`
`Shelton, IV
`Patent of:
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`8,479,969
`U.S. Pat. No.:
`July 9, 2013
`Issue Date:
`Appl. Serial No.: 13/369,609
`Filing Date:
`Feb. 9, 2012
`Title:
`DRIVE INTERFACE FOR OPERABLY COUPLING A
`MANIPULATABLE SURGICAL TOOL TO A ROBOT
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`Attorney Docket No.: 11030-0049IP5
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` 11030-0049IPA
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`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`SUPPLEMENTAL DECLARATION OF
` DR. BRYAN KNODEL IN SUPPORT OF
`PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,479,969
`IPR2018-01247
`IPR2018-01254
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`1
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`Exhibit 1017
`Intuitive v. Ethicon
`IPR2018-01254
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`U.S. Patent No. 8,479,969
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`I, Bryan Knodel, declare as follows:
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`INTRODUCTION
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`1.
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`I have been engaged as an expert by Fish & Richardson P.C. on behalf
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`of Intuitive Surgical, Inc. (“Petitioner”) for the above-captioned inter partes review.
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`I understand that this proceeding involves United States Patent No. 8,479,969
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`entitled “Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a
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`Robot” by Frederick E. Shelton IV, filed February 9, 2012, and issued July 9, 2013
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`(the “’969 Patent” or “’969”). I understand that the ’969 Patent is currently
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`assigned to Ethicon LLC.
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`2.
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`I have previously submitted a declaration in this matter that provides my
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`qualifications, and this declaration responds to specific issues raised in the Patent
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`Owner Response and supporting expert declarations in this proceeding.
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` RESPONSE TO SPECIFIC ISSUES RAISED BY PATENT OWNER
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`3.
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`I understand that Patent Owner has submitted declarations by Dr.
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`Fegelman (a surgeon) and Dr. Awtar in support if the Patent Owner Response. In those
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`declarations, both Dr. Fegelman and Dr. Awtar assert that handheld linear
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`stapler/cutters would not be combined with Anderson or Wallace (which disclose
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`surgical robots) because those surgical robots allegedly fail to disclose tactile feedback,
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`and that a handheld linear stapler/cutter with passive articulation, such as disclosed by
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`U.S. Patent No. 8,479,969
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`Timm would not be combined Anderson, as I proposed because, again, Anderson does
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`not disclose tactile feedback.
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`4.
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`I disagree with those conclusions for two reasons. First, a person of
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`ordinary skill in the art would have understood that both Anderson and Wallace in fact
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`disclose tactile feedback. Second, even if they had not disclosed tactile feedback, a
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`person of ordinary skill in the art would nonetheless have been motivated to make the
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`combinations I propose (including Timm with Anderson and Giordano/Shelton with
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`Wallace).
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`5.
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`As the ’969 Patent explains, there are different forms of feedback in
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`robotic systems, which can include video feedback and tactile feedback. Video
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`feedback allows a surgeon operating a surgical robot to see what the end effectors
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`are doing so that the surgeon can properly control the movement of the end
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`effectors. Tactile feedback is force feedback to the surgeon’s hands so that the
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`surgeon feels the forces being applied to the end effectors. The ’969 Patent
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`explains: “the robotic controller 1001 system may provide the surgeon with an
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`indication that signifies the closure of the anvil. Such indication may be, for example, in
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`the form of a light and/or audible sound, tactile feedback on the control members, etc.”
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`’969 Patent, 67:32-36.
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`6. With regard to passive articulation, Dr. Fegelman has stated:
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` Because passive articulation brings the end effector into contact with
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`U.S. Patent No. 8,479,969
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`other structures, passive articulation requires nearly instantaneous,
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`tactile feedback to ensure that excessive forces are not applied to the
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`structures. This is particularly true when the exterior of the end effector is
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`being pressed against a structure in the body. With hand-held laparoscopic
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`devices, the surgeon’s grip on the hand-held portion (which is connected to
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`the end effector through the shaft of the instrument) provides this tactile
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`feedback. The surgeon also views the surgical site on video; however, the
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`video does not provide an indication of the forces that are being applied.
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`Thus, the tactile feedback provided through the surgeon’s grip on the hand-
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`held portion is critical to the use of passive articulation.
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`Fegelman Declaration, ¶19.
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`7. While I agree that passive articulation against a structure in the body
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`raises concerns of damaging tissue due to excessive force, such concerns may be
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`addressed by a skilled surgeon, and in any event are not applicable when passive
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`articulation is performed by pressing one instrument against another instrument.
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`Tactile feedback is not a necessity and is not “critical” when using passive
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`articulation against a second instrument.
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`8.
