Ex Parte 6905675 et al

Board of Patent Appeals and Interferences

Jan 21, 2009

90008068 (B.P.A.I. Jan. 21, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte MEDICIS PHARMACEUTICAL CORPORATION,
Patent Owner and Appellant
____________________

Appeal 2008-5830
Reexamination Control No. 90/008,068
U.S. Patent 6,905,675
Technology Center 3900
____________________

Decided: January 21, 2009
____________________

Before CAROL A. SPIEGEL, DONALD E. ADAMS, and
ROMULO H. DELMENDO, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL

I. Statement of the Case
This is an appeal under 35 U.S.C. §§ 134 and 306 from an Examiner’s
final rejection of claims 1-4, 8-11, 15-20, 23-26, and 35-39, as subsequently
amended 11 September 2007 (App. Br.1 5-6; Ans.2 2). The Examiner has
indicated claims 5-7, 12-14, 21, 22, 27, and 28, the only other pending

1 Appeal Brief filed 1 October 2007 ("App. Br.").
2 Examiner's Answer mailed 12 February 2008 ("Ans.").
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claims, as patentable and/or confirmed (id.). We have jurisdiction under 35
U.S.C. § 306. We AFFIRM.
The subject matter on appeal is directed to cleanser compositions
comprising about 5% sulfur3 and about 10% sodium sulfacetamide for
topical treatment of skin conditions including rosacea and acne. Illustrative
compositions claims 1 and 15 read (App. Br. 37 and 40, Claims App'x4):
1. A composition suitable for topical
application to human skin or hair, comprising:
Sulfur at about 5% by weight; Sodium
sulfacetamide at about 10% by weight; and a
pharmaceutically acceptable carrier; wherein the
carrier is a cleanser and the composition has a pH
of from about 6.5 to about 8.1.
15. A composition for treating acne rosacea
comprising:
a. sulfur at about 5% by weight and sodium
sulfacetamide at about 10% by weight; and
b. a pharmaceutically acceptable carrier,
wherein the carrier is a cleanser.
Illustrative method claims 23 and 16 for treating acne rosacea recite (a)
applying the composition of claim 1 and 15, respectively, to the skin of a
user and (b) "removing the composition from the skin by rinsing within a
few minutes after being applied to the skin" (App. Br. 40-41, Claims App'x).

3 All references to "%" in this opinion are to weight percent, unless specified
otherwise.
4 The Claims Appendix to the Appeal Brief erroneously numbered claims 35
through 39 as claims 34 to 38. Compare these misnumbered claims to the
amended claims appended to the Response to Office Action filed 11
September 2007 and entered by the Examiner in the Advisory Action mailed
28 September 2007.
2
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The Examiner has rejected claims 1-4, 8-11, 15-20, 23-26, and 35-39
as unpatentable under 35 U.S.C. § 103(a) over
(i) Cetaphil in view of Novacet Lotion, Sulfacet Lotion, or Trice and
Wortzel and Connors, "as evidenced by the Product Information of
Cetaphil," and
(ii) Novacet Lotion, Sulfacet Lotion, or Trice in view of Cetaphil,
Wortzel and Connors, "as evidenced by the Product Information" (Ans. 4).5
The Examiner relies on the following references of record:
Martin H. Wortzel, MD "A New Sulfanilylacetamide Detergent Suspension
for Seborrhea Capititis," Clinical Medicine, Vol. 7, 991-994, (Clinical
Medicine Publication, Inc. May 1960): ("Wortzel").

E.Randolph Trice, MD, "Treatment of Acne Vulgaris with Secomat®-S
Lotion," Virginia Medical Monthly, Vol. 93, 78-79 (Medical Society of
Virginia, February 1966): ("Trice").

Kenneth.A. Connors et al., CHEMICAL STABILITY OF
PHARMACEUTICALS: A HANDBOOK FOR PHARMACISTS,
"Sulfacetamide," 311-317 (John Wiley & Sons, New York, 1979)
("Connors").

PHYSICIANS' DESK REFERENCE, "Cetaphil® Lotion," 1587, 31 ed.
(Medical Economics Data Production Company, 1977), ("Cetaphil").

PHYSICIANS' DESK REFERENCE, "Sulfacet-R® Acne Lotion," 934-935
47 ed. (Medical Economics Data Production Company, 1993), ("Sulfacet
Lotion").

