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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`NEW WORLD MEDICAL, INC.,
`Petitioner,
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`v.
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`MICROSURGICAL TECHNOLOGY, INC.,
`Patent Owner.
`_______________________
`Case IPR2020-01573
`U.S. Patent No. 9,107,729
`_______________________
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`PATENT OWNER’S SECOND SET OF OBJECTIONS
`TO EVIDENCE UNDER 37 C.F.R. § 42.64(b)(1)
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`1
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`In accordance with 37 C.F.R. § 42.64(b)(1), Patent Owner MicroSurgical
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`Technology, Inc. (“Patent Owner” or “MST”) objects to the admissibility of
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`evidence submitted by Petitioner with Petitioner’s Reply to Patent Owner’s
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`Response to Petition on August 31, 2021 (the “Reply”). Specifically, Patent Owner
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`objects to Exhibits 1030-1038 cited by Petitioner in its Reply. Patent Owner also
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`renews its objections to Exhibit 1004 on the grounds raised in Patent Owner’s First
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`Set of Objections to Evidence, Paper No. 24. Patent Owner further objects to any
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`reference to and reliance upon Exhibits 1030-1038 in Petitioner’s Reply and in
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`Exhibit 1030, the Reply Declaration of Dr. Peter Netland, Petitioner’s Expert. As
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`required by 37 C.F.R. § 42.62, Patent Owner’s objections below apply the Federal
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`Rules of Evidence (“F.R.E.”).
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`These objections are submitted within 5 business days from service of
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`Petitioner’s evidence. Patent Owner lists the evidence objected to and provides
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`grounds for its objections below. Patent Owner also objects to Petitioner’s reliance
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`on or citation to any objected evidence in its papers.
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`I.
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`Identification of Challenged Evidence and Grounds
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`A. Objections to Exhibit 1030 (Reply Declaration of Dr. Netland) and
`Any Reference to or Reliance on Exhibits 1004 and 1031-1038
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`Patent Owner objects to Exhibit 1030 under F.R.E. 703 to the extent it relies
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`upon Exhibits 1004 and 1031-1038 because those Exhibits are inadmissible for the
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`reasons below and therefore the probative value does not outweigh the prejudicial
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`effect. Patent Owner further objects to Exhibit 1030 under F.R.E. 602 for lack of
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`2
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`personal knowledge to the extent that it fails to provide evidence sufficient to support
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`a finding that Dr. Netland has personal knowledge of the matters to which his
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`testimony pertains.
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`Patent Owner also objects to Exhibit 1030 under F.R.E. 702-703 and 37
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`C.F.R. § 42.65 because the testimony is not based on sufficient facts or data and for
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`failing to disclose the underlying facts or data on which the opinions set forth are
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`based. Throughout his declaration, Dr. Netland draws conclusions when there is no
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`indication that the testimony is based on reliable facts or data. Moreover, there is no
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`indication that the testimony will aid the Board in understanding the evidence or
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`determining a fact in issue.
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`Patent Owner further objects to Exhibit 1030 under F.R.E. 801-802 as
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`inadmissible hearsay to the extent Petitioner relies on the exhibits cited therein for
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`the truth of the matter asserted.
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`B. Objections to Exhibits 1031-1033 (Reply Declaration Videos)
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`Patent Owner’s grounds for objection include F.R.E. 401, 402 (“Relevance”),
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`F.R.E. 403 (“Excluding Relevant Evidence for Prejudice, Confusion, Waste of Time,
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`or Other Reasons”), F.R.E. 801, 802 (“Hearsay”), F.R.E. 702-703 (Expert Opinions),
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`and 37 C.F.R. § 42.65. Patent Owner further objects to Exhibits 1031-1033 because
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`they consist of improper and inadmissible new evidence raised for the first time in a
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`3
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`reply.
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`Exhibits 1031-1033 are irrelevant because they have no tendency to prove the
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`matter sought to be proved. For example, Petitioner relies on Exhibits 1031-1033 in
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`an attempt to explain what Petitioner’s lead prior art reference (Quintana, Ex. 1004)
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`purports to teach to a person of skill in the art at the time of the invention. But these
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`Exhibits are not prior art and they post-date Quintana as well as the undisputed
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`priority date of the invention by decades. There is thus no relationship between
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`Exhibits 1031-1033 and any issue properly before the Board in this matter.
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`Patent Owner also objects to Exhibits 1031-1033 under F.R.E. 702-703 and
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`37 C.F.R. § 42.65 because the demonstrations in the videos are not based on
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`sufficient facts or data and do not disclose the underlying facts or data on which the
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`opinions set forth are based. There is also no indication that the videos will aid the
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`Board in understanding the evidence or determining a fact in issue.
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`Exhibits 1031-1033 are also hearsay. For example, Exhibits 1031-1033
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`contain multiple out of court “statements” or depictions purportedly relating to the
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`procedure described in Quintana, Exhibit 1004, and Petitioner relies on these out of
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`court statements for the truth of the matters asserted therein, i.e., that if Exhibits
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`1031-1033, which were made many years after both Quintana and the undisputed
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`priority date, shows cutting strips of tissue from the TM, so does Quintana. Exhibits
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`4
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`1031-1033 are therefore inadmissible. F.R.E. 801, 802.
