- Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. v. Ouraring, Inc.No claims unpatentablePTAB · Jul 10, 2026 · IPR2025-00147 · APJ Linda E Horner · IPR · Final written decision
The Board found claims 1–6 and 8–20 not shown unpatentable under three obviousness grounds, principally because the proposed combinations did not establish a feasible curved battery or transparent potting encapsulating the components.
RulingsFinal written decision- Skill levelSkill level board ownOther
“at least a four-year degree in electrical engineering, mechanical engineering, biomedical engineering, optical engineering, or related field of study, or equivalent experience, and at least two years’ experience in academia or industry studying or developing physiological monitoring devices such as non-invasive biosensors. Pet. 8 (citing Ex. 1002 ¶ 29). Petitioner also contends that a person of ordinary skill would have been “familiar with, e.g., sensor system design, including inertial and other motion sensor system design, and signal processing” and that “[a] higher level of education or skill might make up for less experience, and vice versa.” Id. Patent Owner agrees with Petitioner’s proposed definition of a person of ordinary skill in the art. Resp. 25. We adopt this uncontested definition of the level of ordinary skill in the art. This definition is supported by the record and consistent with the disclosure in the ’124 patent and the references cited in the Petition.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not reach the issue of whether the preamble is limiting for purposes of determining patentability of the challenged claims. Even were we to agree with Patent Owner that the preamble is limiting and the claims are limited to a finger-worn ring wearable computer device, Petitioner has relied on Schröder in each ground to disclose a “wearable computing device configured to be worn around a finger of a wearer.” Pet. 22 (Ground 1), 45 (Ground 2, relying on Yuen for adding the functionality of light sources with a photodetector, temperature sensors, and varying the sampling frequency of sensor data acquisition), 56 (Ground 3). We agree with Petitioner that Schröder discloses such a device. Thus, no explicit claim construction is necessary for this decision.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successReasonable expectation not foundNot shown unpatentableNot shown unpatentable
“We are not persuaded by Petitioner’s arguments and find that Patent Owner has the better position for several reasons. First, the record supports Patent Owner’s argument that Mestas’s batteries are much too large to fit within a ring form factor, and “would have to be reduced in size on the 6 There is no Exhibit 2022 in the record of this case. magnitude of 5-10x from its current size to fit in a ring of Schröder.” Resp. 38 (citing Dr. Anthony’s cross-examination testimony at Ex. 2021, 313:12). Second, Petitioner relies on evidence in the Reply that Petitioner failed to specifically identify in the Petition. Compare Reply 3–5 (citing Ex. 1369 ¶¶ 7–14; Ex. 1079 ¶¶ 47, 71; Ex. 2022, 138:7–143:1; Ex. 1002 ¶¶ 96, 337; Ex. 2021, 12–13, 307:7–17; Ex. 2020, 212:6–214:13; Ex. 1081, 130:18–131:14; Ex. 1010 ¶ 168), 9 (referring back to Section § II.B.2) with Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99; Ex. 1010 ¶¶ 157, 163, 168, 201, Fig. 6). More specifically, while the portion of Dr. Anthony’s Declaration cited in the Petition (see Pet. 25–26 (citing Ex. 1002 ¶¶ 193–99)) mentions the Technology Background Section V of his Declaration (Ex. 1002 ¶¶ 42–147), neither Petitioner nor Dr. Anthony sufficiently explains what evidence supports his opinion that it was feasible to incorporate batteries or battery-like devices into finger-rings, or how a person of ordinary skill in the art would have miniaturized a curved battery for incorporation into Schröder’s ring. Ex. 1002 ¶ 196 (describing that rechargeable batteries powering wearable electronic devices were “well-known by 2013” and “had also undergone significant advances in terms of miniaturization and energy density [that] made it feasible to incorporate batteries or battery-like devices such as supercapacitors into smaller form factors, such as finger rings, without sacrificing functionality” such as “lithium-polymer (Li-Po) batteries and solid-state batteries.”). Moreover, some of Petitioner’s citations in the Reply appear to be incorrect as there is no Exhibit 2022 of record in this case, as noted above. These issues undermine the strength of Petitioner’s showing by making it difficult to follow its reasoning, much less identify where in the record that reasoning finds support. See DeSilva v. DiLeonardi, 181 F.3d 865, 866–67 (7th Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”); United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (“Judges are not like pigs, hunting for truffles buried in briefs.”). Third, even considering Petitioner’s new Reply arguments and” slip op. at 27
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“We credit Dr. Mercier’s testimony over Dr. Anthony’s and agree that Dr. Anthony’s testimony fails to account for the constraints of a substantially smaller form factor in Schröder’s finger-ring as compared to Mestas’s wrist device. Ex. 2018 ¶ 140. Although large curved batteries suitable for use in a wrist band or other larger wearable device, such as shown in Mestas, were known at the time of the ’124 patent, we also have evidence that prior art “finger ring wearables up to the ’124 patent had used ‘coin’ type batteries.” Resp. 40 (citing Ex. 2018 ¶ 140). We credit Dr. Mercier’s testimony that a person having ordinary skill in the art would have looked to a coin type battery for the necessary power requirements of Schröder’s device. Ex. 2018 ¶ 141. Indeed, this testimony is consistent with the other art of record that consistently shows the use of flat batteries in finger-ring devices, often stacked above and protruding from the general ring shape of the device. See, e.g., Ex. 1005 (Niwa), Figs. 22, 28; Ex. 2025 (Asada ’701 patent), Fig. 4; Ex. 1035 (Rhee), Figs. 7-1, 8-1, 8-2; Ex. 1037 (Asada article), Fig. 9; Ex. 1034 (Asada ’199 patent), Fig. 2; Ex. 1028 (Kimura patent), Fig. 24; Ex. 2018 ¶¶ 74–84. In fact, Oura’s first-generation ring design, released in 2015, used a Superbowl ring type design, with the battery and other components mounted on top of the ring. Ex. 2034; Ex. 2018 ¶ 85. We also agree with Dr. Mercier that Dr. Anthony’s testimony lacks evidence or a technical analysis of the power requirements for the various sensors he suggests including in a wearable device and the capacity of the proposed GMBPow battery. See, e.g., Ex. 1002 ¶¶ 94, 210, 214–17; Ex. 2018 ¶ 97. Moreover, Dr. Anthony does not address the issues with the batteries that are identified in the references he discusses. For example, Dr. Anthony does not address Lee’s disclosure that “direct coating of electrode slurry onto plain paper led to the occasional internal-shorting of the device due to the leakage of the electrode material through a large-sized hole in the paper.” Ex. 1019, 2415. In contrast, Dr. Mercier discusses the pitfalls the skilled artisan faced in developing finger-ring devices. See, e.g., Ex. 2018 ¶¶ 77–79 (discussing the issues Rhee’s and Asada’s large rings), 83 (identifying power requirements as a design constraint). For example, Dr. Mercier explains that “flexible or curved batteries include flexible packaging materials such as aluminum laminated films that house the electrodes and electrolyte” such that “once the battery packaging is added to a battery such as GMBPow and then placed within a housing (e.g., external housing shell and internal potting), the resulting device would have dimensions that are not suitable for a finger-worn ring.” Id. ¶ 96 (citing Ex. 2026).” slip op. at 34
