`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`PFENEX INC.,
`Petitioner,
`
`v.
`
`GLAXOSMITHKLINE BIOLOGICAL S.A.,
`Patent Owner.
`____________________
`
`Case IPR2019-01028
`Patent 9,422,345
`____________________
`
`PFENEX INC. OBJECTIONS
`37 C.F.R. §42.64(b)(1)
`
`
`
`Petitioner (“Pfenex”) submits the following objections to evidence of Patent
`
`Owner (“GlaxoSmithKline Biologicals S.A.” or “GSK”).
`
`I.
`
`OBJECTIONS
`
`EX2046:
`
`JIANCHUN CHEN ET AL. ROLE OF EGFRECEPTOR
`ACTIVATION IN ANGIOTENSIN II-INDUCED RENAL
`EPITHELIAL CELL HYPERTROPHY, 17 JOURNAL OF THE
`AMERICAN SOCIETY OF NEPHROLOGY 1615-1623 (2006)
`FRE 402 (relevance); FRE 403 (confusion, waste, prejudice)
`
`This exhibit as used and relied on by Dr. James Galen is not relevant to any
`
`ground upon which trial was instituted or to Patent Owner’s Revised Contingent
`
`Motion to Amend. The exhibit’s probative value is substantially outweighed by its
`
`confusion of the issues to be decided, its waste of Board and Pfenex time, and the
`
`danger that it will lead to unfair prejudice if used later in the proceeding or on
`
`appeal.
`
`FRE 105 (limited purpose)
`
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in the Declaration of Dr. James E. Galen in Support of Patent
`
`Owner’s Revised Contingent Motion to Amend.
`
`EX2047: DECLARATION OF DR. JAMES E. GALEN IN SUPPORT OF
`PATENT OWNER’S CONTINGENT REVISED MOTION TO
`AMEND
`FRE 402 (relevance)
`
`Paragraphs 3-4, 7-10, 14-22, and 29-30 are not relevant to any ground upon
`
`IPR2019-01028
`
`-1-
`
`U.S. Patent No. 9,422,345
`
`
`
`which trial was instituted or to Patent Owner’s Revised Contingent Motion to
`
`Amend.
`
`FRE 403 (confusion, waste, prejudice)
`
`The probative value of paragraphs 3-4, 7-10, 14-22, and 29-30 to any ground
`
`upon which trial was instituted or to Patent Owner’s Revised Contingent Motion to
`
`Amend is substantially outweighed by the danger of unfair prejudice, confusing the
`
`issues, or wasting time.
`
`FRE 602 (personal knowledge)
`
`Paragraphs 3-4, 14-22, and 29-30 include assertions for which evidence has
`
`not been introduced sufficient to show that the witness has personal knowledge of
`
`the matters asserted.
`
`FRE 701 (improper lay testimony); FRE 702 (unqualified expert testimony)
`
`Pfenex has not yet had the opportunity to cross-examine the declarant as to
`
`his testimony. Pfenex therefore cannot yet determine whether the declarant is
`
`qualified to opine on what a person of ordinary skill in the art would understand, to
`
`opine on patent claim limitations, to perform claim construction, and/or to perform
`
`legal analysis of patent invalidity. In addition, Pfenex cannot yet determine
`
`whether the opinion testimony offered in this exhibit is scientific, technical, or
`
`other specialized knowledge or whether it is based on personal knowledge.
`
`FRE 802 (hearsay within hearsay)
`
`IPR2019-01028
`
`-2-
`
`U.S. Patent No. 9,422,345
`
`
`
`Pfenex has not yet had the opportunity to cross-examine the declarant as to
`
`his testimony. Without cross-examination, the exhibit is offered to prove the truth
`
`of the matter asserted without meeting any hearsay exception.
`
`
`
`FRE 105 (limited purpose)
`
`If the exhibit is admitted, its use should be limited to the purpose for which
`
`it was offered in Patent Owner’s Revised Contingent Motion to Amend.
`
`II.
`
`CONCLUSION
`
`These objections address GSK’s use of the exhibits thus far and provide
`
`sufficient basis for exclusion of these exhibits. If GSK uses its exhibits in a
`
`subsequent filing, additional objections may be warranted.
`
`Date: June 24, 2020
`
`Respectfully submitted,
`
` /Jeffrey W. Guise/
`Jeffrey W. Guise,
`Lead Counsel for Pfenex Inc.
`Reg. No. 34,613
`
`IPR2019-01028
`
`-3-
`
`U.S. Patent No. 9,422,345
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that the foregoing Petitioner’s Objections under 37 C.F.R.
`
`§42.64(b)(1) were served on June 24, 2020, on the Patent Owner at the
`
`correspondence address of the Patent Owner as follows:
`
`Charles E. Lipsey (Lead Counsel)
`Rich B. Racine (Back-up Counsel)
`Joann M. Neth (Back-up Counsel)
`Amanda Murphy (Back-up Counsel)
`Trenton A. Ward (Back-up Counsel)
`Yieyie Yang (Back-up Counsel)
`
`charles.lipsey@finnegan.com
`rich.racine@finnegan.com
`joann.neth@finnegan.com
`amanda.murphy@finnegan.com
`trenton.ward@finnegan.com
`yieyie.yang@finnegan.com
`
`Date: June 24, 2020
`
`Respectfully submitted,
`
` /Jeffrey W. Guise/
`Jeffrey W. Guise,
`Lead Counsel for Pfenex Inc.
`Reg. No. 34,613
`
`IPR2019-01028
`
`-4-
`
`U.S. Patent No. 9,422,345
`
`
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