Microfluidic technologies for diagnostic applications - Sample

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KnowMadePatent & Technology Intelligence
Microfluidic Technologies
for Diagnostic Applications
Patent Landscape Analysis
January 2017
Samsung Electronics
Affymetrix
Caltech
Handylab
UniversityofCalifornia
Micronics
GPB Scientific

2
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Microfluidic Technologies for Diagnostic Applications - Patent Landscape Analysis | January 2017 | Ref.:KM17001
TABLE OF CONTENTS
INTRODUCTION 4
Microfluidic technologies for diagnostic applications
Scope of the report
Related reports
Key features of the report
Objectives of the reports
METHODOLOGY 12
Patent search, selection and analysis
Search strategy
Terminologies for patent analysis
MAIN ASSIGNEES 20
EXECUTIVE SUMMARY 25
PATENT LANDSCAPE OVERVIEW 29
Time evolution of patent publications
Countries of patent filings
Time evolution by country of filing
Ranking of main patent applicants
Ranking of main players
Time evolution of main patent applicants
Countries of filings for main patent applicants
Mapping of main current IP holders
Mapping of main current IP applicants
Summary of applicant’s patent portfolio
IP leadership of patent applicants
Degree of specialization
Citations analysis
Strength index of patent portfolios
IP blocking potential of patent applicants
Patent applicants IP network
Key patent families
Granted patents near expiration
TECHNICAL ISSUES 51
Main IPC classes
Time evolution by IPC
Matrix main priority countries / main IPC
Matrix main applicants / main IPC
Search equations
Material
Disease
Diagnostic technique
Conclusions
MAIN PATENT LITIGATIONS 77
IP PROFILE OF KEY PLAYERS 83
Abbott
Agilent Technologies
Becton Dickinson
Caltech
GPB Scientific
HP
MGH
Micronics
MIT
Philips
Roche
Samsung Electronics
Siemens
Ningbo University
University of California
For each player:
Company presentation
Summary of the patent portfolio
Key patents
CONCLUSION 99
KNOWMADE PRESENTATION 105

3
Microfluidic technologies are very suitable for diagnostic applications. By miniaturizing the diagnostic system, microfluidic technologies allow to reduce drastically the volume of the
sample needed to perform the diagnostic assay as well as the processing time. The development of microfluidic technologies also led to the development of easy-to-use point-of-care
(POC) assay. Microfluidic-based diagnostics cover a wide range of pathologies, including genetic, infectious, oncology, blood coagulation, cardiac markers,… Microfluidic systems can be
used at different levels of a disease : detection and characterization, disease evolution monitoring and treatment efficiency monitoring. Most microfluidic diagnostic systems are chips, but
flow cells and paper-based systems also exists.
A recent report from Yole Développement estimates that the market for microfluidic chips and microfluidic-based tests for point-of-need (PoN) testing applications should increase from
$6 billion in 2015 to 17.2 billion in 2021*. Many companies have developed and marketed microfluidic devices for diagnostic applications, including :
Piccolo Xpress
Chemistry analyzer and microfluidic discs
(kidney, liver, metabolic diseases, lipids,…)
Microfluidics cartridges and analyzer
hormones testing (fertility,
pregnancy, thyroid)
Alere™ q
HIV-1/2 Detect PCR system
FACSPresto
Measurement of CD4 T lymphocytes and
total hemoglobin concentration in whole
blood samples (AIDS applications).
Idylla
Real-time PCR based molecular
diagnostic system
GeneXpert® IV
On-demand molecular diagnostic
system and Xpert cartridge
Flow cells HiSeq system (HiSeq2500)
Ultra-high-throughput
sequencing system
PanNAT® Molecular diagnostic system
Point of care infectious disease diagnosis
based on single and/or multiplexed
nucleic acid amplification assay.
Minicare I-20
Near-patient diagnosis device based on Philips’
Magnotech biosensor technology (immunoassay).
It measures the level of Troponin-1, a cardiac
marker (heart attack).
cobas Liat system
Real-time PCR system for diagnosis for
Influenza A/B and Strep A (developed with
the technology of Iquum, acquired in 2014).
*Source : Yole Développement, Point-of-Need Testing: Application of Microfluidic Technologies 2016 report (September 2016) (link)
INTRODUCTION
Microfluidic Technologies for Diagnostic Applications

