• Pfizer, Inc. v. Chugai Pharmaceutical Co. Ltd.No claims unpatentable
  PTAB · Nov 28, 2018 · IPR2017-01358 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1–7, 12, and 13 were not shown unpatentable because Shadle did not establish the claimed molarity and conductivity limitations, and the obviousness showing was insufficient.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “and several years of postgraduate training or practical experience in a relevant discipline such as biochemistry, process chemistry, protein chemistry, chemical engineering and/or biochemical engineering, among others.” Pet. 6 (citing Ex. 1002 ¶ 28). Petitioner further contends that “[s]uch a person would also understand that protein purification is a multidisciplinary field, and could take advantage of the specialized skills of others using a collaborative approach.” Id. (citing Ex. 1002 ¶ 28). Patent Owner does not address Petitioner’s position on this matter and does not propose its own description for a person of ordinary skill in the art at the time of the invention. We agree with Petitioner, and adopt Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’815 patent. We also note that the applied prior art reflects a level of skill at the time of the claimed invention consistent with our determination. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “Consistent with the Institution Decision, we determine that “the plain language of the claims, as well as the specification of the ’815 patent, indicates that the term ‘molarity’ refers to the total concentration of solute present in the solution, rather than the concentration of one particular solute.” Id. at 10–11. The claims of the ’815 patent refer consistently to the overall molarity of solutions, and not of any particular solute in a given solution. For example, claim 1 requires “an acidic aqueous solution of low conductivity . . . having a molarity of 100 mM or less” (Ex. 1001, 12:42–44 (emphasis added)), and further recites that the molarity of the “adjusted sample is 100 mM or less” (id. at 12:45–47 (emphasis added)). Claim 2 9 similarly limits the molarity of the “acidic aqueous solution.” Id. at 12:50– 52. Notably, these claims do not identify any particular solute to which the term molarity refers; rather, the claims of the ’815 patent describe solutions having certain characteristics, of which solution molarity is one. As we stated in our Institution Decision: Similarly, the specification of the ’815 patent refers to the molarity of the complete solution, rather than one solute in that solution. See, e.g., id. at 4:61–64 (“As used herein, a ‘neutral aqueous solution . . .’ generally refers to an aqueous solution . . . which has a molarity of 0 to 100mM”), 5:28–31 (“an ‘acidic aqueous solution of low conductivity’ generally refers to an aqueous solution . . . , which has a molarity of 0 to 100 mM”). The file history of the ’815 patent likewise references the molarity of the solution, rather than of a given solute in the solution. See e.g., Ex.1005, 82 (“an important feature of the present invention is to adjust pH value of the solution, the eluate, to from 4 to 8 while maintaining the molarity of the solution at 100mM or less.”), 107 (“0.1 M buffer was used as an eluent, and 1 M Tris-HCl was used to adjust the pH of the eluted fraction, that is, the fact that 0.1 M and 1 M solutions were used means that the molarity of the eluted fration [sic] must be over 0.1 M (100 mM)”). Inst. Dec. 11.” slip op. at 9

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

    “In the Institution Decision, we concluded that the claim terms “conductivity” and “ionic strength,” for which Petitioner proffered constructions in its Petition (Pet. 30, 35–36), did not require express construction for purposes of this proceeding. Dec. 8. Neither Petitioner nor Patent challenges that determination. See PO Resp. 11–22; Reply, passim. In its Response, Patent Owner proposes constructions for several additional 11 terms. Namely, Patent Owner contends that the preambles of claims 1 and 13 should be construed as limiting (PO Resp. 12), “to form particles” should be construed to require that the solution becomes clouded (id. at 16), and “the treated sample containing a physiologically active protein,” as recited in claim 5, should be interpreted to mean “the sample resulting from performing the method of claim 1, which concludes with removing particles in step 3” (id. at 17). Because interpretation of these claim terms is not necessary to our anticipation or obviousness analyses, we need not construe them. See Nidec, 868 F.3d at 1017.” slip op. at 11

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

    “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either expressly or inherently. Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1341 (Fed. Cir. 2016). “To establish that a prior art reference inherently—rather than expressly— discloses a claim limitation, ‘the limitation at issue necessarily must be present, or [is] the natural result of the combination of elements explicitly disclosed by the prior art.’” Endo Pharm. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381 (Fed. Cir. 2018) (alteration in original) (quoting PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014)). Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” slip op. at 14

