- 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 - Delta T, LLC v. Macroair Technologies, Inc.All claims unpatentablePTAB · Dec 12, 2022 · IPR2021-01214 · APJ Tina E Hulse · IPR · Final written decision
The Board held claim 15 unpatentable as obvious over Madsen, finding the mounting shaft could be detachably secured in the hub openings and have a constant cross section.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not discern a substantive difference between the parties’ respective definitions of the level of ordinary skill in the art, nor do the parties assert that there exists any such difference. Although Petitioner’s definition includes specific knowledge of fans or other rotary machines, we understand Patent Owner’s broader definition to include such knowledge. We, therefore, adopt Petitioner’s definition of the level of ordinary skill in the art as reasonable and consistent with the level of skill reflected in the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining the prior art itself may reflect an appropriate level of skill in the art). We also find Drs. Sheard and Paulus are qualified to opine on the perspective and understanding of a person of ordinary skill in the art, as they have at least ordinary skill in the art. See Ex. 1002 ¶¶ 3–11; Ex. 1003; Ex. 2001 ¶¶ 4–11; Ex. 2002; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case— like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 7
- Prior constructionPrior construction adoptedDecided for petitioner
“2. District Court Constructions In the related district court proceeding, the district court construed certain claim terms of the ’588 patent. Ex. 1014. Petitioner proposes claim constructions that are consistent with the district court’s constructions. Pet. 10–17. Patent Owner states that it “adopts the district court’s claim constructions for the purposes of this Response.” PO Resp. 10 (citing Ex. 1014). The district court has construed the following ’588 patent claim terms: Term Construction “hub assembly” “a hub with multiple parts that are assembled together” (Ex. 1014, 13– 14) “openings” “one or more locations where the arm members may be detachably secured” (Ex. 1014, 12–13) “detachably secured”” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Rather than rely on the definitions of “secure” from a general dictionary, we focus on the Specification as the “single best guide to the meaning of a disputed term.” Phillips, 415 F.3d at 1315 (internal citation omitted). The Specification describes the use of nuts and bolts that can be used to fix or attach the arms into the slots of the hub. Ex. 1001, 4:47–51 (stating “nuts 212 can then be used to secure the arms 144 in the slots 202”) (emphasis added). But that is not the only use of “secure” in the Specification. As Petitioner notes, the Specification also describes a “securing assembly 152 that inhibits the hub from falling when the motor shaft breaks or the hub otherwise disengages from the shaft.” Id. at 3:42–45 (emphasis added). We also credit Dr. Sheard’s explanation of the operation of the ’588 patent’s securing assembly as allowing for rotational movement while preventing loss: [T]he hub 110 of the ‘588 Patent is “secured” to the motor mount 106 by way of the “securing assembly 152.” This securing assembly prevents the hub from “falling away from the motor mount” (i.e., prevents the hub from becoming lost or coming loose), but the relative engagement between the first member 154 and the second member 170 of the securing assembly continues to allow for relative rotation between the hub 110 and the motor mount 106. This relative rotation between the hub 110 and the motor mount 106 of the ‘588 Patent is not only allowed, but is absolutely necessary if the hub is going to rotate so that the fan blades may turn. Ex. 1024 ¶ 67. Patent Owner argues that the securing assembly is irrelevant to the construction of “secured” because it does not refer specifically to the arm members being detachably secured in the openings. PO Sur-reply 13. We disagree. Claim terms must be read in light of the specification and must not import limitations from the specification into the claims. Phillips, 415 F.3d at 1323. Moreover, we presume the specification uses a word consistently throughout the patent, even if describing a different embodiment. See Energy Transp. Grp., Inc. v. William Demant Holding A/S, 697 F.3d 1342, 1349–50 (Fed. Cir. 2012) (relying on the specification’s use of the word “programmable” to describe a different embodiment to construe the same term in the claim, as “there is no reason to construe the term ‘programmable’ differently when used to describe [the embodiment of the claimed invention]”); see also Phillips, 415 F.3d at 1314 (noting “claim terms are normally used consistently throughout the patent”). Thus, we decline to limit the construction of “secured” to the preferred embodiment, as proposed by Patent Owner, and consider the Specification’s description of the “securing assembly” to inform the meaning of “secured” as encompassing rotational movement and preventing loss. Accordingly, we construe the term “secured” to mean the arm members are “fixed or attached (while allowing for rotational movement) so that the arm members cannot be lost.”” