throbber
Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 45
`Entered: November 25, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`SEQUENOM, INC.,
`Petitioner,
`
`v.
`
`THE BOARD OF TRUSTEES OF
`THE LELAND STANFORD JUNIOR UNIVERSITY,
`Patent Owner.
`_______________
`
`Case IPR2013-00390
`Patent 8,195,415 B2
`_______________
`
`
`Before LORA M. GREEN, FRANCISCO C. PRATS, and SCOTT E. KAMHOLZ,
`Administrative Patent Judges.
`
`PRATS, Administrative Patent Judge.
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
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`

`

`Case IPR2013-00390
`Patent 8,195,415 B2
`
`
`I. INTRODUCTION
`A. Statement of the Case
`Sequenom, Inc. (“Petitioner”) filed a Petition requesting inter partes review
`of claims 1–17, all of the claims, of U.S. Patent No. 8,195,415 B2 (Ex. 1001, “the
`’415 patent”). Paper 1 (“Pet.”). The Board of Trustees of the Leland Stanford
`Junior University (“Patent Owner”) did not file a Preliminary Response. We
`instituted trial on the following grounds of unpatentability:
`Reference[s]
`Basis
`Claim[s] challenged
`Lo II1
`§ 102(e)
`1–6, 8–12
`
`Lo II, Hillier,2 Smith3
`
`Lo II, Wang4
`
`Lo II, Shimkets,5 Dohm6
`
`§ 103
`
`§ 103
`
`§ 103
`
`7
`
`13, 16
`
`14
`
`
`1 Lo et al., U.S. Patent App. Pub. No. 2009/0029377 A1 (filed July 23, 2008) (Ex.
`1002, “Lo II”).
`2 LaDeana W. Hillier et al., Whole-genome Sequencing and Variant Discovery in
`C. elegans, 5 NATURE METHODS 183–88 (published online Jan. 20, 2008) (Ex.
`1006).
`3 Andrew D. Smith et al., Using Quality Scores and Longer Reads Improves
`Accuracy of Solexa Read Mapping, 9 BMC BIOINFORMATICS 128 (Feb. 28, 2008)
`(Ex. 1009).
`4 Tian-Li Wang et al., Digital Karyotyping, 99 PNAS 16156–61 (Dec. 10, 2002)
`(Ex. 1005).
`5 Shimkets et al., U.S. Patent App. Pub. No. 2005/0221341 A1 (published Oct. 6,
`2005) (Ex. 1004).
`6 Juliane C. Dohm et al., Substantial Biases in Ultra-short Read Data Sets from
`High-throughput DNA Sequencing, 36 NUCL. ACIDS RES. e105 (published online
`July 26, 2008) (Ex. 1007).
`
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`Case IPR2013-00390
`Patent 8,195,415 B2
`
`Reference[s]
`Lo II, Quake7
`
`Basis
`§ 103
`
`Claim[s] challenged
`15
`
`Lo II, Wang, Hillier, Smith § 103
`
`17
`
`Decision to Institute 21–22 (Paper 7, “Dec.”).
`After the Board instituted trial, Patent Owner filed a Response (Paper 24;
`“PO Resp.”) and Petitioner filed a Reply (Paper 38; “Pet. Reply”). Oral Hearing
`was held on August 5, 2014, and the Hearing Transcript (“Tr.”) has been entered in
`the record. Paper 44.
`We have jurisdiction under 35 U.S.C. § 6(c). This Final Written Decision is
`entered pursuant to 35 U.S.C. § 318(a). We conclude that Petitioner has failed to
`prove by a preponderance of the evidence that claims 1–17 of the ʼ415 patent are
`unpatentable.
