Ex Parte Scherr

Patent Trial and Appeal Board

Apr 30, 2013

11370597 (P.T.A.B. Apr. 30, 2013)

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.
11/370,597 03/09/2006 George H. Scherr BBMG-115US 1836
23122 7590 05/01/2013
RATNERPRESTIA
P.O. BOX 980
VALLEY FORGE, PA 19482-0980
EXAMINER
GILBERT, ANDREW M
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
05/01/2013 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 GEORGE H. SCHERR
__________

Appeal 2011-004993
Application 11/370,597
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and ERICA A. FRANKLIN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to devices to
secure catheters. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses a patch that can be used to secure
catheters or other devices when they are inserted into the body (Spec.,
Abstract). Figure 1 of the Specification is shown below:
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Application 11/370,597

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Figure 1 shows a face view of the disclosed patch (id. at 10). The patch
includes “a slit (Figure 1 - No. 1) which extends from the edge of the patch
to the center of a hole cut in the patch (Figure 1 - No. 2) [and] provides the
insertion site of the patch over a catheter” as well as additional slits (No. 3)
that “will significantly reduce the distortion of the patch if the diameter of
the catheter is greater than the diameter of the opening (No. 2) in the center
of the patch” (id.).
Claims 1, 2, and 4-18 are on appeal. Claim 1 is representative:
1. A device to be used to secure catheters, wound drainage devices,
and/or drug delivery devices, when said catheter or related devices are
inserted into the body, the device comprising a patch defining an outer edge
and a central hole, wherein an entrance slit extends through the patch from
the outer edge of the patch to the central hole in the patch, and wherein at
least one additional slit extending through the patch emanates from the
central hole, the entrance slit and the at least one additional slit are
configured as narrow passages such that a clear opening is not defined
between portions of the patch adjacent to the respective slit.

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The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1, 2, 8, 9-13, and 18 in view of Buttaravoli
1
and
Mandelbaum;
2
and
• Claims 1, 2, and 4-18 in view of Yamamoto
3
and Mandelbaum.
I.
The Examiner has rejected claims 1, 2, 8, 9-13, and 18 under 35
U.S.C. § 103(a) as obvious in view of Buttaravoli and Mandelbaum. The
Examiner finds that Buttaravoli discloses a patch to secure catheters
comprising a central hole, an entrance slit from the outer edge, and
“additional slits along the central hole (see 90; Fig 13b; for example,
wherein each leg of the star is formed by slits)” (Answer 3-4). The
Examiner finds that Buttaravoli does not disclose that the additional slits are
“narrow passages such that a clear opening is not defined between portions
of the patch adjacent to the respective slit” (id. at 4).
The Examiner finds that “Mandelbaum teaches additional slits … that
do not form a clear opening for the purpose of making it easier to bring a
tube and other objects through the hole to secure” (id.). The Examiner
concludes that it would have been obvious “to modify the device of
Buttaravoli … to include additional slits that do not form clear openings as
taught by Mandelbaum for the purpose of making it easier to bring a tube
and other objects through the hole to secure” (id.).

1
Buttaravoli, US 3,918,446, issued Nov. 11, 1975.
2
Mandelbaum, US 4,221,215, issued Sept. 9, 1980.
3
Yamamoto et al., US 4,915,694, issued Apr. 10, 1990.
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Appellant argues that “[i]f the proposed purpose to combine … is to
make it easier to bring objects through the hole, one skilled in the art would
have used the „enlarged‟ perforation of Buttaravoli” (Appeal Br. 10).
Appellant argues that “there would not have been any reasonable basis to
narrow the „enlarged‟ perforation of Buttaravoli to prevent a clear opening
as each embodiment of Buttaravoli shows the perforation covered by the
upper pad” (id.). Appellant also argues that even if the references were
combined, one skilled in the art “would be taught to leave the opening 90 of
Buttaravoli as it is shown in Fig. 13b (with triangular slits) and to apply a
gauze pledget across the opening 90,” with slits in the gauze pledget (id.).
We agree with Appellant that the Examiner has not shown that the
cited references would have made obvious the device of claim 1.
Buttaravoli discloses “a device for securing and protecting an infusion
needle or catheter” (Buttaravoli, col. 1, ll. 7-8). Figure 1 of Buttaravoli is
shown below:

