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`EXHIBIT (cid:25)(cid:23)
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`EXHIBIT 64
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`US. Patent No. 8,318,430
`
`Attorney Docket No: 465157US
`
`Issued: November 27, 2012
`
`Filed: Feb. 7, 2012
`
`For: METHODS OF FETAL
`
`ABNORMALITY DETECTION
`
`RES QUEST FOR EX PAR TE REEXAMINATION OF
`US. PATENT N0. 8,318,430
`
`Mail Stop Ex Pane Reexam
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`Pursuant to the provisions of35 U.S.C. § 302 and 3'? CPR. § 1.510 et seq., the
`
`undersigned, on behalf of Ariosa Diagnostics, Inc., requests ex parte patent reexamination of
`
`claims 1-30 of US. Patent No. 8,318,430 (“the ‘430 patent," Exhibit A).
`
`The “430 patent is assigned on its face to Verinata Health, Inc. (“Verinata” or “Patent
`
`Owner"). Formerly known as Artemis Health, Inc., Verinata Health, Inc., is a wholly owned
`
`subsidiary of Illumina, Inc.
`
`Co-Pending Litigation
`
`The “430 patent is the subject of a litigation captioned Irrerr‘nata Health, Inc. er of. v.
`
`Ariosa Diagnostics, Inc. e! a/., Case No. 3:12-cv-05501-Sl (ND. Cal), currently stayed.
`
`Requester notes that USPTO policy dictates that patent reexaminations involved in
`
`concurrent litigation are to be accorded a special status. “Any cases involved in litigation,
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`whether they are reexamination proceedings or reissue applications, will have priority over all
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`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`other cases.” MPEP § 2261. As such, it is respectfully requested that the USPTO accord this
`
`proceeding special status such that it may advance to a timely conclusion.
`
`Ex Pane Patent Reexamination Filing Requirements
`
`Pursuant to 37 CPR. § 1.510(b)(1), statements pointing out at least one substantial new
`
`question of patentability based on material, non-cumulative prior art patents for claims 1-30 of
`
`the ‘430 patent are provided in Section VI. of this Request. Although some of these prior art
`
`references were previously cited in the record during the original prosecution of the “430 patent,
`
`these references have not been considered in the new light demonstrated by the proposed
`
`substantial new questions of patentability.
`
`Pursuant to 3? CFR. § 1.510(b)(2), reexamination of claims 1-30 of the ‘430 patent is
`
`requested, and a detailed explanation of the pertinency and manner of applying the cited prior art
`
`to claims 1-30 is provided in Section VII. ofthis Request.
`
`Pursuant to 37 CFR, § 1.5]0(b)(3), copies of every patent relied upon or referred to in
`
`the statement pointing out each substantial new question of patentability or in the detailed
`
`explanation of the pertinency and manner of applying the cited prior art are provided as Exhibits
`
`A-X of this Request.
`
`Pursuant to 3? CPR, § 1.510(b)(4), a copy ofthe “430 patent is provided as Exhibit A of
`
`this Request.
`
`Pursuant to 37 C.F.R, § 1.5l0(b)(5), the attached Certificate of Service indicates that a
`
`copy of this Request, in its entirety, has been served on Patent Owner at the following address of
`
`record for Patent Owner, in accordance with 37 C.F.R. § l.33(c):
`
`WSGRKVERINATA
`
`650 Page Mill Road
`
`Palo Alto, CA 94304
`
`ii
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`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`Also submitted herewith is the fee set forth in 3? C.F.R. § 120(c)(1).
`
`Pursuant to 3'? C.F.R. § 1.510(b)(6), Requester hereby certifies that neither the statutory
`
`estoppel provisions of35 U.S.C. § 3 l 5(e)(1) nor 35 U.S.C. § 325(e)(|) prohibit Requester from
`
`filing this ex parle patent reexamination request for two reasons, both of which are explained
`
`more detail in Section 11., below. First, the Final Written Decision declined to institute trial
`
`based on the ground presented herein at Section VILC on the basis that that ground was
`
`redundant with another ground on which trial was instituted. Ex. L at 20; Ex. M at 20-2].
