UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
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`______________________
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`ETHICON ENDO-SURGERY, INC.
`Petitioner
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`v.
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`COVIDIEN AG
`Patent Owner
`
`______________________
`
`CASE IPR: UNASSIGNED
`U.S. PATENT NO. 8,241,284
`______________________
`
`DECLARATION OF DAVID C. YATES
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` 1
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`______________________
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`
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`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`
`
`ETHICON ENDO-SURGERY, INC.
`Petitioner
`
`v.
`
`COVIDIEN AG
`Patent Owner
`
`______________________
`
`CASE IPR: UNASSIGNED
`U.S. PATENT NO. 8,241,284
`______________________
`
`DECLARATION OF DAVID C. YATES
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` 1
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`I, David C. Yates, do hereby declare and say:
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`1.
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`I am over the age of twenty-one (21) and competent to make this
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`declaration. I am also qualified to give testimony under oath. The facts
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`and opinions listed below are within my personal knowledge.
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`2.
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`I am not being compensated for my time in this matter beyond my
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`general compensation as an employee of Ethicon Endo-Surgery, Inc. My
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`compensation in no way depends on the outcome of this proceeding or
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`the content of my opinions.
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`3.
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`I have been asked to review certain documents, including U.S. Patent No.
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`8,241,284 (which I refer to as the ‘284 Patent) (Ex. 1001), and to provide
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`my opinions on what those documents disclose. The documents I was
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`asked to review include those addressed in more detail in the rest of this
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`declaration. I provide my conclusions regarding the disclosures of these
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`documents below.
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`4.
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`I was also asked to provide my opinion on the technical feasibility of
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`combining certain aspects of certain documents. I have offered my
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`opinion on the feasibility of these combinations in this declaration.
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`5.
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`I was asked to review the Patent Trial and Appeal Board’s (“Board”)
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`Decision Denying Institution in IPR2015-01275, which I understand also
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`related to the ‘284 Patent. (Ex. 1010). I was asked to provide certain
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`observations on that document. I was also asked to assume that the
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` 2
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`Board’s claim construction determinations as reflected in Exhibit 1010
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`apply here.
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`6.
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`I am not offering any conclusions as to the ultimate determinations I
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`understand the Board will make in this proceeding. I am simply
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`providing my opinion on the technical aspects of the documents
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`(including, where asked, the application of what I understand Petitioner
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`and/or the Board asserts is the appropriate construction for this
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`proceeding) and on the motivations and combinability of the concepts
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`disclosed in those documents from a technical perspective.
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`BACKGROUND
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`7.
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`I am an electrical engineer with over 30 years of experience in medical
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`device research and development, product design, and field engineering.
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`8. My experience in these areas spans treatment and diagnostic devices,
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`technology integration with disposable and reusable laparoscopic
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`products, and electronic circuit and system design.
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`9.
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`As part of my experience, I have managed products from idea to design to
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`implementation to customer installation, maintenance, and satisfaction. I
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`have also observed hundreds of human surgical procedures, many using
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`products I have designed. I have extensive experience working with
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`tissue lab evaluation of prototype medical devices.
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` 3
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`10.
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`I received my Bachelor’s of Science degree in Electrical Engineering
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`from Rose-Hulman Institute of Technology in Terre Haute, Indiana in
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`1984.
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`11. Upon graduating from Rose-Hulman, I was hired by General Electric
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`Medical Systems, which was based in Waukesha, Wisconsin, as a field
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`engineer and eventually a product development engineer for various GE
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`products, including the Advantx™ X-Ray system that is still in use today.
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`In 1988, I was hired by Catheter Research, Inc. in Indianapolis, Indiana to
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`manage aspects of electronics development and manufacturing related to
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`an electronically steerable catheter for peripheral vascular use.
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`12.
