PUBLIC VERSION
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
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`CERTAIN HUMAN MILK
`OLIGOSACCHARIDES AND METHODS OF
`PRODUCING THE SAME
`
`Inv. No. 337-TA-1120
`
`ORDER NO. 33: GRANTING-IN-PART RESPONDENT JENNEWEIN
`BIOTECHNOLOGIE GMBH'S MOTIONS IN LIMINE
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`(May 2, 2019)
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`On April 16, 2019, respondent Jennewein Biotechnologie GmbH ("Jennewein") filed a
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`motion in limine (1120-027) with five subparts. On April 29, 2019, complainant Glycosyn LLC
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`("Glycosyn") and the Commission Investigative Staff ("Staff') responded to the motion. On May 1,
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`2019, Glycosyn filed a motion for leave (1120-028) to file missing exhibits from its April 29, 2019
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`opposition. This motion for leave (1120-028) is hereby granted.
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`For the reasons detailed below, Jennewein's motion (1120-027) is granted-in-part.
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`Jennewein's Motion in Limine No. 1
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`Jennewein's Motion in Limine No. 1 seeks to preclude Glycosyn "from arguing that activity
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`below exactly 0.05 Miller Units would infringe or practice the '018 patent." (Mot. at 1.) Jennewein
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`looks to the Markman order in this investigation for support as it construed the claim term 13-
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`galactosidase activity comprises between 0.05 and [200 units / 5 units / 4 units / 3 units / 2 units]" as
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`requiring activity "exactly" within the stated range. (Id at 2-3 (citing Order No. 22 at 22-23).)
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`Jennewein also contends prosecution history estoppel prevents an activity outside of the stated range
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`from infringing under the doctrine of equivalents. (See id at 3-7.) Jennewein identifies pages 72-74
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`of Glycosyn's prehearing brief and Q542-548 of CX-0004C as material which should be struck. (Id
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`at 7.)
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`1
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`PUBLIC VERSION
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`Glycosyn opposes the motion and disputes that the Markman order precludes it from asserting
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`doctrine of equivalents because "[t]he Chief AL's construction of this limitation was with regard to
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`literal infringement, not the doctrine of equivalents." (Opp. at 2 (emphasis in original).) Glycosyn
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`cites Abbott Labs. v. Dey, L.P., 287 F.3d 1097, 1107-1108 (Fed. Cir. 2002) for the proposition "[t]he
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`fact that a claim recites numeric ranges does not, by itself, preclude [Glycosyn] from relying on the
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`doctrine of equivalents." (Id. at 2-3.) Glycosyn further disputes that prosecution history estoppel
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`prevents it from asserting doctrine of equivalents; principally because "[its] proposed equivalents, are
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`just hundredths of a Miller unit under the lower limit of claimed range, not the upper limit, which was
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`the focus of the patentee's amendment and the Examiner's repeated rejections." (Id. at 8.)
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`The Staff supports Jennewein's motion and explains:
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`All parties agreed that if the term was not indefinite (as Jennewein
`contended), then claims 1, 18, and 25-28 of the '018 Patent all called
`for exact numerical ranges. Id. In the Staff's view, at that point
`Glycosyn waived any argument that the disclosed ranges were only
`approximations, such that 13-galactosidase activity slightly below 0.05
`Miller units could still infringe.
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`(Staff Resp. at 2.) Setting aside the Markman order, the Staff agrees that Glycosyn's introduction of
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`an exact numerical range to overcome a rejection based on 35 U.S.C. § 112 during the prosecution
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`history triggers an estoppel against any infringement by activity outside the recited numerical range.
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`(See id. at 3-4.)
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`Upon review, Jennewein's Motion in Limine No. 1 is hereby denied. With respect to the
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`Markman order in this investigation, it did not, as Jennewein argues, define what would or would not
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`be an equivalent amount of enzyme activity as compared to the claimed range. It only adopted the
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`parties' agreement that that claimed ranges were bound "exactly" by the stated numerical values, as
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`opposed to approximations. (Order 22 at 22-23.) With respect to prosecution history estoppel, I find
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`this determination requires further argument from the parties and thus will be made in the final initial
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`determination on violation.