`
`Accordingly, the estoppel provisions of 35 U.S.C. § 315(c)(1) cannot apply to that ground.
`
`Apotex v. Mieth, [PR2015-00873, Paper 8, p. 9 (“[B]ecause the Board denied institution of [a
`
`ground] as redundant, and Petitioner could not have raised [the ground] again once institution
`
`was denied as to that ground. Estoppel under 35 U.S.C. § 315(e)(1), therefore, does not bar
`
`Petitioner from maintaining a proceeding before the Office on [that ground]"). Second, estoppel
`
`does not apply to the remaining grounds presented herein because on December 23, 2015 the
`
`Federal Circuit issued the formal mandate entering the judgment of the Federal Circuit which
`
`vacates the Final WIitten Decision of the Patent Trial and Appeal Board (PTAB) in the matter of
`
`Ariosa Diagnostics, Inc. v. V’rmara Health, Inc, IPR2013-00276 and [PR2013-OOZT7. See Exs.
`
`T and U. When a judgment is vacated, the effect is to “nullify the judgment entirely and place
`
`the parties in the position of no trial having taken place at all." United States v. Williams, 904
`
`F.2d 7, 8 (7th Cir, 1990); (fluted States v. Ayres, 76 US. 608, 610 (l869) (“[I]t is quite clear, that
`
`[an] order granting the new trial has the effect of vacating the formerjudgment, and to render it
`
`null and void, and the parties are left in the same situation as if no trial had ever taken place in
`
`the cause"); see also UniledStates v. Lawson, 336 F.2d 835 (2d Cir.1984) (“It has long been
`
`established
`
`that when ajudgment has been reversed and the case remanded for a new trial, the
`
`iii
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`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`effect is to nullify the judgment entirely and place the parties in the position of no trial having
`
`taken place"). In a similar context the PTAB held that the one—year bar of 3? C.F.R. § 315(a)
`
`does not apply where a district court complaint was dismissed without prejudice because “[t]he
`
`Federal Circuit has consistently interpreted the effect of such dismissals as leaving the parties as
`
`though the action had never been brought.” Mac-aura v. BUS GmbH & KG, IPR2012—00004,
`
`Paper 18, p. 15 (PTAB Jan 24, 2013). The same reasoning applies to the estoppel provision of
`
`35 U.S.C. §315(e)(l) — the vacatur of the final written decisions places the parties in the position
`
`as if no final written decisions had been rendered. Ariosa Diagnostics is thus not estopped from
`
`filing the present request under 37 C.F.R. §315(e)(l) or 37 C.F.R. §325(e)(l).
`
`iv
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`

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`TABLE OF CONTENTS
`
`TABLE OF EXHIBITS ................................................................................................................ vii
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1
`
`THE ESTOPPEL PROVISIONS OF 35 USC §§ 315, 325 DO NOT BAR THIS
`REQUEST ........................................................................................................................... 5
`
`III.
`
`CITATION OF PRIOR ART PATENTS AND PRINTED PUBLICATIONS RELIED
`
`UPON IN REQUEST FOR REEXAMINATION .............................................................. 8
`
`IV.
`
`OVERVIEW OF THE ‘430 PATENT ................................................................................ 9
`
`A.
`
`B,
`
`C.
`
`D.
`
`E.
`
`Background of the ‘430 Patent and Level of Skill in the Art ................................. 9
`
`Summary of the “430 Patent ................................................................................. IO
`
`Prosecution History of the ‘430 Patent ................................................................. 'l 1
`
`The Inter Parres Review Proceedings .................................................................. 12
`
`The Appeal to the Federal Circuit ......................................................................... 15
`
`V.
