• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01820 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious over the Advisory Committee Art under § 103(a), based on the Board’s finding that the references were publicly accessible and disclose or suggest the claimed limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420–21 (2007). As the title, field of the invention, and background discussion in the ’107 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’107 patent priority date. Pet. 3–6; see also Ex. 1001, Related Application, 1:6–9 (indicating earliest priority date for the ’107 patent).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “In our Decision on Institution, we construed the phrase “determining with the computer processor . . . patterns of potential prescription abuse . . . from periodic reports generated only by the central database” to mean “using the central database via the computer processor to generate periodic reports containing prescriber, patient, and/or prescription related information, which permits evaluation of potential abuse of a prescription drug.” Dec. on Inst. 22. Patent Owner indicates that it generally agrees with that construction, but proposes that the construction is incomplete in relation to the term “periodic reports.” PO Resp. 25. Patent Owner contends that “periodic reports” should be construed to mean “at regular frequencies or intervals, as opposed to intermittently or upon request.” Id. at 25–26 (citing Ex. 2046 ¶¶ 30–38; Ex. 2047 ¶¶ 28–35). In support, Patent Owner points to the specification of the ’107 patent, such as Figures 13A–C, and where the specification states “[e]ach report has an associated frequency or frequencies.” Id. at 26–27; Ex. 1001, 8:22–28. The cited portions of the specification, however, describe Figures 13A–C as “descriptions of sample reports obtained by querying a central database having fields represented in Fig. 7.” Ex. 1001, 8:22–24 (emphasis added); see also id. at 2:55–57 (also describing Figs. 13A–C as describing “sample reports”); Reply 13. Thus, we do not agree that the specification indicates that “periodic reports” as recited in the claims refers only to reports obtained at regular frequencies or intervals, even if the term includes such reports.” slip op. at 16

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’107 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436). Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 27 (quoting Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’107 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 26–28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Petitioner’s Internet Archive evidence indicates that a file link to “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.16 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act. We are not persuaded by Patent Owner’s argument that Petitioner’s Internet Archive evidence is insufficient, given the totality of evidence presented in this case. PO Resp. 5–9. For example, Patent Owner submits the Second Affidavit of Christopher Butler and asserts that, if one clicks on the links shown in Exhibits 1019, the earliest archive dates for the URLs corresponding to Exhibits 1004–1006 are dated after the ’107 priority date: 16 The 3754 code is consistent with the code used for other Xyrem Advisory Committee documents, as discussed above in subsection II.C.1.b. August 30, 2003, for Exhibit 1006; September 13, 2011 for Exhibit 1005; and November 21, 2011 for Exhibit 1004. Id. at 8–9 (citing Ex. 2052, 6, 129, 483, 495, 498, and 501). As Petitioner explains, however, quoting from a Third Affidavit of Christopher Butler, the first available archive or “captured” date of a URL “does not represent the first time that the pdf was posted online at that address and it is possible that the pdf was available at this URL on an earlier date.” Reply 6–7 (citing Ex. 1058 ¶¶ 6–8). The pdf “may have been available days, weeks, months, or years prior to the date it was first captured.” Ex. 1058 ¶ 6; see also Rackspace US, Inc. v. Personalweb Techs., LLC, Case IPR2014-00059, slip op. at 35 (PTAB April 15, 2014) (Paper 9) (“[T]he mere fact that a ‘downloaded’ copy of [the prior art reference] has a date subsequent to the critical date is not sufficient to rebut Rackspace’s supporting evidence that [the reference] was posted originally on publicly accessible sites well known to those interested in the art before the critical date.”). We further note that Patent Owner’s Internet Archive evidence corroborates the fact that pdf files for each of Exhibits 1004–1006 were linked to the FDA’s website with the code “briefing/3754b1.” Ex. 2052, 5 (Ex. 1004 “Preliminary Clinical Safety Review” - “briefing/3754b1_02_section %203.pdf”), 128 (Ex. 1005 “Briefing Booklet” - “briefing/3754b1_01_1-orphan-medical.pdf ”), 482 (Ex. 1006 “Video Script 2/2/01” - “briefing/3754b1_01_2-orphan-medical%20video%20tape%20Revised%20Script.pdf”). “Briefing/3754b1” is the same code linking the “Briefing Information” to the FDA’s website as of June 17, 2001 (Ex. 1018, 5) and July 1, 2001 (Ex. 1019). As in” slip op. at 33

  Patent outcomesUS 7,765,107 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,107
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01815 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–8 are unpatentable as obvious over the Advisory Committee Art because it disclosed or suggested the claimed distribution controls and a skilled artisan would have combined the references.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’106 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:11– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’106 patent priority date. Pet. 3–6; see also Ex. 1001, Related U.S. Application Data, 1:6–9 (indicating earliest priority date for the ’106 patent).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther

    “1. “exclusive central computer system” and “exclusive computer database” In our Decision on Institution, we construed the term “exclusive central computer system” to mean “single or sole computer system,” and the term “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 20–21. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 9; PO Resp. 25 n.8. Based on our review of the complete record, we do not perceive any reason or evidence that now compels any deviation from these interpretations.” slip op. at 15

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’106 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436).” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Petitioner’s circumstantial evidence. As discussed above, it is undisputed that Exhibit 1003 was available as a file link on the FDA’s website no later than October 4, 2001. It is also undisputed that Exhibits 1004–1006 were prepared and submitted to the Xyrem Advisory Committee just over one month prior to the June 6, 2001 meeting. The Safety Review (Ex. 1004) has a few redactions that tend to indicate the document was prepared for public dissemination, and the Briefing Booklet (Ex. 1005) contains the statutory legend indicating it is available for public disclosure without redaction. Reply 2–3 (citing Ex. 1057, 415). Thus, the evidence indicates Exhibits 1004–1006 were prepared, distributed to the Xyrem Advisory Committee, and available for posting to the FDA’s website 24 hours prior to the meeting, as stated in the Federal Register Notice (Ex. 1015). The Federal Register Notice even provided instructions on how to locate materials from the FDA’s website—“Click on the year 2001 and scroll down to the Peripheral and Central Nervous Systems Drugs meetings.” Reply 5 (citing Ex. 1015). As Petitioner points out, Patent Owner has not adduced evidence to indicate the FDA failed to follow the public inspection requirements of the Federal Advisory Committee Act and FDA’s own guidance document in effect at the time. Reply 2–4 (citing Ex. 1057, 2, 4, 6, 8). FDA’s guidance document states that seven business days prior to an advisory committee meeting “the sponsor package and CDER’s [Center for Drug Evaluation and Research] redacted package will be submitted . . . for posting on the FDA website.” Ex. 1057, 8 ¶ 9. The guidance document further states that 24 hours prior to the meeting “FDA will post on its website the sponsor 15 Our citations are to the internal numbering of the document, consistent with Petitioner’s citations. package and CDER’s redacted package.” Id. at ¶ 10. If for some reason the FDA is unable to post the documentation prior to a meeting, “the two packages will be made publicly available at the location of the advisory committee meeting, and the two packages will be posted on the Agency website after the meeting.” Id. The transcript of the Xyrem Advisory Committee Meeting contains internal references to the briefing material made available to the committee members and discussed at the meeting, thus tending to corroborate the availability of Exhibits 1004–1006 as of the June 6, 2001 meeting date. Reply 4 (citing Ex. 1003, 12, 179, 284, 330, 342). Petitioner’s Internet Archive evidence indicates that a file link to “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.16 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act.” slip op. at 32

  Patent outcomesUS 7,765,106 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,106
• Amneal Pharmaceuticals, LLC / Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01813 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–26 are unpatentable as obvious over the Advisory Committee Art under § 103.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’182 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54), 1:15–31. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “First, we agree with Petitioner that the preamble language “[a] method of treatment of a narcoleptic patient” in the independent claims is not “necessary to give life, meaning, and vitality” to the claims of the ’182 patent. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). The claims recite method steps for controlling distribution of a prescription drug prone to abuse, misuse, or diversion; the claims do not recite treating a patient, administering a compound or drug product for therapeutic effect, or other treatment-related method steps. See, Ex. 1007 ¶ 37. Therefore, we determine the preamble language “[a] method of treatment of a narcoleptic patient” to be non-limiting.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner

    “Second, the wherein clause at issue does not recite a method step. Independent claims 1, 8, and 19 consistently recite method steps using the present participle verb form, “receiving,” “entering,” “checking,” and “authorizing.” The wherein clause, however, recites the GHB drug product “treats” cataplexy, rather than reciting a method step of “treating” cataplexy. The absence of the present participle verb form and the use of a wherein clause indicate an intended use or inherent property of the GHB drug product to treat cataplexy, not a method step. See Credle v. Bond, 25 F.3d 1566, 1572 (Fed. Cir. 1994) (“[B]efore each clause containing an undisputed present participle designating the method steps—‘providing an insert;’ ‘joining two opposed webs’ . . . there is a comma, indicating the beginning of a new, distinct step . . . . There is no such comma preceding ‘flexibly securing.’ This suggests that ‘securing’ is not a present participle signifying a distinct method step.”).” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Petitioner’s Internet Archive evidence indicates that a file link to “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.15 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act.” slip op. at 28

  Patent outcomesUS 8,589,182 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,589,182
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00554 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–11 of the ’730 patent and claims 1–15 of the ’988 patent are unpatentable as obvious over the Advisory Committee Art, with claims 2 and 10 of the ’988 patent also obvious over that …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’730 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54), 1:4–26. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’730 patent priority date. Pet. 3–6: Ex. 1001, filing date (22).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 28 (citing Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’730 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “The specification of the ’730 patent indicates that “[a]n example of one prescription and enrollment form is shown at 900 in FIG. 9.” Ex. 1001, 8:4–5 (emphasis added). Thus, the enrollment form of Figure 9 describes one example of the type of information that may be information identifying a patient. The specification does not indicate, however, that “information identifying the patient,” as recited in the claims, necessarily includes each and every piece of information in the enrollment form of Figure 9. Similarly, nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims. Thus, we construe “prescription requests [for GHB] containing information identifying patients” to refer to information identifying a patient, which may include the type of information presented in the enrollment form of Figure 9 and noted by Patent Owner (PO Resp. 30), but is not limited to that information nor requires all of that information.” slip op. at 19

