Ex Parte Miret Carceller et al

Patent Trial and Appeal Board

May 29, 2018

11997160 (P.T.A.B. May. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/997, 160 03/05/2008
7609 7590 05/29/2018
RANKIN, HILL & CLARK LLP
23755 Lorain Road - Suite 200
North Olmsted, OH 44070-2224
FIRST NAMED INVENTOR
Jordi Miret Carceller
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.
GIL-18017 3665
EXAMINER
PURDY, KYLE A
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
05/29/2018 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JORDI MIRET CARCELLER, SERGI FIGUERAS ROCA, and
ROGER SEGRET PONS
Appeal2016-008401
Application 11/997, 160 1
Technology Center 1600
Before DONALD E. ADAMS, RY ANH. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
preservative system comprising a cationic surfactant, which have been
rejected as anticipated and/or obvious. We have jurisdiction under 35
U.S.C. § 6(b ).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as "Laboratorios MIRET,
S.A." (Br. 2.) Herein, when citing to Appellants' Appeal Brief, we refer to
the brief submitted April 8, 2015 ("Br."), except when referring to the
appealed claims specifically, which were submitted as the Claims Appendix
by supplemental Appeal Brief filing on June 16, 2015 (also "Br.").
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Application 11/997, 160
STATEMENT OF THE CASE
Food and cosmetic products require protection from microbial
contamination. (Spec. 2.) Cationic surfactants are used as preservatives in
the food industry. (Id.) A large number of preservatives are used in
cosmetic compositions, but most preservative systems have been shown to
have incompatibilities with skin, such as causing irritation or allergies. (Id.)
Cationic surfactants derived from lauric acid and arginine have been found
to protect against growth of microorganisms and the ethyl ester of the
lauramide of arginine monohydrochloride ("LAE") has been found to be
well tolerated in humans. (Id.) LAE combined with potassium sorbate,
calcium sorbate, or sorbic acid was determined "to be highly effective in
food preservation." (Id. at 2-3.) The present invention is directed to
"provid[ing] further improved preservative systems on the basis of LAE."
(Id. at 5.)
Claims 21, 23, 25, 27, 29-32, 34, and 35 are on appeal. Claims 21,
23, and 29 are representative and read as follows:
21. A preservative system comprising a cationic surfactant, of the
formula:
/
/
!
/
i
(
\
\
\ ....
\+
\
'\
\
l
f
{
I
,i
l
/
wherein x- is an anion derived from an acid selected from the
group consisting of lactic acid and glutamic acid.
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Application 11/997, 160
23. A preservative system comprising:
and
(a) a cationic surfactant, of the formula:
wherein x- is an anion derived from organic or inorganic acids,
(b) at least one salt selected from the group consisting of
sodium citrate, sodium glutamate, sodium fumarate, sodium
gluconate, sodium laurate, sodium lactate, sodium
hexametaphosphate, sodium tertiary butyl hydroquinonate,
sodium propylparabenate, glucosamine hydrochloride and
ethanolamine hydrochloride, and combinations thereof,
excluding salts of sorbic acid.
29. A preservative system comprising a cationic surfactant, of the
formula:
I
/
/
I
I
I'
\
\
\
wherein X is an anion derived from organic or inorganic acids,
and wherein the cationic surfactant is in an encapsulated form.
(Br., Claims App. 2, 4.)
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Application 11/997, 160
The following grounds of rejection by the Examiner are before us on
review:
Claims 29 and 30 under 35 U.S.C. § I02(a) as anticipated by Urgell. 2
Claims 21, 23, 25, 27, 29, 30, 32, 34, and 35 under 35 U.S.C. § 103 as
unpatentable over Urgell, Bastin, 3 Waranis, 4 and Raths. 5
Claim 31 under 35 U.S.C. § 103 as unpatentable over Urgell, Bastin,
W aranis, Raths, and Herpens. 6
DISCUSSION
I. Anticipation: Claims 29 and 30
The Examiner finds that Urgell discloses a preservative system that
includes LAE used in cosmetic formulations. (Final Action 7; Ans. 2.) The
Examiner explains that the formulations to which the LAE may be added are
oil-in-water emulsions, e.g., Example 1, and that the preservative system that
includes LAE can also include the cationic molecule quatemium-15. (Id.)
