• Aardevo North America, LLC v. Agventure B.V.Institution denied
  PTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution

  Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.

  RulingsInstitution decision

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

    “Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15

  • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable

    “Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

    “XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 11,140,841
• Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Institution denied
  PTAB · May 17, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable over Perkins or the asserted combinations.

  RulingsInstitution decision

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

    “We have authority under 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Accordingly, we deny institution of post-grant review.” slip op. at 2

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for patent owner

    “Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that Perkins is prior art to the ’366 patent only to the extent that the subject matter disclosed in Perkins is likewise described in the Perkins Provisional. Accordingly, we do not consider Petitioner’s arguments that rely on subject matter unsupported by the Perkins Provisional. For example, support for Petitioner’s argument that Perkins discloses “mutant VSV-G envelope protein containing only four mutations at N180, I182, T352, and E353” is not found in the Perkins Provisional and is therefore not considered. Pet. 73 (quoted with Petitioner’s emphasis). Thus, insofar as Petitioner is suggesting that Perkins describes a list of mutations that is narrowed to four positions including a mutation at I182, rather than a listing of thirteen potential positions for mutations (and various combinations thereof with hypothetical mutations at a variety positions), we find no such narrower listing in the Perkins Provisional. Compare Ex. 1005, 22:2–5, with Ex. 1006, 17–18.” slip op. at 19

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “genus even if the species are not themselves recited.” Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001); see also, Atofina, 441 F.3d at 999 (“[A] very small genus can be a disclosure of each species within the genus.” (citing In re Petering, 301 F.2d at 682)). In Petering, for example, the prior art disclosed a small genus of only 20 compounds that included the claimed species. In re Petering, 301 F.2d at 682. In its discussion concluding that a small genus may anticipate a species of that genus, the Court of Customs and Patent Appeals explained that “it is not the mere number of compounds in this limited class which is significant here, but rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus.” Id. at 681–682. Having considered the parties’ positions and evidence of record, summarized above, we do not find that Perkins discloses a limited class as exemplified in Petering. To begin, while it is undisputed that Perkins discloses a class of mutant VSV-G envelope proteins that encompasses the recited I182E or I182D mutations, it is also undisputed that Perkins does not disclose the I182E or I182D mutations. Prelim. Resp. 22. Furthermore, and by contrast to the limited class of compounds at issue in Petering, Perkins discloses a class of mutant VSV-G envelope proteins defined as proteins containing one or more of 20 possible mutations or alterations, a class that includes at least 254 proteins. Ex. 1006, 17–18; Prelim. Resp. 26–27. Furthermore, as Patent Owner correctly points out, “[t]he Perkins Provisional does not include any disclosure of the specific mutations to be made at any of these locations. That is, the Perkins Provisional does not indicate the other amino acid(s) to be substituted at the listed locations.” Prelim. Resp. 26. Thus, Perkins fails to provide a POSA with a “‘pattern of preferences’ that serves to narrow the genus.” See, e.g., Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006) (“there is no such clear ‘pattern of preferences’ [as found in Petering] that serves to narrow the genus in claim 2 to a narrow class that includes clopidogrel bisulfate”).” slip op. at 22

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

    “Obviousness is a question of law based on underlying findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009). A conclusion of obviousness is appropriate where the prior art “contain[s] detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988); see also, In re Kubin, 561 F.3d at 1359 (KSR “actually resurrects [the Federal Circuit]’s own wisdom in In re O’Farrell”). However, to render a claim obvious, prior art cannot be “vague” and must collectively, although not explicitly, guide an artisan of ordinary skill towards a particular solution. Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009). That is, when a field is “unreduced by direction of the prior art,” and when prior art gives “no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” an invention is not obvious. Bayer Schering, 575 F.3d at 1347 (citing In re O’Farrell, 853 F.2d at 903). Having considered the parties’ positions and evidence of record, summarized above, we are not persuaded that Perkins discloses a finite set or limited class of 19 mutations. Pet. 66. Rather, we agree with Patent Owner that Perkins discloses a large genus of mutant VSV-G polypeptides containing at least 254 species—“Perkins Provisional discloses mutations at I182 among a group of 20 other possible locations for modifications[,] . . . [13] of these 20 positions are specific amino acids that . . . can be changed to any of the 19 other natural amino acids” —each species combinable to create a vast number of species. Prelim. Resp. 32. Perkins does not indicate any preference among the 13 disclosed mutations, does not indicate any preference among the 19 other amino acids, and does not indicate any preference as to which mutations should be combined to successful effect. Ex. 1006, 17–18. Thus, while Perkins discloses that one or more mutations “inhibit the envelope protein’s ability to bind its native target, while preserving the envelope protein’s fusogenic properties,” beyond that, a POSA would have no direction for selecting the route to create the I182E or I182D mutations specified by the challenged claims among the various unpredictable alternatives suggested by Perkins. Ex. 1006 at 16; Ex. 1002 ¶ 193. We do not find this to be the easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness. KSR, 550 U.S. at 402. slip op. at 34

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 11,767,366
• Mara Renewables Corporation v. DSM IP Assets, B.V.Institution denied
  PTAB · Apr 18, 2024 · IPR2024-00070 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–15 were anticipated by Radianingtyas or obvious over either asserted combination.

