UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
`
`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
`______________________
`
`PETITION FOR INTER PARTES REVIEW
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`Covidien Exhibit 2003
`Ethicon Endo-Surgery, Inc. v. Covidien AG
`IPR2016-00944
`
`Page 1 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`Table of Contents
`
`I.
`
`II.
`
`INTRODUCTION ...........................................................................................1
`
`THE ‘284 PATENT.........................................................................................1
`
`A. Overview of the ‘284 Patent..................................................................1
`
`B.
`
`C.
`
`Prosecution of the ‘284 Patent ..............................................................3
`
`The Petition Relies On Previously Unapplied Combinations...............5
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)).................................6
`
`IV. PAYMENT OF FEES (37 C.F.R. §§ 42.15 and 42.103) ................................6
`
`V. MANDATORY NOTICES (37 C.F.R. § 42.8(b)) ..........................................7
`
`A.
`
`B.
`
`C.
`
`Real Parties-In-Interest (37 C.F.R. § 42.8(b)(1))..................................7
`
`Related Matters (37 C.F.R. § 42.8(b)(2))..............................................7
`
`Lead and Backup Counsel and Service (37 C.F.R. § 42.8(b)(3)-
`(4)) .........................................................................................................7
`
`VI. PERSON OF ORDINARY SKILL IN THE ART ..........................................8
`
`VII. CLAIM CONSTRUCTION ............................................................................8
`
`A.
`
`B.
`
`“Jaw Members Movable With Respect To The Elongated Shaft” .......8
`
`“Drive Rod Assembly…”....................................................................10
`
`VIII. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE (37 C.F.R. § 42.22(a) AND 42.104(b))..............11
`
`A. Ground 1: Claims 1-11 Are Unpatentable Under 35 U.S.C. §
`103(a) As Obvious Over Fox In View Of Eggers ‘142 ......................11
`1.
`Overview of the Prior Art .........................................................11
`
`2. Motivation to Combine.............................................................14
`
`3.
`
`Specific Identification of Challenge .........................................18
`
`i
`
`Page 2 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`B.
`
`C.
`
`Ground 2: Claim 11 Is Unpatentable Under 35 U.S.C. § 103(a) As
`Obvious Over Fox In View Of Eggers ‘142 and Slater......................32
`1.
`Overview of the Prior Art .........................................................32
`
`2. Motivation to Combine.............................................................33
`
`3.
`
`Specific Identification of Challenge .........................................34
`
`Ground 3: Claims 1 to 18 are Unpatentable Under 35 U.S.C. §
`103(a) as Obvious Over Eggers ‘471, Wales, Fox, and Eggers
`‘142......................................................................................................35
`1.
`Overview of the Prior Art .........................................................35
`
`2. Motivation to Combine.............................................................36
`
`3.
`
`Specific Identification of Challenge .........................................39
`
`D. Ground 4: Claim 11 Is Unpatentable Under 35 U.S.C. § 103(a) As
`Obvious Over Eggers ‘471, Wales, Fox, Eggers ‘142, and Slater .....53
`1. Motivation to Combine.............................................................53
`
`2.
`
`Specific Identification of Challenge .........................................54
`
`E.
`
`Ground 5: Claims 12-18 Are Unpatentable Under 35 U.S.C. §
`103(a) As Obvious Over Schulze In View Of Fox and Eggers ‘142..54
`1.
`Overview of the Prior Art .........................................................54
`
`2. Motivation to Combine.............................................................55
`
`3.
`
`Specific Identification of Challenge .........................................56
`
`IX. CONCLUSION..............................................................................................60
`
`ii
`
`Page 3 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`List of Exhibits
`
`Ex. 1001
`
`U.S. Patent No. 8,241,284 (“‘284 Patent”)
`
`Ex. 1002
`
`Prosecution History of U.S. Patent No. 7,473,253
`
`Ex. 1003
`
`Prosecution History of U.S. Patent No. 8,241,284
`
`Ex. 1004
`
`Declaration of Mr. David C. Yates
`
`Ex. 1005
`
`Curriculum Vitae of Mr. David C. Yates
`
`Ex. 1006
`
`U.S. Patent No. 5,674,220 to Fox et al. (“Fox”)
`
`Ex. 1007
`
`U.S. Patent No. 5,891,142 to Eggers et al. (“Eggers ‘142”)
`
`Ex. 1008
`
`U.S. Patent No. 5,800,449 to Wales (“Wales”)
`
`Ex. 1009
`
`U.S. Patent No. 5,330,471 to Eggers et al. (“Eggers ‘471”)
`
`Ex. 1010
`
`PCT App. No. PCT/US01/11340, PCT Publication No.
