Ex Parte Sanders et al

Patent Trial and Appeal Board

Dec 18, 2012

10895700 (P.T.A.B. Dec. 18, 2012)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO./
CONTROL NO.
FILING DATE FIRST NAMED INVENTOR /
PATENT IN REEXAMINATION
ATTORNEY DOCKET NO.
10/895,700 07/21/2004 Teryl Blane Sanders VAC-743 US

EXAMINER
Kinetic Concepts, Inc.
c/oSNR Denton US LLP
P. O. Box 061080
Chicago IL 60606-1080
ZALUKAEVA, TATYANA
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE

12/18/2012 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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte TERYL BLANE SANDERS and ROBERT P. WILKES
__________

Appeal 2011-004124
Application 10/895,700
Technology Center 3700
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a wound
dressing. The Examiner entered rejections for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1, 4, 5, 7-10, and 13 stand rejected and appealed (App. Br. 4).
Claims 1 and 7 illustrate the appealed subject matter and read as follows:
1. A wound dressing for use under negative pressure, the wound
dressing comprising:
a fluid manifold having a receiving site and fluid communicator
arms extending from the receiving site;
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a drape formed from an occlusive material and having an inner
drape and an outer drape enclosing the fluid manifold, and an aperture
formed on the outer drape that is substantially aligned with the
receiving site, and wherein the inner drape includes a plurality of
fenestrations in a wound contact region substantially aligned with the
fluid communicator arms; and
further comprising an extension region interposed between the
receiving site and fluid communicator arms.

7. A wound dressing for use under negative pressure, comprising:
a concave porous pad adapted for placement on a wound;
a fluid manifold having a receiving site and fluid communicator
arms extending from the receiving site;
a clear drape formed from an occlusive material and adapted for
positioning over and around the concave porous pad, wherein said
clear drape encloses said fluid manifold, an adhesive on at least an
edge of said clear drape for sealing said at least a portion of said clear
drape to an area surrounding the wound, and a plurality of
fenestrations formed on the clear drape; and
wherein said fluid communicator arms terminate in loops to
allow viewing of the area around the wound through the clear drape.

The following rejections are before us for review:
(1) Claims 1, 4, and 5, under 35 U.S.C. § 102(e) as anticipated by
Howard1 (Ans. 3-5);
(2) Claims 7-10, under 35 U.S.C. § 102(e) as anticipated by Howard,
or in the alternative, under 35 U.S.C. § 103(a) as obvious over Howard,
Lockwood,2 and Vogel3 (Ans. 5-7); and

1 U.S. Patent App. Pub. No. 2002/0150720 A1 (filed April 16, 2002).
2 U.S. Patent App. Pub. No. 2002/0082567 A1 (published June 27, 2002).
3 U.S. Patent No. 6,135,116 (issued October 24, 2000).
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(3) Claim 13, under 35 U.S.C. § 103(a) as obvious over Howard
alone, or in the alternative, over Howard, Lockwood, Vogel, and
Zamierowski4 (Ans. 8).
ANTICIPATION – HOWARD
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.

As to the issue of anticipation, it is well settled that for a reference to
anticipate a claim “[e]very element of the claimed invention must be literally
present, arranged as in the claim.” Richardson v. Suzuki Motor Co., Ltd.,
868 F.2d 1226, 1236 (Fed. Cir. 1989) (emphasis added).
We agree with Appellants that a preponderance of the evidence does
not support the Examiner’s finding that Howard describes a wound dressing
having all of the features configured as required by claim 1.
As Appellants point out, “claim 1 requires an enclosed fluid manifold.
The fluid manifold is enclosed in the inner drape and outer drape” (App. Br.
9).
Howard discloses a wound dressing that has inner and outer layers
which sandwich an irrigation system which in turn supplies beneficial fluid
to a wound covered by the dressing (see Howard [0034]; see also id. at
Figure 1(a)). Howard discloses one embodiment in which the irrigation

