Ex Parte Donnellan et al

Patent Trials and Appeals Board

May 13, 2019

13808183 - (D) (P.T.A.B. May. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/808, 183 01/03/2013 Peter Donnellan
158673 7590 05/15/2019
ED/Rutan & Tucker, LLP
611 ANTON BL VD
SUITE 1400
COST A MESA, CA 92626
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
101672.0223P 2438
EXAMINER
GHALI, ISIS AD
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
05/15/2019 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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents@rutan.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER DONNELLAN, MARIE NI BEILIU,
and KEITH REAL
Appeal2017-008918
Application 13/808,183
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal under 35 U.S.C. § 134 involving
claims to a dressing device. The Examiner rejected the claims for lack of
written description and for obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
We reverse the rejection for lack of written description, but affirm the
rejections for obviousness.
1 Appellants identify the Real Party in Interest as Bard Access Systems, Inc.
App. Br. 4.
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Application 13/808,183
STATEMENT OF THE CASE
Appellants' "invention relates to a wound device, particularly for use
with IV catheters and other percutaneous devices." Spec. 1 :4-5.
"Mechanical complications such as haemorrhage and thrombosis are
associated with catheterization." Id. at 1:14-15. Moreover, the
Specification explains, "[ c Jatheter use causes a semi-permanent breach of
the skin that provides an access point for pathogens to enter the body,
placing the patient at risk for local and systemic infectious complications."
Id. at 1 :22-24. According to the Specification, "[t]hough dressings for
antimicrobial effectiveness have long been available no product deals
sufficiently with the bleeding from these wound types" and "[t]here remains
a need for an effective dressing for use with IV catheters that stops bleeding
and is an effective antimicrobial solution." Id. at 1: 17-20.
Claims 1-3, 5-11, and 13-23 are on appeal. Claims 1 and 18 are
illustrative and are reproduced below.
1. A dressing device for use with a transcutaneous medical
device such as a cannula or a catheter, the dressing device
compnsmg:
a flexible hydrophilic polyurethane foam matrix,
compnsmg:
a haemostatic agent, comprising
polyanhydroglucuronic acid or salt thereof in an amount
to achieve a haemostatic effect, and
an antimicrobial agent comprising chlorhexidine
di-gluconate in an amount of 9% to 16% (w/w) to
achieve an antimicrobial effect without adversely
affecting wound healing.
18. A dressing device, comprising:
a polyurethane foam structure, comprising:
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polyanhydroglucuronic acid or a salt thereof in an
amount to achieve a haemostatic effect, and
chlorhexidine di-gluconate in an amount to achieve
an antimicrobial effect without adversely affecting wound
healing;
a moisture vapor-transmissive polyurethane
backing supporting the polyurethane foam
structure; and
an adhesive on a skin-contacting surface of the
dressing device.
App. Br. 28, 30 (Claims App'x).
The claims stand rejected as follows:
I. Claim 19 under 35 U.S.C. § 112, first paragraph, for failure of
the written description requirement ("Rejection I").
II. Claims 1-3, 5-10, and 13-23 under 35 U.S.C. § 103(a) as
obvious over Bhende,2 Levinson,3 "Haemostatic Agents,"4
Ruzickova,5 Huey,6 and Ward7 ("Rejection II").
III. Claim 11 under 35 U.S.C. § 103(a) as obvious over Bhende,
Levinson, Haemostatic Agents, Ruzickova, Huey, Ward, and
Mandelbaum8 ("Rejection III").
2 Shubhangi Bhende & Daniel Spangler, In Vitro Assessment of
Chlorhexidine Gluconate-Impregnated Polyurethane Foam Antimicrobial
Dressing Using Zone of Inhibition Assays, 25 INFECTION CONTROL AND
HOSPITAL EPIDEMIOLOGY 8, 664-667 (2004).
3 US 2003/0093115 Al, published May 15, 2003.
4 M. Verstraete, Haemostatic agents for topical use, HAEMOSTATIC DRUGS
142-144 (1977).
5 WO 2008/010199 A2, published Jan. 24, 2008.
6 US 2008/0027365 Al, published Jan. 31, 2008.
7 US 4,941,882, issued July 17, 1990.
8 US 4,221,215, issued Sept. 9, 1980.
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Application 13/808,183
I. WRITTEN DESCRIPTION
Issue
The issue on appeal is whether a preponderance of the evidence
supports the Examiner's finding that claim 19 fails to comply with the
written description requirement.
Analysis
As pointed out by the Examiner, dependent claim 19 recites, inter
alia, "a balance of the polyurethane foam itself together with a structure-
regulating surfactant." Final Act. 3; App. Br. 30. According to the
Examiner, however, "[with] [ r Jecourse to the specification, no support has
been found to such a limitation." Final Act. 3. The Examiner asserts, "[i]f
applicant contends there is support for this limitation, then applicant is
requested to specify the page and line of said support." Id.
Appellants respond that "at least Example 1 in combination with
Table 1 [in the Specification] provides a number of different examples
supporting the polyurethane foam structure of Claim 19 ." App. Br. 10
( citing Spec. 8-9). More specifically, Appellants contend Example 1
describes the preparation of the claimed polyurethane foam from an aqueous
phase including a polyurethane pre-polymer, PAGA [polyanhydroglucuronic
acid], CHG [chlorhexidine di-gluconate], 9 and a surfactant. App. Br. 10.
