• Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01332 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Gerber and O’Donnell; claims 1–4 and 6–11 are also unpatentable as obvious over Gerber and Barrie.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s contention that a person of ordinary skill in the art would be a physician specializing in urology, endocrinology, or oncology, or a person holding a Ph.D. in pharmacology, biochemistry or a related discipline, such as pharmaceutical science. Additional experience could substitute for the advanced degree. To the extent necessary, one of skill in the art may collaborate with one or more other persons of skill in the art for one or more aspects with which the other person may have expertise, experience and/or knowledge that was obtained through his or her education, industrial or academic experiences. For example, one of skill may consult with an endocrinologist, oncologist, or medical biochemist and thus may rely on the opinions of such specialists in evaluating the claims. Pet. 7 (citations omitted). Patent Owner does not appear to dispute Petitioner’s definition in its Patent Owner Response. See generally PO Resp. The level of ordinary skill in the art in this case is further demonstrated by the prior art asserted in the Petition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 10

  • Prior constructionPrior construction adoptedDecided for petitioner

    “Patent Owner also submitted a claim construction of the terms “treatment” and “treating” by the district court in a companion litigation. Ex. 2004. The district court, after a lengthy analysis, construed the disputed terms as follows: “Treatment/treating means the eradication, removal, modification, management or control of a tumor or primary, regional, or metastatic cancer cells or tissue and the minimization or delay of the spread of cancer.” Id. at 30. The district court read out of the definition the term “includes.” Id. Although we are not bound by the district court’s reasoning and claim constructions in related proceedings, we do not disregard the determinations of a court interpreting the same claim term in a related patent in a concurrent proceeding. Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1326–27 (Fed. Cir. 2015) (“The fact that the board is not generally bound by a previous judicial interpretation of a disputed claim term does not mean, however, that it has no obligation to acknowledge that interpretation or to assess whether it is consistent with the broadest reasonable construction of the term.”). Thus, although we acknowledge and have considered the district court’s interpretation, we retain our broadest reasonable construction of the terms “treat,” “treatment,” and “treating.” We see no reason to modify our claim construction positions in light of the record developed at trial, and we maintain our claim constructions from the Decision on Institution for the purposes of this Decision. No other claim terms have been presented to us for construction following institution of trial, and we determine that no other claim terms require express construction. B. Principles of Law” slip op. at 8

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

    “results from its studies, O’Donnell discusses that, in the clinical use of ketoconazole, “it is common practice to administer supplementary hydrocortisone” and that, therefore, “further studies with abiraterone acetate will be required to ascertain if concomitant therapy with glucocorticoid is required on a continuous basis, at times of physiological stress, if patients become symptomatic or indeed at all.” Id. at 2323. This statement represents the proposition that one of ordinary skill in the art would use the example of ketoconazole’s clinical use to take the next investigative steps with abiraterone acetate. We have not been presented with evidence that dissuades us from taking this statement at face value. Thus, we are persuaded that one of ordinary skill in the art would understand that both ketoconazole and abiraterone are CYP17 inhibitors, albeit with different mechanisms. With this knowledge, and given the teachings of the prior art on administration of ketoconazole and administration of abiraterone acetate, we find that one of ordinary skill in the art would look to the administration of ketoconazole for guidance on how to administer abiraterone acetate.” slip op. at 19

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

    “The teachings of the references do not rise to the level of teaching away from Petitioner’s proposed combination—they do not criticize, discredit, or otherwise discourage the solution claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (explaining “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”). Rather, as Petitioner argues, the prior art encourages exploration of such a combination. Pet. 38–42. Thus, we find that the prior art does not teach away from administration of prednisone to mCRPC patients.” slip op. at 32

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• Tricklestar LLC v. Embertec Pty Ltd.All claims unpatentable
  PTAB · Dec 20, 2017 · IPR2016-01336 · APJ Stacy B Margolies · IPR · Final written decision