  Patent outcomesUS 7,927,815 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,927,815
• Pfizer, Inc. v. Chugai Pharmaceutical Co. Ltd.No claims unpatentable
  PTAB · Nov 28, 2018 · IPR2017-01357 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1–8 and 13 were not held unpatentable because Petitioner failed to prove anticipation by Shadle or obviousness over Shadle.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the art at the time of the invention would have had “at least a graduate degree, such as a Ph.D., 6 and several years of postgraduate training or practical experience in a relevant discipline such as biochemistry, process chemistry, protein chemistry, chemical engineering and/or biochemical engineering, among others.” Pet. 6 (citing Ex. 1002 ¶¶ 28–29). Petitioner further contends that “[s]uch a person would also understand that protein purification is a multidisciplinary field, and could take advantage of the specialized skills of others using a collaborative approach.” Id. (citing Ex. 1002 ¶¶ 28–29). Patent Owner does not address Petitioner’s position on this matter and does not propose its own description for a person of ordinary skill in the art at the time of the invention. We agree with Petitioner, and adopt Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’289 patent. We also note that the applied prior art reflects a level of skill at the time of the claimed invention consistent with our determination. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 6

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

    “Consistent with the Institution Decision, we determine that “the plain language of the claims, as well as the specification of the ’289 patent, indicates that the term ‘molarity’ refers to the total concentration of solute present in the solution, rather than the concentration of one particular solute.” Id. at 10. The claims of the ’289 patent refer consistently to the overall molarity of solutions, and not of any particular solute in a given solution. For example, claim 1 requires “an acidic aqueous solution of low conductivity having a molarity of 100 mM or less” (Ex. 1001, 12:50–51 (emphasis added)), and further recites that the “molarity of the neutralized 9 eluate is 100 mM or less” (id. at 12:54 (emphasis added)). Claim 2 similarly limits the molarity of the “acidic aqueous solution.” Id. at 12:59–61. Notably, these claims do not identify any particular solute to which the term molarity refers; rather, the claims of the ’289 patent describe solutions having certain characteristics, of which solution molarity is one. As we stated in our Institution Decision: Similarly, the specification of the ’289 patent refers to the molarity of the complete solution, rather than one solute in that solution. See, e.g., id. at 4:61–66 (“As used herein, a ‘neutral aqueous solution . . .’ generally refers to an-aqueous [sic] solution . . . which has a molarity of 0 to 100mM”), 5:28–31 (“an ‘acidic aqueous solution of low conductivity’ generally refers to an aqueous solution . . . , which has a molarity of 0 to 100 mM”). The prosecution history of the ’289 patent likewise references the molarity of the solution, rather than of a given solute in the solution. See e.g., Ex.1005, 12 (“an important feature of the present invention is to adjust pH value of the solution, the eluate, to from 4 to 8 while maintaining the molarity of the solution at 100mM or less.”), 37 (“0.1 M buffer was used as an eluent, and 1 M Tris-HCl was used to adjust the pH of the eluted fraction, that is, the fact that 0.1 M and 1 M solutions were used means that the molarity of the eluted fration [sic] must be over 0.1 M (100 mM)”). Inst. Dec. 10–11.” slip op. at 9

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

    “In its Response, Patent Owner proposes constructions for several additional terms. Namely, Patent Owner contends that the preamble of claim 1 should be construed as limiting (PO Resp. 12), “to form particles” should be construed to require that the solution becomes clouded (id. at 17), and “the treated sample containing an antibody,” as recited in claim 5, should be interpreted to mean “the sample resulting from performing the method of claim 1, which concludes with removing particles in step 4” (id. 11 at 18). Because interpretation of these claim terms is not necessary to our anticipation or obviousness analyses, we need not construe them. See Nidec, 868 F.3d at 1017.” slip op. at 11