According to the Examiner, because Appellants "define[] the encapsulated
form as being an oil-in water emulsion ... the composition ofUrgell would
necessarily have the surfactant being in an encapsulated form." (Final
Action 7; Ans. 3; see also Ans. 10.) In furtherance of this position, the
2 Urgell-Beltran et al., US 2004/0166082 Al, published Aug. 26, 2004
("Urgell").
3 Bastin et al., Salt Selection and Optimisation Procedures for
Pharmaceutical New Chemical Entities, 4 Organic Process Res. & DEV.
427-35 (2000).
4 Waranis et al., US 7,029,698 B2, issued Apr. 18, 2006.
5 Raths et al., US 6,277,359 Bl, issued Aug. 21, 2001
6 Herpens et al., US 2002/0119109 Al, published Aug. 29, 2002.
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Application 11/997, 160
Examiner notes that the oil-in-water emulsion of Example 1 ofUrgell, which
is "completed with LAE," is "essentially identical" to Example 177 of
Appellants' Specification and that "the only disclosed process of making the
instantly claimed LAE [oil-in-water] emulsion is identical to that of [Urgell],
[ therefore,] the resulting product must be the same." ( Ans. 10-11.)
Appellants argue that Urgell's oil-in-water emulsion to which LAE is
added does not meet the limitations of claim 29 because the LAE is not an
encapsulated LAE. (Br. 10-11.) The LAE that is added is not described as
LAE that has been encapsulated, and the LAE when added to the oil-in-
water emulsion does not inherently become encapsulated in oil and
dispersed in water as required by Claim 30. (Id.) Appellants' provided two
declarations of Dr. Joan Bonaventura, 8 which they contend provide evidence
that the oil-in-water emulsion of Urgell does not inherently result in the
encapsulation of LAE. (Br. 11-15.)
We find Appellants argument and evidence persuasive in
demonstrating that Urgell does not inherently anticipate an encapsulated
form of LAE surfactant.
7 In light of the description of the composition provided by the Examiner in
the rejection, we conclude that the Examiner meant to refer to Example 17
of Appellants' Specification and not Example 18, because Example 18 does
not provide the list of ingredients and the amounts in which they are used, to
which the Examiner refers in the rejection.
8 A first declaration of Joan Seguer Bonaventura was submitted by
Applicants November 29, 2012 with a response to the Office Action of
September 6, 2012, (hereinafter the "2012 Bonaventura Declaration"). (See
Br. 11-13.) A second declaration of Joan Seguer Bonaventura was
submitted on by Applicants on August 4, 2014 with a response to the Office
Action of February 11, 2014 (hereinafter the "2014 Bonaventura
Declaration"). (Id.)
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"A reference may anticipate inherently if a claim limitation that is not
expressly disclosed 'is necessarily present, or inherent, in the single
anticipating reference.' The inherent result must inevitably result from the
disclosed steps; '[i]nherency ... may not be established by probabilities or
possibilities."' In re Montgomery, 677 F.3d 1375, 1379-80 (Fed. Cir. 2012)
( citations omitted, alterations in original).
Even if it were true that the process described for making the oil-in-
water emulsion of Example 1 ofUrgell is the same as making the oil-in-
water emulsion of Example 17 of Appellants' Specification, as posited by
the Examiner (Ans. 10-11), such does not establish the LAE that is added to
Example 1 of Urgell is "in an encapsulated form" as required by claim 29.
