• Illumina, Inc. v. Natera, Inc.No claims unpatentable
  PTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.

  RulingsFinal written decision

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

    “In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48

  • ExcludeMotion to exclude, deniedDenied

    “As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54

  • Strike new argumentNew argument disregardedDecided for patent owner

    “success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30

  Patent outcomesUS 8,682,592 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,682,592
• Genome & Company v. The University Of ChicagoAll claims unpatentable
  PTAB · Apr 14, 2020 · PGR2019-00002 · APJ John E Schneider · PGR · Final written decision

  Claims 1–29 are unpatentable: claims 1–17 and 19–28 for lack of enablement and obviousness; claims 18 and 29 for obviousness.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Dr. Braun, Petitioner’s proffered expert, defines a person of ordinary skill in the art as having an advanced degree or its substantial equivalent in the biological sciences, including specifically in the fields of immunology, microbiology and the microbiome, and oncology, coupled with research experience in those fields. Ex. 1002 ¶ 40. Patent Owner does not contest Petitioner’s definition of a person of ordinary skill in the art. See generally, PO Resp. We determine that Petitioner’s description of the level of ordinary skill in the art is supported by the current record. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “interprets claim terms in an 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) (2018);3 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to trial proceeding before the USPTO.). 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 construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 9

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “We have considered the arguments presented by the parties and the evidence of record and conclude that the unpredictability of the art weighs in favor of finding non-enablement with respect to CPIs in general. While we agree with Patent Owner that CPIs can be effective in treating some cancers, the Specification and the evidence of record show that all of the effective CPIs are antibodies. For example, all of the CPIs listed in the chart of page 10 of Patent Owner’s Response are antibodies. Tr. 39. We find nothing in the record, other than attorney argument that one skilled in the art would know how to make of use other CPIs, such as an interfering nucleic acid molecule, in the claimed method. For example, as Petitioner points out, Patent Owner’s expert did not consider CPIs other than antibodies, in reaching his conclusions regarding enablement. Pet. Reply, 4; Ex. 1042, 19–29. The record also does not support the contention that one skilled in the art could predict the action of non-antibody CPIs based on the action of an antibody CPI. The art and the Specification identify one non-antibody CPI, and the Fe region of human IgG. Ex. 1001, col. 5, ll. 20–23; Ex. 2034, 206. At the time the ’302 patent was filed, studies of this potential CPI indicated that it acted differently than antibody CPIs and that efficacy was lacking compared to other CPIs. Id. This evidence supports Petitioner’s contention that the use of CPIs, especially non-antibody CPIs, was unpredictable at the time the ’302 patent was filed. We also agree with Petitioner that the selection of Bifidobacterium was unpredictable. The evidence of record supports Petitioner’s contention that the immunostimulatory activity of Bifidobacterium varies from strain to strain, even within the same species. Pet. 44–45. O’Mahony teaches that Bifidobacterium longum strain AH1714 is immunosuppressive while another stain of B. longum exhibits immunostimulatory activity. Ex. 1017 ¶¶ 103– 109. Similarly, Lopez evaluated 12 strains of four different species of Bifidobacterium and concluded that the properties exhibited by Bifidobacterium varied among the strains. Ex. 1038, Abstr. Patent Owner’s arguments regarding the credibility of O’Mahony and Lopez are unpersuasive. Patent Owner made specific representations to the Examiner on several occasions that strain AH1714 disclosed in O’Mahony was immunosuppressive to support Patent Owner’s argument that one would not combine an immunosuppressive agent with an immunostimulatory agent. See, e.g. Ex. 1014, 8–9. Patent Owner suggests that it was not asserting that the statements in O’Mahony were accurate, but merely argues that those statements would have led away from making the combination proposed by the Examiner. PO Sur-Reply 10. This argument fails in its logic. If one skilled in the art upon reading O’Mahony would have recognized the alleged errors in O’Mahony’s teachings and disregarded them as Patent Owner now combination advanced by the Examiner in prosecution as Patent Owner argued. With respect to Lopez, Lopez states unambiguously that the immune effects of Bifidobacteria are species and strain specific. Petitioner has advanced evidence that those skilled in the art accepted these conclusions, citing Lopez in subsequent articles. Pet. Reply 10–11 (citing Ex. 1044). Moreover, the present inventors found Lopez to be sufficiently credible to incorporate the teachings of Lopez in their entirety into the instant Specification of the ’302 patent. Ex. 1001, col. 37, l. 62–col. 38, l. 4.” slip op. at 23

