• Intel Corporation v. Advanced Cluster Systems, Inc.All claims unpatentable
  PTAB · Sep 1, 2026 · IPR2025-00914 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–19 are unpatentable as obvious over Menon, Trefethen, RS6000, and POEref.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and We adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the ’679 patent, the prior art of record, and the testimony of both experts.” slip op. at 10

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

    “The Petition relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard. Pet. 12–13 (citing 37 C.F.R. § 42.100(b)). The Petition also addresses the construction of “peer-to-peer architecture” recited in independent claim 1 of the ’679 patent, a limitation we need not construe to resolve the parties’ dispute in this proceeding. Id. at 13; see, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Owner relies on the ordinary and customary meaning of the claim terms consistent with the Phillips standard without further analysis. Resp. 7.” slip op. at 11

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

    “RS6000 with Menon, namely because RS6000 provides an overview of the IBM SP2 multiprocessor and Menon teaches the use of “IBM SP2, a modern high performance distributed memory multiprocessor” used in the MultiMATLAB system. Id. at 24–25 (citing Ex. 1003 ¶¶ 142–145; Ex. 1005, 5–6, 14; Ex. 1007, 1, 11). The Petition also explains why POEref pertains to the field of cluster computing in a parallel operating environment. Id. at 26 (citing Ex.1008, 11 (“PE Software is designed to run on an … RS/6000 network cluster”)); (further citing Ex. 1001, 1:14–15; Ex. 1003 ¶¶ 146–149). The Petition contends that a POSITA would have been motivated to combine the teachings of POEref with Menon “because Menon suggests the combination by teaching that MultiMATLAB uses ‘POE, IBM's Parallel Operating Environment.’” Id. at 26–27 (citing Ex. 1005, 6); (further citing Ex. 1003 ¶¶ 150–153; Ex. 1005, 14; Ex. 1008, 11, 46). We agree with Petitioner’s analysis. We find the Petition’s argument and evidence of a motivation to combine the asserted prior art references in the manner claimed to be compelling, persuasive, consistent with the disclosures in the references, which include internal cross-references to each other, and supported by the expert testimony of Dr. Bajaj.” slip op. at 19

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Patent Owner argues that Menon teaches away from a combination with Trefethen because “Menon expressly states that Trefethen’s first-generation architecture is inadequate for the objectives that motivated the newer design.” Resp. 35–37. The evidence does not support Patent Owner’s position. First, Patent Owner’s teaching away argument is inconsistent with the strong evidence of a motivation to combine Menon and Trefethen discussed above. Second, Patent Owner’s teaching away argument is contrary to the evidence of record for the reasons given in Petitioner’s Reply. Reply 13–15 (e.g., “Menon explicitly cites Trefethen and explains that Menon builds on the teachings of Trefethen.”) (citing Pet. 22; Ex. 1003 ¶ 70; Ex. 1005, 1–3; Ex. 1163 ¶¶ 47–53). We are further persuaded by Dr. Bajaj’s reply testimony: the “MultiMATLAB teachings in Trefethen. In fact, Menon describes enhancing the system of Trefethen. For example, Menon describes a list of “goals” already achieved by MultiMATLAB and then states that the architecture has been “redesigned to achieve two further goals.” One of these two “further goals” is “extensibility,” which Menon achieves by its description of adding “MEX routines” to the system of Trefethen. Far from showing an “incompatibility” between Menon and Trefethen as the POR argues, Menon’s addition of the “MEX routines” to MultiMATLAB shows that such a modification was within the capabilities of a POSITA, because the authors of the Menon paper actually implemented the modification. Ex. 1163 ¶ 49 (citing Ex. 1005, 1–3). Dr. Bajaj’s testimony is unrebutted, credible, and supported by the record. We agree with Dr. Bajaj’s reasoning, which is based on direct quotes in Menon. We further agree with Dr. Bajaj’s conclusion that Menon does not teach away from the combination with Trefethen. Id. ¶¶ 50–52. Menon’s description of building on and enhancing the teachings of Trefethen—the earlier work of the same research group at Cornell—by adding MEX routines to achieve high-performance parallel computing and extensibility for MATLAB, demonstrates a classic motivation for a POSITA to combine the teachings of Menon and Trefethen. RS6000 and POEref are specifically referenced in Menon-Trefethen and add operational details of the parallel operating platform that teach a POSITA how to implement the MultiMATLAB system with a reasonable expectation of success. Such facts are inconsistent with Patent Owner’s teaching away and lack of motivation arguments.” slip op. at 24

