- Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution deniedPTAB · Dec 30, 2022 · IPR2022-01115 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving the challenged claims obvious, including the claimed tagging efficiency.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“inter partes review may not be instituted “unless . . . 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). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claim 1. Pet. 18–19. Petitioner asserts that a “POSA [person of ordinary skill in the art] would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. at 19 (citing Ex. 1002 ¶¶ 133–136). Patent Owner does not dispute Petitioner’s construction. Prelim. Resp. 32–33. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“40–60% tagging efficiency, Petitioner fails to sufficiently explain why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer the adaptor.” Ex. 1009 ¶ 38.” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,801,063 - Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution deniedPTAB · Dec 30, 2022 · IPR2022-01116 · APJ Tina E Hulse · IPR · Institution
The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that the claims were obvious over the asserted prior art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“inter partes review may not be instituted “unless . . . 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). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’858 patent on any ground.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claims 22 and 24. Pet. 19. Petitioner asserts that a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. (citing Ex. 1002 ¶¶ 133– 136). Patent Owner does not dispute Petitioner’s constructions. Prelim. Resp. 24. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“40–60% tagging efficiency, Petitioner fails to explain sufficiently why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi-degenerate bases) in the adaptor.” Ex. 1009 ¶ 38. Moreover, as Patent Owner notes, Petitioner is silent as to how the references’ different starting sample sizes affect tagging efficiency. Prelim. Resp. 37–38. According to the KAPA data sheet submitted by Petitioner, “[t]he proportion of fragmented DNA that is successfully converted to adapter-ligated molecules decreases as input is reduced.” Ex. 1015, 4. The KAPA data sheet states that “[w]hen starting library construction (end repair) with >100 ng fragmented DNA, 15–40% of input DNA is typically recovered as adapter-ligated molecules, whereas the recovery typically ranges from 0.5 to 15% for libraries constructed from 100 pg–100 ng DNA.”” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,889,858 - PTAB · Dec 14, 2022 · IPR2023-00016 · APJ Michael A Valek · IPR · Institution
The Board instituted review of claims 1–6 on the petition’s unpatentability grounds and granted MSN’s motion to join IPR2022-00722 as a silent understudy.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IPR2022-00722, challenging the same claims based on the same grounds and relying on the same declarant testimony and other evidence for support. See Pet. 4–5 (stating its grounds are “substantially identical,” “challenge the same claims over the same prior art,” and “rely on the same exhibits, arguments and expert testimony presented with the Mylan Petition”). Patent Owner does not dispute that MSN’s Petition is substantially identical to Mylan’s, nor identify any material distinction between the arguments” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“agree with the arguments MSN makes for joinder. See Paper 4, 8–12. As discussed above, the Petition raises the same unpatentability grounds as IPR2022-00722, and no others. Thus, this review does not present any ground not already at issue in IPR2022-00722. Efficiency favors addressing these challenges in a joined proceeding.” slip op. at 4
NonePatents in suitUS 7,041,786 - Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution deniedPTAB · Dec 13, 2022 · IPR2022-01152 · APJ Michael A Valek · IPR · Institution
The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that Narayan and Schmitt taught or suggested the claimed use of unpaired reads.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“inter partes review may not be instituted “unless . . . 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). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’221 patent on any ground.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience. Pet. 19 (citing Ex. 1002 ¶¶ 27–30). Patent Owner does not offer a proposed definition of the level of ordinary skill in the art at this stage of the proceeding. On this record, we adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Regarding the phrase “a number of double-stranded cfDNA molecules that map to the mappable base position” in claims 6 and 18, Petitioner contends a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample” and generally be equal to the amount of HGEs. Pet. 20, (citing Ex. 1002 ¶¶ 133–136). Patent Owner does not dispute Petitioner’s understanding, but contends no construction is necessary at this stage. See Prelim. Resp. 30 We agree with Patent Owner that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“The Petition frames Ground 1 as the combination of Schmitt’s DCS with