• Illumina, Inc. v. The Trustees Of Columbia University In The City Of New YorkAll claims unpatentable
  PTAB · Sep 9, 2019 · IPR2018-00797 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1 and 2 are unpatentable as obvious over the instituted grounds; the Board also denied Petitioner’s motion to exclude and found no estoppel against Patent Owner.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “II. PETITIONER’S MOTION TO EXCLUDE In support of its briefing, Patent Owner provided a declaration of” slip op. at 9

  • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

    “proceedings or would otherwise have a collateral estoppel effect on the current proceedings. See Paper 59, 4–5. For the reasons set forth below, we determine that the claims of the ’985 patent have material differences from the claims at issue in the previous proceedings, and that there is no inconsistency between Patent Owner’s positions in the current proceeding and in the previous proceedings. Accordingly, we determine that there is no estoppel attaching to Patent Owner with respect to the present inter partes reviews. Below, we provide a brief history of the previous proceedings and then address Petitioner’s contentions.” slip op. at 61

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

    “analogues for SBS, and Metzker reports actually achieving such a molecule. Accordingly, the preponderance of the evidence supports our determination that a person of ordinary skill in the art would have had a reasonable expectation of success and reasonable likelihood of success in “meet[ing] the limitations” of claim 1 to the extent the claim requires using such an analogue. Intelligent Bio-Systems, Inc., 821 F.3d at 1367.” slip op. at 50

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

    “analogues for SBS, and Metzker reports actually achieving such a molecule. Accordingly, the preponderance of the evidence supports our determination that a person of ordinary skill in the art would have had a reasonable expectation of success and reasonable likelihood of success in “meet[ing] the limitations” of claim 1 to the extent the claim requires using such an analogue. Intelligent Bio-Systems, Inc., 821 F.3d at 1367.” slip op. at 50

  Patent outcomesUS 9,868,985 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,868,985
• Mylan Laboratories Limited v. Aventis Pharma S.A.All claims unpatentable
  PTAB · Sep 21, 2017 · IPR2016-00712 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–5 and 7–30 are unpatentable; the contingent motion to amend claims 27–30 with substitute claims 31–34 is denied.

  RulingsFinal written decision

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

    “unpatentable. Therefore, we address Patent Owner’s contingent motion to enter proposed substitute claims 31–34. MTA 1, App. (claims 31–34). For the reasons that follow, Patent Owner’s motion is denied.” slip op. at 66

  • ExcludeMotion to exclude, deniedDenied

    “McSorley’s Declaration in connection with Exhibits 1089 or 1090 to support our decision. Therefore, Patent Owner’s Motion to Exclude Exhibits 1089 and 1090 is denied as moot.” slip op. at 81

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “e. Conclusion When we balance Petitioner’s strong evidence of obviousness against” slip op. at 52

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73(a) regarding the patentability of the challenged claims. In this case, the claimed treatment method, administering a 20 to 25 mg/m2 dose of cabazitaxel in combination with prednisone to docetaxel-refractory metastatic prostate cancer patients, was disclosed more than one year before the earliest effective filing date to which the ’592 patent might be entitled.4 Therefore, for the reasons that follow and based on our review of the complete trial record, we determine Petitioner has shown by a preponderance of the evidence that claims 1–5 and 7–30 of the ’592 patent are unpatentable. We further determine that Patent Owner’s Contingent Motion to Amend claims 27–30 is denied.” slip op. at 4

  Patent outcomesUS 8,927,592 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,927,592
• Institut Straumann AG / Dental Wings Inc. v. Sirona Dental Systems GmbHSome claims unpatentable
  PTAB · Nov 15, 2016 · IPR2015-01190 · APJ Brian P Murphy · IPR · Final written decision

  Claims 1–8 were held unpatentable as obvious over Bannuscher and Truppe; claims 9–10 were not shown unpatentable; the motion to amend was denied.

