PTAB
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  • PTAB · Jan 26, 2022 · IPR2021-01272 · APJ Timothy G Majors · IPR · Institution

    The Board instituted review of claims 55–63, 66–69, 80–91, 94–96, 126–130, 132, and 133 on all asserted grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied

      “We do not agree with Patent Owner that Factor 1 weighs in favor of discretionary denial here. To the extent there is any relationship between Illumina and the earlier challengers, we find that such relationship is not a “significant” one, such as contemplated by Valve. First, although Illumina, Natera, Quest, and Labcorp are each defendants accused of infringing the ’277 patent, unlike Valve, they are not co-defendants in the same case. Valve at 9–10. Nor were Illumina and the other parties sued at the same time—Patent Owner instead sued those parties in seriatim district court complaints filed over approximately six months starting in mid-2020. Exs. 2086, 2087, 2088, and 2089. Thus, the staggered nature of the alleged follow-on challenges by those parties can be reasonably explained by Patent Owner’s elected timetable for suing the defendants.” slip op. at 19

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

      “7. Balancing the Fintiv Factors Altogether, considering and balancing the Fintiv factors holistically, we decline to invoke our authority to deny the Petition on a discretionary basis under § 314(a).” slip op. at 38

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “IV. CONCLUSION On this preliminary record, Petitioner has established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable based on grounds advanced in the Petition. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is granted, and we institute inter partes review of claims 55–63, 66–69, 80–91, 94–96, 126–130, 132, and 133 based on the grounds asserted in this Petition;” slip op. at 66

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

      “Based on the current record, we find that Petitioner has met its institution burden in establishing that Landes is entitled to claim the priority benefit of the Landes Provisional and, thus, is prior art to the ’277 patent. On the matter of written description support under § 112, the claims of Landes (claims 1–4) appear unchanged in the Landes Provisional (claims 1– 4). Compare Ex. 1003, 22–23, with Ex. 1006, 21–22. Petitioner also provides citations to the specification of the Landes Provisional that, while broad, correspond to several disclosed alternative embodiments, and the various working examples (Materials and Methods and Experimental Examples 1–5) that describe and explain how to carry out the methods claimed. Pet. 17–19 (citing, e.g., Ex. 1006, 8:7–9:27, and 10:1–20:12). Patent Owner cites precedents for the proposition that, in some circumstances, the presence of the same claim language in an original disclosure may not be enough to satisfy the description requirement. Prelim. 49 Resp. 23–24. But Patent Owner provides neither specific argument nor evidence that this is one of those circumstances. If Patent Owner believes there is some particular deficiency with respect to Landes’s claims and the written description requirement, Patent Owner leaves it unsaid.” slip op. at 49

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 7,332,277
  • PTAB · Jan 11, 2022 · IPR2021-01201 · APJ David Cotta · IPR · Institution

    Instituted review of claims 1–3, 5–8, 10–18, and 20 on all three proposed grounds because the petition showed a reasonable likelihood of prevailing on obviousness.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “(“[T]he PTO is permitted, but never compelled, to institute an IPR proceeding.”). In determining if non-institution under § 325(d) is proper, we follow the two-part framework set forth in Advanced Bionics, LLC v. MED- EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) (precedential, designated March 24, 2020). Specifically, the Board must determine: “(1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Id. at 8.” slip op. at 6

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “Id. at 6. “These factors relate to whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Id. In evaluating these factors, we take “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. (citing Patent Trial and Appeal Board Consolidated Trial Practice Guide November 2019 (“CTPG”), 584). We address the Fintiv factors below.” slip op. at 11

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “IV. CONCLUSION For the foregoing reasons, we determine Petitioner has demonstrated there is a reasonable likelihood it would prevail in establishing the unpatentability of claims 1–3, 5–8, 10–18, and 20 as having been obvious over the teachings of ChloraPrep PAR alone or in combination with Degala. Accordingly, based on the Supreme Court’s holding that a decision under § 314 may not institute review on fewer than all claims challenged in the petition, we institute on all three proposed challenges. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1355–56 (2018); see also PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition”). Additionally, we decline to exercise our discretion under 35 U.S.C. § 325(d) or § 314 to deny the proposed challenges to patentability. Our factual findings, conclusions of law, and determinations at this stage of the proceeding are preliminary, and based on the evidentiary record developed thus far. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our final decision will be based on the record as fully developed during trial.” slip op. at 45