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “The key inquiry is whether a reference was made “sufficiently accessible to the public interested in the art” before the critical date, here December 17, 2001. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). “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.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006). Indexing of a reference is not “a necessary condition for a reference to be publicly accessible,” but it is one among various factors that may bear on public accessibility. In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009). “Whether a reference is publicly accessible is determined on a case-by-case basis based on the ‘facts and circumstances surrounding the reference’s disclosure to members of the public.’” Voter Verified, Inc., v. Premier Election Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012) (quoting In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009)). With these principles in mind, we consider the parties’ arguments below.” slip op. at 22

  Patent outcomesUS 7,668,730 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,668,730
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00551 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–11 of the ’730 patent and claims 1–15 of the ’988 patent are unpatentable under § 103 over the Advisory Committee Art, with claims 2 and 10 of the ’988 patent also obvious over …

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’730 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54), 1:4–26. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’730 patent priority date. Pet. 3–6: Ex. 1001, filing date (22).” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’730 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:9–7:2; Reply 13–14 (citing Ex. 1047, 6; Ex.1048, 9 (ll. 12–19), Fig. 4 (436)). Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 28 (citing Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’730 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “presentation slides, thus confirming the description of the Internet Archive file links (3754t) as containing 381 pages. Compare Ex. 1003, with Ex. 1020, 8. We are persuaded that the Federal Register Notice is evidence of the FDA’s general practice under the Federal Advisory Committee Act and tends to indicate an approximate timeframe when background information and advisory committee meeting minutes, transcripts, and presentation slides are posted on the FDA’s website. Case IPR2014-00059, slip op. at 34 (Apr. 15, 2014) (Paper 9) (citing In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1988)); 5 U.S.C. App 2 § 10(b) (2001) (“[T]he records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection . . . .”). The Federal Register Notice states that the minutes, transcript, and slides of the Xyrem Advisory 13 The October 4, 2001 Internet Archive page contains a URL date code of “20011004” (Ex. 1020, 8–9). Ex. 1028 ¶ 5. Committee Meeting are “generally posted about 3 weeks after the meeting.” Ex. 1015. The Internet Archive evidence indicates the meeting transcript, presentation slides, and meeting minutes were not posted on the FDA’s website as of June 17, 2001, less than three weeks after the meeting, but were posted not later than October 4, 2001. Ex. 1018; Ex. 1020; Ex. 1028. Thus, the Federal Register Notice is consistent with the Internet Archive evidence. Petitioner further emphasizes that Patent Owner does not contest the sufficiency of the evidence establishing the public accessibility of Exhibit 1003 on the FDA’s website as of October 4, 2001. Reply 2 n.2; Tr. 6:1–9; see PO Resp. 4–14. Therefore, for the reasons given above, we find that Petitioner has established by a preponderance of the evidence that the Xyrem Advisory Committee Meeting transcript and presentation slides (Exhibit 1003) were publicly accessible on the FDA’s website not later than October 4, 2001.” slip op. at 26

