Paper 10
`Trials@uspto.gov
`Entered: January 21, 2021
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`BALT USA, LLC,
`Petitioner,
`v.
`MICROVENTION, INC.,
`Patent Owner.
`
`IPR2020-01259
`Patent 10,076,338 B2
`
`
`
`
`
`
`
`
`
`Before MITCHELL G. WEATHERLY, SUSAN L. C. MITCHELL, and
`JAMIE T. WISZ, Administrative Patent Judges.
`MITCHELL, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. §§ 314, 325(d)
`
`
`
`
`
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`IPR2020-01259
`Patent 10,076,338 B2
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`I.
`
`INTRODUCTION
`
`A. Background
`On July 8, 2020, Balt USA, LLC (“Petitioner”) filed a Petition
`(Paper 2, “Pet.”) requesting an inter partes review of claims 1 through 10
`(the “challenged claims”) of U.S. Patent No. 10,076,338 B2 (Ex. 1001, “the
`’338 patent”). See 35 U.S.C. §§ 311–319. On October 23, 2020,
`MicroVention, Inc. (“Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 7 (“Prelim. Resp.”). On December 4, 2020, Petitioner filed
`an authorized Reply addressing discretionary denial under 35 U.S.C.
`§ 314(a). Paper 8; Ex. 1034. On December 11, 2020, Patent Owner filed an
`authorized Sur-Reply responding to Petitioner’s arguments concerning
`discretionary denial. Paper 9; Ex. 1034.
`We have the authority and discretion to determine whether to institute
`an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4. We may not
`institute an inter partes review “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). After considering the
`Petition, Patent Owner’s Preliminary Response, and associated evidence, we
`exercise our discretion to deny institution of inter partes review under
`35 U.S.C. §325(d).
`B. Real Parties in Interest
`Petitioner identifies itself, a wholly owned subsidiary of Balt
`Incorporated, as the real party-in-interest for Petitioner. Pet. 67. Patent
`Owner identifies itself, a subsidiary of Terumo Americas Holding, Inc., as
`the real party-in-interest for Patent Owner. Paper 5, 1.
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`Patent 10,076,338 B2
`C. Related Proceedings
`The parties identify that the ’338 patent is the subject of the following
`related matter: MicroVention, Inc. v. Balt USA, LLC, Case No. 8:19-cv-
`01335-JLS-KES (C.D. Cal.). Pet. 68; Paper 5, 1.
`D. The ’338 Patent (Ex. 1001)
`The ’338 patent issued on September 18, 2018, and is titled
`“Detachable Coil Incorporating Stretch Resistance.” Ex. 1001, codes (45),
`(54). The named inventors are Matthew J. Fitz, Cathy Lei, Joseph
`Gulachenski, Maricruz Castaneda, and Gary Currie. Id. at code (72). The
`’338 patent claims priority to Application No. 12/180,834, the prosecution of
`which will be extensively discussed below in relation to our analysis under
`35 U.S.C. § 325(d). See infra Section II.A.
`The subject matter of the ’338 patent involves “[a]n implantable
`embolic device having a stretch-resistant member passing therethrough that
`also serves as a tether for connecting the device to a delivery system.” Id. at
`code (57). Such implantable devices include coils, stents, and filters that
`may be placed in a body cavity such as blood vessels, fallopian tubes,
`malformations such as fistula and aneurysms, heart defects, and other
`luminal organs. Id. at 2:1–5. When the implant is a coil, the stretch-
`resistant member may be a tether, such as a monofilament, that runs through
`the inside of the lumen of the coil and be attached to the distal end of the
`coil. Id. at 2:23–27, 46–48. “This design not only joins the implant to the
`pusher [or delivery catheter], but also imparts stretch resistance to the coil
`without the use of a secondary stretch resistant member.” Id. at 2:6–7,
`48–51.
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`Patent 10,076,338 B2
`The ’338 patent also describes an implant delivery and detachment
`system to deliver the implantable embolic device such as the claimed
`microcoil. Figure 4 set forth below shows an example of such a system.
`
`
`
`Figure 4 is described as a cross-sectional side view of a preferred
`embodiment of the detachment system. Id. at 5:57–59, 9:4–5. In Figure 4,
`detachment system 300 is shown to include delivery pusher 301 containing
`heater 306 that detaches implant device 302 and tether 310 that is disposed
`in proximity to heater 306 with a proximal end fixed within the delivery
`pusher 301 and a distal end coupled to implant device 302. Id. at 9:7–21.