4
INTRODUCTION
Scope of the Report
• This report provides a detailed picture of the patent landscape for microfluidic technologies for diagnostic applications.
• This report covers patents published worldwide up to October 2016.
• We have selected and analyzed more than 1,150 patent families relevant to the scope of this report.
Included in the report Not included in the report
US2015094227 US2016160283
CN204788465
Diagnostic systems that do not involve microfluidics : test strips, large volume,…
Microfluidic systems that are not intended for biomedical or diagnostic applications
KR20110009022
US2014017776 US2015152481US2010267162
Microfluidic-based diagnostic systems and methods : microchips,
cartridges, discs, flow cells, paper-based microfluidic systems…
WO2014100725US2016116427 WO2015138648

5
METHODOLOGY
Patent Search, Patent Selection, Patent Analysis (1/2)
•The data were extracted from the FamPat worldwide database (Questel-ORBIT) which provides 90+ million patent documents from 95
offices.
•The search for patents was performed in October 2016, hence patents published after this date will not be available in this report.
• The patents were grouped by patent family. A patent family is a set of patents filed in multiple countries to protect a single invention by a
common inventor(s). A first application is made in one country – the priority country – and is then extended to other countries.
• The selection of the patents has been done both automatically and manually (all details in next slides).
• The statistical analysis was performed with Orbit IP Business Intelligence web based patent analysis software from Questel.
• The patents were manually categorized in technical segments using keyword analysis of patent title, abstract and claims, in conjunction
with expert review of the subject-matter of inventions (all details in next slides).
• For legal status of European (EP) and PCT (WO) patent applications, EPO Register Plus has been used. For legal status of US patents,
USPTO PAIR has been used. For legal status of other patents, information have been gotten from their respective national registers.
Number of selected patent families for microfluidic technologies for diagnostic applications :
1,154 over a number of returned results > 2,000

6
METHODOLOGY
Patent Search, Patent Selection, Patent Analysis (2/2)
Keywords and term-set definition
Search equations / Search strategy
Manual screening of the results
Patent classification
Relevant Non relevant
Refine search using
IPC classes and
citations analysis
Patent
Segmentation
Patent
Analysis
Segmentation improved
during patent analysis
Landscape
Overview
In-depth analysis of
Key Technology Segments
and Key Players
Patent Ranking and
Key Patents analysis
Phase I
Phase II
Phase III

7
METHODOLOGY
Search Strategy
• + Truncation replacing any number of characters
• ? Truncation replacing zero or one character
• # Truncation replacing one character
• _ Truncation for word that may have a space (ex: semiconductor, semi conductor)
• OR Finds references containing at least one of the words
• AND Finds references containing all words
• S Finds references containing the terms in the same sentence
• nD Finds references containing adjacent terms, regardless of the order, and may be separated by a maximum of n words
• ( ) Parentheses are necessary to combine different operators
• /TI/OTI Search in Title
• /BI Search in Title and Abstract
• /CLMS Search in Claims
• /OBJ Search in the object of the invention
• /PA.FLD Search in Patent Assignees
• /IC Search in International Patent Classification (IPC)
Step Search Equation Results
Patent Related to microfluidic
technologies for diagnostic
applications
Step 1
((+DIAGNOS+ OR XXXX_XX_XXXX)/BI/CLMS/OBJ OR (A61B-XXX+ OR A61B-
XXX+)/IC) AND (MICRO_FLUID+ OR XXXX_XXXX+ OR MICRO_XXXXXXX+ OR
XXXX_XXXXXXX+ OR XXX_XX_XXXX? OR XXX_XX_X_XXXX OR
XXXX_XXXX_XXXXXXX_XXXXX?)/BI/CLMS/OBJ
>2,000
Citing and Cited Patents Step 2 CITING AND CITED PATENTS OF SELECTED PATENTS FROM STEP 1 >18,500
Manual Selection Step 3 SELECTED PATENT FAMILIES 1,154

8
OVERVIEW
Time Evolution of Patent Publications
Note: The patent search was done in October 2016, the data corresponding to the year 2016 are not complete here.
Microfluidics emerged in the 1980s for various applications. However, patents dedicated to microfluidics claiming diagnostic applications were firstly published in the late 1990s. In
particular, a patent of Affymetrix, published in 1997, is related to a microfluidic system for nucleic acid based diagnostic applications (WOxxxxxxx). From the late 1990s, the number of
new patent publications increase regularly until 2010. Main patent applicants in the late 2000s involve APPLICANT XXX, APPLICANT XXX, APPLICANT XXX and APPLICANT XXX. After a
slight decrease, the number of publications increase again in 2013, but it seems to increase more slowly in the last 2 years. To this date, over 1,150 patent families have been published
related to microfluidic technologies for diagnostic applications. It represents over 4,500 patents. In 2016, main applicants are APPLICANT XXX, APPLICANT XXX and APPLICANT XXX.