  Claims 1–4, 7, and 9 are unpatentable as anticipated by EP ’379; claims 5 and 6 are unpatentable as obvious over EP ’379 and EP ’752.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We determine that the level of ordinary skill proposed by Petitioner and Petitioner’s declarant is consistent with the challenged patent and the asserted prior art, and we therefore adopt that definition of the level of ordinary skill in the art for the purposes of the analysis below. See Ex. 1001, 1:14–15 (“The invention relates to aspects of the monitoring of electrical power supply to electrical equipment.”); Ex. 1002 ¶ 1 (“The present invention relates to a method and system to provide power saving for electronic devices while such devices are in the standby mode and are not in use, particularly for a setting accommodating multiple electronic devices especially in the end-user sector.”); Ex. 1003 ¶ 1 (“The present invention relates to an automatic means switch device used to disconnect a load from” slip op. at 9

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

    “We determine that we do not need to expressly construe “input” (claim 1), “electrical input” (claim 9), “sensor” (claims 1 and 9), and “alert device” (claim 5) to determine whether Petitioner has shown by a preponderance of the evidence that claims 1–7 and 9 are unpatentable.” slip op. at 11

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

    “EP ’379 was published April 22, 2009. Ex. 1002, [43]. Because EP ’379 was published before the earliest possible invention date of record in this proceeding, Petitioner has shown by a preponderance of the evidence that EP ’379 is prior art to claims 1–4, 7, and 9 of the ’099 patent at least under 35 U.S.C. § 102(a).” slip op. at 16

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

    “Pet. 16. As illustrated above, Petitioner adds red ovals around what it contends, and with which we agree, correspond to the claimed sensor and microprocessor: infrared receiver unit 10 and microprocessor 12. Id. EP ’379 discloses that infrared receiver unit 10 is coupled to microprocessor 12 and that the infrared receiver unit monitors wireless output signals from a remote control. Ex. 1002, Fig. 3, ¶¶ 24, 26. Specifically, EP ’379 discloses that “the signals of the remote controls of electronic devices connected to the subject controller [are] sensed, identified, and interpreted by the controller.” Id. ¶ 23; see also id. ¶ 26 (stating that “the remote control signals controlling the devices connected to the controller can also be sensed by the controller”). According to EP ’379, “[t]he controller unit identifies as to which electronic device’s remote control the user has depressed by means of the signal receiver (10) on itself.” Id. ¶ 24. EP ’379 also discloses that the microprocessor terminates power supplied to the external electrical device based upon the absence of detection of signals from the remote control. Id. ¶ 26. EP ’379 states the following: The controller can be set to a predetermined time period in order to save power, and if no signal is received within this time period from a remote control of any device connected to it, the controller can turn OFF such devices in turn or at the same time according to a predetermined power saving rule. Id. EP ’379 adds an example of a user setting the automatic turn-off period to three hours. Id. Under this example, according to EP ’379, “if the user does not depress any key on any remote control of any electronic device connected to the controller, or if no signal is sensed by the controller within three hours, the controller may power off the electronic devices connected to itself in sequence according to an automatic turning-off rule.” Id. In sum, Petitioner shows by a preponderance of the evidence that claim 1 is unpatentable as anticipated by EP ’379.” slip op. at 20

  Patent outcomesUS 9,106,099 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,106,099
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentable
  PTAB · Nov 28, 2017 · IPR2016-01096 · APJ Lora M Green · IPR · Final written decision

  Claims 1–13 and 17–23 were not shown unpatentable because Petitioner did not prove the claimed viscosity was necessarily present in either obviousness combination.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In that regard, we note that Petitioner must “meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒ 96.” slip op. at 17

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

    “In the Institution Decision, we determined that none of the terms in the challenged claims require express construction at that time. Dec. Inst. 6 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting that only claim terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states that there is no need to expressly construe any of the claim terms. PO Resp. 13‒14. On the present record, we agree with Patent Owner and determine that none of the claim terms require explicit construction for purposes of this Decision.” slip op. at 7

  • Skill levelOther

    “We conclude that, for practical purposes, there is little difference between Petitioner’s and Patent Owner’s definitions of the ordinary artisan. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition. In addition, the level of ordinary skill in the art in this case is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “Patent Owner argues also that objective indicia of non-obviousness, such as unexpected results and commercial success support the patentability of the challenged claims. PO Resp. 59‒61. As we conclude that the preponderance of evidence of record does not support Petitioner’s obviousness challenge, we need not address Patent Owner’s evidence of secondary indicia.” slip op. at 29

  Patent outcomesUS 6,667,061 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,667,061
• Securus Technologies, Inc. v. Global Tel*link CorporationNo claims unpatentable
  PTAB · Nov 16, 2017 · IPR2016-01123 · APJ Georgianna W Braden · IPR · Final written decision

  Claims 1–11 were not shown unpatentable under either § 103 ground because Petitioner failed to explain adequately why or how a skilled artisan would combine the references.

