`Party
`
`Correspondence
`Address
`
`Submission
`Filer's Name
`Filer's e-mail
`Signature
`Date
`Attachments
`
`Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA654506
`ESTTA Tracking number:
`02/06/2015
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`91194218
`Defendant
`Meridian Bioscience, Inc.
`J MICHAEL HURST
`KEATING MUETHING & KLEKAMP
`1 E 4TH ST, STE 1400
`CINCINNATI, OH 45202 3752
`UNITED STATES
`mhurst@kmklaw.com, trademarks@kmklaw.com
`Defendant's Notice of Reliance
`J. Michael Hurst
`mhurst@kmklaw.com
`/J. Michael Hurst/
`02/06/2015
`Notice of Reliance - Illumina v. Meridian - 6 Feb 2015 - EX-
`ECUTED.PDF(399294 bytes )
`Noctice of Reliance Exhibit 1 Public.pdf(431696 bytes )
`Noctice of Reliance Exhibit 1 Public Pt.2.pdf(8681 bytes )
`EXHIBIT 2.a.pdf(1065041 bytes )
`EXHIBIT 2.b.pdf(3127772 bytes )
`EXHIBIT 2.c.pdf(1398720 bytes )
`EXHIBIT 2.d.pdf(5411803 bytes )
`EXHIBIT 2.e.pdf(1248112 bytes )
`EXHIBIT 2.f.pdf(889428 bytes )
`EXHIBIT 2.g.pdf(911913 bytes )
`EXHIBIT 2.h.pdf(1356274 bytes )
`EXHIBIT 3.pdf(746362 bytes )
`EXHIBIT 4.pdf(336199 bytes )
`EXHIBIT 5.pdf(748688 bytes )
`EXHIBIT 6.pdf(326219 bytes )
`EXHIBIT 7.pdf(190591 bytes )
`EXHIBIT 8.pdf(1635290 bytes )
`Noctice of Reliance Exhibit 9 Public.pdf(8624 bytes )
`EXHIBIT 10.pdf(922542 bytes )
`EXHIBIT 11.pdf(4529661 bytes )
`EXHIBIT 12.pdf(3840393 bytes )
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL APPEAL BOARD
`
`ILLUMINA, lNC.,
`
`-v-
`
`Opposer/Petitioner,
`
`MERIDIAN BIOSCIENCE, |NC.,
`
`Applicant/Registrant.
`
`xyxyx./\/\/\./\./\./\/s/g/g/xy
`
`Opposition No. 91194218 (parent)
`Ser. No. 77/768176
`
`Opposition No. 91194219
`Ser. No. 77/775316
`
`Cancellation No. 92053479
`
`Reg. No. 3887164
`
`Cancellation No. 92053482
`
`Reg. No. 3868081
`
`APPLlCANT’S I REG|STRANT’S NOTICE OF RELIANCE
`
`Pursuant to 37 C.F.R. §§ 2.120 and 2.122, and the parties’ stipulation dated 16 July
`
`2014, pursuant to 37 C.F.R. § 2.121(a)(1), Applicant / Registrant Meridian Bioscience,
`
`Inc.
`
`(“Meridian”) makes the following of record:
`
`Exhibit 1
`
`Opposer’s Supplemental Responses and Objections
`
`to App|icant’s First Set of
`
`interrogatories to Opposer dated 10 June 2013; Opposer’s Responses and Objections to
`
`Applicant’s Second Set of interrogatories to Opposer dated 2 January 2014; and Opposer’s
`
`Supplemental Responses and Objections to Applicant’s First Set of lnterrogatories to Opposer
`
`dated 4 February 2014.
`
`Exhibit 2
`
`Opposer’s Annual Reports and 10(k) filings from the years 2003 through 2011. Exhibit 2
`
`is relevant generally to show the industries in which Opposer operated between 2003 and 2011.
`
`The exhibit demonstrates no likelihood of confusion between Opposer’s marks and Meridian’s
`
`5912466.1
`
`
`
`marks due to the lack of similarity between channels of trade, relevant consumers, and lack of
`
`priority.
`
`Exhibit 3
`
`Genomeweb article published online 14 March 2012,
`titled, "Q & A: Matt Posard on
`l||umina’s Clinically Focused Business Unit.”
`Exhibit 3 is relevant generally to show the
`
`channels of trade and relevant consumers Opposer’s products, as well as the timing of its
`
`expansion into Meridian’s market. The exhibit demonstrates no likelihood of confusion between
`
`Opposer’s marks and Meridian’s marks due to the lack of similarity between channels of trade,
`
`relevant consumers, and lack of priority.