    • Skill levelSkill level board ownDecided for patent owner

      “encountered in the art, the art’s solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner contends that a person of ordinary skill in the art at the time of the alleged invention would have possessed “at least an undergraduate degree in the pharmaceutical sciences, pharmacy, biochemistry, microbiology, or a related field, and a Masters in a similar field and at least 6 years industry experience or a Ph.D in a similar field and at least 4 years industry experience in the field developing sterilization processes, sterile medical devices and/or formulations or tests for evaluating sterility.” Pet. 15. Patent Owner states that it “does not believe the particular definition of a POSA is determinative at this stage because the Petition can be denied under Petitioner’s own proposed skill level.” Prelim. Resp. 16. Patent Owner nonetheless challenges Petitioner’s proposal, stating:” slip op. at 18

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,398,642
  • PTAB · Jan 11, 2022 · IPR2021-01202 · APJ Georgianna W Braden · IPR · Institution

    The Board instituted IPR on claims 1–3, 5–8, and 10–19 for all three grounds, finding a reasonable likelihood of obviousness over ChloraPrep PAR alone or with Degala.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner

      “We turn next to the second part of the Advanced Bionics framework and consider Becton factors (c), (e), and (f) in determining “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, Paper 6 at 10. As explained below in our patentability analysis, Petitioner has demonstrated a reasonable likelihood that it will prevail in showing that at least one of the challenged claims would have been obvious over the cited art. In this regard, Petitioner has shown the materiality of Degala (as applied in combination with ChloraPrep PAR) to the patentability of the challenged claims. See infra §§ III. We find that the Examiner erred in overlooking the teachings of Degala, including specifically Degala’s express description of a “method for sterilizing an antiseptic solution.” Ex. 1007 ¶ 7. Furthermore, Petitioner has presented additional evidence and facts that were not before the Examiner, including support for why an ordinarily skilled artisan would have combined the teachings of Degala and ChloraPrep PAR. See Pet. 61– 63; Ex. 1003 ¶¶ 163–166. Thus, Becton factors (c), (e), and (f) weigh heavily in favor of finding error under the second part of the Advanced Bionics framework. Accordingly, we decline to exercise our discretion to deny institution under 35 U.S.C. § 325(d).” slip op. at 12

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “Based on the facts of the case as discussed below, we find that the merits of the case support institution. Our determination is preliminary, however, and we are not prepared on this preliminary record to characterize the merits of Petitioner’s challenge as especially “strong.” Accordingly, we find this factor to be neutral. 7. Summary We consider the above factors and take “a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Fintiv, Paper 11 at 6. Weighing the factors together, we determine that they weigh against exercising our discretion not to institute inter partes review. For the above reasons, we do not exercise our discretion under 35 U.S.C. § 314(a) to deny institution of a trial proceeding.” slip op. at 20

    • Skill levelSkill level board ownOther

      “Response, it “does not believe the particular definition of a POSA is determinative at this stage because the Petition can be denied under Petitioner’s own proposed skill level.” Prelim. Resp. 16. Patent Owner nonetheless challenges Petitioner’s proposal, stating: Petitioner’s proposal regarding the level of ordinary skill for a POSA is disconnected from the disclosure of the 067 Patent. (Pet. 15.) As a preliminary matter, even though the 067 Patent relates to sterilized chlorhexidine products, Petitioner’s proposed definition requires no experience with antiseptics or chlorhexidine. Thus, under Petitioner’s definition, the POSA who is generally aware of “sterilization processes, sterile medical devices and/or formulations or tests for evaluating sterility” may be unfamiliar with the unique challenges of sterilizing antiseptics such as CHG or creating antiseptic products and articles that are able to contain and deliver sterilized CHG compositions. Additionally, while not requiring knowledge in the relevant field (experience with sterilization processes for medical products and their components, as well as familiarity with antiseptics such as chlorhexidine), Petitioner artificially inflates the educational requirements without explanation to require a Master’s or PhD. Id. at 16–17 (emphasis and footnote omitted). At this stage of the proceeding, we determine that a person of ordinary skill in the art at the time of the invention would have possessed at least an undergraduate degree in the pharmaceutical sciences, pharmacy, biochemistry, microbiology, or a related field, with experience with sterilization processes for medical products and their components, as well as familiarity with antiseptics such as chlorhexidine. Such level of skill in the art is consistent with the ’067 patent and the asserted prior art of record.” slip op. at 26

