Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`
`Paper 10
`
`Date: October 23, 2017
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CELLTRION, LLC,
`Petitioner,
`
`v.
`
`BIOGEN, INC. AND GENENTECH, INC.,
`Patent Owner.
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`
`
`
`Before ERICA A. FRANKLIN, SHERIDAN K. SNEDDEN, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`Paper 10
`
`Date: October 23, 2017
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`CELLTRION, LLC,
`Petitioner,
`
`v.
`
`BIOGEN, INC. AND GENENTECH, INC.,
`Patent Owner.
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`
`
`
`Before ERICA A. FRANKLIN, SHERIDAN K. SNEDDEN, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`I. INTRODUCTION
`Celltrion, Inc. (“Petitioner”) filed a Petition to institute an inter partes
`review of claims 23–35 and 37–57 (Paper 2; “Pet.”) of U.S. Patent No.
`7,682,612 B1 (Ex. 1101; “the ’612 patent”). Biogen, Inc. and Genentech,
`Inc. (“Patent Owner”) filed a Patent Owner Preliminary Response. Paper 8.
`We have authority to determine whether to institute an inter partes
`review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). Upon considering
`the Petition and the Preliminary Response, we determine that Petitioner has
`not shown a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 23–35 and 37–57. Accordingly, we deny the
`Petition and decline to institute an inter partes review.
`Related Proceedings
`A.
`The parties inform us of no related pending litigations. Pet. 4;
`Paper 6.
`The ’612 patent is currently the subject of IPR2017-01230, filed
`concurrently with this proceeding by Petitioner. Petitioner also filed a
`petition for inter partes review of U.S. Patent No. 8,206,711 (IPR2017-
`01229), which is related to the ’612 patent.
`The ’612 Patent (Ex. 1101)
`B.
`The ’612 patent discloses therapeutic regimens involving the
`administration of anti-CD20 antibodies for the treatment of chronic
`lymphocytic leukemia (CLL). Ex. 1101, Abst., 2:16–21. “[A] particularly
`preferred chimeric anti-CD20 antibody is RITUXAN® (rituximab), which is
`a chimeric gamma 1 anti-human CD20 antibody.” Id. at 3:18–20.
`With regard to dosing, the ’612 patent discloses that “[t]ypically
`
`2
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`effective dosages will range from about 0.001 to about 30 mg/kg body
`weight, more preferably from about 0.01 to 25 mg/kg body weight, and most
`preferably from about 0.1 to about 20 mg/kg body weight.” Id. at 3:50–54.
`“Such administration may be effected by various protocols, e.g., weekly, bi-
`weekly, or monthly, dependent on the dosage administered and patient
`response.” Id. at 3:55–57. “A particularly preferred dosage regimen will
`comprise administration of about 375 mg/m2 weekly for a total of four
`infusions.” Id. at 3:64–66.
`Illustrative Claims
`C.
`Petitioner challenges claims 23–35 and 37–57 of the ’612 patent.
`Independent claims 23 and 28 are illustrative of the challenged claims and
`are reproduced below:
`23. A method of treating chronic lymphocytic leukemia in a
`human patient, comprising administering an anti-CD20 antibody
`to the patient in an amount effective to treat the chronic
`lymphocytic leukemia, wherein the anti-CD20 antibody therapy
`is combined with chemotherapy, wherein the method does not
`include treatment with a radiolabeled anti-CD20 antibody.
`
`28. A method of treating chronic lymphocytic leukemia in a
`human patient, comprising administering an anti-CD20 antibody
`to the patient in an amount effective to treat the chronic
`lymphocytic leukemia, wherein the anti-CD20 antibody is
`administered to the patient at a dosage of about 500 to about 1500
`mg/m2, wherein the anti-CD20 antibody therapy is combined
`with chemotherapy, and wherein the method does not include
`treatment with a radiolabeled anti-CD20 antibody.
`
`
`3
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`
`D.
`
`The Asserted Grounds
`
`1
`
`2
`
`Petitioner challenges claims 23–35 and 37–57 of the ’612 patent on
`the following grounds. Pet. 33–66.
