Trials@uspto.gov
`571-272-7822
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` Paper No. 7
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`Entered: May 2, 2018
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEVRO CORP.,
`Petitioner,
`
`v.
`
`BOSTON SCIENTIFIC NEUROMODULATION CORP.,
`Patent Owner.
`____________
`
`Case IPR2018-00143
`Patent 7,891,085 B1
`____________
`
`
`
`Before HUBERT C. LORIN, MICHAEL W. KIM, and AMANDA F. WIEKER,
`Administrative Patent Judges.
`
`WIEKER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`IPR2018-00143
`Patent 7,891,085 B1
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`I.
`
`INTRODUCTION
`A. Background
`Nevro Corp. (“Petitioner”) filed a Petition requesting an inter partes review
`of claims 1–19 (“the challenged claims”) of U.S. Patent No. 7,891,085 B1
`(Ex. 1001, “the ’085 patent”). Paper 2 (“Pet.”). Boston Scientific
`Neuromodulation Corp. (“Patent Owner”) filed a Preliminary Response. Paper 6
`(“Prelim. Resp.”).
`We have authority under 35 U.S.C. § 314, which provides that an inter
`partes review may not be instituted unless the information presented in the Petition
`and the Preliminary Response shows that “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; see also 37 C.F.R § 42.4(a) (“The Board institutes the
`trial on behalf of the Director.”). Taking into account the arguments presented in
`the Preliminary Response, we conclude that the information presented in the
`Petition does not establish a reasonable likelihood that Petitioner would prevail
`with respect to the challenged claims.
`Accordingly, we decline to institute an inter partes review.
`
`B. Related Proceedings
`The parties identify the following matter related to the ’085 patent (Pet. 72;
`Paper 4, 2):
`
`Boston Scientific Corp. et al. v. Nevro Corp., Case No. 1:16-cv-
`01163 (D. Del.).
`
`C. The ’085 Patent
`The ’085 patent is titled “Electrode Array Assembly and Method of Making
`
`Same” and issued on February 22, 2011, from U.S. Application No. 11/329,907,
`which was filed on January 11, 2006. Ex. 1001, (21), (22), (54).
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`The ’085 patent discloses a percutaneous lead, as shown in Figures 3A and
`
`5A, which are reproduced below.
`
`
`
`Figure 3A depicts a side view of the distal end of a percutaneous lead, and
`Figure 5A depicts a cross-sectional view of the lead. Id. at 3:12–13, 3:21–22.
`
`Lead 16 delivers electrical stimulation to, e.g., neural tissue, through
`electrode contacts 17. Id. at 4:17–21. As shown in Figure 3A, electrode contacts
`17 are separated by spacers 61, which serve to insulate contacts 17 from each
`other. Id. at 4:17–23. Each electrode contact 17 is connected to conductor wire
`122, which is made up of individual strands 120, as shown in Figure 5A. Id. at
`5:15–18, 5:35–39, 5:42–45. Each conductor wire is located within individual
`conductor lumen 116, wherein conductor lumens 116 encircle central stylet lumen
`114. Id. at 5:40–41, 5:47–49, Fig. 5A.
`
`The ’085 patent also discloses a method of making such a lead. Figures 6A–
`B are reproduced below.
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`Patent 7,891,085 B1
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`Figure 6A depicts a longitudinal view of the distal portion of a lead assembly, and
`Figure 6B depicts how voids within that lead are filled. Ex. 1001, 3:26–30.