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionOther

      “Moreover, Patent Owner’s proposed construction is consistent with the Specification, which discloses that “the terms the chlorhexidine article, or components and compositions thereof, may be referred to as the ‘sterilized’ component or composition upon being exposed to suitable processing where such sterility can be validated.” Ex. 1001, 3:58–65. Accordingly, on this preliminary record, we construe “sterilized” to mean that the “component or composition has been subjected to a suitable sterilization process such that sterility can be validated.” Additionally, based on our review of the Petition and Preliminary Response, we do not believe that any other claim terms require express construction at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017); Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 23

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,688,067
  • PTAB · Dec 8, 2021 · IPR2021-00972 · APJ David Cotta · IPR · Institution

    Instituted IPR of claims 1–23 on all three asserted §103 grounds; Apple showed a reasonable likelihood that at least one challenged claim is unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “We typically take courts’ trial schedules at “face value,” and decline Petitioner’s invitation to speculate that the target date for completion of the ITC Investigation will slip as a result of the COVID-19 pandemic. Fintiv, IPR2020-00019, Paper 15 at 13 (informative). Accordingly, for purposes of analyzing this factor, we assume that the ITC Investigation will conclude on October 26, 2022. We also decline Petitioner’s invitation to assume an earlier date for issuance of our FWD. Although we appreciate Petitioner’s willingness to expedite resolution of this case, Patent Owner raises valid concerns that compressing the reply period will also compress the window for taking depositions. Moreover, the statutory due date for our FWD is triggered by the date of our institution decision and is unaffected by the date on which Petitioner files its reply. See 35 U.S.C. § 316(a)(11). Given that our FWD in this case is due seven weeks after the targeted completion of the ITC Investigation, we determine that this factor weighs marginally in favor of exercising our discretion to deny institution.” slip op. at 10

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “Petitioner shows, based on this preliminary record, where each of the limitations of the challenged claims is taught or suggested by the combination of Shmueli and Osorio. Pet. 11–64. Petitioner’s assertions above are backed by the cited prior art and by the testimony of its declarant, Dr. Chaitman. Id.; see also Ex. 1003 ¶¶ 68–150. On this preliminary record, we determine that Petitioner’s arguments and evidence are sufficient for purposes of institution. We focus our discussion on Patent Owner’s arguments that Petitioner has not sufficiently supported a motivation to combine Shmueli and Osorio and that Shmueli and Osorio do not disclose “key elements” of the independent claims. Prelim. Resp. 30–42.” slip op. at 36

    • Skill levelSkill level board ownOther

      “As such, Dr. Chaitman would appear to qualify as one of ordinary skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we note that we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., No. 10-CV-1835 JAP TJB, 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary” Ex. 2001 ¶¶ 52–53 (emphasis added).9 Indeed, considering that the claims of the ’941 patent relate to, e.g., “method[s] of cardiac monitoring” to “confirm a presence of the arrhythmia,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. Ex. 1001, 17:1–18. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial. C. Claim Construction” slip op. at 25

    • Expert testimonyPetitioner expert creditedOther

      “cardiac arrhythmia as opposed some other heart condition. Id. at 31–32. In this respect Patent Owner’s declarant, Dr. Efimov, testifies that Shmueli makes no attempt to define “irregular heart condition” with any specificity, and “one can only speculate” as to its meaning because “numerous conditions can be considered heart irregularities: normal autonomic nervous system control, autonomic dysfunction, heart failure, ischemia, myocardial infarction, heart block, etc.” Ex. 2001 ¶ 69. At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that Shmueli discloses “both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 54 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of the ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, which is “one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. Considering the present record, Petitioner has established sufficiently 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. See Pet. 13–14 (citing, e.g., Ex. 1003 ¶ 54).” slip op. at 37