First, in Appellants' Specification's Example 17, it is explained that
already encapsulated LAE compositions are added to an oil-in-water
emulsion or free LAE is added. (Spec. 53-54; see also 2014 Bonaventura
Declaration ,r 7.) Example 17 of the Specification notes that the oil phase,
which consists of stearic acid, glyceryl stearate S.E., cetyl alcohol,
paraffinum, isopropyl myristate, caprylic-caproic triglycerides, and
dimethicone, is added to the water phase, which consists of propylene
glycol, cellulose gum, triethanolamine and water, under stirring at about
5000 rpm by Ultraturrax. (Spec. 53-54.) The emulsion is then cooled to
room temperature quickly while stirring at a low speed, and the pH of that
emulsion is adjusted. (Id. at 54.) After the emulsion is formed either
different LAE treatments are added to the emulsion or no additional
treatment is added. (Id.) One of the treatments is the addition of free LAE,
while four other treatments involve the addition of encapsulated LAE, e.g.,
"LAE encapsulated with palm oil." Thus, the process described by Example
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17 is not one of encapsulating LAE, but as utilizing already-encapsulated
LAE.
Based on our review of Urgell Example 1, we do not find it to
describe the addition of "encapsulated LAE." Table 1 of Urgell lists
numerous preservative systems that were tested in combination with an oil in
water emulsion that includes a non-ionic surfactant. (Urgell ,r,r 44--45.) The
LAE preservative systems were:
1 LAE at 0.2%
9 LAE at 0.1 % with 2-bromo-2-nitro-1,3- propanediol (bronopol)
at 0.01 %
10 LAE at 0.1 % with 2-methyl-5-chloro-3,4-isothiazolinone/2-
methyl-3,4-isothiazolinone at 0.0005%
11 LAE at 0.1 % with 1,3-dimethylol-5,5-dimethylhydantoin at
0.11 %
12 LAE at 0.1 % with 2-phenoxyethanol at 0.17%
13 LAE at 0.1 % with imidazolidinyl urea at 0.15%.
14 LAE at 0.1 % with parabens (methyl and propyl parabens) at
0.16%
15 LAE at 0.1% with quatemium-15 at 0.03%
(Id. ,r 45.) None of these LAE systems are the same as the encapsulated
LAE enumerated in the Specification Example 17, which are:
3. LAE encapsulated with palm oil 0.20 g ofLAE/kg
4. LAE emulsion with soybean oil 0.20 g of LAE/kg
5. LAE in lecithin at 0.20 g ofLAE/kg
6. LAE with tween 20 at 0.20 g of LAE/kg
LAE+palm
LAE+emSy
LAE+leci
LAE+t20
(Spec. 54.) Consistent with our review ofUrgell, the 2012 Bonaventura
Declaration states that the Urgell patent does not describe encapsulating
LAE. (2012 Bonaventura Declaration ,r,r 6, 9.)
In the 2014 Bonaventura Declaration, Bonaventura explains that in
Urgell, "LAE is added to a preparation which is the form of an oil in water
emulsion." (2014 Bonaventura Declaration ,r 6.) In other words, free LAE
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Application 11/997, 160
is added to an already formed oil-in-water emulsion. Thus, the Examiner is
incorrect in his assertion that "the art is not suggesting adding LAE to an
already made 0/W." (Ans. 14.)
Second, the Examiner provides no scientific evidence to support the
assumption that when free LAE is added to the oil-in-water emulsion of
Urgell, the LAE would become encapsulated LAE. (Ans. 13-14.)
Appellants' Specification provides at pages 19-22 and 29-30 a number of
methods for encapsulating a cationic surfactant such as LAE. The physical
methods enumerated include "spray chilling, spray drying, rotary disk
atomisation, fluid bed coating, stationary nozzle co-extrusion, centrifugal
head co-extrusion, submerged nozzle co-extrusion, pan coating, etc." (Spec.
21, 29-30 (Examples 5 and 6)) and the chemical methods enumerated
include "phase separation, solvent evaporation, solvent extraction, interfacial
polymerisation, simple and complex coacervation, in-situ polymerisation,
liposome technology, nanoencapsulation, etc." (Spec. 21, 30 (Examples 7
and 8) ). The Specification describes additional ways to encapsulate LAE
"such as mixed micelles, emulsions oil in water, emulsions water in oil,
micro emulsions (o/w, w/o or bicontinuous), multiple layered emulsion,
solubilization of the cationic surfactants in different solvents or with
different salts or products dissolved in order to change auto-aggregation of
the cationic surfactants (micelles (size and quantity), crystal liquid, etc.),
etc." (Spec. 21.)
