Ex Parte Plott

Patent Trial and Appeal Board

Jun 12, 2013

11347708 (P.T.A.B. Jun. 12, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/347,708 02/02/2006 R. Todd Plott 06-40030-US 4384
7590 06/12/2013
William J. McNichol, Jr., Esquire
Reed Smith LLP
Intellectual Property
P.O. Box 7990
Philadelphia, PA 19101
EXAMINER
BADIO, BARBARA P
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
06/12/2013 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 R. TODD PLOTT1
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Appeal 2012-001618
Application 11/347,708
Technology Center 1600
__________

Before ERIC GRIMES, JOHN G. NEW, and SHERIDAN K. SNEDDEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
corticosteroid treatment method, which have been rejected for anticipation
and obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellant states that the Real Party in Interest is Medicis Pharmaceutical
Corp. (Appeal Br. 3).
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Application 11/347,708

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STATEMENT OF THE CASE
“Topical glucocorticoid preparations have been divided in the field
into seven classes based on potency. . . . Class 1 includes the most potent,
while class 7 contains the least potent.” (Id. at 2:2-5.) “Fluocinonide is a
synthetic corticosteroid with clinically proven anti-inflammatory and anti-
pruritic therapeutic efficacy.” “It is one member of a large class of
gluococorticoids [sic] which are used topically.” (Spec. 3:10-14.)
“The interdependent feedback mechanism between the hypothalamus
(responsible for secretion of corticotrophin-releasing factor), the pituitary
gland (responsible for secretion of adrenocorticotropic hormone), and the
adrenal cortex (which secretes cortisol) is termed ‘the hypothalamic-
pituitary-adrenal (HPA)-axis.’ The HPA-axis may be suppressed by topical
corticosteroids.” (Id. at 3:21 to 4:2.)
The Specification states that the “risk of corticosteroid-induced HPA
axis suppression is presumed to be greater in the pediatric population than in
adults. As a result of this increasing risk with increasing potency,
corticosteroids of greater potency are generally not recommended for use in
pediatric patients.” (Id. at 4:14-17.) The Specification discloses, however,
that “[f]luocinonide (0.1% cream), formulated as a class I steroid,
administered once daily does not result in suppression of the HPA-axis in
patients 3 months to <18 years of age” (id. at 6:12-14).
Claims 1, 2, 4-9, 11-15, and 17-33 are on appeal. Claim 1 is
representative and reads as follows:
1. A method of treating pediatric patients suffering from a
corticosteroid-responsive inflammatory or pruritic skin disorder comprising
topically applying Class I fluocinonide composition to an affected area of a
Appeal 2012-001618
Application 11/347,708

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patient in need thereof wherein said application does not result in clinically
significant HPA-axis suppression.
The claims stand rejected as follows:
• Claims 1, 2, 19, and 20 under 35 U.S.C. § 102(e) as anticipated by
McCadden2 (Answer 4); and
• Claims 1, 2, 4-9, 11-15, and 17-33 under 35 U.S.C. § 103(a) as
obvious based on McCadden and Gans3 (Answer 5).
I.
The Examiner has rejected claims 1, 2, 19, and 20 as anticipated by
McCadden (Answer 4). The Examiner finds that McCadden teaches “the
use of high-, mid- or low-potency corticosteroids that provide the desired
therapeutic effect with little or no risk of causing atrophy of the skin,
induction of telangieclasia [sic] or, in infants, suppression of hypothalamic-
pituitary-adrenal axis (HPA) (see section 0023)” (id.).
Appellant argues that McCadden teaches that “high potency steroid
compositions (such as those including fluocinonide) ‘[i]f applied to large
surface areas on infants, ... can cause systemic effects with suppression of
hypothalamic-pituitary-adrenal axis.’ McCadden at ¶ 24. In a population of
infant patients, use of high potency corticosteroids does cause HPA-axis
suppression in the prior art.” (Appeal Br. 12.) Appellant argues that
McCadden does not teach every limitation of the claimed method because
“Applicant’s claims exclude any clinically significant HPA axis suppression
from its patient population” (id. at 14).