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`I was hired by ETHICON in 1991 and have worked at various Johnson &
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`Johnson companies, including ETHICON, Ethicon Endo-Surgery, and
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`Indigo Medical for the balance of my career. I have worked on several
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`therapeutic energy-based vessel sealing devices, electrosurgery
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`generators, surgical stapling instruments, electro-optic and other electrical
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`and electro-mechanical instruments. Throughout my time at Johnson &
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`Johnson companies, I have become intimately familiar with all aspects of
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`bipolar electrosurgical instruments, including the electrical and
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`mechanical considerations that go into designing these devices. I
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`understand the physiological considerations involved with such devices,
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`including the need for pressure, spacing, and energy to create effective
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`tissue seals.
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`13.
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`In my career, I have been awarded more than 60 U.S. Patents for six
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`different companies. In addition, I currently have more than 70 U.S.
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`Patent Applications pending in the United States Patent and Trademark
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`Office. Many of these patents and patent applications relate to bipolar
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`electrosurgery and energy applications, stapling, and electromechanics.
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`14. One of the documents I was asked to review in this proceeding is a patent
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`on which I am a named inventor: U.S. Patent No. 5,674,220 to Fox et al.
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`(which I refer to as Fox) (Ex. 1006).
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`15. Fox was a patent generated as a result of a project called “C-Cubed.” “C-
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`Cubed” stood for the three functions the instrument was designed to
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`perform: Clamp, Coagulate, and Cut. The commercial product that
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`resulted from “C-Cubed” was called the TriSector Forceps.
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`16. For these reasons and because of my technical experience and training as
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`outlined in my curriculum vitae (Ex. 1019), I believe I am qualified to
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`offer technical opinions regarding the ‘284 Patent and the other
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`documents I reviewed as part of my work in this matter. I believe I am
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`capable of opining about the state of the art in these areas at various
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`points in time from the early 1990s to the present, as I have been familiar
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` 5
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`with the academic and commercial work being done by Ethicon and
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`others in the industry during my time at the company.
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`U.S. PATENT NO. 8,241,284
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`17. The ‘284 Patent is titled “Vessel Sealer And Divider With Non-
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`Conductive Stop Members.” (Ex. 1001). It was filed on January 5, 2009
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`as a continuation of an application that issued as U.S. Patent No.
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`7,473,253. I have been asked to assume (and I have assumed) for
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`purposes of my analysis that the ‘284 Patent has an effective filing date of
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`April 6, 2001. I have therefore tried to offer opinions in this declaration
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`through the eyes of one of skill in the art (as defined below in paragraph
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`41) as of April 6, 2001.
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`18. The ‘284 Patent discloses an endoscopic bipolar forceps having jaw
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`members connected to a source of electrical energy so that the jaw
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`members can conduct electricity between themselves and through tissue
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`grasped between them. (Ex. 1001 at Abstract). It also discloses that the
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`endoscopic bipolar forceps have a “longitudinally reciprocating knife
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`which severs the tissue after sealing.” (Ex. 1001 at Abstract).
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`19. The ‘284 Patent discloses what it terms non-conductive “stop members”
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`on the jaw members to “regulate the gap distance between the jaw
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`members when tissue is held therebetween.” (Ex. 1001 at Abstract). It
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`discloses that in addition to “control[ling] the gap distance,” the stop
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` 6
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`
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`members “enhance the manipulation and gripping of tissue during the
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`sealing and dividing process.” (Ex. 1001 at 1:24-26).
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`20. The ‘284 Patent discloses several configurations of non-conductive stop
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`members, which it illustrates in, for example, Figs. 6A through 6F. Figs.
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`6A, 6C, 6D, and 6F are reproduced below as examples of some of the
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`different arrangements of non-conductive stop members in the ‘284
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`Patent, with the stop members (referred to with designators 50a-50g)
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`shaded in red:
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`21. The discussion of non-conductive stop members can primarily be found
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`in columns 10-13 of the ‘284 Patent. (Ex. 1001 at 10:60-13:13).
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`22. The ‘284 Patent contains two primary embodiments with regard to these
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`“stop members.” In a first embodiment, described generally with regard
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`to Fig. 6D illustrated above, a single stop member is illustrated. The ‘284
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`Patent describes this embodiment as follows:
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`[I]n order to achieve a desired spacing between the
`electrically conductive surfaces 35 of the respective jaw
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` 7
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`
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`members 22 and 24, (i.e., gap distance) and apply a desired
`force to seal the tissue 150, at least one jaw member 22
`and/or 24 includes at least one stop member, e.g., 50a,
`which limits the movement of the two opposing jaw
`members 22 and 24 relative to one another.