`B. Related Proceedings
`The ’415 patent is asserted in a co-pending district court case captioned as
`Verinata Health, Inc. and the Board of Trustees of the Leland Stanford Junior
`University v. Sequenom, Inc. and Sequenom Center for Molecular Medicine LLC,
`United States District Court for the Northern District of California, Case No. 3:12-
`cv-00865-SI. Pet. 1. The ’415 patent also is involved in Interference No. 105,922,
`declared on May 3, 2013. Id. Petitioner also filed a second petition seeking
`review of the claims of the ’415 patent, Case IPR2014-00337. Paper 32. The
`Board declined to institute trial on the grounds presented in that petition.
`Sequenom, Inc. v. Bd. of Trustees of the Leland Stanford Junior Univ. (“Sequenom
`
`
`7 Quake et al., U.S. Patent No. 7,888,017 B2 (filed Feb. 2, 2007, ) (Ex. 1008).
`
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`Case IPR2013-00390
`Patent 8,195,415 B2
`
`II”), Case IPR2014-00337 (PTAB July 16, 2014) (Paper 11); Sequenom II, Paper
`14.
`
`C. The ’415 Patent
`The ’415 patent describes prenatal genetic diagnosis methods that allow
`detection of chromosomal aberrations without the use of invasive techniques, such
`as amniocentesis or chorionic villus sampling, which pose potentially significant
`risks to both fetus and mother. See Ex. 1001, col. 1, ll. 30–54. The ’415 patent
`explains that, because fetal DNA can constitute nearly ten percent of the cell-free
`DNA in maternal plasma, fetal aneuploidy can be detected by determining the
`sequences of the DNA fragments in the maternal plasma. See id. at col. 1, l. 55–
`col. 2, l. 24. More particularly, the ’415 patent describes “the successful use of
`shotgun sequencing and mapping of DNA to detect fetal trisomy 21 (Down
`syndrome), trisomy 18 (Edward syndrome), and trisomy 13 (Patau syndrome),
`carried out non-invasively using cell-free fetal DNA in maternal plasma.” Id. at
`col. 4, ll. 17–21.
`Claim 1, reproduced below, illustrates the challenged subject matter:
`1. A method of testing for an abnormal distribution of a
`specified chromosome portion in a mixed sample of normally
`and abnormally distributed chromosome portions obtained from
`a subject, comprising:
`
`(a)
`
`
`(b)
`
`
`
`sequencing DNA from the mixed sample to obtain
`sequences from multiple chromosome portions,
`wherein said sequences comprise a number of
`sequence tags of sufficient length of determined
`sequence to be assigned to a chromosome location
`within a genome;
`
`assigning the sequence tags to corresponding
`chromosome portions
`including at
`least
`the
`
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`Case IPR2013-00390
`Patent 8,195,415 B2
`
`
`the
`comparing
`by
`chromosome
`specified
`determined sequence of the sequence tags to a
`reference genomic sequence;
`
`
`(c) determining values for numbers of sequence tags
`mapping to chromosome portions by using a
`number of windows of defined length within
`normally and abnormally distributed chromosome
`portions to obtain a first value and a second value
`therefrom; and
`
`
`(d) using the values from step (c) to determine a
`differential, between the first value and the second
`value, which is determinative of whether or not the
`abnormal distribution exists.
`
`
`II. ANTEDATING LO II
`A. The Parties’ Positions
`Patent Owner contends that Lo II, which Petitioner relies upon in every
`instituted ground of unpatentability, does not qualify as prior art under 35 U.S.C.
`§ 102(e) because the invention recited in the ’415 patent claims was reduced to
`practice before Lo II’s filing date of July 23, 2008. PO Resp. 31. Patent Owner’s
`contentions in that regard involve a paper published in the Proceedings of the
`National Academy of Sciences (“the PNAS paper”),8 which was co-authored by
`the two inventors of the ’415 patent, Drs. Hei-Mun Christina Fan and Stephen R.
`Quake, along with others. Id. at 38–39.
