Ex Parte Watt et al

Board of Patent Appeals and Interferences

Jan 26, 2012

11609964 (B.P.A.I. Jan. 26, 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.
11/609,964 12/13/2006 Paul William Watt 101713-01-5042-US 1993
28977 7590 01/27/2012
MORGAN, LEWIS & BOCKIUS LLP
1701 MARKET STREET
PHILADELPHIA, PA 19103-2921
EXAMINER
TREYGER, ILYA Y
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
01/27/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL WILLIAM WATT, SARA JAYNE GREGORY,
PATRICK JOHN TROTTER, MICHELLE DEL BONO,
BREDA MARY CULLEN, PAUL HOWARD LOWING,
DEREK WALTER SILCOCK,
and
DONALD CHRISTOPHER MARSDEN
__________

Appeal 2010-007764
Application 11/609,964
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-11. We have jurisdiction under 35 U.S.C.
§ 6(b).
Appeal 2010-007764
Application 11/609,964

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STATEMENT OF THE CASE
Claim 1 is the only independent claim on appeal, and reads as follows:
1. A wound dressing for vacuum therapy comprising: a cover
configured for placement over the wound to maintain a reduced
pressure over the wound and adapted for communication with a
source of vacuum, and a screen structure comprising oxidized
regenerated cellulose (ORC) for placement between the cover and the
wound, wherein the screen structure is adapted to remove or inactivate
undesirable components from the wound environment and/or to
concentrate desirable components present in the wound environment.

The following grounds of rejection are before us for review:
I. Claims 1-3, 5, 7, 10, and 11 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Argenta
1

and Pendharkar.
2
As Appellants do not argue the claims
separately, we focus our analysis on claim 1, and claims 2, 3, 5, 7,
10, and 11 stand or fall with that claim. 37 C.F.R.
§ 41.37(c)(1)(vii).
II. Claims 4, 6, and 9 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Argenta and Pendharkar,
as further combined with Quarfoot.
3

III. Claim 8 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Argenta and Pendharkar, as further
combined with Juhasz.
4

1
Argenta et al., US 5,636,643, issued Jun. 10, 1997.
2
Pendharkar, US 2004/0101548 A1, published May 27, 2004.
3
Quarfoot et al., US 4,909,244, issued Mar. 20, 1990.
4
Juhasz et al., US 4,715,857, issued Dec. 29, 1987.
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Application 11/609,964

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We affirm.
ISSUE
Does the preponderance of evidence of record support the Examiner’s
conclusion that it would have been obvious to incorporate the oxidized
regenerated cellulose of Pendharkar in the screen of the vacuum therapy
system of Argenta?

FINDINGS OF FACT
FF1. The Specification teaches that the invention is drawn to wound
treatment systems incorporating improved wound dressings in vacuum
therapy systems (Spec. 1).
FF2. As to oxidized regenerated cellulose (ORC), the Specification teaches:
ORC is usually made by oxidation of a regenerated cellulose
fabric or fibers with dinitrogen tetroxide. It is available as
loose fibers, fabrics (such as the fabrics available under the
Registered Trade Marks SURGICEL, NU-KNIT and
INTERCEED from Johnson & Johnson), or sponges.
Advantages of fibrillar ORC include that it is resorbable and the
degradation products stimulate cell proliferation and
chemotaxis. ORC is an effective haemostat and is bactericidal.
ORC can modify the pH of the wound environment, which in
turn may stimulate chronic wound repair.
Data presented in EP-A-0918548 have shown that ORC
alone can positively influence the wound environment by
modulating growth factor function and inactivating proteases.
The data also show that ORC binds to growth factors present in
wound fluid. The gradual breakdown of the ORC in vivo then
releases the growth factors back into the wound, thereby
promoting wound healing.

(Id. at 9.)
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Application 11/609,964

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FF3. The Examiner finds that Argenta teaches all of the elements of claim
1, except for teaching that the screen structure may comprise ORC (Ans. 3).
FF4. Specifically, Argenta provides
a wound treatment apparatus . . . for treating a wound by
applying reduced pressure (i.e. pressure that is below ambient
atmospheric pressure) to the wound in a controlled manner for a
selected time period. The application of reduced pressure to a
wound provides such benefits as faster healing, increased
formation of granulation tissue, closure of chronic open
wounds, reduction of bacterial density within wounds,
inhibition of burn penetration, and enhancement of flap and
graft attachment. Wounds that have exhibited positive response
to treatment by the application of negative pressure include
infected open wounds, decubitus ulcers, dehisced incisions,
partial thickness burns, and various lesions to which flaps or
grafts have been attached.

