Ex Parte Sefton

Board of Patent Appeals and Interferences

Jun 26, 2009

10820298 (B.P.A.I. Jun. 26, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JOHN SEFTON
____________

Appeal 2007-0864
Application 10/820,298
Technology Center 1600
____________

Decided:1 June 26, 2009
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and DEMETRA J.
MILLS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1-11, the only
claims pending in this application. We have jurisdiction under 35 U.S.C. §
6(b).

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 the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2007-0864
Application 10/820,298

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STATEMENT OF THE CASE
The claims are directed to a method for treating proliferative skin
diseases (claims 1-5) and a method for treating psoriasis in a human subject
(claims 6-11). Claim 1 is illustrative:
1. A method for treating proliferative skin diseases comprising the
administration of an effective amount of tazarotene and an effective amount
of a corticosteroid.

The Examiner relies on the following evidence:
Yamamoto US 5,236,906 Aug. 17, 1993
Nagpal et al. US 5,650,279 Jul. 22, 1997
Sequeira et al. US 4,775,529 Oct. 4, 1998
Smith US 5,874,074 Feb. 23, 1999

Appellant relies on the follow evidence:
H. Gollnick and A. Menter, Combination therapy with tazarotene plus a
topical corticosteroid for the treatment of plaque psoriasis, 140(Suppl. 54)
British Journal of Dermatology 15-23 (1999).

Beddingfield Declaration, executed February 2, 2005.

The rejections as presented by the Examiner are as follows:
1. Claims 1-11 stand rejected under 35 U.S.C § 103(a) as unpatentable over
the combination of Yamamoto and Nagpal.
2. Claims 1-11 stand rejected under 35 U.S.C § 103(a) as unpatentable over
Smith or Sequeira in combination with Nagpal.
We affirm.

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PRINCIPLES OF LAW
In proceedings before the Patent and Trademark Office, the Examiner
bears the burden of establishing a prima facie case of obviousness based
upon the prior art. In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). On
appeal to this Board, Appellant must show that the Examiner has not
sustained the required burden. See Ex parte Yamaguchi, 88 USPQ2d 1606,
1608 and 1614 (BPAI 2008) (precedential); Ex parte Fu, 89 USPQ2d 1115,
1118 and 1123 (BPAI 2008) (precedential); Ex parte Catan, 83 USPQ2d
1569, 1570 and 1577 (BPAI 2007) (precedential); Ex parte Smith, 83
USPQ2d 1509, 1512-1514, 1519 (BPAI 2007) (precedential).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that is was obvious under § 103.

Id. at 421. It is proper to “take account of the inferences and creative steps
that a person of ordinary skill in the art would employ.” Id. at 418. See also
id. at 421 (“A person of ordinary skill is also a person of ordinary creativity,
not an automaton.”). “In determining whether obviousness is established by
combining the teachings of the prior art, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
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in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
“[W]hen a prima facie case is made, the burden shifts to the
applicant to come forward with evidence and/or argument
supporting patentability.” In re Glaug, 283 F.3d 1335, 1338
(Fed. Cir. 2002). Rebuttal evidence is “merely a showing of
facts supporting the opposite conclusion.” In re Piasecki, 745
F.2d 1468, 1472 (Fed. Cir. 1984). . . . When a patent applicant
puts forth rebuttal evidence, the Board must consider that
evidence. See In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995)
(stating that “all evidence of nonobviousness must be
considered when assessing patentability”); In re Sernaker, 702
F.2d 989, 996 (Fed. Cir. 1983) (“If, however, a patent applicant
presents evidence relating to these secondary considerations,
the board must always consider such evidence in connection
with the determination of obviousness.”).

In re Sullivan, 498 F.3d 1345, 1351 (Fed. Cir. 2007). “When prima facie
obviousness is established and evidence is submitted in rebuttal, the
decision-maker must start over.” In re Rinehart, 531 F.2d 1048, 1052
(CCPA 1976); In re Hedges, 783 F.2d 1038, 1039 (Fed. Cir. 1986) (“If a
prima facie case is made in the first instance, and if the applicant comes
forward with reasonable rebuttal, whether buttressed by experiment, prior art
references, or argument, the entire merits of the matter are to be
reweighed”).
However, in order to establish unexpected results for a claimed
invention, objective evidence of non-obviousness must be commensurate in
scope with the claims which the evidence is offered to support. In re
Greenfield, 571 F.2d 1185, 1189 (CCPA 1978); In re Lindner, 457 F.2d 506,
508 (CCPA 1972); In re Tiffin, 448 F.2d 791, 792 (CCPA 1971).

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The combination of Yamamoto and Nagpal:

ISSUE

Are Appellant’s unexpected results sufficient to overcome the
Examiner’s prima facie case of obviousness?

