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Ariosa Diagnostics, Inc. v. Illumina, Inc.

Docket IPR2014-01093, Patent Trial and Appeal Board (July 2, 2014)
Lora Green, Tina Hulse, Toni Scheiner, Zhenyu Yang, presiding
Case TypeInter Partes Review
Patent
7955794
Petitioner Ariosa Diagnostics, Inc.
Patent Owner Illumina, Inc.
Assignee NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
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83 Order: Decision Denying Petitioners Request for Rehearing

Document IPR2014-01093, No. 83 Order - Decision Denying Petitioners Request for Rehearing (P.T.A.B. Sep. 29, 2016)
Indeed, in view of the Board’s new application of Dynamic Drinkware, good cause exists for the Board to consider evidence that Ariosa meets its newly articulated legal requirement.
Petitioner asserts that it identified for the Board multiple cases and legislative history expressly finding that Wertheim does not apply to published patent applications.
In Appendix A to Petitioner’s Request for Rehearing, Petitioner’s declarant, Dr. Cantor, points to where support for claim 1 of the Fan published patent application may be found in the ’810 provisional.
p. 21(47): (1) Although we have not yet determined the minimal amount of total RNA required for each experiment, this method has the potential to detect alternative splicing events from a single cell because of signal amplification of annealed oligos after poly(A)+ selection ... (4) The poly(A)+ selection step eliminates excess oligos as well as those that are nonspecifically hybridized to RNA (in the presence of fRNAs and tRNAs as competitors) or stick to the container surface.
We will then carry out the ligation reaction at room temperature (or higher) using T4 DNA ligase to link the upstream and the downstream oligos that are bridged together through spliced mRNA.
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81 Order: Decision PO Motion to Terminate Reexamination

Document IPR2014-01093, No. 81 Order - Decision PO Motion to Terminate Reexamination (P.T.A.B. May. 24, 2016)
Patent Owner also cites to the legislative history of the AIA,11 noting: Congress intended for serial invalidity attacks that unduly multiply the proceedings to be terminated under §§ 315(d) & 325(d) and 37 C.F.R. § 42.122(a).
Petitioner asserts further that Roche acquired Ariosa after this proceeding was instituted, and, thus, on April 24, 2015, filed a petition in IPR2015-01091 that included grounds over Straus, as well as over a new reference, Shuber.
The statute expressly contemplates denial of review when the art applied in two petitions is different, but the arguments are “substantially the same.” Id. Petitioner raised patentability over the work of Straus initially in the instant proceeding, and then again in IPR2015-01091.
Petitioner does not appear to have provided an explanation as to why it could not have presented its invalidity grounds challenging the ’794 patent in its requests for ex parte reexamination in the petition filed in the instant proceeding.
Petitioner has provided no reason why it waited until December 2015 and January 2016 to file its requests for ex parte reexamination, using variations of art it cited in both the instant proceeding, and IPR2015-01091.
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69 Final Decision: Final Written Decision 35 USC 318a and 37 CFR 4273

Document IPR2014-01093, No. 69 Final Decision - Final Written Decision 35 USC 318a and 37 CFR 4273 (P.T.A.B. Jan. 7, 2016)
We determined that the information presented in the Petition and the Preliminary Response demonstrated that there was a reasonable likelihood that Petitioner would prevail in challenging claims 1–22 as unpatentable under 35 U.S.C. § 102.
According to Patent Owner, “[c]onclusory assertions that the ’810 application discloses certain claim elements is not the same as showing that the disclosures made in the Fan Pub are supported by the ’810 application.” Id. at 12.
The Court of Appeals for the Federal Circuit affirmed the Board’s determination that the petitioner had failed to demonstrate that the ’555 patent was entitled to the filing date of the ’490 provisional.
In doing so, the court noted that the Board properly placed the burden on the petitioner “to prove that the prior art [’555] patent was entitled to the filing date of its provisional application.” Id. at 1379.
Thus, as Dynamic Drinkware makes clear, the claims of the patent document must be supported by the earlier filed application to which priority is being sought, in compliance with 35 U.S.C. § 112, first paragraph.
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68 Order: Order Conduct of the Proceeding

