- Resmed, Inc. v. New York UniversityAll claims unpatentablePTAB · Dec 7, 2023 · IPR2022-00992 · APJ Bart A Gerstenblith · IPR · Final written decision
Claims 1–14 are unpatentable as obvious: claims 1–5 and 7–14 over Sullivan995 and Sullivan460, and claim 6 over those references and Matthews.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“A. “troubled wakefulness” Petitioner proposes that we construe “troubled wakefulness” to mean” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“not implicitly define the phrase “analyzes the data to determine the patient’s breathing patterns,” as proposed, because Patent Owner has failed to show any sufficient evidence that the ’024 patent clearly expresses an intent to redefine the phrase or define the phrase in terms other than its plain and ordinary meaning. In other words, implied lexicography does not apply here. Accordingly, after reviewing Patent Owner’s contentions in light of all the evidence of record, we do not adopt Patent Owner’s proposed construction; instead, we apply the plain and ordinary meaning of “analyzes the data to determine the patient’s breathing patterns” in our consideration of the issues before us.” slip op. at 31
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“Accordingly, for the reasons explained above, we find Petitioner has” slip op. at 53
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“because it too is based on Patent Owner’s proposed construction of “analyzes the data to determine the patient’s breathing patterns,” which we do not adopt for the reasons explained above. Patent Owner’s additional arguments in response to Ground 2 are directed to motivation to combine, reasonable expectation of success, and objective indicia of nonobviousness, which we address below. For the reasons discussed above, we find Petitioner’s arguments persuasive as to claim 6 and supported on the complete record before us. Accordingly, we find that the combination of Sullivan995, Sullivan460, and Matthews satisfies the subject matter of claim 6.” slip op. at 70
Patent outcomesUS 10,384,024 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,384,024 - Resmed, Inc. v. New York UniversityAll claims unpatentablePTAB · Dec 6, 2023 · IPR2022-00994 · APJ Alyssa A Finamore · IPR · Final written decision
Claims 1, 3, 7, 9, 11, and 13 are unpatentable as obvious over Sullivan995, Sullivan460, and Matthews; the Board did not reach the other grounds.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Plain and ordinary meaningDecided for petitioner
“the specification . . . we do not read limitations from the embodiments in the specification into the claims.” Hill-Rom Servs., 755 F. 3d at 1371 (citing Liebel–Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 904 (Fed. Cir. 2004)). “We depart from the plain and ordinary meaning of claim terms based on the specification in only two instances: lexicography and disavowal.” Id. In order for a patentee to act as its own lexicographer, the “patentee must ‘clearly set forth a definition of the disputed claim term other than its plain and ordinary meaning’” and “must ‘clearly express an intent’ to redefine the terms.” Bradium Tech., 923 F.3d at 1044.” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art “would have had at least a bachelor’s degree in mechanical engineering, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience” and that “[a]dditional experience could substitute for less education, and additional education could likewise substitute for less experience.” Pet. 23 (citing Ex. 1003 ¶ 89). Petitioner further contends that the “Petition does not turn on this precise definition, and the challenged claim[s] would be unpatentable from the perspective of any reasonable person of ordinary skill in the art at the relevant time.” Id. (citing Ex. 1003 ¶ 90). Patent Owner does not object to Petitioner’s definition for the level of ordinary skill in the art. PO Resp. 11. Petitioner’s definition for the level of ordinary skill in the art is consistent with the problems addressed in the ’344 patent and the prior art. We, therefore, apply Petitioner’s level of ordinary skill in the art in this Decision.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“At the outset, we agree with Petitioner that “enablement ‘is not a requirement to prove invalidity under § 103.’” Pet. Reply 23 (quoting Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1357 (Fed. Cir. 2003)). Moreover, we also agree with Petitioner that a person of ordinary skill in the art would have understood a preset level is established from previously-acquired data, such as an average level, as Sullivan995 discloses. Id. at 22 (citing Ex. 1005, 17:3–27, Fig. 12; Ex. 2015, 38:2–16). Sullivan995 discloses the computing system may “calculate control values of patterns for each patient based on moving average values or such values or patterns will be pre-programmed into the computing system.” Ex. 1005, 17:14–18. According to Sullivan995, when “signals deviate from predetermined values or patterns the computer system generates a signal which is sent to the feedback speed controller on the blower motor.” Id. at 17:19–22.” slip op. at 48