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`2
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`PUBLIC VERSION
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`Jennewein's Motion in Limine No. 2
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`Jennewein's Motion in Limine No. 2 seeks to preclude certain testimony from Glycosyn's
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`expert, Dr. Prather, because it "is untimely and extends beyond the scope of her prior disclosures and
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`testimony in this investigation." (Mot. at 7.) Jennewein identifies the offending content as portions
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`of Q124, Q441-442, and Q458 because they "rely[] on documents not cited in her expert reports or
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`discussed at her deposition." (Id. at 7-8.)
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`Glycosyn opposes the motion and argues a first document, discussed in Q124, is not a new
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`document but an updated version of a previously cited document. (Opp. at 11-12.) Glycosyn adds
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`that a second document, discussed in Q441-442, was included in the expert's list of materials
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`considered and is therefore also not new. (See id. at 14.) For Q458, Glycosyn contends many of the
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`documents discussed are similarly included in that list of materials considered (id at 15-16), while
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`others are used simply to show "Dr. Prather's understanding of what the files, as represented by
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`Jennewein, contain" resulting in very little prejudice to Jennewein (id at 17).
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`The Staff supports Jennewein's motion in part. The Staff submits that Q124 should have been
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`limited to the previously cited document, and thus should not discuss the updated version. (Staff
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`Resp. at 5.) The Staff also submits, however, that the effect of striking this testimony is limited given
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`the testimony of Q125 which is not a subject of Jennewein's motion. (Id.) For Q441-442, the Staff
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`finds the testimony is appropriate given the listing of the documents in the expert's list of materials
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`considered and otherwise does not exceed the scope of her expert report. (Id. at 6.) For Q458, the
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`Staff argues those documents not discussed in either expert report or at deposition should not be
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`discussed in witness statement testimony. (Id. at 7.)
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`Upon review, Jennewein's Motion in Limine No. 2 is hereby denied. While it may be true that
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`several of the documents discussed in Q124, 441-442, and 458 were not previously cited in the
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`expert's reports or deposition, I find the testimony itself results in very little prejudice for Jennewein
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`3
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`PUBLIC VERSION
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`as it is limited to an identification of what those documents are without further analysis. (See Mot.,
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`Ex. 3 at Q124, 441-442, 458). It is also notable that Jennewein does not seek to exclude the documents
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`themselves from the record—only this particular witness's identification of them. The testimony is
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`therefore allowed.
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`Jennewein's Motion in Limine No. 3
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`Jennewein's Motion in Limine No. 3 seeks to preclude additional testimony from Dr. Prather
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`related to the FDA's "Generally Recognized as Safe" or "GRAS" procedures, process, and
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`requirements. (See Mot. at 13-15.) Jennewein argues the testimony should be struck either under
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`Fed. R. Evid. 702 as Dr. Prather has no knowledge or expertise in this area (id. at 14) or Ground Rule
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`10 which states, "legal experts or testimony concerning the meaning of laws, treaties, regulations,
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`etc., are typically not permitted" (id. at 15 (citing Order No. 2 at 26)). Jennewein identifies the
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`offending content as Q71, Q411, Q413, Q424, Q428, Q433, and Q435 from CX-0004C. (Id at 16.)
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`Glycosyn opposes the motion and first argues that Jennewein only met and conferred over the
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`exclusion of Q71, warranting the denial of the motion in its entirety. (Opp. at 20.) Further, Glycosyn
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`argues "Dr. Prather's alleged improper testimony are factual assertions not subject to Daubert
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`scrutiny. An examination of the Q/A pairs identified by Jennewein shows that Dr. Prather is
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`examining the factual record and offering opinion testimony by applying those facts using her proven
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`technical expertise." (Id at 21; see id. at 21-24 (discussing each question and answer pair).)
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`The Staff opposes the motion "on the grounds that the contested testimony in fact does not
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`discuss GRAS procedures and requirements." (Staff Resp. at 8.) More specifically, the Staff explains
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`101 but one of the contested questions and answers discuss the contents of Jennewein's GRAS
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`Notice, rather than the procedures and requirements for submitting such a notice to the FDA," which,
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`the Staff's view, does not "requiren expertise in FDA procedures." (Id.)
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`4
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`PUBLIC VERSION
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`Upon review, Jennewein's Motion in Limine No. 3 is hereby denied. Contrary to Jennewein's
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`assertion, the challenged testimony does not amount to an expert explanation of GRAS procedures,
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`process, and requirements. Rather, it simply: identifies a given exhibit as a GRAS notice (see Mot.,
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`Ex. 3 at Q411, 413); repeats the contents of the notice (id. at Q424, 428, 435); mentions the notice as
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`an item considered in the formation of the expert's opinion (id at Q433); or explains in generalities
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`how GRAS notices are used (id at Q71). Specialized scientific or technical knowledge has not been
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`applied to provide this information.