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`(Ex. 1001 at 10:60-66). As is clear from the language “at least one stop
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`member” and the illustration in Fig. 6D, this embodiment covers devices
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`with a single stop member.
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`23.
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`In this embodiment, the single stop member “extends from the sealing
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`surface or tissue contacting surface 35 a predetermined distance
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`according to the specific material properties (e.g., compressive strength,
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`thermal expansion, etc.) to yield a consistent and accurate gap distance
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`during sealing.” (Ex. 1001 at 10:66-11:4). The disclosed stop member is
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`made from an “insulative material” (Ex. 1001 at 11:9-12) and can “be
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`configured in any known geometric or polynomial configuration, e.g.,
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`triangular, rectilinear, circular, ovoid, scalloped, etc., depending upon a
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`particular purpose” (Ex. 1001 at 11:36-39).
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`24. The ‘284 Patent also contains a second general embodiment:
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`configurations relying on multiple stop members. (Ex. 1001 at 11:28-30,
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`11:40-42). These multiple stop member configurations are shown, for
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`example, in Figs. 6A, 6B, 6C, 6E and 6F. The stop members in the
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`multiple stop member embodiment are made from an insulative material
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`and can be configured in any geometric configuration desired. (Ex. 1001
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` 8
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`
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`at 10:66-11:4, 11:9-12, 11:36-39). The ‘284 Patent describes that for the
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`multiple stop member embodiments, “[p]referably, the gap distance
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`between opposing sealing surfaces 35 during sealing ranges from about
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`0.001 inches to about 0.005 inches and, more preferably, between about
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`0.002 and about 0.003 inches.” (Ex. 1001 at 11:4-8).
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`25. This description of dimensions in the ‘284 Patent is consistent with
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`disclosures I have made to the patent office reflecting the understanding
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`of those of skill in the art in the late 1990s, including Statutory Invention
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`Registration No. H1904. (Ex. 1012). In that SIR, dimension G, which is
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`“measured from tissue surface 90 to tissue surface 92 with jaws 32 and 34
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`closed, is preferably in the range from approximately 0.0 inches to
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`approximately 0.020 inches and preferably approximately 0.001 inches.”
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`(Ex. 1012 at 7:42-48). Thus, the gap dimensions disclosed in the ‘284
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`Patent were known prior to the filing of the ‘284 Patent.
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`26. As I describe below, the prior art shows both an example of the single
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`stop member embodiment (Fox and Kese) and an example of the multiple
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`stop member embodiment (Fox and Kese modified by Eggers ‘142).
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`Thus, whichever of the embodiments the ‘284 Patent claims cover, the
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`prior art also discloses those embodiments.
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`27. While the ‘284 Patent discusses and illustrates several configurations of
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`stop members in these portions of the specification (and corresponding
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` 9
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`figures), the ‘284 Patent does not appear to identify any benefits or even
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`differing functionality for one configuration versus other configurations.
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`28. To the contrary, the ‘284 Patent generically states that:
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`It is envisioned that one or more stop members, e.g., 50a and
`50g, can be positioned on either or both jaw members 22 and
`24 depending upon a particular purpose or to achieve a
`desired result. As can be appreciated by the present
`disclosure, the various configurations of the stop members
`50a-50g are designed to both limit the movement of the
`tissue 150 prior to and during activation and prevent short
`circuiting of the jaw members 22 and 24 as the tissue 150 is
`being compressed.
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`(Ex. 1001 at 11:19-27; see also 11:13-15, 11:36-42, 12:39-46). The ‘284
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`Patent generally discloses that the details of the non-conductive stop
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`members is driven, in large measure, by the “compressive strength of the
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`material along with the desired or ultimate gap distance required…” (Ex.
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`1001 at 12:59-13:3).
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`29.
