- 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 - Apple, Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Dec 6, 2022 · IPR2021-00971 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–30 are unpatentable under § 103 over Shmueli alone or in combinations with Osorio, Li 2012, Kleiger, and Chan.
RulingsFinal written decision- Skill levelSkill level board ownPetitioner expert creditedOther
“Patent Owner’s assertion that our originally proposed definition, would “classify all cardiologists as POSITAs,” is well taken. 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 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Patent Owner notes that the ITC applied the plain and ordinary meaning to the terms “arrhythmia” and “confirm” or “confirming.” PO Resp. 21 (citing Ex. 2010, 12–13). We understand “arrhythmia” as used in the context of the ’731 patent refers to “a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachychardia) or slower (bradycardia) than normal.” See id. at 24–25 (quoting Ex. 1001, 1:40–42). This term does not appear to be in dispute. See Tr. 21:18-22:3 (“[Board”]: . . . Patent Owner raised the issue of claim construction for the term arrhythmia. Is there any dispute there? [Petitioner’s counsel]: Honestly, Your Honor, we considered that -- put a lot 23 of energy into considering it. We don’t believe so.”); see also, Tr. 53:24-54:2 (“[Board]: . . . Your claim construction of arrhythmia is merely a matter of precision and clarification rather than a contested point; is that correct? [Patent Owner’s counsel]: I believe that’s largely correct.”). Patent Owner also asserts, and we agree, that “confirm” and “confirming” are discrete requirements from “detect” in claims 3, 5, 6, 19, 21, and 22. See id. at 25. Accepting these clarifications, we apply the plain and ordinary meaning to all claim terms. D. Ground 1: Obviousness over Shmueli” slip op. at 30
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“sensor and “detect, based on the PPG data, the presence of an arrhythmia.”11 According to Petitioner, although Shmueli does not explicitly use the term arrhythmia, one of ordinary skill in the art reading Shmueli would have found it obvious that the text “Detect Irregular Heart Condition,” in element 38 of Shmueli’s Figure 7, refers to detecting the presence of arrhythmia based on PPG data. See Pet. 22–24; Ex. 1003 ¶¶ 47–51. For the purpose of instituting trial, we determined that “one of ordinary skill in the art would have understood Shmueli’s use of ‘irregular heart condition’ as referring to—or at a minimum, encompassing— arrhythmia, and, thus, disclosing the detection of arrhythmia.” DI 33–34. As discussed below, the arguments and evidence adduced at trial confirm our initial understanding.” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“pages 17–18 of Petitioner’s Reply, which we adopt in full. In short, Osorio relates to medical device systems and methods capable of detecting a pathological body state of a patient. Ex. 1005 ¶ 2. As discussed above, we do not read Osorio as limiting “pathological state” to epilepsy or other neurological condition. To the contrary, one of ordinary skill in the art would have understood Osorio’s teachings applicable to “any pathological state,” including arrythmia. See e.g., id. at 44. As such, the references are not directed to different problems as Patent Owner urges. Further, even if one of ordinary skill in the art were to read Osorio as limited to the detection neurological events such as epilepsy, Osorio contains express teachings to monitor heart rate and heart rate variability for signs of arrhythmia. See Ex. 1005 ¶¶ 42, 43, 45, 46, 71; Ex. 1069, 58:23–59:3; 61:13–62:7. Whether Osorio’s detection of arrhythmias is viewed as a standalone goal, or as data for use in monitoring for epileptic seizures, does not materially affect the analysis. “Because Shmueli already renders arrhythmia detection obvious and Osorio motivates use of activity tracking to improve detection of any heart-related pathological conditions,” including arrhythmias, it is irrelevant whether Osorio’s ultimate goal is the detection of neurological events. Reply 18 (citing Pet. 23–24; Ex. 1004, 13:9–17, Fig. 7). With respect to Patent Owner’s reliance on Adidas, it is well established that a finding of obviousness does not require that all features of a secondary reference are “bodily incorporated into the structure of the primary reference.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. Id. “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In the present case, we do not understand Petitioner to argue for the wholesale incorporation of Osorio into Shmueli’s device. Rather, Petitioner more narrowly argues that one of ordinary skill in the art would find it obvious to incorporate two elements of Osorio into Shmueli’s device: “using activity level monitoring to improve the accuracy of detecting a pathological event (e.g., arrhythmia), and (ii) determining HRV from HR and using HRV to detect the pathological event (e.g., arrhythmia),” because, for example, “HRV analysis is more robust . . . and is less affected by noise.” Pet. 30, 43–44, 48–49; see generally Ex. 1003 ¶¶ 151–167. Thus, even were Osorio ultimately limited to the detection of neurological events, Patent Owner’s suggestion that these targeted improvements would render Shmueli’s device inoperable for its intended purpose is unavailing. In view of the above, and all the argument and evidence adduced at trial, Petitioner has established sufficiently that one of ordinary skill in the” slip op. at 47
Patent outcomesUS 10,595,731 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,595,731 - Apple, Inc. v. Alivecor, Inc.All claims unpatentablePTAB · Dec 6, 2022 · IPR2021-00970 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–20 are unpatentable: claims 1–6, 10–16, and 20 as obvious over Shmueli and Osorio; claims 7–9 and 17–19 as obvious over those references and Hu 1997.