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`Jennewein's Motion in Limine No. 4
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`Jennewein's Motion in Limine No. 4 seeks to preclude Dr. McCoy, a co-inventor of the
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`asserted patent, "from testifying about the accuracy of
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`, as speculative and lacking foundation pursuant to Federal Rule of Evidence
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`602, and as improper opinion testimony under Rule 701." (Mot. at 16.) Jennewein notes, "Dr.
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`Merighi himself will be attending the evidentiary hearing and providing live testimony as an adverse
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`witness called by Jennewein." (Id.) Jennewein identifies the offending content as portions of Q32,
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`Q36, Q44, Q46, Q49, Q67-69 from CX-0002C and Q12, Q13, Q20, Q21, Q22, Q25, and Q39 from
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`CX-0488C. (Id)
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`Glycosyn opposes the motion. With respect to foundation, Glycosyn argues the testimony
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`falls within Dr. McCoy's personal knowledge because Dr. McCoy hired Dr. Merighi
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`Melighi "started with some o
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`whereupon Dr.
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`(Id. at 26-27 (citations omitted))
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`Glycosyn adds "Dr. McCoy's direct testimony demonstrates the foundation for his testimony
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`sponsoring the work of all Glycosyn's scientists (including Dr. Merighi)" (id at 28 (citations
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`omitted)) which explains why Jennewein, allegedly, "cites no facts, evidence, or basis, to support its
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`5
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`PUBLIC VERSION
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`claim that Dr. McCoy lacks sufficient personal knowledge for his direct testimony" (id). With
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`respect to improper opinion testimony, Glycosyn again argues the challenged testimony is within Dr.
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`McCoy's personal knowledge and is otherwise "admissible as to his state of mind regarding the
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`substance of Jennewein's [inequitable conduct] allegations." (Id. at 28-29.) Accordingly, Glycosyn
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`notes that Dr. McCoy has been Glycosyn's Chief Scientific Office since 2007 and the challenged
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`testimony all involves Glycosyn strains, assays, and other testing procedures. (See id. at 30-31
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`(citation omitted).)
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`The Staff also opposes the motion and argues "the suggestion that Dr. McCoy does not have
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`personal knowledge of Dr. Merighi's activities at Glycosyn, as documented in Dr. Merighi's lab
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`notebooks, is implausible." (Staff Resp. at 10.) The Staff observes "[t]he disputed testimony
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`concerns the contents of Dr. Merighi's lab notebooks from the time period that he and Dr. McCoy
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`worked together" and supposes "it would have been difficult for Dr. McCoy to avoid having personal
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`knowledge of Dr. Merighi's work." (Id.) The Staff also contends that Jennewein's claim of
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`inequitable conduct "is predicated on an assertion that Dr. McCoy had personal knowledge of Dr.
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`Merighi's activities" providing further grounds to deny Jennewein's motion. (Id at 11.)
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`Upon review, Jennewein's Motion in Limine No. 4 is hereby granted-in-part. Of the
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`challenged testimony, those portions of Q13 and Q25 highlighted by Jennewein (Mot., Ex. 8 at Q13,
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`25) are struck. These portions contain opinions on the scientific accuracy of work done by another,
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`Dr. Merighi, which are not based on personal experience with that work but on scientific, technical,
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`and specialized knowledge in the field. (See id. at Q13
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`) Thus, the opinions more properly qualify as expert
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`6
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`PUBLIC VERSION
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`witness opinion under Fed. R. Evid. 702 than lay witness opinion under Fed. R. Evid. 701. The
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`remainder of the challenged testimony is allowed, however. Jennewein's motion fails to establish
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`that Dr. McCoy would have lacked firsthand knowledge of Dr. Merighi's mental impressions or
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`feelings given the collaborative working relationship between the two as employees of Glycosyn.