`When current is applied through wires 308 and 309, heater 306 heats up
`until tether 310 breaks and releases implant device 302. Id. at 9:21–23.
`
`The Specification of the ’338 patent further describes enhancing the
`attachment of tether 310 to implant device 302 using collar member 322
`welded to implant device 302 at weld 318 and sized to fit within the outer
`reinforced circumference 312 of delivery pusher 301. Id. at 9:37–41.
`Tether 310 is also tied around the proximal end of implant device 302 to
`form knot 316, and adhesive 314 around knot 316 prevents untying or
`unwanted decoupling. Id. at 9:41–45.
`
`The Specification of the ’338 patent further describes that tether 310
`may be axially pre-tensioned during assembly to assist in detachment of
`implant device 302. Id. at 9:46–50. With specific reference to the
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`IPR2020-01259
`Patent 10,076,338 B2
`embodiment shown in Figure 4 above, the Specification provides that after
`attachment of tether 310 near the proximal end of implant device 302 as
`described above:
`
`The free end of the tether 310 is threaded through a distal
`portion of the delivery pusher 301 until it reaches an exit point
`(not shown) of the delivery pusher 301. Tension is applied to
`the tether 310 in order to store energy in the form of elastic
`deformation within the tether material by, for example, placing
`a pre-determined force on the free end of the tether 310 or
`moving the taut tether 310 a pre-determined displacement. The
`free end of the tether 310 is then joined to the delivery pusher
`301 by, for example, tying a knot, applying adhesive, or similar
`methods known in the art.
`
`When present, the release of potential energy stored in
`the system operates to apply additional pressure to separate the
`implant device 302, and the portion of the tether 310 to which
`the implant device 302 is coupled, away from the heater 306
`when the implant device 302 is deployed. This advantageously
`lowers the required detachment time and temperature by
`causing the tether 310 to sever and break.
`Id. at 9:53–10:2.
`
`Figure 9 shown below depicts a side elevation view of an implant
`device “having a stretch-resistant member passing therethrough.” See id.
`at 6:4–5, 15:59–64.
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`Patent 10,076,338 B2
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`Figure 9 shows implant 500 described as follows.
`The stretch-resistant member 502 has a distal end and a
`proximal end and runs through the interior lumen of the coil
`501 and, preferably, exits the winds of the coil 501 near the
`proximal end of the coil 501. The stretch-resistant member 502
`is then configured to wrap or tie around one or more winds of
`the coil 501 near the proximal end of the coil 501. The stretch-
`resistant member 502 is then preferably attached near the distal
`end of a coil 501 by wrapping or tying a knot (503, as shown in
`FIG. 9), adhesive bonding, melting the end of the stretch-
`resistant member 502 to form a ball, or a combination of the
`methods.
`. . . .
`The proximal end of the stretch-resistant member 502 is
`then passed through, around and/or in proximity to a heater
`element and tension is then placed on the proximal portion of
`the stretch-resistant member 502 . . . . Since the distal portion
`of the stretch-resistant member 502 is at least partially isolated
`from the proximal portion of the stretch-resistant member 502
`by the wrap or knot 503, the tension in the distal portion of the
`stretch-resistant member 502 that is distal to the wrap or knot
`503 will be less than the tension in the proximal portion of the
`stretch-resistant member 502 that is proximal to the wrap or
`knot 503. The proximal end or a proximal segment of the
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`Patent 10,076,338 B2
`stretch-resistant member 502 is then tied, bonded or otherwise
`attached to the delivery catheter.
`Id. at 16:11–53.
`E. Challenged Claims
`Petitioner challenges claims 1 through 10 of the ’338 patent.
`Independent claim 1 is directed to a detachable implant delivery system, and
`independent claim 7 is directed to a method of detaching a microcoil from an
`implant delivery system. See Ex. 1001, 17:15–35, 18:13–33. Claims 2
`through 6 depend directly from claim 1, and claims 8 through 10 depend
`directly from claim 7.
