Trials@uspto.gov
`571-272-7822
`
`Paper No. 7
`Entered: October 2, 2019
`
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`ETHICON LLC,
`Patent Owner.
`_______________
`
`Case IPR2019-00880
`Patent 7,490,749 B2
`_______________
`
`
`Before JOSIAH C. COCKS, BENJAMIN D. M. WOOD, and
`MATTHEW S. MEYERS, Administrative Patent Judges.
`
`WOOD, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
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`571-272-7822
`
`Paper No. 7
`Entered: October 2, 2019
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`ETHICON LLC,
`Patent Owner.
`_______________
`
`Case IPR2019-00880
`Patent 7,490,749 B2
`_______________
`
`
`Before JOSIAH C. COCKS, BENJAMIN D. M. WOOD, and
`MATTHEW S. MEYERS, Administrative Patent Judges.
`
`WOOD, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`
`
`
`
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`
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`IPR2019-00880
`Patent 7,490,749 B2
`
`
`I.
`
`INTRODUCTION
`
`Background
`A.
`Intuitive Surgical, Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”)
`requesting inter partes review of claims 1 and 3 of U.S. Patent No.
`7,490,749 B2 (Ex. 1001, “the ’749 patent”). Ethicon LLC (“Patent Owner”)
`did not file a Preliminary Response.
`We have authority under 35 U.S.C. § 314, which provides that an
`inter partes review may not be instituted “unless . . . there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of the
`claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering
`the Petition, we determine that Petitioner has shown a reasonable likelihood
`that it would prevail in showing the unpatentability of at least one of the
`challenged claims. Accordingly, we authorize an inter partes review to be
`instituted as to all challenged claims of the ’749 patent on all grounds raised
`in the Petition. Our factual findings and conclusions at this stage of the
`proceeding are based on the evidentiary record developed thus far (prior to
`Patent Owner’s Response). This is not a final decision as to patentability of
`the challenged claims. Any final decision will be based on the record as
`fully developed during trial.
`
`Related Proceedings
`B.
`The parties state that the ’749 patent is the subject of Civil Action No.
`1:18-cv-01325 filed August 27, 2018 in the U.S. District Court for the
`District of Delaware. Pet. 1; Paper 5, 2. Petitioner also states that it has
`filed other petitions for inter partes review of patents owned by Patent
`Owner and asserted against Petitioner in the District of Delaware. Id.
`
`2
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`IPR2019-00880
`Patent 7,490,749 B2
`
`
`The ’749 Patent
`C.
`The ’749 patent issued February 17, 2009 from an application filed
`March 28, 2007, and is titled “Surgical Stapling and Cutting Instrument with
`Manually Retractable Firing Member.” Ex. 1001, at codes (45), (22), (54).
`The ’749 patent describes a surgical stapler that applies lines of staples to
`tissue and cuts the tissue between the staple lines, and particularly to such
`staplers with manual retraction capabilities. Id. at 1:17–24. Figure 1,
`reproduced below, depicts a surgical stapler according to the ’749 patent:
`
`
`
`
`
`Figure 1, reproduced above, depicts surgical stapling and severing
`instrument 10 comprising end effector 12 coupled to elongate shaft assembly
`18, which in turn is coupled to handle 20. Id. at 5:36–43. End effector 12
`comprises anvil 14 pivotally attached to elongate channel 16 to form
`opposing jaws for clamping tissue. Id. at 5:39–41. Closure tube 24 of shaft
`assembly 18 is coupled between closure trigger 26 and anvil 14. Id. at 5:60–
`
`3
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`IPR2019-00880
`Patent 7,490,749 B2
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`61. Firing rod 321 is positioned for longitudinal movement and coupled
`between anvil 14 and multiple-stroke firing trigger 34. Id. at 6:6:–8.
`In an endoscopic operation, a surgeon first inserts end effector 12 and
`shaft assembly 18 in the surgical site and positions the end effector around
`the tissue to be stapled and severed. The surgeon then depresses closure
`trigger 26 fully toward pistol grip 36 to move closure tube 24 distally to
`push anvil 14 pivotally toward elongate channel 16, thereby clamping the
`tissue between the anvil and elongate channel. Id. at 6:19–22, 7:20–23.
