Ex Parte Kroepke et al

Patent Trial and Appeal Board

Feb 16, 2016

12360684 (P.T.A.B. Feb. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/360,684 01127/2009
13897 7590 02/18/2016
Abel Law Group, LLP
8911 N. Capital of Texas Hwy
Bldg 4, Suite 4200
Austin, TX 78759
FIRST NAMED INVENTOR
Rainer KROEPKE
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.
3321-P35903 6791
EXAMINER
FRAZIER, BARBARA S
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
02/18/2016 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):
mail@Abel-IP.com
hmuensterer@abel-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAINER KROEPKE, KERSTIN BOHNSACK, FRANK RIPPKE,
and ALEXANDER FILBRY1
Appeal2013-0080035
Application 12/360,684
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
cosmetic or dermatological preparation, which have been rejected as
obvious.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
1 Appellants identify the Real Party in Interest as Beiersdorf AG. (Appeal
Br. 3.)
2 In addition to the rejections based on obviousness, all of the claims on
appeal stand provisionally rejected based on obviousness-type double
patenting. (Office Action mailed Aug. 10, 2012, page 11.) Appellants do
not appeal the double patenting rejection. (Appeal Br. 19.)
Appeal2013-008035
Application 12/360,684
STATEMENT OF THE CASE
The Specification states that "[a]llergens in the air can trigger not only
asthma and hay fever, but also reactions on the skin." (Spec. 2 i-f 10.) The
Specification discloses "the use of lipids or lipid mixtures for the manufacture
of a cosmetic or dermatological preparation for combating or substantially
preventing pollen allergies." (Id. at 2 i-f 12.)
Claims 21--40 are on appeal. Claims 21, 29, 34, and 35 are illustrative
and read as follows:
21. A method of reducing pollen allergies, wherein the
method comprises applying to skin in an amount which is
effective for reducing pollen allergies a cosmetic or
dermatological preparation which comprises or essentially
consists of a lipid phase which (i) comprises one or more lipids,
and (ii) has a spreading coefficient of less than about 800
mm2/10 min at 25°C and a viscosity of from about 40 mPas to
about 25,000 mPas.
29. The method of claim 28, wherein the one or more
stabilizers are present in a concentration of from about 0.1 % to
about 30% by weight, based on a total weight of the
preparation.
34. The method of claim 21, wherein the preparation is
present as an emulsion.
35. The method of claim 33, wherein the preparation
comprises at least about 5% by weight of water, based on a total
weight of the preparation.
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The claims stand rejected as follows:
Claims 21-28, 30-34, and 36-39 under 35 U.S.C. § 103(a) as obvious
based on Eini,3 Ansmann,4 and Meffert5 (Ans. 3) and
Claims 29, 35, and 40 under 35 U.S.C. § 103(a) as obvious based on
Eini, Ansmann, Meffert, and Tamarkin6 (Ans. 7).
I
Issue
The Examiner has rejected claims 21-28, 30-34, and 36-39 as
obvious based on Eini, Ansmann, and Meffert. The Examiner finds that Eini
teaches treating skin with a thixotropic composition that comprises a
hydrophobic solvent (lipid phase), where the compositions are semi-solid
when applied to the skin and tum into a liquid upon spreading. (Ans. 3--4.)
The Examiner finds that Ansmann "teaches that cosmetic oil bodies
can be divided into low-spreading (below 300 mm2/10 min), medium
spreading (about 300 to 1000 mm2/10 min) and high-spreading oils (above
1000 mm2/10 min)." (Id. at 4.) The Examiner finds that Meffert teaches
that "the viscosity of the liquid composition is preferably in a range from
about 1 to 6000 mPas, while the viscosity of the gel-like composition is
preferably in a range greater than 600 to 60,000 mPas." (Id.)
The Examiner finds that it would have been obvious to formulate
Eini' s composition to have the spreading coefficient and viscosity recited in
3 US 6,994,863 B2, issued Feb. 7, 2006.
4 US 7,083,780 B2, issued Aug. 1, 2006.
5 US 2004/0146477 Al, published July 29, 2004.
6 US 2005/0186147 Al, published Aug. 25, 2005.
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claim 21 because the composition is applied as a semi-solid, and "low-
spreading" oily components have a spreading coefficient of less than about
300 mm2/10 min, as taught by Ansmann, and gel-like compositions have a
viscosity in the range of 600 to 60,000 mPas, while liquid compositions have
a viscosity in the range of 1 to 6000 mPas, according to Meffert. (Id. at 5.)