9
OVERVIEW
Time Evolution by Country of Filing
Note: International (WO) and European (EP) applications may hide other countries that are not yet published.
Patenting activity related to microfluidic technologies for diagnostic applications started in the USA in the late 1990s, it has been increasing ever since. In 2016,
publications in the domain represent over 100 patents. In Europe, the patenting activity started at the same period as in the USA, however, it is still low. The
peak observed in 2008 in Europe is correlated with a high number of applications from APPLICANT XXX and APPLICANT XXX. The IP activity in China was at the
same level as in Europe during the late 2000s/early 2010s. However, the publication of Chinese applications is greatly increasing since 2014. The IP activity in
China in the domain of microfluidic technologies for diagnostic applications involves in particular numerous Chinese applicants.
FILING
COUNTRY
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
AUSTRALIA 1 2 2 3 15 9 10 12 14 6 11 5 7 2 3 9 11 13 18 8
CANADA 1 1 1 4 5 3 11 15 11 11 10 9 5 12 14 12 12 13
CHINA 1 2 3 4 8 8 22 26 37 38 36 32 33 41 65 63
EUROPE 2 2 3 5 7 16 15 25 36 52 26 46 35 34 27 35 35 47
GERMANY 1 1 6 3 5 13 4 5 4 15 9 5 3 2
INDIA 2 10 9 7 13 4 7 9 8 6 12
JAPAN 1 2 1 1 7 9 10 8 19 35 29 27 12 20 27 23 24 29
KOREA 1 1 1 4 3 8 10 13 9 6 13 16 15 17 15 9
USA 1 2 5 6 22 16 24 34 38 44 59 59 87 88 74 80 94 91 110
WO (PCT) 2 3 2 5 13 14 14 14 29 39 47 53 46 50 33 50 55 65 67 77
10-19 patent families
20-29 patent families 40-49 patent families
≥ 50 patent families
0-9 patent families
30-39 patent families
Publication year

10
OVERVIEW
Ranking of Main Patent Applicants
The domain of microfluidic technologies for
diagnostic applications represents over 1,150
patent families. The Top-15 of the main assignees
owns almost 25% of the whole patent families.
The portfolios of the main patent assignees
include less than 40 families. Therefore the IP
landscape of microfluidic technologies for
diagnostic applications involves numerous
assignees with small portfolios.
Currently, main IP applicants are US players, both
industrial and academic : 10 US assignees appear
in the Top-15 ranking of main applicants.
APPLICANT XXX owns the largest portfolio, with
36 patent families. Moreover, the portfolio of
APPLICANT XXX includes a high number of
patents and over half of them are granted or
pending. Three European companies are also well
ranked, in particular APPLICANT XXX who holds
the 2nd largest portfolio. The Dutch company has
also well developed its portfolio by filing many
patents. APPLICANT XXX shows the same profile
with 13 patent families including over 280
patents. Two Asian assignees appear among the
15 main patent applicants : APPLICANT XXX (3rd
largest portfolio) and APPLICANT XXX (6th).
However, APPLICANT XXX only owns 1 patent per
family, and these patents are exclusively published
in China.
Note: the number of patents assigned to a company doesn’t necessarily reflect the strength of its portfolio or its market dominance.

11
OVERVIEW
Mapping of Main Current IP Applicants
Already having a significant granted portfolio in the USA, APPLICANT XXX keeps reinforcing its presence in the country by filing new applications, while showing
a strong interest in Europe as well as Japan. COMPANY XXX, who acquired APPLICANT XXX in 2009, is also showing a strong IP activity in the USA and Japan
recently. As expected, APPLICANT XXX is the main current patent applicant in China. In this country, the IP activity of national applicants seems to increase.
With APPLICANT XXX, the American companies APPLICANT XXX and APPLICANT XXX have been the most active applicants in 2016. APPLICANT XXX is well
ranked among the main applicant in Europe and the USA and APPLICANT XXX filed over 10 PCT applications recently. Thus, the importance of both companies
in the IP landscape of microfluidic technologies for diagnostic applications should increase in the near future.
Number of patent families
containing pending applications
in the corresponding country.

