Ex Parte Dow et al

Patent Trial and Appeal Board

Nov 19, 2013

11408105 (P.T.A.B. Nov. 19, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
11/408,105 04/20/2006 Gordon J. Dow 767.0087 8949
29085 7590 11/19/2013
HOWARD EISENBERG, ESQ.
1220 LIMBERLOST LANE
GLADWYNE, PA 19035
EXAMINER
KANTAMNENI, SHOBHA
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
11/19/2013 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 GORDON J. DOW and DANIEL M. STEWART
__________

Appeal 2012-009861
Application 11/408,105
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 31-76. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.

1 The Real Parties in Interest are Dow Pharmaceutical Sciences, Inc. and
Dermalogix Partners, Inc. (App. Br. 3.)
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STATEMENT OF THE CASE
The claims are directed to a method for treating psoriasis. Claim 71 is
representative of the claims on appeal, and reads as follows:
71. A method for treating an individual suffering from psoriasis,
comprising
spraying onto skin afflicted with two or more psoriasis plaques a
sprayable composition comprising 0.005% to 0.05% by weight of clobetasol
propionate, an emollient compound, and a volatile solvent,
wherein the composition is sprayed onto the afflicted plaques daily for
at least 4 weeks, and
wherein the spraying onto the skin for 4 weeks does not result in a
significant change in the incidence of systemic side effects compared to that
obtained by spraying the composition onto the skin daily for only two
weeks.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 31-42, 59, and 62-76 in view of Crutchfield2 and Clobex3
(Ans. 2);
• Claims 31-76 in view of Seidel4 and Clobex (Ans. 2); and
• Claims 31, 34-37, 45, and 71-76 in view of Crutchfield WWW5
(Ans. 2).

2 Crutchfield, III, US 6,579,512 B2, issued Jun. 17, 2003.
3 Clobex (clobetasol propionate) Lotion, 0.05%, (Galderma Laboratories
2004).
4 Seidel, US 5,972,920, issued Oct. 26, 1999.
5 Charles E. Crutchfield III, (World Wide Web Journal), The Temporal
Dermatohistopathologic Examination of Human Psoriatic Skin Treated with
a Novel Topical Liquid Formulation Containing Clobetasol Propionate
(Sept. 9, 2010), http://www.epress.com/w3jbio/vol3/crutchfield/paper.htm
(“Crutchfield WWW”).
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I.
Issue
The Examiner has rejected claims 31-42, 59, and 62-76 under 35
U.S.C. § 103(a) as obvious in view of Crutchfield and Clobex (Ans. 2). The
claims have not been argued separately and, therefore, stand or fall together.
37 C.F.R. § 41.37(c)(1)(iv). We focus our analysis on claim 71, and claims
31-42, 59, 62-70, and 72-76 stand or fall with that claim.
The issues presented are: Does the preponderance of the evidence of
record support the Examiner’s conclusion that Crutchfield and Clobex would
have rendered obvious the claim 71 psoriasis treatment method such that
“spraying … the skin for 4 weeks does not result in a significant change in
the incidence of systemic side effects compared to that obtained by spraying
… the skin daily for only two weeks”? If so, have Appellants provided
sufficient evidence of unexpected results, that when weighed with the
evidence of obviousness, is sufficient to support a conclusion of
nonobviousness?
Findings of Fact
FF1. The Specification teaches that the “invention relates to a method
for treating psoriasis with clobetasol” (Spec. 1). Specifically, the
Specification discloses a “spray formulation of clobetasol propionate 0.05%”
(id. at 5).
FF2. The Examiner finds that Crutchfield discloses a psoriasis
treatment method that comprises spraying a “composition consisting of
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clobetasol propionate, an alcohol such as ethanol, and emollient such as
isopropyl myristate” onto the skin of a mammal (OA6 2-3).
FF3. The Examiner finds that Crutchfield discloses that the
composition contains clobetasol propionate “in an amount of 0.01 to 10%
(%w/w), preferably … 0.05 % (%w/w)” (id. at 3).
FF4. The Examiner finds that “Crutchfield also teaches that ‘Patients
who do not respond after 1 to 4 weeks of treatment should be reevaluated’
i.e [teaches that the] pharmaceutical composition consisting of clobetasol
propionate can be employed for 4 weeks” (id.).
FF5. More Specifically, Crutchfield discloses a treatment
composition for “inflammatory skin conditions [that] consists essentially of
clobetasol propionate, an alcohol, a propellant, and isopropyl myristate,
suitable for topical administration” (Crutchfield, col. 2, l. 66 – col. 3, l. 2).
FF6. Crutchfield discloses that the inflammatory skin condition may
be psoriasis (id. at col. 3, ll. 47 - 66, claims 1 and 8).
FF7. Crutchfield discloses that “[p]referably, the clobetasol
propionate is present in about 0.01 to 10% (%w/w). . . . Most preferably . . .
in the amount of 0.05% (%w/w)” (id. at col. 3, ll. 6-10).
FF8. The Examiner notes that “Crutchfield does not explicitly teach
that the composition . . . is employed for at least 4 weeks” (OA 3).
FF9. The Examiner finds that Clobex discloses a “0.05 % clobetasol
propionate lotion . . . for the treatment of . . . psoriasis, [such that] localized

