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`evin D. NESS
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`INFORMATION DISCLOSURE First Named Inventor|KevinD. NESS
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`STATEMENT BY APPLICANT
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`| QLI3A21-QLP0001-CON Applications,” Journal of Microelectromechanical Systems, Vol. 17, No. 3, pgs. 573-581, June 2008
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`Examiner Name
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`LAUSELL-TORMOS, JENIFER et al., “Droplet-Based Microfluidic Platforms for the Encapsulation and Screening of
`ammalian Cells and Multicellular Organisms,” Chemistry & Biology, Vol. 15, pgs. 427-437, May 2008
`
`EH, SHIA-YEN et al., “Droplet microfluidics,” Lab on a Chip, Vol. 8, pgs. 198-220, January 11, 2008
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`hlorcform (Phenomenex}, Solvent Miscibility Table, Internet Archive WayBackMachine, 3 pgs., February 1, 2008
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`BEER, N. REGINALD etal., “On-Chip Single-Copy Real-Time Reverse-Transcription PCRin Isolated Picoliter
`Droplets,” Analytical Chemistry, Vol. 80, No. 6, pgs. 1854-1858, March 15, 2008
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`EHTA, SOMILC. et a., “Mechanism of Stabilization of Silicone Oil — Water Emulsions Using Hybrid Siloxane
`Polymers,” Langmuir, Vol. 24, No. 9, pgs. 4558-4563, March 26, 2008
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`SHAH, RHUTESHK.et al., “Polymersfit for function Making emulsions drop by drop,” Materials Today, Vol. 11, No. 4,
`ngs. 18-27, April 2008
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`ABDELGAWAD, MOHAMED et al., “All-terrain droplet actuation,” Lab on a Chip, Vol. 8, pgs. 672-677, April 2, 2008
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`UNG, LUNG-HSIN etal., “Rapid microfabrication of solvent-resistant biocompatible microfluidic devices,” Lab ona
`hip, Vol. 8, pgs. 983-987, April 8, 2008
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`UMARESAN, PALANI et al., “High-Throughput Single Copy DNA Amplification and Cell Analysis in Engineered
`anoliter Droplets,” Analytical Chemistry, 17 pgs., April 15, 2008
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`UK, VIVIENNE N. et al., “Pluronic Additives: A Solution to Sticky Problemsin Digital Microfluidics,” Langmuir, Vol. 24,
`jo. 12, pgs. 6382-6289, May 16, 2008
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`IN, YEN-HENG etal., “Droplet Formation Utilizing Controllable Moving-Wall Structures for Double-Emulsion
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`Application Number
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`INFORMATION DISCLOSURE First Named Inventor|KevinD. NESS
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`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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` Attorney Docket Number
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`| QLI3A21-QLP0001-CON ethod,” Nucleic Acids Research, Vol. 37, No. 3, pgs. 1-7, (2009)
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`Examiner Name
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`DUBE, SIMANTetal., “Mathematical Analysis of Copy NumberVariation in a DNA Sample Using Digital PCR ona
`anofluidic Device,” PLoS ONE, Vol. 3, Issue 8, pgs. 1-9, August 6, 2008
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`QIN, JIAN et al., “Studying copy numbervariations using a nanofluidic platform,” Nucleic Acids Research, Vol. 36, No.
`8, pgs. 1-8, August 18, 2008
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`OLTZE,C. et al., “Biocompatible surfactants for water-in-fluorocarbon emulsions,” Lab on a Chip, Vol. 8, pgs.