9 For purposes of this decision, we treat "CHG" as used in the Specification
as referring to chlorhexidine di-gluconate as claimed. See, e.g., Spec. 5: 1. It
is unclear, however, that the Specification is always consistent in its use of
"CHG" as referring only to chlorhexidine di-gluconate. See, e.g., Spec.
12:4-8 (Example 4: referencing disks containing "92mg CHG (Biopatch;
Ethicon)"). The cited prior art uses the acronym "CHG" to refer to
chlorhexidine gluconate. See, e.g., Bhende 665 ("Table"). We note that
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Appellants further contend the surfactant is described in the Specification as
regulating cell size and structure of the foam and, thus, is "structure-
regulating" as in claim 19. Id.; see Spec. 9:9-12 ("Surfactants ... used for
the dual purpose of acting as anti foaming compounds in the aqueous phase
while regulating the correct cell size and structure and overall physical
appearance of the foam."). According to Appellants, Table 1 of the
Specification describes the respective weight percent of PA GA, CHG, and
polyurethane (e.g., 15% PAGA, 15% CHG, 70% polyurethane). App. Br.
11; Spec. 9 (Table 1 ). Although Table 1 does not expressly list example
concentrations of the surfactant, Appellants argue it must be present ( even if
in minor amounts) in the foam structure in order to provide the necessary
structure-regulating effect. App. Br. 11; Reply Br. 7-8 ("Because the
surfactant is also at least minutely present in the polyurethane foam, the
surfactant also forms part of the balance with the polyurethane.").
"[T]he test for sufficiency [ of the written description] is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en bane). "[H]ow the specification accomplishes this is not
material." In re Herschler, 591 F.2d 693, 700-701 (CCPA 1979) (internal
citations omitted) ("The claimed subject matter need not be described in
CHG-containing polyurethane foam tested in, for example, Bhende, is
described as "BIOPATCH Antimicrobial Dressing, Johnson & Johnson
Wound Management, Ethicon, Inc.," which is described as including
"chlorhexidine gluconate." Id. ("Methods"). This would suggest that the
CHG-containing Biopatch disk in the Specification includes chlorhexidine
gluconate, not chlorhexidine di-gluconate.
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haec verba to satisfy the description requirement. It is not necessary that the
application describe the claim limitations exactly, but only so clearly that
one having ordinary skill in the pertinent art would recognize from the
disclosure that appellants invented processes including those limitations.").
The preponderance of the evidence favors Appellants. We find, on
this record, that the skilled artisan would recognize possession of the subject
matter of claim 19 from at least the cited disclosures on the Specification.
True, Table 1 expressly lists three, and only three, components (PAGA,
CHG, and polyurethane) and their respective weight percentages. But, when
Table 1 is read in conjunction with other disclosures, particularly those on
pages 8 and 9 of the Specification describing how the Table 1 formulations
are made, Appellants persuade us that the skilled artisan would recognize
that at least some surfactant would be present in the polyurethane foam-
even if only in trace amounts. The Examiner's demand for more explicit
support in the Specification, specifying the exact "balance" of polyurethane
and surfactant, is not necessary. Ans. 3. And the Examiner provides
insufficient evidence or persuasive reasoning to explain how the foam
formulations in Table 1 would exclude a surfactant. Id. at 4.
For the reasons above, we reverse the rejection of claim 19 for lack of
written description support.
II. OBVIOUSNESS
Issue
We address the obviousness rejections (Rejection II and Rejection III)
together because they tum on the same issues and arguments. On appeal, we
determine whether the preponderance of the evidence supports the
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Examiner's conclusion that claims 1-3, 5-11, and 13-23 would have been
obvious over the cited combinations of prior art.
Findings of Fact (FF)
The Examiner's findings of fact and statement of the rejection are
provided at pages 4-14 of the Final Rejection dated August 30, 2016. See
also Adv. Act. (Nov. 9, 2016) 2; Ans. 5-25. The following findings are
provided for emphasis and convenient reference.
FF 1. Bhende teaches that "[p Jercutaneous [ surgical] devices
represent a particular challenge because they breach the skin, which is the
body's primary defense to infection, and provide a tract along which
microorganisms can migrate into the body." Bhende 664. According to
Bhende, "such percutaneous devices include intravenous catheters." Id.
Bhende discloses that "the annual cost of caring for patients with eve
[ central venous catheter ]-associated bloodstream infections (BSis) ranges
from $296 million to $2.3 billion." Id. Bhende teaches, however, that
"[ c ]linical studies have shown that the use of the novel chlorhexidine
gluconate-impregnated foam dressing at the catheter insertion site
significantly reduces the incidence of catheter-related BSI." Id.
FF 2. Bhende teaches that"[ c ]hlorhexidine gluconate is a cationic
biguanide, a well-known antiseptic with broad-spectrum antimicrobial and
antifungal activity." Bhende 665 ("Discussion"). Bhende describes an
"evaluat[ion] [ of] an antimicrobial dressing consisting of hydrophilic
polyurethane foam with chlorhexidine gluconate for activity against several
antibiotic-resistant clinical isolates." Bhende 664 (Abstract).