  • ExcludeOther

    “Petitioner asserts that Patent Owner untimely introduced Exhibits 2201–2207 for the first time during the deposition of Petitioner’s Reply declarant, Dr. Przybycien. Paper 36, 4. Petitioner additionally asserts that the challenged exhibits are inadmissible because they are irrelevant. Id. Patent Owner responds that the objected-to exhibits were timely introduced because they were used to challenge opinions presented by Dr. Przybycien for the first time in conjunction with Petitioner’s Reply. Paper 44, 2. Patent Owner further asserts that the exhibits are relevant because they illuminate gaps in Dr. Przybycien’s Reply testimony. Id. at 3. Because we have not relied on Exhibits 2201–2207, or Dr. Przybycien’s testimony regarding those exhibits in this Final Written Decision, we dismiss Petitioner’s Motion to Exclude Exhibits 2201–2207 as moot.” slip op. at 33

  Patent outcomesUS 7,332,289 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,332,289
• Alcatel-Lucent USA Inc. / Ciena Corporation et al. v. Oyster Optics, LLCInstitution denied
  PTAB · May 1, 2018 · IPR2017-02173 · APJ Jameson Lee · IPR · Institution

  The Board denied institution because petitioner had not shown a reasonable likelihood of prevailing on any challenged claim, chiefly because it did not establish a reason to loop transmitted signals back to the receiver.

  RulingsInstitution decision

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

    “In each of independent claims 1, 14, 25, and 36, prior to the recitation of “the optical signals,” there is only one introduction of an element as “optical signals.” That element is the signals transmitted by the transmitter. Independent claims 1, 14, 25, and 36 each recite “the transmitter transmitting optical signals for telecommunication as a function of the input data.” Ex. 1101, 6:51–53, 7:32–34, 8:12–14, 8:57–59 (emphasis added). Nothing else is expressly introduced in any of independent claims 1, 14, 25, and 36 as optical signals. Although data carried by the second optical fiber also are optical signals, they are referred to in these claims simply as data and not as optical signals. Thus, in these claims there is clear antecedent basis for the recitation “the optical signals.” The recited term refers to optical signals transmitted by the recited transmitter on the transceiver card.” slip op. at 12

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

    “Petitioner’s explanation does not constitute reasoning with rational underpinning for routing the signals from the first optical fiber, transmitted by the recited transmitter on the transceiver card, to the second optical fiber to be sent back and received by the receiver on the same transceiver card. Notably, Petitioner uses the word “could” to support its reasoning. But the issue is not whether one with ordinary skill in the art “could” perform an operation but whether one with ordinary skill in the art, without hindsight based on the disclosure of the ’327 patent, would have reason to do so. 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”); Fresenius USA, Inc. v. Baxter Intern., Inc., 582 F.3d 1288, 1299 (Fed. Cir. 2009). Petitioner has not articulated sufficient motivation for one with ordinary skill in the art, without hindsight based on the claims of the ’327 patent, to convert transmitted output into received input on the same transceiver card.” slip op. at 24

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

    “For the foregoing reasons, Petitioner has not shown a reasonable likelihood that it would prevail in establishing that claims 1 and 36 would have been obvious over the combination of Kitano and Choy. 4. Claims 2 and 9 Each of claims 2 and 9 depends directly from claim 1 and thus includes all the limitations of claim 1. 35 U.S.C. § 112, fourth paragraph. All of the Petition’s deficiencies in the context of claim 1 carry through to each of dependent claims 2 and 9. Accordingly, we determine that Petitioner has not shown a reasonable likelihood that it would establish unpatentability of claims 2 and 9 as obvious over Kitano and Choy.” slip op. at 27

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,620,327
• Resmed Limited / Resmed Inc. et al. v. Fisher & Paykel Healthcare LimitedNo claims unpatentable
  PTAB · Mar 7, 2018 · IPR2016-01724 · APJ Rama G Elluru · IPR · Final written decision

  Claims 1, 2, 5–8, 11–13, 21, 22, 26, and 27 were not shown unpatentable under § 103 because motivation to combine and reasonable expectation of success were not established.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “had “a bachelor’s degree in electrical engineering or biomedical engineering or a related discipline with an understanding of circuit design principles, and a reasonable amount of relevant product design experience to develop a level of competence in the field of respiratory therapy, or an equivalent advanced education.” Pet. 18; Ex. 1003 ¶ 22. Patent Owner does not dispute Petitioner’s definition of a person of ordinary skill in the art. PO Resp. 9. We adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an” slip op. at 6