12
OVERVIEW
Summary of Applicant’s Patent Portfolio (1/2)
ASSIGNEE
No. of
patent
families
Oldest
priority
date of the
portfolio
No. of
families
filed / yr
(average)
No. of
patent
documents
No. of
patents /
Family
(average)
Patent
average age
(yr)
%
granted
% pending
% dead
(revoked
lapsed
expired)
No. of alive
patents /
Family
(granted,
pending)
No. of granted patent
families by country
US EP JP CN KR
APPLICANT XXX xx 20xx 2.3 225 xx xx 22% xx% xx% 4.1 17 1 3 5 -
APPLICANT XXX xx 2003 2.7 xx 8.1 7 xx% xx% 65% xx 5 1 2 4 -
APPLICANT XXX 25 2008 xx 25 1 xx 4% xx% xx% 0.4 - - - 1 -
APPLICANT XXX 21 20xx 1.3 194 9.2 xx xx% 25% xx% xx 11 4 6 3 -
APPLICANT XXX xx 20xx 1.4 xx 15.8 5 xx% xx% 54% 7.2 5 3 - 2 -
APPLICANT XXX xx 2001 xx 145 xx xx 38% xx% xx% xx 13 4 7 8 12
APPLICANT XXX 17 20xx 1.1 xx xx xx 36% xx% xx% xx 10 1 1 1 -
APPLICANT XXX 16 2003 xx xx 13.1 5 47% xx% xx% 10.1 5 3 3 2 -
APPLICANT XXX xx 2002 1.1 xx 6.2 5 xx% 14% xx% 2.4 4 1 - 1 -
APPLICANT XXX xx 20xx 1 98 xx xx 33% xx% 31% xx 4 - 1 2 -
APPLICANT XXX xx 2001 0.9 289 xx 7 xx% 1% xx% 9.2 9 7 5 4 -
APPLICANT XXX 12 2005 xx xx xx xx 4% 80% xx% xx - - - - -
APPLICANT XXX xx 20xx 0.8 58 xx 4 xx% x% 28% xx 2 - - - -
APPLICANT XXX xx 2010 xx 18 xx 0 11% xx% 11% 1.6 2 - - - -
APPLICANT XXX xx 19xx 0.5 18 xx xx xx% 28% 61% xx 2 - - - -
highest value in column lowest value in column

13
OVERVIEW
Summary of Applicant’s Patent Portfolio (2/2)
Most of the main assignees in the domain of microfluidics for diagnostic applications started their IP activity in the domain in the early 2000s. APPLICANT XXX
shows a very important IP activity. Holding the 1st largest portfolio (36 families), APPLICANT XXX also extends significantly each of its families (6.3
patents/family in average). Moreover, many of those patents are alive : 22% of granted patents (50 patents) and 44% of pending applications (99 applications).
Thus, APPLICANT XXX seems to have invested in the R&D of microfluidic technologies for diagnostic applications and is also developing its IP outside of the USA
as well, mainly in Europe, Japan and China. In particular, APPLICANT XXX is developing cell-based assay technologies (see TECHNICAL ISSUES chapter).
APPLICANT XXX, 2nd largest portfolio, also shows a high level of dead patents in its portfolio (65%). APPLICANT XXX also holds 24% of pending applications,
among which, many PCTs. However, it should be noted that APPLICANT XXX patents are often abandoned during the examination procedure.
APPLICANT XXX is showing the highest level of granted patents and the highest number of granted patents per family. The IP activity of APPLICANT XXX in the
domain of microfluidic technologies for diagnostic applications is related to the acquisition of the portfolio of APPLICANT XXX in 2009. The technologies
developed by APPLICANT XXX focus on nucleic acid analysis (see TECHNICAL ISSUES chapter).
The portfolio of APPLICANT XXX is composed of 13 patent families and includes 289 patents. This gives APPLICANT XXX the highest ratio of patents per family
(22.2). If the company has only a few pending applications, APPLICANT XXX is holding many granted patents worldwide (40% of its portfolio). Thus APPLICANT
XXX is an important player in the IP landscape of microfluidic technologies for diagnostic applications.
APPLICANT XXX shows an IP profile similar to APPLICANT XXX. APPLICANT XXX has 20 patent families which include 315 patents (ratio of 15.8 patents per
family). Almost half of APPLICANT XXX portfolio is alive, it represents 7.2 patents alive per family.
APPLICANT XXX shows a steady IP activity in the domain of microfluidic technologies for diagnostic applications since the mid-2000s. The company is the only
main IP applicant with granted patents in Korea.
The last main assignees to enter the IP landscape are APPLICANT XXX (2005), APPLICANT XXX (2008) and APPLICANT XXX (2010). APPLICANT XXX shows the
highest rate of patent filing per year (3.1), but filed only 1 patent per family. Moreover, 64% of its portfolio is already dead. Thus, APPLICANT XXX is not
currently an IP leader in the domain of microfluidic technologies for diagnostic applications. APPLICANT XXX holds a medium portfolio (12 families) and it
includes a very high percentage of pending applications (80%). In particular, APPLICANT XXX filed 7 PCTs in 2015, thus its portfolio could potentially grow in the
near future with new publications in several countries.

