Ex Parte Rosenberg et al

Patent Trial and Appeal Board

Aug 8, 2016

11956054 (P.T.A.B. Aug. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111956,054 12/13/2007 E. William Rosenberg
86378 7590 08/10/2016
Pearne & Gordon LLP
1801East9th Street
Suite 1200
Cleveland, OH 44114-3108
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.
ROSE-41639US1 6807
EXAMINER
BAEK, BONG-SOOK
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
08/10/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
patdocket@pearne.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte E. WILLIAM ROSENBERG and ROBERT B. SKINNER, JR.
Appeal2014-006379
Application 11/956,054
Technology Center 1600
Before JEFFREY N. FRED MAN, ULRIKE W. JENKS, 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 method
of treating a patient having atopic dermatitis. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Parties in Interest as the inventors, E.
William Rosenberg and Robert B. Skinner Jr. (see App. Br. 2).
Appeal2014-006379
Application 11/956,054
Statement of the Case
Background
"In the prior art it has been suggested to use 0.3% aqueous gentian
violet as a topical treatment for atopic dermatitis" (Spec. i-f 4). "However,
gentian violet is a blue dye that, at 0.3% concentration, stains the skin and
tends to stain anything else ... In other words, topically applied 0.3%
gentian violet is very messy, which has strongly discouraged its use" (Spec.
,-r 4).
The Claims
Claims 14--17, 21, 24, and 25 are on appeal. Claim 14 is
representative and reads as follows:
14. A method of treating a patient having atopic dermatitis,
said method comprising administering a topical composition
comprising an antiseptic dye being present in the range of 0.01
to 0.05 weight percent of said composition, said composition
being in a form effective for topical administration to the skin
of said patient, wherein said antiseptic dye is provided in said
composition in a concentration which is effectively non-
staining to said patient.
The issue
The Examiner rejected claims 14--17, 21, 24, and 25 under 35 U.S.C.
§ 103(a) as obvious over Brockow,2 Bakker, 3 Illner, 4 and Ansel5 (Ans. 2-7).
2 Brockow et al., Effect of Gentian Violet, Corticosteroidand Tar
Preparations in Staphylococcus-aureus-Colonized Atopic Eczema,
199 DERMATOLOGY 231-236 (1999).
3 Bakker et al., Activity Of Gentian Violet And Brilliant Green
Against Some Microorganisms Associated With Skin Infections, 31
INTERNATIONAL J. DERMATOLOGY 210-213 (1992).
4 Illner, H., US 5,709,672, issued Jan. 20, 1998.
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Application 11/956,054
The Examiner finds it obvious to "reduce the concentration of gentian
violet" because the "prior art teaches gentian violet at higher concentrations
can cause unfavorable cosmetic appearance (staining) and skin irritation and
the use of gentian violet in a lower concentration such as 0.01 % by weight
reduce 'tattooing' (staining) or discoloration of tissues without loss of
bacteriostatic activity as evidenced by [Illner ]" (Ans. 6). The Examiner
finds that "a composition containing gentian violet at lower concentrations
would still be effective for treating atopic dermatitis by reducing the
colonization of S. aureus" because "Bakker et al. teach that the highest
critical concentration of gentian violet against S. aureus was 0.00012 %,
which is far below 0.05% and [Illner] teaches that the gentian violet at
concentrations as low as 0.01 % still provides effective antimicrobial
activity, especially against S. aureus" (Ans. 6).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Brocko\~1, Bakker, Illner, and
Ansel render obvious treatment of atopic dermatitis with "a topical
composition comprising an antiseptic dye being present in the range of 0.01
to 0.05 weight percent" that is "non-staining" as required by claim 14?
Findings of Fact
1. Brockow teaches that "gentian violet reduces colonization with
S. aureus as well as clinical severity in patients with S.-aureus-colonized AE
[atopic eczema] ... Topical therapy with antiseptics may be a useful tool in
5 Howard C. Ansel and Nicholas G. Popovich, Pharmaceutical
Dosage Forms and Drug Delivery Systems, 5th Ed. 309-310
(1990).
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Application 11/956,054
the treatment of AE [ atopic eczema] colonized with S. aureus" (Brockow
235, col. 2).
2. Brockow teaches that "0.3% aqueous gentian violet was applied
to 11 patients" (Brockow 232, col. 1 ).
3. Brockow teaches that in "patients treated with gentian violet a
significant reduction of S. aureus density was seen in lesional and unaffected
skin (p < 0.001) after 4 days ... The difference to control areas was highly
significant (p = 0.002)" (Brockow 233, col. 1 ).
