Ex Parte Laurensou

Patent Trial and Appeal Board

Nov 16, 2018

12601699 (P.T.A.B. Nov. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/601,699 04/23/2010 Christelle Laurensou
52835 7590 11/20/2018
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.
20010.0049USWO 9485
EXAMINER
GHALI, ISIS AD
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
11/20/2018 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 CHRISTELLE LAURENSOU 1
Appeal2017-002753
Application 12/601,699
Technology Center 1600
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant identifies LABORATOIRES URGO as the real party-in-interest.
App. Br. 2.
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Application 12/601,699
SUMMARY
Appellant files this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 6-8, 12, 13, 16, and 24--28.
Specifically, claims 6, 7, 12, 16, and 24--28 stand rejected as unpatentable
under 35 U.S.C. § I03(a) as being obvious over the combination of Freeman
(US 5,681,579, October 28, 1997) ("Freeman"), Lipman (US 2004/0241215
Al, December 2, 2004) ("Lipman"), Laskey (US 3,929,741, December 30,
1975), Seppic, Sepinov EMT 10, Doc. XP-002463431 ("Sepinov"), and, with
respect to claim 24, Han et al. (US 2004/0043135 Al, March 4, 2004)
("Han").
Claims 8 and 13 stand rejected as unpatentable under 35 U.S.C. §
I03(a) as being obvious over the combination of Freeman, Lipman, Laskey,
Sepinov, Han, and Michaeli (US 4,912,093, March 27, 1990) ("Michaeli").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to the use of a known compound as
an agent for promoting and/or accelerating fibroblast proliferation and/or
differentiation and, consequently, cicatrization. Abstract.
REPRESENTATIVE CLAIM
Claim 6 is representative of the claims on appeal and recites:
6. A dressing for wound treatment, comprising a
hydrocolloid; and
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an elastomeric mass comprising one or more elastomers
and a copolymer of a salt of 2-methyl-2-[(1-oxo-2-
propenyl)amino ]-1-propanesulfonic acid and of 2-
hydroxyethylpropenoate ester,
wherein the copolymer is included in an amount sufficient
for treating a wound of a subject, and
wherein the amount of the copolymer is between 0.1 % and
20% by weight relative to the weight of the mass into which the
copolymer is incorporated.
App. Br. 10.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's reasoning that the claims
are prima facie obvious over the combined cited prior art. We address
Appellant's arguments below.
A. Rejection of claims 6, 7, 12, 16, and 24--28
Issue
Appellant argues that the Examiner erred in concluding that the claims
are obvious over the cited prior art. App. Br. 4.
Analysis
The Examiner finds that Lipman teaches a wound dressing comprising
polymeric absorbing material. Final Act. 5 ( citing Lipman Abstr., ,r,r 2, 13,
31 ). The Examiner finds that Lipman teaches that the dressing comprises a
layer comprising an adhesive and an absorbent material. Id. ( citing Lipman
,r,r 9, 5). The Examiner finds Lipman teaches that the adhesive comprises an
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Application 12/601,699
elastomer to add dry tack to the adhesive and that that the absorbing
polymeric material, which adds wet tack, comprises hydrocolloid and
hydrophilic copolymers, including polyacrylate polymer, in concentrations
of 10-70%. Id. (citing Lipman ,r,r 32, 38, 39, 51-58, 98).
The Examiner finds that Laskey teaches transparent copolymers
capable of absorbing large amounts of liquid and water while maintaining
their shape and physical stability, and having a high degree of
biocompatibility. Final Act. 5 (citing Laskey Abstr., col. 1, 11. 30-59). The
Examiner finds that Laskey teaches that the copolymer is useful as a wound
and bum dressing, and for controlled release of drug including antibiotics
and antimicrobial agents. Id. (citing Laskey col.2, 11. 46-47, 54--55). The
Examiner finds that Laskey also teaches that the copolymer is a product of
the polymerization of 2-acrylamido-2-methylpropanesulfonic acid and
hydroxyethyl acrylate. Id. (citing Laskey, Ex. 3, 4, 7). The Examiner
further finds that Laskey teaches a sodium salt of 2-acrylamido-2-
methylpropanesulfonic acid
Id. (citing Laskey Ex. 9).
