- PTAB · Mar 22, 2023 · IPR2023-00533 · APJ John G New · IPR · Institution
The Board instituted inter partes review of claims 1–9, 34–39, 41–43, and 45 on the seven grounds instituted in the Mylan IPR, and granted Celltrion’s motion for joinder.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Celltrion Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Having considered the unopposed motion for joinder, and our decision to institute the same grounds in the Mylan IPR, we determine that Petitioner Celltrion has established persuasively that joinder is appropriate and will have little to no impact on the timing, cost, or presentation of the trial on the instituted ground. Thus, in consideration of the foregoing, and in the manner set forth in the following Order, the Motion for Joinder is GRANTED.” slip op. at 6
NonePatents in suitUS 10,888,601 - PTAB · Mar 22, 2023 · IPR2023-00532 · APJ John G New · IPR · Institution
The Board instituted review of claims 1, 3–11, 13, 14, 16–24, and 26 on six anticipation and obviousness grounds, and granted Celltrion’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Celltrion Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“(c) JOINDER. — If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: Set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB” slip op. at 5
NonePatents in suitUS 10,130,681 - PTAB · Feb 10, 2023 · IPR2022-01440 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1–19 based on all asserted grounds, finding a reasonable likelihood that the petitioner would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a). Upon considering the parties’ arguments and evidence, we determine that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–19 of the ’133 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) would have had: a Masters or a Ph.D. degree in nutritional science, chemistry, biology, biochemistry, or a related discipline or an M.D. or doctor of optometry (“O.D.”), and a few years of practical experience in the nutritional supplement area, including an understanding of formulations that could be considered for promoting eye health, including preventing or treating eye disorders such as macular degeneration. Alternatively, such a person could have been a person with a Bachelor’s degree with a greater number of years of experience. The POSITA would have, or would have access to, general information regarding eye health and eye disorders, the convenience and needs of patients who suffer from eye disorders[,] such as macular 5 Lang, WO 01/19383 A1, published Mar. 22, 2001 (Ex. 1009, “Lang”). 6 Brown et al., Nutrition Supplements and the Eye, 12 EYE 127–33 (1998) (Ex. 1014, “Brown”). degeneration, and background information. To the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’133 Patent. Pet. 8–9 (citing Ex. 1024 ¶¶ 15–16) (citations omitted). This definition by Petitioner is uncontested on the current record. See Prelim. Resp. 7–8. Because we find Petitioner’s definition to be reasonable and consistent with the ’133 patent and the cited art, we adopt it for purposes of this Decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “substantially free of meso-zeaxanthin stereoisomers” Independent claims 1, 14, and 19 recite that the zeaxanthin is “present in the 3R-3R' stereoisomer form and is substantially free of meso-zeaxanthin stereoisomers.” Claims 1, 14, 19 (emphasis added). Petitioner contend that the term “substantially free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a POSA would have understood the term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 25– 26 (emphasis removed) (citing Ex. 1024 ¶ 70; Ex. 1031, 3). The Board adopted, preliminarily, this construction by Petitioner in the Institution Decisions in the -0089 IPR and -1029 IPR. -0089 IPR, Paper 7 at 9–10; -1029 IPR, Paper 6 at 8–9. At this stage of the proceeding, we adopt Petitioner’s proposed construction as consistent with the plain and ordinary meaning of the term and the prior decisions in the -0089 IPR and -1029 IPR.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We begin by noting that the challenged claims do not recite that the nutritional supplements are “free of Vitamin A” or “free of all sources of Vitamin A.” Rather, independent claim 1 expressly recites that the supplement is “free of beta-carotene.” See Claim 1. Patent Owner urges us to expand the exclusion of beta-carotene to all forms of Vitamin A. That argument, however, lacks support on the current record. In particular, the support asserted by Patent Owner and its expert, Dr. Dorey, that “nutritional supplements include beta-carotene as Vitamin A equivalent,” see Prelim. Resp. 9–10 (citing Ex. 2001 ¶ 19), establishes little, on its own. Barker does not require the use of beta-carotene as its source of Vitamin A, nor does it limit the source or form of Vitamin A used. Rather, Barker discloses that several “[e]xamples of compounds having