`Ground
`Reference[s]
`Czuczman,1 FDA
`Transcript,2 Batata,3 and
`Maloney4
`Byrd5 and MD Anderson
`Newsletter6
`
`Basis Challenged Claims
`
`§ 103
`
`23–35, 37–57
`
`§ 103
`
`23–35, 37–57
`
`
`1 Ex. 1111, Czuczman, M.S. et al., Chemoimmunotherapy of Low-Grade
`Lymphoma with the anti-CD20 Antibody IDEC-C2B8 in Combination with
`CHOP Chemotherapy, Cancer Invest. 14:59-61 (Abstract 53) (1996)
`(“Czuczman”).
`2 Ex. 1107, Public Hearing Transcript, Biological Response Modifiers
`Advisory Committee, Center for Biological Evaluation and Research, Food
`and Drug Administration, nineteenth meeting (July 25, 1997) (“FDA
`Transcript”).
`3 Ex. 1108, Batata, A. & Shen, B., Relationship between Chronic
`Lymphocytic Leukemia and Small Lymphocytic Lymphoma: A Comparative
`Study of Membrane Phenotypes in 270 Cases, 70(3) CANCER 625-632 (1992)
`(“Batata”).
`4 Ex. 1109, Maloney, D.G. et al., Phase I Clinical Trial Using Escalating
`Single-Dose Infusion of Chimeric Anti-CD20 Monoclonal Antibody (IDEC-
`C2B8) in Patients with Recurrent B-Cell Lymphoma, 84(8) BLOOD 2457-
`2466 (Oct. 15, 1994) (“Maloney 1994”).
`5 Ex. 1110, Byrd, J.C. et al., Old and New Therapies in Chronic
`Lymphocytic Leukemia: Now Is the Time for a Reassessment of Therapeutic
`Goals, 25(1) Semin. Oncol. 65–74 (Feb. 1998) (“Byrd”).
`6 Ex. 1103, Archived website for Leukemia Insights Newsletter, 3(2)
`(Archived on February 2, 1999) (“MD Anderson Newsletter”); Petitioner
`contends that MD Anderson Newsletter was also available as a print version
`
`4
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`
`Ground
`3
`
`Reference[s]
`Byrd, MD Anderson
`Newsletter and Kipps7
`Petitioner supports its challenge with the Declaration of Michael
`Andreeff, M.D (Ex. 1105).
`
`Basis Challenged Claims
`§ 103
`41–42
`
`II. ANALYSIS
`Claim Interpretation
`A.
`We interpret claims using the “broadest reasonable construction in
`light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`§ 42.100(b); Cuozzo Speed Techs. LLC v. Lee, 136 S. Ct. 2131, 2144–46
`(2016). Under the broadest reasonable construction standard, claim terms
`are generally given their “ordinary and customary meaning,” as would be
`understood by one of ordinary skill in the art at the time of the invention. In
`re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (quoting
`Phillips v. AWH Corp, 415 F.3d 1303, 1312 (Fed. Cir. 2005)).
`Petitioner and Patent Owner propose constructions for certain claim
`terms. Pet. 21–25; Prelim. Resp. 14–24. We determine that no explicit
`construction of any claim term is necessary to determine whether to institute
`a trial in this case. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d
`795, 803 (Fed. Cir. 1999) (Only terms which are in controversy need to be
`construed, and only to the extent necessary to resolve the controversy).
`
`(Ex. 1163).
`7 Ex. 1155, Kipps, T.J. Chapter 106: Chronic lymphocytic leukemia and
`related diseases, in Williams Hematology Fifth Edition, 1017–1039
`(Beutler, E. et al., eds., 1995) (“Kipps”).
`5
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`
`B.
`and 37–57
`
`Enablement and Written Description Support for Claims 23–35
`
`The ’612 patent issued from an application filed on November 9,
`1999, and claims priority to U.S. Provisional Application No. 60/107,658
`(“the ’658 provisional application”; Ex. 1102), filed on November 9, 1998.
`Ex. 1101. The Petitioner argues that claims 23–35 and 37–57 are not
`entitled to the November 9, 1998 filing date because these claims allegedly
`lack written description or enablement support in the ’658 provisional
`application. Pet. 19–21.
