- Mara Renewables Corporation v. DSM IP Assets, B.V.Institution deniedPTAB · Feb 23, 2024 · IPR2023-01342 · APJ Jon B Tornquist · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was anticipated or obvious over the asserted references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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) (2018). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’959 patent. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that, as of the earliest claimed priority date of the ’959 patent, an ordinarily skilled artisan “would have had a Master of Science degree in an academic discipline emphasizing chemistry, chemical engineering, or biochemistry, in combination with training or at least two to three years of related work experience with lipid chemistry technologies, including but not limited to lipid extraction technologies.” Pet. 6 (citing Ex. 1003 ¶¶ 63–64). Alternatively, Petitioner proposes that an ordinarily skilled artisan “could have also had a Doctorate degree in a relevant academic discipline with one to two years of related work experience in the same discipline.” Id. Petitioner argues that an ordinarily skilled artisan “would have been familiar with microbial oils” and “would have understood the benefits of polyunsaturated fats (PUFAs), microbial sources for obtaining them, and methods for culturing and extracting oils from those microbial sources.” Id. (citing Ex. 1003 ¶¶ 36–48, 64). Patent Owner does not provide a definition of the level of ordinary skill in the art, but “reserves its right to proffer what it contends to be the appropriate level of ordinary skill in the art should the Board institute review.” Prelim. Resp. 15. Patent Owner asserts, however, that a person of ordinary skill in the art would have a detailed understanding of the information provided in its Technology Background section, including “the expected impact of cellular biomass growth characteristics on the proportion of triglycerides and phospholipids produced during a microbial fermentation.” Id. For purposes of this Decision, we adopt Petitioner’s definition of the skill level of an ordinarily skilled artisan as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). As to the background knowledge possessed by the ordinarily skilled artisan, we agree that such an artisan would have been aware of methods for culturing and extracting oils from microbial sources, including the impact of growth characteristics on the proportions of triglycerides and phospholipids produced during microbial fermentation. Pet. 6; Prelim. Resp. 15.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that all claim terms of the ’959 patent “should be given their plain and ordinary meaning.” Pet. 3. Patent Owner does not contend that any claim terms require construction. Prelim. Resp. 14–15. 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.”)).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“3. Analysis In order to anticipate a claim, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” NetMoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Radianingtyas discloses microbial oils with various levels of DHA and arachidonic acid. There is no disclosure of an individual microbial oil, however, that contains at least 45% DHA and 1.5% or less arachidonic acid by weight as required by claim 1. With respect to the level of DHA, although Radianingtyas might be interpreted to disclose that some microorganisms can produce up to 60% DHA,8 Radianingtyas discloses that the DHA content of ONC-T18 is “typical[ly]” 35% of the total intracellular fatty acids, and in each experiment disclosed in Radianingtyas DHA was produced by ONC-T18 at 8 Radianingtyas discloses that “the oil producing microbe can produce a lipid composition comprising from about 25% to about 40% of an omega-3 fatty acid, such as n-3 DHA.” Ex. 1007, 26:31–33. It then gives examples that include 15%, 20%, 45%, 50%, 55%, and 60%, which are outside of the disclosed range. Id. at 26:33–34. Dr. Curtis contends the disclosure as a whole should be read as “from about 15% to about 60% of an omega-3 fatty acid, such as n-3 DHA.” Ex. 1003, 39 n.1. Dr. Curtis identifies no microbe in Radianingtyas, however, that is shown to produce more than 40% DHA, and Radianingtyas expressly notes that the typical DHA content produced by ONC-T18 is 35%. Thus, we question Dr. Curtis’ conclusions regarding the DHA content disclosure of Radianingtyas. levels less than “at least 45%.”9 Ex. 1007, 32:21–25 (noting that the “typical composition of fatty acids” produced by ONC-T18 includes 25% DHA), 34:4–37:14 (noting that the control microorganism produced 