Ex Parte Lenn et al

Patent Trial and Appeal Board

Dec 20, 2017

13202780 (P.T.A.B. Dec. 20, 2017)

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.
13/202,780 08/23/2011 Jon Lenn PU63777 1910
20462 7590
GlaxoSmithKline
GLOBAL PATENTS -US, UW2220
709 Swedeland Road
P. O. BOX 1539
KING OF PRUSSIA, PA 19406-0939
EXAMINER
SCHLIENTZ, NATHAN W
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
12/22/2017 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):
US_cipkop @ gsk. com
laura.m.mccullen@gsk.com
eofficeaction @ appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JON LENN, HANS HOFLAND, BARRY HUNT,
and EDWARD HSIA1
Appeal 2017-000396
Application 13/202,780
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state that the real party-in-interest is Stiefel Laboratories, Inc.
App. Br. 2.
Appeal 2017-000396
Application 13/202,780
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s final rejection of claims 1, 9-11, 13—15, 17—19, 21, 23, 27, 29,
and 35. Specifically, the claims stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination of unpatentable over
Wolf et al. (DE 195 40 465 Al, May 7, 1997) (“Wolf’) (as translated),
Samour et al. (WO 99/39680, August 12, 1999) (“Samour”), and H. Degreef,
Clinical Forms of Dermatophytosis (Ringworm Infection), 166
Mycopathologia, 257-65 (2008) (“Degreef’).
Claims 1, 9-11, 13—5, 17—19, 21, 23, 27, 29, and 35 also stand
rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of unpatentable over Schlievert et al. (WO 2006/017594 A2,
February 16, 2006) (“Schlievert”), Samour, and Degreef.
Claims 1, 9-11, 13—5, 17—19, 21, 23, 27, 29, and 35 also stand
rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of unpatentable over Scholz et al. (WO 2005/023233 A2,
March 17, 2005) (“Scholz”) and Degreef.
Claims 1,11, and 35 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being unpatentable over Isaacs et al. (EP 0 465 423 A2, January
8, 1992) (“Isaacs”) and Degreef.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
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NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to a method of treating a fungal
condition caused by Trichophyton rubrum by administering a composition
comprising a fatty acid monoester of glycerol. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method for the treatment or prophylaxis of a fungal
condition caused by Trichophyton rubrum in a patient, the
method comprising topically applying to the patient a
pharmaceutically acceptable composition comprising a
therapeutically effective amount of a fatty acid monoester of
glycerol of the formula la:
CHr-O-R
CM O H
CHj-O-H
(la)
wherein R is a straight chain acyl group which is -C(0)-C9Hi9,
and a pharmaceutically acceptable carrier or diluent thereof, and
optionally a second pharmaceutically active agent.
App. Br. 19.
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ISSUES AND ANALYSES
We adopt the Examiner’s findings of fact and conclusions that the
appealed claims are obvious over the cited prior art. We address the
arguments raised by Appellants below.
A. Rejection of claims E 9-11, 13—15, 17—19, 21, 23, 27, 29, and 35 over
Wolf Samour. and Degreef
Issue
Appellants argue the Examiner erred in finding that the combined
cited prior art teaches or suggests using the claimed compound to treat a
fungal condition caused by Trichophyton rubrum in a patient. App. Br. 9—
10.
Analysis
The Examiner finds that Wolf teaches that Appellants’ claimed
compound may be used to treat dermatomycoses, such as Trichophyton,
Athlete’s foot, and onychomycosis. Final Act. 3 (citing Wolf 2, 10). The
Examiner acknowledges that Wolf does not explicitly disclose examples of
treatment or prophylaxis of a fungal condition caused by Trichophyton
rubrum as claimed, but finds that Wolf teaches that the claimed composition
is suitable for protection against infestation with mycobionts, including
dermatophytes such as Trichophyton. Id. at 4 (citing Wolf 1—2, 5). The
Examiner further finds that Wolf teaches that Appellants’ claimed
compositions are effective against mycobionts, especially in the form of
impact dermatomycoses. Id. (citing Wolf 10).
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The Examiner also finds that Samour teaches that Trichophyton
rubrum is the most common cause of tinea unguium (onychomycosis)
Final Act. 4 (citing Samour 1). The Examiner finds that Degreef teaches
that Trichophyton rubrum is the most common cause of tinea unguium
(onychomycosis), accounting for 70% of all cases. Id. (citing Degreef 25).
The Examiner finds Degreef also teaches T. rubrum is the cause of
numerous dermatophytic infections, including tinea corporis (ringworm),
tinea cruris, tinea faciei, tinea pedis (foot ringworm) and tinea manus. Id. at
4—5 (citing Degreef 258—59, 260, 261, Fig. 3).