Appellants contend that claim 21 does not indicate that the claimed
composition can be thixotropic and the Specification's description of
measuring spreading coefficient "is a clear indication that the preparation
used in the method recited in the instant claims is a liquid even in the
absence of shear forces acting on the preparation." (Appeal Br. 7.)
Appellants also argue that Ansmann teaches away from using low-spreading
cosmetic oil bodies (id. at 11) and that Meffert indicates that compositions
with a viscosity between 600 mPas and 6000 mPas "qualifies as both a
liquid and a (self-supporting) gel" and therefore is contradictory and at least
partly incorrect (id. at 12).
The issue with respect to this rejection is whether the cited references
would have made obvious a composition comprising a lipid phase having the
characteristics recited in claim 21.
Findings of Fact
1. Appellants' Specification states:
Measuring the spreading coefficient (in mm2/10 min) . . . is
carried out according to the following method. 20 µl of the
substance to be tested is dripped centrally on a Rotband filter
paper from Schleicher & Schull, Germany. At the same time a
stopwatch is started and after 10 min the area is measured that
has been wetted by the substance during this time.
(Spec. 4 ii 21.)
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2. Appellants' Specification states that mineral oils have viscosities
of 43.9 to 98 mPas, Cannabis sativa (hemp) seed oil has a viscosity of 46
mPas, and olive oil has a viscosity of 78 mPas. (Id. at 5---6, i-f 23.)
3. Appellants' Specification states that "[t]he viscosity of the lipid
phase of a preparation of the present invention can be increased by
rheological modifiers and lipid thickeners. (Id. at 6, i-f 24.)
4. Eini discloses
a method of treating a disease or disorder of a skin or a mucosal
membrane, the method comprising the step of topically
administrating to the skin or the mucosal membrane a
pharmaceutical or cosmetic composition containing (a) a
pharmaceutical or cosmetic carrier containing, by weight, 1-25
percent of a solidifying agent and 7 5-99 percent of a
hydrophobic solvent; and (b) a therapeutically or cosmetically
effective amount of a biologically active substance.
(Eini 4: 14--22.)
5. Eini states that skin diseases or disorders that can be treated
include inflammation caused by an allergic inflammatory agent. (Id. at 5:6-
12.)
6. Eini states that, in preferred embodiments, the hydrophobic solvent
can be mineral oil, olive oil, or hempseed oil. (Id. at 4:34--45.)
7. Eini states that a solidifying agent can be a "fatty alcohol having at
least 15 carbon atoms in its carbon backbone and/ or at least one fatty acid,
having at least 18 carbon atoms in its carbon backbone." (Id. at 7:55-57.)
8. Eini states that its composition "provid[ es] a biologically active
carrier or composition, which is semi solid at rest and liquefies upon
application of shear forces thereto." (Id. at 6:15-18.)
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9. Eini states that its composition "may further include a variety of
pharmaceutical or cosmetic ingredients, which ... may be selected from the
group consisting of water, surfactants, emulsifiers, diglycerides,
triglycerides, stabilizing agents, antioxidants, glycerol, ethanol, propanol,
isopropanol, butanol, polymeric gelling agents, flavoring, colorant and
odorant agents." (Id. at 19:60 to 20:3.)
10. Ansmann discloses that "cosmetic oil bodies can be divided into
low-spreading (below 300 mm2/10 min), medium spreading (about 300 to
1000 mm2/10 min) and high-spreading oils (above 1000 mm2/10 min)."
(Ansmann 1:24--27 .)
11. Meffert discloses "compositions ... [that] have a liquid to gel-
like consistency." (Meffert 2 i-f 41.)
(Id.)
12. Meffert states that
[t]his is generally understood as meaning rheological properties
\vhich range from thin-liquid via pasty/ointment-like to gel-like.
The viscosity of the liquid compositions is preferably in a range
from about 1 to 6000 mPas. "Gel like consistency" is shown by
compositions which have a higher viscosity than a liquid and
which are self-supporting, i.e. they retain a shape given to them
without a shape-stabilizing coating. In contrast to solid
formulations, however, gel-like formulations can be readily
deformed under the application of gravitational forces. The
viscosity of the gel-like compositions is preferably in a range
greater than 600 to about 60 000 mPas.
Analysis
We agree with the Examiner that the method of claim 21 on appeal
would have been obvious based on the cited references. Eini discloses a
method of treating a skin disorder, such as allergic inflammation, by
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applying to the skin a cosmetic composition comprising a carrier and an
active substance (FF4, FF5).
