Ex Parte Loupenok

Patent Trial and Appeal Board

Jul 14, 2017

13553036 (P.T.A.B. Jul. 14, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/553,036 07/19/2012 Leon LOUPENOK PU63776TC1 8758
90434 7590 07/18/2017
OlaYO Smith Kline
EXAMINER
c/o NATH, GOLDBERG & MEYER PIPIC, ALMA
112 SouthWest St.
Alexandria, VA 22314-2825 ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
07/18/2017 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):
3g876j9ydo9fd6n@jetable.net
j goldberg @ nathlaw. com
USPTO@nathlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LEON LOUPENOK
Appeal 2015-003481
Application 13/553,0361
Technology Center 1600
Before RACHEL H. TOWNSEND, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an oil-in-water
emulsion aerosol foam composition. The Examiner entered final rejections
for obviousness and non-statutory obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
1 Appellant identifies the Real Party in Interest as STIEFEL RESEARCH
AUSTRALIA. App. Br. 3.
Appeal 2015-003481
Application 13/553,036
STATEMENT OF THE CASE
Background
The Specification discloses “aerosol foam compositions containing a
pharmaceutically active agent for the treatment of skin disease.” Spec. 1:9—
10.
The present invention is directed to an oil in water
emulsion aerosol foam composition having an oil phase and a
water phase, said composition comprising a pharmaceutically
active agent, water, oil, an oil miscible organic solvent, a
surfactant, and a propellant. The present invention provides for
a low oil and a low surfactant content in an oil in water emulsion
aerosol foam composition.
Id. at 2:10-14.
The Claims
Claims 1, 4—13, 16, 18, and 25—41 are on appeal. App. Br. 5. Claims
1 and 18 are illustrative and read as follows:
1. An oil in water emulsion aerosol foam composition
comprising an oil phase and a water phase, said composition
comprising:
i) tazarotene,
ii) water in an amount from about 65% to about 90% by
weight,
iii) an oil present in an amount of less than about 10% by
weight,
iv) an oil miscible organic solvent,
v) a surfactant component comprising a hydrophilic
ethoxylated fatty alcohol ether, in an amount from about 0.1 %
to about 10% by weight, and
vi) a propellant; and
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wherein the tazarotene is solubilized in the oil phase of the
composition, and the particle size of the oil phase is less than
about 1000 nm, and wherein all percentages are based on the total
weight of the composition.
18. An oil in water emulsion aerosol foam composition
comprising an oil phase and a water phase, said composition
comprising:
i) tazarotene;
ii) water in an amount from about 70% to about 85% by
weight;
iii) an oil selected from the group consisting of azulene,
chamazulene, isoparaffin, linear alpha olefins,
cyclohexlidenediphenyl methane, didecene,
diethylhexylcyclohexane, eicosane, isododecane, isoeicosane,
isohexadecane, longifolene, mineral oil, paraffin,
pentahydrosqualene, petrolatum, squalane, squalene,
tetradecene, and mixtures thereof; and wherein the oil is present
in an amount from about 3% to about 8% by weight;
iv) an oil miscible organic solvent selected from the group
consisting of diisopropyl adipate, isopropyl myristate, octyl
dodecanol and caprylic / capric triglyceride, and mixtures
thereof;
v) a non-ionic surfactant component comprising a
hydrophilic ethoxylated fatty alcohol ether, in an amount from
about 2% to about 6% by weight;
vi) a hydrocarbon propellant; and
wherein the tazarotene is solubilized in the oil phase of the
composition, and the particle size of the oil phase is less than
about 1000 nm, and wherein all percentages are based on the total
weight of the composition.
App. Br. (Claims App.) 42-44.
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Application 13/553,036
The Rejections
The following rejections are before us to review:
A. Claims 1, 4—13, 16, 18, 25, 26, 29, 30, 34, and 35 are rejected
under pre-AIA 35 U.S.C. § 103(a) as obvious over Tamarkin,2Larm,3
Remington’s,4 Bee,5 Evans,6 and Wood.7 Ans. 2.
B. Claims 27 and 28 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Tamarkin, Larm, Remington’s, Bee, Evans, Wood, and
Muller.8 Id. at 7.
C. Claims 31—33, 36, and 37 are rejected under pre-AIA 35 U.S.C. §
103(a) as obvious over Tamarkin, Larm, Remington’s, Bee, Evans, Wood,
and Tamarkin 2.9 Id. at 8.
D. Claims 38-41 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Tamarkin, Larm, Remington’s, Bee, Evans, Wood, and
Abram.10 Id. at 9—10.
E. Claims 1, 4—13, 16, 18, and 25—28 are provisionally rejected and
claims 29 and 34—37 are newly rejected on the ground of nonstatutory
2 Tamarkin et al., WO 2007/007198 A2, published January 18, 2007
(“Tamarkin”).
3 Larm et al., US 2006/0057168 Al, published March 16, 2006 (“Larm”).
4 Remington’s Pharmaceutical Sciences, 323 (Alfonso R. Gennaro et al.
eds., 1985) ((MackPubl. Co., 17th Ed.) (“Remington’s”).
5 Bee et al., US 4,985,250, issued January 15, 1991 (“Bee”).
6 Evans et al., US 5,026,548, issued June 25, 1991 (“Evans”).
7 Wood et al., US 2012/0111352 Al, published May 10, 2012 (“Wood”).
8 Muller et al., US 6,511,655 Bl, issued January 28, 2003 (“Muller”).
9 Tamarkin et al., US 2006/0275218 Al, published December 7, 2006
(“Tamarkin 2”).
10 Abram et al., US 7,141,237 B2, issued November 28, 2006 (“Abram”).
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Application 13/553,036
obviousness-type double patenting as obvious over claims 1, 16—18, 20, 23,
29, 31, 35, 36, 41—44, 48, 49, 53, and 56—60 of copending Application No.
12/711,337 (Loupenok ’194).11 Id. at 12.
F. Claims 1, 4—13, 16, 18, and 25^40 are rejected on the ground of
nonstatutory double patenting as obvious over claims 1—3 of U.S. Patent No
8,808,716 B2 (Loupenok ’716) in view of Larm. Id. at 15.
D. Claim 41 is rejected on the ground of nonstatutory double
patenting as obvious over Loupenok ’716 in view of Larm and Abram. Id.
at 17.
FINDINGS OF FACT (FF)
Findings of Fact
1. Tamarkin teaches “[a] composition and therapeutic kit
including an aerosol packaging assembly including a container
accommodating a pressurized product and an outlet capable of releasing a
foamable composition, including a retinoid as a foam.” Tamarkin Abstract.