Figure 1 shows a “securement device 10 [that] includes a bottom pad 12 and
an upper pad 14” (id. at col. 3, ll. 34-36). The bottom pad 12 has “slit 16
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extending from one edge 18 … and terminating in a[n] enlarged perforation
20 comprising a medicament well for ointment or encapsulated ointment 22”
(id. at col. 3, ll. 38-41).
Buttaravoli‟s Figures 3 and 4 are shown below:

Figures 3 and 4 show the first steps of applying the securement device
of Figure 1 to a patient (id. at col. 3, ll. 8-10). Specifically, a flap portion of
upper pad 14 is folded back and “the slit 16 is carefully slid around the …
catheter 48 until the skin puncture site is surrounded [by] the well 20 at the
end of the slit 16” (id. at col. 4, ll. 61-64). After the pad is correctly
positioned, backing sheet 28 is removed from upper flap 40, which is then
pressed down and affixed to the bottom pad (id. at col. 5, ll. 4-11).
Panels A, B, and C of Buttaravoli‟s Figure 13 are shown below:

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Figure 13 shows “exemplary end enlarged perforations which may be used
with the securement devices” (id. at col. 3, ll. 20-22). Figures 13A, 13B and
13C show “perforations, 88, 90 and 92, each with an associated slit 94, 96
and 98, in the bottom pads 100, 102 and 104, respectively” (id. at col. 7,
ll. 16-19).
Mandelbaum discloses a “surgical dressing used to anchor medical
devices, such as chest tubes, to a patient” (Mandelbaum, Abstract). Figure 1
of Mandelbaum is shown below:

Figure 1 shows a surgical dressing that includes an upper portion 14 and a
lower portion 16 (id. at col. 4, ll. 36-41), as well as opening 30 (id. at col. 5,
ll. 8-9). Mandelbaum discloses that a “gauze pledget 40 spans the opening
30” (id. at col. 5, l. 17) and a “slot 44 is defined in the gauze pledget and can
be in the form of a single slot as shown in FIG. 1, or a pair of crossed slots
which extend diagonally of an opening” (id. at col. 5, ll. 48-51).
Mandelbaum discloses that “[i]t is easier to bring the tube T and the skin
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sutures through the X-shaped slot than through other shapes of that slot” (id.
at col. 7, ll. 60-62).
The Examiner reasons that, because Mandelbaum “teaches that the
„X‟ shaped slit configuration makes it easier to insert a tube and other
objects through the dressing .… [m]odifying Buttaravoli‟s Fig 13b star-
shaped opening 90 with additional slits would make it easier for tubes to be
inserted through and then secured by the dressing.” (Answer 6). The
Examiner provides the following annotated drawing to illustrate the
proposed modification of Buttaravoli:

(Answer 7.) The annotated drawings show Buttaravoli‟s Figures 13A and
13B with an additional X-shaped slit added to the circular or star-shaped
central hole.
We agree with Appellant, however, that the Examiner has not shown
that the proposed modification would have been obvious to a skilled artisan
viewing the cited references without the benefit of hindsight. Claim 1
requires a patch defining a central hole, an entrance slit, and at least one
additional slit that emanates from the central hole, where the slits are
“configured as narrow passages such that a clear opening is not defined.”
Buttaravoli discloses a patch device for securing a catheter to the human
body, having an enlarged opening that surrounds a catheter and serves as “a
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medicament well for ointment” (Buttaravoli, col. 3, ll. 38-41). Although
Buttaravoli discloses that the enlarged opening can be star-shaped, it does
not disclose that it includes slits – i.e., narrow passages – as required by
claim 1.
Mandelbaum discloses a patch device with a gauze-covered hole
having either a straight slit or X-shaped slits in it. However, neither
Buttaravoli nor Mandelbaum discloses the claimed configuration of a central
hole with slits extending from it. Rather, Mandelbaum and Buttaravoli
appear to disclose that a central hole and a slit (or pair of slits) were both
known means for allowing passage of a tube through a pad. The Examiner
has not provided persuasive evidence or technical reasoning to show that a
person of ordinary skill in the art would have recognized a reason to add slits
to the circular or star-shaped medicament well of Buttaravoli.
Thus, we reverse the rejection of independent claim 1, and dependent
claims 2 and 8, as being obvious in view of Buttaravoli and Mandelbaum.
Independent claim 9, like claim 1, requires a patch having a through hole, an
entrance slit, and at least one additional slit emanating from the central hole,
“wherein the entrance slit and the at least one additional slit are configured
as narrow passages such that a clear opening is not defined.” Thus, we also
reverse the rejection of claim 9 and dependent claims 10-13 and 18 for the
reasons discussed above.
II.
The Examiner has rejected claims 1, 2, and 4-18 under 35 U.S.C.
§ 103(a) as obvious in view of Yamamoto and Mandelbaum. The Examiner
finds that “Yamamoto discloses a patch to be used to secure catheters”
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(Answer 4), having a central hole and one slit but no additional slits (id. at 4-
5). The Examiner finds that “Mandelbaum teaches additional slits … that do
not form a clear opening for the purpose of making it easier to bring a tube
and other objects through the hole” (id. at 5). The Examiner concludes that
it “would have been obvious to one of ordinary skill in the art … to modify
the device of Yamamoto to include additional slits that do not form clear
openings as taught by Mandelbaum for the purpose of making it easier to
bring a tube and other objects through the hole” (id.).
Appellant argues that Yamamoto teaches against the combination
proposed by the Examiner (Appeal Br. 13) because Yamamoto discloses that
friction between the collar and the catheter hold the catheter tightly enough
to avoid longitudinal movement of the catheter through the collar (id.).
Appellant argues that since Yamamoto “teaches a frictional fit of the collar
13 … one skilled in the art would not combine the references as suggested to
increase the size of the hole” (id.).
We agree with Appellant that the Examiner has not shown that the
proposed modification would have been obvious based on the cited
references. Yamamoto discloses an antimicrobial catheter shield
(Yamamoto, abstract). Figure 1 of Yamamoto is shown below:

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Figure 1 shows Yamamoto‟s catheter shield 10, with “central catheter collar
13 orthogonally projecting above the plane of the flange 11” (id. at col. 2,
ll. 17-19). Yamamoto discloses that
the interior diameter of the collar 13 is such that it is
approximately equal to the outer diameter of the catheter …
[and] therefore the frictional forces between the inner surface of
the collar 13 and the outer surface of the catheter will be such
that the catheter will be held tightly enough to avoid
longitudinal movement of the catheter through the collar during
normal use.
(Id. at col. 2, ll. 37-44.)
Thus, Yamamoto discloses that a catheter is to be held tightly by the
collar 13. The Examiner asserts that adding “slits would not decrease the
frictional fit engagement … [because the] surface area between the collar
and catheter in engagement would remain the same” (Answer 9). However,
the Examiner not provided evidence or sound technical reasoning to support
this position. On the contrary, Mandelbaum‟s disclosure that “additional
slits … mak[e] it easier to bring a tube and other objects through the hole”
(Answer 5), suggests that adding slits to Yamamoto‟s catheter collar would
result in the collar permitting greater movement of the catheter. Thus, we
agree with Appellant that the Examiner has not shown that a skilled artisan
would have considered it obvious to add slits to the collar of Yamamoto.
We therefore reverse the rejection of claims 1 and 9, and dependent claims
2, 4-8, and 10-18 as being obvious in view of Yamamoto and Mandelbaum.
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SUMMARY
We reverse the rejection of claims 1, 2 and 4-18 under 35 U.S.C.
§ 103(a).

REVERSED

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