`
`During manufacture, monofilament 60 is inserted into void spaces 70 within
`conductor lumens 116. Id. at 5:66–6:2, 6:10–12, Figs. 6A, 6B(i). The distal
`portion of the lead is then heated to a temperature just below the melting
`temperature of spacer 61 and/or monofilament 60, e.g., 190o Celsius for thirty
`seconds. Id. at 6:12–19. The ’085 patent explains that “[a]t this just-below-
`melting temperature, the spacer and monofilament will reflow and thermally fuse
`together,” as shown in Figure 6B(ii). Id. at 6:19–21, 6:35–38 (explaining that the
`heating temperature is chosen to ensure reflow of either, or both, spacer 61 and/or
`monofilament 60). According to the ’085 patent, this process minimizes or
`eliminates tooling and molding, is faster than using epoxy, ensures more uniform
`stiffness, and yields a better bond within the lead. Id. at 7:45–63.
`
`Illustrative Claim
`D.
`Of the challenged claims, claim 1 is independent. Claim 1 is illustrative and
`is reproduced below.
`1.
`
`A method of manufacturing a stimulation lead having a
`proximal end and a distal end, comprising:
`providing a plurality of conductive contacts located at an end of
`a lead body of the stimulation lead;
`disposing a plurality of conductor wires in a plurality of
`conductor lumens formed in the lead body;
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`IPR2018-00143
`Patent 7,891,085 B1
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`connecting at least one of the plurality of conductor wires to each
`of the conductive contacts;
`placing spacers between pairs of adjacent conductive contacts,
`wherein portions of the conductor lumens are located beneath the
`plurality of conductive contacts and the spacers;
`inserting monofilament into at least one portion of at least one
`of the conductor lumens of the lead body that is not occupied by the
`conductor wires; and
`reflowing at least one of the spacers or monofilament into at least
`one portion of at least one of the conductor lumens not occupied by the
`conductive wires by heating the spacers and monofilament to a
`temperature to cause thermal flow or melting of at least one of the
`spacers or monofilament.
`Ex. 1001, 8:11–31 (emphasis added).
`
`E. Applied References
`Petitioner relies upon the following references:
`Stolz et al., U.S. Patent Publication No. 2003/0199950 A1, filed
`April 22, 2002, published October 23, 2003 (Ex. 1005, “Stolz”);
`Ormsby et al., PCT Publication No. WO 00/35349, filed
`December 16, 1999, published June 22, 2000 (Ex. 1006, “Ormsby”);
`Black et al., U.S. Patent No. 6,216,045 B1, filed April 26, 1999,
`issued April 10, 2001 (Ex. 1008, “Black”);
`Wessman et al., U.S. Patent Publication No. 2002/0143377 A1,
`filed March 30, 2001, published October 3, 2002 (Ex. 1009,
`“Wessman”);
`Modern Plastics Encyclopedia 1986–1987, October 1986,
`Vol. 63, No. 10A (Ex. 1010, “Modern Plastics”); and
`Mark Saab, Using Thin-Wall Heat-Shrink Tubing in Medical
`Device Manufacturing, Medical Device & Diagnostic Industry April
`1, 1999, 54–62 (Ex. 1011, “Saab”).
`Pet. 4–5. Petitioner also relies upon the Declaration of Michael Plishka
`(“the Plishka Declaration,” Ex. 1003). Id. at 5.
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`F. Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–19 of the ’085 patent
`based on the following grounds. Pet. 4.
`No.
`References
`1
`“Stolz, Ormsby, Black, and the knowledge of
`POSA” (see Pet. 4)
`2 Ground 1 further in view of Modern Plastics
`3 Ground 1 further in view of Wessman
`4 Ground 3 further in view of Saab
`
`Basis Claim(s) Challenged
`§ 103 1–3, 6–12, and 14–17
`
`§ 103 4, 5, and 13
`§ 103 18
`§ 103 19
`
`II. DISCUSSION
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given their
`broadest reasonable interpretation in light of the specification of the patent in
`which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Tech., LLC v. Lee,
`136 S. Ct. 2131, 2144–46 (2016). Under that standard, we generally give claim
`terms their ordinary and customary meaning, as understood by a person of ordinary
`skill in the art in the context of the entire patent disclosure. In re Translogic Tech.,
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`We determine that no claim term requires express construction for purposes
`of this Decision. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`(Fed. Cir. 1999); see also Pet. 7–8; Prelim. Resp. 23.
