· · · · · · · UNITED STATES PATENT AND
`· · · · · · · · · ·TRADEMARK OFFICE
`· · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`· · ·ANCESTRY.COM DNA, LLC,· · · )
`· · ·Petitioner,· · · · · · · · ·)
`· · · · · · · · · · · · · · · · ·)· Patent No.
`· · · · · vs.· · · · · · · · · · )· 8,221,381
`· · · · · · · · · · · · · · · · ·)· Inter Partes
`· · ·DNA GENOTEK INC.,· · · · · ·)· Review No.
`· · · · · · · · · · · · · · · · ·)· 2016-00060
`· · ·Patent Owner· · · · · · · · )
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`· · · · · · · · · · ·The· deposition of TERRY
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`· · ·LAYTON, Ph.D. called by the Patent Owner for
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`· · ·examination, pursuant to notice, taken
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`· · ·before LAURA MUKAHIRN, CSR, a notary public
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`· · ·within and for the County of Cook and State
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`· · ·of Illinois, at 300 East Randolph Street,
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`· · ·Chicago, Illinois, on May 25, 2016,
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`· · ·scheduled to commence at 9:00 o'clock a.m.
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`DNA Genotek, Inc. Exhibit 2004 Page 1
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`· · · · · · · · · ·TRADEMARK OFFICE
`· · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`· · ·ANCESTRY.COM DNA, LLC,· · · )
`· · ·Petitioner,· · · · · · · · ·)
`· · · · · · · · · · · · · · · · ·)· Patent No.
`· · · · · vs.· · · · · · · · · · )· 8,221,381
`· · · · · · · · · · · · · · · · ·)· Inter Partes
`· · ·DNA GENOTEK INC.,· · · · · ·)· Review No.
`· · · · · · · · · · · · · · · · ·)· 2016-00060
`· · ·Patent Owner· · · · · · · · )
`·
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`· · · · · · · · · · ·The· deposition of TERRY
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`· · ·LAYTON, Ph.D. called by the Patent Owner for
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`· · ·examination, pursuant to notice, taken
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`· · ·before LAURA MUKAHIRN, CSR, a notary public
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`· · ·within and for the County of Cook and State
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`· · ·of Illinois, at 300 East Randolph Street,
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`· · ·Chicago, Illinois, on May 25, 2016,
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`· · ·scheduled to commence at 9:00 o'clock a.m.
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`DNA Genotek, Inc. Exhibit 2004 Page 1
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`·1· ·A P P E A R A N C E S:
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`·2· · · · FENWICK & WEST, LLP
`· · · · · Silicon Valley Center
`·3· · · · 801 California Street
`· · · · · Mountain View, California 94041
`·4· · · · (650)988-8500
`· · · · · BY:· MR. MICHAEL SACKSTEDER
`·5· · · · · · ·MS. JENNIFER R. BUSH
`· · · · · · · ·Appeared on behalf of the
`·6· · · · · · ·Petitioner;
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`·7· · · · MORRISON & FOERSTER
`· · · · · 12531 High Bluff Drive
`·8· · · · Suite 100
`· · · · · San Diego, California 92130-2040
`·9· · · · (858)314-5415
`· · · · · BY:· MR. PENG CHEN
`10· · · · · · ·MR. BRIAN M. KRAMER
`· · · · · · · ·Appeared on behalf of the Patent
`11· · · · · · ·Owner.
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`·1· · · · · · · · · · · I N D E X
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`·2· · ·Examinations· · · · · · · · · · · · · ·Page
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`·3· ·Examination· · · · · · · · · · · · · · · · · ·4
`· · ·By Mr. Chen
`·4
`· · ·Cross-Examination· · · · · · · · · · · · · ·164
`·5· ·By Mr. Sacksteder
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`·6· ·Redirect Examination· · · · · · · · · · · · 168
`· · ·By Mr. Chen
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`· · · · · · · · · · ·E X H I B I T S
`·8· · ·No.· · · · · · · · · · · · · · · · · · Page
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`·9· · ·Layton Exhibit No. 2009· · · · · · · · · · 35
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`10· · ·Layton Exhibit No. 2010· · · · · · · · · · 47
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`11· · · · · E X H I B I T S (Previously marked)
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`12
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`13· · ·Ancestry Exhibit 1003· · · · · · · · · · · 53
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`14· · ·Ancestry Exhibit 1014· · · · · · · · · · · 54
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`15· · ·Ancestry Exhibit 1012· · · · · · · · · · · 54
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`16· · ·Ancestry Exhibit 1013· · · · · · · · · · · 54
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`17· · ·Ancestry Exhibit 1001· · · · · · · · · · · 62
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`18· · ·Ancestry Exhibit 1007· · · · · · · · · · · 96
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`19· · ·Ancestry Exhibit 1010· · · · · · · · · · ·150
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`20· · ·Ancestry Exhibit 1011· · · · · · · · · · ·151
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`DNA Genotek, Inc. Exhibit 2004 Page 3
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`·1· · · · · · · · · · · · · · ·(Witness sworn.)
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`·2· · · · · · · ·TERRY LAYTON, Ph.D.
