- Apple Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Oct 26, 2023 · IPR2022-01186 · APJ Jeffrey N Fredman · IPR · Final written decision
Claims 1–14 are unpatentable as obvious, including under the Albert–Vyshedskiy–Platt and Batkin–Vyshedskiy grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had either (1) at least a bachelor of science in electrical engineering, mechanical engineering, or biomedical engineering, or a related discipline, with at least two years of relevant multidisciplinary work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals, or (2) a medical degree and at least five years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals. Pet. 5; Ex. 1003 ¶ 15. Patent Owner “applies the level of skill provided in the petition.” PO Resp. 9; Ex. 2003 ¶ 25. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). For this decision, we apply Petitioner’s stated level of ordinary skill in the art, which is consistent with the level of skill reflected in the ’042 patent and the prior art of record.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Here, we construe only those claim terms that require analysis to determine the patentability of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”). Petitioner asserts “no formal claim constructions are necessary in this proceeding.” Pet. 5–6. Patent Owner asserts “no claim term needs to be expressly construed to find that Petitioner has not met its burden in establishing the unpatentability of the claims by a preponderance of the evidence. EX2003, ¶¶26-27.” PO Resp. 9. We agree that no terms require claim construction.” slip op. at 7
- Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for petitioner
“Ph.D., in support of the asserted grounds. Ex. 1003. Patent Owner relies upon the declaration of Dr. Roozbeh Jafari, Ph.D. Ex. 2003. Based on the statements of qualifications and curricula vitae, we find Petitioner’s declarant Dr. Sarrafzadeh qualified to provide technical opinions from the perspective of a person of ordinary skill in the art in this proceeding. See 1 Because the patent was filed before March 16, 2003, pre-AIA § 103(a) is applicable. 2 Albert et al., US 5,735,285, issued Apr. 7, 1998. Ex. 1022. 3 Vyshedskiy et al., US 2004/0220488 A1, published Nov. 4, 2004. Ex. 1005. 4 Platt et al., US 6,485,416, issued Nov. 26, 2002. Ex. 1006. 5 Annavaram et al., Multimodal Sensing for Pediatric Obesity Applications, Proceedings of the International Workshop on Urban, Community, and Social Applications of Networked Sensing Systems (UrbanSense) 1–5 (Nov. 2008). Ex. 1007. 6 Batkin et al., US 2005/0239493 A1, published Oct. 27, 2005. Ex. 1008. 7 Sacco Boschetti, US 7,394,899 B2, issued July 1, 2008. Ex. 1021. curricula vitae, we find Patent Owner’s declarant Dr. Jafari qualified to provide technical opinions from the perspective of a person of ordinary skill in the art in this proceeding. See Ex. 2003 ¶¶ 1–9.” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundDecided for patent owner
“Patent Owner asserts that Petitioner’s reliance on avoidance of voice interference as a rationale is based on hindsight. See PO Resp. 17–19. Petitioner does not point to any specific disclosure in either Albert, Vyshedskiy, or Platt that suggests voice interference would have been an issue in the transmission of the ECG acoustic signals, instead relying on statements of Dr. Sarrafzadeh such as to choose a carrier frequency from about 6 kHz to about 20 kHz (e.g., 42 f3=7,500 Hz, f4=10,000 Hz, f5=12,500 Hz, f6=15,000 Hz, f7=17,500 Hz, f8=20,000 Hz) to avoid interference from human voice, which can reach the frequency of about 5 kHz. Ex. 1003 ¶ 53 (cited in Pet. 12). Dr. Jafari acknowledges in deposition testimony that “the interference was a known fact. But in the context of how this invention is expected to operate, was novel at the time in my opinion.” Ex. 1027, 65:23–65:1. We agree with Dr. Jafari and Patent Owner that simply because interference of sound waves was a known phenomenon at the time of the invention does not demonstrate that the ordinary artisan would have had reason to select particular carrier frequencies for the ECG acoustic signals that avoided human voice frequencies in the absence of any disclosure that such frequencies were known to interfere. Rather, we agree with Patent Owner that this is hindsight reasoning because until the ’042 patent pointed out this concern in the context of claim 1, there is no indication the prior art recognized that human voice interference was an issue.” slip op. at 29
Patent outcomesUS 9,649,042 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,649,042 - Apple Inc. v. Alivecor, Inc.Some claims unpatentablePTAB · Oct 26, 2023 · IPR2022-00872 · APJ Jeffrey N Fredman · IPR · Final written decision
Claims 1, 2, 4–8, 10, 12, and 13 are unpatentable as obvious; claims 3, 9, and 11 were not shown unpatentable because the combinations lacked a persuasive reason to record spoken messages simultaneously with ECG …
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for patent owner