`
`B. Principles of Law
`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences between
`the subject matter sought to be patented and the prior art are such that the subject
`matter as a whole would have been obvious at the time the invention was made to a
`person having ordinary skill in the art to which said subject matter pertains.” KSR
`Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is
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`resolved on the basis of underlying factual determinations, including (1) the scope
`and content of the prior art; (2) any differences between the claimed subject matter
`and the prior art; (3) the level of skill in the art; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). When
`evaluating a combination of teachings, we must also “determine whether there was
`an apparent reason to combine the known elements in the fashion claimed by the
`patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441, F.3d 977, 988 (Fed.
`Cir. 2006)). Whether a combination of elements produced a predictable result
`weighs in the ultimate determination of obviousness. Id. at 416–417.
`“In an [inter partes review], the petitioner has the burden from the onset to
`show with particularity why the patent it challenges is unpatentable.” Harmonic
`Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). The burden of
`persuasion never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l
`Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015).
`We analyze the challenges presented in the Petition in accordance with the
`above-stated principles.
`
`C. Level of Ordinary Skill in the Art
`Relying on the Plishka Declaration, Petitioner contends that a person of
`ordinary skill in the art of the ’085 patent would have had “general knowledge of
`implantable medical devices and various related technologies as of January 11,
`2005” and, furthermore, “would have had (1) at least a bachelor’s degree in a
`relevant life sciences field, mechanical engineering, electrical engineering,
`biomedical engineering, or equivalent coursework, and (2) at least one year of
`experience researching or developing implantable medical devices, and/or methods
`of their manufacture.” Pet. 6 (citing Ex. 1003 ¶¶ 21–24). In its Preliminary
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`Response, Patent Owner does not provide an express assessment of skill level. See
`generally Prelim. Resp.
`
`On this record, we are persuaded by, and adopt, the assessment of the level
`of ordinary skill in the art asserted by Petitioner.
`
`D. Obviousness over
`“Stolz, Ormsby, Black, and the knowledge of POSA”
`Petitioner contends that claims 1–3, 6–12, and 14–17 of the ’085 patent would
`have been obvious in light “Stolz, Ormsby, Black, and the knowledge of POSA.”
`Pet. 4, 9, 16–59. For reasons that follow, we determine that Petitioner has not
`demonstrated a reasonable likelihood of prevailing as to the challenged claims.
`1. Overview of Stolz (Ex. 1005)
`Stolz is a U.S. Patent Publication titled “Implantable Lead with Isolated
`Contact Coupling.” Ex. 1005, (54). Stolz explains that “[i]mplantable leads have
`conductors that are connected to contacts to form electrical paths.” Id. ¶ 4. These
`elements should have a “solid mechanical,” “low impedance electrical
`connection,” but the prior art presented problems with respect to these connections.
`Id. Thus, Stolz discloses “an implantable lead with an isolated contact connection
`for connecting a conductor to a contact [that] reduces the opportunity for conductor
`material to migrate to a contact or into a patient.” Id. ¶ 5.
`Figures 8 and 9 are reproduced below.
`
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`Figure 8 depicts an implantable lead with a distal end enlargement, which is
`expanded in Figure 9. Ex. 1005 ¶¶ 14–15.
`
`Stolz discloses that the implantable lead includes a lead body, at least two
`conductors 34 extending from proximal end 38 to distal end 40, contacts 36
`electrically connected to the conductors 34, stylet lumen 100, conductor lumens
`102, and distal tip 300. Id. ¶ 34. Stolz explains that distal tip 300 can be formed
`by molding. Id. ¶ 36. Specifically, “heat conducted from the mold to the lead
`distal tip 300, melts the surrounding material into the conductor lumen 102 and
`into the stylet lumen 100, completely sealing them from the outside.” Id.
