Ex Parte Gradl

Patent Trial and Appeal Board

Nov 29, 2012

11935034 (P.T.A.B. Nov. 29, 2012)

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.
11/935,034 11/05/2007 Georg Gradl M&N-PVA-111 7087
24131 7590 11/29/2012
LERNER GREENBERG STEMER LLP
P O BOX 2480
HOLLYWOOD, FL 33022-2480
EXAMINER
SU, SUSAN SHAN
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
11/29/2012 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 GEORG GRADL
__________

Appeal 2011-008622
Application 11/935,034
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
wound dressing. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
The Specification describes a wound dressing comprising a wound
pad, a reservoir mounted on the non-body-facing side of the wound pad, and
“nonreturn valves” located between the wound pad and reservoir (Spec. 8, ll.
16-19; see also Figs 1, 2). The Specification teaches that it is “advantageous
for the reservoir to possess connections (drain) for application of a vacuum,”
although “wound fluid that collects in the reservoir may also be removed, in
a further embodiment, by means of a syringe” (id. at 4, l. 30 – 5, l. 4).
Claims 27-30, 32, 33, 35, 37-47, and 49-54 are on appeal.
Independent claim 27 is representative and reads as follows (emphasis
added):
27. A wound dressing for treating wounds, comprising:
a fluid-absorbing wound pad impregnated with an osmotically
active material having a body-facing side and an opposite, non-body-
facing side, said wound pad being configured to be directly disposed
on the wound for substantially always maintaining the wound moist;
a reservoir for fluid accommodation disposed on said non-
body-facing side of said wound pad, said reservoir including
connections for application of syringes; and
flow means disposed to establish communication between said
wound pad and said reservoir for producing a directed flow of fluid
from said wound pad into said reservoir, said flow means being
configured as non-return check valves between said wound pad and
said reservoir.
The claims stand rejected under 35 U.S.C. §103(a) as follows:
(I) claims 27-30, 32, 33, 35, 37-45, 50-51, and 54 as obvious over
Arnold
1
in view of Radl
2
and Singh
3
; and

1
Arnold (US 5,759,570) (issued Jun. 2, 1998).
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(II) claims 46, 47, 49, 52, and 53 as obvious over Arnold, Radl, and
Singh, and further in view of Greenway.
4

I.
Issue
Does the Examiner establish by a preponderance of the evidence that
claim 27 is obvious over Arnold in view of Radl and Singh?
Findings of Fact
1. Arnold describes a multilayered wound dressing that “rapidly
absorb[s] wound exudate while maintaining a moist wound surface”
(Arnold, col. 1, ll. 9-12). One embodiment is shown in Figure 1:

Figure 1 depicts a multilayer wound dressing (1) comprising an outer
protective membrane (2), an intermediate absorbent layer (3), a molecular
filtration membrane (4), a wound contact layer (5), and a release-coated
protective film (7) that protects contact layer (5) prior to use (id. at col. 5, ll.
60-64; col. 7, ll. 6-9).
2. As stated in Arnold, absorbent layer (3) is a layer of absorbent
material, such as polyurethane foam (id. at col. 6, ll. 15-18). Wound layer

2
Radl et al. (US 2005/0101940 A1) (published May 12, 2005).
3
Singh (US 3,912,704) (issued Oct. 14, 1975).
4
Greenway (US 4,630,603) (issued Dec. 23, 1986).
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(5) is a “wound-friendly bioabsorbable gel in contact with wound exudate”
(id. at ll. 61-63). “The molecular filtration membrane 4 is hydrophilic to
assist wicking of exudate through the membrane” (id. at ll. 56-60).
3. Radl discloses a device for treating wounds (Radl [0002]), such as
shown in Figure 1.