FF 3. Bhende discloses that "[ s ]terile polyurethane foam with
chlorhexidine gluconate (250 µg of chlorhexidine gluconate per milligram of
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disc ... was used as a test material" versus a control, a polyurethane foam
without chlorhexidine gluconate. Id. at 665 ("Methods"). Bhende teaches
that "zones of inhibition were observed under and around the chlorhexidine
gluconate-treated foam against all the challenge organisms" while "[ n Jo
zones of inhibition were observed with the control samples." Id.
("Results"). Bhende concludes that "polyurethane foam with chlorhexidine
gluconate is effective against a variety of antibiotic-resistant clinical isolates
as well as reference strains known to be most commonly involved in
infections related to percutaneous devices." Id. at 666.
FF 4. Levinson "relates generally to medical devices for applying
hemostatic composition to a puncture or wound site with indwelling tubular
element, such as a catheter, ... particularly a hemostatic pad with an
opening therethrough in order to allow egress of the indwelling tubular
element." Levinson, Abstract; see id. ("[T]he hemostatic pad provide[s]
hemostasis at the hemorrhaging site."); see also id. ,-i 28, Fig. 1 (showing
hemostatic pad with opening (12) and slit (26) to allow device egress).
FF 5. Levinson identifies, among other hemostatic agents, "oxidized
cellulose," and discloses that "conventional devices and methods of
application are designed as a pad or dressing, incorporating these hemostatic
agents to the bleeding site, puncture site or wound site." Id. ,-i 4.
FF 6. Haemostatic Agents provides an overview of"[ s Jeveral
substances [that] have been proposed as haemostatics for local use."
Haemostatic Agents 142. Among them, Haemostatic Agents identifies
oxidized cellulose and oxidized regenerated cellulose, which "is prepared
from alpha cellulose and is also a polyanhydroglucoronic acid." Id. at 144.
According to Haemostatic Agents, with this product, "clotting proceeds
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rapidly and the swollen material provides a matrix for fibrin, forming a
partially artificial coagulum." Id.
FF 7. Ruzickova describes a mesh comprising nano fibers or
molecules of oxidized polysaccharide uniformly dispersed in a fiber-forming
polymer. Ruzickova, Abstract. Ruzickova teaches such "mesh may be used
in wound dressings." Id.; see also id. at 20 ( disclosing that the nanofibrilar
structures of oxidized cellulose "can be used as hydrating, haemostatic or
anti-adhesive layers applied to commonly available dressing materials such
as bandages ... [ and] can also be used as the basis for new dressing
materials suitable for both acute and chronic wound management").
FF 8. According to Ruzickova, the "oxidised polysaccharide may be
polyanhydroglucuronic acid or salts or intermolecular complexes thereof."
Id.; see also id. at 2 ("The oxidised polysaccharide may be oxidised glucan.
The oxidised glucan may be polyanhydroglucuronic acid [PAGA] or salts or
intermolecular complexes [IMCs] thereof.") (brackets in original).
Ruzickova teaches that the fiber-forming polymer may include polymers
such as "polyurethane, polyacrylate, polyesters or cellulose derivatives." Id.
at 2. Ruzickova teaches that, in embodiments, "the weight ratio of
polysaccharide to fibre-forming polymer is from 99: 1 to 20:80." Id.
FF 9. Ruzickova discloses that the mesh products may include
"complexes of a chemotherapeutic with PAGA such as complexes of an
antiseptic with PAGA." Id. at 4. Ruzickova teaches that "[a]ntiseptic type
cations in complexes with PAGA may be amino compounds such as the
biguanid derivatives (e.g.[,] chlorhexidine )," among others. Id. Ruzickova
teaches that the mesh products may "comprise one or more additives ...
selected from the group comprising: antimicrobials, antiseptics,
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antibacterials, ... healing agents and chemotherapeutics." Id. at 10.
According to Ruzickova, "[t]he antibacterial may be one or more selected
from the group comprising: chlorhexidine, iodine, [and] chiniofon," among
others. Id. Ruzickova teaches "the additives may be impregnated into the
mesh" or, "[ a ]ltematively, the additives may form a biocompatible
intermolecular complex (IMC) with the oxidised polysaccharide." Id.; see
also id. at claims 1, 4, 11, 31, 32, 35, 37, 38, and 46.
FF 10. Huey discloses "an apparatus for promoting hemostasis [that]
includes oxidized cellulose in the form of a compressible, shapeable mass
that is formed into a sheet for placement on a bleed site." Huey, Abstract.
Huey discloses a bandage with a substrate and the oxidized material attached
to it, and that the "oxidized cellulose material is arranged to contact a
bleeding wound when the bandage is applied thereto." Id.; see also id. at
Fig. 4 (depicting bandage (26) with a sheet (10) of oxidized cellulose
material on substrate (12), which includes an adhesive layer (22)); id. ,-i 34.
Huey teaches that such devices "are directed to the clotting of blood and the
dressing of wounds," and "can be used in various surgical procedures." Id.
,-J 8; see also id. ,-i 10 ("Upon contacting the bleeding wound with the
oxidized cellulose material, a clotting effect is realized.").
FF 11. Huey teaches that "[ o ]xidized cellulose is a chemically
oxidized form of common cellulose fiber ... and is also known as cellulosic
acid, absorbable cellulose, or polyanhydroglucuronic acid [PAGA]." Id.