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`Accordingly, passive articulation is not a necessity and is not critical
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`in the proposed combination of Timm with a surgical robot because Timm
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`expressly discloses passive articulation either by pressing against a body organ or
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`U.S. Patent No. 8,479,969
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`by pressing against another instrument. Accordingly, a person of ordinary skill in
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`the art reading Timm would be motivated to combine Timm with a surgical robot
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`and employ Timm’s passive articulation with the expectation that the passive
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`articulation would be performed, as taught by Timm, at least by pressing the
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`instrument against another instrument. Timm specifically discloses:
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`To use this embodiment, the clinician positions the tool assembly 100
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`in the patient and then applies an articulation force to the tool
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`assembly with another surgical instrument or by bringing the tool
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`assembly 100 into contact with a portion of the patient to articulate the
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`tool assembly to a desired position before drawing the actuation
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`member 3050 in the proximal direction PD.
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`Timm, 32:32-38.
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`9.
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`The above passage from Timm is quoted by Dr. Awtar (at paragraph
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`41 of his Declaration). However, nothing in Timm mandates that the second
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`option (pressing against the body) for use of passive articulation must be used, and
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`a person of ordinary skill in the art would readily understand that either option may
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`be used. A person of ordinary skill in the art would understand that when adapting
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`Timm to a robot that lacked tactile feedback, a surgeon could simply articulate one
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`instrument by pressing it against another instrument. Tactile feedback is not
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`necessary or critical when using passive articulation in this manner. Furthermore,
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`U.S. Patent No. 8,479,969
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`the surgeon remains in complete control of the process because a surgeon would
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`typically operate multiple instruments with the surgical robot.
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`10. To the extent that Dr. Awtar intended to assert that tactile feedback
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`for passive articulation against another instrument is necessary or critical, such
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`an assertion is unsubstantiated.
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`11. Moreover, there is nothing in Timm that defines the force required to
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`actuate the passive articulation joint. A person of ordinary skill in the art would be
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`well capable of designing the passive articulation joint that moves easily in its
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`unlocked state with minimal resistance such that the actuation force would be
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`minimal. Thus the articulation force could be designed to be low enough to easily
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`permit articulation against another instrument, or even against an internal
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`anatomical structure. In fact, there are internal anatomical structure options that
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`are quite robust and many that are delicate. A skilled surgeon could easily choose
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`an appropriate structure to safely articulate the instrument using a low force
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`passive articulation mechanism.
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`12.
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`It must be remembered that robotic surgical instruments, such as
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`graspers, are used against body tissue without tactile feedback and there is no basis
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`to conclude that passive articulation would require more forces than those applied
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`by other instruments against the body. I note that although Dr. Awtar discusses the
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`forces provided by such instruments (e.g., at paragraph 81), he does not explain
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`U.S. Patent No. 8,479,969
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`why those instruments are in fact able to be used without the alleged “critical”
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`tactile feedback, but for some reason passive articulation forces would require
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`tactile feedback.
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`13. Moreover, the entire discussion about the lack of tactile feedback is
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`not relevant here because both Anderson and Wallace disclose robotic systems that
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`have tactile feedback.
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`14. Anderson states:
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`The control System typically includes at least one processor which
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`relays input commands from the master control devices to the
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`associated robotic arm and instrument assemblies and from the arm and
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`instrument assemblies to the associated master control devices in the
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`case of, e.g., force feedback, or the like.
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`Anderson, 2:62-3:1.
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`15. A person of ordinary skill in the art would understand that this
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`passage refers to tactile feedback in which forces from the manipulation of the
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`instruments are fed back to the master control devices, which are the controllers
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`held by the surgeon. (Anderson, 16:14-24 (discussing the master controllers) and
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`6:33-37 (discussing feedback sensors in the motor pack, which can detect forces on
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`the instrument by the resistance the motor senses as it tries to move the instrument
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`or hold the instrument in a single position).
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`U.S. Patent No. 8,479,969
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`16. Wallace likewise discloses tactile feedback. Wallace is largely
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`focused on a wrist mechanism and thus leaves much of the discussion of the
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`surgical robot to incorporated material. Wallace incorporates by reference other
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`references for the disclosure of the surgical robot in general. One such
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`incorporated reference is U.S. Patent Application No. 08/975,617:
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`Robotic surgery systems and methods are further described in co-
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`pending U.S. patent application Ser. No. 08/975,617, filed Nov. 21,
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`1997, the full disclosure of which is incorporated herein by reference.
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`Wallace, 3:25-29.
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`17. This application issued as U.S. Patent No. 6,132,368. That
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`incorporated reference states: “Position, force, and tactile feedback sensors (not
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`shown) may also be employed to transmit position, force, and tactile sensations
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`from the surgical tools back to the surgeon's hands as he/she operates the
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`telerobotic system.” Accordingly, a person of ordinary skill in the art would
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`understand that Wallace discloses a robotic system with tactile feedback. U.S.
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`Patent No. 6,132,368, 3:43-48; 5:9-18; 5:46-67; 9:56-66.
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`8
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`Il. CONCLUSION
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`I hereby declare that all statements made herein of my own knowledgeare
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`true and that all statements made on information and belief are believed to be true.
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`I further declare that these statements are made with the knowledgethat willful
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`false statements and the like so made are punishable by fine or imprisonment, or
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`both (under Section 1001 of Title 18 of the United States Code).
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`Executed this 15th day of July, 2019.
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`eae
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`
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`Dr. Bryan Knodél
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`9
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