2. Tamarkin teaches an oil-in-water foamable emulsion
composition in Example 1 (TZ-1) that contains, among other things,
tazarotene, mineral oil 5.6% w/w, isopropyl palmitate 5.6% w/w, sorbitan
stearate 2% w/w, PPG15-stearyl ether 1% w/w, glyceryl monostearate
0.45% w/w, propellant 10% w/w, preservative, and water to 100 % w/w. Id.
1112. The Examiner finds that because “all of the components except for
11 Application 12/711,337 was published as U.S. Publication 2010/0221194
A1 on September 2, 2010 (“Loupenok ’194”).
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Application 13/553,036
water comprise 26.11 % w/w, water is necessarily present in an amount of
73.89% w/w). Id.', Ans. 3.
3. T amarkin teaches:
According to one or more embodiments of the present
invention, the surface-active agent has a hydrophilic lipophilic
balance (HLB) between about 9 and about 14, which is the
required HLB (the HLB required to stabilize an O/W emulsion
of a given oil) of most oils and hydrophobic solvents. Thus, in
one or more embodiments, the composition contains a single
surface active agent having an HLB value between about 9 and
14, and in one or more embodiments, the composition contains
more than one surface active agent and the weighted average of
their HLB values is between about 9 and about 14. Yet, in other
embodiments, when a water in oil emulsion is desirable, the
composition contains one or more surface active agents, having
an HLB value between about 2 and about 9.
Id. 1 84.
4. Tamarkin discloses that:
The surface-active agent is selected from anionic, cationic,
nonionic, zwitterionic, amphoteric and ampholytic surfactants,
as well as mixtures of these surfactants . . . Nonlimiting
examples of possible surfactants include . . . poly(oxyethylene)
alkylyl ethers, such as poly(oxyethylene) cetyl ether,
poly(oxyethylene) palmityl ether, polyethylene oxide hexadecyl
ether, polyethylene glycol cetyl ether.
Id. 1 84.
5. Tamarkin teaches:
In one or more embodiments, the surface active agent
includes a mixture of at least one non-ionic surfactant and at least
one ionic surfactant in a ratio in the range of about 100:1 to 6:1.
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Application 13/553,036
In one or more embodiments, the non-ionic to ionic surfactant
ratio is greater than about 6:1, or greater than about 8:1; or greater
than about 14:1, or greater than about 16:1, or greater than about
20:1.
In one or more embodiments of the present invention, a
combination of a non-ionic surfactant and an ionic surfactant
(such as sodium lauryl sulphate and cocamidopropylbetaine) is
employed, at a ratio of between 1:1 and 20:1, or at a ratio of 4:1
to 10:1. The resultant foam has a low specific gravity, e.g., less
than O.lg/ml.
It has been surprisingly discovered that the stability of the
composition is especially pronounced when a combination of at
least one non-ionic surfactant having HLB of less than 9 and at
least one non-ionic surfactant having HLB of equal or more than
9 is employed. The ratio between the at least one non-ionic
surfactant having HLB of less than 9 and the at least one non­
ionic surfactant having HLB of equal or more than 9, is between
1:8 and 8:1, or at a ratio of 4:1 to 1:4. The resultant HLB of such
a blend of at least two emulsifiers is between about 9 and about
14.
Thus, in an exemplary embodiment, a combination of at
least one nonionic surfactant having HLB of less than 9 and at
least one non-ionic surfactant having HLB of equal or more than
9 is employed, at a ratio of between 1:8 and 8:1, or at a ratio of
4:1 to 1:4, wherein the HLB of the combination of emulsifiers is
between about 9 and about 14.
Id. 11 87-90.
6. Tamarkin claims 18 and 19 recite:
18. The kit of claim 2, wherein the emulsion is a water in oil
emulsion and wherein the HLB of the surface active agent is
between about 9 and about 14.
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Application 13/553,036
19. The kit of claim 2, wherein the emulsion is a water in oil
emulsion and wherein the HLB of the surface active agent is
between about 2 and about 9.
Id. at 46.
7. Tamarkin discloses:
Solubility of the retinoid is an important factor in the
development of a stable foamable composition according to the
present invention. Thus, in one or more embodiments, the
retinoid is soluble in the aqueous phase of the emulsion; in other
embodiments, wherein the agent possesses hydrophobic
characteristics the agent is soluble in the oil phase of the
emulsion. Yet, in additional embodiments, the retinoid is
difficult to solubilize in either the aqueous phase of the water
phase and thus, it is suspended in the emulsion, which contains
suspension-stabilizing agents, i.e., the polymeric agents that are
listed herein. Thus, in certain embodiments of the present
invention, the composition and properties of the aqueous phase
of the emulsion (e.g., pH, electrolyte concentration and chelating
agents) and/or the composition of the oil phase of the emulsion
are adjusted to attain a desirable solubility profile of the active
agent.
Id. 140.
8. Tamarkin discloses:
The therapeutic foam of the present invention may further
optionally include a variety of formulation excipients, which are
added in order to fine-tune the consistency of the formulation,
protect the formulation components from degradation and
oxidation and modify their consistency. Such excipients may be
selected, for example, from stabilizing agents, antioxidants,
humectants preservatives, colorant and odorant agents and other
formulation components, used in the art of formulation.
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Application 13/553,036
Id. 1100 (emphasis added).
9. T amarkin teaches:
[t]he surface-active agent is selected from anionic, cationic,
nonionic, zwitterionic, amphoteric and ampholytic surfactants,
as well as mixtures of these surfactants. Such surfactants are well
known to those skilled in the therapeutic and cosmetic
formulation art. Nonlimiting examples of possible surfactants
include . . . isoceteth-20.
Id. 1 85.
10. Larm teaches:
The size of a particle is critical to its ability to cross the skin
barrier and therefore its ability to deliver a pharmaceutically active
ingredient for the treatment of local or systemic medical
conditions of the patient concerned. As particles become smaller
(particularly below 100 nm), the percentage of exposed surface
area of a particle in proportion to its total volume when compared
to unrefined material is increased, and hence its potential efficacy
is increased.
Larm 13.
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Application 13/553,036
11. Larm teaches “[t]he characteristics of sub-micron particles in
their application to the delivery of pharmaceutically active ingredients across
the skin barrier may be summari[z]ed as follows:
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12. Wood teaches that isoceteth-20 has an HLB value of 15.7 and
sorbitan stearate has an HLB value of 4.7. Wood 1 50 (Table 1).
13. Remington’s teaches “[t]he relationship between HLB values
and the application of the surface-active agent is show in Table XV” below:
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Table XV above states the relationship between HLB Range and Surfactant
Application. Remington’s 323.
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Application 13/553,036
14. Bee teaches “[t]he external oil/water emulsifier will normally
have an HLB of at least 8 and examples are polyoxyethylene sorbitan
esters.” Bee 2:67—3:1.