,-J 25. Huey further teaches that "pharmaceutically-active compositions may
be incorporated into the oxidized cellulose," and that such agents include
"antimicrobial agents." Id. ,-i 12; see also id. ,-i,-i 42-43 ("Various materials
may be mixed with, associated with, disseminated throughout, embedded
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into, or incorporated into the oxidized cellulose to maintain an antiseptic
environment or to provide functions that are supplemental to the hemostatic
functions of the oxidized cellulose."); see also id. ,i,i 46-4 7.
FF 12. Ward relates to a "dressing for retaining a cannula on the
skin," such that the "dressing fits around the indwelling cannula." Ward,
Abstract; see id. at Fig. 3 ( depicting the dressing adhered over an injection
site and indwelling catheter (15)). Ward discloses that the dressing may
include "[s]uitable backing films," which are preferably "a flexible
polymeric film," such as one made of polyurethane. Id. at 2: 14-52 ("A
second favoured form of flexible film may be formed from any moisture
vapour permeable transparent hydrophilic polymer. Suitable materials
include polyurethanes .... "). Ward discloses that the dressing further
includes an "adhesive layer," which "may be applied to the backing film as a
continuous layer or as a discontinuous layer." Id. at 2:66-3:16; see also id.
at Fig. 2 ( depicting a cross-section of the dressing with backing layer (9) and
adhesive layer (7) ). Ward teaches that the adhesive layer "is formed from a
skin compatible adhesive such as polyvinylethyl ether or polyacrylate ester
copolymer adhesive." Id. at 7: 13-16; see also id. at 3:4-13. Moreover,
Ward teaches, "the adhesive may contain a medicament such as an
antibacterial agent." Id. at 3:24-25. According to Ward, "the adhesive may
contain from 1 to 10% by weight of the adhesive as medicament," and
"[ s Jui table antibacterial agents include chlorhexidine and salts thereof such
as chlorhexidine diacetate and chlorhexidine digluconate." Id. at 3:25-31
( emphases added).
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Analysis
Claim 1
The Examiner finds that Bhende teaches, inter alia, a "polyurethane
foam dressing impregnated with chlorhexidine gluconate [that] shows
antimicrobial activity against all the challenge organisms," and that Bhende
further discloses that the "foam is effective against infection associated with
percutaneous devices." Final Act. 6. According to the Examiner, however,
Bhende does not teach the use of PAGA as a hemostatic agent in the
dressing or "explicitly teach chlorhexidine digluconate as claimed." Id.
( emphasis added). So, the Examiner turns to the other cited references.
The Examiner finds that Levinson teaches the use of hemostatic
agents, such as oxidized cellulose, in dressings for transcutaneous medical
devices is a known and "conventional" practice. Id. The Examiner finds
that Haemostatic Agents identifies PAGA as a compound that provides rapid
clotting of blood without causing local irritation. Id. at 6-7. The Examiner
finds Ruzickova teaches a dressing having PAGA molecules or fibers
dispersed in polyurethane to form a mesh. Id. at 7. Also, the Examiner
finds, Ruzickova discloses that the dressing and mesh may further comprise
chlorhexidine as an antimicrobial agent. Id. And, the Examiner cites Huey
as teaching that PAGA is a suitable hemostatic agent for use in wound
dressings, and that such dressings may "comprise antimicrobial agent." Id.
As for chlorhexidine digluconate, the Examiner cites Ward. The
Examiner finds that Ward "teaches chlorhexidine digluconate suitable as
antibacterial agent in flexible polyurethane dressing for retaining cannula on
the skin," and that such "[a]ntibacterial agent is present in an amount of 1-
10%," partially overlapping the 9-16% range in claim 1. Id. at 7, 9.
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The Examiner reasons that the skilled artisan "would have been
motivated to use PAGA, which is an oxidized cellulose, as a hemostatic
agent" in formulating a polyurethane dressing like disclosed in Bhende in
order to "arrest bleeding without spreading the infection from the puncture
site." Id. at 8. According to the Examiner, this is consistent with
"conventional" practice as evidenced by Levinson, and reinforced by the
teachings of Haemostatic Agents, Ruzickova, and Huey, which collectively
show that PAGA was a known hemostatic agent for wound dressings-
including dressings comprising a polyurethane matrix. Id. at 8-9. Citing
Ward, the Examiner reasons that chlorhexidine digluconate is merely an
alternative antimicrobial agent to the chlorhexidine gluconate disclosed in
Bhende. Id. at 9. Accordingly, the Examiner reasons, it would have been
obvious for the skilled artisan to have predictably substituted chlorhexidine
gluconate in Bhende with Ward's chlorhexidine digluconate to arrive at the
subject matter of claim 1. Final Act. 9; see also Ans. 8 ("It is obvious to
replace the [ chlorhexidine] gluconate with the [ chlorhexidine] digluconate of
the same compound known to be used for the same reason, antimicrobial
agents. It is a simple substitution and within the grasp of one having
ordinary skill in the art.") (citing KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398
(2007)).
We agree with, and adopt, the Examiner's findings and reasoning in
support of the rejection of the claims over Bhende, Levinson, Haemostatic
Agents, Ruzickova, Huey, and Ward. See Final Act. 4-14; Ans. 6-25. The
combined teachings demonstrate that wound dressings, including dressings
comprising a polyurethane foam or polyurethane fiber matrix, are known in
the art and usable in conjunction with transcutaneous medical devices,
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including catheters. See, e.g., FF 1-2, 4, 12. The cited art also teaches that
it was known, indeed conventional, to use hemostatic agents and
antimicrobial agents in such wound dressings. See, e.g., FF 2, 5, 7-12.