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledEnabledMixed

    “evidence of record and conclude that applying the all the Wands factors, Petitioner has demonstrated by a preponderance of the evidence that claims 1–17 and 19–28 are not enabled. In reviewing the evidence of record, we find that the nature of the invention that involves very broad claims, the high level of skill required in such an unpredictable art, and the dearth of working examples and lack of specific guidance on the full range of CPIs and cancers challenged claims are not enabled. Because claims 18 and 29 require known CPIs, however, we find that Petitioner has failed to show that these claims are not enabled.” slip op. at 26

  Patent outcomesUS 9,855,302 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 9,855,302
• SZ Dji Technology Co., Ltd. / Parrot Inc. v. Drone-Control, LLCAll claims unpatentable
  PTAB · Jun 11, 2019 · IPR2018-00207 · APJ Frances L Ippolito · IPR · Final written decision

  Claims 1–15 are unpatentable: claims 1, 3–6, 8–11, and 13–15 are anticipated by Thornberg ’983; claims 2, 7, and 12 are obvious over Thornberg ’983 and Karem. The motion to amend is denied.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner did not file a Patent Owner Response and has not otherwise disputed Petitioner’s proposed level of skill. See Tr. 77:1–6. We find, based on our review of the complete record, that the evidence of record supports a level of ordinary skill in the art consistent with Petitioner’s definition. Our findings are supported by the level of ordinary skill in the art reflected by the prior art of record and the ’116 patent. See Ex. 1001, 1:36–37 (“This invention relates generally to radio controlled toys such as airplanes and helicopters.”); Ex. 1006, 1:8–10 (“The present invention relates to the control of remotely operated vehicles, and more particularly to a variable reference for the control of a remotely operated vehicle.”), see id. at 3:41–44 (“The system provides for the referencing of vehicle commands based on an operator frame of reference so that control commands provided by the operator remain intuitive and independent of the orientation of the vehicle with respect to the operator.”). Thus, we adopt Petitioner’s proposed level of ordinary skill in the art and apply it to our discussion below.” slip op. at 11

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

    “Ex. 1006, 5:22–29. We further observe that once the disclosed pitch/roll commands (i.e., command data) are provided to the pitch axis and roll axis transformation functions, the pitch axis transformation 410 and roll axis transformation 412 use transformation equations to determine a transformed pitch stick signal (TPSS) and a transformed roll stick signal (TRSS). See Ex. 1006, 6:17–28. In other words, the flight control computer transforms received command pitch/roll data into TPSS and TRSS commands. In performing this transformation, the pitch axis transformation function 410 and the roll axis transformation function 412 also receive a transformation angle (θ) input. Id. at 5:30–32. Thornberg ’983 teaches that the transformation angle θ is determined based on the true heading of the vehicle as determined by the navigation system 36 and the desired vehicle reference and vehicle reference mode. Id. at 5:31–35. As discussed above, we find that the true heading of the vehicle as determined by navigation system 36 provides motion data generated by a sensor. Thornberg ’983 teaches that the transformations into TPSS and TRSS take into account transformation angle (θ), which Thornberg ’983 teaches is determined based on the true heading (i.e., motion data) of the vehicle and the control data (pitch/roll commands) received from control panel 200 of the remote operator control. See Ex. 1006, 4:29–33, 5:23–25, 5:36–38. Further, in the operator reference mode, the orientation of the operator/remote control upon activation of the operator mode is used as the reference axis (i.e., operator’s coordinate system). Additionally, as noted in the Petition (see Pet. 30–31), Thornberg ’983 teaches a variable operator reference mode in which the operator reference changes based on changes in the orientation of the operator control panel. Ex. 1006, 7:32–35. Based on the disclosure discussed above, we find that the pitch and roll commands received at lines 405, 415 in the operator mode teach command data in “a first coordinate system from a perspective of the remote control device” as recited in claim 1. Moreover, we find that Thornberg ’983 teaches that the received pitch/roll command data is transformed into control data in “a second coordinate system that is from a perspective of the RC aircraft.” Specifically, Thornberg ’983 teaches that the transformation equations 1 and 2 transform the pitch command and roll command based on the difference between the aircraft heading and the reference heading. See Ex. 1066, 7:9–11, 7:19–24. Further, Dr. Hansman testifies that TPSS and TRSS control data control the vehicle in the vehicle’s coordinate system, which is from the perspective of the vehicle. Ex. 1003 ¶ 411. We credit Dr. Hansman’s undisputed testimony in this regard because this testimony is consistent with the disclosure of Thornberg ’983, which teaches, among other things, that “[t]he system provides for the referencing of vehicle commands based on an operator frame of reference so that control commands provided by the operator remain intuitive and independent of the orientation of the vehicle with respect to the operator.” Ex. 1006, 3:41–44.” slip op. at 19