15. Evans discloses “[t]he more polar, hydrophilic, surfactants tend
to be more soluble in water and promote the formation of oil-in-water
emulsions, whereas the less polar, lipophilic, surfactants tend to be more
soluble in oil and promote water-in-oil emulsions.” Evans 6:31—35.
OBVIOUSNESS
A. Rejection over Tamarkin, Larm, Remington’s, Bee, Evans, and Wood
The Examiner finds Tamarkin teaches an
oil in water emulsion aerosol composition comprising an oil
phase and a water phase . . . comprising components i) through
vi) [of claim 1] and an antibacterial agent as described in the
claims, wherein the particle size of the oil phase is less than about
1000 nm, and wherein all percentages are based on the total
weight of the composition.
Ans. 2. The Examiner finds Tamarkin discloses the composition as a
foamable retinoid packaged under pressure in a container. Id. The
Examiner finds composition TZ-1 “is an oil in water foamable emulsion
composition comprising: tazarotene . . . ; mineral oil 5.6% w/w . . . ;
isopropyl palmitate 5.6% w/w . . . ; sorbitan stearate 2% w/w (surfactant);
propellant 10% w/w ... ; preservative . . . ; [and] water to 100 % w/w,”
noting that “[s]ince all of the components except for water comprise 26.11 %
w/w, water is necessarily present in an amount of 73.89% w/w.” Id. at 2—3.
The Examiner finds Tamarkin discloses use of the emollients “isopropyl
palmitate and diisopropyl adipate[,] among others.” Id. at 3. The Examiner
finds that Tamarkin discloses “[hjydrophilic emulsifiers form oil in water
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Application 13/553,036
emulsions,” that a “surfactant with an HLB . . . about 9 to about 14 is
required to stabilize an oil in water emulsion” and that “[sjuitable surface
active agents include poly(oxyethylene) alkyl ethers such as isoceteth-20.”
Id. The Examiner finds Tamarkin discloses “suitable propellants include
volatile hydrocarbons such as butane.” Id.
The Examiner finds composition TZ-1 of Tamarkin
utilize[s]. . . stearate surfactant, which has an HLB value of 4.7.
Tamarkin’s claim 19 recites utilizing a surfactant with an HLB
value from 2 to 9 in an oil in water emulsion, and Tamarkin's
claim 18 recites utilizing a surfactant with an HLB value from
about 9 to about 14 in an water in oil emulsion. Based [on] the
teachings of Tamarkin there seems to be some ambiguity
regarding which surfactants are suitable for use in oil in water
emulsions.
Id. at 3^4.
The Examiner relies on the teachings of Remington’s, Bee, and Evans
to clarity the ambiguity the Examiner finds is present in Tamarkin “and to
show that it is well known in the art that surfactants with low HLB
(lipophilic) values are used for making water in oil emulsions and that
surfactants with high HLB (hydrophilic) value are used for making oil in
water emulsions.” Id. at 4. The Examiner finds Remington’s discloses that
“surfactants with an HLB value that ranges from 8 to 18 are used for
emulsifying oil in water emulsions and surfactants with HLB value of 4—6
are used for emulsifying water in oil emulsions.” Id. The Examiner finds
that Bee discloses that “to stabilize a water in oil emulsion it is required to
use a surfactant with an HLB value of no more than 6 ... , and for oil in
water emulsions it is required to use an emulsifier with an HLB value of at
least 8. . . .” Id. (citations omitted). The Examiner finds that Evans
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Application 13/553,036
discloses that “hydrophilic surfactants promote the formation of oil in water
emulsions, whereas the lipophilic surfactants promote the formation of water
in oil emulsions.” Id.
The Examiner concludes that the teachings of Remington’s, Bee, and
Evans would inform the skilled artisan “that Tamarkin’s teachings in
paragraphs 0083 and 0084 [regarding the use of a surfactant with an HLB
value of 9—14 to stabilize an oil in water emulsion] are scientifically correct”
and that the artisan would disregard the information in Tamarkin’s claims 18
and 19. Id.
The Examiner finds that Wood discloses that isoceteth-20 has an HLB
value of 15.7 and sorbitan stearate has an HLB value of 4.7. Id.
The Examiner finds Larm discloses “a method of formulating
microemulsions useful in therapeutic and cosmetic application in the field of
dermatology” and teaches that particle size is “critical to its ability to cross
the skin barrier and therefore its ability to deliver a pharmaceutically active
ingredient for the treatment of local or systemic medical condition” such that
smaller particles have increased potential efficacy because “the percentage
of exposed surface area of a particle in proportion to its volume is increased.
Id. at 5. The Examiner finds Larm discloses that “potential efficacy is
increased” with the percentage of exposed surface area of a particle in
proportion to its volume and that “[s]ub-micron emulsion (100-300 nm) and
microemulsions (10-100 nm) show enhanced transdermal delivery compared
to an emulsion (300-1000 nm). Id.
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to combine Larm, Wood, and Tamarkin (as
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clarified by Remington’s, Bee, and Evans) to modify Tamarkin’s low oil
content, oil in water tazarotene emulsion, TZ-1, by replacing the sorbitan
stearate surfactant with a high HLB value surfactant such as Wood’s
isoceteth-20, and formulated the emulsion with the particle size of oil
droplets of less than about 1000 nm to improve transdermal delivery, in
order to form a stable, pharmaceutically effective oil in water emulsion, with
a reasonable expectation of success. Id. at 5—6. The Examiner further
concludes the skilled artisan would have found it obvious “to have
substituted the emollient isopropyl palmitate with diisopropyl adipate, with a
reasonable expectation of success” because Tamarkin teaches they are
equivalents. Id.
Except as specifically discussed below, we adopt the Examiner’s
findings of fact, reasoning on scope and content of the prior art, and
conclusions set out in the Final Office Action and Answer with regard to this
rejection. Final Act. 3—8; Ans. 2—7; See also our factual findings FF1—15.
We conclude that the Examiner has established a prima facie case that the
claims would have been obvious over the cited art. Appellant has not
produced persuasive evidence or argument showing that the Examiner’s
determinations are incorrect. Only those arguments made by Appellant in
the Briefs have been considered in this Decision. Arguments not presented
in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We
address Appellant’s arguments below.
Appellant argues that the skilled artisan would recognize that
“Tamarkin’s disclosure and teaching fully support Tamarkin’s use of
sorbitan stearate, a lipophilic surfactant, as one of several surfactants
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included in the tazarotene formulation TZ-1.” App. Br. 18. Accordingly,
Appellant argues, the skilled artisan would not have looked beyond
Tamarkin’s teachings to find a substitute for sorbitan stearate or “even for a
high HLB, hydrophilic surfactant to be included in a tarazotene
formulation.” Id. Appellant further argues the Examiner failed to appreciate
that the TZ-1 composition includes additional surfactants “PPG15-stearyl
ether, with an HLB value of 10, and thus relatively hydrophilic; and glyceryl
monostearate, with a lipophilic HLB value of 3.8.” Id. at 19.
