MEDTRONIC ARDIAN LUXEMBOURG SARL

Patent Trials and Appeals Board

Nov 3, 2020

14379917 - (D) (P.T.A.B. Nov. 3, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
14/379,917 08/20/2014 Neil Barman C00003341.USN4 6224
28390 7590 11/03/2020
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
EXAMINER
KUO, JONATHAN T
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
11/03/2020 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
rs.patents.five@medtronic.com
rs.vasciplegal@medtronic.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte NEIL BARMAN, AYALA HEZI-YAMIT, and
STEFAN TUNEV

Appeal 2019-003582
Application 14/379,917
Technology Center 3700
____________

Before BRADLEY B. BAYAT, TARA L. HUTCHINGS, and
ROBERT J. SILVERMAN, Administrative Patent Judges.

SILVERMAN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision rejecting claims 23–46, 48, and 49. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real party in interest as:
“Medtronic Ardian Luxembourg S.a.r.l., which is a subsidiary of Medtronic,
Inc. Medtronic, Inc. is a wholly-owned subsidiary of Medtronic plc (an Irish
incorporated public limited liability company).” Appeal Br. 1.
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Application 14/379,917

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ILLUSTRATIVE CLAIM
23. A method for treating a human subject having a
diagnosed overeating disorder, the method comprising:
percutaneously introducing a neuromodulation
assembly at a distal portion of a treatment device
proximate to sympathetic neural fibers innervating a
gastrointestinal organ of the subject;
at least partially ablating the sympathetic neural
fibers innervating the gastrointestinal organ via the
neuromodulation assembly; and
removing the neuromodulation assembly from the
subject after treatment,
wherein at least partially ablating the sympathetic
neural fibers causes a decrease in gastric motility in the
subject following treatment and after removing the
neuromodulation assembly from the subject, thereby
resulting in a therapeutic improvement in the diagnosed
overeating disorder of the subject.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Leung et al.
(hereinafter “Leung”)
US 2011/0264075 A1 Oct. 27, 2011
Danielle Barry et al., Obesity and Its Relationship to Additions: Is
Overeating a Form of Addictive Behavior?, 18 Am. J. Addiction 439
(2009) (hereinafter “Barry”)
Felix Mahfoud et al., Effect of Renal Sympathetic Denervation on
Glucose Metabolism in Patients with Resistant Hypertension,
123 Circulation 1940 (2011) (hereinafter “Mahfoud”)