  Patent outcomesUS 12,021,679 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 12,021,679
• Intel Corporation v. Advanced Cluster Systems, Inc.All claims unpatentable
  PTAB · Aug 26, 2026 · IPR2025-00913 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–30 are unpatentable: claims 1–25, 27–28, and 30 as obvious over Menon, Trefethen, RS6000, and POEref; claims 26 and 29 over those references plus MPIref.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citing Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)). “These factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art.” Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). There is uncontested evidence in the record before us that reflects the knowledge and experience of a POSITA. We adopt the Petition’s formulation of the level of ordinary skill in the art, which is consistent with the ’034 patent, the prior art of record, and the testimony of both experts.” slip op. at 11

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

    “processor,” “multi-core” processor, or “singular ‘hardware processor’ that ‘comprises’ (or ‘with’) multiple ‘processing cores’” as Patent Owner contends. Resp. 11–12, 21; see also Ex. 1163 ¶ 22 (“The claim does not recite ‘single chip,’ ‘single package,’ ‘single die,’ or ‘single multi-core microprocessor.’”). Nor do the claims recite a plurality of processing cores “within” a single-chip package or read as “multi-core within a processor” as argued by Patent Owner. Resp. 12–14; Sur-Reply 2; see Reply 6 (citing Ex. 1163 ¶ 23 (“Thus, the phrase ‘with a plurality of processing cores’ identifies the required processing resources associated with the hardware processor; it does not import a packaging limitation.”)). The claims do recite a hardware processor “with” a plurality of processing cores; a critical distinction even Patent Owner reads as open-ended, i.e., as a hardware processor that “comprises” a plurality of processing cores. See Resp. 11 (“the claims require a singular ‘hardware processor’ that ‘comprises’ (or ‘with’) multiple ‘processing cores’”). Consequently, the claim language does not support Patent Owner’s proposed construction of “a . . . hardware processor with a plurality of processing cores” as a single multi-core processor. cores it contains” in reliance on a parsed description in the ’034 patent specification: The specification explains: “Each processor can contain one or more processor cores that are capable of single-threaded execution. Processor cores are generally independent microprocessors, but more than one can be included in a single-chip package.” Id. at 1212 (partially quoting Ex. 1001, 5:11–16); Sur-Reply 2. The quoted description does not support Patent Owner’s contention that the claimed “a . . . hardware processor with a plurality of processing cores” must be limited to a “single multi-core processor” that “locates multiple cores within a ‘single-chip package,’” i.e. limited to a single multi-core microprocessor such as “a Core 2 Duo is one processor package with two cores.” Resp. 12– 13, 21 (citing Ex. 1001, 7:15–25). The description quoted above from column 5, moreover, describes a “processor” that “can contain one or more processor cores” each of which can be an independent microprocessor. Reply 2–3 (citing Ex. 1001, 5:11–16; Ex. 1163 ¶¶ 10–14). As Petitioner emphasizes, the specification distinguishes a “processor” from a “microprocessor” and describes a “processor” that “can be one or more general purpose single-core or multi-core microprocessors,” rather than limiting a “processor” to a single multi-core microprocessor. Reply 3–5 (citing Ex. 1001, 7:14–36, Fig. 1; Ex. 1163 ¶¶ 15–18).” slip op. at 13

