Ex Parte Laurensou

Patent Trials and Appeals Board

Jun 25, 2019

12601718 - (D) (P.T.A.B. Jun. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/601,718 07/06/2010 Christelle Laurensou
52835 7590 06/27/2019
HAMRE, SCHUMANN, MUELLER & LARSON, P.C.
45 South Seventh Street
Suite 2700
Minneapolis, MN 55402-1683
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.
20010.0050USWO 9590
EXAMINER
GHALI, ISIS AD
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
06/27/2019 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):
PTOMail@hsml.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRIS TELLE LAURENSOU1
Appeal2018-000855
Application 12/601,718
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims relating
to a wound dressing, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
"Many dressings which use compositions consisting of fatty
substances ... and/or of an elastomeric matrix, into which more or less large
amounts of hydrocolloid particles can be incorporated, are today used for
treating wounds." Spec. 1 :3-6. "Compositions for dressings incorporating
1 Appellant identifies the Real Party in Interest as LABO RA TO IRES
URGO. Appeal Br. 2.
Appeal2018-000855
Application 12/601,718
various active substances ... have also been designed." Id. at 1 :24-27.
"However, the incorporation of an active substance into these compositions
based on a fatty substance and/or on an elastomeric matrix is a complex
problem." Id. at 1:36 to 2:4. "[T]he active substance [also] has a more or less
marked tendency to remain trapped in the composition." Id. at 2:7-8.
The Specification discloses that surfactants have been used to promote
release of active agents but have the drawback of being toxic to fibroblasts.
Id. at 2:27 to 3:6. The Specification discloses "using, as agent for releasing an
active substance, a copolymer of a salt of 2-methyl-2-[(l-oxo-2-
propenyl)amino ]-1-propanesulfonic acid and of 2-hydroxyethylpropenoate
ester." Id. at 3:24-28. The Specification states that this copolymer is known,
"in particular in the cosmetics field, owing to its emulsifying-stabilizing
properties and its good thickening capacity," and is sold under the trade name
Sepinov EMT 10®. Id. at 3:35 to 4:3. "[T]his copolymer, unlike the known
surfactant compounds, has a tendency to induce fibroblast proliferation." Id.
at 4:13-15.
Claims 6, 9, 10, 12, 13, 16-19, and 21-34 are on appeal. Claim 6 is
illustrative and reads as follows:
6. A dressing comprising a mass, wherein the mass
comprises a hydrocolloid in an amount of between 2 and 20%
by weight of the mass, at least one selected from the group
consisting of a fatty substance and an elastomeric matrix, at
least one active substance, and a copolymer of a salt of 2-
methyl-2-[ ( l -oxo-2-propenyl)amino ]-1-propanesulfonic acid
and of 2-hydroxyethylpropenoate ester,
wherein the copolymer is included in an amount
sufficient for increasing an amount of the active substance that
is released from the dressing as compared to that of a
corresponding dressing that does not comprise the copolymer,
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Application 12/601,718
wherein the amount of the copolymer included in the
dressing is between 1 % to 20% by weight, and
wherein the amount of the active substance included in
the dressing is between 0.01 % and 15% by weight.
Claim 16 is the only other independent claim and is directed to a
"method for releasing an active substance from a dressing composition"
comprising incorporating the copolymer recited in claim 6, in the same
amount, in a dressing composition that comprises the other components of
claim 6.
The claims stand rejected as follows:
Claims 6, 9, 10, 12, 13, 16-19, 21-24, and 31-34 under 35 U.S.C.
§ 103(a) as obvious based on Freeman,2 Lipman,3 Laskey,4 Sepinov,5 and
Fares6 (Final Action7 3);
Claims 25 and 26 under 35 U.S.C. § 103(a) as obvious based on
Freeman, Lipman, Laskey, Sepinov, Fares, and Michaeli8 (Final Action 10);
and
Claims 27-30 under 35 U.S.C. § 103(a) as obvious based on Freeman,
Lipman, Laskey, Sepinov, Fares, and Cochrum9 (Final Action 12).