Patent outcomesUS 11,188,124 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,188,124 - Axion Biosystems, Inc. v. Agilent Technologies, Inc.No claims unpatentablePTAB · Feb 2, 2026 · IPR2024-01467 · APJ David Cotta · IPR · Final written decision
Claims 1–8 and 11–15 were not shown unpatentable over Xu-752 and Jones because the proposed combination did not establish obvious millisecond time resolution.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends a person of ordinary skill in the art (“POSA”) as of May 2009 “would have had a B.S. in electrical/mechanical/biomedical engineering or biological science, or a related field, and approximately 2 years of relevant experience or equivalent study in systems and methods for bioanalysis of cells.” Pet. 14 (citing Ex. 1003 ¶¶ 23–25). Patent Owner adopts this definition for purposes of this proceeding. PO Resp. 9 (citing Ex. 2009 ¶ 19). We find Petitioner’s description of the level of ordinary skill in the art to be consistent with the level of skill reflected in the ’508 patent and in the prior art of record. Accordingly, we apply Petitioner’s definition in this decision.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“As used herein, “impedance measurement at millisecond time resolution” refers to the ability to perform a series of at least two consecutive impedance measurements within milliseconds of one another for each and every well of the system where each well is associated with an electrode array for impedance measurement. In each instance the time between two consecutive impedance measurements are less than 300 milliseconds from one another. Id. at 10:8–15. There does not appear to be any dispute as to the definitional nature of the first sentence in the passage above. That is, the parties agree that millisecond time resolution should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15 (proposing construction); Pet. Reply. 23 (“Axion also agrees that the term ‘millisecond time resolution’ is ‘the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.’”). The parties also agree that we do not need to determine whether the time interval between two consecutive impedance measurements is less than 300 milliseconds, as set forth in the definition portion of the specification, or whether it can be met by some other time interval, as suggested by other portions of the specification. See e.g., Ex. 1001, 23:49–55 (explaining that “[i]n some embodiments 500 millisecond time resolution is sufficient”), 24:37–39 (similar); PO Resp. 15 (arguing that “the distinction between 300 milliseconds and 500 milliseconds is immaterial to the dispute in this IPR because Jones teaches a 1.5 second update period, thus at least three times longer than the 500 milliseconds formulation”); Pet. Reply 23–24 (section headed “[Petitioner] Agrees That, In This IPR, The 300 Versus 500 Milliseconds Distinction is Immaterial To Addressing the Unpatentability of the Challenged Claims”), see also, Pet. Reply 24–26 (asserting that the claims are indefinite because it is not clear whether they require a 300 or a 500 millisecond time interval, but arguing that “the claims’ unpatentability can be determined without resolving the 300 versus 500 milliseconds indefiniteness issue”). We agree with the parties that “millisecond time resolution” should be construed to mean: “the time between two consecutive impedance measurements for each and every well being evaluated in the claimed apparatus or system.” PO Resp. 15; Pet. Reply. 23. We further agree that resolution of this case does not require that we determine whether the period between two consecutive impedance measurements is less than 300 or less than 500 milliseconds because Petitioner has not carried its burden under either time interval.” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1003 ¶ 179. But Dr. Kim does not cite to any additional supporting evidence or provide any technical reasoning to support his statements. The notion that one can reduce the time between measurements by, e.g., reducing the number of frequencies measured, has intuitive appeal and appears mathematically correct. However, the absence of technical reasoning and supporting evidence diminishes the persuasiveness of Dr. Kim’s testimony that the POSA would made such modifications to reduce the time between measurements. Dr. Kim does provide some technical reasoning in connection with his discussion of eliminating all reference channels as a way to get the time resolution down to the levels required by, e.g., claim 14, which recites a millisecond time resolution of “less than 5 milliseconds.” See e.g., Ex. 1003 ¶ 172 (“A POSA seeking to study biological cell phenomena occurring on the order of a few milliseconds would have recognized that after measuring the reference network channels at the start, the reference network channels would not need measured again for some time, e.g., because temperature and other drift factors do not change appreciably on a millisecond time scale.”). However, even if we were to credit this testimony, Dr. Kim still lacks support and reasoning for the selection of the other parameters in his noreference-channel calculations. See, e.g., id. ¶ 173 (positing, but not providing technical reasoning for using, a no-reference-channel impedance system with 16 wells, a single 10kHz measurement frequency, and 16 daughter boards that measure simultaneously rather than sequentially).” slip op. at 29
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable
“Given that Jones’s only exemplified embodiment targets a 1.5 second update period, that Jones does not suggest reducing the update period, and that much of Jones’s focus is on benefits other than speed of measurement, Jones’s impedance analyzer seems an unlikely choice for a POSA seeking to take measurements having millisecond time resolution. Put another way, we find no persuasive non-hindsight reason that supports Petitioner’s assertion that the POSA would have sought to apply Jones’s impedance analyzer to Xu-752’s system in order to take measurements in millisecond time resolution.” slip op. at 22
Patent outcomesUS 11,906,508 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,906,508 - MSN Laboratories Private Ltd. / MSN Pharmaceuticals Inc. v. Bausch Health Ireland LimitedNo claims unpatentablePTAB · Jan 27, 2026 · IPR2022-00722 · APJ Michael A Valek · IPR · Remand
Claims 1–6 were not shown unpatentable because the unexpected results from the Glu3 substitution outweighed the prima facie obviousness showing; Patent Owner’s motion to exclude was granted.