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“presented at trial, we find Petitioner has the better position. We are persuaded that a person of ordinary skill in the art, seeing the unlabeled fasteners identified by Petitioner, would have found it obvious to use removable fasteners such as screws or bolts to detachably secure the mounting shafts in the openings formed by the bearing housings. See Ex. 1006, Figs. 3 and 5 (reproduced and annotated at Pet. 41). We credit the testimony of Dr. Sheard that a person of ordinary skill in the art would have been motivated to make the fan blade mounting shaft of Madsen detachably secured in the openings of the hub to “allow for the replacement of worn or broken parts, or for replacement of parts according to an ordinary course of maintenance.” Ex. 1002 ¶ 119. Dr. Sheard explains that the bearings of Madsen facilitate the rotation of the fan blade mounting arms within the bearing housing and are subject to wear and tear by the nature of the friction to which they are exposed during normal use. Id. ¶ 120. Thus, we are persuaded that a person of ordinary skill in the art would understand that the bearings of Madsen may need to be repaired, replaced, or maintained over time, which would require a user to access the inside of the bearing housing. Id. According to Dr. Sheard, “the [person of ordinary skill in the art’s] general knowledge of the need to repair, replace, or maintain fan parts such as bearings would motivate the [ordinary artisan] to combine this knowledge with Madsen in order to make the bearing housing 54 detachable from the hub.” Id. Moreover, as Dr. Sheard further explains, we find that the ordinary artisan “would be motivated to make the unlabeled fasteners illustrated in Figure 3 of Madsen . . . to be removable fasteners (e.g. screws, bolts, or other threaded fasteners). This use of removable fasteners provides a well known and easy manner for the user to access these parts in need of replacement.” Id. Dr. Sheard opines that because fans of different sizes may require blades of different lengths and fan blade mounting shafts of different designs, a person of ordinary skill in the art would have been motivated to make a single hub that accommodates different mounting shafts and blade lengths using a detachably secured mounting shaft. Id. ¶ 123. In doing so, manufacturers could avoid the cost of making multiple different hubs for different sized mounting shafts and would allow the end user the advantage of choosing different blades lengths and types for a given hub. Id. Thus, we are persuaded that these known problems in the art would have motivated a person of ordinary skill to modify Madsen to use a detachably secured mounting shaft. See ABT Sys., LLC v. Emerson Elec. Co., 797 F.3d 1350, 1360 (Fed. Cir. 2015) (“It is well settled that, even where references do not explicitly convey a motivation to combine, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.”) (internal quotations and citation omitted). Finally, we find a preponderance of the evidence supports Petitioner’s assertion that because detachably secured connections between an intermediate arm member and hub were well known to a person of ordinary skill in the art, it would have been obvious to combine those known connections with the design of Madsen “as an art equivalent type of connection, yielding the predictable result of restraining movement of the intermediate arm member with respect to the hub.” Id. ¶ 124; see also KSR, 550 U.S. at 416 (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”).” slip op. at 25
Patent outcomesUS 8,579,588 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,579,588 - Guardant Health, Inc. v. University Of Washington Through Its Center For CommercializationInstitution deniedPTAB · Nov 17, 2022 · IPR2022-00935 · APJ John G New · IPR · Institution
The Board denied institution on all grounds because the petition did not show a reasonable likelihood that claims 1–23 were unpatentable over the asserted obviousness combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response, and the evidence of record, we determine that the evidence presented does not demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of the challenged claims of the ’631 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 17–18; Prelim. Resp. 5. Nor do we perceive, at this stage of the proceeding, a need to construe any claim term of the ’631 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need to be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs in the context of an inter partes review).” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“filing would typically have had an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field. Pet. 15 (citing Ex. 1002, ¶¶ 53–54). Alternatively, Petitioner proposes, a skilled artisan could have less education but significant professional experience in one or more of these fields. Id. Patent Owner does not contest Petitioner’s proposed definition of a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding and for purposes of our analysis in this Decision, we therefore adopt Petitioner’s proposed definition. We find that this definition is consistent with the level of skill in the art as reflected by the prior art. See, e.g., Exs. 1003, 1006, 1007, 1010, 1021; see also 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” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig was insufficient for our analysis. IPR2022-00816, Paper 16 at 14 (citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (holding that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”)). In the ’816 IPR, we further observed that, to answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe- SeqS approach, Petitioner contends that “Kinde identifies Craig in expressly discussing exogenous barcodes with DNA molecules.” IPR2022-00816, Paper 16 at 14 (citing Paper 3 at 22, 30). Again, Petitioner repeats the same argument in the present Petition. See Pet. 44; see also Ex. 1002 ¶ 42. But, as we observed in the ’816 proceeding, Kinde does not use Craig’s approach. IPR2022-00816, Paper 16 at 14. Instead, we found that immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Id. (quoting Ex. 1006, 9531). We therefore found that Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs. Id. The same reasoning applies equally here.” slip op. at 33
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,287,631 - PTAB · Nov 17, 2022 · IPR2022-01029 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–20 on all asserted grounds, finding 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
“We have authority under 35 U.S.C. § 314, which provides that an 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 in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–20 of the ’431 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Person of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art at the time of the invention would have had: a Masters or a Ph.D. degree in nutritional science, chemistry, biology, biochemistry, or a related discipline or an M.D. or doctor of optometry (“O.D.”), and a few years of practical experience in the nutritional supplement area, including an understanding of formulations that could be considered for promoting eye health, including preventing or treating eye disorders such as macular degeneration. Alternatively, such a person could have been a person with a Bachelor’s degree with a greater number of years of experience. The POSITA would have, or would have access to, general information regarding eye health and eye disorders, the convenience and needs of patients who suffer from eye disorders, such as macular degeneration, and background information. And to the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’431 Patent. Pet. 8–9 (citing Ex. 1024 ¶ 16) (citations omitted). We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary 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)Plain and ordinary meaningDecided for petitioner
“1. “substantially free of meso-zeaxanthin stereoisomers” Petitioner contends the term “substantially free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would have understood this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 20–22 (citing Ex. 1024 ¶ 62; Ex. 1031, 3). The Board adopted this construction in the -089 IPR. -089 IPR, Paper 7 at 9–10. 2. “mixed tocopherols” Petitioner contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and deltatocopherols.” Pet. 23–24 (citing Ex. 1024 ¶ 69). The Board adopted this construction in the -089 IPR. -089 IPR, Paper 7 at 10. 3. Conclusion At this stage of the proceeding, we adopt Petitioner’s proposed constructions as consistent with the plain and ordinary meaning of the terms 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
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,045,431 - Neuroderm Ltd. v. Abbvie Inc.InstitutedPTAB · Nov 14, 2022 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Institution
The Board instituted PGR on claims 1–17 based on all asserted grounds, finding the petition showed they more likely than not lacked written description support and enablement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons explained below, we find that Petitioner has met the threshold showing for post-grant review of claims 1–17 with respect to the first challenge (written description support for the claimed genus). On that basis, we institute post-grant review of all challenged claims. See SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1358 (2018); 37 C.F.R. § 42.208(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims . . . .”). We address this challenge first, then provide the parties guidance on Petitioner’s second written description challenge (support for carbidopa itself).” slip op. at 19
- Skill levelSkill level board ownOther
