• 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 · IPR2015-01817 · 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

    “In view of the claims at issue here, we are not persuaded that the level of ordinary skill in the art is limited to the level of skill or interest of a pharmacist that dispenses FDA-approved drugs, such as one that “sits behind the counter at Walgreens.” Id. at 31:1–5. We adopt the level of ordinary skill in the art as described by Petitioner and its witness, Dr. Valuck, because it is consistent with the subject matter before us, the ’730 patent, and with prior art of record, such as Talk About Sleep (Ex.1033), Honigfeld (Ex. 1034), Elsayed (Ex. 1035), and Lilly (Ex. 1036). See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 12

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

    “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 18

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

    “24. Patent Owner’s attack emphasizes Petitioner’s lack of such direct evidence, but does not address persuasively the cumulative effect of 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, 417). 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 (quoting 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 17 Our citations are to the internal numbering of the document, consistent with Petitioner’s citations. 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 package and CDER’s redacted package.” Id. at 8 ¶ 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).” slip op. at 31

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

    “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”).” 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 · IPR2015-00554 · 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 · IPR2015-00546 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–8 are unpatentable as obvious over the Advisory Committee Art under § 103(a), which the Board found publicly accessible before the patent’s priority date.

  RulingsFinal written decision

  • 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, 1312 (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 23

  • 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

  • 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 ¶ 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

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

    “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

  Patent outcomesUS 7,765,106 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,106
• 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
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-00547 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–6 are unpatentable as obvious over the Advisory Committee Art under 35 U.S.C. § 103(a).

  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)Term construed petitioner constructionOther

    “1. “exclusive central pharmacy” In our Decision on Institution, we construed the term “exclusive central pharmacy” to mean “single or sole pharmacy.” 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. 8; 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 that interpretation.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
  • 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, 1312 (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 7,765,107 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 7,765,107
• 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
• Mastercard International Inc. v. Leon StamblerAll claims unpatentable
  PTAB · Jul 6, 2016 · CBM2015-00044 · APJ Peter P Chen · CBM · Final written decision

  Claims 51 and 53 are unpatentable as anticipated by Davies; claims 51, 53, 55, and 56 are unpatentable as obvious over Davies and Meyer; claim 55 over Davies and Nechvatal; and claim 56 over Davies, …

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “F. Level of Ordinary Skill in the Art Petitioner’s proposal for the level of ordinary skill in the art is “at least a bachelors degree in computer programming and two years’ experience as a programmer or developer in the field of computer science, with a working understanding of cryptographic operations for transforming original input into a coded output using a known algorithm.” Pet. 14–15. Patent Owner has proposed similarly, that one of ordinary skill in the art would possess “(1) undergraduate education in mathematics, physics, computer science, electrical engineering or similar technical subject; and (2) either postgraduate education in networking, cryptography, or other discipline encompassing information theory, or equivalent experience with applications involving communication of financial, military, medical or similarly sensitive data over secure and non-secure networks.” Prelim. Resp. 30–31. We determine that an express definition of the level of ordinary skill is not required. The level of ordinary skill in the art can be reflected in the cited prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.’”) (internal quotations omitted); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Therefore, we find the level of ordinary skill in the art to be reflected in the cited references.” slip op. at 16

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

    “1. “variable authentication number (VAN)” In the Decision to Institute, we construed the term “variable authentication number” or “VAN” as “a variable number resulting from a coding operation that can be used in verifying the identity of a party or the integrity of information or both.” Dec. to Inst. 8. See also Case IPR2014-00694, slip op. at 8–9 (PTAB Oct. 31, 2014) (Paper 10). Patent Owner “does not challenge this construction.” PO Resp. 16–17. Patent Owner asserts additional construction of the term is necessary for CBM standing issues, but does not elaborate further. PO Resp. 1. Patent Owner also argues we incorrectly applied the broadest reasonable interpretation to the term in the Decision to Institute. PO Resp. 9. The Decision to Institute noted that our review of the claims of the expired ’302 patent is similar to that of a district court’s review, In re Rambus, Inc., 694 F.3d 42, 46 (Fed. Cir. 2012); Phillips v. AWH Corp., 415 F.3d 1303, 1327 (Fed. Cir. 2005), but inadvertently mentioned the broadest reasonable interpretation standard in construing this term. Dec. to Inst. 7–8. We reaffirm our agreement with Patent Owner that the Phillips framework is applied to the expired ’302 patent. Our construction of “VAN” is the same under either claim construction standard. We reject Patent Owner’s undeveloped argument regarding standing, and maintain the construction of VAN from the Decision to Institute, as the ordinary and customary meaning of the term: “a variable number resulting from a coding operation that can be used in verifying the identity of a party or the integrity of information or both.”” slip op. at 10

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

    “2. Sequence of method steps: receiving, generating In the Decision to Institute, we agreed with Patent Owner and construed the sequence of method steps in independent claim 51 to mean that at least a portion of the receiving step must precede the generating step. Dec. to Inst. 8. See also Case IPR2014-00694, slip op. at 11–14 (PTAB Oct. 31, 2014) (Paper 10). We maintain that construction as the ordinary and customary meaning of the sequence of the receiving and generating method steps.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “intended use of an invention is generally not treated as limiting the scope of the claim. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). However, “a preamble limits the invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (citing Pitney Bowes Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). “The effect preamble language should be given can be resolved only on review of the entirety of the patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). When the limitations in the body of the claim rely upon or derive essential structure from the preamble elements, e.g., the preamble serves as an antecedent basis for limitations in the claim, then the preamble acts as a necessary component of the claimed invention and is limiting. See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003). In this case, the preamble of independent claim 51 recites “a credential being previously issued,” and the limitations of the claim include “determining whether the at least a portion of the received funds transfer information is authentic by using the VAN and the credential information.” Ex. 1001, 33:18–19, 33:29–31. Thus, the preamble’s recitation of “a credential” is an antecedent basis for the recited “the credential information” in the “determining” step, and we determine that the preamble limits the scope of the challenged independent claim 51 and dependent claims 53, 55, and 56.” slip op. at 11