(Argenta, col. 2, ll. 49-62.)
FF5. Argenta teaches further:
The present invention also includes a method of treating
damaged tissue which comprises the steps of applying negative
pressure to a wound for a selected time and at a selected
magnitude sufficient to reduce bacterial density in the wound.
Open wounds are almost always contaminated with harmful
bacteria. Generally a bacterial density of 10
5
bacterial
organisms per gram of tissue is regarded as infected. It is
generally accepted that at this level of infection, grafted tissue
will not adhere to a wound. These bacteria must be killed,
either through the wound host’s natural immune response or
through some external method, before a wound will close. The
application of negative pressure to a wound appears to reduce
the bacterial density of the wound. It is believed that this effect
is due to either the bacteria’s incompatibility with a negative
pressure environment or the increased blood flow to the wound
area, as blood brings with it cells and enzymes to destroy the
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Application 11/609,964

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bacteria. The method can be used to reduce bacterial density in
a wound by at least half. More preferably, it can be used to
reduce bacterial density by at least 1,000 fold. Most preferably,
the method can be used to reduce bacterial density by at least
1,000,000 fold.

(Id. at col. 13, ll. 24-45.)
FF6. As to the screen, Argenta teaches:
The wound screen . . . is placed over substantially the expanse
of the wound to prevent its overgrowth. The size and
configuration of the wound screen . . . can be adjusted to fit the
individual wound. It can be formed from a variety of porous
materials. The material should be sufficiently porous to allow
oxygen to reach the wound. The wound screen . . . may be in
the form of an open-cell polymer foam, such as a polyurethane
foam, which is sufficiently porous to allow gas flow to and/or
from the wound . . . . Foams may be used that vary in thickness
and rigidity, although it may be desirable to use a spongy
material for the patient's comfort if the patient must lie upon the
appliance during treatment. The foam may also be perforated
to enhance gas flow and to reduce the weight of the appliance.
As shown in FIG. 1, the screen . . . is cut to an appropriate
shape and size to fit within the wound . . . . Alternatively, the
screen may be sufficiently large to overlap the surrounding skin
. . . .

(Id. at col. 6, ll. 46-64.)
FF7. The Examiner finds that Pendharkar teaches conventional wound
dressing that comprises ORC (Ans. 3).
FF8. Specifically, Pendharkar teaches:
Oxidized regenerated cellulose, as described herein below and
commonly referred to as ORC, due to its biodegradability,
bactericidal, and hemostatic properties, has long been used as a
hemostatic wound dressing in a variety of surgical procedures,
including neurosurgery, abdominal surgery, cardiovascular
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Application 11/609,964

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surgery, thoracic surgery, head and neck surgery, pelvic
surgery, and skin and subcutaneous tissue procedures. ORC, as
recognized heretofore by those skilled in the art of wound
dressings, is carboxylic-oxidized, regenerated cellulose
comprising reactive carboxylic acid groups. In other words, the
oxidized cellulose is carboxyl-modified to contain a certain
amount of carboxylic acid moieties.

(Pendharkar, col. 1, ¶2.)
FF9. The Examiner concludes that it would have been obvious to the
ordinary artisan at the time of invention to “to employ the screen comprising
ORC, as suggested by Pendharkar to the device of Argenta in order to
provide the wound dressing with the biodegradability, bactericidal, and
haemostatic properties” (Ans. 4).