Document IPR2014-01093, No. 68 Order - Order Conduct of the Proceeding (P.T.A.B. Jan. 7, 2016)
A conference was held on Tuesday, January 5, 2016, among counsel for the parties and Judges Green, Yang, and Hulse.
Patent Owner argued that Petitioner was engaging in gamesmanship by waiting until a few weeks before the final decision in this proceeding needed to be issued before filing its requests for ex parte reexamination.
For example, Petitioner noted that one of the reexaminations raised obviousness over the combination of Fan and Lizardi, upon which we declined to institute trial in the instant proceeding.
Petitioner stated also that it was not engaging in improper gamesmanship as we declined to institute trial in IPR2015-01091 in November, and it took a certain amount of time to prepare the requests for ex parte reexamination.
In view of the complexity of this issue, we authorize Petitioner to file a motion to terminate the ex parte reexaminations challenging the ’794 patent.
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65 Notice: Record of Oral Hearing

Document IPR2014-01093, No. 65 Notice - Record of Oral Hearing (P.T.A.B. Sep. 24, 2015)
And our positio n, Your Honors, is that a person of ordinary skill in the art reading this -- but not just this because there's references to genomewide, large scale, CD44 with a thousand different isoforms that they would understand that what we were talking about is mor e than a hundred probes.
What I was referring to was Your Honors' citation of the case, and I recognize the facts are somewhat different and I'm not trying to equate them in terms of the facts, but to the extent the court was talking about sort of the natural resul t flowing from the operation sought in the prior art, which was the Apotext case, that's really what I was told to lean on, which I think really sort of says, you know, look at what the natural result of doing the experiment with 50 to 100 genes in the con text of what you're being instructed to do by the prior art which is to monitor the alternative splices.
And so what we did is we went and we actually, you know, went out and got Dr. Cantor who's one of the really foremost scientists in the world on splice isoforms and this type of technology and he basically -- and, of course, Dr. Ward had already said this in his deposition, but what he said is a person of ordin ary skill in the art reading Case IPR2014-01093 U.S. Patent 7,955,794 this -- and, again, in response to their argument that, you know, singular is not enough to show identicality.
Figure 2d does not disclose that the sample is attached to a first solid support as required by claim 1, step A. And Dr. Cantor conceded this in his deposition, and the testimony is at Exhibit 2045 at page 272, lines 2 through 17.
And, moreover, if you look at page 22 of the '810 application, it expressly states that all of the exper iments involving hybridization to the bead arrays including imaging and data analysis in this R21 phase will be conducted by Dr. Jian -Bing Fan at Illumina.
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48 Notice: Order Trial Hearing 37 CFR 4270

Document IPR2014-01093, No. 48 Notice - Order Trial Hearing 37 CFR 4270 (P.T.A.B. Jul. 14, 2015)
Patent Owner had no objection to moving the hearing, but lead counsel for Petitioner, Mr. Gardella, stated that he will be unavailable.
The Board asks the parties to confine demonstrative exhibit objections to those identifying egregious violations that are prejudicial to the administration of justice.
The parties are directed to St. Jude Medical, Cardiology Division, Inc. v. The Board of Regents of the University of Michigan, IPR2013-00041 (PTAB January 27, 2014) (Paper 65), for guidance regarding the appropriate content of demonstrative exhibits.
The parties are reminded that the presenter must identify clearly and specifically each demonstrative exhibit (e.g., by slide or screen number) referenced during the hearing to ensure the clarity and accuracy of the reporter’s transcript.
Accordingly, it is ORDERED that oral arguments in this proceeding shall take place beginning at 4:00 PM Pacific Time on August 24, 2015, at Santa Clara University.
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41 Notice: ORDER Petitioners Motion for Pro Hac Vice Admission of Mr Gunther

Document IPR2014-01093, No. 41 Notice - ORDER Petitioners Motion for Pro Hac Vice Admission of Mr Gunther (P.T.A.B. May. 28, 2015)
Petitioner’s Motion for Pro Hac Vice Admission of Robert J. Gunther, Jr.
Case IPR2014-01093 Patent 7,955,794 B2 Petitioner has filed an unopposed motion for pro hac vice admission of Robert J. Gunther, Jr. in this proceeding.
The motion is supported by a declaration of Mr. Gunther.
The Board has reviewed the submissions and determined that the requirements of 37 C.F.R. § 42.10 have been met and there is good cause to admit Mr. Gunther pro hac vice.
It is, therefore, ORDERED that Petitioner’s motion for admission of Robert J. Gunther, Jr. pro hac vice is granted.
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