RulingsFinal written decision- Skill levelSkill level board ownOther
“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 POSITAs,” is well taken. 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 25
- Expert testimonyPetitioner expert creditedPatent owner expert creditedOther
“the art even under Patent Owner’s then-proposed definition. See DI 26–28. Despite Patent Owner’s subsequent position that the ordinarily skilled artisan should have an engineering degree and “design experience” in developing wearable cardiac sensors, the arguments and evidence adduced at trial do not alter our initial determination. See, e.g., PO Resp. 37–41; Reply 27–28; Sur-reply 22–24; see generally Tr. 40:25–46:19, 55:2–56:13. Rather, we agree with Petitioner’s argument in support of Dr. Chaitman’s qualifications, that this proceeding involves “piecing together known technologies and . . . the analysis of cardiac data” including PPG data, ECG data and activity level. Tr. 38:4–18. Thus, one of ordinary skill in the art with an understanding of cardiac monitoring technology “would understand how these types of data work, how they interplay and how the data could be processed on these devices.” Id.” slip op. at 26
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“meaning to the terms “arrhythmia,” “alert,” and “heart rate monitor.” PO Resp. 32 (citing Ex. 2010, 12–13). We understand “arrhythmia” as used in the context of the ’499 patent refers to “a cardiac condition in which the electrical activity of the heart is irregular or is faster (tachycardia) or slower (bradycardia) than normal.” Id. at 31–36 (quoting Ex. 1001, 1:31–33). This term does not appear to be in dispute. See Tr. 21:18–22:3 (“[Board”]: . . . Patent Owner raised the issue of claim construction for the term arrhythmia. Is there any dispute there? [Petitioner’s counsel]: Honestly, Your Honor, we considered that -- put a lot of energy into considering it. We don’t believe so.”); see also id. at 53:24–54:2 (“[Board]: . . . Your claim construction of arrhythmia is merely a matter of precision and clarification rather than a contested point; is that correct? [Patent Owner’s counsel]: I believe that’s largely correct.”). With the above understanding, we apply the plain and ordinary meaning to all claim terms. D. Ground 1: Obviousness over Shmueli and Osorio” slip op. at 27
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“In light of the above, and all the evidence adduced at trial, we agree with Petitioner that one of ordinary skill in the art would have understood Shmueli to teach or disclose methods and systems for “determining the presence of an arrhythmia,” as required by the challenged claims.” slip op. at 36
Patent outcomesUS 9,572,499 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,572,499 - Beckman Coulter, Inc. v. Becton, Dickinson And CompanyInstitution deniedPTAB · Dec 1, 2022 · IPR2022-01122 · APJ Michael A Valek · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–13 unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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. V. ORDER Accordingly, it is: ORDERED that the Petition is denied, and no inter partes review is instituted” slip op. at 33
- Skill levelOther
“We are sympathetic to Patent Owner’s argument that a POSA would have had at least some experience with the optical systems used in optical analyzers. All of the claims recite an “optical analyzer” and the Specification is replete with references to optical analyzers and their operation. See, e.g., Ex. 1001, Abstr., 1:14–15, 2:3–4, 2:18–29, 3:38–57, 9:55–10:59 (claims reciting an “optical analyzer”). Moreover, Patent Owner cites other evidence that also suggests a POSA would have such experience. See Prelim. Resp. 12–13. However, on the current record, we are not convinced that the ordinary level of skill in the art would necessarily require the amount of specific experience (i.e., two years working and/or designing optical systems in optical analyzers) that Patent Owner urges. Petitioner’s declarant, Dr. Fang, testifies that two years of experience “in the field of optical imaging, with a specific focus on laser optics” would suffice. See Ex. 1002 ¶ 9. Thus, while it seems likely that a POSA would have at least some experience specific to optical analyzers, we see no reason why additional experience with laser optics more generally could not provide the balance of the two years of experience noted in the parties’ definitions. In any event, we need not resolve this issue here because we would reach the same outcome under either parties’ POSA definition.” slip op. at 8
- Expert testimonyPetitioner expert discountedDecided for patent owner