`
`Exhibit 4
`
`Genomeweb article published online 21 January 2009, titled, "|llumina Unveils Strategy
`
`to Enter Molecular Diagnostics Market.” Exhibit 4 is relevant generally to show the channels of
`
`trade and relevant consumers Opposer’s products, as well as the timing of its expansion into
`
`Meridian’s market. The exhibit demonstrates no likelihood of confusion between Opposer’s
`
`marks and Meridian’s marks due to the lack of similarity between channels of trade, relevant
`
`consumers, and lack of priority.
`
`Exhibit 5
`
`U-T San Diego article published online 26 November 2013,
`
`titled, "|l|umina Scores
`
`Medical Sequencing Breakthrough." Exhibit 5 is relevant generally to show the channels of
`
`trade and relevant consumers Opposer’s products, as well as the timing of its expansion into
`
`Meridian’s market. The exhibit demonstrates no likelihood of confusion between Opposer’s
`
`5912466.1
`
`
`
`marks and Meridian’s marks due to the lack of similarity between channels of trade, relevant
`
`consumers, and lack of priority.
`
`Exhibit 6
`
`Genomeweb article published online 20 June 2012, titled, “lllumina Sees Diagnostics as
`
`Largest Growth Opportunity; Dx Strategy to Focus on Cancer.” Exhibit 6 is relevant generally to
`
`show the channels of trade and relevant consumers Opposer’s products, as well as the timing of
`
`its expansion into Meridian’s market. The exhibit demonstrates no likelihood of confusion
`
`between Opposer’s marks and Meridian’s marks due to the lack of similarity between channels
`
`of trade, relevant consumers, and lack of priority.
`
`Exhibit 7
`
`lllumina press release issued 3 May 2010,
`
`titled, “lllumina Receives FDA 510(k)
`
`Clearance for its BeadXpress Multiplex Analysis System. Exhibit 7 is relevant generally to show
`
`the channels of trade and relevant consumers Opposer’s products, as well as the timing of its
`
`expansion into Meridian’s market. The exhibit demonstrates no likelihood of confusion between
`
`Opposer’s marks and Meridian’s marks due to the lack of similarity between channels of trade,
`
`relevant consumers, and lack of priority.
`
`Exhibit8
`
`Website
`
`printouts
`
`from Opposer’s webpage,
`
`including
`
`product
`
`advertisements
`
`information sheets available on Opposer’s website, relating to its TruGenome product. Exhibit 8
`
`is relevant generally to show the channels of trade and relevant consumers of Opposer’s
`
`products, as well as the lack of similarity between Opposer’s and Meridian’s goods and
`
`services. The exhibit demonstrates no likelihood of confusion between Opposer’s marks and
`
`5912466.1
`
`
`
`Meridian’s marks due to lack of similarity between channels of trade, relevant consumers, and
`
`the goods/services themselves.
`
`Exhibit 9
`
`List of “top 25 customers” of Opposer produced in response to Meridian's lnterrogatory
`
`No. 13. Exhibit 9 is relevant generally to identify the relevant consumers of Opposer’s products.
`
`The exhibit demonstrates no likelihood of confusion between Opposer’s marks and Meridian’s
`
`marks due to the sophistication of the purchasers.
`
`Exhibit 10
`
`Product brochure for Opposer’s TruGenone Clinical Sequencing Services dated 2013.
`
`Exhibit 10 is
`
`relevant generally to show the channels of trade and relevant consumers
`
`Opposer’s products, the timing of its expansion into Meridian’s market, and its coexistence with
`
`Meridian’s TRU-formative marks. The exhibit demonstrates no likelihood of confusion between
`
`Opposer’s marks and Meridian’s marks due to the lack of similarity between channels of trade,
`
`relevant consumers, lack of priority, and dissimilarity of goods/services.
`
`Exhibit 11
`
`Product brochure for Opposer’s MiSeqDx diagnostic platform dated 2013. Exhibit 11 is
`
`relevant generally to show the channels of trade and relevant consumers Opposer’s products,
`
`the timing of its expansion into Meridian’s market, and the goods/servies of the parties. The
`
`exhibit demonstrates no likelihood of confusion between Opposer’s marks and Meridian's marks
`
`due to the lack of similarity between channels of trade, relevant consumers, lack of priority, and
`
`dissimilarity of goods/services.