6 Office Action (Non-Final Rejection) mailed Dec. 19, 2011, referred to
herein as “OA.”
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lesions that have not sufficiently improved after the initial 2-week treatment
. . . may be treated for up to 2 additional weeks” (OA 3-4).
F10. More specifically, Clobex discloses a lotion containing clobetasol
propionate (0.05% w/w) for dermatologic use (Clobex 1, paragraph titled
“Description”).
FF11. Clobex discloses that the lotion
contains a super-high potent topical corticosteroid; therefore
treatment should be limited to … 2 consecutive weeks for the
relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses . . . and up to 2 additional
weeks in very localized lesions of . . . psoriasis … that have not
sufficiently improved after the initial 2 weeks of treatment … .

(Id. at 2 (emphasis omitted), paragraph titled “Dosage and Administration.”)
FF12. Clobex discloses that, for the treatment of psoriasis, “localized
lesions … that have not sufficiently improved after the initial 2-week
treatment . . . may be treated for up to 2 additional weeks. Any additional
benefits of extending treatment should be weighed against the risk of HPA
axis suppression before prescribing for more than 2 weeks” (id. at 1,
paragraph titled “Indications and Usage”).
FF13. The Examiner concludes that it would have been obvious to a
person of ordinary skill in the art to use the Crutchfield spray composition to
treat psoriasis for four weeks because both Crutchfield and Clobex disclose
four week treatment regimens and because one of ordinary skill in the art
would have arrived at four week treatment regimen “because the
optimization of result effect parameters . . . [such as] dosing duration is …
within the skill of the artisan, involving merely routine skill in the art” (OA
4).
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FF14. Appellants have provided a declaration under 37 C.F.R.
§ 1.132 (Declaration of Jeffrey Sugarman, filed May 12, 2011, App. Br. 27).
FF15. Dr. Sugarman declares that his Declaration provides “expert
testimony concerning HPA (hypothalamus-pituitary-adrenal) axis
suppression, the seriousness of this condition, and the potential of topically
administered corticosteroids, especially superpotent corticosteroids such as
clobetasol, to induce HPA axis suppression” (Sugarman Decl., ¶ 2 and ¶¶ 3-
10).
FF16. Dr. Sugarman declares that the “likelihood that a topically
administered corticosteroid will produce HPA suppression is increased in
relation to the duration of therapy, the amount of corticosteroid that is
applied, the body surface area to which the corticosteroid is applied, and the
potency of the corticosteroid” (id. at ¶ 11).
FF17. Dr. Sugarman declares that the “most potent group of
corticosteroids used topically to treat skin dis[e]ases includes those referred
to as superpotent corticosteroids. Included in the superpotent corticosteroids
are halobetasol and clobetasol” (id.).
FF18. Dr. Sugarman describes a comparison of the “incidence of
HPA axis suppression in adults following treatment with clobetasol lotion or
cream formulations, as reported in Cook, and with a spray formulation, as
reported in the prescribing information for Clobex® spray” as shown in
Table 1 below:

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(Id. at ¶ 13.)7
FF19. Dr. Sugarman declares that the data shows that the “incidence
of HPA axis suppression was shown to be markedly lower when treatment
was with a spray formulation of clobetasol than with either a lotion or cream
formulation” (id.).
FF20. Dr. Sugarman declares that it
[I]s especially noted that the incidence of HPA axis suppression
was not higher in the spray treatment groups after 4 weeks than
it was after only two weeks and that the incidence of HPA axis
suppression in the spray formulation group was lower after four
weeks of treatment than it was in the groups treated with other
clobetasol formulations after only two weeks.

(Id.)
FF21. The Specification discloses the clinical evaluation of the
following spray formulation: clobetasol propionate (0.05% w/w); ethanol
(92.8% w/w) (49.25 w/w%); isopropyl myristate (50.30%); sodium lauryl
sulfate (0.1% w/w); and undecylenic acid (0.3%) (Spec. 15:15-16:2).

7 Denise Cook, M.D., Rx Topical Corticosteroids: HPA Axis Suppression
and Cutaneous Effects, FOOD AND DRUG ADMINISTRATION (FDA)
NONPRESCRIPTION DRUGS ADVISORY COMMITTEE AND THE DERMATOLOGIC
AND OPHTHALMIC DRUGS ADVISORY COMMITTEE (March 24, 2005).

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F22. The Specification discloses that a safety evaluation after four
weeks of treatment showed that there “was no clinically detectable HPA axis
suppression” (id. at 20:3).
FF23. The Specification discloses that the “increase of the treatment
period from 2 to 4 weeks increased clinical benefit with additional clearing
and improvement of disease with no substantial change in the safety profile”
(id. at 20:6-9).
FF24. The Specification discloses that isopropyl myristate is an
emollient compound (id. at 7:12).
Analysis
Appellants argue that the Examiner erred in asserting that the
Crutchfield disclosure that “the composition is most effective and easily
tolerated by patients when administered in a spray form by means of a
propellant”8 suggests a better safety profile (App. Br. 14-16). Appellants
cite Leyden9 and Tan10 as providing evidence that “the term ‘tolerability’ as
used in the art refers to the subjective perceptions of local
comfort/discomfort that an individual experiences when a topical medication
is applied to the skin … [and the] term does not refer to un-sensed systemic
adverse effects, such as HPA axis suppression” (id. at 14).
That argument is not persuasive. As noted by the Examiner,
Crutchfield indicates that the compositions may be used from one to four