`Specifically, Patent Owner contends that two early drafts of the PNAS
`paper, presented in Exhibits 2111, 2112, and 2113, as well as email
`
`8 Dr. Hei-Mun Christina Fan et al., Noninvasive Diagnosis of Fetal Aneuploidy by
`Shotgun Sequencing DNA from Maternal Blood, available at
`www.pnas.org/cgi/doi/10.1073/pnas.0808319105 (2008) (Ex. 2139).
`
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`Case IPR2013-00390
`Patent 8,195,415 B2
`
`correspondence associated with the drafts, and testimony by Dr. Yair J.
`Blumenfeld, one of the other PNAS paper co-authors, establish that the inventors
`had actually reduced to practice the subject matter recited in claims 1–17 of the
`’415 patent before Lo II’s July 23, 2008 filing date. Id. Patent Owner presents a
`chart to support its assertion that the two drafts of the PNAS paper describe all of
`the subject matter claimed in the ’415 patent. Id. at 39–59.
`Petitioner does not contend that the disclosures in Lo II relied upon to show
`unpatentability in the instituted grounds are entitled to the benefit of the earlier
`filing date of Lo II’s corresponding provisional application, Lo I. 9 See Pet. Reply
`7–13. Instead, Petitioner argues that Patent Owner has failed to advance evidence,
`independent of the inventors’ testimony, that sufficiently corroborates the asserted
`actual reduction to practice before Lo II’s filing date. Id. at 7–8. Petitioner
`summarizes its arguments as follows:
`[Inventor] Quake’s declaration has been withdrawn, and [inventor]
`Fan’s allegation of a reduction to practice lacks corroboration. Other
`than the Fan declaration (Ex. 2132), the only evidence of an actual
`reduction to practice proffered by Patent Owner is an unwitnessed and
`unsigned laboratory notebook (Ex. 2110), emails between the
`inventors and various parties that fail to reference the specific steps of
`the ’415 Patent claims, and testimony by third parties who lack
`specific knowledge of the inventors’ alleged activities during the
`relevant time period ([Dr. J. Chris] Detter) and fail to corroborate a
`reduction to practice of the steps of the ’415 Patent claims
`(Blumenfeld).
`
`
`Id.
`
`
`9 Lo et al., U.S. Provisional Patent Application 60/951,438 (filed July 23, 2007)
`(Ex. 1003, “Lo I”).
`
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`Case IPR2013-00390
`Patent 8,195,415 B2
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`Petitioner argues in particular that Patent Owner has not advanced evidence,
`independent of the inventors’ testimony, corroborating Patent Owner’s assertion
`that the copies of the drafts of the PNAS paper presented in Exhibits 2111 and
`2113 are the actual documents communicated by inventor Dr. Christina Fan to the
`asserted corroborating witness, Dr. Blumenfeld. Id. at 9–11. Further, Petitioner
`argues, the Declaration by Dr. Blumenfeld (Ex. 2134) submitted by Patent Owner
`is:
`
`critically deficient because it provides no statement as to what Blumenfeld
`actually knew and understood about the methods recited in the ’415 Patent
`claims at the time of the alleged reduction to practice, and certainly no
`evidence that he was aware of all of the steps or that he recognized a
`complete reduction to practice.
`
`Id. at 12.
`B. The Issue
`In light of the discussion above, the critical issue in this case is whether
`Patent Owner has advanced evidence sufficient to corroborate an actual reduction
`to practice of the subject matter of the ’415 patent’s claims before the July 23,
`2008 filing date of the Lo II reference. See 35 U.S.C. § 102(e)(1) (patent-defeating
`published application must be “filed . . . before the invention by the applicant for
`patent”).10 For the reasons discussed below, we conclude that Patent Owner has
`established an actual reduction to practice before the relevant date.
`
`
`10 The application which that issued as the ’415 patent, serial number 12/696,509,
`is a divisional application of serial number 12/560,708, which was filed on
`September 16, 2009. Ex. 1001, 1. Accordingly, the version of § 102(e) in effect
`before the Leahy-Smith America Invents Act (“AIA”) applies to the claims of the
`’415 patent. See AIA, Pub. L. No. 112-29, § 3, 125 Stat. 288 (2011).
