Ex Parte Benjamin

Board of Patent Appeals and Interferences

Mar 30, 2009

10484321 (B.P.A.I. Mar. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte NIGEL BENJAMIN2
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Appeal 2009-1033
Application 10/484,321
Technology Center 1600
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Decided: March 30, 20091
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2
Before JAMES T. MOORE, Vice Chief Administrative Patent Judge, and
RICHARD TORCZON and SALLY G. LANE, Administrative Patent
Judges.

MOORE, Vice Chief Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134 (2002) from a final
rejection of claims 1-17 and 19.3 We have jurisdiction under 35 U.S.C.
§ 6(b) (2002).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from
Mail Date (paper delivery) or Notification Date (electronic delivery).
2 The real party in interest is Strakan Limited. (App. Br. 1).

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The Appellant’s claims are directed to a method of topically treating a
subungual infection.4
Claim 1 is the only independent claim in the application. The
Appellant does not argue any claims separately. We select independent
claim 1 to decide the appeal. See 37 C.F.R. § 41.37(c)(1)(vii)(2006). The
remaining claims stand or fall with claim 1.
Claim 1 reads as follows:
1. A method for the treatment or prophylaxis of a subungual
infection in a patient, the method comprising:
generating nitrogen oxide by combining a nitrite and an
organic acid, wherein the nitrite and the organic acid are
separately disposed from each other prior to being combined,
and combining the nitrite and the organic forms of a
compositions, wherein the composition is generated on, or
applied to, a nail of the patient in an amount that effectively
treats an infection under the nail.

(App. Br. 10, Claims Appendix).

THE EVIDENCE

The Examiner relies upon the following as evidence in support of the
rejections:
Seitz 6, 103,275 Aug. 15, 2000
Benjamin 6,709,681 Mar. 23, 2004
Benjamin WO 95/22335 Aug. 24, 1995
Ormerod WO 99/44622 Sep. 09, 1999

3 Claims 18 and 20-23 have been canceled, withdrawn. (App. Br. 1).
4 Beneath a fingernail or toenail.

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Weller, et al., A randomized trial of acidified nitrite cream in the
treatment of tinea pedis.5 J. Am. Acad. of Hematol. 38:559-563 (1998).

Tucker, et al., Effect of nitric-oxide generating system on
microcirculatory blood flow in skin of patients with severe Raynaud’s
syndrome: a randomised trial. Lancet 354:1670-1675 (1999).

THE REJECTIONS
The following rejections are before us for review:
1. Claims 1, 3-5, 10, and 11 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Weller.
2. Claims 1-6, 7, 10-14, and 19 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over the combination of Benjamin (WO 95/22335)
and Weller.
3. Claims 1, 3-7, 11-17 and 19 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over the combination of Tucker and Weller.
4. Claims 1, 3-7, 8-13 and 19 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Seitz and Weller.
5. Claims 1-7, 11-12, 15-17 and 19 stand rejected under 35 U.S.C. §
103(a) as being unpatentable over Ormerod and Weller.
6. Claims 1-7, 10-17, and 19 stand rejected under 35 USC. 103(a) as
being unpatentable over Benjamin (6,709,681) and Weller.
We REVERSE the anticipation rejection under 35 U.S.C. §102(b),
and AFFIRM the rejections under 35 U.S.C. §103(a).

5 Athlete’s foot.

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ISSUES
Has the Appellant established that the Examiner erred in determining
that the prior art anticipates using a composition that is generated on or
applied to a nail in an amount that effectively treats an infection under the
nail?
Has the Appellant established that the Examiner erred in determining
that it would have been obvious to one of ordinary skill in the art at the time
the invention was made to apply a composition known to treat tinea pedis on
the surface of a foot to a nail in an amount that effectively treats an infection
under the nail?
FINDINGS OF FACT
The record supports the following findings of fact by a preponderance
of the evidence.
1. Weller describes a randomized trial of acidified nitrite cream in
the treatment of tinea pedis. (Weller Title).
2. Weller describes that the active group of patients in the study
received a pair of creams, one containing salicylic acid in aqueous cream
and the other potassium nitrite in aqueous cream. (Id. p. 560).
3. Weller also describes that the creams were applied twice daily and
mixed on the surface of the feet. (Id.)(emphasis added).
4. Weller describes examining the feet to assess the features of tinea
pedis including fissures, crusting, maceration, pruritus, scaling, erythema
and burning. (Id.).