`632-1639, September 2, 2008
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`SHENDURE,JAY et al., “Next-generation DNA sequencing,” Nature Biotechnology, Vol. 26, No. 10, pgs. 1135-1145,
`October 2008
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`vy IMMERMANN, BERNHARDG. etal., “Digital PCR: a powerful new tool for noninvasive prenatal diagnosis?,”
`Prenatal Diagnosis, Vol. 28 pgs. 1087-1093, November 10, 2008
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`ISS, MARGARET MACRIS etal., “High-Throughput Quantitative Polymerase Chain Reactionin Picoliter Droplets,”
`Analytical Chemistry, 8 pgs., downloaded November 17, 2008
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`BRANSKY, AVISHAYetal., “A microfluidic droplet generator based on a piezoelectric actuator,” Lab on a Chip, Vol. 9,
`ngs. 516-520, November 20, 2008
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`EITZ, DAVID A., “Novel Surfactants for Stabilizing Emulsions of Water or Hydrocarbon Oil-Based Droplets in a
`luorocarbon Oil Continuous Phase,” Harvard Office of Technology Development: Available Technologies, pgs. 1-3,
`Hownloaded November 28, 2008
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`BEER, NEIL REGINALD et al., “Monodisperse droplet generation and rapid trapping for single molecule detection and
`eaction kinetics measurement,” Lab on a Chip, Vol. 9, pgs. 841-844, December 5, 2008
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`ABATE, ADAM R. et al., “Functionalized glass coating for PDMS microfluidic devices,” Lab on a Chip Technology:
`abrication and Microfluidics, 11 pgs., (2009)
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`AWTHON, RICHARD M., “Telomere length measurement by a novel monochrome multiplex quantitative PCR
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`Application Number
`Filing Date
`INFORMATION DISCLOSURE
`First Named Inventer|Kevin D. NESS
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Art Unit |
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` Attorney Docket Number
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`| QLI3A21-QLP0001-CON IARKEY, AMELIAL. et al., “High-throughput droplet PCR,” Methods, Vol. 50, pgs. 277-281, February 2, 2010
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`Examiner Name
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`HEN, CHIA-HUNGet al., “Janus Particles Templated from Double Emulsion Droplets Generated Using Microfluidics,”
`angmuir, Vol. 29, No. 8, pgs. 4320-4323, March 18, 2009
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`IDALGO,LUIS M. et al., “Coupling Microdroplet Micrcreactors with Mass Spectrometry: Reading the Contents of
`Single Droplets Online,” Angewandte Chemie, Vol. 48, pgs. 3665-3668, April 7, 2009
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`ARSTECKI, PIOTRetal., “Mechanism for Flow-Rate Controlled Breakup in Confined Geometries: A Route to
`jonodisperse Emulsions,” Physical Review Letters, 164501, pgs. 164501-1 — 164501-4, April 29, 2005
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`AZUTIS, LINAS etal., “A fast and efficient microfluidic system for highly selective one-to-one droplet fusion,” Lab on
`Chip, Vol. 9, pgs. 2665-26772, June 12, 2009
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`AZUTIS, LINAS etal., “Droplet-Based Microfluidic Systems for High-Throughput Single DNA Molecule Isothermal
`Amplification and Analysis,” Analytical Chemistry, Vol. 81, No. 12, pgs. 4813-4821, June 15, 2009
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`CCAUGHAN, FRANK et al., “Single-molecule genomics,” Journal of Pathology, Vol. 220, pgs. 297-306, November
`9, 2009
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`Nooa
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`wNoNoNoNo=Sowoco~ao
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`OUNG, Lee W., Authorized officer, International Searching Authority, International Search Report, PCT Application
`Serial No. PCT/US2009/05317- mailing date: November 20, 2009.
`
`OUNG, Lee W., Authorized officer, International Searching Authority, Written Opinion of the International Searching
`Authority, PCT Application Serial No. PCT/US2009/0531 7; mailing date: November 70, 2009.
