(admitted pro hac vice) (admitted pro hac vice) Jonathan E. Bachand

Transcription

1 Filed July 1, 2015 On behalf of Patent Owner Illumina, Inc. by: Kerry S. Taylor Adrian C. Percer William R. Zimmerman (admitted pro hac vice) Edward R. Reines Michael L. Fuller (admitted pro hac vice) Jonathan E. Bachand KNOBBE, MARTENS, OLSON & Derek C. Walter BEAR, LLP (admitted pro hac vice) 2040 Main Street, 14 th Floor Irvine, CA WEIL, GOTSHAL & MANGES, LLP Tel.: (949) Redwood Shores Parkway Fax: (949) Redwood Shores, CA Tel.: (650) Fax: (650) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD ARIOSA DIAGNOSTICS, INC. Petitioner, v. ILLUMINA, INC. Patent Owner. IPR U.S. Patent 7,955,794 B2 ILLUMINA OBJECTIONS TO ADMISSIBILITY OF EVIDENCE SERVED WITH ARIOSA REPLY TO ILLUMINA PATENT OWNER RESPONSE

2 Pursuant to 37 C.F.R (b)(1), Patent Owner Illumina, Inc. ( Illumina ) hereby timely files its objections to the admissibility of evidence served with the June 24, 2015 Reply of Ariosa Diagnostics, Inc. ( Ariosa ) to Illumina s Patent Owner Response to Ariosa s Petition Alternative Splicing Definition 1 Relevance (FRE 401, 403) This reference is not relevant to any issue in this proceeding (e.g., it is not prior art, and it does not provide any disclosure of the number of probes used in the 810 application) and is not cited to or relied upon in Ariosa s Reply. Hearsay (FRE 802) The exhibit includes out-of-court statements offered for the truth of the matter purportedly asserted. Authentication (FRE 901) Ariosa offers no evidence that this exhibit is what it claims to be. 1

3 1036 Alternative Splicing Definition 2 Relevance, Prejudicial (FRE 401, 402, 403) This reference is not relevant to any issue in this proceeding (e.g., it is not prior art, and it does not provide any disclosure of the number of probes used in the 810 application) and is not cited to or relied upon in Ariosa s Reply. Hearsay (FRE 802) The exhibit includes out-of-court statements offered for the truth of the matter purportedly asserted. Authentication (FRE 901) Ariosa offers no evidence that this exhibit is what it claims to be Alternative Splicing Definition 3 Relevance, Prejudicial (FRE 401, 402, 403) This reference is not relevant to any issue in this proceeding (e.g., it is not prior art, and it does not provide any disclosure of the number of probes used in the 810 application) and is not cited to or relied upon in Ariosa s Reply. Hearsay (FRE 802) The exhibit includes out-of-court statements offered for the truth of the matter purportedly asserted. Authentication (FRE 901) Ariosa offers no evidence that this exhibit is what it claims to be. 2

4 Provisional Application 60/297,609 filed June 11, 2001 (pages 0-93) Fig. 2b to 810 Fig 1b comparison Fig 1b to 810 Fig 2b comparison Relevance, Misleading (FRE 401, 402, 403) This reference is not relevant to any issue in this proceeding (e.g., it is not prior art, and it does not provide any teaching regarding how one of ordinary skill in the art would understand the disclosures in the 810 application). This reference also is misleading because it is asserted as defining the scope of the claims. Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. 3

5 Fig 2b to 810 Fig 4 comparison Fig 1b to 810 Fig 3 comparison Fig. 4 to 810 Fig 2b comparison Fig. 6 to 810 Fig 2d comparison Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. 4

6 Declaration of Dr. Charles Cantor Relevance, Misleading (FRE 106, 401, 402, 403): 19 is not relevant to any issue raised in the Petition and improperly mischaracterizes the teachings of the 810 application. 22 is not relevant to any issue raised in the Petition and improperly mischaracterizes the teachings of the 810 application are not relevant to any issue raised in the Petition or Patent Owner s Response and do not support the contention for which they are cited. 30 is not relevant to any issue raised in the Petition. 31 is not relevant to any issue raised in the Petition and does not support the contention for which it is cited. 32 is not relevant to any issue raised in the Petition. 33 is not relevant to any issue raised in the Petition and improperly mischaracterizes the teachings of the 810 application. 34 is not relevant to any issue raised in the Petition and improperly mischaracterizes the teachings of the 810 application. 35 is not relevant to any issue raised in the Petition and improperly mischaracterizes the teachings of the 810 application and Dr. Kramer s testimony. 5

