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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`NEW WORLD MEDICAL, INC.,
`Petitioner,
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`v.
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`MICROSURGICAL TECHNOLOGY, INC.,
`Patent Owner.
`_______________________
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`Case IPR2020-01573
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`U.S. Patent No. 9,107,729
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`_______________________
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`PATENT OWNER’S FIRST SET OF
`OBJECTIONS TO PETITIONER’S EXHIBITS
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`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
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`in a representative capacity for Patent Owner Microsurgical Technology, Inc.
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`(“MST”), hereby submits the following objections to Petitioner New World Medical,
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`Inc.’s (“NWM”) Exhibits 1004, 1005, 1007-1014, 1018, 1020 and 1021, and any
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`reference to/reliance on the foregoing, including without limitation citations to
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`Exhibits 1004, 1005, 1007-1014, 1018, 1020 and 1021 in Petitioner’s Petition (Paper
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`1) and Exhibit 1003 (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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`1. Objections to Exhibit 1020 and Any Reference to/Reliance Thereon
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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”); F.R.E. 901 (“Authenticating or Identifying
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`Evidence”); and F.R.E. 403 (“Excluding Relevant Evidence for Prejudice,
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`Confusion, Waste of Time, or Other Reasons”).
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`Exhibit 1020 is irrelevant because Exhibit 1020 has no tendency to prove the
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`matter sought to be proved. For example, Petitioner relies on Exhibit 1020 in an
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`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.
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`Specifically, Petitioner relies on Exhibit 1020 for the proposition that “Quintana’s
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`surgical procedure would result in cutting ‘strips of tissue’ from the TM.” Petition
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`at p. 34 (citing Ex. 1003, ¶¶98-100). But Exhibit 1020 post-dates Quintana by 34
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`years. Exhibit 1020 also post-dates the undisputed priority date of the invention by
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`16 years. There is thus no relationship between Exhibit 1020 and any issue properly
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`before the Board in this matter.
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`Exhibit 1020 also is hearsay. For example, Exhibit 1020 contains multiple out
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`of court statements purportedly relating to “bent ab interno needle goniectomy”
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`(“BANG”). See Ex. 1020. In the Petition, Petitioner relies on these out of court
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`statements in support of the following:
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`Shute (Ex.1020) describes a procedure called “bent ab interno needle
`goniectomy” (“BANG”) that involves, like Quintana, using a standard
`needle having a bent tip to “completely excise a segment of TM” and
`in which the needle’s “cutting edges” create a “double blade” “capable
`of excising tissue en bloc.”
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`Petition at pp. 34-35 (citing Ex. 1020, 1; Ex. 1003, ¶98). Petitioner thus relies on the
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`out of court statements in Exhibit 1020 for the truth of the matters asserted therein,
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`i.e., that if Exhibit 1020, which was published many years after both Quintana and
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`the undisputed priority date, shows cutting strips of tissue from the TM, so does
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`Quintana. Exhibit 1020 is therefore inadmissible. F.R.E. 801, 802.
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`Moreover, Petitioner fails to provide for Exhibit 1020 the authentication
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`required by F.R.E. 901. “To satisfy the requirement of authenticating or identifying
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`an item of evidence, the proponent must produce evidence sufficient to support a
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`finding that the item is what the proponent claims it is.” F.R.E. 901(a). On its face,
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`Exhibit 1020 purports to be a poster abstract published at the American Glaucoma
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`Society 24th Annual Meeting. But Petitioner provides nothing that would
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`authenticate Exhibit 1020, 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. It is 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 Exhibit
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`1020 without providing any authenticating evidence sufficient to support a finding
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`that the item is what Petitioner claims it is, in violation of F.R.E. 901.
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`Furthermore, to the extent the Petition, Exhibit 1020, or any other submission
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`of Petitioner purports to refer to or rely on Exhibit 1020, Patent Owner objects to
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`such reference to/reliance on evidence that is also misleading and unfairly
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`prejudicial under F.R.E. 403.
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`2. Objections to Exhibit 1021 and Any Reference to/Reliance Thereon
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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”); F.R.E. 901 (“Authenticating or Identifying
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`Evidence”); and F.R.E. 403 (“Excluding Relevant Evidence for Prejudice,
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`Confusion, Waste of Time, or Other Reasons”).