5 The Examiner has withdrawn the rejections of (1) claims 1-3, 8-10, 15, and
17-19 as unpatentable under 35 U.S.C. § 102(b) over Tarimci (Journal of
Clinical Pharmacy and Therapeutics, 22(4):300-303 (August 1997), and (2)
claims 1-4, 8-11, 15-20, and 23-26 as unpatentable under 35 U.S.C. 102(b)
over Novacet Lotion (PDR, 1994, p. 998) (Ans. 3).
3
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PHYSICIANS' DESK REFERENCE, "Novacet® Lotion," 998-999, 48 ed.
(Medical Economics Data Production Company, 1994), ("Novacet Lotion").

Galderma Canada, "Cetaphil® Product Info," (2002-2007),
http://www.cetaphil.ca/prodinfo.cfm (downloaded January 2007) ("Cetaphil
Product Information").

Galderma Canada, "Cetaphil® Skin Basics,"
http://www.cetaphil.ca/skinbasics.cfm (downloaded 7 February 2008) ("Skin
Basics").6

In addition to Cetaphil, Sulfacet Lotion, Novacet Lotion, Trice,
Wortzel, Connors, and Cetaphil Production Information, Appellant relies on:
U.S. Patent 4,847,071, Photoprotection Compositions Comprising
Tocopherol Sorbate and an Anti-Inflammatory Agent, issued 11 July 1989,
to Bissett et al. ("Bissett").

Declaration of Rodger Bogardus, dated 31 May 2007 ("Bogardus Decl.").

Declaration of Harold B. Hopfenberg, Ph.D., dated 31 May 2007
("Hopfenberg Decl.").

Declaration of Guy F. Webster, M.D., Ph.D., dated 31 May 2007 ("Webster
Decl.").

Essentially, the Examiner concluded that it would have been obvious
to provide a known rosacea acne treatment medicament, i.e., 5% sulfur and
10% sodium sulfacetamide as taught by Novacet Lotion, Sulfacet Lotion or
Trice in a composition having a cleanser carrier base, e.g., Cetaphil, and to

6 As noted by Appellant (Reply Brief filed 10 April 2008 ("Reply Br."), at
12n.2), the date on which Skin Basics became available on the internet is not
of record. We note the reference is indicated as having six pages (see upper
right corner page 1 of 6, e.g.). However, the only copy available to us is
missing page 6 of 6.
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use the cleanser-based composition to treat acne rosacea (Ans. 6 and 9-10).
The Examiner found Cetaphil has a balanced pH as evidenced by Cetaphil
Product Information and concluded that, in any event, it would have been
obvious to provide the cleanser-based composition with a neutral pH
because Wortzel taught sodium sulfacetamide is maximally absorbed with
minimal irritation at neutral pH (Ans. 6).
Appellant argues that the Examiner's findings and conclusions are in
error because a skilled artisan would not have characterized Cetaphil as a
cleanser (App. Br. 25-26; Reply Br.7 7-10). Appellant further argues that
the pH of Cetaphil has not been established and, even if it were a "balanced"
pH, a balanced pH is not necessarily a neutral pH and addition of active
ingredients to Cetaphil would effect its pH (App. Br. 33-35; Reply Br. 10-
13). Moreover, Appellant contends that the Examiner incorrectly equated
N-sulfanilylamide with sodium sulfacetamide (App. Br. 32; Reply Br. 15-
18). Finally, Appellant argues it would not have been obvious to use the
same concentrations of sulfur and sodium sulfacetamide used in a leave-on
composition in a rinse-off cleanser composition (App. Br. 29; Reply Br. 14-
15).
The issues in this case revolve around whether Cetaphil is a cleanser
and why an ordinarily skilled artisan would have provided a cleanser-based
composition containing about 5% sulfur and about 10% sulfacetamide with a
neutral pH.

7 Reply Brief filed 10 April 2008 ("Reply Br.").
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II. Findings of Fact ("FF")
The following findings of fact are supported by a preponderance of
the evidence of record.
A. Litigation background
[1] U.S. Patent 6,905,675 B2 ("the 675 patent," cover sheet), Sulfur
Containing Dermatological Compositions and Methods for Reducing
Malodours in Dermatological Compositions, issued 14 June 2005,
based on application 10/283,102 ("the 102 application"), filed 29
October 2002.
[2] The 102 application is a continuation of application 09/607,881, filed
30 June 2000 (the 675 patent, cover sheet).
[3] The 675 patent is assigned to Medicis Pharmaceutical Corporation
(Medicis) (the 675 patent, cover sheet).
[4] On 3 November 2005, Medicis filed suit against Upsher-Smith
Laboratories, Inc. and Prasco, L.L.C. (No. 05-3458-PHX-SMM (D.
Ariz.)) (RR8 1-2).
[5] The litigation involves claims of patent infringement and
counterclaims of patent invalidity (RR 1-2).
[6] On 16 June 2006, Medicis filed a request for ex parte reexamination
of the 675 patent, citing fifteen (15) prior art references not of record
in the file of the 675 patent said to raise a substantial new question of
patentability regarding issued claims 1-28 of the 675 patent (RR 2).