`The dispute concerning the claims focuses on the components of the
`detachable implant delivery system, most importantly the stretch resistant
`member (claim 1) or tether (claim 7), that is recited in all claims. Claim 1 is
`illustrative of the system and recites:
`A detachable implant delivery system, comprising:
`1.
`a delivery device having a heater coil proximate a distal end of
`said delivery device;
`a microcoil comprising a helical wire; and,
`a stretch-resistant member characterized by a single
`monofilament and connecting said delivery device and said microcoil;
`said stretch-resistant member passing through a lumen of said
`microcoil and being attached at a first location near a distal end of
`said microcoil, at a second location near a proximal end of said
`microcoil, and at a third location near a distal end of said delivery
`device, such that said stretch-resistant member is located within said
`heater coil;
`wherein a first portion of said stretch-resistant member is
`between said second location and said third location is tensioned so as
`to enhance breakage upon application of heat by said heater coil, and
`wherein a second portion of said stretch-resistant member is isolated
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`References
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`IPR2020-01259
`Patent 10,076,338 B2
`from the tension of said first portion so as to resist stretching and
`thereby retain an original configuration of said microcoil.
`Id. at 17:15–35.
`F. Prior Art and Asserted Grounds of Unpatentability
`Petitioner argues that claims 1 through 10 of the ’338 patent are
`unpatentable based on the following grounds:
`Claim(s) Challenged
`35 U.S.C. §
`Fitz2
`1 through 10
`103(a)1
`Fitz and Ken3
`1 through 10
`103(a)
`Petitioner submits the Declaration of Marc-Alan Levine, in support
`
`of its Petition. See Ex. 1004 (“the Levine Declaration”).
`II. ANALYSIS
`Patent Owner asserts that both the Fitz and Ken references upon
`which Petitioner relies here were considered by the Examiner during
`prosecution of the ’338 patent and its parent application, in which the
`Examiner issued a rejection based on the combination of Fitz and Ken.
`Prelim. Resp. 12. Patent Owner concludes that “Petitioner fails to present
`any new arguments that are supported under a proper reading of the
`references. Nor does Petitioner present any meaningful additional evidence
`that warrant[s] reconsideration of Fitz or Ken.” Id. at 12. Thus, Patent
`Owner concludes that we should exercise our discretion to deny Petitioner’s
`
`1 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112-29, 125
`Stat. 284, 287–88 (2011), amended 35 U.S.C. §§ 102, 103, and 112,
`effective March 16, 2013. Because the ’338 patent issued from a
`continuation application that was filed prior to the effective date of the AIA,
`we apply the pre-AIA version of 35 U.S.C. § 103.
`2 Matthew Fitz and Joseph Gulachenski, US 2006/0052815 A1, published
`Mar. 9, 2006 (Ex. 1002, “Fitz”).
`3 Christopher G. M. Ken, Joseph C. Eder, Clifford Teoh, U.S. Patent No.
`6,193,728 B1, issued Feb. 27, 2001 (Ex. 1003, “Ken”).
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`request for inter partes review under 35 U.S.C. § 325(d). We agree for the
`reasons expressed below.
`We have discretion to deny review when “the same or substantially
`the same prior art or arguments previously were presented to the Office.”
`35 U.S.C. § 325(d). In that respect, section 325(d) provides that the Director
`may elect not to institute a proceeding if the challenge to the patent is based
`on matters previously presented to the Office.4 Advanced Bionics, LLC v.
`Med-El Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 7
`(PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”).
`In evaluating matters under § 325(d), the Board uses the following
`two-part framework: (1) determining whether the same or substantially the
`same art previously was presented to the Office or whether the same or
`substantially the same arguments previously were presented to the Office;
`and (2) if either condition of the first part of the framework is satisfied,
`determining whether the petitioner has demonstrated that the Office erred in
`a manner material to the patentability of challenged claims. Advanced
`Bionics, Paper 6 at 8.
`In applying the two-part framework, we consider several nonexclusive
`factors, including:
`(a)
`the similarities and material differences between the asserted art
`and the prior art involved during examination;
`the cumulative nature of the asserted art and the prior art
`evaluated during examination;
`the extent to which the asserted art was evaluated during
`examination, including whether the prior art was the basis for
`rejection;
`
`4 The Board institutes trial on behalf of the Director. 37 C.F.R. § 42.4(a);
`Advanced Bionics, Paper 6, 7 n.7.
