Imagine
pulling
up
to
a
new
restaurant
on
Friday
night.
It
has
had
wonderful
reviews,
and
you
are
excited
to
try
it.
But
a
minute
after
you
are
seated,
you
receive
an
urgent
text
from
the
artificial
intelligence
(AI)
app
on
your
phone
telling
you
what
you
can
order.
The
app
has
analyzed
your
medical
records,
it
knows
where
you
are
from
the
phone’s
GPS,
and
it
has
already
evaluated
the
menu
and
the
nutritional
profiles
for
each
appetizer
and
entree.
Wait,
it
now
tells
you
to
simply
go
home
because
it
has
also
evaluated
the
prices
and
your
credit
card
and
bank
balances!
Did
that
describe
a
dystopian
future
in
which
we
have
lost
individual
control,
or
a
utopian
future
in
which
we
are
given
sophisticated
analysis
in
an
instant?
What
if
your
AI
app
also
kept
a
score
on
how
often
you
complied
with
its
suggestions
and
sent
that
score
to
your
health
insurance
company?
AI
and
Medicine
3.0
AI
is
having
a
substantial
impact
on
healthcare.
Numerous
AI
products
have
been
developed
and
deployed
to
assist
with
the
reading
of
X-rays,
CAT
scans
and
pathology
studies.
In
every
case,
the
program
is
a
tool
to
assist
a
physician
make
a
final
decision.
And
as
these
AIs
continue
to
improve,
they
still
are
only
part
of
Medicine
2.0
–
a
term
coined
to
mean
the
traditional
diagnosis
and
treatment
of
disease
after
the
patient
has
gotten
sick.
Medicine
3.0
refers
to
a
practice
that
reduces
the
risk
of
a
patient
developing
a
disease
or
disorder.
It
will
look
more
deeply
at
genetic
information
and
lifestyle
modification
for
each
patient
to
produce
a
more
focused
plan
to
improve
“health
span”
as
well
as
lifespan.
AI,
such
as
the
AI
example
above,
should
be
the
perfect
tool
for
evaluating
the
large
data
set
that
represents
each
of
us.
What
motivates
the
development
of
such
tools?
We
might
think
it
is
driven
by
a
universal
concern
for
our
fellow
man.
But,
in
some
cases,
it
is
driven
by
greed
and
the
wealth
that
the
developer
hopes
to
acquire.
AI
is
the
next
big
thing,
and
most
developers
want
to
protect
those
programs
and
systems.
The
answer
is
intellectual
property
protection
and
specifically
patent
protection.
Patents
and
healthcare
AI
A
patent
is
a
grant
from
a
government
to
an
inventor
that
provides
him
with
the
right
to
stop
others
from
making,
using
or
selling
the
patented
invention.
In
the
United
States,
the
Patent
and
Trademark
Office
(PTO)
is
responsible
for
evaluating
whether
an
invention
is
patentable
and
then
issuing
a
patent
for
those
that
pass
its
examination.
The
patent
is
effective
for
a
period
of
twenty
years
from
the
date
the
application
is
filed.
An
invention
must
clear
three
hurdles
to
pass
the
PTO’s
examination.
First,
the
invention
must
be
novel
–
meaning
that
no
other
disclosure
predates
the
patent
application’s
filing
date
that
describes
the
same
invention.
Second,
the
invention
must
be
“nonobvious.”
Even
if
the
invention
is
novel,
it
must
display
some
aspect
that
is
inventive
and
cannot
be
an
obvious
variation
over
an
existing
invention.
Finally,
the
invention
must
fall
into
a
category
of
“patentable
subject
matter.”
The
patent
laws
define
these
categories
as
machines,
processes,
articles
of
manufacture
and
compositions
of
matter.
An
AI
invention
is
subjected
to
the
exact
same
requirements
as
any
other
invention
presented
to
the
PTO.
Of
those
three
requirements,
the
most
difficult
is
establishing
the
AI
as
patentable
subject
matter.
Patentable
subject
matter
(PSM)
It
seems
like
in
healthcare
AI
is
a
“process”
–
that
is
a
series
of
steps
that
takes
you
from
an
input
to
an
output.
But
how
often
have
you
heard
that
machine
learning
creates
its
own
connections
and
that
the
developer
does
not
necessarily
know
how
the
AI
determines
its
output.
What
kind
of
process
is
involved
if
the
developer
can’t
even
describe
it?
Another
troubling
attribute
for
AI,
and
computer
software
in
general,
is
that
it
seems
to
simply
replicate
how
a
human
would
think
through
the
same
problem.
Is
it
really
an
invention
if
it
only
does
the
thinking
for
us
at
a
much
faster
pace?
The
PTO
is
left
the
job
of
determining
when
an
AI
invention
is
PSM
and
when
it
falls
short.