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`In my study of the ‘284 Patent, it appears that the only purposes disclosed
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`for the various configurations of stop members are (1) maintaining a “gap
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`distance between opposing seal surfaces” to prevent short circuiting and
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`(2) limiting movement of tissue while it is being grasped or manipulated.
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`(See, e.g., Ex. 1001 at 11:4-8, 11:23-30, 12:19-29, 12:42-46). There do
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`not appear to be any articulated benefits of any particular configuration or
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`shape of stop members. If any such benefits exist, the ‘284 Patent
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`appears to be silent about what those might be.
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`10
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`30. The ‘284 Patent also discloses several manufacturing techniques for
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`forming non-conductive stop members on the jaws of the disclosed
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`endoscopic bipolar forceps. For example, it discloses molding
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`techniques, stamping techniques, or deposition techniques. (See, e.g., Ex.
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`1001 at 12:4-18, 12:30-38). In my review, the ‘284 Patent does not
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`appear to identify any benefits or detriments of any of these techniques.
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`Instead, it appears that the disclosed manufacturing techniques are driven
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`largely by the type of material selected for the stop members. If a plastic
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`material is going to be used to form non-conductive stop members,
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`appropriate manufacturing techniques for plastic (such as molding
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`techniques) would be employed.
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`THE BOARD’S DECISION
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`31. As I noted above, I was asked to review Exhibit 1010, which I understand
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`is the Board’s decision not to institute a previous ‘284 Patent IPR. One
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`area I was asked to focus on was the claim construction portion of the
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`Board’s decision found at pages 4 to 8.
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`32. The Board’s conclusion on claim construction was that “a uniform
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`distance between the jaw members along the length thereof” means
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`“when tissue is held between the opposing jaw members (i.e., ‘the jaw
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`members cooperate to grasp tissue therebetween,’ as recited in both
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`11
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`
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`independent claims), the distance between the jaw members is the same
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`along the entire length thereof.” (Ex. 1010 at 8).
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`33.
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`I am surprised by the Board’s interpretation of the claims, as in my
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`opinion this is not how a person of ordinary skill in the art would read the
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`requirement in the claims for “a uniform distance between the jaw
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`members along the length thereof.” Instead, in my opinion, a person of
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`skill in the art would understand this requirement to be directed to the
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`distance between the jaws when the jaws are in a fully closed position,
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`without tissue grasped therebetween. This is the “gap distance”
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`discussed in the ‘284 Patent in my review of that patent above. This, too,
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`is reflected in the SIR I mentioned above, which discloses that
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`“Dimension G is measured without tissue engaged.” (Ex. 1012 at 7:46-
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`47).
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`34. This is my opinion because the only position disclosed in the ‘284 Patent
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`where it makes sense to talk about “uniform distance” is the position
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`illustrated in Fig. 2, where the jaws are closed without tissue held
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`therebetween. It is evident from Figs. 1, 3, and 5 of the ‘284 Patent that
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`when the jaws are in an open position, the distance between the jaws is
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`not uniform. Instead, the distance at the distal tip is much greater than the
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`distance near the hinge point. On the contrary, in Fig. 2, the distance
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`between the jaw members can be uniform if the height of the stop
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`12
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`
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`members is equal to the diameter of the pivot point of the jaw members.
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`In this case, the uniform distance is equal to the height of the stop
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`members/diameter of the pivot point.
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`35.
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`It is also my opinion that it does not make sense to talk about uniformity
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`of distance between jaw members when tissue is held therebetween. To
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`those of skill in the art, the recitation of “tissue” held between jaws does
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`not convey anything about the grasped tissue. As can be seen from Figs.
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`7 and 8 of the ‘284 Patent, grasped tissue has a non-zero thickness even
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`when compressed in the jaws. This thickness affects whether the distance
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`between the jaws is uniform – if the distance between the jaws is uniform
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`when there is no tissue held therebetween, the distance will not be
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`uniform when tissue is held therebetween. While the non-uniformity may
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`be minor for very thin tissue, having any tissue held between the jaws
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`will nonetheless change the distance between the jaws while grasping
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`tissue versus without tissue held therebetween.