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REJECTIONS
I. Claims 23–32 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Leung and Barry.
II. Claims 33–46, 48, and 49 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Leung and Mahfoud.
FINDINGS OF FACT
The findings of fact relied upon, which are supported by a
preponderance of the evidence, appear in the following Analysis.
ANALYSIS
Independent Claim 23; Dependent Claims 24–32
In rejecting independent claim 23, the Examiner relies primarily upon
Leung, but states:
Leung does not teach the human subject having a
diagnosed overeating disorder. Leung does teach that obesity
could be treated ([0371] “may enable treatment of . . . obesity”).
Barry teaches that obesity is related to overeating disorder
(Abstract; p. 2 third paragraph). Thus it would have been
obvious to a person of ordinary skill in the art at the time the
invention was made to modify the teaching of Leung to include
using the method steps to treat overeating disorder since Barry
teaches that overeating disorder is related to obesity. In other
words, it would be obvious to try treating overeating disorder
the same way one would treat obesity.
Final Act. 12–13.
The Appellant argues that the Examiner does not adequately establish
a reason to combine the teachings of Leung and Barry; instead, according to
the Appellant, the rejection of claim 23 suffers from impermissible
hindsight. Appeal Br. 7–18.
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Although, as the Appellant points out (id. at 9–10), the Examiner
employs the phrase “obvious to try” (Final Act. 12), in regard to relying on
Barry’s teachings, the Examiner does not employ the reasoning typically
associated with that phrase. As our reviewing court has explained,
demonstrating obviousness under an “obvious to try” theory requires
“show[ing] (1) a design or market need to solve a particular problem, and
(2) that ‘there are a finite number of identified, predictable solutions’ that
would lead to an expectation of success.” Grunenthal GmbH v. Alkem Labs.
Ltd., 919 F.3d 1333, 1345 (Fed. Cir. 2019) (quoting KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 421 (2007)). The rejection of claim 23, however, does
not involve selecting a solution from among a finite number of identified,
predictable alternatives. Instead, the Examiner relies upon Barry for the
suggestion to use Leung’s neuromodulation technique — identified as
applicable to subjects exhibiting the symptom of obesity (Leung ¶¶ 370–72)
— to treat an “overeating disorder,” which Barry indicates to be a cause of
obesity (Barry 1–2).
Disputing the rejection, the Appellant argues that the Examiner’s
approach amounts to mistaking the treatment of a symptom for treating the
underlying disease, which the Appellant contends “is not an accepted
practice in medicine.” Appeal Br. 13.
As the Examiner points out, in response, the Appellant’s assertion is
an attorney argument that cannot take the place of factually supported
objective evidence. Answer 5 (citing In re Huang, 100 F.3d 135, 139–140
(Fed. Cir. 1996)). Moreover, the Examiner challenges the Appellant’s view
that medical therapies treating symptoms do not address the underlying
causes thereof:
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Medical practice for treatment of disease does include treating
the symptoms of the disease; e.g. cold medicine treats
symptoms such as headaches, fever, and congestion which are
the result of viral infection. Therefore, a person of ordinary
skill in the art would find it obvious to go from treating obesity
to treating overeating with a reasonable expectation of success
in light of the teachings of Leung and Barry.
Id. at 5–6.
Notwithstanding Barry’s position that some instances of overeating
may be regarded as a psychiatric ailment, akin to addictions to drugs or
alcohol (see Barry 2), the Examiner relies upon Barry only for the teaching
that overeating disorder is a cause of obesity — regardless of the nature of
the fundamental biological or psychiatric mechanisms involved (see Answer
4–5). Barry’s discussion of a possible psychiatric basis for some overeating
behavior does not negate the relationship between overeating and obesity.
Id. at 6–7. Therefore, the Appellant does not adequately show error in the
Examiner’s position that a person of ordinary skill in the art, at the relevant
time, would have had a reasonable expectation of success in the combination
of Leung and Barry, per the Examiner’s rejection of claim 23. See Answer
4–7.
The Appellant also argues that “the whole of the prior art of record
cited by the Examiner during the prosecution of the present application has
taught away from the claimed elements recited in claim 23.” Appeal Br. 15.
The Appellant’s reference to “the whole of the prior art” purports to include,
in particular, the Maschino (US 2007/0093870 A1, pub. Apr. 26, 2007) and
Dobak (US 2003/0181958 A1, pub. Sept. 25, 2003) references, which were
cited in Office Actions that predated the Final Office Action at issue in the
present Appeal. Id. at 15–16.
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The Appellant misapplies the patent law doctrine of “teaching away.”
As our reviewing court has explained,
[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 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). Yet, the “teaching away”
doctrine focuses on whether one or more of the prior art references, which
are relied upon to establish unpatentability of claimed subject matter,
undermines the reason for combining those references. See In re ICON
Health & Fitness, Inc., 496 F.3d 1374, 1382 (Fed. Cir. 2007) (“[A] reference
teaches away from a combination when using it in that combination would
produce an inoperative result.”) Contrary to this principle, the Appellant
ascribes the “teaching away” capacity to Maschino and Dobak — neither of
which is relied upon in the combination of references being reviewed in this
Appeal. As the Examiner states:
While there may have been art in the field that proposed other
