• Genus PLC v. Inguran, LLCInstituted
  PTAB · Dec 14, 2021 · IPR2021-01027 · APJ Ulrike W Jenks · IPR · Institution

  The Board instituted IPR of claims 1–5 on all three grounds, finding a reasonable likelihood that at least one challenged claim would be anticipated or obvious.

  RulingsInstitution decision

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

    “determine whether to institute an inter partes review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a)(2020). Inter partes review may not be instituted unless “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Supreme Court held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that a person of ordinary skill in the art would have had at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine” and “would have been well-acquainted with methods of commercial breeding of lines and breeds within a genetic nucleus for the purpose of promoting genetic progress, the use of sex-selected semen in breeding schemes, including those within the genetic nucleus, genetic evaluation of livestock for desirable and undesirable traits, and the use of genetic markers, e.g., SNPs, and various other genotype data, to guide selection strategies to 1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16, 2013. Because the priority application from which the ’734 patent issued was filed before that date, our citations to Title 35 are to its pre-AIA version. 2 Petitioner contends that claims 1–5 are anticipated by Dekkers, as evidenced by either Maxwell, Garner, or Kim. Pet. 26–41. Alternatively, Petitioner contends that claims 1–5 are obvious over Dekkers and either Maxwell, Garner, or Kim. Pet. 41–45. 3 In the table identifying ground III, Petitioner does not list Kim. Pet. 4. However, in the arguments provided for this ground in regard to claim 5, Petitioner includes Kim. Pet. 48. improve desirable traits and/or minimize undesirable traits.” Pet. 13 (citing Ex. 1002 ¶ 22). Patent Owner states, “[s]olely for purposes of this Preliminary Response, Patent Owner and its expert apply this portion of Petitioner’s proposal, while reserving the right to dispute it later.” Prelim. Resp. 17. On this record, we adopt Petitioner’s definition of the level of ordinary skill in the art as Patent Owner also does. We also 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)). B. Principles of Law” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “would not find the additional language in Petitioner’s proposed definition accurate in describing a genetic nucleus. Prelim Resp. 21 (citing Ex. 2001 ¶ 21). Patent Owner contends “that the plain and ordinary meaning of ‘genetic nucleus’ is ‘an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure.’” Id. (citing Ex. 2001 ¶ 24 (“The ’734 Patent does not specify this additional requirement as part of the meaning of ‘genetic nucleus,’ nor would the additional language be accurate in describing every genetic nucleus.”). On the present record, Petitioner has the better argument. The ’734 specification describes pig breeding as pyramid with the “nucleus herd” at the top of the pyramid and commercial farms at the bottom. Ex. 1001, 9:43– 44. “A nucleus herd is typically comprised of 12 to 15 lines, although any number of lines may be represented, with each line comprising a number of desirable traits. . . . Only the offspring with the highest measured selection index are retained in the nucleus herd.” Id. at 9:47–49. The retention of offspring with the most desirable features in the nucleus herd reasonably implies that these individuals are selected to propagate the desirable trait in the nucleus heard. Accordingly, at this stage of the proceeding, we construe “genetic nucleus” as “an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure, wherein certain offspring of the herd are used for breeding within the herd.”” slip op. at 12