“The testimony Petitioner offers from its declarant, Dr. Fang, does not provide the missing explanation. Paragraphs 115 and 127 of Dr. Fang’s declaration, provide his opinions that “adapting a lens to focus a light beam onto a focal spot within a sample analysis region is no different from adapting a lens to focus a light beam into any region in space in other applications” and that a POSA would “understand that Lynch is generally applicable to light sources emitting collimated beams, and that such light sources were well-known in the art.” Ex. 1002 ¶¶ 115, 127. In paragraph 126, Dr. Fang testifies that a POSA would have a reasonable expectation of success in implementing the system described in Lynch.11 None of this testimony explains why a POSA would have been motivated to modify Lynch for implementation in an optical analyzer. For these reasons and based on the current record, Petitioner has not” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Whether to treat a preamble as a limitation is a determination ‘resolved only on review of the entirety of the patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.”’ In re Cruciferous Sprout Litig., 301 F.3d 1343, 1347 (Fed. Cir. 2002) (citation omitted). “In general, a preamble limits the claimed invention if it recites essential structure or steps, or if it is necessary to give live meaning and vitality to the claim.” Id. (citation and quotations omitted). This may be ascertained by review of the entirety of the patent to determine whether the preamble “discloses a fundamental characteristic of the claimed invention” as opposed to merely “stat[ing] a purpose or intended use.” Poly-Am., L.P. v. GSE Lining Tech., Inc., 383 F.3d 1303, 1310 (Fed. Cir. 2004). As Patent Owner points out, the ’197 patent is replete with references describing the invention as an optical analyzer. See Prelim. Resp. 24–25 (bullet pointing quotes from the Specification). The Specification begins by explaining that optical or “[p]article analyzers . . . are well known analytical tools that enable the characterization of particles on the basis of optical parameters such as light scatter and fluorescence.” Ex. 1001, 1:16–19. The Specification explains that “[t]he present invention” provides both “illumination optics for use in an optical analyzer” and “an optical analyzer incorporating the illumination optics of the present invention.” Ex. 1001, 2:3–4, 2:18–19. Claims 1–13, each of which recites an “optical analyzer” comprising a set of optical elements, are specifically directed to the latter. Id. at 9:55–10:59. The Specification further demonstrates that the preamble term is limiting by explaining that “the invention addresses a concern specific to” optical analyzers. See Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349 1358 (Fed. Cir. 2012) (finding that the specification “demonstrates that the preamble phrase ‘rotary cutter deck’ is a limitation” because it “explains that the invention addresses a concern specific to rotary cutters”). The Specification explains that in a flow cytometer, i.e., an exemplary type of optical analyzer, “the excitation light from a laser . . . is focused onto a focal spot to illuminate the core stream (the fluid stream containing the particles to be analyzed).” Ex. 1001, 1:39–42. According to the Specification, “[a]ccurate focusing of the excitation light beam on the core stream is important,” “[o]ptimal performance is compromised if the focused light beam is not properly adjusted on the core stream,” and because the particles being analyzed are only a “few microns in size, the precision of the light beam adjustment also needs to be in the micron range.” Id. at 1:42–51; see also id. at 3:38–49 (explaining that “fine control over the focus spot” is useful in optical analyzers). The present invention addresses these concerns by providing an optical analyzer “adapted to focus an illumination beam onto a sample analysis region,” configured to obtain a “high degree of precision over the adjustment of the focal spot using less expensive lens adjusting mechanisms,” and comprising “detection optics for measuring the light emitted from the analysis region.” See id. at 2:18–23, 7:3–8. We also agree with Patent Owner that the recitation of an “optical analyzer” in the preamble informs the meaning of the phrase “a focusing lens . . . adapted to focus the light beam onto a focal spot within a sample analysis region” in the claim body. The term “sample analysis region” refers to a structural feature of the claimed “optical analyzer,” i.e., the area configured to contain the sample to be analyzed. This is confirmed by the Specification, which explains that in addition to illumination optics “[t]he optical analyzer will further comprise detection optics for measuring the light emitted from the analysis region. In a preferred embodiment, the optical analyzer is a flow cytometer, and the sample analysis region is a sample detection region in a fluid stream containing particles to be optically analyzed.” Ex. 1001, 2:21–26. In this regard, the preamble informs the meaning of “sample analysis region” by indicating that the recited “sample analysis region” is configured such that it can contain a sample and that light emitted from that region can be measured by the analyzer. See Deere, 703 F.3d at 1358 (explaining that “rotary cutter deck” in the claim preamble “informs the meaning of the ‘torsional stiffness’ limitation––the claimed structure must possess sufficient stiffness to withstand the torsional loads imposed by the operation of a rotary cutter”). By the same measure, holding that the “sample analysis region” need not be so configured would undermine the benefits the Specification indicates the recited illumination optics achieve. See Ex. 1001, 1:39–55, 2:30–48, 7:3–7 (explaining that “accurate focusing” is important because the sample to be analyzed may be very small and that the present invention obtains “precise positioning control” using less expensive components). The fact that the preamble informs the meaning of a term in the claim body, distinguishes it from “nonlimiting preamble terms” that “merely state a name or a use” by demonstrating that the optical analyzer recited in the preamble of the presently challenged claims is a “fundamental characteristic of the claimed invention.” Deere, 703 F.3d at 1358 (quoting Poly-Am., 383 F.3d at 1310).9 slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,787,197 - Apple Inc. v. Alivecor, Inc.Institution deniedPTAB · Nov 14, 2022 · IPR2022-00873 · APJ David Cotta · IPR · Institution