8 Request for Reexamination filed 16 June 2006 by patent owner, Medicis.
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[7] On 1 August 2006, the Patent and Trademark Office ("PTO") granted
Medicis' request for ex parte reexamination of the 675 patent
(Decision Granting Ex Parte Reexamination mailed 1 August 2006).
[8] On 19 October 2006, the district court granted Medicis' motion to stay
proceedings pending the outcome of the PTO's reexamination of the
675 patent (RLSR9 at 12).
B. The 675 patent under reexamination
[9] The 675 patent is, in part, directed to methods of reducing, inhibiting
or eliminating the unpleasant characteristic "rotten egg odor" of
sulfur-containing dermatological and cosmetic compositions which
occurs over time (675 patent 1:11-15, 33-35; 2:14-19).
[10] According to the 675 patent, the rotten egg odor may be reduced,
inhibited or eliminated by adjusting the pH of the composition to
between about 6.0 and 8.5 (675 patent abstract; 2:22-32).
[11] Exemplary dermatological and cosmetic compositions include lotions,
masks, and cleansers (675 patent 2:39-42).
[12] The 675 patent incorporates Bissett by reference for its disclosure of
the ingredients used in carriers for dermatological compositions and
carriers, such as lotions, creams, oils, gels, etc. as well as Bissett's
discussion of cleaning compositions useful in dermatological
compositions (675 patent 3:54-60).

9 Reexamination Litigation Search Report provided by the PTO 10 January
2007 ("RLSR").
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[13] Examples 1-3 of the 675 patent describe a sulfur containing lotion,
mask, and cleanser composition, respectively (675 patent 5:63-67;
7:48-53; 9:22-25).
[14] The lotion composition of Example 1 is preferably applied to human
skin once or twice daily and left on the skin (675 patent 6:66-67).
[15] The cleanser composition of Example 3 is preferably applied and
massaged into the skin surface, often with added water, for a few
minutes and then rinsed off (675 patent 10:26-28).
[16] "While on the skin and during its' [sic] removal, it is believed to
removes [sic] the excess oil, sloughed cells, live and dead
microorganisms and mites with their endotoxins and exotoxins; all of
which can be irritants that may contribute to . . . the itching, redness
and irritation that are characteristic of rosacea" (675 patent 10:28-34).
C. Definition of a cleanser
1. Bissett
[17] According to Bissett, products are classified as either cleaning
compositions or pharmaceutical/cosmetic compositions based on
variations in carrier formulations (Bissett 8:46-50).
[18] Pharmaceutical/cosmetic compositions, e.g., lotions, can be classified
into two basic types of carrier systems, i.e., solutions and emulsions
(Bissett 8:53-59; 11:47).
[19] Skin cleaning compositions comprise surfactants (Bissett 15:51-54).
[20] Exemplary surfactants useful in skin cleaning compositions include
anionic surfactants that are well-known in the detergent art, e.g.,
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sodium alkyl sulfates having an alkyl radical containing from about 8
to about 22 carbons (Bissett 16:8-21).
2. Bogardus Declaration
[21] Mr. Bogardus testified that a cleanser is a composition containing a
sufficient amount of surfactant(s) to reduce surface tension at the
external boundary of a liquid so that it can wet the skin, remove oil
from the surface, and suspend it to be rinsed away leaving the skin
clean (Bogardus Decl. ¶¶ 11, 16-18, 21, and 27).
3. Hopfenberg Declaration
[22] Dr. Hopfenberg testified that a cleanser must contain a sufficient
amount of surfactant to permit the surfactant to form structures called
micelles which encapsulate oily debris and thereby effect removal of
oily debris from the skin (Hopfenberg Decl. ¶¶ 13-16).
4. Webster Declaration
[23] According to Dr. Webster, a cleanser removes even non-water soluble
(oily) debris from the skin, while a leave-on lotion cannot remove
anything from the skin because it remains on the skin after
application, adding more debris to the skin (Webster Decl. ¶¶ 9-10).
D. The Cetaphil references
1. Cetaphil
[24] Cetaphil was published in 1977.
[25] Cetaphil is stated to be "a washable, greaseless base containing cetyl
alcohol, steryl alcohol, sodium lauryl sulfate, propylene glycol, butyl,
methyl and propyl parabens and purified water" (Cetaphil 1587).
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[26] We find that sodium lauryl sulfate is an anionic surfactant, prepared
by esterification of sulfuric acid with lauryl alcohol (C12H25OH).10
[27] According to Cetaphil, it is a "skin cleanser for atopic dermatitis and
other diseases which may be aggravated by oily and greasy substances
of animal and vegetable origin. It may be used in lieu of soap and
water" (Cetaphil 1587, emphasis added).
[28] Further according to Cetaphil, it "may also be used as a vehicle for
most drugs prescribed for topical use including . . . precipitated
sulfur, . . . sodium sulfacetamide, . . . and others" (Cetaphil 1587,
emphasis added).
[29] To use as a cleanser, "apply with the fingertips and massage gently to
produce lather. The excess may be gently removed with a soft cloth
or allowed to remain on the skin" (Cetaphil 1587).
2. Cetaphil Product Information
[30] The earliest copyright information given on Cetaphil Product
Information is 2002.
[31] According to Cetaphil Product Information, Cetaphil cleansers and
moisturizers are "pH balanced" and are suitable for use in conditions
such as acne, rosacea, and seborrheic dermatitis (Cetaphil Product
Information).
[32] Mr. Bogardus testified that "one with ordinary skill in the art cannot
determine what the pH of Cetaphil cleanser is" based on the Cetaphil
and Cetaphil Product Information references (Bogardus Decl. ¶ 28).