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “the context of artificial insemination for the purpose of directing piglet production toward creating predominantly male or female offspring. Petitioner’s expert explains that the state of the art at the time the invention was made required at least an 80% or better sex sorted semen in order to be able to use the sorted semen in to skew the piglet production in a littler to be either predominantly female or male offspring. See Ex. 1002 ¶ 113. Specifically, Petitioner’s expert avers that one of ordinary skill in the art would have understood that “[f]rom a commercial pig production perspective, using semen with less than 80% sex skew (i.e., purity for X or Y chromosomes) would not be efficient or economical, and consumers (e.g., pig producers) would not purchase such poorly enriched samples.” Ex. 1002 ¶ 113. Petitioner’s expert testimony is supported by the teachings of Maxwell (Ex. 1005) and Garner (Ex. 1006), both of which are expressly cited in Dekkers as evidencing “sperm sexing technology . . . for the production of either male or female offspring for sire or dam lines.” See Ex. 1004, 396, 420, 422. In particular, Maxwell teaches that “[i]n combination with the orientating nozzle and changes in the design of the sorter electronics, this allowed significant increases in sorting rates (15 million spermatozoa per hour) to be achieved while maintaining more than 85% purity.” Ex. 1005, 81. In addition, Gardner teaches that “acceptable sperm sexing efficiency, usually at 90% accuracy.” Ex. 1006, Abstract. Based on the current record, Petitioner’s expert testimony reasonably supports the position that Dekkers application of sex sorting technology at the level of the nucleus or multiplication tiers would require at least an 80% sex sorting efficiency. Patent Owner contends that Petitioner is improperly relying on Maxwell and Garner in order to support its anticipation argument over Dekkers. Prelim. Resp. 26 (citing Callaway Golf Col. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir. 2009)). On the record at the stage of the proceeding, Petitioner has made an adequate showing to supports its anticipation argument. In particular, Dekkers disclosure of using sex sorted semen to allow for the production of either male or female offspring for sire or dam lines, reasonably suggests that the sorted sperm is at a sufficient purity level to achieve the stated result. Ex. 1004, 396. Petitioner relies on the testimony of its expert to establish that at the time the invention was made one of ordinary skill in the art would have understood that 80% or better sex sorted semen is a necessary level in order to skew the sex of the litter. See Ex. 1002 ¶ 113. Here, Petitioner’s expert testimony is supported by the teachings of either Maxwell (Ex. 1005) or Garner (Ex. 1006) to establish the knowledge of one of ordinary skill in the art at the time of Dekkers publication. Accordingly, we are not persuaded by Patent Owner’s contention that Petitioner is improperly relying on Maxwell and Garner. Accordingly, having considered the arguments and evidence presented by the parties at this stage, Petitioner has made a sufficient showing that Dekkers discloses the claim limitations of element 1c.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,542,734
• Apple, Inc. v. Alivecor, Inc.Instituted
  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
• Apple, Inc. v. Alivecor, Inc.Instituted
  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
• Apple, Inc. v. Alivecor, Inc.Instituted
  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
• Spectrum Solutions LLC v. Longhorn Vaccines & Diagnostics, LLCInstituted
  PTAB · Nov 18, 2021 · IPR2021-00854 · APJ Wesley B Derrick · IPR · Institution

  The Board instituted IPR on claims 1–35 and all asserted grounds, finding a reasonable likelihood that claim 1 is anticipated by Birnboim.

  RulingsInstitution decision

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

    “review. See 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition shows that there is “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Federal Circuit has interpreted the statute to require “a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.” PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Thus, based on the information presented, we institute an inter partes review of claims 1–35 of the ’240 patent on all grounds.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that A person of ordinary skill in the art . . . would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid 10 Koller, WO 91/02740, published Mar. 7, 1991. Ex. 1016. 11 Robert E. Farrell, Jr., Ph.D., “RNA Methodologies: A Laboratory Guide for Isolation and Characterization,” (3rd Ed., 2005). Ex. 1026. extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 7 (citing Ex. 1002 ¶ 38). Patent Owner does not dispute Petitioner’s proposed definition at this stage. Prelim. Resp. 7. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’240 patent. Cf. 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)). B. Claim Construction” slip op. at 7

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

    “Neither Petitioner nor Patent Owner offer any position on the construction of any claim term. See Pet.; Prelim. Resp. 7. On this record, and for purposes of this Decision, we decline to construe any claim terms beyond the limited extent we do so below in our analysis, because it is not necessary to do so in reaching our decision on institution. C. Principles of Law” slip op. at 9

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

    “and particularly claim 1. Petitioner provides a detailed analysis of where each element of claim 1 is found in Birnboim. Pet. 13–19. Specifically, Petitioner asserts that Birnboim’s Example 3 discloses an aqueous composition comprising the one or more chaotropes, one or more detergents, one or more reducing agents, one or more chelators, and one or more buffers, as recited in the claim. Id. at 13–18. Petitioner also asserts that “Birnboim’s reagents are present in an amount sufficient to perform the claimed functions.” Id. at 18–23 (heading capitalization normalized and underlining omitted).” slip op. at 13

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,669,240
• Spectrum Solutions LLC v. Longhorn Vaccines & Diagnostics, LLCInstitution denied
  PTAB · Nov 18, 2021 · IPR2021-00851 · APJ Wesley B Derrick · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that the challenged claims were obvious, chiefly failing to establish the required one-step nucleic acid extraction.

  RulingsInstitution decision

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

    “A party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools International, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (citations omitted). “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic, 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) as “requiring [inter partes review] petitions to identify ‘with particularity . . . the evidence that supports the grounds for the challenge to each claim’”). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing Corp. v.” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. U.S., 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that [a] person of ordinary skill in the art . . . would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 7–8 (citing Ex. 1002 ¶¶ 34–35). Patent Owner does not dispute Petitioner’s proposed definition at this stage. Prelim. Resp. 7. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’330 patent. Cf. 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

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “A party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools International, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (citations omitted). “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic, 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) as “requiring [inter partes review] petitions to identify ‘with particularity . . . the evidence that supports the grounds for the challenge to each claim’”). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (citing Tech. Licensing Corp. v.” slip op. at 9

  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,415,330
• Spectrum Solutions LLC v. Longhorn Vaccines & Diagnostics, LLCInstituted
  PTAB · Nov 12, 2021 · IPR2021-00860 · APJ Robert A Pollock · IPR · Institution

  The Board instituted inter partes review of claims 1–20 on all petitioned grounds because Petitioner showed a reasonable likelihood that at least one challenged claim is unpatentable.