Eini' s carrier comprises a hydrophobic solvent and a solidifying agent
(FF4). Eini states that the hydrophobic solvent can be mineral oil, olive oil,
or hempseed oil (FF6). Appellants' Specification states that these oils have
viscosities between 43.9 mPas and 98 mPas (FF2). Eini discloses that its
combination of a solidifying agent with a hydrophobic solvent results in a
composition that is semi-solid at rest and liquefies when subjected to shear
forces (FF8).
Ansmann discloses that low-spreading cosmetic oil bodies have
spreading below 300 mm2/10 min and medium-spreading oil bodies have
spreading from 300 to 1000 mm2/10 min (FFlO). Meffert discloses
compositions that range from liquid to pasty/ointment-like to gel-like (FFl 1,
FF12). Meffert states that its liquid compositions have a viscosity of 1 to
6000 mPas, and its gel-like compositions have a viscosity of 600 to 60,000
mPas (FFl 1).
We agree with the Examiner that it would have been obvious to a
person of ordinary skill in the art to formulate Eini' s composition to have the
viscosity and spreading coefficient required for the lipid phase recited in
claim 21. Specifically, Ansmann discloses that cosmetic oil bodies with
spreading below 800 mm2 /10 min, as recited in claim 21, are classified as
either low-spreading or medium-spreading. It would have been obvious to
formulate Eini' s composition to be low-spreading, or at most medium-
spreading (and therefore with a spreading coefficient of less than 800
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mm2/10 min) because Bini discloses that its composition is intended to be
semi-solid when at rest.
In addition, it would have been obvious to use mineral oil, olive oil, or
hempseed oil as the hydrophobic solvent in Bini's composition because Bini
expressly suggests doing so. Appellants' Specification provides evidence
that these oils have viscosities on the low end of what is required by claim
21, so Bini's solidifying agent would be expected to increase the viscosity, if
it changed the viscosity at all. Appellants' Specification suggests that
rheological modifiers and lipid thickeners can be used to change the
viscosity of the lipid phase of the claimed preparation (FF3).
Thus, it is reasonable to conclude that the addition of a solidifying
agent to Bini's composition would not increase the viscosity above the range
recited in claim 21. Meffert confirms this expectation, since it states that its
gel-like compositions can have viscosities ranging from 600 mPas to 60,000
mPas. We therefore conclude that the method of claim 21 would have been
obvious based on Bini, Ansmann, and Meffert.
Appellants argue that the Specification states that spreading
coefficients are determined by dripping the substance to be tested onto a
filter paper, and therefore claim 21 requires a liquid preparation, not one that
is semi-solid at rest as disclosed by Bini. (Appeal Br. 7.)
This argument is unpersuasive. Appellants have pointed to no
evidence to support their position that a semi-solid composition could not be
tested for spreading in the assay described in the Specification. To the
contrary, Meffert discloses that gel-like compositions, which are reasonably
understood to be similar to Bini's semi-solid composition, "can be readily
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deformed under the application of gravitational forces" (FF12). It is
reasonable to expect, in the absence of evidence to the contrary, that a
composition that can be readily deformed by gravity could be dripped onto a
filter paper. Appellants' Specification, in fact, states that the lipid phase that
is tested for spreading can include thickeners (FF3).
Appellants also argue that Ansmann "would discourage the use of
low-spreading cosmetic oil bodies because 'only a less marked feel of
smoothness is achieved which remains virtually unchanged over a prolonged
period'." (Appeal Br. 11.)
This argument is also unpersuasive, because the Examiner's rejection
is not based on combining a low-spreading cosmetic oil body with Bini's
composition, but on modifying Eini' s composition to have a spreading
coefficient corresponding to that of low-spreading cosmetic oil bodies, based
on Eini' s description of its composition as being semi-solid at rest. (See
Ans. 5: "[O]ne skilled in the art would be motivated to formulate the
preparation of Eini with a spreading coefficient of less than about 300
mm2/10 min.") Thus, whether Ansmann discourages the use of low-
spreading oil bodies per se is not germane to the basis of the rejection.
Finally, with regard to claim 21, Appellants argue that Meffert is
contradictory, because it states that liquids have a viscosity of up to 6000
mPas, while gels have a viscosity of 600-60,000 mPas (Appeal Br. 127).