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`Jennewein's Motion in Limine No. 5
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`Jennewein's Motion in Limine No. 5 seeks to preclude Glycosyn "from suggesting, either
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`through argument or through questions posed to witnesses, that any adverse inference should be
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`drawn from test results properly withheld by Jennewein on the basis of attorney work-product
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`privilege." (Mot. at 24 (citations omitted).) Jennewein explains:
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`In preparation for trial, Jennewein's attorneys explored different
`aspects of Jennewein's E. coli production strains, and they directed an
`independent laboratory to perform separate types of tests on those
`strains. The obtained test results are "documents and tangible things
`that are prepared in anticipation of litigation or for trial," and thus
`qualify for the work-product privilege. Fed. R. Civ. P. 26(b)(3).
`Glycosyn has not challenged that the withheld tests are protected by the
`work-product privilege. See generally Glycosyn's Mot. to Compel
`(Mot. 1120-025). Doing so now would be procedurally improper in
`view of Commission Rule 210.27. See 19 CFR § 210.27.
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`(Id at 25-26.) Jennewein does not identify any material from Glycosyn's pre-hearing brief or witness
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`statements to strike but contends the motion is ripe because, "Glycosyn has nevertheless refused to
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`agree not to 'through its questioning of witnesses, briefs or otherwise, suggest that any adverse
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`inference should be drawn from any test results that have been withheld by Jennewein on the basis of
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`privilege." (Id at 26 (citing Mot., Ex. 9).)
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`Glycosyn opposes the motion, first alleging that it is, in fact, "not a proper motion in limine"
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`because it "does not identify any trial exhibits or other evidence that it seeks to exclude, nor does it
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`identify a single instance of Glycosyn requesting, or intending to request, any adverse inferences at
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`all." (Opp. at 32.)
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`7
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`PUBLIC VERSION
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`The Staff similarly opposes the motion and contends it is moot as Jennewein has identified
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`nothing to preclude. (Staff Resp. at 15.) The Staff additionally suggests, as Glycosyn had done
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`earlier, that " if Jennewein finds any questioning or statement by Glycosyn to be objectionable at the
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`hearing, any objections of this type can be raised at that time." (Id. (citing Mot., Ex. 9).)
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`Upon review, Jennewein's Motion in Limine No. 5 is hereby denied. The parties may address
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`the question of what the evidence shows, along with what inferences should be drawn from that
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`evidence, in their post-hearing briefing following the evidentiary hearing. Further, the general
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`prohibition against adverse inferences arising from the invocation of privilege or work product
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`protection has less importance in Section 337 proceedings where there is no risk of jury confusion.
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`See, e.g., Certain Intraoral Scanners and Related Hardware and Software, Inv. No. 337-TA-1090,
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`Order No. 42 at 2 (Nov. 2, 2018).
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`Within seven days of the date of this document, the parties shall submit to the Office of the
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`Administrative Law Judges a joint statement as to whether or not they seek to have any portion of
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`this document deleted from the public version. If the parties do seek to have portions of this document
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`deleted from the public version, they must submit to this office a copy of this document with red
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`brackets indicating the portion or portions asserted to contain confidential business information. The
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`submission may be made by email and/or hard copy by the aforementioned date and need not be filed
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`with the Commission Secretary.
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`SO ORDERED.
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`Cameron Elliot
`Administrative Law Judge
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`8
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`CERTAIN HUMAN MILK OLIGOSACCHARIDES AND
`METHODS OF PRODUCING THE SAME
`
`INV. NO. 337-TA-1120
`
`PUBLIC CERTIFICATE OF SERVICE
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`I, Lisa R. Barton, hereby certify that the attached Order No. 33 has been served by hand upon
`the Commission Investigative Attorney, Lisa Murray, Esq. and the following parties as
`indicated, on MAY 1 32019
`
`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street SW, Room 112A
`Washington, DC 20436
`
`FOR COMPLAINANT GLYCOSYN LLC
`
`Michael C. Newman, Esq.
`MINTZ LEVIN COHN FERRIS GLOVSKY
`AND POPEO PC
`One Financial Center
`Boston, MA 02111
`
`( ) Via Hand Delivery
`( ) Express Delivery
`(j) Via First Class Mail
`( ) Other:
`
`FOR RESPONDENT JENNEWEIN BIOTECHNOLOGIE GmbH
`
`Gary M. Hnath, Esq.
`MAYER BROWN, LLP
`1999 K Street, NW
`Washington, DC 20006
`
`( ) Via Hand Delivery
`( ) Express Delivery
`(J) Via First Class Mail
`( ) Other:
`
`