`The surgeon then fires the instrument. Id. at 6:26–30. Figures 7 and
`9, reproduced below, depict portions of the instrument’s firing mechanism:
`
`
`
`
`Figures 7 and 9, reproduced above, provide left and right views,
`respectively, of portions of linked transmission firing drive 150. Upper
`portion 204 of firing trigger 34 engages each of links 196a-d of linked rack
`200 (shown more clearly in Figures 8 and 10) during each firing stroke
`depression, incrementally advancing linked rack 200 distally. Id. at 10:19–
`43. Because firing rod 32 is attached to linked rack 200, it also advances
`
`
`1 The ’749 patent also refers to this structure as “firing bar 32.” See, e.g.,
`Ex. 1001, 12:11, 56–57.
`
`4
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`IPR2019-00880
`Patent 7,490,749 B2
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`distally, causing a wedge-shaped sled and cutting blade to simultaneously
`staple and cut the tissue. Id. at 6:26–35, 7:24–8:18.
`Instrument 10 also comprises a manual retraction system that allows
`the surgeon to retract firing rod 32 after the firing operation. The manual
`retraction system is depicted in Figures 16 and 17, reproduced below:
`
`
`
`
`Figures 16 and 17, reproduced above, depict retraction assembly 500.
`Id. at 12:9–10. First gear 220 meshes with toothed upper surface 222 of
`linked rack 200. Id. at 12:16–18. First gear 220 also engages second gear
`230, which is attached to smaller right-side ratchet gear 231. Ratchet gear
`231 fits into handle 42 and engages with pawl 516, which is fitted into upper
`recess 512 of the handle. Id. at 12:37–45.
`After the firing sequence has been completed, the surgeon can retract
`firing rod 32 by sequentially depressing and releasing manual retraction
`lever 42. Id. at 12:55–59. When handle 42 is depressed, pawl 516 drives
`ratchet gear 231, and thus second gear 230, clockwise when viewed from the
`left. Id. at 12:59–64. This drives first gear 220 counterclockwise, which
`moves linked rack 200 and firing rod 32 longitudinally in the proximal
`direction until it is fully retracted. Id. at 12:64–13:6. Retraction assembly
`500 generates a “sole” retraction motion because it is “configured to enable
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`IPR2019-00880
`Patent 7,490,749 B2
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`the surgeon to manually retract firing rod 32 without any other assistance
`from springs or other retraction arrangements that serve to place a drag on
`the firing system and which ultimately require the generation of higher firing
`forces to actuate the firing mechanism.” Id. at 12:9–15, 16:23–28.
`
`The Challenged Claims
`D.
`Petitioner challenges claims 1 and 3 of the ’749 patent. Pet. 1. Claim
`1 is independent and claim 3 depends from claim 1. Claim 1 is reproduced
`below:
`
`1. A surgical instrument, comprising:
`a handle assembly;
`an end effector for performing a surgical operation, said
`end effector operably coupled to said handle assembly and
`operably supporting a firing member that is movable from a
`retracted position to a fired position in response to a longitudinal
`firing motion applied thereto;
`a firing drive supported by said handle assembly and
`configured to selectively generate said longitudinal firing motion
`upon actuation of a firing trigger operably coupled to said handle
`assembly; and
`a retraction assembly supported by said handle assembly
`and interfacing with said firing drive such that manual actuation
`of said retraction assembly causes said firing drive to generate a
`sole retraction motion which is communicated to said firing
`member to cause said firing member to move from said fired
`position to said retracted position.
`
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`6
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`IPR2019-00880
`Patent 7,490,749 B2
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`
`Asserted Grounds of Unpatentability
`E.
`Petitioner contends that the challenged claims are unpatentable based
`on the following specific grounds (Pet. 3):
`
`No.
`1
`2
`3
`
`Claims
`1 and 3
`1 and 3
`1 and 3
`
`Reference
`Basis
`§ 102/103 Shelton II2
`§ 102/103 Swayze3
`§ 102
`Shelton I4
`
`
`In support of its proposed grounds, Petitioner relies on the Declaration
`of Dr. Bryan Knodel (Ex. 1003).
