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`Paper 165
`Entered: March 5, 2014
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`RECORD OF ORAL HEARING
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`ARIOSA DIAGNOSTICS,
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`Petitioner
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`V.
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`ISIS INNOVATION LIMITED,
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`Patent Owner
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`____________
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`Cases IPR2012-00022 and IPR2013-00250
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`Patent 6,258,540
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`___________________
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`Oral Hearing Held January 24, 2014
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`____________
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`WITNESSES
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`Before LORA M. GREEN, FRANCISCO C. PRATS, and JEFFREY B.
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`ROBERTSON, Administrative Patent Judges.
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`
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`Cases IPR2012-00022 and IPR2013-00250
`Patent 6,258,540
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`GREGORY GARDELLA,
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`KEVIN B. LAURENCE and
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`DIANNA L. DEVORE
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`Oblon, Spivak, McClelland, Maier & Neustadt, LLP
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`1940 Duke Street
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`Alexandria, VA 22314
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`
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`ON BEHALF OF THE PATENT OWNER:
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`ELDORA L. ELLISON, PH.D. and
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`MICHAEL J. MALECEK
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`Kaye Scholer, LLP
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`Two Palo Alto Square
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`Suite 400
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`3000 El Camino Real
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`Palo Alto, CA 94306-2112
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`1100 New York Avenue, NW
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`Washington D.C. 20005
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`P R O C E E D I N G S
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`JUDGE GREEN: Good morning and welcome. This is
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`the final oral hearing for the following cases, IPR2012-00022
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`and 2013-00250. At this time, I would like counsel to
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`introduce themselves and your colleagues, and I'll start with
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`the Petitioner.
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`MR. GARDELLA: This is Greg Gardella, from Oblon
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`Spivak, on behalf of Petitioner, Ariosa Diagnostics. I'm
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`joined by Dianna DeVore also of Ariosa Diagnostics.
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`JUDGE GREEN: Thank you. And Patent Owner?
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`MS. ELLISON: Good morning. I'm Eldora Ellison,
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`on behalf of Isis Innovation, and I'm here with Mr. Michael
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`Malecek. We have several people in the audience. I'm not
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`sure if you want me to introduce them, as well.
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`JUDGE GREEN: If they aren't going to be
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`speaking, I’m not going to worry about it.
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`MS. ELLISON: Okay. Thank you.
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`JUDGE GREEN: Thank you. And welcome to the
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`Board. Consistent with our order, each party has one hour to
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`present their arguments. Petitioner will proceed first in
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`the action charged claimed. Petitioner may reserve rebuttal
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`time for its case and time to respond to objections with
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`regard to the motion to amend. Thereafter, Patent Owner will
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`respond to Petitioner's case and also present its own case
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`with regards to the motion to amend claims. Patent Owner may
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`reserve rebuttal time for its case after the motion to amend
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`patent claims.
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`After that, the Petitioner will make use of the
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`rest of its time responding to Patent Owner's presentation of
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`all matters. And then if Patent Owner reserves rebuttal
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`time, Patent Owner will only address the issues raised by the
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`Petitioner regarding the motion to amend claims.
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`At this time I would like to ask counsel if they
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`have the demonstrative -- if they have copies of the
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`demonstratives for the panel, the other side and the court
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`reporter. And you can approach the bench.
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`(Whereupon, the demonstrative was distributed to
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`all parties.)
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`JUDGE GREEN: Counsel for Petitioner, you may
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`proceed when you're ready. And how much rebuttal time would
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`you like to reserve (indiscernible)?
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`MR. GARDELLA: A half hour, Your Honor.
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`JUDGE GREEN: 30 minutes? Okay, thank you.
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`MR. GARDELLA: Good morning, Judge Green, Judge
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`Prats, Judge Robertson. Thanks for having us here today. I
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`would like to start with the broadest reasonable
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`interpretation. The Board correctly noted that the Patent
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`Owner's own expert, Dr. Evans, in connection with litigation
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`analyzed the accused product of Petitioner Ariosa and in his
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`analysis, clearly indicated and reflected in the analysis in
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`which it was not necessary to distinguish maternal from fetal
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`DNA, and that's the principal debate between the parties at
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`this point.
