• Hengdian Group Dmegc Magnetics Co., Ltd. / Zhejiang Innuovo Magnetics Co., Ltd. et al. v. Hitachi Metals, Ltd.Rehearing denied
  PTAB · Dec 21, 2017 · IPR2017-01313 · APJ Jo-Anne M Kokoski · IPR · Rehearing

  The Board denied Petitioner’s rehearing request and left in place its § 325(d) denial of institution for claims 1–8 because materially the same prior art had been considered by the Office.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. ANALYSIS A request for rehearing must identify specifically all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. 37 C.F.R. § 42.71(d). Additionally, Petitioner, as the party challenging the Decision, has the burden of showing it should be modified. Id. When rehearing a decision on a petition, the Board will review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined “if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors.” Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004) (citing In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000)).” slip op. at 3

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for patent owner

    “As an initial matter, we note that Petitioner states that, for purposes of its Request, it “do[es] not argue Uchida and Uchida II are not materially the same.” Req. Reh’g 3. Because we have discretion to reject a petition if “the same or substantially the same prior art or arguments previously were presented to the Office,” see 35 U.S.C. § 325(d) (emphasis added), Petitioner has not established that we abused our discretion in denying the Petition. Given that Uchida (asserted here) and Uchida II (previously presented to the Office) are “materially the same,” substantially the same prior art was previously before the Office. Indeed, the presence of Uchida in the Petition and the materially-identical Uchida II in the prosecution history alone is a sufficient basis to exercise our discretion under Section 325(d).” slip op. at 3

  Discretionary denial
  Patents in suitUS 6,527,874
• Guardant Health, Inc. v. Foundation Medicine, Inc.Rehearing denied
  PTAB · Nov 8, 2017 · IPR2017-01170 · APJ Richard J Smith · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving instituted review of claims 65, 66, 72, 73, 75–77, and 80–85 based on its reasonable-likelihood determination.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “DISCUSSION When rehearing a decision on petition, the Board reviews the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted). A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” 37 C.F.R. § 42.71(d).” slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “According to the ’830 patent, the term “bait” is defined as including “a nucleic acid molecule . . . which can hybridize to (e.g., be complementary to), and thereby allow capture of a target nucleic acid.” Ex. 1001, 28:47–50. Patent Owner acknowledges that “both primers and baits hybridize to a complementary portion of the target nucleic acid.” Req. Reh’g. 3 (citing Prelim. Resp. 30). However, Patent Owner does not explain or otherwise persuasively address why the subject nucleic acids in Shah are not included within that definition of “bait.” We did not overlook Patent Owner’s explanation of why, in its view, “primers” are not “baits.” Rather, at this stage of the proceeding, we found such explanation unpersuasive as we stated in the Decision. Dec. 13. (stating “we are not persuaded that the definition of the term ‘bait,’ as set forth in the ’830 patent, does not include primers”). Moreover, because we did not overlook Patent Owner’s explanation, we find no basis to reconsider the disclosures of Shah.” slip op. at 4

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

    “We did not overlook and/or misapprehend Patent Owner’s argument. We expressly addressed that argument with respect to bait sets (i) and (ii) by stating that “we find that choosing bait sets that select somatic mutations that appear at a frequency of about 5% or less and at a frequency of about 10% or higher is taught or suggested by the combined teachings of Levin and Shah.” Dec. 17 (emphasis added); see also Dec. 20 (“Having considered the arguments and evidence, we are persuaded at this stage of the proceeding that Petitioner has sufficiently shown that the limitations of claim 65 are taught or suggested by, or would have been obvious in view of, the combined teachings of Levin and Shah.”). Moreover, contrary to Patent Owner’s argument, the fact that the Decision may not recite the words “used together” does not indicate that we overlooked and/or misapprehended Patent Owner’s argument. See Novartis AG v. Torrent Pharms. Ltd., 853 F.3d 1316, 1328 (Fed. Cir. 2017) (stating “this court has said on multiple occasions that failure to explicitly discuss every issue or every piece of evidence does not alone establish that the tribunal did not consider it”) (citing cases).” slip op. at 5