8 Crutchfield, col. 2, ll. 47-49.
9 James Leyden et al., Tolerability of clindamycin/tretinoin gel vs. Tretinoin
microsphere gel and adapalene gel, 8 J. DRUGS DERMATOLOGY 383 (2009).
10 Jerry Tan, New Developments in the Topical Management of Acne,
SUPPLEMENT TO DERMATOLOGY TIMES 23-30 (2011).
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weeks, thus the ordinary artisan would have had a reason to employ the
composition for four weeks (Ans. 5). Moreover, as noted by the Examiner
(id.), as Crutchfield teaches using a spray composition having the same
concentration of clobetasol propionate as required by claim 71, and also
suggests its use from 1 to 4 weeks, it would inherently have the property of
not resulting in a significant change in the incidence of systemic side effects.
See In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (“It is a general
rule that merely discovering and claiming a new benefit of an old process
cannot render the process again patentable.”); see also Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005) (noting that the
realization of a new benefit of an old process does not render that process
patentable); Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246
F.3d 1368, 1376 (Fed. Cir. 2001) (stating in the context of a claimed process
that was drawn to the same use comprising the same steps of the prior art,
“[n]ewly discovered results of known processes directed to the same purpose
are not patentable because such results are inherent.”).
Appellants argue that “prior to the present application, because of the
high incidence of systemic toxicity (i.e. HPA axis suppression), it was not
possible for a patient with severe psoriasis to obtain this more effective
treatment by utilizing a topical formulation of clobetasol propionate for long
durations of 4 weeks or more” (App. Br. 17). Appellants argue that “prior
art preparations of clobetasol propionate have been determined to cause an
unacceptable level of serious systemic side effects which increase upon
prolonged administration, especially when applied to a substantial portion of
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the surface area of the body, which is the common situation in psoriasis”
(id.).
This argument is not persuasive. Claim 71 does not require the
application of the formulation spraying onto a substantial portion of the
surface area of the body but only to two or more plaques. Additionally,
since the Crutchfield sprayable composition is comparable to the instantly
claimed sprayable composition, i.e. 0.05% clobetasol propionate in a
sprayable ethanol/isopropyl myristate carrier (FF2, 3, and 7), one of skill in
the art would expect that the systemic side effects would be comparable.
Appellants argue that Olux, Temovate, Cook, and PDR provide
evidence that “all prior art formulations of clobetasol, propionate, other than
a spray formulation, produce unacceptably high levels of HPA axis
suppression” (App. Br. 17-18).
This argument is not persuasive because the Examiner’s prima facie
case of obviousness cites Crutchfield, which is directed to a spray
composition that is comparable to the spray composition of instant claim 71,
and thus one of skill in the art would expect the Crutchfield spray
composition to have the properties as instantly claimed.
Appellants argue that the prescribing information for Clobex® spray,11
“a clobetasol spray formulation that is identical to that . . . illustrated in the
examples of the present application … [discloses that] [t]he incidence of
suppression following use … for 2 weeks was 19% and after 4 weeks the
incidence was substantially unchanged at 15 to 20%” (App. Br. 20).