  RulingsFinal written decision

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

    “interpretation of the language used in claim 1 and the additional limitations of dependent claims 9 and 10. Patent Owner’s proposed construction also impermissibly reads limitations from the preferred embodiment of Figure 5 into claim 1. Patent Owner would limit the pilot hole location exclusively to a position directly over the implant position and require the drill bit to pass through the pilot hole while drilling a bore hole into the patient’s jaw. The language recited in claim 1, in the context of the ’006 specification, does not so-limit the “determinating a pilot hole” step. First, Patent Owner fails to consider the present participle form “determinating”5 at the beginning of the recited method step at issue. As a result, Patent Owner conflates the recited device production step with a specific process for drilling a bore hole into a patient’s jaw during tooth implant surgery. PO Resp. 14–15. For example, Patent Owner relies on Dr. Erickson’s Declaration testimony (and Dr. Benjamin’s deposition testimony) for the proposition that “pilot hole” is a term of art referring to “an initial hole through which a pilot drill passes during an operation.” Ex. 2002 ¶ 37 (cited at PO Resp. 16–17); see also PO Resp. 16–17 (citing Ex. 2023, 24:3– 22, 25:18–27:2, 52:2–9). The ’006 patent does not describe or reference any such “pilot drill” or “initial hole” being made during a tooth implant operation. Regardless, the claim limitation at issue is a step in a method of producing a drill template. It recites defining a pilot hole in a drill template with reference to the surfaces of neighboring teeth, nothing more. The function of actually passing a drill through a pilot hole in a drill template” slip op. at 11

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

    “Petitioner argues that the term “pseudo-x-ray picture” is not a term that has a commonly understood meaning to a POSA. Pet. 19 (citing Ex. 1002 ¶ 45 [47]). Patent Owner does not comment on the construction of “pseudo-x-ray picture.” PO Resp. 15–19. Having reviewed the complete record, we adopt Petitioner’s argument and evidence in support of Petitioner’s proposed broadest reasonable interpretation of “pseudo-x-ray picture.” Therefore, we adopt Petitioner’s proposed broadest reasonable interpretation of “pseudo-x-ray picture” as “any representation of measured data records of the three-dimensional optical measuring that can be superimposed on an x-ray image.” Pet. 19 (citing Ex. 1002 ¶ 49).” slip op. at 17

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

    “stylus is used to penetrate the surface of the gum repeatedly to measure the structure of the jaw bone displayed in Figure 25. PO Resp. 30–31 (citing Ex. 1007, 24:53–65 (“[S]tylus member 52 is provided with a sharp stylus 574 (FIG. 1) having a length sufficient[ly] long to penetrate gum tissue and contact the bone surface. . . . [P]ractitioner repeats the procedure of piercing the gum tissue in a region about the desired implantation site and taking point data until enough data has been collected . . . to map . . . the entire surface of bone 558 [Fig. 25] about the implantation site.”)). We agree with Patent Owner and find that the use of a sharp stylus to pierce the gum and take multiple data points via contact digitization of the jaw bone beneath the skin surface is not a 3-D optical measuring of the visible surfaces of a patient’s jaw.” slip op. at 21

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

    “would have been motivated to combine their teachings with respect to correlating X-ray imaging data of the jaw and 3-D surface data of the jaw and teeth. Reply 22–23 (citing Ex. 1002 ¶¶ 89, 92; Ex. 1008, 1:10–11 (“precise planning of the surgical operation is necessary”); Ex. 1010, 5:19– 25 (“it is possible to carry out the entire implantological, treatment and operation planning on a scientific basis . . . to implement holistic planning results in a precisely clinical manner”)). More particularly, Bannuscher discloses the desire to obtain “all the necessary [clinical] parameters” relevant to pre-surgical implant planning, which can be “combined together” (“correlated” in the language of claim 1) using planning simulation software, for transfer to a drill template. Ex. 1010, 5:44–6:13, 6:24–40, 7:38–8:4. As Dr. Erickson testified, it would have been desirable for a POSA to have as much diagnostic information as possible when planning for dental implant surgery. Ex. 1029, 31:12–21. Truppe discloses the advantage of correlating three-dimensional X-ray imaging data of the jaw and optical imaging data of the jaw and teeth, using simulation software, to obtain a “vivid” representation. Ex. 1008, 2:7–16, 3:19–28, 3:56–58; 4:1–5. Truppe, therefore, discloses a similar process to that disclosed in Bannuscher with respect to correlating 3-D X-ray imaging data and 3-D optical data representing the surfaces of the jaw and teeth, to generate the best possible representation of the patient’s jaw and teeth. Ex. 1002 ¶¶ 89–92. A POSA would have been motivated to use Truppe’s optical measurement system to generate 3-D surface data of the jaw and teeth for use in Bannuscher’s planning simulation software, in order to produce an enhanced image for determining the optimal bore hole and pilot hole in the drill template. Id.; Ex. 2023, 186:8–187:13 (“the optical imaging [of Truppe] would basically just enhance the diagnostic data [of Bannuscher]”). For example, a POSA would have optically measured the plaster model of the jaw and teeth referenced in Bannuscher and the patient’s actual jaw and teeth, as in Truppe, to produce a “vivid” image for correlation with the X-ray imaging data. Ex. 1002 ¶¶ 89, 92.20 Bannuscher’s determination of the optimized bore hole and corresponding pilot hole in the drill template would be based on the enhanced imagery generated from the correlated 3-D data sets. In short, we are persuaded that a POSA would have had reason to incorporate the teaching of Truppe’s enhanced 3-D optical measurement technique into Bannuscher’s method for correlating 3–D X-ray image and model geometry data sets, to determine an optimal bore hole and corresponding pilot hole in the drill template. For the reasons given above, we are persuaded that Petitioner has established a sufficient motivation for a POSA to combine the relevant teachings of Bannuscher and Truppe, with a reasonable expectation of success, by a preponderance of the evidence.” slip op. at 40