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

    “[a] POSITA would have been motivated to modify Thornberg’s control panel 200 to “control” the UAV 100 in a hovering state, i.e., by sending appropriate lift command data to the vehicle when the operator releases the input controls as Karem teaches, in order to facilitate aerial tasks that may involve a hovering state, such as airborne surveillance, inspection, maintenance, and repair, that Thornberg teaches were “well known” uses of UAVs. Ex. 1006, 1:15-24; Ex. 1003, ¶443. Pet. 45. We are persuaded that Petitioner’s rationale and evidence demonstrate by a preponderance of the evidence that claims 2, 7, and 12 would have been obvious in view of Thornberg ’983 and Karem. For example, Petitioner’s arguments are supported by the disclosure of Karem, which teaches a remotely-operated vehicle in a hovering state (Ex. 1008, 7:13–23, 32–39, and Thornberg ’983 teaches remotely operated vehicles include helicopters (Ex. 1006, 1:14–17). Further, Petitioner’s arguments are supported by Dr. Hansman’s undisputed testimony that a POSITA would have been motivated to modify Thornberg ’983’s control panel 200 to control UAV 100 in a hovering state, i.e., by sending appropriate lift command data to the vehicle when the operator releases the input controls as Karem teaches, in order to facilitate aerial tasks that may involve a hovering state, such as airborne surveillance, inspection, maintenance, and repair. Ex. 1003 ¶ 443. This testimony is supported by Thornberg ’983’s teaching that (1) airborne surveillance, inspection, maintenance, and repair were well known uses of UAVs; and (2) remote operation of UAVs apply to remotely operated helicopters. See Ex. 1006, 1:15–24.” slip op. at 29

  • Expert testimonyPetitioner expert creditedOther

    “In the same manner described in the ’116 patent, we find that the orientation of the control panel in Thornberg ’983 indicates the angular displacement (i.e., position data) of the vehicle relative to the operator mode reference axis because the control panel is directed toward the vehicle. Thornberg ’983’s Figure 2 discloses that the control panel is directly facing the remotely operated vehicle, which is nearly identical to placement of the remote control device and RC aircraft in Figure 5 of the ’116 patent. Ex. 1001, 3:67–4:2, Fig. 5; Ex. 1006, Fig. 2.” slip op. at 50

  Patent outcomesUS 9,079,116 unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 9,079,116
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34

  Patent outcomesUS 8,007,826 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,007,826
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01850 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703 patent were not shown unpatentable because S-1 was not prior art under § 102(a) or (b), defeating each instituted § 103 ground.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for patent owner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  Patent outcomesUS 8,440,703 not shown unpatentable
  Claim construction§ 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,440,703
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01858 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–40 of the ’437 patent were not shown unpatentable under § 103 because S-1 was not prior art under § 102(a) or (b).