“Ex. 1006, 1 (citations omitted). Accordingly, when considering the ’507 patent’s purpose, the type of problems encountered in the art, and prior art solutions to those problems, it is clear that with respect to levodopa/carbidopa treatments for Parkinson’s Disease, the pharmaceutical formulation and its resulting pharmacokinetics and patient experience are intertwined, thus supporting a requirement that a person of ordinary skill in the art have knowledge or experience in each of these areas. See, e.g., Indivior Inc. v. Dr. Reddy’s Labs., S.A., 930 F.3d 1325, 1345 (Fed. Cir. 2019) (finding no clear error in district court’s compromise measure of level of ordinary skill in the art as a team comprising different skill sets). In view of the above considerations, we preliminarily find that a person of ordinary skill in the art would be a member of a team that includes person(s) with (a) a Ph.D. in a field related to the development of pharmaceuticals (for example, pharmacology, pharmacokinetics, pharmaceutics, pharmaceutical chemistry, organic chemistry, biochemistry, molecular biology, medicinal chemistry, formulation development, or a related field), or equivalent degree, and 2–4 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, or a B.S. or M.S. degree in a field related to the development of pharmaceuticals, or equivalent degree, and 4–6 years of experience in the analysis of pharmacokinetic data, pharmaceutical formulation development, and/or drug discovery or development, and (b) a medical degree or equivalent degree with experience in treating patients with Parkinson’s disease. In subsequent briefing, should the parties propose any differences from the team approach articulated above, they should support their proposal and address the impact, if any, of the differences on the pertinent disputes in this proceeding. Any final determination on the level of ordinary skill in the art will be made on the full trial record.” slip op. at 15
- Expert testimonyPetitioner expert creditedOther
“Additionally, based on their statements of qualifications and curricula vitae, for purposes of this Decision we find Drs. LeWitt and Sloan qualified to provide technical opinions from the perspective of a person of ordinary skill in the art. Ex. 1003 ¶¶ 1–10, pp. 87–119 (Dr. LeWitt’s statement of qualifications and curriculum vitae); Ex. 1004 ¶¶ 1–11, pp. 45–71 (Dr. Sloan’s statement of qualifications).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with the parties that the express definition provided during prosecution should be adopted. See, e.g., Biotec Biologische Naturverpackungen GmbH v. Biocorp, Inc., 249 F.3d 1341, 1346–47 (Fed. Cir. 2001) (construing claims in accordance with definition provided in declarations submitted during prosecution). Accordingly, we preliminarily construe the term “a compound comprising levodopa” in accordance with the full definition Dr. Okun provided during prosecution, i.e., “any molecule with a levodopa core moiety including levodopa itself, as well as prodrugs, salts, and hydrates of levodopa.”” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,091,507 - PTAB · Oct 19, 2022 · IPR2022-01513 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8 on all five grounds previously instituted in IPR2022-00517 and granted Teva’s motion to join that proceeding.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Teva’s Petition here is substantively identical to Mylan’s Petition in the -517 IPR, challenging the same claims based on the same art and the same grounds. Compare IPR2022-00517, Paper 1 with IPR2022-01513, Paper 2. For the same 1 European Medicines Agency, Assessment Report, Xarelto, EMA/CHMP/794349/2012 (2013). Ex. 1005 (“EMA”). 2 Foley et al., Antithrombotic therapy in peripheral artery disease, 21 VASCULAR MED. 156–69 (2016). Ex. 1006 (“Foley”). 3 Plosker, Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, 74 DRUGS 451–64 (2014). Ex 1007 (“Plosker”). reasons stated in our Decision Granting Institution of Inter Partes Review in IPR2022-00517, we institute trial in this proceeding on the same five grounds. See IPR2022-00517, Paper 15.” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Motion for Joinder. Based on authority delegated to us by the Director, we have discretion to join an inter partes review to a previously instituted inter partes review. 35 U.S.C. § 315(c). Section 315(c) provides, in relevant part, that “[i]f the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311.” Id. When determining whether to grant a motion for joinder, we consider factors such as timing and impact of joinder on the trial schedule, cost, discovery, and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 4
NonePatents in suitUS 10,828,310 - PTAB · Oct 13, 2022 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Institution