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

    “We did not overlook and/or misapprehend Patent Owner’s argument; rather, we considered it and found it unpersuasive. See Dec. 13 (stating “on this record, we find that Levin’s disclosure of multiple baits would include multiple bait sets”). In particular, we found that Levin teaches the use of multiple bait sets, not one bait set as argued by Patent Owner. See id. Furthermore, Patent Owner’s argument that all of the baits in Levin were “designed in precisely the same way” was based on Levin’s statement that “[b]aits were designed in a tiling fashion with minimal overlap to span the entire protein-coding region of each transcript.” See Prelim. Resp. 28 (citing Ex. 1010, 2). However, that statement suggests the design of multiple different baits that would include multiple different bait sets.” slip op. at 6

  Claim construction§ 103 obviousness
  Patents in suitUS 9,340,830
• Hengdian Group Dmegc Magnetics Co., Ltd. / Zhejiang Innuovo Magnetics Co., Ltd. et al. v. Hitachi Metals, Ltd.Institution denied
  PTAB · Nov 6, 2017 · IPR2017-01313 · APJ Jo-Anne M Kokoski · IPR · Institution

  The Board denied institution for claims 1–8 under § 325(d), finding the petition relied on substantially the same prior art or arguments previously considered by the Office.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied

    “the same prior art and arguments as those previously presented to the Office, we now decide whether to exercise our discretion to deny institution under § 325(d). Our discretion under § 325(d) involves a balance between several competing interests. See Neil Ziegman, N.P.Z., Inc. v. Stephens, Case IPR2015-01860, slip op. at 12–13 (PTAB Feb. 24, 2016) (Paper 11). “On the one hand, there are the interests in conserving the resources of the Office and granting patent owners repose on issues and prior art that have been considered previously.” Fox Factory, Inc. v. SRAM, LLC, Case IPR2016- 01876, slip op. at 7 (PTAB Apr. 3, 2017) (Paper 8). “On the other hand, there are the interests of giving petitioners the opportunity to be heard and correcting any errors by the Office in allowing a patent—in the case of an inter partes review—over prior art patents and printed publications.” Id. For the following reasons, we deny the Petition. The disclosures of the primary references asserted by Petitioner were previously presented to, and considered by, the Office. Specifically, the disclosures in Uchida and Kaneko II upon which Petitioner relies were presented to the Office in Uchida II and Kaneko III, both of which were considered by the Office during prosecution of the ’104 application. Petitioner is thus asking the Board to readjudicate the Office’s previous decision on substantially the same issues, without providing any arguments distinguishing the Examiner’s prior consideration of Uchida II and Kaneko III, or any compelling reason why we should re-evaluate substantially the same prior art as that presented during prosecution and considered by the Examiner. Moreover, although we acknowledge that Petitioner has a direct interest in pursuing the instant Petition, we also acknowledge the burden and expense to Patent Owner in having to defend the ’874 patent based on substantially the same prior art or arguments already considered by the Office. We are not persuaded that adjudicating disputes on already-considered issues is an efficient use of Board or party resources. See Unified Patents Inc. v. John L. Berman, Case IPR2016-01571, slip. op. at 12 (PTAB Dec. 14, 2016) (Paper 10) (informative); see also Cultec, Inc. v. StormTech LLC, Case IPR2017-00777 (PTAB Aug. 22, 2017) (Paper 7) (informative) (denying institution of inter partes review under § 325(d) because the same or substantially the same prior art or arguments previously were presented to the Office during prosecution); Hospira, Inc. v. Genentech, Inc., Case IPR2017-00739 (PTAB July 27, 2017) (Paper 16) (informative) (denying institution of inter partes review under § 325(d) because the Office already decided the dispositive issue of whether the asserted references qualified as prior art with respect to the challenged patent); Juniper Networks, Inc. v. Mobile Telecomm’ns Techs., LLC, Case IPR2017-00642, slip op. at 13 (PTAB July 27, 2017) (Paper 24) (finding that “the Examiner was aware of the contents of [the” slip op. at 15

  Discretionary denial
  Patents in suitUS 6,527,874
• Baker Hughes, A GE Company, LLC (F/K/A Baker Hughes Incorporated) v. Liquidpower Specialty Products Inc. (F/K/A Lubrizol Specialty Products, Inc.)All claims unpatentable
  PTAB · Nov 1, 2017 · IPR2016-00734 · APJ Michelle N Ankenbrand · IPR · Final written decision