`
`59124661
`
`
`
`Exhibit 12
`
`Selection of third—party |LLUMl-formative registrations with evidence of current use of
`
`each mark supported by Declaration of Stephanie A. Ferguson. Exhibit 12 is relevant generally
`
`to the strength of Opposer’s marks and the widespread use of ILLUMI-formative marks in the
`
`relevant
`
`industry. The exhibit demonstrates no likelihood of confusion between Opposer’s
`
`marks and Meridian’s marks due to lack of similarity between the parties’ respective marks.
`
`Exhibit 13
`
`Selection of third—party LUMl-formative registrations with evidence of current use of each
`
`mark supported by Declaration of Stephanie A. Ferguson. Exhibit 13 is relevant generally to the
`
`strength of Opposer’s marks and the widespread use of LUMI-formative marks in the relevant
`
`industry. The exhibit demonstrates no likelihood of confusion between Opposer’s marks and
`
`Meridian’s marks due to lack of similarity between the parties’ respective marks.
`
`Exhibit 14
`
`Meridian’s registrations for TRU RSV, Registration No. 3407186; TRU FLU, Registration
`
`No. 3407185; TRU EBV-M, Registration No. 3468631; TRU EBV-G, Registration No. 3468630;
`
`TRU BLOCK, Registration No. 3877361; TRU LEGIONELLA, Registration No. 4255343; and
`
`TRU HSV 1 AND 2 IGG, Registration No. 4277182; and l||umina‘s registrations and applications
`
`for TRUSEQ, Registration No. 4064847; TRUSIGHT, Registration No. 4498222;
`
`and
`
`TRUGENOME, Serial No. 86/096366 with evidence of current use of each mark supported by
`
`Declaration of Stephanie A. Ferguson. Exhibit 14 is relevant generally to the coexistence of
`
`Meridian’s TRU-formative marks with Opposer’s TRU-formative marks.
`
`The
`
`exhibit
`
`demonstrates no likelihood of confusion between Opposer’s marks and Meridian’s marks due to
`
`lack of similarity between the goods.
`
`5912466.1
`
`
`
`Exhibit 15
`
`Xconomy article published online 15 January 2013, titled, "|||umina CEO Jay Flatley on
`
`Diagnostics, the $1K Genome & China.” Exhibit 15 is relevant generally to show the channels
`
`of trade and relevant consumers Opposer’s products, as well as the timing of its expansion into
`
`Meridian's market. The exhibit demonstrates no likelihood of confusion between Opposer’s
`
`marks and Meridian’s marks due to the lack of similarity between channels of trade, relevant
`
`consumers, and lack of priority.
`
`The above-described documents are filed concurrently herewith.
`
`Dated this 6"‘ day of February, 2015.
`
`Respectfully submitted,
`
`
`
`" ATING MUETHING & KLEKAMP PLL
`One East Fourth St.
`Suite 1400
`
`Cincinnati, Ohio 45202
`Phone: (513) 562-1401
`Fax: (513) 579-6457
`mhurst@kmklaw.com
`
`Attorney for Applicant / Registrant,
`Meridian Bioscience, Inc.
`
`5912466.]
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a copy of the foregoing App|icant’s / Registrant’s Notice of Reliance
`
`was served upon Susan M. Natland, Knobbe, Martens, Olson & Bear, LLP, 2040 Main Street,
`
`Fourteenth Floor, Irvine, California, 92614 by first class mail this 6th day of February, 2015.
`
`Lag Evans
`
`5912466.1
`
`
`
`NOTICE OF RELIANCE EXHIBIT 1
`
`(PUBLIC)
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Illumina, Inc.,
`
`Opposition No. 91 194218 (parent)
`Serial No.: 77/768176
`
`Opposer,
`
`Mark: ILLUMIPRO
`
`V.
`
`Meridian Bioscience, Inc.,
`
`Opposition No. 91194219
`Serial No.: 77/775316
`
`Mark: ILLUMIPRO-10
`
`Applicant.
`
`OPPOSER’S SUPPLEMENTAL RESPONSES AND OBJECTIONS TO
`APPLICANT’S FIRST SET OF INTERROGATORIES TO OPPOSER
`
`Pursuant to Fed. R. Civ. P. 33 and subject to the General Objections and the Objections to
`
`Definitions and Instructions in Opposer’s Responses and Objections to Applicant’s First Set of
`
`Interrogatories to Opposer, Illumina, Inc. hereby serves following supplemental responses and
`
`objections to Applicant’s First Set of Interrogatories to Opposer.