`In this manner,
`distal tip 300 seals the conductor lumens 102 free from adhesive or
`solvents. The conductor lumens 102 closed off by the formed distal tip
`300 improve electrical isolation between the conductors 34. The
`formed distal tip 300 penetrates the lumens 100, 102 of the lead body.
`The material filling reaches no further into the lumens than making
`contact to the enclosed conductors 34.
`Id. ¶ 35. Stolz also explains that forming distal tip 300 from the same material as
`the lead body “minimizes the possibility of separation.” Id. ¶ 36.
`2. Overview of Ormsby (Ex. 1006)
`Ormsby is a PCT Publication titled “Guidewire Having Sidewise Looking
`Imaging Capabilities and Methods.” Ex. 1006, (54). Ormsby discloses a
`guidewire that is deployed through a patient’s vasculature to a desired location. Id.
`at (57). The guidewire includes an ultrasonic transducer, which allows a surgeon
`to view the desired location, while a catheter is advanced over the guidewire and
`placed in that location. Id. at (57), 3, 8–9 (discussing operation of the device).
`Ormsby’s Figure 3 is reproduced below.
`
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`Figure 3 depicts an enlarged cross-sectional view of the distal extremity of a
`guidewire. Id. at 2. As shown, guidewire 11 includes tubular member 26 with
`lumen 29 extending therethrough. Id. at 3. Transducer assembly 36, with
`transducer element 46, is carried on the guidewire. Id. at 4. Conductors 56, 57 are
`also provided in the lumen of the guidewire. Id. at 5. Ormsby explains,
`In order to substantially increase the kink resistance of the
`flexible elongate tubular member 26, the lumen 29 therein can be
`filled with a filler 81 of a suitable material such as a liquid epoxy
`or resin and permitted to harden. Alternatively, a polymer can
`be utilized in powder form and can be melt formed therein. Thus
`it can be seen that the filler 81 fills the void within the lumen and
`greatly reduces the possibility of kinking of the hypotube
`forming the flexible elongate tubular member 26.
`Id. at 7.
`
`3. Overview of Black (Ex. 1008)
`Black is a U.S. Patent titled “Implantable Lead and Method of
`Manufacture.” Ex. 1008, (54). Figure 5 is reproduced below.
`
`Figure 5 depicts a plan view of an assembly of elements on a mandrel, prior to
`formation of a lead. Id. at 3:10–12. As shown in Figure 5, the lead produced by
`Black’s method includes, inter alia, terminals 16 (separated by terminal spacers
`30) and electrodes 18 (separated by electrode spacers 28). Id. at 6:5–10. Once
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`arranged as depicted in Figure 5, the assembly is “over-molded, using well known
`injection molding techniques.” Id. at 7:5–10. According to Black,
`This process has the beneficial effect of unitizing the element
`assembly to form lead 10. Moreover, electrode spacers 28 and terminal
`spacers 30 are placed in a state of flow, which, at least in part, results
`in a filling of regions between terminals 16/electrodes 18 and stylet
`guide 24. Consequently, terminals 16 and electrodes 18 are partially
`surrounded (i.e., along an interior surface) and supported by a fused
`matrix of material. Importantly, as electrode spacers 28 and terminal
`spacers 30 are formed of a material mechanically equivalent to that of
`body 22/outer tubing 23, 20 the stimulation/sensing portion and
`terminal portion of lead 10 are stabilized and strengthened while also
`retaining their flexible properties.
`Id. at 7:11–23.
`
`4. Analysis of Independent Claim 1
`Of particular importance to our analysis, claim 1 recites, “inserting
`
`monofilament into at least one portion of at least one of the conductor lumens of
`the lead body that is not occupied by the conductor wires.” Ex. 1001, 8:23–25.
`Petitioner contends that Stolz discloses much of this limitation. Pet. 9, 21, 33. For
`example, Petitioner contends that “Stolz teaches inserting material into conductor
`lumens 102, e.g., to seal them.” Id. at 33 (citing Ex. 1005 ¶¶ 35–36, 46, Figs. 8–9).