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc.,” slip op. at 14

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “We agree with Patent Owner that the Provisional provides adequate written description support for the challenged claims of the ’703 patent. We agree with Drs. Lublin and Peck and credit their testimony that one of skill in art reading the Study Design schematic for Example 11 would have understood that a patient in the 10 mg b.i.d. arm of the study would have received 10 mg b.i.d. throughout the two-week upward titration period. As 10 mg b.i.d. is the lowest dose except for placebo, we find that it necessarily 30 follows that those patients in the 10 mg b.i.d. arm of the study do not need upward titration to the treatment dose because they start and finish at the lower 10 mg dose.” slip op. at 30

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

    “Although the burden of persuasion for unpatentability never shifts from Petitioner during the trial, the burden of production may shift. See Dynamic Drinkware, 800 F.2d at 1379. Petitioner adequately met its burden of production by presenting S-1 as prior art that on its face lists authors that differ from the inventors of the patents at issue. See Ex. 1003, 92. Patent Owner has responded with ample and persuasive evidence, however, that Drs. Blight and Cohen are the sole source of the disclosure of S-1. Thus, Patent Owner satisfies any burden of production to refute Petitioner’s case that S-1 is prior art under 35 U.S.C. § 102(a). See supra. Petitioner’s response to Patent Owner’s evidence does not persuade us that the portions of S-1 upon which they rely are not solely attributable to Drs. Blight and Cohen. Specifically, Petitioner offers evidence from the S-1 of a statement that the MS-F202 clinical trial was designed “after extensive consultation with a panel of expert MS neurologists and with the FDA,” arguing that statement indicates that Drs. Blight and Cohen may not be the sole authors 41 of the protocol for this clinical trial. Reply 2. Petitioner further argues that Drs. Blight and Cohen’s deposition testimony supports its contention that Drs. Blight and Cohen may not be the sole authors of the protocol for this clinical trial because they could not recall the details of that consultation. Id. at 3 (citing Ex. 1064, 64:18–65:14; Ex. 1063, 76:20–77:20, 80:9–81:14, 110:13–111:2). Petitioner also takes issue with another statement in S-1 indicating that in early 2002, Drs. Blight and Cohen drafted descriptions of the MS-F201 and MS-F202, although version 1.0 of the MS-F202 protocol is dated October 2002. Id. at 2 (citing Paper 28, 16; Ex. 2050, 6). Finally, Petitioner points to publications discussing MS-F201 and MS-F202 where Drs. Blight and Cohen are not consistently named as authors and other authors, such as Drs. Goodman and Katz, are listed. Id. at 3–4. We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face,” slip op. at 41

  Patent outcomesUS 8,354,437 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,354,437
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01857 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–8 of the ’685 patent were not shown unpatentable because S-1 was not prior art, alone or with Hayes or Juarez.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

    “Because the Provisional provides written description support for the challenged claims, S-1 potentially qualifies as prior art only under 35 U.S.C. § 102(a), but not § 102(b), because the S-1 publication date of September 26, 2003 is less than one year before the filing date of the Provisional of April 9, 2004. As discussed in more detail below, however, Patent Owner has provided evidence that S-1 is not prior art to the claims of the ’703 patent under § 102(a) either because the pertinent portions of the S-1 are the original work of inventors Drs. Blight and Cohen. See 35 U.S.C. § 102(a); Katz, 687 F.2d at 454 (stating “one’s own work is not prior art under sec. 102(a) even though it has been disclosed to the public in a manner or form which otherwise would fall under [sec.] 102(a)”).” slip op. at 37