2 McCadden, US 2005/0191366 A1, published Sept. 1, 2005.
3 Gans et al., US 2004/0198709 A1, published Oct. 7, 2004.
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Application 11/347,708

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We agree with Appellant that the Examiner has not shown that
McCadden identically discloses the claimed method. McCadden discloses a
“composition for topical treatment . . . which contains a corticosteroid of the
appropriate potency for the condition being treated” (McCadden 1-2, ¶ 11).
McCadden states that the “corticosteroid preferably provides the desired
therapeutic effect with little or no risk of causing atrophy of the skin,
induction of telangieclasia [sic] or, in infants, suppression of hypothalamic-
pituitary-adrenal axis” (id. at 2, ¶ 23).
McCadden discloses that
[f]or pediatric patients . . . low potency steroids are generally
preferred in view of certain disadvantages of high-potency
steroids. Fluorinated steroids . . . can cause undesirable effects
including skin atrophy, rebound phenomenon and
telangiectasia. If applied to large surface areas on infants, they
can cause systemic effects with suppression of hypothalamic-
pituitary-adrenal axis.
(Id. at 3, ¶ 24.) McCadden provides a list of exemplary low-potency steroids
(id. at 3, ¶¶ 25-35), which does not include fluocinonide.
McCadden also states that “[s]ome cases of contact dermatitis and
conditions in . . . non-pediatric patients require a fluorinated mid-potency
steroid or high-potency steroid for effective treatment” (id. at 3, ¶ 42).
McCadden provides a list of “fluorinated mid-potency steroids and high-
potency steroids” (id.), which does include fluocinonide (id. at 4, ¶ 56).
Thus, McCadden does not expressly describe topical application of
fluocinonide to pediatric patients; expressly suggests other, low-potency
steroids for that use; and warns against the undesirable effects – including
“systemic effects with suppression of hypothalamic-pituitary-adrenal axis” –
that can result from using fluorinated steroids like fluocinonide on pediatric
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Application 11/347,708

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patients. We therefore agree with Appellant that McCadden does not
describe each and every limitation of claim 1 or claim 19, which include the
same relevant limitations. Claims 2 and 20 depend on claims 1 and 19,
respectively. We therefore reverse the rejection of claims 1, 2, 19, and 20 as
anticipated by McCadden.
II.
The Examiner has rejected all of the claims on appeal as obvious
based on McCadden and Gans (Answer 5). The Examiner relies on the same
findings with respect to McCadden, and finds that Gans discloses “the use of
topical corticosteroids as dermatological agents” (id.) and use of a vehicle
comprising at least two penetration enhancers and a solvent and/or
emulsifier, as required by some of the claims on appeal (id.). The Examiner
concludes that the references would have made obvious “the use of a
composition comprising 0.1% fluocinonide and a vehicle as taught by Gans
for treating skin disorders such as atopic dermatitis in infants without the
suppression of HPA axis” (id. at 6).
Appellant argues that “McCadden identifies the problem of HPA axis
suppression when fluorinated steroids are applied to infants . . . [and] notes
that low potency steroids are preferred in pediatric patients for this reason”
(Appeal Br. 16). Appellant notes that “McCadden discloses fluocinonide as
an exemplary mid or high-potency corticosteroid to treat ‘non-pediatric’
patients but . . . only discloses low-potency corticosteroids to treat pediatric
patients” (id.). Appellant also argues that Gans would not have prompted
those of ordinary skill in the art to combine its teachings with McCadden so
as to result in the claimed method (id. at 17).
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Application 11/347,708

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We agree with Appellant that the Examiner has not persuasively
shown that the claimed methods would have been obvious based on the
disclosures of McCadden and Gans. As discussed above, McCadden directs
those skilled in the art to low-potency corticosteroids for use in pediatric
patients, and classifies fluocinonide as a fluorinated mid- or high-potency
steroid (McCadden 3, ¶ 42; 4, ¶ 56). McCadden, in fact, warns that using
such steroids on pediatric patients can cause undesirable effects, including
“systemic effects with suppression of hypothalamic-pituitary-adrenal axis”
(id. at 3, ¶ 24). The Examiner has not identified a persuasive reason – taught
by either McCadden or Gans, or within the general knowledge of those
skilled in the art – that would have led a skilled worker to disregard the
warnings of McCadden and nonetheless treat pediatric patients with
fluocinonide.
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). That burden has not been carried here, and we therefore reverse the
rejection of the claims on appeal as obvious based on McCadden and Gans.
SUMMARY
We reverse both of the rejections on appeal.

REVERSED

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