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

    “For the purposes of this Decision, we determine that no claim term needs express interpretation. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 7

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

    “Tempered against Petitioner’s evidence of an alleged motivation to combine MR810, Gradon, and Edirisuriya is the uncertainty of operability of the proposed combination. With respect to each of the proposed circuit designs that Petitioner contends a skilled artisan would have been aware of to implement the combined teachings, a skilled artisan would have been faced with the real-world fact that there was uncertainty as to the operability of the design. First, the circuit designs that Petitioner proposes a skilled artisan would have utilized are not based on disclosure in the prior art. See Pet. Reply 5–7; Ex. 1032 ¶¶ 13–22. Petitioner does not rely on any prior art showing a circuit that allows a heater wire also to carry measurement signals. Pet. Reply 5–7; Ex. 2018, 19:6–21:17 (Petitioner’s expert, Mr. Bath, confirms that he did not locate any prior art references disclosing a circuit design in which the heater wire is utilized to carry electrical signals from measuring sensors). Moreover, Petitioner does not otherwise sufficiently rely on evidence that any of the proposed circuit designs would have been reasonably expected to be operable in any device, much less a humidification system. See Pet. Reply 5–7. Furthermore, Mr. Bath admits that these proposed designs are incomplete and would require additional non-trivial components. Ex. 2018, 89:13–90:21. He stated, “An engineer designing this system would need to take into account one change in the system by adjusting the rest of it to suit.” Id. at 89:16–18.” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightDecided for patent owner

    “We further find that Petitioner’s challenges rest on impermissible hindsight reconstruction of the disclosure in the ’641 patent. See Grain Processing Corp. v. Am.-Maize Prods. Co., 840 F.2d 902, 907 (Fed. Cir. 1988) (“Care must be taken to avoid hindsight reconstruction by using ‘the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.’” (quoting Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1012 (Fed. Cir. 1983))). All of the circuit designs Petitioner proposes a skilled artisan could have used to implement the asserted combination are hindsight reconstructions based on the disclosure in the ’641 patent. The ’641 patent describes switching the heater wire between two modes of use— carrying temperature measurement signals and heating the gas delivery tube —by inserting a component in parallel with a temperature measuring thermistor to switch the current path of the heater wire between the thermistor and the parallel-connected component. Specifically, the ’641 patent discloses switching the current flowing in heater wire 21, 28 between the parallel paths of thermistor 23 and diode 22, depending on whether heater wire 21, 28 is being used to carry temperature measurement signals or heat gas delivery tube 3, respectively. Ex. 1001, 4:8–21. Each of Petitioner’s proposed circuits, drawn solely from the testimony of Mr. Bath and not supported by the prior art, has a similar purpose. Petitioner’s first proposed circuit contains a capacitor connected in parallel with a thermistor to switch the path of the heating wire current between the thermistor, when the heating wire is being used to carry temperature measurement signals, and the capacitor, when the heating wire is being used to heat the breathing tube. Ex. 1032 ¶¶ 15–16. Petitioner’s second proposed circuit contains a gate-todrain connected MOSFET connected in parallel with a thermistor to switch the path of the heating wire current between the thermistor, when the heating” slip op. at 25

  Patent outcomesUS 8,453,641 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,453,641
• Resmed Limited / Resmed Inc. et al. v. Fisher & Paykel Healthcare LimitedAll claims unpatentable
  PTAB · Mar 7, 2018 · IPR2016-01735 · APJ Tina E Hulse · IPR · Final written decision

  Claims 1–7, 9, 10, 13–15, 19, 20, 27, and 33 are unpatentable as obvious over Makin and Gradon.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “education.” Pet. 14–15; Ex. 1003 ¶ 22. Patent Owner does not contest the level of ordinary skill in the art in its Response. PO Resp. 5. We adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 6

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

    “unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings). Under that standard, and absent any special definitions, we generally give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). We determine that it is unnecessary to expressly construe any claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be” slip op. at 6