13.54%, 19.98%, 18.77%, 18.77%, 21.48%, 28.48%, and 14.13% DHA) (Figure 12), 91 (Table 5) (noting that total DHA produced by ONC-T18 was from 24- 34.2%), 99:22–24 (“Of particular interest is ONC-T18 which produces up to 90% of its C20 to C22 content as DHA which is approximately 35% of the total intracellular fatty acids.”). Thus, we are not persuaded that Radianingtyas discloses microbial oils produced by ONC-T18 that have a DHA content of “at least 45%.” As noted by Petitioner, Radianingtyas provides a definition of “purify” and “purifying,” and notes that when these terms are used, it means that a composition could be, for example, 90% pure. Pet. 11; Ex. 1007, 7:26–8:2. As an example of how the term “purified” may be used, Radianingtyas states “[f]or example, if a disclosed eukaryotic microorganism, for example, produces 35% DHA, this could be further ‘purified’ such that the final lipid composition was greater than 90% DHA.” Id. at 8:2–4. We are directed to no actual microbial oil in Radianingtyas, however, that was purified to have increased levels of DHA. Rather, Petitioner only proffers what Radianingtyas might say if such an oil existed or had been purified to increase levels of DHA.10” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,757,959 - PTAB · Feb 21, 2024 · IPR2023-01312 · APJ Jamie T Wisz · IPR · Adverse judgment
The Board entered adverse judgment against Patent Owner on claims 1–18 after Patent Owner disclaimed all claims, and terminated the proceeding.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“requisite fees. See Ex. 2104; see also 37 C.F.R. § 1.321 (setting forth requirements for statutory disclaimer). Under 37 C.F.R. § 42.73(b), “[a]ctions construed to be a request for adverse judgment include . . . (2) [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Because Patent Owner has disclaimed all claims of the ’992 patent, we construe this disclaimer as a request for adverse judgment, and we enter adverse judgment against the Patent Owner with respect to claims 1–18 of the ’992 patent. Accordingly, it is ORDERED that judgment is entered under 37 C.F.R. § 42.73(b) against Patent Owner with respect to claims 1–18 of U.S. Patent No. 10,464,992 B2; and” slip op. at 2
NonePatents in suitUS 10,464,992 - PTAB · Feb 21, 2024 · IPR2023-00462 · APJ Jamie T Wisz · IPR · Adverse judgment
After Patent Owner disclaimed claims 1–18, the Board entered adverse judgment against Patent Owner on those claims and terminated the proceeding.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Patent Owner has disclaimed all claims of the ’992 patent and paid the requisite fees. See Ex. 2104; see also 37 C.F.R. § 1.321 (setting forth requirements for statutory disclaimer). Under 37 C.F.R. § 42.73(b), “[a]ctions construed to be a request for adverse judgment include . . . (2) [c]ancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” Because Patent Owner has disclaimed all claims of the ’992 patent, we construe this disclaimer as a request for adverse judgment, and we enter adverse judgment against the Patent Owner with respect to claims 1–18 of the ’992 patent. Accordingly, it is ORDERED that judgment is entered under 37 C.F.R. § 42.73(b) against Patent Owner with respect to claims 1–18 of U.S. Patent No. 10,464,992 B2; and” slip op. at 2
NonePatents in suitUS 10,464,992 - Atea Pharmaceuticals, Inc. v. Gilead Sciences, Inc.Institution deniedPTAB · Feb 21, 2024 · PGR2023-00046 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Atea did not show claim 1 was more likely than not unpatentable for lack of written description, lack of enablement, or anticipation.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that claim 1 is unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The major differences between Petitioner’s and Patent Owner’s definitions of a skilled artisan include the number of years of drug discovery experience that is necessary and the breadth of the fields of endeavor with which a POSA should be familiar. We agree with Patent Owner that a POSA includes a team of skilled artisans with skill sets in the various aspects of drug development, but determine that Petitioner has addressed those necessary skill sets in its definition. We also determine on this record that Petitioner has assessed adequately the level of experience needed, and do not agree with Patent Owner that greater years of experience are necessary for a POSA in this instance. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’361 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail on its challenges to claim 1. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“C. Claim Construction We construe claims “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. § 42.200. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Both parties agree that we need not construe any claim terms here to resolve the issues in this proceeding. See Pet. 16; Prelim. Resp. 18–19. We agree with the parties that we need not construe any claim terms in this proceeding to resolve whether to institute a post-grant review.” slip op. at 11