FINDINGS OF FACT
FF 1. The instant Application is a continuation of Application No.
09/367,712, which was involved in Appeal Nos: 2002-1369 and 2005-0938.
Application No. 09/367,712 subsequently issued as U.S. Patent No.
6,974,807.
FF 2. Appellant does not dispute the Examiner’s conclusion that it would
have been prima facie obvious at the time the invention was made to
combine tazarotene and corticosteroid to treat skin disease (Ans. 3-4).
FF 3. Instead, Appellant contends that his evidence of unexpected results
overcomes the Examiner’s prima facie case of obviousness (App. Br. 3-11).
FF 4. Appellant discloses that the invention includes the use of low-
potency, mid-potency, or high-potency corticosteroid (see, e.g., Spec. 3: 20-
21).
FF 5. Appellant discloses that in treating patients with a combination of
tazarotene and corticosteroid “[t]he most common adverse events resulting
from the treatment were burning, pruritus and erythema; however there was
a lower incidence of such adverse events in patients treated with tazarotene
plus the medium- or high-potency corticosteroid” (Spec. 9: 26-29).
FF 6. Appellant discloses that “treating psoriasis in humans with a
combination of tazarotene and a mid-potency or high-potency corticosteroid
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is more effective than a combination of tazarotene and low-potency or
placebo and results in a lower incidence of adverse events such as burning
pruritis and erythema” (Spec. 10: 1-4).
FF 7. Beddingfield declares that based upon the evidence in the instant
application and in Gollnick “there appears to be a general trend that
combinations of tazarotene and corticosteroids increase efficacy in the
treatment of psoriasis while reducing the adverse events as compared to
tazarotene alone” (Beddingfield Dec. ¶ 3).
FF 8. In this regard, Beddingfield declares that “based upon the same
evidence, there appears to be a trend of reduction in adverse events for the
combination treatment of tazarotene and corticosteroid as the potency of the
corticosteroid is increased” (Beddingfield Dec. ¶ 6).
FF 9. According to Appellant’s Specification,
The overall incidence of adverse events that were possibly, probably or
definitely treatment-related decreased with increased corticosteroid potency,
falling from 42% in the taz/plac group, to 36%, 32% and 31% in the
tazarotene/low-potency corticosteroid (taz/low), taz/med, and taz/high
groups, respectively. (See Table II, below.)

(Spec. 12: 8-25.)
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FF 10. In proceedings on Appeal No. 2005-0938, in parent application
09/367,712, Appellant’s Appeal Brief included a table that compiled the
total adverse events for each combination of tazarotene from placebo
through high-potency corticosteroid (see 09/367,712, March 29, 2004 App.
Br. 6 and Decision on Appeal No. 2005-0938: 9). For clarity that table is
reproduced below:

(Id.)
FF 11. Gollinick reports on “the benefits of using a mid- or high-potency
corticosteroid in an additive combination regimen with tazarotene, compared
with tazarotene plus placebo” (Gollinick 22: col. 1, ll. 44-47).
FF 12. Gollinick reports that “[t]he addition of a mid- or high-potency
topical corticosteroid to tazarotene therapy offers a valuable means of
optimizing the efficacy and tolerability of treatment for plaque psoriasis”
(Gollinick 22: col. 2, ll. 47-50).

ANALYSIS
The claims have not been argued separately and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is representative and is
drawn to a method for treating proliferative skin diseases. The method of
claim 1 comprises the administration of an effective amount of tazarotene
and an effective amount of a corticosteroid. The corticosteroid set forth in
claim 1 is open to include the use of low-potency, mid-potency, or high-
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potency corticosteroid (FF 4). Accordingly, claim 1 reads on a method
comprising the administration of tazarotene and low-potency corticosteroid.
Accordingly, we limit our discussion to the combination of tazarotene and
low-potency corticosteroid.
Appellant contends that there is “a general reduction of adverse events
for the combination of tazarotene and a corticosteroid as compared to
tazarotene alone” (App. Br. 4). In addition, Appellant contends that while
“the adverse event contribution of each of the drugs in a combination may be
different, the total number of adverse events is the most important quantity
to be evaluated in terms of unexpected results” (id.). In this regard,
Appellant’s contend that “the comparison of medium to high potency
corticosteroid is irrelevant to whether combining corticosteroids with
tazarotene results in reduced side effects as compared to tazarotene alone”
(App. Br. 5).
We agree that the question is whether the combination of tazarotene
with a low-potency corticosteroid results in reduced side effects relative to
the use of tazarotene alone. Accordingly, we are not persuaded by
Appellant’s table illustrating the average of “the adverse event profile of the
corticosteroid combination groups”, e.g., the average of the observed side
effects associated with tazarotene in combination with low-, mid-, and high-
potency corticosteroid (App. Br. 6). This data tells us nothing about the
reduction in side effects associated with the combination of tazarotene and a
low-potency corticosteroid.
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The total number of adverse events for tazarotene alone or in
combination with low-, mid-, or high-potency corticosteroid as reported by
Appellant in Table II (FF 9) is reproduced below:

(FF 10.) Appellant’s Reply Brief recognizes, however, that there is a
discrepancy between the data recorded in Table II of Appellant’s
Specification and the text that corresponds to Table II. Specifically, while
the total adverse events from Table II is accurately reproduced in the
foregoing table, Appellant’s Specification reports that the total “incidence of
adverse events is 42% for tazarotene alone, and 36%, 32%, and 31% for the
tazarotene/low-, med-, and high-potency corticosteroid respectively” (Reply
Br. 7). While Appellant recognizes the discrepancy – Appellant contends
that “both sets of data points [come] to the same conclusion. The groups
receiving both tazarotene and a corticosteroid had fewer adverse events than
those that received tazarotene only” (id.). We are not persuaded.
Instead, we consider the data presented in Table II (FF 9) to be most
relevant as this is the data that was used and represented on Appeal in an
effort to demonstrate an “unexpected” result (FF 10). We are, however, not
persuaded that the data presented in Table II of Appellant’s Specification
establishes unexpected results for a method of treating skin disease
comprising administering a combination of tazarotene and a low-potency
corticosteroid. In this regard, we recognize the complete lack of any
statistical analysis establishing that the four percent difference (see, e.g., FF
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10) in adverse effects between the treatment with tazarotene alone (e.g.,
Taz/plac) and tazarotene in combination with a low-potency corticosteroid is
relevant and unexpected. To the contrary, it would appear that at the time
the Specification was written Appellant agreed that “treating psoriasis in
humans with a combination of tazarotene and a mid-potency or high-potency
corticosteroid is more effective than a combination of tazarotene and low-
potency or placebo and results in a lower incidence of adverse events such as
burning pruritis and erythema” (FF 6 (emphasis added)).
We recognize Appellant’s reliance on the post-filing date Gollinick
reference (see, e.g., App. Br. 7). We also recognize Appellant’s tables and
graphs of the numbers reported in Gollinick and conclusion that Gollinick
supports the full breath of the invention set forth in claim 1 (see generally,
App. Br. 7-9 and Reply Br. 9-12). We are not persuaded.
While Gollinick does experiment with low-potency corticosteroid,
Appellant does not identify and we do not find a teaching in Gollinick that
suggests the use of a low-potency corticosteroid for the treatment of any
disease. Instead, Gollinick limits its discussion to mid- and high-potency
corticosteroids (FF 11-12). The Beddingfield Dec., which relies on
Appellant’s Specification and Gollinick, fairs no better at making a specific
fact based statement that suggests that a method of treating a skin disorder
with a combination of tazarotene and low-potency corticosteroid would be
expected to exhibit a reduction in adverse effects over the use of tazarotene
alone.
Therefore, despite Appellant’s contention that two experts have
observed the trend asserted by Applicant (App. Brief, 8), neither
Beddingfield nor Gollinick state that the combination of tazarotene and low-
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potency corticosteroid results in a reduction of adverse effects. Stated
differently, while there may be a “trend” associated with increased
corticosteroid potency, the question is when does this “trend” become
statistically relevant? There is no evidence on this record that the reported
results for tazarotene in combination with placebo is statistically different
than the results reported for tazarotene in combination with low-potency
corticosteroid.
In order to establish unexpected results for a claimed invention,
objective evidence of non-obviousness must be commensurate in scope with
the claims which the evidence is offered to support. In re Greenfield, 571
F.2d at 1189. For the foregoing reasons, the evidence on this record fails to
establish unexpected results for a combination of tazarotene and low-
potency corticosteroid. Accordingly, the evidence of record is not
commensurate in scope with claim 1.

CONCLUSION OF LAW
Appellant’s unexpected results are not sufficient to overcome the
Examiner’s prima facie case of obviousness.
The rejection of claim 1 under 35 U.S.C § 103(a) as unpatentable over
the combination of Yamamoto and Nagpal is affirmed. Since they are not
separately argued, claims 2-11 fall together with claim 1.

Smith or Sequeira in combination with Nagpal:

ISSUE
Are Appellant’s unexpected results sufficient to overcome the
Examiner’s prima facie case of obviousness?
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FINDINGS OF FACT
FF 13. Appellant does not dispute the Examiner conclusion that it would
have been prima facie obvious at the time the invention was made to
combine tazarotene and corticosteroid to treat skin disease (Ans. 5).

ANALYSIS
Appellant contends that “[t]he arguments made for part A ‘Rejection
over Yamamoto and Nagpal above also apply here” (App. Br. 11).
For the reasons set forth above, we are not persuaded.

CONCLUSION OF LAW
Appellant’s unexpected results are not sufficient to overcome the
Examiner’s prima facie case of obviousness.
The rejection of claim 1 under 35 U.S.C § 103(a) as unpatentable over
Smith or Sequeira in combination with Nagpal is reversed. Since they are
not separately argued claims 2-11 fall together with claim 1.

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).

dm

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