“PO Resp. 9. Patent Owner asserts “a POSA would have understood the plain and ordinary meaning of the term ‘acoustic signal’ [is] a signal that is transmitted as a sound wave through the ambient environment.” Id.; Ex. 2003 ¶ 25. Patent Owner therefore asserts a POSA would have understood the claimed “frequency modulated ECG acoustic signal” is a signal that is transmitted as a sound wave through the ambient environment, [and excludes] signals transmitted by electronic or wireless radio means, because claim 1 requires the acoustic signal to be “received from a built-in microphone of the smartphone.” PO Resp. 9; Ex. 2003 ¶ 26. Petitioner responds by asserting that “a POSITA would have understood that acoustic transmission is a form of wireless transmission.” Pet. Reply 24; Ex. 1021, 46:7–47:5 (citing the Jafari Deposition where Dr. Jafari stated “in the event of an acoustic signal, there is no need to connect a wire”) Having considered the entire record, we do not find there is a substantive dispute over the term “acoustic signal” as both Patent Owner and Petitioner agree that acoustic signals include wireless signals transmitted as a sound wave through the environment. We will apply this understanding in our further analysis.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A person of ordinary skill in the art (“POSITA”) would have had either (1) at least a bachelor of science in electrical engineering, mechanical engineering, or biomedical engineering, or a related discipline, with at least two years of relevant multidisciplinary work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals, or (2) a medical degree and at least five years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals or parameters of mammals.” slip op. at 5
- Expert testimonyPetitioner expert creditedPatent owner expert creditedDecided for petitioner
“interference of sound waves was a known phenomenon at the time of the invention does not demonstrate that the ordinary artisan would have had reason to select particular carrier frequencies for the ECG acoustic signals that avoided human voice frequencies in the absence of any disclosure that such frequencies were known to interfere. Rather, we agree with Patent Owner that this is hindsight reasoning because until the ’882 patent pointed out this concern in the context of claim 1, there is no indication the prior art recognized that human voice interference was an issue.” slip op. at 26
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMixed
“that Vyshedskiy’s disclosure of a list of preferred carrier frequencies represents a permissible “obvious to try” situation. In KSR, the Supreme Court stated that a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421. And simply because the prior art “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). The instant facts represent a situation where, at the time of invention in 2010, it would have been obvious to try the known carrier frequencies of Vyshedskiy for modulation of the acoustic ECG signal of Albert in the claimed frequency range of 6 kHz to 20 kHz because these carrier frequencies would have been obvious alternatives to try to address Vyshedskiy’s disclosed design need for simultaneous measurement of heart sound auscultation and ECG heart cycle. See Pet. 17 (citing Ex. 1005 ¶¶ 13– 15).” slip op. at 27
Patent outcomesUS 8,509,882 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,509,882 - Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentablePTAB · Oct 11, 2023 · IPR2022-00796 · APJ David Cotta · IPR · Final written decision
Claims 1–13 are unpatentable as obvious over Sun and the Teva Press Release; the Board did not reach the Bigal ground.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“POSA helpful. Moreover, Patent Owner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’434 patent. We do not see a need to specify that the POSA would have experience studying the role of CGRP in migraine. Accordingly, for purposes of this Decision, we accept Patent Owner’s proposed definition of the person of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). The differences between Petitioner’s and Patent Owner’s identification of the POSA do not materially affect our decision. Put another way, we would reach the same decision under either definition.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“adverse event” beyond the portion of the Specification defining “inadequate response” to include when “treatment has to be interrupted because of adverse events that made it intolerable.” Ex. 1045, 6:45–52; PO Resp. 13– 14 (acknowledging that “[t]he ’434 patent does not provide an express definition of an ‘adverse event’” and citing only extrinsic evidence); Pet. Reply 22–25 (citing only extrinsic evidence); PO Sur-Reply 18–19 (citing only extrinsic evidence). Like the parties, we do not find any other intrinsic evidence bearing on the construction of “adverse event.” Accordingly, we turn to the extrinsic evidence provided by the parties. slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“d) Conclusion regarding motivation to combine We find that Petitioner has established, by a preponderance of the” slip op. at 64
- ExcludeMotion to exclude, deniedMixed
“A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 102