10 See e.g., Sodium lauryl sulfate, from Wikipedia, downloaded 5 January
2009 from http://en.wikipedia.org/w/index.php?title=Sodium-
_lauryl_sulfate&printable=yes and FF 20.
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[33] Mr. Bogardus further testified that "pH balanced" may refer to a pH of
about 5.5 (the pH of skin) or a pH of about 7.0 (neutral) or something
else (Bogardus Decl. ¶ 28).
3. Skin Basics
[34] Skin Basics was downloaded from the internet in 2008.
[35] According to Skin Basics, a pH of 7 is neutral, a pH lower than 6.5 is
acidic, and the pH of skin is slightly acidic at 5.5 to 6.0 (Skin Basics
1).
[36] Further according to Skin Basics, it is important to use a cleanser with
a neutral or acid pH which does not disrupt the acid pH of the skin or
irritate the skin (Skin Basics 1).
[37] Skin Basics discusses various Cetaphil cleansers as having pHs of 5.5-
7.0, 6.5-7.5, and 5.5-6.1 (Skin Basics 2) and Cetaphil Moisturizing
Lotion as having a pH of 5.0-6.0 (id. 4).
E. The acne rosacea lotion references
1. Novacet lotion
[38] Novacet Lotion is a composition containing 10% sodium
sulfacetamide and 5% sulfur, propylene glycol, isopropyl mysristate,
propylene glycol stearate, cetyl alcohol, PEG-8 stearate, benzyl
alcohol, sodium thiosulfate, EDTA disodium, buffering agent,
emulsifying wax and purified water (Novacet Lotion 998).
[39] Novacet Lotion is indicated for the topical control of acne vulgaris,
acne rosacea, and seborrheic dermatitis (Novacet Lotion 998).
[40] To use, apply the Novacet Lotion to affected areas 1 to 3 times daily
(Novacet Lotion 999).
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2. Sulfacet lotion
[41] Sulfacet Lotion is a composition containing 10% sodium
sulfacetamide and 5% sulfur, purified water, alkylaryl sulfonic acid
salts, hydroxycellulose [sic], propylene glycol, xanthan gum, lauric
myrtahnolamide [sic], polyoxyethylene laurate,
butylpantheothylparaben [sic], silicone emulsion, talc, zinc oxide,
titanium dioxide, attapulgite, iron oxides, pH buffers and 3-bromo-8-
propane-1,3-diol (Sulfacet Lotion 934).
[42] Sulfacet Lotion is indicated for the topical control of acne vulgaris,
acne rosacea, and seborrheic dermatitis (Sulfacet Lotion 934).
[43] To use, apply the Sulfacet Lotion to the affected areas 1 to 3 times
daily (Sulfacet Lotion 935).
3. Trice
[44] Trice discloses treating acne vulgaris, rosacea, and seborrheic
dermatitis with a "Secomat-S" lotion containing 10% sodium
sulfacetamide and 5% precipitated sulfur formulated to produce a thin,
non-sticky, drying film which is slightly tinted with iron oxide so that
it is imperceptible when applied to the skin (Trice 78).
[45] To use, cleanse the area with an astringent cleaner, wait three or four
minutes, apply Secomat-S lotion, repeat two to four times daily (Trice
78).
F. Wortzel
[46] Wortzel discloses a neutral pH (pH 7) suspension containing 5% N-
sulfanilylacetamide, 3% colloidal sulfur, and 1% salicylic acid in a
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detergent vehicle for treatment of seborrheic dermatitis, i.e., a
medicated shampoo (Wortzel 992-993).
[47] To use, massage a small amount of the suspension into the scalp for
about five minutes and rinsed out (Wortzel 993-994).
[48] Wortzel states "[s]odium sulfacetamide is highly soluble at the
physiologic pH of 7.4, a fact directly related to penetration and
absorption. Maximum absorption and minimum irritation are
achieved with solutions of a hydrogen ion concentration approaching
neutrality" (Wortzel 992).
G. N-sulfanilylacetamide versus sodium sulfacetamide
1. Connors
[49] Connors discusses the chemical and physical properties of
sulfacetamide (Connors 311-317).
[50] According to Connors, sulfacetamide has the formula C8H10N2O3S, is
also known as N-sulfanilylacetamide and p-
aminobenzenesulfonacetide, and has a molecular weight of 214.24
(Connors 311).
[51] Further according to Connors, sulfacetamide is also available as its
sodium salt (C8H9N2NaO3S·H2O) (Connors 311).
2. Hopfenberg Declaration
[52] Dr. Hopfenberg testified that N-sulfanilylacetamide and sodium
sulfacetamide are different chemical compounds with different
compositions and physical properties based on the 2005 United States
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Pharmacopeia ("USP") and ninth edition of The Merck Index
("Merck")11 (Hopfenberg Decl. ¶¶ 5-12).
[53] According to the USP, sulfacetamide has the formula C8H10N2O3S, is
also known as N-sulfanilyalacetmide, and has a molecular weight of
214.24 (USP 1815).
[54] According to the USP, the sodium salt of sulfacetamide has the
formula C8H9N2NaO3S·H2O, is also known as N-sulfanilylacetamide
monosodium salt monohydrate, and has a molecular weight of 254.24
(USP 1816).
[55] According to Merck, N-sulfanilylacetamide, also known as N-
acetylsulfanilamide, p-aminobenzenesulfonoacetamide, and
sulfacetimide [sic], has the formula C8H10N2O3S, a molecular weight
of 214.24, and is soluble in 150 parts water at 20o, in 15 parts alcohol,
in 7 parts acetone, and insoluble in ether (Merck 14)
[56] According to Merck, the sodium salt monohydrate of
sulfanilylacetamide has the formula C8H9N2NaO3S·H2O, is soluble in
1.5 parts water, and is sparingly soluble in alcohol and acetone
(Merck 14).
[57] According to Merck, N-sulfanilylacetamide is an antimicrobial and its
sodium salt is an antibacterial, topically used in veterinary medicine
for eye and skin infections (Merck 14).