RulingsRemand decision- RemandOther
“More specifically, the Federal Circuit identified “three reasons” why “the Board’s determination that the[se] experiments compared the claimed invention with the closest prior art lack[ed] adequate explanation” and instructed us to address these issues on remand. See CAFC Dec. 11–13. First, the Court stated we “should determine, based on the evidence put forward by the parties, whether plecanatide exhibits topoisomerism and whether the testing of the challenged claims should encompass both the active and inactive forms.” Id. at 12.3 Second, the Court instructed us to reconsider what the closest prior art compound is in view of Patent Owner’s “contention that highly pure A-form uroguanylin could be maintained as a lyophilized powder,” noting that “[i]f it is true . . . that uroguanylin can be maintained and therefore tested in its active A form as a lyophilized powder, that would support that the experiments [which were conducted in solution] did not use the closest prior art.” Id. Third, the Court observed that the Decision did not sufficiently address “whether the experiments submitted by [Patent Owner] actually used” the closest prior art and instructed the Board “to reevaluate the experimental evidence consistent” with the determinations noted above. Id. at 12–13.” slip op. at 3
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for patent owner
“In sum, we find that there is a sufficient nexus between Patent Owner’s results and the challenged claims and that those results are reasonably commensurate with the same. Accordingly, for all of reasons explained above, the unexpected results Patent Owner relies upon are probative of non-obviousness. E. Conclusion for Ground 1 Weighing the record as a whole in view of the findings and analysis above as well as our findings and analysis relating to Petitioner’s prima facie showing in the Decision, we conclude that Petitioner has not met its burden to show that claim 1 would have been obvious over Currie and Li. The evidence suggesting that it would have been obvious to make the Glu3 substitution because it is a conservative substitution (see Dec. 20–38 (§ III.E.ii)) is substantially outweighed by Patent Owner’s comparatively strong evidence demonstrating unexpected results relating to improved interconversion stability, potency, and binding affinity from the Glu3 substitution. See Millennium Pharms., Inc. v. Sandoz Inc., 862 F.3d 1356, 1368 (Fed. Cir. 2017) (“Evidence of objective indicia [such as unexpected results] ‘can be the most probative evidence of nonobviousness in the record,’ and . . . enable[s] ‘the court to avert the trap of hindsight.’”) (quoting Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013). Indeed, the interconversion and potency categories of Patent Owner’s unexpected results showing are particularly strong such that even without the additional results in Liu, we would still reach the same ultimate conclusion on obviousness. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 1 is unpatentable.” slip op. at 56
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for patent owner
“same combination of Currie and Li for the limitations of claim 1 and the similar limitations recited in the other independent claims. In the Decision, we found that, based on the teachings in those references, an ordinarily-skilled artisan would have been motivated both to select human uroguanylin as a lead compound and modify its sequence by making a conservative Glu3 substitution for uroguanylin’s Asp3. Dec. 15–37. We did not, however, credit Petitioner’s other purported rationales for that modification. Id. at 34–37. Those findings were not disturbed on appeal. See CAFC Dec. 6–8 (rejecting 9 The Leahy-Smith America Invents Act, Pub. L. No. 112–29, 125 Stat. 284 (2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective after the filing of the application that led to the ’786 patent. Therefore, we apply the pre-AIA version of 35 U.S.C. § 103. 10 U.S. Pat. 5,489,670, issued Feb. 6, 1996 (Ex. 1005) (“Currie”). 11 Z. Li et al., Purification, cDNA Sequence, and Tissue Distribution of Rat Uroguanylin, 68 Regulatory Peptides 45–56 (1997) (Ex. 1006) (“Li”). 12 R. Narayani et al., Polymer-coated Gelatin Capsules as Oral Delivery Devices and their Gastrointestinal Tract Behavior in Humans, 7 J. Biomater. Sci. Polymer Edn. 39–48 (1995) (Ex. 1007) (“Narayani”). 13 M. Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone in Active Crohn’s Disease, 41 Gut 209–214 (1997) (Ex. 1008) (“Campieri”). 14 U.S. Pat. 5,359,030, issued Oct. 25, 1994 (Ex. 1009) (“Ekwuribe”). Patent Owner’s alternative arguments for affirmance). We incorporate by reference the portions of the Decision addressing Petitioner’s prima facie showing herein. See Dec. 8–37 (§§ III.A–D and E.i–ii). We consider the findings and explanation therein to the extent it bears on our analysis below.” slip op. at 10
- ExcludeMotion to exclude, grantedGranted
“motion. The American Peptide letter contains out of court statements from a third party submitted by the EPO opponent. The statements in the letter were not made under oath, nor is there evidence that Patent Owner was ever able to question the author of that letter or anyone else with personal knowledge of the statements therein. Petitioner argues that the American Peptide letter is evidence “to doubt that the ‘singular peak’ for uroguanylin in Liu represents the active topoisomer of uroguanylin” because it evidences that American Peptide “provided its customers with the ‘B’ (i.e., inactive) form of uroguanylin at the time.” Pet. Remand Resp. 25. That is, Petitioner relies on the American Peptide letter for the truth of the matters asserted therein. Such use plainly implicates the rule against hearsay and falls squarely within our prior reasoning for excluding the Currie submission portion of Exhibit 1067. We incorporate that analysis herein. See Dec. 61–72. Petitioner asserts that the American Peptide letter is admissible under the residual hearsay exception in FRE 807. MTE Opp. 3–5. We disagree. The American Peptide letter was submitted by the EPO opponent specifically for the purpose of opposing a foreign counterpart to the ’786 patent. We see no reason to distinguish it from the other materials previously excluded as hearsay in the Currie submission. Petitioner’s assertion that it contains sufficient guarantees of trustworthiness because it was “provided by a neutral third-party” (American Peptide) and “an individual having first- hand knowledge, [American Peptide Company’s] VP of sales and marketing” is speculation. See id. at 3–4. Based on the record before us, Patent Owner has never been afforded an opportunity to examine anyone regarding the statements in this letter or even confirm that it is, in fact, a letter from the American Peptide Company. The mere fact that it was submitted in a foreign patent proceeding does not make it any more trustworthy than any other untested assertion offered by an adverse party in a legal proceeding. For these reasons, we grant Patent Owner’s motion to exclude page 86 of Exhibit 1067.” slip op. at 58