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`·3· ·called as a witness herein, having been
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`·4· ·first duly sworn, was examined and
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`·5· ·testified as follows:
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`·6· · · · · · · · · ·Examination
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`·7· · · · · · · · · ·By Mr. Chen
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`·8· · · · Q.· · ·Good morning.
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`·9· · · · A.· · ·Good morning.
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`10· · · · Q.· · ·Dr. Layton, I understand that
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`11· ·your capacity being an expert in this case
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`12· ·depends on, among other things, your
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`13· ·educational experiences and working
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`14· ·experiences; is that correct?
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`15· · · · A.· · ·Yes.
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`16· · · · Q.· · ·Including your working
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`17· ·experiences on some of the fluid collection
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`18· ·devices you worked on before?
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`19· · · · A.· · ·Yes.
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`20· · · · Q.· · ·Now, on these devices you
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`21· ·worked before, do they involve multiple
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`22· ·parts?
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`23· · · · A.· · ·Yes.
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`24· · · · Q.· · ·And to be used -- or to be made
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`25· ·and used, the parts are sometimes connected
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`DNA Genotek, Inc. Exhibit 2004 Page 4
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`·1· ·or engaged and disengaged by the users?
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`·2· · · · A.· · ·Yes.
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`·3· · · · Q.· · ·Now, did you design these
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`·4· ·devices?
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`·5· · · · · · · ·MR. SACKSTEDER:· Object to the
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`·6· ·form.
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`·7· · · · · · · ·THE WITNESS:· I didn't
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`·8· ·understand the question.
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`·9· ·BY MR. CHEN:
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`10· · · · Q.· · ·Well, for those collection
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`11· ·devices you worked on them, are you the
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`12· ·designer for these devices?
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`13· · · · A.· · ·I'd have to look at the patents
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`14· ·and see which ones.· You know, 40 years.
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`15· ·Some of the collection -- I believe a
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`16· ·couple of the collection devices, like the
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`17· ·tissue pressure measuring device.· Yes,
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`18· ·some of them are.
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`19· · · · Q.· · ·So you did design some of the
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`20· ·devices?
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`21· · · · A.· · ·Yes.
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`22· · · · Q.· · ·And those --
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`23· · · · A.· · ·Patents on them.
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`24· · · · Q.· · ·Yeah.· And those devices
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`25· ·include multiple parts?
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`DNA Genotek, Inc. Exhibit 2004 Page 5
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`·1· · · · A.· · ·Yes.
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`·2· · · · Q.· · ·And some parts have to be
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`·3· ·connected or engaged?
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`·4· · · · A.· · ·Yes.
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`·5· · · · Q.· · ·And sometimes they have to be
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`·6· ·removed from each other?
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`·7· · · · A.· · ·Yes.
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`·8· · · · Q.· · ·So when you design these
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`·9· ·devices, if the parts have to be engaged
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`10· ·together or removed from each other, do you
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`11· ·design each part to have a particular
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`12· ·feature or structure for the user to engage
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`13· ·or disengage?
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`14· · · · · · · ·MR. SACKSTEDER:· Object to the
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`15· ·form.
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`16· · · · · · · ·THE WITNESS:· It depends.· Some
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`17· ·of them you're following a standard, a
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`18· ·guidance document.· So the connection meets
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`19· ·the guidance document.· And sometimes if
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`20· ·you design and you find your customer wants
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`21· ·something added to it, you may add to it.
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`22· ·So it depends on the design and the
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`23· ·questions and the customer preference.
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`24· ·BY MR. CHEN:
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`25· · · · Q.· · ·But at the minimum if, let's
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`DNA Genotek, Inc. Exhibit 2004 Page 6
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`·1· ·say, for example, the parts have to be
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`·2· ·connected, do you design to have the parts
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`·3· ·have certain structure so they can be
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`·4· ·connected with each other?
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`·5· · · · A.· · ·Well, there's some that are
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`·6· ·defined that they have to be that way.
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`·7· · · · Q.· · ·Right.· For those that have to
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`·8· ·be, have to -- must have the connecting
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`·9· ·parts, you have structures for them to do
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`10· ·that, right?
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`11· · · · A.· · ·Yes.
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`12· · · · Q.· · ·So if some of the parts have to
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`13· ·be removed, do you also design to have
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`14· ·structures on the parts that the user can
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`15· ·remove them?
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`16· · · · · · · ·MR. SACKSTEDER:· Object to the
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`17· ·form.
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`18· · · · · · · ·THE WITNESS:· Designing of the
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`19· ·parts that collect collection.· I'll give
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`20· ·you an example.· Take the example of a
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`21· ·syringe and a catheter, or a syringe and a
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`22· ·stopcock, or a syringe and a vial.· The tip
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`23· ·of the syringe has to meet an ANSI spec.
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`24· ·It has to have a particular taper.· It has
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`25· ·to have particular dimensions.· The needle
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`DNA Genotek, Inc. Exhibit 2004 Page 7
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`·1· ·that it's going into has to have a
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`·2· ·particular taper, has to have particular
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`·3· ·dimensions so that the syringe and the
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`·4· ·needle mate, works properly, doesn't leak.