`
`(c)
`
`(b)
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`(f)
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`IPR2020-01259
`Patent 10,076,338 B2
`(d)
`the extent of the overlap between the arguments made during
`examination and the manner in which petitioner relies on the
`prior art or patent owner distinguishes the prior art;
`(e) whether petitioner has pointed out sufficiently how the
`examiner erred in its evaluation of the asserted prior art; and
`the extent to which additional evidence and facts presented in
`the petition warrant reconsideration of the prior art or
`arguments.
`Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586,
`Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to Section III.C.5,
`first paragraph) (“Becton, Dickinson”).
`Factors (a), (b), and (d) of the Becton, Dickinson factors relate to
`whether the art or arguments presented in the Petition are the same or
`substantially the same as those previously presented to the Office. Advanced
`Bionics, Paper 6 at 10; see also Advanced Bionics at 10. Factors (c), (e), and
`(f) “relate to whether the petitioner has demonstrated a material error by the
`Office” in its prior consideration of that art or arguments. Id. Only if the
`same or substantially the same art or arguments were previously presented to
`the Office do we then consider whether petitioner has demonstrated a
`material error by the Office. Id.
`
`A. Whether the Same or Substantially the Same Art or Arguments
`Were Previously Presented to the Office
`We first consider whether Petitioner asserts the same or substantially
`the same art or arguments that previously were presented to the Office.
`Advanced Bionics, Paper 6 at 8. Patent Owner asserts that the two
`references asserted in the two grounds in the Petition, Fitz and Ken, were
`before the Examiner during prosecution of the ’338 patent and its parent
`application. Prelim. Resp. 12 (citing Ex. 1005, 22, 56; Ex. 2001, 192–197).
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`Patent Owner asserts that “[b]oth of these references were evaluated
`substantively by the Examiner and were also cited by the Examiner in
`rejecting proposed claims.” Id. at 12–13. We agree with Patent Owner that
`the same art was previously considered by the Office during prosecution of
`the ’338 patent and its parent application.
`In rejecting the claims of the parent application of the ’338 patent, the
`Examiner rejected the majority of the then pending claims as anticipated by
`Fitz. See Ex. 2001, 192–195.5 With respect to the then pending claim 1, the
`Examiner stated that Fitz discloses the following limitations:
`Claim 1. A detachable implant delivery system
`comprising:
`A delivery device (301) having a distal end and a heater
`(306) proximate the distal end;
`An implant (302) attached to the distal end of the
`delivery device, wherein the implant defines a lumen;
`A stretch-resistant member (310) connecting the delivery
`device and the implant, the stretch-resistant member passing
`through the lumen and attached to at least two locations on the
`implant (see knot in figure below), the stretch-resistant member
`continuing proximally in operable proximity to the heater, such
`that upon activation of the heater, the stretch-resistant member
`breaks, releasing the implant (Fig. 4, [0051]).
`
`
`5 We are citing to the pagination added by Patent Owner to Exhibit 2001.
`
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`Ex. 2001, 192–193 (annotated by the Examiner to show first and second
`attachment points).
`
`The Examiner also rejected claims 23 and 24 over Fitz and Ken. Id.
`at 196–197. The Examiner explained that Fitz
`fails to disclose the stretch-resistant member prevents
`elongation by connecting a distal end of the implant to a
`proximal end of the implant wherein the tension is isolated
`from between the distal end of the implant and the proximal end
`of the implant. However, Ken et al teaches it is old and well
`known in vaso-occlusive devices to prevent elongation by
`connecting a distal end of the implant (135) to a proximal end
`of the implant (Fig. 3c) wherein the tension is isolated from
`between the distal end of the implant and the proximal end of
`the implant. (col. 7, ll. 54-col. 8, ll. 4, i.e. tension is isolated
`between the proximal and distal end of the implant because that
`is the region the tensioned stretch-resistant member occupies).
`
`Id.
`
`In response, Patent Owner amended claim 1 to delete “at least
`two locations” and add “said implant at a first attachment point
`near a distal end of” said implant, “and at least a second
`attachment point near a proximal end of said implant.” Ex. 2001,
`207. Patent Owner further explained:The Examiner is taking the
`position that the knot in Figure 4 of Fitz shows at least two
`attachment points in one knot.