`In support of this position, Petitioner quotes Stolz’s disclosure that “heat conducted
`from the mold to the lead distal tip 300 melts the surrounding material into the
`conductor lumen 102 and into the stylet lumen 100, completely sealing them from
`the outside.” Id. (quoting Ex. 1005 ¶ 36). Thus, Petitioner contends that distal tip
`300 “penetrates the lumens 100, 102 of the lead body . . . [and] reaches no further
`into the lumens than making contact to the enclosed conductors.” Id. (quoting
`Ex. 1005 ¶ 35). According to Petitioner, “the reflowed portion of Stolz’s distal tip
`may not penetrate very far,” such that the lead “may still have a long, unoccupied
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`space between the distal tip and the conductor.” Id. at 34 (citing Ex. 1003 ¶¶ 144–
`146).
`Petitioner contends that “a POSA would have recognized that leaving long,
`
`empty portions of a conductor lumen could be an undesirable condition,” because
`such an empty portion could lead to perforation, kinking, variable flexibility, or
`separation of components. Pet. 34–35 (citing Ex. 1003 ¶ 145). To avoid such
`outcomes, Petitioner contends that a person of ordinary skill in the art would have
`“searched for other known techniques for filling the unoccupied portions of the
`conductor lumens.” Id. at 35. To that end, Petitioner contends that Ormsby
`“provides the motivation to modify Stolz to fill the unoccupied portions of the
`conductor lumens.” Pet. 9, 22. According to Petitioner, “Ormsby teaches that it is
`desirable to fill lumen spaces to prevent kinking or crushing, if stressed.” Id. at 22,
`35–36 (citing Ex. 1006, 7:3–10; Ex. 1003 ¶¶ 145–157). Specifically, Petitioner
`contends that “Ormsby teaches various methods for filling a lumen, including with
`powder, liquid adhesive, epoxy, or resin.” Id. at 22 (citing Ex. 1003 ¶¶ 88–93), 36.
`
`Petitioner acknowledges that “Stolz in view of Ormsby still does not
`expressly disclose ‘inserting a monofilament’ to fill the void within the conductor
`lumen.” Pet. 36. However, Petitioner relies upon the Plishka Declaration to
`support Petitioner’s contention that “a POSA would have found it obvious to use
`monofilament to fill the empty spaces in Stolz’s conductor lumens instead of the
`powder of Ormsby,” because “a POSA would have naturally looked for a filling
`option that would match the size, shape, and configuration of the lumen it would
`be designed to fill—such as monofilament.” Id. at 36–37 (citing Ex. 1003 ¶¶ 151–
`157). Petitioner alleges that “a POSA would have recognized that there are a
`limited number of ways to fill a lumen,” such that it would have been “at least
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`obvious to try and fill the lumen with a non-powder, solid material, like a
`monofilament.” Id. at 37–38 (citing Ex. 1003 ¶¶ 153–161).
`
`Patent Owner disputes Petitioner’s contentions regarding claim 1. Prelim.
`Resp. 23–30, 32–43. Patent Owner argues, inter alia, that Ormsby does not
`disclose filling an empty, void space within a conductor lumen, as claimed, but
`rather discloses a fill material that surrounds the conductor wires within the lumen.
`Id. at 27–28. Patent Owner also argues that “the Petition, as well as its
`accompanying expert declaration, still fails to establish that one skilled in the art
`would have [been] motivated to substitute monofilament for the epoxy or
`powdered fill materials disclosed in [Ormsby].” Id. at 39.
`
`We agree with Patent Owner on both points. First, we are not persuaded by
`Petitioner’s contention that “Ormsby . . . provides the motivation to fill the portion
`of Stolz’s conductor lumens that are not occupied by its conductive wires.”
`Pet. 22; see also id. at 9. Ormsby’s Figure 3 is reproduced below.
