• Ericsson Inc. / Telefonaktiebolaget LM Ericsson v. Intellectual Ventures II LLCNo claims unpatentable
  PTAB · Feb 15, 2017 · IPR2015-01872 · APJ David C Mckone · IPR · Final written decision

  Claims 1–4, 7, 11–14, 17, and 20–25 were not shown unpatentable because Lu did not teach providing resources to queued users of packet data.

  RulingsFinal written decision

  • Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesDecided for petitioner

    “1. Means-plus-function Terms Claims 11–14 and 17 recite several terms in means-plus-function format. Claim 24 recites several terms in the form of “logic for” performing the functions of parallel terms recited in claim 11. In the Institution Decision, we adopted Petitioner’s proposed constructions, set forth at pages 10–15 of the Petition, as our constructions for the means-plus-function terms of claims 11–14 and 17. Dec. 17–18. We also determined to treat the “logic for” terms of claim 24 as means-plus-function terms, see Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015), and adopted Petitioner’s statement of the structure corresponding to the “logic for” terms (Pet. 10–13). Id. at 18. Patent Owner does not dispute these constructions. PO Resp. 8. On the complete record, we maintain these constructions.” slip op. at 8

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

    “Read in light of the Specification, “providing said communication resource to queued packet data users on a tier-by-tier basis,” as recited in claim 1, means providing the communication resource to queued users of packet data on a tier-by-tier basis. We are persuaded by Patent Owner that this is the only reasonable reading that is consistent with the Specification. Petitioner provides no examples in the Specification consistent with its reading. Although the preamble of claim 1 recites a “method of processing queued data packets,” this is consistent with the Specification’s general statement that the invention pertains to “an improved packet data queueing algorithm,” Ex. 1001, 9:3. We do not read this general statement in the preamble of claim 1 (or the similar preamble recitations in claims 11 and 24) to provide a basis for construing more specific language in the body of the claim in a manner inconsistent with the description in the Specification. In sum, the only reasonable reading of “queued packet data users,” in the context of the dependent claims, and in light of consistent description in the Specification, is queued users of packet data, not users of queued packet data.” slip op. at 14

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

    “such as initial class queues 416–438, organized into high, medium, and low classes, are “a plurality of individual packet data queues.” Pet. 19–20. As to claim element 1[b], “determining a total number of data packets that can use an available communication resource,” Petitioner points to Lu’s description of using a weight-based scheduling scheme to transfer packets from one level queue to another. Id. at 23–24. Petitioner identifies the transmission capacity of the output link (e.g., 209) as the “available communication resource,” and contends that such weighted transfer during a cycle includes determining a total number of data packets that can be transferred for a cycle.5 Id. at 24. Petitioner further contends that Lu’s description of using subscriber weights based on subscriber volumes for particular classes teaches “allocating different weights to each tier of service based on a number of users requiring access to the available communication resource,” as recited in claim element 1[c]. Id. at 28–30. Regarding claim element 1[d], Petitioner argues that “[b]ecause the weights of Lu vary with the 4 We refer the claim elements 1[a]–1[e] as identified in Section I.E, above. 5 Patent Owner contends that Lu does not teach claim element 1[b]. PO Resp. 12–23. Because we decide that Petitioner has not shown that Lu teaches claim element 1[e], as detailed below, we do not decide whether Petitioner has shown that Lu teaches claim element 1[b]. available capacity (which in turn would affect the ‘total number of data packets that can use an available communication resource’), the weights of Lu consistently indicate how much (i.e., ‘proportion’) of the capacity (‘total number of data packets’) each class (i.e., ‘tier of service’) will receive.” Id. at 32.” slip op. at 22

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Petitioner’s Reply argument is not simply rebuttal to the Patent Owner Response. Rather, it is an attempt to formulate a new prima facie case of obviousness. The Office has instructed that such improper Reply argument will not be considered: A reply may only respond to arguments raised in the corresponding opposition. [37 C.F.R.] § 42.23. While replies can help crystalize issues for decision, a reply that raises a new issue or belatedly presents evidence will not be considered and may be returned. . . . Examples of indications that a new issue has been raised in a reply include new evidence necessary to make out a prima facie case for the patentability or 6 In the Institution Decision, we considered Petitioner’s argument and evidence (including Mr. Lanning’s testimony, Ex. 1006 ¶¶ 96–97) and determined that Petitioner did not present evidence sufficient to show a reason to modify Lu and, accordingly, declined to institute as to claims 5 and 15. Dec. 26–27. unpatentability of an original or proposed substitute claim, and new evidence that could have been presented in a prior filing. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,767 (Aug. 14, 2012); see also Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1370 (Fed. Cir. 2016) (The “Board did not err in refusing the reply brief as improper under 37 C.F.R. § 42.23(b) because IBS relied on an entirely new rationale.”). Accordingly, we do not consider Petitioner’s Reply argument for claim element 1[e]. For the same reasons, we do not consider the argument Petitioner made for the first time at the oral argument (Tr. 22:17–23:2). Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768 (“A party may rely upon evidence that has been previously submitted in the proceeding and may only present arguments relied upon in the papers previously submitted. No new evidence or arguments may be presented at the oral argument.”); see also Dell Inc. v. Acceleron, LLC, 818 F.3d 1293, 1301 (Fed. Cir. 2016) (“In this case, the Board denied Acceleron its procedural rights by relying in its decision on a factual assertion introduced into the proceeding only at oral argument, after Acceleron could meaningfully respond.”).” slip op. at 25

  Patent outcomesUS 7,385,994 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,385,994
• Samsung Electronics Co., Ltd. / Samsung Display Co., Ltd et al. v. Surpass Tech Innovation LLCAll claims unpatentable
  PTAB · Sep 6, 2016 · IPR2015-00887 · APJ Beth Z Shaw · IPR · Final written decision

  Claims 1–5 are unpatentable under § 103 as obvious over the instituted combinations of Janssen ’708 with Horii or APA, and Kubota for claims 4–5.