Patent outcomesUS 10,392,434 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,392,434 - Wuhan Healthgen Biotechnology Corp. v. Ventria Bioscience Inc.Institution deniedPTAB · Oct 2, 2023 · IPR2023-00684 · APJ Michael A Valek · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–29 were unpatentable, failing to establish the required endotoxin limitation.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For these reasons, we find that Petitioner has not met its burden with respect to the endotoxin limitation. Because that limitation is required by all of the challenged claims, Petitioner has not met its burden for any of the challenged claims.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Petitioner relies upon for its asserted combination of references. The rHSA exemplified in Hatsuyama’s Reference Example 1 and described in Table 1 is produced in and purified from yeast according to methods described in other publications not cited or relied upon in the Petition. Ex. 1004 ¶ 69. The Petition does not address those methodologies or suggest that it would have been obvious to employ them in combination with Deeter. Rather, Petitioner alleges that it would have been obvious to substitute the yeast-derived rHSA exemplified in Hatsuyama with Deeter’s rHSA, which is produced in rice and purified according to a different process. See Ex. 1005 ¶¶ 116–117. Petitioner has not demonstrated that a POSA would have understood Deeter’s rice-derived rHSA to have the same properties as the yeast-derived rHSA in Hatsuyama’s Table 1. Indeed, the data in the Specification of the ’389 patent shows that Deeter’s rHSA had substantially higher levels of endotoxin than the rHSA in Hatsuyama’s Table 1. Compare Ex. 1001, Fig. 10C (showing greater than 20 EU endotoxin levels in old (B000) process) with Ex. 1004, Table 1 (less than 0.5 EU); see also Ex. 2010 ¶¶ 4–8.” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“likelihood of establishing that any of the challenged claims are unpatentable on any of the grounds in the Petition. Accordingly, institution of inter partes review is denied. Because we determine that Petitioner has not met the burden for institution on the merits, we do not reach Patent Owner’s arguments for discretionary denial under 35 U.S.C. § 325(d).” slip op. at 18
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,492,389 - PTAB · Sep 25, 2023 · IPR2023-00760 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted anticipation or obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that an ordinarily skilled artisan should encompass the inventor. See Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256–57 (Fed. Cir. 2007). On this record, we also decline to include publication of academic articles as a requirement. After reviewing the record, for purposes of this Decision, we adopt Patent Owner’s definition as it is consistent with the prior art’s demonstration of the skill level at the time of the invention.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingTerm construed patent owner constructionDecided for patent owner
“In general, “a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Catalina, 289 F.3d at 808 (quotation marks omitted). But even then, “[w]hether a preamble stating the purpose and context of the invention constitutes a limitation of the claimed process is determined on the facts of each case in light of the overall form of the claim, and the invention as described in the specification and illuminated in the prosecution history.” Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563, 1572–73 (Fed. Cir. 1996). We determine that, read in view of the Specification, the preamble, even though it states an intended purpose, is limiting, because “it is necessary to give life, meaning, and vitality to the claim.” See Catalina, 289 F.3d at 808 (quotation marks omitted). The ’308 patent discloses “an adoptive cellular immunotherapy composition comprising a genetically modified helper T lymphocyte cell [i.e., CD4+ T cell] preparation that augments the genetically modified cytotoxic T lymphocyte cell [i.e., CD8+ T cell] preparation[’]s ability to mediate a cellular immune response.” Ex. 1001, 9:4–8, see also id. at 9:36–42 (disclosing that in some embodiments, an adoptive cellular immunotherapy composition “comprises an antigen-reactive chimeric antigen receptor modified naïve CD4+ T helper cell that augments the CD8+ immune response.”), 9:48–51 (the same). The ’308 patent also discloses that in some embodiments, an adoptive cellular immunotherapy composition further “comprises a chimeric antigen receptor modified tumor-specific CD8+ cytotoxic T lymphocyte cell preparation that elicits a cellular immune response.” Id. at 9:14–17, 23–26.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“the claimed composition are surface positive for “CD62L and/or CD45RA,” and the CAR-modified CD8+ T cells are surface positive for “CD62L and/or CD45RO.” Petitioner proposes that the term “and/or” includes “embodiments having the element preceding ‘and/or,’ the element following ‘and/or,’ or both the element preceding ‘and/or’ and the element following ‘and/or’.” Pet. 20 (citing Ex. 1002 ¶ 86). Under this construction, Petitioner argues, the CD4+ T cells recited in claim 1 can be surface positive for CD62L, for CD45RA, or both. Id. (citing Ex. 1002 ¶ 87). And because CD62L+ can be either TN or TCM cells, Petitioner contends “claim 1’s CAR-modified CD4+ T cells can be either majority TCM or TN.” Id. at 17 (citing Ex. 1002 ¶¶ 62–66). For similar reasons, Petitioner argues that “claim 1’s CD8+ T cells can be majority TN, TCM, TEM, or TE.” Id. (citing Ex. 1002 ¶¶ 67–70); Id. at 20 (citing Ex. 1002 ¶¶ 87–88). At this stage, Patent Owner does not dispute Petitioner’s proposed construction or provide its own construction of “and/or.” Based on the current record, we agree with Petitioner’s proposed construction because it is supported by the claim language and the Specification of the ’308 patent.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,987,308 - Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentablePTAB · Sep 25, 2023 · IPR2022-00739 · APJ David Cotta · IPR · Final written decision
Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the separate Dodick and Sharma ground.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“(iii) Conclusion with respect to Group I patients In sum, we find that the only difference between Sun’s patients who” slip op. at 33
- Expert testimonyPetitioner expert creditedOther
“be advantageous as compared to galcanezumab on the basis that galcanezumab is a “less selective agent” than erenumab. Patent Owner and Dr. Grosberg cite Shi 2016 (Ex. 2049) as teaching the “high selectivity” of erenumab for blocking the CGRP complex as compared to “less selective agents,” and use this teaching to imply that galcanezumab is less selective than erenumab. PO Resp. 22; Ex. 2037 ¶ 218. But, as Dr. Hay explains, “[t]he ‘less selective agents’ that Shi 2016 refers to are the small-molecule CGRP receptor antagonists, Gepants, not galcanezumab.” Ex. 1239 ¶ 29. We find Dr. Hay’s testimony on this point persuasive, as it is consistent with Shi 2016. See Ex. 2049, 2 (discussing concerns regarding small molecule CGRP antagonists that have prevented their approval and opining that “[a] monoclonal antibody may be a preferred modality to target the CGRP receptor”). Moreover, Shi 2016 concludes with a discussion of the advantages of the superior selectivity of mAbs as a class. Id. at 8 (discussing advantages of mAbs over small molecule CGRP-receptor antagonists, noting “[i]n addition to high potency and superior selectivity, which may provide the benefit of fewer off-target side effects, monoclonal antibodies provide advantages that make them better suited for preventive treatment compared with small molecules”); Ex. 1239 ¶ 32 (interpreting Shi as teaching that “antibodies as a class have limited off-target effects as compared to small molecules because they bind to fewer biological targets and are therefore considered more specific.”). Accordingly, the evidence of” slip op. at 50
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1002, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’161 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’161 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1002, 18:61–19:7. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8
- ExcludeMotion to exclude, deniedMixed
“A. Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 We do not rely on Exhibits 1065, 1073, 1088, 1089, 1220, and 1221 in our Final Written Decision. Accordingly, we dismiss Patent Owner’s Motion as it relates to these exhibits.” slip op. at 107
Patent outcomesUS 11,028,161 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,028,161 - Eli Lilly And Company v. Teva Pharmaceuticals International GmbHAll claims unpatentablePTAB · Sep 25, 2023 · IPR2022-00738 · APJ David Cotta · IPR · Final written decision
Claims 1–30 are unpatentable as obvious over Sun, Dodick, and Sharma; the Board did not reach the alternative ground.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“B. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the problems” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“1. “A subject having refractory migraine” The phrase “a subject having refractory migraine” appears in the preamble to claim 1. Ex. 1001, 173:2–3. The parties agree that the preamble is limiting because it provides context and antecedent basis for terms in the body of the claim. Pet. 12 (“Claim 1’s preamble . . . should be construed as limiting at least because it provides context and antecedent [basis] for the claimed ‘therapeutically effective amount.’”); PO Resp. 9 (“There is no dispute that the preamble ‘[a] method of treating or preventing migraine in a subject having refractory migraine, the method comprising’ is limits the claim for the reasons expressed by the parties. Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (finding that the phrase “treatment of sleep apneas” in the preamble of an interference count was limiting because it provided antecedent basis for the phrase “to a patient in need of such treatment” in the body of the interference count); see also Eli Lilly Co. v. Teva Pharmas Int’l GmbH, 8 F.4th 1331, 1340–41 (Fed. Cir. 2021) (discussing construction of claims directed to “methods of using a composition for a specific purpose,” explaining, “while there is no bright-line rule for determining whether a preamble is limiting, we have generally construed statements of intended purpose in such method claims as limiting”). We turn now to the meaning of the phrase “a subject having refractory migraine.” The parties agree that the ’160 patent expressly defines the phrase “a subject having refractory migraine.” Pet. 13; PO Resp. 9. In this