- BurdenNot shown unpatentable
“In applying the rubric set forth in Ariad to determine whether claim 1 has appropriate written description support, we can look for structural features common to the members of the subgenus of claim 1 so that one of skill in the art can “visualize or recognize” the members of the subgenus. See Ariad, 598 F.3d at 1350. To do this, we look “for blaze marks within the disclosure that guide attention to the claimed species or subgenus.” See Regents of the Univ. of Minn., 61 F.4th at 1356. In this regard, the fourteenth aspect of the third embodiment is the blaze mark that points to the subgenus of claim 1. We do not need to find blaze marks that identify the fourteenth aspect of the third embodiment as the only formula of merit or the only one that should be claimed. Rather, we look to the written description to see if it describes sufficient structural features common to the members of the subgenus of claim 1 such that a POSA can visualize or recognize the members of that subgenus, thereby demonstrating that the inventors possessed the subject matter of the claim at the time they filed their application.” slip op. at 20
Claim construction§ 102 anticipation§ 112 disclosurecites KSRPatents in suitUS 11,642,361 - PTAB · Feb 1, 2024 · IPR2023-01298 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–30 and all asserted grounds, finding a reasonable likelihood that Chell anticipates at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). The Board determines whether to institute a trial on behalf of the Director. 37 C.F.R. § 42.4(a). A decision to institute is “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).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have possessed a strong understanding in the use and development of genetics and genomics approaches for detecting or monitoring human diseases, such as spatial detection of a target analyte (e.g., mRNA or DNA) in a tissue, and would typically have a Ph.D. in a relevant field (e.g., molecular biology, genetics, and bioinformatics) with two years of experience. Pet. 14 (citing Ex. 1002 ¶¶ 24–25). For the purposes of its Preliminary Response, Patent Owner does not provide its own proposed level of skill. Prelim. Resp. 10. For purposes of this Decision, we apply Petitioner’s unchallenged definition as it is consistent with the cited prior art and disclosure of the ’689 patent.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownOther
“a) contacting the tissue sample with a plurality of nucleic acid probes, wherein each of the nucleic acid probes comprise a target binding domain that binds to the at least one target analyte, wherein the tissue sample [has been] is treated to facilitate binding of the nucleic acid probes to the target analyte b/c) collecting the nucleic acid probes, or portions thereof, bound to the at least one target analyte in a first/second location of the tissue sample under conditions that release the nucleic acid probes, or portions thereof, from the first/second location of the tissue sample d/e) performing an extension reaction that incorporates at least one nucleic acid sequence that identifies the first/second location of the tissue sample into each of the nucleic acid probes, or portions thereof, collected in step (b), thereby forming a first plurality of extension products that comprise the nucleic acid probes, or portions thereof, collected in step (b) and the at least one nucleic acid sequence that identifies the first/second location of the tissue sample Ex. 1001, 145:51–147:11 (emphasis added). Thus, according to claim 1, the “nucleic acid probe” must 1) comprise a target binding domain that binds to the at least one target analyte, 2) be bound to the at least one target analyte; 3) be released in whole or as a portion, and 4) have a location-identifying nucleic acid sequence incorporated into it through an extension reaction. Steps a), b), and c) occur in relation to the target analyte, while steps d) and e) occur after the probe is” slip op. at 21