And, in that regard, the cited art demonstrates that PAGA was a well-known
hemostatic agent to help clotting ( e.g., FF 6, 7-8, 10), and that chlorhexidine
and its salts were well-known antimicrobial agents used to reduce infection
(e.g. FF 1-3, 9, 12).
That no single reference here expressly discloses a polyurethane foam
dressing with both PAGA and chlorhexidine digluconate is not decisive.
Quite the opposite, the issue is obviousness. When obviousness is the issue,
we ask "whether the improvement is more than the predictable use of prior
art elements according to their established functions." KSR, 550 U.S. at 417.
The answer, on this record, is "no." This case involves the obvious
combination or substitution of known features with no demonstrable change
in their known functions. As noted by the Examiner, the skilled artisan
would have predictably included PAGA as a known hemostatic agent in
Bhende's polyurethane foam dressing to provide a blood-clotting effect-
just as PAGA was known to do in other dressings, including polyurethane-
based dressings. And the skilled artisan would have predictably substituted
Bhende's chlorhexidine salt (chlorhexidine gluconate) for Ward's
chlorhexidine salt ( chlorhexidine digluconate )-as the prior art expressly
teaches that those salts are suitable antimicrobial agents for wound dressings
to fight infection. Id. at 416 ("[W]hen a patent claims a structure already
known in the prior art that is altered by the mere substitution of one element
for another known in the field, the combination must do more than yield a
predictable result.").
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We address Appellants' arguments below.
Appellants contend that the prior art does not teach all of the claim
elements, in particular, "CHG combined with PAGA in a polyurethane
foam." App. Br. 12. In support, Appellants argue the references
individually, which is generally inadequate to rebut a rejection for
obviousness. In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986)
("Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references"). Appellants, for example, contend that none of
Bhende, Ruzickova, or Huey teach chlorhexidine digluconate (CHG). App.
Br. 12. The Examiner acknowledges as much, but cites Ward as teaching
that chlorhexidine salts are suitable antimicrobial agents, including expressly
chlorhexidine digluconate as claimed. Ans. 8-10; FF 12. Appellants argue
that "a PHOSITA would differentiate between Bhende's chlorhexidine
gluconate and other species such as CHG." App. Br. 12. But Appellants fail
to support this attorney argument with evidence, much less evidence
explaining why, even if the salts are literally different, a simple substitution
of one antimicrobial chlorhexidine salt for another would have been
nonobvious. The Board is unpersuaded that chlorhexidine digluconate
(having one molecule of chlorhexidine for every two molecules of gluconic
acid) is a nonobvious variation to chlorhexidine gluconate (having one
molecule of chlorhexidine for every molecule of gluconic acid), particularly
when the combined art broadly discloses that chlorhexidine (Ruzickova) and
chlorhexidine salts (Bhende and Ward) are suitable antimicrobial agents for
wound dressings. FF 1-3, 9, 12.
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Appellants argue that the prior art does not teach use of 9-16%
chlorhexidine digluconate in a polyurethane foam. App. Br. 14-15. Here
again, Appellants point out differences between individual prior art
references without grappling persuasively with what the references teach and
suggest as a whole. Appellants, for example, contend "Ward does not teach
a CHG-containing polyurethane foam." Id. at 14. According to Appellants,
Ward's 1-10% CHG is not embedded in the polyurethane backing film on
Ward's dressing, but instead is present in the dressing's "adhesive layer,"
which is comprised of a different polymeric material ( e.g., polyacrylate ester
copolymer). Id. at 14-15. Conversely, Appellants argue Bhende's
polyurethane foam does not include chlorhexidine digluconate as its
antimicrobial, but only chlorhexidine gluconate-at a concentration (20%
w/w) that is above the claimed range of 9-16%. App. Br. 15-16.
Appellants contend Ruzickova's dressing is a polyurethane mesh, not a
foam, and that Ruzickova teaches "chlorhexidine" and a "chlorhexidine-
p AGA complex" in an unknown ratio in the mesh. Id.
Even if Appellants' characterization of the individual disclosures of
each of Bhende, Ruzickova, and Ward were correct, Appellants argument
does not rebut the Examiner's prima facie case of obviousness, which is
based on the references' combined teachings. 10 On this record, as explained
above, a skilled person would have predictably substituted one known
10 Insofar as Appellants' arguments suggest that Ruzickova teaches only a
PAGA-chlorhexidine "complex," that is incorrect. App. Br. 12-13, 15;
Reply Br. 10. Ruzickova teaches that the chlorhexidine may be embedded
or dispersed as an additive in the polyurethane and PAGA mesh and, in
alternative embodiments, that chlorhexidine may form an intermolecular
complex with the PAGA. FF 9.