2 Freeman, US 5,681,579, issued October 28, 1997.
3 Lipman, US 2004/0241215 Al, published December 2, 2004.
4 Laskey, US 3,929,741, issued December 30, 1975.
5 Seppic, "Sepinovâ„¢ EMT 10 New "2-in-l' powder polymer" (2005).
Sepinov was cited in an Information Disclosure Statement filed Nov. 24,
2009.
6 Fares et al., US 2006/0018852 Al, published January 26, 2006.
7 Office Action mailed Nov. 17, 2016.
8 Michaeli, US 4,912,093, issued March 27, 1990.
9 Cochrum et al., US 2002/0197302 Al, published December 26, 2002.
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Application 12/601,718
DISCUSSION
The Examiner has rejected claims 6, 9, 10, 12, 13, 16-19, 21-24, and
31-34 as obvious based on Freeman, Lipman, Laskey, Sepinov, and Fares,
and has rejected claims 25-30 as obvious based on the same references,
further combined with Michaeli or Cochrum. The same issue is dispositive
for all of the rejections.
The Examiner finds that "Freeman teaches wound dressing ...
compris[ing] hydrocolloid-containing polymeric support layer." Final Action
4. "The hydrocolloid is mixed with mineral oil or fatty substance such as
petroleum jelly, and elastomer." Id. "The hydrocolloid comprises active
agent." Id. "The dressing further comprises absorbent material to promote
absorption and wound healing. Absorbent polymeric materials and
superabsorbent include acrylate and polyacrylate polymers." Id. The
Examiner finds that Freeman "does not explicitly teach the instantly claimed
copolymer." Id. at 5.
The Examiner finds that Lipman teaches a wound dressing that
comprises an "absorbing polymeric material compris[ing] hydrocolloid and
hydrophilic polymer, including polyacrylate polymer, in amount from 10-
70%." Id. The Examiner finds that Lipman's dressing also comprises
hydrocolloids, petrolatum, and an active agent. Id.
The Examiner finds that "Laskey teaches transparent copolymer
capable of absorbing large amount of liquid and water ... [ and] useful for
wound and bum dressing and for controlled release of drug[ s]." Id. at 6.
"The copolymer is a product of polymerization of 2-acrylamido-2-
methylpropanesulfonic acid and hydroxyethyl acrylate." Id.
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Application 12/601,718
The Examiner finds that Sepinov "teaches Sepinov EMT 10
copolymer is non-hemolyzing, non-denaturing, non-irritant and non-
sensitizing. The copolymer can be included in topical compositions in an
amount from 0.3 to 1.5% of the composition." Id. The Examiner also finds
that "Fares teaches dermatological composition comprising 0.1-15%, and
preferably 0.5-5% of thickening/gelling agent, and preferred thickener/
gelling agent is Sepinov EMT-10." Id.
The Examiner concludes that it would have been obvious
to provide wound dressing comprising hydrocolloid, elastomer,
active agent and absorbent acrylate polymer as taught by any of
Freeman, and use absorbent in acrylate polymer in amount 10-
70% as taught by Lipman, and replace the acrylate absorbent
polymer with copolymer of 2-acrylamido-2-methylpropane-
sulfonic acid and hydroxyethyl acrylate, or its sodium salt,
taught by Laskey.
Id. at 6-7. 10 The Examiner reasons that a skilled worker would have
expected the resulting wound dressing to have "excellent absorbency for the
wound exudate to reduce[] wound maceration and promote its healing and
meanwhile release[] useful active agent ... to accelerate healing." Id. at 7.
The Examiner also concludes that"[ o ]ne having ordinary skill in the
art would have been motivated to use 0.3-1.5% of Sepinov EMT-10 taught
by ... Sepinov, or use 0.1-15% Sepinov EMT-10 as taught by Fares
because both references teach suitability of such amounts in topical and
dermatological compositions." Id. The Examiner also notes that "Sepinov
teaches that the copolymer is non-hemolyzing, non-denaturing, non-irritant
10 Laskey refers to the components of its copolymer by different names than
those used in the claims but Appellant does not dispute that the copolymers
are the same. See Appeal Br. 8-9.
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Application 12/601,718
and non-sensitizing, and Fares teaches Sepinov EMT-10 is preferred
thickener in dermatological composition." Id.