Patent outcomesUS 7,041,786 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,041,786 - PTAB · Sep 10, 2025 · IPR2025-00141 · APJ Ken B Barrett · IPR · Remand
The Board instituted IPR of claims 1–21 on all asserted grounds after finding a reasonable likelihood of prevailing on the Nishida-based challenges.
RulingsRemand decision- Director reviewDirector review, grantedGranted
“partes review of U.S. Patent No. 8,266,749 B2 (“the ’749 patent,” Ex. 1001). Paper 1 (“Pet.”). The Petition challenges the patentability of claims 1–21 of the ’749 patent. Nike, Inc. (“Patent Owner”)2 filed a Preliminary Response to the Petition. Paper 6 (“Prelim. Resp.”). With our authorization, Petitioner filed a Reply to Patent Owner’s Preliminary Response (Paper 10) and Patent Owner filed a Sur-reply (Paper 13). We discretionarily denied institution under 35 U.S.C. § 325(d). Paper 20. Petitioner filed a request for Director Review of the Decision denying institution. Paper 21. Director Review was granted, the Decision denying institution of inter partes review was vacated, and the case was remanded to the Board. Id. at 4. Specifically, the case was “remanded to the Board with instructions to consider Petitioner’s Nishida grounds and to determine whether the Petition should be instituted.” Id. at 3–4.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the Petition and the Preliminary Response “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’749” slip op. at 2
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“In support of Petitioner’s position, Dr. Adanur testifies that “Nishida discloses that the unfinished surface area 1.1 is part of the web 1 itself,” that Nishida discloses that the computer-controlled process can (using Nishida’s phrase) “put in” up to seven different textile fibers or yarns into the web of material in one operation, and that, “[t]hus, Nishida discloses simultaneously knitting its layouts 2 and tongue 40 (each a ‘textile element’) with the unfinished surface area 1.1 (a ‘surrounding textile structure’).” Ex. 1002 ¶ 216 (citing Ex. 1022, 2:12–20, 4:47–55, 5:45–49). For purposes of institution, we credit that testimony over the testimony of Dr. Pastore, because, on the current record, we regard Dr. Adanur’s testimony as more consistent with the evidence. This and the other related issues may be explored more fully during the trial.” slip op. at 23
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that: A person of ordinary skill in the art (“POSITA”) in the field of the ’749 patent in March 2004 would have been someone with at least a few years of experience in knit materials and knitting methods and machines that can be used in making footwear, or a bachelor’s degree in textile-related sciences, engineering, or industrial product design, or equivalent academic or work experience, including in the footwear industry. EX1002, ¶68. Such a person of ordinary skill would have at least a general understanding of general construction processes and materials used in the manufacturing process of fabric-based articles. For individuals with a lower educational level, a person could still be of ordinary skill in the art provided that person’s working experience compensates for any such lower educational level, or vice versa. See id. Pet. 23–24. Patent Owner states that, “[f]or purposes of this Preliminary Response, Nike applies Skechers’ definition for a person of ordinary skill in the art.” Prelim. Resp. 14. Petitioner’s definition is consistent with the level of ordinary skill reflected in the prior art references of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). For purposes of this decision, we apply Petitioner’s definition of the person of ordinary skill in the art.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,266,749 - Duration Media LLC v. Rich Media Club LLCNo claims unpatentablePTAB · Aug 19, 2024 · IPR2023-00953 · APJ Michael J Fitzpatrick · IPR · Final written decision
Claims 1–10 were not proven unpatentable under either §103 ground because the evidence did not show the claimed viewability determination.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find Patent Owner’s argument persuasive. Indeed, it is unclear how Petitioner’s proposal accounts for the types of problems encountered in the art or prior art solutions to those problems. See Daiichi Sankyo, 501 F.3d at 1256 (identifying these factors, among others, as “a guide to determining the level of ordinary skill in the art”). Nor does Petitioner, in its Reply, address, let alone rebut, Patent Owner’s arguments that a person of ordinary skill in the art would have had some experience and/or knowledge in internet advertising. See generally Pet. Reply. Patent Owner proposes that a “person of ordinary skill in the art would have a bachelor’s degree in computer science or a similar major involving computer programming (or at least four years of practical computer programming experience) and at least two years of experience (in or out of college) in the field of internet advertising.” PO Resp. 12 (citing Ex. 2045 ¶54). We agree that a person of ordinary skill in the art would have some experience in internet advertising, although we fail to see why one year would not be enough to familiarize sufficiently a computer scientist and/or programmer with the types of problems encountered in the art or prior art solutions to those problems. Based on the competing proposals, arguments, and evidence before us, we adopt and apply the following level of skill in assessing Petitioner’s challenges to the patentability of the claims of the ’329 patent: a person that would have had a bachelor’s degree in computer science, computer engineering, or electrical (or similar) engineering with about three years of experience being in the field of internet advertising.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner
“Petitioner’s resurrected argument is based on a fundamental misunderstanding of § 311(b). Section 311(b) provides: “A petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed cancel the claims of the ’329 patent on the basis of Badros, Harkins, and Krassner. Pet. 11. Petitioner did not base its request, in whole or in part, on the Krassner publication. Id. Krassner clearly is a patent. It issued on August 13, 2019, far too late to be § 102(b) prior art. Even if we assume Krassner is also a “printed publication” withing the meaning of § 311(b), the same date would apply: August 13, 2019. Petitioner has not presented any evidence that the document that is Krassner was published prior to when it issued on August 13, 2019. That another document (the Krassner publication), which published much earlier, may contain the same or similar disclosure is not relevant to when Krassner was patented or published. In sum, Krassner is not prior art under 35 U.S.C. § 102(b). b) Whether Krassner is Prior Art Under 35 U.S.C. § 102(e) Although Krassner is not prior under 35 U.S.C.§ 102(b), we” slip op. at 13
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Petitioner responds that, contrary to Patent Owner’s argument, “Harkins teaches that its invention can be used in web pages.” Pet. Reply 18 (citing Ex. 1004 ¶30). Although Petitioner’s citation is off by one paragraph, Petitioner’s response about what Harkins teaches is correct. See Ex. 1004 ¶29 (“The present invention may be implemented for provision of virtually any type of advertising (e.g., print, radio, television, Internet, billboard, etc.) via any type of advertising medium (e.g., newspaper, magazine, radio broadcast, Web pages, billboards, etc.) without departing from the scope of the present invention.”). We find that Harkins is from the same field based on its express statement that it is applicable to “virtually any type of advertising” and “any type of advertising medium,” including “Web pages.” Ex. 1004 ¶29. Further, even if this were insufficient to place Harkins in the same field as the ’329 patent, we find that Harkins is reasonably pertinent to the particular problems with which the ’329 patent inventors were involved. In sum, we find that Harkins is analogous art to the ’329 patent.” slip op. at 19
- Strike new argumentNew argument disregardedGranted
“Paper 60 (“PO Mot. To Exclude”), 9–10.6 Patent Owner is correct in this regard and, thus, we grant Patent Owner’s Motion to Exclude with respect to the testimony in the second Smedley Declaration and the Madansky Declaration opining that Badros teaches the determination limitation. Paper 60, 9–12. Petitioner, in its Opposition to the Motion to Exclude, argues that Patent Owner’s arguments about the “viewability test” were “surprising.” Paper 62, 8. We are not persuaded by Petitioner’s argument. The “viewability test” is a claim limitation. Petitioner should have anticipated that Patent Owner would argue that limitation. See In re Gardner, 449 F. App’x 914, 916 (Fed. Cir. 2011) (“This court has held that when evaluating claims for obviousness under 35 U.S.C. § 103, all the limitations of the claims must be considered and given weight.” (citing Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983)); Univ. of Strathclyde v. 6 Patent Owner’s Motion to Exclude seeks to exclude, in part or in whole, Exhibits 1020–1022, 1025–1030, and 1034–1040, which were submitted with Petitioner’s Reply, of which Exhibits 1026 and 1027 are the declaration by Dr. Madansky and the second declaration by Dr. Smedley, respectively. Mot. To Exclude. The Motion to Exclude also seeks to exclude “Exhibits” 1017 and 1018, which are not filed or of record in this case but which are referenced in the Reply. Id. For example, Exhibit 1017 is the Krassner publication, which Petitioner unsuccessfully moved to add to the record as supplemental information. See Paper 21, 3 n.1 (expunging the Krassner publication and stating that it “need not -- and indeed may not -- be re-filed under a new exhibit number”). Apart from the portions of Dr. Smedley’s second declaration and Dr. Madansky’s declaration opining that Badros teaches the “determination” limitation, we dismiss the Motion to Exclude as moot. obviousness determination generally requires a finding that “all claimed limitations are disclosed in the prior art’.” (citing PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014)). Petitioner argues that “[v]iewability tests were well known for well over a decade prior to the ’329 patent’s priority date.” Reply 9. If that were the case, then Petitioner should have made its argument in the Petition. Section 312(a) of Title 35 is titled “Requirements of Petition,” and it specifies that a petition must identify, among other things, “the evidence that supports the grounds for the challenge to each claim, including . . . (B) affidavits or declarations of supporting evidence and opinions, if the petitioner relies on expert opinions.” 35 U.S.C. § 312(a)(3); see also 37 C.F.R. § 42.104(b)(4)–(5) (“The petition must specify where each element of the claim is found in the prior art patents or printed publications relied upon; and . . . the supporting evidence relied upon to support the challenge.”). Thus, “Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Board’s Consolidated Trial Practice Guide, 73 (Nov. 21, 2019).7 Dr. Smedley’s testimony in his second declaration, that “Badros discloses Patent Owner’s ‘viewability test’” (Ex. 1027 ¶11), is clearly evidence to make out a prima facie case of unpatentability. The same is true of Dr. Madansky’s testimony that she agrees with Dr. Smedley in this regard. Ex. 1026 ¶4.” slip op. at 25
Patent outcomesUS 11,443,329 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,443,329 - Synthego Corporation v. Agilent Technologies, Inc.All claims unpatentablePTAB · May 17, 2023 · IPR2022-00403 · APJ Michael A Valek · IPR · Final written decision