  RulingsFinal written decision

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

    “Petitioner proposes constructions for the claim terms “continuous noise detection algorithm” and “power distribution filter algorithm.” Pet. 24–28. Patent Owner disputes Petitioner’s proposed constructions for these terms. Prelim. Resp. 8–11. After analyzing the claims and supporting specification of the ’726 patent, we determine that we need not provide express constructions for the disputed claim terms in order to reach our decision.” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not dispute Dr. Williams’ testimony. See generally Prelim. Resp. Patent Owner’s Declarant, Dr. Leonard J. Forys (“Dr. Forys”), however, proffers his own assessment regarding a person of ordinary skill in the art relevant to the ’726 patent. According to Dr. Forys, one of ordinary skill in the art would have had “a B.S. degree in Electrical Engineering, Computer Science, or an equivalent field as well as at least 3–5 years of academic or industry experience in communications systems, or comparable industry experience.” Ex. 2002 ¶ 29. Dr. Forys does not address Dr. Williams’ testimony in this regard or otherwise indicate whether his analysis would change if Dr. Williams’ proffered level of ordinary were adopted. Id. We have reviewed the ’726 patent, the types of problems and solutions described in the ’726 patent and cited prior art, and the testimony of Dr. Williams and Dr. Forys (who mostly agree as to the level of skill of an ordinarily skill artisan). Based on our review, we adopt and apply Dr. Williams’s definition of a person of ordinary skill in the art at the time of the claimed invention for purposes of this Decision. In addition, our analysis would not change if Dr. Forys’ proffered level of ordinary skill were adopted.” slip op. at 14

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “time of the ’726 patent would likely understand the relationship between power and energy. We also agree that there is a relationship between power and energy, and that it is possible to derive information about one from the other. See Ex. 1012, 18:14–25:8; Ex. 2001, 25:10–27:14; Ex. 2005, 238. Based on the evidence of record, we do not agree, however, that power and energy “are essentially equivalent and can be used interchangeably” as asserted in the Petition. See id.; see Pet. 36 (citing Ex. 1009 ¶¶ 174–177). Nor do we agree one of ordinary skill in the art would have understood that the Gupta energy threshold is the same as the power level threshold disclosed in Li. See Ex. 1012, 18:14–25; Ex. 2001, 25:10–27:14; Ex. 2005, 238. Petitioner’s reliance on Dr. Williams’s testimony regarding Gupta’s disclosure that “[a] minimum energy threshold may be programmed to [the cadence tone’s] required power level for a valid signal on a line” is equally unpersuasive. Ex. 1009 ¶ 181 (citing Ex. 1004, 6:41–44). We are unpersuaded because neither Petitioner nor Dr. Williams explains sufficiently how Gupta’s minimum energy threshold relates to a required power level or how it relates to Li’s power estimator and the purpose of Li’s power estimators. Given the lack of equivalence between power and energy, we find Petitioner fails to present sufficient evidence explaining why a person of ordinary skill in the art would have switched from detecting a power threshold, such as that described in Li and required by the challenged claims, to detecting an energy threshold as disclosed in McNitt and Gupta. Petitioner must articulate a reason why a person of ordinary skill in the art would combine the prior art references. Personal Web Techs. v. Apple, 848 F.3d 987, 991–92 (Fed. Cir. 2017); In re NuVasive, 842 F.3d 1376, 1382 (Fed. Cir. 2016); Metalcraft of Mayville, Inc. v. The Toro Company, 848 F.3d 1358, 1366 (Fed. Cir. 2017) (“[I]t is insufficient to simply conclude the [prior art] combination would have been obvious without identifying any reason why a person of skill in the art would have made the combination.”); see Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”). Conclusory statements alone, even those provided by a declarant, are inadequate to demonstrate a rationale for why a person of ordinary skill in the art would combine the teachings from prior art references. NuVasive, 842 F.3d at 1383. Instead, Petitioner’s arguments must be supported by a “reasoned explanation.” Id. (citing In re Lee, 277 F.3d 1338, 1342, 1345 (Fed. Cir. 2002)). We understand that a person of ordinary skill is a person of ordinary creativity, not an automaton, but “[w]ithout any explanation as to how or why the references would be combined to arrive at the claimed invention, we are left with only hindsight bias that KSR warns against.” Metalcraft, 848 F.3d at 1367 (“‘[T]he obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation,’ we also recognize that we cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention” (quoting KSR, 550 U.S. at 420–21)).” slip op. at 30