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

    “art because they pertain to the same “field of cluster computing” as the ’034 patent and “are reasonably pertinent to the problem of the ’034 patent, namely, executing a single program on multiple nodes.” Pet. 22 (citing Ex. 1001, 1:14–15; Ex. 1003, ¶¶ 65–69; Ex. 1005, 2; Ex. 1006, Abstract). The Petition emphasizes that Menon expressly cites and builds on the MultiMATLAB system taught by Trefethen. Id. (citing Ex. 1003 ¶ 71; Ex. 1005, 1–2). The Petition contends that: combination of prior art elements according to known methods (executing MATLAB code on a multiprocessor system) to yield the predictable result discussed in both papers: the MultiMATLAB system executing MATLAB in parallel to perform mathematical calculations. Id. at 22–23 (citing Ex. 1003 ¶ 70; Ex. 1005, Abstract; Ex. 1006, 2–7). The Petition further contends that a POSITA would have found it predictable to combine Trefethen with Menon with a reasonable expectation of success “because researchers had a strong desire to parallelize MATLAB.” Id. at 23–24 (citing Ex. 1003 ¶ 73; Ex. 1005, 2; Ex. 1006, 11–12.)” slip op. at 27

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

    “A POSITA would have had an especially strong reason to read these references together because they address the same project, the same MATLAB-based parallel-computing problem, and the same MultiMATLAB command environment. Menon expressly identifies Trefethen’s MultiMATLAB work and then describes a redesigned architecture that preserves the same user-level objective––parallel MATLAB computations—while improving implementation details and extensibility. A POSITA therefore would not view the references as mutually exclusive alternatives. Rather, a POSITA would understand Trefethen as teaching specific MultiMATLAB commands and examples, including Eval, Send, Recv, and the architecture was implemented and improved in a later version. Ex. 1163 ¶¶ 71–72 (emphases added). We find the above reasoning persuasive and adopt it as our own. Petitioner and Dr. Bajaj demonstrate a sound technical motivation for a POSITA—someone having a bachelor’s degree in computer science, computer engineering, or electrical engineering and two years of experience working in the field of cluster computing or parallel processing—to combine Menon and Trefethen: to improve MATLAB’s operational performance and extensibility in a parallel operating environment. Menon builds on Trefethen to improve and extend the parallel processing capabilities of MultiMATLAB: “This system will enable users to access high-performance parallel routines from within the MATLAB environment, to extend the environment with new parallel routines, and to use these routines to develop parallel applications with the MATLAB language.” Ex. 1005 Abstract. Menon is intended to be read in conjunction with Trefethen, as would be expected from two references generated by the same research group at the same university addressed to the same technical subject matter about a year apart. Ex. 1005, 1; Ex. 1006, Ex. 1086 ¶¶ 65, 101, 102. The very first citation in Menon is to Trefethen. Ex. 1005, 2, 16.” slip op. at 30

  Patent outcomesUS 11,570,034 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 11,570,034
• Stingray Group Inc. / Stingray Music USA, Inc. v. Edwin A. Hernandez-MondragonSome claims unpatentable
  PTAB · Jun 10, 2026 · IPR2025-00350 · APJ Jason M Repko · IPR · Final written decision

  Claims 7–12 were held unpatentable over Wannamaker alone or with Avellan; claims 1–6 and 13 were not shown unpatentable because Avellan did not teach the claimed screen-capture sequence and assembly.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Patent Owner submits a similar definition and does not take issue with the Petition’s characterization of the level of ordinary skill in the art. PO Resp. 17. We determine that no express finding is necessary and that the level of ordinary skill in the art is reflected by the prior art of record. Any perceived difference in how each party characterizes a POSITA’s education, knowledge, and work experience does not change our analysis or conclusions.” slip op. at 5