Claims 1–33 are unpatentable: claims 1–5, 8–21, and 24–33 are anticipated by Pioneer Hi-Bred; the remaining claims are obvious over the stated combinations.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Patent Owner agrees that a POSA would have this educational level. Resp. 23. Patent Owner “also agrees that a POSA would have knowledge of prior art RNA based gene regulating technologies, but disagrees that the teachings of those technologies are relevant in the manner that Dr. Furneaux [and Petitioner] attempt[] to apply them” in the Petition’s grounds. Id. at 23– 24. We find the parties’ agreed understanding of the level of ordinary skill in the art to be supported by the record and apply that description in our analysis herein. To the extent the parties disagree regarding the application of a POSA’s general knowledge of nucleic acids and related prior art techniques to the Petition’s grounds, such disputes are addressed in our analysis below.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Independent claims 1 and 19 recite a guide RNA or crRNA molecule having “gRNA functionality comprising associating with a Cas protein and targeting the gRNA:Cas protein complex to the target sequence.” Ex. 1001, 257:42–44, 259:5–7. This claim language makes clear that the recited “gRNA functionality” requires a molecule that can: (1) associate with a Cas protein, and (2) target that complex to a target sequence in a polynucleotide. To the extent Petitioner suggests that a gRNA “need only bind to the Cas protein” to have “gRNA functionality,” we disagree because the claims additionally recite the above-quoted targeting functionality. See Reply 16 (emphasis added). At the same time, we agree with Petitioner that “a gRNA need not cleave the target DNA” to have the claimed “gRNA functionality.” Reply 16. The Specification defines “gRNA functionality” as “one or more functions of naturally occurring guide RNA, such as associating with a Cas protein, or a function performed by the guide RNA in association with a Cas protein” and lists various gRNA functions, e.g., “associating,” “targeting,” “binding,” “nicking,” and “cleaving,” that may be present “in certain embodiments” of the invention. Ex. 1001, 6:56–7:1. However, as noted above, the claims recite “gRNA functionality comprising” only the associating and targeting functions. Thus, while a molecule may have additional functions such as cleaving a target polynucleotide, it need only exhibit the recited “associating” and “targeting” functions to have the “gRNA functionality” in claims 1 and 19. Our determination that “gRNA functionality” requires the recited “associating” and “targeting” functions, but not additional, unrecited functions such as cleaving, is also consistent with the parties’ position that the claim language has its plain and ordinary meaning. See Pet. 17; Resp. 24. The parties do not dispute the construction of any other terms, nor do we discern that any further claim construction is necessary to resolve the issues in this proceeding. See Nidec Motor Corp. v. Zhongshan Broad OceanMotor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“established that “anticipation does not require actual performance of suggestions in a disclosure.” Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985). Moreover, the Petition need not assert that “gRNA functionality” is inherently disclosed because Petitioner has shown that Pioneer Hi-Bred’s expressly discloses this limitation. Pet. 25–26 (citing evidence). There is no additional requirement that this express disclosure be backed by test data in order for the reference to be anticipatory. See, e.g., Novo, 424 F.3d at 1355; Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005) (“[P]roof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”).” slip op. at 22
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Second, even if those sequences were truncated, the record does not support Patent Owner’s argument that a POSA would doubt that they have gRNA functionality. Patent Owner’s argument is premised on Dr. Marshall’s testimony that these sequences “are truncated to a point that would render them nonfunctional.” Ex. 2025 ¶ 200. But the references he cites do not support that position. See Ex. 2025 ¶ 202 (citing Ex. 1033 (“Fu”); Ex. 2044 (“Cencic”); and Ex. 2045 (“Mali”)). To the contrary, Fu evidences that “truncated gRNAs, with shorter regions of target complementarity <20 nucleotides in length” are functional and that truncation to 17 nt is beneficial. Ex. 1033, Abstr.; see also id. at 283 (“[W]e found that [truncated] gRNAs with 17 or 18 nucleotides of complementarity generally function efficiently at the intended target site and have improved specificities.”). Cencic and Mali likewise do not suggest that a 17 nt VT domain would lack gRNA functionality. See Ex. 2025 ¶ 202 (citing Cencic as showing “truncated gRNA tests showed that a guide sequence of only 16 nucleotides” abolished cleavage activity); Ex. 2045, Supp. Fig. 10 (“1-3 bp 5’ [gRNA] 11 Patent Owner asserts that Dr. Furneaux “adopted the definition of ‘truncated gRNAs’ as those with ‘regions of target complementarity <20 nucleotides in length” in paragraph 79 of his opening declaration. Sur-reply 8 n. 1. We disagree. The testimony in paragraph 79 refers to the particular results in Fu. See Ex. 1003 ¶ 78 (citing Ex. 1033). We see nothing there that suggests Dr. Furneaux agrees with Patent Owner’s position that any gRNA with a VT region of less than 20 nt is truncated. truncations are indeed well tolerated, but larger deletions lead to loss of activity”). Accordingly, we credit Dr. Furneaux’s testimony (see, e.g., Ex. 1003 ¶ 78, Ex. 1059 ¶¶ 73–75) over the competing testimony offered by Dr. Marshall on these points.” slip op. at 24
Patent outcomesUS 10,900,034 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,900,034 - Life Spine, Inc. v. Globus Medical, Inc.Institution deniedPTAB · Apr 18, 2023 · IPR2022-01601 · APJ Kristi L R Sawert · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–8, 10–18, and 20 were unpatentable over Chung, Olmos, or Olmos in view of Chung.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Petitioner ultimately bears the burden of persuasion to prove unpatentability of each challenged claim by a preponderance of the evidence. 35 U.S.C. § 316(e). This burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). The Board may authorize an inter partes review if we determine that the information presented in the Petition and Patent Owner’s Preliminary Response shows that there is a reasonable likelihood that Petitioner will prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a).” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“1[d] and 11[d] recite that the “second expansion portion” is “longitudinally spaced from the first expansion portion.” Ex. 1001, 21:54–55, 22:38–39 (emphasis added). On this record, we find that the annotated excerpt of Chung’s Figure 2 is inconclusive as to whether dovetail (32) (blue) is longitudinally spaced from the expansion portion (yellow). Based on the excerpt of Chung’s Figure 2, it is equally likely that the structures colored blue and yellow terminate in the same plane, as shown in Patent Owner’s annotated excerpt of Chung’s Figure 2, reproduced below: Prelim. Resp. 45–46. In Patent Owner’s annotated excerpt of Chung’s Figure 2 reproduced above, Patent Owner demonstrates that Chung’s dovetail (32) longitudinally terminates in the same plane as the ramped surfaces that flank the dovetail (shown by the orange arrows), and does not appear to be longitudinally spaced past the plane where the expansion portion terminates. See id. (citing Ex. 1005, 10; Ex. 2001 (Culbert Decl.) ¶ 85). On this record, we find Patent Owner’s interpretation of Chung Figure 2 more plausible than Petitioner’s.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“certain limitations of claims 1 and 11 (i.e., limitations 1[f], 1[g], 11[f], 11[e]), but relies only on Olmos for limitations 1[d] and 11[d]. See Pet. 99 (stating that “Olmos discloses each and every element of” the challenged claims); id. at 99–101 (discussing the combination of Olmos and Chung with respect to only limitations 1[f], 1[g], 11[f], 11[e]); see also Prelim. Resp. 82 (noting that, for claim limitations 1[d] and 11[d], “Petitioner’s analysis of the asserted combination relies completely on its discussion of Olmos”). We refer back to our analysis above in determining that Petitioner has not sufficiently shown for institution that Olmos teaches limitations 1[d] and 11[d] (relating to “second expansion portion” that is “longitudinally spaced from the first expansion portion”). Supra § II.G. Accordingly, for at least the same reasons discussed above for claims 1 and 11, on this record we determine that Petitioner has not shown a reasonable likelihood that these claims are unpatentable as obvious over Olmos in view of Chung.” slip op. at 30
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted
“Seal. Paper 3 (“Motion”). Petitioner requests that we seal Exhibit 1010 (a claim chart submitted as an exhibit to Patent Owner’s litigation infringement contentions). Id. at 1. Petitioner represents that the material it seeks to seal contains its trade secrets. Id. at 2–3. Petitioner filed a proposed protective order, which includes modifications to the Board’s default protective order. See Ex. 1018; Ex. 1019. Patent Owner filed a Response to Petitioner’s Motion. Paper 7. Patent Owner indicates that it does not oppose “the Board sealing Petitioner’s confidential information,” but does oppose Petitioner’s proposed protective order. Id. at 1 (citing Ex. 1018; Ex. 1019). However, Patent Owner represents that “the parties have conferred and agree to the terms of the stipulated protective order filed as Exhibit 2100.” Id.; see also Ex. 2101 (redline comparison of Ex. 2100 to the Board’s default protective order). We find that Petitioner has established good cause to seal its trade secret information. Accordingly, we grant Petitioner’s Motion. 37 C.F.R. § 42.14. We also enter the stipulated protective order filed as Exhibit 2100.” slip op. at 31
§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,925,752 - Life Spine, Inc. v. Globus Medical, Inc.InstitutedPTAB · Mar 24, 2023 · IPR2022-01434 · APJ Cynthia M Hardman · IPR · Institution
Instituted IPR on all asserted grounds against claims 1–15 after finding a reasonable likelihood that claim 15 is anticipated by Chung.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“the same or substantially the same prior art or arguments previously were presented to the Office.” The Board analyzes this issue under a two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“After considering all of the arguments and evidence of record, we determine that for purposes of institution, Petitioner has sufficiently shown that Chung discloses an intervertebral implant that teaches all limitations of claim 15. See Pet. 57–62. The arguments and evidence for limitation 15[g]’s “extension” are the same as for the “extension” of claim 1. See, e.g., Pet. 58, Prelim. Resp. 32–47. Thus, we refer back to our analysis above (see supra Section II.F.1.a.i) in determining that Petitioner has sufficiently shown for purposes of institution that Chung teaches the claimed “extension.” On this record, Petitioner has shown a reasonable likelihood of establishing that claim 15 is anticipated by Chung. On that basis, we institute an inter partes review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed” slip op. at 43
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“On this preliminary record, Petitioner has the better argument. It appears that Patent Owner’s construction improperly reads in limitations from example embodiments, such as the embodiments depicted in Figures 25 and 46 of the ’731 patent. See Prelim. Resp. 39 (Patent Owner’s annotated Figures 25 and 46). Petitioner demonstrates that both the Specification and the Examiner used the term “extension” more broadly to refer to a variety of structures, not merely to structures that “increase the length of the central ramp.” See, e.g., Prelim. Reply 3; Ex. 1001, 5:47–58, Fig. 10, 11:8–10, 11:40–42, Fig. 23, 9:40–45, 10:1–19, Fig. 24, claims 2, 3; Ex. 1004, 42–44, 66–67, 126–27. Patent Owner seeks to ignore the Specification and Examiner’s use of the term “extension” in connection with structures other than the central ramp (see, e.g., Prelim. Sur-reply 4), but on this record nothing indicates that the patentee intended a special definition for the term “extension” in the context of the central ramp. For purposes of this Decision, we apply the plain and ordinary meaning of the term “extension,” i.e., “an addition to a main structure.” See Ex. 3001, 4. This construction is consistent with the broad use of the term “extension” in the Specification to refer to a variety of additions to a main structure having a variety of shapes.