  Patent outcomesUS 6,319,006 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,319,006
• Fca US LLC v. Signal IP, Inc.Some claims unpatentable
  PTAB · Oct 19, 2016 · IPR2015-01118 · APJ John A Hudalla · IPR · Final written decision

  Claim 3 is unpatentable under § 103 over three instituted combinations; claims 1 and 2 were not shown unpatentable over Mock and Steele.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We disagree with Signal. In particular, FCA cites Dr. Lall’s testimony on “experience in vehicle electronics” and “experience in the design of automobile components.” Pet. 17 (citing Ex. 1009 ¶¶ 17–19). In addition, Dr. Lall testified at his deposition that an ordinarily skilled artisan also would have had the general background tools provided by obtaining a bachelor’s degree in mechanical or electrical engineering, as defined by the standard curricula for those degrees. See, e.g., Ex. 2001, 11:16–15:22. Dr. Lall also referenced his familiarity with these curricula based on his employment as a professor in the Department of Mechanical Engineering at Auburn University. See id. at 12:19–13:5; Ex. 1009 ¶ 4. Accordingly, we do not agree with Signal that Dr. Lall’s testimony as to the level of ordinary skill in the art for the ’374 patent is conclusory and/or lacking a factual basis. As such, we decline to discount the weight given to Dr. Lall’s testimony on that issue.6 Importantly, Signal never proposed an alternative definition of the ordinary level of skill in the art. See Tr. 48:17–25. As such, we have no indication from Signal about what particular aspects of FCA’s definition Signal believes are incorrect, if any. FCA’s proposed definition of the level of ordinary skill comports with the qualifications a person would need to understand and implement the teachings of the ’374 patent and the prior art of record. Accordingly, we apply it for purposes of this Decision.” slip op. at 16

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We disagree with Signal. In particular, FCA cites Dr. Lall’s testimony on “experience in vehicle electronics” and “experience in the design of automobile components.” Pet. 17 (citing Ex. 1009 ¶¶ 17–19). In addition, Dr. Lall testified at his deposition that an ordinarily skilled artisan also would have had the general background tools provided by obtaining a bachelor’s degree in mechanical or electrical engineering, as defined by the standard curricula for those degrees. See, e.g., Ex. 2001, 11:16–15:22. Dr. Lall also referenced his familiarity with these curricula based on his employment as a professor in the Department of Mechanical Engineering at Auburn University. See id. at 12:19–13:5; Ex. 1009 ¶ 4. Accordingly, we do not agree with Signal that Dr. Lall’s testimony as to the level of ordinary skill in the art for the ’374 patent is conclusory and/or lacking a factual basis. As such, we decline to discount the weight given to Dr. Lall’s testimony on that issue.6” slip op. at 16