`
`WO02/080795, to Dycus et al. (“Dycus PCT”)
`
`Ex. 1011
`
`U.S. Patent No. 5,396,900 to Slater et al. (“Slater”)
`
`Ex. 1012
`
`U.S. Patent No. 5,599,350 to Schulze et al. (“Schulze”)
`
`Ex. 1013
`
`U.S. Patent No. 5,403,312 to Yates et al. (“Yates”)
`
`Ex. 1014
`
`U.S. Patent No. 5,540,684 to Hassler, Jr. (“Hassler”)
`
`Ex. 1015
`
`U.S. Patent No. 5,443,463 to Stern et al. (“Stern”)
`
`iii
`
`Page 4 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`I.
`
`INTRODUCTION
`Ethicon Endo-Surgery, Inc. (“Petitioner”) petitions for inter partes review
`
`(“IPR”) of claims 1 to 18 of U.S. Patent No. 8,241,284 (“‘284 Patent”) (Ex. 1001).
`
`II. THE ‘284 PATENT
`
`Patent Owner Covidien AG (“PO”) obtained the ‘284 Patent by arguing that
`
`adding insulative “stop members” to grasping surfaces of known electrosurgical
`
`instruments was a meaningful distinction over the prior art. As described in detail
`
`below, art not before the Examiner illustrates the fallacy of that argument, and
`
`shows that the benefits of stop members and their use on endoscopic devices were
`
`well known long before the earliest possible filing date of the ‘284 Patent. Thus,
`
`the claims of the ‘284 Patent are invalid and should be cancelled.
`
`A. Overview of the ‘284 Patent
`
`The ‘284 Patent is directed to a bipolar forceps for endoscopic surgical
`
`procedures. (Ex. 1001 at 1:17-19). These instruments are not new; in addition to
`
`its eight pages of “References Cited,” the ‘284 Patent provides a detailed overview
`
`of existing devices that “utilize both mechanical clamping action and electrical
`
`energy to effect hemostasis by heating the tissue and blood vessels to coagulate,
`
`cauterize, and/or seal tissue.” (Id. at 1:31-2:59, 3:4-28; Ex. 1004 at ¶ 26).
`
`For example, the ‘284 Patent admits that “[s]everal journal articles have
`
`disclosed methods for sealing small blood vessels using electrosurgery.” (Ex. 1001
`
`at 1:53-54).
`
`In known sealing devices, electrodes in a pair of jaws (sometimes
`
`1
`
`Page 5 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`referred to as an “end effector”) are “charged to a different electric potential[s]
`
`such that when the jaw members grasp tissue, electrical energy can be selectively
`
`transferred through the tissue.”
`
`(Id. at 2:2-5). The ‘284 Patent admits that
`
`“[e]lectrosurgical methods may be able to seal larger vessels using an appropriate
`
`electrosurgical power curve, coupled with an instrument capable of applying a
`
`large closure force to the vessel walls.” (Id. at 2:22-25).
`
`Accordingly, the ‘284 Patent does not disclose the first endoscopic bipolar
`
`vessel sealing instrument capable of sealing both smaller and larger vessels.
`
`Indeed, it admits that Petitioner’s own U.S. Patent No. 5,674,220 to Fox et al.
`
`(“Fox”, Ex. 1006) “discloses a transparent vessel sealing instrument which
`
`includes a longitudinally reciprocating knife which severs the tissue once seated
`
`[sic - sealed].” (Ex. 1001 at 3:7-10).1 The alleged invention instead involves non-
`
`conductive stop members associated with the jaw members “to control the gap
`
`distance between opposing jaw members and enhance the manipulation and
`
`gripping of tissue during the sealing and dividing process.” (Id. at 1:21-26).
`
`This alleged point of novelty, however, was not new. Fox discloses stop
`
`members: an “island of
`
`insulation…establish[es] an insulative gap between the
`
`conductive surfaces.”
`
`(See Ex. 1006 at 4:25-29). Likewise, U.S. Patent No.
`
`5,891,142 to Eggers et al.
`
`(“Eggers ‘142”, Ex. 1007), discloses various
`
`1
`
`All emphasis herein added unless otherwise indicated.
