- Restem, LLC. v. Jadi Cell, LLCNo claims unpatentablePTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64
Patent outcomesUS 9,803,176 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,803,176 - PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision
The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20
- 112 supportMotion to amend, deniedDenied
“In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26
§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,596,190 - Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentablePTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29
- ExcludeMotion to exclude, deniedDenied
“As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“For the above reasons, on the full trial record we determine that” slip op. at 26
Patent outcomesUS 10,682,414 mixed§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,682,414 - Apple Inc. v. Masimo CorporationInstitution deniedPTAB · Feb 1, 2023 · IPR2022-01300 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–30, exercising § 314(a) discretion because Apple did not justify filing a second petition challenging the same claims.
RulingsInstitution decision- Parallel petitionsInstitution denied discretionary otherDenied
“’1299 Petition before the present Petition. Notice 2. Petitioner argues that both Petitions are warranted “[d]ue to word count constraints.” Id. at 5. In support of its position, Petitioner argues that the asserted grounds “are nonredundant at least in their reliance on different combinations of references that demonstrate the obviousness of the Challenged Claims in materially different ways.” Id. at 27. Petitioner contends, for example, that whereas the present Petition relies on Dietiker as its “primary reference,” the ’1299 Petition relies on Yamada. Notice, 2–3. To the extent this is true, we note that the present Petition also relies on Yamada, as well as the Leibowitz and Noguchi references asserted in the ’1299 Petition, thus, indicating a substantial degree of overlap between the two petitions. Moreover, in the Notice’s sole statement attempting to distinguish between the two “primary” references, Yamada and Dietiker, Petitioner asserts that “the Dietiker combinations describe active temperature regulation for LEDs in an oximetry instrument.” Id. at 3 (citing Ex. 1010 ¶¶ 24–25). At the high level of generality offered in the Notice, we see little difference between this description of Dietiker, and the ’1299 Petition’s description of Noguchi as “controlling the emission spectrum of an LED with high precision,” by “enabl[ing] the device to compensate for temperature-induced shifts in the wavelengths of light emitted by an LED.” See ’1299 Petition, 50–53. We further note that despite Petitioner’s designation of Dietiker as a primary reference, each ground in the present” slip op. at 9
Discretionary denialPatents in suitUS 7,761,127 - 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 - Apple Inc. v. Masimo CorporationInstitution deniedPTAB · Jan 24, 2023 · IPR2022-01273 · APJ Josiah C Cocks · IPR · Institution
Institution was denied for claims 1–30 because Apple did not show a reasonable likelihood of prevailing on either proposed obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“Based on the record here, we conclude that Petitioner has not shown a reasonable likelihood of success based on any of the proposed grounds that involve the combined teachings of Mendelson-799, Aizawa, Ohsaki, and Scharf.12” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends the following in connection with a person of ordinary skill in the art: A person of ordinary skill in the art relating to the subject matter of the ’502 Patent as of July 3, 2008 (“POSITA”) would have been a person with a working knowledge of physiological monitoring technologies. The person would have had a Bachelor of Science degree in an academic discipline emphasizing the design of electrical, computer, or software technologies, in combination with training or at least one to two years of related work experience with capture and processing of data or information, including but not limited to physiological monitoring technologies. Alternatively, the person could have also had a Master of Science degree in a relevant academic discipline with less than a year of related work experience in the same discipline. Pet. 4 (citing Ex. 1003 ¶¶ 22–23). Resp. 10. For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the prior art and the ’502 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“35 U.S.C. § 282(b) “including construing the claim 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.” 37 C.F.R. § 42.100(b). When applying that standard, we interpret the claim language as it would have been understood by one of ordinary skill in the art in light of the specification. Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1279–80 (Fed. Cir. 2017). Thus, we give claim terms their ordinary and customary meaning as understood by an ordinarily skilled artisan. See Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Only terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017). Neither party offers any express construction for any claim term. See Pet. 4; Prelim. Resp. 9. We determine that all claim terms should be given their ordinary and customary meaning and that it is unnecessary to make that meaning explicit for any term.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableMotivation not foundNot shown unpatentable
“Although it is certainly the case that an obviousness analysis may take into account the inferences and creative steps that a skilled artisan might glean from the teachings of the prior art (see, e.g., KSR , 550 U.S. at 418), one must be cognizant that “hindsight is not an available analytical mechanism to show obviousness.” See In re Omeprazole Patent Litig., 483 F.3d 1364, 1381 (Fed. Cir. 2007) (Newman, J., dissenting). Indeed, “we cannot allow hindsight bias to be the thread that stitches together prior art patches into something that is the claimed invention.” See Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1367 (Fed. Cir. 2017). Without the guidance provided by the claims of the ’502 patent, it is difficult to conclude that Petitioner’s postulation as to a particular structure that results from combining the teachings of Mendelson-799, Aizawa, Ohsaki, and Scharf is based on an objective assessment of what those teachings would have conveyed to a skilled artisan. It is clear from the Petition, however, that such structural configuration is necessary as the basis for” slip op. at 18
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,912,502 - 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.Institution deniedPTAB · Nov 15, 2022 · IPR2022-01173 · APJ Jeffrey N Fredman · IPR · Institution
The Board denied institution because AliveCor disclaimed all challenged claims, claims 1–13.
RulingsInstitution decision- Adverse judgmentAdverse judgmentDenied
“37 C.F.R. § 1.321(a); see also Vectra, 162 F.3d at 1382 (holding that a § 253 disclaimer is immediately “recorded” on the date that the Office receives a disclaimer meeting requirements of 37 C.F.R. § 1.321(a) and that no further action is required in the Office). “No inter partes review will be instituted based on disclaimed claims.” 37 C.F.R. § 42.107(e); see also General Electric Co. v. United Techs. Corp., IPR2017-00491, Paper 9 at 3 (PTAB July 6, 2017) (precedential). is, the USPTO Patent Application Information Retrieval (PAIR) database containing the image file wrappers and other information for the ’175 patent), we conclude that a disclaimer of claims 1–13 of the ’175 patent under 35 U.S.C. § 253(a) has been recorded in the Office as of October 11, 2022. Exhibit 2001, a copy of the filed disclaimer, is signed by Patent Owner’s attorney of record, Abhijit P. Adisesh. Ex. 2001, 1. Exhibit 2001 also identifies the ’175 patent; identifies that all of the claims at issue in the petitions (claims 1–13) are disclaimed; and states that AliveCor, Inc. is the owner of 100% of the instant patent by virtue of an assignment recorded at Reel 049503 and Frame 0327. Id. The image file wrapper in PAIR for the ’175 patent includes a fee worksheet and receipt for the requisite fee filed with the disclaimer on October 11, 2022. Because Patent Owner filed a statutory disclaimer in compliance with 35 U.S.C. § 253(a) and 37 C.F.R. § 1.321(a) disclaiming all the claims of the ’175 patent, no inter partes review is instituted in this proceeding.” slip op. at 3
Discretionary denialPatents in suitUS 11,103,175
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.