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`One thing I'd like to bring to your attention is
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`that in the Article 3 proceedings, to my knowledge, the
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`Patent Owner, through its exclusive licensee Sequenom, has
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`never once argued for the limitation, the narrower
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`construction that it is seeking here. Never once.
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`Ariosa believed, and still believes, that the
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`proper Phillips construction is narrower, but that's not the
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`issue here. The issue here is broadest reasonable
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`interpretation, which we submit should, at the absolute
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`minimum, encompass that which has been advocated successfully
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`by the Patent Owner in Article 3 Core.
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`JUDGE GREEN: Can you tell us what the status is
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`of the co-pay litigation, then?
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`MR. GARDELLA: In the beginning in the district
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`court, the summary judgment was granted of unpatentable
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`subject matter under 101. The Court found that the claimed
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`subject matter was merely discovery, a natural phenomenon.
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`That is on appeal to the Federal Circuit currently.
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`JUDGE GREEN: And do you have any idea as to when
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`that may be heard or you're just looking for the case to be
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`docketed and set for hearing?
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`MR. GARDELLA: I am not personally familiar with
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`the specific status. I can ask co-counsel, if you’d like. I
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`don't believe -- well, actually, come to think of it, I just
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`saw in the e-mail opposing counsel's brief. So that would be
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`the Appellant's brief, so it's in briefing. So the ball is
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`now in Ariosa's court for responsiveness. So I guess I do
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`know that.
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`JUDGE GREEN: Okay. Thank you.
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`MR. GARDELLA: Any other questions about the
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`district court litigation?
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`JUDGE GREEN: I was just wanting to know where it
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`was.
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`MR. GARDELLA: No, yeah, please with any -- with
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`any questions. Most of what I’m going to say you already
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`know. So if you have questions, please don't -- don’t feel
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`bad about interrupting me.
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`So also noteworthy is that most of Patent Owner's
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`experts, especially in their second round, have been using
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`the narrower definition. So to the extent they apply
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`non-detect, they're using this narrower definition, which
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`again was not used, not advocated even by the Patent Owner in
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`district court. But yet now, they are coming here before
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`this panel and arguing for broadest reasonable
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`interpretation, which is actually narrower than the Phillips
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`construction, which they advocated successfully in the
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`district court. We submit that that attempt should be
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`rejected. The broadest reasonable interpretation should, at
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`a minimum, encompass that which was successfully advocated by
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`the Patent Owner.
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`And, in particular, their expect Dr. Evans, who
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`they characterize as one of the luminaries in the field of
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`prenatal medicine.
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`JUDGE GREEN: In that regard, I do know that
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`there was an opinion by Judge Rader, Federal Circuit,
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`regarding the preliminary injunction. How are we bound by
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`the instruction or mitigating instruction again called for in
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`that opinion?
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`MR. GARDELLA: Well, that is the Phillips
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`construction. That's not the BRI, that's the thing I'll
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`start with. But the takeaway from the opinion is this. We
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`were arguing for a narrower construction -- a narrower
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`construction under Phillips, which was different than what
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`Patent Owner is arguing here. It's known in advance, which
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`is what we thought was really thought-enabled by the patent.
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`That's what we were are advocating.
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`And Judge Rader -- I mean the holding really is
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`just that, no, the claims are not so limited. The claims
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`that there is no basis in the prosecution history is
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`insufficient basis to read the claims narrowly. So the
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`consequence, the holding was they're broad.
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`And on remand, the district court then agreed
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`with Dr. Evans that the claim -- the term “detect” covers
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`discovery or detecting the existence, presence or fact of.
