Ex Parte Abram et al

Patent Trials and Appeals Board

Feb 25, 2019

13498346 - (D) (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/498,346 07/24/2012
20462 7590 02/27/2019
GlaxoSmithKline
Global Patents UP4110
1250 South Collegeville Road
Collegeville, PA 19426
FIRST NAMED INVENTOR
Albert Zorko Abram
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.
PU63799 8761
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
02/27/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
US_cipkop@gsk.com
laura.m.mccullen@gsk.com
eofficeaction@appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALBERT ZORKO ABRAM and IULIAN GOLDSTEIN
Appeal2017-004408
Application 13/498,346
Technology Center 1600
Before DEMETRA J. MILLS, DEBORAH KATZ, and
ULRIKE W. JENKS, Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2017-004408
Application 13/498,346
Appellants 1 seek our review, under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 24, 29--34, 36-38, 40, and 42--49.
(Appeal Brief filed March 18, 2016 ("App. Br.") 1.) We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM.
Appellants' Specification is directed to aerosol foams comprising aloe
vera. (Specification ("Spec.") 1 :6.) The Specification also provides for
pharmaceutically active agents, including the keratolytic agents a- and B-
hydroxy acid, to be included in the aloe vera foams. (See, e.g., Spec. 7:32-
35.)
The Examiner rejected all of Appellants' claims as being obvious
under 35 U.S.C. § 103(a) over either Cunningham,2 Milbradt, 3 and
Tamarkin4 or over Cunningham and Abram. 5 (See Examiner's Answer,
issued August 25, 2016 ("Ans.") 2.) Appellants do not argue for the
separate patentability of any of the rejected claims. We focus on
representative claim 24 in our review. See 37 C.F.R. § 4I.37(c)(l)(iv).
1 Appellants report that the real party in interest is Stiefel Research Australia
Pty Ltd, a subsidiary of GlaxoSmithKline plc. (App. Br. 3.)
2 Cunningham et al., U.S. Patent Application Publication 2008/0268188 Al,
published October 30, 2008.
3 Milbradt, et al., U.S. Patent Application Publication 2006/0110352 Al,
published May 25, 2006.
4 Tamarkin et al., U.S. Patent Application Publication 2008/0253973 Al,
published October 16, 2008.
5 Abram and Goldstein, U.S. Patent Application Publication 2008/0015271
Al, published January 17, 2008.
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Appellants' claim 24, the only independent claim, is recited below,
with spacing and indentations added to clarify elements:
A topical aerosol composition comprising:
(a) unconcentrated aloe vera gel or concentrated aloe vera gel
which is diluted with water to achieve the equivalent of
unconcentrated aloe vera gel,
(b) a non-ionic surfactant present in an amount from about
0.1 % to about 5% by weight, based on the total weight of the
composition, and
( c) a keratolytic agent present in an amount from about 0.1 % to
about 10% by weight, based on the total weight of the composition,
which is selected from the group consisting of an a-hydroxy acid and
a B-hydroxy acid, and mixtures thereof,
wherein the topical aerosol composition is a single phase
aqueous composition, and
wherein the topical aerosol composition is packaged in a
pressurized container containing a hydrocarbon propellant, and is
dispensed from the pressurized container as a topical aerosol foam.
(App. Br. 18, Claims App'x.)
Analysis
Appellants' claimed compositions have three elements:
(a) aloe vera gel;
(b) a non-ionic surfactant (0.1 % - 5%); and
(c) a-hydroxy acid and/or B-hydroxy acid (0.1 % - 10%).
(See App. Br. 6.) The claimed composition must be present in a single,
aqueous phase and must be packaged in a container with a hydrocarbon
propellant.