The Examiner concludes that it would have been prima facie obvious
for one of ordinary skill in the art to treat, with a reasonable expectation of
success, fungal conditions causing dermatomycoses, including those fungal
conditions caused by Trichophyton rubrum, with the claimed compound, as
taught by Wolf. Final Act. 5.
Appellants argue that Wolf teaches a very broad range of fimgi/fimgal
infections, and is only a general introductory overview of fungi rather than a
specific disclosure that mono-, di- and tri-glycerol monocarboxylic acid
esters are necessarily effective in treating all (or some) of the fungal
infections described therein. App. Br. 8—9. Appellants contend that,
although there are references in Wolf to “Trichophyton,” “athlete’s foot,”
and “onychomycosis,” these disclosures are simply part of a broad
introductory overview of fungi rather than a teaching that the compounds of
Wolf are effective in treating certain specified conditions. Id. at 9.
Appellants point to Wolfs teaching that “dermatomycoses” can be divided
into four groups: dermatophytoses (including Trichophyton), mycoses
caused by yeasts, mycoses caused by molds and mildews, and systemic
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mycoses. Id. (citing Wolf trans. 2). According to Appellants, there is no
teaching or suggestion in Wolf that the recited compounds can be used to
specifically treat Trichophyton, let alone specifically Trichophyton rubrum.
Id.
Appellants contend that Wolf generically teaches that the object of the
invention is to eliminate the disadvantages of the prior art, and to cure or
prevent superinfections. App. Br. 9 (citing Wolf trans. 4). Appellants assert
that the only specific teaching of Wolf concerning the conditions that may
be treated using the mono-, di- and tri-glycerol monocarboxylic acid esters is
in the control of Pityrosporum ovale (i.e., in treating dandruff). Id. (citing
Wolf 10-11; see also claim 2). Otherwise, Appellants argue, Wolf teaches
generally that its recited compounds are antimycotic. Id. Appellants assert
that, given the great diversity of fungi, and the known selectivity of
antifungal agents, a person of ordinary skill in the art would not have had a
reasonable expectation that the compounds described in Wolf (including
Appellants’ claimed compound) would be effective in treating a fungal
condition caused by Trichophyton rubrum. Id.
Appellants also contend that Wolf provides no explicit example or
embodiment showing that that the claimed composition may be used to treat
an infection caused by Trichophyton rubrum or, more generally, an infection
caused by fungi. App. Br. 10. According to Appellants, Examples 1—26
illustrate only a broad range of different types of formulations that may
comprise the compounds, such as a water-in-oil cream or lotion, an oil-in­
water cream or lotion, an ointment, bath oil or lipstick. Id. Appellants assert
that, reading Wolf as a whole, a person of ordinary skill in the art would not
have had a reasonable expectation that the glycerol esters and, specifically,
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Appellants’ claimed compound, would be effective in treating a fungal
condition caused by Trichophyton rubrum as recited in the claims. Id.
With respect to the teachings of Samour and Degreef, Appellants
argue that the references teach that the most common causes of tinea
unguium (onychomycosis) are Trichophyton rubrum, T. mentagrophytes and
Epidermophyton floccusum, however, Appellants assert, these references fail
to cure the alleged deficiencies of Wolf. App. Br. 10. According to
Appellants, Samour and Degreef fail to teach or suggest that monocaprin is
effective for the treatment of tinea unguium (onychomycosis), or the
treatment of a fungal condition caused by Trichophyton rubrum. Id.
Specifically, Appellants argue, Samour is primarily directed to a proprietary
penetration enhancer, i.e., SEPA (column 4) in a nail lacquer. Id.
Appellants contend that the lacquer, with the proprietary SEPA enhancers
can include many active ingredients, but does not include Appellants’
claimed compound. Id. at 10-11 (citing Samour 11—13).
Appellants argue Degreef teaches various clinical aspects of
dermatophytic infections and, specifically, that there are many types of
dermatophytic infections caused by different organisms. App. Br. 11.
Appellants assert that the general teachings of Degreef, like that described in
Wolf, would not have necessarily led a person of ordinary skill in the art to
the treatment of one particular condition by one particular fungus. Id.
Finally, Appellants point to Example 2 of their Specification, which
they contend demonstrates that that their claimed compound is significantly
more effective than a commercial competitor (PENLAC nail lacquer)
containing cyclopirox as the antifungal agent) in treating a Trichophyton
rubrum infection. App. Br. 11. Appellants argue that these results are
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particularly and unexpectedly effective and are indicative of
nonobviousness. Id.
