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  • PTAB · Dec 14, 2021 · IPR2021-00862 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted review of claims 1–24 on all petition grounds, finding a reasonable likelihood of obviousness over the Swinger-based combinations in grounds 1–3.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’001 patent is unpatentable. Accordingly, an inter partes review of all of the claims and all of the grounds presented in the Petition is hereby instituted.” slip op. at 2

    • Skill levelSkill level board ownOther

      “For purposes of this Decision, at this stage of the proceeding we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’001 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as also including a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers, and that these people may collaborate. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which includes a significant number of prior art references authored by PhDs, MDs, and BSs and combinations thereof. See, e.g., Ex. 1015 (we understand includes inventors that are PhDs and MDs); Ex. 1039 (we understand includes PhDs and MDs as inventors); Ex. 1040 (we understand inventor is a JD with a BS); Ex. 1041 (we understand authors are MDs); Ex. 1042 (we understand authors are PhDs, MD, and BS); Ex. 1043 (we understand authors are MDs); Ex. 1045 (we understand inventor is MD); see also Ex. 1053; Ex. 1054; 1; Ex. 2010; Ex. 2019. However, our decision to institute trial in this proceeding is not dependent upon the specific definition of ordinarily skilled artisan and would not change were we to adopt Patent Owner’s proposed definition.” slip op. at 11

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

      “Petitioner does not assert that any claim term requires express construction. See Pet. 6 (stating that it “reserves the right to respond to any constructions that PO submits”). Patent Owner does not present any remarks regarding claim construction. See generally Prelim. Resp. On this record and for purposes of this Decision, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). To the extent further discussion of the meaning of any claim term is” slip op. at 12

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

      “After considering both the Petition and the Preliminary Response, we determine that Petitioner’s arguments and evidence on the issues of motivation to combine and reasonable expectation of success provide a sufficient basis on which to institute trial. We recognize the merit of Patent Owner’s counterarguments, which are supported by the expert testimony of Dr. Kang. Prelim. Resp. 21–22, 27–29 (citing generally Ex. 2002). The issues identified by Patent Owner implicate genuine issues of fact more appropriately resolved at trial. 37 C.F.R. § 42.108(c). We decline to engage in weighing of the information presented at this stage of the proceeding. We will evaluate both parties’ arguments and evidence once the record is fully developed during trial.” slip op. at 29

    Claim construction§ 103 obviousness
    Patents in suitUS 8,709,001
  • 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
  • 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 · Dec 6, 2021 · IPR2021-00846 · APJ Jon B Tornquist · IPR · Institution

    The Board instituted inter partes review of claims 1–12 on all asserted grounds after finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.

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

      “review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the parties’ arguments and evidence, and for the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’356 patent. Accordingly, we institute an inter partes review of” slip op. at 2

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

      “A petition must “identify with particularity the grounds for institution and evidence supporting such grounds,” including “the prior art relied upon and evidence that it qualifies as such.” Hulu, Paper 29 at 13 (citing 35 U.S.C. § 312(a)). The Petition identifies the grounds for institution and the evidence supporting such grounds, and presents evidence that Weikert qualifies as prior art under 35 U.S.C. § 102(b). Pet. 5–6, 27. For example, Petitioner and Dr. Lubatschowski assert that CATARACT AND REFRACTIVE SURGERY “is a quarterly review series comprising chapters written by well-known specialists,” and that Weikert was included in the 2005 edition of” slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

      “We are not persuaded, on this record, that this disclosure rises to the level of a teaching away. First, Weikert does not address the specific laser system disclosed in Blumenkranz, which is already designed to successfully treat eyes with cataracts, and Patent Owner and Dr. Kang do not persuasively explain why Weikert’s concerns would apply to a non-excimer laser surgery system that is already designed to treat “eyes with cataracts.” See Ex. 1017 ¶ 8; Ex. 2002 ¶ 62; see also Ex. 2002 ¶ 57 (Dr. Kang asserting that the PRK and LASIK excimer laser systems disclosed in Weikert are unrelated to the claimed relaxation incision made during cataract surgery). Second, Weikert suggests that eyes with cataracts “could reduce the efficacy and safety of laser treatment” and that refractive keratotomy “can be an effective” option, but does not indicate that laser surgery is never, or is generally not, suitable for treating astigmatism in eyes with cataracts. Ex. 1019, 227 (emphasis added). As such, we are left with a disputed issue of material fact that is best resolved on a complete trial record.” slip op. at 17