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

    “Neither party has offered any claim construction arguments, relying on ordinary and customary meaning. Pet. 19–20; PO Resp. 18. We determine that construction of claim terms is not necessary to resolve the disputes raised by the parties in this proceeding.” slip op. at 5

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Yet paragraph 122 of Mr. Lipoff’s declaration merely repeats the Petition’s argument almost verbatim. Compare Ex. 1007 ¶ 122, with Pet. 28. Mr. Lipoff does not add any citation to Avellan or any other source that supports his testimony. See Ex. 1007 ¶ 122. Nor does Mr. Lipoff offer any additional technical reasoning than what is stated in the Petition. Testimony may be entitled to little weight if it merely restates the petition’s unsupported, conclusory assertions without adding supporting evidence or technical reasoning. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). That is the case here.” slip op. at 8

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “We are persuaded by Patent Owner’s argument that claim 1 is not obvious over Avellan because it does not assemble a media stream of multimedia items using the recited screen captures. See PO Resp. 21–23. We agree with Patent Owner that the plain language of the claim requires more than transmitting individual media items. PO Sur-reply 20. To the extent that Avellan captures images, those images do not meet the claimed requirements for a “temporal sequence of screen captures” in the independent claims, which must (1) be of the web page rendered by a browser, (2) “define all the content of the web page at a given time,” (3) “illustrate a dynamic change of at least a portion of the content over time” when two of them are compared, and (4) used to assemble “the at least one media stream.” Rather, the record better supports Patent Owner’s argument that Avellan transmits the multimedia items separate from any media stream assembled from screen captures. PO Resp. 21–23; PO Sur-reply 20.” slip op. at 7

  Patent outcomesUS 10,524,002 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 10,524,002
• Stingray Group Inc. / Stingray Music USA, Inc. v. Edwin A. Hernandez-MondragonSome claims unpatentable
  PTAB · May 28, 2026 · IPR2025-00351 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–9 are unpatentable as obvious over the stated combinations; claims 10–26 were not shown unpatentable because Avellan does not teach limitations [10d]–[10f].

  RulingsFinal written decision

  • Skill levelOther

    “would have a bachelor’s or equivalent degree in computer science or a related field and at least 2 years of experience in multimedia processing or delivery using internet protocols.” Pet. 10 (citing Ex. 1002 ¶¶ 67–68). The Petition further states that “a person with less formal education but more experience, or more formal education but less experience, could have also met the relevant standard for a POSITA.” Id. Patent Owner submits a similar definition and does not take issue with the Petition’s characterization of the level of ordinary skill in the art of delivering multimedia content. Resp. 18. We determine that no express finding is necessary and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Any perceived difference in how each party characterizes a POSITA’s education, knowledge, and work experience does not change our analysis or conclusions. slip op. at 7

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

    “Neither party has offered any claim construction arguments, relying on ordinary and customary meaning. Pet. 11; Resp. 18–19; Reply 5. We determine that construction of claim terms is not necessary to resolve the disputes raised by the parties in this proceeding. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 8

  • Expert testimonyPetitioner expert creditedDecided for petitioner
  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentableNot shown unpatentable

    “To establish inherency, the extrinsic evidence “must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.” Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991). “‘Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’” Id. at 1269 (quoting In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981)). Reasonable inferences of a POSITA may suffice to establish inherent disclosure in a prior art reference such as Farber. See Eli Lilly v. Los Angeles Biomedical Research Institute, 849 F.3d 1073, 1074–1075 (Fed. Cir. 2017) (“[T]he dispositive question regarding anticipation is whether one skilled in the art would reasonably understand or infer from a prior art reference that every claim element is disclosed in that reference.”). Here, however, we find the Petition’s argument and evidence insufficient to establish by a preponderance of the evidence that Farber inherently discloses limitation [1b].” slip op. at 16

  Patent outcomesUS 11,140,441 mixed
  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 11,140,441
• Google LLC / Motorola Mobility LLC v. Multifold International Incorporated Pte. Ltd.All claims unpatentable
  PTAB · Apr 22, 2026 · IPR2025-00060 · APJ Arthur M Peslak · IPR · Final written decision

  Claims 1, 2, 4–9, 12–16, and 20 are unpatentable: claims 1, 2, 12, 13, and 20 as anticipated by Ogawa, and claims 4–9 and 14–16 as obvious over the stated combinations.