    § 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,638,941
  • PTAB · Dec 8, 2021 · IPR2021-00971 · APJ Robert A Pollock · IPR · Institution

    The Board instituted IPR on claims 1–30 on all grounds in the Petition, finding a reasonable likelihood that at least one challenged claim is unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied

      “and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 58 & n.2, (“Trial Practice Guide”).6 We consider the following factors to assess “whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding”: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 5–6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”). In evaluating these factors, we “take[] a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id. at 6. Upon consideration of these factors, we decline to exercise our discretion to deny the Petition. A. Whether the Court Granted a Stay or Evidence Exists That One May Be Granted if a Proceeding is Instituted” slip op. at 10

    • Skill levelSkill level board ownOther

      “skill in the art under Patent Owner’s proposed definition. Given Patent Owner’s focus on “specialized engineering skills necessary for the design, configuration, and operation of portable computing devices,” however, we consider the weight of his, or any other expert’s opinions, in light of the strengths and weaknesses of their background. We further note that the research and development of medical devices is often the work of a multidisciplinary team, and courts and tribunals have frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary.” Ex. 2001 ¶¶ 52–53 (emphasis added).10 Indeed, considering that the ’731 patent “relates to methods and systems for managing health and disease such as cardiac diseases including arrhythmia and atrial fibrillation,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial.” slip op. at 27

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “We interpret a claim “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(b). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes 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))). At this stage of the proceeding, no term requires construction. 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.”). The parties are, of course, welcome to address the meaning of any relevant claim term at trial. D. Ground 1: Obviousness over Shmueli” slip op. at 29

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “At this stage of the proceeding, however, we credit Dr. Chaitman’s testimony that, “Shmueli discloses both detecting the ‘irregular heart condition’ based on PPG data and confirming the diagnosis with an ECG measurement.” Ex. 1003 ¶ 48 (citing Ex. 1004, Abstract, Fig. 8; 8:23–28). And although Shmueli “offers an expansive definition of ‘irregular heart condition,’” one of ordinary skill in the art would have understood this term as referring to arrhythmia, “which is one of the most obvious (if not the most obvious) types of ‘irregular heart condition[s]’ that can be determined using PPG and ECG data.” Id. (citing, Ex. 1016, 6081; Ex. 1020, Abstract, 44:29– 32; Ex. 1011, Abstract; Ex. 1023, 2; Ex. 1047, 320–321; Ex. 1001, 1:40–42; Ex. 1004, 8:11–13, 15:3–5) (alteration in original). Considering the present record, Petitioner has established sufficiently 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. See Pet. 10–12 (citing, e.g., Ex. 1003 ¶ 48).” slip op. at 33

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 10,595,731
  • PTAB · Dec 8, 2021 · IPR2021-00970 · APJ Robert A Pollock · IPR · Institution

    The Board instituted IPR on claims 1–20 under the asserted obviousness grounds based on Shmueli and Osorio, with Hu for claims 7–9 and 17–19.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “and merely argues that Petitioner does not rely on Hu to correct the alleged deficiencies of Shmueli–Osorio combination of Ground 1. Prelim. Resp. 42– 43. As discussed above, however, we do not find Petitioner’s arguments with respect to Ground 1 deficient for the purposes of institution. Accordingly, on this record, Petitioner has shown sufficiently that one of ordinary skill in the art would have considered at least one claim of the ’499 patent obvious for the reasons set forth in the Petition.” slip op. at 47

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “grounds, arguments, and/or evidence than the ITC Investigation. Although Patent Owner argues that the prior art cited in the Petition has “already entered the ITC case,” that argument was made before Petitioner narrowed the number of prior art references it intended to rely upon, as required by the ITC’s Order Setting Procedural Schedule. Ex. 2006; Ex. 1057. Currently there does not appear to be any overlap in arguments or evidence between the two proceedings. Moreover, we agree with Petitioner that its stipulation mitigates to some degree concerns of duplicative efforts and possibly conflicting decisions between the Board and the ITC. Indeed, Petitioner’s stipulation echoes the one cited in Sand Revolution II, LLC v. Continental Intermodal Group-Trucking LLC, which the Board determined weighed “marginally in favor of not exercising discretion to deny institution.” IPR2019-01393, Paper 24 at 16 (PTAB June 16, 2020) (informative). Finally, we agree with Petitioner that this proceeding will likely include claims that are not at issue in the ITC Investigation. We are not persuaded by Patent Owner’s argument that Petitioner has failed to explain why the narrowed set of claims would be substantially different than those challenged in the IPR petition because, based on the ITC’s Order Setting Procedural Schedule, Patent Owner had yet to narrow the number of asserted claims as of the deadline for Petitioner to brief this issue. See Ex. 3001 (email from the Board authorizing the parties to brief discretionary denial issues, setting a deadline of October 25, 2021 for Petitioner to file its” slip op. at 18