`
`CLAIM CONSTRUCTION .............................................................................................. 16
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`“selectively enriching a plurality of non-random polynucleotide sequences”
`(Claimsl and 19) .................................................................................................. 16
`
`“at least 100 different non-random polynucleotide sequences selected from a first
`chromosome tested for being aneuploid and at least 100 different non-random
`polynucleotide sequences selected from a reference chromosome” (Claim 1)
`
`18
`
`“at least one chromosome region tested for being aneuploidy” (Claim 19) ......... 19
`
`“sequence reads corresponding to enriched and indexed fetal and maternal non-
`random polynucleotide sequences” (Claims 1 and 19) ......................................... 19
`
`(Claim
`“reference chromosome” (Claim 1) or “chromosome control region”
`1 9) ......................................................................................................................... 20
`
`VI.
`
`STATEMENT POINTING OUT EACH SUBSTANTIAL NEW QUESTION OF
`PATENTABILITY FOR THE CHALLENGED CLAIMS .............................................. 21
`
`A.
`
`B.
`
`C.
`
`D.
`
`Subject Matter, Which if Taught by Prior Art Patents or Printed Publications,
`Raises a Significant New Question of Patentability for the Challenged Claims .. 21
`
`The Combination of Dhallan II, Craig and the lllumina Brochure Presents a
`Substantial New Question of Patentability for Claims 1-30 of the ‘430 Patent
`
`The Combination of Dhallan II, Parameswaran and Hamady Presents a
`Substantial New Question of Patentability for Claims 1-30 of the ‘430 Patent
`
`23
`
`26
`
`The Combination Dhallan I and Binladen Presents a Substantial New Question of
`Patentability for Claims 1-30 of the ‘430 Patent .................................................. 28
`
`VII.
`
`DETAILED EXPLANATION OF THE PERTINENCE AND MANNER OF
`
`APPLYING THE PRIOR ART REFERENCES TO EVERY CLAIM FOR WHICH
`
`REEXAIVIINATION IS REQUESTED ............................................................................ 31
`
`

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`Request for Ex Pane Reexamination
`Reexamination OPUS. Patent No‘ 8.318.430
`
`A.
`
`B,
`
`C.
`
`Dhallan II in View of Craig and the Illumina Brochure Renders Obvious Claims
`'l-3O of the “430 Patent Under (pre-AIA) 35 U.S.C‘ § 103(a) .............................. 31
`
`Dhallan II in View of Parameswaran and Hamady Renders Obvious Claims 1-30
`of the “430 Patent Under (pre-AIA) 35 U.S.C. § 103(a) ....................................... 64
`
`Dhallan I in Combination with Binladen Renders Obvious Claims l-3O of the
`
`“430 Patent Under (pre-AIA) 35 U‘S.C. § 103(a) ................................................. 97
`
`VIII. CONCLUSION ............................................................................................................... 12?
`
`vi
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`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`Exhibit A
`
`Exhibit B
`
`Exhibit C
`
`Exhibit D
`
`Exhibit E
`
`Exhibit F
`
`Exhibit G
`
`Exhibit H
`
`Exhibit I
`
`Exhibit I
`
`Exhibit K
`
`Exhibit L
`
`Exhibit M
`
`Exhibit N
`
`Exhibit 0
`
`Exhibit P
`
`TABLE OF EXHIBITS
`
`US. Patent No. 8,318,430 to Chuu et al, (for reexamination)
`
`Prosecution history of US. Patent No. 8,318,430 (US. Patent Application No.
`13l368,035)
`
`US. Patent No. 7,332,2'l'l to Dhallan (“Dhallan I”)
`
`The Use of Coded PCR Primers Enables High-Throughput Sequencing of
`Multiple Homolog Amplification Products by 454 Parallel Sequencing, Jonas
`Binladen et al., PLoS ONE. 200?; 2(2): e19? (“Binladen”)
`
`US. Patent Pub. App. No. 2006l012l452 t0 Dhallan II (“Dhallan II”)
`
`Ideniificalion ofGeueiic Variants Using Barcoded Multiplexed Sequencing, Nat.