Appellant further argues that Tamarkin advocates use of “a
combination of at least one non-ionic surfactant having HLB of less than 9
and at least one non-ionic surfactant having HLB of equal or more than 9” to
provide pronounced stability to the foam composition, but that many of
Tamarkin’s examples have blended HLB values outside the range of about 9
to about 14. Id. at 20. Thus, according to Appellant, Tamarkin also
considers compositions having a lower blended HLB value than 9 to 14 to be
“stable foam compositions.” Id. at 21. Appellant argues, therefore, that
Tamarkin teaches “there is no absolute HLB range for successfully using
this unique blend of lipophilic and hydrophilic surfactants” and that
Tamarkin in essence teaches only that a blending of one lipophilic surfactant
and at least one surfactant that is relatively hydrophilic will provide a
stabilizing effect. Id. at 21—22.
Appellant further argues that, specific to tazarotene formulations, the
TZ-1 formulation “demonstrates successful use of Tamarkin’s teaching, with
a blended HLB less than the optimal range of 9 to 14” and the TZ-2
formulation is a demonstration of a higher than the reported “‘optimal’ HLB
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range of 9 to 14.” Id. at 22. Accordingly, Appellant argues Tamarkin’s
teachings of “a broad range of successful surfactant combinations including
at least one lipophilic surfactant and at least one hydrophilic surfactant, even
if the blended HLB value falls outside the ‘optimal’ range” would not be
“inconsistent or ambiguous regarding choice of surfactants.” Id.
Appellant further argues that even if the skilled artisan were to
conclude that the sorbitan stearate should be replaced with a more
hydrophilic surfactant with a higher HLB value, the natural conclusion
would be to use one of those disclosed in Tamarkin rather than looking
outside Tamarkin to locate the specific class of claimed surfactants. Id. at
22—23. Appellant concludes that Tamarkin “should be recognized to teach
away from the pending claims’ choice of one particular type of hydrophilic
surfactant, without any need for any lipophilic surfactant” and further that its
teachings do not provide motivation “to substitute sorbitan stearate from the
combination of three non-ionic surfactants at all, let alone to choose
specifically a hydrophilic ethoxylated fatty alcohol ether.” Id. at 23—24.
Appellant’s arguments do not persuade us that the Examiner erred in
finding that combined teachings of the references render the claims obvious.
We elect claim 1 as representative of the subject matter of this
rejection. Claim 1 recites an oil-in-water composition comprising
tazarotene, less than 10% by weight of oil, an oil miscible organic solvent, a
hydrophilic ethoxylated fatty alcohol ether surfactant of 0.1—about 10%, a
propellant, and requires that the particle size of the oil phase be less than
about 1000 nm. App. Br. 42. Tamarkin teaches all elements of the claimed
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composition except the particle size of the oil phase.12 FF1—9. Accordingly,
because Tamarkin teaches that isoceteth-20 is suitable for use as a surfactant
in its compositions (FF9), we are not persuaded by Appellant’s argument
that the skilled artisan would need to look beyond Tamarkin for a reason to
replace sorbitan stearate with isoceteth-20. See Wm. Wrigley Jr. Co. v.
Cadbury Adams USALLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (finding a
“strong case of obviousness based on the prior art references of record. [The
claim] recites a combination of elements that were all known in the prior art,
and all that was required to obtain that combination was to substitute one
well-known . . . agent for another”); and KSR Ini 7 Co. v. Teleflex Inc., 550
U.S. 398, 416 (2007) (“The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” “If a person of ordinary skill can implement a
predictable variation, § 103 likely bars its patentability.” Id. at 417).
In addition, we agree with the Examiner that “claim 1 recites ‘a
surfactant component comprising a hydrophilic ethoxylated fatty alcohol
ether’, therefore the surfactant component is open to containing other
surfactants in addition to a hydrophilic ethoxylated fatty alcohol ether.”
Ans. 21. Accordingly, the claimed composition encompasses adding
isoceteth-20 in the claimed amount, without needing to remove sorbitan
stearate. It would have been obvious to the skilled artisan to include an
12 Although the Examiner relies on Wood for the teaching of using isoceteth-
20 as a surfactant, Tamarkin also discloses isoceteth-20 as an optional
surfactant for use in its compositions nm. FF10—11. Accordingly, the
skilled artisan armed with the teachings of Larm would have had reason to
create an emulsion with particle sizes in the. FF9.
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additional surfactant — such as isoceteth 20 — so that the HLB value would
be in the 9—14 range taught by Tamarkin. FF3, FF5.
Larm teaches the importance of small particle size to the ability to
cross the skin barrier and discloses emulsions containing particles in the
range of less than 1000 range of less than 1000 nm to improve the ability of
the composition to cross the skin barrier.
Appellant argues that Tamarkin teaches a number of compositions
that are stable, both in and outside the “optimal” range of 9—14, and thus the
skilled artisan would be dissuaded from looking outside Tamarkin for
surfactants aside from sorbitan stearate (App. Br. 22—24) such as to Wood,
which teaches that isoceteth-20, a hydrophilic ethoxylated fatty alcohol ether
surfactant, has an HLB value of 15.7 while sorbitan stearate has an HLB
value of 4.7. FF12. But, as discussed above, Tamarkin teaches use of
isoceteth-20 as a surfactant. FF9. Accordingly, we are unpersuaded that the
skilled artisan knowing only the teachings of Tamarkin would only have
used sorbitan stearate as a surfactant.
Given the teachings of Tamarkin, the skilled artisan would know that
if stability was desired, then an oil-in-water composition should be made by
using components providing a combined HLB value of about 9 to about 14.
FF3. The artisan would recognize that exchanging sorbitan stearate (HLB
value 4.7) for isoceteth-20 (HLB value 15.7), or adding isoceteth-20 to the
composition, would increase the HLB value of the composition consistent
with the teachings of Tamarkin. Because Tamarkin teaches isoceteth-20 is a
suitable surfactant for use in its compositions (FF9), we agree with the
Examiner that substituting isoceteth-20 for sorbitan stearate is consistent
18
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Application 13/553,036
with the teachings of Tamarkin. The fact finder “can take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ.” KSR, 550 U.S. at 418. That the Examiner may have failed to
appreciate that composition TZ-1 contained four surfactants and may have
already fallen within the optimal range of about 9 to about 1413 is immaterial
as Tamarkin teaches that isoceteth-20 is a suitable surfactant and including
isoceteth-20 in addition to or in place of one of the other four surfactants is
consistent with Tamarkin’s optimal HLB range teaching.