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We further interpret “collecting the nucleic acid probes” to mean “releasing all or a portion of the nucleic acid probe bound to the at least one target analyte through application of a force followed by retrieval of the released probe or portion of the probe.” The question then becomes whether So-465, which teaches replication of a probe that was bound and then at least partially released to make genomic amplicons, followed by collection of those genomic amplicons, anticipates collection of probes as recited in claims 1 and 16. On this record, we do not see sufficient evidence that the genomic amplicons disclosed in So-456 that Petitioner identifies as “captured” were ever “bound to the analyte” in part or in whole as required by the claim language, but rather were amplified in situ from the probe or partial probe that was released. Ex. 1005 ¶¶ 181–183. In particular, the process of So-456 differs from the ’689 patent claims in that the extension reaction to incorporate the tissue-identifying nucleic acid sequence in So-465 occurs after the identifier nucleotide is cleaved from the tissue sample. “Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). Petitioner has not demonstrated that So-456 teaches this claim limitation or otherwise demonstrates that this limitation would have been inherent in the disclosure of So-456 for claims 1 and 16. For these reasons, on this record we determine that Petitioner has not shown a reasonable likelihood that So-456 anticipates either of independent claims 1 or 16.” slip op. at 24
Claim construction§ 102 anticipation§ 103 obviousnesscites GrahamPatents in suitUS 11,377,689 - PTAB · Jan 31, 2024 · IPR2024-00298 · APJ Ryan H Flax · IPR · Institution
Instituted IPR on claims 1–30 of the ’572 patent on all asserted grounds and granted Biocon’s motion to join IPR2023-00884.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We explained in our Institution Decision in IPR’884 why we conclude that Samsung demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See generally IPR’884 DI. The present Petition advances identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning here as in our IPR’884 Institution Decision, and conclude that Petitioner is likely to prevail in demonstrating the unpatentability of the same challenged claims. Id. We incorporate our previous analysis regarding the asserted grounds of unpatentability and conclude that Petitioner demonstrates a reasonable likelihood of prevailing at trial with respect to at least one claim of the ’572 patent challenged in the Petition for the same reasons as in IPR’884. See id. Therefore, we determine that the Petition warrants institution of inter partes review on all claims and all grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (“When instituting . . . review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 9
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“joinder is discretionary. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. We determine whether to grant joinder on a case-by-case basis, taking into account the particular facts of each case, substantive and procedural issues, and other considerations. When exercising that discretion, we are mindful that patent trial regulations, including the rules for joinder, must be construed to secure the just, speedy, and inexpensive resolution of every proceeding. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). As the moving party, Petitioner bears the burden of proving that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for joinder should: (1) set forth the reasons joinder is appropriate; (2) identify any new grounds of unpatentability asserted in the petition; and (3) explain what impact (if any) joinder would have on the trial schedule for the existing review. See Kyocera Corp. v. Softview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013); see also, USPTO, America Invents Act (AIA) Frequently Asked Questions,” available at: uspto.gov/patents/laws/americainvents-act-aia/america-invents-act-aia-frequently-asked#type-inter-partesreview_3244 (last visited February 2, 2022). B.” slip op. at 10
NonePatents in suitUS 11,253,572 - PTAB · Jan 30, 2024 · IPR2024-00260 · APJ Ryan H Flax · IPR · Institution