Notably, none of those methods of encapsulating LAE described in
Appellants' Specification involve simply adding LAE to an already formed
oil-in-water emulsion. Furthermore, the 2014 Bonaventura Declaration
provides evidence demonstrating that the LAE added to the oil-in-water
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Application 11/997, 160
emulsion of Urgell would more likely than not have exchanged places with
the surfactant surrounding the oil droplet of the oil-in-water emulsion and
not be encapsulated by the oil droplet. (2014 Bonaventura Declaration ,r,r
11-15.) Bonaventura explained that Ziani9 describes the exchange of
surfactants, including LAE, with Tween 80 in an oil-in-water emulsion. (Id.
,r,r 12-13; Ziani 6251 (nanoemulsions consisted of "5% lipid phase (25%
thyme oil/75% com oil) stabilized by 0.5% T80").) The nanoemulsion was
made via homogenization, and then LAE was simply added to the prepared
nanoemulsion. (Ziani 6248, 6251.) The initial nanoemulsion with Tween
had a negative zeta potential 10 of about -4 m V, and after LAE was added, the
zeta potential increased to a positive charge. (Ziani 6251.) Bonaventura
notes that the fact that a surfactant exchange takes place with respect to the
emulsifier coating is evidenced by the change in the electrical charge of the
oil droplet. (Id.; Ziani 6251-52 ("There was an appreciable increase in the
positive charge on the droplets from -4 to + 39 m V when the LAE
concentration was increased from Oto 0.32%. The change in droplet charge
with increasing LAE concentration was steepest from Oto 0.08%, but still
increased gradually from 0.08 to 0.32%, and did not appear to reach a
plateau region. This suggested that the cationic LAE molecules had
adsorbed to the oil-water interface and displaced at least some of the
nonionic T80 molecules.").) Bonaventura explains that the same effect is
9 K. Ziani et al., Influence of Surfactant Charge on Antimicrobial Efficacy
of Surfactant-Stabilized Thyme Oil Nanoemulsions, 59 J. Agric. Food Chem.
6247-55 (2011).
10 Zeta potential is a measure of the electrical charge of the droplets. (Ziani
6248.)
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described in Saberi. 11 (2014 Bonaventura Declaration ,r 14.) In Saberi, the
nanoenmlsions were of vitamin E in buffer. (Saberi 1626, 1628 ("increasing
amounts of cationic surfactant (lauric arginate) to the VE-nanoemulsions
increased the positive charge on the droplets. . . . These results suggested
that the ionic surfactants adsorbed to the surfaces of the droplets in the VE-
nanoemulsions and altered their electrical characteristics.").) Bonaventura
notes that the change in charge would not have been observed if the LAE
surfactant were incorporated into the inside of the droplet. (2014
Bonaventura Declaration ,r 16.)
Bonaventura further explains that there is "no theoretical basis" to
assume that "in an oil-in-water emulsion system containing the cationic
surfactant LAE in the aqueous phase of the emulsion there will be a new
equilibrium in which LAE will be distributed between the oil phase and the
aqueous phase." (2014 Bonaventura Declaration ,r 17). The Examiner
contends that because the LAE added to the oil-in-water emulsion in Urgell
exhibited lower antimicrobial activity than the LAE added to the water-in-oil
formulations in Urgell, such "supports the notion that the 0/W results in
encapsulated LAE because encapsulated LAE would reduce the amount of
aqueous LAE available to inhibit microbes." (Ans. 13.) According to the
Examiner, "[g]iven that the 0/W emulsion exhibits less activity than the
W/0 emulsion, [this] suggests that the LAE is in fact encapsulated." (Id.)
We disagree. Appellants have provided scientific evidence that suggests the
LAE is not encapsulated, but rather exchanges place with the emulsifier
11 A.H. Saberi et al., Stabilization of Vitamin £-Enriched Nanoemulsions:
Influence of Post-Homogenization Cosurfactant Addition, 62 J. Agric. Food
Chem. 1625-33 (2014).