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “We find that Petitioner’s evidence that allegedly casts doubt on the authorship of the relevant portions of S-1 is not sufficient to overcome the ample, unequivocal evidence presented by Patent Owner that supports our finding that the relevant portions of S-1 are the original work of Drs. Blight and Cohen alone. See In re Katz, 687 F.2d at 455. Both Drs. Cohen and Blight state that they alone are the inventors and sole originators of the work in S-1 upon which Petitioner relies. See Exs. 2044, 2045. Five other declarants, intimately involved in the development of S-1, two of which now work for entities other than Acorda, substantiate this testimony. See Exs. 2046–2048, 2052, 2056. Relying on statements that may, on their face, 42 indicate that others may have been involved without any evidence that others were, in fact, originators of the work in question or inventors is simply not enough to carry Petitioner’s burden to show that the S-1 is prior art under 35 U.S.C. § 102(a). For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9” slip op. at 42

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityNot reached

    “For the reasons discussed above, we determine that S-1 does not qualify as prior art to the claims of the ’703 patent under 35 U.S.C. § 102(a) or (b). Thus, all of Petitioner’s challenges to the patentability of the claims of the ’703 patent, which depend on S-1 alone or in combination with Hayes or Juarez, fail. Petitioner, therefore, has not carried its burden to prove unpatentability of claims 1–52 of the ’703 patent by a preponderance of the evidence.9 D. IPR2015-01853; IPR2015-01857; and IPR2015-01858 Petitioner’s patentability challenges to the claims of U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), U.S. Patent No. 8,007,826 B2 (“the ’826 patent”), and U.S. Patent No. 8,354,437 B2 (“the ’437 patent”), at issue in IPR2015-01853, IPR2015-01857, and IPR2015-01858, respectively, essentially raise the same issues presented in the patentability challenge to the claims of the ’703 patent in IPR2015-01850. Therefore, we chose to 9 Because we find that S-1 is not prior art under 35 U.S.C. § 102(a), we need not reach whether S-1 is a printed publication.” slip op. at 43

  Patent outcomesUS 8,663,685 not shown unpatentable
  § 102 anticipation§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,663,685
• Sega Of America, Inc. / Ubisoft, Inc. et al. v. Uniloc USA, Inc. And Uniloc Luxembourg S.A.All claims unpatentable
  PTAB · Mar 10, 2016 · IPR2014-01453 · APJ Donna M Praiss · IPR · Final written decision

  Claims 1–20 are unpatentable: claims 1–11 and 17–20 as anticipated by Schull; claims 10–11 also as obvious over Schull; claims 12–14 as anticipated by Logan or obvious over Haines and Manduley; claims 15–16 as obvious …

  RulingsFinal written decision

  • Skill levelOther

    “between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). An invention “composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. Moreover, a determination of unpatentability on the ground of obviousness must include “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). The obviousness analysis “should be made explicit” and it “can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418.” slip op. at 24

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In addition, we do not find credible Dr. DiEuliis’s testimony that the text in Figure 2B, which states “registration no. generated from user details added to serial no. is encrypted and re-arranged,” describes the addition of two numbers (registration no. and serial no.). There is no previous step in the flowchart depicted in Figure 2B that describes the step of generating the registration number to indicate that the registration number is an input, rather than an output. Ex. 1025, Fig. 2B; see Ex. 1026, Fig. 2. Further, as explained next, the “user details” encompass text, which further explains why the flowchart is not discussing the addition of numbers.” slip op. at 17

  • Disclosure Requirements (§112) › Written description (Ariad)Not reached

    “Regarding Petitioner’s assertion that certain claim terms lack definiteness or written description support, because those issues are neither appropriate for an inter partes review proceeding nor briefed by the parties, we do not address them in this decision. See 35 U.S.C. § 311(b). For purposes of this decision and for the reasons expressed by the District Court, we adopt and apply the constructions provided in the table above. See Ex. 1008, 53–54, 58–61.” slip op. at 12

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

    “We are persuaded by Petitioner’s argument that Schull discloses a summation algorithm for generating its Passwordable ID. As explained by Petitioner, Schull’s algorithm combines three ID numbers: Program ID, Feature ID, and Target ID, which Petitioner refers to as X, Y, and Z in its explanation. Pet. 21. The X number has “N” digits, the Y number has “M” digits, and the Z number has “T” digits. Id. The algorithm combines the numbers X, Y, and Z “(e.g., by concatenating them to produce a number” slip op. at 28