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

    “Petitioner must articulate a reason why a person of ordinary skill in the art would combine the prior art references. Personal Web Techs. v. Apple, 848 F.3d 987, 991–92 (Fed. Cir. 2017); In re NuVasive, 842 F.3d 1376, 1382 (Fed. Cir. 2016); Metalcraft of Mayville, Inc. v. The Toro Company, 848 F.3d 1358, 1366 (Fed. Cir. 2017) (“[I]t is insufficient to simply conclude the [prior art] combination would have been obvious without identifying any reason why a person of skill in the art would have made the combination.”); see Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”). Conclusory statements alone, even those provided by a declarant, are inadequate to demonstrate a rationale for why a person of ordinary skill in the art would combine the teachings from prior art references. NuVasive, 842 F.3d at 1383. Instead, Petitioner’s arguments must be supported by a “reasoned explanation.” Id. (citing In re Lee, 277 F.3d 1338, 1342, 1345 (Fed. Cir. 2002)). We understand that a person of ordinary skill is a person of ordinary creativity, not an automaton, but “[w]ithout any explanation as to how or why the references would be combined to arrive at the claimed invention, we are left with only hindsight bias that KSR warns against.” Metalcraft, 848 F.3d at 1367 (“‘[T]he obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion, and motivation,’ we also recognize that we cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention” (quoting KSR, 550 U.S. at 420–21)). We agree with Petitioner that the cited references do not need to be physically combinable to render claim 1 obvious. In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.”); see also In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc). Obviousness, however, “may not be established using hindsight or in view of the teachings or suggestions of the inventor.” Para-Ordnance Mfg. v. SGS Importers Int’l, 73 F.3d 1085, 1087 (Fed. Cir. 1995) (citing W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1551, 1553 (Fed. Cir. 1983)). Additionally, it is impermissible for Petitioner to “use the claimed invention as an instruction manual or ‘template’ to piece together the teachings of the prior art so that the claimed invention is rendered obvious.” In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) (citing In re Gorman, 933 F.2d 982, 987 (Fed. Cir. 1991)). Accordingly, Petitioner must set forth clearly in the Petition which references it is relying on for each specific limitation and how those combined teachings would render the challenged claims obvious. See 35 U.S.C. § 312(a)(3).” slip op. at 31

  Patent outcomesUS 8,630,726 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,630,726
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Nov 8, 2017 · IPR2016-01028 · APJ Christopher G Paulraj · IPR · Final written decision

  Claim 1 is unpatentable as obvious over Palermo, the Handbook, and McGinity, and also over McGinity, Joshi, Bastin, and the PDR.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 22–23 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 25. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13

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

    “We agree with Patent Owner that the broadest reasonable construction of “PEG applied onto the core matrix” is a “PEG coating of the core matrix.” Petitioner’s proposed construction would read “applied onto the core matrix” (emphasis added) out of the claim, which we decline to do. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 951 (Fed. Cir. 2006) (noting that claim language “should not [be] treated as meaningless”).” slip op. at 14

  Patent outcomesUS 9,060,976 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 9,060,976
• Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentable
  PTAB · Nov 8, 2017 · IPR2016-01027 · APJ Christopher G Paulraj · IPR · Final written decision

  Claim 1 is unpatentable as obvious over McGinity, Joshi, and Palermo.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 24 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 26. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9

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

    “The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for patent owner

    “iv. “core matrix” The parties agree that the broadest reasonable construction of “core matrix” is “a blended mixture having: (a) PEO having a molecular weight of from about 300,000 to about 5,000,000 daltons, (b) magnesium stearate, and (c) oxycodone or a pharmaceutically acceptable salt of oxycodone.” Ex. 3001. We adopt that agreed-upon construction for purposes of this Decision. v.” slip op. at 14

  Patent outcomesUS 9,060,976 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 9,060,976
• Securus Technologies, Inc. v. Global Tel*link CorporationInstitution denied
  PTAB · Oct 11, 2017 · IPR2017-01177 · APJ Kevin F Turner · IPR · Institution

  Instituted review of claims 1–20: claims 1–6 and 8–15 on obviousness over Otto, and claims 7 and 16–20 on obviousness over Otto, Gainsboro, and San Martin.