The Examiner next finds that Sepinov teaches that the Sepinov EMT
10 copolymer is non-hemolyzing, non-denaturing, non-irritant and non-
sensitizing. Final Act. 7. The copolymer can be included in topical
compositions in an amount from 0.3 to 1.5% of the composition. Id. (citing
Sepinov 19, 22-30).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to provide a wound dressing comprising
hydrocolloid, elastomer, active agent and absorbent acrylate polymer as
taught by Freeman and Lipman and, particularly to use the absorbent
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acrylate polymer in concentrations of 10-70% as taught by Lipman. Final
Act. 7. The Examiner concludes that it would have been further obvious to
replace the acrylate absorbent polymer of Lipman with copolymer of 2-
acrylamido-2-methylpropanesulfonic acid and hydroxyethyl acrylate, or its
sodium salt, taught by Laskey. Id. The Examiner concludes that a skilled
artisan would have been motivated to do so because Lipman teaches
suitability of 10% of acrylate polymer as an absorbent in a wound dressing
and because Laskey teaches that the copolymer of 2-acrylamido-2-
methylpropanesulfonic acid and hydroxyethyl acrylate is useful for wound
and bum dressing and for the controlled release of drugs including
antibiotics and antimicrobial agents, and is further capable of absorbing
large amount of liquid and water while maintaining shape and physical
stability and having a high degree of biocompatibility. Id.
Finally, the Examiner concludes that Sepinov, which teaches the
copolymer composition claimed by Appellant (see Spec. 4) teaches the use
of the copolymer in the treatment of wounds in concentrations within the
range claimed by Appellant.
Appellant argues initially that the claimed copolymer range of
"between 0.1 % and 20% by weight" recited in claim 6 excludes its
endpoints, 0.1 % and 20% by weight, respectively. App. Br. 4. Appellant
then points to the Declaration of Christelle Laurensou, filed December 12,
2014 (the "Laurensou Declaration"), the inventor of the claimed invention.
Id. Appellant points to Examples 6 and 7, which employ concentrations of
the claimed copolymer at 0.05 and 0.1 %, respectively, and Examples 8 and
9, which employ concentrations of 20% and 25%, respectively. Id. (citing
Laurensou Deel. ,r,r 4, 8 (including tables)). Appellant notes that the
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Laurensou Declaration states, with respect to Examples 6 and 7, that both
references demonstrate no significant fibroblast proliferation compared to
control values presented in Example 1 of Appellant's Specification, whereas
higher values within the claimed range demonstrated increased fibroblast
proliferation. 2 Id. With respect to Examples 8 and 9, the Laurensou
Declaration states that concentrations of 20% and 25% of their claimed
copolymer are not suitable for preparing a wound dressing that includes a
hydrocolloid and an elastomer due to degradation that results from the
higher melting temperatures necessary to melt the claimed copolymer and
the elastomer when preparing the wound dressing. Id. ( citing Laurensou
Deel. ,r,r 8-9). Appellant therefore asserts that the results presented in
Appellant's Specification and the Declaration establish that the claimed
range is critical in achieving the superior effects in the context of a wound
dressing that includes a hydrocolloid and an elastomer in accordance with
claim 6. Id.
We do not find Appellant's arguments persuasive. We need not
address Appellant's argument that the limitation reciting a range of:
"between 0.1 % and 20% by weight" necessarily excludes the endpoint
values of0.1 % and 20%, because we do not find Appellant's contention that
these endpoint values, and especially the data from Examples 6 and 7 of the
Laurensou Declaration, for which data is provided, persuasive of Appellant's
arguments that there is no substantial effect on fibroblast proliferation by
Sepinov EMT 10 at these values.
2 Fibroblast proliferation is measured as the amount of incorporation of 3H-
thymidine in the DNA of fibroblasts incubated with the elastomer and
Sepinov.
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Specifically, Example 6 (with 0.05% of Sepinov EMT 10)
demonstrated fibroblast proliferation of 308% and 352% of control
proliferation at 24 and 48 hours incubation time respectively. Laurensou
Deel. ,r 5. Example 7 (with 0.1 % EMT 10) demonstrated proliferation of
329% and 390% of control proliferation at 24 and 48 hours incubation time
respectively. Id. These values both considerably exceed the values
presented in Table 3 of Appellant's Specification for Example 2, which, in
identical experiments, produced a lower value, 260% of control, for a
concentration of Sepinov an order of magnitude greater or more ( 1 % ) than
the concentrations of Examples 6 and 7. See Spec. 8, Table 1. Indeed, the
Laurensou Declaration shows that proliferation of fibroblasts in the absence
of Sepinov EMT 10 (377%) is similar to that of0.5% and 0.1 % after 48
hours.