  RulingsFinal written decision

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

    “Claim 1 also recites “wherein the first and second states comprise an open application state.” Given the usage of “comprise” in this clause, we determine that the possible first and second states must include an open application state but the states are not limited to an open application state. Claim 12 similarly recites a processor that is operable to “displaying an icon associated with the application in at least one of the first display and the second display, wherein the icon indicates that the application is in one of two or more states associated with a display status of the application” and “wherein the first and second states comprise an open application state.” Ex. 1001, 16:12–19. Given the usage of “comprise” in these clauses, we determine that the first and second states must include an open application state but are not limited to an open application state that is being displayed in the corresponding display status as argued by Patent Owner. Patent Owner’s proposed construction, which requires the application to be “open and being displayed in the corresponding display condition/status,” further narrows the wherein clauses of claims 1 and 12 which do not require the application to be open and displayed. In fact, Patent Owner’s declarant, Dr. Surati, testified that the applications have multiple states and are not limited to open application states. Ex. 1016, 50:4–51:4. Patent Owner does not cite to an any portion of the Specification or prosecution history in support of its construction. PO Resp. 7–9.” slip op. at 13

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “would have had an undergraduate degree in electrical engineering, computer engineering, computer science or a related field along with two years of work experience in the field of user interface technologies, including e.g., graphical interface technologies, or a related field. . . . More education can supplement practical experience and vice versa. Pet. 5–6 (citing Ex. 1002 ¶¶ 20–21). Patent Owner applies Petitioner’s definition of a person of ordinary skill in the art. PO Resp. 10. We apply Petitioner’s uncontested definition because it appears consistent with the problems addressed in the ’080 patent and the prior art.” slip op. at 10

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

    “For the following reasons, we find that Petitioner establishes that Ogawa discloses this limitation. Patent Owner’s contentions are not responsive to Petitioner’s mapping of Ogawa to claim limitation [1.f]. This claim limitation recites that “the morphing comprising changing the shape and size of the icon.” Ex. 1001, 15:4–7. Petitioner relies on the size and shape of access bar 42 changing as shown by a comparison of Ogawa’s Figure 4(B) and Figure 4(C). Pet. 24– 25. Patent Owner does not dispute that the size and shape of access bar 42 changes from Figure 4(B) to Figure 4(C). See PO Resp. 10–16. Patent Owner focuses on the color of access bar 42 shown as cross- hatching in Figure 4 to argue that the icon does not represent the state of the application. PO Resp. 12–14. However, the color of access bar 42 and the size and shape of access bar 42 are set independently of each other by different functions. Ogawa explains that: [t]he splitting position of the screen is indicated by a pointer 44. When the pointer 44 is designated with the pen 12 and the pen is moved left or right (along the access bar 42), the splitting ratio (horizontal size ratio) of the two screens 13A, 13B changes as depicted in FIG. 4(C). Ex. 1005 ¶ 19.” slip op. at 29