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

      “The evidence set forth by Patent Owner presents significant issues of fact to be addressed at trial. On the one hand, it is evident that modifying cataract surgical systems for use on the cornea, or providing a system that is capable of performing both corneal and lens surgery, was extremely difficult. Ex. 2006, 5:33–36, 25:27–31; Ex. 2007, 8:32–39, 15:53–58; Ex. 2009, 1209–11. On the other hand, Blumenkranz specifically asserts that its system is useful for not only cataract surgery, but also surgery on other areas of the eye, including the sclera, and Dr. Lubatschowski testifies that the system of Blumenkranz is “well-suited to perform . . . anterior incisions to permit access to the inner eye chamber.” Ex. 1017 ¶ 71; Ex. 1001 ¶¶ 107–108. Such evidence facially supports Petitioner’s case for obviousness. Thus, considering this evidence as a whole, we are left with a material issue of fact as to the capabilities of the Blumenkranz system that is best resolved on a complete trial record, and after reviewing the cross-examination testimony of the parties’ declarants.” slip op. at 20

    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 10,376,356
  • PTAB · Dec 6, 2021 · IPR2021-00849 · APJ Jon B Tornquist · IPR · Institution

    The Board instituted IPR on claims 1–14, finding a reasonable likelihood that the claims would be unpatentable on the asserted obviousness grounds.

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

      “review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the parties’ arguments and evidence, and for the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’548 patent. Accordingly, we institute an inter partes review of claims 1–14 of the ’548 patent. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2

    • Skill levelSkill level board ownDecided for patent owner

      “For purposes of this Decision, we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosures of the ’548 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the appropriate level of ordinary skill in the art may be reflected in “the prior art itself”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which demonstrates individuals having a broad array of scientific degrees that collaborate as a team. We note, however, that our decision to institute trial in this proceeding would not change were we to adopt Patent Owner’s proposed definition.” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “Both parties provide a construction of the term “cataract incision.” Pet. 7–9; Prelim. Resp. 17–18. Upon review of the parties’ arguments and supporting evidence, we determine that no claim terms require construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 9

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artPrinted publication establishedDecided for petitioner

      “and evidence supporting such grounds,” including “the prior art relied upon and evidence that it qualifies as such.” Hulu, Paper 29 at 13 (citing 35 U.S.C. § 312(a)). The Petition identifies the grounds for institution and the evidence supporting such grounds, and presents evidence that Weikert qualifies as prior art under 35 U.S.C. § 102(b). Pet. 5–6, 28–29. For example, Petitioner and Dr. Lubatschowski assert that CATARACT AND REFRACTIVE SURGERY “is a quarterly review series comprising chapters written by well-known specialists,” and that Weikert was included in the 2005 edition of CATARACT AND REFRACTIVE SURGERY as Chapter 14: Refractive Keratotomy: Does it Have a Future Role in Refractive Surgery? Ex. 1001 ¶ 73. Although minimal, given the type of document involved, and in the absence of any reason to question Petitioner’s and Dr. Lubatschowski’s assertions, Petitioner’s evidence is sufficient to present a reasonable likelihood that Weikert is prior art to the ’548 patent under 35 U.S.C. § 102(b).” slip op. at 11

    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 10,709,548
  • PTAB · Nov 18, 2021 · IPR2021-00841 · APJ Ryan H Flax · IPR · Institution

    The Board instituted IPR of claims 1–15 on all six asserted obviousness grounds, finding a reasonable likelihood of success on at least one ground.