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`·5· ·They can take it apart and put it onto a
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`·6· ·stopcock.· They can take Company A's
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`·7· ·needle, Company B's syringe, they have to
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`·8· ·fit together.· So it's designed that way.
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`·9· · · · · · · ·Another example is like the
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`10· ·breathing circuits, the endotracheal tubes.
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`11· ·Here, again, you have a connector.
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`12· ·Connector on an endotracheal tube, which
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`13· ·happens to be, I think it's an ASTM spec,
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`14· ·879, where you have connect -- patient is
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`15· ·intubated.· You have to help them breathe.
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`16· ·You want to connect that endotracheal tube
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`17· ·up to the breathing circuit.· So the
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`18· ·connections have to be the same.· There,
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`19· ·again, it's the taper, and it's the
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`20· ·dimensions so that they meet.· You don't
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`21· ·want air to go out.· You want the air to go
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`22· ·into the lungs.· If it's in the operating
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`23· ·room, you don't want the gasses to leak out
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`24· ·from the connections.· The connections are
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`25· ·designed and they mate and they meet and
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`DNA Genotek, Inc. Exhibit 2004 Page 8
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`·1· ·the tapers have to meet from Company A to
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`·2· ·Company B to Company C.· Also you can
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`·3· ·exchange parts.· What if you want to put a
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`·4· ·filter on between the endotracheal tube and
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`·5· ·the breathing circuit.· You put on a
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`·6· ·filter, again, it's got to have the same
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`·7· ·dimensions and the taper.
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`·8· · · · · · · ·So those type of devices, when
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`·9· ·you're looking at medical devices, you look
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`10· ·to see if you have specifications like
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`11· ·that.· And, in some cases, you do, and you
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`12· ·follow that law.· That's the law, in my
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`13· ·definition.
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`14· ·BY MR. CHEN:
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`15· · · · Q.· · ·Feels like a law, I guess?
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`16· · · · A.· · ·Yeah.· You've got to do it.
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`17· ·That's good manufacturing.· That's medical
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`18· ·devices.
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`19· · · · Q.· · ·Now, some of the examples you
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`20· ·talked about, do they require the user to
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`21· ·take them apart after they're done?
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`22· · · · A.· · ·Yes.
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`23· · · · Q.· · ·How does the user go about
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`24· ·taking them apart from each other?
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`25· · · · · · · ·MR. SACKSTEDER:· Object to the
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`DNA Genotek, Inc. Exhibit 2004 Page 9
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`·1· ·form.
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`·2· · · · · · · ·THE WITNESS:· Fingers.· They
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`·3· ·just pull them apart.· You engage it and
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`·4· ·you disengage it.· And then you put them
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`·5· ·together.· You take the case of the syringe
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`·6· ·and the needle.· You can have a slip,
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`·7· ·meaning it just slips in and holds, and it
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`·8· ·slips out when you want to take it apart.
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`·9· ·Or you can put it in and you can lock it so
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`10· ·there's a luer lock or a luer slip;
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`11· ·depending on what the situation is, what
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`12· ·the nurse wants, what the doctor wants, or
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`13· ·what type of stopcock you want or syringe
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`14· ·you want.· You can lock them that way.
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`15· · · · · · · ·I was telling you about the
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`16· ·breathing circuits.· There have been
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`17· ·designs where someone puts a lock on a
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`18· ·breathing circuit so they stay together,
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`19· ·and then you undo the lock if you want to
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`20· ·disconnect it.· Otherwise they just engage,
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`21· ·friction fit, push them in, pull them out.
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`22· ·BY MR. CHEN:
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`23· · · · Q.· · ·So if I understand you
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`24· ·correctly, so when the user is going to
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`25· ·take them apart, they will just use their
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`DNA Genotek, Inc. Exhibit 2004 Page 10
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`·1· ·hand to hold on to some parts of the
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`·2· ·components and just remove them?
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`·3· · · · A.· · ·Of the examples I gave you,
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`·4· ·correct.
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`·5· · · · Q.· · ·All right.· Again, also for
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`·6· ·some of the devices you worked on, you
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`·7· ·know, each part is there for a particular
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`·8· ·function or reason, correct?
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`·9· · · · A.· · ·Correct.· When you design, you
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`10· ·put together a product requirement
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`11· ·definition.· What does the doctor want?
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`12· ·What does the nurse want?· What type of
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`13· ·patient is it going to be used on?· What
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`14· ·environment is it being used?· So, yes,
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`15· ·you've got requirements.
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`16· · · · Q.· · ·Let's say, for example, there's
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`17· ·a certain requirement for the device to
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`18· ·work or a certain function for the device
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`19· ·to work, and you design a part to provide
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`20· ·that function, right?
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`21· · · · A.· · ·You work on one design or
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`22· ·several designs, multiple designs.· In the
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`23· ·beginning you may be thinking about
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`24· ·multiple designs to meet that function.
