- Aurobindo Pharma USA, Inc.No claims unpatentablePTAB · Dec 28, 2018 · IPR2017-01648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–25 were not shown unpatentable over Timmins and Cheng because Petitioner did not establish that the combination would have targeted the claimed mean Tmax range.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“In the Patent Owner Response, Patent Owner acknowledged the Board’s characterization of the knowledge of an ordinarily skilled artisan as consistent with the proposals of both parties (PO Resp. 12–13), and neither party further addressed the proper level of ordinary skill in the art or disagreed with our characterization from the Institution Decision. See PO Resp., Reply. Our determination regarding the patentability of the challenged claims does not turn on the differences between the parties’ definitions. We adopt Petitioner’s assessment, but note that our conclusions would be the same under Patent Owner’s assessment. C. Testimony of Dr. Akhlaghi” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We agree with Petitioner that Dr. Akhlaghi’s qualifications and deposition testimony, when read in context, indicate that Dr. Akhlaghi is sufficiently experienced to opine on the knowledge of one of skill in the art at the time of the ’866 patent. As noted in the August 13, 2018 update to our Trial Practice Guide: An expert witness must be qualified as an expert by knowledge, skill, experience, training, or education to testify in the form of an opinion. Fed. R. Evid. 702. There is, however, no requirement of a perfect match between the expert’s experience and the relevant field. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). See Notice of Update to Office Patent Trial Practice Guide, 83 Fed. Reg. 156, (Aug. 13, 2018) (text of update available at https://www.uspto.gov/sites/default/files/documents/2018_Revised_Trial_Pr actice_Guide.pdf). In addition, we are well able to consider the value of an expert opinion and afford it appropriate weight. Perreira v. Secretary of the Dept. of HHS, 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the soundness of the reasons supporting it.”) D. Claim Interpretation” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner
“Tmax” In our Institution Decision, we noted that the term “Tmax” appears in each of the challenged claims, and that both parties agreed that Tmax should be construed as stated in the Specification: “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours).” Inst. Dec. 7 (citing Pet. 24; Prelim Resp. 18; Ex. 1001, col. 7, ll. 49–53). We concluded that the proposed definition was consistent with the Specification and defined the claim term with reasonable clarity, deliberateness, and precision, and we adopted the parties’ construction. Neither party addressed the issue of construction of Tmax in further briefing, but the parties disagree about how Dr. Akhlaghi applied the definition in her testimony. See, eg., Pet. Reply 9–10. For purposes of analyzing the patentability of the challenged claims, we continue to interpret the term as “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours),” because that definition is consistent with the Specification, and because the parties themselves agreed to the definition of Tmax. Inst. Dec. 7. E. Overview of the Prior Art slip op. at 11
- BurdenNot shown unpatentable
“Based on our review of the record, we determine that Petitioner has not shown sufficiently that combining the teachings of Timmins and Cheng as Petitioner contends would have resulted in a dosage form that provides a mean Tmax of metformin from 5.5 to 7.5 hours after administration.” slip op. at 19
Patent outcomesUS 6,866,866 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,866,866 - Nevro Corp. v. Boston Scientific Neuromodulation Corp.Rehearing deniedPTAB · May 31, 2018 · IPR2017-01831 · APJ Hubert C Lorin · IPR · Rehearing
The Board denied rehearing and maintained its denial of institution for claims 1, 3, 14, and 15 because Nevro did not sufficiently show Schulman rendered the no-stimulation voltage-measurement limitation obvious.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. ANALYSIS A request for rehearing must identify specifically all matters that the requesting party believes the Board misapprehended or overlooked. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, the Board will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsNot shown unpatentable