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

    “Petitioner next contends that it would have been obvious to an ordinarily skilled artisan to modify “Ogawa’s display control method using Yook’s technique such that Ogawa’s method would have included first displaying a program across both logically divided displays of display input surface 13 . . . to increase the viewing area for the program as shown and described [in] Yook’s figures 4b and 4d.” Pet. 54–55 (citing Ex. 1002 ¶ 137). Petitioner further contends that the modification would “include[] minimizing the program to occupy only one of the first and second parts of display input surface 13 . . . as also shown and described with reference to Yook’s figures 4b and 4d.” Id. at 55. Petitioner then provides an example of the modification. Id. Namely, Ogawa’s operation would have been modified so that “when a user elects to split a screen in figure 4(A) using the split screen menu 41, the program is first displayed like in figure 4(C) . . . across two displays and then, based on user input to minimize the program size” resulting in the program displayed on one display. Id. (citing Ex. 1002 ¶ 137; Ex. 1005, Figs. 4(A)–4(C)). Petitioner next contends that the modification of Ogawa with Yook “would have involved the substitution of one known way of displaying a program” as shown in Ogawa “with another known display method” as shown in Yook, “and thus would yield a predictable result.” Pet. 56–57 (citing Ex. 1002 ¶ 139). Patent Owner does not address claim 4. See PO Resp. 10–18. We have reviewed Petitioner’s evidence and argument and find that Petitioner has shown that an ordinarily skilled artisan would have been motivated to combine Ogawa and Yook as a simple substitution of one known way of displaying a program for another with a predictable result. Ex. 1002 ¶ 139. Further, Petitioner has also shown that the combination of Ogawa and Yook teaches the limitations of claim 4. For the foregoing reasons, Petitioner establishes by a preponderance” slip op. at 43

  Patent outcomesUS 8,842,080 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,842,080
• Par Pharmaceutical, Inc. / Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Jul 27, 2016 · IPR2015-01814 · 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). Xyrem is a sensitive prescription drug prone to potential abuse or diversion. Ex. 1001, 3:14–19. Prior to Xyrem, sensitive prescription drugs such as Accutane, Clozaril, and thalidomide were known to use controlled distribution systems to protect against potential side effects, abuse, and diversion. Pet. 4–5 (citing Ex. 1007 ¶¶ 21–24). Accutane, a prescription drug from the 1980s that could cause birth defects, was distributed under a program requiring i) informed consent forms completed by patient and physician, ii) patient counseling to avoid pregnancy and use of birth control, and iii) a negative blood serum test for pregnancy prior to beginning treatment. Id. at 4 (citing Ex. 1007 ¶ 21). Distribution of Clozaril, indicated for treating schizophrenia but also capable of causing a fatal blood disorder, was controlled using a national registry system and computerized database for identifying patients and physicians. Id. at 4–5 (citing Ex. 1007 ¶ 22). In 1999, the manufacturers of thalidomide developed a system that combined the computerized registry of Clozaril with the controls imposed by the Accutane distribution system. Id. at 5 (citing Ex. 1007 ¶ 24). Based on such prior art activity, we find that by December 2002 a person of ordinary skill would have known the active ingredient in Xyrem – sodium oxybate – was a sensitive drug susceptible to abuse and diversion, and such person would have known of several available techniques to control and mitigate the risks associated with Xyrem’s distribution. Id. at 3 (citing Ex. 1007 ¶ 20); Ex. 1007 ¶¶ 21–27, 47.” slip op. at 11

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

    “1. “exclusive central pharmacy” and “exclusive computer database” In our Decision on Institution, we construed the term “exclusive central pharmacy” to mean “single or sole pharmacy,” and the term “exclusive computer database” to mean “single or sole computer database.” Dec. on Inst. 21. Our constructions are consistent with those proposed by Petitioner, and Patent Owner takes no position regarding Petitioner’s arguments in this regard. Pet. 10; 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 14

  • 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 ’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

    “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

  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 · IPR2015-01816 · APJ Jacqueline Wright Bonilla · IPR · Final written decision

  Claims 1–16 are unpatentable as obvious over the Advisory Committee Art under § 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 ’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” slip op. at 10

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

    “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.” slip op. at 14

  • 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 ¶ 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 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 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 (PTAB Apr. 15, 2014) (Paper 9) (citing In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986)); 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 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 two weeks after the meeting, but were posted no 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. 3–15. Thus, 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

  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 · IPR2015-01820 · 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

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.