Figure 1 depicts a device (100) comprising an adhesive-backed flexible
sheet (1) for sealing wound (W) and a suction source (2) for suctioning
waste fluids from wound (W) (Radl [0018]). “Contained within the housing
of suction source 2 is a resilient element 5 that springs back after
compression,” where resilient element (5) may be “an open-cell foam” (id. at
[0021]).
4. As described in Radl:
When suction source 2 is compressed either by hand or any other
means, air and/or liquids are expelled from the volume within the
suction source 2 through outlet valve 8. When the compressing force
is released from the suction source 2 the resilient element 5 expands
and creates suction within suction source 2. This suction then draws
fluids from wound W through opening 7 in adhesive backed flexible
sheet 1 and through inlet valve 6.
(Id. at [0022].) Valves 6 and 8 may be a “[o]ne-way valves” (id. at [0025],
[0026]).
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5. Radl states that in “an alternate embodiment, an external vacuum
source may be coupled to suction source 2 to either provide periodic or
constant suction, thus permitting less attention from the medical practitioner.
Other suction sources may include a suction bulb or a spring loaded
cylinder” (id. at [0024] (emphasis added)).
6. Singh describes protease inhibitors, including those used topically in
wound dressings, where the inhibitors are “most advantageously employed
in solution in a pharmacologically acceptable vehicle, for example
physiological saline, glucose solution, …” (Singh, col. 1, ll. 44-47, ll. 62-
67).
Analysis
The Examiner finds that Arnold discloses the wound dressing of claim
27, except that Arnold does not teach, inter alia, that “flow means are
formed of non-return check valves disposed between the wound pad and the
reservoir” or “connections for the application of syringes” (Ans. 5). The
Examiner finds that “Radl teaches a non-return check valve (6, see [0025])
disposed between the wound pad (1) and the reservoir (5) of a wound
dressing” (id.) The Examiner also finds that “Radl‟s teaching of connections
is capable of accepting the application of syringes because in the art they are
known equivalents to suction bulbs,” and also that “any connection can
allow a syringe to be applied to it” (id. at 6).
Appellant argues that Radl‟s device “does not include any connections
for syringes in contrast to the invention of the instant application” as recited
in claim 27 (App. Br. 9, 13). Along the same lines, Appellant contends that
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“Radl discloses solely the possibility of applying an external vacuum source
or other suction sources, but no syringes (in paragraph [0024])” (id. at 10).
As the Examiner states, “Radl teaches in paragraph [0024] coupling to
suction source 2 an external vacuum source such as suction bulb or spring
loaded cylinder (therefore a „connection‟ necessarily exists between suction
source 2 and the additional external vacuum source)” (Ans. 11) (FF 5). The
Examiner finds that “the connection taught by Radl, which is disclosed to be
connectable to suction bulbs (wherein suction bulbs and syringes are well
known equivalents in the art as supported by numerous references [citations
omitted]), would be capable of accepting the application of syringes” (id.;
see also 6 (stating that “syringes “are known equivalents to suction bulbs”).
Appellant does not persuade us otherwise by asserting that “perhaps
syringes and suction bulbs are interchangeable in certain prior art devices,
but certainly not in Radl and not in the present invention” (App. Br. 13).
Appellant does not explain why one would not have used suction bulbs and
syringes interchangeably when making the device of Radl or a modified
version of Radl‟s device using the wound dressing of Arnold in place of the
“flexible sheet 1” and “resilient element 5” described in Radl (FF 3-4).
Appellant also argues that upon pressing element (5) in Radl‟s device,
“a rather strong vacuum is applied which promotes a transfer of the wound
fluid from the wound to the foam 5” (App. Br. 9). Appellant asserts that this
vacuum “in turn, dries the wound and slows down the healing process” (id.
at 9-10; see also id. at 12 (stating that a “permanent vacuum created for the
suction of the wound dries the wound”)). As an initial matter, we note that
the record before us provides no evidence that a vacuum created by
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compressing and releasing foam (5) in Radl‟s device would be so “strong”
that it would dry a wound and/or cause pain to a patient, as compared to
what a patient would experience when using a syringe (App. Br. 8-9).
In any event, as the Examiner explains, “Arnold substantially teaches
the structures of the claimed wound dressing except the two structural
elements that are remedied by the Radl teachings” (Ans. 11), i.e., the
“connections for application of syringes” and a “flow means being