11 Dr. Hopfenberg based his opinion in part on The Merck Index, 11th
edition, page 1403 (Hopfenberg Decl. ¶ 5). The file, however, contains The
Merck Index, 9th edition, page 14. We note that the asserted disclosure in
the 11th edition is found in the 9th edition, which we have considered.
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3. Finding
[58] We find that sodium sulfacetamide is the sodium monohydrate salt of
sulfanilylacetamide.
Other findings of fact follow below.
III. Discussion
A. The Examiner's findings and conclusions
The Examiner found Cetaphil is a skin cleanser that may be used as a
vehicle for most drugs prescribed for topical use, including sulfur and
sodium sulfacetamide (Ans. 6 and 10). The Examiner found Novacet
Lotion, Sulfacet Lotion, and Trice each teach treating rosacea by topical
application of compositions containing 5% sulfur and 10% sodium
sulfacetamide (Ans. 6 and 9-10). The Examiner concluded it would have
been obvious to use Cetaphil as the vehicle for the 5% sulfur and 10%
sodium sulfacetamide routinely found in compositions for treating rosacea
(Ans. 6 and 10). The Examiner found Wortzel teaches that sodium
sulfacetamide is highly soluble at a physiological pH and the maximum
absorption and minimum irritation are achieved when the solution
approaches a neutral pH (Ans. 6 and 10). The Examiner found Cetaphil
Product Information is evidence that Cetaphil has a balanced, i.e., neutral,
pH (Ans. 6 and 10). The Examiner concluded it would have been obvious to
prepare a skin cleansing composition having a neutral pH and comprising
5% sulfur and 10% sodium sulfacetamide based on the combined teachings
of Cetaphil, as evidenced by the Cetaphil Product Information, Novacet
Lotion, Sulfacet Lotion, Trice, and Wortzel to arrive at the claimed
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compositions with a reasonable expectation that the modified cleanser
composition would be effective for treating rosacea (Ans. 6-7).
Alternatively, the Examiner found that a cleaning composition is a
well known alternative to a lotion as a vehicle for delivery active
ingredients, such as sulfur and sodium sulfacetamide. The Examiner
concluded a cleansing composition comprising sulfur and sodium
sulfacetamide with a neutral pH would be expected to be efficient in the
delivery of the active ingredients for the successful treatment of rosacea
(Ans. 10).
B. Appellant's position
Appellant argues that the Examiner's findings and conclusions are in
error because a skilled artisan would not have characterized Cetaphil as a
cleanser (App. Br. 25-26; Reply Br. 7-10). Cetaphil is either used without
water, i.e., is not removed from the skin by rinsing as required by method
claims 16, 23-26, and 35-38, or it is left one the skin (App. Br. 24-25; Reply
Br. 8-9). Neither uses satisfy the definition of a cleanser, testified to by Mr.
Bogardus and Dr. Webster, which is meant to be applied to the skin, allowed
to remain for a few minutes to lift oil-soluble and water-soluble debris from
the skin, and then removed from the skin to remove the debris (App. Br. 25-
26; Reply Br. 9-10).
Appellant further argues that the pH of Cetaphil has not been
established and, even if it were a "balanced" pH, a balanced pH is not
necessarily a neutral pH and addition of active ingredients to Cetaphil would
effect its pH (App. Br. 33-35; Reply Br. 10-13). Specifically, Appellant
contends that Cetaphil Product Information is not available as prior art
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against the 675 patent and even if it were, there is no evidence that the 1997
Cetaphil is the same product as the 2002 Cetaphil product (App. Br. 33;
Reply Br. 10-11). Thus, the 1997 Cetaphil product cannot be used to
establish a prima facie case of obviousness for the claims 1-4, 8-11, 17-20,
23-26, and 37-39 containing pH limitations (Reply Br. 10). Furthermore, the
Examiner failed to provide a basis for equating a "balanced pH" with a