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “We disagree with Patent Owner’s inference that members of the Advisory Committee were not POSAs, i.e., people interested in the distribution, safety, and abuse of a sensitive drug. Testimony of the Advisory Committee members cited by Patent Owner (PO Resp. 51–55 (citing Ex. 1003)) indicates that the members were interested in, and discussed at length, the distribution, safety, and abuse of Xyrem. In addition, even assuming the Advisory Committee indicated a preference for one course of action over another, that disclosure does not dictate that a less “preferred” option is not obvious. DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (stating that a “reference does not teach away . . . if it merely expresses a general preference for an alternative invention but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed” (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004))); Reply 24. We are not persuaded that testimony of Advisory Committee members, as cited by Patent Owner (PO Resp. 51–55 (citing Ex. 1003)), criticizes, discredits, or otherwise discourages providing educational materials regarding Xyrem before shipping the drug to a patient. We agree with Petitioner that by asking questions on this point, the Advisory Committee suggested at least some value in taking that course of action. Reply 24. Contrary to Patent Owner’s arguments, the FDA Advisory Committee expressly considered the alternative of confirming that the patient has read the Xyrem educational material prior to shipping the first prescription. The FDA reviewers specifically listed as an additional “Risk Management Recommendation[]” to the drug sponsor to include: “Obtaining the patient’s signed confirmation that he/she fully understands how GHB is to be used prior to the first prescription being mailed.” Ex. 1004, 115 (14.4); see also Ex. 1007 ¶ 71 (quoting the same passage). We are satisfied that the ACA discloses a process step to a POSA for confirming that a patient has read the Xyrem educational material prior to shipping the first dose of a potentially dangerous drug. Ex. 1007 ¶ 71. We also find the portions of the ACA identified by Petitioner and discussed by Dr. Valuck suggest, if not teach expressly, the step of confirming with a patient that educational materials were received and/or read prior to shipping Xyrem. Pet. 30 (citing (Ex. 1003, Tr., 371:10–12. 374:7–20; Ex. 1004, 115; Ex. 1007 ¶ 71). Both parties agree that the ACA teaches sending the Xyrem educational material (“Xyrem Patient Success Program”) with their first shipment of Xyrem, consistent with the “preferred” course of action noted by Patent Owner. Pet. 30 (citing Ex. 1003, 182:3–8); PO Resp. 49 (citing Ex. 1003 at 182:3–8, slide 157; Ex. 1006, 8–9 n.34–n.37, V10 at 00:05-00:40), id. at 53–55 (addressing what some Committee members indicated was “preferred”). Disclosures in the Preliminary Clinical Safety Review (Ex. 1004, 115), as discussed above, especially in view of the questions raised by the Advisory Committee, sufficiently suggest or teach as an alternative, and establish that a POSA would have had reason, to confirm with a patient that educational material had been received and/or read prior to shipping Xyrem. See, e.g., Ex. 1003, 374:7–20 (raising the idea of patients signing a form confirming that they “read the materials” “before they even get the first dose”). Patent Owner does not persuade us otherwise by arguing that “the ACA discloses to a POSA that the ‘registry information’ in Ex. 1004 is not the same as the educational based ‘registry form’ discussed in Ex. 1003.” PO Resp. 52 n.17. Patent Owner’s arguments in this regard do not address the teachings in the Preliminary Clinical Safety Review (Ex. 1004, 115) discussed above, regardless of any distinction between “registry information” and a “registry form.” Nor are we persuaded otherwise by Patent Owner’s critique of Dr. Valuck’s testimony and his alleged “process” of analyzing the ACA prior art, because this testimony and argument fail to address the teachings in the Preliminary Clinical Safety Review (Ex. 1004, 115) discussed above. PO Resp. 57–58 (quoting Ex. 2044, 198:6–22). Based on the complete record before us, we find Petitioner establishes by a preponderance of the evidence that the ACA discloses a method of distributing a prescription drug that comprises “confirming with a patient that educational material has been received and/or read prior to shipping the prescription drug,” as recited in Step 1.4 of challenged claims. See also KSR, 550 U.S. at 418; In re Bell, 991 F.2d at 785.” slip op. at 50

  Patent outcomesUS 8,457,988 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,457,988
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00548 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–16 are unpatentable as obvious over the Advisory Committee Art under § 103(a), which the Board found publicly accessible and sufficient to teach or suggest the claimed limitations.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420–21 (2007). As the title, field of the invention, and background discussion in the ’059 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title, 1:10– 27. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year before the ’059 patent priority date. Pet. 3–7; see also Ex. 1001, Related Application, 1:6–9 (indicating earliest priority date for the ’059 patent).” slip op. at 10

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 34 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 32 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’059 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436). Patent Owner also points us to a Merriam-Webster’s Collegiate Dictionary definition of the term “periodic,” which defines the term as “occurring or recurring at regular intervals,” or something that is “repeated.” PO Resp. 27 (quoting Ex. 2043, 3). Petitioner points us to several other dictionary definitions, which define “periodic” as also including “intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining “periodic” as including “[t]aking place now and then” or “INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including “[h]appening or appearing now and then” or “intermittent, occasional”). Upon considering all of the evidence before us, we are not persuaded that the plain and ordinary meaning of “periodic” in the context of the ’059 patent limits “periodic reports” to those generated only at regular intervals, as Patent Owner contends. PO Resp. 25–28. Rather, the term includes reports generated at regular intervals and reports generated “now and again” or “intermittently,” without any particular regularity in time between events. Thus, we construe “periodic reports” as recited in the challenged claims to refer to reports that are generated at regular intervals or intermittently, i.e., now and again, including those not generated at regular intervals.” slip op. at 17

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner

    “1. “exclusive central pharmacy,” “exclusive computer database” and “the central pharmacy authorizing the prescription drug to be dispensed to the patient by another pharmacy” In our Decision on Institution, we construed “exclusive central pharmacy” to mean “single or sole pharmacy,” and we construed “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 20. We also construed the phrase “the central pharmacy authorizing the prescription drug to be dispensed to the patient by another pharmacy” in dependent claims 7, 10, and 15 to mean “the exclusive central pharmacy may authorize another pharmacy to prepare and give the prescription drug to a patient.” Id. at 22–23. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 9–11; PO Resp. 24 n.8. Based on our review of the complete record, we do not perceive any reason or evidence that now compels any deviation from those interpretation.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