  Patent outcomesUS 5,490,216 unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 5,490,216
• Sega Of America, Inc. / Ubisoft, Inc. et al. v. Uniloc USA, Inc. And Uniloc Luxembourg S.A.All claims unpatentable
  PTAB · Mar 10, 2016 · IPR2015-01026 · APJ Donna M Praiss · IPR · Final written decision

  Claims 1–20 are unpatentable: claims 1–11 and 17–20 over Schull, claims 12–14 over Logan and Haines with Manduley, and claims 15–16 over Logan and Grundy.

  RulingsFinal written decision

  • Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner

    “We are not persuaded by Patent Owner’s evidence that the Australian provisional applications conveyed to a person of ordinary skill in the art a summation algorithm or a summer and equivalents thereof. The preponderance of the evidence is that the cited disclosures from the Australian provisional applications are insufficient for this purpose.” slip op. at 15

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “In addition, we do not find credible Dr. DiEuliis’s testimony that the text in Figure 2B, which states “registration no. generated from user details added to serial no. is encrypted and re-arranged,” describes the addition of two numbers (registration no. and serial no.). There is no previous step in the flowchart depicted in Figure 2B that describes the step of generating the registration number to indicate that the registration number is an input, rather than an output. Ex. 1025, Fig. 2B; see Ex. 1026, Fig. 2. Further, as explained next, the “user details” encompass text, which further explains why the flowchart is not discussing the addition of numbers.” slip op. at 17

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

    “We are persuaded by Petitioner’s argument that Schull discloses a summation algorithm for generating its Passwordable ID. As explained by Petitioner, Schull’s algorithm combines three ID numbers: Program ID, Feature ID, and Target ID, which Petitioner refers to as X, Y, and Z in its explanation. Pet. 21. The X number has “N” digits, the Y number has “M” digits, and the Z number has “T” digits. Id. The algorithm combines the numbers X, Y, and Z “(e.g., by concatenating them to produce a number 3 Patent Owner does not dispute Dr. Madisetti’s observation that Schull contains a typographical error (referring first to P, F, and T-digits and then to N, M, and T-digits) and his determination that N and M are equivalent to P and F. Ex. 1007 ¶ 41. with N+M+T digits)”. Ex. 1002, 7:24–25; Pet. 21; Ex. 1007 ¶ 41. In 1992, concatenating three integers to produce the desired result “boils down to two basic approaches: (1) multiplying the first integer and second integer by a power of ten (dependent on the number of digits of the subsequent numbers) and adding the three integers together, or (2) converting the integers to ‘strings,’ concatenating the strings, and converting the result back to an integer.” Ex. 1007 ¶ 42. Using the former approach to produce a number with the combined number of digits as the numbers being combined, which Petitioner argues is the one disclosed in Schull, Dr. Madisetti describes the mathematical operations that can be performed programmatically. The mathematical operation provided by Dr. Madisetti is X*10(M+T) + Y*10T + Z, which uses multiplication and addition. Id. ¶¶ 44; Pet. 21. According to Dr. Madisetti, this approach is a summation algorithm and is “computationally quicker” for the reason that “it is a matter of performing basic calculations and processing smaller numbers, as opposed to converting, combining and reconverting large strings . . . .” Ex. 1007 ¶ 43.” slip op. at 28