The Examiner responds that Wolf teaches it was known in the art that
antimycotic agents were disadvantageous in that they have an unpleasant
odor and/or can irritate the affected skin, or even cause pain. Ans. 3 (citing
Wolf 4). The Examiner finds Wolf teaches that monoglycerol
monocarboxylic acid monoesters, including Appellants’ claimed
composition, are suitable antimycotic active substances for use in cosmetic
or dermatological preparations. Id. (citing Wolf 5). The Examiner therefore
finds that Wolf teaches treating fungal infections of the skin and nails,
including those caused by Trichophyton, which is one of the most common
dermatomycoses. Id. The Examiner therefore finds that Wolf suggests
treating Trichophyton-based infections with the monoglycerol
monocarboxylic acid monoesters, including Appellants’ claimed compound.
Id.
With respect to Appellants’ argument that the examples of Wolf teach
that the compounds are effective in controlling Pityrosporum ovate, the
Examiner responds that a reference may be relied upon for all that it would
have reasonably suggested to one having ordinary skill the art, including
nonpreferred embodiments, and that disclosed examples and preferred
embodiments in a prior art reference do not constitute a teaching away from
a broader disclosure or nonpreferred embodiments. Ans. 4 (citing, inter alia,
Merck & Co. v. Biocraft Laboratories, Inc., 874 F.2d 804 (Fed. Cir. 1989);
In re Susi, 440 F.2d 442 (C.C.P.A. 1971).
The Examiner further finds that Samour teaches nail lacquers
effective for the treatment or prevention of fungal infections, especially
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onychomycosis. Ans. 5. The Examiner finds that Degreef teaches that T.
rubrum is the most common cause of tinea unguium (onychomycosis),
accounting for 70% of all cases, and also causes numerous dermatophytic
infections, including tinea corporis (ringworm), tinea cruris, tinea faciei,
tinea pedis (foot ringworm) and tinea manus. Id.
The Examiner therefore concludes that it would have been obvious to
a person of ordinary skill in the art to treat T. rubrum infections, including
onychomycosis, tinea corporis, tinea cruris, tinea faciei, tinea pedis, and
tinea manus, with Appellants’ claimed composition, as suggested by Wolf.
Id.
Finally, the Examiner points out that the Specification’s comparison
of Appellants’ claimed composition and cyclopirox is not indicative of
unexpected efficacy because cyclopirox is not structurally or chemically
related to the claimed composition. Ans. 6. The Examiner finds, rather, that
Wolf teaches that the claimed composition would be expected to possess
antimycotic efficacy, including control of Trichophyton, in such infections
as athlete’s foot and onychomycosis. Id.
We agree with the Examiner. Wolf teaches that:
“Dermatomycoses can essentially be divided into the following four groups:
[including A.] Dermatophyes (e.g., Epidermophytie, Favus, Microsporum,
Trichophyton), Hefemycosen.” Wolf trans. 2 (emphasis added). Wolf
teaches further that:
It has been found, and this is the solution of all the tasks, the use
of one or more substances selected from the group consisting of
monoglycerol monocarboxylic acid monoesters, diglycerol
monocarboxylic acid monoesters and triglycerol
monocarboxylic acid monoesters as antimycotic active principle
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in cosmetic or dermatological [preparations as antimycotic
agents overcomes the disadvantages of the prior art.
Wolf trans. 5. Wolf teaches, specifically, that Appellants’ claimed
composition is among the effective antimycotic agents, id. (“Another object
of the invention was thus to provide antimycotically effective means
available which do not have the advantages of the prior art.”), and is
especially effective against Dermatomycoses. Id. at 10. Finally, Wolf
claims the: “[u]se of one or more substances selected from the group
consisting of monoglycerol monocarboxylic acid monoesters, diglycerol
monocarboxylic acid monoesters and triglycerol monocarboxylic acid
monoesters as antimycotic active principle in cosmetic or dermatological
preparations.” Wolf trans. claim 1. In light of these teachings, we agree
with the Examiner’s findings that Wolf teaches use of Appellants’ claimed
composition as an antimycotic agent directed against fungal skin infections,
of which Trichopyhton is included.
Furthermore, Degreef teaches that T. rubrum is well known in the art
as one of the most common infectious agent in a number of different skin
fungal infections, this is also taught by Samour. Degreef 259-61, 263;
Samour 1. We therefore agree with the Examiner’s conclusion that, in view
of the teachings of the combined cited prior art, it would have been obvious
to a person of ordinary skill to have used Appellants’ claimed compound,
which was well known in the art as a useful antifungal agent when directed
against skin infections, against infections caused by T. rubrum, which was
known as one of the most common infectious fungal agents in skin diseases.
