Obesity Treatment usingNeurostimulation

Technology Evolution& Patent Landscape

Industry Insight

Deeper Insight. Better Outcomes

R

$ 7000

$ 6000

$ 5000

$ 4000

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$ 2000

$ 1000

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015$ 0

$ m

illion

s

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

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1990 1995 2000 20050

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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

Neurostimulation for Obesity Treatment

825 281

Stimulation methods

183

StimulatingLocation

54

MonitoringMethod

44

Other medicalmethods

326

Stimulator peripherals

30Signal Modulator

65

CommunicationFacilitator

106Control System

116Testing & monitoringsystem

9Miscellaneous

389

Neurostimulators

117Vagus Nerve

5Splanchnic Nerve

40Deep Brain

1Spinal Cord

87Autonomous Nerve

187Other Nerves

7Miscellaneous

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 Propertyin Neurostimulation

3

Figure 3: Patent Classification

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1

1

1

1

1

1

4

4

23

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3

32

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 MapA 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 Tree4 5

The number inside the circle denotes the number of US patents / applications

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 JeffreyHargrove

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 forthe stimulation

Detecting neurological events

Detecting physiological parameters

Detecting condition of the nerve

Detecting biochemicalsof nerve tissues

Modulating the signal basedon the feedback

Redelivery of signals aftertemporary signal halting

Prediction of stimulation resultusing statistical data

Blanking/blocking the signal

Using imaging technique formonitoring

Stimulating after feedback

Monitoring plurality of nerves

Simulataneous stimualtion of pluralityof electrodes with different signals

Sending non-therapeutic stimulusbefore the therapeutic stimulatingsignal

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Figure 4: Claim-wise Mapping

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