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coating of the oil-in-water emulsion. This exchange would result in the
reduction of "free" LAE available for antimicrobial activity. And, thus,
while the same amount of free LAE may have been added in the oil-in-water
emulsion as was added to the water-in-oil system, there is less of it available
for antimicrobial activity. Given the scientific evidence provided by
Appellants, we do not find the Examiner's conclusion of encapsulation,
which is unsupported by scientific evidence, persuasive.
In addition to the foregoing, Appellants' Specification establishes a
head-to-head comparison of the addition of free LAE to an oil-in-water
emulsion versus addition of encapsulated LAE added to an oil-in-water
emulsion. (Spec. 55.) The data demonstrates that encapsulated LAE when
added has better antimicrobial activity than when free LAE is added (id.),
which supports that free LAE added to an already prepared oil-in-water
emulsion does not result in encapsulated LAE.
In light of the foregoing, we disagree with the Examiner that the
formulation of Example 1 of Urgell and the formulation of Example 17, in
which free LAE was added, even if they were both produced with the same
process, inherently produce an encapsulated LAE as required by claim 29,
much less an encapsulated form that is an oil-in-water emulsion as required
by claim 30.
Thus, for the reasons above, we reverse the Examiner's rejection of
claims 29 and 30 under 35 U.S.C. § 102(a) as anticipated by Urgell.
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II. Obviousness: Claims 21 and 32
The Examiner contends that claim 21 is obvious over Urgell, Bastin,
Waranis, and Raths. 12 Unlike claim 29, claim 21 does not require an
encapsulated LAE. Rather, claim 21 requires the preservative system to be
LAE and an anion that is "selected from the group of lactic acid and
glutamic acid." The Examiner explains that Urgell teaches the use of LAE
as an antimicrobial in cosmetic formulations, but does not "teach the X
component as being an anion with the proviso that X is not a chloride ion, a
bromide ion or a sulfate ion." (Final Action 8-10; Ans. 4). The Examiner
notes, however, that Bastin teaches that salt selection and optimization is
well known for pharmaceuticals to maximize various properties, such as
aqueous solubility and chemical stability. (Final Action 10-11; Ans. 5.)
The Examiner notes that Bastin provides a table of commonly used salts to
optimize those properties, and in that table is lactate and glutamate. (Id.)
According to the Examiner, "while the use of anions such as chloride,
bromide and sulfate are excluded by some of the instant claims, other
counter ions such as acetate, lactate (lactic acid), glutamate (glutamic acid),
benzoate, tartrate, etc. would be readily envisaged because salt selection is
routinely performed so as to optimize the chemical stability and utility of the
compound." (Id.) The Examiner relies on Waranis, which teaches
acetaminophen complexed with an alkali metal lactate salt, such as sodium
12 The rejection of claim 21 under 35 U.S.C. § 103 is lumped together with
claims 23, 25, 27, 29, 30, 32, 34, and 35 and includes the Raths reference as
well. However, the Examiner does not rely on Raths for any limitation
relevant to claim 21. Raths is only relied upon for the alleged obviousness
of including chitosan and the enzyme inhibitor triethyl citrate, which relate
to limitations recited in claims 25 and 27. (See Final Action 12.)
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lactate, to establish that it would have been obvious to use an acid form of
lactate with LAE. (Final Action 11; Ans. 5---6.) In light of the foregoing, the
Examiner contends that it would have been obvious to modify Urgell with
Bastin and Waranis and arrive at LAE with lactate as the product of
"ordinary skill and common sense in optimizing the formulation, not one of
innovation." (Final Action 11; Ans. 6).
As to Bastin, Appellants argue that "[t]he skilled artisan reading the
Bastin article, would not find it obvious to develop new salts of LAE and
find effectiveness in them." (Br. 17.)