ANALYSIS
Appellants assert that the Examiner has not established that there was
a reasonable expectation of success of combining Argenta and Pendharkar to
arrive at the claimed invention (App. Br. 7). Specifically, Appellants assert
that the Examiner has given no reason as why one would use ORC, a
material with “known haemostatic properties,” with a vacuum source that is
increasing blood flow (id.).
Appellants assert that if one were to adopt the Examiner’s reasoning,
Argenta would have to read as being drawn to healing of non-bleeding
wounds, while Pendharkar would have to read as being drawn to healing of
bleeding wounds (id. at 7). Thus, Appellants assert, Pendharkar is not drawn
to Appellants’ field of invention, that is, the treatment of chronic wounds,
which are not bleeding wounds (id. at 8).
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Appellants argue further that Pendharkar teaches away from the
invention, because as known to the ordinary artisan, “ORC-induced
hemostasis includes vascular spasm—i.e., a decrease in blood flow by
vasoconstriction” (id. at 9). Thus, Appellants assert, the teachings of
Pendharkar are contrary and opposite of those of the wound therapy system
of Argenta, which reestablishes blood flow via vasodilation (id.).
Appellants’ arguments have been carefully considered, but are not
convincing. The Supreme Court has emphasized that “the [obviousness]
analysis need not seek out precise teachings directed to the specific subject
matter of the challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If a person of ordinary
skill can implement a predictable variation, § 103 likely bars its
patentability.” (Id.) Under the correct obviousness analysis, “any need or
problem known in the field of endeavor at the time of invention and
addressed by the patent can provide a reason for combining the elements in
the manner claimed.” Id. at 420.
Thus, as to Appellants’ arguments that Pendharkar is not drawn to
Appellants’ field of invention, the motivation to combine references need
not come from the problem solved by Appellants. As noted by the Examiner
(see Ans. 3), both Argenta and Pendharkar are drawn to the treatment of
wounds. Argenta teaches vacuum therapy of a wound utilizing a screen.
Pendharkar teaches that wound dressings comprising ORC are well known
in the art. Thus, we agree with the Examiner that it would have been
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obvious to use the ORC of Pendharkar in the screen of the vacuum therapy
system of Argenta due to the known use of both in the treatment of wounds.
As to Appellants’ arguments that Pendharkar teaches away from the
combination, and that there was no reasonable expectation of success of
arriving at the claimed wound dressing, we note:
A reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was
taken by the applicant. The degree of teaching away will of
course depend on the particular facts; in general, a reference
will teach away if it suggests that the line of development
flowing from the reference’s disclosure is unlikely to be
productive of the result sought by the applicant.
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
“The fact that the motivating benefit comes at the expense of another
benefit … should not nullify its use as a basis to modify the disclosure of
one reference with the teachings of another. Instead, the benefits, both lost
and gained, should be weighed against one another.” Medichem S.A. v.
Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
In this case, not only does the ORC have known haemostatic
properties, but it also has additional beneficial properties, such as its
biodegradability and bactericidal properties (FF8; see also FF2). Argenta
teaches that reducing bacterial density in a wound is desirable in its method
(FF5). It would have been well within the level of skill of the ordinary
artisan to weigh the benefits, lost and gained. Moreover, all that is required
is a reasonable expectation of success, not absolute predictability of success.
See In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988).
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Citing pages 2-4 of the instant Specification, Appellants assert that “it
is a surprising and unexpected result of the instant application that in
combination, the elements of the instant invention perform the function of
removing or inactivating undesirable components from the wound
environment and/or to concentrating desirable components present in the
wound environment” (App. Br.10-11).
We have reviewed the Specification, with particular attention to the
pages relied upon by Appellants, but conclude that the Specification does
not support Appellants’ assertion of unexpected results, as the Specification
presents no data comparing the claimed system to the closest prior art.
It is well settled that results must be established by factual evidence. “Mere
argument or conclusory statements in the specification does not suffice.” In
re DeBlauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Moreover, “when
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.” In re
Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
As to the remaining rejections, Appellants reiterate the arguments
above, and also assert that the additional references relied upon by the
Examiner do not make up for the deficiencies of Argenta and Pendharkar
(see App. Br. 11-12). Those arguments are not convincing for the reasons
set forth above.

CONCLUSION OF LAW
We conclude that the preponderance of evidence of record supports
the Examiner’s conclusion that it would have been obvious to incorporate
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the oxidized regenerated cellulose of Pendharkar in the screen of the vacuum
therapy system of Argenta. We thus affirm the rejection of claim 1 under 35
U.S.C. § 103(a) as being rendered obvious by the combination of Argenta
and Pendharkar. As claims 2, 3, 5, 7, 10, and 11 stand or fall with that
claim, we affirm the rejection as to those claims as well.
For the reasons set forth above, we also affirm the rejection of claims
4, 6, and 9 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Argenta and Pendharkar, as further combined with Quarfoot;
as well as the rejection of claim 8 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Argenta and Pendharkar, as further
combined with Juhasz.

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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