We therefore find that the data presented by the Laurensou
Declaration is inconclusive at best, significant methodological deficiencies
of Appellant's analysis notwithstanding. 3 We are consequently not
3 For example, both the control and experimental values in Example 1 of
Appellant's Specification are from triplicate runs (n=3) in the Specification
and five runs (n=5) in the Declaration studies. Spec. 12. The control
values are derived from a preparation without the dressing and without
dilution, but with a plug that otherwise holds the dressing in place. Id. at
11. However, the proper control values to show the effect of Sepinov
EMT 10 would have been obtained from compositions containing 0% of
the copolymer (Sepinov EMT 10) incubated with the dressing in wells with
fibroblasts because the data appear to indicate a positive effect resulting
from incubation with the dressing without the Sepinov EMT 10 (see
Example 1 of Spec., but see infra). See Table 3.
The three individual control values, quantified as 3H-thymidine DNA
incorporation measured via a scintillation counter, were presumably (it is
not clear) averaged to provide a mean control value that was then
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Application 12/601,699
persuaded by Appellant's argument that the claimed concentration range
necessarily defines a set of values within which the beneficial effects of
Appellant's claimed composition are obtained.
Appellant next argues that Freeman and Lipman do not disclose a
copolymer of a salt of 2-methyl-2-[(1-oxo-2-propenyl) amino ]-1-
propanesulfonic acid and of 2-hydroxyethylpropenoate ester within the
ranges recited in claim 6. App. Br. 5. According to Appellant, Laskey is
directed to providing new hydrophilic acrylamide polymers and is silent as
to the amounts of the copolymer required by claim 6. Id. at 5-6 ( citing
Laskey col. 1, 11. 37-38).
Appellant argues further that the combination of Freeman, Lipman
and Laskey does not provide any reason to expect that the use of the claimed
copolymer in particular amounts within the context of a wound dressing
containing a hydrocolloid and an elastomer as recited in claim 6 can lead to
superior proliferation and/or differentiation as demonstrated, for example, by
the data disclosed in Appellant's Specification and the Laurensou
Declaration. App. Br. 6. Appellant notes that Laskey, which was published
in 1974, is silent as to the particular effects of the claimed copolymer, much
less whether its use would lead to fibroblast stimulation within the context of
a wound dressing containing a hydrocolloid and an elastomer as recited in
normalized to 100% and measured against the normalized mean of each of
the experimentally-derived values (i.e., incubated with different
concentrations of copolymer). Id. at 11-12. However, Appellant provides
no statistical treatment of the data concerning the amount of variation
between runs either within or between the control and sample groups. As
such, it is impossible to evaluate the statistical significance of the data, or,
indeed, whether there is any scientifically meaningful difference between
the control and sample groups.
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claim 6. Id. Appellant states that it is generally accepted in the art that there
are numerous types of polymer materials that are applied to wounds in
various ways to achieve different types of effects. Id. (citing, e.g., J.S.
Boateng et al., Wound Healing Dressings and Drug Delivery Sytems: A
Review, 97(8) J. PHARM. SCIENCES. 2892-23 (2008); J.L. Monaco et al.,
Acute Wound Healing: An Overview, 30 CLINICS IN PLASTIC SURG. 1-12 30
(2003); P. Martin et al., Cellular and Molecular Mechanisms of repair in
Acute and Chronic Wound Healing, 173 BRIT. J. DERMATOL. 370-78
(2015)).
Appellant argues further that Sepinov and Han are similarly silent as
to the distinct functions of hydrocolloids and the claimed copolymer within
the context of the wound dressing. App. Br. 7. Therefore, Appellant asserts,
it would not have been obvious to combine the references and achieve the
advantageous effects allegedly demonstrated by the data disclosed in
Appellant's Specification and the Laurensou Declaration.
We are not persuaded by Appellant's arguments. Sepinov teaches the
claimed copolymers, as admitted by Appellant's Specification, being used in
skin treatment compositions in concentrations that coincide with the range
recited in the claims. See Sepinov 23-30 (teaching the use of Sepinov EMT
10 in concentrations of 0.9-2%).