`Methods, Craig et al., Nat. Methods, 5(10):88'l-93 (2008) (“Craig")
`
`Illumina Brochure “Multiplexed Sequencing with the Illumina Genome Analyzer
`System" (2008) (“Illumina Brochure")
`
`A pymsequeusing-tailored nucleotide bareode design unveils opportunitiesfor
`large—scale sample mulriplexiug, Parameswaran, et al., Nucleic Acids Research,
`35(19):e130 (200?) (“Parameswaran”)
`
`Error-correcting bai‘codedprimers allow hundreds ofsamples to
`be pyrosequeiiced iii multiplex, Hamady, et al., Nat. Methods, S(3):235-37 (2008)
`(“Hamady”)
`
`US. Patent Pub. App. No. 2008l0090239 to Shoemaker, et al. (“Shoemaker”)
`
`File History for Inier Parles Review of [PR2015-008'l3, Paper 8.
`
`File History for liuer Furies Review of claims 1-18 of the “430 patent
`(lPR2013-00276)
`
`File History for lurer Panes Review of claims 19-30 of the “430 patent
`(IPR2013-002Tl)
`
`Supplementary Material referred to on page 8 of Craig.
`
`Declaration of Dr. Steven Rosenberg
`
`Solicitor’s brief in Scholi Gemiron Corp. v. SSWh’oldiug (.70., Appeal No. 2015-
`1073.
`
`Exhibit Q
`
`Printout of http://wwwnature.comlnmethljoumalle/n10lfulllnmeth.1251.htm1
`
`vii
`
`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No: 8.318.430
`
`Exhibit R
`
`Exhibit S
`
`Exhibit T
`
`Exhibit U
`
`Exhibit V
`
`Printout of http:f/wwwnaturecomfnmethfjournal/vSln3lfulli’nmeth.1 l84.html
`
`Printout of http:fa’nar.oxfordjournals.orgfcontentf3 5/ 19/e1 30.full
`
`Federal Circuit Mandate Entering the Judgment and Order in Case No. 15-12 I 5
`
`Federal Circuit Judgment and Order Vacating the Final Written Decisions in
`IPRZO'I 3-00276 and [PR2013-00277
`
`Claim Chart for the First Ground: Dhallan II in combination with Craig and the
`Illumina Brochure
`
`Exhibit W
`
`Claim Chart for the Second Ground: Dhallan II in combination with
`
`Parameswaran and Hamady
`
`Exhibit X
`
`Claim Chart for the Third Ground: Dhallan I in combination with Binladen
`
`viii
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`

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`I.
`
`INTRODUCTION
`
`This request for reexamination and the proposed grounds of rej ection raised herein are
`
`supported by a declaration from Dr. Steven Rosenberg, a pioneer in the diagnostics field that
`
`developed two multivariate diagnostic tests which are in clinical use today. See Ex. 0. Dr.
`
`Rosenberg’s declaration summarizes and reflects his knowledge, technical expertise, and
`
`understanding of the scope and content of the prior art applied in this request for reexamination.
`
`Id. at W 2-3, 35-44, MPEP § 2258. The state of the art at the time of the filing of the ‘430 patent
`
`is presented by Dr. Rosenberg in this request for reexamination.
`
`The ‘430 patent is generally directed to a method for detecting fetal aneuploidies in
`
`multiple samples of pregnant women by counting, in a maternal blood sample, the number of
`
`DNA fragments from a chromosome suspected of being aneuploid and the number of fragments
`
`from a reference chromosome or control region from a chromosome that is not aneuploid. Ex. A
`
`at Abstract, 1:23-61 2:4-11, 6120-2? and 13:59-64; Ex. 0 at1l1] 14, 45. The two numbers are
`
`compared to determine whether there is an abnormal level of DNA associated with the
`
`chromosome suspected of being aneuploid. Id; Id. at 111] 14, 32, 34, and 45. This method is
`
`performed in a multiplexed fashion for a plurality of maternal blood samples using indexing (i.e.,
`
`tagging or labelling) techniques to distinguish results from different samples. Id. at 2219-29; Id.