4. Bakker teaches that the range of critical concentrations of
gentian violet for S. aureus is 2.5 x 10-6 to 2.6 x 10-6 (see Bakker 211, table
1) while testing with "[ fJresh solutions of gentian violet (Aldrich, Brussels,
Belgium) ... prepared weekly, 1 day prior to use. The concentrations used
were 0.5%, 0.25%, 0.1 %, 0.05%, 0.025%, and 0.01 % (w/v)" (Bakker 210,
col. 2).
5. Bakker teaches that a "0.25% or 0.5% solution of gentian violet
was reported to be as effective as, and less irritating than, 1%to2%
solutions" (Bakker 210, col. 2).
6. Bakker teaches that the "highest observed critical concentration
for gentian violet against S. aureus was 1.2x 1 o-4% (Fig. 1 ), which is far
below the highest concentration (0.5%) studied" (Bakker 211, col. 2 to 212,
col. 1 ).
7. Illner teaches that "antimicrobially and antifungally effective
amounts of gentian violet are further defined as about 0.008% to less than
about 1.0% . . . Even more particularly, the antimicrobially effectively
amount of gentian violet constitutes about 0.02% to about 0.09% gentian
violet" (Illner, col. 3, 11. 38--45).
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Appeal2014-006379
Application 11/956,054
8. Illner teaches that "[g]entian violet also has a characteristic
purple color that, when used at the relatively high concentrations discussed
in the art, causes an undesirable 'tattooing' or staining effect on tissues"
(Illner, col. 2, 11. 58---61 ). Illner further explains that by employing
"amazingly effective antimicrobial activity at concentrations several fold
lower than gentian violet concentrations previously contemplated ...
Potential undesirable characteristics associated with 'tattooing' or
discoloration of tissues are thus reduced, without loss of bacteriostatic
activity" (Illner, col. 3, 11. 20-25).
9. Table 10 of Illner demonstrates that 0.01 % of gentian violet
inhibited S. aureus as reproduced below:
TAHLE 10
Bacteriml:asis effects of vario!.l!> coo:}e1ltratk\m; of gentian violet
Jn!atme:at of p&yureth.ane
OJJ1% GV
Mem1
0.10% GV
11
12
11
10
H.\
17
0
0
8
s
2
6
6
7
10
.5
7
7
4
g
1
11
12
8
"As illustrated in Table 10, the treated catheter segments exhibited
consistent growth inhibition of three of the tested pathogens" (Illner, col. 23,
11. 10-40).
10. Ansel teaches that "[ v ]ehicles that increase the amount of
moisture imbibed by the skin generally favor the percutaneous absorption of
drugs" (Ansel 309, col. 2).
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Appeal2014-006379
Application 11/956,054
Principles of Law
In cases involving overlapping ranges, we and our predecessor
court have consistently held that even a slight overlap in range
establishes a prima facie case of obviousness .... We have also
held that a prima facie case of obviousness exists when the
claimed range and the prior art range do not overlap but are
close enough such that one skilled in the art would have
expected them to have the same properties.
In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Analysis
We adopt the Examiner's findings regarding the scope and content of
the prior art (Ans. 2-7; FF 1-10) and agree that the claimed method would
have been obvious over the teachings of Brockow, Bakker, Illner, and Ansel.
We address Appellants' arguments below.
Appellants contend that: "Brockow fails to disclose administering a
topical composition comprising an antiseptic dye being present in the range
of 0.01 to 0.05 weight percent" (App. Br. 7); that "Bakker is entirely silent
as to use of gentian violet to treat atopic dermatis" (App. Br. 8); that "Illner
is entirely silent as to treatment of atopic dermatitis and compositions for
application to a patient's skin" (App. Br. 10); and that "Ansel does not
disclose a composition having a specific concentration of antiseptic dye"
(App. Br. 11 ).
We do not find these arguments persuasive. "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., 800 F.2d 1091, 1097 (Fed. Cir. 1986). A reference "must be read, not
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Appeal2014-006379
Application 11/956,054
in isolation, but for what it fairly teaches in combination with the prior art as
a whole." Id.
Here, the Examiner has reasonably established a prima facie case of
obviousness based on the combined teachings of the references, specifically
combining Brockow's teaching that a 0.3% topical gentian violet
composition treats atopic eczema by reducing S. aureus density (FF 1-3)
with Bakker's teaching that 0.00012% solution of gentian violet is capable
of inhibiting S. aureus (FF 6; cf Ans. 4) and Illner's teaching that an
"antimicrobially effectively amount of gentian violet constitutes about
0.02% to about 0.09% gentian violet" (FF 7, 9).
The ordinary artisan, interested in minimizing staining as suggested
by Illner (FF 8) and minimizing skin irritation as disclosed by Bakker (FF 5)
due to higher gentian violet concentrations while retaining antimicrobial
efficacy in treating S. aureus caused eczema, would have reasonably
reduced the amount of gentian violet to concentrations kno\~1n to inhibit S.
aureus disclosed in Bakker and Illner (FF 6, 7, 9; cf Ans. 10). The range
disclosed in Illner substantially overlaps the claimed range, rendering that
range prima facie obvious. Peterson, 315 F.3d at 1329.