We are also unpersuaded that Tamarkin teaches away from the
claimed compositions’ “choice of one particular type of hydrophilic
surfactant, without any need for any lipophilic surfactant” and further that its
teachings do not provide motivation “to substitute sorbitan stearate from the
combination of three non-ionic surfactants at all, let alone to choose
specifically a hydrophilic ethoxylated fatty alcohol ether.” App. Br. 24.
Under the proper legal standard, a reference will teach away
when it suggests that the developments flowing from its
disclosures are unlikely to produce the objective of the
applicant’s invention. ... A statement that a particular
combination is not a preferred embodiment does not teach away
absent clear discouragement of that combination. . . .
Syntax (U.S.A.) LLCv. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005)
(citations omitted). Rather, “[i]t is well settled that a prior art reference is
relevant for all that it teaches to those of ordinary skill in the art.” In re
Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (citation omitted).
13 At oral argument, Appellant’s counsel offered that the HFB value of the
TZ-1 composition is 9.51, according to his calculations. Transcript of Oral
Hearing dated May 22, 2017 (id. at 4:21—5:1; 6:1—9) (“Tr.”).
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Application 13/553,036
In addition, our reviewing court has held that improvement-related
factors may implicitly motivate a combination:
[A]n implicit motivation to combine exists not only when a
suggestion may be gleaned from the prior art as a whole, but
when the “improvement” is technology-independent and the
combination of references results in a product or process that is
more desirable, for example because it is stronger, cheaper,
cleaner, faster, lighter, smaller, more durable, or more efficient.
Because the desire to enhance commercial opportunities by
improving a product or process is universal—and even common-
sensical— . . . there exists in these situations a motivation to
combine prior art references even absent any hint of suggestion
in the references themselves. In such situations, the proper
question is whether the ordinary artisan possesses knowledge
and skills rendering him capable of combining the prior art
references.
DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1368 (Fed. Cir. 2006) (bold emphasis added). As discussed in
detail above, the teachings regarding enhanced stability and absorbability
along with the surfactant options provided in Tamarkin provide sufficient
motivation for the skilled artisan to make new compositions that incorporate
the teachings of the prior art, thereby finding an optimum composition that
included isoceteth-20, with a reasonable expectation of success.
We further note that the claimed compositions do not require a
specific stability, specify an HLB value, or limit the number of surfactants
used. Accordingly, we are not persuaded that Tamarkin’s teachings would
dissuade the skilled artisan from making the claimed compositions because
none of the limitations Appellant argues would guide the skilled artisan
away from or toward a particular composition appear in the claims.
SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir.
20
Appeal 2015-003481
Application 13/553,036
2004) (“Though understanding the claim language may be aided by the
explanations contained in the written description, it is important not to
import into a claim limitations that are not a part of the claim”).
Appellant further argues Larm does not remedy the alleged
deficiencies of Tamarkin and, because it “teaches inclusion of at least one
lipophilic surfactant and at least one hydrophilic surfactant to produce the
disclosed microemulsions” rather than instructing the use of “a hydrophilic
ethoxylated fatty alcohol ether surfactant without need to include a lipophilic
surfactant.” Appellants thus argue that Larm should be recognized as
consistent with Tamarkin in teaching away from the claimed composition
and not motivating the skilled artisan to search for additional information
regarding tazarotene formulations. Id. at 32—33.
This argument is not persuasive as the Examiner cited Larm for its
teaching on improved skin absorption with reduced particle size. Ans. 5;
FF10, 11. As noted above, Tamarkin teaches that isoceteth-20 is a suitable
surfactant for use in its compositions (FF9); therefore Larm need not address
this issue.
Appellant further argues that Remington’s, Bee, Evans, and Wood do
not remedy the alleged deficiencies of Tamarkin because the Examiner’s
reasoning in looking to these references to clarity the teaching of Tamarkin
is flawed. Id. at 33—34. Appellant argues that were the skilled artisan to be
motivated to modify the composition TZ-1, the artisan would “likely would
look no further than to the higher HLB surfactants used with tazarotene in
Example 2 of Tamarkin, i.e., polysorbate 80 and PEG-40 stearate,” which
21
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Application 13/553,036
would leave the artisan with no motivation to combine the teachings or
expectation of success in doing so. Id. at 34.
This argument is not persuasive. As discussed above, Tamarkin
teaches use of isoceteth-20 as a surfactant in its compositions (FF9), and that
high HLB surfactants and high HLB surfactant mixtures are optimal for
making a stable oil in water emulsion. Accordingly, even if Remington’s,
Bee, and Evans were not consulted for clarifying information as the
Examiner suggests, Tamarkin teaches the relevant information, and the
skilled artisan could create the claimed components without relying on
Remington’s, Bee, and Evans. FF1—9.
Appellant further argues that Tamarkin does not address the chemical
stability of any disclosed formulation, in contrast to the claimed
formulations, and does not teach anything regarding “possible chemical
interaction between tazarotene and any surfactant or other ingredient.” App.
Br. 25-26.
This argument is not persuasive as stability of the composition is not a
limitation of the claims at issue. SuperGuide Corp., 358 F.3d at 875. Nor
has Appellant explained or provided persuasive evidence why a “possible
chemical interaction between tazarotene and any surfactant or other
ingredient” would dissuade a skilled artisan from making the claimed
compositions in light of the teachings of the prior art discussed above.
Appellant submits that the Declaration of Albert Zorko Abram14
establishes that the TZ-1 formulation “produces a white foam which persists
14 Declaration of Albert Zorko Abram under 37 C.F.R. § 1.132, signed April
29, 2013.
22
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Application 13/553,036
for greater than 5 minutes” and argues this fact would further dissuade the
skilled artisan from departing from Tamarkin’s teachings. App. Br. 27. The
Abram Declaration reports the results of testing the composition of TZ-1,
made by Appellant according to Tamarkin (“Prior Art Foam”) in comparison
to the claimed composition (“Inventive Foam”). Id. at 29.
Abram declares “[sjamples of each composition were subjected to an
elevated temperature storage study where samples were stored at 50-C for 0,
3.5, and 5.5 weeks.” Abram Deck 5. The samples were then tested for
physical stability by measuring persistence of foam expelled from the
container for 5 minutes and chemical stability by measuring percent
persistence of tazarotene in composition following storage as measured by
conversion to tazarotene sulfoxide, a tazarotene degradant. Id. at 12—18.