The Examiner bears the burden of establishing a prima facie case of
obviousness based upon the prior art. In re Fritch, 972 F.2d 1260, 1265
(Fed. Cir. 1992). The Supreme Court has stated:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that is was obvious under § 103.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,421 (2007). Moreover, we note
that the Supreme Court has further explained that
it can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does ... because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.
Id. at 418-19.
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While we agree with the Examiner that the selection of an appropriate
salt is grounded in optimization and is a standard part of product
development, that alone is insufficient to support a conclusion of
obviousness. Claim 21 requires one of two specific salt forms. KSR
authorized an "obvious-to-try" analysis where there is a design need or
market pressure, and "there are a finite number of identified, predictable
solutions." Id. at 421. That mere routine testing is required to ascertain the
properties of various salt forms ignores the KSR predicate requirement of up-
front predictability. That is, the Examiner's obviousness position does not
explain how the two salt forms claimed would have been known to yield an
optimized LAE preservative system. Indeed, there is no persuasive evidence
that using the claimed salts would have been expected to provide any
advantage. The Examiner has not established why the skilled artisan would
have modified the preservative used in a cosmetic formulation of Urgell by
substituting, or trying to substitute, lactate or glutamate disclosed from the
table of "common pharmaceutical salts" in Bastin. That it would be possible
to do so is not enough.
Thus, for the reasons above, we reverse the Examiner's rejection of
claim 21 under 35 U.S.C. § 103 as unpatentable over Urgell, Bastin,
Waranis, and Raths.
Claim 32 depends from claim 21 and adds further limitations. We
reverse the Examiner's rejection of claim 32 under 35 U.S.C. § 103 as
unpatentable over Urgell, Bastin, Waranis, and Raths for the same reasons
we reverse the obviousness rejection as to claim 21.
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III. Obviousness: Claims 34 and 35
The Examiner has rejected claims 34 and 35 under 35 U.S.C. § 103 as
being obvious over Urgell, Bastin, Waranis, and Raths. Claims 34 and 35,
like claim 29, require the LAE to be in an encapsulated form. The
Examiner's position regarding the encapsulated form requirement of the
claim is the same as it was for the anticipation rejection, namely that Urgell
teaches an emulsion formed by dispersion of an oil phase in a water phase
(Example 1) and may comprise animal and vegetable oils "which would be
expected to form a coating around the encapsulated LAE of the emulsion."
(Compare Final Action 8-9, with Final Action 6-7; Ans. 4.) As for claim
35, the Examiner contends that the patentability of this product-by-process
claim does not depend on its method of production where the product is the
same or obvious from a product from the prior art. (Final Action 9; Ans. 4.)
The Examiner notes that Urgell' s deficiency with respect to these claims
( and others) is that it does not provide for an anion X to be other than a
chloride, bromide, or sulfate ion and proceeds to the remaining references to
indicate why other anions would have been obvious. (Final Action 10-12;
Ans. 4.) 13
Thus, we understand the Examiner's rejection of claims 34 and 35 to be
the same as the anticipation position with respect to claim 29, i.e., that
Urgell necessarily results in an encapsulated form as claimed. As discussed
above with respect to the Examiner's rejection of claims 29 and 30 as being
anticipated by Urgell, we find the Examiner's position regarding Urgell
13 We note that claims 34 and 35 do not exclude X anions from being
chloride, bromide, or sulfate.
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teaching an encapsulated form of the claimed LAE surfactant is not
supported. For the reasons above, we reverse the Examiner's rejection of
claims 34 and 35 under 35 U.S.C. § 103 as unpatentable over Urgell, Bastin,
Waranis, and Raths.
IV. Obviousness: Claims 23, 25, and 27
The Examiner has also rejected claims 23, 25, and 27 under 35 U.S.C.
§ 103 as being obvious over Urgell, Bastin, Waranis, and Raths. Unlike
claims 34 and 35, claims 23, 25, and 27 do not recite that the LAE cationic
surfactant is in an encapsulated form. And, unlike claim 21, claims 23, 25,
and 27 do not require that the preservative system of LAE include a specific
amon.