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

    “supports Petitioner’s assertion that claim 12 would have been obvious over the combination of Haines and Manduley. As an initial matter, we find Haines and Manduley to be analogous art. The PTO and its reviewing courts have developed and applied a two-step “test” to determine whether a prior art reference is “analogous” art and therefore may be used as evidence with respect to a question of obviousness under § 103. See In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992); In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992); In re Wood, 599 F.2d 1032 (CCPA 1979). Step 1 requires an answer to the following question: “Is the reference within the field of the inventor’s endeavor?” If the answer is “yes,” then the reference is “analogous” and therefore may be used as evidence. If the answer is “no,” then Step 2 requires an answer to the following question: “Is the reference reasonably pertinent to the particular problem the inventor was trying to solve?” If the answer is “yes,” then the reference is analogous and therefore may be used as evidence. Haines and Manduley are analogous art because, like the ’216 patent, they relate to systems for remotely permitted use of software on a device. Ex. 1007 ¶ 59. The scope of the ’216 patent is not limited to personal computers, but, rather, any “platform” on which software runs. Ex. 1001, 2:52–55 (“In broad terms, the system according to the invention is designed and adapted to allow digital data or software to run in a use mode on a platform . . . .”), 2:24–30 (“[T]he term ‘platform’ denotes an environment to be associated with a computer device such as a microprocessor or other data processing device which permits execution of the digital data . . . .”). Even if the Haines and Manduley references could be considered in a different field of endeavor than the ’216 patent because their intended use is postage and parcel systems rather than a personal computer, they are analogous art for the additional reason that they relate to the problem of restricting access to software to those who have a right to use it. Ex. 1001, 2:40–44 (“In this specification, ‘use mode’ refers to use of the digital data or software by its execution on a platform so as to fulfill the seller’s/licensor’s obligations in relation to the sale or license of the right to execute the digital data or software in the use mode.”); Ex. 1005, Abstr., 1:41–49 (“only authorized meter reconfigurations can occur”), 11:13–17; Ex. 1006, Abstr, 1:29–32 (“the marketer may wish to charge the customer a separate amount for each software function or each variety of data and the customer may wish to pick and choose among the functions and/or varieties”), 2:31–63.” slip op. at 43

  Patent outcomesUS 5,490,216 unpatentable
  § 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
  Patents in suitUS 5,490,216
• Intermix Media, LLC v. Bally Gaming, Inc.Institution denied
  PTAB · Jan 20, 2016 · CBM2015-00154 · APJ Hyun J Jung · CBM · Institution

  The Board denied institution because the petition did not show that claims 1–34, 38, 39, and 45–77 were more likely than not ineligible under § 101.

  RulingsInstitution decision

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

    “Petitioner fails to provide a credible analysis considering the elements of the challenged claims “individually and ‘as an ordered combination”’ to determine whether the additional elements transform the nature of the challenged claims into a patent-eligible application in accordance with the second step of the Alice analysis. The Petition fails to provide a credible and sufficient explanation as to whether an element or combination of elements is sufficient to ensure that the ’918 patent in practice amounts to significantly more than a patent upon the ineligible concept itself. The Petition, instead, asserts cursory and conclusory arguments with no or insufficient evidence that the additional claim elements are well known or recite generic structure. See Pet. 31–80. Petitioner’s failure to do a full analysis under Alice constitutes a breach of 37 C.F.R. § 42.304(b)(4), as well as 35 U.S.C. § 322(a)(3), which requires identifying the grounds “with particularity.”” slip op. at 7

  • Patent Eligibility (§101) › Alice/Mayo step two — inventive conceptStep2 no inventive conceptNot shown unpatentable

    “Petitioner fails to provide a credible analysis considering the elements of the challenged claims “individually and ‘as an ordered combination”’ to determine whether the additional elements transform the nature of the challenged claims into a patent-eligible application in accordance with the second step of the Alice analysis. The Petition fails to provide a credible and sufficient explanation as to whether an element or combination of elements is sufficient to ensure that the ’918 patent in practice amounts to significantly more than a patent upon the ineligible concept itself. The Petition, instead, asserts cursory and conclusory arguments with no or insufficient evidence that the additional claim elements are well known or recite generic structure. See Pet. 31–80. Petitioner’s failure to do a full analysis under Alice constitutes a breach of 37 C.F.R. § 42.304(b)(4), as well as 35 U.S.C. § 322(a)(3), which requires identifying the grounds “with particularity.”” slip op. at 7

  § 101 eligibilitycites Alice · Mayo · Bilski
  Patents in suitUS 5,816,918

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.