Abram declares the Inventive Foam exhibited “superior chemical stability”
because 100 percent of the tazarotene remains after 5.5 weeks storage while
the Prior Art Foam is “unstable with respect to the chemical stability of the
tazarotene” because 0.0035% w/w tazarotene sulfoxide is formed after 5.5
weeks storage. Id. Figure 3 from the Abram Declaration reflecting the
percentage loss in Tazarotene is reproduced below:
23
Appeal 2015-003481
Application 13/553,036
compositions after storage at SOT for 0, S,5 arid
S,S weeks
-$■ Pisssf Art JSSAS-5'J
it KmutOvefism 2£94?»5-4
8
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Figure 3 shows the results of a test performed to assess the amount of
tazarotene remaining in foam compositions at designated intervals. Based
on the data in the Abram Declaration, Appellant argues a skilled artisan
would not have been motivated to depart from the “explicit and successful
teachings” of Tamarkin. App. Br. 27. However, Appellant also claims that
Tamarkin failed to address the chemical stability of its disclosed
compositions, while the claimed compositions “provide physically stable
foams [and] maintain chemical stability of the tazarotene and other key
ingredients.” App. 28. According to Appellant, the TZ-1 formulation
“resulted in relatively decreased pH stability, tazarotene stability, and
increased formation of the tazarotene degradant, tazarotene sulfoxide.” Id.
at 28-29.
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f X 98.fi t
i ^ s
e \I 57fi- i-
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24
Appeal 2015-003481
Application 13/553,036
Appellant cites a second Abram Declaration15 that “repeated his
earlier study with the key difference being that both the ‘Prior Art Foam’
and the ‘Inventive Foam’ were free of the antioxidant butylated
hydroxytoluene (BHT).” Id. at 28. According to Appellant, the second
Abram Declaration establishes that “the TZ-1 formulation was unstable with
regard to the tazarotene active ingredient, while the exemplary formulation
proved to be chemically stable” and that the results are statistically
significant. App. Br. 29, Abram Deck 110.
Appellant further references a study that was performed and is
addressed by the Houlden Declaration.16 Appellant claims the object of the
study was to reflect a comparison of “the stability of tazarotene foam
compositions prepared using ceteareth-12 (on the one hand) versus sorbitan
monooleate, sorbitan monostearate, sorbitan monolaurate or sorbitan
monopalmitate (on the other hand).” Id.', Houlden Deck, 13. Appellant
argues Figure 1 shows the Inventive Foam “appeared to display superior
chemical stability of the tazarotene active agent compared with all of the
Comparative Foams which comprise a mixture of a sorbitan ester and PEG-
40 hydrogenated castor oil / PEG-60 hydrogenated castor oil as the
surfactant.” Houlden Dec. 1 8. Figure 1 is reproduced below.
15 Declaration of Albert Zorko Abram under 37 C.F.R. § 1.132, signed
March 3, 2014.
16 Declaration of Robert James Houlden under 37 C.F.R. § 1.132, signed
August 26, 2013.
25
Appeal 2015-003481
Application 13/553,036
fjf VJ.i>ib«F Olrt-cm By &«•*!»»
Figure 1
Figure 1 reflects the percent of tazarotene remaining in tested compositions
over time.
Appellant argues that the Houlden Declaration establishes that “that
the enhanced chemical stability he observed from the use of ceteareth-12 is
broadly representative of the class of hydrophilic ethoxylated fatty alcohol
ether surfactants.” App. Br. 31. Appellant argues the Abram and Houlden
Declarations “consistently demonstrate that the use of a hydrophilic
ethoxylated fatty alcohol ether surfactant, such as ceteareth-12, affords
superior chemical stability of the tazarotene active agent.” Id. at 32.
Appellant further argues that the Houlden Declaration17 establishes that the
particular surfactant used in the claimed compositions, ceteareth-12, confers
17 Appellant identifies the Houlden Declaration as having been filed
September 26, 2013 in co-pending Application 12/711,337. App. Br. 29.
26
Appeal 2015-003481
Application 13/553,036
chemical stability to the composition because it is chemically compatible
with tazarotene, and that the class of hydrophilic ethoxylated fatty alcohol
ether surfactants would likewise be compatible. Id. at 29-31. According to
Appellant, the superior chemical stability profile as demonstrated by the
collective declarations “is a powerful secondary indicium of non­
obviousness” and that the Examiner ignores the impact of the statistically
significant finding in the second Abram Declaration. Id. at 31—32.
The Examiner responds that:
Appellant has not met the requirement set forth by MPEP [§]
716.02(b) and the instant claims are not commensurate in scope
with the example that provided alleged unexpected result.
Appellant has not provided any evidence to show that the alleged
unexpected results are expected to occur over the entire breadth
of the instant claims. Claim 1 broadly recites tazarotene without
specific amount, water in a range of concentrations, an
unspecified oil in a range of concentrations, an unspecified oil
miscible solvent without any concentrations, a surfactant
component comprising a hydrophilic ethoxylated fatty alcohol
ether in a range of concentrations, and propellant; whereas the
composition that produced the alleged unexpected results
contains specific ingredients in specific concentrations.
Ans. 27—28. See also id. at 28—36 (discussing multiple comparative
deficiencies in the Abram and Houlden Declarations, as further reasons the
Declarations are unpersuasive). We agree with the Examiner’s reasoning
that the Abram and Houlden Declarations are unpersuasive because they fail
to demonstrate that the alleged unexpected results are commensurate with
the full scope of the claimed invention and for the various reasons discussed
at pages 28—36 of the Answer (e.g., failure to include data points to permit
error analysis, failure to account for contributions of other surfactant
components, and failure to test other representative species to demonstrate
27
Appeal 2015-003481
Application 13/553,036
that the results apply to the full breadth of the claim). In addition, Houlden
did not compare the results of his composition to the closest prior art, the
TZ-1 composition of Tamarkin. “To be particularly probative, evidence of
unexpected results must establish that there is a difference between the
results obtained and those of the closest prior art, and that the difference
would not have been expected by one of ordinary skill in the art at the time
of the invention.” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752
F.3d 967, 977 (Fed. Cir. 2014). Accordingly, we are not persuaded that the
advantage noted by Houlden would not have been expected. For all of these
reasons, we are unpersuaded that the Declarations establish unexpected
results sufficient to overcome the Examiner’s prima facie case of
obviousness.
At oral argument, Appellant advanced two arguments that were not
addressed in the record: 1) that “the Examiner erroneously considered the
reference Larm to provide ... a genuine basis for reasonable expectation of
success with regard to particle size in the emulsion” (Tr. 3:1—3); and 2) that
Tamarkin does not teach a composition with less than 10% oil, as recited by
claim 1 {id. at 7:7—11). Appellant has not explained what “good cause”
there might be to consider the new arguments aside from an affirmed
rejection in a companion case. 18 See Ex parte Borden, 93 USPQ2d 1473,
1477 (BPAI 2010) (informative) (“Properly interpreted, the Rules do not
18 See In re Loupenok, decision on Appeal No. 2014-006162, affirming
similar claims for obviousness over some of the same art, including
Tamarkin, the primary reference asserted here.
