Ex Parte Carroll et al

Board of Patent Appeals and Interferences

Jan 26, 2010

10587535 (B.P.A.I. Jan. 26, 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 IAN CARROLL, DAVID CLARK, and SEAN MACKEY

Appellants
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Appeal 2009-009980
Application 10/587,535
Technology Center 1600

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Decided: January 26, 2010
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Before RICHARD TORCZON, MICHAEL P. TIERNEY, and SALLY
GARDNER LANE, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL
I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134(a), is from a Final Rejection of
Appellants’ claims 1-10 and 12. Appellants cancelled claims 11 and 13-16.
(App. Br. 1). We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellants’ application is directed to methods of treating pain or
cardiovascular conditions by creating an extended sympathetic nerve block
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with a neurotoxin administered to a sympathetic ganglion. (Spec. ¶¶ [19] –
[22]).
The Examiner relied on the following U.S. Patent Application
Publications:
Donovan 2001/0023243 September 20, 2001
Brushey 2001/0056275 December 27, 2001
The Examiner also relied on the following publications:
• Henrard, et al., Thoracic Sympathectomy for Prinzmetal Angina
with Normal Coronary Arteries, 75 ARCH. MAL. COEUR,
1317-20 (1982) (English abstract) (“Henrard”);
• Erickson & Hogan, CT-guided Injection of the Stellate Ganglion:
Description of Technique and Efficacy of Sympathetic Blockade,
188 RADIOLOGY, 707-09 (1993) (“Erickson”); and
• Kim et al., Effects of Botulinum Toxin Type A on the Superior
Cervical Ganglia in Rabbits, 102 AUTONOMIC
NEUROSCIENCE: BASIC AND CLINICAL, 8-12 (2002)
(“Kim”).
Claims 1-3 and 5-6 were rejected under 35 U.S.C. § 103(a) over Kim
and Donovan. Appellants did not argue for the separate patentability of any
of these rejected claims. We focus on claim 1 in our review. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Claims 1-6 were rejected under 35 U.S.C. § 103(a) over Kim,
Donovan, and Brushey. Appellants did not argue for the separate
patentability of any of these rejected claims.
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Claims 1-3 and 5-7 were rejected under 35 U.S.C. § 103(a) over Kim,
Donovan, and Erickson. Appellants did not argue for the separate
patentability of any of these rejected claims.
Claims 1-3, 5-6, 8-10, and 12 were rejected under 35 U.S.C. § 103(a)
over Kim, Donovan, and Henrard. Appellants did not argue for the separate
patentability of any of these rejected claims.
II. FINDINGS OF FACT
1. Appellants’ claim 1 recites:
A method for treating sympathetically maintained chronic pain,
the method comprising:
administering by percutaneous injection a therapeutically
effective dose of a botulinum toxin type A, B, C1, D, E, F, or G to a
sympathetic ganglion of a human patient, thereby achieving a
sympathetic block for an extended period of time.

(App. Br. 15, Claims App’x).
2. Kim teaches that botulinum toxin type A (“BTA”) has
sympathetic ganglion blocking effects that last for over one month in rabbits,
without causing pathological changes in the ganglion. (Kim abstract).
3. Kim reports the results of studies in which BTA was injected
into an exposed ganglion in the neck of a rabbit and the sympathetic
response of varying pupil size (“miosis”) was measured. (Kim p.9, ¶ 2.2).
4. Kim teaches that sympathetic ganglion block by BTA may be
used to control sympathetically maintained pain. (Kim, p. 11, right col., last
paragraph).
5. Kim does not teach administering botulinum toxin by
percutaneous injection to a sympathetic ganglion of a human.
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6. Donovan teaches administration of botulinum toxin to humans,
generally for treating parathyroid disorders. (Donovan ¶ [0001] and [0088]-
[0092]).
7. Donovan teaches that intractable pain in humans has been
treated by percutaneous injection of substances into a ganglion to create a
block. (Donovan ¶ [0090]).
III. ISSUE
Would those of skill in the art have found it obvious to administer
botulinum toxin to treat chronic pain by achieving a sympathetic block for
an extended period of time from the teachings of both Kim and Donovan?
IV. ANALYSIS
Appellants’ claim 1 provides a method of treating chronic pain by
injecting botulinum toxin to a sympathetic ganglion in a patient. (FF 1)1.
Kim teaches that BTA can block sympathetic ganglions for over a
month in rabbits without damaging the nerve (FF 2) and suggests that it
might be used to control sympathetically maintained pain (FF 4). Kim does
not provide experiments showing actual pain control in humans (FFs 3
and 5), but Donovan teaches that it was known that intractable pain can be
treated with percutaneous injection of substances into human ganglia.
(FF 7).
Those of skill in the art would have had reason to modify the teaching
in Kim that BTA can block sympathetic nerves, with the teaching in
Donovan that percutaneous injection of substances into human ganglia can