7 36-38, 40 are not relevant to any issue raised in the Petition, improperly mischaracterize the teachings of the 810 application, and are inconsistent with Dr. Ward s testimony. 39 is misleading, incomplete, and irrelevant are incomplete, their use in this context is misleading, they are not relevant to any issue raised in the Petition or IPR, and they improperly mischaracterize the teachings of the 810 application and Dr. Kramer s testimony are not relevant to any issue raised in the Petition, and improperly mischaracterize the teachings of the 810 application, Dr. Kramer s testimony, and Dr. Fu s testimony are not relevant to any issue raised in the Petition, and improperly mischaracterize the teachings of the 810 application, Illumina s position, and Dr. Kramer s testimony. 54 is not relevant to any issue raised in the Petition, and improperly mischaracterizes the teachings of the 810 application, Dr. Kramer s testimony, and Dr. Fu s testimony. 55 is not relevant to any issue raised in the Petition, and improperly mischaracterizes the teachings of the 810 application, Dr. Kramer s testimony, and Dr. Ward s testimony are not relevant to any issue raised in the Petition, and improperly mischaracterize the teachings of the 810 application and Dr. Fu s testimony. 6

8 58 is not relevant to any issue raised in the Petition and improperly mischaracterizes the teachings of the 810 application and Dr. Kramer s testimony are not relevant to any issue raised in the Petition, and improperly mischaracterize the teachings of the 810 application and Dr. Kramer s testimony are not relevant to any issue raised in the Petition and improperly mischaracterize the teachings of the 810 application. 63 is not relevant to any issue raised in the Petition are not relevant to any issue raised in the Petition, and improperly mischaracterize the teachings of the 810 application, Dr. Kramer s testimony, Dr. Fu s testimony, and Dr. Ward s testimony. 66 is not relevant to any issue raised in the Petition, and improperly mischaracterizes the teachings of the 810 application, Dr. Kramer s testimony, and Dr. Ward s testimony are not relevant to any issue raised in the Petition, and improperly mischaracterize the teachings of the 810 application, Dr. Kramer s testimony, Dr. Fu s testimony, and Dr. Ward s testimony are not relevant to any issue raised in the Petition. 7

9 72 is not relevant to any issue raised in the Petition. 73 is not relevant to any issue raised in the Petition. Improper Testimony by Expert Witness (FRE 702): are not based on sufficient facts and 31 is not based on sufficient facts and data, and does not reliably apply facts and data using scientific principles. 33 does not reliably apply the cited facts and data 34 is not based on sufficient facts and data, and does not reliably apply facts and data using scientific principles , 40 are not based on sufficient facts and data, and do not reliably apply facts and data are not based on sufficient facts and are not based on sufficient facts and are not based on sufficient facts and 8

10 53 is not based on sufficient facts and data, and does not reliably apply facts and data using scientific principles. 54 is not based on sufficient facts and data, and does not reliably apply facts and data using scientific principles. 55 is not based on sufficient facts and data, and does not reliably apply facts and data using scientific principles are not based on sufficient facts and 58 is not based on sufficient facts and data, and does not reliably apply facts and data using scientific principles are not based on sufficient facts and are not based on sufficient facts and are not based on sufficient facts and 66 is not based on sufficient facts and data, and does not reliably apply facts and data using scientific principles. 9

11 67-69 are not based on sufficient facts and Transcript of Dr. Fred Kramer Deposition Relevance, Misleading (FRE 106, 401, 402, 403) 38:13-39:4 does not establish the understanding of one skilled in the art prior to the filing date of the 794 patent. Also, the testimony is incomplete when taken in isolation, and misleading in the manner in which it is used. 45:25-46:9 The use of this testimony is incomplete and misleading when taken in isolation, making it irrelevant to an issue in the IPR. 51:4-12 This testimony does not appear relevant to an issue in the IPR, is misleading and incomplete when taken in isolation, and is used in a misleading manner. 70:10-21 The use of this testimony is misleading and incomplete when taken in isolation, and is used in a misleading manner. 70:23-74:4 This testimony does not appear relevant to an issue in the IPR, and is used in a misleading manner inconsistent with the testimony of Dr. Fu. 71:20-72:1 and 72:3-13 do not support the 10

12 contention for which they are cited. 73:25-76:6 does not support the contention for which it is cited, and other testimony contradicts this contention. 113:5-12 does not support the contention for which it is cited, and other testimony contradicts this contention. 116:18-117:7 and 117:25-118:9 do not support the contention for which they are cited, and other testimony contradicts this contention. 134:12-136:9 This testimony is misleading and incomplete when taken in isolation, is used in a misleading manner, and does not appear relevant to an issue in the IPR. 137:7-21 The use of this testimony is misleading and incomplete when taken in isolation. 159:19-25 does not support the contention for which it is cited, and other testimony contradicts this contention. Additionally, this testimony does not appear relevant to an issue in the IPR. 161:18-162:5 The use of this testimony is misleading and incomplete when taken in isolation. 206:14-208:23 The use of this testimony is misleading, incomplete, and irrelevant. There are a number of additional requirements of the probe sets of the claim not contained in this questioning. 11