We also find that there would have been a reasonable expectation of success
in light of the teachings of Wolf as well, since Wolf teaches the claimed
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composition can be used topically on skin infections in an antimycotically
effective amount to treat Dermatomycoses, of which Trichopyhton is
included.
Nor are we persuaded by Appellants’ argument that the allegedly
unexpected efficacy of Appellants’ composition against T. mbnim, when
compared to cyclopirox, is sufficient evidence of nonobviousness to
overcome the Examiner’sprima facie conclusion. “[W]hen 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). In this case, the closest prior art
is Wolf, which teaches Appellants’ claimed compound, as well as other
glycerol-based monocarboxylic acid monoesters, as being effective
antifungal agents in skin preparations, including against Dermatomycoses.
Appellants adduce no evidence that the claimed composition is unexpectedly
or surprisingly more effective than the related compounds taught by Wolf,
and we are not persuaded that the effectiveness of their claimed compound,
when compared to a chemically-unrelated antifungal agent, is necessarily
unexpected or surprising. We consequently affirm the Examiner’s rejection
on this ground.
B. Rejection of claims F 9—1F 13—15, 17—19, 21, 23, 27, 29, and 35 over
Schlievert, Samour. and Degreef
The Examiner finds Schlievert teaches compositions, including
Appellants’ claimed composition, which are suitable for treating
dermatophytes (ringworm). Final Act. 7 (citing Schlievert 1—2, 7—9).
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Appellants argue that Schlievert teaches that glycerol-based
compounds, such as glycerol monolaurate (monolaurin)2 and related
compounds, are suitable for treating specific fungal and bacterial infections.
App. Br. 12 (citing Schlievert 1—2, 8—9). Appellants contend that, although
a broad range of potential fungi, including “dermatophytes (ringworms)”, is
taught by Schlievert (citing, e.g., Schlievert 7), this is in the context of a
broad disclosure of fungal infections that may possibly be treated using the
disclosed glycerol-based compounds. Id. Appellants argue that Schlievert,
“stops well short of supporting the breadth of this disclosure with examples,
and merely illustrates in Examples 1—5, the use of glycerol monolaurate
(monolaurin) for the treatment of Candida, Aspergillus and Penicillium
fungal infections.” Id. (emphasis added).
According to Appellants, Schlievert does not name Trichophyton
rubrum amongst the many organisms against which they believe their
compounds would be useful and that, given the uncertain and unpredictable
nature and selectivity for certain fungi demonstrated by antifungal
compositions, a person of ordinary skill in the art would not have had a
reasonable expectation that their composition would be effective in treating
a fungal condition caused by T. rubrum.
We are not persuaded by Appellants’ arguments. Schlievert teaches
that “GML [glycerol monolaurate] and related molecules are likely to be
effective therapeutic or prophylactic agents against infections involving
fungi and certain bacterial microorganisms.” Schlievert 1. Schlievert
2 Appellants’ claimed composition is also known as glycerol monocaprylate
(monocaprin) and is also expressly taught by Schlievert. See Schlievert 9.
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expressly teaches a method of applying Appellants claimed composition and
teaches: “Infectious fimgal microorganisms [treatable with Appellants’
composition] can also be monomorphic fungi, for example, dermatophytes
(ringworms). .Schlievert 2.
We acknowledge Schlievert does not expressly mention T. rubrum.
However, Degreef expressly teaches that T. rubrum is a very common
etiologic agent in cases of ringworm infections of both glabrous and
keratinized skin. See, e.g., Degreef 259-61, 263; see also Samour 1. We
agree that a person of ordinary skill in the art would understand from
Schlievert’s teaching that Appellants’ claimed composition, which is taught
to be effective against dermatophytic ringworm, would likely be effective
against the common infectious agent causing ringworm, i.e., T. rubrum. We
therefore affirm the Examiner’s rejection on this ground.
C. Rejection of claims E 9—11, 13—15, 17—19, 21, 23, 27, 29, and 35 over
Scholz and Degreef
The Examiner finds Scholz teaches antimicrobial compositions,
including Appellants’ claimed composition, comprising an antimicrobial
lipid component, wherein the compositions are suitable for treating and/or
preventing conditions caused by fungi. Final Act. 10 (citing Scholz Abstr.,
3). The Examiner also finds Scholz teaches that the compositions according
to their invention can treat and/or prevent afflictions that are caused by
fungi, such as tinea pedis (i.e., athlete’s foot), tinea cruris (i.e., jock itch),
and tinea corporis (i.e., ringworm). Id. at 10-11 (citing Scholz 23—24).