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`36. Moreover, the ‘284 Patent itself talks about tissue having a diameter of
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`less than two millimeters and tissue having a diameter larger than two
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`millimeters. (Ex. 1001 at 1:47-52, 1:58-60). Thus, those of skill in the
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`art reading the ‘284 Patent would understand that it is concerned with the
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`ability to treat tissue having a range of thicknesses. Even if a device was
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`designed so that the distance between the jaws was uniform when a
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`13
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`
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`particular thickness of tissue is held therebetween, grasping tissue of any
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`other thickness will cause the jaws to no longer have a uniform distance
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`therebetween.
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`37.
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`It is therefore surprising and unexpected to see the Board construe the
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`claims to require a uniform distance between jaws when tissue is held
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`therebetween. I was not asked to (and cannot) comment on the legal
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`correctness of this decision, but to those of skill in the art, interpreting
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`this claim language in this way is surprising and unexpected based on the
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`descriptions contained in the ‘284 Patent.
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`SUMMARY OF OPINIONS
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`38. As discussed in more detail below, my review of prior art documents in
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`this proceeding demonstrates that the individual components of the ‘284
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`Patent were well-known as of the earliest possible priority date of April 6,
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`2001. Specifically, Kese and Fox disclose bipolar endoscopic forceps
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`having a proximal handle for actuating a distal pair of jaws prior to
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`delivering bipolar energy to grasped tissue. Fox discloses a separately
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`actuatable knife within the shaft of the forceps. Kese, Fox, and Eggers
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`‘142 disclose the use of non-conductive stop members to set a minimum
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`gap between jaws (to prevent shorting) and to assist in grasping tissue.
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`And Eggers ‘142 and Slater disclose the well-known technique of
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`14
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`
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`molding to provide specific zones of conductivity and insulation on
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`bipolar electrosurgical devices.
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`39. At a high level, the features disclosed in the ‘284 Patent were not new as
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`of April 6, 2001. My review of the documents referenced in the
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`preceding paragraph comports with my experience that those of skill in
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`the art prior to 2001 knew of and regularly worked with devices having
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`the features mentioned in the above paragraph.
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`40. Moreover, the combinations I was asked to consider in the instant
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`proceeding (i.e., (1) Kese combined with Fox and Eggers ‘142, and (2)
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`Kese combined with Fox, Eggers ‘142 and Slater) could and would have
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`been made by a person of ordinary skill in the art as of April 6, 2001. I
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`was asked to perform that task without using “hindsight” reasoning.
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`Instead, I was asked to consider the feasibility and combinability of
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`references through the eyes of a person of skill in the art as of April 6,
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`2001. As I describe below, the individual references, which are all
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`attributable to well-known players in the bipolar electrosurgical
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`instrument space in the late 1990’s and early 2000’s, contain statements
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`and teachings that motivate those of skill in the art to look to the other
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`references in the combinations I was asked to consider.
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`15
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`LEVEL OF SKILL IN THE ART
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`41.
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`I was asked to provide my opinion about the experience and background
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`a person of ordinary skill in the art of the ‘284 Patent would have had as
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`of April 6, 2001. In my opinion, such a person of skill in the art would
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`have had at least a bachelor’s of science degree in either electrical
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`engineering or mechanical engineering with at least four years’
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`experience designing electrosurgical instruments. Such a person would
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`understand the electrical concepts involved in electrosurgical instruments
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`relating to the heating of tissue and the potential for negative electrical
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`consequences (such as arcing and shorting) depending on device design,
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`and would also understand the mechanical constraints within which these
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`electrical considerations must be implemented.
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`42.
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`I understand that the Patent Owner has asserted, in another proceeding
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`directed to similar technology, that a person of ordinary skill in the art
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`would have had at least a bachelor’s degree in a relevant field of
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`engineering (e.g., biomedical engineering, electrical engineering,
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`mechanical engineering) with considerable experience in the relevant
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`field (e.g., electrosurgical instruments and sealing tissue using the same).