Instituted review of claims 1–30 on all asserted grounds and granted Celltrion’s motion to join IPR2023-00884.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We explained in our Institution Decision in IPR’884 why we conclude that Samsung demonstrated a reasonable likelihood of prevailing at trial in showing that the challenged claims are unpatentable. See generally IPR’884 DI. The present Petition advances identical arguments, challenging the same claims over the same combinations of prior art. We consequently adopt the same reasoning here as in our IPR’884 Institution Decision, and conclude that Petitioner is similarly likely to prevail in demonstrating the unpatentability of the same challenged claims. Id. We incorporate our previous analysis regarding the asserted grounds of unpatentability and conclude that Petitioner demonstrates a reasonable likelihood of prevailing at trial with respect to at least one claim of the ’572 patent challenged in the Petition for the same reasons as in IPR’884. See id. Based on the record before us, we determine that the Petition warrants institution of inter partes review on all claims and all grounds asserted in the Petition. 37 C.F.R. § 42.108(a) (“When instituting . . . review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”); see also SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 11
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner certifies and we agree that the Petition is substantively identical to that of IPR’884, where we found Samsung had met its burden to show a reasonable likelihood it would prevail at trial in establishing at least one challenged claim unpatentable under the asserted grounds. Mot. 5; see generally IPR’884 DI. Petitioner also certifies, and we agree, that it relies on the same evidence here as in IPR’884. Mot. 5. Patent Owner waives its right to file a preliminary response in this proceeding, for the sake of efficiency. See Paper 7, 2. Petitioner also certifies that it will be a “silent understudy” to Samsung in IPR’884 if the proceedings are joined, thus, there will be no impact to the schedule of that instituted trial. Mot. 5–6. Moreover, Petitioner asserts that, structured in this way, the joined proceeding will simplify briefing and discovery (i.e., they will be singular, rather than occurring in two proceedings). Id. at 6–7.” slip op. at 12
NonePatents in suitUS 11,253,572 - Twinstrand Biosciences, Inc. v. Guardant Health, Inc.No claims unpatentablePTAB · Jan 26, 2024 · IPR2022-01400 · APJ Michael A Valek · IPR · Final written decision
Claims 1–29 were not shown unpatentable over the asserted obviousness grounds because the prior-art combinations did not teach key limitations of claims 1, 17, and 29.
RulingsFinal written decision- BurdenNot shown unpatentable
“Having considered these arguments on the full trial record, we find Patent Owner has the better position because Petitioner’s showing that element 1(b) is taught by Schmitt is unpersuasive. We begin with Patent Owner’s argument concerning the distinction between the cfDNA molecules and the duplex tag comprising the molecular barcode found in the text of claim 1. Element 1(a) recites “a population of cell-free deoxyribonucleic acid (cfDNA) molecules.” Ex. 1001, 61:7–9. Element 1(b) recites “tagging a plurality of the cfDNA molecules in the population” of element 1(a) “with duplex tags comprising molecular barcodes to produce tagged parent polynucleotides . . . wherein the duplex tags are attached to both ends of a added). We agree with Patent Owner and credit the testimony of its declarant that this claim language distinguishes the duplex tags from the ends of the cfDNA molecule to which they are attached. Resp. 8; Ex. 2015 ¶¶ 38–39, 60, 61. That is, the duplex tag is not part of the cfDNA molecule itself, but rather is “attached to both the ends” of that molecule by “tagging” it as recited in element 1(b). We also agree with Patent Owner that given this distinction, claim 1 does not encompass Schmitt’s hybrid embodiment. Resp. 18–20. As Petitioner notes, “[i]n Schmitt’s hybrid-tag embodiment, the strands are grouped based on the combination of the short n-mer barcode and the end of the target DNA.” Pet. 11; see Resp. 17 (“[T]he combination of the endogenous shear sequence and exogenous 3-mer sequence together provide the SMI used for grouping and matching in Schmitt’s DCS process.”). Petitioner and its declarant illustrate the grouping in Schmitt’s hybrid embodiment with the following diagram. Pet. 12; Ex. 1002 ¶¶ 96–98. Petitioner’s diagram shows the PCR products produced from sequencing a “Target DNA” molecule that has been tagged with 3-mers X and Y according to Schmitt’s hybrid embodiment. See Ex. 1002 ¶ 98 (describing diagram). A portion of the endogenous sequence of the DNA molecule labeled L and R is used in combination with the 3-mer sequence to group the resulting strands into two families labeled the “X+L→R+Y Family” and the “R+Y→X+L Family.” Ex. 1002 ¶ 98; Ex. 2015 ¶ 62 (explaining that Petitioner’s diagram shows that “the relied upon hybrid SMI sequences of Schmitt include sequence from the sample DNA molecule not contained in the adapter or the duplex tags”). SMIs, differently label the strands