`
`at1l1l 14, 31,45 and 48.
`
`The USPTO has considered the subject matter claimed in the ‘430 patent allowable
`
`because the indexing methods taught in cited secondary references were believed to be
`
`incompatible with the sequencing techniques taught in the primary references. See Sections
`
`PVC and IV.D, irgfi‘a.
`
`Neither the ex parte examiner nor the PTAB has addressed the merits of any of the
`
`grounds presented in this request, each of which provides a combination of art in which the
`
`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`indexing or multiplexing technique is fully compatible with the sequencing method.
`
`Parameswaran, P., et al. “A Pyrosequencing-Tailored Nucleotide Barcode Design Unveils
`
`Opportunities for Large-Scale Sample Multiplexing.” NtrcleicAcidv Research, 3S(|9):el 30
`
`(2007) (“Parameswaran”) (Ex. H) and Hamady, M., et a1. “Error-Correcting Barcoded Primers
`
`Allow Hundreds of Samples to be Pyrosequenced in Multiplex.” Nat. Methods, 5(3):235-37
`
`(2008) (“Hamady”) (Ex. I) were not before the PTAB during the inter partes reviews. US.
`
`Patent Pub. App. No. 2006/0121452 to Dhallan II (“Dhallan II”) was likewise not before the
`
`PTAB, although a related Dhallan reference (“Dhallan I“) (US. Patent No. 7,332,2??, Ex. C)
`
`was considered. See, e.g., Ex. L, Paper 1 l at 14-20; Ex. M, Paper 1 l at 14-21. However, the
`
`PTAB expressly declined to consider whether the claimed subject matter was rendered obvious
`
`by Dhallan I taken in view of documentation describing commercially available prior art
`
`massively parallel sequencing systems. See Ex. L, Paper 43 at 19, Ex. M, Paper 43 at 19.
`
`Accordingly, even as to Dhallan I the PTAB did not consider whether that reference rendered the
`
`claimed subject matter obvious when considered in combination with then-conventional and
`
`commercially available massively parallel sequencing systems.
`
`The substantial new questions of patentability presented in this request are
`
`straightforward. Dhallan II, filed in 2004, teaches all limitations recited in the claims except the
`
`detection method which employs i) indexing or tagging samples from different patients so they
`
`can be processed simultaneously (sometimes called multiplexing), and ii) using massively
`
`parallel sequencing to sequence the indexed samples. Ex. 0 at 1] 35.
`
`Neither of these latter techniques was commercially available at the time of the filing of
`
`the Dhallan II reference. However, both were present in massively parallel sequencing systems
`
`which were commercially available and widely used by scientists by January 23, 2010, the
`
`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`earliest claimed priority date of the “430 patent. See Exs. F and G. For instance, the Illumina
`
`Genome Analyzer was available in 2008, as was a Multiplexing Kit which was marketed in
`
`conjunction with the Illumina Genome Analyzer. The combined use of the Illumina Genome
`
`Analyzer and the Multiplexing Kit were advertised as providing fast, high throughput analysis of
`
`multiple samples with high quality data, improved productivity and reduced time and cost. Ex.