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`I understand that the Patent Owner has also asserted that depending on
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`the background and level of education of the person, it would have taken
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`a few years for a person to become familiar with the problems
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`16
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`
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`encountered in the art and become familiar with the prior and current
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`solutions to those problems.
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`43.
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`I do not believe that Patent Owner’s articulation of the level of skill in the
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`art differs from mine. Moreover, under either definition, I believe that I
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`was a person of ordinary skill in the art as of April 6, 2001. Furthermore,
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`I believe that I can opine today about what those of skill in the art would
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`have known and understood as of April 6, 2001.
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`THE KESE PATENT
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`44. As part of my work in this proceeding, I was asked to review U.S. Patent
`
`No. 6,024,744 to Kese et al. (“Kese”) (Ex. 1005).
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`45. Kese is entitled “Combined Bipolar Scissor and Grasper” and is generally
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`directed to open surgery and endoscopic versions of a combined bipolar
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`electrosurgical cutting and grasping instrument. (Ex. 1005 at Abstract).
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`46. Figs. 1A and 1B of Kese illustrate “the operating (or distal) end of the
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`inventive combined bipolar scissors and grasper instrument 10.” (Ex.
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`1005 at 6:54-56). The Kese device includes first and second jaw
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`members 12, 14 each “having a cutting edge 16, 18, a cutting surface 17,
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`19, and a grasping surface 20, 22.” (Ex. 1005 at 6:56-59). Kese
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`describes that “in the closed position…the first grasping surface 20
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`substantially meets the second grasping surface 22 to form a clamp for
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`
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`17
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`
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`grasping and clamping tissue and vessels therewithin.” (Ex. 1005 at
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`7:20-25).
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`47. Kese also discloses certain electrically insulating material “to electrically
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`isolate the first jaw member 12 from the second jaw member 14.” (Ex.
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`1005 at 7:26-28). This material includes “a second insulating coating 28
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`[] secured to the second grasping surface 22 thereby insulating the first
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`grasping surface 20 from the second grasping surface 22.” (Ex. 1005 at
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`7:36-39). The insulating coatings, including insulating coating 28, “are
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`preferably aluminum oxide, plasma deposited on the instrument surfaces.
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`The thickness of the aluminum oxide coatings can be between 0.003 and
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`0.010 inches thick, preferably between 0.005 and 0.007 inches thick to
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`withstand a voltage of approximately 1,500 volts.” (Ex. 1005 at 7:44-49).
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`48. Figs. 3A to 3D of Kese show embodiments where “the second insulating
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`coating 28 preferably covers only a portion of the second grasping
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`surface 22.” (Ex. 1005 at 7:58-60). This allows for a situation where,
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`“[w]hen tissue is grasped between the first grasping surface 20 and
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`second grasping surface 22, RF energy from one jaw member will be
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`conducted to the other in the portions of the second grasping surface 22
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`which are uncoated, thereby cauterizing the tissue between the grasping
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`surfaces 20,22 in the region of the uncoated portions.” (Ex. 1005 at 7:60-
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`65).
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`18
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`
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`49. Kese states that “[s]ince the second insulating coating 28 covers only a
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`portion of the second grasping surface 22 it can therefore take on a
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`variety of shapes and sizes. FIG. 3A shows the second insulating coating
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`28a applied as a semi-circle across the width of the second grasping
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`surface 22.” (Ex. 1005 at 7:66-8:3). Kese also notes that “FIG. 3C shows
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`an alternatively shaped second insulating coating 28b applied as a strip
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`across the length of the first grasping surface 20.” (Ex. 1005 at 8:30-32).
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`Figs. 3A and 3C are reproduced below for reference:
`
`50.
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`In my opinion, Kese discloses the use of at least one non-conductive stop
`
`member akin to the disclosure in the first embodiment of the ‘284 Patent
`
`discussed above, and akin to the disclosure in Fox of an island of
`
`insulation discussed below. Moreover, Kese discloses alternate shapes
`
`for such stop members, including semi-circular and elongated shapes.