  Claims 1–11 are unpatentable: claims 1, 3, 4, 6, 7, and 11 as anticipated by Eaton; claims 1–7 and 11 as obvious over Eaton and Strausz; claims 8–10 as obvious over Eaton, Strausz, and Naiman.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Eaton discloses that a different size flow loop—not dilution—was utilized to achieve turbulent flow of the Bow River crude oil. Ex. 1002, 14:40–42 (“The 1" flow loop was used to test the . . . BOW RIVER crude oil[], which [is] so viscous that [it] do[es] not generate turbulent flow in a ¼" flow loop.”); see id. at 14:42–55 (describing the flow loop test procedure).11 We decline to credit Dr. Dunn’s testimony over Eaton’s explicit disclosure. Accordingly, we determine that Petitioner establishes, by a preponderance of the evidence, that Eaton discloses the API gravity limitation.” slip op. at 27

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

    “Eaton discloses that a different size flow loop—not dilution—was utilized to achieve turbulent flow of the Bow River crude oil. Ex. 1002, 14:40–42 (“The 1" flow loop was used to test the . . . BOW RIVER crude oil[], which [is] so viscous that [it] do[es] not generate turbulent flow in a ¼" flow loop.”); see id. at 14:42–55 (describing the flow loop test procedure).11 We decline to credit Dr. Dunn’s testimony over Eaton’s explicit disclosure. Accordingly, we determine that Petitioner establishes, by a preponderance of the evidence, that Eaton discloses the API gravity limitation.” slip op. at 27

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

    “persuaded by Petitioner’s argument and Dr. Epps’s testimony that the combination of Eaton and Strausz suggests drag reducing polymers having the solubility parameter limitation, because the solubility parameter limitation merely states what one of ordinary skill already knew and would have applied—that the drag reducing polymer must be soluble in the liquid hydrocarbon. See Pet. 41; Ex. 1005 ¶ 32. We also credit Dr. Epps’s testimony setting forth how one of ordinary skill in the art, knowing the target solubility parameter of the liquid hydrocarbon (e.g., for Bow River crude oil, a range of 17.1–19.6 MPa1/2), would have consulted the literature or used calculations to determine which of Eaton’s homopolymers or copolymers would provide a solubility parameter within the target range, and then used Eaton’s disclosed methods to prepare that polymer or polymers. Ex. 1005 ¶¶ 81–92 (citing Ex. 1002, 9:8–18; Ex. 1003, 465–467; Ex. 1007, VII-686, VII-707; Ex. 1012, 1025; Ex. 1037, 252–253). Accordingly, Petitioner establishes, by a preponderance of the evidence, that the combined teachings of Eaton and Strausz disclose the solubility parameter limitation of the challenged claims.” slip op. at 45

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

    “of ordinary skill in the art would have a reason to combine the teachings of Eaton and Strausz and, in making that combination, a person of ordinary skill would have had a reasonable expectation of success at achieving a drag reducing polymer meeting the limitations of claims 1–7 and 11. That does not end our inquiry, however, because Patent Owner presents arguments and evidence regarding objective indicia of nonobviousness that we must consider before reaching our conclusion on obviousness. WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1328 (Fed. Cir. 2016). We consider those arguments and evidence below.” slip op. at 57

  Patent outcomesUS 8,022,118 unpatentable
  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,022,118
• Mylan Laboratories Limited v. Aventis Pharma S.A.All claims unpatentable
  PTAB · Sep 21, 2017 · IPR2016-00712 · APJ Brian P Murphy · IPR · Final written decision

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

  RulingsFinal written decision

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

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

  • ExcludeMotion to exclude, deniedDenied

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

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

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

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

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

  Patent outcomesUS 8,927,592 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,927,592
• Autodesk, Inc. v. Uniloc USA, Inc. And Uniloc Luxembourg, S.A.All claims unpatentable
  PTAB · Sep 11, 2017 · CBM2016-00043 · APJ Christopher M Kaiser · CBM · Final written decision

  Claims 1, 2, 4–7, and 12–19 are unpatentable under § 101; claims 3, 8–11, and 20 are subject to adverse judgment after disclaimer.