`
`G at 1. Dr. Rosenberg explains in his declaration that any first year post-doctoral student in a
`
`molecular biology laboratory would have considered it routine (and quite advantageous) to
`
`perform the techniques utilized in the aneuploidy detection method taught by Dhallan II in 2004
`
`using the later-developed Illumina Genome Analyzer and Multiplexing Kit as a replacement for
`
`the labor-intensive detection technique actually used in the examples of Dhallan II. Ex. 0 llll 62-
`
`64; Ex. F (Craig, describing the Illumina Genome Analyzer). The Dhallan II reference expressly
`
`envisions that various sequencing methods could be used with the disclosed aneuploidy detection
`
`assay, stating “[a]ny method that provides information on the sequence of a nucleic acid can be
`
`used," and lists over 20 different detection methods that could be used in addition to the
`
`detection technique actually used in the examples. Ex. E at 1i [0228]. Thus, the claims of the
`
`‘430 patent are rendered obvious by Dhallan II in view of Craig (teaching how to perform
`
`multiplexed processing on the Illumina Genome Analyzer) and further in View of the Illumina
`
`Multiplexing Kit Brochure. Ex. 0 at1l1| 45-52 and 67-191
`
`The second substantial new question of patentability and proposed rejection is similar.
`
`Dhallan II could be alternatively combined with a different massively parallel sequencing
`
`platform sold by 454 Life Sciences, later acquired by Roche before the earliest claimed priority
`
`date. The Roehef454 massively parallel sequencing platform also could have been
`
`advantageously used to perform the method disclosed by Dhallan II, as it too is a more efficient
`
`

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`Request for Ex Pane Reexamination
`Reexamination oIU.S. Patent No. 8.318.430
`
`and cost effective detection method than the detection method taught in Dhallan II.
`
`Parameswaran teaches the use of the Rochef454 massively parallel sequencing platform for
`
`multiplexed detection of multiple samples (Ex. H), and references such as Hamady teach the
`
`efficiency of multiplexing using indexes with the Roche/454 massively parallel sequencing
`
`platform (Ex. 1), Ex. 0 at W 40-41. Thus the claims of the ‘430 patent also are rendered
`
`obvious by Dhallan II in view of Parameswaran (describing large-scale multiplexing using the
`
`Rochei’454 massively parallel sequencing platform) and further in view of Hamady (describing
`
`use of error correcting indexes for multiplexing on the Rochei’454 platform).
`
`Id. at W 53-55,
`
`198-326.
`
`The third substantial new question of patentability is Dhallan I and Binladen. This
`
`ground was presented in the [PR petitions but the Board chose to institute trial instead on a
`
`related but different ground involving a different primary reference — the combination of
`
`Shoemaker, Dhallan I and Binladen. Ex. L, Paper 1] at 20; Ex. M, Paper 1] at 20. The
`
`combination of Dhallan I and B presented herein is fundamentally different that the combination
`
`of Shoemaker, Dhallan I and Binladen addressed during the IPR. The combination of Dhallan I
`
`and Binladen relies on the sequencing techniques of Dhallan I being replaced by those described
`
`in Binladen (118., multiplexed massively parallel sequencing),
`
`In contrast, the ground considered
`
`in the [PR 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). Ex. L, Paper 1 at 38; Ex. M, Paper 1 at 38. Because the combination of Dhallan I
`
`and Binladen also present the technical teaching believed to be missing from the prior art (a
`
`multiplexing method which is compatible with the sequencing method), this combination also
`
`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No, 8.318.430
`
`presents a substantial new question of patentability and renders the claimed subject matter
`
`obvious. Ex. 0 at 111] 56-61 and 327-466.
`
`II.
`
`THE ESTOPPEL PROVISIONS OF 35 USC §§ 315, 325 DO NOT BAR THIS
`REQUEST
`
`Neither 35 U.S.C. § 315(c)(1) nor 35 U.S.C. § 325(c)(1) prohibit Requester from filing
`
`this exparte patent reexamination request. Only the former is relevant here, as the latter applies
`
`to Covered Business Method Review proceedings, which have not occurred relative to the ‘430
`
`patent.
`
`Even if the Final Written Decision had not been vacated, the estoppel provision of 35
`
`U.S.C. § 315(c)(1) cannot apply to grounds presented but not included in the trial proceedings.