`
`
`Figure 3 is an enlarged cross-sectional view of the distal extremity of a guidewire.
`Ex. 1006, 2. As seen in Figure 3, lumen 29 includes conductors 56, 57. Id. at 5.
`Ormsby explains that “to substantially increase the kink resistance of the flexible
`elongate tubular member 26, the lumen 29 therein can be filled with a filler 81 of
`suitable material.” Id. at 7. Thus, Ormsby discloses that material 81 fills the
`portion of conductor lumen 29 that is occupied by conductive wires 56, 57.
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`In light of these teachings, Petitioner has not explained persuasively why or
`
`how Ormsby would have motivated a person of ordinary skill in the art to,
`nonetheless, “fill the portion of Stolz’s conductor lumens that are not occupied by
`its conductive wires.” Pet. 22 (emphasis added), 35–36. Ormsby is silent as to any
`benefit associated with filling portions of the conductor lumen that are not
`occupied by conductor wires, and Petitioner does not demonstrate sufficiently that
`any benefits of kink resistance also would be realized if fill material were utilized
`in a portion of the lumen that lacks the conductor wires present in Ormsby’s
`lumen. Thus, because Ormsby does not address using a fill material in a “portion
`of at least one of the conductor lumens of the lead body that is not occupied by the
`conductor wires,” as claimed, we find Petitioner’s contention that Ormsby would
`have motivated such a modification to lack sufficient support in Ormsby’s
`disclosure.
`
`Moreover, the cited portions of the Plishka Declaration fail to support
`Petitioner’s contention. Id. at 35–36 (citing Ex. 1003 ¶¶ 78, 146–150). Cited
`paragraph 78 concerns Stolz and, as such, does not support Petitioner’s contention
`regarding the motivation purportedly offered by Ormsby. Ex. 1003 ¶ 78. Cited
`paragraph 146 states, “Ormsby, in addition to explaining why a POSA would fill
`long, unoccupied lumen spaces, also provides alternative methods for filling a
`lumen.” Id. ¶ 146. However, this statement is not supported by Ormsby, which
`does not fill “unoccupied lumen spaces.” See Ex. 1006, 7 (addressing how to fill
`lumen spaces occupied by conductor wires 56, 57); compare Ex. 1003 ¶ 146, with
`id. ¶¶ 147–148 (acknowledging conductors 56, 57 occupy lumen). Additionally,
`cited paragraph 149 states that “filling Stolz’s empty conductor lumens would
`provide the benefit, as taught by Ormsby, of reducing the possibility of kinking in
`Stolz’s lead, while improving axial stability.” This paragraph, however, fails to
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`provide any support for the conclusion that benefits associated with filling lumen
`spaces in which conductor wires are present would also apply when filling empty
`lumen spaces. Ex. 1003 ¶ 149. For these reasons, we are not persuaded by
`Petitioner’s contention that Ormsby would have motivated a person of ordinary
`skill in the art to fill Stolz’s empty conductor lumen portions.
`
`Second, even if Ormsby would have provided a motivation to fill the empty
`portions of Stolz’s conductor lumens, we are not persuaded by Petitioner’s
`contention that it would have been obvious to “insert[ ] monofilament” to fill such
`voids. Petitioner contends that this modification would have been obvious to try
`because there are a limited number of ways to fill a lumen that has the specific
`shape, size, and configuration disclosed by Stolz, e.g., “a straight, narrow,
`cylindrical void.” Pet. 37. To support this position, Petitioner relies on
`Mr. Plishka’s testimony that “a POSA would have naturally looked for a filling
`option that would match the size, shape, and configuration of the lumen.”
`Ex. 1003 ¶ 151. Mr. Plishka’s testimony appears to be conclusory, in that he does
`not provide any evidence, or much supporting analysis, as to why this statement is
`correct. However, even if true, Petitioner has additionally not shown that “there
`are a limited number” of options, such that it would have been obvious to try
`monofilament.
