Ex Parte Patel

Board of Patent Appeals and Interferences

Feb 24, 2009

10425359 (B.P.A.I. Feb. 24, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PRAVIN M. PATEL
__________

Appeal 2008-5302
Application 10/425,359
Technology Center 1600
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Decided:1 February 24, 2009
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Before DONALD E. ADAMS, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal2 under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1-19. We have jurisdiction under 35
U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
2 This Appeal was heard on Tuesday, February 3, 2009.
Appeal 2008-5302
Application 10/425,359

STATEMENT OF THE CASE
The claims are directed to a topical skin composition. Claim 1 is
representative of the claims on appeal, and reads as follows:
1. A topical composition for the treatment of skin conditions, said
composition comprising:
a liposomal vehicle comprising a lipid phase disposed in an aqueous
phase;
an antibiotic disposed in said aqueous phase; and
a retinoid disposed in said lipid phase.
The Examiner relies on the following evidence:
Mezei 4,761,288 Aug. 2, 1988
Abra 5,945,122 Aug. 31, 1999
Naeff WO 98/30215 July 16, 1998

Ch. C. Zouboulis et al., “A multicentre, single-blind, randomized
comparison of a fixed clindamycin phosphate/tretinoin gel formulation
(Velac®) applied once daily and a clindamycin lotion formulation
(Dalacin T®) applied twice daily in the topical treatment of acne vulgaris”,
143 BRITISH JOURNAL OF DERMATOLOGY 498-505 (2000).

We affirm.

ISSUE
The Examiner concludes that claims 1-19 are rendered obvious by the
combination of Naeff, Zouboulis, Mezei, and Abra.
Appellant contends that the technical background of the claims on
appeal is complex, involves more than the simple substitution of one known
element for another, and arises in a field where unpredictability of results is
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more common than predictability, and further contends that the combination
relied upon by the Examiner in fact teaches away from the claimed
composition.
Thus, the issue on Appeal is: Has Appellant demonstrated that the
Examiner erred in combining Naeff, Zouboulis, Mezei, and Abra to arrive at
the claimed invention?

FINDINGS OF FACT
FF1 According to the Specification, the invention is drawn to the treatment
of skin conditions, such as acne (Spec. 1).
FF2 The Specification teaches that prior art therapies often include a
combination of antibiotics and/or retinoids in combination with other active
agents such as antibiotics, but that phase separation or chemical degradation
may occur in such compositions, affecting their efficacy and shelf-life (id. at
2). Thus, combination therapies have been employed wherein separate
topical compositions are employed, or a combination of topical and oral
therapy has been used (id.)
FF3 Thus, as taught by the Specification, the compositions of the present
invention include a liposomal vehicle, comprising a discontinous lipid phase,
dispersed in a continuous aqueous phase, wherein an antibiotic such as
clindamycin is disposed in the aqueous phase, and a retinoid, such as
tretinoin, is disposed in the lipid phase (id. at 3).
FF4 The Examiner rejects claims 1-19 under 35 U.S.C. § 103(a) as being
obvious over the combination of Naeff, Zouboulis, Mezei, and Abra (Ans.
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3). As Appellant does not argue the claims separately, we focus our analysis
on claim 1, and claims 2-19 stand or fall with that claim. 37 C.F.R.
§ 41.37(c)(1)(vii).
FF5 The Examiner cites Naeff for teaching “liposomally encapsulated
topical trentinoin formulations for the treatment of acne.” (Ans. 3 (citing
Naeff Abstract, Examples, and Claims).)
FF6 The Examiner also finds that Naeff teches the inclusion of an
antibiotic, such as clindamycin, in the composition (id. (citing Naeff 8)).
FF7 Naeff also teaches that inclusion of the tretinoin in a liposome
increases its stability and extends its shelf life (Naeff 3).
FF8 Naeff teaches that other substances that have theurapeutic activity on
the skin, such as clindamycin, may be included in the liposome compositions
(id. at 8).
FF9 The Examiner notes that what is “lacking in [Naeff] is the inclusion of
. . . clidamycin in an unencapsulated form.” (Ans. 3.)
FF10 The Examiner cites Zouboulis for its teaching of a gel of clindamycin
phosphate/tretinoin for the treatment of acne, and that the inclusion of
clindamycin reduces the irritant activity of tretinoin (id. (citing Zouboulis
Abstract, p. 499)).
FF11 The Examiner notes that in Zouboulis, neither the clindanycin nor the
tretinoin are encapsulated in a liposome (Ans. 3).
FF12 Specifically, Zouboulis teaches a clindamycin 1%/tretinoin 0.025%
gel formulation (Zouboulis Abstract).
FF13 The Examiner cites Mezei for its teaching of a multiphase liposome
composition containing an active agent or agents, such as clindamycin and
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tretinoin, wherein the active agents are present in both encapsulated and
unencapsulated form (Ans. 4).
FF14 The Examiner also cites Mezei for teaching formulating the
composition into a gel (id.)
FF15 The Examiner notes that “Mezei . . . does not teach the combination of
two agents, one in free form and the other in an encapsulated form.” (Ans.
4.)
FF16 The Examiner cites Abra for teaching anti-tumor agents encapsulated
in a liposome, and for teaching that the composition can contain a second
agent which is present in unencapsulated form (id.).
FF17 Specifically, Abra teaches that the combination therapy may include
the anti-tumor agent, in this case cisplatin, in combination with another
chemotherapeutic, which may be present in free form or liposome-entrapped
form (Abra col. 7, ll. 36-40).
FF18 The Examiner concludes:
The inclusion of clindamycin in the liposomal
compositions of [Naeff] would have been obvious to one of
ordinary skill in the art since clindamycin is known to reduce
the irritant activity of tretinoin and the use of the combination
of tretinoin and clindamycin for the treatment of acne as evident
from Zouboulis [ ]. Administration of a composition in which
clindamycin is in an unencapsulated form would have been
obvious to one of ordinary skill in the art with a reasonable
expectation of success because of the advantages taught by
Mezei and because of Abra’s suggestion that free drugs can be
administered together with liposomally encapsulated drugs.