vitamin Aactivity or precursors thereof are retinol and esters thereof, such as retinyl palmitate; α- and β-carotene, β-cryptoxanthin, and lycopene.” Ex. 1011, 2:11–13. Thus, Barker discloses a number of exemplary compounds to supply Vitamin A to its nutritional supplement that are not beta-carotene. Accordingly, based on the current record, we disagree with Patent Owner’s argument that the challenged claims exclude all forms of Vitamin A and that Barker, therefore fails to anticipate those claims. Having considered the arguments and evidence at this stage in the proceeding, we are persuaded that Petitioner has shown sufficiently for institution that Barker discloses a nutritional supplement that is “free of beta-carotene.” Therefore, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing in showing that claims 1, 2, 5, and 9–12 are anticipated by Barker.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,173,133 - Apple Inc. v. Masimo CorporationInstitutedPTAB · Feb 1, 2023 · IPR2022-01299 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–30 on all asserted grounds, 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
“For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’127 patent is unpatentable, we institute an inter partes review of all challenged claims on each of the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1 A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not address the above definitions in its Preliminary Response but its expert, Mr. Goldberg, disagrees with Petitioner’s first definition insofar as it requires an academic discipline emphasizing both electrical and thermal technologies. Ex. 2051 ¶ 16. In this respect, Mr. Goldberg states that “he is unaware of such an academic discipline being available, whereas, Petitioner’s expert, Dr. Anthony, appears to assert that he has worked with “many such persons.” Cf. Ex. 2051 ¶ 16 with Ex. 1003 ¶ 21. Mr. Goldberg states that one of ordinary skill in the art would have had a Bachelor of Science degree in an academic discipline emphasizing the design of electrical systems, in combination with training or at least one to two years of related work experience with thermal management of electrical systems and capture and processing of data or information, including physiological monitoring technologies. Alternatively, the person could have had a Master of Science degree in a relevant academic discipline with less than a year of related work experience in the same discipline. Ex. 2051 ¶ 16. Despite providing an alternative definition of one of ordinary skill in the art, Mr. Goldberg indicates that his opinions with respect to the applied. Id. On the current record, we accept Petitioner’s proposed definitions, as” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“At this stage of the proceeding, we find the language “to reliably estimate LED wavelengths” and “used to estimate wavelengths of multiple LEDs” descriptive of intended use of the underlying terms rather than descriptive of what they are. Although Patent Owner points to evidence that certain embodiments of the ’127 patent use “thermal mass” and “bulk temperature” in the manner described in Patent Owner’s proposed constructions, we decline to import these use limitations into the claim terms. See In re Prater, 415 F.2d 1393, 1404–05 (CCPA 1969) Reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from reading limitations of the specification into a claim, to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim. We further note that Patent Owner fails to evidence the meets and bounds of “reliably estimate[ing] LED wavelengths,” such that the construction appears indefinite. In this respect, we note the Specification’s teaching that some embodiments include “a relatively significant thermal mass, which stabilizes and normalizes the bulk temperature so that the thermistor measurement of bulk temperature is meaningful.” Ex. 1001, 10:62–11:4. Considering the intrinsic evidence, we understand a “meaningful” temperature reading in the context of the ’127 patent to be one on a scale relevant to estimating LED wavelengths. aspects of construction upon which the parties appear to agree (see e.g., Prelim. Resp. 24 (citing Ex. 1012, 213)), we provisionally construe “thermal mass” as a mass having resistance to temperature change on a scale relevant to estimating LED wavelengths, and “bulk temperature” as a temperature representative of all or substantially all of a thermal mass.