The Board denied institution because Apple did not show a reasonable likelihood that claims 1–15 were unpatentable over the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1–15 of the ’444 patent.” slip op. at 2
- BurdenDecided for patent owner
“In sum, the Petition asserts that the claimed “converter assembly” is present in Libbus as part of the “wireless communication circuitry,” but the evidence cited in support does not persuade us that Petitioner is reasonably likely to prevail in establishing that: 1) that Libbus fairly suggests that its wireless communication circuitry includes a converter assembly, 2) that a converter assembly is inherently present in Libbus’s wireless communication circuitry, or 3) that the POSA would have at once envisaged that Libbus’s wireless communication circuitry includes a converter assembly. In reaching this conclusion, we give Dr. Fletcher’s testimony diminished weight because he does not provide or explain the underlying facts or data on which his opinion is based and because his assertion that the converter assembly includes a processor appears contrary to Libbus’s disclosure of where the processor is located. F. Ground 2 In Ground 2, Petitioner asserts that claims 12 and 14 would have been obvious over the combination of Libbus and Batkin. Pet 48–56. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly.” Id. Petitioner does not introduce any additional evidence in connection with Ground 2 bearing on the “converter assembly” limitation. Id. For the reasons already discussed, Petitioner has not carried its burden to establish that Libbus’s “wireless communications circuitry” includes a “converter assembly.” G. Ground 3 In Ground 3, Petitioner asserts that claims 5 and 13 would have been obvious over the combination of Libbus, Faarbaek, and Vyshedskiy. Pet 56–64. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly” (for claims 5 and 13) and on Faarbaek as disclosing a “credit card form factor” (for claim 5). Id. Petitioner does not introduce any additional evidence in connection with Ground 3 bearing on the “converter assembly” or “credit card form factor” limitations. Id. For the reasons already discussed, Petitioner has not carried its burden to establish that Libbus’s “wireless communications circuitry” includes a “converter assembly” or that Faarbaek discloses a “credit card form factor.” H. Ground 4 In Ground 4, Petitioner asserts that claim 13 would have been obvious over the combination of Libbus, Batkin, and Vyshedskiy. Pet 64–65. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly.” Id. Petitioner does not introduce any additional evidence in connection with Ground 4 bearing on the “converter assembly” limitation. Id. For the reasons already discussed, Petitioner has not carried its burden to establish that Libbus’s “wireless communications circuitry” includes a “converter assembly.” I. Ground 5 In Ground 5, Petitioner asserts that claims 7 and 15 would have been obvious over the combination of Libbus, Faarbaek, and the Headset Profile. Pet. 65–68. As with Ground 1, Petitioner relies on Libbus as disclosing the claimed “converter assembly” (for claims 7 and 15) and on Faarbaek as disclosing a “credit card form factor” (for claim 7). Id. Petitioner does not introduce any additional evidence in connection with Ground 5 bearing on” slip op. at 23
- Expert testimonyPetitioner expert discountedOther
“Petitioner also cites the testimony of Dr. Fletcher to support its position that the POSA would have “understood” Libbus’s wireless communication circuitry to include a converter assembly. Pet. 24 (citing Ex. 1003 ¶ 84). As an initial matter, Dr. Fletcher’s testimony that a POSA would understand Libbus’s wireless communications circuitry to include a converter is not well explained, nor is it supported by evidence beyond Dr. Fletcher’s assertion that it is so. Dr. Fletcher merely parrots the statement in the Petition that a POSA “would have understood the wireless communication circuitry to include a converter assembly and a transmitter because the wireless communication circuitry is connected to the electrocardiogram circuitry, modulates an ECG signal, and wirelessly transmits the ECG signal to another device.” Ex. 1003 ¶ 84. And Dr. Fletcher’s evidentiary support is the same unpersuasive evidence cited in the Petition—paragraphs 48 and 59 of Libbus. Id. We give Dr. Fletcher’s testimony some weight, but that weight is substantially diminished by the absence of persuasive explanation and supporting evidence. See Rohm & Haas Co. v. Brotech Crop., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (“Nothing in the rules or in our jurisprudence requires the fact finder to credit the unsupported assertions of an expert witness.”); see also 37 C.F.R. § 42.65 (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”).” slip op. at 18