`
`2
`
`Page 6 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`configurations of insulative spacers “to space the tissue grasping surfaces apart an
`
`optimum distance, T, when substantially in a closed orientation.” (Ex. 1007, 3:46-
`
`52, see also 3:59-60).
`
`Nor can the ‘284 Patent find patentability in the particular arrangements of
`
`non-conductive stop members recited in some of its dependent claims. The ‘284
`
`Patent does not identify any differing functionality, much less benefits, of the
`
`arrangements of stop members in Figs. 6A-6F. (Ex. 1001 at 12:30-46 (speculating
`
`that other configurations “may be equally effective”); Ex. 1004 at ¶¶ 20-23).
`
`Notwithstanding, Eggers ‘142 disclosed the stop member configurations claimed
`
`in the ‘284 Patent almost four years before the invention of the ‘284 Patent. (See,
`
`e.g., Ex. 1007 at Figs. 8-10, 15, 17-18).
`
`B.
`
`Prosecution of the ‘284 Patent
`
`The claims of the ‘284 Patent and its parent, U.S. Patent No. 7,473,253
`
`(“‘253 Patent”), were allowed because of arguments selectively focused on
`
`individual references, not on prior art combinations. When the prior art is
`
`properly viewed as described herein, the claims of the ‘284 Patent are obvious.
`
`During examination of the ‘253 Patent, the Examiner rejected the pending
`
`claims over U.S. Patent No. 5,800,449 to Wales (“Wales”) (Ex. 1008) in view of
`
`EP Pub. No. 0 986 990 to Eggers et al. (“Eggers”), a European counterpart of
`
`Eggers ‘142.
`
`(Ex. 1002 at pp. 520-26). The Examiner reasoned that “[i]t would
`
`3
`
`Page 7 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`have been obvious to have provided the jaws of Wales with the stop members of
`
`Eggers…” (Id. at p. 524). Applicant responded by admitting that “Eggers et al. do
`
`include a spacer region,” but asserted that the claimed stop members had a
`
`different purpose than those in Eggers.
`
`(Id. at p. 566). Specifically, while the
`
`Eggers spacers are provided to “securely grasp tissue and extrude the tissue into
`
`the recesses between the spacer regions to assure uniform and consistent power
`
`density along the current paths between the conductive surfaces”, the claimed stop
`
`members “control[] the distance between the jaw members when tissue is held
`
`therebetween.” (Id.) (emphasis in original).2
`
`After several rejections, Applicant filed the amendment on April 10, 2008
`
`that preceded allowance of the ‘253 Patent.
`
`(Ex. 1002 at pp. 705-22). Therein,
`
`Applicant amended the claims to require “jaw members being independently
`
`movable with respect to the elongated shaft” and to require that “the distance
`
`between clamped jaw members is substantially uniform along the length of the jaw
`
`members.” (Id. at pp. 706-714). Focusing on Eggers (and ignoring the Examiner’s
`
`incorporation of Eggers’ stop members into Wales), Applicant argued that Eggers
`
`did not have jaws independently movable with respect to an elongated shaft and
`
`that there was not substantially uniform distance between the jaws when tissue was
`
`2
`
`PO nonetheless admitted “another purpose of the spacer regions of Eggers et
`
`al. is to separate the grasping surfaces a distance ‘T’ when closed…” (Id.)
`
`4
`
`Page 8 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`held. (Id. at pp. 717-719). Applicant’s only comment on Wales was that it “does
`
`not
`
`teach a ‘stop member…which controls the distance between the jaw
`
`members.’” (Id. at p. 719).
`
`The Applicant filed the application that issued as the ‘284 Patent with claims
`
`broader than the claims of the ‘253 Patent in two respects: (1) they did not require
`
`“the jaw members being independently movable with respect to the elongated
`
`shaft” and (2) they did not define the geometry of the device “when tissue is held
`
`therebetween.” (Ex. 1003 at pp. 29-33). The Examiner rejected the continuation
`
`claims over Wales and Eggers.
`
`(Id. at pp. 176-182). Applicant amended and
`
`argued that Wales’ end effector included a serrated portion that “is not flat and is
`
`not configured to support a plurality of stop members thereon so that the plurality
`
`of stop members are disposed along the same plane with respect to one another.”