`
`Interrogatory No. 10:
`
`Identify all publications in which Opposer’s products/services bearing the ILLUMINA
`
`Marks have been promoted in the United States.
`
`Response:
`
`Opposer incorporates its General Objections as if fully set forth herein. Opposer objects
`
`to this interrogatory as overly broad, unduly burdensome and vague in that it fails to define the
`
`terms “publications,” “bearing” and “promoted” thus rendering the interrogatory unintelligible.
`
`Subject to and without waiving its objections, Opposer answers that its website,
`
`<<http://www.illumina.com/publications/list.ilmn>>, includes a list of the numerous
`
`
`
`publications in which researchers successfully used Opposer’s products bearing Opp0ser’s
`
`ILLUMINA Marks for a wide range of genetic analysis applications.
`
`Supplemental Response and Objection(s):
`
`Subject to and without waiving its objections, Opposer provides the following list of print
`
`and electronic publications in which Opposer’s products/services bearing the ILLUMINA Marks
`
`have been promoted in the United States:
`
`Print Placements
`
`American Journal of Human Genetics
`
`Biotechniques
`Cancer Cell
`
`CAP Today
`CELL
`
`Cytogenetics & Genomic Research
`Drug Discovery News
`Genetic Engineering & Biotechnology News
`Genome Research
`
`Genome Technology
`Human Molecular Genetics
`
`Journal of Molecular Diagnostics
`Methods (Cell)
`Molecular Cell Microbe Magazine Nature
`Nature
`
`Nature Biotechnology
`Nature Genetics
`Nature Medicine
`
`Nature Methods
`Nature Reviews Cancer
`Nature Reviews Genetics
`
`Nature Reviews Microbiology
`Plant Physiology
`Science
`
`Seed Today
`Seed World
`
`The Plant Cell
`The Scientist
`
`Electronic Placements
`
`AACR Cancer Research
`
`
`
`American Journal of Human Genetics
`Animal Genetics
`
`ASPB (American Society of Plant Biologists)
`BioMCC
`
`BioMed Central
`BioMed Central Cancer Portal
`
`Biotechniques
`Cancer Cell
`
`Cell
`
`Crop Science
`Drug Design, Development and Therapy
`DDN
`
`Drug Discovery
`Dx/PGX
`
`EJHG (European Journal of Human Genetics)
`ESHJ
`G3 Journal
`GEN
`
`Gene Therapy
`Genes & Development
`Genetics
`Genome Research
`Genome Web
`Genome Web PCR Insider
`Genome Web: Clinical Genomics
`
`In Sequence
`International Journal of Cancer
`
`Journal of Clinical Microbiology
`Journal of Molecular Diagnostics
`Lab Matters: Association of Public Health Laboratories
`
`Molecular Cyto genetics
`Molecular Microbiology
`Nature
`
`Nature Genetics
`
`Nature Heredity
`Nature Methods
`
`Nature Reviews Cancer
`Nature Reviews Genetics
`
`Nature Reviews Microbiology
`PGX Reporter (Genome Web)
`Plant Physiology
`PLoS Genetics
`
`Proceeding of National Academy of Sciences
`Science
`Scientific Direct
`
`SeedQuest
`
`
`
`Select Science Microbiology
`SeqAnswers
`The Plant Cell
`
`The Scientist
`
`lnterrogatory No. 30:
`
`Identify and describe each instance of confusion, mistake, or deception of any kind
`
`between Oppose1"s ILLUMINA Marks and Applicant’s ILLUMIPRO Marks, and identify each
`
`person with knowledge of each instance.
`
`Response:
`
`Opposer incorporates its General Allegations as if fully stated herein. Opposer objects to
`
`this interrogatory as overly broad, unduly burdensome and vague in that it is impossible for
`
`Opposer to be aware of every instance of consumer confusion as there have most likely been
`
`times where consumers were confused but never made Opposer aware of that confusion. Thus, it
`
`is impossible to formulate a complete answer for this question.
`
`Supplemental Response and Objection(s):
`
`Subject to and without waiving its objections, Opposer answers that it has not yet
`
`documented any instances of confusion between Opposer’s ILLUMINA Marks and Applicant’s
`
`ILLUMIPRO Marks by consumers of the parties’ good and services.
`
`Respectfully submitted,
`
`ILLUMINA, INC.
`
` Date: June 10, 2013
`
` James R. Menker
`
`Attorney for Opposer
`HOLLEY & MENKER, P.A.
