Ex Parte Whitehurst et al

Patent Trials and Appeals Board

Sep 11, 2014

12358002 - (D) (P.T.A.B. Sep. 11, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/358,002 01/22/2009 Todd K. Whitehurst 07-00383-02 1725
71422 7590 09/11/2014
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
ALTER MORSCHAUSER, ALYSSA MARGO
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
09/11/2014 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte TODD K. WHITEHURST, RAFAEL CARBUNARU,
KRISTEN N. JAAX, ANDREW DIGIORE, BRETT SCHLEICHER,
GREG BALDWIN, and ROGER HASTINGS
__________

Appeal 2012-005345
Application 12/358,002
Technology Center 3700
__________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for treating pancreatitis pain. The Examiner rejected the claims on
obviousness grounds. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.

1 Appellants identify the Real Party in Interest as Boston Scientific
Neuromodulation Corporation (see App. Br. 2).
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STATEMENT OF THE CASE
Background
The invention described in the Specification relates to the treatment of
pancreatitis pain caused by “sphincter of Oddi dysfunction.” “The sphincter
of Oddi is a muscular structure that encompasses the confluence of the distal
common bile duct and the pancreatic duct of the pancreas as they penetrate
the wall of the duodenum. The term ‘sphincter of Oddi dysfunction’
describes a clinical syndrome of biliary or pancreatic obstruction related to
mechanical or functional abnormalities of the sphincter of Oddi” (Spec. ¶3).
“[S]phincter of Oddi dysfunction may lead to a build-up of pancreatic juices
within the pancreatic and bile ducts, thereby causing ductal distension, tissue
damage, and pain” (id., ¶4). According to the Specification,
[m]ethods of treating a patient with pancreatitis pain
include providing a stimulator, configuring one or more
stimulation parameters to control sphincter of Oddi
function, programming the stimulator with the one or more
stimulation parameters, generating a stimulus configured
to control sphincter of Oddi function with the stimulator in
accordance with the one or more stimulation parameters,
and applying the stimulus with the stimulator to one or
more stimulation sites in accordance with the one or more
stimulation parameters.
(Id., ¶ 5).
The Claims
Claims 1 and 4-16 are on appeal. Claim 1, the sole independent
claim, is representative, and reads as follows:
1. A method of treating a patient with pancreatitis pain, comprising:
generating a first stimulus and a second stimulus with a stimulator
implanted within the patient; and
applying the first stimulus and the second stimulus to a stimulation
site comprising at least one or more of a region of the sphincter of Oddi and
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a nerve innervating a sphincter of Oddi of the patient, such that the first
applied stimulus contracts the sphincter of the Oddi during a first period and
the second applied stimulus relaxes the sphincter of the Oddi during a
second period to treat the pancreatitis pain.

The Issue

The Examiner rejected the claims under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Errico2 and Fischell.3 The issue
presented on appeal is whether the Examiner presented a prima facie
showing of obviousness.

FINDINGS OF FACT
FF1. Errico teaches that “the sphincter of Oddi may be stimulated by
direct application of electrical stimulation to the smooth muscles of
the sphincter, or by modulation of the signals applied to the
sphincter through the hepatic plexus” (Errico, ¶ 30). Errico further
teaches that “[s]timulation to reduce spasms, or to relax and/or
tighten this portion of the smooth muscle is critical to preventing
pancreatitis and/or relieving the intractable pain associated with
pancreatic cancer” (id., ¶ 31).
FF2. Errico teaches “a method of treating a patient's pancreatic pain
associated with hypertension of pancreatic fluids comprising
applying an electrical stimulation signal to at least one smooth
muscle of a patient’s sphincter of Oddi whereby relaxation of said

2 Errico, US 2007/0106338 A1, published May 10, 2007.
3 Fischell et al., US 6,591,137 B1, issued July 8, 2003.
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muscle is affected and reduced pancreatic fluid pressure is
affected” (id., ¶ 67). Errico further provides that
treatment of pancreatic pain can be achieved also by
relaxing the muscles described above, by applying an
electrical stimulation signal to at least one nerve fiber,
such that relaxation of at least one smooth muscle of a
patient’s sphincter of Oddi is affected, and reduced
pressure of pancreatic fluids is affected.
(Id., ¶ 68).
FF3. Errico teaches:
In a very appealing aspect, the present invention
includes a method of reducing a patient’s blood
cholesterol levels. This method comprises applying an
electrical stimulation signal to at least one smooth
muscle of a patient's sphincter of Oddi whereby a
tightening of said muscle is affected and reduced bile
flow from the patient's common biliary duct into the
patient's digestive tract is affected.
(Id., ¶ 70).
Errico further teaches that reduced blood cholesterol may be
achieved “by applying an electrical stimulation signal to at least
one nerve fiber, such that tightening of at least one smooth muscle
of a patient's sphincter of Oddi is affected and increased bile
pressure in the patient's biliary duct is affected” (id., ¶71).
FF4. Errico teaches that “the stimulation of muscle tissue to contract (or
in the case of a sphincter, to tighten) requires a different form of
applied electrical signal than those typically used to relax muscle
tissue” (id., ¶76).
FF5. Errico teaches that “a treatment system may employ electrical
signals to . . . control functions like contracting and relaxing of one
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or more sphincters and/or structures of the gall bladder, pancreas,
liver, bile duct, and/or Sphincter of Oddi system” (id., ¶78).
FF6. Fischell teaches
The present invention is a neuromuscular stimulator
for sequential responsive stimulation to restore normal
GI function. The most likely scenario for treating acid
reflux will involve electrodes placed at the esophageal
sphincter and stomach wall. When initiated, the
stimulator will close the esophageal sphincter and start
a timer. At the end of a preset time (e.g. 0.5-2 hours)
the stomach electrodes will be energized to empty the
stomach. At the end of a follow on period of time, at
which the stomach should now be empty, the device
will turn off all stimulation and be ready for the next
sequence.
(Fischell, col. 2 ll. 54-64).
FF7. Fischell teaches that “[e]ach electrode 15A through 15N can be
used for either sensing electrical signals from the gastrointestinal
tract or for stimulating the gastrointestinal tract to cause the
opening or closing of the esophageal sphincter or contractions of
digestive organs like the stomach, duodenum, small intestine, large
intestine or bowel” (id., col. 6 ll. 3-8).