`
`(Id. at p. 250). It also argued that Eggers’ stop members did not extend along the
`
`length of tines 112 and 222. (Id. at p. 254). On the basis of these arguments, the
`
`Examiner allowed the claims. (Id. at pp. 260-264).
`
`C. The Petition Relies On Previously Unapplied Combinations
`This Petition relies on the stop members of Eggers ‘142 (Ex. 1007), a U.S.
`
`counterpart to the Eggers publication discussed during examination. Despite the
`
`Examiner’s consideration of the EP counterpart of Eggers ‘142, Fox (Ex. 1006),
`
`which was not relied-on during examination, demonstrates that PO’s arguments
`
`5
`
`Page 9 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`about Wales were technically flawed. Contradicting PO’s characterization of the
`
`art during examination, Fox discloses endoscopic bipolar forceps with end
`
`effectors having planar seal surfaces divided by a knife channel (see, e.g., Ex. 1006
`
`at Fig. 5, 4:46-5:24) and the use of stop members on such devices (id. at 4:25-29).
`
`Fox therefore shows that PO’s arguments about the inapplicability of Eggers’ stop
`
`members to devices like in Wales are contradicted by Fox’s express art teachings.
`
`U.S. Patent No. 5,599,350 to Schulze et al. (“Schulze”) (Ex. 1012) is not
`
`cited on the face of the ‘284 Patent. While the other art relied on in this Petition
`
`was cited, it was buried among hundreds of references and not relied on by the
`
`Examiner. Moreover, the Examiner did not have the benefit of the declaration of
`
`David C. Yates (Ex. 1004), an expert in the field of the prior art and the ‘284
`
`Patent (Ex. 1004 at ¶¶ 1-16, 27-29; Ex. 1005). Thus, the arguments herein are
`
`new, and prosecution of the ‘284 Patent should not preclude institution of this IPR.
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`
`Petitioner certifies that (1) the ‘284 Patent is available for IPR; (2) Petitioner
`
`is not barred or estopped from requesting IPR of the ‘284 Patent on the grounds
`
`identified herein; and (3) Petitioner has not filed a complaint relating to the ‘284
`
`Patent. This Petition is filed in accordance with 37 C.F.R. § 42.106(a).
`
`IV. PAYMENT OF FEES (37 C.F.R. §§ 42.15 and 42.103)
`
`Petitioner authorizes the USPTO to charge the required fees for IPR of 18
`
`6
`
`Page 10 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`claims, and any additional fees, to Deposit Account No. 02-1818.
`
`V. MANDATORY NOTICES (37 C.F.R. § 42.8(b))
`
`A.
`
`Real Parties-In-Interest (37 C.F.R. § 42.8(b)(l))
`
`Ethicon Endo-Surgery, Inc., 4545 Creek Rd., Blue Ash, OH 45242,
`
`is a
`
`wholly owned subsidiary of Johnson & Johnson, 1 One Johnson & Johnson Plaza,
`
`New Brunswick, NJ, 08933. Both entities are real parties-in-interest.
`
`B.
`
`Related Matters (37 C.F.R. § 42.8(b)(2))
`
`The ‘253 Patent is a parent of the at-issue ‘284 Patent. U.S. Patent App. No.
`
`13/584,194, filed August 13, 2012, is a currently pending continuation of the ‘284
`
`Patent. Petitioner is unaware of other related matters per 37 C.F.R § 42.8(b)(2).3
`
`C.
`
`Lead and Backup Counsel and Service (37 C.F.R. § 42.8(b)(3)—(4))
`
`Lead Counsel
`
`Backu u Counsel
`
`F: 312 345-1843
`
`Jason A. Engel
`Reg. No. 51,654
`K&L GATES LLP
`
`Benjamin E. Weed
`Reg. No. 65,939
`K&L GATES LLP
`
`70 W. Madison Street, Suite 3100 70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`Chicago, IL 60602
`Jason.Engel.PTAB@klgates.com Benjamin.Weed.PTAB@klgates.com
`T: (312) 807-4236
`T: (312) 781-7166
`F: 312 827-8145
`
`Petitioner consents to electronic service by email.
`
`Petitioner is concurrently requesting IPR of PO’s U.S. Patent No. 7,887,536.
`
`While this patent also claims stop members added to known electrosurgical
`
`devices, it is does not have any familial relationship with the ‘284 Patent.