`
`The Board held in Apolex Inc. v. Wyeth LLC, [PR2015-0083’3, Paper 8 at 3-9 (Sept. 16, 2015)
`
`(Ex. K) that
`
`An inter partes review does not begin until the Office decides to
`institute review; prior
`to that point, our Rules
`refer
`to a
`“preliminary proceeding’ that begins with the filing of a petition
`and ends with a decision whether to institute trial.
`.
`.
`.
`[G]rounds
`raised during the preliminary proceeding, but not made part of the
`instituted trial, are not raised ‘during’ an inter partes review and
`cannot be the basis for estoppel under 35 U.S.C.
`§ 315(e)('l).
`(internal citation omitted).
`
`In Aporex, the Board concluded that the 35 U.S.C. § 315(e)(]) provision did not apply “because
`
`the Board denied institution of [a ground] as redundant, and Petitioner could not have raised [the
`
`ground] again once institution was denied as to that ground. Estoppel under 35 U.S.C.
`
`§ 3 15(e)( 1), therefore, does not bar Petitioner from maintaining a proceeding before the Office
`
`on [that ground]”. Ex. K at 9. The Director of the United States Patent and Trademark Office
`
`likewise has taken the position that § 315(c)(1) estoppel does not apply to grounds on which trial
`
`

`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`was not instituted.
`
`In the solicitor’s brief in Schott Gemrmn Corp. 12. SSW Holding (70., Appeal
`
`No. 2015-1073, the Office argued that
`
`Contrary to Schott's argument, estoppel does not prevent Schott
`from asserting the
`subset of proposed grounds
`that were
`not part of the [PR proceeding in this case. Under the AIA,
`estoppel applies for "any ground that
`the petitioner raised or
`reasonably could have raised during that inter partes review."
`
`Ex. P at 38 (emphasis in original, citations omitted).
`
`Here, the Board exercised its discretion and declined to institute on the combination of
`
`Dhallan I and Binladen (presented herein at Section VII.C) on the basis that it was redundant
`
`with another ground involving a different primary reference:
`
`3. Obviousness of claims 1-18 over the Combination of
`
`Dhallan and Binladen
`
`Given our determination that there is a reasonable likelihood that
`
`1-18 are
`Ariosa would prevail on the ground that claims
`unpatentable as obvious over Shoemaker, Dhallan, and Binladen,
`we exercise our discretion to deny as redundant Ariosa’s asserted
`ground that claims 1-18 are rendered obvious over Dhallan and
`Binladen.
`
`Ex. L at 20; Ex. M at 20-2]. Accordingly, under the rule set forth in Aporex and the solicitor’s
`
`brief in Soho“, no estoppel can apply to the combination of Dhallan I and Binladen because trial
`
`was not instituted on the ground. Ex. K at 38.
`
`Turning to the remaining grounds presented herein, estoppel does not apply because on
`
`December 23, 2015 the Federal Circuit issued the formal mandate entering thejudgment of the
`
`Federal Circuit, which vacates the final written decisions of the Patent Trial and Appeal Board
`
`(PTAB) in the matter of Ariosa Diagnostics, Inc. v. Verinata Health, Inc., IPR2013-00276 and
`
`IPR2013-002T?. See Exs. T and U. Requester is unaware of any decision specifically
`
`addressing the impact of a vacamr of a final written decision on the estoppel provisions of
`
`

`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`§ 315(e), so it is a case of first impression. Moreover, the legislative history does not appear to
`
`address this issue.
`
`That being said, in a closely related context the Board has held that the one-year bar
`
`provision of 37 C.F.R. § 315(a) does not apply where a district court complaint was dismissed
`
`without prejudice because “[t]he Federal Circuit has consistently interpreted the effect of such
`
`dismissals as leaving the parties as though the action had never been brought.” Macamo v. 805'
`
`GmbH at KG, lPR2012-00004, Paper 18, p. 15 (PTAB Jan 24, 2013).