11 Clobex (clobetasol propionate) Spray, 0.05%.
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Appellants argue that these “unexpected advantageous properties are not
disclosed or suggested” by Crutchfield (id. at 21).
This argument is not persuasive. Here, as discussed above, the
combination of Crutchfield and Clobex suggest a psoriasis treatment for four
weeks with the Crutchfield spray composition. Additionally, as discussed
above, the Crutchfield sprayable composition is comparable to the instantly
claimed and tested spray composition and thus would be expected to have
similar side effects. Thus, Appellants appear to be claiming a newly-
recognized benefit of an old process.
Appellants argue that they “have shown unexpected advantageous
properties of the presently claimed method . . . [i.e.] no significant change in
the incidence of systemic side effects when the composition is sprayed onto
skin daily for 4 weeks compared to when the skin is sprayed . . . for only two
weeks” (App. Br. 26).
This argument is not persuasive. The burden of demonstrating
unexpected results rests on the party asserting them. In addition, “when
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.” In re
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Appellants cite a First Study in the Specification (citing the Spec. at
pages 11-14) as showing that no adverse events occurred when “27 subjects
with plaque psoriasis were treated for 4 weeks with the spray formulation of
the invention” (App. Br. 20). Appellants also cite a Second Study in the
Specification (citing the Spec. at pages 15-20) as showing treatment of “a
larger patient pool with moderate to severe plaque psoriasis affecting at least
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2% of the body surface area. The spray formulation . . . was applied twice
daily for 4 weeks to the lesions. . . . ‘There was no clinically detectable HPA
axis suppression.’” (Id.)
This evidence cited in the Specification is not sufficient to establish
unexpected results because there was no comparison with Crutchfield, the
closest prior art.
Appellants further cite the Sugarman Declaration as providing
evidence of unexpected results (App. Br. 27). Appellants cite a comparison
described in the Sugarman Declaration in which the incidence of
suppression of the HPA axis, after two weeks and four weeks, was compared
between clobetasol propionate spray, cream and lotion preparations (id.).
Again, this evidence is not sufficient to establish unexpected results.
Crutchfield discloses a sprayable composition that consists essentially of
clobetasol propionate, a volatile solvent, a propellant, and an emollient
compound, which is comparable to the composition of claim 71. Clobex
lotion, in contrast, contains clobetasol propionate (0.05%) in a vehicle base
composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene
glycol 300 isostearate, carbomer 1342, sodium hydroxide, and purified
water. The composition of clobetasol cream (i.e. Temovate E Cream) does
not appear to be of record. Thus, the Crutchfield sprayable composition
would be the closest prior art for a comparison to establish unexpected
results, and Appellants evidence is not sufficient to establish unexpected
results because there was no comparison with the closest prior art.
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Thus, we affirm the rejection of claim 71 as being obvious in view of
Crutchfield and Clobex. Claims 31-42, 59, 62-70, and 72-76 fall with claim
71. 37 C.F.R. § 41.37(c)(1)(iv).
Conclusion of Law
The preponderance of the evidence of record supports the Examiner’s
conclusion that Crutchfield and Clobex would have rendered obvious the
claim 71 psoriasis treatment method such that “spraying … the skin for 4
weeks does not result in a significant change in the incidence of systemic
side effects compared to that obtained by spraying … the skin daily for only
two weeks.” Appellants have not provided evidence of unexpected results,
that when weighed with the evidence of obviousness, is sufficient to support
a conclusion of nonobviousness.
II.
Issue
The Examiner has rejected claims 31-76 under 35 U.S.C. § 103(a) as
obvious in view of Seidel and Clobex (Ans. 2). The claims have not been
argued separately and, therefore, stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(iv). We focus our analysis on claim 71, and claims 31-70 and
72-76 stand or fall with that claim.
The issues presented are: Does the preponderance of the evidence of
record support the Examiner’s conclusion that Seidel and Clobex would
have rendered obvious the psoriasis treatment method of claim 71 such that
“spraying … the skin for 4 weeks does not result in a significant change in
the incidence of systemic side effects compared to that obtained by spraying
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… the skin daily for only two weeks?” If so, have Appellants provided
sufficient evidence of unexpected results, that when weighed with the
evidence of obviousness, sufficient to support a conclusion of