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`Exhibits 1031-1033 are also improper, inadmissible new evidence advanced
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`for the first time in a reply in violation of 37 C.F.R. § 42.23 (a “reply may only
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`respond to arguments raised in the corresponding opposition, patent owner
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`preliminary response, or patent owner response”). To the extent that Petitioner
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`purportedly relies on Exhibits 1031-1033 in an attempt to rebut Patent Owner’s
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`expert, as Petitioner concedes, Patent Owner’s expert did not perform the procedure
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`described in the Quintana reference. Reply, p. 13 n.3. Petitioner had every
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`opportunity to prepare such videos in advance of filing the Petition. However,
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`Petitioner never prepared, submitted, or discussed these Exhibits until filing the
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`Reply. Because Patent Owner’s expert did not perform the procedure described in
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`Quintana, there is no basis for Petitioner to have done so for the first time in reply.
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`Further, to the extent Petitioner relied on Exhibits 1031-1033 in an attempt to rebut
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`the Affidavit of Dr. Quintana, Ex. 2020, this Exhibit is currently the subject of a
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`pending Motion to Strike, filed by Petitioner. To the extent the Board determines to
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`strike the Affidavit of Dr. Quintana from evidence, then Exhibits 1031-1033 must
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`also be stricken as must any reliance thereon in the Reply or in Exhibit 1030.
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`Furthermore, to the extent the Petition, Exhibit 1030, or any other submission
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`of Petitioner purports to refer to or rely on Exhibits 1031-1033, Patent Owner objects
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`to Exhibits 1031-1033 and such reference to/reliance on evidence that is also
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`5
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`misleading and unfairly prejudicial under F.R.E. 403.
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`C. Objections to Exhibits 1035 (Becker) and 1036 (Spencer)
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`Patent Owner’s grounds for objection include F.R.E. 801, 802 (“Hearsay”);
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`and F.R.E. 901 (“Authenticating or Identifying Evidence”). Patent Owner also
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`objects because these Exhibits are new evidence raised for the first time in a reply
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`in violation of 37 C.F.R. § 42.23 (a “reply may only respond to arguments raised
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`in the corresponding opposition, patent owner preliminary response, or patent
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`owner response”).
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`Exhibits 1035 and 1036 are hearsay. In the Petition, Petitioner relies on these
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`Exhibits as purported prior art or evidence as to what a person of ordinary skill may
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`have been aware of at the time of the invention at issue. Petitioner thus relies on the
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`out of court statements in Exhibits 1035 and 1036 for the truth of the matters asserted
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`therein, making them hearsay under F.R.E. 801, 802. Further, to the extent any of
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`these Exhibits may constitute a statement from a periodical or pamphlet, neither
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`Petitioner nor its expert have established any of Exhibits 1035 and 1036 as a reliable
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`authority as required under F.R.E. 803(18)(B). And, even if Petitioner or its expert
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`attempt to do so, Exhibits 1035 and 1036 still may not be received as an exhibit.
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`F.R.E. 803(18) (“If admitted, the statement may be read into evidence but not
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`received as an exhibit,”). As such, even if any of Exhibits 1035 and 1036 qualified
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`as an exception to hearsay pursuant to F.R.E. 803(18), they would still not constitute
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`6
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`“evidence” under 37 C.F.R. 42.63(a) (“All evidence must be filed in the form of an
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`exhibit.”).
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`Moreover, Petitioner also fails to authenticate Exhibits 1035 and 1036 as
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`required by F.R.E. 901. On its face, these Exhibits purport to be various publications
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`relating to ophthalmology, but Petitioner provides nothing that would authenticate
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`Exhibits 1035 and 1036, like testimony of a witness with knowledge (see F.R.E.
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`901(b)(1)) or other evidence that satisfies the requirement. They are also not self-
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`authenticating, because it is not a public document, official publication by a public
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`authority, or other material that requires “no extrinsic evidence of authenticity in
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`order to be admitted” (see F.R.E. 902). Petitioner thus improperly cites to Exhibits
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`1035 and 1036 without providing any authenticating evidence sufficient to support
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`a finding that the item is what Petitioner claims it is, in violation of F.R.E. 901.
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`Exhibits 1035 and 1036 are also improper, inadmissible new evidence
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`advanced for the first time in a reply. As one non-limiting example, Petitioner uses
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`Exhibits 1035 and 1036 to show that the Quintana reference generally teaches
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`removing a strip of trabecular meshwork (Reply pp. 8-9), which is not necessarily
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`disclosed in Quintana. Although Exhibits 1035 and 1036 are cited in Quintana,
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`Petitioner never submitted or discussed them until filing the Reply. Further, by
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`relying on Exhibits 1035 and 1036 as evidence that prior art teaches removing a strip
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`of trabecular meshwork, Petitioner is framing Exhibits 1035 and 1036 as alternatives
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`7
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`to Quintana. For at least these reasons, Petitioner is presenting a new rationale not
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`asserted in the petition.