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`25· · · · Q.· · ·And let's say for one
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`DNA Genotek, Inc. Exhibit 2004 Page 11
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`·1· ·particular function, do you always use a
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`·2· ·single part to provide the function, or
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`·3· ·sometimes you can provide multiple parts to
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`·4· ·work together to achieve the function?
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`·5· · · · A.· · ·Yes.· You can be single, it can
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`·6· ·be multiple, depending on what the function
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`·7· ·is and what the design that you're
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`·8· ·following is.
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`·9· · · · Q.· · ·And, again, your capacity for
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`10· ·designing a device, do you consider, you
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`11· ·know, who will be the user, how they're
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`12· ·going to use the device?
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`13· · · · A.· · ·Yes.
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`14· · · · Q.· · ·And if the operation of the
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`15· ·device needs a user to do certain things or
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`16· ·steps, then you would consider that?
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`17· · · · · · · ·MR. SACKSTEDER:· Object to the
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`18· ·form.
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`19· · · · · · · ·THE WITNESS:· Part of the --
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`20· ·Part of the requirement definition is
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`21· ·looking at the functions and the
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`22· ·requirements; and there's musts, needs, and
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`23· ·wants.· Some things you have to zero in on
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`24· ·and find out what's a must and what is a
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`25· ·want.· So that's a question that you really
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`DNA Genotek, Inc. Exhibit 2004 Page 12
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`·1· ·have to look at each particular one, what
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`·2· ·role it plays in your design and whether
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`·3· ·it's mandatory or whether it's something
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`·4· ·they want and what the other requirements.
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`·5· ·I mean the classic example always is that I
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`·6· ·want the best thing for three cents.· Well,
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`·7· ·you can get something for three cents, but
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`·8· ·it's not the best thing.
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`·9· · · · · · · ·So that's why I say, you got to
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`10· ·look at each -- You can't say in a general
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`11· ·statement that it's one thing or another.
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`12· ·You have to look at each particular
`
`13· ·attribute or design characteristic that
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`14· ·you're working on.
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`15
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`16· ·BY MR. CHEN:
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`17· · · · Q.· · ·Okay.· For any device you would
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`18· ·design in such a way that it allow the user
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`19· ·to actually use the device?
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`20· · · · A.· · ·If that's what the purpose of
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`21· ·it is.· I mean what's the design
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`22· ·requirement?· Is it for -- Is a syringe for
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`23· ·someone to hold in their hand, or is the
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`24· ·device to sit on a table?· What's the
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`25· ·requirement?
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`DNA Genotek, Inc. Exhibit 2004 Page 13
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`·1· · · · Q.· · ·Right.· So, for example, you
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`·2· ·know, the connections you talked before,
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`·3· ·and you would provide the structures for
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`·4· ·the parts to be connected, and the user can
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`·5· ·do that?
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`·6· · · · · · · ·MR. SACKSTEDER:· Object to the
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`·7· ·form.
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`·8· · · · · · · ·THE WITNESS:· It goes back again
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`·9· ·to the requirements.· Do you want the --
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`10· ·you know, there can be instances where you
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`11· ·don't want the user to connect or
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`12· ·disconnect.· What's the requirement?
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`13· ·BY MR. CHEN:
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`14· · · · Q.· · ·Yeah.· So let's -- assuming,
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`15· ·for the device we worked on, it does
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`16· ·require the user to connect and disconnect.
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`17· · · · A.· · ·Okay.· If we make that
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`18· ·assumption, okay.
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`19· · · · Q.· · ·And then you would provide the
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`20· ·structure items for the user to do the
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`21· ·connection or connect them?
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`22· · · · A.· · ·I may provide three or four
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`23· ·options.· That's part of the design.
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`24· · · · Q.· · ·Is that the same thing for the
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`25· ·disconnecting?· If you -- if the user has
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`DNA Genotek, Inc. Exhibit 2004 Page 14
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`·1· ·to disconnect them and you will provide
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`·2· ·structures on the parts on the device so
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`·3· ·the user can use them to remove them?
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`·4· · · · A.· · ·It goes back to the
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`·5· ·requirements, again, and how -- who,
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`·6· ·when -- Who's going to remove it?· You
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`·7· ·know, sometimes you look at the size of the
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`·8· ·hands or the size of the person and that
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`·9· ·type of thing relative to it and the
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`10· ·holding of the device.· So they all go back
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`11· ·to the requirements of all this information
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`12· ·and who's using it.· You know, you sit and
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`13· ·see and hear that products are only good
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`14· ·for a part of the population.· Well, they
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`15· ·were designed for adults.· They weren't
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`16· ·designed for children.
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`17· · · · · · · ·Likewise, you have to look at
`
`18· ·your design of the requirements of who's
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`19· ·doing it and where's it going to be used.
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`20· ·And if it's going to be the universe, then
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`21· ·you try to come up with something that can
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`22· ·be the universe.· But then you may find
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`23· ·that you have alternate designs.
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`24· · · · Q.· · ·So you would consider, if I
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`25· ·understand you correctly, you would
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`DNA Genotek, Inc. Exhibit 2004 Page 15
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`·1· ·consider the user's ability to use the
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`·2· ·device according to the design?