14
OVERVIEW
IP Leadership of Patent Applicants
APPLICANT XXX shows a very strong leadership, with a high number a granted patents and a very important current patenting activity (99 pending applications). This IP activity is associated with a
worldwide strategy. APPLICANT XXX also holds a high number of pending applications, but as previously noted the applications of the company are often abandoned during the examination procedure.
Thus, the importance of its IP leadership should be taken carefully. APPLICANT XXX, APPLICANT XXX and APPLICANT XXX have a significant leadership : they hold an important number of granted patents
as well as pending applications. The leadership of APPLICANT XXX is linked to the acquisition of the APPLICANT XXX and its IP portfolio in 2009. APPLICANT XXX and APPLICANT XXX hold smaller portfolios
and a few granted patents. However, both show currently an important patenting activity. Pending applications represent 80% of APPLICANT XXX portfolio. APPLICANT XXX has drastically reduced its
patenting activity currently, but the company holds a very large granted portfolio, which is evidence of an important investment from the company in microfluidic technologies for diagnostic applications.
Globally, apart from APPLICANT XXX, the IP leadership in microfluidic technologies for diagnostic applications is overtaken by US assignees.
Bubble size represents the
number of patent families
selected for the study

15
Bubble size represents the
number of patent families
selected for the study
OVERVIEW
IP Blocking Potential of Patent Applicants
The IP blocking potential is an indicator of how an IP player and its patents are difficult to circumvent in a technology. The IP blocking potential is not necessarily linked to the size of the
portfolio.
APPLICANT XXX holds the highest IP blocking potential related to microfluidic technologies for diagnostic applications. The patents of APPLICANT XXX (in particular USxxxxxxxxxx and
USxxxxxxxxxx) receive a high number of forward citations from many different applicants, and in particular from APPLICANT XXX. Several assignees show a medium IP blocking potential:
APPLICANT XXX APPLICANT XXX, APPLICANT XXX, APPLICANT XXX, APPLICANT XXX and APPLICANT XXX.
The more the number of forward citations from different patent applicants is high, the more the capacity to hamper the other firms’ attempts to patent a related invention is important.
Note: This graph is at patent family level. The identification of a “blocking patent” requires an in-depth specific analysis of each patent documents composing the patent families.