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

    “Makin’s temperature sensor by adding the sensor housing means of Gradon. Having considered the complete trial record, we find that a person of ordinary skill in the art would have had a reason to combine the temperature sensor of Makin with Gradon’s housing with a reasonable expectation of success to protect the temperature sensor from the flow of humidified gas in the system. See Ex. 1003 ¶ 42; Ex. 1032 ¶¶ 7–11. Bath, support our finding. For example, Gradon expressly provides a reason to combine, stating that the sensor housing means completely encases the thermistor “[t]o protect [the] thermistor.” Ex. 1005, 9:14–15. A person of ordinary skill in the art reading Gradon would have been motivated to apply that suggested housing to protect Makin’s similar temperature sensor. Ex. 1032 ¶ 7. We credit the testimony of Mr. Bath, who explains that the housing “protect[s] the thermistor from the flow of humidified gases while providing reliable and accurate temperature measurement.” Ex. 1003 ¶ 42. This testimony is consistent with Gradon’s disclosure, which refers to the need “to reduce or eliminate the occurrence of liquid water accumulation on the sensors.” Ex. 1005, 10:4–6. As Mr. Bath testified, protecting the thermistor “was a recognizable benefit that would have prompted a [person of ordinary skill in the art] to likewise implement a protective housing suitable for Makin’s system.” Ex. 1032 ¶ 8. Thus, we find that adding a housing to Makin’s temperature sensor amounts to no “more than the predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417.” slip op. at 10

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

    “Nor are we persuaded by Mr. Darby’s testimony that Gradon would have directed one of ordinary skill away from a housing because Gradon teaches that housings reduce sensor accuracy. Ex. 2008 ¶ 50 (citing Ex. 1005, 9:34–38). Mr. Darby’s testimony is not persuasive because the cited portion of Gradon refers to the flow sensing means, which both parties agree cannot be covered by a housing to function properly. Tr. 17:10–15 (Petitioner); 47:1–8 (Patent Owner). In contrast, for the temperature sensing means, Gradon teaches that a housing is appropriate because the material is thin enough such that “the temperature reading obtained is still accurate.” Ex. 1005, 9:13–17. Thus, we are not persuaded that one of ordinary skill reading Gradon would have considered adding a housing to Makin’s temperature sensor to be disadvantageous, as Patent Owner claims. Instead, we find that a person of ordinary skill in the art would have had a reason to combine Gradon’s housing with Makin’s temperature sensor because such a person would recognize the benefit of protecting the temperature sensor from the flow of humidified gases without compromising the accuracy of the temperature reading. Ex. 1003 ¶ 42; Ex. 1005, 9:14–18.” slip op. at 14

  Patent outcomesUS 9,265,902 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,265,902
• Cisco Systems, Inc. / Oclaro, Inc. v. Oyster Optics, LLCInstitution denied
  PTAB · Feb 21, 2018 · IPR2017-01882 · APJ Jameson Lee · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable under the asserted obviousness grounds.

  RulingsInstitution decision

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

    “institute inter partes review of claims 14–21, 23, 25–32, 34, and 36–38 of U.S. Patent No. 7,620,327 B2 (Ex. 1001, “the ’327 patent”). Patent Owner2 filed a Preliminary Response (Paper 7, “Prelim. Resp.”). To institute an inter partes review, we must determine that the information presented in the Petition and any preliminary response show “that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Having considered the Petition and its supporting evidence, as well as Patent Owner’s Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in establishing the unpatentability of any of claims 14–21, 23, 25–32, 34, and 36–38 of the ’327 patent. We, therefore, do not institute trial on any challenged claim on any ground asserted by Petitioner. B.” slip op. at 2

  • Skill levelSkill level board ownOther

    “With regard to the level of ordinary skill in the art, we determine that no express finding is necessary, on this record, and that the level of ordinary skill in the art is reflected by the prior art of record. See Okajima v. 4 On page 23 of the Petition, in the caption statement of the alleged ground of unpatentability, Petitioner appears to have inadvertently omitted identification of Hooijmans. Hooijmans is expressly relied on and discussed in Petitioner’s analysis. See, e.g., Pet. 28–33. We include Hooijmans in the formal statement of the alleged ground of unpatentability. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). A.” slip op. at 9