    • Skill levelSkill level board ownOther

      “frequently identified the hypothetical person of ordinary skill as a composite or team of individuals with complementary backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v. Anchen Pharm., Inc., 2012 WL 1065458, at *19, *22 (D.N.J. Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013) (collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases). In the present case, such a team might include specialists in electrical engineering, mechanical engineering, biomedical engineering, computer science, and cardiology. In this respect, Patent Owner’s expert does not discount the benefit of a background in cardiology. In particular, Dr. Efimov testifies that although a cardiologist may or may not possess the specialized engineering skills to understand the design, configuration, and operation of the subject technology, “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with arrhythmia detection tools would also be necessary” Ex. 2001 ¶ ¶ 51–52 (emphasis added). Indeed, considering that the ’499 patent “relates to methods and systems for managing health and disease such as cardiac diseases including arrhythmia and atrial fibrillation,” we find it reasonable that one of ordinary skill in the art would encompass a multidisciplinary team including a cardiologist. In view of the above, we provisionally define one of ordinary skill in the art as a multidisciplinary team comprising persons with advanced degrees in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology. The parties are welcome to further address the level of ordinary skill in the art at trial.” slip op. at 28

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Furthermore, at this stage in the proceeding, we need only construe the claims to the extent necessary to determine whether to institute inter partes 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))). Patent Owner notes that claim terms “heart rate sensor” and those relating to “alert” are at issue in the related ITC Investigation but neither party proposes any construction here. See Prelim. Resp. 29 (citing Ex. 2009). At this stage of the instant proceeding no term requires construction. 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.”). The parties are, of course, welcome to address the meaning of any relevant claim term at trial. D. Ground 1: Obviousness over Shmueli and Osorio” slip op. at 29

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 9,572,499
  • PTAB · Nov 24, 2021 · IPR2021-00935 · APJ David Cotta · IPR · Institution

    The Board instituted IPR on claims 1–3, 6, 7, 9–11, and 13 because Petitioner showed a reasonable likelihood that at least one challenged claim is obvious over the asserted grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “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.” We have reviewed the arguments and evidence of record. Based on the preliminary record, we find that Petitioner has established a reasonable likelihood that at least 1 of the challenged claims is unpatentable based on the grounds advanced in the Petition. Thus, for reasons explained below, we institute inter partes review of claims 1–3, 6, 7, 9–11, and 13 of the ’335 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In the Preliminary Response, Patent Owner does not oppose Petitioner’s proposal, nor does it offer a proposal of its own. See generally Prelim. Resp. Notably, Patent Owner’s declarant, Dr. Jones, accepts Petitioner’s definition of the POSA. Ex. 2002 ¶ 20 (“For purposes of this declaration, I accept Dr. Zadok’s proposed qualifications of a [POSA].”). Petitioner’s definition of the POSA is consistent with the specification of the ’335 patent and the prior art currently of record. Accordingly, we adopt it for purposes of this Decision. 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 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “The parties do not propose a particular construction for any claim term. Pet. 9; see Prelim. Resp. In the course of our discussion, we highlight several claim construction issues that the parties may wish to address. However, at this stage in the proceeding, we determine that no explicit construction of any claim term is necessary to resolve the issues 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 9