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“The Board uses a two-step analysis in evaluating nexus between the claimed invention and objective evidence. Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, Paper 33 at 32–33 (PTAB Jan. 24, 2020) (precedential), aff’d sub nom. Zaxcom, Inc. v. Lectrosonics, Inc., 2022 WL 499848 (Fed. Cir. Feb. 18, 2022). We first consider whether the patent owner has demonstrated “that its products are coextensive (or nearly coextensive) with the challenged claims,” resulting in a rebuttable presumption of nexus. Id. at 32. If not, that “does not end the inquiry into secondary considerations”; “the patent owner is still afforded an opportunity to prove nexus by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Id. at 33 (quoting Fox Factory, 944 F.3d at 1373–75). “Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” Id. (citing In re Kao, 639 F.3d 1057, 1068–69 (Fed. Cir. 2011)). There is no requirement that the objective evidence of non-obviousness be tied exclusively to claim elements that are not disclosed in the prior art, and the claimed combination as a whole may serve as a nexus for the objective evidence. Id. (citing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1331 (Fed. Cir. 2016)).” slip op. at 56
Patent outcomesUS 9,168,344 unpatentableClaim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 9,168,344 - Resmed, Inc. v. New York UniversityAll claims unpatentablePTAB · Dec 4, 2023 · IPR2022-00989 · APJ James A Tartal · IPR · Final written decision
Claims 1, 2, 5–11, 13, and 15–30 are unpatentable as obvious over Sullivan995 and Sullivan460; anticipation was not shown, and the other obviousness ground was not reached.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Petitioner contends that a person of ordinary skill in the art would have had “at least a bachelor’s degree in mechanical engineering, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience” and “[a]dditional experience could substitute for less education, and additional education could likewise substitute for less experience.” Pet. 19 (citing Ex. 1003 ¶ 77). Petitioner further states that the “Petition does not turn on this precise definition, and the challenged claims would be unpatentable from the perspective of any reasonable person of ordinary skill in the art at the relevant time.” Id. (citing Ex. 1003 ¶ 78). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill in the art. PO Resp. 15–16. We find that the ’539 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected in these references and in the ’539 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“awake state” Claim 24 recites, in part, “to determine whether breathing patterns indicate an asleep state or an awake state.” Ex. 1001, 11:36–12:7; see also id. at 9:49–64 (claim 1 reciting “between an awake state and an asleep state”), 10:42–56 (claim 11 reciting “at least one of an awake state or an asleep state”). In regard to its allegations of obviousness, Petitioner’s arguments suggest an “awake state” ordinarily means when a patient is not asleep. Pet. 36–37, 42. By contrast, with regard to its allegations of anticipation, Petitioner argues that under Patent Owner’s “implied construction of ‘an awake state’ based on [Patent Owner’s] infringement allegations” in district court, “the patient is in an awake state when there is an absence of obstructions or other breathing patterns indicative of sleep.” Id. at 68–70 (citing, e.g., Ex. 1018 ¶¶ 2, 158, 159). Petitioner provides no further support for this “implied construction” purportedly taken from Patent Owner’s district court allegations. Id. Dr. Kirkness, in support of Petitioner, applied the plain meaning of all terms and phrases. See, e.g., Ex. 1003 ¶ 80. In regard to supporting Petitioner’s allegations of anticipation, Dr. Kirkness merely assumed Patent Owner’s purported district court claim construction “position to be true.” Ex. 1003 ¶ 253. In this proceeding Patent Owner does not propose an express meaning for “awake state.” See PO Resp. 29–33. More generally, Patent Owner states that the ’539 patent “teaches how to distinguish between an awake state and an asleep state.” Id. at 8. From the arguments of the Parties, we discern no dispute in this proceeding that a plain and ordinary meaning of an “awake state” is a state in which a patient is not asleep. See Ex. 1001, 3:1–5 (distinguishing between “a wake state” and “a sleep state”), 7:22–24 (describing an embodiment with a processing arrangement that “may determine whether the patient is in a sleep state or a wake state based on the breathing pattern”).8 We apply the plain and ordinary meaning of “awake state” in this proceeding and further determine that Petitioner has not shown by a preponderance of the evidence that an awake state means “an absence of obstructions or other breathing patterns indicative of sleep.