regard, the ’160 patent states: As used herein, refractory migraine patients (or “subject having refractory migraine”) are considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to at least two preventive medications (from a different cluster, defined below). Refractory migraine patients can also be considered refractory if they have a documented inadequate response (in a medical chart or by treating physician’s confirmation) to two to four classes of prior preventive medications (from different cluster[s], as defined below), e.g., inadequate response to two classes of prior preventive medications, inadequate response to three classes of prior preventative medications, or an inadequate response to four classes of prior preventative medications. Ex. 1001, 18:59–19:5. Thus, a “subject having refractory migraine” should be construed as: a migraine patient having a documented inadequate least two preventive medications from a different cluster. Id.” slip op. at 8
- Expert testimonyPatent owner expert discountedDecided for petitioner
“understand the term “adverse event” to be limited to “serious” events. Ex. 2004, 1; Ex. 1208, 1; Ex. 1209, 6; Ex. 1210, 8. The only evidence to the contrary is the testimony of Dr. Grosberg. Ex. 2037 ¶ 45. Because Dr. Grosberg’s testimony is inconsistent with the evidence he relies upon, we decline to give it substantial weight. We recognize that the Specification of the ’160 patent includes language imposing some degree of severity on the “adverse event.” Specifically, the adverse event must be significant enough to cause treatment to be “interrupted” because the event made the treatment become “intolerable by the patient.” But, we find no support in the record for imposing an additional severity requirement by effectively limiting the term “adverse event” to “serious adverse events.” Accordingly, we decline to construe the term “adverse event” to mean “a serious undesirable experience associated with the use of a treatment” as proposed by Patent Owner. PO Resp. 12. We do not find it necessary to further construe the term “adverse event” to resolve this dispute.” slip op. at 14
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“d) Conclusion regarding Sun’s disclosure of the claimed patients For the reasons discussed supra §§ II.F.1.a–c, we find that Petitioner” slip op. at 40
Patent outcomesUS 11,028,160 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,028,160 - Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Sep 6, 2023 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–21 are unpatentable: claims 1–14, 17–19, and 21 as obvious over Teigen and Grey; claims 15–16 over Teigen, Grey, and Yang; and claim 20 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. PERSON OF ORDINARY SKILL IN THE ART In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The level of ordinary skill in the art is “a prism or lens through which . . . the Board views the prior art and claimed invention” to prevent hindsight bias. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’253 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 38:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’253 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 3:8–11. In the ’253 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’253 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1034 ¶¶ 13–14. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” We disagree with Patent Owner’s contention that our construction imports limitations from a single embodiment into the claims. As explained above, the ’253 patent clearly defines the term “forward flow” and this definition is not limited to a single embodiment. In fact, the ’253 patent indicates that, while “[f]orward flow is defined as greater than 6 microliters of fluid . . . [l]ess forward flow is also included in this definition.” Ex. 1001, 38:21–24. The ’253 patent specifies that “the amount of forward flow can be restricted to no greater than 2 microliters or, in a particularly beneficial embodiment, forward flow is approximately zero microliters.” Id. at 38:24– 29. This language indicates that our construction encompasses multiple embodiments from the ’253 patent. We also disagree with Patent’s Owner’s proposed construction of “forward flow” because it is not supported by the ’253 patent specification. Patent Owner contends that “there is ‘no forward flow’ until the full extent of the distal portion” exits the distal end and thus forward flow is prevented when only less than “the full extent of the distal portion” exits the distal end. PO Resp. 9 (emphasis omitted). To adopt Patent Owner’s proposed construction, we would have to essentially ignore the ’253 patent’s express definition of this term. Further, there is no support in the ’253 patent specification for “full extent” or “fully exiting.” We also agree with Petitioner that Patent Owner’s construction effectively eliminates the concept of preventing forward flow because, as Patent Owner acknowledges, it could allow, for example, 20 milliliters of fluid to exit the catheter, which could displace the thrombus into the patient’s vasculature, a problem that the ’253 patent seeks to avoid. See PO Resp. 10–12 (citing Ex. 2014 ¶¶ 48–51); Pet. Reply 8–9 (citing Ex. 1034 ¶¶ 14–15).” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construe “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosures from the ’011 provisional application that describe the desire to have “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” these disclosures would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 35 (citing Ex. 1003 ¶¶ 15, 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 36–37 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges that fall within the ’253 patent’s definition of “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1034 ¶ 25; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Further, we note that the ’253 patent differentiates between embodiments that allow forward flow and embodiments in which no forward flow occurs. See Ex. 1001, 32:58–60, 37:19–22; Pet. Reply 10–11. For example, the ’253 patent describes an embodiment in which the “momentum causes a small amount of fluid to move through the distal portion of the catheter [] and create a small distal movement of the clot.” Ex. 1001, 32:47– 51. This same embodiment is disclosed in the ’011 provisional application. Compare Ex. 1003 ¶ 126 with Ex. 1001, 32:16–60. The ’253 patent describes this disclosure as an “exemplary embodiment” in which the “flow of fluid forward . . . is intentional, which is in contrast to other exemplary embodiments herein where substantially no forward flow occurs.” Ex. 1001, 32:57–60; see also, id. at 37:19–22 (“Turning now to embodiments . . . without the forward flow”).8 The ’011 provisional application does not include the subsequent embodiments from the ’253 patent that are described as being “without the forward flow.” See Ex. 1005 ¶ 68; Ex. 1034 ¶¶ 22–23. This further demonstrates that the ’011 provisional application does not support the limitation of “prevent[ing] forward flow.” We also note that the ’011 provisional application does not contain adequate support for the limitation of “substantially prevent[ing] forward flow” even under Patent Owner’s proposed construction. While the ’011 provisional discloses “controlling the distal movement of the fluid column” (Ex. 1003 ¶¶ 15, 16), this does not support Patent Owner’s assertion that the ’011 provisional teaches that “the distal portion of the fluid column is substantially prevented from fully exiting the distal end.” PO Resp. 35–36. For example, as discussed above, the ’011 provisional application discloses permitting distal flow of up to 1,000 microliters, which would likely exceed the amount that could be characterized as the full distal portion. Ex. 1003 ¶ 91; Ex. 1034 ¶ 25. Thus, we find that the ’011 provisional application does not “clearly allow persons of ordinary skill in the art to recognize that [the inventors] invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 8 Patent Owner contends that the statement in the ’253 patent regarding the “exemplary embodiment” of “forward flow” is referring to an embodiment in which the volume of the liquid drawn out from the lumen of the catheter is “approximately 0.2 ml.” PO Resp. 40–41 (citing Ex. 1001, 32:35–36; Ex. 1003 ¶ 126; Ex. 2014 ¶ 99). Even if this is correct, the ’011 provisional application does not include the embodiments that the ’253 patent specifically characterizes as being “without the forward flow.” Pet. Reply 10–11; Ex. 1005 ¶ 68; Ex. 1034 ¶ 22–25.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“Based on the above, we determine that, for prior-art determinations under AIA § 102, “there is no need to evaluate whether any claim of [a reference] patent document is actually entitled to priority or benefit under 35 U.S.C. 119, 120.” MPEP § 2154.01(b) (emphasis added). Rather, under the AIA, a reference patent document need only meet the “ministerial requirements” of §§ 119 and 120, and the provisional or other earlier application(s) to which the reference patent document claims a right of priority must “describe[] the subject matter” relied upon in the reference patent document as prior art. 35 U.S.C. § 102(d)(2). Patent Owner has not contested that Teigen meets the procedural requirements for claiming priority to the ’712 patent or the ’095 PCT application. Teigen also appears to meet the ministerial requirements for claiming priority to the provisional applications because it properly claims the benefit of these applications, the ’095 PCT application was filed co-pending with the provisional applications, and the applications share common inventors. Ex. 1007, codes (22), (60), (63), (72); Ex.1008, 2; Ex. 1009, 2; Ex. 2005, codes (22), (30), (72). Patent Owner does not dispute that Teigen meets the “ministerial requirements” of § 119. Because we find that the Dynamic Drinkware analysis does not apply here, we agree with Petitioner and Patent Owner, that we need not reach the issue of whether a claim from Teigen is supported by either Teigen provisional application. PO Sur-Reply 8; Pet. Reply 12–13.” slip op. at 30
Patent outcomesUS 10,722,253 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,722,253 - Lifescan, Inc. v. Facet Technologies, LLCInstitution deniedPTAB · Sep 1, 2023 · IPR2023-00713 · APJ James A Tartal · IPR · Institution
The Board denied institution of review of claims 11–15 under § 314(a), finding petitioner did not justify a second petition challenging the same patent.