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`D. Objections to Ex. 1037 (Herschler), and 1038 (Scheie)
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`Patent Owner’s grounds for objection include F.R.E. 401, 402 (“Relevance”),
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`F.R.E. 801, 802 (“Hearsay”); and F.R.E. 901 (“Authenticating or Identifying
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`Evidence”).
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`Exhibits 1037 and 1038 are irrelevant because they have no tendency to prove
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`the matter sought to be proved. For example, Petitioner relies on Exhibits 1037 and
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`1038 in an attempt to explain aspects related to incising or removing trabecular
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`meshwork tissue, but these Exhibits relate to nasal trabecular sheets or Descemet’s
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`membrane, not trabecular meshwork tissue. There is thus no relationship between
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`Exhibits 1031-1033 and any issue properly before the Board in this matter.
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`Exhibits 1037 and 1038 are hearsay. In the Petition, Petitioner relies on these
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`Exhibits as purported prior art or evidence as to what a person of ordinary skill may
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`have been aware of at the time of the invention at issue. Petitioner thus relies on the
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`out of court statements in Exhibits 1037 and 1038 for the truth of the matters asserted
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`therein, making them hearsay under F.R.E. 801, 802. Further, to the extent any of
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`these Exhibits may constitute a statement from a periodical or pamphlet, neither
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`Petitioner nor its expert have established Exhibits 1037 and 1038 as reliable
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`authorities as required under F.R.E. 803(18)(B). And, even if Petitioner or its expert
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`8
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`attempt to do so, Exhibits 1037 and 1038 still may not be received as an exhibit.
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`F.R.E. 803(18) (“If admitted, the statement may be read into evidence but not
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`received as an exhibit,”). As such, even if any of Exhibits 1037 and 1038 qualified
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`as an exception to hearsay pursuant to F.R.E. 803(18), they would still not constitute
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`“evidence” under 37 C.F.R. 42.63(a) (“All evidence must be filed in the form of an
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`exhibit.”).
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`Moreover, Petitioner also fails to authenticate Exhibits 1037 and 1038 as
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`required by F.R.E. 901. On its face, these Exhibits purport to be various publications
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`relating to nasal trabecular sheets or Descemet’s membrane, but Petitioner provides
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`nothing that would authenticate Exhibits 1037 and 1038, like testimony of a witness
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`with knowledge (see F.R.E. 901(b)(1)) or other evidence that satisfies the
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`requirement. They are also not self-authenticating, because it is not a public
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`document, official publication by a public authority, or other material that requires
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`“no extrinsic evidence of authenticity in order to be admitted” (see F.R.E. 902).
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`Petitioner thus improperly cites to Exhibits 1037 and 1038 without providing any
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`authenticating evidence sufficient to support a finding that the item is what Petitioner
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`claims it is, in violation of F.R.E. 901.
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`9
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`E. Renewal of Objections to Exhibit 1004 (Quintana)
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`Patent Owner also renews its objections to Exhibit 1004 on the grounds raised
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`in Patent Owner’s First Set of Objections to Evidence, Paper No. 24. Patent Owner’s
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`grounds for objection include F.R.E. 801, 802 (“Hearsay”); and F.R.E. 901
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`(“Authenticating or Identifying Evidence”).
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`II. Conclusion
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`To the extent Petitioner fails to correct the defects identified above, Patent
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`Owner may file a motion to strike and/or a motion to exclude under 37 C.F.R. §
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`42.64(c) at the appropriate time in accordance with the Scheduling Order in this
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`proceeding.
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`Dated: September 8, 2021
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`Respectfully submitted,
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`/s/ Lawrence M. Sung
`Lawrence M. Sung
`Reg. No. 38,330
`Mary Sylvia
`Reg. No. 37,156
`Teresa M. Summers
`(pro hac vice)
`WILEY REIN LLP
`1776 K Street, NW
`Washington, DC 20006
`Tel. 202.719.7000
`Fax 202.719.7049
`lsung@wiley.law
`msylvia@wiley.law
`tsummers@wiley.law
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`10
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`Counsel for Patent Owner
`MicroSurgical Technology, Inc.
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`11
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on September 8, 2021, a true and
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`correct copy of the foregoing PATENT OWNER’S OBJECTIONS TO
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`EVIDENCE UNDER 37 C.F.R. § 42.64(b)(1) was served by email on the
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`following counsel of record for New World Medical, Inc.:
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`
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`Todd R. Tucker (Lead Counsel)
`Reg. No. 40,850
`Kyle T. Deighan (Back-up Counsel)
`Reg. No. 75,525
`John Reulbach (Back-up Counsel)
`(pro hac vice to be requested)
`CALFEE, HALTER & GRISWOLD LLP
`The Calfee Building
`1405 East Sixth Street
`Cleveland, OH 44114
`P: 216-622-8551 / F: 216-214-0816
`ttucker@calfee.com
`kdeighan@calfee.com
`jreulbach@calfee.com
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`/s/ Lawrence M. Sung
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`Counsel for Patent Owner
`MicroSurgical Technology, Inc.
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