`PO Box 331937
`
`Atlantic Beach, FL 32233
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that
`
`a
`
`true and correct copy of the foregoing “OPPOSER’S
`
`SUPPLEMENTAL RESPONSES AND OBJECTIONS TO APPLICANT’S FIRST SET OF
`
`INTERROGATORIES TO OPPOSER” was served on J. Michael Hurst of Keating Muething &
`
`Klekamp PLL, with an address at One East Fourth Street, Suite 1400, Cincinnati, OH 45202, via
`
`first class mail, postage prepaid, today June 10, 2013.
`
`
`
`
`
`Tel: 904-247-2620
`
`Fax: 202—280—1 1177
`
`email: eastdocket@ho11eymenker.com
`
`
`
`VERIFICATION
`
`I, William Noon, Ph.D., Patent Attorney of Opposer, am authorized to verify this
`
`response on behalf of Opposer.
`
`I have read the foregoing OPPOSER’S SUPPLEMENTAL
`
`RESPONSES AND OBJECTIONS TO APPLICANTS FIRST SET OF INTERROGATORJES
`
`TO OPPOSER and know their contents. The statements are true and correct and are of my own
`
`personal knowledge, except for those matters stated to be upon information and belief, and as to
`
`those matters, I believe them to be true.
`
`I declare under penalty of perjury under the laws of the United States of America that the
`
`foregoing is true and correct.
`
`June 7, 2013
`Date
`
`QMJ{am/H/flex,
`
`William Noon, Ph.D.
`Patent Attorney
`Illumina, Inc.
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
` Opposition No. 91 194218 (parent)
`
`
`
`
`Serial No.: 77/768176
`
`Opposer,
`
`Mark: ILLUMIPRO
`
`V.
`
`Meridian Bioscience, Inc.,
`
`Opposition No. 91194219
`Serial No.: 77/775316
`
`Mark: ILLUMIPRO—l0
`
` Applicant.
`
`
`OPPOSER’S RESPONSES AND OBJECTIONS TO
`
`APPLICANT’S SECOND SET OF INTERROGATORIES TO OPPOSER
`
`Pursuant to Fed.R.CiV.P. 33, Illumina, lnc., (“Opposer”), hereby serves its responses and
`
`objections to, Meridian Bioscience, Inc.’s (“Applicant”) First Set of Interrogatories to Opposer.
`
`Preliminary Statement
`
`These responses are made solely for the purpose of and in relation to this matter.
`
`Opposer has not fully completed it investigation, discovery, analysis, legal research, and
`
`preparation for trial in this matter. The responses contained herein are based only upon the
`
`information and documentation that is presently available and known to Opposer, and which has
`
`been identified as containing relevant information. It is possible that finther investigation,
`
`discovery, analysis, legal research and/or preparation may result in the ascertainment of
`
`additional information or documentation, or provide additional meaning to known factual
`
`conclusions and legal contentions, all of which may result in modification of these responses.
`
`Accordingly, Opposer reserves the right, but does not assume the obligation, to modify its
`
`
`
`
`
`responses herein based upon subsequently ascertained, identified, or developed information,
`
`facts and contentions.
`
`Subject to the objections asserted herein, 0pposer’s responses are made in a good faith
`
`effort to reasonably respond to the Interrogatory based upon presently available information and
`
`documentation. These responses are provided without prejudice to Opposer’s right to conduct
`
`further investigation, discovery, analysis, legal research and/or preparation, and shall not limit
`
`Opposer’s right to utilize any additional evidence or documents that may be identified,
`
`discovered, or developed.
`
`Specific objections to each separate Interrogatory are made on an individual basis in
`
`Opposer’s responses below. In addition to the specific objections, Opposer makes certain general
`
`and continuing objections as well as objections to the definitions and instructions (“General
`
`Objections”) to all of the Interrogatories. These General Objections are hereby incorporated by
`
`reference into the responses made with each Interrogatory. Opposer’s response to each
`
`individual Interrogatory is submitted without prejudice to, and without waiving in any respect,
`
`any General Objections not expressly set forth in that response. Accordingly, the inclusion of
`
`any specific objection to an Interrogatory in any response below is neither intended as, nor in any
`way shall be deemed to be, a waiver of any General Objection or any other specific objection
`
`made herein or that may be asserted at a later date. In addition, the failure to include at this time
`
`any general or specific objection to an Interrogatory is neither intended as, nor shall in any way
`
`be deemed, a waiver of Opposer’s right to assert that or any other objection at a later date.
`
`General Objections
`
`1.