28
Appeal 2015-003481
Application 13/553,036
require the Board to take up a belated argument that has not been addressed
by the Examiner, absent a showing of good cause”).
Claim 1 requires “an oil present in an amount of less than about 10%
by weight.” The Examiner found that Tamarkin teaches 5.6% by weight
mineral oil in composition TZ-1, and thereby teaches this limitation. Final
Act. 4. Appellant now contends that Tamarkin teaches “about 12 percent of
oil” and, thus, does not teach the low oil limitation. Tr. 4:2—14. Appellant’s
argument is based on the written content of Tamarkin. See Tr. 8:20—9:17.
Thus, although the Examiner found that Tamarkin taught this limitation in
the Final Office Action dated May 20, 2014, Appellant did not raise this
issue until oral argument.19 Appellant provided no information at oral
argument regarding the basis for its argument that Larm fails to provide a
reasonable expectation of success in making the composition with the
claimed particle size. Furthermore, neither argument iss supported by
evidence.
The Board will not consider new arguments “not raised in the appeal
brief, or [that are] not responsive to an argument raised in the examiner’s
answer . . . unless good cause is shown.” 37 C.F.R. § 41.41(b)(2). We find
no good cause was shown, and, consequently, we shall not consider these
new arguments.
19When asked where the Appellant had advanced this argument in the
record, Appellant stated the argument had not been specifically included but
that Appellant had generally argued the prior art did not teach all elements of
the claim. Tr. 10:4—11. This is not sufficient to preserve the issue. See 37
C.F.R. §41.37(c)(l)(iv) (2015).
29
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B. Rejection over Tamarkin, Larm, Remington’s, Bee, Evans, Wood, and
Muller
Claim 27 depends from claim 1 and further recites “wherein the
hydrophilic ethoxylated fatty alcohol ether is selected from the group
consisting of’ and then recites a Markush group including ceteareth-12.
App. Br. 46. Claim 28 depends from claim 27 and further recites “wherein
the hydrophilic ethoxylated fatty alcohol ether is ceteareth-12.”
The Examiner finds that, in addition to the teachings of Tamarkin,
Larm, Remington’s Pharmaceutical Sciences, Bee, and Evans as evidenced
by Wood as discussed above, Muller teaches oil-in-water type cosmetic or
dermatological preparations. Ans. 7. The Examiner finds Muller teaches
including emulsifiers “suitable for the preparation of oil in water emulsions .
. . selected from ceteareth-12 and isoceteth-20.” Id. The Examiner finds
that because the cited references are all
related to emulsions suitable for skin applications, ... it would
have been obvious to combine their respective teachings [and] to
have modified Tamarkin’s composition TZ-1 [] in view of Larm
by substituting isoceteth-20 with ceteareth-12, with a reasonable
expectation of success because isoceteth-20 and ceteareth-12 are
recognized in the art as equivalent surfactants that are suitable
for oil in water emulsions.
Id. at 7—8.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer with regard to this rejection. Final Act. 8—9; Ans. 7—8; FF1—15.
We address Appellant’s arguments below.
Appellant reiterates its argument that the skilled artisan would not
seek out the teachings of Muller on the use of ceteareth-12 in the preparation
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Application 13/553,036
of oil-in-water emulsions because of Tamarkin’s teachings on the subject, as
discussed above. App. Br. 35. Appellant further states without elaboration
that Muller does not remedy the alleged deficiencies, and reiterates the
argument that the unexpected results discussed above rebut any prima facie
case of obviousness. Id. at 35—36.
Appellant’s arguments are unpersuasive for the reasons discussed
above, and we affirm the rejection of claims 27 and 28.
C. Rejection over Tamarkin, Larm, Remington’s, Bee, Evans, Wood, and
Tamarkin 2
Claim 30 depends from claim 1 and recites that the composition
further comprises an antioxidant added to the composition. App. Br. 46.
Claim 31 depends from claim 30, and recites a Markush group of
antioxidants, including butylated hydroxytoluene. Id. Claim 32 specifies
that the antioxidant is butylated hydroxytoluene and claim 33 recites that the
antioxidant is present in an amount from “about 0.05% to about 0.5% by
weight.”
Claim 35 depends from claim 1 and recites that the composition
further comprises a preservative. Id. at 47. Claim 36 depends from claim
35, and recites a Markush group of antioxidants, including sorbic acid or a
salt derivative thereof. Id. Claim 37 recites “wherein the preservative is
sorbic acid or a salt thereof.” Id.
The Examiner finds that, in addition to the teachings of Tamarkin,
Larm, Remington’s, Bee, and Evans as evidenced by Wood as discussed
above, Tamarkin 2 teaches “pharmaceutical compositions comprising
foamable vehicles [that] are intended to be in the form of O/W or W/O [(oil-
31
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Application 13/553,036
in-water or water-in-oil)] emulsions. ...” Ans. 8 (citations omitted). The
Examiner finds the disclosed formulations are “suitable for delivering
tazarotene” and “contain preservatives such as butylated hydroxytoluene and
sorbic acid, among others, and mixtures thereof. . . .” Id. (citation omitted).
The Examiner finds that Tamarkin teaches “preservatives in an amount of
0.25% w/w in the composition TZ-1” but does not identify any specific
preservatives suitable for the composition. Id. at 9. The Examiner
concludes that it would have been obvious
to have selected a known preservative that is utilized in
formulations intended for skin use [and] to have modified
Tamarkin’s composition by utilizing either sorbic acid, butylated
hydroxytoluene, or a mixture thereof in an amount of 0.25%
w/w, with a reasonable expectation of success because those are
known preservatives that are used in foamable skin care
formulations. . . . Butylated hydroxytoluene is known in the art
as an antioxidant. The claimed range of antioxidant
concentrations in claim 33 is obvious because it encompasses the
prior art value of 0.25% w/w. The instant claims do not require
the preservative and the antioxidant to be different compounds.
Id. at 8—9.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer with regard to this rejection. Final Act. 8—9; Ans. 7—8; FF1—15.
We address Appellant’s arguments below.
Appellant reiterates its arguments that the skilled artisan would not
seek out the teachings of Tamarkin 2 on the use of ceteareth-12 in the
preparation of oil-in-water emulsions because of Tamarkin’s teachings on
the subject, as discussed above. App. Br. 36—37. Appellant further argues
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Tamarkin 2 does not remedy the alleged deficiencies, and that the
unexpected results rebut any prima facie case of obviousness. Id. at 36.
Those arguments are unpersuasive for the reasons discussed above,
and we affirm the rejection of claims 31—33, 36, and 37.