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5. Weller describes that the study shows the efficacy of an
exogenous nitrogen oxide - releasing system in treating a cutaneous
infection. (Id. 562).
6. The Appellant’s specification states, “The fungi involved in nail
infections are mainly those that cause athlete’s foot (or tinea pedis)
spreading from the toe cleft to the nail.” (Specification p. 1).
PRINCIPLES OF LAW
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
"Under the principles of inherency, if the prior art necessarily
functions in accordance with, or includes, the claimed limitations, it
anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir.
2002).
“Section 103 forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented 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 art to which said
subject matter pertains.’” KSR International Co. v. Teleflex Inc., 127 S. Ct.
1727, 1734 (2007).
ANALYSIS
I. The Anticipation Rejection
Claims 1, 3-5, 10, and 11 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Weller. Specifically, the Examiner found that Weller

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describes “the efficacy of acidified nitrite cream as a treatment for the
contagious fungal foot infection tinea pedis (Athlete’s foot).” (Final
Rejection, July 3, 2006, p. 2)(citing Weller Abstract). The Examiner also
found that Weller describes that the treatment is packaged as a kit containing
a salicylic acid in an aqueous cream and a potassium nitrite in an aqueous
cream that generate nitrogen oxide when combined. (Id. pp. 2-3).
Additionally, the Examiner found that Weller describes that the creams are
applied and mixed on the surface of the feet. (Id.)(citing Weller p. 560).
According to the Examiner, the surface of the feet includes the nails. (Id.
p. 3). Therefore, the Examiner concluded that Weller anticipates the claims.
(Id.).
The Appellant challenges the Examiner’s anticipation rejection by
asserting that Weller “does not teach the application of a composition to the
patient’s nail, as required by claim 1.” (App. Br. 5; Reply Br. 1). According
to the Appellant, Weller describes a composition that “is applied directly to
the skin.” (App. Br. 5).
We find that Weller describes a composition that is “applied twice
daily and mixed on the surface of the feet.” (Weller p. 560). Therefore,
determining whether the reference teaching anticipates an application to a
nail, as claimed, requires considering whether the prior art describes “the
surface of the feet” as specifically including application to the nail.
Although it is a very close call, we conclude that Weller does not
specifically describe the claimed subject matter.
Reading the reference as a whole, it is clear that the subjects of the
study had a “clinical diagnosis of interdigital tinea pedis.” (Weller p. 560).

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In the art, this condition is well known as athlete’s foot occurring on the skin
between the toes, i.e., not the nail. Additionally, the reference describes that
assessment of the effectiveness of the treatment was scored based upon
features of tinea pedis, including fissures, crusting, maceration, pruritus,
scaling, erythema and burning. (Id.). Each of these features relate to the
skin of the foot, not the nail. Therefore, because Weller discusses its
treatment in terms of a clinical diagnosis and a clinical assessment relating
to the skin of the foot and not the nails, we find that the phrase “surface of
the feet,” as discussed in Weller refers to the surficial skin of the foot and
does not necessarily and inevitably include the nails. See In re Cruciferous
Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002)( “Under the principles of
inherency, if the prior art necessarily functions in accordance with, or
includes, the claimed limitations, it anticipates.”).
Consequently, we do not find that Weller anticipates the limitation
requiring the composition to be “generated on, or applied to, a nail,” as
recited in claim 1. See Verdegaal Bros. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987)(“A claim is anticipated only if each and
every element as set forth in the claim is found, either expressly or
inherently described, in a single prior art reference.”).
Accordingly, we reverse the Examiner’s anticipation rejection of
claims 1, 3-5, 10, and 11.
II. The Obviousness Rejections
Claims 1-17 and 19 each stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over a combination of references, including Weller.
(Final Rejection, July 3, 2006, pp. 3-11). Specifically, the Examiner

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concluded that the combination of references would have rendered the
claimed subject matter obvious to one of ordinary skill in the art at the time
the invention was made.
Here again, the Examiner relied on Weller in the combinations as
teaching the limitations of independent claim 1.
The Examiner further found that Weller describes that “Trichophyton
rubrum was cultured from patients in the study.” (Id. p. 4)(citing Weller p.
560). According to the Examiner, “[i]t is known in the art that the
dermatophyte fungi Trichophyton rubrum is a principal agent causing both
athlete’s foot and onychomycosis [a fungal infection of the nail].” (Id. pp.
4-5).
Therefore, the Examiner concluded that it would have been obvious to
one of ordinary skill in the art at the time of the invention “to treat a fungal
infection caused by Trichophyton rubrum, as suggested by Weller et al.,
where the infection is a subungual infection, to produce the instant
invention.” (Id. p. 5). The Examiner found that an ordinarily skilled artisan
would have been motivated to combine the references with a reasonable
expectation of success because Weller teaches that acidified nitrite cream is
fungicidal to T. rubrum. (Id.)(citing Weller p. 562).
The Appellant challenges each of the obviousness rejections by
asserting that Weller neither teaches “treat[ing] a subungual infection by
generating a composition on or applying it to the nail,” nor discloses “the
surprising teaching that the generally short-lived nitrogen oxides at issue can
penetrate the nail in amounts effective to treat infection.” (App. Br. 6).