4 U.S. Patent 6,071,267 (issued June 6, 2000).
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system supplies an exudate-removing vacuum to the wound (see id. at
[0064]).
The Examiner found that Howard’s irrigating system 56 corresponds
to claim 1’s “fluid manifold” (Ans. 4).
The only structure in Howard’s wound dressing referred to as a
“manifold” is “manifold (or hub) 568” which allows the wound-irrigating
fluid to be “administered through a single conduit 569 and distributed
throughout the irrigation system 56” (Howard [0043]). Contrary to claim
1’s requirement that the manifold be enclosed between the inner and outer
drapes, however, Howard’s manifold 568 is shown as being some distance
away from the inner layer 52 and outer layer 54 that the Examiner interprets
(Answer 4) as corresponding to the claimed inner and outer drapes (see, e.g.,
Howard, Figs. 1(a) and 1(b)).
Moreover, even assuming that Howard’s overall irrigation system 56
can be considered a manifold as required by claim 1, claim 1 also requires
the outer drape to have an aperture that substantially aligns with the
receiving site of the enclosed manifold. While the Examiner points to
Figure 1(d) as disclosing such apertures in the side of the dressing (see Ans.
4), the Examiner points to no description in the supporting disclosure of
apertures in Howard’s outer layer. Rather, as seen Howard’s Figures 1(a)
and 1(b), the conduits 562 enter the dressing from between the inner and
outer layers, rather than from an aperture in the outer layer, as claim 1
requires.
Accordingly, we are not persuaded that the Examiner has adequately
explained how or why Howard describes, explicitly or inherently, a wound
dressing that has all of the features required by claim 1, configured in the
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manner required by the claim. We therefore reverse the Examiner’s
anticipation rejection of claim 1, and its dependent claims 4 and 5, over
Howard.
ANTICIPATION/OBVIOUSNESS
The Examiner rejected claims 7-10 as anticipated by Howard, or in
the alternative, as obvious over Howard, Lockwood, and Vogel (Ans. 5-7).
As a “first position” the Examiner found, based on Howard’s
disclosure, that there was “sufficient factual evidence for one to conclude
that such same structure also allows the same function, property or
capability, i.e. the termination of the fluid communicator arms in loops
allows viewing of the area around the wound through the clear/transparent
drape” (Ans. 6-7 (citing MPEP § 2112.01 (substantially identical structures
presumed to inherently have substantially the same properties))).
As a “second position” the Examiner reasoned that, even if Howard’s
disclosure did not describe the claimed wound dressing within the meaning
of § 102,
to employ a clear drape and/or concave dressing/pad as taught
by [Vogel] and [Lockwood] on the [Howard] device … would
be obvious to one of ordinary skill in the art in view of the
recognition that such clarity and/or shape of drape would
provide viewing of the wound and/or a shape to cover a
particular portion of the body and the desire of [Howard] for
such. In so doing, either the prior art which contemplates the
same structure provides sufficient evidence for one to conclude
that such same structure necessarily and inevitably includes the
same function as set forth in 4), i.e. the termination of the fluid
communicator arms in loops to allow viewing of the area
around the wound through the clear drape, or it would be
obvious to one of ordinary skill in the art to provide such loops
on [Howard] since such would provide an unobstructed view
and the desire by [Howard] to provide such a view.
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(Ans. 7.)
Among other things, Appellants argue that “[n]othing in Howard
shows or teaches a fluid manifold as claimed” (App. Br. 12). In particular,
Appellants urge that, rather than forming loops, “Figure 3(a) of Howard
shows squares formed as a matrix pattern of the conduits 562” (App. Br. 10).
Thus, Appellants contend, the “squares of Howard are not termination
points, are not formed from a fluid manifold, and are not strictly loops” (id.).
We conclude that Appellants have the better position as to these
rejections as well.
Claim 7 recites a wound dressing that includes a fluid manifold
enclosed by a clear drape, the fluid manifold including fluid communicator
arms that “terminate in loops to allow viewing of the area around the wound
through the clear drape” (App. Br. 16). Claim 10, the other independent
claim subject to these rejections, similarly recites a wound dressing that
includes a fluid manifold enclosed by a clear drape, the fluid manifold
including a fluid communicator arm “comprised of a plurality of contiguous
loops to allow viewing of the area around the wound through the clear
drape” (id. at 17).
As seen in Appellants’ Figure 2, “loops 24” (Spec. [0024]) are curved
structures that allow “viewing the wound perimeter when, as in the preferred
embodiment, inner and outer drapes 16a and 16b comprise a transparent
material” (id.). The Specification contrasts the loops from “an alternative
embodiment (not shown), in which fluid communicator arm 22 may
terminate in fingers that extend distally from the fluid communicator arms
22 without forming loops” (id.).
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The Examiner found that the network of conduits in Howard’s Figure
3(a) includes the loops required by the claims (see Ans. 5). We are not
persuaded.
In contrast to being composed of curved structures that an ordinary
artisan would consider to be loops encompassed by claims 7 and 10,
particularly when those claims are viewed in light of the supporting