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Plain and ordinary meaningDecided for petitioner
“Next, we turn to the Specification. “While we read claims in view of the specification . . . we do not read limitations from the embodiments in the specification into the claims.” Hill-Rom Servs., 755 F. 3d at 1371 (citation omitted). “We depart from the plain and ordinary meaning of claim terms based on the specification in only two instances: lexicography and disavowal.” Id. In order for a patentee to act as its own lexicographer, the “patentee must ‘clearly set forth a definition of the disputed claim term other than its plain and ordinary meaning’” and “must ‘clearly express an intent’ to redefine the terms.” Bradium Tech., 923 F. 3d at 1044. In this case, Patent Owner does not argue that it disavowed the full scope of the plain and ordinary meaning of claim 24, nor does Patent Owner argue that it explicitly defined “analyzing the breathing patterns” in the Specification. See, e.g., PO Resp. 29–32. We determine that there is no disavowal nor any explicit lexicographic definition of “analyzing the breathing patterns” in the Specification. Patent Owner instead relies on an “implied lexicography” theory as to why we should construe the phrase as Patent Owner proposes. PO Sur-reply 2, 6–7 (citing, inter alia, AstraZeneca AB v. Mut. Pharm. Co., Inc., 384 F.3d 1333, 1339 (Fed. Cir. 2004)). We disagree.” slip op. at 27
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We disagree with Patent Owner’s arguments—that Petitioner fails to show any motivation to combine and that Sullivan460 is not enabled— merely because Dr. Kirkness indicated in a deposition that he did not know how a preset level is calculated from a sentence in Sullivan460. As Petitioner explains, enablement “is not a requirement to prove invalidity under §103.” Amgen, 314 F.3d at 1357 (under §103, “a reference need not be enabled; it qualifies as a prior art, regardless, for whatever is disclosed therein”). Moreover, we agree with Petitioner that the Challenged Claims do not require any preset level for a flow rate, and a person of ordinary skill “would have understood that a preset level is established from previously-acquired data or data from a previous window of time, such as an average level, for example, as taught in Sullivan995.” Pet. Reply 15 (citing Ex. 2014, 38:2–16; Ex. 1005, 17:3–27, Fig. 12). Patent Owner responds that Petitioner’s assertion is unsupported, and that “Petitioner is obligated to address this challenge, and failed to do so.” PO Sur-reply 18–19 (citing In re Morsa, 713 F.3d 104, 110 (Fed. Cir. 2013)). We find Petitioner’s arguments persuasive because they are supported by the asserted references. Sullivan995 discloses that the computing system may “calculate control values of patterns for each patient based on moving average values or such values or patterns will be pre-programmed into the computing system.” Ex. 1005, 17:14–18. According to Sullivan995, when “signals deviate from predetermined values or patterns the computer system generates a signal which is sent to the feedback speed controller on the blower motor.” Id. at 17:19–22. Based on this disclosure, and given that Sullivan460 incorporates Sullivan995 by reference, we agree with Petitioner that Sullivan460’s disclosure of detecting that the flow rate has fallen below a preset level would have informed a person of ordinary skill that this level was predetermined, so that “the controller 100 activates the nCPAP apparatus 90 to supply air to the patient 30 at a pressure which ameliorates or eliminates the upper airway flow limitation.”16 Ex. 1006, 10:17–21.” slip op. at 50
Patent outcomesUS 9,427,539 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,427,539 - Resmed, Inc. v. New York UniversityAll claims unpatentablePTAB · Dec 4, 2023 · IPR2022-00988 · APJ James A Tartal · IPR · Final written decision