Appellants contend that "[t]he rejection of claim 7 under 35 U .S.C. §
103(a) is in error because consideration of the Declaration of Dr. Rosenberg
provides secondary consideration" (App. Br. 11; emphasis omitted). 6 In
particular, Appellants contend that "Dr. Rosenberg further states that in view
of the 0.3 weight percent concentration, one skilled in the art would not
6 We assume the reference to claim 7 to be an inadvertent error and
interpret the argument to refer to independent claim 14.
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Application 11/956,054
reasonably use or expect success with the claimed concentrations for
treatment of atopic dermatitis" (App. Br. 12). Appellants further contend
that:
Dr. Rosenberg states there has been an on-going failure of
others and a long-felt need in the medical industry to develop
compositions to improve treatment of atopic dermatitis wherein
such compositions eliminate the problem of patient non-
compliance and the associated problem of staining of the skin.
The claimed composition having a 0.01 to 0.05 weight percent
concentration of antiseptic dye effectively treats atopic
dermatitis and eliminates the long known staining problem of
using gentian violet.
(App. Br. 12).
We have considered the Rosenberg Declaration, 7 but are not
persuaded of any unexpected results or evidence of long felt, unsatisfied,
need. The Rosenberg Declaration contends that "[ n ]othing in the methods
described in Brockow would motivate one of ordinary skill in the art to
employ an antiseptic dye, such as gentian violet, at the claimed
concentration of 0.01to0.05 weight percent to treat a patient with atopic
dermatitis" (Rosenberg Dec. i-f 8).
The Rosenberg Declaration does not, however, address the teachings
in Bakker and Illner, where Illner demonstrates that an overlapping range of
"about 0.02% to about 0.09% gentian violet" was expected to be
antimicrobially effective (FF 7) and that by employing "amazingly effective
antimicrobial activity at concentrations several fold lower than gentian violet
concentrations previously contemplated ... Potential undesirable
7 Declaration of Dr. E. William Rosenberg, dated Dec. 21, 2009.
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Appeal2014-006379
Application 11/956,054
characteristics associated with 'tattooing' or discoloration of tissues are thus
reduced, without loss of bacteriostatic activity" (FF 8).
Thus, Illner specifically suggests that reduced amounts of gentian
violet may be used that retain antimicrobial activity but eliminate the
staining problem (FF 8). Bakker further evidences that lower amounts of
gentian violet would be expected to have antimicrobial activity against S.
aureus, the causative agent of atopic dermatitis (FF 1, 6).
We recognize, but find unpersuasive, the Rosenberg Declaration's
contention that "[t]here has been an on-going failure of others and a long-felt
need in the medical industry to develop compositions to improve the
treatment of atopic dermatitis wherein such compositions eliminate the
unsightly staining and associated drawbacks" (Rosenberg Dec. i-f 8).
Establishing long-felt need requires objective evidence that an art-
recognized problem existed in the art for a long period of time without
solution. 1\feivell Cos., Inc. v. Kenney 1'.1.fg. Co., 864 F.2d 757, 768 (Fed. Cir.
1988), and the long-felt need must not have been satisfied by another before
the invention by applicant. See Id., 864 F.2d at 768 ("[O]nce another
supplied the key element, there was no long-felt need or, indeed, a problem
to be solved .... ").
Here, even if we accepted the Rosenberg Declaration's statements
alone as evidence that there was a long-felt need for lower concentration
gentian violet compositions that did not stain, Illner specifically satisfies this
need by teaching lower concentration gentian violet compositions that
reduce staining (FF 8), obviating the secondary consideration. We also
conclude that even if the long-felt need provides some evidence of a
secondary consideration, the showing is insufficient to overcome the strong
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Appeal2014-006379
Application 11/956,054
showing of obviousness in this case. See Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1372 (Fed. Cir. 2007) ("[W]e hold that even if Pfizer showed that
amlodipine besylate exhibits unexpectedly superior results, this secondary
consideration does not overcome the strong showing of obviousness in this
case. Although secondary considerations must be taken into account, they
do not necessarily control the obviousness conclusion. Newell Cos., Inc. v.
Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988)").
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Brockow, Bakker, Illner, and Ansel render obvious treatment of atopic
dermatitis with "a topical composition comprising an antiseptic dye being
present in the range of 0.01 to 0.05 weight percent" that is "non-staining" as
required by claim 14.
SUMMARY
In summary, we affirm the rejection of claim 14 under 35 U.S.C.
§ 103(a) as obvious over Brockow, Bakker, Illner, and Ansel. Claims 15-
17, 21, 24, and 25 fall with claim 14. 37 C.F.R. § 41.37(c)(l)(iv).
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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