As with claims 21, 32, 34, and 35, the Examiner's obviousness
rejection of claims 23, 25, and 27 addresses the obviousness of providing an
anion X to be other than a chloride, bromide, or sulfate ion. We note,
however, that none of claims 23, 25, and 27 recite a proviso that the anion X
not be bromide, chloride, or sulfate. Rather, each of these claims merely
requires the anion X to be "derived from organic or inorganic acids."
Claims 23, 25, and 27 require an additional compound be included in
the preservative system aside from the LAE plus anion derived from organic
or inorganic acids. Claim 23 requires a salt selected from a particular group
of salts, but excluding salts of sorbic acid. Claim 25 requires the addition of
at least one of "an ester compound, arginine acetamide, and an enzyme
inhibitor." (Br., Claims App. 3.) Claim 27 requires the addition of at least
one of "ethyl arginate, glucosamine, of [sic] chitosan and glutamic acid."
(Id. at 3--4.)
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A. Claim 23
In the obviousness rejection of claim 23, the Examiner's position is
that Bastin supports the obviousness of including "counter ions such as
acetate, lactate (lactic acid), glutamate (glutamic acid), benzoate, tartrate,
etc. [as they] would be readily envisaged because salt selection is routinely
performed so as to optimize the chemical stability and utility of the
compound." (Final Action 10-11; Ans. 5.) The Examiner asserts that while
"[t]he combination ofUrgell and Bastin fail to teach the counter ions as
being in the form of a salt such as sodium lactate," such a counter ion would
have been obvious in light of Waranis, which teaches acetaminophen
"complexed with an alkali metal lactate salt such as sodium lactate." (Final
Action 11; Ans. 5---6.) The Examiner, however, does not explain why the
addition of sodium lactate as a separate salt apart from also being the X
anion of LAE being derived from organic or inorganic acids would have
been obvious. (See Ans. 14--15 ("Waranis is provided to demonstrate that
lactate salts include sodium lactate and are known for producing salts with
other compounds such as acetaminophen. It would have been well within
the skill of an ordinary artisan to modify Bastin such that the counter ion
associated with the LAE was any one of the species suggested, such as
lactate, with a reasonable expectation for success in modulating the
properties of the compound.").) As noted above, the Examiner bears the
burden of establishing a prima facie case of obviousness based upon the
prior art. Fritch, 972 F.2d at 1265. In the absence of any discussion by the
Examiner as to the obviousness of including one of the salts listed in (b) of
claim 23 in addition to providing LAE complexed with an X anion as
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required by claim 23, we are constrained to reverse the Examiner's rejection
of claim 23 as being obvious over Urgell, Bastin, Waranis, and Raths.
B. Claims 25 and 27
The Examiner explains with respect to claim 25 and 27 that Raths,
which is directed to deodorizing shampoo formulations, renders obvious the
addition of chitosan and the enzyme inhibitor triethyl citrate to the shampoo
formulation disclosed in Urgell that includes an LAE preservative system
with a reasonable expectation of success. (Final Action 12; Ans. 6-7.) The
Examiner explains that Raths teaches that "chitosan is a useful antidandruff
agent and that triethyl citrate inhibits extracellular enzymes such as esterases
which are responsible for malodor formation." (Final Action 12; Ans. 6.) In
light of this, the Examiner explains that "[ o ]ne would have been motivated
to include chitosan [in the Urgell shampoo formulation] as it provides an
antidandruff benefit" and "[ o ]ne would have been motivated to [likewise]
include an esterase inhibitor such that the formation of bad odors on the
scalp or hair would be inhibited." (Final Action 12; Ans. 7.)
We agree with the Examiner's findings with regard to Raths.
Moreover, as noted above, claims 25 and 27 do not exclude the bromide,
chloride, and sulfate acids being the X anion of the LAE surfactant system.
Thus, Urgell' s disclosure of LAE with any one of those ions meets the
cationic surfactant requirements of claims 25 and 27.