Appellant argues that "[a] combination of Freeman and Lipman does
not disclose a copolymer of a salt of 2-methyl-2-[(l-oxo-2-propenyl)amino ]-
1-propanesulfonic acid and of 2-hydroxyethylpropenoate ester, much less
teach or suggest the accompanying advantages of its use in a wound
dressing." Appeal Br. 7.
While correct, this argument is unpersuasive because the Examiner
cites Laskey, Sepinov, and Fares, not Freeman or Lipman, for the copolymer
recited in the claims.
Appellant also argues that "Laskey is directed to a polymer product
that is primarily intended to absorb and retain a superior amount of water,"
and "speculates that their hydrophilic polymer product may be used for
'controlled release of drugs of antibiotics and of nutrient supplements'
among a long list of possible applications." Appeal Br. 8.
Appellant argues that "a dressing mass that includes hydrocolloids ...
along with a fatty substance or an elastomeric matrix as recited in claim 6
... ha[ s] a tendency of trapping active agents within the elastomeric matrix
so that the active agents are not readily released." Id. at 9. Appellant also
argues that, "[ a Js taught by Freeman, surfactants are generally used for
promoting the release of active agents in such wound dressings." Id.
These arguments are consistent with the Specification's discussion of
pre-existing wound dressings. See Spec. 1 :3-6 ("Many dressings which use
compositions consisting of fatty substances, generally based on oil or on
petroleum jelly, and/or of an elastomeric matrix, into which more or less
large amounts of hydrocolloid particles can be incorporated, are today used
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for treating wounds."); 2:6-8 ("[T]he active substance has a more or less
marked tendency to remain trapped in the composition."). See also id. at
2:27-30 ("It has been proposed ... to incorporate a surfactant ... into the
composition in order to promote the release of the active substance.").
Appellant argues that,
given that Laskey teaches a polymer product that has a
completely different property, that is, a very high hydrophilic
water-absorbing property ... , one would not have reasonably
expected that the claimed copolymer in particular amounts
within a wound dressing ... as recited in claim 6 could lead to
superior release of an active substance, without being cytotoxic
to fibroblasts as demonstrated, for example, by the
experimental work of the specification and the Declaration[ s]
submitted on December 3, 2014 and March 4, 2016.
Appeal Br. 9.
The Specification provides data regarding, among other things, the
release of the active agents potassium sucrose octasulfate and silver
sulfadiazine in the presence or absence of the copolymer recited in the
claims (Sepinov EMT 10). Spec. 17 (Table 1, Examples 1-4), 23 (Table 4).
The results show that the percentage of potassium sucrose octasulfate
released from a dressing increased from 2.63% in the absence of Sepinov
EMT 10 to 28.40% in its presence, and the percentage of silver sulfadiazine
released from a dressing increased from 0.65% in the absence of Sepinov
EMT 10 to 13.5% in its presence. Spec. 23 (Table 4).
Dr. Christene Laurensou states that the results show that "the presence
of copolymer enormously increases the release of active substance ....
[W]ithout the copolymer, they are hardly released from the wound dressing
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Application 12/601,718
at all, but there is a considerable enhancement in the presence of the
copolymer." First Laurensou Decl. 11 ,i 4.
The First Laurensou Declaration presents results for compositions
containing four additional active agents ( aspirin, lidocaine, urea, and
hyaluronic acid), with or without Sepinov EMT 10. First Laurensou Deel.
,i 6. The results show that the percentage active agents released with and
without Sepinov EMT 10 were as follows: aspirin, 46.3% with, 15.8%
without; lidocaine, 55.0% with, 15.6% without; urea, 63.1 % with, 41.8%
without; and hyaluronic acid: 70.9% with, 32.2% without. Id. ,i 7. Dr.
Laurensou states that "for each of the pairs of results ... the copolymer in
the hydrocolloid-containing wound dressing has a significant effect, i.e., if
the copolymer is not present, considerably less of the active agent is
released." Id. ,i 8.
Appellant also provided data for compositions comprising different
amounts (2, 10, and 19 wt%) Sepinov EMT 10, in combination with three
active agents ( aspirin, lidocaine, and hyaluronic acid). Second Laurensou
Deel. 12 ,i 7 (page 3). The results show that, for each of the active agents, a
higher amount of Sepinov EMT 10 correlated with a higher percentage of
active agent released. Id. (page 8). Dr. Laurensou states that "in every case
the copolymer in the hydrocolloid-containing wound dressing has a
significant effect on active agent release .... [ A ]n increase in the amount of
copolymer leads to an increase in the amount of active agent released." Id.