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`So that's what the district court found. And then the
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`question becomes, does that phrase, if one were to accept
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`that that is the proper construction, does that require or
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`does it not require distinguishing maternal from fetal, and
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`Dr. Evans clearly says that it does not. But that is the
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`import of the Federal Circuit ruling. Again, it is under
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`Phillips. And closely read, it was rejecting a narrow
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`construction, which is similar to but not identical to what
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`Patent Owner is arguing here.
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`JUDGE GREEN: So I guess with respect to
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`detecting the presence of paternally inherited nucleic acid
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`of fetal origin would be comprising language, but that could
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`include detecting both maternal and fetal, but not
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`necessarily distinguishing one from the other.
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`MR. GARDELLA: Correct. Correct. And that's
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`certainly what's been advocated in district court. In
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`particular, the Petitioner Ariosa has a non-polymorphic assay
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`that does not do that. And that has been accused of
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`infringement. And to my knowledge, that infringement
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`allegation has been maintained. So that was -- that was the
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`genesis, if you will, for that coming into issue. And that
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`is the basis on which Dr. Evans testified and Patent Owner
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`advocated that there is no requirement with the term detect,
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`that you distinguish maternal from fetal.
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`So for purposes of this presentation and one
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`shorthand way I oftentimes think of it in the context of this
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`case or that I've come to think of it is that the claims
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`essentially require application and visualization. In the
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`context of PCR, I think that's an easier way and clearer way
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`to think of the claim terms under the broadest reasonable
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`interpretation of the term detect, which again is broader
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`than their experts have used, and what a lot of people would
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`use in the field, it essentially requires amplification and
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`visualization.
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`JUDGE GREEN: So, it could be when you repeat
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`that reaction and it may not result.
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`MR. GARDELLA: Exactly. And if it's there, if
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`it's part of what was visualized in the gel, in the band,
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`then it's -- we’ve met the claim language, according to the
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`Patent Owner's theory and thus the court in PRI.
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`JUDGE GREEN: Thank you.
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`JUDGE PRATS: In a strict sense, though, did
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`Kazakov actually, in using the dictionary definition that
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`Dr. Evans is advancing, did Kazakov strictly discover,
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`determine the existence, presence or fact of
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`paternally-inherited nucleic acid? He never said that it's
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`there, right?
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`MR. GARDELLA: Yeah, he wasn't able to determine
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`it with certainty. So if one uses the term detect, as many
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`scientists would, and -- and there are a bunch of different
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`synonyms that are implicated by your question -- it is the
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`case that if you construe the term detect as required in the
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`(indiscernible) you’re identifying the yes/no, it's fetal for
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`sure that's in here.
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`Well, really, let me rephrase it slightly. The
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`direct answer to your question more properly is this, that
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`the Patent Owner is advocating that you have to be able to
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`distinguish the two, but your question, I think, is the much
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`better one. Did Kazakov detect under even this discover or
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`determine the presence or fact of, and the answer to that is
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`yes. And the reason is the -- at least a portion, in all
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`likelihood the vast majority of what you see, if not the
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`entirety, of what you see visualized in Kazakov's -- excuse
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`me, Mansfield's gel was paternally-inherited nucleic acid.
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`But in Kazakov, at least a portion of it was. So a portion
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`of the reaction product that was visualized and seen in that
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`gel is, without question, paternally-inherited fetal nucleic
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`acid. What the exact percentage is, we don't know.
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`So that is where the rubber would meet the road.
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`Would detect require you to know how much of that visualized
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`band is attributable to paternally-inherited fetal nucleic
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`acid.
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`JUDGE PRATS: Well we know some is, is the best
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`-- what we're saying. Some percentage say maybe 3.9 to maybe
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`10 percent that signal comes from -- comes from the fetal.
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`MR. GARDELLA: Correct. And it may not be quite
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`that straightforward given the primers that were used. But
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`given that alleles are essentially evenly spread throughout
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`the genome, I think that's a fair estimation.
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`JUDGE PRATS: And that would be at both gels,
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`Figure 1 and Figure 2 of Kazakov?
