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GlaxoSmithKline Biologicals SA v. Pfenex, Inc

Docket IPR2020-00890, Patent Trial and Appeal Board (May 7, 2020)
Susan Mitchell, Ulrike Jenks, presiding
Case TypeInter Partes Review
Patent8530171
Patent Owner Pfenex, Inc
Petitioner GlaxoSmithKline Biologicals SA
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11 Refund Approval: Notice of Refund

Document IPR2020-00890, No. 11 Refund Approval - Notice of Refund (P.T.A.B. Oct. 28, 2020)
Petitioner’s request for a refund of certain post-institution fees paid on May 7, 2020 in the above proceeding is hereby granted.
The amount of $27,600.00 has been refunded to Petitioner’s deposit account.
The parties are reminded that unless otherwise permitted by 37 C.F.R. § 42.6(b)(2), all filings in this proceeding must be made electronically in the Patent Trial and Appeal Board End to End (PTAB E2E), accessible from the Board Web site at http://www.uspto.gov/PTAB.
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9 Termination Decision Document: Dismissal Prior to Institution of Trial

Document IPR2020-00890, No. 9 Termination Decision Document - Dismissal Prior to Institution of Trial (P.T.A.B. Aug. 28, 2020)
On May 7, 2020, GlaxoSmithKline Biologicals SA (“Petitioner”) filed a Petition requesting an inter partes review of claims 1–36 of U.S. Patent No. 8,530,171 B2 (“the ’171 patent”).
On June 29, 2020, pursuant to authorization by the Board, Petitioner filed a Motion to Withdraw Petition for Inter Partes Review in this proceeding.
In the Motion, Petitioner states that “[o]n May 26, 2020, Petitioner filed a Second Petition in IPR2020-00962 (Paper 1, “’962 IPR Petition”) against the same claims of the ’171 patent to account for a potential dispute regarding the prior art status of the Blais reference.” Motion 2.
Petitioner also indicates that “withdrawal of the petition at this very early stage of the proceeding would preserve both the Board’s and the parties’ resources and would further the objective of 37 C.F.R. § 42.1(b) in ‘secur[ing] the just, speedy, and inexpensive resolution of every proceeding.’” Id. at 4.
This proceeding is at an early stage, and we have not yet considered the IPR2020-00890 Petition’s merits, nor have we instituted a trial.
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4 Notice of Filing Date Accorded to Petition: Notice of Accord Filing Date

Document IPR2020-00890, No. 4 Notice of Filing Date Accorded to Petition - Notice of Accord Filing Date (P.T.A.B. May. 20, 2020)
For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.
Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.
The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.
Charles E. Lipsey Richard B. Racine Joann M. Neth, Ph.D. Trenton A. Ward Amanda Murphy Yieyie Yang
If the parties actually engage in alternative dispute resolution, the PTAB would be interested to learn what mechanism (e.g., arbitration, mediation, etc.) was used and the general result.
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7 Motion: Motion to Withdraw Petition for Inter Partes Review

Document IPR2020-00890, No. 7 Motion - Motion to Withdraw Petition for Inter Partes Review (P.T.A.B. Jun. 29, 2020)
As authorized by the Board on June 26, 2020, GlaxoSmithKline Biologicals SA (“Petitioner”) files this motion to withdraw its Petition for Inter Partes Review of U.S. Patent No. 8,530,171 (“the ʼ171 Patent”) and thereby terminate IPR2020- 00890, which is in its preliminary phase.
In order to preserve the resources of the Board and the parties, Petitioner requests the withdrawal of its petition for inter partes review and termination of IPR2020- 00890.
The instant petition challenges claims 1-36 of the ʼ171 Patent based on PCT Application No. WO 2011/042516 (“Blais”) as a primary prior art reference.
On May 26, 2020, Petitioner filed a Second Petition in IPR2020-00962 (Paper 1, “’962 IPR Petition”) against the same claims of the ’171 patent to account for a potential dispute regarding the prior art status of the Blais reference.
In view of the foregoing, Petitioner requests for withdrawal of the instant petition for inter partes review and termination of IPR2020-00890 should be granted.
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1 Petition: Petition for Inter Partes Review