16
OVERVIEW
Key Patent Families
The selection of key patent families is based on the family size, current legal status of patents, citations analysis and impact on the technological segment. See annexes for methodology for key patent
identification. Patent numbers correspond to representative member of the families, assignee names take into account original applicants and reassignments.
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Earliest
application year
of the family
APPLICANT XXX
USxxxxxxx
Integrated biosensor and
simulation system for …
APPLICANT XXX
USxxxxxxx
Integrated nucleic acid
diagnostic device
APPLICANT XXX
USxxxxxxx
Integrated active flux
microfluidic …
APPLICANT XXX
APPLICANT XXX
USxxxxxxx
Polymer-based
micromachining…
APPLICANT XXX
USxxxxxxx
Sers diagnostic platforms,
methods and systems
including …
APPLICANT XXX
USxxxxxxx
Clinically intelligent diagnostic
…
APPLICANT XXX
USxxxxxxx
Manipulation of
microparticles…
APPLICANT XXX
USxxxxxxx
Integrated microfluidic devices
APPLICANT XXX
USxxxxxxx
Integrated microfluidic
devices
APPLICANT XXX
USxxxxxxxxxx
Miniaturized genetic analysis …
APPLICANT XXX
USxxxxxxx
Integrated microchip genetic …
APPLICANT XXX
USxxxxxxxxxx
Microfluidic devices
APPLICANT XXX
USxxxxxxx
Diagnostic radio frequency
identification sensors …
APPLICANT XXX
USxxxxxxx
Personal diagnostic devices and …
APPLICANT XXX
USxxxxxxx
Analyte monitoring and
…
APPLICANT XXX
USxxxxxxx
Microfluidic sequencing…
APPLICANT XXX
USxxxxxxx
Integrated system for
processing microfluidic
samples, …
APPLICANT XXX
USxxxxxxx
Digital analyte analysis
APPLICANT XXX
APPLICANT XXX
CNxxxxxxxxx
Rapid parallel nucleic acid
detection method …
APPLICANT XXX
USxxxxxxxxxx
Paper substrate diagnostic
apparatus and …
APPLICANT XXX
WOxxxxxxxxxx
Device for preparation and
analysis of …
APPLICANT XXX
WOxxxxxxxxxx
Devices and methods for
sample analysis

17
TECHNICAL ISSUES
Search Equations
SEARCH EQUATION SELECTED
MATERIAL
POLYMER
(POLYMER+ OR POLY_METHYL_METHACRYLATE OR PMMA OR POLY_DIMETHYLSILOXANE OR POLY_SILOXANE OR PDMS OR POLY_CARBONATE OR PC OR
POLY_ETHYLENE_TEREPHTHALATE OR PETG OR CYCL+ OLEFIN CO_POLYMER OR COC OR POLYSTYRENE OR PS OR POLY_VINYL_CHLORIDE OR PVC OR
POLY_TETRA_FLUORO_ETHYLENE OR TEFLON)/BI/CLMS/DESC
XXX
GLASS (GLASS+ OR SILICA+ OR SIO2 OR PYREX)/BI/CLMS/DESC XXX
SILICON (SILICON OR SILICON_BAS+)/BI/CLMS/DESC 92
PAPER (PAPER OR PAPER_BASE+ OR CELLULOS+)/BI/CLMS/DESC XXX
DISEASE
CANCERS
(CANCER? OR CARCINOMA? OR LEUKEMIA OR CTC? OR CIRCULATING TUMOR CELL? OR PROSTATE OR BREAST OR TUMOR+ OR TUMOUR+ OR LYMPHOMA OR
PAPILLOMA OR SARCOMA)/BI/CLMS/DESC
XXX
GENETIC DISORDERS (GENETIC DISORDER? OR GENETIC ABNORMALIT+ OR GENETIC DISEASE? OR MUTATION?)/BI/CLMS/DESC XXX
INFECTIOUS
DISEASES
ALL INFECTIOUS DISEASES (INFECT+ OR VIRUS+ OR BACTERIA? OR PATHOGEN+)/BI/CLMS/DESC XXX
HIV (HIV OR AIDS OR HUMAN IMMUNODEFICIENCY VIRUS OR ACQUIRED IMMUNODEFICIENCY)/BI/CLMS/DESC 112
MALARIA (MALARIA OR PLASMODIUM)/BI/CLMS/DESC XXX
NEURODEGENERATIVE DISORDERS (NEURO_DEGENERA+ OR PARKINSON OR ALZHEIMER OR HUNTINGTON OR SCLEROSIS)/BI/CLMS/DESC XXX
DIABETES (DIABETES OR GLUCOSE OR BLOOD SUGAR OR GLYC_MIA)/BI/CLMS/DESC XXX
DIAGNOSTIC
TECHNIQUE
NUCLEIC ACID AMPLIFICATION (((NUCLEIC ACID? OR DNA OR RNA) S AMPLIF+) OR PCR OR POLYMERASE CHAIN REACTION OR LAMP OR LOOP MEDIATED ISOTHERMAL AMPLIFICATION)/BI/CLMS/DESC XXX
IMMUNOASSAYS (IMMUNO_ASSAY+ OR IMMUNO_DETECT+)/BI/CLMS/DESC 115
CELL-BASED ASSAYS (PROLIFERATION OR MOTILITY OR (CELL+ S (SHAPE OR NUMBER OR COUNT+ OR MORPHO+ OR SIZE)))/BI/CLMS/DESC XXX
CHEMISTRY ASSAY ((+CHEMICAL OR +CHEMISTRY) S (ASSAY? OR ANALYS+ OR DETECT+)) OR (PH OR ELECTROLYTE? OR ENZYM+ OR COAGULAT+ OR CLOT+)/BI/CLMS/DESC XXX
The patent families related to microfluidic technologies for diagnostic applications have been classified according to several technical segments (material, disease and diagnostic technique) and sub-
segments. Then, each technical segments has been analyzed.