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Additionally, the Appellant asserts that none of the secondary references
remedy the alleged deficiency of Weller. (App. Br. 6-8).
While we found that Weller does not anticipate by a specific
disclosure of treatment of the nail, we are not persuaded that the Examiner
erred in determining that claim 1 is obvious over Weller.
It is well settled that “[s]ection 103 forbids issuance of a patent when
‘the differences between the subject matter sought to be patented 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
art to which said subject matter pertains.’” KSR International Co. v. Teleflex
Inc., 127 S. Ct. 1727, 1734 (2007).
Without addressing the level of ordinary skill in the art with
persuasive evidence, the Appellant merely asserts that the difference
between claim 1 and the prior art is that Weller does not teach “treat[ing] a
subungual infection by generating a composition on or applying it to the
nail.” (App. Br. 6). That analysis is misdirected.
As the Examiner stated, “[i]t is known in the art that the dermatophyte
fungi Trichophyton rubrum is a principal agent causing both athlete’s foot
and onychomycosis [a fungal infection of the nail].” (Final Rejection, pp. 4-
5)(emphasis added); (see also Specification, p. 1)(“The fungi involved in
nail infections are mainly those that cause athlete’s foot....”).
Therefore, the Examiner concluded that it would have been obvious to
a skilled artisan that Weller’s treatment for tinea pedis would also be
effective to treat a subungual infection because both infections are known to
be caused by the same fungus, T. rubrum, targeted by Weller’s treatment.

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Similarly, it would have been obvious to the skilled artisan to apply Weller’s
treatment to the location of the infected portion of the foot, whether the
surface skin of the foot, or the nail.
Consequently, we agree with the Examiner that claim 1 would have
been obvious in view of Weller and when considering the ordinary skill in
the art. See, e.g., In re Bozek, 416 F.2d 1385 (CCPA 1969)(obviousness
considers the common knowledge and common sense of the person of
ordinary skill in the art apart from any specific hint or suggestion in a
particular reference).
To overcome an obviousness rejection, the Appellant must establish
that the Examiner erred in determining that a person of ordinary skill in the
art at the time of the invention who reviewed Weller would not have found it
obvious to modify Weller’s method of application to the surface, i.e., skin of
the foot to include application to the nail. See KSR International Co. v.
Teleflex Inc., 127 S. Ct. 1727, 1734. The Appellant has not done so.
We now turn to the allegation of unexpected results. Counsel for the
applicant urges that there is a “surprising” teaching that the generally short-
lived nitrogen oxides at issue can penetrate the nail in amounts effective to
treat infection. (App. Br. 6). This statement is also found in the
specification. (See Specification, p. 3, ll. 1-3).
We find this assertion to be unpersuasive. “[I]t is well settled that
unexpected results must be established by factual evidence.” In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997). The Appellant has not directed our
attention to sufficient evidence that a skilled artisan would have found the
difference between the application of Weller’s fungal treatment and the

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claimed invention to be surprising or unexpected, such that it would
overcome the totality of the evidence establishing that it would have been
obvious to one of ordinary skill in the art. Rather, the Appellant has merely
supported the assertion of unexpected results with attorney argument and
conclusory statements in the specification. Such evidence “does not
suffice.” In re De Blauwe, 736 F.2d 699, 705 (Fed.Cir.1994); see also, Süd-
Chemie Inc. v. Multisorb Technologies Inc., 554 F.3d 1001 (Fed. Cir. 2009).
Consequently, we do not find that the Appellant has established error
on the part of the Examiner.
Accordingly, we affirm the Examiner’s obviousness rejections.
CONCLUSION OF LAW
On the record before us, the Examiner has not established a prima
facie case of anticipation regarding claims 1, 3-5, 10, and 11.
However, the Appellants have not shown error with the Examiner’s
finding that the claims 1-17 and 19 are obvious over the prior art. It would
have been obvious to one of ordinary skill in the art at the time the invention
was made to apply a composition known to treat tinea pedis on the surface
of a foot to a nail in an amount that effectively treats an infection under the
nail.
DECISION
The Rejection of claims 1, 3-5, 10, and 11 under 35 U.S.C. § 102(b)
as being anticipated by Weller is REVERSED.
The Rejection of claims 1-6, 7, 10-14, and 19 under 35 U.S.C.
§ 103(a) as being unpatentable over the combination of Benjamin (WO
95/22335) and Weller is AFFIRMED.

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The Rejection of claims 1, 3-7, 11-17 and 19 under 35 U.S.C. § 103(a)
as being unpatentable over the combination of Tucker and Weller is
AFFIRMED.
The Rejection of claims 1, 3-7, 8-13 and 19 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Seitz and Weller is AFFIRMED.
The Rejection of claims 1-7, 11-12, 15-17 and 19 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Ormerod and Weller is
AFFIRMED.
The Rejection of claims 1-7, 10-17, and 19 under 35 U.S.C. § 103(a)
as being unpatentable over Benjamin (6,709,681) and Weller is
AFFIRMED.

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)(iv) (2006).

AFFIRMED

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MAT

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