- Skill levelSkill level petitioner adoptedOther
“Pet. 6. According to Petitioner, a “greater amount of education . . . with a focus on designing wearable devices and/or sensors for measuring physiological signals . . . would also qualify for the hypothetical person of ordinary skill in the art in lieu of fewer years of multidisciplinary work experience.” Id. Patent Owner does not challenge Petitioner’s proposed definition of the POSA. See generally Prelim. Resp. Petitioner’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 ’444 patent. Accordingly, for purposes of this Decision, we accept Petitioner’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)).” slip op. at 7
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,342,444 - Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentablePTAB · Nov 1, 2022 · IPR2021-00902 · APJ Timothy G Majors · IPR · Final written decision
Claims 81–96 and 133 were not shown unpatentable because a skilled artisan would not have been motivated to combine the asserted art with Chiu.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal genetic abnormalities in maternal samples, as described in the ’277 patent and the prior art here. See, e.g., Ex. 1001, 1:31–5:59 (Field of Invention and Background Art); Ex. 1003 (Chiu). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. Okajima v. Bourdeau, 261 F.3d 1350, 14 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). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.13” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“n.3; PO Sur-Reply 14–15; see generally Papers 51 and 52.14 It is not necessary for us to further construe those dependent claims to resolve this case. Petitioner relies on formaldehyde or formaldehyde donors, as disclosed in Bianchi, Granger, and Rao, to satisfy the claimed “agent” term, and urges the addition of such compounds to Chiu’s method for isolating and detecting cffDNA in a maternal sample. There is no dispute on this record that formaldehyde and formaldehyde donors meet the claimed “agent” term. We are, thus, able to determine if the asserted art discloses an “agent” as claimed and whether a POSA would have been motivated to add formaldehyde or a formaldehyde donor to Chiu, which issue we find is decisive here, without further interpreting dependent claims 90, 91, or 133. 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.”) (internal quotation marks omitted). 14 The disagreement on interpretation of this handful of dependent claims arose in relation to Rao’s prior-art status for those claims (Pet. Reply 5 n.3; PO Sur-Reply 14–15), and Patent Owner’s nexus showing for secondary considerations of nonobviousness (id. at 21). See Pet. Reply 3 n.2 (noting the priority “arguments are only relevant to Ground 3” because the prior art status of Chiu, Bianchi, or Granger is uncontested). But, as we discuss below, Petitioner’s challenge to the claims fails on this record regardless of the disagreement on Rao’s prior art status and, because Petitioner has not made the necessary threshold showing that a POSA would have combined the asserted art in the manner proposed, we need not reach secondary considerations of nonobviousness.” slip op. at 16
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“detection method of Chiu.27 More specifically, we find on this record that a POSA would have been dissuaded from adding Bianchi’s paraformaldehyde because the POSA would have expected Bianchi’s paraformaldehyde to create gaps in the cell membranes, providing a means for maternal DNA to escape into the sample. We also find on this record that a POSA would have been dissuaded from adding paraformaldehyde to Chiu’s methods because formaldehyde was known to damage nucleic acids.28 Patent Owner’s reasoning and evidence on those issues, separately and cumulatively, outweigh Petitioner’s comparatively weak showing on whether a POSA would have combined the art in the manner proposed. We discuss in greater detail below. We begin with the issue that paraformaldehyde contributes to permeabilization of the cellular membrane. We credit Dr. Van Ness’s opinion that adopting Bianchi’s approach to treating cells with paraformaldehyde creates a means for cellular DNA to escape. Ex. 2078 27 WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1327 (Fed. Cir. 2016) (“Whether an ordinarily skilled artisan would have been motivated to modify the teachings of a reference is a question of fact.”) (citations omitted); Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006) (“The presence or absence of a motivation to combine references in an obviousness determination is a pure question of fact”). 28 When asked whether he considered “any differences between paraformaldehyde and formaldehyde that might be relevant to DNA damage in forming your opinions,” Dr. Edwards testified “[t]here should be no differences” and that “[i]n this field, these terms are often used interchangeably.” Ex. 2299, 69:3–20. We find, therefore, that the issues, including DNA damage, with formaldehyde would have been understood to also apply to paraformaldehyde on this record. 