UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD. ARIOSA DIAGNOSTICS Petitioner. ILLUMINA, INC.

Transcription

1 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD ARIOSA DIAGNOSTICS Petitioner v. ILLUMINA, INC. Patent Owner U.S. Patent No. 7,955,794 Trial No PETITIONER S OPPOSITION TO PATENT OWNER S MOTION TO EXCLUDE EVIDENCE

2 TABLE OF CONTENTS Page I. RELIEF REQUESTED... 1 II. ILLUMINA HAS NOT ESTABLISHED A BASIS TO EXCLUDE ANY OF ARIOSA S EXHIBITS, EACH OF WHICH IS DIRECTED TO AN ISSUE THAT IS PROPERLY BEFORE THE BOARD... 2 A. Exhibits , Documents Introduced at Dr. Kramer s Deposition... 2 B. Exhibit 1038, 1047, and Patent Priority Applications... 4 C. Exhibit 1045 Declaration of Dr. Charles Cantor... 5 D. Exhibit 1046 Transcript of Illumina Expert Dr. Kramer E. Exhibits 1048 & 1049 Material Cited in Cantor Declaration F. Exhibits 1051 and 1052 ʼ794 Patent File History III. CONCLUSION i

3 TABLE OF AUTHORITIES FEDERAL CASES Page(s) Ava Ruha Corp., 113 U.S.P.Q. 2d 1575 (P.T.O. Jan. 29, 2015)... 6 Fagiola v. Nat l Gypsum Co. AC & S., 906 F.2d 53 (2d Cir. 1990)... 4 PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299 (Fed. Cir. 2008)... 5 ADDITIONAL AUTHORITIES Corning Inc. v. DSM IP Assets B.V., IPR , 2014 WL (May 9, 2014)... 8 Corning Inc. v. DSM IP Assets B.V., IPR , 2014 WL (May 1, 2014)... 6 Liberty Mut. Ins. Co. v. Progressive Casualty Ins. Co., CBM , 2014 WL (Mar. 13, 2014)... 13, 14 Liberty Mut. Ins. Co. v. Progressive Casualty Insurance Co., CBM , 2014 WL (Jan. 23, 2014)... 6 Shaw Indus. Grp., Inc. v. Automated Creel Systems, Inc., IPR , 2014 WL (July 24, 2014)... 1 ii

4 I. RELIEF REQUESTED Petitioner Ariosa Diagnostics, Inc. ( Ariosa ) submits this opposition to Patent Owner Illumina, Inc. s ( Illumina ) Motion to Exclude Evidence ( Motion ) (Paper No. 52). Because the challenged exhibits are plainly relevant and probative to disputed issues before the Board, the Motion should be denied. The central theme of Illumina s Motion is that because Illumina disagrees with positions of Ariosa s expert, or with Ariosa s characterization of the record evidence, certain evidence should be excluded because it is supposedly irrelevant or misleading. But evidence is not inadmissible merely because an opponent disagrees with the conclusions that may be drawn from it. See Shaw Indus. Grp., Inc. v. Automated Creel Systems, Inc., IPR , 2014 WL , at *22 (July 24, 2014) (disagreement with petitioner s characterization of the evidence is an insufficient basis to exclude evidence). Indeed, the evidence offered by Ariosa including the exhibits from the deposition of Illumina s expert Dr. Kramer, cites to Dr. Kramer s deposition testimony, the declaration of Ariosa s expert Dr. Cantor, and priority and file history documents from the challenged patent are all directly relevant to the issues in this proceeding, will assist the Board, and are not unduly prejudicial. Illumina s motion should be denied. 1