and therefore are the recited “duplex tags.” See Pet. 27–28 (“duplex tags comprise both the fragment DNA end sequences and a shorter n-mer tag”) (emphasis added) (internal quotations omitted). However, we credit Dr. Quackenbush’s testimony that end sequences L and R are not “attached to both ends” of the cfDNA molecule by “tagging” it as recited in element 1(b). See Ex. 2015 ¶ 59–62 (explaining that Schmitt’s hybrid SMI sequences include a portion of the sample DNA molecule, which is “not contained in adapter molecules or duplex tags that are attached to the DNA molecules”). Rather, end sequences L and R are the pre-existing, endogenous ends of that molecule. Id. Thus, Petitioner’s theory of unpatentability does not account for the distinction the claim language draws between the cfDNA molecule and the duplex tags. Petitioner’s argument that the ’306 patent defines “duplex tag” as a” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“That is, although Meyer teaches that its particular protocol results in 40–60% tagging efficiency, Petitioner has not sufficiently explained 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, the Petition does not 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. 1083 ¶ 30. sticky-end adapter-DNA litigation to be even more efficient than Meyer’s blunt-end adapter-DNA ligation” is also unpersuasive. See Pet. 60–61. The KAPA data sheet discloses sticky-end adapter DNA ligation, but KAPA teaches that only 0.5 to 15% tagging efficiency is expected when the starting sample is 100 pg–100 ng of “high quality DNA.” Ex. 1015, 4. Thus, the KAPA data suggests that the use of sticky-end adapters, such as what Schmitt discloses, does not in and of itself teach or suggest the tagging efficiency limitations. Moreover, the record shows that tagging efficiency depends on a variety of other factors, including the quality of the input DNA. The KAPA data sheet states that tagging efficiency “can be significantly lower for DNA of lower quality.” Ex. 1015, 4. Fisher also explains that “the efficiency of adaptor ligation varies between samples, probably because of variation in input DNA quality.” Ex. 1031, 5–6. Petitioner’s argument that the DNA the KAPA data sheet refers to as “lower quality” is “from formalin-fixed, paraffin-embedded (‘FFPE’) samples (well known for having chemically damaged DNA)” is unavailing. See Reply 25–26 (citing Ex. 1098 ¶¶ 96–98). First, neither Petitioner, nor its declarant, address the similar teaching in Fisher. Second, even if the specific type of lower quality DNA in the KAPA data sheet is different, the salient point, i.e., that tagging efficiency depends on DNA quality, remains unrebutted. This is significant because Petitioner does not sufficiently address how the quality of the cfDNA of Narayan compares to the quality of the genomic DNA samples of Meyer and Schmitt or how that would affect the expected tagging efficiency. Petitioner’s assertion that “significant quantities of cfDNA could be isolated from blood samples” (see Reply 26), fact that a significant quantity of cfDNA could be obtained does not show that the quality of that DNA is similar such that a POSA using such would have expected to achieve a tagging efficiency similar to that in Meyer.” slip op. at 40
- Strike new argumentNew argument disregardedDenied
“We are not persuaded. First, this is an inappropriate new argument. The Petition presents a different mapping, alleging that the “duplex tag” comprises both the endogenous end sequence of the cfDNA molecule and the 3-mer barcode of Schmitt’s hybrid tag embodiment. Pet. 27 (“the duplex tags comprise both the fragment DNA end sequences and ‘a shorter n-mer tag’ to serve as ‘unique molecular identifiers’”) (quoting Ex. 1083 ¶ 30, Ex. 1002 ¶¶ 162–163); see also Tr. 62:13–63:19 (Petitioner’s counsel noting he was unaware of any explicit statement in the Petition that Schmitt’s duplex tag comprised just the 3-mer without the end sequence). Nor did Petitioner regarding element 1(b). See Reply 8–10. Rather, consistent with the mapping in the Petition, the Reply identifies “Schmitt’s hybrid tags,” i.e., the combination of the endogenous end sequence and the n-mer, as the duplex tags in element 1(b). See Reply 8 (urging that “duplex tags” are “tags that differently label the complementary strands,” which “is precisely what Schmitt’s hybrid tags do”). Because this argument was not previously presented, Patent Owner has not been afforded a sufficient opportunity to address it. Thus, Petitioner’s new argument excluding the end sequences in Schmitt’s hybrid tag embodiment from the alleged “duplex tags comprising molecular barcodes” has been