nonobviousness?
Additional Findings of Fact
FF25. The Examiner finds that Seidel discloses a topical psoriasis
treatment method using a spray “formulation comprising about 0.05 % by
weight of clobetasol propionate; 0.1 % by weight of … sodium lauryl
sulfate; 0.3 % by weight of undecylenic acid; and a carrier formed from a
combination of two components in a volume ratio of about 50/50” (OA 12).
FF26. The Examiner finds that Seidel discloses that the first carrier
component “is selected from ethyl alcohol, isopropyl alcohol, and [the]
second component is isopropyl myristate” (id.).
FF27. The Examiner finds that the compositions were “used over a
period of 14 days, reversed the [treated] skin conditions” (id.).
FF28. More specifically, Seidel discloses the example composition
shown in Table 3, which contained, by weight percent, 0.05% clobetasol
propionate, 99.6 % isopropyl myristate/ethyl alcohol (50/50 vol.), 0.25%
zinc pyrithione (Seidel, col. 6, ll. 47-57).
FF29. Seidel discloses that the result of an evaluation of the
composition showed that the composition was “[s]prayable; no lingering
odor; no complaints of harshness; positive results in approximately 80% of
patients tested” (id. at col. 6, ll. 55-57).
FF30. The Examiner relies on Clobex as set forth above.
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FF31. The Examiner concludes that it would have been obvious to a
person of ordinary skill in the art to employ the Seidel composition for at
least 4 weeks on “skin . . . afflicted with two or more psoriasis plaques”
because Clobex teaches that lesions that have not improved after treatment
with a lotion containing 0.05% clobetasol propionate may be treated for up
to 2 additional weeks (Ans. 10).
Analysis
Appellants argue that Seidel discloses therapy duration of fourteen
days, which reversed the skin condition in all users, and thus there is no
suggestion of a treatment period of longer than fourteen days (App. Br. 23).
Appellants argue that Seidel’s disclosure suggests that “the formulations are
not hazardous when used ... for brief durations such as the 14 days
disclosed” (id. at 23-24).
This argument is not persuasive. When Seidel is taken in view of
Clobex, one of skill in the art would have found it obvious that, at least for
very localized lesions, the Seidel spray could be applied for four weeks as
directed in Clobex since the Seidel spray has the same active ingredient at
the same concentration as the Clobex lotion.
Appellants also argue that evidence of unexpected results has
overcome any prima case of obviousness (App. Br. 26-28). The evidence
and arguments presented are the same as those discussed above with regard
to the rejection of the claims in view of Crutchfield and Clobex.
This argument is not persuasive. Seidel discloses a sprayable
composition that is comparable to the instantly claimed and tested
composition and that contains, by weight percent, 0.05% clobetasol
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propionate, 99.6 % isopropyl myristate/ethyl alcohol (50/50 vol.) and 0.25%
zinc pyrithione. Although the Seidel composition also contains zinc
pyrithione, this compound is not a corticosteroid,and Appellants have not
explained why zinc Pyrithone would be expected to affect the HPA axis as it
is not a corticosteroid. Thus, the Seidel composition would be the closest
prior art for comparison to establish unexpected results rather than the
clobetasol lotion or the clobetasol cream (Temovate E Cream) discussed in
the Sugarman Declaration.
Thus, we affirm the rejection of claim 71 as being obvious in view of
Seidel and Clobex. Claims 31-70 and 72-76 fall with claim 71. 37 C.F.R.
§ 41.37(c)(1)(iv).
Conclusion of Law
The preponderance of the evidence of record supports the Examiner’s
conclusion that Seidel and Clobex would have rendered obvious the claim
71 psoriasis treatment method such that “spraying . . . the skin for 4 weeks
does not result in a significant change in the incidence of systemic side
effects compared to that obtained by spraying . . . the skin daily for only two
weeks.” Appellants have not provided sufficient evidence of unexpected
results, that when weighed with the evidence of obviousness, sufficient to
support a conclusion of nonobviousness.
III.
Issue
The Examiner has rejected claims 31, 34-37, 45, and 71-76 under
35 U.S.C. § 103(a) as obvious in view of Crutchfield WWW (Ans. 2). The
claims have not been argued separately and, therefore, stand or fall together.
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37 C.F.R. § 41.37(c)(1)(iv). We focus our analysis on claim 71, and claims
31, 34-37, 45, and 72-76 stand or fall with that claim.
The issues presented are: Does the preponderance of the evidence of
record support the Examiner’s conclusion that Crutchfield WWW would
have rendered obvious the psoriasis treatment method of claim 71 such that
“spraying … the skin for 4 weeks does not result in a significant change in
the incidence of systemic side effects compared to that obtained by spraying