Narayan’s cfDNA. See Pet. 33–36. It relies on Schmitt’s “methods of error correction for NGS by generating duplex consensus sequences (i.e., reducing or tracking redundancy in sequence reads)” as Petitioner’s alleged motivation for that combination. Id. at 33–34; see also id. at 37 (arguing that a POSA would have had a reasonable expectation of success because “the prior art expressly taught that DCS could enhance accuracy when sequencing cfDNA”) (internal quotations omitted). According to Schmitt, the error correction and improved accuracy of DCS results from grouping reads into paired families in order to “capitalize[] on the redundant information stored in double-stranded DNA, thus overcoming technical limitations of prior methods utilizing data from only one of the two strands.” Ex. 1083, 47 (Abstract); see also id. ¶¶ 7, 43. Thus, Petitioner’s theory of unpatentability is inextricably tied to DSC’s use of paired reads, as opposed to unpaired reads, to generate consensus sequences. To the extent Petitioner contends that the collapsing of reads into SSCSs prior to the formation of Schmitt’s double-stranded consensus sequences discloses the use of unpaired reads, such a theory is not sufficiently supported on the current record. The portions of Schmitt the Petition relies on for element 1(e) describe the use of paired families to generate a double-stranded consensus sequence. See Pet. 31–33 (citing Ex. 1083 ¶¶ 13, 60, 68, Fig. 3). For example, Petitioner points to the” slip op. at 16
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,118,221 - Beckman Coulter, Inc. v. Becton, Dickinson And CompanyInstitution deniedPTAB · Dec 1, 2022 · IPR2022-01122 · APJ Michael A Valek · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–13 unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“likelihood of establishing that any of the challenged claims are unpatentable on any of the grounds in the Petition. Accordingly, institution of inter partes review is denied. V. ORDER Accordingly, it is: ORDERED that the Petition is denied, and no inter partes review is instituted” slip op. at 33
- Skill levelOther
“We are sympathetic to Patent Owner’s argument that a POSA would have had at least some experience with the optical systems used in optical analyzers. All of the claims recite an “optical analyzer” and the Specification is replete with references to optical analyzers and their operation. See, e.g., Ex. 1001, Abstr., 1:14–15, 2:3–4, 2:18–29, 3:38–57, 9:55–10:59 (claims reciting an “optical analyzer”). Moreover, Patent Owner cites other evidence that also suggests a POSA would have such experience. See Prelim. Resp. 12–13. However, on the current record, we are not convinced that the ordinary level of skill in the art would necessarily require the amount of specific experience (i.e., two years working and/or designing optical systems in optical analyzers) that Patent Owner urges. Petitioner’s declarant, Dr. Fang, testifies that two years of experience “in the field of optical imaging, with a specific focus on laser optics” would suffice. See Ex. 1002 ¶ 9. Thus, while it seems likely that a POSA would have at least some experience specific to optical analyzers, we see no reason why additional experience with laser optics more generally could not provide the balance of the two years of experience noted in the parties’ definitions. In any event, we need not resolve this issue here because we would reach the same outcome under either parties’ POSA definition.” slip op. at 8
- Expert testimonyPetitioner expert discountedDecided for patent owner
“The testimony Petitioner offers from its declarant, Dr. Fang, does not provide the missing explanation. Paragraphs 115 and 127 of Dr. Fang’s declaration, provide his opinions that “adapting a lens to focus a light beam onto a focal spot within a sample analysis region is no different from adapting a lens to focus a light beam into any region in space in other applications” and that a POSA would “understand that Lynch is generally applicable to light sources emitting collimated beams, and that such light sources were well-known in the art.” Ex. 1002 ¶¶ 115, 127. In paragraph 126, Dr. Fang testifies that a POSA would have a reasonable expectation of success in implementing the system described in Lynch.11 None of this testimony explains why a POSA would have been motivated to modify Lynch for implementation in an optical analyzer. For these reasons and based on the current record, Petitioner has not” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Whether to treat a preamble as a limitation is a determination ‘resolved only on review of the entirety of the patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.”’ In re Cruciferous Sprout Litig., 301 F.3d 1343, 1347 (Fed. Cir. 2002) (citation omitted). “In general, a preamble limits the claimed invention if it recites essential structure or steps, or if it is necessary to give live meaning and vitality to the claim.” Id. (citation and quotations omitted). This may be ascertained by review of the entirety of the patent to determine whether the preamble “discloses a fundamental characteristic of the claimed invention” as opposed to merely “stat[ing] a purpose or intended use.” Poly-Am., L.P. v. GSE Lining Tech., Inc., 383 F.3d 1303, 1310 (Fed. Cir. 2004). As Patent Owner points out, the ’197 patent is replete with references describing the invention as an optical analyzer. See Prelim. Resp. 24–25 (bullet pointing quotes from the Specification). The Specification begins by explaining that optical or “[p]article analyzers . . . are well known analytical tools that enable the characterization of particles on the basis of optical parameters such as light scatter and fluorescence.” Ex. 1001, 1:16–19. The Specification explains that “[t]he present invention” provides both “illumination optics for use in an optical analyzer” and “an optical analyzer incorporating the illumination optics of the present invention.” Ex. 1001, 2:3–4, 2:18–19. Claims 1–13, each of which recites an “optical analyzer” comprising a set of optical elements, are specifically directed to the latter. Id. at 9:55–10:59. The Specification further demonstrates that the preamble term is limiting by explaining that “the invention addresses a concern specific to” optical analyzers. See Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349 1358 (Fed. Cir. 2012) (finding that the specification “demonstrates that the preamble phrase ‘rotary cutter deck’ is a limitation” because it “explains that the invention addresses a concern specific to rotary cutters”). The Specification explains that in a flow cytometer, i.e., an exemplary type of optical analyzer, “the excitation light from a laser . . . is focused onto a focal spot to illuminate the core stream (the fluid stream containing the particles to be analyzed).” Ex. 1001, 1:39–42. According to the Specification, “[a]ccurate focusing of the excitation light beam on the core stream is important,” “[o]ptimal performance is compromised if the focused light beam is not properly adjusted on the core stream,” and because the particles being analyzed are only a “few microns in size, the precision of the light beam adjustment also needs to be in the micron range.” Id. at 1:42–51; see also id. at 3:38–49 (explaining that “fine control over the focus spot” is useful in optical analyzers). The present invention addresses these concerns by providing an optical analyzer “adapted to focus an illumination beam onto a sample analysis region,” configured to obtain a “high degree of precision over the adjustment of the focal spot using less expensive lens adjusting mechanisms,” and comprising “detection optics for measuring the light emitted from the analysis region.” See id. at 2:18–23, 7:3–8. We also agree with Patent Owner that the recitation of an “optical analyzer” in the preamble informs the meaning of the phrase “a focusing lens . . . adapted to focus the light beam onto a focal spot within a sample analysis region” in the claim body. The term “sample analysis region” refers to a structural feature of the claimed “optical analyzer,” i.e., the area configured to contain the sample to be analyzed. This is confirmed by the Specification, which explains that in addition to illumination optics “[t]he optical analyzer will further comprise detection optics for measuring the light emitted from the analysis region. In a preferred embodiment, the optical analyzer is a flow cytometer, and the sample analysis region is a sample detection region in a fluid stream containing particles to be optically analyzed.” Ex. 1001, 2:21–26. In this regard, the preamble informs the meaning of “sample analysis region” by indicating that the recited “sample analysis region” is configured such that it can contain a sample and that light emitted from that region can be measured by the analyzer. See Deere, 703 F.3d at 1358 (explaining that “rotary cutter deck” in the claim preamble “informs the meaning of the ‘torsional stiffness’ limitation––the claimed structure must possess sufficient stiffness to withstand the torsional loads imposed by the operation of a rotary cutter”). By the same measure, holding that the “sample analysis region” need not be so configured would undermine the benefits the Specification indicates the recited illumination optics achieve. See Ex. 1001, 1:39–55, 2:30–48, 7:3–7 (explaining that “accurate focusing” is important because the sample to be analyzed may be very small and that the present invention obtains “precise positioning control” using less expensive components). The fact that the preamble informs the meaning of a term in the claim body, distinguishes it from “nonlimiting preamble terms” that “merely state a name or a use” by demonstrating that the optical analyzer recited in the preamble of the presently challenged claims is a “fundamental characteristic of the claimed invention.” Deere, 703 F.3d at 1358 (quoting Poly-Am., 383 F.3d at 1310).9 slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,787,197 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 8, 2022 · IPR2022-00963 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution of IPR on claims 1–27 under § 325(d), finding substantially the same art and arguments had been presented to the Office and no material error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“substantially the same as those previously presented to the Office. Advanced Bionics, 8–10. “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office,” then we advance to the second part of the analysis to determine “whether the petitioner has demonstrated a material error by the Office” in view of factors (c), (e), and (f). Id. Advanced Bionics instructs that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Id. at 9–10.” slip op. at 10