    “but proposes that the construction is incomplete in relation to the term “periodic reports.” PO Resp. 25. Patent Owner contends that “periodic reports” should be construed to mean “at regular frequencies or intervals, as opposed to intermittently or upon request.” Id. at 26–27 (citing Ex. 2046 ¶¶ 31–39; Ex. 2047 ¶¶ 29–36). In support, Patent Owner points to the specification of the ’059 patent, such as Figures 13A–C, and where the specification states “[e]ach report has an associated frequency or frequencies.” Id. at 26–27; Ex. 1001, 8:22–29. The cited portions of the specification, however, describe Figures 13A–C as “descriptions of sample reports obtained by querying a central database having fields represented in Fig. 7.” Ex. 1001, 8:22–24 (emphasis added); see also id. at 2:55–57 (also describing Figs. 13A–C as describing “sample reports”); Reply 13. Thus, we do not agree that the specification indicates that “periodic reports” as recited in the claims refers only to reports obtained at regular frequencies or intervals, even if the term includes such reports. Patent Owner also responds to testimony by Petitioner’s expert, Dr. Valuck, who states that “periodic reports” can be generated on either “an ad hoc basis or on a regular basis.” PO Resp. 27 (quoting Ex. 2044, 184:8–16). Patent Owner argues that a POSA “would understand that ad hoc reports are done for a particular purpose,” and, therefore, a “POSA would not consider ‘ad hoc’ reports to be ‘periodic.’” Id. at 27 (citing Ex. 2046 ¶¶ 34, 38; Ex. 2047 ¶¶ 32, 35, Ex. 1001, Figs. 4B, 13A–C)). Patent Owner also argues that Figure 4B illustrates generating “ad hoc” reports prepared for the particular purpose of investigating specific early refill requests, and not “periodic” reports as recited in the challenged claims. PO Resp. 27–28 (citing Ex. 2046 ¶ 37; Ex. 2047 ¶ 34). We are not persuaded by Patent Owner’s arguments or the testimony of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not explain adequately why generating a report for a particular purpose or “ad hoc” precludes it from being a report generated periodically. See, e.g., PO Resp. 28 (citing Ex. 2046 ¶ 34 (testimony by Dr. DiPiro stating that “POSA would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not generated with any regular frequency.”); Ex. 2047 ¶ 32 (testimony by Dr. Bergeron stating same). As noted above, the specification does not limit “periodic reports” to those generated with “regular frequency.” Moreover, to the extent that Figure 4B in the ’059 patent illustrates generating “ad hoc” reports, as Patent Owner contends, such disclosure supports a construction that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001, 6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436).” slip op. at 16

  Patent outcomesUS 7,895,059 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,895,059
• Amneal Pharmaceuticals, LLC / Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00545 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–26 are unpatentable as obvious over the Advisory Committee Art under § 103.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We begin with the premise that a hypothetical POSA is presumed to be aware of the pertinent art in the field of endeavor at the time of the invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the invention, and background discussion in the ’182 patent make clear, the relevant field of endeavor is the distribution of sensitive prescription drugs prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54), 1:15–31. Petitioner provides substantial evidence of the state of the art of such sensitive drug distribution systems as of December 17, 2001, one year” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “First, we agree with Petitioner that the preamble language “[a] method of treatment of a narcoleptic patient” in the independent claims is not “necessary to give life, meaning, and vitality” to the claims of the ’182 patent. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). The claims recite method steps for controlling distribution of a prescription drug prone to abuse, misuse, or diversion; the claims do not recite treating a patient, administering a compound or drug product for therapeutic effect, or other treatment-related method steps. See, Ex. 1007 ¶ 37. Therefore, we determine the preamble language “[a] method of treatment of a narcoleptic patient” to be non-limiting.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner

    “Second, the wherein clause at issue does not recite a method step. Independent claims 1, 8, and 19 consistently recite method steps using the present participle verb form, “receiving,” “entering,” “checking,” and “authorizing.” The wherein clause, however, recites the GHB drug product “treats” cataplexy, rather than reciting a method step of “treating” cataplexy. The absence of the present participle verb form and the use of a wherein clause indicate an intended use or inherent property of the GHB drug product to treat cataplexy, not a method step. See Credle v. Bond, 25 F.3d 1566, 1572 (Fed. Cir. 1994) (“[B]efore each clause containing an undisputed present participle designating the method steps—‘providing an insert;’ ‘joining two opposed webs’ . . . there is a comma, indicating the beginning of a new, distinct step . . . . There is no such comma preceding ‘flexibly securing.’ This suggests that ‘securing’ is not a present participle signifying a distinct method step.”).” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Briefing Information 3754b1.htm” was posted on the FDA’s website not later than June 17, 2001. Ex. 1018, 5. Petitioner’s Internet Archive evidence further indicates this link led to file links for Orphan Medical’s “Briefing Information” (Ex. 1005 Briefing Booklet) and Xyrem “Video Script 2/2/01” (Ex. 1006) and for the FDA’s “Safety Review” (Ex. 1004 Preliminary Clinical Safety Review), which were posted on the FDA’s website not later than July 1, 2001. Ex. 1019. We also note the URL for the FDA website address in Exhibit 1019 concludes with the code “briefing/3754b1.htm,” which matches the Briefing Information code linked in Exhibit 1018.15 Thus, the Internet Archive evidence supports Petitioner’s contention that the documents of Exhibits 1004–1006 were publicly accessible on the FDA’s website for the Xyrem Advisory Committee not later than July 1, 2001, in accordance with the Federal Advisory Committee Act. slip op. at 28