1 “FF” indicates a Finding of Fact.
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reduce pain, because Donovan teaches how BTA can be administered.
(FF 6).
Appellants argue that Kim does not teach administering botulinum
toxin to result in a “sympathetic block,” but instead uses the term
“neurolytic,” which Appellants assert means that it destroys neurons instead
of blocking them. (App. Br. 4). Kim states that the results presented “imply
that BTA may be used clinically as a safe sympathetic neurolytic agent,”
(Kim, p. 11, paragraph bridging right and left columns (emphasis added);
see also p. 11, left col., last full paragraph), but we do not read this statement
in the context of the rest of Kim to mean that it does not provide a
“sympathetic block.” “During examination, ‘claims . . . are to be given their
broadest reasonable interpretation consistent with the specification, and . . .
claim language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.’” In re American Academy of
Sci. Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004) (citation omitted).
Appellants cite to a dictionary definition of “neurolysis” (see App. Br. 4),
but they do not explain why a “sympathetic block for an extended period of
time” is not achieved by destroying the neuron, especially given that
Appellants’ claims do not limit the duration of the block. In fact,
Appellants’ specification states that “neurolytic techniques have also been
used as a sympathetic block.” (Spec. ¶ [09]). Thus, the broadest reasonable
interpretation of the claim term “sympathetic block” would include a block
produced by a neurolytic agent. We are not persuaded that Kim fails to
teach that BTA can achieve a sympathetic block, as claimed.
Appellants also argue that Kim does not provide any expectation of
success in using botulinum toxin to treat sympathetically maintained chronic
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pain in humans, because it was known in the art that pupil dilation, or
miosis, is not indicative of pain. (App. Br. 4-5). Appellants argue that the
results in Kim are not reliable or consistent (App. Br. 6-7), citing Kim for a
discussion of a “lack of close agreement between the BTA injection and
resultant occurrence of miosis. . . .” (Kim, p. 11, left col., second full
paragraph). Appellants cite to Onal, et al., 33 Gen. Pharmacol., 83-89
(1999) (“Onal”), which states that when investigating analgesic drugs, “it is
difficult to evaluate the analgesic response with the pupil diameter.” (Onal
abstract). According to Appellants, because Kim does not show a
correlation between miosis and pain, those of skill in the art would not
expect success from the results of BTA blockage reported. (App. Br. 4-5).
More generally, Appellants argue that animal models for neuropathic pain
are not necessarily predictive of human pain. (App. Br. 7).
We are not persuaded by these arguments since they take into account
only the teachings of Kim. While Kim does postulate animal to animal
variations for the dosages used and efficiency (see id. p. 11, left col., third
full paragraph) and a “lack of close agreement between the BTA injection
and resultant occurrence of miosis,” Kim ultimately concludes that BTA
showed sympathetic ganglion blocking effects in at least some animals. (FF
2). Taking into account the teachings of Kim along with Donovan’s
teaching that it was known to inject blocking substances into human ganglia
to relieve pain, one skilled in the art would have expected that the block
taught by Kim would work in humans when injected as taught by Donovan.
(FF 7). Appellants have not provided sufficient evidence to show that when
reading Kim in light of Donovan, those in the art would doubt that the
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claimed method would work. (See App Br. 17, Evidence App’x (“There are
no Exhibits.”)).
Appellants argue that Donovan teaches using only neurolytic agents