`
`II. ANALYSIS
`
`Level of Ordinary Skill in the Art
`A.
`Petitioner asserts that one of ordinary skill in the art at the time of the
`invention “would have had the equivalent of a Bachelor’s degree or higher
`in mechanical engineering, or a related field directed towards medical
`mechanical systems, and at least 3 years working experience in research and
`development for surgical instruments.” Pet. 23 (citing Ex. 1003 ¶ 25). On
`this record and for purposes of this decision, we adopt Petitioner’s
`definition. Further, we presume that the cited prior art references reflect the
`level of ordinary skill at the time of the invention. See Okajima v.
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
`
`
`2 U.S. Pat. Publ. No. 2006/0175375 (pub. Aug. 10, 2006) (Ex. 1004).
`3 U.S. Pat. Publ. No. 2005/0178813 (pub. Aug. 18, 2005) (Ex. 1005).
`4 U.S. Pat. No. 8,322,455 (iss. Dec. 4, 2012) (Ex. 1006).
`
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`IPR2019-00880
`Patent 7,490,749 B2
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`
`Claim Construction
`B.
`We construe the claims “using the same claim construction standard
`that would be used to construe the claim in a civil action under 35 U.S.C. [§]
`282(b), including construing the claim in accordance with the ordinary and
`customary meaning of such claim as understood by one of ordinary skill in
`the art and the prosecution history pertaining to the patent.” 37 C.F.R.
`§ 42.100(b) (Nov. 2018); see Phillips v. AWH Corp., 415 F.3d 1303, 1312–
`13 (Fed. Cir. 2005). Any special definitions for claim terms must be set
`forth in the Specification with reasonable clarity, deliberateness, and
`precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Petitioner asserts that claim terms “should generally be given their
`plain and ordinary meaning consistent with the ’749 Patent’s specification.”
`Pet. 15. Petitioner further asserts that four claim terms require construction
`under 35 U.S.C. § 112, paragraph 65: “firing member,” “retraction
`assembly,” “firing drive,” and “closure drive.” Id. at 15–23. Patent Owner
`has not filed a Preliminary Response, and therefore has not proposed any
`constructions for any claim terms, or responded to Petitioner’s proposed
`constructions.
`For the purpose of determining whether Petitioner demonstrates a
`reasonable likelihood of prevailing in its challenges, we determine that no
`express construction is required for any claim term. See Vivid Techs., Inc. v.
`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that
`
`5 Because the ’749 patent issued from an application that claims priority to a
`date before the effective dates of the amendments to the Patent Statute
`enacted by the Leahy-Smith America Invents Act (AIA), we apply the pre-
`AIA version of the statute. See Leahy-Smith America Invents Act (AIA),
`Pub. L. No. 112–29, §§ 3(n)(1), 4(e), 125 Stat. 284, 293, 297 (2011).
`
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`IPR2019-00880
`Patent 7,490,749 B2
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`only terms that are in controversy need to be construed, and “only to the
`extent necessary to resolve the controversy”); Nidec Motor Corp. v.
`Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017)
`(applying Vivid Techs. in the context of an inter partes review).
`
`C. Ground 1: Claims 1 and 3—Anticipated by or Obvious over
`Shelton II
`Petitioner alleges that claims 1 and 3 are anticipated by or would have
`been obvious over Shelton II. Pet. 24–50.
`Shelton II (Ex. 1004)
`1.
`Shelton II describes a surgical stapling and cutting instrument that
`may be equipped with a manual retraction mechanism. Ex. 1004 ¶¶ 2, 14.
`Figure 31 is reproduced below:
`
`
`
`
`Figure 31, reproduced above, depicts surgical stapling and severing
`instrument 1010 comprising staple applying apparatus 1012 coupled to
`elongate shaft 1018, which in turn is attached to handle 1020. Id. ¶ 125.