`
`Opposer renews and incorporates by reference the General Objections set forth in
`
`Opposer’s Responses and Objections to Applicant’s First Set of Interrogatories to Opposer.
`
`
`
`
`
`Objections to Definitions
`
`1.
`
`Opposer renews and incorporates the Objections to Definition set forth in
`
`Opposer’s Responses and Objections to Applicant’s First Set of Interrogatories to Opposer.
`
`Without waiving these objections, Opposer responds as follows:
`
`Interro gatory No. 44:
`
`Identify the date on which Opposer first sold or offered for sale (whichever is earlier)
`
`products or services under the ILLUMINA Marks that could be used in a clinical diagnostics lab
`
`of a hospital or reference laboratory.
`
`Response:
`
`Opposer incorporates its General Objections and its Objections to Definitions as if fully
`
`set forth herein. Opposer objects to this interrogatory as vague in that it is not clear what is
`
`meant by “could be used”.
`
`Subject to and without waiving its objections, Opposer responds that it first offered for
`
`sale services under the ILLUMINA Marks that could have been ordered by or delivered to
`
`individuals employed in a clinical diagnostics lab of a hospital or reference laboratory at least as
`
`early as December 5, 2006.
`
`Interrogatory No. 45:
`
`Identify the date on which Opposer first sold or first offered for sale (whichever is
`
`earlier) products or services under the ILLUMINA Marks that are approved by the U.S. Food
`
`and Drug Administration (“FDA”) for in vitro diagnostic (“IVD”) uses as further described here:
`
`h
`
`://Wvvw.fda. ov/MedicalDevices/DeviceRe
`
`ationandGuidance/IVDRe
`
`lato Assistance/u
`
`cml23682.htm.
`
`
`
`Response:
`
`Opposer incorporates its General Objections and its Objections to Definitions as if fully
`
`set forth herein. Opposer objects to this interrogatory as overly broad, unduly burdensome and
`
`vague in that it is not clear what is meant by “approved”. The page from the FDA website listed
`
`in the interrogatory references “premarket approval” and “marketing clearance” amongst other
`
`types of approvals that could be relevant. Subject to and without waiving its objections, Opposer
`
`responds that it first offered for sale products approved by the U.S. Food and Drug
`
`Administration (“FDA”) for in vitro diagnostic (“IVD”) uses under the ILLUMINA Marks
`
`following immediately after the approval of its BeadXpress Multiplex Analysis System on April
`
`28, 2010.
`
`Respectfully submitted,
`
`ILLUMINA, INC.
`
`Date: Januag 2, 2014
`
`-x.
`
`/ James R. Menker
`
`Attorney for Opposer
`HOLLEY & MENKER, P.A.
`PO Box 331937
`
`Atlantic Beach, FL 32233
`Tel: 904-247-2620
`Fax: 202-280-11177
`
`email: eastdocket@hol1eymenker.com
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that a true and correct copy of the foregoing “OPPOSER’S RESPONSES
`
`AND OBJECTIONS TO APPLICANTS FIRST SET OF INTERROGATORTES TO
`
`OPPOSER” was served on J. Michael Hurst of Keating Muething & Klekamp PLL, with an
`
`address at One East Fourth Street, Suite 1400, Cincinnati, OH 45202, via first class mail,
`
`postage prepaid, today January 2, 2014.
`
`
`
`
`
`NOTICE OF RELIANCE EXHIBIT 1
`
`(CONFIDENTIAL)
`
`
`
`
`
`EXHIBIT 2.a
`EXHIBIT 2.a
`
`
`
`2003 Annual Report
`
`ILLUM-1902
`
`
`
`Sentrix® 16-array BeadChip
`Each array can genotype 1536 SNPs.
`Dense geometry; 6-micron spacing.
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`Sentrix 8-sample BeadChip
`for Focused Expression
`700 genes per sample.
`20-micron feature-to-feature spacing.
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`Sentrix RefSeq BeadChip
`Query 8 samples in parallel,
`24,000 transcripts each, derived
`from RefSeq sequences.
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`Sentrix Whole Genome BeadChip
`Six genomes on a single microarray.
`Over 10 million features.
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`Sentrix Array Matrix
`Microplate-compatible. 96 arrays
`in parallel. 50,000 features per array,
`with 1536-multiplex assay protocol.