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

    “Only terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). For purposes of this Decision, we see no need to construe expressly any claim term. We, however, clarify the following issue raised by Patent Owner with respect to the scope of the challenged claims. Patent Owner asserts that claim 1 does not contain a loop-back requirement wherein the output signals from the transmitter are fed back to the receiver on the same transceiver card. Prelim. Resp. 15. According to Patent Owner, Petitioner incorrectly assumes that requirement in claim 1. Id. Patent Owner’s argument is misplaced. Petitioner nowhere asserts that such a loop-back of optical signals from the transmitter to the receiver on the same transceiver card is required by claim 1. While it is true that the modified structure Petitioner proposes for meeting claim 1 does include the loop-back arrangement, that does not mean Petitioner has interpreted the claim to require the loop-back. Petitioner is free to rely on whatever combined structure it believes satisfies the claim, including those that have even more elements than required. In other words, a certain arrangement of elements can practice a patent claim without the patent claim being limited to only that arrangement of elements. On this record, we determine that there is no need to provide an express construction for any term. B.” slip op. at 10

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

    “Furthermore, the Petition is deficient with regard to replacing the separate transmitter and receiver of Roberts ’840 with the single unit transceiver of Ade. Roberts ’840 describes its receiver as remotely located from the transmitter. Ex. 1009, 8:26–28. Specifically, Roberts ’840 states: “Optical power levels could be measured at a remote location such as the receiver, and data or control commands communicated to the site of the elements to be controlled.” Id. (emphasis added). Given that the receiver of Roberts ’840 is located remotely from the transmitter, Petitioner has not articulated sufficient reasoning for implementing them as a single transceiver on one chip. The idea of a remote location for the receiver to receive signals from the transmitter is contradictory to the idea of implementing the transmitter and receiver on a single chip as a transceiver.” slip op. at 21

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,620,327
• Amerigen Pharmaceuticals Limited / Argentum Pharmaceuticals LLC v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01317 · 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

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

    “would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 6

  • 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 or oncology, or holding a Ph.D. in pharmacology, biochemistry or a related discipline. 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 enzymologist and/or molecular biologist 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” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Regarding the interpretation of O’Donnell’s Synacthen test, we do not agree with Patent Owner that the results “lack any significance.” See PO Resp. 20. We are persuaded that one of ordinary skill in the art would understand the results of this test to be an indicator that something was amiss with the O’Donnell Study C patients’ cortisol levels following administration of abiraterone acetate. Results of the Synacthen test led O’Donnell to conclude that further studies were needed to determine whether glucocorticoid replacement would be necessary. Ex. 1003, 2323. We understand Patent Owner’s position that the “Synacthen test results in O’Donnell do not give a complete picture of a patient’s glucocorticoid production.” PO Resp. 21. We, however, do not perceive that a complete picture of a patient’s glucocorticoid production is required for one of ordinary skill in the art to be motivated to explore whether glucocorticoid replacement therapy was necessary. Petitioner’s experts opine that O’Donnell’s results for the Study C patients were “unquestionably abnormal” and implied that abiraterone acetate could result in chronic cortisol deficiency “for which glucocorticoid replacement therapy could be required.” Reply 6– 7 (citing Ex. 1093, 22, 68; Ex. 1023, 1245). We credit this testimony as supporting Petitioner’s argument that one of ordinary skill in the art, upon reviewing O’Donnell’s Synacthen test results and statement regarding impact on adrenal reserve, would not conclude that they lack any significance; rather, they would conclude that they are significant enough to merit further investigation of administration of abiraterone acetate with glucocorticoids.” slip op. at 19

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

    “aware of the differences and the similarities in the mechanisms and, nevertheless, would have compared and analogized between the two. See, e.g., Tr. 14:20–15:5; Ex. 1003, 2318, Figure 1; Ex. 1188, 168:22–169:23. Both O’Donnell and Barrie refer to ketoconazole in their discussions of abiraterone acetate, indicating that teachings regarding ketoconazole administration were a starting point for exploration of abiraterone acetate administration. Ex. 1003, 2318; Ex. 1005, Table 1. For example, O’Donnell, after evaluating ketoconazole as an agent, turns to an evaluation of abiraterone acetate as a more selective CYP17 inhibitor, i.e., as an improvement on ketoconazole. Ex. 1003, 2318. After presenting the 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. Patent Owner’s expert testified that ketoconazole, as “an inhibitor of steroid biosynthesis that had been used at that point,” was a basis for comparison: “When you write scientific papers, you always like to make comparisons with what is known and explain why your results are different or the same or what the caveats are. And I think that’s setting up . . . to understand what comes next, why they did this experiment.” Ex. 1188, 169:15–23. 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 17

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• Wockhardt Bio AG v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2016-01582 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1–20 are unpatentable as obvious over Gerber, O’Donnell, and Sartor because the combination would have provided a reasonable expectation of success.