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antimicrobial agent for another-chlorhexidine digluconate for
chlorhexidine gluconate. There is no evidentiary basis here to show that
substituting one gluconate salt form of chlorhexidine for another in
Bhende's polyurethane foam would involve anything more than routine skill
possessed by the ordinary artisan. There is further no evidentiary basis here
to suggest, much less show, that using chlorhexidine digluconate rather than
chlorhexidine gluconate in Bhende's polyurethane foam would present
problems or render the dressing inoperable. To the contrary, for reasons
given by the Examiner, we similarly conclude the skilled artisan would
reasonably expect Bhende's polyurethane foam dressing would provide an
antimicrobial effect with Ward's antibacterial chlorhexidine digluconate salt.
See, e.g., Ans. 11-12 ("The cited references show that it was well known in
the art at the time of the invention to use the claimed ingredients in wound
dressing: polyurethane foam, CHG and PAGA .... No patentable invention
resides in combining old ingredients of known properties where the results
obtained thereby are no more than the additive effect of the ingredients.").
As to the 9-16% w/w range of CHG in claim 1, as the Examiner
notes, the claimed range overlaps with the 1-10% w/w CHG range taught in
Ward. Final Act. 9-10; In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003) ("[W]e and our predecessor court have consistently held that even a
slight overlap in range establishes a prima facie case of obviousness.")
( emphasis omitted). And, as Appellants note, Bhende discloses the use of a
20% w/w amount of chlorhexidine gluconate in a polyurethane foam
dressing. App. Br. 15.
On this record, we agree with the Examiner that "[ d]etermining the
optimal concentration of CHG is deemed to be routine and well within the
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skill of the artisan." Final Act. 15; Ans. 13-14. At minimum, the amounts
of antimicrobial chlorhexidine salts recited in Ward and Bhende provide
starting points for the skilled artisan's expected experimentation to
determine suitable or optimized concentrations in a modified polyurethane
foam dressing. Under such circumstances, we conclude that the skilled
artisan would have predictably arrived at concentrations of CHG within the
range recited in claim 1. Indeed, where, as here, "the general conditions of a
claim are disclosed in the prior art, it is not inventive to discover the
optimum or workable ranges by routine experimentation." In re Aller, 220
F.2d 454,456 (CCPA 1955). That is particularly so when, as here, no
argument is made or evidence cited to show that the claimed concentrations
are critical. MPEP 2144.05(II)(A) ("Generally, differences in concentration
or temperature will not support the patentability of subject matter
encompassed by the prior art unless there is evidence indicating such
concentration or temperature is critical."). 11 Again, Appellants are not
putting the three ingredients of claim 1 (CHG, PAGA, and a polyurethane
foam) to any unknown or nonobvious use; Appellants have simply combined
11 "The law is replete with cases in which the difference between the claimed
invention and the prior art is some range or other variable within the claims.
. . . In such a situation, the applicant must show that the particular range is
critical, generally by showing that the claimed range achieves unexpected
results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir. 1990); In re Dillon, 919 F.2d 688, 692-93 (Fed. Cir. 1990) (en
bane) ("[S]tructural similarity between claimed and prior art subject matter,
proved by combining references or otherwise, where the prior art gives
reason or motivation to make the claimed compositions, creates a prima
facie case of obviousness, and that the burden (and opportunity) then falls on
an applicant to rebut that prima facie. ") ( emphases omitted).
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those ingredients for uses already disclosed in the combined prior art-as an
antimicrobial agent, a hemostatic agent, and as a substrate forming a wound
dressing.
Appellants also argue that a skilled artisan would not be motivated to
combine CHG and PAGA in a polyurethane foam to form a dressing, with a
reasonable expectation of success, without the benefit of hindsight. App. Br.
13. Appellants' argument is unavailing. The Examiner does not invoke
impermissible hindsight. Rather, the Examiner points to teachings of each
of the claim elements in the prior art, and persuasively establishes that each
ingredient of the claim is being used for its known and intended function as
discussed above (PAGA as a hemostatic agent, CHG as an antimicrobial
agent, etc.). The Examiner further provides persuasive reasoning, as
discussed above, to establish that it would have been routine and obvious for
the skilled artisan to treat known chlorhexidine salts as interchangeable and
to optimize the amount of those salts for their known antimicrobial effect in
a wound dressing. Appellants fail to provide persuasive evidence otherwise.
Claim 18
Claim 18 is similar to claim 1, but does not recite any particular
concentration of CHG. App. Br. 30. Claim 18 also adds that the dressing
includes a moisture vapor-transmissive polyurethane backing and an
adhesive on a skin-contacting surface. Id.
To reiterate, we agree with, and adopt, the Examiner's findings and
reasoning in support of the rejection of independent claim 18. Final Act. 5-
11; see also Ans. 15-16. We do not repeat the findings and reasoning here.
Appellants argue "the adhesive on the skin-contacting side of the
claimed dressing device is an intervening adhesive in that it intervenes
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between skin on a first side and the claimed polyurethane foam comprising
the CHG and PAGA on a second side." App. Br. 16 (emphasis added).
Appellants contend this configuration "is evident from the language of claim
18 when the claimed invention is viewed as a whole." Reply Br. 13.
According to Appellants, the cited art does not teach this alleged
"intervening" adhesive structure. App. Br. 16-17.
Appellants' argument is unpersuasive. As the Examiner points out,
claim 18 does not recite or require that the adhesive layer is an "intervening"
adhesive between the skin on one side and the foam on the other side. Ans.