The Board held claims 1–30 unpatentable by a preponderance of the evidence, based on the asserted obviousness grounds.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“ORDER21 Upon consideration of the record before us, it is: ORDERED that Patent Owner’s Motion to Exclude (Paper 45) is denied; FURTHER ORDERED that Petitioner’s Motion to Exclude (Paper 46) is denied;” slip op. at 82
- Skill levelOther
“B. Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“1. “troubled wakefulness” Dependent claims 12 and 22 each recite, “wherein the awake state is a” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“not implicitly define the phrase “analyzes the data to determine the patient’s breathing patterns,” as proposed, because Patent Owner has failed to show any sufficient evidence that the ’009 patent clearly expresses an intent to redefine the phrase or define the phrase in terms other than its plain and ordinary meaning. In other words, implied lexicography does not apply here. Accordingly, after reviewing Patent Owner’s contentions in light of all the evidence of record, we do not adopt Patent Owner’s proposed construction; instead, we apply the plain and ordinary meaning of “analyzes the data to determine the patient’s breathing patterns” in our consideration of the issues before us.” slip op. at 32
Patent outcomesUS 9,108,009 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,108,009 - PTAB · Nov 17, 2023 · IPR2023-00884 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR of claims 1–30 on every asserted ground, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the preliminary record, we conclude Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’572 patent is unpatentable under the presented grounds. Therefore, we grant institution of inter partes review. We note that there are disputed issues in this proceeding under 35 U.S.C. § 325(d) and § 314(a) concerning discretionary denial; however, we determine institution should be not be denied. See Pet. 63–68; Prelim. Resp. 49–62. Our reasoning is discussed below.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits.” slip op. at 67
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“We agree with Petitioner that the Examiner committed error in failing to make any rejections over the references asserted here. As noted above, certain of Petitioner’s grounds for unpatentability present compelling merits and had the Examiner correctly evaluated the asserted references, a rejection under § 102 or § 103 would have been made. Accordingly, we determine that Petitioner demonstrates that the Office erred in a manner material to the patentability of the challenged claims. 3. Summary For the reasons discussed above, we decline to exercise our discretion under § 325(d) to deny the Petition.” slip op. at 77
Discretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,253,572 - Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Sep 1, 2023 · IPR2023-00620 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution because claims 1–4 had been statutorily disclaimed.
RulingsInstitution decision- Adverse judgmentAdverse judgmentDenied
“Under 37 C.F.R. § 42.107(e), “patent owner may file a statutory disclaimer under 35 U.S.C. 253(a) in compliance with § 1.321(a) of this chapter, disclaiming one or more claims in the patent” and “[n]o inter partes review will be instituted based on disclaimed claims.” A disclaimer under 35 U.S.C. § 253(a) is “considered as part of the original patent” as of the date on which it is “recorded” in the Office. 35 U.S.C. § 253(a). For a disclaimer to be “recorded” in the Office, the document filed by the Patent Owner must:” slip op. at 2
NonePatents in suitUS 10,406,226 - Osteomed LLC v. Stryker European Operations Holdings LLCAll claims unpatentablePTAB · Aug 8, 2023 · IPR2022-00488 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–3 and 6–18 are unpatentable as obvious over Arnould and Zahiri, with claim 6 also relying on Myerson; the Board did not reach Grounds 1–3.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“While both parties’ descriptions are similar, we find that Patent Owner’s description is better supported by the record. As Patent Owner points out, the main distinction between the parties’ proposals is that Patent Owner’s description is broader because it includes orthopedic surgeons. The record supports the inclusion of such individuals in the description of a POSITA. See Ex. 2005 ¶¶ 37, 41; Ex. 2009, 38:21–39:7 (Petitioner’s declarant testifying that he would “include an orthopedic surgeon that has some experience developing implants as a person of ordinary skill in the art”). Thus, we apply Patent Owner’s description of a POSITA for our analysis.