- Pfenex, Inc. v. Glaxosmithkline Biologicals SAInstitution deniedPTAB · Feb 10, 2020 · IPR2019-01478 · APJ Jo-Anne M Kokoski · IPR · Institution
The Board denied institution of review of claims 1, 2, 4–14, and 16–21 under § 314(a), finding all General Plastic factors favored discretionary denial.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“asserted in this Petition when it filed the petitions in the 1027 and 1028 IPRs. Petitioner’s only excuse for its delay in filing this Petition is that Patent Owner “could not have foreseen” that the 230 IPR would settle and terminate. Paper 2, 5. Settlement and termination of an inter partes review proceeding, however, is neither unusual nor rare. Moreover, if Petitioner was interested in pursuing the same challenge as that presented in the 230 IPR, it could have requested joinder under 37 C.F.R. § 42.122(b), which provides that “[j]oinder may be requested by a patent owner or petitioner” and “must be filed, as a motion under § 42.22, no later than one month after the institution date of any inter partes review for which joinder is requested.” That the 230 IPR settled after institution is not an adequate excuse for delay. We are also not persuaded that the fact the Board previously determined that the challenges presented in the 230 IPR presented a reasonable likelihood of success justifies the additional burden of a second petition directed to the ’345 patent, when a trial has already been instituted in the 1028 IPR. See Paper 2, 4. This is particularly true here, where Petitioner ranked the 1028 IPR petition and the 1027 IPR petition ahead of the current Petition, indicating Petitioner’s preference that we consider the merits of this Petition last. Id. at 3.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“set forth above, we exercise discretion under 35 U.S.C. § 314(a) and decline to institute an inter partes review of the ’345 patent.10 IV. ORDER In consideration of the foregoing, it is hereby ORDERED that the Petition is denied and no inter partes review is instituted. 10 Consequently, we do not reach the merits of Petitioner’s challenges, nor do we reach the issue of whether the Petition should be denied under 35 U.S.C. § 325(d).” slip op. at 14
Discretionary denialPatents in suitUS 9,422,345 - Pfenex Inc. v. Glaxosmithkline Biologicals SAInstitution deniedPTAB · Nov 13, 2019 · IPR2019-01027 · APJ Richard J Smith · IPR · Institution
The Board denied institution on claims 1, 2, 4, 6, 8, 12–14, 17–19, and 21, exercising § 314(a) discretion because the concurrent petition did not justify its added burden.
RulingsInstitution decision- Parallel petitionsDenied
“challenge the same claims of the same patent, i.e., the ’345 patent. See Paper 2; Pfenex, IPR2019-01028, Paper 2. Moreover, we do not find the asserted differences between the ’028 Petition and ’027 Petition, as explained by Petitioner, to be sufficiently material to outweigh the inefficiencies and costs to the Board and Patent Owner that would result from instituting on both the ’027 Petition and the ’028 Petition. See TPG July 2019 Update, 26 (“Two or more petitions filed against the same patent at or about the same time . . . may place a substantial and unnecessary burden on the Board and the patent owner and could raise fairness, timing, and efficiency concerns.”). The ’028 Petition advances two obviousness challenges that rely on art regarding CRM197 and art regarding “a vector that directs the export of the mutant proteins into the periplasmic space.” Paper 10, 4. Although the ’027 Petition advances an anticipatory challenge based on Mekada, Petitioner relies on Mekada for its teachings of CRM197, similar to its reliance on Davis and Zhou in the ’028 Petition. Id. As for the signal peptide “capable of directing transport of said bacterial toxin polypeptide to the bacterial periplasm,” Petitioner points to the disclosure of expression vector pET-22b in Mekada to argue that “the periplasmic secretion function of pET-22b is an inherent property, regardless of whether this function is discussed in Mekada.” Pet. 26–27. Petitioner characterizes its two obviousness challenges in the ’027 Petition as relying on Mekada and art “which present[s] vector maps that encode a signal peptide for potential periplasmic location,” similar to Petitioner’s reliance on Inouye and Ikemura for “a vector that directs the export of the mutant proteins into the periplasmic space” in the ’028 Petition. Paper 10, 4. We thus agree with Patent Owner that “the redundancy of Petitioner’s references and the similar manner in which Petitioner relies on them is evident from Petitioner’s own characterization of their teachings.” Paper 11, 2. Although Petitioner describes some differences between the ’028 Petition and ’027 Petition, it fails to persuasively explain “why the issues addressed by the differences are material.” TPG July 2019 Update, 27. We are not persuaded on this record that merely arguing that different art is cited, or that the ’027 Petition includes an anticipation challenge, explains “why the issues addressed by the differences are material.” See id.; Paper 10, 4.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied discretionary otherInstitution denied
“Accordingly, we institute an inter partes review on all grounds presented in the ’028 Petition (see IPR2019-01028), and exercise the Director’s discretion under 35 U.S.C. § 314(a) to deny institution of the present Petition. ORDER Accordingly, it is ORDERED that Petitioner’s request for an inter partes review of claims 1, 2, 4, 6, 8, 12–14, 17–19, and 21 of the ’345 patent is denied and no inter partes review is instituted.” slip op. at 14