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`Exhibit 1021 is irrelevant because, like Exhibit 1020, Petitioner relies on
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`Exhibit 1021 in an attempt to explain what Petitioner’s lead prior art reference
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`(Quintana, Ex. 1004) purports to teach to a person of skill in the art at the time of the
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`invention. But Exhibit 1021 post-dates Quintana by 32 years. Exhibit 1021 also post-
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`dates the undisputed priority date of the invention by 14 years. There is thus no
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`relationship between Exhibit 1021 and any issue properly before the Board in this
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`matter. As such, Exhibit 1021 has no tendency to prove the matter sought to be
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`proved and is irrelevant.
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`Exhibit 1021 also is hearsay. For example, Exhibit 1021 is an out-of-court
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`video purportedly showing a surgeon performing the BANG procedure on a patient’s
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`eye. See Ex. 1021. In the Petition, Petitioner relies on Exhibit 1021 for the
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`proposition that, when using the BANG procedure on a patient’s eye, it results in “a
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`strip of TM tissue adher[ing] to the needle tip after being cut from the TM.” Petition
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`at p. 35 (citing Ex. 1021; Ex. 1003, ¶¶99-100). Petitioner thus relies on the out of
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`court statements in Exhibit 1021 for the truth of the matters asserted therein, i.e., that
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`if Exhibit 1021, which was published many years after both Quintana and the
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`undisputed priority date, shows cutting strips of tissue from the TM, so does
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`Quintana. Exhibit 1021 is therefore inadmissible. F.R.E. 801, 802.
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`Moreover, Petitioner also fails to authenticate Exhibit 1021 as required by
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`F.R.E. 901. On its face, Exhibit 1021 purports to be a video showing a surgeon
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`performing the BANG procedure, but Petitioner provides nothing that would
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`authenticate Exhibit 1021, 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. It is 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 Exhibit
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`1021 without providing any authenticating evidence sufficient to support a finding
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`that the item is what Petitioner claims it is, in violation of F.R.E. 901.
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`Furthermore, to the extent the Petition, Exhibit 1021, or any other submission
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`of Petitioner purports to refer to or rely on Exhibit 1021, Patent Owner objects to
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`such reference to/reliance on evidence that is also misleading and unfairly
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`prejudicial under F.R.E. 403.
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`3. Objections to Exhibits 1004, 1005, 1007-1014, and 1018 and Any
`Reference to/Reliance Thereon
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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”).
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`Exhibits 1004, 1005, 1007-1014, and 1018 are hearsay. In the Petition,
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`Petitioner relies on these Exhibits as purported prior art or evidence as to what a
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`person of ordinary skill may have been aware of at the time of the invention at issue.
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`Petitioner thus relies on the out of court statements in Exhibits 1004, 1005, 1007-
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`1014, and 1018 for the truth of the matters asserted therein, making them hearsay
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`under F.R.E. 801, 802. Further, to the extent any of these Exhibits may constitute a
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`statement from a treatise, periodical or pamphlet, neither Petitioner nor its expert
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`have established any of Exhibits 1004, 1005, 1007-1014, or 1018 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 1004, 1005, 1007-1014, and 1018 still may not be received
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`as an exhibit. F.R.E. 803(18) (“If admitted, the statement may be read into evidence
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`but not received as an exhibit.”). As such, even if any of Exhibits 1004, 1005, 1007-
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`1014, or 1018 qualified as an exception to hearsay pursuant to F.R.E. 803(18), they
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`would still not constitute “evidence” under 37 C.F.R. 42.63(a) (“All evidence must
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`be filed in the form of an exhibit.”).
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`Moreover, Petitioner also fails to authenticate Exhibits 1004, 1005, 1007-
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`1014, and 1018 as required by F.R.E. 901. On its face, these Exhibits purport to be
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`various publications relating to ophthalmology, but Petitioner provides nothing that
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`would authenticate Exhibits 1004, 1005, 1007-1014, or 1018, like testimony of a
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`witness with knowledge (see F.R.E. 901(b)(1)) or other evidence that satisfies the
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`requirement. It is also not self-authenticating, because it is not a public document,
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`official publication by a public authority, or other material that requires “no extrinsic
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`evidence of authenticity in order to be admitted” (see F.R.E. 902). Petitioner thus
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`improperly cites to Exhibits 1004, 1005, 1007-1014, and 1018 without providing
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`any authenticating evidence sufficient to support a finding that the item is what
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`Petitioner claims it is, in violation of F.R.E. 901.
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`Dated: March 22, 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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`Counsel for Patent Owner
`MicroSurgical Technology, Inc.
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR § 42.6(e), I certify that on March 22, 2021, a true and
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`correct copy of the foregoing Patent Owner’s Objections to Evidence Under 37
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`C.F.R. § 42.64 was served by email on the following counsel of record for New
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`World Medical, Inc.:
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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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