(Ans. 4.)

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PRINCIPLES OF LAW
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l v. Teleflex Inc., 550 U.S. 398, ___, 127 S. Ct. 1727, 1741 (2007). “The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” Id. at 1739.
An “[e]xpress suggestion to substitute one equivalent for another need not be
present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301
(CCPA 1982). Moreover, “[w]hen there is a design need or market pressure
to solve a problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue the known
options within his or her technical grasp. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill and
common sense.” KSR, 127 S. Ct. at 1742.

ANALYSIS
Citing KSR, Appellant argues that in determining obviousness, where
the “‘interrelated teachings of multiple patents’” must be looked to, “the
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path to achieving the claimed invention from the pieces of prior art is often
more difficult and complex than simply substituting one prior element for
another.” (App. Br. 9.) Appellant contends that, “in sharp contrast to the
KSR case, the technical background to the claims on appeal is much more
complex, involves far more than the simple substitution of one known
element for another, and arises in a field where unpredictability of results is
more common than predictability.” (Id.) According to Appellant, “it is very
relevant to the patentability of the claims at issue that the prior art has
implemented every possible combination of antibiotics, retinoids, and
liposomes except for the specific combination which comprises Appellant’s
invention.” (Id. at 10.) According to Appellant, the Examiner has not met
the burden of explaining how the present composition is a predictable
variation of the compositions taught by the prior art (id. at 11; see also 13-
15).
Appellant’s arguments are not convincing. As Appellant notes, the
prior art teaches or suggests virtually every combination of encapsulated
and/or free liposome and/or retinoid except for the claimed combination.
Thus, Naeff suggests encapsulating both the tretinoin and clindamycin in a
liposome (FF6, FF9), Zouboulis teaches the use of a composition wherein
both the tretinoin and clindamycin are in free form (FF11), and Mezei
teaches a composition wherein the tretinoin and clindamycin are each
present in encapsulated form and free form (FF13). The compositions are all
useful for the treatment of acne (see, e.g., FF5, FF10).
As Appellant notes, one combination that is not explicitly taught by
the prior art is one in which the retinoid is encapsulated in a liposome and
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the antibiotic, clindamycin, is in free form. Abra, however, demonstrates the
level of skill in the art, and teaches that in combination therapy, one active
agent may be present in liposome-encapsulated form and the second active
agent may be present in unecapsulated form (FF16, FF17).
Thus, we agree with the Examiner (see FF18) that it would have been
obvious to form a composition in which the retinoid, tretinoin, is
encapsulated in a liposome, and the antibiotic, clindamycin, is present in free
form. The ordinary artisan would have encapsulated the tretinoin in a
liposome because Naeff teaches that inclusion of the tretinoin in a liposome
increases its stability and extends its shelf life (FF7), and the inclusion of
clindamycin in either free or encapsulated form would have been two
obvious alternatives.
Appellant argues further that the prior art teaches away from the
claimed composition (App. Br. 11). Appellant argues that the Examiner
states that when one combines Mezei with Naeff, “‘one of ordinary skill in
the art would be motivated to obtain a prolonged and sustained release
action as well as the combined effect of both the retinoid and the
antibiotic,’” which would suggest combining both the retinoid and the
antibiotic in a liposome, which would provide both the sustained release and
combined action (id. at 12-13 (quoting Final Rejection 5)). Appellant argues
further that a composition wherein both the retinoid and antibiotic and
contained in the liposome would be simpler to prepare than the claimed
composition, and thus, the prior art in fact teaches away from the claimed
composition (App. Br. 13).
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“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 applicant’s invention. A statement that a particular
combination is not a preferred embodiment does not teach away absent clear
discouragement of that combination.” Syntex (USA) LLC v. Apotex, Inc.,
407 F.3d 1371, 1380 (Fed. Cir. 2005) (citations deleted). In the instant case,
Appellant does not point to any reason or evidence that one would not want
to use the antibiotic, clindamycin, in free form, while the retinoid, tretinoin,
is present in encapsulated form. Moreover, while Appellant argues that a
composition wherein both the retinoid and antibiotic and contained in the
liposome would be simpler to prepare than the claimed composition, no
evidence is presented to that effect, and arguments of counsel cannot take
the place of evidence in the record. In re Scarbrough, 500 F.2d 560, 566
(CCPA 1974).

CONCLUSIONS OF LAW
We conclude that Appellant has not demonstrated that the Examiner
erred in combining Naeff, Zouboulis, Mezei, and Abra to arrive at the
claimed invention.
We thus affirm the rejection of claims 1-19 under 35 U.S.C. § 103(a)
as being obvious over the combination of Naeff, Zouboulis, Mezei, and
Abra.

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TIME LIMITS
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
LP

GIFFORD, KRASS, SPRINKLE, ANDERSON & CITKOWSKI, P.C
PO BOX 7021
TROY MI 48007-7021
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