Consequently, we agree with the Examiner's conclusion that claims
25 and 27 would have been obvious to one of ordinary skill in the art over
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Urgell and Raths. 14 Appellants argue that there is no motivation to combine
Raths with Urgell, Bastin, and Waranis. (Br. 17.) In light of our discussion
above, the only relevant issue with respect to claim 25 and 27 is whether the
Examiner has provided sufficient evidence of a motivation to combine the
teachings of Raths with Urgell. We disagree with Appellants' position that
evidence of motivation to combine is absent. Urgell teaches LAE used as a
preservative in shampoo formulations. (Urgell i-fi-f73-7 4 (Example 11) and ,r
61 ("Further formulations 4 to 15 are described hereafter. The experimental
results obtained in the examples 1 to 3 are representative for the examples 1
to 15.").) The Examiner's rationale, stemming from the teachings of Raths,
to add chitosan as an antidandruff ingredient and triethyl citrate as an
esterase inhibitor so as to inhibit malodor on the scalp is sound.
Appellants additionally point out that Raths' surfactant is "completely
different from a cationic surfactant as defined in the instant invention." (Br.
17-18.) While this difference may be exist, Appellants argument is
unavailing. The test for obviousness is what the combined teachings of the
prior art would have suggested to one of ordinary skill in the art. In re
Keller, 642 F.2d 413,425 (CCPA 1981). Appellants have not established
why the different surfactants used in Urgell as compared to the surfactants
used in Raths would preclude one of ordinary skill in the art from
recognizing that the chitosan used in Raths' shampoo formulation can be
used as an antidandruff component in the Urgell shampoo formulation
14 The Board may rely on less than all of the references applied by the
Examiner in an obviousness rationale without designating it as a new ground
of rejection. In re Boyer, 363 F.2d 455, 458 n.2 (CCPA 1966) (citing In re
Bush, 296 F.2d 491,496 (CCPA 1961)).
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containing the same LAE cationic surfactant encompassed by claims 25 and
27. Nor have Appellants established why the different surfactants used in
Urgell as compared to the surfactants used in Raths would preclude one of
ordinary skill in the art from recognizing that triethyl citrate, used as an
esterase inhibitor so as to inhibit malodor on the scalp in Raths' shampoo
formulation, can be used as such in the Urgell shampoo formulation.
Accordingly, we affirm the Examiner's rejection of claims 25 and 27
as being unpatentable under 35 U.S.C. § 103 over Urgell, Bastin, Waranis,
and Raths.
V. Obviousness: Claim 31
Claim 31 depends from claim 30, which depends from claim 29.
Thus, the LAE required by claim 3 1 is one that is encapsulated. The
Examiner's rejection of claim 31 as being obvious under 35 U.S.C. § 103,
over Urgell, Bastin, Waranis, Raths, and Herpens, relies on Herpens for
teaching various oily phases in an oil-in-water type emulsion. (See Final
Action 13.) As discussed above with respect to the Examiner's rejection of
claims 29 and 30 as being anticipated by Urgell, we find the Examiner's
position regarding Urgell teaching an encapsulated form of the claimed LAE
surfactant is not supported. Because the addition by the Examiner of
Herpens does not cure the defect of Urgell in not teaching an encapsulated
LAE, as discussed above, we reverse the Examiner's rejection of claim 31
under 35 U.S.C. § 103 as being unpatentable over Urgell, Bastin, Waranis,
Raths, and Herpens.
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SUMMARY
We affirm the Examiner's rejection of claims 25 and 27 under 35
U.S.C. § 103 as being unpatentable over Urgell, Bastin, Waranis and Raths.
We reverse the Examiner's rejection of claims 29 and 30 under 35
U.S.C. § 102(a) as being anticipated over by Urgell.
We reverse the Examiner's rejection of claims 21, 23, 32, 34, and 35
under 35 U.S.C. § 103 as being unpatentable over Urgell-Beltran, Bastin,
Waranis, and Raths.
We reverse the Examiner's rejection of claim 31 under 35 U.S.C.
§ 103 as being unpatentable over Urgell, Bastin, Waranis, Raths, and
Herpens.
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-IN-PART
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