2. $ 7000
$ 6000
$ 5000
$ 4000
$ 3000
$ 2000
$ 1000
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
$ 0
$millions
Obesity Pharmaceutical Sales ($millions)
Bariatric Surgical Device Sales ($millions)
The key players in this field include:
• Medtronics Inc
• Cyberonics Inc
• Advanced Neuromodulation Systems (now a part of
St. Jude Medical)
• Biocontrol Medical Ltd
• Leptos Biomedical Inc
• Enteromedics
100
90
80
70
60
50
40
30
20
10
1990 1995 2000 2005
0
Numberofpatentapplications
Year
Year
The concept of neurostimulation to affect functioning of
organs has been extensively used in medical
practice to treat various disorders such as Parkinson's
disease, multiple sclerosis, epilepsy, chronic pain, etc.
The use of neurostimulation for obesity treatment was
first suggested in the early 1990s. Ever since, there has
been a steady growth in Intellectual Property
investments in this domain, especially in the US (Figure2).
The incidence of obesity has more than doubled in the
last 25 years, now affecting around 33% of adult
population in the United States according to the
Centers for Disease Control & Prevention (CDC). The
World Health Organization (WHO) predicts that obesity
may soon replace more traditional public health
concerns such as under-nutrition and infectious
diseases, as the most significant cause of poor health.
The healthcare cost of obesity in the United States (US)
is estimated to be $147 billion annually (equivalent to
9.1% of total medical spending)[1]
.
The principal treatments currently available for obesity
include diet modification and exercise, pharmaceutical
therapies and surgical procedures like gastric bypass
and vertical banded gastroplasty. Besides these, the
industry has witnessed a flurry of activities around the
idea of using neurostimulation for treatment of obesity.
The market size for treatments related to obesity is also
expected to grow significantly over the next decade
(Figure 1).
[1] “Annual Medical Spending Attributable To Obesity: Payer-And
Service-Specific Estimates” by Eric A. Finkelstein, Justin G.
Trogdon, Joel W. Cohen and William Dietz.
Health Affairs, 28, no. 5 (2009):w822-w831
[2] Medmarket Diligence Report #S825 – “Worldwide Market
for the Clinical Management of Obesity, 2007”
Introduction Neurostimulation for
Obesity Treatment
2
Figure 1: Bariatric Surgical Devices and Pharmaceuticals in
Obesity, Worldwide Sales 2006-2015 [2]
Figure 2: Patent filing trend in the US
3. Neurostimulation
for Obesity
Treatment
825
281
Stimulation
methods
183
Stimulating
Location
54
Monitoring
Method
44
Other medical
methods
326
Stimulator
peripherals
30
Signal Modulator
65
Communication
Facilitator
106
Control System
116
Testing & monitoring
system
9
Miscellaneous
389
Neurostimulators
117
Vagus Nerve
5
Splanchnic Nerve
40
Deep Brain
1
Spinal Cord
87
Autonomous Nerve
187
Other Nerves
7
Miscellaneous
Level 1 Level 2 Level 3
Intellectual Property (IP) investments and the patents
granted in this domain can be classified into three
broad categories (Figure 3) –
• Neurostimulators
• Stimulation methods
• Stimulator peripherals
Identifying anatomical locations for stimulation has
been the most prominent patenting field. The industry
has also seen significant IP investments, especially in
patents related to stimulators for autonomous nerve or
more specifically Vagus nerve. However, not many
patents are present in the field of neurostimulators
specific for Splanchnic nerves.
Most of the patents related to neurostimulators belong
to Advanced Neurostimulation Systems and Biocontrol
Medical. Cyberonics dominates the field of stimulation
methods while Medtronics has made considerable
investments in stimulator peripherals.
Stimulation of Vagus nerve has received extensive
focus from these industry leaders resulting in significant
patenting activity in this domain.
This article presents a detailed analysis of the evolution
of Vagus nerve stimulation technology. Further, it
provides insight on related technology areas that offer
scope for innovation and an investment opportunity for
IP protection.
Intellectual Property
in Neurostimulation
3
Figure 3: Patent Classification
4. 2
2
2
5
2
1
1
1
1 1
2
4 5
1
7
1
1
1
2
2
2
2
1
1
1
1
2
1
5
2
1
1
1
7
1
1
1
1
1
1
4
4
2
3
3
3
3
3
2
3
Communication Facilitation &
Other Peripherals
Use of Control Unit
Stimulation Signal Patterns
Screening and Monitoring Methods
New Stimulation Effects
Vagus nerve stimulation for
obesity treatment
Gastric Band with Electrodes
Neurostimulator Designs
Transcutaneous Neurostimulation
New Stimulation Locations
1991 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Biocontrol Medical Ltd.