waived. Second, even if we were to consider it on the merits, Petitioner’s new mapping for element 1(b) is inconsistent with Petitioner’s allegations for element 1(e). Element 1(e) recites “reducing or tracking redundancy” in sequence reads “using at least sequencing information from the molecular barcodes of the duplex tags to determine distinct cfDNA molecules.” Ex. 1001, 61:26–30. For these limitations, the Petition points to Schmitt’s grouping of reads into families based on their SMI and asserts that Schmitt determines distinct cfDNA molecules based on “the complementary nature of the SMI on the two strands of the duplex.” See Pet. 30–32 (internal quotations omitted). Thus, like Petition’s mapping for element 1(b), Petitioner’s allegations for element 1(e) rely on a duplex tag that includes both the 3-mer and the end sequence of the cfDNA molecule. Petitioner has not sufficiently explained, much less shown by a preponderance of the evidence, that Schmitt teaches or suggests the limitations in element 1(e) based on its new mapping of the 3-mer alone as duplex tags.” slip op. at 25
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Motion to exclude, deniedDenied
“We do not rely on any of these exhibits in rendering our decision on Petitioner’s grounds. Therefore, we dismiss as moot Petitioner’s motion to exclude Exhibits 1069, 1074, 1078, 1079, and 1085–1088.” slip op. at 46
Patent outcomesUS 11,149,306 not shown unpatentable§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,149,306 - Mara Renewables Corporation v. DSM IP Assets, B.V.Institution deniedPTAB · Jan 25, 2024 · IPR2023-01167 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood of prevailing on any challenged claim under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“When asserting unpatentability under obviousness, the patent challenger must show a reasonable expectation of success, that is, “the likelihood of success in combining references to arrive at the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). Thus, “[t]he reasonable-expectationof-success analysis must be tied to the scope of the claimed invention.” Teva Pharms. USA, Inc. v. Corcept Therapeutics, Inc., 18 F.4th 1377, 1381 (Fed. Cir. 2021); Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (holding the trial court’s failure to consider the appropriate scope of the claimed invention in evaluating the reasonable expectation of success constitutes a legal error). Relevant to our Decision here, claim 3 requires its microbial lipid to have, among others, at least 60% by weight DHA in the triglyceride fraction and an AV of 0.5 to 26.” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we adopt Petitioner’s definition of the skill level because it is consistent with the prior art’s demonstration of the level of ordinary skill at the relevant time. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“We emphasize that our finding is not on lack of reasonable expectation of success per se. Instead, we merely find neither the Petition nor the Curtis Declaration persuasively addresses “the expected differences in the oxidizability and oxidation rate—and their expected impact on anisidine values—of an oil containing 42% ARA (for which Schaap discloses limited experimental data) versus one containing 60% DHA in the triglyceride fraction (for which Schaap does not).” See id. at 27. In sum, we find Petitioner has not shown sufficiently that an ordinarily skilled artisan, based on the teachings of the asserted prior art, would have had a reasonable expectation of success for the appropriate scope of the claimed invention (that is, a microbial lipid having at least 60% DHA in the triglyceride fraction and an AV of 0.5 to 26). As a result, on this record, Petitioner has not established a reasonable likelihood that it would prevail in this challenge.” slip op. at 13
§ 103 obviousnesscites PhillipsPatents in suitUS 10,392,578 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00566 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Owner and its experts proposed claim construction of “effectively treating” as meaning “noninferior,” “statistically noninferior,” or “comparable.” Pet. Reply 4. Petitioner asserts that Patent Owner, and its expert, Dr. Do, advance the proposed construction of “effectively treating, ” with no explanation for what that means, or how it comports with the challenged dependent claims that recite visual acuity limitations ranging from losing less than 15 letters to gaining more than 15 letters. Id. at 4–5.” slip op. at 32
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601
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.