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted

      “Petitioner shows, based on this preliminary record, where each of the 16 limitations of the challenged claims is taught or suggested by Kahn. Pet. 16–61. Petitioner’s assertions above are backed by the cited prior art and by the testimony of its declarant, Dr. Zadok. Id.; see also Ex. 1003 ¶¶ 101–209. On this preliminary record, we determine that Petitioner’s arguments and evidence are sufficient for purposes of institution. We focus our discussion on the elements of the challenged claims that Patent Owner contends are not disclosed or suggested by Kahn.” slip op. at 16

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,762,335
  • PTAB · Nov 24, 2021 · IPR2021-00934 · APJ Karl D Easthom · IPR · Institution

    Instituted IPR of claims 1, 4, 8, and 15 based on obviousness over Chefalas and Tivoli Redbook.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “partes review (“IPR”). See 35 U.S.C. § 314(b) (2018). Under 35 U.S.C. § 314(a), the Board may not authorize an inter partes review unless the information in the Petition and the Preliminary Response “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons that follow, we institute an inter partes review as to the challenged claims, claims 1, 4, 8, and 15 of the ’671 patent, on the sole ground of unpatentability presented.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Level of Ordinary Skill in the Art Relying on the testimony of Dr. Zadok, Petitioner contends that [a] person having ordinary skill in the art (PHOSITA) at the time of the ’671 Patent would have been a person having at least a Bachelor’s Degree in an Engineering discipline such as Electrical, Computer, or Software Engineering, or a Bachelor’s Degree in Computer Science, Information Systems, or equivalent degree, and at least two years of relevant experience in the research, design, development and/or administration of data storage systems, with additional education substituting for less experience and vice versa. Pet. 6 (citing Ex. 1003 ¶¶ 89–90). The Preliminary Response does not address Petitioner’s proposed level of skill. The present record, including the ’671 patent specification and prior art, supports Petitioner’s proposed level of ordinary skill in the art, and we adopt it, at least for purposes of institution. 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))). C.” slip op. at 7

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “On this preliminary record and for purposes of institution, no claim terms require explicit construction. See, e.g., Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 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))). D.” slip op. at 12

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

      “Id. at 33–34 (emphasis by Petitioner) (quoting Ex. 1005, 59). This passage and others noted below appear to describe transmitting metadata generated at the client to store at the server database.10 The Petition also explains that a person of ordinary skill in the art “would be motivated to update the metadata” in order to locate the data objects during a “disaster recovery,” otherwise “the backup system would be unable to locate the proper data in order to perform the restoration, rendering the secondary copies useless.” 10 This passage also appears to disclose copying “metadata from this client node.” Similarly, Tivoli Redbook describes “two sessions” between “[t]he IBM Tivoli Storage Manager server and client node . . . : one to move metadata and the other to move data.” Ex. 1005, 59 (emphasis added). During trial, the parties will have the opportunity to address any difference between moving or storing metadata from the client, as described by Tivoli Redbook, and copying metadata, as claimed. Id. at 34–35 (emphasis added) (citing Ex. 1003 ¶¶ 141–142). Petitioner applies this updating motivation to copying, and the parties agree that copying includes updating. See Pet. 43–44; Ex. 2002 ¶ 41 (“‘Updating,’ in some circumstances, can be performed by ‘copying’ but is not limited to being performed by ‘copying.’); Prelim. Resp. 21 (quoting Ex. 2002 ¶ 41). Similarly, Tivoli Redbook states that during journal-based backup “[t]he backup-archive client, as always, still sends data (files) to the IBM Tivoli Storage Manager server and, as has always been the case, the IBM Tivoli Storage Manager server populates the IBM Tivoli Storage Manager database with the file details and location.” Ex. 1005, 113 (emphasis added); see Pet. 34 (quoting same; citing Ex. 1003 ¶¶ 138–140). Such populating of “file details and location” further suggests for institution purposes copying metadata associated with the file details at the second metabase, as Petitioner’s comparison to Chefalas’s Figure 5 and other metadata also suggests. See Pet. 45–46. And “[i]n all cases, ‘[w]hen the file or object has been committed to a storage pool device, the IBM Tivoli Storage Manager database is updated to keep track of its location in the database Tracking section.’” Id. at 34 (quoting Ex. 1005, 59) (emphasis omitted). On this preliminary record, Tivoli Redbook discloses updating metadata, and at least suggests copying metadata, as Petitioner argues. See Pet. 34–36 (updating), 43–48 (copying).” slip op. at 36