`
`Page 11 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`VI. PERSON OF ORDINARY SKILL IN THE ART
`
`A person of ordinary skill in the art is a hypothetical person presumed to
`
`know the relevant prior art. Gnosis S.p.A. v. South Alabama Med. Sci. Found.,
`
`IPR2013-00116, Final Written Decision (Paper 68) at 9. Such person is of
`
`ordinary creativity, not merely an automaton, and is capable of combining
`
`teachings of the prior art. Id. (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
`
`420-21 (2007)). A person of ordinary skill in the art as of April 6, 2001 would
`
`have had at least a bachelor’s of science degree in either electrical engineering or
`
`mechanical
`
`engineering with at
`
`least
`
`four years’
`
`experience designing
`
`electrosurgical instruments. (Ex. 1004 at ¶¶ 28-29, see also ¶¶ 17-27).
`
`VII. CLAIM CONSTRUCTION
`
`The claims of the ‘284 Patent should be given their “broadest reasonable
`
`construction in light of the specification.”
`
`37 C.F.R. § 42.100(b).
`
`For a
`
`construction to be correct under this standard, that construction must be “consistent
`
`with the specification” of the patent. In re Cuozzo Speed Tech., LLC, Case No. 14-
`
`1301, slip op. at 12, 14-15 (Fed. Cir. Feb. 2, 2015).
`
`A.
`
`“Jaw Members Movable With Respect To The Elongated Shaft”
`
`Claim 12 is directed to an endoscopic bipolar forceps including an elongated
`
`shaft and “jaw members movable with respect to the elongated shaft.” (Ex. 1001
`
`at 14:53-54). The frame of reference for this limitation is the elongated shaft; the
`
`limitation requires both jaw members to move when viewed from that frame of
`
`8
`
`Page 12 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`reference. Accordingly, there is no reasonable interpretation of claim 12 under
`
`which only one jaw of the claimed bipolar endoscopic forceps moves relative to
`
`the shaft and the other jaw is fixed relative to the shaft (i.e., where the device has a
`
`“unilateral” design).
`
`Instead, the broadest reasonable interpretation requires both
`
`jaws to be movable with respect to the shaft (i.e., the device has a “bilateral”
`
`design). This is further mandated by the recitation in claim 12 of “a handle
`
`attached to the drive rod assembly for imparting movement of the first and
`
`second jaw members between the first and second positions” and that both jaw
`
`members must be movable. (Id. at 14:53-54, 15:1-3).
`
`This interpretation is consistent with the intrinsic record,
`
`in which all
`
`illustrated embodiments include bilateral jaws. (Ex. 1001 at Figs. 1-3, 5). When
`
`discussing jaw members 22 and 24, the ‘284 Patent refers to jaw members moving
`
`and to compression of jaw members about tissue. (See, e.g., Id. at 5:67-6:4, 6:60-
`
`61, 8:15-16, 8:28-29, 9:22-29, 10:15-16). Further, the mechanism that drives the
`
`jaws (described in incorporated-by-reference PCT App. No. PCT/US01/11340
`
`(“Dycus PCT”), see Ex. 1001 at 6:20-27) only functions when “longitudinal
`
`reciprocation of the cam pin 170 rotates jaw members 110 and 120 about pivot pin
`
`160 from the open to closed positions.” (Ex. 1010 at Figs. 7-8, 12, 22:5-6).
`
`Thus, the broadest reasonable interpretation of this claim term requires that
`
`“both jaw members are movable with respect to the elongated shaft.”
`
`9
`
`Page 13 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`B.
`
`“Drive Rod Assembly…”
`
`Claim 12 requires a “drive rod assembly that connects the jaw members to a
`
`source of electrical energy.” (Ex. 1001 at 14:60-61). Claim 12 further requires “a
`
`handle attached to the drive rod assembly for imparting movement of the first and
`
`second jaw members between the first and second positions.”
`
`Under the broadest reasonable interpretation of claim 12, the drive rod
`
`assembly, which is the structure that imparts movement on the jaws, must be
`
`specifically designed to carry electrical energy of the requisite first and second
`
`potentials to the jaw members. No reasonable interpretation of claim 12 covers a
`
`situation in which the component that imparts movement on the jaws simply
`
`encloses or houses another conductor that delivers electrical potential to the jaws.
`
`The only uses of the word “connect” in the specification of the ‘284 Patent
`
`are in the electrical context, as opposed to a mechanical context. (See Ex. 1001 at
`
`3:47-50, 3:57-61, 4:50-53, 5:7-8, 13:14-15). Moreover, claim 12 recites that the
`
`elongated shaft (not the drive rod assembly) provides the structural support for the
`
`“opposing jaw members,” which are “at a distal end thereof.” (Id. at 14:52-53).