Cunningham, Milbradt, and Tamarkin
The Examiner rejected claim 24 under 35 U.S.C. § 103(a) as being
obvious over the combination of the teachings of Cunningham, Milbradt,
and Tamarkin. (See Final Office Action mailed November 5, 2015 ("Final
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Act.") 3-8.) Cunningham teaches foamable moisturizing compositions that
can include aloe extract as a humectant and either a-hydroxyl, B-hydroxyl
acids or combinations thereof. (See Cunningham ,r,r 24 and 35; see Final
Act. 4.) The compositions of Cunningham are present in a single aqueous
phase. (See Cunningham ,r 11; see Final Act. 4.) The compositions of
Cunningham also include surfactants that are quaternary ammonium
surfactants, but not non-ionic surfactants as recited in Appellants' claims.
(See Cunningham ,r,r 4, 17; see Ans. 4.) The foamable compositions of
Cunningham are not made with a propellant, as claimed. (See Final Act. 4.)
Milbradt teaches foamable compositions for the skin with a- and B-
hydroxy acids in concentrations from 0.01 to 20 %, preferably 1 to 5%. (See
Milbradt ,r,r 28 and 41--44; see Final Act 4.) The foamable compositions of
Milbradt are aqueous, being from 0.01 to 89% water, and can include aloe
vera gel. (Milbradt ,r,r 14 7 and 241; see Final Act. 5.) Milbradt does not
teach foamable compositions that include non-ionic surfactants or that are
aerosolized with a propellant.
Tamarkin teaches foamable compositions for the skin that can include
aloe vera as a "relaxing or soothing agent," as well hydroxyl acids and
keratolytic agents. (See Tamarkin ,r,r 45, 68; see Final Act. 5---6.) Tamarkin
teaches including surfactants, such as ceteareth 20, in the foamable
compositions described. (See Tamarkin ,r 56; see Final Act. 5.) The
foamable compositions of Tamarkin use propellants such as butane, propane,
isobutene, and fluorocarbons or mixtures thereof. (Tamarkin ,r 327.)
Tamarkin provides exemplary formulations that include aloe vera, water and
propellant, making a composition described as "a vehicle for aloe vera that
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Application 13/498,346
can generate good quality foam having a collapse time in excess of 5
minutes .... " (Tamarkin ,r 544; see also ,r,r 541-543.)
According to the Examiner, it would have been obvious for one of
ordinary skill in the art to have made a single composition with aloe vera gel
and a- or B-hydroxy acids because the prior art teaches topical aerosol
compositions that include the claimed ingredients. Specifically, the
Examiner finds that Cunningham teaches aqueous single phase foam
moisturizing formulations comprising aloe vera gel and hydroxyl acids; that
Milbradt teach topical foam formulations comprising aloe vera and hydroxyl
acids and surfactants; and that Tamarkin teaches foam formulations
comprising active agents such as keratolytic agents, aloe vera, non-ionic
surfactants, aerosolized by propellants. (See Final Act. 7.)
Appellants argue, first, that Cunningham does not teach an aerosol
foam composition in a pressurized container with a hydrocarbon propellant,
but teaches a non-aerosol pumping device that mixes the composition with
air instead. (See App. Br. 7 and 14.) We are not persuaded by this argument
because it does not address the Examiner's rejection under 35 U.S.C.
§ 103(a) over the combination of Cunningham, Milbradt, and Tamarkin.
"Non-obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants do not address the teaching in Tamarkin of foam compositions,
aerosolized with a propellant, that include aloe vera. (See Tamarkin ,r 544;
see also ,r,r 541-543; see Ans. 4.)
Appellants assert that aerosol foams are different from non-aerosol
foams, but do not attempt to demonstrate that an ordinarily skilled artisan
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would not have modified the composition of Cunningham with the
propellants taught in Milbradt to achieve an aerosol foam. Appellants'
recitation of the differences between different type of foams and the
requirements for a composition formulated for aerosol delivery does not
persuade us that the claimed composition would not have been obvious over
the combined teachings of the prior art cited.