5 II. ILLUMINA HAS NOT ESTABLISHED A BASIS TO EXCLUDE ANY OF ARIOSA S EXHIBITS, EACH OF WHICH IS DIRECTED TO AN ISSUE THAT IS PROPERLY BEFORE THE BOARD A. Exhibits , Documents Introduced at Dr. Kramer s Deposition Exhibits and were introduced as exhibits at Dr. Kramer s deposition and each is discussed by Dr. Kramer in his testimony. See Ex at 34:15-42:6, 105:8-107:1, 118:11-120:21, 167:11-176:13, 194:14-200:1, 221:1-224:19. On this basis, they are part of the record in this proceeding and may be considered by the Board. See 37 C.F.R (f)(7) (expert testimony must be filed as an exhibit). Each of these exhibits is also relevant to the issues in this proceeding. With respect to Exhibits , each includes a definition of alternative splicing. Alternative splicing is relevant to the argument in the Petition that the disclosure of testing 50 to 100 genes in the 810 application discloses the use of more than 100 probes to test for each of at least two alternatively spliced isoforms. Paper 1 at 16. Dr. Kramer s testimony about these definitions, including that an alternative splicing event will result in the presence of more than one isoform per gene, is directly relevant to this argument and arguments in the Reply. See Paper 44 at 7-8. Illumina s arguments that these definitions are irrelevant because they are not prior art and that they constitute hearsay are misplaced. These exhibits are not 2

6 offered as prior art, rather they were used to explore and assess Dr. Kramer s knowledge and understanding of alternative splicing, a key aspect of the 810 application. The exhibits are self-authenticating because each includes an inscription, sign, tag, or label purporting to have been affixed in the course of business and indicating origin, ownership, or control, for example, the Merriam- Webster logo, the Medicine.net logo, and the reference.md URL. Fed. R. Evid. 902(7). Moreover, the header/footer information (including the URLs) on each exhibit is sufficient to support a finding that the item is what the proponent claims it is, i.e., a definition of alternatively splicing. Fed. R. Evid. 901(a). With respect to Exhibits , each provides a side-by-side comparison of figures from the 810 application and U.S. Provisional 60/297,609 ( the 609 application ). These exhibits are directly relevant to Ariosa s argument that the figures of the 810 application are closely related to the 794 patent. See Paper 1 at 1; Paper 44 at 2. Indeed, the figures of the 810 application are repeated in the 609 application, to which the 794 patent claims priority, and that the 609 application describes them as embodiments of the (singular) invention. See Paper 44 at 2, 12. Illumina s attempt to exclude these exhibits from Dr. Kramer s deposition was (correctly) denied during the deposition. See Ex at (denying Illumina s request to preclude questioning regarding 609 application). 3

7 B. Exhibit 1038, 1047, and Patent Priority Applications Exhibit 1038 is the 609 application, which is one of the provisional applications to which the 794 patent claims priority. Petitioner cites this priority document in its Reply because the 609 application contains certain figures that are identical to those in the 810 application. See Paper 44 at 2, 12, 14, 20. Illumina s position that this argument in the Reply is misleading and irrelevant (Mot. at 1), goes only to the weight of the argument about the application s contents, not admissibility of the document itself. See Fagiola v. Nat l Gypsum Co. AC & S., 906 F.2d 53, 58 (2d Cir. 1990) (objections that a party did not fairly represent the evidence go more to weight than admissibility). Exhibit 1047 is U.S. Patent 6,931,884, which issued from U.S. App. No. 09/931,285. The 884 patent is incorporated by reference into the 794 patent. Ex at 1:3-14. Petitioner cites the 884 patent in Reply because it directly contradicts Illumina s argument that the term attached precludes poly(a) hybridization. See Paper 44 at 17, n.7; Paper 31 at 23-24, The statements in the 884 patent are consistent with the 794 patent, which states that: [s]imilarly, affinity capture utilizing hybridization can be used to attach nucleic acids to beads. Ex at 66: As with the 609 application, Illumina s position that this argument is confus[ing], goes only to weight and not admissibility of the document. Mot. at 15. 4