18
TECHNICAL ISSUES
By Disease – Segmentation
DISEASE (636 patent families selected)
ASSIGNEES
Number of
Families
CANCERS
GENETIC
DISORDERS
INFECTIOUS DISEASES
NEURO-
DEGENERATIVE
DIABETESALL INFECTIOUS
DISEASES
HIV MALARIA
TOTAL 1,154 XXX XXX XXX 112 XXX XXX XXX
MAIN ASSIGNEES IN THE SEGMENT
Applicant XXX (US),
Applicant XXX (US),
Applicant XXX (US),
Applicant XXX (US),
Applicant XXX (KR)
Applicant XXX (US),
Applicant XXX (US)
Applicant XXX (CN),
Applicant XXX (US),
Applicant XXX (US),
Applicant XXX(US)
Applicant XXX (US),
Applicant XXX (CN)
Applicant XXX (US),
Applicant XXX (US)
Applicant XXX (KR),
Applicant XXX(US)
Applicant XXX (US),
Applicant XXX (CH)
APPLICANT XXX xx 17 3 13 8 3 1 1
APPLICANT XXX xx 2 - 9 2 - - -
APPLICANT XXX 25 - - 19 6 - - -
APPLICANT XXX 21 1 - 15 4 10 - -
APPLICANT XXX xx 13 5 13 5 2 1 2
APPLICANT XXX xx 8 2 1 - 5 3
APPLICANT XXX 17 6 4 9 1 - - 1
APPLICANT XXX 16 1 1 5 1 1 - -
APPLICANT XXX xx 12 9 7 3 - - 1
APPLICANT XXX xx 2 - 1 - - - 3
APPLICANT XXX xx - - - - - - 4
APPLICANT XXX 12 2 1 4 2 1 - -
APPLICANT XXX xx 8 1 7 3 6 - 4
APPLICANT XXX xx 3 - 3 3 - - -
APPLICANT XXX xx 2 - 2 - - - -
1-4 patent families 5-9 patent families 10-14 patent families ≥ 15 patent families

19
TECHNICAL ISSUES
By Disease – Time Evolution of Patent Publications
The diagnostic of cancers and infectious diseases using microfluidic
systems are the most developed, they were also the 1st targets of the IP
development (early 2000s). Both receive a significant focus from
several main patent applicants in microfluidic technologies for
diagnostic applications. American applicants APPLICANT XXX,
APPLICANT XXX and APPLICANT XXX show an equal interest in both
cancers and infectious disease diagnostics. APPLICANT XXX and
APPLICANT XXX are focused on infectious disease diagnostics. Whereas
APPLICANT XXX filed more patents related on cancers diagnostics and
the company also shows a significant interest in the development of
diagnostics for genetic disorders. It is also the case for APPLICANT XXX,
APPLICANT XXX and APPLICANT XXX. The development of microfluidic
diagnostic systems for diabetes appears in 2004, and the main
applicants for this technology include APPLICANT XXX and APPLICANT
XXX. Neurodegenerative disease diagnostics are the most recent
medical applications (2006), and these applications are mainly
developed by APPLICANT XXX.
0
20
40
60
80
100
120
140
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
NumberofPublications
Publication Years
All families
Cancer
Genetic disorder
Infectious disease
HIV
Malaria
Neurodegenerative disease
Diabetes
Neurodegenerative
diseases
Cancers, infectious diseases,
genetic disorders
Diabetes