`
`As an initial matter, neither the Petition nor Mr. Plishka identify the specific
`shape, size, and configuration of the lumen, to which the filling material must
`match. Petitioner characterizes this shape as “a straight, narrow, cylindrical void”
`(Pet. 37) and Mr. Plishka explains that it is “a straight, cylindrical space” (Ex. 1003
`¶ 151). However, neither specific nor relative dimensions are discussed in any
`manner. As such, any comparison of potential filling materials to this purported
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`shape is necessarily vague, approximate, imprecise, and insufficient to demonstrate
`that a limited number of options would have existed.
`
`Furthermore, Mr. Plishka testifies that the only options available to fill the
`empty portions of Stolz’s conductor lumens would have been “liquids, powdered
`solids, and non-powder solids (gasses not being an attractive option).” Id. ¶ 153.
`However, this testimony establishes that the options would have been quite
`numerous, and certainly not “limited.” Indeed, Mr. Plishka testifies that the
`potential options would have included any material that is “straight” and
`“cylindrical,” and that comes from the general classes of liquids, powders, or
`solids. Id. According to Mr. Plishka, gases are the only materials excluded from
`consideration as a filling material. Id. Thus, we are not persuaded by Petitioner’s
`contention that monofilament is merely one of a “limited number” of options. See,
`e.g., Prelim. Resp. 39–40 (“The Petition does not identify these finite possibilities
`other than by reference to the general categories of liquids, powdered solids, and
`non-powdered solids. By this rationale, using uranium (non-powdered solid),
`gasoline (liquid), or sand (powdered solid) would be just as ‘obvious’ as using
`monofilament.”).
`
`Moreover, the Petition and Mr. Plishka fail to explain sufficiently why or
`how it would have been obvious to choose monofilament specifically, out of all
`possible filling materials. Even accepting Mr. Plishka’s opinion that a person of
`ordinary skill in the art would have selected a material having the same shape as
`the lumen, see Ex. 1003 ¶ 151, the Petition does not explain why monofilament
`would have been chosen over other materials that have, or are capable of having,
`the same shape, e.g., a liquid epoxy or resin as taught by Ormsby (which would
`conform to the straight, narrow, cylindrical shape of the lumen), a polymer powder
`as taught by Ormsby (which would also conform to the straight, narrow,
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`cylindrical shape of the lumen), or even a solid birthday candle (which would
`match the straight, narrow, cylindrical shape of the lumen). Without sufficient
`articulated support, grounded in evidence of record, Petitioner’s choice of
`monofilament appears to be driven by hindsight. Innogenetics, N.V. v. Abbott
`Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) (“We must still be careful not to
`allow hindsight reconstruction of references to reach the claimed invention without
`any explanation as to how or why the references would be combined to produce
`the claimed invention.”); W.L. Gore & Assocs, Inc. v. Garlock, Inc., 721 F.2d
`1540, 1553 (Fed Cir. 1983) (“To imbue one of ordinary skill in the art with
`knowledge of the invention in suit, when no prior art reference or references of
`record convey or suggest that knowledge is to fall victim to the insidious effect of a
`hindsight syndrome wherein that which only the inventor taught is used against its
`teache[s].”).
`
`Paragraph 153 of the Plishka Declaration cites three publications which
`purportedly “confirm [Mr. Plishka’s] understanding of the state of the art.”
`Ex. 1003 ¶ 153. We do not find these citations to cure the deficiencies discussed
`above. For example, the cited Huepenbecker publication discloses a monofilament
`tensile member that is inserted into a lumen, so as to communicate traction forces
`from one end of the lead to another. Ex. 1012, 4–5. However, as seen in Figure 4,
`tensile member 50 does not fill the lumen and, as such, does not support
`Mr. Plishka’s opinion that monofilament would have been one of a limited number
`of options to try, when seeking to fill voids in Stolz’s lumens. Id. at Fig. 4.