  RulingsInstitution decision

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

    “Birnboim, Mori, and Farrell, Petitioner provides a detailed analysis of where each claim element is found in the cited references and discusses why one of ordinary skill in the art would have been motivated to combine those elements with a reasonable expectation of success. See e.g., Pet. 34–42 (discussing motivation to combine and reasonable expectation of success with respect to claim 1). For the purpose of institution, we focus on independent claim 1.” slip op. at 17

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Relying on the testimony of Dr. Taylor, Petitioner asserts that A person of ordinary skill in the art (“POSA”) would have had (1) a Ph.D. in microbiology, molecular biology, biochemistry, or related discipline; (2) at least two years of post-graduate experience in the area of nucleic acid extraction and analysis; and (3) experience with the development or use of nucleic acid extraction formulations, and the literature concerning nucleic acid extraction and analysis. Pet. 10 citing Ex. 1002, ¶¶34–35. Patent Owner presently does not dispute Petitioner’s proposed definition. Prelim. Resp. 6. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, which is not substantively opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’256 patent. Cf. 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)). C. Claim Construction” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionPlain and ordinary meaningDecided for petitioner

    “According to Petitioner, we should apply the plain and ordinary meaning of “stock solution” as meaning “a formulated supply of solution for future use,” which, in the context of the instant claims, refers to “the aqueous composition before it is mixed with a sample.” Pet. 8 (citing Ex. 1029; Ex. 1002 ¶ 38). Patent Owner neither contests Petitioner’s definition of “stock solution” nor requests that we construe any other claim term, but reserves its right to do so. Prelim. Resp. 7. At this stage of the proceeding, we apply the plain and ordinary meaning of “stock” solution as Petitioner proposes. In section II.D.4, below, we note that Patent Owner implicitly relies on narrow constructions of “kills pathogens” and “without degrading nucleic acids.” As these terms may be critical to our final determination but have not been briefed by either party, we provisionally apply their plain and ordinary meaning. D. Ground 1: Obviousness in View of Birnboim, Mori, and Farrell” slip op. at 12

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

    “Petitioner provides reasoned bases for why one of ordinary skill in the art would have combined the cited references to arrive at the claimed invention. See Pet. 34–42 (citations omitted). Summarizing its arguments, Petitioner concludes that one of ordinary skill in the art would have been motivated to prepare solutions comprising a chaotrope, a detergent, a reducing agent, a chelator, a shortchain alkanol, and a buffer (with the associated acid and base) at a pH of 5–7 with a reasonable expectation that, when combined with a biological sample, the solution would denature proteins, inactivate nucleases, and kill pathogens, all without degrading nucleic acids of the sample. Ex. 1002, ¶151. The POSA would have been motivated to use Mori’s surfactants or defoaming agents along with Farrell’s nuclease-free water in Birnboim’s stock solution and would have had a reasonable expectation of success in doing so. Ex. 1002, ¶¶137–152.” slip op. at 19

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,683,256
• Commonwealth Scientific And Industrial Research Organisation v. BASF Plant Science Company GmbHAll claims unpatentable
  PTAB · Oct 1, 2021 · PGR2020-00057 · APJ Robert A Pollock · PGR · Final written decision

  Claims 1–17 are unpatentable based on lack of written description, lack of enablement, and anticipation or obviousness over Bauer, Napier, and Petrie I; the Petrie II obviousness ground was not proven.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Although the precise definition of the person of ordinary skill in the art is not dispositive of Petitioner’s grounds, we find it useful in framing the field of the invention. While we agree with Petitioner’s emphasis on plant recombinant DNA techniques, Patent Owner’s focus on plant genetics and plant lipids is well taken. As noted in the Patent Owner Response, the challenged claims are “directed to plant seed oils produced by a transgenic 10 Petitioner does not contest Patent Owner’s assertions regarding the similarities between the subject matter of the ’870 patent and the patents at issue in the Virginia litigation but asserts that its arguments in the Virginia litigation differed from those presented here, that those arguments were not accepted by the judge, and that “CSIRO ended up giving BASF a covenant not to sue on every single patent that had the language ‘at least a number with no upper limit.’” See Ex. 2005, 5–16; Ex. 2003, 14–16; Tr. 75:25– 76:11. plant,” whereas the portions of the Specification most relevant to those claims describe “genetically modified plants capable of producing certain oils, lipids, and fatty acids, and the genetic techniques related thereto.” PO Resp. 24–25 (citing Ex. 2012 ¶ 54); see also section I.D, above. Considering the above, as well as the ’870 patent and cited art, we view a person of ordinary skill in the relevant art as having a working knowledge of plant recombinant DNA techniques, a Ph.D. in plant molecular biology, lipid biochemistry, or lipid metabolism, and three years of work experience (excluding Ph.D. thesis studies) in lipid biochemistry or lipid metabolism as applied to plants. B.” slip op. at 17

