• 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
• Motorola Mobility LLC / Google LLC v. Multifold International Incorporated Pte. Ltd.All claims unpatentable
  PTAB · May 15, 2026 · IPR2025-00038 · APJ Kristen L Droesch · IPR · Final written decision

  Claims 1–7, 10–13, 16, 17, 19, and 20 are unpatentable as obvious over Chin; the Board did not find them anticipated by Chin or Whitehorn.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Level of Ordinary Skill in the Art Petitioner asserts that [a] person of ordinary skill in the art . . . (‘POSITA’) would have had at least a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field plus at least two years of work or post-graduate experience in image capture, image processing, image display, user interfaces, or a related field. Additional education could offset a lesser amount of experience and vice versa. Pet. 16. Patent Owner accepts Petitioner’s definition. See PO Resp. 25. We adopt Petitioner’s undisputed definition of a person of ordinary skill in the art because it is consistent with the level of skill reflected by the ’842 Patent Specification and the asserted prior art.” slip op. at 9

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

    “We agree with Petitioner that claim construction is unnecessary. As demonstrated in the analysis provided below addressing this claim limitation in view of the prior art, we need not explicitly construe “wherein in each image capture mode a display on the first or second screen is different.” See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only 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))). Similarly, we need not construe any other claim terms or phrases to resolve the controversy between the parties.” slip op. at 9

  • Strike new argumentNew argument disregardedDecided for patent owner

    “We agree with Patent Owner that Petitioner’s arguments relying on Kennametal are belated. A “[p]etitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019)6 at II.I. Thus, we need not consider Petitioner’s belated argument raised for the first time in the Reply. In any event, we agree that Kenneametal is inapplicable for the purpose of supplying a claim limitation missing from Chin’s disclosure. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1274 (Fed. Cir. 2017) (“Kennametal does not stand for the proposition that a reference missing a limitation can anticipate a claim if a skilled artisan viewing the reference would ‘at once envisage’ the missing limitation.”). Chin’s disclosure is silent regarding what is or is not displayed on first display 51 when images are displayed on second display 52 in self-photographing mode, and similarly silent regarding what is or is not 6 Available at www.uspto.gov/patents/ptab/trial-practice-guide. displayed on second display 52 when images are displayed on first display 51 in outward-facing mode. See generally Ex. 1004.” slip op. at 18

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentableNot shown unpatentable

    “We agree with Patent Owner that the theory of inherency was not raised in the Petition and is therefore waived. Compare Pet. 29–33, with Pet. Reply 11–15. In any event, we also agree that Petitioner’s speculation regarding the disclosure of Chin is insufficient to support a theory of inherency. See Pet. Reply 11–15. As explained above, Chin’s disclosure is silent regarding what is or is not displayed on first display 51 when images are displayed on second display 52 in self-photographing mode, and similarly silent regarding what is or is not displayed on second display 52 when images are displayed on first display 51 in outward-facing mode. See Ex. 1004. Speculation regarding the possibilities and probabilities of what is displayed on first display 51 in self-photographing mode, and what is displayed on second display 52 in outward-facing mode are insufficient to establish inherency. See In re Robertson, 169 F.3d at 745. For the forgoing reasons and based on the entire record developed during trial, the preponderance of the evidence does not support Petitioner’s showing that Chin discloses “wherein in each image capture mode a display on the first or second screen is different.” Accordingly, based on the entire record developed during trial the preponderance of the evidence does not support Petitioner’s showing that Chin anticipates claim 1.” slip op. at 20

  Patent outcomesUS 8,836,842 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,836,842
• 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
• Amneal Pharmaceuticals, LLC / Par Pharmaceutical, Inc. v. Jazz Pharmaceuticals, Inc.All claims unpatentable
  PTAB · Mar 22, 2017 · IPR2015-01903 · APJ Brian P Murphy · IPR · Final written decision