`
`51. Kese also discloses that “the second insulating coating 28 is used to
`
`maintain an insulating gap between the first grasping surface 20 and the
`
`second grasping surface 22 equal to the thickness of the coating 28.” (Ex.
`
`1005 at 8:13-16).
`
`
`
`19
`
`
`
`52. Based on the above-cited disclosures, in my opinion, Kese discloses that
`
`the insulating coating 28 has a uniform thickness, and that the uniform
`
`thickness is equal to the distance between grasping surfaces 20 and 22
`
`when the jaws of Kese are closed. In my opinion, to the extent the single-
`
`stop member embodiment of the device in the ‘284 Patent satisfies the
`
`Board’s construction of “uniform distance between the jaw members
`
`along the length thereof,” so too does the second insulating coating 28 of
`
`Kese particularly as shown in Fig. 3C.
`
`53. Kese states that “FIGS. 12A, 12B, and 13 illustrate the present invention
`
`configured to be utilized in endoscopic surgical procedures.” (Ex. 1005
`
`at 11:15-16). In this embodiment, the device includes an elongated tube
`
`202 and jaw members 12, 14 that are “pivotally disposed on the distal end
`
`204 of the elongated tube 202 such that they pivot about the pivot pin,
`
`rivet, or screw 24.” (Ex. 1005 at 11:19-25). It discloses that “[s]uitable
`
`endoscopic actuating mechanisms are numerous in the surgical arts, any
`
`of one of which can be employed in the endoscopic version 200 of the
`
`present invention.” (Ex. 1005 at 11:40-43). Fig. 12A of Kese is
`
`reproduced below for reference:
`
`
`
`20
`
`
`
`
`
`54.
`
`In my opinion, these passages and figures indicate that Kese discloses that
`
`the end effector illustrated in Figs. 3A-3D can be provided at the distal
`
`end of an endoscopic instrument.
`
`55. Kese cites, on its face, to two patents of Phil Eggers. (Ex. 1005 at Cover).
`
`Both of those Eggers patents (U.S. Patent No. 5,484,436 and U.S. Patent
`
`No. 5,766,170) are children of U.S. Patent No. 5,330,471 (Ex. 1009),
`
`which is cited on the face of Eggers ‘142 as discussed in more detail
`
`below. (See Ex. 1017; Ex. 1018). In addition, Kese cites on its face to
`
`the Slater reference discussed in more detail below. (Ex. 1005 at Cover;
`
`Ex. 1011).
`
`THE FOX PATENT
`
`56. As part of my work in this proceeding, I was asked to review U.S. Patent
`
`No. 5,674,220 to Fox et al. (“Fox”) (Ex. 1006). Even prior to my work in
`
`this proceeding, I was familiar with Fox because I am a named inventor.
`
`
`
`21
`
`
`
`57. Fox discloses an electrosurgical hemostatic instrument that it describes as
`
`a “bipolar endoscopic clamping, coagulation and cutting device.” (Ex.
`
`1006 at Abstract). Fig. 4 of Fox illustrates the bipolar forceps 410 and
`
`shows the position of a trigger 430 and closure tube 420 for closing the
`
`jaws 416 and 417 of end effector 412. (See Ex. 1006 at 4:32-45). In the
`
`following version of Fig. 4, the closure tube 420 is highlighted in green,
`
`the jaws 416 and 417 are highlighted in blue, and the trigger 430 is
`
`highlighted in purple:
`
`
`
`Though difficult to see, red highlighting in Fig. 4 illustrates a periphery of
`
`the top jaw 416. In this embodiment, when trigger 430 is closed, the
`
`closure tube 420 is advanced over the camming surface of jaws 416 and
`
`417, driving the jaws together. This is and has been a very common way
`
`
`22
`
`
`
`of closing jaws in bipolar endoscopic forceps, and was well known long
`
`before the filing of the ‘284 Patent. In my opinion, the use of a closure
`
`tube actuated by a trigger, such as in Fox, was common knowledge to
`
`those of skill in the art as of April 6, 2001. This is consistent with the
`
`Kese’s disclosure that such actuating mechanisms were “numerous in the
`
`surgical arts, any of one of which can be employed in the endoscopic
`
`version 200 of the present invention.” (Ex. 1005 at 11:40-43).