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

      “institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions, we conclude Petitioner demonstrates a reasonable likelihood it would prevail in showing that claims of the ’648 patent are unpatentable under the presented grounds. Therefore, we institute inter partes review of all challenged claims (1–15) under the grounds raised in the Petition, pursuant to 35 U.S.C. § 314. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial) (“Guidance”).” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “For purposes of this Decision, at this stage of the proceeding we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’648 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as also including a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers, and that these people may collaborate. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which includes a significant number of prior art references authored by PhDs, MDs, and BSs and combinations thereof. See, e.g., Ex. 1030 (we understand includes inventors that are PhDs and MDs); Ex. 1039 (we understand includes PhDs and MDs as inventors); Ex. 1040 (we understand inventor is a JD with a BS); Ex. 1041 (we understand authors are MDs); Ex. 1042 (we understand authors are PhDs, MD, and BS); Ex. 1043 (we understand authors are MDs); Ex. 1045 (we understand inventor is MD); Ex. 1046 (we understand the inventor is an MD); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019.” slip op. at 24

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

      “CLAIM CONSTRUCTION “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner asserts that, although dependent claim 12 is indefinite, its language, “to determine one or more axial locations of the anterior capsule of the lens; and or more anterior capsule axial locations,” should be construed to mean “to determine one or more axial locations of the anterior capsule of the lens (i.e., one or more anterior capsule axial locations).” Pet. 7–8; see also Ex. 1030, 18:46–50 (claim 12). Petitioner’s position is that, as it reads in the ’648 patent, claim 12’s language is “a nonsense phrase,” rendering it indefinite, but that for the purposes of this proceeding it may be understood by the definition set forth above. Pet. 7–8. Patent Owner does not ask that any claim language be expressly construed. See generally Prelim. Resp. Claim 12 depends from independent claim 1 and is but one of fifteen challenged claims. Ex. 1030, 17:30–18:61. It is not necessary for us to consider the Petition’s specific challenges to claim 12 to render our decision” slip op. at 25

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

      “At this stage of the proceeding, we find Petitioner has sufficiently explained how and why the cited prior art would have been combined, why the ordinarily skilled artisan would have had a reasonable expectation of success in doing so, and that such a combination teaches or suggests the limitations or steps of claims 1–5 and 12–15. We address Patent Owner’s preliminary arguments below. Patent Owner addresses Petitioner’s Grounds 1–3 together; each is based on a combination of Swinger, Baikoff, and Li. Prelim. Resp. 10–31 (citing, inter alia, Ex. 1001 (Izatt) ¶¶ 46–49, 143, 149, 159; Ex. 1030, 2:5– 13, 11:19–26, 17:38–45; Ex. 1039 (Swinger), 17:50–54, 19:23–28, 23:28– 31, 34:30–35:3, 35:18–36:17; Ex. 1041 (Baikoff), 1843–45, 1847, 1849, Fig. 10; Ex. 1043 (Hoppeler); Ex. 1044 (Li); Ex. 1046 (L’Esperance); Ex. 2002 (Kang) ¶¶ 32–39, 46–52, 55–57, 60; Ex. 2004 (Walter) ¶¶ 16–17; Ex. 2006, 286, 296–98).15 Patent Owner addresses the claims in this way as a set, presenting the same arguments for all claims, and addresses the dependent claims as not unpatentable because the additionally cited prior art (Hoppeler and L’Esperance) do not remedy the argued shortcomings regarding Swinger, Baikoff, and Li. Id. Patent Owner argues that the ordinarily skilled artisan would not have combined these references because Swinger requires a surgeon’s direct visualization for cataract surgery, foreclosing using OCT, and because Baikoff and Li teach that OCT is limited to the eye’s anterior chamber, which makes it impossible to obtain satisfactory imaging (e.g., of lens portions behind the iris’s shadow). Id. at 15–18. Patent Owner argues that Swinger’s use of direct visualization and Baikoff’s acknowledgement of an inability to OCT-image the lens where shadowed by the iris teaches away from using OCT in cataract surgery and the combination of the references. Id. at 15–19. Patent Owner argues that the prior art combination does not disclose a device that “generate[s] image data for the patient’s crystalline lens,” or “process[ing] the image data to determine an anterior capsule incision scanning pattern for scanning a focal zone of the laser beam for performing an anterior capsule incision,” as recited by claim 1. Id. at 21–30. Patent Owner also argues that Petitioner took positions before the Office contrary to those it now asserts, specifically that in 2010 OCT imaging could 15 Patent Owner cites this evidence by shorthand names, e.g., “Swinger” and “Kang.” Although Patent Owner is free to cite evidence by any manner it desires, it is more useful to the Board if citations reference exhibit numbers, which facilitates review of the record.” slip op. at 29

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,474,648
  • 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
  • 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
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