`1. Claims 23–35, 37–45, 47–52, and 54–57
`
`Petitioner contends that the specification of the ’658 provisional
`application lacks sufficient written description or enablement support for
`combination therapies using both rituximab and chemotherapeutic agents for
`treating CLL. Id. at 20. In support of this contention, Petitioner argues that
`“[t]here is not a single example, reference study or any demonstrated results
`indicating that the inventors had possession of and taught a POSA how to
`practice the full scope of these combination therapy claims in the ’658
`provisional application.” Id.
`We are not persuaded. The written description and enablement
`requirements do not demand as a matter of law actual examples or an actual
`reduction to practice. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
`1352 (Fed. Cir. 2010) (explaining that “the written description requirement
`does not demand either examples or an actual reduction to practice”); In re
`Wands, 858 F.2d 731, 736 (Fed. Cir. 1988) (“Enablement is not precluded
`by the necessity for some experimentation. . . .”). With regard to the written
`
`6
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`description requirement, we note that the ’658 provisional application
`discloses that “[t]reatment of hematologic malignancy, such as CLL, . . .
`according to the invention will comprise the administration of a
`therapeutically effective amount of an anti-CD20 antibody, which
`administration may be effected alone or in conjunction with other
`treatment(s), e.g., chemotherapy . . . .” Ex. 1102, 006; id. at 009 (describing
`treatment with an anti-CD20 antibody and stating that “it may be desirable
`to combine such administration with other treatments, e.g., radioactive
`therapy, both targeted and non-targeted, chemotherapies, . . . etc.”). The
`’658 provisional application further discloses that “[a] particularly preferred
`chemotherapeutic regimen that may be used in conjunction with the subject
`antibody immunotherapy comprises CHOP immunotherapy, which
`comprises the administration of a combination of cyclophosphamide,
`doxorubicin, vincristine and prednisone,” and that “[o]ther known
`chemotherapeutics include methotrexate, cisplatin, toremifene and
`tamoxifen.” Ex. 1102, 010. Based on those disclosures and similar, we
`conclude that the ’658 provisional application provides adequate written
`description support for combination therapies using both rituximab and
`chemotherapeutic agents for treating CLL. Accordingly, we see no merit in
`Petitioner’s contentions.
`We further determine, based on the current record, that Petitioner fails
`to establish a person of ordinary skill in the art would not have been able to
`practice the inventions of claims 23–35, 37–45, 47–52, and 54–57 based on
`the disclosure of the application together with what was known in the art.
`See HTC Corporation, et al. v. Advanced Audio Devices, LLC, IPR2014-
`
`7
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`01158 (Paper 36) at 10–11 (Jan. 22, 2016) (emphasizing that “the ultimate
`burden of persuasion . . . remains on the Petitioner,” who must “convince the
`Board that the challenged claim is not entitled to the benefit of the earlier
`filing date”).
`Based upon our review, summarized above, we conclude that
`Petitioner fails to establish that claims 23–35, 37–45, 47–52, and 54–57 are
`not entitled to the benefit of priority to the ’658 provisional application
`based on lack of written description support and enablement.
`2. Claims 46 and 53
`Claim 46 is directed to a method according to claim 23 or 28, wherein
`the chemotherapy comprises chlorambucil. Claim 53 is directed to a method
`according to claim 23 or 28, wherein the chemotherapy comprises
`fludarabine. Petitioner argues that that these claims lack sufficient written
`description or enablement support because “there is no mention in the
`provisional application anywhere of using chemotherapeutic agents
`fludarabine or chlorambucil.” Pet. 20.
`Patent Owner does not dispute this contention and fails to direct us to,
`and we do not find, a disclosure in the ’658 provisional application that
`would provide written description support for the subject matter of claims 46
`and 53. Accordingly, for the purposes of this decision, we find that claims
`46 and 53 lack written description support in the ’658 provisional
`application and are entitled to a priority date of November 9, 1999, the filing
`date of the application that matured into the ’612 patent.
`Challenges Based on FDA Transcript
`C.
`Petitioner’s Obviousness Ground 1 relies on FDA Transcript. Pet.
`
`8
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`38–40. Before turning to the merits of these challenges, we address Patent
`Owner’s contention that Petitioner failed to establish that FDA Transcript
`was sufficiently available to the public to constitute a printed publication.
`Prelim. Resp. 25–28.