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`·3· · · · A.· · ·If your product requirement
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`·4· ·asks something about the user, you're going
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`·5· ·to rely on their ability to do what you're
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`·6· ·designing, yes.· You will show it to them.
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`·7· · · · Q.· · ·Aside from their ability to
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`·8· ·actually use the device, do you consider
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`·9· ·user's convenience as well?
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`10· · · · · · · ·MR. SACKSTEDER:· Object to the
`
`11· ·form.
`
`12· · · · · · · ·THE WITNESS:· There, again, you
`
`13· ·look at it as back to the product
`
`14· ·requirement definition.· Convenience, you
`
`15· ·look at it and what is convenience?· You
`
`16· ·have to get a definition to it as an
`
`17· ·engineer.· Does convenience mean that it's
`
`18· ·not going to give you carpal tunnel?· Does
`
`19· ·convenience mean that it's easy to insert?
`
`20· ·And what is easy?· Less than so many pounds
`
`21· ·of pressure.· You know, you can't -- the
`
`22· ·word convenient is not a good word for an
`
`23· ·engineer.· He wants definition to it.
`
`24· · · · Q.· · ·Okay.· So aside from
`
`25· ·considering the user's ability to use the
`
`DNA Genotek, Inc. Exhibit 2004 Page 16
`
`
`
`·1· ·device, when you design the device, do you
`
`·2· ·consider other factors?
`
`·3· · · · A.· · ·Yes.· It goes back to the
`
`·4· ·product requirement definition.· Who, what,
`
`·5· ·why, when, and where, and how.
`
`·6· · · · Q.· · ·If you're faced with several
`
`·7· ·options, it's possible, right, you can have
`
`·8· ·several designs to achieve the same
`
`·9· ·function.· And let's assume among those
`
`10· ·different options, they will give you the
`
`11· ·same functionality.· There's no difference
`
`12· ·there.· But some of the functions is
`
`13· ·perhaps easy -- or some of the designs
`
`14· ·would be, I don't want to use the word
`
`15· ·convenient, but maybe user friendly than
`
`16· ·the other options, do you always consider
`
`17· ·the user-friendly option?
`
`18· · · · · · · ·MR. SACKSTEDER:· Object to the
`
`19· ·form.
`
`20· · · · · · · ·THE WITNESS:· You look at it
`
`21· ·all.· This is where when you're doing a
`
`22· ·design and you have design reviews, you're
`
`23· ·showing the different options to get the
`
`24· ·feedback from the potential people that are
`
`25· ·involved in this team.· And the user being
`
`DNA Genotek, Inc. Exhibit 2004 Page 17
`
`
`
`·1· ·one member of the team.· If someone came to
`
`·2· ·you with an idea to design something,
`
`·3· ·you're going to get feedback from them.· Is
`
`·4· ·it -- You're using words of convenience or
`
`·5· ·et cetera type of thing.· You're going to
`
`·6· ·ask them and work with them relative to the
`
`·7· ·selection process.· And you may find, and
`
`·8· ·you do find this, that you have different
`
`·9· ·populations of products; that you build one
`
`10· ·product initially and then you find once
`
`11· ·you designed and worked with and added on
`
`12· ·in the market, you do a modification to it
`
`13· ·and someone else could do it.· And the
`
`14· ·prime example is when I talked about the
`
`15· ·syringe of the luer lock and the luer slip.
`
`16· ·Some people want the slip only.· They don't
`
`17· ·want the lock.· Some people want the lock
`
`18· ·for the security.· So they came up with two
`
`19· ·products to handle attaching the syringe to
`
`20· ·a needle.· So it may happen that way.
`
`21· ·BY MR. CHEN:
`
`22· · · · Q.· · ·Just actually to follow up what
`
`23· ·you discussed in terms of making changes.
`
`24· ·So when you have a product, you will only
`
`25· ·make a change if there's a reason for the
`
`DNA Genotek, Inc. Exhibit 2004 Page 18
`
`
`
`·1· ·change, correct?
`
`·2· · · · A.· · ·Not always.· You may make a
`
`·3· ·change because your find in another market.
`
`·4· · · · Q.· · ·Right.· So there's a need on
`
`·5· ·the market --
`
`·6· · · · A.· · ·A need, not a reason.· It's
`
`·7· ·another market need.· Or a need for a
`
`·8· ·product to be used in another situation.
`
`·9· ·For example, going from an adult to a
`
`10· ·child, a catheter from an adult to a child.
`
`11· ·You're going it make changes.
`
`12· · · · Q.· · ·Maybe I'm just using the word
`
`13· ·reason very loosely.· But really you're not
`
`14· ·going to just make changes just because you
`
`15· ·can make the change?
`
`16· · · · A.· · ·No.· You always have that
`
`17· ·product requirement definition that is the
`
`18· ·law and that you're looking at and paying
`
`19· ·attention to all through the design.· And
`
`20· ·there's the feedback.· There's the feedback
`
`21· ·during all your design reviews of where
`
`22· ·you're looking at what the requirements
`
`23· ·happen to be versus what the product that
`
`24· ·your -- this design has, this design has,
`
`25· ·this design has.· And you're constantly
`
`DNA Genotek, Inc. Exhibit 2004 Page 19
`
`
`
`·1· ·comparing.· Am I meeting the product
`
`·2· ·requirements, or am I not meeting -- what
`
`·3· ·if one of the product requirements was it
`
`·4· ·had to be less than 5 cents and you're
`
`·5· ·finding that it's 7 and a half cents.· Do
`
`·6· ·you throw it out the window?· Maybe not.