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`The New Architecture for Genetic Analysis
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`ILLUM-1903
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`2003 ANNUAL REPORT
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`2003 Highlights
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`In 2003, Illumina shipped the first of a developing family of products built on our New Architecture
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`for Genetic Analysis. These products help researchers speed genetic discoveries that are essential
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`for personalized medicine. As a result of this progress and the hard work of our employee teams,
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`our revenue for 2003 exceeded $28 million, nearly three times the level of 2002.
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`We planted cornerstones for future success around the
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`world in 2003, installing six genotyping BeadLabs at leading
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`genomics centers in Asia, North America and Europe.
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`The BeadLab is a production laboratory that delivers on the
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`promise of a turnkey system. In less than 30 days, we can
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`convert empty lab space into an operation that generates
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`over one million genotypes per day.
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`In 2003 we introduced the Sentrix® BeadChip, a flexible,
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`highly configurable complement to our Sentrix Array
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`Matrix. We design BeadChips to address various market
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`opportunities by trading off the number of samples
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`analyzed on each chip with the complexity of the analysis
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`Jay Flatley and John Stuelpnagel
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`of each sample. BeadChips use the same manufacturing
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`methods and infrastructure perfected for the fiber optic-
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`based Array Matrix as well as identical genetic content and
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`assay methods. This results in lower-cost manufacturing
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`MEETING AND EXCEEDING 2003 MILESTONES
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`for Illumina while providing unequaled platform flexibility
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`for our customers.
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`Our aggressive business plans require effective team
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`execution across multiple disciplines and functional areas.
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`Our teams have worked tirelessly to exceed our internal
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`expectations and more importantly, those of our customers
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`and investors. The following pages recap Illumina’s 2003
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`performance.
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`• Sign 15 Service Contracts
`Signed 26 genotyping service agreements
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`• Ship 5 Production-Scale BeadLabs
`Shipped and installed 6 BeadLabs
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`• Develop 100,000 Assays for the HapMap Project
`Completed in Q4, 2003
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`• Launch First Whole-Genome Oligo Set
`Completed in Q1, 2003
`
`• Launch First Product for Gene Expression Profiling
`Launched Focused Gene Expression Program
`in Q3, 2003
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`ILLUM-1904
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`ILLUMINA, INC.
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`2003 ANNUAL REPORT
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`Commercial
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`The market for SNP genotyping and gene expression prod-
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`ucts exceeds $1 billion annually and is growing robustly,
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`fueled by expanded use of microarray methods to study
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`genetic variation and function. Illumina technologies are
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`ideally suited to address research initiatives that increas-
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`ingly require the generation of large data sets—the product
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`of large numbers of samples and high complexity per
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`sample. For example, the International HapMap Project,
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`for which Illumina is both a Principal Investigator and a
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`supplier, will generate in excess of 250 million data points
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`over approximately two years. This project will serve as
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`a catalyst for new genotyping projects and will help
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`standardize SNP-based pharmacogenomics initiatives.
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`In 2003, we installed BeadLabs at six of the world’s most
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`Tristan Orpin, Sales; Susan Eddins, Marketing; Kirk Malloy,
`Customer Solutions
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`respected research institutions: The Wellcome Trust Sanger
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`Longer term, we believe that the largest opportunity for
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`Institute, Shanghai's National Center
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`for Biochip
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`SNP genotyping will be the broader market of core
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`Technology, The Eli and Edyth L. Broad Institute (formerly
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`laboratories and individual researchers who require more
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`the Whitehead Institute/MIT Center for Genome Research),
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`moderate throughput levels. The BeadStation 500G was
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`Genome Quebec Innovation Centre, Human Genome
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`announced in November 2003 to address this emerging
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`Center of the Institute of Medical Science of the University
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`opportunity. Built on the same technology platform as
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`of Tokyo, and
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`Johns Hopkins University/Center for
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`BeadLab,
`
`the BeadStation
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`features a streamlined
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`Inherited Disease Research (CIDR). Strategically, these
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`GoldenGate™ assay and flexible multiplex levels, enabling
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`BeadLab placements give Illumina the ability to build
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`researchers to achieve low-cost, high-accuracy genotyping
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`relationships with the thought leaders of our industry.
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`without the use of robotics or information management
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`In 2003, we installed
`BeadLabs at six of the
`world’s most respected
`research institutions.
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`systems. We began BeadStation shipments in March 2004.
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`In September 2003, we entered the gene expression
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`market with the launch of our focused array program. This
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`flexible program allows customers to order standard
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`or custom gene content (to query a specific organism or
`
`disease state) and to use the content interchangeably on
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`two Sentrix® platforms: our 96-sample Array Matrix and
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`our 8-sample BeadChip.