`
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`Case IPR2013-00390
`Patent 8,195,415 B2
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`C. Analysis
`“Generally, the invention of a process is completed, or reduced to practice,
`when it is successfully performed.” Shurie v. Richmond, 699 F.2d 1156, 1159
`(Fed. Cir. 1983). “In order to establish an actual reduction to practice, an
`inventor’s testimony must be corroborated by independent evidence. . . . [A] ‘rule
`of reason’ analysis is applied to determine whether an inventor’s testimony
`regarding reduction to practice has been sufficiently corroborated.” Cooper v.
`Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (citation omitted). This “rule of
`reason” analysis “requires an evaluation of all pertinent evidence when
`determining the credibility of an inventor’s testimony.” Id. Under that analysis,
`“to corroborate a reduction to practice, it is not necessary to produce an actual
`over-the-shoulder observer. Rather, sufficient circumstantial evidence of an
`independent nature can satisfy the corroboration requirement.” Id.
`Corroborating evidence may be “testimony of a witness, other than an
`inventor, to the actual reduction to practice or it may consist of evidence of
`surrounding facts and circumstances independent of information received from the
`inventor.” Hahn v. Wong, 892 F.2d 1028, 1032–33 (Fed. Cir. 1989).
`Corroboration, however, “is not necessary to establish what a physical exhibit
`before the [B]oard includes. Only the inventor’s testimony requires corroboration
`before it can be considered.” Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir.
`1993) (citation omitted).
`In the instant case, as discussed above, Patent Owner advances Exhibits
`2111 and 2113, which are essentially identical, to support its contention of
`reduction to practice. PO Resp. 38–39. Patent Owner asserts that Exhibits 2111
`and 2113 include a draft of the PNAS paper, which inventor Dr. Christina Fan
`forwarded on June 19, 2008, to PNAS paper co-authors Drs. Stephen Quake and
`
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`Yair Blumenfeld. Id. Patent Owner explains that Dr. Blumenfeld’s collaboration
`with Drs. Fan and Quake consisted of providing patient blood samples for the fetal
`aneuploidy diagnosis test conducted by Drs. Fan and Quake, and preparing the
`protocol and consent forms “for the Institutional Review Board (‘IRB’) in order to
`collect the samples from patients.” Id. at 32 (citing Ex. 2134 ¶ 6 (Blumenfeld
`Decl.)).
`We note that Exhibits 2111 and 2113 include a copy of a manuscript entitled
`“Universal Non-Invasive Diagnosis of Fetal Aneuploidy with Direct Sequencing,”
`listing Drs. Fan, Quake, and Blumenfeld as co-authors. Ex. 2111, 1–14; Ex. 2113,
`1–14. Exhibits 2111 and 2113 also include a copy of an email dated June 19,
`2008, from Dr. Fan to Drs. Quake and Blumenfeld stating, “[a]ttached is a rough
`draft of the non-invasive study.” Ex. 2111, cover page; Ex. 2113, cover page.
`Inventor Dr. Fan testifies that she sent the draft of the PNAS paper in
`Exhibits 2111 and 2113 to Drs. Quake and Blumenfeld on June 19, 2008. Ex.
`2132 ¶ 44.
`Dr. Blumenfeld testifies as follows:
`On June 19, 2008, Dr. Fan sent to Stephen Quake and me a
`“rough draft of the non-invasive study,” (Ex. 2111, 2113) which was
`based on their first Solexa sequencing run and was to be submitted to
`the journal Proceedings of the National Academy of Sciences, USA,
`which ultimately published as the article “Noninvasive diagnosis of
`fetal aneuploidy by shotgun sequencing DNA from maternal blood,”
`Proc. Natl. Acad. Sci. USA (2008) 105(42):16266-16271 (“first draft
`of the PNAS manuscript”; Ex. 2113). I was listed as an author on that
`paper, along with Christina Fan, Usha Chitkara, Louanne Hudgins and
`Stephen Quake.