  RulingsInstitution decision

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

    “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 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 › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim term “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id.; see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (holding that the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application”). 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 construe any claim term.” slip op. at 6

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not provide a definition of the level of ordinary skill in the art. See Prelim. Resp. 19. Patent Owner also states that any differences between the parties’ proposed definition of the skill level would not impact its arguments. Id. 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

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “triglyceride, DHA, and heptadecanoic acid content recited therein. 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) (quotation marks omitted). A reference, however, can anticipate a claim “even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed. Cir. 2017) (quotation marks and brackets omitted). As explained below, here, Petitioner has not shown Radianingtyas discloses a microbial oil comprising the required triglyceride, DHA and heptadecanoic acid content. Specifically, although the exemplified strain ONC-T18 produces oil that meets the claimed triglyceride fraction and heptadecanoic acid level, Petitioner has not shown the same oil contains the recited DHA level.” slip op. at 10

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
  Patents in suitUS 8,207,363
• Mara Renewables Corporation v. DSM IP Assets, B.V.Institution denied
  PTAB · 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 · Graham
  Patents in suitUS 10,757,959
• Atea Pharmaceuticals, Inc. v. Gilead Sciences, Inc.Institution denied
  PTAB · 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 KSR
  Patents in suitUS 11,642,361
• Mara Renewables Corporation v. DSM IP Assets, B.V.Institution denied
  PTAB · 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 Phillips
  Patents in suitUS 10,392,578
• Microbiotica, Limited v. Board Of Regents, The University Of Texas SystemInstitution denied
  PTAB · Nov 21, 2023 · PGR2023-00026 · APJ Susan L C Mitchell · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–19 were unpatentable, including because the proposed prior-art combination lacked a sufficient reason to select Ruminococcus for skin …

  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.”1 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 at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

    “7 Patent Owner requested that we exercise our discretion to deny institution under 35 U.S.C. § 325(d). See Prelim. Resp. 11–49. Because we determine on the merits that no post-grant review should be instituted, we will not address Patent Owner’s arguments concerning Section 325(d).” slip op. at 44

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner counters that Petitioner has set the level of skill of a person of ordinary skill in the art too low. Prelim. Resp. 9–11; Ex. 2001 ¶ 25. Patent Owner asserts that a POSA would have a more advanced degree than a bachelor of science and would have more specific work experience. Id. For instance, Patent Owner asserts: A POSA for the ’838 Patent typically would have an advanced degree, such as an M.D. or a Ph.D., with experience and training in oncology, have several years of experience with administering oncology treatments to subjects and evaluating results of such treatments, and have experience or knowledge in microbiome science and its modulation, inclusive of studies that involve stool microbiome profiling, as well as experience in, or knowledge of, related research and development of bacterial-based cancer treatments. A POSA may also have worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. For example, such a team may include a clinician, an immunologist, microbiologist, bioinformatician, molecular biologist, manufacturing specialist, and/or pharmaceutical formulator. Prelim. Resp. 9–10 (citing Ex. 2001 ¶¶ 26–27). Patent Owner concludes that by applying the inappropriately low level of skill of a POSA, “Petitioner overstates the amount of guidance needed in the specification to describe and enable the claimed methods.” Prelim. Resp. 11. Patent Owner confirms, however, that all arguments on all grounds presented in the Preliminary Response “apply regardless of which party’s POSA definition is used.” Prelim. Resp. 11 n.2. We disagree with Patent Owner that a POSA is required to have a” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “Patent Owner acted as its own lexicographer and expressly defined “isolated” and “purified” as follows. The term “isolated” encompasses a bacterium or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental 6 Available at https://www.uspto.gov/sites/default/files/documents/IndefinitenessMemo.pd f?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email& utm_name=&utm_source=govdelivery&utm_term=. setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated bacteria may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated bacteria are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. As used herein, a substance is “pure” if it is substantially free of other components. The term “purify,” “purifying” and “purified” refer to a bacterium or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A bacterium or a bacterial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the bacterium or bacteria population, and a purified bacterium or bacterial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60% about, 70%, about 80%, about 90% or above about 90% and still be considered “isolated.” In some embodiments, purified bacteria and bacterial populations are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of bacterial compositions provided herein, the one or more bacterial types present in the composition can be independently purified from one or more other bacteria produced and/or present in the material or environment containing the bacterial type. Bacterial compositions and the bacterial components thereof are generally purified from residual habitat products. Ex. 1001, 28:40–29:11. In reviewing the express definitions of “isolated” and “purified,” it is not surprising that the two similar terms, “isolated” and “purified,” may have overlapping definitions. We agree with Patent Owner that such overlap does not mean the definitions lack “reasonable clarity, deliberateness, and precision” that would inform a POSA with reasonable certainty about the scope of claim 1. We also agree with Patent Owner that a POSA would understand the two parts of the definition of “isolated” set forth above.” slip op. at 30

  Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · Nautilus
  Patents in suitUS 11,395,838
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.

  RulingsInstitution decision

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

    “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “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.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11

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

    “We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). D. Overview of Asserted References” slip op. at 12

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 8,129,343
• Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution denied
  PTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution

  Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.

  RulingsInstitution decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14

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

    “The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 15

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

    “For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2

  • BurdenNot shown unpatentable

    “Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43

  Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · Graham
  Patents in suitUS 8,536,122
• Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution denied
  PTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution

  Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.

  RulingsInstitution decision

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

    “APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19

  • BurdenDecided for patent owner

    “As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33

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

    “Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20

  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,253,572

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.