RulingsInstitution decision- Parallel petitionsInstitution denied discretionary otherDenied
“compelled, to institute an IPR proceeding.”). More specifically, the Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“CTPG”)10 states that “one petition should be sufficient to challenge the claims of a patent in most situations” and that “multiple petitions by a petitioner are not necessary in the vast majority of cases.” CTPG 59. According to the CTPG, “[t]wo or more petitions filed against the same patent at or about the same time (e.g., before the first preliminary response by the patent owner) may place a substantial and unnecessary burden on the Board and the patent owner and could raise fairness, timing, and efficiency concerns.” Id. (citing 35 U.S.C. § 316(b)). The CTPG also sets forth the following guidance: To aid the Board in determining whether more than one petition is necessary, if a petitioner files two or more petitions challenging the same patent, then the petitioner should, in its petitions or in a separate paper filed with the petitions, identify: (1) a ranking of the petitions in the order in which it wishes the Board to consider the merits, if the Board uses its discretion to institute any of the petitions, and (2) a succinct explanation of the differences between the petitions, why the issues addressed by the differences are material, and why the Board should exercise its discretion to institute additional petitions if it identifies one petition that satisfies petitioner’s burden under 35 U.S.C. § 314(a).” slip op. at 14
Discretionary denialPatents in suitUS 8,840,635 - PTAB · Sep 1, 2023 · IPR2023-00712 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 6–8, 14, and 16–18 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Fintiv Order 5–6. In evaluating these factors, “the Board takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6. Additionally, the Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation issued by the Director of the United States Patent and Trademark Office (the “Memorandum”)10 provides that the Board will not discretionarily deny institution of inter partes review “where a petitioner presents a stipulation not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB.” Memorandum, 3.” slip op. at 9
- Parallel petitionsNot reached
“9 Petitioner filed an Explanation of Parallel Petitions in both this proceeding and in IPR2023-00713 stating that it requests that the Board consider the Petition in this proceeding first, followed by the petition filed in IPR2023- 00713. Paper 4, 1. Accordingly, we do not reach the issue of whether institution of inter partes review based on a second petition is warranted in this proceeding.” slip op. at 8
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2022). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Moreover, a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham, 383 U.S. at 17–18; Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)). In determining the level of ordinary skill in the art, various factors may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree and/or master’s degree in mechanical engineering or industrial design, along with at least 4 to 6 years of experience designing consumer or medical device products to optimize human factors such as handleability or ergonomics.” Pet. 7. Patent Owner asserts that a person of ordinary skill in the art would have “completed college-level coursework, and/or obtained a bachelor’s degree, in engineering, such as mechanical engineering or biomechanical engineering, or another similar discipline, and (2) have had at least one year of experience researching, developing, and/or designing mechanical medical devices.” Prelim. Resp. 5. Patent Owner further states that its Preliminary Response “does not turn on the definition of a [person of ordinary skill in the art].” Id. Although Patent Owner notes that Petitioner proposes “a higher level of skill,” at this stage of the proceeding neither Party has shown a material difference between the levels of skill each has proposed and either Party may further address the issue, if necessary, during the trial. For purposes of this Decision, we apply Petitioner’s proposed level of skill because, on the current record, it is consistent with the level of skill at the time of the claimed invention reflected by the ’635 patent and the cited prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,840,635
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.