`
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`Case IPR2013-00390
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`Ex. 2134 ¶ 9. Dr. Blumenfeld also testifies that “[o]n July 7, 2008, Drs. Quake,
`Fan and I discussed revisions to the PNAS manuscript. (Ex. 2112, 2131).” Id. at
`¶ 11.
`Exhibit 2131, which Dr. Blumenfeld cites in his statement immediately
`above regarding his discussions with Drs. Quake and Fan about revisions to the
`PNAS manuscript, includes a copy of an email dated July 7, 2008, from Dr.
`Blumenfeld to Dr. Fan. Ex. 2131, 1.11 Dr. Blumenfeld also copied Dr. Quake on
`his July 7, 2008 email. Id. Dr. Blumenfeld’s email reads as follows:
`Hi Christina,
`
`It looks great. I think I answered most of the comments you directed
`towards me and I added a little bit about the recent ACOG Practice
`Bulletin which recommends that invasive testing now be offered to
`ALL women, regardless of risk factors. I think it will play nicely with
`the need for a “risk-free” non-invasive diagnostic test.
`
`Thanks,
`
`Yair
`
`Id.
`Dr. Blumenfeld’s testimony, considered in conjunction with the exhibits he
`cites, persuades us that Patent Owner has advanced sufficient evidence,
`independent of the inventors’ testimony, to corroborate reduction to practice of the
`subject matter of claims 1–17 of the ’415 patent as of June 19, 2008. In particular,
`Dr. Blumenfeld’s testimony persuades us that the copy of the draft of the PNAS
`
`
`11 Exhibit 2131 does not include page numbers. We cite to the first page as page 1
`and the remaining pages as if consecutively numbered.
`
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`Case IPR2013-00390
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`paper presented in identical Exhibits 2111 and 2113 is the document that Dr. Fan
`sent to Dr. Blumenfeld on June 19, 2008.
`Specifically, when referring to the draft of the PNAS paper Dr. Fan sent him
`on that date, Dr. Blumenfeld expressly identifies Exhibits 2111 and 2113. Ex.
`2134 ¶ 9 (“On June 19, 2008, Dr. Fan sent to Stephen Quake and me a ‘rough draft
`of the non-invasive study,’ (Ex. 2111, 2113) . . . .”). Dr. Blumenfeld’s status as a
`co-author of the paper, as well as his testimony that he reviewed Exhibit 2111 (Ex.
`2134 ¶ 5), persuades us that Dr. Blumenfeld was aware of the contents of
`Exhibit 2111 when he identified it as the document he received from Dr. Fan on
`June 19, 2008. Moreover, as noted above, in addition to identifying Exhibits 2111
`and 2113 as containing the document he received from Dr. Fan on June 19, 2008,
`Dr. Blumenfeld testifies that, on July 7, 2008, he, Dr. Quake, and Dr. Fan
`discussed revisions to the PNAS manuscript. Ex. 2134 ¶ 9. In so stating,
`Dr. Blumenfeld cites to Exhibit 2131, which includes an email from
`Dr. Blumenfeld explaining his revisions to the draft, and stating that the draft
`“looks great.” Id.; see also Ex. 2131, 1. Consequently, Petitioner does not
`persuade us (Pet. Reply 10) that Patent Owner proffers no testimony to verify that
`the document in Exhibits 2111 and 2113 is a copy of the actual document received
`by Dr. Blumenfeld on June 19, 2008. To the contrary, Dr. Blumenfeld’s testimony
`that he provided an evaluation of the document in Exhibits 2111 and 2113, as well
`as proposed revisions to it, shows that he reviewed that document, and
`corroborates further that the document in Exhibits 2111 and 2113 is in fact a copy
`of the document Dr. Blumenfeld received from his co-author Dr. Fan on June 19,
`2008.