7 In addition to the argument summarized above, Appellants argue that they
have provided evidence regarding the viscosities of several liquid
substances. (Appeal Br. 12-13.) We have not considered the cited web sites
because their contents were not included in an Evidence Appendix, nor do
they appear to have been submitted to the Examiner previously. Since
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Appellants argue that, based on Meffert, a composition with a viscosity of
600-6000 mPas "qualifies as both a liquid and a (self-supporting) gel. It is
apparent that a substance which is a liquid cannot at the same time be a
(self-supporting) gel." (Id.)
This argument is also unpersuasive. Meffert makes clear that its
compositions span a spectrum "from thin-liquid via pasty/ointment-like to
gel-like" (FF12). Thus, no particular viscosity can be identified that marks a
transition from liquid to gel-like (or semi-solid). Meffert also states that its
gel-like compositions "can be readily deformed under the application of
gravitational forces" (FF12). Thus, we agree with the Examiner that "a thick
liquid could also be characterized as a thin gel, and thus there may be
overlap in terms of their respective viscosities." (Ans. 12.)
With regard to claim 34, Appellants argue that Bini's disclosure of
"water, surfactants and emulsifiers as examples of hundreds, if not
thousands of optional components which may be present in the compositions
disclosed therein does not render it obvious to one of ordinary skill in the art
to provide the compositions of EINI in the form of emulsions." (Appeal Br.
15.) Appellants present the same argument with respect to claim 3 6 (and
claims that depend from it). (Id. at 16-17.)
We agree with Appellants that the Examiner has not provided
sufficient evidence to show that it would have been obvious to formulate
Eini' s composition as an emulsion. The Examiner points to Eini' s
disclosure that its composition "may further include a variety of
Appellants' argument is apparently based on evidence that is not of record, it . .
1s unpersuasive.
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pharmaceutical or cosmetic ingredients, which ... may be selected from the
group consisting of water, surfactants, emulsifiers, diglycerides," etc. (FF9).
The Examiner reasons that "if water, surfactants and/or emulsifiers are
present in the composition of Eini, the composition would be expected to be
present as an emulsion." (Ans. 15.) The Examiner's position appears to be
that the presence of water, surfactants, and/or emulsifiers in Bini's
composition would inherently produce an emulsion. The Examiner,
however, points to no evidence supporting this position, and an "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, 1380 (Fed. Cir. 2012) (alterations in original). We therefore
reverse the rejection of claims 34 and 36. Claims 37-39 depend from claim
36; we therefore reverse the rejection of these claims for the same reason.
Conclusion of Law
The cited references would have made obvious a composition
comprising a lipid phase having the characteristics recited in claim 21.
The Examiner has not shown that the cited references would have
made obvious an emulsion, as required by claims 34 and 36-39.
Claims 22-28 and 30-33 have not been argued separately and
therefore fall with claim 21. 37 C.F.R. § 41.37(c)(l)(iv).
II
Issue
The Examiner has rejected claims 29, 35, and 40 under as obvious
based on Eini, Ansmann, Meffert, and Tamarkin. With regard to claim 40,
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Application 12/360,684
which depends from claim 36, we agree with Appellants (Appeal Br. 17)
that, for the reasons discussed above in regard to claim 36, the Examiner has
not shown that the cited references would have made obvious an emulsion,
as required by claim 40.
With regard to claims 29 and 35, the Examiner finds that Eini teaches
that its composition can include a variety of optional ingredients, including
water and stabilizers. (Ans. 7.) The Examiner finds that Tamarkin discloses
a thixotropic composition comprising water (10-85%) and a stabilizer (0.1-
5%). (Id.) The Examiner concludes that it would have been obvious to
include water and a stabilizer in Eini' s composition, in amounts within the
ranges disclosed by Tamarkin, because Tamarkin discloses that those
amounts provide for thixotropic properties. (Id. at 7-8.)
Appellants contend that Tamarkin discloses foamable compositions
"which are completely different from the compositions of EINI." (Appeal
Br. 17.) Appellants also contend that the Examiner's statement that the
disclosed amounts of water and stabilizer "denote thixotropic properties" is
not supported by the cited passage of Tamarkin. (Id. at 18-19.) Finally,
Appellants argue that Tamarkin discloses that its composition avoids a semi-
solid texture, in contrast to Eini' s composition. (id. at 19.)
The issue with respect to this rejection is whether a person of ordinary
skill in the art would have considered it obvious to include water and a
stabilizer in the claimed amounts in Eini' s composition, based on the
disclosures of Eini and Tamarkin.