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“That said, we do not agree with Patent Owner that the Specification defines “bone plate” as it contends. In the background of the invention, the Specification states that “[t]he invention relates to the technical field of orthopedic implants. More particularly, the invention relates to a plate for arthrodesis or osteosynthesis adapted to be fixed between two bone parts.” Ex. 1001, 1:27–31. Contrary to Patent Owner’s argument, this passage does not “define” the term “bone plate” nor otherwise suggest that the patentee acted as its own lexicographer. See Resp. 9. Moreover, nothing in the record suggests that the ordinary meaning of “bone plate” requires the plate to be fixed between two bone parts. The medical dictionaries Patent Owner cites do not include such a requirement in their definitions. See Ex. 2012, 1478 (defining “bone plate” as “a metal bar with perforations for the insertion of screws, used to immobilize fractured segments”); Ex. 2013, 241 (defining “bone plate” as “a metal plate used to reconstruct a bone that has been fractured” and “designed to hold the bone fragments in apposition”). Both of these definitions are consistent with Mr. Sherman’s testimony that a bone plate is “not always” placed across the fracture. See Ex. 2009, 52:9–53:1 (identifying particular instances in which a plate is not placed across the fracture). We credit that testimony over the competing testimony of Patent Owner’s declarant, Mr. Leinsing. Ex. 2005 ¶ 34 (referring to the statements from the Specification and dictionary definitions discussed above). For these reasons, we agree with Petitioner that the term “bone plate” as recited in the challenged claims has its ordinary meaning and that meaning does not exclude plates located on only one side of a joint or fracture.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We do not agree that the ordinary meaning of “between” is as restrictive as Patent Owner contends. First, Patent Owner’s definition of “between” does not require an object that is “between” two others to lie along the same axis defined by the two other objects. A “space separating two objects” is not so restrictive. Instead, a more expansive ordinary meaning of “between” is evidenced by the intrinsic evidence of the ’751 patent as Petitioner explained with reference to Figure 2 of the ’751 patent, which shows a third hole 1a1 between the other holes even though it is “offset” and in a different plane from the longitudinal axis of the bone plate. Patent Owner attempts to draw a distinction between Arnould’s Figure 2 and Figure 2 of the ’751 patent, by asserting “like Arnould, a hand is in a different plane and offset and its axis is not in relation to the body. In contrast, the angled tab shown in Figure 2 of the ’751 patent is not in a different plane and offset from the plate, and the hole axis forms an angle with the plate.” Sur-reply 8. Patent Owner’s distinction here appears to be whether the third hole lies at an angle below or above the bone plate as shown in Figure 2 of the ’751 patent (which would be “between” according to Patent Owner) versus also being positioned to either side of the bone plate as shown in Figure 2 of Arnould (which in Patent Owner’s view would mean that hole is no longer “between” the others). We see no basis for drawing such a fine distinction regarding the meaning of “between,” especially when the narrower definition Patent Owner seeks is not made explicit in the Specification of the ’751 patent. To the extent any further claim construction is necessary to resolve” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“contends. A reference is considered to be analogous art if it is in the “same field of endeavor” as the patent at issue. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Here, the Specification states that “[t]he invention relates to the technical field of orthopedic implants.” Ex. 1001, 1:27–28. Zahiri falls squarely within this field, describing “fixation devices for compressing bone fractures of a human being.” Ex. 1007, 1:9–11; see also, e.g., id. at Fig. 1 (depicting the use of Zahiri’s plate as an orthopedic implant to fix two bone parts). The differences Patent Owner identifies in Zahiri’s device do not show otherwise. In this regard, we find the testimony of Mr. Sherman (Ex. 1002 ¶ 245) on this point to be more credible than the competing testimony offered by Mr. Leinsing (see Ex. 2005 ¶¶ 121–29, 238). Mr. Sherman persuasively testifies that “Arnould and Zahiri disclose bone plates with diagonal fixation members configured to compress the intersection of a first and second bone,” demonstrating Arnould and Zahiri “are therefore in analogous fields of invention” to the ’751 patent. Ex. 1002 ¶ 245. Mr. Leinsing, on the other hand, continues to assert that Zahiri discloses only “a guide that directs a lag