`To qualify as a “printed publication,” a reference “must have been
`sufficiently accessible to the public interested in the art” before the critical
`date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). Whether a
`reference is publicly accessible is determined on a case-by-case basis
`dependent on the “facts and circumstances surrounding the reference’s
`disclosure to members of the public.” In re Lister, 583 F.3d 1307, 1311
`(Fed. Cir. 2009) (quoting In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir.
`2004)). “A reference is considered publicly accessible if it was
`‘disseminated or otherwise made available to the extent that persons
`interested and ordinarily skilled in the subject matter or art[,] exercising
`reasonable diligence, can locate it.’” Id. (quoting Kyocera Wireless Corp. v.
`Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)); see also, SRI
`Int’l, Inc. v. Internet Security Sys., Inc., 511 F.3d 1186, 1194–97 (Fed. Cir.
`2008) (finding that a “paper was not publicized or placed in front of an
`interested public” although the paper was on a FTP server and available to
`anyone who managed to find it); Groupon, Inc. v. Blue Calypso LLC,
`CBM2013-00044, 2014 WL 7273564 at *11 (PTAB. Dec. 17, 2014)
`(finding that a paper was not a printed publication where it “was only
`available for ‘viewing and downloading’ to members of the public who
`happened to know that the [] paper was there”). Petitioner bears the burden
`of establishing public accessibility of the prior art references it relies upon
`
`9
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`for its patentability challenges. See Blue Calypso, LLC v. Groupon, Inc.,
`815 F.3d 1331, 1350 (Fed. Cir. 2016) (finding that petitioner in an AIA
`proceeding “failed to carry its burden of proving public accessibility”).
`Having considered the evidence of record, we agree with Patent
`Owner that Petitioner failed to establish that FDA Transcript was
`sufficiently available to the public to constitute a printed publication.
`Petitioner relies upon a letter from Dynna Bigby from the Division of
`Dockets Management (“DDM”) (Ex. 1154) at the FDA to support its
`contention that FDA Transcript is a prior art printed publication. Pet. 26–27.
`According to Petitioner, the letter establishes that (a) the FDA Transcript
`would have been received on August 8, 1997, the date stamped on the FDA
`Transcript; (b) the DDM would have made the document publicly available
`via the DDM Public Reading Room; and (c) access to the FDA Transcript
`would have required filling out a reading room request form for the
`document. Id. Even if each of those assertions were taken as true, the
`record is missing a supported explanation that such availability of the FDA
`Transcript was in a manner and to an extent that persons interested and
`ordinarily skilled in the subject matter or art exercising reasonable diligence
`would have been able to locate it. In other words, Petitioner has not
`explained how such persons may have known that this particular transcript
`existed and was available, upon request, in the DDM Public Reading Room.
`Without that information, Petitioner has not shown that the FDA Transcript
`is a prior art printed publication.
`Consequently, the reference is unavailable as prior art to support
`Petitioner’s obviousness Ground 1. Thus, based on the information
`
`10
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`presented, we determine that Petitioner has not shown sufficiently that there
`is a reasonable likelihood that it would prevail in showing the
`unpatentability of any claim of the ’612 patent based on any ground that
`relies on FDA Transcript, namely, Ground 1 as set forth in the Petition.
`D. Challenges Based on MD Anderson Newsletter
`
`Each of Petitioner’s Grounds 2 and 3 rely on MD Anderson
`Newsletter. Pet. 53–66. Relying on the testimony of its expert, Dr.
`Andreeff, Petitioner contends that MD Anderson Newsletter was publically
`available as a print version (Ex. 1163) and as an online version (Ex. 1103).
`Pet. 28–30 (citing Ex. 1105 ¶¶ 78–85). Although Petitioner relies on the
`online version of the newsletter to support its unpatentability contentions, it
`references the purported availability of the print version to buttress its
`position that the MD Anderson Newsletter was publicly accessible.8 Id.
`Patent Owner responds that the MD Anderson Newsletter cannot
`qualify as a printed publication because Petitioner has not established a
`reasonable likelihood that the newsletter was publicly accessible before the
`November 9, 1998 priority date of the ’612 patent.9 Prelim. Resp. 29–38.