`
`·7· ·Maybe you raise the requirement to 7 and a
`
`·8· ·half cents.· So you have the feedback,
`
`·9· ·you're monitoring, you're modifying.
`
`10· · · · Q.· · ·Yeah.· So every modification is
`
`11· ·based on some reason or need or design?
`
`12· · · · A.· · ·There's a design review
`
`13· ·process.· Validate it and you verify it.
`
`14· · · · Q.· · ·So for the devices you worked
`
`15· ·on that use multiple parts for connection,
`
`16· ·are any of them or do any of them use the
`
`17· ·friction fit as a way for connecting?
`
`18· · · · A.· · ·Oh, yes.· Like I said, some of
`
`19· ·the ones where you use the needle syringe
`
`20· ·type of a fit.
`
`21· · · · Q.· · ·So that's actually based on the
`
`22· ·friction fit?
`
`23· · · · A.· · ·That's a friction fit. A
`
`24· ·syringe tip to a needle is a friction fit.
`
`25· · · · Q.· · ·All right.· So are these
`
`DNA Genotek, Inc. Exhibit 2004 Page 20
`
`
`
`·1· ·connections designed to be permanent
`
`·2· ·connection or the removable connection?
`
`·3· · · · A.· · ·There, again, it depends on
`
`·4· ·what the requirements happen to be.· You
`
`·5· ·know, you have situations where you want to
`
`·6· ·change.· I'll mention, say, for instance,
`
`·7· ·you have a syringe that's gone into an IV
`
`·8· ·bag and you have a 5ML syringe and you --
`
`·9· ·the medication you're putting in is
`
`10· ·adequate in a 5ML.· Well, what if you have
`
`11· ·something that's 20MLs?· You're going to
`
`12· ·get a 25 cc syringe.· So it's adapting back
`
`13· ·and forth.
`
`14· · · · · · · ·So it depends there, again,
`
`15· ·what some of the definition is and how
`
`16· ·you're going to work with it at this stage
`
`17· ·and at the future stages.
`
`18· · · · Q.· · ·Okay.· So based on -- or using
`
`19· ·the friction fit mechanism, it really
`
`20· ·depends on the design.· It's possible to
`
`21· ·have either a permanent or a removable
`
`22· ·connection?
`
`23· · · · A.· · ·Yes.· You can have both.
`
`24· · · · Q.· · ·Again, back to the product
`
`25· ·design.· We talked before that each part is
`
`DNA Genotek, Inc. Exhibit 2004 Page 21
`
`
`
`·1· ·putting to a product for a particular
`
`·2· ·reason or for a function, correct?
`
`·3· · · · A.· · ·Yes.· It plays a role.· It's
`
`·4· ·part of the requirement.
`
`·5· · · · Q.· · ·So let's say, again, the
`
`·6· ·function here we're talking about is for
`
`·7· ·connecting the parts or removing the parts,
`
`·8· ·right, because that's what we're talking
`
`·9· ·about.· So if those features are needed,
`
`10· ·you would provide elements for the parts to
`
`11· ·be connected or removed?
`
`12· · · · · · · ·MR. SACKSTEDER:· Object to the
`
`13· ·form.
`
`14· · · · · · · ·THE WITNESS:· Going into the
`
`15· ·design requirement, you will look at the
`
`16· ·options and you will design accordingly.
`
`17· ·And if you want it to be permanent and
`
`18· ·lock, you'll design it to be permanent and
`
`19· ·lock.· If you want it to be removable, you
`
`20· ·will design it to be removable.· If you
`
`21· ·want it to be locked and removable, you'll
`
`22· ·design it to be locked and removable.· It
`
`23· ·goes back to what the design requirement
`
`24· ·happens to be.· Why am I doing that?
`
`25· ·What's the need?· What's the medical need?
`
`DNA Genotek, Inc. Exhibit 2004 Page 22
`
`
`
`·1· ·What's the product need?· And if it
`
`·2· ·requires one or the other or all, you work
`
`·3· ·with that.
`
`·4· ·BY MR. CHEN:
`
`·5· · · · Q.· · ·Let's say again, for example,
`
`·6· ·let's use removal as one of the examples as
`
`·7· ·the function.· If the design, let's say, is
`
`·8· ·a permanent -- is designed for permanent
`
`·9· ·connections or removal is not needed for
`
`10· ·the user, let's say that's the design
`
`11· ·you're going after, then there's no need to
`
`12· ·provide some structures for the removal,
`
`13· ·correct?
`
`14· · · · A.· · ·Depends on what the definition
`
`15· ·is.
`
`16· · · · Q.· · ·The definition of what?
`
`17· · · · A.· · ·The definition for the product.