`In order to further distinguish claim 1 from Fitz, the
`Applicant has amended claim 1 to recite said stretch-resistant
`member passing through said lumen and attached to said
`implant at a first location near a distal end of said implant, and
`at least a second location near a proximal end of said implant.
`The tether 310 shown in Figure 4 of Fitz is not attached to the
`implant at a first location near a distal end of said implant, and
`at . . . least a second location near a proximal end of said
`implant.
`Id. at 213–214.
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`In response to the rejections of claim 23 and 24, Patent Owner
`canceled claim 23 and amended claim 24 to depend from independent
`claim 22, which was newly amended to recite: “a stretch-resistant member
`both connecting said delivery device and said implant and preventing
`elongation of said implant, said stretch-resistant member attached to said
`implant near a proximal end and again near a distal end of said implant such
`that said stretch-resistant member is under tension without altering a shape
`of said implant” and amended claim 24 to depend from claim 22. Id. at 211.
`In light of this amendment, Patent Owner asserted that Ken’s stretch-
`resistant member does not connect its delivery device and its implant, nor is
`Ken’s stretch resistant member capable of being under tension without
`altering a shape of its implant. Id. at 214.
`
`The Examiner finally rejected the amended independent claims 1
`and 22, stating:
`
`Fitz et al fails to disclose the two attachment locations
`comprise: a first attachment point near a distal end of on said
`implant, and at least a second attachment point near a proximal
`end of said implant. However, Teoh6 teaches a vaso-occlusive
`coil (102) with a stretch-resistant member (108) that has a first
`distal attachment point on the implant and a second proximal
`attachment point on the implant ([0041] and [0042]).
`Therefore, it would have been obvious to one of ordinary skill
`in the art at the time the invention was made to modify the
`device of Fitz et al with the two attachment point locations as
`taught by Teoh, to prevent axial stretching of the implant.
`Id. at 229–230.
`
`The Interview Summary for an interview conducted after the final
`rejection stated:
`
`
`6 Clifford Teoh, U.S. 2004/0002733 A1, published Jan. 1, 2004 (“Teoh”).
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`Applicant described to Examiner how the invention works.
`Applicant clarified a single loop as the attachment point would
`result in slipping. A certain amount of contact area is necessary
`and the more loops present, the less the tether will slip. The
`knot at the proximal end gives the device strength. The
`Examiner suggested adding more structural limitations to the
`current term “attachment point.” The Examiner clarified that in
`the current final rejection, Fitz et al was used to teach two
`attachment points, and Teoh was used to modify one of the
`attachment points to the distal end of the implant.
`Id. at 242, 253.
`In a Request for Continued Examination, Patent Owner complied with
`the Examiner’s suggestion to add more structural limitations stating that
`independent claims 1 and 22 were amended “to recite a ‘knot’ rather than a
`‘second attachment point.’ This amendment avoids confusion arising from a
`single knot having multiple attachment points,” as the Examiner had asserted
`with annotated Figure 4 depicted above. Id. at 253. Patent Owner argued
`that the amended claim 1 was patentable because “Fitz has a stretch-resistant
`member that terminates in a knot at a proximal end of the implant. Teoh has
`a stretch-resistant member that extends from one end of its implant to the
`other but this member is not connecting the delivery device and the implant.
`As such, claim 1 is patentable over Fitz in view of Teoh.” Id. at 254.
`The Examiner again rejected claim 1 this time over Fitz and Simon7.
`The Examiner stated:
`Fitz et al fails to disclose the stretch-resistant member is
`attached to said implant near a distal end of on said implant.
`However, Simon et al teaches a detachable implant delivery
`system, wherein the stretch-resistant member is attached to said
`implant near a distal end of on said implant as well as on the
`proximal end, wherein the stretch-resistant member connects
`
`7 Joan Simon and Cindy Truong, US 2007/0239193 A1, published Oct. 11,
`2007 (“Simon”).
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`the delivery device and the implant ([0042], [0049], [0050],
`[0051]). Therefore, it would have been obvious to one of
`ordinary skill in the art at the time the invention was made to
`modify Fitz et al with the stretch-resistant member extending to
`near the distal end to attach with said implant, to prevent
`unwanted stretching of the implant along its length.