  RulingsInstitution decision

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

    “III. CONCLUSION For the foregoing reasons, we conclude that there is a reasonable likelihood that Petitioner would prevail in showing that claims 1–20 of the ’250 Patent are unpatentable. The Board has not made a final determination with respect to the patentability of these claims. The Board’s final determination will be based on the record as developed fully during trial.” slip op. at 25

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied

    “As quoted by Patent Owner, 35 U.S.C. § 325(d) addresses whether “the same or substantially the same prior art or arguments previously were presented to the Office.” To evaluate this criterion, we examine what arguments and art were presented to and considered by the Examiner during prosecution. Although Otto was considered by the Examiner (Ex. 1004, 243 indicates Otto was included in an Information Disclosure Statement by the Applicant), the Examiner did not rely on Otto in any rejection of the issued claims in view of Otto. We are further persuaded that the Examiner has not been shown to have considered Otto in the instant context, i.e., with claims 10 being argued as being obvious over Otto and with declaration testimony opining that the claims would have been obvious over Otto (Ex. 1002). Patent Owner also faults Petitioner for not distinguishing Otto from San Martin (Prelim. Resp. 7), but it is not necessarily incumbent on a petitioner to distinguish the disclosures of newly applied and previously applied prior art references. Patent Owner points out similarities in the disclosures of Otto and San Martin (id. at 6–7), but does not demonstrate what similar portions of Otto and San Martin would have been considered in finding certain claims allowable. See Ex. 1004, 219. Such a consideration is important because Patent Owner incorporated the allowable subject matter into the independent claims to gain allowance. See Ex. 1004, 290. At this stage of the proceedings, we are persuaded that that there is a reasonable likelihood that Petitioner would prevail in showing the subject matter of the independent claims are taught or suggested by Otto, and as discussed below, we are not persuaded that the disclosures of Otto and San Martin are necessarily cumulative.” slip op. at 10

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “With respect to the level of ordinary skill in the art, Petitioner asserts that such a person “would have held at least a bachelor’s degree in electrical engineering, computer engineering, or a similar field, and had at least two years of experience (or the academic equivalent) working with speaker-dependent voice recognition in the context of telecommunications.” Pet. 7 (citing Ex. 1002 ¶¶ 38–41). Patent Owner does not offer an alternate characterization at this time. As such, we adopt Petitioner’s statement of the level of ordinary skill in the art for purposes of this decision.” slip op. at 7

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

    “Hence, we determine that “match” would have been understood as determining whether two data items are identical or finding a data item that is identical to a key. See Ex. 3001. Furthermore, we determine that “substantially” would have been understood as to a great or significant extent, or for the most part or essentially. See Ex. 3002. Therefore, we determine that the broadest reasonable construction, consistent with and in 7 the context of the specification, of “substantially matches” is “determining whether two data items are for the most part or essentially identical.” See also Verve v. Crane Cams, 311 F.3d 1116, 1120 (Fed. Cir. 2002) (“Expressions such as “substantially” are used in patent documents when warranted by the nature of the invention, in order to accommodate the minor variations that may be appropriate to secure the invention.”)); see, e.g., Ecolab Inc. v. Envirochem, Inc., 264 F.3d 1358, 1367 (Fed. Cir. 2001) (explaining that “like the term ‘about,’ the term ‘substantially’ is a descriptive term commonly used in patent claims to avoid a strict numerical boundary to the specified parameter”) (citation omitted). Although Petitioner does not proffer an explicit construction for the claim term “substantially matches,” Petitioner does argue that the prior art discloses “both exact matches and matches that deviate from exact matches by predetermined amounts.” Pet. 29 (citing Ex. 1002 ¶ 74). Therefore, we are persuaded that Petitioner is implicitly applying a claim construction of “substantially matches” that comports with the broadest reasonable construction determined herein.” slip op. at 7