    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,725,671
  • PTAB · Oct 19, 2021 · IPR2021-00788 · APJ Timothy G Majors · IPR · Institution

    The Board instituted IPR on claims 55–63, 66–69, 80–94, 96, and 126–133 after finding a reasonable likelihood of obviousness over the asserted combinations.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “Only if the same or substantially the same art or arguments were previously presented to the Office do we then consider whether petitioner has demonstrated error. Advanced Bionics at 8–10. “If the petitioner fails to show that the Office erred, the Director may exercise his discretion not to institute inter partes review.” Id. at 8–9 (“If a condition in the first part of the framework [i.e., substantially same art or arguments] is satisfied and the petitioner fails to make a showing of material error, the Director generally will exercise discretion not to institute inter partes review”). “At bottom, this [§ 325(d)] framework reflects a commitment to defer to previous Office evaluations of the evidence of record unless material error is shown.” Id. at 9. On the question of material error, “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id.” slip op. at 19

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “only estimated. Prelim. Reply 6. The schedule submitted here is unsigned by the court. Ex. 2035, 14. Although we usually take courts’ trial schedules at “face value,”23 that is not necessarily so with trial dates that are only estimates. See, e.g., Progenity, Inc. v. Natera, Inc., IPR2021-00279, Paper 12 at 29 (PTAB June 11, 2021) (concluding “there is no trial date scheduled for the parallel proceeding” based on an email from the court’s clerk merely providing an estimated trial date); Intel Corp., v. FG SRC LLC, IPR2020- 01449, Paper 13 at 15 (PTAB Mar. 3, 2021) (explaining that estimated trial dates are not firm trial dates). Therefore, “[w]hether the trial takes place before, contemporaneously with, or after our final written decision statutory deadline involves speculation.” Progenity, IPR2021-00279 at 29. In additional briefing, the parties further dispute whether trial is likely to commence on July 11, 2022. Petitioner contends the presiding judge (Judge Albright) has more pending patent cases on his docket than any other 22 We further consider the Natera lawsuit in light of the Fintiv factors, below in our discussion under Factor 6. 23 Fintiv, IPR2020-00019, Paper 15 at 13 (informative). 31 district court in the country, and that roughly 200 cases are scheduled for trial between now and the estimated trial date—including multiple additional cases that are also tentatively scheduled for trial on July 11, 2022. Prelim. Reply 7. Patent Owner responds that, although some of Judge Albright’s trials have been rescheduled to later dates, some cases have proceeded as scheduled and some have started earlier than scheduled. Prelim. Sur-Reply 7. From this, Patent Owner contends the court has signaled it plans to bring patent cases to trial at or near their estimated trial dates. Id. Petitioner raises legitimate questions about whether the court will be able to hold trial for the Quest lawsuit on July 11, 2022. But we cannot answer those questions. Nor can we say whether Patent Owner’s forecasts about potential trial timing will hold true. How the court might manage its large docket of patent cases, including scheduling any trial in this matter, involves guesswork from us on this record. In any event, even if the July 11, 2022, date had been firmly set, it is still within a few months of the Board’s deadlines and, balanced with other considerations (e.g., Petitioner’s diligence, low investment, and absence of overlapping validity arguments) discussed below, it would not weigh heavily in favor of discretionary denial.” slip op. at 31

    • 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 55–63, 66–69, 80–94, 96, and 126– 133 of the ’277 patent.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “encountered in the art, the art’s solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). Petitioner contends: A POSA in the field of the ’277 Patent would be a Ph.D., M.D. or M.D./Ph.D., with a doctoral degree or Board certification in medical genetics, human genetics, molecular genetics, clinical genetics or related fields, with 2-3 years of relevant research experience in an academic or industry setting in, e.g., prenatal or cancer diagnosis. Pet. 22–23 (citing Ex. 1002 ¶ 118). Patent Owner does not directly oppose Petitioner’s proposal. Prelim. Resp. 23. Patent Owner’s own proposal is similar but describes the fields of advanced study as including “area[s] such as genetics, biochemistry, molecular biology, cell biology, or microbiology.” 42 Id. Patent Owner proposes that a POSA would have “at least one to two years of work” in those areas and, alternatively, that a POSA “could have a Bachelor’s degree in one of the foregoing areas and at least three to four years of work in” such areas. Id. (citing Ex. 2001 ¶ 19). Petitioner’s proposal of the POSA level is more precise and appears to be generally consistent with the cited prior art. Accordingly, we adopt it for purposes of this Decision. 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)). We also note that Patent Owner’s declarant, Dr. Van Ness, testifies that the parties’ proposed POSA levels are not “materially different” and that his opinions would not change under either proposal. Ex. 2001 ¶ 21.” slip op. at 42