Lipman teaches a wound dressing comprising a: "fluid-absorbing
pressure-sensitive adhesive includes a mixture of an adhesive material and at
least one water-soluble and/or water-swellable polymer." Lipman ,r 31.
Lipman teaches that: "In one embodiment, a particularly useful rubber-based
adhesive is that which has a thermoplastic elastomeric component and a
resin component." Id. at ,r 38. Lipman further teaches that: "In one
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embodiment, the water-soluble and/or water-swellable polymer comprises
one or more hydrophilic absorbent polymers" and that: "In one embodiment,
the water-soluble and/or water-swellable polymer may comprise one or more
water-soluble hydrocolloids, alone or blended with one or more swellable
polymers." Id. at ,r 54--55. Lipman also teaches, with respect to the
copolymers: "The amount of hydrophilic absorbent polymer, the water-
soluble and/or water-swellable polymer, may be from about 10% to about
70% of the total weight of the fluid-absorbing pressure-sensitive adhesive
material, in one embodiment from about 20% to about 55% of the total
weight of the fluid-absorbing pressure-sensitive adhesive material." Lipman
,r 58. Lipman thus teaches: "A dressing for wound treatment, comprising a
hydrocolloid; and ... an elastomeric mass [and] ... a copolymer" in
concentrations that overlap the range: "wherein the amount of the copolymer
is between 0.1 % and 20% by weight relative to the weight of the mass into
which the copolymer is incorporated, as recited in claim 6.
Laskey is similarly directed to the use of hydrophilic polymers in the
medical arts. Laskey col. 1, 11. 10-13. Laskey teaches compositions that
comprise a hydrophilic polymer obtained by polymerization of an
acrylamido sulfonic acid. Id. at col 1, 11. 62---64. Laskey further teaches
that: "The most preferred polymer according to the present invention is
obtained by polymerizing 2-acrylamido-2-methylpropane-sulfonic acid,"
closely related to Appellant's claimed 2-methyl-2-[(1-oxo-2-propenyl)
amino ]-1-propanesulfonic acid recited in claim 6. Laskey col. 2, 11. 34--36.
Laskey further teaches the use of a salt of acrylamido-2-methylpropane
sulfonic acid. Id. at col. 7, 11. 1-18. Laskey also teaches a copolymer of the
latter compound with: "[ u ]nsaturated esters ( e.g., hydroxyethyl methacrylate,
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hydroxypropyl acrylate). Id. at col. 4, 11. 17-18. Hydroxyethyl acrylate, as
recited in claim 6, is one such unsaturated ester.
Finally, and as we have noted supra, Sepinov expressly teaches
Appellant's claimed copolymer for use in a variety of topical skin
treatments, Sepinov 21, thus suggesting its equivalent use in other topically
applied compositions that use similar copolymers, including the
compositions of Lipman and Laskey.
We agree with the Examiner that a person of ordinary skill in the art
would have found it obvious to combine the teachings of Lipman, Laskey,
and Sepinov to arrive at Appellant's claimed invention. "The combination
of familiar elements according to known methods is likely to be obvious
when it does no more than yield predictable results." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398,416 (2007).
Furthermore, we are not persuaded by Appellant's argument that the
"special properties," i.e., increased proliferation of fibroblasts, renders their
claimed invention patentable distinct. As an initial matter, if Appellant
means to argue, even impliedly, that the claimed composition has surprising
or unexpected results, Appellant is required to show that the results would
have been unexpected when compared to the closest prior art. See In re
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (holding that:
"when unexpected results are used as evidence of nonobviousness, the
results must be shown to be unexpected compared with the closest prior
art"). Appellant adduces no persuasive evidence to demonstrate that the
allegedly unexpected and beneficial properties of their composition would
have been unexpected and different in kind from those properties of
compositions taught by the prior art. See Iron Grip Barbell Co. v. USA
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Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (holding that unexpected
results that are probative of nonobviousness are those that are "different in
kind and not merely in degree from the results of the prior art").