20
TECHNICAL ISSUES
By Disease – Countries of Patent Filings
The USA are the favorite country of filings for all diagnostic applications considered, followed by Europe and China, Japan and Korea. This
probably reflects the high number of American players among the patent applicants. In all countries, infectious diseases and cancers are by
far the most diagnostic applications claimed.
Country by Disease targeted Disease targeted by Country
0
50
100
150
200
250
300
350
400
NumberofPatentFamilies
TOTAL
TOTAL
TOTAL
TOTAL
TOTAL
TOTAL
TOTAL
0
50
100
150
200
250
0
20
40
60
80
100
120
140
0
20
40
60
80
100
120
140
0
10
20
30
40
50
60
70
80
90
100
0
5
10
15
20
25
30
35
40
45
50
673 families 393 families 403 families
135 families
237 families

21
TECHNICAL ISSUES
By Disease – Key Patents
PATENT
NUMBER
ASSIGNEE TITLE PDF
CURRENT
LEGAL STATUS
EXPIRATION
DATE*
SEGMENT
(disease)
USxxxxxxx APPLICANT XXX Clinically intelligent diagnostic device… Open Granted 2021-06-02
Cancer, genetic disorder,
infectious disease (HIV)
USxxxxxxx APPLICANT XXX Manipulation of microparticle… Open Granted 2020-02-22 Infectious disease (HIV)
USxxxxxxxxxx APPLICANT XXX Integrated microfluidic assay… Open Lapsed 2014-12-31
Infectious disease
(HIV, malaria)
USxxxxxxx APPLICANT XXX Personal diagnostic devices including… Open Granted 2024-09-02
Infectious disease (HIV),
diabetes
USxxxxxxx APPLICANT XXX Medical device for analyte monitoring… Open Granted 2023-09-11
Cancer, infectious
disease, diabetes
USxxxxxxx APPLICANT XXX Devices and methods for enrichment… Open Granted 2026-04-05
Cancer, genetic disorder,
infectious disease
WOxxxxxxxxxx APPLICANT XXX Microfluidic system and method for analysis of gene… Open Lapsed 2009-08-02 Cancer
USxxxxxxx APPLICANT XXX Microfluidic nucleic acids… Open Granted 2023-10-02 Infectious disease
USxxxxxxx APPLICANT XXX Microfluidic device for cell separation… Open Granted 2026-01-24
Cancer, infectious
disease
The selection of key patents is based on the family size, current legal status of patents, citations analysis and impact on the technological segment. See annexes for methodology for key patent
identification.

22
TECHNICAL ISSUES
Conclusions
Among all the materials use for microfluidic system for diagnostic applications, polymer materials represent a material of choice. They can be used for any diagnostic technique and it is less expensive
than other materials. Glass is suitable in particular for applications requiring high-precision and multiplexing. The patenting of paper material is much more recent. Paper-based systems are cheap and
easy to use. However, cell-based assay can not be performed on this kind of systems.
Infectious diseases and cancers are the major diseases targeted by patent applicants in the domain of microfluidic technologies for diagnostic applications. Biomarkers, tumor cells, pathogens or viral
particles are usually accessible in the circulating blood of the patient.
Nucleic acid amplification is the most widespread diagnostic technique in selected patents. It can be adapted to diagnose various kind of diseases by detecting a specific genetic fingerprint, usually
present in the blood of the patient : tumor mutations of circulating tumor cells, detection of genetic disorders, DNA/RNA of viruses… It allows the analysis of thousands of nucleic acid biomarkers in one
assay.

23
KEY PLAYERS
APPLICANT XXX
Large
portfolio
2003
Oldest priority date
7
Patent average age
35
Families
EP, CN, US, JP
Main countries of
filings
29
Granted
patents
69
Pending
applications
Low
IP Blocking
potential
284
Patents
Low
Portfolio Strength
Medium
Leadership
5 1
1 5 4 3
- 1
2 9
Families comprising granted patents
Families comprising pending patents
MATERIAL DISEASE DIAGNOSTIC TECHNIQUE
Polymer Infectious disease Nucleic acid amplification
Cell-based assay
Summary of applicant’s patent portfolio Map of granted and pending patents
The patent portfolio of this company is mainly focused on :

24
EXCEL DATABASE
Containing all the patents analyzed in this report with technology segmentation
This database allows multi-criteria searches and includes patent publication number, hyperlinks to the original documents, priority date, title, abstract,
patent assignees, and legal status for each member of the patent family.

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