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Findings of Fact
13. Eini discloses that optional ingredients, such as water and
stabilizing agents, can be included in its composition "in order to fine-tune
the consistency of the formulation, protect the formulation components from
degradation and oxidation and bestow their cosmetic acceptability." (Eini
19:62---65.)
14. Tamarkin discloses "cosmetic or pharmaceutical foam products,
comprising a high concentration of particulate matter, suitable for treatment
of skin conditions." (Tamarkin 1 i-f 2.)
15. Tamarkin discloses that, "[i]n one or more embodiments of [its]
invention," the composition comprises, among other things, about 10-85%
water and "stabilizer/gelling agent in a concentration sufficient to stabilize
the solid in the composition, yet low enough to avoid formation of a semi-
solid texture." (Tamarkin 1 i-fi-17-12.)
16. Tamarkin states that, "according to one or more embodiments of
the present invention, the gelling/stabilizing agent is present in a
concentration in the range of about 0.1 % to about 5% (wt) of the foamable
composition." (Id. at 4 i-f 56.)
17. Tamarkin states that, "[i]n an embodiment, the gelling agent or
agents denote thixotropic properties to the composition, a semi-solid gel
state at rest and liquid or viscous liquid under shear." (Id. at 4 i-f 57.)
Analysis
We agree with the Examiner that the disclosures of Eini and Tamarkin
would have suggested including in Eini' s composition water and a stabilizer
within the amounts recited in claims 29 and 35. Eini expressly suggests
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water and stabilizing agents as optional ingredients (FF9), which are
included "in order to fine-tune the consistency of the formulation, protect the
formulation components from degradation and oxidation and bestow their
cosmetic acceptability" (FF13). Tamarkin discloses a composition with
thixotropic properties (FFl 7), containing 10-85% water (FF15) and 0.1-5%
of a stabilizing agent. Thus, it would have been obvious to include amounts
of water and stabilizer within these ranges in Eini' s composition, based on
Bini's suggestion that they are optional ingredients and Tamarkin's
disclosure that such amounts are consistent with a thixotropic composition.
Appellants argue that Tamarkin's compositions are completely
different from Eini' s, because Tamarkin describes it compositions as
foamable and Eini does not. (Appeal Br. 17-18.)
This argument is unpersuasive, because the Examiner's rejection is
not based on physically combining Tamarkin's entire composition with
Eini' s. The Examiner cites Tamarkin as evidence that amounts of water and
stabilizer that are encompassed by claims 29 and 35 would have been
obvious components in Bini's thixotropic composition. For the reasons
discussed above, that conclusion is supported by the cited evidence.
Appellants also argue that Tamarkin does not describe the water in its
composition as denoting thixotropic properties on the composition. (Id. at
18-19.) This argument is factually correct-Tamarkin states that "the
gelling agent or agents denote thixotropic properties" (FF 17}-but irrelevant
to the rejection. Bini's composition includes ingredients that result in its
thixotropic properties, and suggests including water as an optional ingredient
for other reasons (FF13). Thus, Eini provides ample reason to include water
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in its composition regardless of whether Tamarkin suggests doing so in order
to denote thixotropic properties.
Finally, Appellants argue that Tamarkin discloses avoiding amounts
of stabilizer/gelling agent that result in a semi-solid texture. (Appeal Br.
19.)
This argument is also unpersuasive, because (as the Examiner found
(Ans. 7-8)), Tamarkin expressly suggests amounts of stabilizer that are
encompassed by claim 29 (FF 16), and suggests including stabilizer in order
to "denote thixotropic properties to the composition, a semi-solid gel state at
rest and liquid or viscous liquid under shear" (FFl 7). Thus, Tamarkin
expressly suggests embodiments of its composition that, like Eini' s
composition, have thixotropic properties.
Conclusion of Law
A person of ordinary skill in the art would have considered it obvious
to include water and a stabilizer, in the amounts recited in claims 29 and 35,
in Eini' s composition, based on the disclosures of Eini and Tamarkin.
SUMMARY
We affirm the rejection of claims 21-28 and 30-33 under 35 U.S.C.
§ 103(a) based on Eini, Ansmann, and Meffert.
We reverse the rejection of claims 34 and 36-39 under 35 U.S.C.
§ 103(a) based on Eini, Ansmann, and Meffert.
We affirm the rejection of claims 29 and 35 under 35 U.S.C. § 103(a)
based on Eini, Ansmann, Meffert, and Tamarkin.
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We reverse the rejection of claim 40 under 35 U.S.C. § 103(a) based
on Eini, Ansmann, Meffert, and Tamarkin.
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
KRH
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