`Petitioner gives us no credible reason to doubt that Exhibits 2111 and 2113
`are copies of the actual document Dr. Blumenfeld received, nor does Petitioner
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`Case IPR2013-00390
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`direct us to specific evidence that undercuts Dr. Blumenfeld’s testimony in that
`regard, or otherwise supports a contrary finding. Moreover, Petitioner does not
`explain how the other co-authors and collaborators of the PNAS paper, with the
`exception of Dr. Quake, were involved in the interchange between Drs. Fan and
`Blumenfeld described in Dr. Blumenfeld’s Declaration. Accordingly, Petitioner
`does not persuade us that the absence of testimony from those individuals warrants
`drawing an “adverse inference” against Patent Owner on this issue. See Pet. Reply
`13. Further, because, under the law, testimony by co-inventor Dr. Quake cannot
`serve to corroborate evidence that the draft appearing in Exhibits 2111 and 2113 is
`the document Dr. Fan sent to Dr. Blumenfeld, we decline to draw an adverse
`inference based on the absence of Dr. Quake’s testimony. See id.
`Regarding the content of the draft of the PNAS paper appearing in Exhibits
`2111 and 2113, the fact that Dr. Blumenfeld might not have expressly mentioned
`the method steps of the ’415 patent as being described in those Exhibits, or
`discussed his understanding of those steps, does not demonstrate that the draft in
`Exhibits 2111 and 2113 fails to describe an actual reduction to practice of the
`processes recited in claims 1–17 of the ’415 patent. Similarly, the fact that the
`Declarations of Drs. Blumenfeld and Detter (Exs. 2134, 2138) might not set forth
`an explanation of the legal standard for actual reduction to practice does not
`persuade us that the experiments disclosed in Exhibits 2111 and 2113 fail to
`describe an actual reduction to practice. Specifically, as noted above,
`“corroboration is not necessary to establish what a physical exhibit before the
`[B]oard includes. Only the inventor’s testimony requires corroboration before it
`can be considered.” Price, 988 F.2d at 1195 (internal quotations omitted). As
`explained in Price, “[w]hile evidence as to what the drawing [in the Exhibit at
`issue] would mean to one of skill in the art may assist the [B]oard in evaluating the
`
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`drawing, the content of [the] Exhibit [at issue] does not itself require
`corroboration.” Id. at 1195–96; see also Mahurkar v. C.R. Bard, Inc., 79 F.3d
`1572, 1577–78 (Fed. Cir. 1996) (“The trier of fact can conclude for itself what
`documents show, aided by testimony as to what the exhibit would mean to one
`skilled in the art.”).
`In reviewing Exhibits 2111 and 2113, claims 1–17 of the ’415 patent, and
`the claim charts presented by Patent Owner, we detect no deficiency in Patent
`Owner’s assertion that the draft of the PNAS paper appearing in those exhibits
`describes the subject matter of claims 1–17 of the ’415 patent. See PO Resp. 39–
`60 (presenting claim charts); Ex. 2138 ¶ 7 (Second Declaration by Dr. J. Chris
`Detter) (same). Moreover, Petitioner does not allege error in Patent Owner’s
`assertion that the draft of the PNAS paper in Exhibits 2111 and 2113 describes the
`subject matter of claims 1–17 of the ’415 patent. See Pet. Reply 7–13. Nor does
`Petitioner advance expert testimony refuting that assertion or the accuracy of the
`claim charts. See id. Indeed, Petitioner does not point to clear or specific evidence
`contravening the central assertion in the draft in Exhibits 2111 and 2113, namely
`that “[w]e demonstrate here the successful use of massively parallel sequencing to
`detect fetal trisomy 21 (Down Syndrome) and trisomy 18 (Edward Syndrome) non-
`invasively using cell-free fetal DNA in maternal plasma.” Ex. 2111, 2; Ex. 2113,
`2. Thus, Petitioner does not advance clear or specific evidence suggesting that the
`draft of the PNAS paper in Exhibits 2111 and 2113 fails to describe successful
`performance of the processes recited in the claims of the ’415 patent. Accordingly,
`we are persuaded that the evidence of record not only reasonably supports Patent
`Owner’s assertion that the draft of the PNAS paper appearing in Exhibits 2111 and
`2113 is the draft of the PNAS paper that Dr. Fan sent to Dr. Blumenfeld on June
`19, 2008, but also reasonably supports Patent Owner’s assertion that that document
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`describes an actual reduction to practice, on that date, of claims 1–17 of the ’415
`patent, the claims challenged in this proceeding.