`
`Thus, there is no embodiment of the ‘284 Patent wherein the drive rod assembly is
`
`not actually conducting electricity to the jaws of the bipolar endoscopic forceps.
`
`Nor should such an embodiment be covered under the broadest reasonable
`
`interpretation of this claim limitation. If PO presents a contrary argument that the
`
`10
`
`Page 14 of 65
`
`

`
`12-18
`
`E; ers ‘I42
`
`Eggers ‘471 in view of Wales, Fox, and
`Eggers ‘471 in View of Wales, Fox,
`
`E; ers ‘I42, and Slater
`Schulze in view ofF0x and E ers ‘142
`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`“drive rod assembly” can “connect” the jaws to sources of electrical potential in
`
`satisfaction of claim 12 simply by housing other conductors that carry electrical
`
`potential, Ground 5 shows that such arrangements were well-known.
`
`VIII. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`
`REASONS THEREFORE (37 C.F.R. § 42.22(a) AND 42.104(b))
`
`Petitioner requests IPR of claims 1-18 based on the following grounds:
`
`Statuto Basis
`1- 35 U.S.C. § 103
`35 U.S.C. § 103
`
`Relied-On Reference
`Fox in view ofEers ‘I42
`Fox in view ofE ers ‘142 and Slater -_
`
`35 U.S.C. § 103
`
`A.
`
`Ground 1: Claims 1-11 Are Unpatentable Under 35 U.S.C. §
`103(a) As Obvious Over Fox In View Of Eggers ‘I42
`
`1.
`
`Overview of the Prior Art
`
`(a)
`
`Fox
`
`Fox (Ex. 1006) was filed on September 29, 1995 and issued on October 7,
`
`1997.
`
`(Ex. 1004 at 1] 30). Accordingly, Fox is prior art under 35 U.S.C. § 102(b).4
`
`It discloses a “bipolar coagulation device which may be used to grasp and treat
`
`tissue and may further include a cutting element to cut the treated tissue-” (Ex.
`
`1006 at 2:62-65, see also Abstract, 3:45-53). Fox ’s bipolar forceps includes an end
`
`effector which contains the jaws that grasp tissue for treatment.
`
`(See, e.g., id. at
`
`4
`
`Petitioner’s expert, David C. Yates, is a named inventor of Fox.
`
`Page 15 of 65
`
`11
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`4:46-52). The device includes a closure tube 420, a handle 426, and a knife button
`
`424 to close the jaws and actuate the knife. (Id. at 4:38-45; Ex. 1004 at ¶ 31).
`
`In the Fig. 5 embodiment, jaw members 116 and 117 include flat tissue
`
`grasping surfaces 118 and 119.
`
`(Ex. 1006 at Fig. 5, 4:46-50; Ex. 1004 at ¶ 34).
`
`The jaws can include features, such as grasping teeth, to enhance the grasping.
`
`(Ex. 1006 at 5:33-40; Ex. 1004 at ¶ 33).
`
`In some embodiments, these grasping
`
`teeth may be rounded (i.e., “they may have a radius…”).
`
`(Ex. 1006 at 5:42-43).
`
`Closure tube 115 “is adapted to close the jaws 116 and 117 together as tube 115 is
`
`advanced distally.” (Id. at 4:54-55). The jaws also include a knife channel and
`
`knife “adapted to cut tissue by moving distally in knife channel 143 when jaws 116
`
`and 117 are closed to grip tissue.” (Id. at 5:17-19, 4:58-63; Ex. 1004 at ¶ 35).
`
`Fox addresses the problem of shorting raised in the ‘284 Patent (Ex. 1001,
`
`3:33-35), stating “[w]here 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 4:25-29; Ex. 1004 at ¶ 36). This disclosure is made with
`
`respect to Fig. 3, which, like Fig. 5, illustrates that the grasping surfaces 27 and 36
`
`are flat surfaces. (Ex. 1006 at Fig. 3).
`
`(b) Eggers ‘142
`Eggers ‘142 (Ex. 1007) was filed on June 18, 1997 and issued on April 6,
`
`12
`
`Page 16 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`1999.
`
`(Ex. 1004 at ¶ 41). Eggers ‘142 is prior art under 35 U.S.C. § 102(b).