Assignees
Cyberonics
Enteromedics
Medtronics
Neuro & Cardiac Technologies
Others
The idea of stimulating the Vagus nerve to treat obesity
was conceived and patented in the year 1991 by
Cyberonics. Thereafter, many players have adapted
and actively entered the field of Vagus nerve
stimulation (Figure 4).
The technology evolution tree shows the entry and
activity of key players in the domain in the last 20 years.
It can be observed that Cyberonics entered the field
first, followed by Neuro & Cardiac Technologies.
Biocontrol Medical Method. entered the domain in the
year 2001. Biocontrol was started by an entrepreneur
named Yossi Gross who also founded
companies like DuoCure, Beta Stim which work in the
domain of Vagus nerve stimulation.
The players in the field of Vagus nerve stimulation have
focused their research resources on few specific areas.
For instance, Medtronic entered this field in 2002, and
developed its footprint in the area of ‘Screening &
Monitoring Methods’ for Vagus nerve stimulation.
Similarly, Enteromedics and Biocontrol Medical have
many patents on ‘Use of Control Unit’, while Neuro &
Cardiac Technologies has focused on development of
‘Communication facilitation & other peripherals’.
There are technology areas related to Vagus nerve
stimulation that have not witnessed significant
patenting activity till date. These areas include
‘Stimulation signal patterns’, ‘Neurostimulators designs’
along with ‘Gastric bands with electrodes’, and
‘Transcutaneous neurostimulation’.
There are significant number of patents related to
‘Screening & Monitoring Methods’, ‘New Stimulation
locations’ and ‘Communication facilitation & other
peripherals’.
In technology areas that have higher number of
patents, claim-wise mapping of the patents may help in
understanding the protection provided by them. Apart
from this, claim-wise mapping also throws some light on
the possibility of overlap among the patents in question.
To illustrate this, a detailed claim-wise overlap analysis
of patents in ‘Screening & Monitoring methods’ is
explained in the next section.
Screening & Monitoring
Methods: Claim-wise Map
A significant number of patents that deal with Vagus
nerve stimulation discuss ‘Screening & Monitoring
methods’. Many companies have ventured into this
technology area and filed for patents with Medtronic
and Cyberonics leading the pack. Figure 5 shows the
claim-wise overlap analysis of the patents in this area.
The analysis helps in identifying the key players and their
focus areas. Medtronic is the major assignee in this
sub-domain with 5 patent applications. These patents
are related to modulating the stimulating signal based
on the feedback received from the patient. Cyberonics
also has a significant presence in this sub-domain, with
4 patent applications. The applications relate to giving
stimuli prior to the induction of therapeutic stimulating
signal.
The claim wise overlap analysis further helps in
identifying the features that are extensively covered by
the existing patents and applications. For example,
features like ‘determining stimulating parameters’,
‘modulating the signal based on feedback’ and
‘stimulating after feedback’ have been covered in
various patents and applications. On the other hand,
features like ‘detecting condition of the nerve’,
‘redelivery of signals after temporary signal halting’ and
‘using imaging techniques for monitoring’ are present in
just one patent / application each.
Vagus Nerve Stimulation:
Evolution of Technology
Figure 4: Technology Evolution Tree
4 5
The number inside the circle denotes the number
of US patents / applications
5. The concept of neurostimulation for treatment of
obesity has gained momentum in the past decade.
There has been substantial patenting activity related to
Vagus nerve stimulation. However, there are ample
opportunities in the field of Splanchnic nerve stimulation
for the new players who wish to venture into obesity
treatment using neurostimulation.
For those interested in Vagus nerve stimulation, there is
scope for innovation around design of neurostimulators
and understanding the signal patterns and their
application. On the other hand, screening and
monitoring methods used in Vagus nerve stimulation
have been extensively patented.
For the players that wish to develop products related to
screening and monitoring methods used in Vagus nerve
stimulation, it would be beneficial to perform a detailed
FTO, especially if they are planning to include features
like modulating the signal based on feedback and
stimulating after feedback. On the other hand,
innovation and product development around
detecting condition of the nerve, redelivery of signals
after temporary signal halting and using imaging
techniques for monitoring can be less risky.