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“With respect to motivation to combine, Petitioner posits that one of ordinary skill in the art would have been motivated “to implement a thermal core as suggested by Chadwick in Yamada’s board/substrate 15” to achieve various benefits, such as to “reduc[e] the amount of heat transmitted to the patient and increasing the ‘exposure time’ by which the patient can don the sensor without discomfort or heat-related safety concerns,” and/or “mitigate heat-induced spectral shifts in the wavelengths of light emitted by LEDs” Pet. 15–18; Ex. 1003 ¶¶ 42–48. With respect to the first of these, Patent Owner argues that motivation is lacking because Chadwick’s metal core heat (citing Ex. Parte Burns, Appeal No. 2016-00351, 2017 WL 2132361, *2 (PTAB Apr. 28, 2017)). This would appear contrary to Patent Owner’s assertions that “Yamada provides no discussion regarding the purpose, function, or use of substrate 15,” whereas the purpose of Chadwick’s metal core is to dissipate heat and act “as a heat sink to cool the electronics.” Prelim. Resp. 35, 37 (citations omitted). As such, we do not find Patent Owner’s argument availing. With respect to Petitioner’s argument that one of ordinary skill in the art would have been motivated to combine Chadwick and Yamada to “mitigate heat-induced spectral shifts in the wavelengths of light emitted by LEDs,” Patent Owner argues that “the claimed invention does not reduce wavelength shift; in fact, the ’127 patent accepts wavelength shift and provides a solution to compensate for it.” Prelim. Resp. 42. Accordingly, Patent Owner asserts, motivation is lacking because “[r]educing wavelength shift points in a different direction from the invention.” Id. at 43 (citing Ex. 2051 ¶ 80. This argument is also unavailing because, on the current record, claim 7 does require a solution to compensate for wavelength shift. See Section II.C.2, above. Accordingly, Petitioner’s proposed motivation does not “point[] in a different direction,” as Patent Owner contends. Patent Owner similarly argues that Petitioner has not shown a reasonable expectation of success because “[t]here is no evidence anyone before the inventors would have expected that a thermal mass could be designed to provide a bulk temperature to reliably estimate multiple LED wavelengths.” Again, Patent Owner’s argument is predicated on Patent Owner’s interpretation of claim 7, which we disagree with on the current record for the reasons provided above. See Section II.C.1–2. We do not read Moreover, as explained more fully above, LED wavelength has a known relationship to temperature and Petitioner has reasonably shown that LEDs of the Yamada/Chadwick combination would be thermally coupled to the thermal core, and thus dependent on the bulk temperature of the thermal core.” slip op. at 28
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 7,761,127 - PTAB · Jan 11, 2023 · IPR2022-01225 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is anticipated by Dixon because the exclusion criteria likely lack patentable weight.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged claim 1 of US 9,254,338 B2 (the “’338 patent”) recited preamble language identical to that recited in claim 1 of the ’681 patent, viz., “a method for treating an angiogenic eye disorder in a patient.” See Ex. 1001 col. 21, ll. 40–41; Ex. 3001, 7. The Board found that this preamble was limiting upon the remainder of the claim. Ex. 3001, 18. Specifically, the Board found that: Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, … in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find, for the purposes of this Decision, that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting upon the claims.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“[W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner’s proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder, but does not require a “high level of efficacy,” as proposed by Patent Owner. See Ex. 3001, 22.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses “secondary doses” are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001 col. 3, ll. 36–44. We do not find persuasive Patent Owner’s argument that the definition of these terms require a high, or otherwise defined, degree of efficacy. As we stated in the -00881 Decision: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.” Ex. 3001, 25 (emphasis added). We see no need or reason to upend this construction now and, for the purposes of this Decision, we adopt Petitioner’s proposed definition of the claim terms “initial dose,” “secondary doses,” and “tertiary doses” as the express definition provided by the ’681 Specification.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“Claim(s) 35 U.S.C. § Reference(s)/Basis Challenged 4 1, 3–11, 13, 14, 103 Dixon alone or in view of 16–24, 26 Papadopoulos5 and/or Wiegand6 5 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Rosenfeld-20067, and if necessary, Papadopoulos patent and/or Wiegand 6 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Heimann-2007, and if necessary, Papadopoulos and/or Wiegand” slip op. at 5
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,130,681 - PTAB · Jan 11, 2023 · IPR2022-01226 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and all petition grounds, finding a reasonable likelihood that claim 34 is anticipated by Dixon.