`
`Vacatur of the final written decision has the same effect and should produce the same
`
`result, r‘.e., the parties should be left is the same position as though the decision had not been
`
`rendered. The Supreme Court has held that “vacating the former judgment [] render[s] [the
`
`judgment] null and void, and the parties are left in the same situation as if no trial had ever taken
`
`place in the cause.” Unified States v. Ayres, 76 US. 608, 610 (1869). The Seventh Circuit
`
`similarly has held that when a judgment is vacated, the effect is to “nullify the judgment entirely
`
`and place the parties in the position of no trial having taken place at all." (Wired States v.
`
`Williams, 904 F.2d 7, 8 (7th Cir. 1990); see also {flirted States v. Lawson, 736 F.2d 835 (2d
`
`Cir. 1984) (“It has long been established [] that when ajudgment has been reversed and the case
`
`remanded for a new trial, the effect is to nullify thejudgment entirely and place the parties in the
`
`position of no trial having taken place").
`
`Because the controlling precedent dictates that vacatur of a decision orjudgm ent puts the
`
`parties in the same position as though the decision orjudgment had not been rendered, the
`
`reasoning adopted by the Board in Mac-aura applies with equal force here. The vacatur of the
`
`final written decisions places the parties in the position as ifno final written decisions had been
`
`rendered. Ariosa Diagnostics is thus not estopped under 37 CPR. § 315(c)(1).
`
`

`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`III.
`
`CITATION OF PRIOR ART PATENTS AND PRINTED PUBLICATIONS
`
`RELIED UPON IN REQUEST FOR RE-EXAMINATION
`
`Reexamination of claims 1-30 of the ‘430 patent is requested in view of the following
`
`prior art patents and printed publications:
`
`US. Patent No. 7,332,277 to Dhallan (“Dhallan I") is attached hereto as Exhibit C.
`
`Dhallan [was filed on September 1 l, 2003 and issued on Feb. 19, 2008, and is available as prior
`
`art under 35 U.S.C. § 102(b).
`
`Binladen, J ., et al. “The Use of Coded PCR Primers Enables High-Throughput
`
`Sequencing of Multiple Homolog Amplification Products by 454 Parallel Sequencing.” PLUS
`
`ONE. 2(2):el97 (2007) (“Binladen”) is attached hereto as Exhibit D, Binladen was published in
`
`February 2007 and is available as prior art under 35 U.S.C. § 102(b).
`
`US. Patent Pub. App. No. 200670121452 to Dhallan (“Dhallan II”) is attached hereto as
`
`Exhibit E. Dhallan II was filed on March 1, 2004 and published on June 8, 2006, and is
`
`available as prior art under 35 U.S.C. § 1 02(b).
`
`Craig, David W., et al. “Identification of Genetic Variants Using Barcoded Multiplexed
`
`Sequencing.”Nat. Methods, 5('IO):887-93 (2008) (“Craig”) is attached hereto as Exhibit F. Craig
`
`was published online on September 14, 2008, and is available as prior art under 35 U.S.C.
`
`§ 102(b). The online publication date is shown at
`
`http:li’www.nature.comlnmethfjoumalfvan101'fullfnmeth. 1251.html, attached as Ex. Q.
`
`Illumina Brochure “Multiplexed Sequencing with the Illumina Genome Analyzer
`
`System," 2008 (“Illumina Brochure") is attached hereto as Exhibit G. The Illumina Brochure
`
`was publically available in 2008 and is available as prior art under 35 U,S.C. § 102(b). The
`
`Illumina Brochure is ascribed a publication date of December 2, 2008 on the face of the ‘430
`
`patent. Ex, A at 1, Other Publications. Consistent with this representation, the Illumina
`
`

`

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`Request for Ex Pane Reexamination
`Reexamination ofU.S. Patent No. 8.318.430
`
`Brochure bears an indication that it was copyrigh