  RulingsFinal written decision

  • Adverse judgmentAdverse judgmentGranted

    “B. Statutory Disclaimer During the pendency of this proceeding, Patent Owner filed a disclaimer pursuant to 35 U.S.C. § 253(a) and 37 C.F.R. § 1.321(a). Ex. 2014. According to this disclaimer, Patent Owner disclaims claims 3, 8–11, and 20 of the ’820 patent. Id.; see also Resp. 1 (“Contemporaneously with the filing of this Response, Patent Owner is disclaiming claims 3, 8, 9, 10, 11, and 20 of the ’820 Patent.”). Our rules provide for entry of adverse judgment against a Patent Owner who disclaims “a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). Although Patent Owner does not disclaim all the challenged claims, and although Patent Owner therefore has some claims remaining in this trial, we construe the disclaimer of claims 3, 8–11, and 20 as a request for the entry of adverse judgment solely with respect to those claims. We grant the request and enter adverse judgment with respect to claims 3, 8–11, and 20.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “1. Add-On Computer Software Code Both parties propose construing “add-on computer software code,” a term that appears in every challenged claim. Ex. 1001, 78:43–82:36. Petitioner argues that this term should be interpreted as a “set of computer code that cannot be run independently from a parent program.” Pet. 22. Patent Owner argues that the term should be interpreted as “set of computer code that is designed to run within a parent computer software application or code, particularly architectural CAD software (or another architectural, civil, industrial, or other software design tool), as an internal component.” Resp. 42–43. We agree with Patent Owner. Patent Owner’s construction is taken directly from the written description of the ’820 patent, which provides a reasonably clear, deliberate, and precise definition of the term. See Paulsen, 30 F.3d at 1480; Ex. 1001, 61:42–51 (“The plug-in (add-on) computer software code is . . . .”). To the extent that Petitioner’s proposed construction seeks to limit add-on software code further by requiring that the software code be incapable of running independently from a parent program, as opposed merely to being designed to run within the parent program as an internal component, this further limitation is inconsistent with the lexicography undertaken by the patentee of the ’820 patent. Accordingly, we construe “add-on computer software code” as a “set of computer code that is designed to run within a parent computer software application or code, particularly architectural CAD software (or another architectural, civil, industrial, or other software design tool), as an internal component.”” slip op. at 6

  • Patent Eligibility (§101) › Alice/Mayo step one — 'directed to'Step1 directed to exceptionUnpatentable

    “As discussed above, the ’820 patent describes solving problems with the generation of cost estimates of construction projects, including that the process takes significant time and effort, that the estimates produced are difficult to revise, and that the estimates can be inaccurate, leading to cost overruns and difficulties obtaining construction loans. Ex. 1001, 1:15–62. The claims recite a computer readable medium or system for automating the process of generating a price schedule, which is used to develop the overall project cost estimate. Id. at 78:43–82:36. In so doing, the claims do not recite any “specific asserted improvement in computer capabilities,” such as the “self-referential table for a computer database” in Enfish, 822 F.3d at 1336. Instead, the claims of the ’820 patent “invoke[]” known aspects of computer technology, including “[a] non-transitory computer readable medium,” “a computer that includes a processor and a memory,” “an add-on computer software code,” “a software design tool,” and “a database,” “merely as a tool” for solving the problem of improving the known process of generating construction project cost estimates. Id.; Ex. 1001, 78:43–60. Accordingly, the claims of the ’820 patent are not like those considered in Enfish, where the claims were determined at the first step of the Alice framework not to be directed to abstract ideas because they were directed to “[a] specific asserted improvement in computer capabilities.” 822 F.3d at 1336. Instead, Petitioner has shown by a preponderance of the evidence that the challenged claims of the ’820 patent are focused “on a process that qualifies as an ‘abstract idea.’” Id. The ’820 patent makes clear that the heart of the claimed subject matter is generating prices for construction projects, a process that can be accomplished without automation technology. Ex. 1001, 1:15–62. The claims themselves recite “[a] non-transitory computer readable medium [that] causes [a] computer to generate a price schedule” and “[a] system for creating a pricing schedule.” Id. at 78:43–51, 82:4. As discussed above, the computer technology recited in the claims is used merely as a tool to automate the process of determining the price of a construction project. Determining a price is an abstract idea. See Versata Dev. Grp., 793 F.3d at 1333–34 (Fed. Cir. 2015). Thus, on the current record, Petitioner has made a sufficient showing that the claims of the ’820 patent are directed to an abstract idea under the first step of the Alice analysis.” slip op. at 20

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

    “application of an abstract idea. Mayo, 566 U.S. at 78. Petitioner argues that the challenged claims have no such elements, because “the challenged claims add nothing more than well-understood, routine, conventional activity to the abstract idea of calculating a price.” Pet. 32–48. Patent Owner argues that the presence of the add-on computer software code limitations in the challenged claims transforms those claims into patent-eligible applications. Resp. 49–50. We are persuaded that Petitioner has shown by a preponderance of the evidence that the challenged claims of the ’820 patent do not add an inventive concept sufficient to ensure that the patent in practice amounts to significantly more than a patent on the abstract idea itself. Alice, 134 S. Ct. at 2355.” slip op. at 23