8 Exhibit 1050 is U.S. Prov. App. 60/311,271, another application to which the 794 patent claims priority. In the Petition, Ariosa identified the 946 Pub as prima facie prior art to the 794 patent under Section 102(e), shifting the burden of production to Illumina to establish a priority date before the date of the 946 Pub. Paper 1 at 4, 14-26; see PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, (Fed. Cir. 2008) ( the burden [is] on [patentee] to come forward with evidence to prove entitlement to claim priority to an earlier filing date. ). Ariosa cited Exhibit 1050 in its Reply to demonstrate that Illumina did not, and could not, sustain its burden, because the first disclosure of more than 100 probes is in the 271 application, which post-dates the 946 Pub. Paper 44 at 23. Illumina s argument that the prior art status of the 946 Pub. is irrelevant is clearly mistaken, and its position that Ariosa new[ly] asserted that the 946 Pub. is prior art is belied by the Petition. Paper 1 at 4, C. Exhibit 1045 Declaration of Dr. Charles Cantor Exhibit 1045 is the Declaration of Charles Cantor ( Cantor Declaration ), which Ariosa submitted in support of its Reply and to respond to the opinions of Illumina s expert, Dr. Kramer. Illumina moves to exclude much of the Cantor Declaration pursuant to Fed. R. Evid. 106, , and 702, and on the grounds that it contains opinions that are purportedly inconsistent with those of other experts. Mot. at 1-2. Illumina also complains that Dr. Cantor s interpretations of 5

9 Dr. Kramer s testimony are incorrect, and that us[ing] Dr. Cantor to interpret Dr. Kramer s opinions... is improper. Id. at 2. None of these arguments, which relate to the appropriate weight to be given to Dr. Cantor s testimony, come close to satisfying Illumina s burden to exclude Dr. Cantor s expert testimony. Liberty Mut. Ins. Co. v. Progressive Casualty Insurance Co., CBM , 2014 WL , at *34 (Jan. 23, 2014) (denying motion to exclude expert testimony because it is better to have a complete record of the evidence submitted by the parties than to exclude particular pieces ); Ava Ruha Corp., 113 U.S.P.Q. 2d 1575 (P.T.O. Jan. 29, 2015) (quoting Gulf States Utilities Co. v. Ecodyne Corp., 635 F.2d 517, 519 (5th Cir. 1981) ( Rule 403 assumes a trial judge is able to discern and weigh the improper inferences that a jury might draw from certain evidence, and then balance those improprieties against probative value and necessity.... [as well as] exclude those improper inferences from his mind in reaching a decision. ) (alterations in original)); Corning Inc. v. DSM IP Assets B.V., IPR , 2014 WL , at *11 (May 1, 2014) (Because the Board is well positioned to weigh the evidence, in inter partes review [proceedings], the better course is to have a complete record of the evidence to facilitate public access as well as appellate review. ). Illumina argues that Dr. Cantor s opinion in 22, 30 and 31 of his declaration that Figures 4 and 2b of the 810 application disclose all elements of 6

10 claim 1 on their own directly contradicts statements made by a prior expert. Mot. at 3. To the contrary, Dr. Ward s testimony regarding the 810 application is fully consistent with Dr. Cantor s opinion that the 810 application discloses an experiment that uses at a minimum more than 100 probes with identical universal primers. Ex at Dr. Ward affirmed that point. See Ex at 30; Ex at 115:7-12. Illumina further argues that Dr. Cantor s opinion in 22, 30, 31, and 66 that washing appl[ies] to Part II of the invention disclosure contradicts Dr. Ward s testimony. Mot. at 3, It does not. Indeed, Dr. Cantor s testimony that a person of ordinary skill would apply a wash step in performing Figure 2d, is fully consistent with the Petition s statement that the 810 application discloses extensive washing in the Figure 4 two-oligo approach, and the Petition s citation to the opinions of Drs. Ward and Fu that removal of unhybridized probes will take place for each protocol in the 946 Pub. (which includes as Figures 4 and 6 reproductions of 810 application Figures 2b and 2d). Paper 1 at (citing Ex at 20; Ex at 19); see also Ex at 132:7-133:12. In any event, Illumina s argument goes to the weight of Dr. Cantor s testimony, not its admissibility. Illumina moves to exclude Dr. Cantor s explanation of the state of the prior art in 28-30, 41-44, and 53 on the ground that it is not supported by sufficient 7