The Board instituted inter partes review of claims 1–30 on all asserted grounds, finding a reasonable likelihood that claim 1 would have been obvious over the Travers references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an 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). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“two-prong framework: (1) whether the art or arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“In general, unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one. Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999) (stating that “not every process claim is limited to the performance of its steps in the order written”). Such a result can ensue, however, when the method steps implicitly require that they be performed in the order written. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342–43 (Fed. Cir. 2001). Based on the current record, we find Patent Owner’s argument concerning the sequential order of the steps is supported by the claim language and the disclosures in the specification. See, e.g., Ex. 1001, 37:31–52 (claim 1), 39:56–40:25 (claim 22), 3:21–27, 15:27–34, Fig. 1. Therefore, we agree with Patent Owner that “(i) the claimed methods require that the amplification step occurs after adapter attachment; but before the sequencing step; and (ii) the sequencing step requires sequencing the amplified adapter-DNA products from the amplification step.” Prelim. Resp. 8. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address any other claim term.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for patent owner
“In general, unless the steps of a method actually recite an order, the steps are not ordinarily construed to require one. Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999) (stating that “not every process claim is limited to the performance of its steps in the order written”). Such a result can ensue, however, when the method steps implicitly require that they be performed in the order written. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342–43 (Fed. Cir. 2001). Based on the current record, we find Patent Owner’s argument concerning the sequential order of the steps is supported by the claim language and the disclosures in the specification. See, e.g., Ex. 1001, 37:31–52 (claim 1), 39:56–40:25 (claim 22), 3:21–27, 15:27–34, Fig. 1. Therefore, we agree with Patent Owner that “(i) the claimed methods require that the amplification step occurs after adapter attachment; but before the sequencing step; and (ii) the sequencing step requires sequencing the amplified adapter-DNA products from the amplification step.” Prelim. Resp. 8. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address any other claim term.” slip op. at 10
Claim construction§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,760,127 - Guardant Health, Inc. v. University Of WashingtonInstitution deniedPTAB · Oct 13, 2022 · IPR2022-00816 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not sufficiently explain why a skilled artisan would combine Kinde and Craig, with or without NEB Expressions, for claims 1–30.
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). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for patent owner
“We agree with Patent Owner that claim 22 explicitly requires the double-stranded DNA fragments of interest be “obtained from a bodily sample.” Claim 22 demonstrates that when Patent Owner wants to limit the source of the DNA fragments, it knows the precise language to do so. Claim 1, however, plainly lacks such language. Indeed, claim 1 puts no limitation on the origin of the DNA fragments of interest. Patent Owner points to step (b) of claim 1, which recites “amplifying original strands of . . . the double-stranded adapter-DNA molecules.” Prelim. Resp. 5. According to Patent Owner, this language shows “the claimed amplification step does not occur on previously generated copies. It occurs on the original strands.” Prelim. Resp. 5. We are not persuaded. Patent Owner conflates the original DNA fragments from a bodily sample, as claim 22 requires, with the original strands of the adapter-DNA molecules, as step (b) of claim 1 recites. For claim 1, step (a) recites attaching adapters to the DNA fragments of interest, regardless of the source of the DNA fragments––they may be from a bodily sample, or they may be the products of a PCR reaction. Step (b) only requires amplification of the original adapter-DNA hybrid molecules; it does not speak to the source of the DNA fragments of interest.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“To the extent Petitioner argues that an ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig’s, that is insufficient for our analysis. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”). To answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe-SeqS approach, Petitioner contends that “Kinde identifies Craig in expressly discussing exogenous barcodes with DNA molecules.” Pet. 21; see also id. at 30 (“[C]iting to Craig, Kinde discusses methods including assigning exogenous barcodes to nucleic acid fragments.”). But, as Patent Owner points out, Kinde does not use Craig’s approach. Prelim. Resp. 10. Instead, immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Ex. 1006, 9531. Thus, Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs.” slip op. at 14
Claim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,760,127
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.