  Patent outcomesUS 8,589,182 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,589,182
• Innovative Environmental Technologies, Inc. v. Peroxychem LLCRehearing denied
  PTAB · Jul 25, 2016 · IPR2016-00198 · APJ Kristina M Kalan · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving institution in place on claims 1, 2, 4, 5, 10, 11, and 13 based on Chowdhury anticipation.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “Decision to Institute. Notably, we did not agree with Patent Owner’s argument that Petitioner failed to show anticipation by Chowdhury; instead, we found that, given the information before us and the standards for institution of inter partes review, “Petitioner has demonstrated that Chowdhury is reasonably likely to anticipate the challenged claims.” Dec. 15. Patent Owner’s attempt to read into our Decision to Institute its own conclusion on express anticipation is unwarranted. In rendering a Decision to Institute, the Board need not address every possible issue and take a position on every potential theory of unpatentability; rather, we determine whether the record, at the time, establishes a reasonable likelihood of success. The standard for institution of an inter partes review requires nothing more. In reaching our determination in the Decision to Institute, we acknowledged Patent Owner’s arguments regarding both express anticipation and inherent anticipation and found that the anticipation ground based on Chowdhury, as presented in the Petition, met the standard required for institution of an inter partes review. Dec. 13– 15. We did not overlook these arguments, and Patent Owner has not shown that the Board misapprehended or overlooked any matter in instituting trial in this proceeding.” slip op. at 4

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

    “Patent Owner did not propose an express construction of the phrase “composition comprising a water soluble persulfate compound and zero valent iron” in its Preliminary Response. See Dec. 6. In our Decision to Institute, we determined that this phrase required no express construction. Id. Although Patent Owner avers that there is no material dispute regarding claim construction, it urges in its Request for Rehearing a construction that Patent Owner has not previously raised. Req. 4–5. A Request for Rehearing is not an opportunity to present a new argument about claim construction, notwithstanding its framing as a matter that is not in dispute.” slip op. at 3

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “Decision to Institute. Notably, we did not agree with Patent Owner’s argument that Petitioner failed to show anticipation by Chowdhury; instead, we found that, given the information before us and the standards for institution of inter partes review, “Petitioner has demonstrated that Chowdhury is reasonably likely to anticipate the challenged claims.” Dec. 15. Patent Owner’s attempt to read into our Decision to Institute its own conclusion on express anticipation is unwarranted. In rendering a Decision to Institute, the Board need not address every possible issue and take a position on every potential theory of unpatentability; rather, we determine whether the record, at the time, establishes a reasonable likelihood of success. The standard for institution of an inter partes review requires nothing more. In reaching our determination in the Decision to Institute, we acknowledged Patent Owner’s arguments regarding both express anticipation and inherent anticipation and found that the anticipation ground based on Chowdhury, as presented in the Petition, met the standard required for institution of an inter partes review. Dec. 13– 15. We did not overlook these arguments, and Patent Owner has not shown that the Board misapprehended or overlooked any matter in instituting trial in this proceeding.” slip op. at 4

  Claim construction§ 102 anticipation
  Patents in suitUS 7,785,038
• Google Inc. v. Network-1 Technologies, Inc.No claims unpatentable
  PTAB · Jun 20, 2016 · IPR2015-00343 · APJ Kevin F Turner · IPR · Final written decision