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`MR. GARDELLA: Correct, yes. B1/C2 and Tc65.
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`JUDGE PRATS: There is the idea, though, that
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`some of the primer wouldn't -- because fetal nucleic acid
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`might be too small, at least maybe the B1 and C2 primer
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`wouldn't give a whole lot of signal.
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`MR. GARDELLA: You know, that -- with regard to
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`size, it is important to remember that fetal nucleic acid
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`exists in a distribution. It is not a step function that
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`everything exists at a certain base parasize.
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`Dr. Lo's testimony was that anything -- he tested
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`for anything below 300. That's consistent with B1/C2 and
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`Tc65, I believe. At the end of the day, it is the case that
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`shortness of fragment could cause at least some of that
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`distribution of cell-free nucleic acid to not be amplified,
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`because it is too short. But again, it's just a question of
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`relative amount, not a question of whether it happened.
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`JUDGE PRATS: Thank you.
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`JUDGE GREEN: And then, what was the question
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`before I let you guys -- I'm sorry, the last question.
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`MR. GARDELLA: Oh, no, I prefer to answer your
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`questions than go through my slides.
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`JUDGE GREEN: What is the status of the challenge
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`of 102(a) or below? I notice you didn't respond to it in
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`your reply.
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`MR. GARDELLA: So as to that, we are not
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`advocating the -- either Lo under 102(a). The evidence that
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`was put forward, we thought that in the scheme of things, was
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`sufficient to cause us to just push the remainder of the
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`arguments forward. And while we do not concede that their
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`evidence is sufficient to remove it as prior art, we no
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`longer contest it for purposes of this proceeding. And we
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`think it's ample and sufficient to rely upon Kazakov and
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`Simpson plus Kazakov.
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`JUDGE GREEN: So when we reach our final
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`decision, we don't need to reach that portion of the
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`challenges?
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`MR. GARDELLA: That is what we're advocating,
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`correct.
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`JUDGE GREEN: Thank you. Thank you.
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`MR. GARDELLA: It is unnecessary.
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`JUDGE GREEN: Thank you.
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`MR. GARDELLA: So again, where we left off before
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`this couple questions was amplification and visualization,
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`which is essentially how I think of the claimed technique.
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`Let's now cover the first slide, please.
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`SmithKline Beecham stands for the proposition
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`that the proper inherency analysis under controlling Federal
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`Circuit law does not require a 100 percent certainty that Dr.
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`Kazakov back in the early 1990s in fact in his particular
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`experiment actually amplified and detected
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`paternally-inherited fetal nucleic acid. Now we think that
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`it is almost certainly true, by the way, but that's not the
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`standard. The standard is, is that the natural and ordinary
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`result of their experimentation.
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`So to contrast that or rather would it be an
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`exceptional result or would you have to take exceptional
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`steps or extraordinary measures to cause the prior art method
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`to result in the amplification and visualization of the
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`paternally-inherited fetal nucleic acid? That is the
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`standard.
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`We submit that the Patent Owner's case is
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`entirely or almost entirely directed, at least in their
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`response, to the theory that the relevant question is, is
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`there a hundred percent certainty that Kazakov himself, in
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`that particular experiment, actually amplified and detected
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`fetal nucleic acids. That is not the question. The question
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`is rather, taking that test, is the ordinary outcome of that
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`experiment, the amplification and visualization of
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`paternally-inherited fetal nucleic acid.
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`Next slide, please?
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`JUDGE GREEN: What about Patent Owner's argument
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`that the experiments were not an exact duplicate of what
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`occurred in the Kazakov records?
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`MR. GARDELLA: You're referring to Mansfield?
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`JUDGE GREEN: Yes.
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`MR. GARDELLA: So the logic flow diagram, the
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`analysis, we submit should flow like this. You look at
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`Kazakov's standing alone and ask would a skilled artisan
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`understand that the natural and ordinary result of that would
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`be the amplification and detection of paternally-inherited
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`fetal nucleic acid or amplification and visualization, the
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`way I refer to it shorthand.