`Id. at 265.
`
`In response, Patent Owner amended claim 1 to require that the stretch-
`resistant member is “characterized by a single, unitary filament.” Id. at 276.
`Patent Owner argued that “Simon uses at least three different components to
`achieve the linkage between its coil’s distal end and the delivery pusher
`instead of the ‘unitary filament’” as recited in claim 1. Id. at 282.
`Therefore, Patent Owner concludes, “Simon fails to make up for the Fitz
`device’s failure to teach a unitary filament both connecting the delivery
`device and the implant, as differently recited in the claims.” Id.
`
`In a Final Rejection, the Examiner took issue with the use of “unitary”
`in the claim amendment as failing to comply with the written description
`requirement because “the instant specification fails to disclose the filament
`is unitary.” Id. at 293. The Examiner finally rejected claim 1 over Fitz and
`Simon. Id. at 294. The Examiner responded to Patent Owner’s argument
`concerning the combination that Fitz is offered as disclosing a single, unitary
`filament (310) that connects both the delivery device and the implant as seen
`in Figure 4, and only lacks a teaching of “the stretch-resistant member being
`attached to the implant near a distal end of the implant.” Id. at 299. The
`Examiner cited to Simon as teaching “extending the stretch-resistant
`member from its proximal attachment point in Fitz to a location near the
`distal end as seen in Simon Fig. 6[]. Such a combination would provide the
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`advantage of preventing unwanted stretching of the implant as disclosed by
`Simon in [0042].” Id.
`
`Patent Owner submitted an amendment after final changing “unitary
`filament” to “monofilament” that is in claim 1 of the ’338 patent as it
`eventually issued. Id. at 307. Patent Owner then explained why Simon does
`not teach attaching the tether at the distal end of an implant to prevent
`unwanted stretching of the implant. Id. at 313–317. The Examiner entered
`the amendment for purposes of appeal to the Board. Id. at 326. The
`Examiner’s rejection was affirmed on appeal to the Board. Id. at 398.
`
`Patent Owner filed a continuation application that resulted in the
`’338 patent. See generally Ex. 1005. In a first office action allowance, the
`Examiner allowed claims 8 through 17, what is now claims 1 through 10 of
`the ’338 patent. See Ex. 1005, 44, 51; compare Ex. 1001, 17:15–18:43
`(claims 1–10), with Ex. 1005, 127–128 (claims 8–17). The Examiner,
`however, rejected claims 1–7, again applying Fitz. See Ex. 1005, 47–50.
`
`In rejecting pending claim 1, the Examiner stated:
`Fitz et al fails to disclose the section is a second section,
`and there also exists a first section extending through said
`micro[co]il and fixed at a distal location of said microcoil;
`wherein said second section of said tether has a higher tension
`than said first section of said tether, such that said second
`section enhances breakage of said tether during activation of
`said heater and said first section resists stretching to retain an
`original configuration of said microcoil.
`Id. at 48. The Examiner relied on Simon for the missing teaching. Id.
`at 48–49.
`An Examiner’s Interview Summary reflects that Patent Owner asked
`if adding the qualification that the tether of the rejected claims is
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`“characterized by a single monofilament” would put these claims in
`condition for allowance. Id. at 34–35. The Examiner responded as follows.
`Unfortunately, the proposed amendment below would not
`appear upon first glance to place claims 1–7 in condition for
`allowance. The tether taught in Fitz and Simon are both a
`single monofilament. Claim 8 is indicated as allowable due to
`not only the tether being a single monofilament, but also
`various other limitations not found in claim 1. For example,
`claim 8 is claimed as a stretch-resistant member with various
`attachment points and different tensions and isolated tensions
`along its length. These features are not found in claim 1.
`Claim 1 as presently recited broadly requires two sections with
`two different tensions as claimed. The prosecution history of
`the parent application 12/180,834, along with the limitations of
`a “single monofilament” feature, as affirmed by Patent and
`Trial Appeal Board dated 1/25/2016, indicates how Fitz in view
`of Simon teaches such a feature.
`Id. at 34. Patent Owner canceled claims 1–7 in light of the rejection and
`asked for a Notice of Allowance for claims 8–17. Id. at 40.