11 Declaration under 37 C.F.R. § 1.132 of Christene Laurensou, filed Dec. 3,
2014.
12 Declaration under 37 C.F.R. § 1.132 of Christene Laurensou, filed March
4, 2016.
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The claims require a dressing composition comprising the recited
copolymer "in an amount sufficient for increasing an amount of the active
substance that is released from the dressing as compared to that of a
corresponding dressing that does not comprise the copolymer." Claims 6, 16.
Appellant's evidence-in the Specification and in the two Laurensou
Declarations-shows that amounts of the recited copolymer between 2 wt%
and 19 wt% increase release of different active agents, as compared to
release of the active agents with no copolymer present.
The Examiner cites Laskey, Sepinov, and Fares for their disclosure of
the copolymer required by the claims. Laskey apparently discloses the same
copolymer, 13 and suggests using it as a "wound and bum covering [or] for
controlled release of drugs[,] of antibiotics and of nutrient supplements."
Laskey 3:46-47. However, Laskey states that its "polymers can be used to
great advantage for many biological purposes," including those just
mentioned, because they "can ingurgitate large quantities of water, and
because of the properties ofbiocompatibility and optical clarity,
transparency, etc." Id. at 3:37-41. Laskey does not describe its polymers as
useful for promoting release of active agents when they are used as a wound
or bum covering, nor does it suggest amounts of its polymers that would be
suitable for such a use. Laskey does not, in fact, suggest amounts of its
polymers that would be suitable for their use as a wound or bum covering.
The Sepinov reference describes exemplary compositions comprising
Sepinov EMT 10 in amounts ranging from 0.3 wt% to 2.0 wt%. Sepinov 23,
13 As noted above, Appellant does not dispute that the copolymer disclosed
by Laskey is the same as that recited in the claims. See Appeal Br. 8-9.
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28. Sepinov' s examples, however, are cosmetic compositions. See id. at 21
("SEPINOVâ„¢ EMT 10 is an essential formulation partner for cosmetics ....
SEPINOVâ„¢ EMT 10 can be combined with many cosmetic active agents.").
The Examiner has not shown that a skilled artisan would have been led to
use Laskey' s liquid-absorbing polymer in a wound dressing, in the amounts
disclosed by Sepinov, based on Sepinov's exemplary cosmetic
compositions.
Likewise, Fares is directed to "cosmetic and dermatological
compositions." Fares, abstract. Although Fares suggests the use of
SEPINOV EMT 10 as a "thickening/gelling agent[]" in an amount of0.1-
15% (id. ,-i,-i 76, 78), the Examiner has not established that that teaching
would have led a skilled artisan to use Fares' amount of Laskey's liquid-
absorbing polymer in Freeman's wound dressing.
We therefore conclude that the Examiner has not established that it
would have been obvious to a skilled artisan, based on the cited references,
to include a copolymer of a salt of 2-methyl-2-[(l-oxo-2-propenyl)amino ]-1-
propanesulfonic acid and of 2-hydroxyethylpropenoate ester in the
hydrocolloid-containing wound dressing disclosed by Freeman, "wherein the
copolymer is included in an amount sufficient for increasing an amount of
the active substance that is released from the dressing as compared to that of
a corresponding dressing that does not comprise the copolymer," as required
by both of the independent claims on appeal.
We reverse the rejection of claims 6, 9, 10, 12, 13, 16-19, 21-24, and
31-34 under 35 U.S.C. § 103(a) based on Freeman, Lipman, Laskey,
Sepinov, and Fares. The rejection of claims 25 and 26 under 35 U.S.C.
§ 103(a) as obvious based on Freeman, Lipman, Laskey, Sepinov, Fares, and
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Application 12/601,718
Michaeli, and the rejection of claims 27-30 under 35 U.S.C. § 103(a) as
obvious based on Freeman, Lipman, Laskey, Sepinov, Fares, and Cochrum,
rely on the same reasoning as the rejection discussed above, and are reversed
for the same reason.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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