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`KSIGENT,"Product Note Eksigent: NanoFlow Metering System", January 1, 2010, 4 pages
`
`EAVER, SUZANNE etal., “Taking qPCRto a higherlevel: Analysis of CNV reveals the power of high throughput
`4PCRto enhance quantitative resolution,” Methods, Vol. 50, pgs. 271-276, January 15, 2010
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`Application Number
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`Filing Date
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`INFORMATION DISCLOSURE
`First Named Inventer|Kevin D. NESS
`STATEMENT BY APPLICANT
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`| QLI3A21-QLP0001-CON eport” in connection with related International App. No. PCT/US2011/030101, dated June 1, 2011, 9 pgs
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`Examiner Name
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`wwwa
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`wao
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`>awwwwoS©co~
`>>WwNo=
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`AM, YOON SUNG etal., “Nanosized Emulsions Stabilized by Semisolid Polymer Interphase,” Langmuir, ACS
`Publications, July 23, 2010
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`SCHUTZE, TATJANAet al., “A streamlined protocol for emulsion polymerase chain reaction and subsequent
`ourification,” Analytical Biochemistry, Vol. 410, pgs. 155-157, November 25, 2010
`
`BHAT, SOMANATHetal, “Effect of sustained elevated temperature prior to amplification on template copy number
`pstimation using digital polymerase chain reaction,” Analyst, Vol. 136, pgs. 724-732, (2011)
`
`ETMUR, JAMESG.., et al., “Linking Emulsion PCR Haplotype Analysis,” PCR Protocols, Methods in Molecular
`iology, Vol. 687, pgs. 165-175, (2011)
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`VHONG, QUN et al, “Multiplex digital PCR: breaking the onetarget per color barrier of quantitative PCR,” Lab ona
`hip, Vol. 11, pgs. 2167-2174, (2011)
`
`HINXXS MICROTECHNOLOGYAG, “Emerald Biosystems: Protein Crystallization,” 1 pg., downloaded March 8, 201
`
`IFFO-SCHMITT, Beate, Authorized Officer, The International Bureau of WIPO, "International Preliminary Report on
`Patentability" in connection with related International Application No. PCT/US2009/005317, dated March 29, 2011, 8
`
`UANG, JIAQI et al., “Rapid Screening of Complex DNA Samples by Single-Molecule Amplification and Sequencing,”
`PLoS ONE,Vol. 6, Issue 5, pgs. 14, May 2011
`
`ULTO, PAUL et al., “Phaseguides: a paradigm shift in microfluidic priming and emptying,” Lab on a Chip, Vol. 11, No.
`, pgs. 1561-1700, May 7, 2011
`
`OUNG, Lee W., Authorized Officer, International Searching Authority, Commissionerof Patents, “International Searc!
`eport” in connection with related International App. No. PCT/US2011/030101, dated June 1, 2011, 2 pgs
`
`ihBK
`
`OUNG, Lee W., Authorized Officer, International Searching Authority, Commissionerof Patents, “International Searc!
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`Application Number
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`Filing Date
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` EKEVI, BURCUet al., “Synthesis and Characterization of Silicone-Based Surfactants as Anti-Foaming Agents,J.
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`INFORMATION DISCLOSURE
`First Named Inventer|Kevin D. NESS
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Examiner Name
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`Attorney Docket Number
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`| QLI3A21-QLP0001-CON
`
`Surfact Deterg (2012), Vol. 15, pgs. 73-81, published online July 7, 2011
`
`PINHEIRO, LEONARDOB. et al., “Evaluation of a Droplet Digital Polymerase Chain Reaction Format for DNA Copy
`umber Quantification,” Analytical Chemistry, Vol. 84, pgs. 1003-1011, November 28, 2011
`
`SOLIMINI, NICOLE L. et al., “Recurrent Hemizygous Deletions in Cancers May Optimize Proliferative Potential,”
`Science, Vol. 337, pgs. 104-109, July 6, 2012
`
`ABSMITH, “CapTiteTM Microfluidic Interconnects’ webpage, downloaded July 11, 2012
`
`ABSMITH, “Microfluid Components’ webpage, downloaded July 11, 2012
`
`ANNER, NATHANA.et al., “Simultaneous multiple target detection in real-time loop-mediated isothermal
`Amplification,” BioTechniques, Vol. 53, pgs. 8-19, August 2012
`
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