15-16. According to the Examiner, the claims merely require the dressing
include an adhesive on a skin-contacting surface and, as described in the
Specification, Appellants' adhesive is used to secure the dressing to the skin
in much the same way as, for example, Huey. Id. at 16-17. We agree with
the Examiner and find that Appellants' arguments fail for arguing limitations
not required in claim 18. In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(" [ A Jppellant' s arguments fail from the outset because ... they are not based
on limitations appearing in the claims.").
Claim 9
Appellants argue claim 9 under a separate heading, but merely cite the
same arguments made for claim 1 and 18. Those arguments are
unpersuasive as explained above.
Claims 2 and 19
Appellants argue claim 19 under a separate heading, Appellants refer
to their arguments concerning claim 18 ( from which 19 depends) and also
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cross-reference their arguments related to the claimed range (9-16% w/w) of
CHG in claim 1. 12 Those arguments are unpersuasive as explained above.
In a separate section, Appellants argue that claims 2 and 19 are
nonobvious because each of those claims requires, among other features, a
PAGA salt in an amount from 3-20% (w/w). App. Br. 28, 30 ( claims 2 and
19); App. Br. 22-23. According to Appellants, Ruzickova teaches
polyurethane nanofibers, not a polyurethane foam. Id. at 22. Moreover,
Appellants contend, Ruzickova at best teaches a 20-99% weight ratio of
PAGA to polyurethane in Ruzickova's mesh. Reply Br. 20. And,
Appellants argue, "a PHOSITA would expect PAGA to be incorporated
differently" in polyurethane nanofibers versus a polyurethane foam so "a
PHOSITA would not simply modify" the art as suggested by the Examiner.
App. Br. 23.
12 Appellants contend "a PHOSITA would understand even a single species
of chlorhexidine can behave quite differently in different environments
including Bhende's polyurethane discs and Ward's polyvinyl ether or
acrylate adhesives." App. Br. 19 ( emphasis omitted). Appellants, however,
provide no evidence to support the argument of counsel. Notwithstanding
Appellants' argument, we observe that Ward broadly teaches that
"chlorhexidine and salts thereof," as well as several other antimicrobials can
be used in its adhesives. Ward, 3:24-35. Ruzickova, for example, teaches
that numerous antimicrobials, one of which is chlorhexidine, can be included
in its polyurethane-PAGA mesh dressings. Ruzickova 10. This suggests
that active antimicrobials (including chlorhexidine and its salts) have broad
application, and can be used for providing an antimicrobial effect across a
broad range of polymeric substrates used for wound dressings. Appellants
cite nothing in Bhende that would suggest its polyurethane foam dressing
would only provide an antimicrobial effect when chlorhexidine gluconate ( as
opposed to an alternative salt like chlorhexidine digluconate) is used.
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Appellants' arguments remain unpersuasive. We agree with the
Examiner that the combined "teachings of the references suggest[] suitability
of combining polyurethane with CHG and PAGA without any adverse
effect." Ans. 23. Hence, the prior art suggests the general conditions of the
claimed subject matter and, as explained above, we conclude that
determining workable concentrations of PAGA and CHG in a polyurethane
foam dressing would have been a matter of routine and obvious optimization
absent evidence of criticality with the claimed concentrations, which
Appellants do not cite. Moreover, even if Ruzickova teaches a ratio that
begins with 20% w/w of PAGA to the polymer, that ratio slightly overlaps
and/or abuts the ratio recited in claims 2 and 19, thus further supporting the
Examiner's prima facie case. In re Peterson, 315 F.3d at 1329. 13
Claims 3, 5, and 6
Claims 5 and 6 depend from claim 1 and recite, inter alia, that the
dressing includes "approximately 11 % (w/w)" CHG. App. Br. 28.
According to Appellants, this claimed amount of CHG is "outside the
Examiner-asserted range of Ward." App. Br. 20.
We conclude, however, that the amount of CHG recited in these
claims remains obvious as a matter of routine optimization based on the
conditions disclosed in the art. As explained above, the combined prior art
13 Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 783 (Fed. Cir.
1985) ("The proportions are so close that prima facie one skilled in the art
would have expected them to have the same properties."). Gentiluomo v.
Brunswick Bowling and Billiards Corp., 36 F.App'x 433, 438-39 (Fed. Cir.
2002) (unpublished) (rejecting argument that overlap of claimed ranges is
necessary to show obviousness, and explaining that evidence of
criticality/unexpected results from the applicant may be required).
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suggests the known use of PAGA and chlorhexidine salts (including
specifically CHG) in wound dressings (including polyurethane mesh and
polyurethane foam dressings) to provide hemostatic and antimicrobial
effects. See, e.g., FF 1-3, 7-9, 12. Bhende expressly teaches polyurethane
foam dressings and merely uses a different chlorhexidine salt than claimed.
FF 1-3. The skilled artisan possesses at least ordinary creativity and
intelligence, and considering the cited prior art, we are persuaded the skilled
person would have combined PAGA and CHG in a polyurethane foam, and
adjusted the respective concentrations of the ingredients as part of the
normal course of research and development. What is wanting here is any
persuasive rebuttal evidence from Appellants to show that the claimed
amounts of PAGA and CHG are critical or, in any way, provide unexpected
results when used in those amounts in a polyurethane foam. Moreover, as
the Examiner notes, use of the term "approximately" in relation to the CHG
concentration in claims 5 and 6 is broad enough to overlap or touch Ward's
1-10% CHG range. Ans. 19-20.