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`ILLUMINA, INC.
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`ILLUM-1905
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`2003 ANNUAL REPORT
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`These new BeadChips
`have the potential to
`dramatically reduce the
`cost of whole-genome
`expression analysis,
`allowing researchers to
`expand the scale and
`reproducibility of bio-
`logical experimentation.
`
`In January 2004, we announced our plan to enter the whole-
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`human-genome expression market with two new Sentrix
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`BeadChip configurations. The first BeadChip analyzes six
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`samples or replicates (48,000 transcripts each) on a single
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`chip, while the second BeadChip generates expression data
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`for eight samples (24,000 RefSeq transcripts) in parallel
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`on one chip. These new BeadChips have the potential to
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`dramatically reduce the cost of whole-genome expression
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`analysis, allowing researchers to expand the scale and
`
`reproducibility of biological experimentation.
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`Collectively, these new products form the base for an
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`integrated suite of products that can readily expand to
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`accommodate additional market-driven requirements.
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`On the service side, we signed 26 genotyping service
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`agreements, reflecting the throughput and consistently
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`high data quality of our internal scientific operations.
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`Additionally, Illumina’s Oligator® oligonucleotide synthesis
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`business continued to gain market share by focusing on
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`researchers engaged in large projects and major accounts
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`that require volume quantities of high-quality oligos.
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`In 2003, we nearly doubled the size of our Sales, Marketing
`
`and Customer Solutions organizations to support an
`
`expanding portfolio of products and to broaden our global
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`coverage and customer service levels. We opened a sub-
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`sidiary in Japan and a new facility in Singapore, along with
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`distributors and support personnel in China and Australia.
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`ILLUM-1906
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`ILLUMINA, INC
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`2003 ANNUAL REPORT
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`Research and Engineering
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`Our success as a company is critically dependent on our
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`ability to effectively convert projects in our development
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`pipeline into innovative new products that provide value to
`
`the markets and customers we serve. Our research and
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`development teams represent a core asset with expertise
`
`across a broad range of disciplines including biochemistry,
`
`bioinformatics, molecular biology, genetics, optical
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`engineering and process engineering. During 2003,
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`we invested considerable energy in optimizing our process-
`
`es for organizing these core resources into high-perform-
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`ance, cross-functional teams that can rapidly define and
`
`deliver new products. While we continue our focus on
`
`improving these processes, we feel great about the
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`progress we have made and the level of performance we
`
`have achieved.
`
`During the year, our teams delivered critical products to
`
`the market including the BeadLab, the BeadChip and the
`
`Focused Array products. These teams also enhanced the
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`core technologies we use across multiple product lines,
`
`including the BeadArray Reader and the multiplex levels of
`
`our assays and arrays.
`
`With our core array platforms fully deployed in manufac-
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`turing, we will now concentrate product development
`
`resources on new applications and assays that will leverage
`
`our technology infrastructure and enhance the capabilities
`
`of our growing installed base.
`
`Michal Lebl, Automation; Bob Kain, Engineering;
`David Barker, Research & Development
`
`Our research and
`development teams
`represent a core asset
`with expertise across
`a broad range of
`disciplines.
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`ILLUMINA, INC.
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`ILLUM-1907
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`2003 ANNUAL REPORT
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`Operations
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`Our scientific operations and manufacturing groups focus
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`on the efficient production of high-quality products and
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`services. In 2003, the company made tremendous progress
`
`in reducing costs, improving yields and increasing capacity
`
`across all our product lines,
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`including arrays, oligos,
`
`software, systems and genotyping data.
`
`Central to this progress is a mission-critical set of
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`enterprise information and LIMS (Laboratory Information
`
`Management) systems that allow us to manage inventory,
`
`schedule manufacturing activity, and integrate data and
`
`sample flows both seamlessly and cost effectively.
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`Illumina continues to be the only microarray manufacturer
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`that is able to ensure the quality of every feature in every
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`array before customers ever use our products. Increasingly,
`
`the customers we serve are recognizing our superior array
`
`performance and data quality, and rewarding us with
`
`repeat purchases and new system sales.
`
`As part of our participation in the International HapMap
`
`Project, we delivered approximately 100,000 assays in 2003.
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`Illumina’s technology continues to demonstrate superior
`
`results across all of our installed sites. In 2004 we expect
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`to generate, along with our HapMap partners, approximate-
`
`ly 400,000 additional assays as part of this seminal interna-
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`tional effort. This library of assays has the