Moreover:
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed
product. ... Whether the rejection is based on 'inherency' under
35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. §
103,jointly or alternatively, the burden of proof is the same, and
its fairness is evidenced by the PTO's inability to manufacture
products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (C.C.P.A. 1977). Appellant has adduced no
persuasive evidence of record to demonstrate that the claimed composition
has properties that would not have been present in the compositions taught
by the combined prior art when combined in the concentrations taught by the
prior art, as found by the Examiner. Absent any such evidence of record,
Appellant has not met the burden of overcoming the Examiner's prima facie
conclusion that the claims are obvious over the combined cited prior art. We
consequently affirm the Examiner's rejection of claim 6.
Appellant argues separately that dependent claim 16 recites that the
amount of the copolymer is between 1 % and 5% by weight, relative to the
weight of the mass into which the copolymer is incorporated. App. Br. 8.
However, Appellant asserts, Lipman teaches a minimum amount of 10% and
up to 70% by weight of the water-absorbing polymer. Id.
We do not find Appellant's argument persuasive, because Sepinov
provides examples of Sepinov EMT 10 being used in skin treatments at
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concentrations of 0.9% to 2.0%, which substantially overlaps Appellant's
claimed range. Furthermore, because the concentration of the polymers is a
result effective variable, as recited in the claims, we conclude that it would
have been well within the skill of an ordinary artisan to determine an optimal
value for the copolymer concentration corresponding to the claimed range.
See In re Boesch, 617 F.2d 272,276 (C.C.P.A. 1980) (holding that
"discovery of an optimum value of a result effective variable ... is ordinarily
within the skill of the art"). We therefore affirm the Examiner's rejection of
this claim.
Appellant argues separately that dependent claim 24 recites that the
amount of the copolymer is an amount sufficient for promoting and/or
accelerating fibroblast proliferation in vivo or ex vivo, and that, as argued
supra, this is not taught by the prior art. App. Br. 8. However, as we have
explained, the Examiner has concluded that Appellant's composition is
obvious over the cited prior art and, therefore, the burden of proof shifts to
Appellant to demonstrate that the claimed properties would not have been
present in a composition derived from the combined cited prior art. Best,
562 F.2d at 1255. Appellant has not met this burden, and we are therefore
not persuaded by Appellant's argument. We consequently affirm the
Examiner's rejection of claim 24.
Appellant further argues that dependent claim 25 recites that the
amount of the copolymer is 5% or more and less than 20 % by weight
relative to the weight of the mass into which the copolymer is incorporated.
App. Br. 8. Appellant points out that Sepinov discloses amounts that are
lower than 5% by weight. Id. However, as we have explained, Lipman
teaches copolymer concentrations in its wound dressings of between from
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about 10% to about 70%. Lipman ,r 58. Appellant's contention throughout
has been that the concentration range of the copolymer is essential to
promote fibroblast proliferation and wound healing. See, e.g., App. Br. 4--6.
As such, Appellant is impliedly arguing that the concentration of copolymer
is a result-effective variable. As such, we conclude that it would be within
the skill of an ordinary artisan to determine the optimal range of
concentrations of copolymer between the ranges taught by Sepinov and
Lipman. See In re Boesch, 617 F.2d 272,276 (C.C.P.A. 1980) (holding that
"discovery of an optimum value of a result effective variable ... is ordinarily
within the skill of the art"). We consequently affirm the Examiner's
rejection of claim 25.
Finally, Appellant argues that dependent claims 26-28 recite the
elastomer and/or the hydrocolloid used in the working examples of
Appellant's Specification. App. Br. 8. Appellant contends that the alleged
showing of superior effects in the experimental work of the specification and
the Laurensou Declaration is commensurate in scope with at least these
claims. Id. We are not persuaded. As we have explained supra, the data
from the studies presented in the Specification are inconclusive, at best.
Moreover, Appellant has not adduced any evidence to demonstrate that the
results obtained are superior to those that would be obtained, by comparison,
to the nearest prior art. Baxter, 952 F.2d at 392. We consequently affirm
the Examiner's rejection if claims 26-28.
B. Rejection of claims 8-28
Appellant argues these claims together. App. Br. 8. Appellant relies
on the arguments presented supra, and asserts that Michaeli does not remedy
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the alleged deficiencies of the cited prior art relied upon in the rejection of
claim 6. Id. We have explained our reasoning as to why we are not
persuaded by Appellant's arguments with respect to claim 6, and we
consequently affirm the Examiner's rejection of claims 8-28.
DECISION
The Examiner's rejection of claims 6-8, 12, 13, 16, and 24--28 as
unpatentable under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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