Ex Parte Fabo et al

Patent Trial and Appeal Board

Mar 26, 2013

11794942 (P.T.A.B. Mar. 26, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte TOMAS FABO, BENGT SODERSTROM, and ANNA SVENSBY
__________

Appeal 2011-008933
Application 11/794,942
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
“component for forming a seal around an opening in the skin, for example a
stoma” (Spec. 1:6-8), which have been rejected for obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses a component “for use around stomas of
various types, for example colostomies, ileostomies and urostomies” (Spec.
2:39 to 3:2). The Specification discloses that using a skin-contacting
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adhesive having a particular range of softness (as measured by a specific
assay; id. at 10:15 to 11:8) provides several advantages (id. at 2:2-38).
Claims 13-20, 22-27, and 29-35 are on appeal. Claim 13 is
representative:
13. A component for protecting skin around a stoma and in
combination with a stoma bandage, comprising:
a carrier which is enclosed between layers of skin-compatible
adhesive, the adhesive having a softness of 8 - 22 mm,
wherein the stoma bandage comprises:
a bag part with an opening,
a fastening part including an adhesive layer secured to the bag part
around the opening, the adhesive comprising a skin-compatible silicone
elastomer, the fastening part being secured to the component in an area near
the stoma after application of the component around the stoma,
and wherein the component is separate from the stoma bandage.
Claim 33, the only other independent claim, also requires a stoma
bandage, separate from the component, that comprises a bag part and a
“fastening part including an adhesive layer secured to the bag part.”
The Examiner has rejected claims 13-17, 19, 20, 22-27, and 29-35
under 35 U.S.C. § 103(a) as obvious based on Cilento
1
and Colas
2
(Answer
3), and has rejected claim 18 as obvious based on Cilento, Colas, and
Davies
3
(Answer 6). The same issue is dispositive with respect to both
rejections.
The Examiner finds that Cilento discloses a system meeting most of
the limitations of claims 13 and 33, including “a component (A) for
protecting skin around a stoma and in combination with a stoma bandage

1
Cilento et al., US 4,775,374, issued Oct. 4, 1988.
2
Colas et al., US 6,846,508 B1, issued Jan. 25, 2005.
3
Davies, US 3,128,030, issued Apr. 7, 1964.
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(Figs. 4 & 6), comprising a carrier (12) and a skin compatible adhesive (11
. . .)” and a “stoma bandage [that] comprises: a bag part (40) with an
opening (20), and a fastening part (C) including an adhesive layer (31)
secured to the bag part around the opening” (Answer 3). The Examiner
reasons that “the component is separate (A, B, and C as shown in Fig. 3 or 6
are distinct pieces of materials and are therefore „separate‟) from the stoma
bandage” (id. at 4). The Examiner concludes that Colas would have
suggested a carrier enclosed between layers of skin-compatible adhesive and
inherently discloses an adhesive having the softness recited in the claims on
appeal (id. at 4-5).
Appellants argue that Cilento‟s Figure 6 shows that “the second
adhesive component (C) is used to secure the coupling element (B), not the
bag part (40). Also, all of [the] embodiments of CILENTO et al., indicate
that the skin barrier is fixed by the second adhesive component (C) while the
pouch is connected to the skin barrier via the coupling member (44 and 10).”
(Appeal Br. 7.)
We agree with Appellants that the Examiner has not shown that
Cilento and Colas would have made obvious a system having the structure
recited in the claims on appeal. Cilento discloses a system for attaching a
pouch to an abdominal stoma (Cilento, col. 1, ll. 8-17, 64-66). Cilento‟s
Figure 6 is reproduced below:

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Figure 6 shows an exploded view of one embodiment of Cilento‟s
composite skin barrier (id. at col. 1, ll. 59-61), which consists of three
components (A, B, and C) (id. at col. 2, ll. 24-33). “Component A [i]ncludes
an adhesive layer 11 and an outer polymeric film 12,” as well as central hole
20 that fits around a stoma (id. at col. 2, ll. 25-28). “Component B is a
coupling element” (id. at col. 4, l. 35). “Component C consists of [a]
microporous adhesive layer 31 and a porous backing layer 32” (id. at col. 4,
ll. 50-51).
In the embodiment of Figure 6, “component C is bonded directly to
polymeric film layer 12 of component A” (id. at col. 6, ll. 8-9). “Coupling
element B is then permanently affixed” (id. at col. 6, ll. 13-14). Cilento also
states that, while its composite skin barrier “has been described as consisting
of three components permanently affixed to one another, it is, of course,
possible to market joined components A and B as a single unit” and attach
component C at the time of use (id. at col. 7, ll. 5-10).
Cilento discloses that its composite skin barriers “are used in
conjunction with an ostomy pouch having a coupling element designed to
mate with coupling element B” (id. at col. 6, ll. 23-25). Cilento‟s Figure 4 is
reproduced below:
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Figure 4 shows a front view of an ostomy pouch having a coupling
element allowing it to be affixed to Cilento‟s skin barrier (id. at col. 1, ll. 54-
56). The “pouch 40 includes a coupling member 44 of channel-shape seen
in any radial cross-section and has . . . a restricted annular mouth or entry
58A into which, in use, the rib 22 of coupling member B is pushed to
connect the pouch to the skin barrier” (id. at col. 6, ll. 26-34).
The Examiner interprets claim 13‟s component-comprising-a-carrier-
and-skin-compatible-adhesive to be component A of Cilento‟s system
(Answer 3), and claim 13‟s stoma-bandage-comprising-a-bag-part-and-a-
fastening-part to be Cilento‟s ostomy pouch 40 and component C (id.). The
Examiner reasons that the ostomy pouch 40 and component C are both parts
of a “stoma bandage,” as recited in claim 13, because they are both attached
to component B when the pouch is in use (id. at 7). At the same time, the
Examiner reasons that component A and component C are “separate,” even
though they are described as “bonded” together (Cilento, col. 6, l. 8) or
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“permanently affixed” (id. at col. 7, l. 7), because they are shown as “distinct
pieces of materials” in Figure 6 (Answer 4).
We conclude that the Examiner‟s claim interpretation is unreasonably
broad. Logically, if two elements (ostomy pouch 40 and component C) that
are transiently connected together (via component B) are considered to be
parts of the same structure (claim 13‟s stoma bandage), then a third element
(component A) that is bonded or permanently affixed to one of those
elements is also a part of that same structure. Alternatively, if two elements
(components A and C) that are bonded or permanently affixed to each other
are nonetheless considered to be separate elements, then a third element
(ostomy pouch 40) that is only transiently and indirectly connected to one of
those elements is also separate from those elements. Under either claim
interpretation, Cilento does not disclose a stoma bandage that comprises a
bag and a fastening part including an adhesive layer, but is separate from a
component comprising a carrier and a skin-compatible adhesive.
In addition, the Examiner has not shown that Cilento discloses a bag,
opening, and fastening part arranged as required by claim 13. The Examiner
finds that Cilento discloses “a bag part (40) with an opening (20), and a
fastening part (C) including an adhesive layer (31) secured to the bag part
around the opening . . . (see Fig. 6)” (Answer 3-4). However, Cilento‟s
Figure 6 shows that element 20 is an opening in layer A, not bag 40; the
Examiner finds that layer A corresponds to the “component” of claim 13.
The Examiner therefore failed to meet her burden of establishing a prima
facie case of unpatentability by failing to establish through persuasive
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evidence or reasonsing that Cilento discloses a stoma bandage having the
structure required by claim 13.
Finally, the Examiner finds that Colas discloses a silicone elastomeric
adhesive that inherently has the softness required by claim 13 (Answer 4).
As evidence to support that finding, the Examiner cites “the Specification on
page 3 lines 7-21)” (id.). Appellants argue that “softness is . . . not an
inherent property of the silicone elastomer but instead is a controlled
variable” (Appeal Br. 9). We conclude that the Examiner‟s finding is not
supported by a preponderance of the evidence. The Specification, at page 3,
lines 7-21, describes a preferred embodiment of the claimed invention, not
properties of all silicone elastomeric adhesives. In addition, the Examiner
fails to establish an evidentiary basis to support a conclusion that “varying
the thickness of the adhesive layer . . . would likely lead to a variation in the
softness of the material” (Answer 8). Thus, the Examiner has not provided
an evidentiary basis for concluding that combining Colas‟ adhesive with
Cilento‟s composite skin barrier would result in a product meeting all of the
limitations of claim 13.
As noted above, claim 33 also includes the same relevant limitations.
We therefore reverse the rejection of claims 13-17, 19, 20, 22-27, and 29-35
as obvious based on Cilento and Colas. With regard to claim 18, the
Examiner relies on the same basic reasoning, and cites Davies only for the
additional limitation of that claim (Answer 6-7). Therefore, we also reverse
the rejection of claim 18.
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SUMMARY
We reverse both of the rejections on appeal.

REVERSED

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