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`Deininger, Fisk, Nussbaum, Vasioukhin --
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`again, Nussbaum is the chief of the Division of Genomic
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`Medicine at UCSF. Vasioukhin is the co-inventor on the final
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`reference cited in the background section of the '540 Patent.
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`They both say that they just -- just they can't envision a
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`circumstance in which if you run this experiment that you
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`wouldn't, to Judge Prats' point, you wouldn't amplify at
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`least some and visualize at least some. That is sufficient
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`standing alone.
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`Cases IPR2012-00022 and IPR2013-00250
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`Now Kazakov, excuse me, Mansfield. This is
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`offered as corroborating evidence. So because we, you know,
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`we happen to have access to the techniques, especially
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`because we clearly believed and were certain that it was
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`true, why not run a test and show it? We did so.
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`Mansfield ran the test, which is simply an
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`example of what Vasioukhin, Nussbaum, Kazakov himself
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`testified to, which is if you run this, you will, in fact, in
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`Dr. Nussbaum's phraseology, "It's hard to even envision a
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`universe in which you wouldn't amplify and visualize at least
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`some." So Dr. Mansfield is offered for that.
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`Now with regard -- I think what you're referring
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`to is these failures that we’ve heard such about. So on
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`this, I think we just have a failure to communicate on the
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`fundamental scientific principles. There were no failures.
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`There was one Tc65 experiment that was run that was
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`essentially what you would call kind of a redo of Kazakov.
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`And then there was another experiment done to determine,
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`okay, of those reaction products, which of -- let's see if
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`there are Y-specific reaction products in there. That's a
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`follow-on test. In those follow-on tests, there was a failed
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`control. And that is not uncommon. That's just, you know,
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`freshman laboratory science. When you have a failed control,
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`you pitch the experiment. That's the Tc65 failure that
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`you've heard about.
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`With regard to B1/C2, it's a -- it is an
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`intra-Alu primer, so it's a short band. So just to do that
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`second round, to just -- for this double-check to determine,
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`hey, were there actually Y-specific sequences in there, which
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`would be relevant, for instance, for Claim 5, designing
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`Y-primers for the B1/C2 would be pretty difficult because
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`it's an intra-Alu primer. So that being pretty difficult --
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`and again, it's not required for the anticipation analysis,
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`it made a lot of sense to us to do two Tc65s. It's much
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`easier to find Y-specific primers to do that double-checking
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`confirmation that, yes, there were in fact Y-specific
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`sequences amplified. So the B1/C2 was just not done by
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`Professor Mansfield for that reason.
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`So I don't understand the argument there were
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`failures. That is what happened. And perhaps we'll hear
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`during opposing counsel's time why they feel that there are
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`failures, but we do not believe there were any internal
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`failures. There was one Tc65 experiment done, and it was
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`successful.
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`JUDGE GREEN: I think one part of me that senses
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`that reaction at issue and therefore we can't consider it at
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`all, because there was a range of (indiscernible) immediate
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`concentration.
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`MR. GARDELLA: So let's go to Slide 4. So this
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`goes to do you have to have -- what sort of detail do you
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`have to have in a prior art reference in order to be
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`enabling, sufficiently enabling for purposes of inherency?
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`The replication -- kind of implicit in that argument is that,
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`well, there's just not enough detail in Kazakov. Also,
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`implicit in that argument, by the way, is that what's
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`relevant is whether Kazakov himself, in fact, in the early
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`1990s reproduced it. That's not the question. The relevant
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`question under SmithKline Beecham is, is the natural result
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`flowing from it, the claimed subject matter amplification and
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`JUDGE PRATS: If I could interject on that point,
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`there are some cases that say -- you're proposing an almost
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`certainty standard as submitted in your brief, but there are
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`some cases that say you have to have -- absolutely be
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`certain, and that's the standard for inherency. Now, how do
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`we -- why should we follow your cases as opposed to these
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`other cases? I can -- the one I'm seeing here is Agilent
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`versus Affymetrix, but there's a number of cases that say
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`absolute certainty is required for inherency, and you're
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`saying, well, maybe it's not. What's the difference in that
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`case?