`
`18· ·Is it ever to be removed?
`
`19· · · · Q.· · ·Let's say, assume it's not to
`
`20· ·be removed.· That's your design goal.
`
`21· · · · A.· · ·Never?
`
`22· · · · Q.· · ·Yeah.
`
`23· · · · A.· · ·Never to be removed?
`
`24· · · · Q.· · ·Yeah.· Or it's not to be
`
`25· ·removed by the user.
`
`DNA Genotek, Inc. Exhibit 2004 Page 23
`
`
`
`·1· · · · A.· · ·But it can be removed?
`
`·2· · · · Q.· · ·Well, I think --
`
`·3· · · · A.· · ·You see what I --
`
`·4· · · · Q.· · ·Go ahead.
`
`·5· · · · A.· · ·The definition --
`
`·6· · · · Q.· · ·I think the definition is, you
`
`·7· ·know, according to the operation of the
`
`·8· ·device, the user does not need to remove.
`
`·9· ·So that's the goal here.
`
`10· · · · · · · ·MR. SACKSTEDER:· What's the --
`
`11· ·Hold on.· That's not a question.· What's
`
`12· ·the question?
`
`13· ·BY MR. CHEN:
`
`14· · · · Q.· · ·I'm just talking about example
`
`15· ·so we can ask the question.· So I want to
`
`16· ·make clear the example we're talking about,
`
`17· ·you're designing a device, and the
`
`18· ·operation of the device does not require
`
`19· ·the user to remove the part, okay?· So
`
`20· ·that's the example we're talking about.
`
`21· · · · A.· · ·If the law is not to be removed
`
`22· ·by anybody any time, that's what you design
`
`23· ·it to.
`
`24· · · · Q.· · ·I think, you know, this is
`
`25· ·slightly different from what I'm talking
`
`DNA Genotek, Inc. Exhibit 2004 Page 24
`
`
`
`·1· ·about.· I'm talking about your device is
`
`·2· ·designed for a certain population of users,
`
`·3· ·right?
`
`·4· · · · A.· · ·Yes.
`
`·5· · · · Q.· · ·Yes.· So let's say for that
`
`·6· ·intended population of the users, the goal
`
`·7· ·is that, you know, they have to be able to
`
`·8· ·connect the parts, but they don't have to
`
`·9· ·remove them afterwards.· I mean are
`
`10· ·those -- we're talking about those type of
`
`11· ·examples, right?· Okay.
`
`12· · · · · · · ·MR. SACKSTEDER:· Object to the
`
`13· ·form.· I -- still you're not asking him a
`
`14· ·question.
`
`15· · · · · · · ·MR. CHEN:· Right.· Again, I'm
`
`16· ·trying to clarify my example so he can
`
`17· ·answer the question.
`
`18· · · · · · · ·MR. SACKSTEDER:· Will you tell
`
`19· ·him what the question is?
`
`20· ·BY MR. CHEN:
`
`21· · · · Q.· · ·I will.· So for that example
`
`22· ·then, no removal is needed by the user,
`
`23· ·then do you still provide some structures
`
`24· ·for the removal?
`
`25· · · · · · · ·MR. SACKSTEDER:· Object to the
`
`DNA Genotek, Inc. Exhibit 2004 Page 25
`
`
`
`·1· ·form.
`
`·2· · · · · · · ·THE WITNESS:· I'm not following.
`
`·3· ·The reason I'm not following is because I
`
`·4· ·don't understand my -- to be put together
`
`·5· ·and not removed.· So I don't -- I'm not
`
`·6· ·understanding.· What's the requirement?
`
`·7· ·That's what I said.· If the requirement is
`
`·8· ·that it is never to be opened, when I
`
`·9· ·engage it I will have a lock on it so it
`
`10· ·can never be opened.· If it's -- If it's
`
`11· ·designed to be put together and difficult
`
`12· ·for one person to open, a kid can't open
`
`13· ·this.· My wife sometimes can't open them.
`
`14· ·The design, you can design it a different
`
`15· ·way.· This is only an adult.· Look at the
`
`16· ·adult medicine caps type of thing.· They're
`
`17· ·designed that particular way.· They're
`
`18· ·locked for that particular reason, so
`
`19· ·there's a percentage of people or group of
`
`20· ·people that can't open it or it's hard for
`
`21· ·them to open it.· And then if that's what
`
`22· ·the requirement is, that's what it is.
`
`23· ·But, you know, what I'm -- what I'm
`
`24· ·thinking so much about a collection
`
`25· ·container is that someone is going to open
`
`DNA Genotek, Inc. Exhibit 2004 Page 26
`
`
`
`·1· ·them sometime.· It might be a laboratory.
`
`·2· ·It might be somebody that they have to do
`
`·3· ·something.· If it's a urine collection
`
`·4· ·device, they're opening it to up to do the
`
`·5· ·urine samples.· They're looking for
`
`·6· ·infections.· That's not going to be locked
`
`·7· ·permanently.
`
`·8· · · · · · · ·So that's why I'm saying, it
`
`·9· ·goes back to the requirements, and it's
`
`10· ·difficult for me to think of an example of
`
`11· ·where it would never be opened.