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 ’601 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“General Plastic, Paper 19 at 9–10. The purpose of the analysis thus established in General Plastic is to 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.” slip op. at 21
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“an Interim Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited December 22, 2022) (the “Interim Procedure”). The Interim Procedure explains that “to benefit the patent system and the public good, the PTAB will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation where a petition presents compelling evidence of unpatentability.” Interim Proc. 2. Specifically, the Interim Procedure states that: Where the information presented at the institution stage is merely sufficient to meet the statutory institution threshold, the PTAB has the authority, where warranted, to exercise discretion to deny institution in view of the other Fintiv factors. In contrast, where the PTAB determines that the information presented at the institution stage presents a compelling unpatentability challenge, that determination alone demonstrates that the PTAB should not discretionarily deny institution under Fintiv.” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following 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 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.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Consequently, we first turn to an analysis of Becton, Dickinson factors (a), (b), and (d) under this framework to determine whether the same or substantially the same art previously was presented to the Office or whether” slip op. at 26
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 10,888,601 - PTAB · Jan 9, 2023 · IPR2022-01224 · APJ Ulrike W Jenks · IPR · Institution
Instituted inter partes review of claims 1–20 on the asserted §103 ground over Votruba, Jaquet, Finn, and Seton; Petitioner showed a reasonable likelihood of prevailing.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“persuaded the circumstances before us warrant discretionary denial of institution. In certain circumstances, the Board has exercised its discretion to deny institution pursuant to § 314(a) based on the advanced state of a district court proceeding in which the challenged patent is asserted. See, Fintiv, IPR2020-00019, Paper 15. Here, even though there is a parallel district court proceeding, “Metrasens will not assert in the above-captioned litigation (1:21-cv-01216) the same invalidity grounds asserted in the IPR, or any other ground that Metrasens reasonably could have raised in the IPR petition, against the corresponding claims.” Ex. 1016; see also Pet. 74. In light of that stipulation, we decline to discretionarily deny institution under Fintiv. See Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation, at 3, 7–8, Memorandum, June 21, 2022.6” slip op. at 7
- Other 314aDenied
“discretion to deny institution based on “egregious behaviors.” Patent Owner’s assertions relate to Petitioner’s submission of Exhibit 1012, “the Mednovus document.”7 See, e.g. Prelim. Resp. 25. However, other than noting that the Mednovus document was submitted to the USPTO, but not made of record during patent prosecution (Pet. 7), the Petition does not rely on the Mednovus document. Petitioner’s declarant, Dr. van der Weide, cites to the Mednovus document twice. See Ex. 1003 ¶¶ 27, 29. Petitioner’s declarant cites the document for positioning the doorway of an MRI room based on the magnetic plot line of the device and the existence of a fringe magnetic field associated with an MRI machine. See Ex. 1003 ¶¶ 27, 29. The Petition, however, relies on Votruba for this limitation and not the Mednovus document. See Pet. 38; Ex. 1006, 7:33–35 (the machine 7 Exhibit 1012, Titled “Third Party Mednovus’ First Emergency Protest Under 37 CFR 1.91 Against Kopp Pending U.S. Application Serial No. 10/095,543,” submitted on Feb. 8, 2009, but not entered into the record during patent prosecution. “generates significant, wide-ranging ‘fringe’ fields extending to considerable distances from the machine”). Because the Petition does not rely on the Mednovus document in any ground, its existence does not affect our decision, and we need not consider whether it constitutes a printed publication. Under the circumstances here, we do not view Petitioner’s challenge to the ’128 patent as contrary to the AIA’s purposes. “The AIA was designed to encourage the filing of meritorious patentability challenges, by any person who is not the patent owner, in an effort to further improve patent quality.” Coalition for Affordable Drugs VI, LLC v. Celgene Corp., IPR2015-01092, Paper 19 at 4 (PTAB Sept. 25, 2015). For these reasons, we decline to exercise our discretion to deny institution under 35 U.S.C. § 314(a).” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the Petition and Preliminary Response, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–20 of the ’128 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“On this record, we adopt Petitioner’s first definition, because it encompasses Petitioner’s alternate definition of the level of skill in the art. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 10
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 7,489,128 - Apple, Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Dec 6, 2022 · IPR2021-00972 · APJ David Cotta · IPR · Final written decision
