorhexidine, triclosan or 2-propanol incorporated
into and present only in the lower portion, and
the lower portion is adapted for a controlled release of
the anti-infective agent from an exposure to liquid, a pH
change, a temperature change, or an exposure to light, wherein
the controlled release is at least one of a sustained release, a
slow release, a prolonged release, or a combination thereof.
OBVIOUSNESS
The Examiner’s Prima Facie Case
The Examiner found that Wooley taught or suggested a multilayer
protector having substantially all of the features required by the rejected
claims except, “[ajlthough Wooley teaches antimicrobial agents,” the
2 US 2006/0260622 A1 (published Nov. 23, 2006).
3 G. Mauriello et al., Antimicrobial activity of a nisin-activated plastic film
for food packaging, 41 Letters in Applied Microbiology 464—69 (2005).
4 Although the Examiner’s Answer includes claims 3 and 4 among the
rejected claims (Ans. 3), claims 3 and 4 have been canceled (see Appeal Br.
3,21).
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Application 12/503,643
reference “does not explicitly recite that it is a controlled release from an
exposure to liquid, pH change, temperature change or exposure to light,” as
recited in Appellant’s claim 1. Ans. 3^4.
As evidence that the protector recited in the rejected claims would
nonetheless have been obvious, the Examiner cited Mauriello as teaching
“the use of antimicrobial agents in a packaging film (a barrier/protector) that
modulates release of the antimicrobial by pH and temperature (Abstract).”
Id. at 4.
In particular, the Examiner found that Mauriello taught that the
“antimicrobial was coated onto a polymer film (polyethylene film) (page
465, left column). Mauriello teaches that the lower pH favored migration of
the active compound from the film (pH controlled release) (page 468).” Id.
Based on the references’ combined teachings, the Examiner
concluded that an ordinary artisan would have considered it obvious “to
have prepared the Wooley anti-infective protector with a controlled release
anti-infective agent as taught by Mauriello with a reasonable expectation of
success.” Id. The Examiner reasoned that the ordinary artisan “would have
been motivated to combine the teaching of Wooley and Mauriello because
Mauriello teaches that antimicrobial packaging could control development
of bacteria by temperature and pH-dependence (page 468). Thereby meeting
the limitations of claims 1 and 7.” Id.
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
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Application 12/503,643
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, but 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).
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
ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
In the present case, Appellant persuades us that the Examiner has not
shown by a preponderance of the evidence that Wooley and Mauriello would
have suggested, to an ordinary artisan, an anti-infective protector having all
of the features required by Appellant’s independent claim 1.
Claim 1 recites a multilayer anti-infective protector that has a liquid
permeable upper portion, and a liquid impervious lower portion. Appeal Br.
21. Claim 1 requires an anti-infective agent, which must be a noble
metal-ion, chlorhexidine, triclosan, or 2-propanol, to be “incorporated into
and present only in” the lower liquid impervious portion of the protector. Id.
(emphasis added).
Claim 1 also requires the lower liquid impervious portion of the
protector to be “adapted for a controlled release of the anti-infective agent
from an exposure to liquid, a pH change, a temperature change, or an
exposure to light, wherein the controlled release is at least one of a sustained
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release, a slow release, a prolonged release, or a combination thereof.”
Appeal Br. 21.
Wooley discloses a disposable drape for covering operating room
equipment. Wooley 12. Like the protector recited in Appellant’s claim 1,
Wooley’s drape includes a liquid permeable upper layer, and a liquid
impervious lower layer. Id. 1 5.
Like the protector recited in Appellant’s claim 1, Wooley also
discloses that, in “one desired embodiment of the present invention, one or
more components of the disposable operating room equipment drape
comprise an antimicrobial agent incorporated therein. Suitable
antimicrobial agents include, but are not limited to, triclosan and other
antimicrobial agents . . . .” Id. 149 (emphasis added).
Like the protector recited in Appellant’s claim 1, Wooley discloses
that the liquid impervious layer of its drape, and only that layer, may contain
the antimicrobial agent. Id. 1 50 (“[OJne or more o/'liquid pervious layer
20, liquid impervious film layer 21, and absorbent composite structure 22
may contain one or more of the above-mentioned additives, such as
antimicrobial agents .. . .”) (emphasis added).
Wooley explains further that the antimicrobial agent may either be
incorporated into the material constituting a particular layer, as recited in
Appellant’s claim 1, or may be coated onto one of the layers before the layer
is incorporated into the drape. Id. 1 51 (“The various additives may be
added to a polymer melt and extruded to incorporate the additive into a fiber
or film component. Alternatively, one or more additives may be coated onto
a fiber or film during or after the fabric or film forming process.”) (emphasis
added); see also Wooley 149 (“[OJne or more additives [may be] coated
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onto or incorporated into one or more of the materials used to form the
individual components. Suitable additives include, but are not limited to,
antimicrobial agents . . . .”) (emphasis added).