  Claim construction§ 103 obviousnessDiscretionary denialcites Nautilus
  Patents in suitUS 9,521,250
• Lupin Ltd. / Lupin Pharmaceuticals, Inc. v. Horizon Therapeutics, Inc.All claims unpatentable
  PTAB · Sep 26, 2017 · IPR2016-00829 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–15 are unpatentable under § 103 over the ’859 publication, Blau, and Simell; claims 3, 6, 11, 14, and 15 also rely on Brusilow ’84.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We are not persuaded by Patent Owner’s argument that the lack of specific residency/fellowship training or certification, disqualifies Dr. Vaux from providing opinion testimony on the motivations, understandings, and actions of those of ordinary skill in the art. Dr. Vaux testifies that he is “a medical doctor with specialty training in Pediatrics and Clinical Genetics” and is currently Professor and Clinical Chief of the Division of Medical Genetics in the Department of Medicine at UC San Diego. Ex. 1002 ¶ 1. He also testifies: Since 1994, I have regularly diagnosed and treated patients with urea cycle disorders (“UCD”), and continue to do so today. In treating UCD patients, I regularly prescribe nitrogen scavenging drugs and treat patients who are maintained on therapy with nitrogen scavenging drugs. Ex. 1002 ¶ 1. Thus, Dr. Vaux has actually treated UCD patients for at least five years (a requirement recited by Patent Owner, see PO Resp. 16), including prescribing drugs. Patent Owner does not direct us to evidence that Dr. Vaux’s testimony is untruthful or that his treatment of UCD patients is ineffective, indicating that he does not understand how to treat them. Accordingly, even if Dr. Vaux does not have the specialized certificates or particular training that Patent Owner argues are necessary, he has done the job for over twenty years of one who would carry out the claimed methods. We consider this experience more relevant than certificates or training. Thus, we determine that Dr. Vaux is qualified to provide opinions about the motivations, understandings, and actions of one of ordinary skill in the art.” slip op. at 15

  • Skill levelSkill level board ownOther

    “Patent Owner and Petitioner define a person of ordinary skill in the art as having similar qualifications (compare Pet. 8–9, citing Ex. 1002 ¶ 19 with PO Resp. 15–16, citing Ex. 2006 ¶ 26), but Patent Owner argues that the ordinarily skilled artisan must additionally have “at least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics.” PO Resp. 15–16, citing Ex. 2006 ¶ 26. We agree with the qualifications on which the parties agree and find that one of ordinary skill in the art would have an M.D. or equivalent degree, with a residency and specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCDs and other nitrogen retention disorders. See Pet. 8– 9; PO Resp. 15–16. We also agree with Patent Owner that one of ordinary skill in the art would have experience treating patients with nitrogen retention disorders, including UCDs. See PO Resp. 16.” slip op. at 15

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

    “Nevertheless, we agree with the parties8 that the claim term “upper limit of normal” (“ULN”) means the highest value in a range of normal values. See Pet. 10; PO Resp. 21. We determine that the plain meaning and the broadest reasonable interpretation of the claim term “less than the upper limit of normal” is any value less than the highest value in the range of normal values. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); see 37 C.F.R. § 42.100(b).” slip op. at 11