PRINCIPLES OF LAW

“[R]ejections on obviousness grounds cannot be
sustained by mere conclusory statements. Instead,
there must be some articulated reasoning with some
rational underpinning to support the legal conclusion
of obviousness” . . . however, the analysis need not
seek out precise teachings directed to the specific
subject matter of the challenged claim, for a court can
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take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citation omitted)
(emphasis added).
ANALYSIS
The claims require “applying the first stimulus and the second
stimulus to a stimulation site . . . such that the first applied stimulus
contracts the sphincter of the Oddi during a first period and the second
applied stimulus relaxes the sphincter of the Oddi during a second period to
treat the pancreatitis pain” (Cl. 1 (emphasis added)). The Examiner finds
that “Errico discloses applying a stimulus to the sphincter of Oddi to
contract and relax the sphincter, but does not disclose that the stimulus to
contract and the stimulus [to] relax are executed consecutively” (Ans. 6,
citing Errico, ¶¶ 68, 70, 78). The Examiner relies upon Fischell to assert that
“[i]t would have been obvious to one having ordinary skill in the art at the
time the invention was made to modify the stimulation device of Errico to
include sequential relaxing and contracting of the GI tract sphincter as
disclosed by Fischell et al. in order to provide the predictable results of
ensuring the proper function of the sphincter by regulating the function with
stimulation” (id., citing Fischell, col. 6 ll. 3-8).
We conclude that a prima facie case of obviousness has not been
established based on the cited teachings of the prior art and the rationale
supplied by the Examiner. In particular, although Errico teaches the
electrical stimulation of the sphincter of Oddi (FF1-5), we do not find a
teaching or suggestion to apply both a first stimulus that “contracts the
sphincter of the Oddi during a first period” and a second stimulus that
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“relaxes the sphincter of the Oddi during a second period” in order to treat
pancreatitis pain. We have considered the Examiner’s response to
Appellants’ arguments, but find that Appellants have the better position.
The Examiner cites to paragraphs 68, 70, and 78 of Errico to assert
that the reference teaches both contracting and relaxing the sphincter of
Oddi. However, paragraph 68 of Errico states that pancreatic pain may be
treated by applying an electrical signal in order to only relax the muscles of
the sphincter (FF2). Paragraph 70, on the other hand, states that cholesterol
levels may be reduced by “applying an electrical stimulation signal to at
least one smooth muscle of a patient’s sphincter of Oddi whereby a
tightening of said muscle is affected” (FF3). Although paragraph 78
indicates that a treatment system may employ electrical signals to . . . control
functions like contracting and relaxing of [the] Sphincter of Oddi,” there is
no suggestion of applying both a contracting stimulus and a relaxing
stimulus in order to treat pancreatitis pain (FF5). Errico’s general disclosure
does not suggest that electrical stimulation to “tighten this portion of the
smooth muscle is critical to preventing pancreatitis and/or relieving the
intractable pain associated with pancreatic cancer” (FF1).
As noted by Appellants, in accordance with Errico’s teachings, “the
two stimuli were never meant to be applied at different time periods in order
to treat a single disease, but rather to be applied singularly depending on
whether pancreatic pain is to be treated or high cholesterol is to be treated”
(App. Br. 4). We find this to be further supported by Errico’s teaching that
“the stimulation of muscle tissue to contract . . . requires a different form of
applied electrical signal than those typically used to relax muscle tissue”
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(FF4). There is no indication that both forms of stimulation may be applied
to the same patient as part of a single course of treatment.
The deficiency in Errico is not made up by the cited teachings of
Fischell relied upon by the Examiner. Specifically, Fischell teaches “a
neuromuscular stimulator for sequential responsive stimulation to restore
normal GI function” (FF6). Fischell further teaches that “stimulating the
gastrointestinal tract to cause the opening or closing of the esophageal
sphincter or contractions of digestive organs like the stomach, duodenum,
small intestine, large intestine or bowel” (FF7). There is no suggestion in
Fischell to specifically stimulate the sphincter of Oddi or to treat pancreatitis
pain. Fischell only discloses that the GI tract can be stimulated to cause the
opening or closing of the esophageal sphincter, and does not disclose that
the GI tract can be stimulated at different times to open and close the
sphincter (id.).
The Examiner further asserts that “providing a reciprocal stimulus
signal (relaxation after contract) will also help normalize the operation of the
sphincter,” and “it is understood that eventually the sphincter will need to
relax after a contraction” (Ans. 6). The Examiner cites to no support for that
rationale in either Errico or Fischell, or the GI art in general. Moreover,
given the different physiological roles of the esophageal sphincter (taught by
Fischell) and the sphincter of Oddi (taught by Errico), we do not find the
Examiner’s stated rationale of “ensuring the proper function of the sphincter
by regulating the function with stimulation” to be a sufficient basis to
modify the teachings in order to arrive at the claimed invention.
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We, therefore, reverse the rejection of claims 1 and 4-16. We need
not address Appellants’ additional arguments concerning dependent claims
13 and 14.
SUMMARY
We reverse the rejections under 35 U.S.C. § 103(a).

REVERSED

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