  RulingsFinal written decision

  • Prior constructionPrior construction adoptedDecided for patent owner

    “treatment,” and “therapeutically effective amount of prednisone.” Pet. 20– 21. Petitioner notes that these claim terms have already been construed in IPR2016-00286,1 Paper 14, and states that it analyzes the claims under those constructions for the purpose of this proceeding. Id. In our Decision on Institution, we applied our claim constructions of “treat,” “treating,” “treatment,” and “therapeutically effective amount of prednisone,” as set forth in IPR2016-00286, to the present case. Dec. 5–7; IPR2016-00286, Paper 14, 5–7. Thus, we construed those terms as follows: 1 IPR2016-00286 is an earlier-filed case involving the ’438 patent, the same grounds, and the same Patent Owner. Claim term(s) Construction “treat,” “treating,” and include the eradication, removal, “treatment” 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 Ex. 1001, 3:46–50 “therapeutically effective an amount of prednisone effective for amount of prednisone” treating prostate cancer Patent Owner states: “Neither party has disputed the Board’s slip op. at 6

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “We adopt Petitioner’s contention that a person of ordinary skill in the art would be a treating clinician specializing in oncology, typically holding an M.D. degree, with at least five years of experience specializing in medical oncology. Alternatively, a POSA would have an M.D., with at least five years of experience specializing in urology and at least two years of clinical experience. A POSA would have also typically worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. Pet. 3–4 (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). D. Overview of the Prior Art” slip op. at 9

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

    “Based on the information presented during trial, we understand that ketoconazole and abiraterone acetate do not have identical mechanisms. See, e.g., Ex. 1005, 2318, Figure 1. As noted by both Petitioner and Patent Owner, however, abiraterone acetate and ketoconazole are both CYP17 inhibitors. Pet. 11–13; PO Resp. 13–15. Although Patent Owner urges us to focus on the differences in the mechanisms of operation of ketoconazole and abiraterone acetate (PO Resp. 13–15), we look not only at the differences, but also at the similarities. The evidence demonstrates that one of ordinary skill would have been aware of the differences and the similarities in the mechanisms, and nevertheless would have compared and analogized between the two. Ex. 1005, 2318, Figure 1; Ex. 1002 ¶ 67. O’Donnell refers to ketoconazole in its discussion of abiraterone acetate, indicating that teachings regarding ketoconazole administration were a starting point for exploration of abiraterone acetate administration. Ex. 1005, 2318. O’Donnell, after evaluating ketoconazole as an agent, turns to an evaluation of abiraterone acetate as a more selective CYP17 inhibitor, i.e., as an improvement on ketoconazole. Ex. 1005, 2318. After presenting the 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 16

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

    “Regarding Patent Owner’s comparison of abiraterone acetate monotherapy with abiraterone acetate/dexamethasone therapy, we agree with Petitioner that “to the extent that [Patent Owner] tries to draw any conclusion between studies that involve a combination with dexamethasone, we respectfully submit that there’s no nexus there” in that “[d]examethasone is not what’s claimed and there’s no nexus to the claims.” Tr. 19:17–20, 20:2– 3. Although dexamethasone and prednisone are both glucocorticoids, Patent Owner does not point us to satisfactory evidence as to why the ordinary artisan would consider dexamethasone and prednisone to be interchangeable for the purpose of comparing results. Cf. Ex. 2038 ¶ 240 (stating that a person of ordinary skill would “understand the dexamethasone extension study results to be due to a class effect of glucocorticoids” without further citation). Because the claims cover prednisone, and not any other glucocorticoid, the results of the combination of dexamethasone with abiraterone acetate are of limited use, as we are not informed of the similarities or differences of the mechanism of action of those glucocorticoids or how the mechanism leads to the asserted unexpected results. Moreover, to the extent the table purportedly compares the abiraterone acetate monotherapy to abiraterone acetate administered with prednisone, the table compares the abiraterone acetate monotherapy administered in clinical trial COU-AA-001 with the abiraterone acetate administered with prednisone in clinical trial COU-AA-002, without explaining or accounting for the differences between the two trials. Tr. 20:10–19. We determine that there is insufficient evidence that the alleged unpredictable and unexpected results of abiraterone acetate and prednisone are objective indicia of nonobviousness of the challenged claims. Patent Owner does not sufficiently tie the allegedly unpredictable and unexpected result to the administration of abiraterone acetate and prednisone as claimed. Thus, we determine this consideration does not weigh in favor of the patentability of the challenged claims.” slip op. at 36