As noted above, the Examiner concedes that Wooley does not
describe its drape as providing the controlled release of the anti-infective
agent required by Appellant’s claim 1, and cites Mauriello as evidence that it
would have been obvious to modify Wooley’s drape to have that feature.
Ans. 3^4.
Mauriello describes a study that investigated the capacity of the
antibacterial bacteriocin compound, nisin, to inhibit bacterial growth in a
manner effective for use in packaging foods, such as milk. Mauriello 464—
65. As Appellant contends, however, Mauriello does not incorporate its
antibacterial agent into a particular material, as required by Appellant’s
claim 1, but instead coats the agent onto an underlying substrate:
Nisin was coated onto a low-density polyethylene (LDPE) film.
As a preliminary step the stock nisin solution was diluted at a
concentration of 6400 AU ml"1 and it was coated manually on
one side of the film using a coating rod .... The film was
dried by exposure to warm air ... .
Id. at 465 (citation omitted).
Appellant persuades us that the Examiner does not explain adequately
how Mauriello’s teaching of coating an antimicrobial compound onto a layer
of material to be used as a food container would have suggested to an
ordinary artisan that the antimicrobial compound should, instead, be
incorporated into the liquid impervious layer of Wooley’s operating room
drape, as required by Appellant’s claim 1. In particular, given Wooley’s
teaching that it was suitable to coat antimicrobial compounds onto the layers
of its drape as a step in its the manufacturing process, which is exactly the
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Application 12/503,643
procedure Mauriello discloses, we are not persuaded that the Examiner has
explained adequately why the artisan would have abandoned the coating
approach taught by both references as being suitable, and instead attempted
to achieve controlled release of the antimicrobial compound using a
technique which neither reference expressly teaches as being suitable.
The Examiner contends that this deficiency in the prima facie case is
addressed by Wooley’s disclosure, noted above, that the antimicrobial
compounds may be incorporated into any of the layers of the operating room
drape. Ans. 9. The Examiner contends, in particular, that “[c]ited art is
useful for not only what it expressly teaches, but also for what it would
reasonably suggest to the skilled artisan, including alternative or non­
preferred embodiments. MPEP § 2123.” Id.
We agree with the Examiner that an ordinary artisan is a person of
ordinary creativity and not an automaton. KSR, 550 U.S. at 421. We also
acknowledge Wooley’s disclosure, noted above, that antimicrobial
compounds may be incorporated into any one of the layers of its operating
room drape. However, the question at hand is not simply where the
antimicrobial compound is placed, but its placement and ability to provide
the claimed controlled release in that position. That is, Appellant’s claim 1
not only requires the anti-infective agent to be incorporated into the liquid
impervious layer, but also requires that incorporation to be in a manner that
provides “controlled release of the anti-infective agent from an exposure to
liquid, a pH change, a temperature change, or an exposure to light, wherein
the controlled release is at least one of a sustained release, a slow release, a
prolonged release, or a combination thereof.” Appeal Br. 21.
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The fact that Wooley discloses that the antimicrobial may be
incorporated into a layer does not address the controlled release feature that
must accompany that placement. Moreover, the Examiner does not direct us
to any teaching in either Wooley or Mauriello that suggests specifically, or
that one of ordinary skill in the art would otherwise have known or
reasonably expected at the time the invention was made, that controlled
release with the properties required by Appellant’s claim 1 would be
achieved by incorporating the antimicrobial compound into the material of
Wooley’s liquid impervious layer. As to Wooley, in fact, the Examiner
concedes that Wooley’s drape does not provide that feature. See Ans. 3^4.
And Mauriello, as noted above, discloses only how an alleged control
release may be obtained by coating the antimicrobial compound onto a
substrate, rather than incorporating it into the material, as required by
Appellant’s claim 1. The Examiner fails to cite any other evidence or
provide persuasive scientific reasoning to make up for these deficiencies,
and to explain why the skilled artisan would have predictably modified the
art in the manner proposed.
Accordingly, for the reasons discussed, we are not persuaded that the
Examiner has provided an adequate evidentiary basis for concluding that the
combination of Wooley and Mauriello teaches or suggests a multilayer
protector having all of the properties required by claim 1. We, therefore,
reverse the Examiner’s rejection of that claim, and its dependents, for
obviousness over those references.
REVERSED
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