screw at a precise angle into a humeral head, not a bone plate” because it is located on only one side of the joint or fracture. Ex. 2005 ¶ 238. Therefore, Mr. Leinsing concludes that the “Zahiri device is directed to a completely different function than Arnould,” and is non-analogous art. Id. Because we find Zahiri discloses a “bone plate” according to the ordinary meaning of that term, Mr. Leinsing’s testimony is unconvincing. See supra § III.C.i (explaining that the ordinary meaning of “bone plate” does not exclude plates located on only one side of a joint or fracture). But even if we agreed with Patent Owner’s and Mr. Leinsing’s interpretation of bone plate, Zahiri’s plate is still an orthopedic implant and therefore analogous art because it is within the same field of endeavor as the ’751 patent.” slip op. at 34
Patent outcomesUS 10,993,751 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,993,751 - Syngenta Crop Protection AG v. Upl Ltd.InstitutedPTAB · Jul 31, 2023 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Institution
Instituted PGR on claims 1–10 and all asserted grounds because the Board found it more likely than not that Tobler anticipates and renders obvious at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We review the Petition under 35 U.S.C. § 324, which provides that a post-grant review may not be instituted unless “it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 324(a). Accordingly, we institute a post-grant review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PTAB Consolidated Trial Practice Guide (“Practice Guide”),1 5–6 (Nov. 2019).” slip op. at 2
- Other 314aInstitution denied discretionary otherDenied
“We disagree. It is unclear which aspect of the Petition that Patent Owner takes issue with. If it is the “multitudinous grounds” presented in the Petition, Patent Owner points to no authority that permits us to deny institution merely because a petition presents numerous grounds. In any event, on the facts of this case, we do not view eight grounds asserted in the Petition to be excessive.6 To the extent Patent Owner urges that we should deny institution because Petitioner’s grounds are “futil[e],” we understand that to be an argument on the merits, and not related to our discretion. See Prelim. 6 The Petition presents five grounds. See generally Pet. We agree with Patent Owner, however, the ground based on Tobler, in fact, encompasses three grounds, and the ground based on De Oliveira, in fact, encompasses two grounds. See Prelim. Resp. 2. Resp. 45. As explained below, we find Petitioner has established that it is more likely than not that claims 1–10 of the ’727 patent are unpatentable over Tobler. See infra Section II.D.2. Because the grounds based on Tobler apply to all challenged claims,7 at least these grounds are not, as Patent Owner asserts, futile. Thus, we decline to exercise discretion to deny the Petition under § 324(a).” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, we “may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. 7 The cases Patent Owner cites do not support its argument on discretionary denial under § 324(a). See Prelim. Resp. 45–46. In those cases, the Board exercised discretion to deny institution because the petitions only met the threshold requirement for institution with regard to a small percentage of the challenged claims. See Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 11 (PTAB Nov. 7, 2018) (stating “instituting a trial with respect to all twenty claims based on evidence and arguments directed to dependent claims 3 and 4 is not an efficient use of the Board’s time and resources”); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 2 (PTAB Jan. 24, 2019) (denying institution because the petitioner only “demonstrated a reasonable likelihood of prevailing with respect to only two of twenty-three challenged claims as to only one of four asserted grounds of unpatentability”). MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). The parties agree that, during prosecution, the relevant disclosure in Tobler was before the Examiner in U.S. Patent Application Publication 2010/0216640, which was cited in an Information Disclosure Statement (“IDS”). Pet. 12; Prelim. Resp. 46. In other words, the first prong of the Advanced Bionics analysis is satisfied. Thus, we must determine whether Petitioner has shown a material error by the Office. We find Petitioner has met its burden on this issue.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, all claim terms should be given their plain and ordinary meaning. Pet. 18; Prelim. Resp. 13. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,445,727 - PTAB · Jul 19, 2023 · IPR2023-00442 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is obvious over Dixon, CATT, MACTEL, and PIER.