  RulingsFinal written decision

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

    “We adopt Petitioner’s proposed constructions for the terms “date lines” and “insulated with each other,” as we determine them to be consistent with the broadest reasonable construction. See Pet. 14–15. We interpret “date lines” as “data lines.” Id. We interpret “insulated with each other” to mean “spaced apart from and parallel to each other.” Id. We preliminarily interpreted these phrases the same way when we instituted trial. Dec. 7. These interpretations are consistent with the Specification’s figures and description of gate lines and data lines being orthogonally crossed. Ex. 1001, 1:45–45, Figs. 1A, 1B, 4–7; Ex. 1013 ¶¶ 33–34. We agree that when reading the description of gate lines and data lines being “orthogonally crossed,” and when viewing the figures of the ’550 patent, a person of ordinary skill in the art would understand that because of the insulation, these lines are not in physical contact with each other. Pet. 15 (citing Ex. 1013 ¶¶ 33–34). We determine that we need not construe any other limitations of the challenged claims.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “As stated in KSR, “the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 401 (2007). Here, a person of ordinary skill in the art would have recognized that the gate drivers of Horii would have made the device of Janssen ’708 functional. Thus, we agree with and adopt Petitioner’s reasoning for the combination of Horii and Janssen ’708. See Pet. 41–42; Ex. 1013 ¶ 60.” slip op. at 11

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “Thus, based on the totality of the evidence before us, we are not persuaded that Janssen ’708 is directed to a lamp display as Patent Owner argues. See PO Resp. 15–28. We find that Janssen ’708 is relevant prior art to the field of LCD technology.” slip op. at 15

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We give Dr. Liu’s testimony substantial weight because this testimony is consistent with both Janssen ’708’s disclosure of video displays and with other evidence of record. As Dr. Liu explains, and as disclosed by Exhibits 1005, 1007, 1022–1024, 1026, 1027, and 1029–1031, thin film transistors are predominantly used to electronically access individual pixels (to charge or discharge the voltages on the pixel electrodes and thereby adjust their brightness) in a LCD device. Ex. 1020 ¶ 11. The amount of current that a thin film transistor conducts in the ON state (or conductive state) is very low (less than one thousandth of an ampere). Id. This very low amount of current is only adequate to charge or discharge a small capacitive load, such as a liquid crystal cell capacitance, and is insufficient to adequately drive a resistive load, such as an incandescent lamp. Id. Incandescent lamps are resistive devices that inherently require a relatively large amount of current (from a few tenths of amperes to tens of amperes) to produce a suitable light output. Id. A single thin film transistor, or even multiple thin film transistors, cannot source such a high level of current. Id. We find that Dr. Liu’s testimony outweighs the other equivocal evidence presented by Patent Owner. In particular, Dr. Liu explains that a person of ordinary skill in the art would understand that Janssen ’708 shows an active matrix liquid crystal display (“AMLCD”) driving circuit for an LCD pixel because a person of ordinary skill in the art would have understood that, by the time the application underlying Janssen ’708 was filed in 2001, the “video display” disclosed in Janssen ’708 with a row-column matrix of pixels is an AMLCD display that uses thin-film transistors” slip op. at 16

  Patent outcomesUS 7,420,550 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 7,420,550
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01818 · 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 › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionTerm construed board ownMixed

    “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

    “For the reasons given above, we find Petitioner’s evidence sufficient to prove by a preponderance that Exhibits 1004–1006 were publicly accessible on the FDA’s website not later than July 1, 2001.” slip op. at 35

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “of the ’730 patent (and claims 1, 4–9, and 12–15 of the ’988 patent) would have been obvious over the ACA (Exhibits 1003–1006), because the ACA is a public disclosure of the proposed risk management system for Xyrem—the same system covered by the ’730 and ’988 patents. Pet. 18–38; Reply 1. Petitioner relies on the Declaration testimony of Dr. Valuck in support of its argument that a POSA would have had “ample” reason to combine the ACA documents because the documents were prepared for the Advisory Committee Meeting and “relate to the same restricted distribution program, which the meeting was convened to discuss.” Pet. 19 (citing Ex. 1007 ¶ 51). Petitioner asserts, in particular, the Preliminary Clinical Safety Review (Ex. 1004), Briefing Booklet (Ex. 1005), and Xyrem Video and Transcript (Ex. 1006) were “all distributed together for a single meeting before the FDA seeking approval for prescription Xyrem®,” and the FDA Advisory Committee Transcript and Slides (Ex. 1003) was “a public transcript of and presentation given at the meeting itself.” Id. at 19 (citing Ex. 1007 ¶ 51) (emphasis added). In addition, according to Petitioner, all four ACA documents “clearly relate to the same restricted distribution program, which the meeting was convened to discuss,” and are “all linked from a single [web] page.” Id. Patent Owner does not address directly the cited evidence in the context of motivation to combine the ACA. Patent Owner challenges the motivation of a POSA to confirm that a patient has read the Xyrem educational material prior to shipping the drug product to the patient (step 1.4), an issue we address below. PO Resp. 37, 49–59. We agree with Petitioner’s analysis and determine that a POSA would have had ample motivation to combine the ACA documents, which were prepared at the same time, relate to the same drug product and the same restricted drug distribution system, were discussed together at the same Xyrem Advisory Committee Meeting, and were made available via file links from a single FDA web page.” slip op. at 39

  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 · IPR2015-01820 · 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

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.