configured as non-return check valves between said wound pad and said
reservoir” as recited in claim 27. We conclude, as the Examiner concludes,
that it “would have been obvious to one of ordinary skill in the art at the
time of the invention to modify Arnold with Radl and Singh for preventing
the wound exudates from pooling in the wound while maintaining non-dry
pharmacological agents against the wound” (Ans. 6).
In this regard, one reading Arnold and Radl would have had reason to
use Arnold‟s wound dressing in place of sheet (1) and foam (5) in Radl‟s
device. Such a modified device would have comprised a one-way valve (6)
and a suction source (2) (FF 3) as disclosed in Radl, where the suction
source included absorbent layer (3), i.e., a “reservoir for fluid
accommodation” (claim 27), as disclosed in Arnold (FF 1). In addition,
upon reading about “an alternative embodiment” in Radl (FF 5), one would
have known to use “other suction sources” such as suction bulbs (or
syringes) to provide periodic and controllable suction as needed to remove
fluid from the reservoir in suction source (2). An ordinary artisan reading
Arnold and Radl would have had reason to use a reservoir comprising
connections for application of suction bulbs or syringes, which would have
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“permitt[ed] less attention from the medical practitioner” (FF 5) in removing
fluids from the reservoir in suction source (2) as needed, “while maintaining
a moist wound surface” as taught in Arnold (FF 1).
Appellant also argues that “the suction source 2 would have to be
completely dismantled to allow a syringe to be placed at the valve 6 or to
remove the foam 5 to allow a syringe to be placed at the valve 8” (App. Br.
12-13). As discussed above, however, one would have had reason to make a
modified version of Radl‟s device including the wound dressing described
by Arnold in the first instance, rather than “completely dismantle” the
embodiment of the Radl device as shown in Figure 1 (FF 3).
In further support, as noted by the Examiner, “Arnold also teaches
that a molecular filtration membrane 4 located between the wound pad
(wound contact layer 5) and reservoir (absorbent layer 3) assists in wicking
fluid and preventing fluid leakage from the reservoir, thus membrane 4
functions like a non-return valve” (Ans. 12; see also FF 1-2). In other
words, both Arnold and Radl described moving bodily fluid in one direction,
i.e., from the wound into a reservoir. An ordinary artisan would have had
reason to use one or both of the molecular filtration membrane (4) (disclosed
in Arnold) or the one-way valve (6) (disclosed in Radl) to achieve the same
result.
Thus, we conclude that the Examiner presents a prima facie case that
claim 27 is obvious over Arnold in view of Radl and Singh. Appellant does
not persuade us with argument or evidence that a preponderance of the
evidence considering “the totality of the record” fails to support a
determination of obviousness here. In re Oetiker, 977 F.2d 1443, 1445 (Fed.
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Cir. 1992). Because Appellant does not argue dependent claims 28-30, 32,
33, 35, 37-47, and 49-54 separately, these claims fall with claim 27. 37
C.F.R. § 41.37(c)(1)(vii).
Conclusion of Law
We conclude that the Examiner establishes by a preponderance of the
evidence that claim 27 is obvious over Arnold in view of Radl and Singh.
II.
Issue
Does the Examiner establish by a preponderance of the evidence that
claims 46, 47, 49, 52, and 53 are obvious over Arnold, Radl, Singh, and
further in view of Greenway?
Analysis
We adopt the Examiner‟s findings regarding Greenway and Singh
(Ans. 9-10; see also Greenway, col. 4, ll. 6-21; Singh, col. 1, ll. 46-48, 62-
67), and conclude that the Examiner presents a prima facie case of
obviousness of dependent claims 46, 47, 49, 52, and 53. In response to the
prima facie case, Appellant argues only that “Greenway does not make up
for the above-noted deficiencies of Arnold, Radl, and Singh,” asserting that
“[s]ince claim 27 is allowable, dependent claims 46, 47, 49, 52, and 53 are
allowable as well” (App. Br. 16). Thus, Appellant relies on arguments
already addressed in the section above. For the same reasons discussed
above, Appellant does not persuade us that a preponderance of the evidence
fails to support a determination of obviousness.
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Conclusion of Law
We conclude that the Examiner establishes by a preponderance of the
evidence that claims 46, 47, 49, 52, and 53 are obvious over Arnold, Radl,
Singh, and further in view of Greenway.
SUMMARY
We affirm the rejection of claims 27-30, 32, 33, 35, 37-45, 50-51, and
54 as obvious over Arnold in view of Radl and Singh. We also affirm the
rejection of claims 46, 47, 49, 52, and 53 as obvious over Arnold, Radl, and
Singh, and further in view of Greenway.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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