`
`58. While Fox discloses an entire instrument (see, e.g., Ex. 1006 at Fig. 4,
`
`4:32-45), Fox focuses on the end effector of the device. (See, e.g., Ex.
`
`1006 at Fig. 5, 4:46-5:24, 1:8-10, 2:65-3:11). Fox’s end effector can take
`
`several forms as illustrated in, for example, Figs. 4, 5, 7, 8, and 9.
`
`59.
`
`In the embodiments of Figs. 4, 7, 8, and 9, the end effector includes
`
`“grasping teeth” which are features on the surfaces of the jaws to enhance
`
`tissue grasping. (Ex. 1006 at 5:34-40).
`
`60.
`
`In the embodiment of Fig. 5, the end effector includes jaw members 116
`
`and 117 having electrodes 147 and 148 with planar tissue grasping
`
`surfaces 118 and 119. (Ex. 1006 at 4:46-50). The below version of Fig.
`
`5 illustrates the planar tissue grasping surfaces 118 and 119 in yellow, the
`
`jaw members 116 and 117 in blue, and a closure tube 115 in green:
`
`
`
`23
`
`
`
`
`
`In this figure, red highlighting illustrates a periphery around the two-
`
`dimensional sealing surfaces of the end effector illustrated.
`
`61. Fox also discloses a “knife 122 [] adapted to cut tissue by moving distally
`
`in knife channel 143 when jaws 116 and 117 are closed to grip tissue.”
`
`(Ex. 1006 at 5:17-19). In the above picture, the knife 122 is highlighted
`
`in orange and includes blades 125 and 126. (Ex. 1006 at 5:20-23).
`
`62. Fox discloses the importance of carefully controlling the relative position
`
`of the pair of electrodes:
`
`The size and shape of the feedback region may be varied by
`varying the portion of outer surface 32 and 34 which are not
`
`
`24
`
`
`
`covered by insulative coating i.e. by varying the size and
`location of outer electrodes 29 and 39. Where necessary,
`shorting may be prevented by, for example, including an
`island of insulation on the grasping surface 27 or 36 of either
`electrode 21 or 22 to establish an insulative gap between the
`conductive surfaces.
`
`(Ex. 1006 at 4:21-29).
`
`63. This passage discloses, to one of skill in the art, that a non-conductive
`
`structure (indicated by the use of the word “insulation”) is disposed on
`
`the sealing surface of the end effector (indicated by the use of the word
`
`“island”) to establish an “insulative gap between the sealing surfaces.” In
`
`my opinion, applying an “island of insulation” to the Fig. 5 embodiment
`
`of Fox results in an end effector wherein jaws have flat sealing surfaces,
`
`at least one of which includes a non-conductive stop member. While Fox
`
`does not visually depict such an island of insulation, Kese does as I
`
`explained above with regard to insulating coating 28.
`
`64. Each embodiment of Fox (including the Fig. 5 embodiment) includes a
`
`knife channel that guides a longitudinally extendable knife. In my
`
`opinion, the “island of insulation” mentioned by Fox is therefore
`
`understood to be disposed on the surfaces of the electrodes on one side of
`
`the knife channel or the other.
`
`65. More generally, Fox discloses that features to improve grasping (such as
`
`the “grasping teeth” of Figs. 4, 7, and 8) are disposed on either side of the
`
`
`
`25
`
`
`
`knife channel. (Ex. 1006 at 5:36-40, Fig. 7). In these embodiments, the
`
`grasping features are positioned on both the top and bottom jaw members.
`
`(Ex. 1006 at 5:36-40, Fig. 7). Fox therefore discloses to one of skill in
`
`the art that where features such as teeth are provided to enhance grasping
`
`of tissue by the end effector, those features can be on either side of a
`
`knife channel in both jaws.
`
`THE EGGERS ‘142 PATENT
`
`66. As part of my work in this proceeding, I was asked to review U.S. Patent
`
`No. 5,891,142 to Eggers et al. (“Egg
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