- PTAB · Mar 22, 2023 · IPR2023-00533 · APJ John G New · IPR · Institution
The Board instituted inter partes review of claims 1–9, 34–39, 41–43, and 45 on the seven grounds instituted in the Mylan IPR, and granted Celltrion’s motion for joinder.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Celltrion Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Having considered the unopposed motion for joinder, and our decision to institute the same grounds in the Mylan IPR, we determine that Petitioner Celltrion has established persuasively that joinder is appropriate and will have little to no impact on the timing, cost, or presentation of the trial on the instituted ground. Thus, in consideration of the foregoing, and in the manner set forth in the following Order, the Motion for Joinder is GRANTED.” slip op. at 6
NonePatents in suitUS 10,888,601 - PTAB · Mar 22, 2023 · IPR2023-00532 · APJ John G New · IPR · Institution
The Board instituted review of claims 1, 3–11, 13, 14, 16–24, and 26 on six anticipation and obviousness grounds, and granted Celltrion’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Celltrion Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 5
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“(c) JOINDER. — If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314. As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: Set forth the reasons joinder is appropriate; identify any new grounds of unpatentability asserted in the petition; and explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB” slip op. at 5
NonePatents in suitUS 10,130,681 - Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentablePTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29
- ExcludeMotion to exclude, deniedDenied
“As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“For the above reasons, on the full trial record we determine that” slip op. at 26
Patent outcomesUS 10,682,414 mixed§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,682,414 - Apple, Inc. v. 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 - PTAB · Oct 19, 2022 · IPR2022-01513 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8 on all five grounds previously instituted in IPR2022-00517 and granted Teva’s motion to join that proceeding.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Teva’s Petition here is substantively identical to Mylan’s Petition in the -517 IPR, challenging the same claims based on the same art and the same grounds. Compare IPR2022-00517, Paper 1 with IPR2022-01513, Paper 2. For the same 1 European Medicines Agency, Assessment Report, Xarelto, EMA/CHMP/794349/2012 (2013). Ex. 1005 (“EMA”). 2 Foley et al., Antithrombotic therapy in peripheral artery disease, 21 VASCULAR MED. 156–69 (2016). Ex. 1006 (“Foley”). 3 Plosker, Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, 74 DRUGS 451–64 (2014). Ex 1007 (“Plosker”). reasons stated in our Decision Granting Institution of Inter Partes Review in IPR2022-00517, we institute trial in this proceeding on the same five grounds. See IPR2022-00517, Paper 15.” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Motion for Joinder. Based on authority delegated to us by the Director, we have discretion to join an inter partes review to a previously instituted inter partes review. 35 U.S.C. § 315(c). Section 315(c) provides, in relevant part, that “[i]f the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311.” Id. When determining whether to grant a motion for joinder, we consider factors such as timing and impact of joinder on the trial schedule, cost, discovery, and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 4
NonePatents in suitUS 10,828,310 - Thorne Research, Inc. v. Trustees Of Dartmouth CollegeAll claims unpatentablePTAB · May 31, 2022 · IPR2021-00268 · APJ John E Schneider · IPR · Final written decision
Claim 2 is unpatentable as anticipated by Stamler and, alternatively, obvious over Stamler.
RulingsFinal written decision- BurdenDecided for petitioner
“2. Anticipation2 “Under 35 U.S.C. § 102, every limitation of a claim must identically appear in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454, 1457 (Fed. Cir. 1997). “[U]nless a reference discloses within the four corners of the document not only all of the 2 As noted above, the pre-AIA provisions of 35 U.S.C. apply to the ’086 patent. the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Entitled to earlier dateDecided for patent owner
“Under § 120, a patent is entitled to the priority date of an earlier filed application if (1) the written description of the earlier filed application discloses the invention claimed in the later filed application sufficient to satisfy the requirements of § 112; (2) the applications have at least one common inventor; (3) the later application is filed before the issuance or abandonment of the earlier filed application; and (4) the later application contains a reference to the earlier filed application. In re NTP, Inc., 654 F.3d 1268, 1277 (Fed. Cir. 2011); see also 35 U.S.C. § 120 . As discussed above and in our Decision to Institute, the ’086 patent meets this criterion. While we agree with Petitioner that the face of the ’086 patent does not include a citation of the ‘701 application, the specification does contain a clear claim of priority back to the ’701 application. Ex. 1001, col. 1. ll. 7–13; Ex. 1004 1.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“the art offered by Patent Owner in the ’1795 IPR, which, as noted above, also involved the ’086 patent, should apply to this proceeding, namely “someone with a Ph.D. in biochemistry or similar field in the pharmaceutical sciences, with familiarity and experience with pharmacokinetics.” Pet. 33. Patent Owner does not dispute Petitioner’s definition and, indeed, Patent Owner’s expert, Dr. Amiji, used the same definition in his analysis. Ex. 2014 ¶ 21. For purposes of this Decision, therefore, we adopt Petitioner’s description. We also note that the applied prior art reflects the appropriate level of skill at the time of the claimed invention and supports Petitioner’s definition. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We have considered the arguments presented by the parties, and find that our initial construction is proper for the reasons set forth in the ’1795 proceeding. Ex. 1018 12–14. We decline to adopt Patent Owner’s construction that calls for an isolation step separate from the process used to manufacture synthetic NR.” slip op. at 16
Patent outcomesUS 8,383,086 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,383,086 - Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentablePTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision
The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedOther
“It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner
“Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16
Patent outcomesUS 10,561,659 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,561,659 - Commonwealth Scientific And Industrial Research Organisation v. BASF Plant Science GmbHAdverse judgmentPTAB · Jan 11, 2022 · PGR2021-00004 · APJ Jo-Anne M Kokoski · PGR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment after it disclaimed all challenged claims, claims 1–9.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Pursuant to our rules, “[a]ctions construed to be a request for adverse judgment include . . . [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). Here, Patent Owner disclaimed claims 1–9 of the ’183 patent under 35 U.S.C. § 253 according to the procedures set forth in 37 C.F.R. § 1.321(a). See Ex. 2001, 1. Accordingly, we construe Patent Owner’s Disclaimer as a request that the Board enter judgment against it with respect to claims 1–9, the only claims at issue in this trial, and we grant that request. See Unified Patents, LLC v. Arsus, LLC, IPR2020-00948, Paper 18 at 2 (PTAB Jan. 27, 2021) (construing statutory disclaimer of all challenged claims as a request for adverse judgment), aff’d Case No. 2021-01648, 2021 WL 5315423 (Fed. Cir. Nov. 16, 2021).” slip op. at 2
NonePatents in suitUS 10,533,183
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.