`
`12· ·BY MR. CHEN:
`
`13· · · · Q.· · ·Okay.· So let's follow up on
`
`14· ·the example you just talked about, medicine
`
`15· ·bottle intended to be opened by adult but
`
`16· ·not by child.· We've seen this example
`
`17· ·before, right?· And for that particular
`
`18· ·example where you provide structures for
`
`19· ·the adult to open it, correct?
`
`20· · · · · · · ·MR. SACKSTEDER:· Object to the
`
`21· ·form.
`
`22· · · · · · · ·THE WITNESS:· You do a design
`
`23· ·that an adult can figure out and open it,
`
`24· ·right.
`
`25
`
`DNA Genotek, Inc. Exhibit 2004 Page 27
`
`
`
`·1· ·BY MR. CHEN:
`
`·2· · · · Q.· · ·Yeah.· And you would not add a
`
`·3· ·feature that it would allow a child to open
`
`·4· ·it?
`
`·5· · · · A.· · ·No.· You put it on there so
`
`·6· ·that the child didn't open it.· They're
`
`·7· ·not -- They don't know how to open it.
`
`·8· · · · Q.· · ·Or that would not allow the
`
`·9· ·child to open it?
`
`10· · · · A.· · ·They don't know how, so they're
`
`11· ·not allowed to.· They can try.
`
`12· · · · Q.· · ·Right.· Certainly you're not
`
`13· ·providing something for the child to open?
`
`14· · · · A.· · ·Well, the purpose, it goes back
`
`15· ·to the requirement.· The requirements in
`
`16· ·this particular case of a medicine bottle
`
`17· ·or a prescription bottle is it's difficult
`
`18· ·to open so kids don't get into them.
`
`19· · · · Q.· · ·Right.· It's designed for the
`
`20· ·adult?
`
`21· · · · A.· · ·Yeah.
`
`22· · · · Q.· · ·And then you would not add
`
`23· ·something that would facilitate the child
`
`24· ·to open?
`
`25· · · · A.· · ·Well, the standard one a child
`
`DNA Genotek, Inc. Exhibit 2004 Page 28
`
`
`
`·1· ·can open.· It's just a screw top.
`
`·2· · · · Q.· · ·Right.· But I'm talking about
`
`·3· ·the special ones only for the adult.
`
`·4· · · · A.· · ·Mm-hmm.
`
`·5· · · · Q.· · ·And you would design it in a
`
`·6· ·way that an adult can open and child
`
`·7· ·cannot?
`
`·8· · · · A.· · ·That was -- If that's in the
`
`·9· ·product requirement definition, then that's
`
`10· ·part of the requirement.· They want a top
`
`11· ·to a medicine bottle that is difficult for
`
`12· ·kids to open and -- but adults can open it,
`
`13· ·yes.
`
`14· · · · Q.· · ·Okay.· So back to the
`
`15· ·collection devices you worked on.· For
`
`16· ·example, some of the fluid collection
`
`17· ·devices you worked on.· They use multiple
`
`18· ·parts.· When these parts are connected,
`
`19· ·while the connection is designed to prevent
`
`20· ·leakage?
`
`21· · · · · · · ·MR. SACKSTEDER:· Object to form.
`
`22· · · · · · · ·THE WITNESS:· In many cases,
`
`23· ·yes.
`
`24· ·BY MR. CHEN:
`
`25· · · · Q.· · ·And what do you do to have
`
`DNA Genotek, Inc. Exhibit 2004 Page 29
`
`
`
`·1· ·design feature to prevent the leak?
`
`·2· · · · A.· · ·Classic example is the two that
`
`·3· ·I described.· The syringe and needle with
`
`·4· ·the taper and the friction fit with it so
`
`·5· ·it doesn't leak.· And then everything from
`
`·6· ·the syringe goes to where you want it to go
`
`·7· ·and doesn't leak out or the breathing
`
`·8· ·circuit, the 15, 22 millimeter connector,
`
`·9· ·they attach together.· So that the gas,
`
`10· ·air, oxygen flows from Point A to Point B
`
`11· ·and doesn't disburse out.· The tapers of
`
`12· ·these devices are such that you have
`
`13· ·surface-to-surface contact and you don't
`
`14· ·have leakage.· And you have -- you go to
`
`15· ·the -- go to the ANSI spec for syringes and
`
`16· ·needles, the luer taper, the luer spec,
`
`17· ·there's a leakage requirement.· So it's
`
`18· ·there.· That's why I say this is such a
`
`19· ·classic example because the world:· Nurses,
`
`20· ·doctors, everybody else expects syringes
`
`21· ·and needles to slip together, to pull
`
`22· ·apart, and not leak.· It happens.
`
`23· · · · Q.· · ·So that is based on the
`
`24· ·friction fit, the example you talked about?
`
`25· · · · A.· · ·I would call that a friction
`
`DNA Genotek, Inc. Exhibit 2004 Page 30
`
`
`
`·1· ·fit, yes.
`
`·2· · · · Q.· · ·And we talked before.· So based
`
`·3· ·on the friction fit, you
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