As to claims 3 and 6, Appellants further argue those claims are
nonobvious over the prior art insofar as those claims require PAGA in an
amount of 8% (w/w). App. Br. 24. We agree with Appellants that this
recited amount of PAGA does not overlap with that disclosed in Ruzickova,
which suggests a range of 20-80%. Reply Br. 21-22. 14 We nevertheless
conclude that the amount of PAGA in the dressing of claims 3 and 6 would
have been obvious under the circumstances ( discussed at length above) as a
14 Appellants persuade us, on this record, that the Examiner's interpretation
of Ruzickova as teaching a 1-99% range of PAGA is not accurate.
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matter of routine experimentation and optimization absent persuasive
evidence of criticality or other objective evidence of nonobviousness.
Claims 20 and 21
Claims 20 and 21 are similar to claims 5 and 6, except claims 20 and
21 do not include the qualifier "approximately" before the amount of CHG
(11 % (w/w)). App. Br. 30. For reasons explained above, however, we
conclude that claims 20 and 21 would have been obvious on this record even
without overlap, in fact, of the claimed and prior art ranges as a matter of
routine experimentation and the use of known ingredients for their known
purposes in a wound dressing. Moreover, even without overlap, the range of
CHG is still close to what is suggested in Ward (1-10% CHG), and between
Ward's range and the amount recited in Bhende (20%) for a closely related
chlorhexidine salt. Under these circumstances, and with no evidence or
argument on criticality, the preponderance of the evidence still favors the
Examiner's conclusion of obviousness. Ans. 21-22.
Claims 16 and 1 7
Appellants argue that claims 16 and 17 are nonobvious because none
of the asserted references describe "homogenously" dispersing PAGA in a
polyurethane foam. App. Br. 25 (emphasis added). IfRuzickova's PAGA
was added to Bhende's disks, Appellants urge, it would simply be "on the
outer surface" or possibly "in the open pores" of such disks. Id.
The Examiner finds, however, that Ruzickova teaches that the PAGA
should be uniformly dispersed (i.e., homogeneously mixed) in the polymer
forming the wound dressing. Final Act. 10; Ans. 25. We do not interpret
the Examiner's rejection as proposing that PAGA would simply be loaded
on top of Bhende's polyurethane disks, as intimated by Appellants. To the
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contrary, Ruzickova teaches that PAGA should be uniformly dispersed
throughout the polyurethane mesh or matrix forming the dressing, thus
providing a skilled artisan a reason and suggestion to do likewise in
Bhende's polyurethane foam. See Ruzickova, Abstract; FF 7-9. The notion
that active agents should be uniformly distributed, impregnated, or
disseminated throughout a dressing would have been obvious to the skilled
artisan on this record. FF 1-3 (Bhende describing a chlorhexidine-salt
impregnated polyurethane foam); FF 7-9 (Ruzickova describing a uniform
dispersion of PAGA in a fiber-forming polyurethane polymer); FF 10-11
(Huey suggesting that antimicrobial agents may be "disseminated
throughout" an oxidized cellulose/PAGA sheet). Accordingly, we find that
the preponderance of the evidence supports the Examiner's conclusion that
claims 16 and 1 7 would have been obvious.
Claim 11
Appellants devote a separate heading to claim 11, but contend only
that "Mendelbaum [sic] does not supply the features missing from the
combination of references" cited above as to claim 1. App. Br. 26. The
Examiner, however, relies on Mandelbaum solely for teaching the shape of
the opening (i.e., "x" or "T" shaped) in the dressing recited in claim 11.
Ans. 25. We are unpersuaded of any "features missing" in the primary
combination of references as argued by Appellants and need not rely on
Mandelbaum to remedy any alleged deficiency in that combination.
Finally, as a backstop, Appellants argue the Examiner has failed to
appreciate "the invention as a whole." App. Br. 26. According to
Appellants, "the invention as a whole cannot be appreciated by merely
pointing to certain claimed features and identifying alleged obvious
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differences between the certain claimed features and those in some
references." Id. at 26-27. But that is not what the Examiner did. The
Examiner addressed the claims as whole and provided specific citations to
where the prior art taught, suggested, and otherwise rendered obvious all the
claimed features-providing a persuasive rationale to explain why the
skilled artisan would have combined those teachings as proposed. As
detailed above, it is the Appellants who here fail to provide persuasive
argument or rebuttal evidence to show that the prior art as a whole does not
teach or suggest the subject matter claimed. Appellants' argument does not
overcome the evidence and reasoning cited by the Examiner, which supports
the Examiner's conclusion of obviousness.
Conclusion of Law
For the reasons discussed above, the preponderance of the evidence
supports the Examiner's conclusion that claims 1-3, 5, 6, 9, and 16-21
would have been obvious over Bhende, Levinson, Haemostatic Agents,
Ruzickova, Huey, and Ward. The preponderance of the evidence also
supports the Examiner's conclusion that claim 11 would have been obvious
over the above combination in further view of Mandelbaum.
Claims 7, 8, 10, 13-15, 22, and 23 have not been argued separately
and, therefore, fall with claims addressed above. 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
We reverse the written description rejection, and affirm the rejections
for obviousness on appeal.
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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. § l .136(a).
AFFIRMED
27