13 226:23-227:11 and 227:25-228:10 are irrelevant as they are not directed to the claim language. 254:22-257:1 This testimony does not appear relevant to an issue in the IPR. 255:23-256:3 does not support the contention for which it is cited, and other testimony contradicts this contention. Additionally, this testimony does not appear relevant to an issue in the IPR. 256:19-257:1 does not support the contention for which it is cited, and other testimony contradicts this contention. Additionally, this testimony does not appear relevant to an issue in the IPR. 272:25-273:7 does not support the contention for which it is cited, and other testimony contradicts this contention. The use of this testimony is also incomplete and misleading when taken in isolation. 303:18-25 does not support the contention for which it is cited, and other testimony contradicts this contention. Best Evidence (Rule 1002) Pages contain extraneous text at lines 1 and 25, obscuring the underlying trancript, and such extraneous text is not present in the original provided by the court reporter 12

14 U.S. Patent 6,913,884 Relevance, Misleading (FRE 401, 402, 403) raised in the Petition, and is being cited to confuse as to the meaning of the term attached as taught in the specification Cantor & Smith, Genomics: The Science and Technology of the Human Genome Project, John Wiley & Sons (1999), excerpt Berg, et al., Hybrid PCR sequencing: sequencing of PCR products using a universal primer, BioTechniques. 17(5): (Nov. 1994) Provisional Application 60/311,271 filed August 9, 2001 Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. Relevance (FRE 401, 402) raised in the Petition or Patent Owner s Response and is not cited to or relied upon in Ariosa s Reply. Relevance, Prejudicial (FRE 401, 402, 403) raised in the Petition, and any potential relevance is outweighed by the potential to cause confusion. 13

15 Request for Certificate of Correction along with Supplemental ADS filed in U.S. Patent 7,955,794 (Application No. 10/177,727) filed on May 29, Petition Decision Dismissing Request for Corrected Patent Application Publication issued in U.S. Application No. 10/177,727 on May 14, 2004 Relevance, Misleading (FRE 106, 401, 402, 403) raised in the Petition. The document also is misleading as being cited with implication that the Certificate of Correction was denied. Relevance, Misleading (FRE 106, 401, 402, 403) raised in the Petition. The document also is misleading as being cited with implication that it was a denial of the Certificate of Correction. 14

16 Respectfully submitted, Dated: July 1, 2015 By: /Kerry Taylor/ Kerry Taylor, Reg. No. 43,947 William R. Zimmerman (admitted pro hac vice) Michael L. Fuller, Reg. No. 36,516 Jonathan E. Bachand, Reg. No. 67,884 KNOBBE, MARTENS, OLSON & BEAR, LLP Adrian C. Percer, Reg. No. 46,986 Edward R. Reines, (admitted pro hac vice) Derek C. Walter (admitted pro hac vice) WEIL, GOTSHAL & MANGES, LLP Attorneys for Patent Owner Illumina, Inc. 15

17 CERTIFICATE OF SERVICE I hereby certify that a true and correct copy of ILLUMINA OBJECTIONS TO ADMISSIBILITY OF EVIDENCE SERVED WITH ARIOSA REPLY TO ILLUMINA OPPOSITION TO PETITION is being served on July 1, 2015, via pursuant to 37 C.F.R. 42.6(e) per agreement of the parties, on counsel for Ariosa Diagnostics, Inc., at the addresses below: Greg Gardella cpdocketgardella@oblon.com OBLON, McCLELLAND, MAIER & NEUSTADT, LLP 1940 Duke Street Alexandria, VA Dianna L. DeVore ddevore@convergentlaw.com CONVERGENT LAW GROUP LLP 475 N. Whisman Road, Suite 400 Mountain View, CA David L. Cavanaugh David.cavanaugh@wilmerhale.com WilmerHale 1875 Pennsylvania Ave., N.W. Washington, D.C William W. Kim William.kim@wilmerhale.com Owen K. Allen Owen.allen@wilmerhale.com WilmerHale 950 Page Mill Road Palo Alto, CA Robert J. Gunther Jr. Robert.gunther@wilmerhale.com Wilmer Cutler et al. 7 World Trade Center New York, NY Dated: July 1, 2015 By: /Kerry Taylor/ Kerry Taylor, Reg. No. 43,947 Attorney for Patent Owner Illumina, Inc