teachings/mechanisms that do not fit the teaching/motivation of
Leung and Barry, this alone cannot be an indication of non-
obviousness since the rejection is based on the art of record
(Leung and Barry).
Answer 8. Essentially, the Appellant’s argument amounts to a position that
a person of ordinary skill in the art — on account of such a person’s
knowledge, skill, and experience — would not have combined the Leung
and Barry references, in the manner of the Examiner’s rejection. However,
the Appellant does not adequately support such a position.
In view of the foregoing, we are not persuaded of error in the rejection
of independent claim 23. Because the Appellant relies upon the same
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arguments, in regard to dependent claims 24–32, we sustain the rejection of
claims 23–32 under 35 U.S.C. § 103(a).
Independent Claims 33 and 48;
Dependent Claims 34–46 and 49
Independent claim 33 recites:
33. A method of treating a human patient diagnosed with
obesity and a gastrointestinal hormone imbalance, the method
comprising:
intravascularly positioning a neuromodulation assembly
within a gastrointestinal blood vessel of the patient and adjacent
to a target gastrointestinal nerve of the patient;
reducing sympathetic neural activity in the patient by
delivering energy to the target gastrointestinal nerve via the
neuromodulation assembly; and
removing the neuromodulation assembly from the patient
after delivering energy to the target gastrointestinal nerve,
wherein reducing sympathetic neural activity results in
an improvement in a gastrointestinal hormone level in the
patient diagnosed with obesity and the gastrointestinal hormone
imbalance following treatment and after removing the
neuromodulation assembly from the patient.
(Emphasis added).
In rejecting claim 33, the Examiner relies upon Leung for treating a
human patient diagnosed with obesity, using the neuromodulation technique.
Final Act. 16–17. As to the claimed “treating a human patient diagnosed
with . . . a gastrointestinal hormone imbalance,” using neuromodulation, the
Examiner states:
Leung does not teach treating a patient with
gastrointestinal hormone imbalance. However, Mahfoud
teaches that a decrease in sympathetic neural activity leads to
improved hormone (insulin and glucagon are hormones) levels
(Abstract; p. 1942 last paragraph “renal denervation
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significantly reduced fasting glucose, insulin, and C-peptide
levels”; p. 1943 right column first paragraph “Inhibition of the
sympathetic nervous system . . . has been shown to improve
glucose metabolism by decreasing glucagon secretion”). Thus
it would have been obvious to a person of ordinary skill in the
art at the time the invention was made to modify the teaching of
Leung to treat a patient with gastrointestinal hormone
imbalance because Mahfoud teaches that a reduction in
sympathetic activity can lead to improved hormone levels.
Id. at 17. Therefore, the Examiner’s analysis relies upon the position that
both insulin and glucagon are “gastrointestinal hormone[s],” per claim 33,
and that the recited “neuromodulation” can improve their respective
“level[s]” or states of “imbalance.”
According to the Appellant, Mahfoud attributes the alteration in
glucagon to a pharmaceutical treatment (i.e., the administration of
moxonidine — not neuromodulation). Appeal Br. 20 (citing Mahfoud
1943). Indeed, Mahfoud states: “Inhibition of the sympathetic nervous
system by moxonidine has been shown to improve glucose metabolism by
decreasing glucagon secretion.” Mahfoud 1943 (emphasis added).
Therefore, with respect to glucagon, we agree with the Appellant that
Mahfoud does not teach the claimed improvement in hormone level, through
the use of neuromodulation.
As to insulin, Mahfoud does attribute improvement in insulin level to
neuromodulation, stating: “therapeutic renal denervation substantially
reduces insulin and glucose levels and calculated insulin resistance.”
Mahfoud 1944. However, the Appellant argues that insulin is “a non-
gastrointestinal hormone.” Appeal Br. 21.
The Specification includes disclosure that illuminates the proper
construction of the claimed “gastrointestinal hormone”:
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In normal digestion, rhythmic contractions called
peristalsis function to move food through the digestive tract. In
patients with gastric motility disorders, peristalsis is abnormal
due to problems with the nerves or hormones that control
muscle contraction or with the muscles themselves. The most
common gastric motility disorder is irritable bowel syndrome
(IBS), symptoms of which include abdominal pain, diarrhea,
and constipation.
Spec. ¶ 16. In view of this disclosure, we understand the term
“gastrointestinal hormone” to refer to hormones that control the
gastrointestinal muscles of the digestive tract.
In view of this construction of the claim language, we agree with the
Appellant’s position that insulin is not a “gastrointestinal hormone,” as
claimed, because insulin does not control the gastrointestinal muscles of the
digestive tract. Rather, insulin “promotes the uptake of glucose by body
cells.” Elizabeth Martin & Robert Hine, A Dictionary of Biology (Oxford
Univ. Press 2008; current online version 2014) (“insulin”),
www.oxfordreference.com (accessed Oct. 27, 2020).
Accordingly, we agree with the Appellant’s position that the
Examiner erred in rejecting claim 33, because Mahfoud does not teach the
use of neuromodulation for “treating a human patient diagnosed with . . . a
gastrointestinal hormone imbalance.” The same shortcoming of Mahfoud
likewise applies to the rejection of independent claim 48 and to dependent
claims 34–46 and 49. Therefore, we do not sustain the rejection of claims
33–46, 48, and 49 under 35 U.S.C. § 103(a).

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
23–32 103(a) Leung, Barry 23–32
33–46, 48,
49
103(a) Leung, Mahfoud 33–46, 48,
49
Overall
Outcome
23–32 33–46, 48,
49

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED-IN-PART