  Patent outcomesUS 8,515,820 unpatentable
  Claim construction§ 101 eligibilitycites Alice · Mayo · Enfish
  Patents in suitUS 8,515,820
• Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-01009 · APJ Michelle N Ankenbrand · IPR · Institution

  The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show a reasonable likelihood of proving obviousness over the cited combination.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . 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). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedOther

    “that, as of November 30, 2007, a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 22–23 (citing Ex. 1302 ¶¶ 62–63). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 13 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7

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

    “Petitioner proposes that we construe the phrase “does not comprise a buffering system.” Pet. 23–24. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding (see Prelim. Resp. 13), neither party identifies a dispute that turns on the meaning of the phrase “does not comprise a buffering system.” See generally Pet.; Prelim. Resp. Thus, we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only 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 successMotivation not foundNot shown unpatentable

    “buffer system of the 2003 HUMIRA formulation based on Fransson’s teachings, we find that Fransson neither discloses nor suggests removing the buffer system from a formulation. To the contrary, as Patent Owner points out, Fransson describes all of its formulations as including a buffer. Prelim. Resp. 33–34. Specifically, Fransson states that the tested formulations “were prepared by mixing disodium phosphate, monosodium phosphate, and sodium chloride in water for injection to give isotonic solutions of different pH and buffer concentration. hIGF-I was added to some of the solutions by ultrafiltration.” Ex. 1304, 1012–13. Petitioner does not explain adequately how that express teaching of buffered formulations, with no disclosure of any tested formulations without a buffer, would have prompted the ordinary artisan to eliminate buffer from the 2003 HUMIRA formulation. Moreover, in summarizing the results of its study, Fransson explains that although an intermediate phosphate buffer concentration of 10 mM resulted in less injection pain than a higher buffer concentration of 50 mM, further reducing the phosphate buffer concentration to 5 mM “did not reduce pain further.” Id. at 1014. In other words, Fransson teaches that reducing the buffer concentration below a particular threshold concentration provides no additional pain reducing benefit. That disclosure fails to support Petitioner’s assertion, and Dr. Radtke’s testimony (Ex. 1302 ¶ 86), that Fransson would have prompted the skilled artisan to eliminate Humira’s buffer system to reduce injection site pain.” slip op. at 14

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,085,619
• Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-01008 · APJ Michelle N Ankenbrand · IPR · Institution

  The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show a reasonable likelihood that either asserted §103 combination would succeed.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . 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). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art. Petitioner contends that, as of November 30, 2007, a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 22 (citing Ex. 1202 ¶ 64). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 15 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7

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

    “Petitioner proposes that we construe the phrase “does not comprise a buffering system.” Pet. 22–23. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding (see Prelim. Resp. 15), neither party identifies a dispute that turns on the meaning of the phrase “does not comprise a buffering system.” See generally Pet.; Prelim. Resp. Thus, we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 8

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

    “buffer system of the 2003 HUMIRA formulation based on Fransson’s teachings, we find that Fransson neither discloses nor suggests removing the buffer system from a formulation. To the contrary, as Patent Owner points out, Fransson describes all of its formulations as including a buffer. Prelim. Resp. 33–34. Specifically, Fransson states that the tested formulations “were prepared by mixing disodium phosphate, monosodium phosphate, and sodium chloride in water for injection to give isotonic solutions of different pH and buffer concentration. hIGF-I was added to some of the solutions by ultrafiltration.” Ex. 1219, 1012–13. Petitioner does not explain adequately how that express teaching of buffered formulations, with no disclosure of any tested formulations without a buffer, would have led the ordinary artisan to eliminate buffer from the 2003 HUMIRA formulation.” slip op. at 16

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 9,085,619
• Coherus Biosciences Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-00823 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution on claims 16–19 and 24–30 because Petitioner did not show Gokarn ’011 anticipated them.