`Staple applying apparatus 1012 comprises anvil 1014 pivotally attached to
`
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`9
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`IPR2019-00880
`Patent 7,490,749 B2
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`elongate (staple) channel 1016. Id. Closure tube 1024 is coupled between
`closure trigger 1026 and anvil 1014. Id. ¶ 1027. Closure trigger 1026 may
`be depressed against pistol grip 1036 to move closure tube 1024 distally to
`push anvil 1014 pivotally toward elongate channel 1016. Id. ¶¶ 1026–1027.
`Multiple stroke firing trigger 1034 can then be depressed against the pistol
`grip, which moves linked rack 1200 distally to transfer a firing force to the
`staple applying apparatus via firing rod 1032. Id. ¶¶ 130, 132, Figs. 33–37.
`Figure 31 also depicts manual firing release lever 1042, which is part
`of a manual retraction mechanism. Figures 42 and 44, reproduced below,
`depict this mechanism:
`
`
`
`
`
`
`Figures 42 and 44, reproduced above, depict manual retraction
`mechanism 1500. Id. ¶ 142. Front idler gear 1220 engages a toothed upper,
`left surface 1222 of linked rack 1200 (shown in Figure 33). Id. Front idler
`gear 1220 also engages aft transmission gear 1230 having a smaller right-
`side ratchet gear 1231. Id. The smaller right-side ratchet gear 1231 extends
`into hub 1506 of manual retraction lever 1024. Id. ¶ 143. Locking pawl
`1516, located in upper recess 1512, is urged downward into engagement
`with ratchet gear 1231 by L-shaped spring tab 1522. Id.; see also id.,
`
`10
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`IPR2019-00880
`Patent 7,490,749 B2
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`Fig. 43. As manual retraction lever 1042 is sequentially raised and lowered,
`locking pawl 1516 rotates clockwise and engages ratcheting gear 1231,
`rotating aft transmission gear 1230 clockwise. Id. ¶ 144. This causes
`forward idler gear 1220 to rotate counterclockwise, which retracts linked
`rack 1200. Id. Combination tension/compression spring 1184 also provides
`a retraction force. Id. ¶ 133. Manual retraction mechanism may operate
`without the assistance of a retraction spring, however. Id. ¶¶ 144, 154.
`Principles of Law
`2.
`Anticipation
`a.
`“To anticipate a claim, a prior art reference must disclose every
`limitation of the claimed invention, either explicitly or inherently.” In re
`Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997); see also Lindemann
`Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452,
`1458 (Fed. Cir. 1984) (“Anticipation requires the presence in a single prior
`art reference disclosure of each and every element of the claimed invention,
`arranged as in the claim.”).
`Obviousness
`b.
`“A patent for a claimed invention may not be obtained,
`notwithstanding that the claimed invention is not identically disclosed as set
`forth in [35 U.S.C. § 102], if the differences between the claimed invention
`and the prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a
`person having ordinary skill in the art to which the claimed invention
`pertains.” 35 U.S.C. § 103. Obviousness is a question of law based on
`underlying findings of fact. Graham v. John Deere Co., 383 U.S. 1, 17
`(1966). The underlying factual considerations “include the scope and
`
`11
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`IPR2019-00880
`Patent 7,490,749 B2
`
`content of the prior art, the differences between the prior art and the claimed
`invention, the level of ordinary skill in the art, and any relevant secondary
`considerations” of non-obviousness, including commercial success of the
`patented product or method, a long-felt but unmet need for the functionality
`of the patented invention, and the failure of others who have unsuccessfully
`attempted to accomplish what the patentee has achieved. Id. at 17–18. The
`obviousness analysis should not be conducted “in a narrow, rigid manner,”
`but should instead focus on whether a claimed invention is merely “the
`result[] of ordinary innovation,” which is not entitled to patent protection.
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
`Discussion
`3.