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Appellants argue that Scholz teaches that glycerol monolaurate
(monolaurin) and glycerol monocaprate (monocaprin) (Appellants’ claimed
composition) are antimicrobial lipids. App. Br. 14 (citing Scholz 9).
According to Appellants, Scholz also teaches a broad range of afflictions
that may be treated using the compositions. Id. However, Appellants argue,
that despite Scholz’s teaching of “tinea pedis (athlete’s foot); tinea c[r]uris
(jock itch); tinea corporis (ringworm)” in the context of a very broad
disclosure of infections that may possibly be treated using the compositions,
Scholz stops short of supporting the breadth of the disclosure with specific
examples. Id.
Appellants therefore assert that given the limited breadth of the
teachings of Scholz, a person of ordinary skill in the art would not have had
a reasonable expectation that the claimed composition would be effective in
treating a fungal condition caused by T. rubriim.
We are not persuaded. Scholz expressly teaches that: “In particular,
compositions of the present invention can be used for preventing and/or
treating [...] tinea pedis (i.e., athlete’s foot); tinea c[r]uris (i.e., jock itch);
tinea corporis (i.e., ringworm)....” Scholz 23—24. Degreef expressly
teaches that T. rubrum is a common etiologic agent for all three conditions.
Degreef 258—60. We agree that a person of ordinary skill in the art would
understand that Scholz’s teaching that Appellants’ claimed composition,
which is taught to be effective against tinea pedis, tinea cruris, and
ringworm, would likely be effective against the common infectious agent
causing all three, i.e., T. rubrum. We therefore affirm the Examiner’s
rejection on this ground.
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D. Rejection of claims 1,11, and 35 over Isaacs and Degreef
The Examiner finds Isaacs teaches compositions, including
Appellants’ claimed composition, which are effective at killing
microorganisms, such as fungi, including those causing ringworm
(dermatophytes) and athlete’s foot. Final Act. 14 (citing Isaacs Abstr., 2, 22,
33, claims 1,7, 11).
Appellants argue that, despite the Examiner’s findings, there is no
experimental support for Isaacs’ asserted antifungal activity of the disclosed
monoglyceride compounds, and that the antifungal activity of the
compounds of the reference is entirely speculative. App. Br. 16.
We have explained our reasoning above as to why a person of
ordinary skill in the art would understand that a composition effective in
treating fungal skin infections such as ringworm or athlete’s foot would be
effective against the causative agent of these conditions, T. rubnim.
Moreover, Appellants question the scientific credibility of the
teachings of Isaacs, but provide no evidence to suggest that any teachings of
Isaacs are “speculative” beyond the mere assertion that they are. “Attorney
argument is not evidence.” Icon Health & Fitness v. Strava, 849 F.3d 1034,
1043 (Fed. Cir. 2017) (citing, e.g., Gemtron Corp. v. Saint-Gobain Corp.,
572 F.3d 1371, 1380 (Fed. Cir. 2009).
The test of obviousness “is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). In this instance, Isaacs teaches
that the claimed composition is an effective antifungal agent for treating
ringworm or athlete’s foot. Specifically, Isaacs teaches that:
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[T]he compositions according to the present invention provide
the practical use of — a method of killing microorganisms in or
on a hos[t] which comprises administering to said host an
antimicrobial component consisting of an effective antimicrobial
amount of one or compounds selected from the group consisting
of C4 to C14 fatty acids and monoglycerides thereof and C4to C22
mono - or polyunsatured acids and monoglycerides thereof,
wherein the antimicrobial component is administrated topically,
perorally, parenterally, intravenously, or rectally.
Isaacs 34. Furthermore, Isaacs teaches that, with respect to microorganisms:
“[T]he compounds of the invention have antimicrobial, especially antiviral
and/or antibacterial, activity. Microorganisms that can be killed according
to the invention include, but are not limited to, the following fungi, yeast,
and viruses: Ringworm.. .Dermatophytes.” Id. at 22. We find that this
disclosure, combined with the teachings of Degreef, would have suggested
to a person of ordinary skill in the art that the claimed composition would
have been effective against T. mbnim, a common causative agent of
ringworm, i.e., dermatophytes. We therefore affirm the Examiner’s
rejection of the claims.
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DECISION
Each of the Examiner’s rejection of claims 1, 9-11, 13—15, 17—19, 21,
23, 27, 29, and 35 as unpatentable under 35 U.S.C. § 103(a) is affirmed, as is
the Examiner’s rejection of claims 1,11, and 35 as unpatentable under 35
U.S.C. § 103(a).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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