38 ¶¶ 96–98; Ex. 2101, 106:4–19 (testimony of Dr. Edwards agreeing that “DNA is one thing that can escape a cell when you permeabilize it”). Although Bianchi discloses a desire to keep “substantially all” of the target molecules inside the cells, by Bianchi’s own definition, “substantially all” includes leakage of up to 50% of the target molecules and cellular DNA. Ex. 1004, 1:42–49; Ex. 2078 ¶¶ 99–101. We find that increasing potential leakage of DNA from the maternal cells runs counter to Chiu’s objectives. As Dr. Edwards concedes, “DNA leaking out of cells” is something “Chiu tells us you do not want it to happen.” Ex. 2101, 107, 21–25.” slip op. at 38
Patent outcomesUS 7,332,277 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,332,277 - PTAB · Oct 14, 2022 · IPR2022-00796 · APJ David Cotta · IPR · Institution
The Board instituted IPR on claims 1–13, finding a reasonable likelihood that they would have been obvious over Sun and the Teva Press Release and over Bigal.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“Teva Press Release is not cumulative of the clinical studies it analyzes. Nonetheless, Sun was considered by the Examiner. Accordingly, we determine that the first part of the Advanced Bionics framework is satisfied. We turn next to the second part of the Advanced Bionics framework, i.e., determining whether Petitioner has demonstrated material error by the Office. Patent Owner argues that Petitioner did not identify any material error” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless 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.” Petitioner has established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. We decline to deny the Petition on a discretionary basis as requested by Patent Owner. Thus, for reasons explained below, we institute inter partes review of claims 1–13 of the ’434 patent.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner identifies the skill level of a person of ordinary skill in the art (“POSA”) as follows: A POSA with respect to the ’434 patent would have possessed a strong understanding of migraine and its treatments. A POSA would typically have a Ph.D. in a relevant field (e.g., neurobiology, neurology, or pharmacology) with several years of experience studying migraine or an M.D. with experience in a relevant field (e.g., neurobiology, neurology, or pharmacology) with several years of experience studying migraine or treating migraine patients. EX2001, ¶¶22-23. A POSA may be part of a multi-disciplinary team, drawing upon his or her own skills and taking advantage of certain specialized skills of others in the team, to solve a given problem. Id. For example, such a team may be comprised of an M.D. specializing in treating migraine patients and a neurobiologist specializing in studying migraine. Prelim. Resp. 6. Petitioner offers a similar definition of the POSA, with the principal differences being: 1) that Petitioner does not identify neurobiology and pharmacology as relevant fields for a POSA having an M.D., and 2) that Petitioner does not propose that a POSA could also be part of a multi-disciplinary team. Pet. 11–12. We find the additional exposition in Patent Owner’s definition of the 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. 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)). At this stage in the proceeding, the differences between Petitioner’s and Patent Owner’s identification of the POSA do not materially affect our decision with respect to institution. Put another way, we would reach the same decision under either definition.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“inadequate response to two or more different classes of preventative migraine treatment” as in need of construction. Pet. 13–14; Prelim. Resp. 9– 12. Patent Owner also argues that we should construe the preamble, which recites “[a] method of treating migraine in a subject.” Prelim. Resp. 8. 1. “A method of treating migraine in a subject” The phrase “[a] method of treating migraine in a subject” appears in the preamble to claim 1. Ex. 1045, 173:27–28. Patent Owner argues that the preamble is limiting “at least because it provides context and antecedent basis to the terms in the body of the claim, e.g., ‘administering to the subject a therapeutically effective amount’ of the recited antibody.” Prelim. Resp. 8. On this preliminary record, which does not include opposing argument from Petitioner on whether any further interpretation of the preamble is appropriate, we agree that the preamble of claim 1 limits the claim for the reasons expressed by Patent Owner. 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 Pharm. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021) (“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”).” slip op. at 16
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,392,434 - PTAB · Oct 12, 2022 · IPR2022-00774 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1–18, finding a reasonable likelihood that claims 1–3 and 5–18 were obvious over Birnboim and Stefan, claim 4 over those references and Tuggle, and claim 10 over those references …