  Patent outcomesUS 5,793,302 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 5,793,302
• Dukane Corporation v. Herrmann Ultraschalltechnik GmbH & Co., KGRehearing denied
  PTAB · May 26, 2016 · IPR2016-00066 · APJ Michelle N Ankenbrand · IPR · Rehearing

  The Board denied rehearing, leaving in place the denial of institution for claims 4, 5, and 7–9 because Petitioner did not show the Board misapprehended or overlooked its arguments.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “Regarding the asserted grounds that Klinstein ’158 anticipates claim 8 and the DPC Manual anticipates claims 6–9, we determined that Petitioner “fail[ed] to address the limitations reciting different target variables for the machining intervals,” which was “fatal to [those] unpatentability assertions.” Dec. 9–10. Likewise, we determined that Petitioner’s failure to address the additional “target variable[s] differ” limitation of claim 8 was fatal to the asserted ground that the subject matter of claim 9 (which depends from claim 8) would have been obvious over the combination of Klinstein ’158 and the iQManual. Id. at 10. Regarding Petitioner’s assertion that Klinstein ’158 anticipates claim 6, we determined that, although Petitioner addressed the “target variable[s] differ” limitation, Petitioner failed to explain adequately how the reference discloses that limitation. Id. at 12–13. With respect to the asserted ground that the subject matter of claims 4 and 5 would have been obvious over Klinstein ’816, we determined that Petitioner did not provide “adequate reasoning based on rational underpinnings to persuade us, in the absence of hindsight, that one of ordinary skill would have modified the welding method of Klinstein ’816 to achieve the claimed subject matter [i.e., the specific features that claims 4 and 5 add to the subject matter of claim 1].” Id. at 16.” slip op. at 3

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

    “Reh’g Req. 5 (citing Pet. 43–53). Petitioner does not direct us to the particular page of the Petition on which it advanced that argument, but, rather, cites ten pages of analysis. After reviewing the cited pages, it appears that Petitioner made the argument in a claim chart to show how the DPC Manual discloses welding variables and target variables, not how the DPC Manual discloses the “target variable[s] differ” limitation. See Pet. 45– 46. Indeed, Petitioner’s claim chart does not address the “target variable[s] differ” limitation. Like the Petition, the claim chart focuses on whether the target values of the target variable differ. Id. at 46. In any event, Petitioner fails to explain how the identification of exemplary target variables set forth in the DPC Manual is an anticipating disclosure of different target variables for each machining interval. In fact, the analysis in the Petition contradicts Petitioner’s argument in this regard because, as explained previously, Petitioner identifies the same variable as corresponding to the first, second, and fifth target variables disclosed in the DPC Manual. Dec. 9 (citing Pet. 57). Petitioner further admits that the DPC Manual discloses “the ‘[c]ontrol parameters [i.e., target variables] for P2 are the same as those used for P1, however the limits set for the parameters are specific to each pressure.’ Thus, the user-specified target values for the first and second control parameters may differ.” Pet. 52 (citing Ex. 1005, 81) (emphasis added). Consistent with that description, Figure 7-16 of the DPC Manual illustrates how to set the dual pressure control and depicts the same control parameter (i.e., target variable) for P2 and P1 (i.e., weld time). Ex. 1005, 82. Accordingly, we are not persuaded that we overlooked or misapprehended Petitioner’s arguments as to what each of Klinstein ’158, Klinstein ’816, and the DPC Manual discloses.” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “detecting a third target variable during the first machining interval and selecting the second target variable depending on the result of the detection. Ex. 1001, 4:52–55. Claim 5 depends from claim 4 and narrows the third target variable to welding time. Id. at 4:56–57. As to these claims, we determined that Petitioner’s argument, which was devoid of discussion and citations to Klinstein ’816, “fails to link the hypothetical detection and selection criteria [that a skilled artisan ‘could have’ used] to any particular teaching, preference, suggestion, or other reasoning derived from Klinstein ’816 and the level of skill in the art.” Dec. 16. We also determined that the Klinstein Declaration “adds no further detail; it merely mirrors the Petition.” Id. Petitioner contends that the entire discussion on pages 31–41 of the Petition relates to the obviousness of claims 4 and 5 from the disclosure of Klinstein ’816. Reh’g Req. 6. As Petitioner concedes in the Rehearing Request, however, “[t]hose pages make it clear, in graphic detail including reproduction of drawings from the [Klinstein] ’816 patent, how claim 1 is anticipated by the [Klinstein] ’816 patent.” Id. (emphasis added). In other words, the analysis on pages 31–41 does not set forth how the additional features of claims 4 and 5 would have been obvious from the disclosure of Klinstein ’816 and the level of skill in the art. Petitioner also repeats in the Rehearing Request essentially the same argument that was raised in the Petition, purporting to establish the link between Petitioner’s hypothetical detection criteria and the disclosure of Klinstein ’816 we found missing from its argument and the Klinstein Declaration. Compare Reh’g Req. 6–7, with Pet. 42 and Ex. 1007 ¶ 55. Petitioner’s argument is no more persuasive on the second telling. That is, Petitioner reargues a case it attempted to make out in the Petition, but fails to point out how we misunderstood its arguments or Mr. Klinstein’s testimony. Accordingly, we are not persuaded we misapprehended or overlooked Petitioner’s arguments with respect to the asserted ground that the subject matter of claims 4 and 5 would have been obvious over Klinstein ’816.” slip op. at 9

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 8,702,883

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.