`Petitioner does not persuade us that the holding in Hahn v. Wong mandates a
`contrary result. In Hahn, the Federal Circuit affirmed the Board’s conclusion that
`a patent applicant had not made a prima facie case of prior reduction to practice
`where the allegedly antedating evidence consisted of spectroscopic graphical data
`from the inventor’s laboratory notebook pages, supplemented with two non-
`inventor affidavits stating that the affiants had read and understood the notebook
`pages. 892 F.2d at 1030–31, 1033–34. The court agreed with the Board’s
`conclusion that the applicant had not shown prima facie reduction to practice,
`because the corroborative affidavits did not explain why the graphical data in the
`laboratory notebook actually represented the chemical compound in the challenged
`claims, and because the dates of the alleged reduction to practice were ambiguous.
`Id. at 1033–34.
`In the instant case, in contrast, Petitioner has not shown ambiguity in the
`asserted date of the draft in Exhibits 2111 and 2113. Nor has Petitioner explained
`convincingly why the draft of the PNAS paper in Exhibits 2111 and 2113, which
`Petitioner does not dispute describes the processes of the challenged claims, and
`which is presented in straightforward manuscript form, requires testimony by a
`technical expert to evaluate whether it describes successful performance of the
`process recited in the challenged claims.
`In sum, for the reasons discussed, non-inventor corroborating evidence
`reasonably supports Patent Owner’s assertion that, on June 19, 2008, inventor Dr.
`Fan sent to Dr. Blumenfeld the draft of the PNAS paper appearing in Exhibits 2111
`and 2113. As also discussed above, the evidence reasonably supports Patent
`Owner’s assertion that that document describes an actual reduction to practice of
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`the processes recited in claims 1–17 of the ’415 patent. We are persuaded,
`therefore, that Patent Owner has shown that the subject matter of the challenged
`claims was reduced to practice before Lo II’s July 23, 2008 filing date.
`Accordingly, because the evidence does not support Petitioner’s position that Lo II
`constitutes prior art to the challenged claims under 35 U.S.C. § 102(e), and because
`Lo II is relied upon in every ground on which trial was instituted, Petitioner has not
`shown by a preponderance of the evidence that any of the challenged claims is
`unpatentable, based on any of the asserted grounds of unpatentability.
`
`III. CONCLUSION
`For the reasons given, we are not persuaded that Petitioner has shown by a
`preponderance of the evidence that claims 1–17 of the ’415 patent are unpatentable
`based on the challenges on which trial was instituted.
`IV. ORDER
`It is ORDERED that claims 1–17 of the ’415 patent have not been shown to
`be unpatentable;
`FURTHER ORDERED that because this is a final written decision, parties
`to the proceeding seeking judicial review of the decision must comply with the
`notice and service requirements of 37 C.F.R. § 90.2.
`
`
`
`
`
`
`
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`Case IPR2013-00390
`Patent 8,195,415 B2
`
`For PETITIONER:
`Michael Wise
`Patrick Morris
`PERKINS COIE LLP
`mwise@perkinscoie.com
`pmorris@perkinscoie.com
`
`For PATENT OWNER:
`R. Danny Huntington
`Sharon Crane
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`dhuntington@rfem.com
`scrane@rfem.com
`
`
`16
`
`
`
`

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