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

    “In summary, the ’859 publication teaches that those of skill in the art would have known to use HPN-100 to treat subjects with UCDs. It also teaches that measuring plasma or blood level of ammonia was known to be useful in determining the effectiveness of a drug regimen for a particular patient and that measuring blood ammonia was a known step in adjusting drug dosages. The ’859 publication teaches that maintaining normal plasma ammonia levels was desirable in the art. Although specific measurements of 8 Patent Owner notes that the parties do not dispute the meaning of any of the claim terms. PO Resp. 2. Because the meaning of the terms in the challenged claims are evident from their ordinary meaning and not controversial, we need not provide a separate analysis of them. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“claim terms need only be construed ‘to the extent necessary to resolve the controversy.’ Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).”). plasma ammonia do not necessarily indicate the upper limit of normal consistently across different ways of measuring it, the ’859 publication teaches that treatment would have been considered to be effective when plasma ammonia levels were less than what is determined to be the upper limit of normal in a given case. In addition to the ’859 publication, Petitioner relies on Blau and Simell for the teaching to collect blood from UCD patients after a fast in order to measure plasma ammonia levels. Ex. 1006 at 273 (Table 11.9); Ex. 1005 at 1118; see Pet. 25–26 (citing Ex. 1002 ¶¶ 58, 59); see also id. 1002 ¶ 46, n.2 (citing Ex. 1015 at S11). Anticipating Patent Owner’s argument that Blau relates to diagnosis not treatment of UCDs, Petitioner also cites to Exhibits 1010 and 1015 as evidence that it was generally recommended to measure plasma ammonia after a fast. See Pet. 16, n.2. Exhibit 1010 is a “Lab Update” about measurement in ammonia in blood, and Exhibit 1015 is a publication entitled “Measurement of ammonia in blood.” Both state that most methods recommend collecting a sample from patients who have fasted for at least 6 hours. See Ex. 1010, 4; Ex. 1015, 1. From this evidence, we agree with Petitioner that those of skill in the art would have known that measuring fasting serum ammonia levels, as taught in at least Simell and Blau, was known to be useful with the methods taught in the ’859 publication. In regard to Ground 2, which challenges claim 3 and the claims that depend on it, Petitioner cites Brusilow ’84 for its teaching of measuring a patient’s fasting plasma ammonia level when he or she is admitted, presumably to a hospital, and, in response to elevated levels, treating with the nitrogen scavenging drugs sodium benzoate and phenylacetate. See Pet.” slip op. at 11

  Patent outcomesUS 9,095,559 unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,095,559
• Osi Pharmaceuticals, LLC / Genentech, Inc. v. Arch Development Corp.All claims unpatentable
  PTAB · Sep 11, 2017 · IPR2016-01034 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–3, 5, and 6 are unpatentable: claims 1–3, 5, and 6 as obvious over Akinaga, Seynaeve, Friedman, and Tam; claim 6 also over Honma.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art as of the effective filing date of the ’512 patent, “would have held an M.D. or Ph.D. in molecular biology, biochemistry, pharmacology, or a related field and have had several years of experience working in cancer research.” Pet. 17 (citing Ex. 1002 ¶ 19); PO Resp. 4. This level of ordinary skill is consistent with the prior art asserted in the Petition. See Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774, 779 n.2 (Fed. Cir. 1983) (indicating that the prior art itself may reflect the appropriate level of ordinary skill in the art). Accordingly, we adopt the parties’ definition for the purpose of this Decision. C.” slip op. at 8

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Plain and ordinary meaningTerm construed board ownDecided for patent owner

    “which defines a “therapeutically effective amount” as “an amount of a DNA damaging agent and tyrosine kinase inhibitor that, when administered to an animal in combination, is effective to kill cells within the animal.” Id. at 5. The challenged claims, however, use “therapeutically effective amount” in a context different from the express definition set forth in the Specification. As noted by Petitioner, the definition at column 4, lines 16 to 19 of the Specification refers to “a combined amount of the DNA damaging agent and the tyrosine kinase inhibitor, while the claims require that only the tyrosine kinase inhibitor be administered in a ‘therapeutically effective amount.’” See Pet. 20.” slip op. at 9

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

    “Specification suggest that the inventors contemplated the induction of a differentiation pathway. See Ex. 2011 ¶ 4. To the contrary, and as discussed above in Section 1(C), the Specification focuses on the use of DNA damaging agents in combination with tyrosine kinase inhibitors to force damaged cells to override the G2 arrest checkpoint and enter mitosis before completing DNA repairs. See, e.g., Ex. 1001, 3:46–48 (“By preventing delays in G2, cells will enter mitosis before the DNA is repaired and therefore the daughter cells will likely die.”). Accordingly, we agree with Patent Owner that, in light of the Specification, one of ordinary skill in the art would not understand the terms “enhanc[ing] cell death” and “enhancing apoptosis” to encompass the a process by which cancer cells are differentiated, become mortal, and, subsequently, “live out their days and die.” See Pet. 29; Ex. 1002, ¶ 127.” slip op. at 14

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

    “The parties agree that the preamble of each challenged claim, as well as the “thereby” clause of claims 1–3 (“thereby improving chemotherapeutic intervention”), are non-limiting. Pet. 17–18, 21–22; Prelim. Resp. 5, 8; Ex. 2001, 15. On the present record, we adopt the parties’ proposed Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (instructing that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). D.” slip op. at 16