Second, Appellants argue that Cunningham does not describe a
combination of aloe vera gel and a-hydroxy acid or B-hydroxy acid. (See
App. Br. 8-10.) According to Appellants, Cunningham mentions aloe vera
gel and a-hydroxy acids/B-hydroxyacids as merely optional ingredients,
provided in long lists with no preference given to either. Appellants argue
further that aloe vera gel and a-hydroxy acid/B-hydroxy acid would be less
likely to be selected because they are not preferred and that, therefore,
Cunningham does not fairly teach the claimed combination. (See App. Br.
9-10.) Appellants argue that only impermissible hindsight would have led
the Examiner to arrive at the claimed composition. (See App. Br. 10.)
We are not persuaded by this argument because, as Appellants
acknowledge, prior art references are relevant for all that they teach. See In
re Lamberti, 545 F .2d 7 4 7, 7 50 ( CCP A 197 6) ("[T]he fact that a specific
symmetric dialkyl is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered.") In evaluating the prior art in regard to the obviousness of
Appellants' claimed compositions, we look to what the cited references
would have suggested to one of ordinary skill in the art at the time the
invention was made, not merely what they expressly teach. Id. Because
both Cunningham and Tamarkin teach compositions that can include aloe
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vera gel and hydroxyl acids, we are not persuaded that one of ordinary skill
in the art would consider combining these two ingredients to be non-
obvious.
Appellants continue by arguing that Cunningham does not utilize a
non-ionic surfactant, but a quaternary ammonium (cationic) surfactant
instead. (See App. Br. 11.) According to Appellants, Cunningham describes
the quaternary ammonium surfactant as an essential feature and makes no
mention of alternative types of surfactants. (See App. Br. 11, citing
Cunningham ,r,r 4 and 21-23 and Examples 1-5.) We do not agree with
Appellants' characterization of Cunningham. Although Cunningham does
discuss only quaternary ammonium surfactants, none of the passages cited
by Appellants indicates that this class of surfactants is "essential" to the
moisturizing compositions taught. Instead, Cunningham states that "the
moisturizing composition of the present disclosure generally contains a
quaternary ammonium surfactant in combination with other compounds."
(See Cunningham ,r 21 ( emphasis added).) The language of "generally"
including an ingredient does not indicate that the ingredient is essential.
Appellants also argue that neither Milbradt nor Tamarkin remedies the
asserted deficiencies of Cunningham. (See App. Br. 11-14.) Appellants
argue that Milbradt is directed to non-aerosol products and fails to describe
foaming products comprising aloe vera gel. (See App. Br. 11-12.)
Appellants argue that Tamarkin teaches including aloe vera and hydroxyl
acids in aerosol foams, but only as options selected from a broad array of
agents listed over several paragraphs. (See App. Br. 12-14, citing Tamarkin
,r,r 42--46 and 68.)
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These arguments do not contemplate the combination of references on
which the Examiner's rejection is based. Appellants' arguments refer to
each alone, but do not address whether an ordinarily skilled artisan would
have considered it obvious to combine elements of each prior art
composition. Appellants do not address whether it would have been obvious
to include ingredients taught in Cunningham and Milbradt in a foam
aerosolized by propellant as taught in Tamarkin. Given that Tamarkin
teaches aerosolizing aloe vera with propellant and Cunningham and Milbradt
teach the combination of aloe vera with hydroxyl acids, in the absence of
evidence to the contrary, we are not persuaded that the Examiner erred in
rejecting Appellants' claims.
Appellants argue that the "aloe vera" described and exemplified in
Tamarkin and the "aloe vera gel" recited in claim 1 are not the same. (See
App. Br. 13-14.) Appellants cite to International Journal of Toxicology 26
(Suppl. 2): 1-50 (2007), as evidence that "aloe vera" is another name for
Aloe barbadensis leaf extract or Aloe barbadensis leaf, and that "aloe vera
gel" is another name for Aloe barbadensis leaf juice. Given these
definitions, Appellants argue that Tamarkin does not describe or exemplify
the "aloe vera gel" recited in claim 1. (See App. Br. 14.)