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any 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.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’681 patent. We therefore institute inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“deny a Petitioner successive attacks on the claims of a single patent, and profiting from those prior attempts by altering a petition’s strategy in response to Patent Owner’s and the Board’s responses. General Plastic, Paper 19 at 9–10. Patent Owner is quite correct, however, that, under Valve Corp., we can consider the relationship between different parties bringing successive challenges to a given patent. Valve Corp., Paper 11, at 2, 9. However, the facts of the present Petition render this present situation readily distinguishable from the facts in Valve Corp. In Valve Corp., we found that the parties bringing successive challenges to the patent-in-suit were “named as co-defendants in that lawsuit and were accused of infringing the ’934 patent based on [co-defendant] HTC’s VIVE devices that incorporate Valve’s technology.” Valve Corp., Paper 11, at 9–10. Furthermore, in that litigation, Valve represented that “HTC’s VIVE devices incorporate certain Valve technologies under a technology license from Valve,” and that “Valve employees did provide HTC with technical assistance during the development of the accused VIVE devices.” Id. at 10. The Board consequently concluded that “there is a significant relationship between Valve and HTC with respect to Patent Owner’s assertion of the ’934 patent. The complete overlap in the challenged claims and the significant relationship between Valve and HTC favor denying institution.” Id. No such facts obtain in the present instance. Petitioner is not a co- defendant with Mylan in the district court infringement action, Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 1:22-cv-00061-TSK (N.D.W. Va.).11 There is no credible evidence of record that Petitioner and Mylan, potential business competitors, have developed any significant relationship, as in Valve Corp. Petitioner has joined the -01226 inter partes review as a “silent” slip op. at 44
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“skill in the art would have been motivated to adopt the exclusion criteria when administering aflibercept via intravitreal injection to minimize the risks of intravitreal infection and complications such as endophthalmitis and that adoption of these criteria reflected basic safety precautions developed to address the risks associated with intravitreal injections generally, regardless of the specific anti-VEGF agent injected. See Pet. 48–52. Petitioner has shown sufficient support on the record before us for such a view. Patent Owner also argues that Petitioner: (1) has not shown motivation to modify the exclusion criteria of PIER by adding the third exclusion criterion; and (2) has not shown motivation to modify the exclusion criteria of CATT and/or MACTEL. We disagree. We have explained above why we conclude that a person of ordinary skill in the art would have found exclusion criterion three to be obvious over not CATT and MACTEL individually and together. See KSR, 550 U.S. at 416. Moreover, Petitioner has, as we have also explained, asserted a persuasive reason why a skilled artisan would have been motivated to adopt the teachings of MACTEL and CATT to reduce the risk of intravitreal infection subsequent to injection of a VEGF receptor antagonist, such as aflibercept. Furthermore, Petitioner has persuasively argued that a person of ordinary skill in the art would also have had a reasonable expectation of success in adopting the exclusion criteria to the studies disclosed by Dixon, viz., that a person of ordinary skill in the art would therefore have reasonably expected that the exclusion criteria developed for prior art VEGF receptor antagonists could be successfully applied to aflibercept. Pet. 53 (citing Ex. 1002 ¶¶ 156–158).” slip op. at 39
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disagrees with Petitioner’s definition of a person of ordinary skill in the art, arguing that the skilled artisan is an ophthalmologist experienced in treating angiogenic eye disorders, including with VEGF antagonists. Prelim. Resp. 11. Patent Owner acknowledges, however, that the parties’ differing definitions of a person of ordinary skill in the art do not affect any argument presented with respect to our present Decision to Institute. Id. As we explain below, with the exception of the exclusion criteria, claim 1 of the ’681 patent is identical to claim 1 of the ’388 patent in the -00881 IPR. We again determine that our definition of a person of ordinary skill in the art is reasonable and consistent with the prior art of record at this stage of the proceeding. For the purposes of this decision, and for the sake of consistency, we adopt our prior definition, quoted above, as the definition of a person of ordinary skill in the art.” slip op. at 10