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`MR. GARDELLA: Well, at SmithKline -- if you can
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`go back to the SmithKline slide, Slide 1. So 2005 Chief
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`Judge Rader, the specific issue was addressed. You know,
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`every case involves a different circumstance. SmithKline
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`Beecham involved a circumstance where it was alleged -- and
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`this we think is quiet germane to our situation. The case
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`you're referring to, I would suspect is not in this type of
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`situation where you have a prior art process, which if you
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`run it in an unusual way or, let's say, you just mess up the
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`experiment, there is human or experimental error, it might
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`not result in the claimed subject matter.
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`The context of those other decisions are quite
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`different. The way I understand the body of case law to
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`which you're referring, Judge Prats, is that it has to be
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`what happens. It can't just be a maybe. So, in other words,
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`if there's four outcomes that can happen from a prior art
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`process of any nature, it's not sufficient that the claimed
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`subject matter be one of those four.
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`Here we're talking about something different.
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`Here we're talking about chemistry, biology, an experiment,
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`which by its very nature can -- there can be an experimental
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`error such as pipetting error. So in the context of a
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`situation like this where you have, yes, the natural and
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`successful -- or natural result of the successful experiment.
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`And again, in context everyone knows that an experiment like
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`this is not always successful because we're human.
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`In this context, that specific argument was
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`raised by the Patent Owner that well, you don't know for
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`sure. It's possible that this other reaction product
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`Cases IPR2012-00022 and IPR2013-00250
`Patent 6,258,540
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`resulted from that prior art experiment. Chief Judge Rader
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`said no. That is too exacting a standard. What we're
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`getting at here in this type of situation, what we care about
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`is, is this what normally results from it or is rather it an
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`exceptional result?
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`So this is not a circumstance -- for instance, I
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`guess I could envision various chemical reactions which have
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`the equilibrium and perhaps several different potential
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`reaction products. The case law that you're referring to
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`would be apropos for those situations here properly run,
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`unless something unusual happens, like a human error or
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`equipment error, we know what's going to happen here. Again,
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`like Dr. Nussbaum and Dr. Vasioukhin said, they can't even
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`conceive of an universe in which in the ordinary course you
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`wouldn't get amplification and visualization of
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`paternally-inherited fetal nucleic acid.
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`So I submit that a close reading of the cases
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`show that SmithKline Beecham is clearly controlling. And
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`logic would dictate that as well. Because under the Patent
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`Owner's standard, you could never have anticipation in any
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`sort of -- in any area of science like this, because it's
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`hard for me to envision in a biological arts any experiment
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`which with 100 percent certainty must have been successful,
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`that it couldn't possibly have been due to some experimental
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`or equipment error.
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`Cases IPR2012-00022 and IPR2013-00250
`Patent 6,258,540
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`So we submitted, the Patent Owner standard is
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`just illogical and would lead to the anomalous result that
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`you could essentially never have inherent participation. And
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`that is precisely what Chief Judge Rader was observing.
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`That's just -- that's just not right. What we care about is,
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`is it the normal result when it's done properly? So just
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`like Noemi Corbetta, Dr. Lo's lab assistant said, "Everyone
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`knows that when it's a failed experiment, you just pitch it
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`and you do it again."
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`JUDGE PRATS: Thank you.
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`MR. GARDELLA: So I have a couple minutes left.
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`Any other questions before we continue for a few minutes?
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`JUDGE GREEN: Actually, I think we've kind of
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`talked a lot about the inherency. I would like to go a
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`little bit about the obviousness objection.
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`MR. GARDELLA: Yes.
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`JUDGE GREEN: Especially to the extent that it’s
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`based on Simpson. We have one line of Simpson. And Simpson
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`is really about the self-reporting and looking at the fetal
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`fraction, the fetal DNA themselves.