11 facts or data. Mot. at 3. Illumina does not (and cannot) dispute that Dr. Cantor was a preeminent expert in the field of alternative splicing in , as demonstrated by his declaration and curriculum vitae, which, among other things, lists numerous scientific papers authored by Dr. Cantor relating to alternative splicing. Ex at 10, App x A. Illumina s assertion that Dr. Cantor s declaration is unsupported ignores his decades of experience, and, in any event, goes to weight, not admissibility. See Corning Inc. v. DSM IP Assets B.V., IPR , 2014 WL , at *28 (May 9, 2014) ( Whether a witness s testimony fails to include underlying facts or data on which an opinion is based goes to the weight that should be accorded the testimony, and not its admissibility. ). Illumina moves to exclude 43 of the Cantor Decl. pursuant to Fed. R. Evid. 403 because Illumina disagrees with how Dr. Cantor characterized Dr. Kramer s testimony that under the requirements of Claim 1 the upstream and downstream primers of Figures 2b and 4 are each probes. Mot. at 3-4 (citing Ex at 206:14-208:23). Illumina s attempt to explain away Dr. Kramer s testimony is not a ground to exclude Dr. Cantor s opinion, especially when the full record of Dr. Kramer s testimony is before the Board. See Ex Illumina s disagreement with Dr. Cantor s characterization of Dr. Kramer s testimony in the remaining sections of its Motion is a thinly veiled, improper sur-reply argument 8

12 that is unrelated to the admissibility of Dr. Cantor s opinion. Illumina argues that Dr. Cantor s opinion in 33, 34, 38, and 69 that the R33 phase of the 810 application would be applied to all disclosed protocols is irrelevant. Mot. at 4-5, 10. This opinion on a key issue with respect to the more than 100 probes limitation is, of course, relevant, and was an argument presented in the Petition. See, e.g., Paper 1 at 16. Nor is it correct that Dr. Cantor s opinion is misleading because Illumina interprets the 810 application differently. Although Illumina argues that the only two protocols possible for the R33 phase were the one- and two-oligo protocols, none of the testimony it cites contradicts Dr. Cantor s opinion that the purpose of the 810 application was to scale up all protocols, including the three-oligo approach. Ex at 34, 69; see also Ex at 141:17-142:1. Illumina argues that Dr. Cantor s opinion in 36 and 40 that the R33 phase of the 810 application discloses the use of more than 100 probes with identical universal primers is irrelevant. Mot. at 5. As noted above, Dr. Cantor s opinion on this issue is directed to a key dispute in this proceeding, and to the position identified in the Petition that the 810 application discloses experiments using a singular upstream and singular downstream probe. See Paper 1 at 16; Ex at 29. Further, in view of Dr. Kramer s testimony that a multiplex method can include multiple reactions, Ex at 46:7-43, Illumina s position 9

13 that Dr. Ward s testimony regarding experiments using a multi-well plate renders Dr. Cantor s opinion irrelevant is misplaced. Illumina s Motion does not seek exclusion of and 49. See Mot. at 5. Rather, the Motion advances sur-reply argument that Dr. Cantor s opinion is misleading and unsupported by evidence because he disagrees with Dr. Kramer. Id. This improper argument goes only to weight, not admissibility. Dr. Cantor s opinion that a skilled artisan monitoring alternative splicing would test for at least two isoforms per gene in the R33 phase of the 810 application is consistent with the testimony of Drs. Fu and Ward on this point. See, e.g., Ex at 28; Ex at 30; see also Paper 1 at 16. The only contrary testimony was from Dr. Kramer, who admitted he was not an expert in alternative splicing. Ex at 31: Turning to 46, 64, and 65, Illumina asks the Board to exclude Dr. Cantor s opinion that the 810 application is enabled because it is purportedly inconsistent with Illumina s interpretation of Dr. Kramer s testimony. See Mot. at 6. This, again, goes to weight, not admissibility. Dr. Cantor s testimony is consistent with the testimony of every expert in this matter, including Dr. Kramer. Dr. Cantor accurately cites Dr. Kramer s testimony that the protocols of the 810 application were feasible, and to the extent there is a dispute about the meaning of that testimony, the entirety of Dr. Kramer s testimony is part of the record. 10