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

    “We are persuaded by Signal’s arguments. “Distinctive” ordinarily means “characteristic of one person or thing, and so serving to distinguish it from others.” Distinctive, NEW OXFORD AMERICAN DICTIONARY (1st ed. 2001) (Ex. 3001). Accordingly, the plain and ordinary meaning of the limitation “distinctive codes for tire transmitters and vehicle function transmitters” must reflect that the recited codes distinguish tire transmitters from vehicle function transmitters. This is consistent with the surrounding language of claim 1, which recites different actions taken depending on whether the transmitted data contains “a distinctive code for tire transmitters” or “a distinctive code for the vehicle function transmitters.” This usage within the claim is important because “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d at 1314. In particular, “the context in which a term is used in the asserted claim can be highly instructive.” Id. We also note that FCA’s proposed interpretation would read out language from the claim. Under FCA’s theory, the claim does not require the codes to distinguish between tire transmitters and vehicle function transmitters, and encompasses codes that are merely distinct from each other. In effect, FCA would have us read the limitation as “the remote transmitters all having the same data format but distinctive codes.” The claim does not stop there, however. The full limitation is “the remote transmitters all having the same data format but distinctive codes for tire transmitters and vehicle function transmitters” (emphasis added). Thus, the codes are distinctive “for” tire transmitters and vehicle function transmitters, and the processor performs different actions depending on whether the transmitted data contains “a distinctive code for tire transmitters” versus “a distinctive code for vehicle function transmitters.” FCA’s proposed interpretation would read out this important aspect of the claim. Interpreting the claim to require the codes to distinguish between the two types of transmitters also is consistent with the Specification. We agree with Signal that the usage of “distinctive codes” in claim 1 is supported by the Specification’s disclosure of an exemplary message format with a “header” that “identif[ies] the source as a tire sender or a keyless entry fob.” Ex. 1001, 4:51–55, Fig. 4. Importantly, the header is separate and distinct from the “unique transmitter identification code,” an identifier unique to each transmitter that corresponds to the “ID” block in Figure 4. Id. at 4:55– 56, Fig. 4. In other words, the Header distinguishes types of transmitters (i.e., a tire sender or keyless entry fob) by their function or category, whereas the ID uniquely identifies a particular transmitter and distinguishes it from the others. An exemplary use of the ID block is illustrated with respect to step 94 of Figure 7, and it serves to show the different uses of the Header and the ID: After a message is determined to be a tire pressure message via category identification at step 78, a low pressure warning may be displayed “for the particular tire position which sent the message as determined by the identification code incorporated in the transmission,” among other things. Id. at 5:20–23, 5:32–44, Fig. 7.” slip op. at 11

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

    “We are not persuaded by Signal’s arguments because we do not agree with Signal that Schuermann’s separate interrogation implies that a sign-up procedure is unnecessary. Rather, Schuermann is silent as to whether and how a sign-up procedure would be used, so FCA is correct that Schuermann “leaves it to persons of ordinary skill in the art to use known techniques for accomplishing transponder sign-up.” Pet. Reply 4. As such, we are persuaded by FCA’s rationale that an ordinarily skilled artisan would have had reason to incorporate Mock’s sign-up procedure to ensure reliable identification of tire transmitters. See Pet. 29–30; Ex. 1009 ¶ 35. We additionally agree with FCA that an ordinarily skilled artisan would have appreciated the benefits of adding Mock’s sign-up procedure based on the cost reductions Mock mentions that are associated with a changeable identification code at the tire transmitter. Ex. 1005, 4:47–51. Signal’s counsel conceded that Mock teaches this benefit at the oral hearing. Tr. 38:4–25.” slip op. at 24

  Patent outcomesUS 5,463,374 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 5,463,374
• Google, Inc. v. Personal Audio LLCSome claims unpatentable
  PTAB · Sep 9, 2016 · IPR2015-00846 · APJ Mitchell G Weatherly · IPR · Final written decision

  Claims 1–4, 9, and 13 are unpatentable as obvious over Chase and Loeb; claims 5–8, 14–17, 28, and 29 were not shown unpatentable.