Discretionary denialPatents in suitUS 9,421,199 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00965 · APJ Michael A Valek · IPR · Institution
The Board denied institution on claims 1–20 under § 325(d), finding substantially the same art and arguments had been considered during prosecution and no material Office error was shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“For these reasons, we determine that both the art and the arguments presented in the Petition are substantially the same as those previously presented to the Examiner.” slip op. at 21
Discretionary denialPatents in suitUS 10,076,515 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00964 · APJ Michael A Valek · IPR · Institution
The Board denied institution of inter partes review of claims 1–19 under § 325(d), finding the art and arguments substantially similar to those previously presented and no material Office error.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“We again determine that Patent Owner has the better position. As explained above, the Examiner considered substantially the same art during prosecution. Although there was no rejection issued over the particular references cited in the Petition, those references were either before the Examiner (Siegel) or are cumulative of references (Chua & Tan and Lund) before the Examiner. There is no evidence that suggests the Examiner overlooked the most pertinent teachings in the art presented during prosecution. Indeed, the Teva rejection presented substantially the same arguments as the grounds in the Petition, including Patent Owner’s argument that there was “insufficient rationale to combine Teva and other references to produce a D2O-based formulation in which atropine is the monotherapeutic agent because atropine and its derivatives are specifically recognized as stable in ordinary water.” Ex. 2003, 69, 87–88. The Examiner credited this argument by withdrawing the Teva rejection and allowing the ’447 patent. Thus, we do not agree with Petitioner’s argument that the Examiner failed to consider whether it would have been “obvious to improve low-concentration atropine with D2O as a monotherapy for treating myopia.” See Pet. 63.” slip op. at 22
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“D. Conclusion Based on the foregoing, we determine that the circumstances of this case warrant the exercise of discretion under 35 U.S.C. § 325(d) and therefore deny institution. ORDER After due consideration of the record before us, and for the foregoing reasons, it is: ORDERED that the Petition is denied, and no inter partes review is instituted.” slip op. at 25
Discretionary denialPatents in suitUS 9,770,447 - Eyenovia, Inc. v. Sydnexis.Institution deniedPTAB · Nov 7, 2022 · IPR2022-00966 · APJ Jamie T Wisz · IPR · Institution
The Board denied institution of inter partes review of claims 1–13, 15–27, and 29–30 under § 325(d), finding substantially the same art and arguments had been presented to the Office and no material error shown.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“For these reasons, we determine that both the art and the arguments presented in the Petition are substantially the same as those previously presented to the Examiner.” slip op. at 20
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied 325dInstitution denied
“D. Conclusion Based on the foregoing, we determine that the circumstances of this case warrant the exercise of discretion under 35 U.S.C. § 325(d) and therefore deny institution. ORDER After due consideration of the record before us, and for the foregoing reasons, it is: ORDERED that the Petition is denied, and no inter partes review is instituted.” slip op. at 26
Discretionary denialPatents in suitUS 10,201,534 - Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution deniedPTAB · Oct 11, 2022 · IPR2022-00747 · APJ Tina E Hulse · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood that claims 1–29 were obvious over the cited art.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“inter partes review may not be instituted “unless . . . 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). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’858 patent on any ground.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner sets forth proposed constructions for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claims 22 and 24. Pet. 19. Petitioner asserts that a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. (citing Ex. 1002 ¶¶ 133– 136). Patent Owner does not dispute Petitioner’s constructions. Prelim. Resp. 24. that it is unnecessary to expressly construe any claim terms for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 550 U.S. at 418. “[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” Id. Moreover, a person of ordinary skill in the art must have had a reasonable expectation of success of doing so. PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1193 (Fed. Cir. 2014).” slip op. at 11
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,889,858
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.