"neutral pH" (App. Br. 34; Reply Br. 11-12). To the contrary, Appellant
relies on the Bogardus Declaration to show that one of ordinary skill in the
art would not have known what a "balanced pH" was (App. Br. 34; Reply
Br. 11-12). Appellant notes that Skin Basics list seven Cetaphil products
with six different "balanced pH" ranges (5.5-7.0, 6.5-7.5, 5.5-6.1, 5.0-6.0,
4.5-5.5,and 5.6-6.0) (Reply Br. 11).
Appellant also contends that the Examiner incorrectly equated N-
sulfanilylamide with sodium sulfacetamide (App. Br. 32; Reply Br. 15-18).
According to Appellant, Wortzel contains two separate and distinct
teachings, i.e., one related to the absorption and irritability of sodium
sulfacetamide by what of background and the other related to a medicated
shampoo (Reply Br. 17). Nowhere does Wortzel teach sodium
sulfacetamide as a substitute for N-sulfanilylamide in a medicated shampoo
(Reply Br. 17-18).
Finally, Appellant argues it would not have been obvious to use the
same concentrations of sulfur and sodium sulfacetamide used in a leave-on
composition in a rinse-off cleanser composition (App. Br. 29; Reply Br. 14-
15). According to Appellant, leave-on lotion compositions and cleansing
compositions are not equivalent carrier vehicles for application of the same
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amount of active ingredient for achieving an identical result (App. Br. 26-29;
Reply Br. 14-15).
C. Legal principles
Claim terms are generally given their ordinary and customary
meaning. See Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Circ.
2005) (en banc). "The ordinary and customary meaning of a claim term is
the meaning that the term would have to a person of ordinary skill in the art
in question at the time of the invention." Id. at 1313.
A claimed invention is unpatentable if the differences between it and
the prior art are such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having ordinary skill
in the pertinent art. 35 U.S.C. §103(a); see also generally KSR Int'l Co. v.
Teleflex Inc., 127 S. Ct. 1727 (2007). The ultimate determination of whether
an invention would have been obvious is a legal conclusion based on
underlying findings of fact. In re Dembiczak, 175 F.3d 994, 998, abrogated
on other grounds by In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000).
Underlying facts include the scope and content of the prior art, the level of
ordinary skill in the art at the time of the invention, objective evidence of
nonobviousness, and differences between the prior art and the claimed
subject matter. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-
18 (1966). Furthermore, "[a] person of ordinary skill is . . . a person of
ordinary creativity, not an automaton." KSR, 127 S.Ct. at 1742.
"Where claimed subject matter has been rejected as obvious in view
of a combination of prior art references, a proper analysis under § 103
requires, inter alia, consideration of two factors: (1) whether the prior art
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would have suggested to those of ordinary skill in the art that they should
make the claimed composition . . . or carry out the claimed process; and (2)
whether the prior art would also have revealed that in so making or carrying
out, those of ordinary skill would have a reasonable expectation of success."
In re Vaeck, 947 F.2d 488, 492 (Fed. Cir. 1991). "Non-obviousness cannot
be established by attacking references individually where the rejection is
based upon the teachings of a combination of references." In re Merck &
Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
A publication dated after an applicant's filing date is acceptable as
evidence of characteristics of prior art products. In re Wilson, 311 F.2d 266,
268-269 (CCPA 1962) ("The board considered that the publication was
properly cited to show a state of fact. After reading the entire publication, so
do we. It [is] clearly a discussion of the properties of polyurethane foam