We are not persuaded that any difference between the aloe vera
component taught in Tamarkin and the claimed "aloe vera gel" renders the
claimed composition non-obvious. We note that despite Appellants'
argument that the term "aloe vera" can mean an Aloe barbadensis leaf, it is
not a reasonable interpretation that the aloe vera used in the foaming
compositions of Tamarkin is a leaf.
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Appellants' remaining argument is that the term "aloe vera" in
Tamarkin refers to Aloe barbadensis leaf extract. (See App. Br. 13.) We are
not persuaded that this extract differs from the "aloe vera gel" Appellants
claim because Appellants' Specification defines an "aloe vera gel" as an
extract from Aloe barbadensis leaves. Specifically, Appellants'
Specification states: "Aloe vera gel is a mucilaginous preparation obtained
from the leaves of Aloe vera (Aloe barbadensis), which is widely used in
cosmetics for its moisturising and revitalising properties." (Spec. 1: 11-13.)
Appellants' Specification also states that "the Aloe vera used herein is Aloe
vera gel, also known as Aloe barbadensis leaf juice." (Spec. 3:15-16.) We
do not discern a difference between the terms "leaf extract," "leaf juice," and
"mucilaginous preparation obtained from the leaves of Aloe vera (Aloe
barbadensis )" and therefore do not discern a difference between the claimed
"aloe vera gel" and the "aloe vera" taught in Tamarkin. Without further
explanation or evidence, we are not persuaded that the "aloe vera" taught
and exemplified in Tamarkin and the claimed "aloe vera gel" would not
have been considered by an ordinarily skilled artisan to be obvious variants
of ingredients that can be incorporated into an aerosol foam.
We are not persuaded by Appellants' arguments that the Examiner
erred in rejecting claim 24, or any other of Appellants' claims, as being
obvious over the combination of Cunningham, Milbradt, and Tamarkin.
Cunningham and Abram
The Examiner also rejected claim 24 as being obvious over
Cunningham and Abram. (See Final Act. 8-11.) Abram teaches foam
formulations comprising water, active agents, and propellants for treatment
of dermatological disorders. (See Abram abstract.) The active agents in the
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foam formulations of Abram include keratolytic agents and non-ionic
surfactants, such as ceteareth-20. (See Abram ,r,r 63 and 81.)
The Examiner determined it would have been obvious to use the
single phase aqueous moisturizing foam formulations of Cunningham, which
include aloe vera gel and hydroxyl acids, in the moisturizing aerosol foam
formulations of Abram. (See Final Act. 10-11.)
Appellants put forth the same arguments against this rejection as
against the rejection discussed above, regarding the Examiner's citation of
Cunningham. (See App. Br. 15.) For the reasons discussed above, mainly
that the arguments do not address the Examiner's rejection as based on a
combination of the teachings of Cunningham and Abram, we are not
persuaded by these arguments.
Appellants also argue that Abram teaches "emulsion foams," which
comprise water, fatty acid, and neutralized fatty acid, and are different from
the "single phase aqueous foams" of the claimed composition and from the
non-aerosol foaming compositions of Cunningham. (See App. Br. 15-16.)
We are not persuaded by this argument because Abram was not relied upon
for a teaching of emulsion foams, but instead, for its teaching of the use of
non-ionic surfactants in foams aerosolized with propellant. (See Ans. 9.)
Appellants' argument that the emulsion foams of Abram are different from
the single phase aqueous foams of Cunningham do not persuade us that it
would not have been obvious to modify the composition of Cunningham in
light of the surfactant and propellant of Abram.
Accordingly, Appellants do not persuade use that the Examiner erred
in rejecting claim 24, or any of Appellants' other claims, as being obvious
over Cunningham and Abram.
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Conclusion
Upon consideration of the record and for the reasons given, the
rejection of claims 24, 29-34, 36-38, 40, and 42--49 under 35 U.S.C.
§ 103(a) is sustained.
Therefore, we affirm the decision of the Examiner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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