`
`As is evident from this detailed discussion of the prosecution history
`of the ’338 patent, including some of its parent applications, not only were
`Fitz and Ken before the Examiner, but Fitz was extensively considered and
`relied upon by the Examiner alone, and in combination with other references
`such as Ken, in examining the claimed subject matter of claims 1–10 of the
`’338 patent. The Examiner repeatedly applied Fitz (and Ken once) to reject
`various iterations of the claims that Patent Owner repeatedly amended in
`light of those rejections to result in claims 1–10 of the ’338 patent claiming
`features that the Examiner conceded was not taught by this prior art.
`Therefore, we determine that the same art was previously presented to the
`Office, and we consider the second part of the Advanced Bionics framework.
`
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`IPR2020-01259
`Patent 10,076,338 B2
`B. Whether the Office Erred in a Manner Material to Patentability
`Because we find that the same art was previously presented to the
`Office, we turn to whether Petitioner demonstrates that the Office erred in a
`manner material to the patentability of the challenged claims. Advanced
`Bionics, Paper 6 at 8, 10; see Becton, Dickinson, Paper 8 at 24. As stated in
`Advanced Bionics:
`
`Factor (c) focuses on the record developed by the Office in
`previously reviewing the art or arguments. It informs,
`therefore, the petitioner’s showing under factors (e) and (f),
`which focus on the petitioner’s evidence of previous Office
`error regardless of the context in which the same or
`substantially the same art or arguments were previously
`presented. For example, if the record of the Office’s previous
`consideration of the art is not well developed or silent, then a
`petitioner may show the Office erred by overlooking something
`persuasive under factors (e) and (f). On the other hand, if the
`alleged error is a disagreement with a specific finding of record
`by the Office, then ordinarily the petitioner’s required showing
`of material error must overcome persuasively that specific
`finding of record. That is, although Becton, Dickinson factor
`(c) evaluates “the extent to which the asserted art was evaluated
`during examination, including whether the prior art was the
`basis for rejection,” the focus should be on the record when
`determining whether the Office erred in evaluating such art or
`arguments.
`Advanced Bionics at 10–11.
`In considering whether the same art or arguments were previously
`presented to the Office, we discussed factor (c)—the extensive record of the
`Examiner’s substantive consideration of Fitz and Ken. In this section we
`will focus on factors (e) and (f)— whether petitioner has pointed out
`sufficiently how the Examiner erred in her evaluation of the asserted prior
`art, and the extent to which additional evidence and facts presented in the
`petition warrant reconsideration of the prior art or arguments.
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`IPR2020-01259
`Patent 10,076,338 B2
`Petitioner does not expressly address exercising discretion to deny
`institution of inter partes review under 35 U.S.C. § 325(d), but does address
`the prosecution history of the ’338 patent in the Introduction section of the
`Petition. See Pet. 1–5. Petitioner acknowledges that the Examiner rejected
`pending claims 1–7 during prosecution of the ’338 patent as obvious over
`Fitz and that Patent Owner canceled those rejected claims. Id. at 2.
`Petitioner suggests, however, that at least canceled claim 1 is “very similar”
`to issued claim 1 of the ’338 patent. See id. at 2–3 (chart comparing claims).
`Petitioner asserts that the Examiner “failed to appreciate material prior art
`disclosures,” citing Fitz alone as disclosing the claimed subject matter of
`claims 1–10 of the ’338 patent. Id. at 3–4 (citing Ex. 1004 ¶ 54). The
`Petitioner also faulted the Examiner for failing to apply Ken to pending
`claims 8–17 that issued as the challenged claims. Id. at 4 (citing Ex. 1004
`¶ 55).
`Specifically, Petitioner asserts that when Fitz’s Figure 4 and its related
`
`disclosure are combined with Figure 1 and its related disclosure, every
`element of the challenged claims is disclosed. Pet. 4. Concomitantly,
`Petitioner argues that the combination of Fitz and Ken also renders the
`challenged claims obvious. Id. at 4–5. Petitioner asserts that “Ken discloses
`a tether or stretch resistant member that continues from the proximal end to
`the distal end of the microcoil, through the lumen, and is ‘loose’ or not under
`tension.” Id. (citing Ex. 1004 ¶¶ 37–42, 141).
`Patent Owner responds that the art was evaluated substantively