`
`It
`
`discloses bipolar electrosurgical forceps for use “in conjunction with conventional
`
`electrosurgical generators having bipolar outputs.” (Ex. 1007 at 5:65-67). “By
`
`applying bipolar, RF current from a noted electrosurgical generator across the
`
`outer working end tips of the forceps, a sealing or congealing of tissue or vessels
`
`can be achieved without substantial risk to adjacent tissue.” (Id. at 1:45-49).
`
`Eggers ‘142 achieves “highly efficient hemostasis of grasped tissue or
`
`vessels” using “electrically insulative spacer regions” that “serve to space the
`
`tissue grasping surfaces apart an optimum distance, T, when substantially in a
`
`closed orientation.” (Ex. 1007 at 3:46-52). These can include “initial strips 124a
`
`and 126a at the respective ends or distal tip regions” of the forceps to “provide[] an
`
`initial ‘snagging’ geometry at the very tip of the forceps, a location most beneficial
`
`to achieve the requisite grasping function….” (Id. at 9:50-56; Ex. 1004 at ¶ 44).
`
`These spacer regions “are in substantially parallel relationship, and are aligned for
`
`movement into mutual contact when in a closed orientation…” (Ex. 1007 at 9:66-
`
`10:1). The spacers can be provided as a plurality of spacers running longitudinally
`
`from the distal end to the proximal end of the grasping surface (id. at 13:54-63,
`
`Fig. 15), an array of “spaced apart cubes” disposed in parallel linear arrays (id. at
`
`14:19-22, Fig. 17), or an array of “discrete circular layers of thickness T” (id. at
`
`14:46-48, Fig. 18).
`
`(Ex. 1004 at ¶ 45). Eggers ‘142 discloses various materials
`
`13
`
`Page 17 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`from which its spacers can be formed, including “electrically insulative glass,
`
`ceramic, or glass/ceramic pegs inserted within [] holes…” (Ex. 1007 at 14:56-59).
`
`Eggers ‘142 discusses dimensions for its spacer regions that are very similar
`
`to the spacing disclosed in the ‘284 Patent.
`
`(Compare Ex. 1001 at 4:27-30 with
`
`Ex. 1007 at 10:56-11:24). A total distance, “T” between grasping surfaces is
`
`“established by the electrically insulative region” and represents the sum of the
`
`thicknesses T1 and T2 of the spacer regions on the two grasping surfaces.
`
`(Ex.
`
`1007 at 10:59-61; Ex. 1004 at ¶ 48). T values between 0.020 and 0.001 inches are
`
`appropriate, although at the smaller end of the range (i.e., under the minimum
`
`“practical” value of 0.003 inches), “arcing may occur.” (Ex. 1007 at 10:61-66; Ex.
`
`1004 at ¶ 49). Accordingly, where T1 and T2 are equal, Eggers ‘142 discloses that
`
`individual spacers may extend from the grasping surfaces distances in the range of
`
`0.010 inches to 0.0005 inches, with a minimum practical width of 0.0015 inches.
`
`2. Motivation to Combine
`
`A person of skill in the art would have been motivated to incorporate the
`
`spacer regions of Eggers ‘142 into the end effector illustrated in Fig. 5 of Fox as
`
`Fox’s disclosed islands of insulation to provide the benefits described in Eggers
`
`‘142 in the Fox endoscopic bipolar forceps. (Ex. 1004 at ¶ 83; see also ¶¶ 84-89).
`
`First, Fox and Eggers ‘142 both discuss “bipolar forceps” (see, e.g., Ex.
`
`1006 at 4:33; Ex. 1007 at 4:45-47), which constitutes a motivation to look to both
`
`14
`
`Page 18 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`references when designing an improved bipolar forceps. The fact that Eggers ‘142
`
`illustrates its concepts in tweezers embodiments does not change its applicability to
`
`devices having the configuration of Fox; in both devices, flat seal surfaces are
`
`enhanced with insulative protrusions to prevent arcing, and the delivery of
`
`electrosurgical energy does not depend on the specific mechanism for applying
`
`closure force to the sealing surfaces.
`
`(Ex. 1004 at ¶¶ 56-57, 86). Nowhere does
`
`Eggers ‘142 limit its disclosure to only tweezers-like devices.
`
`(Id. at ¶ 57).