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 7,332,277
  • PTAB · Oct 19, 2021 · IPR2021-00791 · APJ David Cotta · IPR · Institution

    The Board instituted inter partes review of claims 1–9, 21, 23, and 24 on all asserted grounds, finding a reasonable likelihood that at least claim 1 is obvious.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner

      “Patent Owner contends that both Amicucci and Lo “discuss careful DNA extraction to avoid contamination and obtain clean samples.” Prelim. Sur-Reply 3. We agree. However, the physical means used to avoid contamination from unidentified sources in Amicucci and Lo are materially different from the specific teachings in Hahn and Jen that cell lysis is a source of DNA contamination in samples in which circulating fetal DNA is being analyzed. Lo’s use of N-glycosylase to eliminate uracil containing PCR products is also materially different from Han’s and Jen’s teachings that cell lysis is a source of DNA contamination. Patent Owner does not identify anything in Amicucci or Lo that suggests that cell lysis is a source of contamination or that would address contamination introduced by lysed cells. This is significant because Petitioner repeatedly invokes the identification of maternal cell lysis as a known source of DNA contamination as a reason to introduce an agent to inhibit cell lysis. Pet. 34– 35, 51–52. And, as explained below, we find such reasons persuasive on this preliminary record. For the above reasons, we do not agree with Patent Owner that Hahn and Jen (or the combinations of Chiu with Hahn, or Lo with Jen) are cumulative of Amicucci or Lo. The relied-upon disclosure and argument concerning Hahn and Jen in the asserted combinations is sufficiently unique on this record.” slip op. at 22

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “Accordingly, despite the overlap, in view of Petitioner’s stipulation, we determine this factor to not weigh in favor of discretionary denial.” slip op. at 32

    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

      “For the reasons discussed above, we find that Patent Owner’s argument and evidence on secondary considerations of obviousness are entitled to little weight at this stage. We will reevaluate, if appropriate and to the extent the arguments are preserved, based on a full trial record. Based on the preliminary record, the alleged secondary considerations do not outweigh the evidence of obviousness relied upon by Petitioner. Petitioner has established a reasonable likelihood that it will prevail in showing that at least claim 1 is obvious.” slip op. at 58

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

      “argument that a skilled artisan would have had reasons for adding a cell-lysis inhibitor to the methods suggested by Chiu and Hahn. Pet. 32–38. In general, Petitioner contends that, based on the combined teachings of Chiu and Hahn, a skilled artisan would have recognized the problem caused by lysis of maternal cells, liberation of maternal DNA, and “contamination” of the sample with such DNA. Id. (“A POSA considering Chiu would naturally consider Hahn’s teaching that avoiding such contamination would result in a more effective [cffDNA] sampling method”). Petitioner contends that a skilled artisan would have considered Abbott as identifying a “straightforward solution (preventing [WBC] cell lysis) to the need expressly identified by the combination of Chiu and Hahn (the need to avoid contamination of a sample with maternal DNA due to maternal cell lysis)” 49 and, thus, would have modified the method of Chiu and Hahn accordingly with a reasonable expectation of success. Id. at 32–38. Petitioner’s assertions above are backed by the cited prior art and by the testimony of its declarant, Dr. Wapner, which is uncontested and which we find credible at this preliminary stage. See, e.g., Ex. 1002 ¶¶ 106–148. Patent Owner does not, at present, contest Petitioner’s argument and evidence on the points above. Rather, Patent Owner points to alleged secondary considerations of nonobviousness, which we address in greater detail below. Prelim. Resp. 4–11.” slip op. at 49

    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 7,727,720
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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.