  The Board held claims 1–3, 6–14, 18, 19, 21–27, and 29–37 not shown unpatentable because Conwell did not disclose a non-exhaustive search and Ghias and Philyaw did not teach one.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “exhaustive, as required by independent claims 1, 13, and 25. PO Resp. 23– 32. Patent Owner argues that Conwell teaches identifying a match using a look-up table, but the process is not disclosed to be non-exhaustive. Id. at 24 (citing Ex. 1009, 3:43–44, 5:59–61, Fig. 3; Ex. 2005 ¶¶ 364–366). Patent Owner additionally argues that “[w]hile there are ways to search the lookup table disclosed in Conwell using a non-exhaustive approach, Conwell does not disclose any such non-exhaustive approach.” Id. at 26 (citing Ex. 2005 ¶ 369). We agree that Conwell does not explicitly disclose that the look-up is performed non-exhaustively. Further, Patent Owner argues that Conwell also does not inherently disclose using the look-up table to conduct a non-exhaustive search. Id. at 27–31. Patent Owner continues that “Conwell provides no details as to how the exact-match search between the hashed identifier of the work to be identified and the hashed identifiers in the reference database is actually performed.” Id. at 29 (citing Ex. 1009, 3:43–62). Patent Owner argues that Conwell details how its database is maintained, but does not provide specific disclosures as to how the database is searched. Id. at 31–32. We also agree that Conwell does not inherently disclose that the look-up is performed nonexhaustively.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “As Patent Owner points out, the second search of the identified matches is performed exhaustively of Works A, C, D, and E. Tr. 40–43 (citing Ex. 1010 7:4–9; Ex. 2005 ¶ 288; Ex. 2006, 325:12–21, 336:12–22). If viewed as separate and independent searches, both would be exhaustive of the data set being searched, and if viewed as a single search, all of the initially input records of the data set (i.e., Works A–E) would be searched by that single search, making it exhaustive. As such, we agree that Ghias does not teach or suggest a non-exhaustive search, as recited in the independent claims. Petitioner responds that Ghias’s subsequent searches are non- exhaustive (Reply 13–14), but we have addressed the same in the prior paragraph, not finding it to be persuasive. Petitioner also argues that the queries from the “first” and “second” searches need not be the same, and in fact would likely be different, such that the results for the first query could exclude non-matches from the results, where those non-matches would be matches for the second query, so that the subsequent search for the second query would not consider these excluded references. Id. at 14. We are not persuaded, however, as the search would still be exhaustive to the dataset provided to the search algorithm. As discussed above, we construe “non-exhaustive search” as “a search that locates a match without a comparison of all possible matches.” We are not persuaded that simply because a search does not seek matches outside of its input records would make that search non-exhaustive; that would make every search non-exhaustive, because it is, by definition, limited to the records input or available to the search algorithm. Petitioner also argues that Ghias discloses that its string matching algorithms operate faster than a brute force search (Reply 14–15), but we are persuaded, as discussed above, that this disclosure is related to comparing a work with a single record in the database, and not with respect to all of the records in the database. Petitioner also argues that Ghias discloses that performance may be improved by “packing all the songs into one file,” whereby the non-exhaustive searching within a record would apply to all of the concatenated record, making the search of the records non-exhaustive. Id. at 15. With respect to this latter argument, we agree with Patent Owner that this represents a “new theory” of the ground than that established in the Petition. Paper 24, 1–2. Compare Pet. 47–48, with Reply 14–15. We will not consider such new arguments for the purposes of this decision. See 37 C.F.R. § 42.23(b); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 2016 WL 2620512, at *8–9 (Fed. Cir. May 9, 2016) (concluding the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)).” slip op. at 13

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “i.e., exhaustive and non-exhaustive, and that “one would have envisaged a ‘non-exhaustive’ search as the predominant form of ‘database query,’” such that Conwell discloses the elements of the claims in substance. Reply 11–12 (citing Ex. 2005 ¶ 371; In re Gleave, 560 F.3d 1331, 1334, 1337–38 (Fed. Cir. 2009)). We do not agree. Instead, we find persuasive the testimony of Dr. Karypis that exhaustive methods may be employed to perform the database lookup in Conwell, and that Conwell does not disclose any non-exhaustive approach. Ex. 2005 ¶¶ 367–369. Although Petitioner alleges that Dr. Karypis’s declaration “is replete with attorney argument presented in the guise of expert testimony,” and thus entitled to little weight (Reply 19), we find no fault with his specific review and interpretation of Conwell, and we are persuaded that it demonstrates that the lookup processes in Conwell need not be non-exhaustive.” slip op. at 9

  • Strike new argumentNew argument disregardedDecided for patent owner

    “With respect to this latter argument, we agree with Patent Owner that this represents a “new theory” of the ground than that established in the Petition. Paper 24, 1–2. Compare Pet. 47–48, with Reply 14–15. We will not consider such new arguments for the purposes of this decision. See 37 C.F.R. § 42.23(b); Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 2016 WL 2620512, at *8–9 (Fed. Cir. May 9, 2016) (concluding the Board did not abuse its discretion in refusing to consider reply brief arguments advocating a “new theory” of unpatentability under 37 C.F.R. § 42.23(b)).” slip op. at 14

  Patent outcomesUS 8,640,179 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,640,179
• Google Inc. v. Network-1 Technologies, Inc.Some claims unpatentable
  PTAB · Jun 20, 2016 · IPR2015-00345 · APJ Kevin F Turner · IPR · Final written decision