§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,130,681 - Eyenovia, Inc. v. Sydnexis, Inc.All claims unpatentablePTAB · Jul 13, 2023 · IPR2022-00384 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1, 2, 4–9, and 12–19 are unpatentable under § 103 over Chia, Akorn, and Kondritzer; the Board did not reach the other grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not agree with Patent Owner that the level of ordinary skill in the art should be limited to experience with ophthalmic formulation. The claims at issue generally require a liquid ophthalmic formulation of a small amount of atropine that is stabilized using buffers that can be stored for at least two weeks under certain temperature and humidity conditions. See Ex. 1001, 97:32–44 (claim 1). As Dr. Byrn points out, the technology surrounding use of atropine, a nonselective muscarinic antagonist, to treat myopia, has been extensively studied for over a hundred years and is known as “the oldest and most effective pharmacological treatment to inhibit the development of myopia.” See Ex. 1002 ¶ 26 (quoting Ex. 1008, 1) (citing Ex. 1003, 1; Ex. 1012, 2). The degradation of atropine is also well known to primarily result from cleavage of the acyl-oxygen bond during ester hydrolysis, see id. ¶ 43 (citing Ex. 1017, 1; Ex. 1024, 5), with the rate of acid-catalyzed reaction being much slower than that of the base-catalyzed reaction, leading to stability of atropine at a lower pH range (pH < ~3), see id. ¶ 45 (citing Ex. 1005, 1,4–5). Concerning specifically the use of atropine in the eye, Dr. Byrn points out that it is well known that ophthalmic solutions should be “formulated to be sterile, isotonic and buffered for stability and comfort.” See id. ¶ 47 (quoting Ex. 1019, 52) (noting Ex. 1019, 54 (pH of tear fluid is 7.4).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner states that “[f]or the purposes of this proceeding only, Petitioner does not believe that any claim terms need to be construed.” Pet. 22. Patent Owner “agrees that the claims should be understood according to their ordinary and customary meaning.” PO Resp. 25–26. In reply, Petitioner asserts that the ordinary meaning of “about” is” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find that Patent Owner’s criticism misses the mark. Petitioner is using the DailyMed exhibit as further evidence that Akorn was publicly available as of the revision date of 7/2014 as shown on Akorn, Ex. 1004. See Reply 1 (“As set forth in the Petition, EX1004, a drug label to Akorn, bears July 2014 revision dates that comport with its FDA approval and publication well before the critical date. See Pet., 9; Hulu, 13. It also bears Akorn’s corporate insignia. EX1004, 5. Additional evidence confirms these dates are reliable. EX1056-58.”); 3 (“Public records from DailyMed, part of the NIH’s National Library of Medicine, show that EX1004 was posted publicly on July 24, 2014.”). Whether a POSA could have searched this way for labels published before the critical date is irrelevant; Petitioner is only using the evidence to show that Akorn was, in fact, published in July 2014, before the critical date on a searchable website. See id. Patent Owner does not dispute that DailyMed was searchable by drug name, which would be the logical way a POSA would search such a database for information for a drug of interest.” slip op. at 24
- ExcludeMotion to exclude, deniedDenied
“sufficiency of the support for Dr. Byrn’s opinions goes more to the weight to be accorded such opinions rather than a need to exclude such opinions. See TPG 40–41, 79 (“A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay) but may not be used to challenge the sufficiency of the evidence to prove a particular fact.”). We also note that the findings in the district court litigation are based on a different record that is not before us here. For instance, the district court relies on a Lewis reference and a Harris reference that is not before us and testimony from Dr. Richard Moreton that is also not before us here. See Ex. 2010 ¶¶ 63–69. Therefore, we determine that the district court’s findings are not sufficiently probative of the questions before us here.” slip op. at 31
Patent outcomesUS 10,842,787 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,842,787
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.