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• Mylan Pharmaceuticals Inc. / Actavis Laboratories FL, Inc. et al. v. Janssen Oncology, Inc.All claims unpatentable
  PTAB · Jan 17, 2018 · IPR2017-00853 · 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

  • ExcludeMotion to exclude, deniedMixed

    “responded (Paper 76) and to which Patent Owner filed a Reply (Paper 80). The party moving to exclude evidence bears the burden of proof to establish that it is entitled to the relief requested, e.g., that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a). Patent Owner seeks to exclude Exhibits 1002 ¶ 30; 1017; 1017 [B-1]; 1028; 1040; 1041; 1046–51; 1053–55; 1057; 1064–66; 1088; 1089; 1091 ¶¶ 17–29, 31; 1092–95; 1097, ¶¶ 11–16, 95; 1100, 1102, 1103; 1104 ¶¶ 5–9, 11–13, 88–90, 92–95, and 119–22; 1117; 1125; and 1139. Paper 69, 10. Patent Owner seeks to exclude these exhibits as (a) expert declarations and exhibits that Patent Owner alleges are outside of the scope of the prior art permitted by 35 U.S.C. § 311(b); (b) sections of Petitioner’s declarations that are not cited in the briefs, and therefore irrelevant and prejudicial; and (c) exhibits that lack authenticity or violate the hearsay rule. Id. at 1.” slip op. at 44

  • Prior constructionPrior construction not adoptedDecided for petitioner

    “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 foundDecided for petitioner

    “Based on the information presented during trial, we understand that ketoconazole and abiraterone acetate do not have identical mechanisms. See, e.g., Ex. 2038 ¶¶ 25–39, Figs. 4, 5). As noted by both Petitioner and Patent Owner, however, abiraterone acetate and ketoconazole are both steroid synthesis inhibitors, particularly, CYP17 inhibitors. Pet. 26; PO Resp. 13– 15; Reply 2, 5, 9. Both parties appear to agree that, based on their respective mechanisms of action, administration of ketoconazole would inhibit production of cortisol, and administration of abiraterone acetate inhibits one of the pathways of cortisol production. Pet. 5, 26; Tr. 12:18–19; PO Resp. 14, Figs. 1, 2; Ex. 1003, 2318; Ex. 1023, 3, Fig. 1. Patent Owner takes the position that abiraterone acetate “allows some cortisol to be made.” Tr. 31:27–29. Although Patent Owner urges us to focus on the differences in the mechanisms of ketoconazole and abiraterone acetate, we look not only at the differences, but also at the similarities. The evidence demonstrates that one of ordinary skill would have been aware of the differences and the similarities in the mechanisms and, nevertheless, would have compared and analogized between the two. See, e.g., Ex. 1003, 2318, Figure 1; Reply 6 (citing Ex. 1104 ¶¶ 14–31; Ex. 1097 ¶¶ 44–49). Both O’Donnell and Barrie refer to ketoconazole in their discussions of abiraterone acetate, indicating that teachings regarding ketoconazole administration were a starting point for exploration of abiraterone acetate administration. Ex. 1003, 2318; Ex. 1005, Table 1. O’Donnell, after evaluating ketoconazole as an agent, turns to an evaluation of abiraterone acetate as a more selective CYP17 inhibitor, i.e., as an improvement on ketoconazole. Ex. 1003, 2318. After presenting the 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 18

  Patent outcomesUS 8,822,438 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,822,438
• 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

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.