“Schulman simply discloses that (a) when no stimulation is provided a request is made for a battery recharge and (b) when a battery recharge occurs, battery voltage is measured. Based on that alone, it is unclear when, or even if, the requested recharge will, in fact, ever occur, or whether it will occur when there is no stimulation provided. Arguably, a battery recharge normally follows a battery recharge request. But there is insufficient evidence that a battery recharge request, when there is no stimulation due to low voltage, necessarily leads to the battery being recharged, let alone recharged when there is no stimulation due to low voltage. As we stated in the Decision, “[i]ndeed, we find that the fact that microstimulator 100 has ceased operation when it emits a status signal (due to the low voltage condition) suggests the opposite; that is, the battery is not being recharged and is not performing any operation aside from emitting a status signal, which would include measuring the voltage of the rechargeable battery.” Dec. 15– 16. Accordingly, even Petitioner’s current position lacks sufficient evidence to support Petitioner’s contention that Schulman renders obvious the claimed subject matter whereby “voltage is measured when no stimulation is being provided by the electronic subassembly.”” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“The Petition went no further. No explanation was given as to how one of ordinary skill in the art, given that Schulman discloses (a) requesting battery recharge via emitted periodic signals when no stimulation is provided due to low battery and (b) monitoring (and measuring) voltage during recharge, would have been led to measure voltage “when no stimulation is being provided by the electronic subassembly,” as claimed. The Petition did not explain, for example, as Petitioner now contends, that “[a]t some point, [Schulman’s] recharge request will be honored. And when recharging commences from that low voltage, zero stimulation condition, Schulman will begin measuring voltage where there is still no stimulation.” Req. 3. We could not have misapprehended or overlooked this explanation, as it was not given.” slip op. at 7
§ 103 obviousnessPatents in suitUS 7,437,193 - Nevro Corp. v. Boston Scientific Neuromodulation Corp.Rehearing deniedPTAB · Mar 1, 2018 · IPR2017-01811 · APJ Amanda F Wieker · IPR · Rehearing
The Board denied rehearing of the institution denial, finding Petitioner had not shown that Holsheimer disclosed an electrode array detachably connected to the IPG for claims 8 and 18.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We are unpersuaded that we misapprehended or overlooked Petitioner’s position. Rather, our Decision addresses expressly each aspect of Petitioner’s argument. For example, the Decision relies upon Holsheimer’s Figures 19 and 20, which depict embodiments of Holsheimer’s implantable pulse generator. Dec. 10– 11. As explained in the Decision, Holsheimer discloses that a series of wires 80A– 80F connect the implantable pulse generator’s outputs 72, 74, 76, 78 to electrode array 38. Id. at 10–11 (citing Ex. 1004, 7:17–20, 7:23–28, 7:47–57). Thus, we did not misapprehend or overlook Holsheimer’s disclosure that the implantable pulse generator and electrode array are “connected.” Req. 3–4. Our Decision also states that these portions of Holsheimer “disclose an apparently permanent, unitary connection with wires 80A–F.” Dec. 11. We understand that Holsheimer does not utilize the word “permanent,” see Req. 4, however, as stated in our Decision, “the Petition does not provide any supporting evidentiary basis for [the] otherwise conclusory assertion that wires 80 are detachable from either electrode array 38 or from pulse generator 14.” Dec. 11.” slip op. at 3
- BurdenDecided for patent owner
“position. Rather, our Decision addresses expressly each aspect of Petitioner’s argument. For example, the Decision relies upon Holsheimer’s Figures 19 and 20, which depict embodiments of Holsheimer’s implantable pulse generator. Dec. 10– 11. As explained in the Decision, Holsheimer discloses that a series of wires 80A– 80F connect the implantable pulse generator’s outputs 72, 74, 76, 78 to electrode array 38. Id. at 10–11 (citing Ex. 1004, 7:17–20, 7:23–28, 7:47–57). Thus, we did not misapprehend or overlook Holsheimer’s disclosure that the implantable pulse generator and electrode array are “connected.” Req. 3–4. Our Decision also states that these portions of Holsheimer “disclose an apparently permanent, unitary connection with wires 80A–F.” Dec. 11. We understand that Holsheimer does not utilize the word “permanent,” see Req. 4, however, as stated in our Decision, “the Petition does not provide any supporting evidentiary basis for [the] otherwise conclusory assertion that wires 80 are detachable from either electrode array 38 or from pulse generator 14.” Dec. 11.” slip op. at 3
NonePatents in suitUS 6,895,280
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.