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 argument and evidence presented in the Petition, 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.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s definition of one of ordinary skill in the art is uncontested on the current record. Because we find Petitioner’s definition to be 4 Tuggle et al., U.S. Patent Publication No. 2003/0104424 A1, published Jun. 5, 2003 (Ex. 1006, “Tuggle”). 5 Heath, U.S. Patent No. 5,973,137, issued Oct. 26, 1999 (Ex. 1009, “Heath”). for purposes of this Decision.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner does not propose a construction for any claim term. See generally, Pet. At this stage in the proceeding, we determine that no explicit construction of any claim term is necessary to determine whether to institute review. 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’”).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“combine Birnboim’s method for preserving nucleic acids at room temperature with Stefan’s exemplary use of an anionic detergent and a buffering agent at a pH of 7.5 because both references describe closely related subject matter directed to preserving nucleic acids at room temperature using compositions comprising an anionic detergent and a buffering agent. Id. at 28. Additionally, Petitioner asserts that the POSA would have expected that combination to yield predictable results, as it involved using known reagents for their known functions. Id. at 28–29; Ex. 1002 ¶¶ 63–64.” slip op. at 12
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,000,795 - PTAB · Sep 27, 2022 · IPR2022-00739 · APJ David Cotta · IPR · Institution
The Board instituted IPR on claims 1–30, finding a reasonable likelihood that the claims would have been obvious over Sun, Dodick, and Sharma.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In explaining why the claims of the ’444 application were allowable, the Examiner stated that “the art is silent regarding the efficacy of past treatments” and, more specifically, that “the prior art does not explicitly call out” the species of migraine patients for whom “two or more conventional therapies have been tried and failed.” Ex. 2008, 655–656. In making this statement, the Examiner appears to have overlooked Sun’s suggestion to use an anti-CGRP antibody to treat refractory patients. See e.g., Ex. 1006 ¶¶ 68 with two different classes of migraine prophylactic agents.”); see also, infra § III.F.1. Patent Owner does not identify anything in the prosecution history of the ’161 patent to suggest that the Examiner accounted for Sun’s teachings in allowing the ’161 patent to issue. Given that this error in overlooking Sun’s teachings was central to allowance of the patent that issued from the ’444 application, we find that this error was material. We recognize that Patent Owner disputes that Sun suggests treating the claimed refractory patients, but, on this record, we do not find Patent Owner’s arguments persuasive for the reasons discussed infra § III.F.1. On the current record, Petitioner has sufficiently demonstrated that the Examiner erred materially in finding that the prior art did not suggest using anti-CGRP antibodies to treat refractory patients. Accordingly, we choose not to exercise our discretion under 35 U.S.C. § 325(d) to deny institution on the basis that the prior art has already been considered during prosecution.” slip op. at 11
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Prelim. Resp. 6–7. Petitioner offers a similar definition of the POSA, with the principal differences being: 1) that Petitioner does not identify neurobiology and pharmacology as relevant fields for a POSA having an of a multi-disciplinary team. Pet. 11. We find the additional exposition in Patent Owner’s definition of the 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 ’161 patent. 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)). At this stage in the proceeding, the differences between Petitioner’s and Patent Owner’s identification of the POSA do not materially affect our decision with respect to institution. Put another way, we would reach the same decision under either definition.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion Petitioner shows, based on the present record, where each of the limitations of claim 1 is taught or suggested in the combination of Sun, Dodick, and Sharma. Pet. 21–30. For the reasons discussed supra §III.F.1 we are not persuaded by Patent Owner’s argument that Sun does not disclose treating the claimed patient population. Prelim. Resp. 45–52. Petitioner also provides evidence-backed reasoning to support its argument that a skilled artisan would have had reasons for treating the claimed patient population with galcanezumab. Pet. 30–33. Patent Owner does not challenge that the POSA would have been so motivated and, on the present record, we find Petitioner’s reasoning persuasive. See generally, Prelim. Resp. Finally, Petitioner provides reasons why the POSA would reasonably have expected treating the claimed refractory migraine patients to be successful. Pet. 33– 40. For the reasons discuss supra § III.F.3, we are not persuaded by Patent Owner’s argument that the POSA would not reasonably have expected success. Prelim. Resp. 52–56. Accordingly, we conclude that Petitioner has established a reasonable likelihood that it will prevail in showing that claim 1 would have been obvious over the combination of Sun, Dodick, and Sharma. 30 are taught or suggested in the prior art, and that these claims would have been obvious over the combination of Sun, Dodick, and Sharma. Pet. 42– 45. Petitioner’s contentions with respect to these dependent claims are, at this stage, uncontested by Patent Owner. We have considered Petitioner’s showing with respect to dependent claims 2–30 and find that it is backed by documentary and testimonial support sufficient to support institution.” slip op. at 48