Conclusion
Priority Date Feb-02 Oct-02 Oct-02 Oct-02 Mar-03 Oct-03 Jul-04 Sep-04 Oct-05 Oct-05 Nov-05 Jan-06 Jan-06 Jul-06 May-07
Company
Jeffrey
Hargrove
S.E.Kara-
shurov
Duocure,
Inc
Electrocore Electrocore
Pacesetter,
Inc.
Medtronic, Inc. Medtronic, Inc. Cyberonics, Inc. Cyberonics, Inc.
Patent Applications
Determining stimulating
parameters
Receiving feedback for
the stimulation
Detecting neurological events
Detecting physiological
parameters
Detecting condition of the nerve
Detecting biochemicals
of nerve tissues
Modulating the signal based
on the feedback
Redelivery of signals after
temporary signal halting
Prediction of stimulation result
using statistical data
Blanking/blocking the signal
Using imaging technique for
monitoring
Stimulating after feedback
Monitoring plurality of nerves
Simulataneous stimualtion of plurality
of electrodes with different signals
Sending non-therapeutic stimulus
before the therapeutic stimulating
signal
US20090030476A1
US20040158119A1
US7242983
US20040138516A1
US20070156179A1
US7194301
US20060058851A1
US20070265598A1
US20070093870A1
US20070100378A1
US20070106337A1
US20070173902A1
US20070179557A1
US20080009913A1
US20080300655A1
6
Figure 4: Claim-wise Mapping
6. About iRunway
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iRunway helps corporations and law firms unlock and protect the value of patents. We combine deep
technology expertise with practical business insight to monetize patent portfolios and profoundly improve
litigation outcomes. Our in-depth analysis has contributed to significant courtroom victories and favorable
settlements for our clients.
• Fourth-largest patent jury verdict in the U.S. in 2009
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Our service offerings are designed around our expertise in domains such as biomedical devices, IT, telecom,
software, semiconductor, networking and web technologies. Our services include-
• Landscape analysis, freedom-to-operate analysis, infringement identification, prior art searches,
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• Technology analysis services for litigation including invalidity search, claim charts, source code
review, document review, amending PICs and more
• COMPASSSM
– Patent Portfolio Analysis Service
• Technology evaluation services for M&A due diligence
![$ 7000
$ 6000
$ 5000
$ 4000
$ 3000
$ 2000
$ 1000
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
$ 0
$millions
Obesity Pharmaceutical Sales ($millions)
Bariatric Surgical Device Sales ($millions)
The key players in this field include:
• Medtronics Inc
• Cyberonics Inc
• Advanced Neuromodulation Systems (now a part of
St. Jude Medical)
• Biocontrol Medical Ltd
• Leptos Biomedical Inc
• Enteromedics
100
90
80
70
60
50
40
30
20
10
1990 1995 2000 2005
0
Numberofpatentapplications
Year
Year
The concept of neurostimulation to affect functioning of
organs has been extensively used in medical
practice to treat various disorders such as Parkinson's
disease, multiple sclerosis, epilepsy, chronic pain, etc.
The use of neurostimulation for obesity treatment was
first suggested in the early 1990s. Ever since, there has
been a steady growth in Intellectual Property
investments in this domain, especially in the US (Figure2).
The incidence of obesity has more than doubled in the
last 25 years, now affecting around 33% of adult
population in the United States according to the
Centers for Disease Control & Prevention (CDC). The
World Health Organization (WHO) predicts that obesity
may soon replace more traditional public health
concerns such as under-nutrition and infectious
diseases, as the most significant cause of poor health.
The healthcare cost of obesity in the United States (US)
is estimated to be $147 billion annually (equivalent to
9.1% of total medical spending)[1]
.
The principal treatments currently available for obesity
include diet modification and exercise, pharmaceutical
therapies and surgical procedures like gastric bypass
and vertical banded gastroplasty. Besides these, the
industry has witnessed a flurry of activities around the
idea of using neurostimulation for treatment of obesity.
The market size for treatments related to obesity is also
expected to grow significantly over the next decade
(Figure 1).
[1] “Annual Medical Spending Attributable To Obesity: Payer-And
Service-Specific Estimates” by Eric A. Finkelstein, Justin G.
Trogdon, Joel W. Cohen and William Dietz.
Health Affairs, 28, no. 5 (2009):w822-w831
[2] Medmarket Diligence Report #S825 – “Worldwide Market
for the Clinical Management of Obesity, 2007”
Introduction Neurostimulation for
Obesity Treatment
2
Figure 1: Bariatric Surgical Devices and Pharmaceuticals in
Obesity, Worldwide Sales 2006-2015 [2]
Figure 2: Patent filing trend in the US](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)