  Claims 9–16, 23, and 24 were held unpatentable as anticipated by Iwamura; the Board did not find claims 1–8, 21, 22, 25–27, 29, 30, 33–35, 37, and 38 unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “Although the sections of the Specification of the ’237 Patent cited by Petitioner relate to disk size, that size is a direct result of the number of records in the data set. Claim 1, for example, recites “using the received features extracted from the media work to perform a sub-linear time search of extracted features of identified media works.” For that claim, under our adopted claim construction, the size of the data set would be the number of extracted features of the identified media works. It would not be logical to assume that the size of the data set would be the length of an individual record or the amount of disk space the data set occupies when the number of extracted features would be readily available. Although disk space could be used as a measure, it would be variable with respect to the format of the disk space, for example. Therefore, we are not persuaded that disk space should be used as a determinant of data set size in the construction of “sub-linear search.” As such, the data set would be the number of extracted features, in claim 1, irrespective of the exact number of commercials or frames.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “ii) “non-exhaustive search” With respect to the claim term “non-exhaustive search,” Patent Owner emphasizes that a non-exhaustive search makes a comparison without all possible matches but does not concern itself with whether all data within all possible matches have been compared. PO Resp. 6–7. Petitioner does not dispute the construction, and we remain persuaded that a “non-exhaustive” search need not consider all data within all possible matches, but rather should be exhaustive or non-exhaustive with respect to the number of records in a database. See Dec. 5–7.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for petitioner

    “Petitioner responds that the statements in the Specification do not rise to the level of lexicography or disavowal. Reply 4–5 (citing Facebook, Inc. v. Pragmatus AV, LLC, 582 F. App'x 864, 868 (Fed. Cir. 2014); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998)). We agree, given that the cited portion provides that an approximate nearest neighbor search may be an example of a sublinear search, but not that all approximate nearest neighbor searches must be sub-linear. Additionally, Patent Owner has not provided persuasive evidence that all approximate nearest neighbor searches must be sub-linear, other than the citation to the Specification. As well, similar to our discussion of neighbor searches above, we are not persuaded that if an approximate nearest neighbor search happens to arrive at an exact match, that would negate the nature of the search. We are persuaded that an approximate nearest neighbor search would depend on the search methodology and not on the specific results obtained. Additionally, as Petitioner points out, the instant claims confirm that sublinearity is not necessarily required for an approximate nearest neighbor search. Reply 5–6. Claim 33 recites, in part, a “sublinear approximate nearest neighbor search,” whereas claims 9 and 12 simply recite an “approximate nearest neighbor search,” without the sublinear modifier. Interpreting all recitations of approximate nearest neighbor searches as intrinsically sublinear would render the limitation in claim 33 superfluous. Id. (citing Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005); Digital-Vending Servs. Int’l, LLC v. Univ. of Phoenix, Inc., 672 F.3d 1270, 1274–75 (Fed. Cir. 2012)). For this additional reason, we remain persuaded that an approximate nearest neighbor search corresponds to “identifying a close match that is not necessarily the closest match,” without a requirement of being sublinear.” slip op. at 9

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “in which he agrees that Iwamura’s system compares a work to be identified with each reference work in the database. PO Resp. 26–28 (citing Ex. 2006, 207:18–23, 223:2–8, 247:18–20, 269:19–270:2, 271:19–21); see also Tr. 17:17 (Petitioner conceding at oral hearing that “every song is looked at”). Dr. Moulin also acknowledges that if a non-exhaustive search is one that does not look at each of the melodies in the database, Iwamura discloses an exhaustive search rather than a non-exhaustive search. Ex. 2006, 233:24– 234:14; see PO Resp. 27. Despite Dr. Moulin’s testimony and Iwamura’s description of a search that compares an input melody to each melody in the database, Petitioner contends that Iwamura discloses a non-exhaustive search. First, Petitioner submits that Iwamura specifically identifies its peak note search as a non-exhaustive search because the “search speed using peak notes is 20% of a brute force search.” Pet. 9–10 (quoting Ex. 1012, 9:8–11); Reply 7–8 (citing Ex. 1012, 9:7–11; Ex. 2005 ¶ 82; Ex. 2001). We agree with Patent Owner, however, that Iwamura’s peak note search accelerates a search within a single comparison between a work to be identified and an individual record in the database, while still comparing the work to each record in the database. See PO Resp. 29–30. In other words, the peak search technique may improve the efficiency of an individual comparison between an entered melody and a reference melody in the database, but it is still an exhaustive search because it compares the entered melody with each musical work in the database, as confirmed by Petitioner’s declarant, Dr. Moulin. Id. (citing Ex. 2006, 269:19–270:2). Petitioner further argues that Iwamura discloses a non-exhaustive search because the search can be accelerated by stopping the search when computations “exceed[] a certain limit.” Pet. 10 (quoting Ex. 1012, 7:56– 57). We agree with Patent Owner that this disclosure also refers to improving the speed of a comparison between the work to be identified and a single record in the reference database. See PO Resp. 32 (citing Ex. 2005 ¶ 179). As Dr. Karypis explains and Dr. Moulin confirms, when the total absolute difference computed between the entered melody and a particular reference melody exceeds a certain limit, the computation stops, and the search shifts to the next peak range comparison within the same record. Id. at 32–35 (citing Ex. 2005 ¶¶ 180–81; Ex. 2006, 241:24–242:2). Thus, Iwamura’s computation “limit” does not describe a non-exhaustive search because Iwamura still compares a work to be identified with each reference melody in the database.” slip op. at 16

  Patent outcomesUS 8,205,237 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,205,237

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