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“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.’”); Prelim. Resp. 8 (“The parties agree that the preamble . . . is limiting at least because it provides context and antecedent basis to the terms in the body of the claim, e.g., ‘administering to the subject a therapeutically effective amount’ of the recited antibody.”). We agree that the preamble of claim 1 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 (Fed. Cir. 2021) (“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”). slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,028,161 - PTAB · Sep 27, 2022 · IPR2022-00738 · APJ David Cotta · IPR · Institution
The Board instituted review of claims 1–30 on both §103 grounds, finding a reasonable likelihood that the claims would have been obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“cumulative of Zeller, as discussed above, they were considered by the Examiner. Accordingly, we determine that the first part of the Advanced Bionic framework is satisfied. We turn next to the second part of the Advanced Bionic framework, i.e., determining whether Petitioner has demonstrated material error by the Office. Patent Owner argues that Petitioner did not identify any material error” slip op. at 11
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“4. Conclusion Petitioner shows, based on the present record, where each of the limitations of claim 1 is taught or suggested in the combination of Sun, Dodick, and Sharma. Pet. 21–30. For the reasons discussed supra §III.F.1 we are not persuaded by Patent Owner’s argument that Sun does not disclose treating the claimed patient population. Prelim. Resp. 45–52. Petitioner also provides evidence-backed reasoning to support its argument that a skilled artisan would have had reasons for treating the claimed patient population with galcanezumab. Pet. 30–33. Patent Owner does not challenge that the POSA would have been so motivated and, on the present record, we find Petitioner’s reasoning persuasive. See generally, Prelim. Resp. Finally, Petitioner provides reasons why the POSA would reasonably have expected treating the claimed refractory migraine patients to be successful. Pet. 33– 40. For the reasons discuss supra § III.F.3, we are not persuaded by Patent Owner’s argument that the POSA would not reasonably have expected success. Prelim. Resp. 52–57. Accordingly, we conclude that Petitioner has established a reasonable likelihood that it will prevail in showing that claim 1 would have been obvious over the combination of Sun, Dodick, and Sharma. 30 are taught or suggested in the prior art, and that these claims would have been obvious over the combination of Sun, Dodick, and Sharma. Pet. 42– 45. Petitioner’s contentions with respect to these dependent claims are, at this stage, uncontested by Patent Owner. We have considered Petitioner’s showing with respect to dependent claims 2–30 and find that it is backed by documentary and testimonial support sufficient to support institution.” slip op. at 48
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Prelim. Resp. 6–7. Petitioner offers a similar definition of the POSA, with the principal differences being: 1) that Petitioner does not identify neurobiology and pharmacology as relevant fields for a POSA having an M.D., and 2) that Petitioner does not propose that a POSA could also be part of a multi-disciplinary team. Pet. 11. 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 ’160 patent. 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)). At this stage in the proceeding, the differences between Petitioner’s and Patent Owner’s identification of the POSA do not materially affect our decision with respect to institution. Put another way, we would reach the same decision under either definition.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“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.’”); Prelim. Resp. 8 (“The parties agree that the preamble . . . is limiting at least because it provides context and antecedent basis to the terms in the body of the claim, e.g., ‘administering to the subject a therapeutically effective amount’ of the recited antibody.”). We agree that the preamble of claim 1 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, 1341 (Fed. Cir. 2021) (“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”). slip op. at 15
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,028,160
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.