14 See Ex Moreover, Illumina s argument that Dr. Cantor s opinion is inconsistent with the testimony of Drs. Fu and Ward is not only irrelevant to the question of admissibility, it is incorrect. See Ex at 125:8-14 ( we knew R21 phase is going to work for sure ); id. at 210:2-19; Ex at 52:3-13 ( nothing [more] as far as I can see would be needed to establish the R33 procedure). Illumina argues that Dr. Cantor s quotation (at 52) of Dr. Kramer s testimony that the parts of the 810 application have a substantive relationship to each other is misleading and prejudicial. Mot. at 7-8. As discussed above, Dr. Cantor s quotation is accurate, and the full transcript of Dr. Kramer s deposition is before the Board. Illumina s counterarguments and purportedly contrary evidence are unrelated to the question of admissibility. Indeed, Illumina s counterarguments mischaracterize the record. For example, Illumina notes that Dr. Kramer testified that there is not a wash step identified in Figure 2b, but omits that he also testified that it was intended there was washing in Figure 1a, which also does not explicitly list such a step. Ex at 137:7-15. In paragraphs 56-60, Dr. Cantor indicated his understanding that the Board declined to adopt claim constructions proposed by Illumina in its Preliminary Patent Owner s Response. This understanding was accurate. See Paper 14 at 6. Illumina has cited no authority for its request that the entirety of Dr. Cantor s declaration be excluded, and has made no specific argument regarding 11

15 the substance of Dr. Cantor s opinions that Illumina s proposed constructions of single-stranded and attached are overly narrow. Mot. at 8. Illumina takes issue with the weight to be accorded to Dr. Cantor s testimony that the 810 application discloses probes with identical universal primers and cites over a page of purportedly contrary evidence. See Mot. at 8 (citing Ex at 61 and 62). Putting Illumina s improper sur-reply arguments to the side, Illumina offers no basis to exclude Dr. Cantor s opinion. To the extent that Illumina argues that the Petition did not identify a disclosure of more than 100 probes with identical universal primers, Illumina is incorrect. See Paper 1 at (identifying disclosure of the upstream universal priming site and the downstream universal priming site and stating that [a]fter the ligation step, oligos will be PCR-amplified using two universal primers ). Dr. Cantor s explanation of the reason for using these identical universal primers to avoid biased signal amplification was permissible reply to Illumina s arguments. See, e.g., Surfcast, 2014 WL , at *30. In addition, in his deposition, in response to questions by Illumina s counsel, Dr. Cantor identified the specific use of identical T7 and T3 universal primers on page 23 of the 810 Provisional. See Ex at 251:19-22; 261:4-11; Ex at 23. Illumina also argues that of Dr. Cantor s declaration (to the effect that the limitations of Claims 2, 5-8, and 21 that are present in the