`Petitioner asserts that Shelton II discloses all the limitations of
`independent claim 1. Pet. 24–44. In particular, Petitioner contends that
`Shelton II discloses: (1) a handle assembly (Pet. 27–28 (citing Ex. 1004
`¶¶ 125–126, Figs. 31–37; Ex. 1003 ¶ 91)); (2) an end effector (Pet. 28–29
`(citing Ex. 1004 ¶¶ 76–82, 125–126, Figs. 2–6, 31–33; Ex. 1003 ¶¶ 92–94));
`(3) the end effector supporting a firing member (Pet. 29–31 (citing Ex. 1004
`¶¶ 77–80, Figs. 2, 5, 6; Ex. 1003 ¶¶ 95–98)); (4) a firing drive (Pet. 31–35
`(citing Ex. 1004 ¶¶ 126, 128, 130–132, 138–142, Figs. 31–37, 39, 40;
`Ex. 1003 ¶¶ 99–104)); and (5) a manual retraction assembly that causes the
`firing drive to “generate a sole retraction motion” (Pet. 35–44 (citing
`Ex. 1004 ¶¶ 142–144, 154, Figs. 33, 35, 40, 42–45; Ex. 1003 ¶¶ 105–112)).
`Patent Owner has not yet presented arguments or evidence regarding
`Petitioner’s challenge to independent claim 1. Based on our review of
`Petitioner’s arguments and evidence at this stage of the proceeding,
`however, we determine that Petitioner has demonstrated a reasonable
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`IPR2019-00880
`Patent 7,490,749 B2
`
`likelihood that it would prevail with respect to independent claim 1.
`Accordingly, Petitioner’s arguments and evidence are sufficient for
`instituting inter partes review of all challenged claims on all proposed
`grounds. See Trial Practice Guide Update (July 2019)6 at 31 (“The Board
`will not institute on fewer than all claims or all challenges in a petition.”).
`
`Remaining Grounds
`D.
`Petitioner additionally contends that (1) Shelton II anticipates or
`renders obvious claim 3; (2) Swayze anticipates or renders obvious claims 1
`and 3; and (3) Shelton I anticipates claims 1 and 3. Pet. 3. Petitioner sets
`forth these contentions in detail, and supports them with citations to record
`evidence and declarant testimony. Id. at 44–85.
`Having already determined that institution of inter partes review of all
`challenged claims on all grounds is appropriate based on Petitioner’s
`arguments and evidence regarding the anticipation or obviousness of claim 1
`over Shelton II, and considering that Patent Owner has not yet presented its
`arguments and evidence against any of Petitioner’s challenges, we determine
`that further analysis of Petitioner’s challenges is best left for trial after full
`development of the record.
`
`III. CONCLUSION
`
`For the foregoing reasons, we determine that Petitioner has shown that
`there is a reasonable likelihood that it would prevail with regard to at least
`one of the claims challenged in the Petition. Accordingly, we institute inter
`partes review. 35 U.S.C. § 314(a). At this stage of the proceeding, we have
`
`
`6 Available at https://www.uspto.gov/patents-application-process/patent-
`trial-and-appeal-board/trial-practice-guide-july-2019-update.
`
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`IPR2019-00880
`Patent 7,490,749 B2
`
`not made a final determination as to the patentability of any challenged
`claim or any underlying factual or legal issue.
`
`IV. ORDER
`
`For the reasons given, it is
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 1 and 3 of U.S. Patent 7,490,749 B2 is instituted on all
`grounds asserted in the Petition; and
`FURTHER ORDERED pursuant to 35 U.S.C. § 314(a) and 37 C.F.R.
`§ 42.4 that notice is hereby given of the institution of a trial, which
`commences on the entry date of this Decision.
`
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`IPR2019-00880
`Patent 7,490,749 B2
`
`PETITIONER:
`
`Steven R. Katz
`Joshua A. Griswold
`Kenneth W. Darby, Jr.
`John C. Phillips
`Ryan P. O’Connor
`FISH & RICHARDSON
`katz@fr.com
`griswold@fr.com
`kdarbyfr.com
`phillips@fr.com
`
`
`PATENT OWNER:
`
`Anish R. Desai
`Elizabeth Stotland Weiswasser
`Adrian Percer
`Christopher T. Marando
`Christoper M. Pepe
`WEIL, GOTSCHAL & MANGES LLP
`anish.desai@weil.com
`elizabeth.weiswasser@weil.com
`adrian.percer@weil.com
`christopher.marando@weil.com
`christopher.pepe@weil.com
`
`
`
`15
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`
`
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