Ex Parte Bingaman et al

Board of Patent Appeals and Interferences

Apr 29, 2010

10772963 (B.P.A.I. Apr. 29, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte DAVID P. BINGAMAN, ABBOT F. CLARK,
RAJNI JANI and STELLA M. ROBERTSON,

Appellants
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Appeal 2009-010169
Application 10/772,963
Technology Center 1600
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Decided: 29 April 2010
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Before SALLY GARDNER LANE , Lead Administrative Judge, RICHARD
TORCZON, and MICHAEL P. TIERNEY, Administrative Patent Judges.

LANE, Lead Administrative Patent Judge.
DECISION ON APPEAL
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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134, is from a Final Rejection of
claims 1 and 3-18. Appellants canceled claim 2. (App. Br. 2). We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellants’ specification relates to treatment for pathologic ocular
angiogenesis, which is the formation of new blood vessels in the eye.
(Spec. p. 1, ll. 4-12).
The Examiner relied on the following patent documents:
Name Number Date Abbreviation
Boltralik 4,686,214 August 11, 1987 Boltralik
Clark 5,371,078 December 6, 1994 Clark
Peyman 5,516,522 May 14, 1996 Peyman
Billson WO 95/03807 February 9, 1995 ’807

Appellants appeal the following rejections:
• claims 1, 3-5, and 8-18 under 35 U.S.C. § 103(a) over Clark
and Peyman;
• claims 1, 4-5, and 16-18 under 35 U.S.C. § 103(a) over
Clark and WO 95/03807; and
• claims 1, 3, and 6-7 under 35 U.S.C. § 103(a) over Clark and
Boltralik.
Appellants did not argue for the separate patentability of any of the claims
within these rejections by using a separate heading. To the extent
Appellants address claims dependent on claim 1, we discuss these issues
below, but we focus on claim 1 in our review of each rejection. See
37 C.F.R. § 41.37(c)(vii).
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II. FINDINGS OF FACT
1. Appellants’ claim 1 recites1:
A method for treating pathologic ocular angiogenesis and any
associated edema which comprises, administering a composition
comprising
an effective amount of a glucocorticoid and
an effective amount of anecortave acetate.

(App. Br. 11; Claims App’x).

2. Clark teaches angiostatic steroids, that is, steroids that inhibit
angiogenesis, and their use in controlling hypertension in the eye, such as in
glaucoma. (Clark col. 2, ll. 62-66).
3. The Examiner finds, and Appellants do not dispute, that the
angiostatic steroids taught in Clark include anecortave acetate (which is also
referred to as 4,9(11)-pregnadien-17α,21-diol-3,20dione-21-acetate (see
Spec. p. 8, ll. 13-14)). (Clark col. 3, l. 1, through col. 6, l. 42; see also Clark
claim 2).
4. Peyman teaches that it was known to treat neovascularization
with “steroids with antiproliferative effects.” (Peyman col. 7, ll. 55-58).
5. Peyman teaches that it was known to treat proliferative
vitrioretinopathy (“PVR”) with, among other drugs, glucocorticoids such as
predinisone, prednisolone, and fluorometholone. (Peyman col. 7, ll. 33-55).

1 Claim 1 has been modified by adding an indentation. See 37 C.F.R.
§ 1.75(i).

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6. Appellants’ specification provides that the glucocorticoids
useful in the claimed method include prednisone, prednisolone, and
fluorometholone. (Spec. p. 4, ll. 10-13).
7. The Examiner finds, and Appellants do not dispute, that PVR is
an “ocular angiogenesis-associated disorder.” (Ans. 3).
8. ‘807 teaches that triamcinolone acetonide is useful for treating
age-related macular degeneration. (‘807 abstract and p. 2, ll. 2-3, and p. 3,
ll. 4-5).
9. Appellants’ specification provides that the glucocorticoids
useful in the claimed method include triamicinolone acetonide. (Spec. p. 4,
ll. 10-13).
10. Appellants’ specification provides that age-related macular
degeneration is a pathologic ocular angiogenic condition within the scope of
the claimed method. (Spec. p. 11, ll. 7-11).
11. Boltralik teaches that a compound the Examiner identifies, and
Appellants do not dispute, to be rimexolone, is useful in treating patients
with open angle glaucoma. (Boltralik col.2, ll. 25-38, and col. 4, ll. 3-5).
12. Appellants’ specification provides that the glucocorticoids
useful in the claimed method include rimexolone. (Spec. p. 4, ll. 10-13).
13. Appellants’ specification provides that chronic glaucoma is a
pathologic ocular angiogenesis-related condition within the scope of the
claimed method. (Spec. p. 11, ll. 7-11).
III. ISSUE
Would it have been obvious to combine a glucocorticoid known to be
useful in treating pathologic ocular angiogenesis and anecortave acetate,
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which was also known to be useful in treating pathologic ocular
angiogenesis, to achieve a treatment for the same condition?
IV. ANALYSIS
Appellants claim a method of treating pathologic ocular angiogenesis
by administering a composition comprising a glucocorticoid and anecortave
acetate. (FF2 1).
Appellants do not dispute that Clark teaches anecortave acetate as a
treatment for ocular angiogenesis. (See FF 3).
Peyman, ‘807, and Botralik each teach administering glucocorticoids
to treat ocular disorders that Appellants do not dispute, and acknowledge in
their specification, are angiogenesis-related disorders. (FFs 4-13).
Appellants’ main argument against the obviousness of the claimed
method is that “[t]he question is not whether using two different compounds
to treat pathologic ocular angiogenesis is obvious, but rather, whether using
two different compounds in the same composition is obvious.” (App. Br. 5).
“It is prima facie obvious to combine two compositions each of which is
taught by the prior art to be useful for the same purpose, in order to form a
third composition which is to be used for the very same purpose.” In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Appellants have not provided
evidence to persuade us that those of skill in the art would not have learned
from the prior art that the individual ingredients were known to treat ocular
angiogenesis-related disorders or that the combination of the ingredients
would do the same. Contra Gillette Co. v. S.C. Johnson & Son, Inc., 919