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`Is that one sentence that Lo -- and I'm looking
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`at page 1230 of Simpson. Lo held that was the first to show
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`that fetal cell or at least fetal DNA was indeed present in
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`the blood. Is that enough combined with Kazakov to render
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`obvious to method when people were actually at the time and
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`Cases IPR2012-00022 and IPR2013-00250
`Patent 6,258,540
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`period to be looking at the DNA cells and not the DNA serum
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`of the plasma which the Patent Owner argues?
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`MR. GARDELLA: I am glad you raised this. And
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`may I go a little bit beyond my 30 minutes and reserve a
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`little less time?
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`JUDGE GREEN: We’re asking a lot of questions, so
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`we can go a little bit beyond.
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`MR. GARDELLA: Okay. Yeah, obviously, I'll yield
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`the carryover time. So, good question. And it's important
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`to note that Simpson and Kazakov applies universally. This
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`is the common denominator in the case. Simpson and Kazakov
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`applies even if you accept Patent Owner's claim construction,
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`which again is narrower than the Phillips construction that's
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`been adopted in district court. Even if you accept that and
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`even if you enter the amended claims, Simpson plus Kazakov
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`applies across the board.
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`Now, Simpson plus Kazakov properly -- let's get
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`Slide 5 up if we could? It is a very simple substitution as
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`Your Honor correctly indicated in the decision. We're
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`talking about taking the Simpson method -- and Simpson's body
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`of literature was cited in the back in the Section on the
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`'540 Patent too. Just taking the method disclosed in
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`Simpson, which is PCR on the cellular fraction and
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`substituting in a different starting material. That's it.
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`Cases IPR2012-00022 and IPR2013-00250
`Patent 6,258,540
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`So for purposes of the prima facie case -- and
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`here's the important point, I think, as to this generalized
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`belief we've heard so much about. There was a generalized
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`belief in the art, at least on the prenatal side, not on the
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`molecular diagnostic side, not with folks like Professor
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`Vasioukhin. Anyone on the molecular diagnostic side that
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`suspected this is -- that's my take on the evidence in totum.
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`People in the prenatal space were skeptical, people in the
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`molecular diagnostic space like Professor Vasioukhin were
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`not.
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`But the key thing is, a skilled artisan who has
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`skill probably in both of those fields, this art is cited in
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`the background section of the patent, and Dr. Lo himself in
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`his 1997 paper said it was this work in the molecular
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`diagnostics field which prompted this investigation. So this
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`is part of the skill in the art. The question is, in the
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`inventor's work room you have two things. You don't have
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`that generalized belief. You have Simpson and Kazakov. You
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`have Simpson and you have Kazakov.
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`You have Simpson, which says, it's known to do
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`standard PCR techniques that were around back in the 1980s on
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`cellular fractions, you know, to test for, you know, fetal
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`nucleic acid. You take that, consider further the fact that
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`Simpson teaches that trophoblasts and lymphocytes would
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`probably be the sources, are good sources, and also proposes
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`Cases IPR2012-00022 and IPR2013-00250
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`testing for gender, RhD and fetal aneuploidy, very similar to
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`the Lo patent.
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`Most importantly, though, Simpson says, and now
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`I'm quoting from the bottom left of page 1230, that it says
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`he credits Lo as being the first to show that fetal cells or
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`at least fetal DNA existed in the maternal blood. So what is
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`he suggesting there? Well, it might not be cellular. So
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`that's one piece on the inventor's workshop wall.
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`The other piece is Simpson -- I'm sorry, is
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`Kazakov. And Kazakov clearly states -- and let's go here to
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`-- the Kazakov quote, if you could up in the -- the tail end
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`of the article.
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`That there can be only two sources. What's not
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`on this slide, which is very interesting, I repeatedly in the
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`Kazakov article -- he provides a road map and says it's of
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`great clinical interest and practical and theoretical
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`interest he said at one point in th
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