16 application were identified in the Petition) is misleading and raise new validity theories that were not in the Petition. Mot. at 10. This is not correct. The Petition identifies disclosures from the 810 application that meet each limitation of Claims 2, 5-8, and 21 of the 794 patent. Paper 1 at Dr. Cantor opined that the disclosures identified in the Petition with respect to Figure 1 are present in other Figures (i.e., Figures 2a-2d and 4) as well. These opinions are directly relevant to the unpatentability of the relevant claims. Moreover, Dr. Fu s testimony regarding the one-oligo approaches in the 810 application is not inconsistent with Dr. Cantor s opinions that aspects of the one-oligo approach are also disclosed for multi-oligo approaches. Regardless, Illumina s arguments go to weight, not admissibility. Office Patent Trial Practice Guide, 77 Fed. Reg , (Aug. 14, 2012) (a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact ). D. Exhibit 1046 Transcript of Illumina Expert Dr. Kramer Illumina s motion to exclude asks that the Board strike parts of Ariosa s reply brief that cite Ex. 1046, the deposition transcript of Illumina s expert, Dr. Kramer. See Mot. at This is not the proper subject of a motion to exclude. Moreover, the only basis that Illumina identifies for this extraordinary request is that it takes issue with Ariosa s characterization of the record. These improper sur-reply arguments go to weight, not admissibility. Liberty Mut. Ins. 13

17 Co. v. Progressive Casualty Ins. Co., CBM , 2014 WL , at *32 (Mar. 13, 2014) (a motion to exclude is not an opportunity to file a sur-reply [or] argue that a reply contains new arguments ). E. Exhibits 1048 & 1049 Material Cited in Cantor Declaration Exhibit 1048 is a textbook co-authored by Dr. Cantor. Illumina erroneously argues that exclusion of Exhibit 1048 is warranted because Petitioner failed to discuss the exhibit. Mot. at 1. To the contrary, as explained in Dr. Cantor s declaration at 28, a specific portion of the book is used to support the fact that one of skill in the art would understand that the longer the probe, the more difficult it is to have single base mismatch discrimination. Ex at 28 (citing Ex at 68-79). The Reply similarly states that [a] skilled artisan would understand that the method of the 810 application would employ upstream oligos with identical universal priming sites. Paper 44 at 8 (citing Ex at 61-62). Exhibit 1049 is an article by Berg, et al. entitled Hybrid PCR sequencing: sequencing of PCR products using a universal primer. Illumina argues that exclusion of this exhibit is warranted because Petitioner failed to discuss it. Mot. at 1. Again, this is incorrect. Dr. Cantor cites this article in his declaration to support the proposition that [u]niversal primers were in general use years before the 810 application. Ex at 62; Paper 44 at 18 (citing Ex ). 14

18 F. Exhibits 1051 and 1052 ʼ794 Patent File History Exhibits 1051 and 1052 are parts of the file history of the 794 Patent. In response to Illumina s argument that the 794 patent was entitled to the priority date of its provisional applications (Paper 31 at 7-9), Ariosa cited these documents in its Reply to demonstrate that Applicant did not properly make a priority claim to an intervening utility application, that Applicant s attempts to correct that error were rejected, and that Applicant never submitted a petition under 37 C.F.R. 1.78(e) to properly claim priority. Paper 44 at 23, n.9. Illumina argues that Exhibits 1051 and 1052 should be excluded under FRE for being used in a misleading way. Mot. at 15. However, Illumina has cited no inaccuracy in Ariosa s statements, and the documents speak for themselves. III. CONCLUSION denied. For the reasons described above, Illumina s motion to exclude should be Respectfully Submitted, /Greg H. Gardella/ Date: August 26, 2015 Greg H. Gardella (Reg. No. 46,045) Lead Counsel for Petitioner ARIOSA DIAGNOSTICS OBLON, McCLELLAND, MAIER & NEUSTADT, L.L.P Duke Street Alexandria, Virginia Tel.:

19 CERTIFICATE OF SERVICE I hereby certify that on August 26, 2015, I caused a true and correct copy of the following materials: PETITIONER S OPPOSITION TO PATENT OWNER S MOTION TO EXCLUDE ARIOSA EVIDENCE to be served by electronic mail, as previously agreed upon by the parties, to: BoxIllumina@knobbe.com. Respectfully Submitted, /Greg H. Gardella/ Greg H. Gardella (Reg. No. 46,045) Lead Counsel for Petitioner ARIOSA DIAGNOSTICS 16