2 “FF” indicates a Finding of Fact.
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F.2d 720 (Fed. Cir. 1990) (holding a composition of chemicals to be non-
obvious because the composition forms a post-foaming shaving gel when
none of the individual compounds, though known in the art, was known to
form a post-foaming shaving gel). Appellants have not provided evidence
that those of skill in the art would have been incapable of combining the
teachings of Clark with the other prior art references. Accordingly, we are
not persuaded that the composition would not have been obvious.
According to Appellants, the device for drug delivery taught in
Peyman was intended to be used with one agent, so that Peyman provides
only a suggestion to try using a combination of active agents. (App. Br. 6).
Appellants do not provide evidence for this assertion. “Argument of counsel
cannot take the place of evidence lacking in the record.” Meitzner v.
Mindick, 549 F.2d 775, 782 (CCPA 1977). Furthermore, Peyman was not
cited for teachings regarding the delivery device. It was cited to show that
those of skill in the art knew before Appellants’ filing date that
glucocorticoids have antiproliferative effects and were known to be useful
for treating an ocular angiogenesis-associated disorder. (See FFs 6-8).
Thus, this argument is unpersuasive.
Appellants also argue that it would not have been known by those in
the art that administering a glucocorticoid with a second antiangiogenic
agent would prevent unwanted side effects that occur with the
glucocorticoids alone. (App. Br. 6-7). In a related argument, Appellants
assert that Boltralik teaches away from using an agent in addition to a
glucocorticoid because Boltralik does not teach side effects of
glucocorticoids. (App. Br. 9).
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Appellants do not recite reducing side effects of glucocorticoids in
their claimed method. Thus, whether or not the method incurs side effects
has no bearing on it patentability. Furthermore, “[i]n determining whether
the subject matter of a patent claim is obvious, neither the particular
motivation nor the avowed purpose of the patentee controls . . . . Under the
correct analysis, any need or problem known in the field of endeavor at the
time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed.” KSR Int’l v. Teleflex Inc.,
550 U.S. 398, 419-20 (2007). Even if those of skill in the art would not have
known that the combination would reduce the side effects of glucocorticoids
alone, that the ingredients are individually useful for the same purpose
renders the combination prima facie obvious. See Kerkhoven, 626 F.2d at
850.
To the extent that Appellants argue there are unexpected results from
the claimed method because it was known that glucocorticoids produce
significant side effects (see App. Br. 6-7), they do not provide sufficient
evidence to support that those of skill in the art would not have expected this
result or even that the claimed method reduces side effects. See Meitzner,
549 F.2d at 782; see also App. Br. 13, Evidence App’x: “None.”
Finally, Boltralik does not teach away from the claimed method.
Appellants do not point to, and we do not find, any teaching in Boltralik that
would have discouraged those in the art from adding rimexolone to a
glucocorticoid to treat pathologic ocular angiogenesis. “A reference may be
said to teach away when a person of ordinary skill, upon reading the
reference, would be discouraged from following the path set out in the
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reference, or would be led in a direction divergent from the path that was
taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Appellants also argue that Peyman does not teach doses of steroids
that would be successful for treating pathologic ocular angiogenesis. (App.
Br. 5). Appellants’ claim 1 is not limited to a composition with any specific
dose of glucocorticoid. Thus, we are not persuaded that the teaching of
glucocorticoids in Peyman does not fall within the scope of Appellants’
claim 1.
To the extent that Appellants’ dependent claims recite percentages of
glucocorticoids, Peyman teaches that delivering an effective concentration of
therapeutic agents is one of the “major limiting factors” of successful
treatment. (See Peyman col. 4, ll. 64-67). “[D]iscovery of an optimum value
of a result effective variable in a known process is ordinarily within the skill
of the art. . . . It is well settled that a prima facie case of obviousness may be
rebutted ‘where the results of optimizing a variable, which was known to be
result effective, (are) unexpectedly good.’” In re Boesch, 617 F.2d 272, 276
(CCPA 1980) (quoting In re Antonie, 559 F.2d 618, 618-620 (CCPA 1977).
Appellants have not provided sufficient evidence that the concentrations of
glucocorticoids recited in dependent claims 5, 7, 9, 11, and 13 would have
been considered to be unexpectedly good by those in the art. Accordingly,
Appellants have not persuaded us that the claimed concentrations are not
obvious.
V. CONCLUSION
It would have been obvious to combine a glucocorticoid and
anecortave acetate, both known to be useful in treating pathologic ocular
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angiogenesis, to achieve a treatment for the same condition. Thus, the
Examiner did not err in rejecting Appellants’ claims under 35 U.S.C.
§ 103(a).
VI. ORDER
Upon consideration of the record and for the reasons given,
the rejection of claims 1, 3-5, and 8-18 under 35 U.S.C. § 103(a) over
Clark and Peyman is AFFIRMED;
the rejection of claims 1, 4-5, and 16-18 under 35 U.S.C. § 103(a)
over Clark and WO 95/03807 is AFFIRMED; and
the rejection of claims 1, 3, and 6-7 under 35 U.S.C. § 103(a) over
Clark and Boltralik is AFFIRMED.
FURTHER ORDERED that no time period for taking any subsequent
action in connection with the appeal may be extended under 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

Teresa J. Schultz
Alcon Research, Ltd.
6201 South Freeway, Q-148
Fort Worth, TX 76124-2099