  RulingsFinal written decision

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

    “construction in light of the specification of the patent in which it appears.” 37 C.F.R. § 42.100(b); see also Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming that USPTO has statutory authority to construe claims according to Rule 42.100(b)). When applying that standard, we interpret the claim language as it would be understood by one of ordinary skill in the art in light of the specification, and absent any special definition, we give claim terms their ordinary and customary meaning. See In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010); In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (“The ordinary and customary meaning is the meaning that the term would have to a person of ordinary skill in the art in question.” (internal quotation marks omitted)). Only terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In our Institution Decision, we preliminarily interpreted the “processor for . . .” elements of claims 1 and 4 Dec. 7–8. After our Institution Decision, neither party identified any issues relating to our preliminary interpretation of the “processor for . . .,” and we discern no other reason to modify our interpretation. Accordingly, we maintain our interpretation of the “processor for . . .” for the purposes of this Final Written Decision. Our interpretation is consistent with the findings of the District Court in the Apple Litigation, which interpreted the “processor for . . .” elements as recited in claims 1, 4, 5, 6, and 14 under 35 U.S.C. § 112, ¶ 6. Because the parties raise issues regarding the scope of terms introduced in claims 5, 6, and 14, we also adopt the District Court’s interpretation of those terms and the reasoning supporting those interpretations. The claim interpretations upon which we rely in resolving disputed issues are summarized in the table below.” slip op. at 8

  • Prior constructionPrior construction adoptedDecided for petitioner

    “In our Institution Decision, we preliminarily interpreted the “processor for . . .” elements of claims 1 and 4 Dec. 7–8. After our Institution Decision, neither party identified any issues relating to our preliminary interpretation of the “processor for . . .,” and we discern no other reason to modify our interpretation. Accordingly, we maintain our interpretation of the “processor for . . .” for the purposes of this Final Written Decision. Our interpretation is consistent with the findings of the District Court in the Apple Litigation, which interpreted the “processor for . . .” elements as recited in claims 1, 4, 5, 6, and 14 under 35 U.S.C. § 112, ¶ 6. Because the parties raise issues regarding the scope of terms introduced in claims 5, 6, and 14, we also adopt the District Court’s interpretation of those terms and the reasoning supporting those interpretations. The claim interpretations upon which we rely in resolving disputed issues are summarized in the table below.” slip op. at 8

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

    “As stated by the Federal Circuit, “a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.” In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012). “Rather, the test for obviousness is what the combined teachings of the references would have suggested to those having ordinary skill in the art.” Id. Petitioner does not seek to combine the devices of Chase and Loeb physically. Rather, Petitioner argues that Loeb describes an example of a conventional interface used for controlling a device that plays music and contends that features of that interface would have been recognized as advantageous for Chase’s affiliate terminal. We are persuaded that a skilled artisan would have sought out examples of admittedly conventional interfaces to improve the functionality of Chase’s affiliate terminal. See KSR, 550 U.S. at 417 (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”).” slip op. at 23

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

    “We are not persuaded that Chase teaches away from discontinuing a currently playing song to advance to a next segment. According to Chase, “[t]he jock box is a physical representation of a DAC cart located in a studio. It provides 8 pushbuttons each with an LED and a small LCD display. Conceptually the jock box is a CD player with an automated changer.” Ex. 1007 ¶ 219. As explained above, and shown in Chase’s Figure 4, DAC 52 is a component separate from remote control terminal 54. The jock box is a “physical representation of a DAC cart.” Id. We read this to be a typographical error and view the jock box as a physical representation of a DAC card, e.g., DAC card 52. If “cart” is not a typographical error, it could refer to a “cart machine,” id. ¶ 36, which also is a component separate from remote control terminal 54 (Figure 4 shows line 56 communicating with a cart, not shown). In either case, Chase’s description of a jock box does not refer to the behavior of remote control terminal 54, which is described elsewhere as follows: The DJ may also request, through the remote control terminal, that the DAC 52 start play of the next segment queued in the DAC 52, stop play of the current segment, fast forward/rewind through the current segment or to a next/previous segment. The DJ may use up/down arrows on the remote control terminal to scroll through a play list displayed to the DJ and select, out of turn, a segment from the play list. Id. ¶ 186. This description is consistent with a device that can discontinue play of a current segment and skip to the next. Thus, Chase does not teach away from a player with that behavior.” slip op. at 24

  Patent outcomesUS 7,509,178 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,509,178
• 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 · IPR2015-01816 · 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

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.