  RulingsInstitution decision

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

    “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear” slip op. at 9

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

    “2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear” slip op. at 9

  • Skill levelSkill level petitioner adoptedOther

    “skill in the art of pharmaceutical antibody formulation would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline) with at least two years of experience preparing formulations of proteins suitable for therapeutic use. Pet. 20 (citing Ex. 1102 ¶¶ 61–62). At this stage of the proceeding, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art. Prelim. Resp. 10. On this record, 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 neededOther

    “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 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 7

  Claim construction§ 102 anticipation
  Patents in suitUS 9,085,619
• Coherus Biosciences, Inc. v. Abbvie Biotechnology Ltd.Institution denied
  PTAB · Sep 7, 2017 · IPR2017-00822 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution because Coherus did not show a reasonable likelihood that claims 16–19 and 24–30 were anticipated by Gokarn PCT or obvious over Gokarn PCT and the Humira Label.

  RulingsInstitution decision

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

    “review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). We may not institute an inter partes review “unless . . . 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). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we deny the Petition and do not institute an inter partes review.” slip op. at 2

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

    “Petitioner proposes that we construe the phrase “does not comprise a buffering system,” which appears in independent claim 16, to encompass formulations that have a de minimis amount of buffer components. Pet. 19– 20. Although Patent Owner does not dispute Petitioner’s proposed construction at this stage of the proceeding, it suggests that construction of this term is unnecessary at this stage. See Prelim. Resp. 11. Because Petitioner does not identify a dispute we need to resolve that turns on the meaning of the phrase “does not comprise a buffering system,” see generally Pet., we determine that no claim term requires construction for purposes of this decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”).” slip op. at 8

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “understanding of a person of ordinary skill in the art. Petitioner contends that a person of ordinary skill in the art “would have had an advanced degree in biology, biochemistry, or chemistry (or related discipline)” and “at least two years of experience preparing formulations of proteins suitable for therapeutic use.” Pet. 18–19 (citing Ex. 1002 ¶ 61–62). At this stage of the proceeding, Patent Owner does not dispute Petitioner’s proposed level of ordinary skill, which we adopt for purposes of this decision. See Prelim. Resp. 11 (“For the limited purpose of this Preliminary Response, Patent Owner does not contest Petitioner’s proposed level of ordinary skill in the art.”). We also find, for purposes of this decision, that the prior art itself is sufficient to demonstrate the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art, itself, can reflect the appropriate level of ordinary skill in art).” slip op. at 7

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

    “self-buffering proteins, especially in regard to adalimumab. Although Gokarn PCT describes self-buffering protein formulations, it repeatedly emphasizes that empirical data is needed to determine the buffering capacity of any particular protein. See Ex. 1003, 31:14–28 (stating “the buffer capacity of self-buffering protein formulations in accordance with the invention preferably is determined empirically by both acid titration and base titration over a given range of pH change from the desired pH of the composition”); id. at 36:10–14 (stating empirical measurements of protein buffer capacities are preferred); see also id. at 36:29–38:9 (describing determining protein buffer capacity from pH titration curves). Gokarn PCT does describe methods of predicting protein buffer capacity, but cautions that “[s]uch calculations generally will be of less utility and less accurate than empirical determinations of protein buffer capacity, in accordance with the methods described elsewhere herein. But they can be useful to provide rough maximum estimates of the buffer capacity of proteins in solution.” Id. at 40:15–18; see also id. at 38:10–14 (stating while “empirical determinations as described herein are generally a crucial aspect of formulating self-buffering compositions in accordance with various aspects and preferred embodiments of the invention, theoretical and computations methods also can be productively employed to guide the design, manufacture, and use of such compositions (in conjunction with empirical determinations)”). Gokarn PCT explains why empirical data is so crucial in determining protein buffer capacity: Conformational folding typically partitions large polypeptides and proteins in polar solvents into exposed solvent-accessible regions and more or less non-polar core regions that have little or no contact with the ambient environment. Folding produces many environments between these two extremes. Furthermore, the micro environment around a given amino acid side chain in a protein typically is affected by one or more of: solvent effects; binding of ions, chelation; complexation; association with co-factors; and post-translational modifications; to name just a few possibilities. Each of these can influence the pKa of a given amino acid ionization in a protein. The pKas for specific residues in a given protein, thus, can vary dramatically from that of a free amino acid. Id. at 38:26–39:2. No such empirical data is provided for adalimumab. See generally Ex. 1003; Prelim. Resp. 16. Rather, Gokarn PCT only provides examples of four different self-buffering proteins: Ab-hOPGL, Ab-hB7RP1, Ab-hCD22, and Ab-hIL4R. Prelim. Resp. 5 (citing Ex. 1003, 74:19–80:24).” slip op. at 16

  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,085,619

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.