D. Rejection over Tamarkin, Larm, Remington’s, Bee, Evans, Wood, and
Abram
Claim 3 8 depends from claim 1 and further recites a pH adjusting
agent. App. Br. 47. Claim 39 recites a Markush group of pH adjusting
agents, including citrate/citric acid. Id. Claim 40 recites that the pH
adjusting agent is citrate/citric acid and claim 41 recites “wherein the pH of
the composition is adjusted to a pH in the range of from 4.70 to 5.50.” Id.
The Examiner finds that, in addition to the teachings of Tamarkin,
Larm, Remington’s, Bee, and Evans as evidenced by Wood as discussed
above, Abram teaches “a pharmaceutical composition that is dispensed from
a pressurized container to form a foam [and] comprises at least one
pharmaceutical agent and foaming agent. . ., [and that] the foaming agent
comprises a pH adjusting agent. ...” Ans. 10 (citations omitted). The
Examiner further finds Abram teaches the pharmaceutical agent can
comprise clindamycin phosphate and a retinoid, such as tazarotene. Id.
The Examiner concludes that because the teachings of Tamarkin,
Larm, and Abram are
related to compositions suitable for topical application, ... it
would have been obvious to have combined their respective
teachings [and] to have modified Tamarkin’s composition TZ-1
by adding an antibacterial agent clindamycin phosphate, with a
reasonable expectation of success because Tamarkin teaches that
an antibacterial agent can be added to the tazarotene
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compositions . . . , [and] to have modified the composition by
adding citrate/citric acid in an amount sufficient to adjust the pH
from 4.0 to 6.5 in order to stabilize clindamycin phosphate, with
a reasonable expectation of success because Abram teaches is as
the suitable pH range for the composition . . ., and that buffer is
often used to improve the stability of an active compound and in
the case of aerosol contains, to reduce corrosion of the metal
. . ., and suggested citrate/citric acid as a suitable a [sic] buffer
.... The claimed pH range in claim 41 is obvious because it
overlaps with the range of from 4.0 to 6.5.
Id. at 10—11 (citations omitted).
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer with regard to this rejection. Final Act. 8—9; Ans. 7—8; FF1—15.
We address Appellant’s arguments below.
Appellant reiterates its arguments that the skilled artisan would not
seek out the teachings of Abram regarding use of citrate or citric acid buffer
to adjust the pH of a foam composition because of Tamarkin’s teachings on
the subject, as discussed above. App. Br. 37. Appellant further argues
Abram does not remedy the alleged deficiencies, and that the unexpected
results rebut any prima facie case of obviousness. Id.
Appellant’s arguments are unpersuasive for the reasons discussed
above, and we affirm the rejection of claims 38-41.
DOUBFE PATENTING
E. Rejection over Loupenok ’194 (formerly ’337 application)
The Examiner finds the pending claims and those of the co-pending
application both “encompass an oil in water emulsion aerosol foam
34
Appeal 2015-003481
Application 13/553,036
composition comprising substantially the same components in amounts that
overlap.” Ans. 12.
Appellant requests relief pursuant to MPEP § 804 in the event that the
provisional double patenting rejection is the only rejection remaining at the
time of appeal, and provide no substantive response. As Loupenok ’194
remains pending without a substantive response from Appellant, we
summarily affirm the Examiner’s provisional obviousness-type double
patenting rejection.
F. Rejection over 1—3 ofLeupenock ’716 and Larm
The Examiner finds “[t]he difference between the instant claims and
the patented claims is that the instant claims require that the tazarotene is
solubilized in the oil phase of the composition and that the particle size of
the oil phase is less than about 1000 nm.” Ans. 16. The Examiner finds
Larm teaches a pharmaceutically active ingredient for use in a sub-micron or
microemulsion that have “enhanced transdermal delivery compared to an
emulsion (300-1000 nm).” Id. The Examiner concludes the skilled artisan
would have found it obvious to combine the teachings of Loupenok ’716 and
Larm
to have formulated the emulsion compositions in the patented
claims by making the oil droplets in the range from 10 nm to 300
nm with a reasonable expectation of success in obtaining a
composition that has enhanced transdermal delivery of
tazarotene, because Larm teaches that sub-micron emulsions
(100-300 nm) and microemulsions (10-100 nm) show enhanced
transdermal and that this property is [] desirable.
Id. at 16—17.
Appellant does not contest or address this rejection. Therefore, we
summarily affirm, and will not further discuss, this rejection. See Manual
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Application 13/553,036
of Patent Examining Procedure § 1205.02 (9th Ed., Rev. 07.2015) (“If a
ground of rejection stated by the examiner is not addressed in the appellant’s
brief, appellant has waived any challenge to that ground of rejection and the
Board may summarily sustain it”).
G. Rejection over Loupenok ’716, Larm, and Abram.
The Examiner finds that Abram teaches “a pharmaceutical
composition that is dispensed from a pressurized container to form a foam
. . . the foaming agent comprises a pH adjusting agent.” Ans. 17. The
Examiner finds Abram teaches that a pH of “from 4.0 to 6.5 .. . as the
suitable pH range for the composition . . ., and that buffer is often used to
improve the stability of an active compound . . . and suggests citrate/citric
acid as a suitable a buffer.” Id. at 18. The Examiner concludes the skilled
artisan would have found it obvious to use the teachings of Abram with
those of Loupenok ’716 and Larm discussed above, to arrive at the
composition of claim 41, which claims a pH adjusted to the range of from
4.7—5.5. Id.
Appellant does not contest or address this rejection. Therefore, we
summarily affirm the rejection.
SUMMARY
We affirm the rejection of claims 1, 4—13, 16, 18, 25, 26, 29, 30, 34,
and 35 under 35 U.S.C. § 103(a) as obvious over Tamarkin, Larm,
Remington’s, Bee, Evans, and Wood.
We affirm the rejection of claims 27 and 28 under 35 U.S.C. § 103(a)
as obvious over Tamarkin, Larm, Remington’s, Bee, Evans, Wood, and
Muller.
36
Appeal 2015-003481
Application 13/553,036
We affirm the rejection of claims 31—33, 36, and 37 under 35 U.S.C.
§ 103(a) as obvious over Tamarkin, Larm, Remington’s, Bee, Evans, Wood,
and Tamarkin 2.
We affirm the rejection of claims 38-41 under 35 U.S.C. § 103(a) as
obvious over Tamarkin, Larm, Remington’s, Bee, Evans, Wood, and Abram.
We affirm the rejection of claims 1, 4—13, 16, 18, 25—29, and 34—37
as obvious over claims 1, 16—18, 20, 23, 29, 31, 35, 36, 41—44, 48, 49, 53,
and 56—60 of Loupenok ’194.
We affirm the rejection of claims 1, 4—13, 16, 18, and 25 40 as being
obvious over claims 1—3 of Loupenok ’716 and Larm.
We affirm the rejection of claim 41 as obvious over Loupenok ’716,
Larm, and Abram.
TIME PERIOD LOR 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
37