`The Federal Circuit has held that “public accessibility” is “the
`
`
`8 Petitioner relies on the same arguments to support its contention that the
`MD Anderson Newsletter was publicly available before the November 9,
`1999 filing date of the application that matured into the ’612 patent. Pet.
`28–30.
`9 Patent Owner offers the same arguments against public accessibility of the
`MD Anderson Newsletter regardless of whether the November 9, 1998 filing
`date of the ’658 provisional application or the November 9, 1999 filing date
`of the application that matured into the ’612 patent applies. Prelim. Resp.
`29–38.
`
`11
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`touchstone” in determining whether a reference is a printed publication.
`In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). “A given reference is
`‘publicly accessible’ upon a satisfactory showing that such document has
`been disseminated or otherwise made available to the extent that persons
`interested and ordinarily skilled in the subject matter or art exercising
`reasonable diligence, can locate it.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc.,
`511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground
`Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).
`Petitioner asserts that MD Anderson Newsletter appears in the
`Internet Archive Wayback Machine beginning February 8, 1999. Id. at 28–
`29. Petitioner submits an affidavit of Christopher Butler (Ex. 1164), Office
`Manager of the Internet Archive, in San Francisco, California, which is the
`creator of the Wayback Machine service. Pet. 27–28; Ex. 1164 ¶ 3.
`Attached to the Butler Affidavit is Exhibit A, which includes “true and
`accurate copies of printouts of the Internet Archive’s records of the HTML
`files for the URLs and the dates specified in the footer of the printout.” Ex.
`1164 ¶ 6. Moreover, the Butler Affidavit explains how the date of the
`webpage can be determined from the URL. Ex. 1164 ¶ 5. Exhibit A to the
`Butler Affidavit shows that the webpage disclosing MD Anderson
`Newsletter was archived on February 8, 1999. Based on this evidence, we
`are satisfied that the MD Anderson Newsletter was available on the website
`www.mdanderson.org as of February 8, 1999.
`The availability of a reference on a website does not end the public
`accessibility inquiry, however. “When considering whether a given
`reference qualifies as a prior art ‘printed publication,’ the key inquiry is
`
`12
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`whether the reference was made ‘sufficiently accessible to the public
`interested in the art’ before the critical date.” Voter Verified, Inc. v. Premier
`Election Sols., Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (quoting In re
`Cronyn, 890 F.2d 1158, 1160 (Fed.Cir.1989)). “[E]vidence that a query of a
`search engine before the critical date, using any combination of search
`words, would have led to the [reference] appearing in the search results” is
`probative of public accessibility. Blue Calypso, LLC v. Groupon, Inc., 815
`F.3d 1331, 1349 (Fed. Cir. 2016). Absent such evidence of indexing,
`various additional factors, including testimony indicating that the particular
`online publication in question was well-known to the community interested
`in the subject matter of the reference, and the existence of numerous related
`articles located within the same publication can support a determination of
`public accessibility. See Voter Verified, 698 F.3d at 1380–81.
`In this respect, Petitioner’s position is deficient. Petitioner relies on
`the Declaration of Dr. Andreeff to support its contention that MD Anderson
`Newsletter was publicly accessible by November 9, 1998. See Ex. 1105
`¶¶ 78–85. Dr. Andreeff testifies that
`[i]n 1998, doctors with patients seeking treatment for CLL
`routinely turned to MD Anderson to inquire about our ongoing
`clinical trials and the potential for their patients to be referred to
`MD Anderson for treatment as part of the trial. As part of this
`process, the Newsletter was disseminated to referring physicians,
`and they were free to share the information with their prospective
`patients.
`Ex. 1105 ¶ 83. Dr. Andreeff further testifies that “[t]he physicians
`participating in the study, including myself, were [] especially motivated to
`spread the word about the Newsletters . . . to enroll more patients and
`thereby ensure the trial’s success, and would have discussed the trial with
`13
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`referring doctors with CLL patients.” Id. ¶ 84.