disclosure in the Specification, the lattice-like network of conduits shown in
Howard’s Figure 3(a) includes a series of squared structures terminating in a
series of finger-like dead ends. While the Examiner urges that the claims do
not require the loops to be circular or rounded (Ans. 10), the Examiner
points to no clear or specific evidence of record suggesting that an ordinary
artisan, reasonably interpreting claims 7 and 10 in light of the Specification,
would have considered the claim term “loops” to encompass a lattice-like
structure having the features shown in Howard’s Figure 3(a).
We therefore reverse the Examiner’s anticipation rejection of claims 7
and 10, as well as claims 8 and 9, which both ultimately depend from claim
7.
As to the Examiner’s alternative rejection under § 103(a), while the
Supreme Court has emphasized the importance of a flexible and
commonsense approach when evaluating obviousness, see KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 415, 418 (2007), the Court also advised that fact
finders should nonetheless “be aware, of course, of the distortion caused by
hindsight bias and must be cautious of arguments reliant upon ex post
reasoning.” Id. at 421.
As our reviewing court has explained, rather than relying on reasoning
grounded in hindsight, the Examiner must advance an evidence-based
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explanation to support a conclusion that it would be obvious to modify an
apparatus in a particular manner. See In re Fritch, 972 F.2d 1260, 1266
(Fed. Cir. 1992) (“The mere fact that the prior art may be modified in the
manner suggested by the Examiner does not make the modification obvious
unless the prior art suggested the desirability of the modification.”). Thus,
“[i]t is impermissible to use the claimed invention as an instruction manual
or ‘template’ to piece together the teachings of the prior art so that the
claimed invention is rendered obvious.” Id.
Applying these principles to the rejections before us, we conclude that
the Examiner has not made out a prima facie case of obviousness. The
Examiner reasons that an ordinary artisan would have been prompted to
modify Howard’s conduit system to have the loops required by the claims
because the claimed loop structures would allow viewing of the wound
through the transparent outer layer, which Howard teaches as being desirable
(see Ans. 7; see also Howard [0055] (outer layer may be transparent)).
However, as evidenced by the use of a transparent outer layer, the
conduit system described by Howard already accommodated wound
viewing. Moreover, claim 7 requires the manifold to include, within the
enclosing drape, not only fluid communicator arms, but also loops at the
ends of those communicator arms. Thus, to arrive at the structure required
by claim 7 from the network of conduits shown in Howard’s Figure 3(a),
one would have to modify the structure to have loops at the ends of the
conduits, rather than the dead ends shown in the Figure.
Given the significant modification required, and the fact that
Howard’s conduits already allowed for wound viewing, we are not
persuaded that the Examiner has adequately explained why an ordinary
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artisan would have modified Howard’s conduit system to have the
configuration required in claim 7, absent improper hindsight based on
viewing of Appellants’ disclosure. For the same reasons, as well as the fact
that the Examiner pointed to no clear or specific teaching in the art that
would have directed an ordinary artisan to a loop configuration encompassed
by claim 10, we are not persuaded that the Examiner provided an adequate
evidence-based explanation as to why, in the absence of hindsight, the
artisan would have modified Howard’s lattice-like conduit system to instead
have claim 10’s loop configuration.
Thus, as we are not persuaded that the Examiner has made out a prima
facie case of obviousness as to claims 7 and 10, we reverse the Examiner’s
obviousness rejection of those claims, as well as claims 8 and 9, over
Howard, Lockwood, and Vogel.
The Examiner also rejected claim 13 as obvious over Howard alone,
or in the alternative, as obvious over Howard, Lockwood, Vogel, and
Zamierowski (Ans. 8).
Claim 13 recites “[t]he wound dressing of claim 4, wherein the porous
pad comprises a concave porous pad formed from polyurethane” (App. Br.
17). Claim 13 thus depends ultimately from claim 1.
As noted above, we are not persuaded that the Examiner has
adequately explained how or why Howard describes a wound dressing
having a manifold and drape configuration encompassed by claim 1. While
the Examiner explains why, in view of the teachings of Howard, Lockwood,
Vogel, and Zamierowski, it would have been obvious for Howard’s dressing
to include a polyurethane concave porous pad (Ans. 8), the Examiner’s
rejection of claim 13 does not address the deficiencies in Howard discussed
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above with respect to claim 1. Therefore, as the Examiner’s obviousness
rejection of claim 13 does not address the deficiencies of the cited references
as to claim 1, we reverse that rejection as well.
SUMMARY
We reverse the Examiner’s anticipation rejection of claims 1, 4, and 5
over Howard.
We also reverse the Examiner’s anticipation rejection of claims 7-10
over Howard, as well as the alternative obviousness rejection of claims 7-10
over Howard, Lockwood, and Vogel.
We also reverse the Examiner’s obviousness rejection of claim 13
over Howard alone as well as the alternative obviousness rejection of claim
13 over Howard, Lockwood, Vogel, and Zamierowski.

REVERSED

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