  Patent outcomesUS 7,838,512 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,838,512
• Topgolf International, Inc. v. Amit AgarwalRehearing denied
  PTAB · Sep 5, 2017 · IPR2017-00928 · APJ Lora M Green · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request and left in place institution of inter partes review of claims 1 and 6 based on the reasonable likelihood of obviousness over Bertoncino and Foley.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 2

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

    “most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end.” We note that the term “significantly lower” is a relative term, and Patent Owner does not offer a construction of that term.1 Nor does Patent Owner point us to anything in the prosecution history as providing a construction for that term. In addition, we note further that the Specification of the ’389 patent also does not define the relative term “significantly lower.” The Specification of the ’389 patent, however, teaches that each target green includes a target flag and a receptacle hole that is located near the front section of the green. Ex. 1001, 4:29‒32. According to the Specification of the ’389 patent, the target green is sloped downhill and has the general shape of a concave surface so that the receptacle hole is at the lowest portion of the green. Id. at 4:32‒35. Figure 4C of the ’389 patent is reproduced below: 1 We acknowledge that the ’389 patent expired as of September 2012, and we are, thus, guided by the principle that the words of a claim “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (internal citation omitted). But, “[i]n determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Figure 4C shows a cross-sectional view of a target green. Id. at 3:28‒29. As taught by the ’389 patent, “[t]arget green 30 would appear to the golfer at the teeing area to have a sudden drop off near the front portion of the green, and then a gradual slope upwardly toward the back of the green.” Id. at 4:37‒40. Thus, at best, the Specification of the ’389 patent appears to support a construction of the claim limitation of a target green profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end” as a green that has a sudden drop off near the front portion of the green and then a gradual slope upward toward the back of the green.” slip op. at 10

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

    “established sufficiently a reasonable likelihood that the challenged claims were rendered obvious by the combination of Bertoncino and Foley. Dec. 22. In particular, as to the limitation that the target green has a profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end,” for purposes of institution, we determined: that Petitioner has shown a reasonable likelihood that this claim limitation is rendered obvious by Bertoncino. In particular, Figure 5 of Bertoncino clearly shows that the front ends of the target green on the driving range are substantially lower than the back ends. Ex. 1004, Fig. 5. In addition, we determine that to the extent they are not, Petitioner has reasonably demonstrated that Bertoncino makes such a green obvious by teaching that the ability to see the lie of the ball is dependent on the ability to visually follow the path of the ball (id. at 1:26‒ 29), as well as teaching a “sloped driving range” (id. at 4:12‒ 13; see also id. at 5:37‒39 (“Each target . . . preferably comprises a surface generally sloped towards the tee stands area)). Id. at 19.” slip op. at 3

  • BurdenDecided for petitioner

    “Pet. 49. Figure 5 of Bertoncino, as addressed above, is a schematic perspective of a sloped driving range of Bertoncino. Petitioner also relied on its version of Figure 4 of Bertoncino, which was altered in line with the teaching of that reference that the target green may have only the inner section 22 (Ex. 1004, 6:61–65), and including the slope of the driving range shown in Figure 5 of Bertoncino, reproduced below: Pet. 49 (citing Ex. 1003 ¶ 92). Figure 4 of Bertoncino is a cross-sectional view of the sloped circular target of Figure 3. Ex. 1004, 4:8‒9. That is supported by Petitioner’s expert, Mr. Robbins, who declares that “[a] person of skill in the art would interpret Bertoncino to disclose a range with a plurality of target greens, each of which is composed of a single section with the slope profile of inner section 22” as depicted above. Ex. 1003 ¶ 92. Thus, as we concluded in the Decision on Institution (Dec. 17‒18), Petitioner in its Petition has established reasonably that Bertoncino teaches a target green having a profile wherein the “profile’s forward most end located at the forward portion of the target green having an elevation that is significantly lower than at its rearmost end.” That is, Petitioner has established reasonably for purposes of institution that the target green of Bertoncino meets the “significantly lower” limitation as construed above, as it has as a green that has a sudden drop off near the front portion of the green due to the concave shape of the target green and then a gradual slope upward toward the back of the green. See Ex. 1004, 6:3‒11, 12:6‒12, Figure 4.” slip op. at 12

  Claim constructioncites Phillips
  Patents in suitUS 5,370,389

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.