products generally, products made by the processes of the prior art of record
in this case. . . . As evidence of the characteristics of prior art foam products,
however, we know of no reason in law why it is not acceptable."); In re
Langer, 503 F.2d 1380, 1391 (CCPA 1974) ("the references relied on by the
examiner and the board are not cited as 'prior art' references. Indeed, the
effective date, for prior art purposes, of many of these references is
subsequent to appellant's earliest filing date. Rather, these references are
properly cited for the purpose of showing a fact under the principle of In re
Wilson . . .").
D. Analysis
One of ordinary skill in the art would have reasonably found Cetaphil
to be a cleansing composition suitable for topical administration to human
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skin or scalp based on the evidence of record. Cetaphil is expressly
characterized as a skin cleanser which may be used in lieu of soap and water
(FF 27). Cetaphil contains an anionic surfactant typically used in skin
cleansing compositions, i.e., sodium lauryl sulfate (FF 19, 20, 25, 26). Mr.
Bogardus, Dr. Hopfenberg, and Dr. Webster each testified that cleansing
compositions, by definition, must contain a surfactant in sufficient amount to
remove oily debris (FF 21-23). Since Cetaphil is stated as being useful for
diseases "which may be aggravated by oily and greasy substances" (FF 27),
one of ordinary skill in the art would have had a reasonable basis for
believing Cetaphil contained sufficient surfactant to remove oily debris.
Moreover, none of Mr. Bogardus, Dr. Hopfenberg, or Dr. Webster testified
that Cetaphil was not a cleansing composition.
There is no dispute that topical application of lotions containing 5%
sulfur and 10% sodium sulfacetamide is a well-known treatment for rosacea
(FF 38-45). There is no dispute that Cetaphil may be used as a vehicle for
most drugs prescribed for topical use, including sulfur and sodium
sulfacetamide (FF 28). Appellant does dispute the obviousness of using the
same concentrations of 5% sulfur and 10% sodium sulfacetamide used in a
lotion meant to be left on the skin in a cleansing composition meant to be
washed off of the skin in few minutes. Appellant also disputes the inherency
and the obviousness of providing the cleansing composition with a neutral
pH, i.e., a pH about 7.0.
While a publication dated after an applicant's effective filing date is
acceptable as evidence of characteristics of prior art products, the Examiner
has failed to establish that the product discussed in the 2002 Cetaphil
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Product Information is identical to the Cetaphil product of the 1977 Cetaphil
reference. Indeed, Skin Basics suggests there are various Cetaphil products
with various pH ranges, ranging from the pH of skin to the neutral pH (FF
35, 37). Thus, even assuming arguendo that Cetaphil product discussed in
Cetaphil Product Information is the identical to the 1977 Cetaphil product,
the meaning of a "balanced pH" is indeterminate. As testified by Mr.
Bogardus, a "pH balanced" may refer to a skin-balanced pH or a neutral pH
or some other pH (FF 33, 35).
However, Wortzel teaches that sodium sulfacetamide is highly soluble
at a physiological pH of 7.4, i.e., maximum penetration and absorption of
sodium sulfacetamide, with a minimum of irritation, occurs at pH
approaching neutrality (FF 48). Since sodium sulfacetamide penetrates the
skin to work, one of ordinary skill in the art might reasonably believe that
sufficient sodium sulfacetamide penetrates the skin within a few minutes of
application at a pH approaching neutrality, e.g., a pH about 7.4, that whether
it applied as a leave-on lotion or as a rinse-off cleanser may be irrelevant to
the its effectiveness as a treatment for rosacea.12 Such a belief is buttressed
by Connors' teaching that sulfacetamide, i.e., N-sulfalylacetamide, is
available as its sodium salt (FF 50, 51) and by Wortzel's teaching of a