`Similarly, the cited Mahurkar patent discloses a catheter with nylon reinforcing
`strip 50, which also transmits forces through the catheter and prevents collapse.
`Ex. 1014, 6:43–53, 7:25–31. This element, however, is not located in a lumen and
`is not a monofilament. Id. at Figs. 2, 4–6. Although not referred to explicitly in
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`Mr. Plishka’s Declaration, we note that Mahurkar also discloses spiral 70, which
`may be a monofilament. Id. at 8:3–14. However, spiral 70 is not located in a
`lumen and, as such, does not support Mr. Plishka’s opinion that monofilament
`would have been one of a limited number of options to try, when seeking to fill
`voids in Stolz’s lumens. See id. at Fig. 2. Finally, the cited Whitfill patent
`discloses a logging cable, in which strands 20 are twisted around monofilament 21,
`such that the strands embed in the monofilament when subjected to heat. Ex. 1014,
`1:52–58, 2:62–3:10, Fig. 2. Whitfill, however, does not disclose a lumen. Id. As
`such, Whitfill does not support Mr. Plishka’s opinion that monofilament would
`have been one of a limited number of options to try, when seeking to fill voids in
`Stolz’s lumens.
`
`The Plishka Declaration also cites a patent to Verness, which “has a similar
`disclosure to Ormsby . . . [and] teaches that filling the conductor lumen increases
`its perforation resistance, minimizes the possibility of separation of components of
`the lead body, and better supports components within a fused matrix support.”
`Ex. 1003 ¶ 154 (citing Ex. 1007 ¶¶ 1, 6–10, 12–15). However, Verness does not
`disclose a monofilament, and, thus, does not support Mr. Plishka’s opinion that
`monofilament would have been one of a limited number of options to try, when
`seeking to fill voids in Stolz’s lumens. Moreover, cited paragraph 13 suggests that
`reinforced conductor lumens may cause problems, e.g., reinforcement “can stiffen
`the lead body unduly and may increase the likelihood of stress-related fracture.”
`Ex. 1007 ¶ 13. Similarly, cited paragraph 15 suggests that filling void spaces
`within a lumen “may or may not reduce the possibility of lead conductor fracture
`through abrasion or crushing.” Id. ¶ 15. As such, this disclosure does not support
`Mr. Plishka’s opinion that monofilament would have been one of a limited number
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`of options to try, when seeking to fill voids in Stolz’s lumens, and, indeed,
`suggests against the proposed modification to Stolz’s lumens.
`
`Therefore, on the record before us, we determine that Petitioner has not
`provided persuasive reasoning, with sufficient rational underpinnings, to support
`its contention that it would have been obvious to have “insert[ed] monofilament
`into at least one portion of at least one of the conductor lumens of [Stolz’s] lead
`body that is not occupied by the conductor wires,” as required by claim 1. See In
`re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[Unpatentability based on]
`obviousness grounds cannot be sustained by mere conclusory statements; instead,
`there must be some articulated reasoning with some rational underpinning to
`support the legal conclusion of obviousness.”). As such, Petitioner has not
`demonstrated a reasonable likelihood it would prevail in establishing the
`unpatentability of challenged claim 1.
`5. Dependent Claims 2, 3, 6–12, and 14–17
`Claims 2, 3, 6–12, and 14–17 all depend, directly or indirectly, from claim 1.
`Therefore, for the same reasons discussed above with respect to claim 1, Petitioner
`has not demonstrated a reasonable likelihood it would prevail in establishing the
`unpatentability of these challenged claims.
`
`E. Remaining Asserted Grounds of Unpatentability
`Petitioner contends that claims 4, 5, 13, 18, and 19 would have been obvious
`over Stolz, Ormsby, Black, and the knowledge of a POSA, in further combination
`with Modern Plastics (for claims 4, 5, and 13), Wessman (for claim