Discretionary denialPatents in suitUS 9,422,345 - Initiative For Medicines, Access & Knowledge (I-Mak), Inc. v. Gilead Pharmasset LLCInstitution deniedPTAB · Jun 13, 2018 · IPR2018-00103 · APJ Lora M Green · IPR · Institution
The Board denied institution for claims 1–19 because the Petition did not show a reasonable likelihood that any challenged claim was anticipated by Klecker or Sommadossi, or obvious over Sommadossi and Klecker.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims. Accordingly, we decline to institute an inter partes review for any challenged claim of the ’572 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“reasonable likelihood that claim 1 is anticipated by Klecker. To anticipate a reference must expressly or inherently disclose “within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (2008). Moreover, “anticipation is not proven by ‘multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.’” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (internal citation omitted). “[A] disclosed genus may anticipate a claimed species when the genus is so small that one of ordinary skill in the art would ‘at once envisage each member of this limited class.’” Wasica Fin. GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272, 1285 (Fed. Cir. 2017) (quoting AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014)). In this case, we agree with Patent Owner that Petitioner is improperly using claim 1 as a roadmap to cherry pick teachings of the Klecker reference to arrive at compounds encompassed by the genus of that claim. For example, we acknowledge that Klecker teaches that a fluorine may be placed below the ring at the 2' position of the sugar ring. Ex. 1005, 19:25‒26. Petitioner does not point us to any teaching of Klecker, however, that teaches a compound that has both a methyl group and a fluorine at the 2' position of the sugar ring, regardless of whether the fluorine is in the up position or the down position. That is, although the broad genus of compounds disclosed by Klecker encompasses such compounds, Petitioner does not point us to any teaching, other than the broad disclosure of the genus, wherein “W, X, Y, [and] Z” may be “H, hydroxy, halogen, alkyl (C1- C6), alkoxy (C1-C6)a label containing moiety or a label” (Ex. 1005, 15:3‒5), that would direct the ordinary artisan to choose X and W such that one of X and W is methyl and the other is fluorine, much less pointing to support of X as fluorine and W as methyl.” slip op. at 11
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Petitioner relies on the Declaration of Dr. Fortunak in asserting that because Klecker teaches the X position may be substituted with fluorine and teaches that W can be an alkyl (C1 – C6), the ordinary artisan would understand from “general knowledge and common sense that methyl is a preferred lower alkyl in that group.” Pet. 34 (citing Ex. 1002 ¶ 92). Dr. Fortunak, however, merely repeats the statement in the Petition without citing any evidentiary support. See Ex. 1002 ¶ 92; see also id. ¶¶ 93‒95 (discussing choosing other substituents in the structure of Klecker). Conclusory statements by an expert “that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Furthermore, Petitioner’s conclusory statements (Pet. 34‒35) that because C is the first substituent identified for J, and H and OH are the first two substituents identified for Y and Z and, thus, the ordinary artisan would immediately envisage a compound where J is C, Y is H, and Z is OH, do not sufficiently persuade us that the ordinary artisan would immediately envisage their implementation to arrive at compounds that fall within the genus of claim 1.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“To the extent that Petitioner (Pet. 51‒52) is invoking inherency in arguing that the express teaching of Sommadossi that R7 may be chloro, 6 Britton et al., U.S. Patent 5,420,266, issued May 30, 1995 (Ex. 1011). bromo and iodo, is also an express teaching that R7 may be fluoro, we disagree that the use of fluoro as the R7 group is inherent in the teachings of Sommadossi. “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999), quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). Even though the ordinary artisan may have understood that fluoro is also a halogen and may be substituted for chloro, bromo, or iodo, the fact remains that Sommadossi taught the use of, inter alia, chloro, bromo, or iodo at the R7 position, specifically, rather than a halogen element, generally. Ex. 1006, 13:24‒27. Petitioner’s argument (Pet. 52) that “Sommadossi taught that R6 could be ‘chloro, bromo, fluoro, [or] iodo,’” is actually counter to Petitioner’s assertions. That is, that statement demonstrates that Sommadossi knew that “fluoro” could be included in the list of halogens. Moreover, Sommadossi defined the term “halo” as “chloro, bromo, iodo, and fluoro.” Ex. 1006, 52:31. Thus, to avoid inadvertently excluding a halogen, Sommadossi could have used the term “halo” in listing the possible substituents for the R7 group, but chose not to do so. Accordingly, we determine that Petitioner has not sufficiently established that Sommadossi anticipates the compounds of claim 1. Because, as discussed above in our analysis of the anticipation ground over Klecker, all of the claims require the compound of that claim, or a particular compound that falls within the genus of claim 1, Petitioner has also not sufficiently demonstrated that any of the challenged claims are anticipated by Sommadossi. Accordingly, we decline to institute trial as to any of the challenged claims on the basis that the claim is anticipated by Sommadossi.” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,429,572
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.