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“Petitioner’s annotated excerpt of Chung’s Figure 1 (reproduced above on the left) does not appear to show that extension/dovetail (32) extends in a longitudinal direction from the expansion portion (yellow). Instead, it terminates in the longitudinal direction at or before the edges of the expansion portion (yellow). Additionally, on this record, we find that the annotated excerpt of Chung’s Figure 2 is inconclusive as to whether extension/dovetail (32) extends in a longitudinal direction from the expansion portion (yellow). Based on the excerpt of Chung’s Figure 2, it is equally likely that the structures colored blue and yellow terminate in the same plane, as shown in Patent Owner’s further annotated excerpt of Chung’s Figure 2, reproduced below: Prelim. Resp. 77. In Patent Owner’s further annotated excerpt of Chung’s Figure 2 reproduced above, Patent Owner demonstrates that Chung’s dovetail (blue) protrudes in a direction (shown by the blue dashed arrow) that is acute to the longitudinal axis (red dashed line), but does not appear to extend in a longitudinal direction past the plane where the expansion portion (yellow) terminates. See id. On this record, we find Patent Owner’s interpretation of Chung Figure 2 more plausible than Petitioner’s.” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 8,845,731 - Mylan Pharmaceuticals Inc. v. Bausch Health Ireland LimitedInstitution deniedPTAB · Jan 4, 2023 · IPR2022-01103 · APJ Michael A Valek · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was unpatentable on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Considering the arguments and evidence of record, we determine that the Petition does not demonstrate “a reasonable likelihood that [P]etitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we do not institute an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“14 Because we deny the Petition on the merits, we do not reach Patent Owner’s argument for discretionary denial under 35 U.S.C. § 325(d). Prelim. Resp. 23–39.” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Petitioner contends that as of September 15, 2011 (see supra n.1), a person of ordinary skill in the art (sometimes referred to herein as a “skilled artisan”) “had the equivalent of a graduate degree in pharmaceutics or a related field, and knowledge and experience making oral-dosage formulations. This individual could work with other specialists including, e.g., an M.D., clinical pharmacologist, and medicinal chemist.” Pet. 10–11 (citing Buckton Decl. ¶¶ 81–84). For the purposes of the Preliminary Response, Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 42. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that the claims do not require any construction, but also states that a person of ordinary skill in the art would have understood the term “inert low moisture carrier,” which appears in claim 1, to include Avicel PH112. Pet. 12. For purposes of the Preliminary Response, Patent Owner “does not challenge the claim construction positions set forth in the Petition.” Prelim. Resp. 41. For purposes of this Decision, we determine that no claim terms need to be construed. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 7
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 9,616,097 - Mylan Pharmaceuticals Inc. v. Bausch Health Ireland LimitedInstitution deniedPTAB · Jan 4, 2023 · IPR2022-01105 · APJ Cynthia M Hardman · IPR · Institution
The Board denied institution because Mylan did not show a reasonable likelihood that any challenged claim was unpatentable over the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“On this record Petitioner has not shown a reasonable likelihood of establishing that at least one of the challenged claims is unpatentable as obvious over Shailubhai, Remington, and Mihranyan. We focus our analysis on claim 1’s recitation of “an inert low moisture carrier.”” slip op. at 11
- BurdenDenied
“On this record, we find that Petitioner’s reliance on Lai is insufficient to carry its burden for institution. Petitioner and Dr. Buckton generically cite Lai’s first page (page 489), but fail to articulate any specific reason why a skilled artisan would have been motivated to use a low-moisture MCC carrier in a peptide formulation (let alone in the claimed plecanatide formulation). At most, Lai page 489 is equivocal about the impact of moisture on peptides, stating only that, among other factors, moisture “may impact the chemical stability of proteins and peptides in the solid-state.” Id. (emphasis added). Neither Petitioner nor Dr. Buckton adequately explains how this teaching (or any other teaching in Lai) would have informed a person of ordinary skill in the art that peptides were moisture-sensitive, thereby motivating use of a low-moisture MCC carrier.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“to carry its burden for institution. Petitioner and Dr. Buckton generically cite Lai’s first page (page 489), but fail to articulate any specific reason why a skilled artisan would have been motivated to use a low-moisture MCC carrier in a peptide formulation (let alone in the claimed plecanatide formulation). At most, Lai page 489 is equivocal about the impact of moisture on peptides, stating only that, among other factors, moisture “may impact the chemical stability of proteins and peptides in the solid-state.” Id. (emphasis added). Neither Petitioner nor Dr. Buckton adequately explains how this teaching (or any other teaching in Lai) would have informed a person of ordinary skill in the art that peptides were moisture-sensitive, thereby motivating use of a low-moisture MCC carrier.” slip op. at 13
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Dr. Buckton’s testimony does not provide the missing explanation. He merely repeats the Petition’s statement that Lai teaches “peptides in particularly are generally subject to degradation from moisture during storage,” without explaining how Lai supports that conclusion. Buckton Decl. ¶ 104; see also id. ¶ 144. Dr. Buckton also cites Aulton, but again fails to indicate exactly what in Aulton indicates that peptides generally, much less plecanatide specifically, are moisture-sensitive. Id. ¶ 144. Indeed, the cited page of Aulton does not mention peptides at all. See Ex. 1029 (Aulton), 9. On this record, Dr. Buckton’s testimony lacks sufficient explanation and is not persuasive to support Petitioner’s burden for institution. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Verlander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (noting that Board has discretion to accord little weight to expert’s “broad conclusory statements that it determined were unsupported by corroborating references”).” slip op. at 16
Claim construction§ 103 obviousnessDiscretionary denialcites GrahamPatents in suitUS 9,925,231
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.