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Ariosa Diagnostics, Inc. v. The Board of Trustees of the Leland Stanford Junior Uni...

Docket IPR2013-00308, Patent Trial and Appeal Board (May 24, 2013)
Lora Green, Rama Elluru, Scott Kamholz, Toni Scheiner, presiding
Case TypeInter Partes Review
Patent8296076
Petitioner Ariosa Diagnostics, Inc.
Patent Owner The Board of Trustees of the Leland Stanford Junior University
Assignee NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
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Ariosa Diagnostics v. Verinata Health, Inc.

Docket IPR2013-00276, Patent Trial and Appeal Board (May 10, 2013)
Francisco Prats, Lora Green, Michael Tierney, Rama Elluru, Toni Scheiner, presiding
Case TypeInter Partes Review
Patent8318430
Petitioner Ariosa Diagnostics
Patent Owner Verinata Health, Inc.
Assignee ILLUMINA, INC.
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Ariosa Diagnostics v. Verinata Health, Inc.

Docket IPR2013-00277, Patent Trial and Appeal Board (May 10, 2013)
Francisco Prats, Lora Green, Michael Tierney, Rama Elluru, Toni Scheiner, presiding
Case TypeInter Partes Review
Patent8318430
Patent Owner Verinata Health, Inc.
Petitioner Ariosa Diagnostics
Assignee ILLUMINA, INC.
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64 Order: DECISION ON REMAND

Document IPR2013-00276, No. 64 Order - DECISION ON REMAND (P.T.A.B. Aug. 15, 2016)
ordinary skill in the art would necessarily have made in order to combine the disparate elements.” ’276 Final Decision, 16.5 We concluded, therefore, that the Petition and accompanying Declarations failed to provide “an ‘articulated reason[] with some rational underpinning to support the legal conclusion of obviousness.’” Id. (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
As to Exhibit 1010, we noted that we were not “persuaded by the belated attempt in the Reply and Dr. Morton’s Second Declaration to bolster Petitioner’s initial obviousness challenge by reference to technical advances, e.g., massively parallel sequencing (“MPS”), that one of ordinary skill in the art would have been aware of ‘in the years between the filing of Dhallan and the earliest claimed priority date.’” Id. at 17.
The Federal Circuit noted that our language in the Final Written Decision, “on its face,” supported Petitioner’s assertion that we declined to consider Exhibit 1010 as evidence of what the understanding of the ordinary artisan would have been at the relevant time period “simply because the brochure had not been identified at the petition stage as one of the pieces of prior art defining a combination for obviousness.” Id.
Professors Nussbaum and Morton explain in their declarations that a skilled artisan would also have readily understood that Shoemaker’s methods for determining the presence of fetal abnormalities could be carried out with the use of cell-free DNA described in Dhallan and the multiplexed detection techniques taught in Binladen.
The inadequacy of the obviousness analysis in the Petition and accompanying Declarations is readily apparent when the disparate elements of the references are scrutinized closely, as in Patent Owner’s response, and we decline to search through the record and piece together those teachings that might support Petitioner’s position.
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62 Order: DECISION ON REMAND

Document IPR2013-00277, No. 62 Order - DECISION ON REMAND (P.T.A.B. Aug. 15, 2016)
ordinary skill in the art would necessarily have made in order to combine the disparate elements.” ’276 Final Decision, 16.5 We concluded, therefore, that the Petition and accompanying Declarations failed to provide “an ‘articulated reason[] with some rational underpinning to support the legal conclusion of obviousness.’” Id. (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
As to Exhibit 1010, we noted that we were not “persuaded by the belated attempt in the Reply and Dr. Morton’s Second Declaration to bolster Petitioner’s initial obviousness challenge by reference to technical advances, e.g., massively parallel sequencing (“MPS”), that one of ordinary skill in the art would have been aware of ‘in the years between the filing of Dhallan and the earliest claimed priority date.’” Id. at 17.
The Federal Circuit noted that our language in the Final Written Decision, “on its face,” supported Petitioner’s assertion that we declined to consider Exhibit 1010 as evidence of what the understanding of the ordinary artisan would have been at the relevant time period “simply because the brochure had not been identified at the petition stage as one of the pieces of prior art defining a combination for obviousness.” Id.
Professors Nussbaum and Morton explain in their declarations that a skilled artisan would also have readily understood that Shoemaker’s methods for determining the presence of fetal abnormalities could be carried out with the use of cell-free DNA described in Dhallan and the multiplexed detection techniques taught in Binladen.
The inadequacy of the obviousness analysis in the Petition and accompanying Declarations is readily apparent when the disparate elements of the references are scrutinized closely, as in Patent Owner’s response, and we decline to search through the record and piece together those teachings that might support Petitioner’s position.
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63 Order: Decision PO Motion to Terminate Reexamination

Document IPR2013-00276, No. 63 Order - Decision PO Motion to Terminate Reexamination (P.T.A.B. May. 24, 2016)
We determined that Petitioner had established a reasonable likelihood that claims 19–30 were rendered obvious by the combination of Shoemaker, Dhallen, and Binladen, and instituted trial on that challenge.
We concluded in both proceedings that Petitioner had failed to establish by a preponderance of the evidence that the challenged claims were rendered obvious by the combination of Shoemaker, Dhallen, and Binladen.
Petitioner responds that § 325(d) of the America Invents Act states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Paper 57, 2.
In contrast, the ground instituted by the Board in this IPR involved Shoemaker’s sequencing techniques being modified only to include the use of extracellular DNA (from Dhallan I) and multiplexing samples from multiple patients (from Binladen).
In addition, Illumina 2008 was of record and the subject of the remand from the Court of Appeals for the Federal Circuit in both IPR2013-00276 and IPR2013-00277, even though not explicitly relied Cases IPR2013-00276 and IPR2013-00277 Patent 8,318,430 B2 upon in the challenge on which trials were instituted.
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62 Order: EXPUNGED

Document IPR2013-00276, No. 62 Order - EXPUNGED (P.T.A.B. May. 24, 2016)
BLANK BLANKBLANKBLANK
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61 Order: Decision PO Motion to Terminate Reexamination

Document IPR2013-00277, No. 61 Order - Decision PO Motion to Terminate Reexamination (P.T.A.B. May. 24, 2016)

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