such as ethanol and phenol to treat pain, not botulinum toxin. (App. Br. 8).
Appellants also argue that Donovan does not teach any correlation between
relief of parathyroid or calcium disorders and relief of pain and does not
report on any pain studies. (App. Br. 9). However, “[n]on-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., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The Examiner
found that Kim shows botulinum toxin to be useful as a sympathetic
ganglion blocking agent and thus Donovan need not have provided such a
teaching. Donovan shows that such agents can be, and have been,
effectively injected percutaneously into humans.
The Examiner did not err in rejecting claim 1 under 35 U.S.C.
§ 103(a) over Kim and Donovan.
The Examiner rejected claims 1-6 over Kim, Donovan, and Brushy
(Ans. 5) and claims 1-3 and 5-7 over Kim, Donovan, and Erickson (Ans. 4-
5), both under 35 U.S.C. § 103(a).
Appellants repeat the same arguments against the rejection of these
claims as for claim 1 (see App. Br. 9-11). For reasons noted, we found these
arguments to be unpersuasive. Appellants argue further that neither Brushy
nor Erickson cures the deficiencies of Kim and Donovan because neither
teaches that botulinum toxin would be useful in treating sympathetically
maintained pain. (App. Br. 10-11). Because Appellants provide no new
arguments against the rejection of claim 1 and do not dispute that Brushy
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and Erickson teach the additional elements recited in these claims,
Appellants have not shown that the Examiner erred.
The Examiner also rejected claims 1-3, 5-6, 8-10, and 12 over Kim,
Donovan, and Henrard under 35 U.S.C. § 103(a). (Ans. 6). Appellants’
claim 8 recites a method for treating cardiovascular conditions, the method
comprising administering botulinum toxin type to a sympathetic ganglion of
a human patient by percutaneous injection. (See App. Br. 16; Claims
App’x).
Kim and Donovan were relied upon for the same reasons as discussed
above in regard to the rejection of claim 1. Henrard was relied upon for
teaching that angina pain from spasms of coronary arteries can be alleviated
with surgery to interrupt a sympathetic nerve ganglion. (Henrard translation
abstract).
Appellants argue that Henrard teaches a highly invasive procedure
that produces a global effect, in contrast to the claimed method which
impacts only a specific biochemical pathway. (App. Br. 12). According to
Appellants, because of this difference, those in the art would not have had an
expectation of success in using botulinum toxin to treat cardiovascular
disease. (Id.). Appellants also repeat the same arguments against the
rejection of claim 1. (Id.).
We are not persuaded by Appellants’ arguments. Appellants are
essentially arguing that none of the cited references alone renders the
claimed method obvious, rather than addressing the combination of their
teachings. See Merck, 800 F.2d at 1097. Henrard would have informed one
skilled in the art that blockage of a sympathetic ganglion was one approach
to treating peripheral vascular disease. Thus, one skilled in the art would
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have had reason to use the blocking agents and injection method taught by
Kim and Donovan for treating cardiovascular disease. Appellants have not
shown that the Examiner erred.
V. ORDER
Upon consideration of the record and for the reasons given,
the rejection of claims 1-3 and 5-6 under 35 U.S.C. § 103(a) over Kim
and Donovan is AFFIRMED;
the rejection of claims 1-6 under 35 U.S.C. § 103(a) over Kim,
Donovan, and Brushey is AFFIRMED;
the rejection of claims 1-3 and 5-7 under 35 U.S.C. § 103(a) over
Kim, Donovan, and Erickson is AFFIRMED; and
the rejection of claims 1-3, 5-6, 8-10, and 12 under 35 U.S.C. § 103(a)
over Kim, Donovan, and Henrard is AFFIRMED.
FURTHER ORDERED that 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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