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “In light of the above, the many variables affecting DHA production render the functional upper bound of “at least 1% docosahexaenoic acid (DHA)” a moving target. We thus return to the intrinsic evidence and the plain language of the independent claims. Applying the ordinary and customary meaning in accord with Phillips, we adopt Petitioner’s proposed construction of “at least 1% docosahexaenoic acid (DHA)” as covering amounts of DHA from 1% to 99% (since the claims also require a minimum amount of 1% EPA). See Pet. 30; Ex. 1002 ¶ 57. For similar reasons, and because Patent Owner does not expressly argue the meaning of the remaining terms, we further adopt Petitioner’s proposed construction of “a ratio of DHA to [DPA] of at least 2,” as covering a ratio from 2 up to infinity; and “a conversion rate of DPA to DHA of at least 75%,” as covering a conversion rate of 75% to 100%. See Pet. 30–31; Ex. 1002 ¶ 57; Dec. 13–14. We further adopt Petitioner’s uncontested explanation that the “ratio of DHA to DPA of 2.9” recited in claims 6 and 15 indicates “an implicit upper limit of 73.6% DHA.” See Pet. 56 n.15.” slip op. at 29

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “We consider, first, the evidence of record under our construction of “at least 1% docosahexaenoic acid (DHA)” as covering amounts of DHA from 1% to 99% (since the claims also require a minimum amount of 1% EPA). Patent Owner argues that such levels are “impossible” and does not contest Petitioner’s assertion that the challenged claims are unpatentable for lack of written description under this construction. PO Resp. 27, 28. Indeed, Dr. Sederoff admitted that the ’870 patent neither describes nor enables one 15 The arguments and evidence adduced in this proceeding do not address whether the conversion of 18:2 and 18:3 to DHA could be accomplished using a subset of the enzyme activities shown in Figure 1 by omitting some of the enzymes that permit formation of alternative intermediates. To the extent this is possible, it would not alter the thrust of our reasoning throughout this Decision. of ordinary skill in the art to make a transgenic Brassica plant (as recited in claims 5 and 13) that produces more than 50% DHA. Ex. 1016, 64:23–66:2, 67:24–68:4. But although reaching the upper limit of “at least 1% docosahexaenoic acid (DHA)” may be impossible under any of the constructions considered herein, the Federal Circuit “repeatedly and consistently has recognized that courts may not redraft claims, whether to make them operable or to sustain their validity.” Chef Am., Inc. v. Lamb- Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (collecting cases). For the above reasons, we find that a preponderance of the evidence supports Petitioner’s contention that claims 1–17 do not comply with the written description requirement as set forth in Ground 1 under our construction of “at least 1% docosahexaenoic acid (DHA),” with respect to any plant including Arabidopsis. Considering claims 5 and 13, in particular, the ’870 patent does not describe a transgenic Brassica plant that produces more than 50% DHA.” slip op. at 35

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “In view of the above, we find that one of ordinary skill in the art would have understood that even in high copy number lines, unpredictable effects such as gene silencing could prevent the accumulation of high levels of enzymes such as those listed in Table 4 of the ’870 patent. Moreover, even if high enzyme levels were achieved, the extent to which those enzymes would catalyze the desired reactions would have been unknown. Accordingly, from a quantitative standpoint, the evidence adduced points to a high level of unpredictability in the art. Focusing on the last step of the pathway illustrated in Figure 1 of the ’870 patent, Patent Owner also asserts that the ordinarily skilled artisan “knew how to introduce multiple additional copies of the key enzyme responsible for the rapid and efficient conversion of DPA to DHA, the Δ4 desaturase from Emiliana huxleyi, to achieve ratios of DHA to DPA approaching infinity, and conversion rates approaching 100%.” Sur-reply 21 (citing Ex. 2021 ¶¶ 136, 142 (stating that “no technical limitation prevents reaching a ratio nearing infinity,” i.e., 100% conversion of DPA to DHA)). Ex. 2012 ¶¶ 100, 113, 136, 142. Although we accept that the ordinarily skilled artisan could understand how and why to carry out those steps, the evidence discussed above persuades us that achieving the stated conversion efficiency for this step alone would have entailed undue experimentation. Considering that Patent Owner’s proposed construction requires, not just one, but every step of the pathway illustrated in Figure 1 proceed with (or at least near) 100% efficiency, the evidence of record persuades us that it would have required undue experimentation to achieve the claimed invention under any construction of “at least 1%” DHA advanced in this proceeding. In light of the above, and considering all the evidence, we find that a” slip op. at 61

  Patent outcomesUS 10,351,870 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,351,870

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.