  Claims 24, 26, and 27 are unpatentable as obvious over the Advisory Committee Art and Korfhage.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “8 Petitioner relies on Dr. Valuck’s testimony (Ex. 1007 ¶ 21) to describe a POSA as having a “Bachelor’s or Doctor of Pharmacy degree and a license as a registered pharmacist with 3-5 years of relevant work experience, or a computer science undergraduate degree or equivalent work experience and work experience relating to business applications, for example, including familiarity with drug distribution procedures.” (Id.) “Alternatively, a POSA may have a blend of computer science and pharmacy drug distribution knowledge and/or experience.” (Id.) “[S]uch a POSA may have computer science education qualifications and experience relating to computerized drug distribution systems, or pharmacy education qualifications and experience relating to computerized drug distribution systems.” (Id.). Patent Owner does not dispute Petitioner’s description of a POSA. Therefore, we adopt and apply Petitioner’s description of a POSA to our analysis in this Decision.” slip op. at 9

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

    “13A–C as “descriptions of sample reports obtained by querying a central database having fields represented in Fig. 7.” Ex. 1001, 8:24–26 (emphasis added); see also id. at 2:59–61 (also describing Figs. 13A–C as “sample reports”). The description of sample reports is hardly exclusionary of the type of ad hoc early prescription refill report described in Figure 4B, which involves generating a risk diversion report whenever a patient calls to request an early refill. Id. at Fig. 4B (406, 432, 434). Thus, we do not agree that the specification excludes the generation of ad hoc or intermittent reports from the term “periodic reports,” or refers only to reports obtained at regular frequencies or intervals, even if the term “periodic” includes such reports. To the contrary, the ’963 patent specification and prosecution history support the inclusion of ad hoc reports, such as risk diversion reports generated whenever an early prescription refill is requested, within the meaning of the term “periodic reports.”” slip op. at 12

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

    “the Board issued final written decisions, dated after Patent Owner’s Response, determining that the ACA was publicly accessible and qualifies as prior art under 35 U.S.C. § 102(b). Reply 4 (citing Case IPR2015-00551, slip op. at 38 (PTAB July 27, 2016 (Paper 70))). Petitioner is correct. Therefore, we adopt our finding in IPR2015-00551 for the same reasons given therein, namely that Petitioner has shown by a preponderance of the evidence that Exhibits 1003–1006 (the ACA) were publicly accessible to an interested POSA exercising reasonable diligence more than one year before the December 17, 2002 earliest priority date of the ’963 patent. Case IPR2015-00551, slip op. at 21–38 (PTAB July 27, 2016 (Paper 70)); 35 U.S.C. § 102(b). Petitioner’s evidence of record regarding the public accessibility issue in IPR2015-00551 is also of record in the present case, and the exhibit numbers are the same, but for a few exceptions.11 See Exhibits 1003–1006, 1007 (¶ 64), 1015, 1019, 1020, 1027, 1028, 1052, and 1053.” slip op. at 16

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

    “the evidence that a POSA would have been motivated to distribute the ACA’s single, centralized computer database over multiple computers, for reasons of cost, efficiency, and the anticipated volume of prescription-related information to be received, entered, and queried. Pet. 25–30 (citing, inter alia, Ex. 1003, 24:21–25; Ex. 1004, 110; Ex. 1005, cover letter; Ex. 1006, 6 n.24; Ex. 1007 ¶¶ 78, 79, 85–87), 51–52 (citing Ex. 1007 ¶ 144; Ex. 1037, 276).” slip op. at 23

  Patent outcomesUS 8,731,963 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 8,731,963
• 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 · IPR2015-01814 · 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 · IPR2015-01810 · 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 before the patent’s priority date.

  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)Other

    “[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 18

  • 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

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

    “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 ’059 patent. Pet. 18– 39; Reply 1. Petitioner relies on the Declaration testimony of Dr. Valuck in support of its argument that a POSA would have had reason to combine the ACA documents. Id. at 18 (citing Ex. 1007). Specifically, Petitioner asserts that 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 FDA Advisory Committee Transcript and Slides (Ex. 1003) “were a public transcript of and presentation given at the meeting itself.” Id. at 18 (citing Ex. 1007 ¶ 52). 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. at 18–19. 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 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 7,895,059 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 · IPR2015-01816 · 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

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.