`Absent from Dr. Andreeff’s testimony, however, is any indication that
`he, or anyone else, in fact accessed or distributed the MD Anderson
`Newsletter. Dr. Andreeff does not, for example, provide evidence as to the
`number of page views for the MD Anderson Newsletter, or demonstrate that
`the newsletter was indexed or otherwise available via search engines during
`the relevant time. Nor does Dr. Andreeff testify that the MD Anderson
`Newsletter itself (as contrasted with the MD Anderson Cancer Center) was
`well-known to the community interested in the subject matter of that
`reference, or that numerous related articles were located within the same
`online publication. Furthermore, even crediting Dr. Andreeff’s testimony
`that he and his colleagues were “especially motivated to spread the word”
`and “would have discussed the trial” (id.), absent from that testimony is any
`indication that Dr. Andreeff or his colleagues did in fact discuss the edition
`of the MD Anderson Newsletter relied upon in this proceeding with another
`physician, or direct anyone to that newsletter. In addition, it is unclear from
`Dr. Andreeff’s testimony what version of the newsletter purportedly would
`have been discussed with and disseminated to referring physicians, the
`online version presently asserted as prior art, or the print version, which is
`not independently proffered as prior art. Stated plainly, there is insufficient
`evidence to show “that a person of ordinary skill interested in [the relevant
`technology] would have been independently aware of [the online
`publication] as a prominent forum for discussing such technologies.” Voter
`Verified, 698 F.3d at 1380–81.
`Similarly, to the extent Petitioner seeks to rely on Dr. Andreeff’s
`
`14
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`testimony that “MD Anderson printed and distributed a Summer 1998 issue
`of the Leukemia Insights Newsletter” (Ex. 1105 ¶ 80), which was
`purportedly “mailed out to several thousand referring Hematology-Oncology
`physicians in the United States” (id. ¶ 81) to support its contention that the
`MD Anderson Newsletter was publicly accessible, we observe that such
`testimony is based not on Dr. Andreeff’s firsthand knowledge, but on his
`conversations with Sherry Pierce, R.N., who herself has not submitted a
`declaration in this matter. Moreover, we note that Dr. Andreeff does not
`testify as to when MD Anderson Newsletter was actually published.
`Ex. 1005 ¶ 80. Nor does Dr. Andreeff direct us to any corroborating
`document supporting the contention that the MD Anderson Newsletter was
`published in or around the Summer of 1998. Id. In addition, even assuming
`that the MD Anderson Newsletter was published in or around the Summer of
`1998, such testimony does not show that the newsletter was then available to
`members of the interested public.
`Accordingly, in view of the above, we conclude that Petitioner has
`failed to establish that MD Anderson Newsletter was publically accessible as
`of the critical date of November 9, 1998.10 Thus, on this record, MD
`Anderson Newsletter fails to qualify as prior art under 35 U.S.C. § 102, and
`Petitioner cannot establish the anticipation or obviousness of the challenged
`claims based on that reference.
`
`
`10 Because the above-described deficiencies in Petitioner’s public
`accessibility argument apply, for the reasons set forth above, we likewise
`conclude that Petitioner has not shown that the MD Anderson Newsletter
`was publicly accessibility as of the November 9, 1999 critical date of
`claims 46 and 53.
`
`15
`
`
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`
`III.
`
`CONCLUSION
`
`For the foregoing reasons, we conclude that the information presented
`in the Petition does not establish a reasonable likelihood that Petitioner
`would prevail in showing that claims 23–35 and 37–57 of the ’612 patent are
`unpatentable.
`
`IV.
`
` ORDER
`
`Accordingly, it is hereby:
`ORDERED that Petitioner’s request for an inter partes review of
`claims 23–35 and 37–57 of the ’612 patent is denied.
`PETITIONER:
`
`Michelle Rhyu
`James Brogan
`COOLEY LLP
`rhyums@cooley.com
`jbrogan@cooley.com
`
`PATENT OWNER:
`
`Michael Fleming
`Gary Frischling
`Keith Orso
`Yite John Lu
`David Gindler
`Lauren Drake
`IRELL & MANELLA LLP
`mfleming@irell.com
`gfrischling@irell.com
`korso@irell.com
`yjlu@irell.com
`dgindler@irell.com
`ldrake@irell.com
`
`16
`
`
`
`Case IPR2017-01227
`
`Case IPR2017-01227
`Patent 7,682,612 B1
`Patent 7,682,612 B1
`
`
`
`
`
`17
`
`17
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