Document IPR2020-00890, No. 1 Petition - Petition for Inter Partes Review (P.T.A.B. May. 7, 2020)
The dependent claims of the ’171 patent recite well-known limitations that also would have been obvious to a POSA in view of the prior art, including signal sequences, tags, promoters, induction conditions, protease-deficient hosts, and codon optimization.
In support of the proposed grounds for unpatentability, this Petition is accompanied by a declaration of Dr. Collier (Ex. 1003), an expert in molecular cloning and expression of recombinant proteins, including diphtheria toxins, in bacterial host cells.
Patent No. 8,530,171 known that P. fluorescens strains “are stable, amenable to genetic or molecular manipulations, and can be cultivated to high cell densities in fully defined mineral salts media in standard fermentors, without oxygen enrichment.” Ex. 1015, 52; Ex. 1005, 54-55; Ex. 1003, ¶ 26.
Thus, the teachings of Blais and Squires would have provided a strong motivation to express Blais’s FlgI-CRM197 construct in a P. fluorescens host with a reasonable expectation of achieving soluble and active CRM197 with a yield of about 0.2 g/L to about 12 g/L, thereby rendering claims 2 and 22 unpatentable as obvious under 35 U.S.C. § 103; Ex. 1003, ¶¶ 16, 97.
Accordingly, Petitioner submits that any argument for noninstitution under 35 U.S.C. § 325(d) is misplaced, and respectfully requests that the Board institute inter partes review on the grounds presented in this Petition and cancel claims 1-36 of the ’171 patent as unpatentable.
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10 Refund Request: Petitioners Request for Refund of Post Institution Fees

Document IPR2020-00890, No. 10 Refund Request - Petitioners Request for Refund of Post Institution Fees (P.T.A.B. Oct. 20, 2020)
Case IPR2020-00890 Patent No. 8,530,171 On May 7, 2020, GlaxoSmithKline Biologicals SA (“Petitioner”) filed a Petition for Inter Partes Review of U.S. Patent No. 8,530,171 (“the ’171 Patent”) and paid the USPTO a total of $47,900, which included $20,300 inter partes review request fees and $27,600 post-institution fees.
On June 29, 2020, prior to any institution decision or preliminary response from the Patent Owner, Petitioner submitted an unopposed motion to withdraw its Petition and terminate IPR2020-00890 (Paper 7), which was granted on August 28, 2020 (Paper 9).
Therefore, Petitioner hereby requests a refund of the $27,600 post-institution fees submitted with the Petition.
Petitioner respectfully requests that the Board credit the refunded post-institution fees to Deposit Account No. 06-0916.
Respectfully submitted, By: /Charles E. Lipsey/ Charles E. Lipsey Lead Counsel for GlaxoSmithKline Registration No. 28,165 Case IPR2020-00890 Patent No. 8,530,171
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8 Exhibit List: Petitioners Updated Exhibit List As Of June 29, 2020

Document IPR2020-00890, No. 8 Exhibit List - Petitioners Updated Exhibit List As Of June 29, 2020 (P.T.A.B. Jun. 29, 2020)
Exhibit 1001 Description U.S. Patent No. 8,530,171 B2, issued September 10, 2013 1002 1003 1004 1005 1006 1007 1008 1009 File History for U.S. Patent No. 8,530,171 B2 Declaration of R. John Collier WO 2011/042516, published April 14, 2011 (“Blais”) Charles H. Squires et al., Heterologous Protein Production in P. fluorescens, BIOPROCESS INTERNATIONAL 2(11):54-59 (2004) (“Squires”) J. H. Choi et al., Efficient secretory production of alkaline phosphatase by high cell density culture of recombinant Escherichia coli using the Bacillus sp.
53:640-645 (2000) (“Choi”) U.S. Patent Application Publication No. 2008/0269070 to Ramseier et al., published October 30, 2008 (“Ramseier I”) U.S. Patent Application Publication No. 2006/0110747 to Ramseier et al., published May 25, 2006 (“Ramseier II”) Bláithín Maunsell et al., Complex regulation of AprA metalloprotease in Pseudomonas fluorescens M114: evidence for the involvement of iron, the ECF sigma factor, PbrA and pseudobactin M114 siderophore, MICROBOLOGY 152:29-42 (2006) (“Maunsell”) 1010 A. M. Pappenheimer, Jr., Diphtheria Toxin, ANN.
Patent No. 8,530,171 Description Donald O. O’Keefe & R. John Collier, Cloned diphtheria toxin within the periplasm of Escherichia coli causes lethal membrane damage at low pH, PROC.
Markus Eser et al., Disulfide bond formation by exported glutaredoxin indicates glutathione’s presence in the E. coli periplasm, PNAS 106(5):1572-1577 (2009) George Georgiou & Laura Segatori, Preparative expression of secreted proteins in bacteria: status report and future prospects,
Michael G. Jobling et al., Construction and Characterization of Versatile Cloning Vectors for Efficient Delivery of Native Foreign Proteins to the Periplasm of Escherichia coli,
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