There
is
a
two-part
PSM
test
used
by
the
PTO.
The
first
question
is
whether
the
claim
made
by
the
inventor
is
only
for
an
abstract
concept.
An
abstract
claim
might
be
for
ownership
of
any
AI
that
improves
health.
This
is
simply
too
vague
to
obtain
protection.
Assuming
that
the
inventor
claims
more,
the
second
question
is
whether
there
is
“significantly
more”
added.
So,
the
AI
example
might
qualify
as
PSM
if
it
was
clear
that
the
AI
evaluated
a
location,
identified
a
restaurant
from
that
location,
downloaded
a
menu
from
that
restaurant’s
website
and
analyzed
the
nutritional
content
of
each
offering
against
a
nutrition
database.
Then,
it
compared
those
offerings
against
an
ideal
diet
for
the
user
based
on
his
last
CBC
and
an
evaluation
of
any
medications
being
taken
for
contraindications.
Each
offering
would
obtain
a
score
and
only
those
above
a
certain
score
could
be
recommended.
If
none
could
be
recommended,
then
an
alternative
plan
would
be
developed
(perhaps
with
AI).
Finding
the
right
balance
Every
patent
is
for
a
unique
idea.
That
requires
careful
consideration
of
how
to
describe
and
claim
the
invention.
Too
much
detail
–
so
you
have
“something
more”
–
may
make
the
claim
so
narrow
that
it
has
little
economic
value.
A
very
detailed
claim
is
easier
for
a
competitor
to
sidestep.
In
contrast,
a
more
abstract
claim
may
not
include
enough
detail
to
satisfy
the
“something
more”
requirement.
The
good
news
is
that
the
PTO
is
finding
its
own
right
balance
in
how
it
examines
these
incredibly
important
patent
applications
in
the
AI/Healthcare
field.
According
to
my
recent
analysis
of
the
PTO
database,
approximately
50%
of
patent
applications
in
this
field
are
issuing
as
patents.
Also,
the
number
of
applications
are
beginning
to
increase.
Almost
9000
patent
applications
were
filed
in
2022
related
to
AI
in
healthcare.
created
by
the
author
Note
that
the
rate
of
issuance
appears
to
be
in
decline.
But
this
is
more
likely
an
indication
that
some
cases
from
2022
and
2023
are
still
being
examined.
Likewise,
the
number
of
applications
shown
for
2024
only
reflects
the
number
filed
by
mid-year.
Conclusions
The
economic
value
of
a
great
patent
can
be
enormous.
The
ability
to
charge
customers
more
for
a
AI
provided
service
improves
when
you
have
a
patent(s)
to
prevent
your
competitors
from
introducing
the
same
service.
Likewise,
understanding
the
patent
positions
of
a
competitor
can
help
your
team
move
its
own
projects
forward
more
efficiently.
However,
the
path
to
get
a
patent
is
difficult
and
requires
a
sophisticated
understanding
of
the
law
around
PSM.
AI
is
changing
healthcare
today.
There
is
no
stopping
its
influence
and
as
the
systems
become
more
robust,
we
will
all
benefit
from
improved
Medicine
3.0.
Photo:
tadamichi,
Getty
Images
David
Carstens
distinguishes
himself
not
only
through
his
comprehensive
knowledge
of
legal
protection
of
Intellectual
Property
(IP)
but
also
through
his
innovative
approaches
to
IP
strategy
and
valuation.
With
an
educational
foundation
that
is
as
diverse
as
it
is
solid
—
holding
bachelor’s
degrees
in
both
Electrical
and
Mechanical
Engineering
from
the
University
of
Texas
at
Dallas
and
Texas
A&M
University,
respectively,
a
J.D.
and
an
MBA
from
Southern
Methodist
University,
along
with
completing
the
General
Management
Program
at
the
Wharton
School
at
the
University
of
Pennsylvania
—
David
offers
a
distinctively
strategic
perspective
in
this
specialized
legal
domain.
His
multifaceted
expertise
demonstrates
his
capacity
to
transcend
traditional
legal
strategies,
offering
his
clients
not
just
defense,
but
a
competitive
advantage
in
various
industries
including
technology,
medical
devices,
cosmetics,
and
telecommunications.
David
is
a
founding
partner
of
Carstens,
Allen
&
Gourley,
LLP
and
has
been
a
pivotal
figure
on
multiple
boards.
His
ability
to
navigate
the
complexities
of
IP
law,
combined
with
his
technical
and
business
acumen,
places
him
at
the
forefront
of
the
field.
This
post
appears
through
the MedCity
Influencers
program.
Anyone
can
publish
their
perspective
on
business
and
innovation
in
healthcare
on
MedCity
News
through
MedCity
Influencers. Click
here
to
find
out
how.