Claims 1–23 are unpatentable as obvious: claims 1, 5, 7–9, 11, 12, 16, 18–20, 22, and 23 over Shmueli and Osorio; remaining claims over combinations adding Lee-2013 or Chan.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Patent Owner argues that we should reject our originally proposed definition in light of, for example, Petitioner’s proposed definition before the ITC, which required an engineering background and “at least two years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals.” PO Resp. 27 (citing Ex. 2004, 6). As noted at oral argument, however, Patent Owner truncates the full extent of Petitioner’s ITC definition, which further states that “a hypothetical person of ordinary skill in the art could also be a person with a medical degree (MD or DO) and with at least two years of work experience using biomedical sensors and/or analyzing their data (in the context of industry, in biomedical academic research, or in practice treating patients).” Ex. 2004, 6; Tr. 40:13– 41:10. Patent Owner’s assertion that our originally proposed definition, would “classify all cardiologists as [persons of ordinary skill in the art],” is well taken. PO Resp. 25. Accordingly, we apply the following modified definition, which is consistent with Petitioner’s representation before the ITC. For the purpose of this proceeding, a person of ordinary skill in the art may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.” slip op. at 24
- Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed
“Dr. Efimov has extensive experience in the design of cardiac monitoring and related technologies, but Petitioner asserts that he “is unable to offer credible testimony on the meaning of [relevant] medical terminology,” because he is not a doctor. Reply 28; Sur-reply 22 (arguing that “Dr. Efimov is a recognized expert in the field of clinical cardiac electrophysiology”). Considering the totality of Dr. Efimov’s background, including extensive work on the physiology, diagnostics, and therapy of cardiac arrhythmias, we do not adopt Petitioner’s position. See, e.g., Ex. 2001 ¶¶ 2–15. In light of the above, we determine that Dr. Chaitman and Dr. Efimov are both qualified to testify as to the understanding of a person of ordinary skill in the art, we, nevertheless, consider the weight of both parties’ experts on a particular topic in light of the strengths and weaknesses of their respective background. C. Claim Construction” slip op. at 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner offers a construction for the claim term “discordance,” proposing that it should be construed to mean “when a first sensed parameter value would not be expected to coincide with a second sensed parameter value.” Pet. 8–10. Patent Owner does not propose a competing construction and, in the ITC Investigation, proposed “[n]o construction required” for the term “discordance.” Ex. 2009, 4. Having reviewed the evidence and argument of record, we determine that we do not need to construe the term “discordance” in order to resolve this dispute. See Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Patent Owner’s proposed construction is consistent with the intrinsic and extrinsic evidence. See e.g., Ex. 1047 (medical dictionary defining arrhythmias as “[a]n abnormal rate or rhythm of the heartbeat” caused by “a disturbance in the electrical impulses within the heart”); Ex. 1001, 4:4 (“Heart function is also measured in terms of regularity of rhythm. . . . When there is an abnormality of rhythm, the condition is typically referred to as an arrhythmia.”). Although it is not clear that the term is in dispute, for clarity, we understand the term “arrhythmia” as used in the context of the ’941 patent to mean: a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachycardia) or slower (bradycardia) than normal.” slip op. at 28
Patent outcomesUS 10,638,941 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,638,941 - PTAB · Nov 17, 2022 · IPR2022-01029 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–20 on all asserted grounds, 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
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–20 of the ’431 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Person of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art at the time of the invention would have had: a Masters or a Ph.D. degree in nutritional science, chemistry, biology, biochemistry, or a related discipline or an M.D. or doctor of optometry (“O.D.”), and a few years of practical experience in the nutritional supplement area, including an understanding of formulations that could be considered for promoting eye health, including preventing or treating eye disorders such as macular degeneration. Alternatively, such a person could have been a person with a Bachelor’s degree with a greater number of years of experience. The POSITA would have, or would have access to, general information regarding eye health and eye disorders, the convenience and needs of patients who suffer from eye disorders, such as macular degeneration, and background information. And to the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’431 Patent. Pet. 8–9 (citing Ex. 1024 ¶ 16) (citations omitted). We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner
“1. “substantially free of meso-zeaxanthin stereoisomers” Petitioner contends the term “substantially free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would have understood this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 20–22 (citing Ex. 1024 ¶ 62; Ex. 1031, 3). The Board adopted this construction in the -089 IPR. -089 IPR, Paper 7 at 9–10. 2. “mixed tocopherols” Petitioner contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and deltatocopherols.” Pet. 23–24 (citing Ex. 1024 ¶ 69). The Board adopted this construction in the -089 IPR. -089 IPR, Paper 7 at 10. 3. Conclusion At this stage of the proceeding, we adopt Petitioner’s proposed constructions as consistent with the plain and ordinary meaning of the terms Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,045,431 - Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00925 · APJ Julia Heaney · IPR · Final written decision
Claims 1, 3, 7–10, 14–16, 19, and 20 are unpatentable as obvious over Stafford and Manno, and Stafford, Manno, and Schuettrumpf.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. Dec. Inst. 22; see Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include (1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of this coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Accordingly, Patent Owner has failed to show that it is entitled to a presumption of a nexus between the objective evidence and the claimed invention. Patent Owner argues that it “need not rely on such presumption [of nexus]” under the Polaris and Fox Factory analysis. PO Resp. 67. Although Patent Owner does not fully explain its position, we note that Fox Factory provides, “[a] finding that a presumption of nexus is inappropriate does not end the inquiry into secondary considerations”; rather, “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.’” Fox Factory, 994 F.3d at 1374 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Here, we find that Patent Owner presents insufficient evidence to establish a nexus by this alternative route. Patent Owner does not present argument as to the “unique characteristics” of the claimed invention, or provide evidence to support such an analysis. See PO Resp. 66–67; PO Sur-reply 26–28. In addition, as discussed above, Patent Owner’s evidence is broadly directed to FIX- R338L, which was in the prior art and does not suggest non-obviousness of the claimed invention as a whole. In summary, Patent Owner does not meet its burden to show a presumption of nexus or show a nexus to the alleged long-felt need for an effective gene therapy for hemophilia B, industry praise, and unexpectedly superior efficacy of AAV-FIX-R338L. Weighing the evidence and arguments presented, we determine that even if there is some nexus, it is weak. See Merck & Cie, 808 F.3d at 837 (Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.”). The failure to show a nexus is fatal to Patent Owner’s contentions regarding objective indicia.” slip op. at 26
- Expert testimonyPatent owner expert discountedDecided for petitioner
“We also find Dr. Pedersen’s opinion with regard to a leucine substitution in FIX-R338 more credible than Dr. Spiegel’s, who states “there is no such thing as ‘conservative amino acid substitutions’ in the sense Dr. Pedersen asserts.” Ex. 2101 ¶ 72. The ’248 patent itself refers to “conservative amino acid substitutions” and states “[i]t is expected that substitutions between these homologous amino acids [including alanine and leucine] would not change the phenotype of the proteins.” Ex. 1001, 4:48– 61. Although Dr. Spiegel notes that substitution is context dependent and “the specification recognizes ... various properties of each unique amino acid all contribute to the amino acid’s interactions” (Ex. 2101 ¶ 75, citing Ex. 1001, 4:48–61; Ex. 1002, 4:45–58; Ex. 1039, 51), his opinions do not account for the knowledge of a person of ordinary skill in the art as to the properties of alanine and leucine and the structure of FIX. See Ex. 1101 ¶¶ 36–39. Further, Dr. Spiegel’s surface-exposure opinion (see, e.g., Ex. 2101 ¶ 99) is undercut by Stafford’s teaching that the 330–338 region of wild-type FIX contains two solvent-exposed leucines. Ex. 1101 ¶ 41 (citing Ex. 1004, 34). Dr. Spiegel’s opinion that a leucine substitution would reduce solubility or increase susceptibility to aggregation also lacks credibility because it is based on the protein hemoglobin S, and not on a modification to FIX positions 330–338. Ex. 2101 ¶ 62; Ex. 1103, 78:15–18; see Ex. 1101 ¶ 60. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art would have had serious concerns whether R338L would be expressed, based on Stafford. As discussed above, Stafford discloses successful expression of R338A in vitro, and as Dr. Wang explains, the understanding of a person of ordinary skill of similarities between R338A and R338L would have supported the understanding that R338L would express at a similar level to R338A, given Stafford’s disclosure that only R338P showed reduced expression, and unlike leucine, “proline is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113– 116. Stafford’s disclosure that mutations at 330–337 cause severe hemophilia due to loss of FIX activity (Ex. 1004, 19:16–20) does not support Patent Owner’s argument, because Patent Owner’s experts do not persuasively explain why the risk of severe hemophilia from single amino acid substitutions at positions 330–337 would be predictive of a similar risk at position 338. See Ex. 1100 ¶¶ 115–119; Ex. 1101 ¶¶ 48–51. As such, we agree with Dr. Wang that a person of ordinary skill in the art would not have expected difficulties in expression of R338L.” slip op. at 38
Patent outcomesUS 9,982,248 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,982,248
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.