Ex Parte Johnson et al

Patent Trial and Appeal Board

Aug 15, 2016

11726020 (P.T.A.B. Aug. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111726,020 0312012007
26813 7590 08/16/2016
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
FIRST NAMED INVENTOR
Clarence Albert Johnson
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.
365.00170101 6489
EXAMINER
CRAIGO, BAHAR ALA WI
ART UNIT PAPER NUMBER
1673
MAILDATE DELIVERY MODE
08/16/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLARENCE ALBERT JOHNSON
and JOHN A. ST. CYR
Appeal2014-006745
Application 11/726,020
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a skin
repair composition. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify the Real Party in Interest as Bioenergy, Inc.
(also known as RiboCor, Inc.) (see App. Br. 1).
Appeal2014-006745
Application 11/726,020
Statement of the Case
Background
The "skin shows signs of damage such as sunburn, roughening,
wrinkling, loss of tone, discoloration, and even malignancies ... While these
effects are often considered to be normal aging, in fact, they are not normal
results of aging but are responses to damage" (Spec. 1 :7-11 ).
The Specification teaches that the "need remains for a composition to
be applied topically to stimulate the growth of epidermal and dermal cells,
thereby improving the condition of the skin and repairing damaged skin"
(Spec. 4:11-13).
The Claims
Claims 16, 18, 20, 23, 25-30, and 32-34 are on appeal. Claim 16 is
representative and reads as follows:
16. A composition comprising (a) 0.1%to10% weight by
volume of an effective agent comprising a monosaccharide, and
(b) a penetrant selected from the group consisting of ethanol,
butanol, propanol, and sodium lauryl sulfate, dissolved in
water; wherein the monosaccharide consists of D-ribose; and
wherein the composition is effective for improving and
repairing skin.
The issues
A. The Examiner rejected claims 16, 18, 20, 23, 25-30, and 32-34 under
35 U.S.C. § 103(a) as obvious over Lorant2 and Al-Saidan3 (Ans. 3---6).
2 Lorant, R., US 6,638,519 Bl, issued Oct. 28, 2003 ("Lorant").
3 Al-Saidan et al., Formulation of an HPMC Gel Drug Reservoir
System with Ethanol-Water as a Solvent System and limonene as a
Penetration Enhancer for Enhancing in vitro Transdermal
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Application 11/726,020
B. The Examiner rejected claims 16, 18, 20, 23, 25-30, and 32-34 under
35 U.S.C. § 103(a) as obvious over Lorant, Al-Saidan, and Tsuzuki4 (Ans.
6-9).
C. The Examiner rejected claims 16, 18, 20, 23, 25-30, and 32-34 under
35 U.S.C. § 103(a) as obvious over Lorant, Al-Saidan, and Bornis-Blasco5
(Ans. 9-12).
Because the same issue is dispositive for all three of these rejections,
we will consider the rejections together.
The Examiner finds that "Lorant teaches a composition comprising at
least one sugar or sugar derivative, wherein the sugar includes ribose ...
Lorant teaches the composition can be used to treat and protect the skin"
(Ans. 3). The Examiner acknowledges that "Lorant does not expressly
disclose a penetrant dissolved in water" but finds that Al-Saidan teaches
"penetration enhance[r]s permit drugs to permeate through the skin at an
appropriate rate for a suitable time" (Id.).
The Examiner finds it obvious to "formulate the D-ribose with a
penetrant comprising ethanol dissolved in water because Al-Saidan et al.
Delivery of Nicorandil, 17 SKIN PHARMACOL. PHYSIOL. 310-320
(2004) ("Al-Saidan").
4 Tsuzuki et al., Effect of primary alcohols on percutaneous
absorption, 46 INT. J. PHARMACEUTICS 19-23 (1988) ("Tsuzuki").
5 Borras-Blasco et al., A mathematical approach to predicting the
percutaneous absorption enhancing effect of sodium lauryl
sulphate, 269 INT. J. PHARMACEUTICS 121-129 (2004)(" Borras-
Blasco").
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Appeal2014-006745
Application 11/726,020
teach this co-solvent system greatly enhances permeation of active drugs
across the skin barrier" (Ans. 5).
Appellants "submit that the teachings of Al-Saidan et al., as a whole,
would not motivate one of skill in the art to modify Lorant to use ethanol
dissolved in water as a penetrant" (Br. 4).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's reason to combine the penetrant of Al-Saidan
with the D-ribose composition of Lorant as required by claim 16?
Findings of Fact
1. Lorant teaches:
a method selected from the group including treating, protecting,
caring for, removing make-up from, and cleaning at least one
selected from the group including the skin, lips and hair, and
combinations thereof, which method includes applying the
above-described composition to the skin, lips or hair. Another
embodiment of the invention provides a method for treating or
caring for at least one selected from the group including dry
skin, dry lips, sensitive skin, and combinations thereof which
includes applying to at least one selected from the group
including dry skin, dry lips, sensitive skin, and combinations
thereof-1.]
(Lorant 2: 12-23).
2. Lorant teaches "to provide a composition for topical
application, and in particular a cosmetic composition, that contains a sugar
and/or sugar derivative, but which does not impart a sticky feeling to the
skin" (Lorant 1 :55---60).
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Application 11/726,020
3. Lorant teaches that "[p]referable sugars, which can be used in
the composition of the invention include, for example ... ribose" (Lorant
5:25-27).
4. Al-Saidan teaches that "[ s ]everal solvents either alone or in
various proportions with other solvents ( cosolvents) are being investigated
as solvent systems to overcome the low permeation of drugs through the
skin ... the use of cosolvents, as a solvent system, may exert a profound
influence on the percutaneous delivery of drugs" (Al-Saidan 313, col. 2).
5. Tsuzuki teaches that butanol functions as a penetration
enhancer for indomethacin (see Tsuzuki 21, table 1).
6. Borras-Blasco teaches that "SLS and Azone® have been used
as [penetration] enhancers" (Borras-Blasco 128, col. 2).
Principles of Law
"' [R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness."' KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
(citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
Analysis
While the Examiner establishes that D-ribose would be a desirable
component of a composition for cleaning skin or treating dry skin (FF 1 ), the
Examiner provides no reason to incorporate a penetrant into a D-ribose
containing composition. Indeed, while Lorant specifically identifies active
components that may be incorporated in the composition (see Lorant 8:36-
51 ), Lorant never indicates that these active components need to penetrate
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Application 11/726,020
the skin. Moreover, Lorant provides three exemplary compositions (see
Lorant 9:55 to 11:14), but the Examiner does not establish that any of these
compositions comprises an ingredient that must penetrate the skin for
efficacy.
We recognize that Al-Saidan provides strong reasons to include a
penetrant in compositions containing drugs that must penetrate the skin (FF
4), but the Examiner has provided no evidence on this record that D-ribose is
such a drug, that D-ribose must penetrate the skin for any effect whatsoever,
or that Lorant's compositions should otherwise contain such a drug
compound. Without such evidence, there is no articulated reasoning to
combine a D-ribose containing makeup removing or dry skin composition
with a penetrant.
Conclusion of Law
The evidence of record does not support the Examiner's reason to
combine the penetrant of Al-Saidan with the D-ribose composition of Lorant
as required by claim 16.
SUMMARY
In summary, we reverse the obviousness rejections.
REVERSED
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