… the skin daily for only two weeks?” If so, have Appellants provided
sufficient evidence of unexpected results, that when weighed with the
evidence of obviousness, sufficient to support a conclusion of
nonobviousness?
Additional Findings of Fact
FF32. The Examiner finds that Crutchfield WWW discloses a
psoriasis treatment method that comprises spraying skin twice daily with a
liquid spray composition “consisting of clobetasol propionate (0.05 % w/v),
an alcohol, emollient such as isopropyl myristate, zinc pyrithione, [and a]
detergent” (OA 17).
FF33. The Examiner finds that Crutchfield WWW also discloses a 42
day treatment period and “that the liquid spray composition is more effective
than equal strength corticosteroids based in cream or ointment vehicles”
(Crutchfield WWW 17-18).
FF34. More specifically, Crutchfield WWW discloses that a patient
was treated for “a psoriatic plaque on his abdomen, twice per day, with a
spray containing the active ingredient clobetasol propionate, 0.05% (in a
vehicle containing isopropyl myristate, alcohol and detergent)” (id. at 1-2).
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FF35. Crutchfield WWW discloses that the “treatment period was 42
days …. Clinical clearing occurr[ed] at day 21” (id. at 2).
FF36. Crutchfield WWW discloses that “[t]opical potent
corticosteroids in a novel liquid vehicle containing detergent, alcohol, zinc
pyrithione, and emollient appear[ ] to be a very effective treatment for
psoriasis. This preparation seems to be more effective than equal strength
corticosteroids based in cream or ointment vehicles” (id. at 3).
FF37. The Examiner finds that Crutchfield WWW “does not
explicitly teach that the composition therein is employed onto the skin
afflicted with psoriasis affecting … two or more psoriasis plaques” (OA 18).
FF38. The Examiner concludes that it would have been obvious to a
person of ordinary skill in the art to spray the Crutchfield WWW
composition onto skin afflicted with two or more psoriasis plaques because
Crutchfield WWW also teaches that the disclosed spray composition is more
“effective than equal strength corticosteroids based in cream or ointment
vehicles” (Crutchfield WWW 3).
Analysis
Appellants argue that Crutchfield WWW discloses the treatment of a
single psoriatic lesion, and it is well known “that the incidence of serious
adverse side effects related to topical corticosteroid use is related both to
duration of treatment and . . . body surface area treated” (App. Br. 25).
Appellants argue that “one of skill in the art would not understand the
teaching of Crutchfield WWW, which pertains to treatment of a single
psoriasis lesion . . . to be any type of a refutation of the established dogma
that, due to the high incidence of systemic side effects associated with . . .
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corticosteroid formulations, the use of such formulations should be limited
in duration” (id. at 25-26).
This argument is not persuasive because claim 71 does not require the
treatment of a large body surface area, but only the treatment of skin
afflicted with two psoriatic lesions.
Appellants also argue that evidence of unexpected results has
overcome any prima case of obviousness (App. Br. 26-28). The evidence
and arguments presented are the same as those discussed above with regard
to the rejection of the claims in view of Crutchfield and Clobex.
This argument is not persuasive. Crutchfield WWW discloses a
sprayable composition that is comparable to the instantly claimed and tested
composition and that consists of clobetasol propionate (0.05 % w/v), an
alcohol, emollient such as isopropyl myristate, zinc pyrithione, and a
detergent. Although the Crutchfield WWW composition also contains zinc
pyrithione, this compound is not a corticosteroid, and, as noted above,
Appellants have not explained why the ordinary artisan would expect it to
affect the HPA axis. Thus, the Crutchfield WWW composition would be the
closest prior art for comparison to establish unexpected results rather than
the clobetasol lotion or the clobetasol cream (Temovate E Cream) discussed
in the Sugarman Declaration.
Thus, we affirm the rejection of claim 71 as being obvious in view of
Crutchfield WWW, and claims 31, 34-37, 45, and 72-76 fall with claim 71.
37 C.F.R. § 41.37(c)(1)(iv).
Appeal 2012-009861
Application 11/408,105

20
Conclusion of Law
The preponderance of the evidence of record supports the Examiner’s
conclusion that Crutchfield WWW would have rendered obvious the claim
71 psoriasis treatment method such that “spraying … the skin for 4 weeks
does not result in a significant change in the incidence of systemic side
effects compared to that obtained by spraying … the skin daily for only two
weeks.” Appellants have not provided sufficient evidence of unexpected
results that when weighed with the evidence of obviousness, sufficient to
support a conclusion of nonobviousness.
SUMMARY
We affirm the rejections of claims 31-76 under 35 U.S.C. § 103(a).
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

cdc