`
`In
`
`fact, Eggers ‘142 makes reference to relevant art in its background section that are
`
`explicitly directed to endoscopic bipolar forceps that are not tweezers. (See, e.g.,
`
`Ex. 1007 at 3:4-5 (Eggers ‘471 and U.S. Patent No. 5,391,166 to one of the
`
`inventors of Eggers ‘142), 3:15 (Ex. 1013 naming Petitioner’s expert David C.
`
`Yates as inventor), 3:30 (Ex. 1014, Petitioner’s U.S. Patent No. 5,540,684); Ex.
`
`1004 at ¶¶ 58-60). A person of skill in the art would have applied Eggers ‘142’s
`
`teachings of insulative spacers to any bipolar forceps device having appropriately
`
`shaped sealing surfaces, such as Fox. (Ex. 1004 at ¶¶ 56-61, 86, 88-89).
`
`Moreover, Fox provides an express motivation to look to references like
`
`Eggers ‘142 in discussing an “island of insulation” to establish an insulative gap.
`
`(Ex. 1006 at 4:25-29; Ex. 1004 at ¶ 84). Fox notes that such an island of insulation
`
`can be positioned on either electrode in a bipolar forceps device to prevent shorting
`
`or arcing during treatment. (Id.). A person of skill would have been motivated, in
`
`15
`
`Page 19 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`view of this disclosure, to look to other references that disclose using similar
`
`insulative materials on similar tools for additional details on how the islands of
`
`insulation could be dimensioned, formed, and applied.
`
`(Ex. 1004 at ¶¶ 84-85).
`
`Accordingly, a person of skill in the art would have incorporated Eggers ‘142’s
`
`teaching of dimensions (see Ex. 1007 at 10:46-11:24), material for (id. at 11:25-27)
`
`and arrangement of stop members on the sealing surfaces (see, e.g., id. at 9:2-23,
`
`Figs. 8, 10-13, 15, 17-18), and mechanisms for affixing stop members (see, e.g., id.
`
`at 11:25-45) to provide Fox’s islands of insulation. (Ex. 1004 at ¶¶ 84-85).
`
`Finally, Fox discloses embodiments in which the grasping benefits of Eggers
`
`‘142 are achieved with other features on the sealing surfaces of opposing
`
`electrodes of the forceps. Fox discloses that “[e]lectrodes 216 and 216 include
`
`tissue grasping teeth 206 and 208…”
`
`(Ex. 1006 at 5:36-37). These teeth are
`
`protruding features that facilitate better gripping of tissue. (Ex. 1004 at ¶¶ 87-89).
`
`A person of skill in the art would have understood that the spacers of Eggers ‘142
`
`are another example of protruding features that assist in the grasping of tissue.
`
`(Ex. 1007 at 3:59-62 (spacer regions “provide for an importantly improved
`
`grasping of tissue even though the exposed metal portions of the grasping surfaces
`
`are made to have smooth surfaces”); 9:45-58). Accordingly, Eggers ‘142 discloses
`
`that its spacer regions can be provided on the sealing surfaces of an electrosurgical
`
`instrument (such as the Fig. 5 embodiment of Fox) to provide the grasping benefits
`
`16
`
`Page 20 of 65
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,241,284
`
`Fox discloses are achieved by its protrusions (e.g., teeth of Fig. 7).
`
`(Ex. 1007 at
`
`3:1-14; Ex. 1004 at ¶¶ 88-89). The proposed modification involves substituting
`
`surface features (Fox’s teeth) with another (Eggers ‘142’s spacers) to yield a
`
`predictable result (improved grasping).
`
`Eggers ‘142’s disclosure that one of the purposes of its disclosed spacers is
`
`to achieve the “originally desired grasping feature” (also described as a “snagging”
`
`performance) achieved using “a roughened or tooth-like surface” further confirms
`
`that its spacers can replace the teeth of a device like Fox.
`
`(Ex. 1007 at 3:1-3,
`
`15:41-45, Figs. 20-21). This is particularly true since Fox’s discloses several kinds
`
`of surface features,
`
`including chamfered teeth, rounded teeth, and islands of
`
`insulation. (Ex. 1006 at 4:25-29, 5:36-43).
`
`PO may also argue that
`
`the spacers of Eggers ‘142 would not be
`
`incorporated along the entire length of Fox’s sealing surface. This argument lacks
`
`merit. Eggers ‘142 teaches disposing its spacers along the grasping length LG of
`
`the instrument, which may be as