12 Although neither the Examiner nor Appellant has discussed Bissett in full,
we note that Bissett teaches that since the active ingredient of its
photoprotective composition, tocopherol sorbate, works by penetrating the
skin, whether the composition is applied as a rub-off, wear-off or wash-off
of tocopherol sorbate is essentially irrelevant (Bissett 5:63-66). We also
note Appellant's statement that "[t]he '675 patent incorporated, by reference,
the entire disclosure of U.S. Patent 4,847,701", i.e., Bissett (App. Br. 12).
Furthermore, as noted by the Examiner, the claims do not specify any
particular degree of effectiveness in the treatment of rosacea (Ans. 17).
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medicated shampoo containing 5% N-sulfalylacetamide and 3% sulfur for
treating seborrheic dermatitis (FF 46-47), a condition which is also treatable
by Novacet Lotion, Sulfacet Lotion, and Trice (FF 39, 42, 44).
We recognize that sulfacetamide and its sodium salt are not identical
compounds. However, we are not persuaded that it would have been outside
of ordinary skill in the art to adjust the pH of a topical application
composition containing known active ingredients to a desired pH which
maximizes skin absorption while minimizing skin irritation or to determine
the minimal amount of time needed for effective absorption of active
ingredient.
Dr. Webster testified that it was surprising to him that sufficient active
ingredient (sulfur and sodium sulfacetamide) is delivered to the skin in a
cleansing composition which is removed shortly after application (Webster
Decl. ¶ 14). This testimony is insufficient to establish unexpected results at
least because it fails to address increased absorption at neutral pH.
Finally, a step of rinsing off a topically applied cleansing composition
is irrelevant to the composition claims. As to method claims 16, 23-26, and
35-38, use of a skin cleanser would have inherently suggested that it be
rinsed off several minutes of application. Although excess Cetaphil may be
gently removed with a soft cloth after being massaged into the skin (FF 29),
one of ordinary skill in the art would have recognized rinsing as an
alternative means of removing a skin cleanser to remove debris from the
skin. Indeed, Wortzel suggests massaging a small amount of its
suspension/medicated shampoo into the scalp for about five minutes and
then rinsing it out (FF 47).
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Therefore, we find the Examiner has provided a sufficient factual
basis to establish that the subject matter of claims 1-4, 8-11, 15-20, 23-26,
and 35-39 are prima facie obvious over the combined teachings of Cetaphil,
Novacet Lotion, Sulfacet Lotion, Wortzel, and Connors.
Accordingly, we sustain the rejections of claims 1-4, 8-11, 15-20, 23-
26, and 35-39 as unpatentable under 35 U.S.C. § 103(a) over (i) Cetaphil in
view of Novacet Lotion, Sulfacet Lotion, or Trice and Wortzel and Connors,
and over (ii) Novacet Lotion, Sulfacet Lotion, or Trice in view of Cetaphil,
Wortzel and Connors. Neither Cetaphil Product Information nor Skin Basics
is necessary to our decision.
IV. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner rejecting claims 1-4, 8-
11, 15-20, 23-26, and 35-39 as unpatentable under 35 U.S.C. § 103(a) over
Cetaphil in view of Novacet Lotion, Sulfacet Lotion, or Trice and Wortzel
and Connors, as evidenced by Cetaphil Product Information is AFFIRMED,
FURTHER ORDERED that the decision of the Examiner rejecting
claims 1-4, 8-11, 15-20, 23-26, and 35-39 as unpatentable under 35 U.S.C.
§ 103(a) over Novacet Lotion, Sulfacet Lotion, or Trice in view of Cetaphil,
Wortzel and Connors, as evidenced by Cetaphil Product Information is
AFFIRMED, and
FURTHER ORDERED that 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

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rvb

MARYELLEN FEEHERY HANK, ESQ.
REED SMITH LLP
2500 One Liberty Place
1650 Market Street
Philadelphia, PA 19103-7301

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