Trials@uspto.gov
`571.272.7822
`
`
` Paper No. 10
`Filed: May 31, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACCLARENT, INC.,
`Petitioner,
`
`v.
`
`FORD ALBRITTON, IV,
`Patent Owner.
`____________
`
`Case IPR2018-00268
`Patent 9,011,412 B2
`____________
`
`
`
`Before JOSIAH C. COCKS, BEVERLY M. BUNTING, and
`RICHARD H. MARSCHALL, Administrative Patent Judges.
`
`MARSCHALL, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`

`

`IPR2018-00268
`Patent 9,011,412 B2
`
`
`I.
`
`INTRODUCTION
`
`Acclarent, Inc. (“Petitioner”) filed a Petition for inter partes review of
`
`claims 8–13 of U.S. Patent No. 9,011,412 B2 (Ex. 1001, “the ’412 patent”).
`
`Paper 1 (“Pet.”), 24. Ford Albritton, IV (“Patent Owner”) filed a
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`Preliminary Response. Paper 8 (“Prelim. Resp.”). Institution of an inter
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`partes review is authorized by statute only when “the information presented
`
`in the petition . . . and any response . . . shows that there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
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`claims challenged in the petition.” 35 U.S.C. § 314(a); see 37 C.F.R.
`
`§ 42.108. For the reasons set forth below, we conclude that the information
`
`presented in the Petition fails to establish a reasonable likelihood that
`
`Petitioner will prevail in showing the unpatentability of claims 8–13.
`
`Accordingly, we decline to institute an inter partes review.
`
`A. Related Matters
`
`Petitioner and Patent Owner identify the following proceeding in the
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`U.S. District Court for the Northern District of Texas as a related matter:
`
`Dr. Ford Albritton IV v. Acclarent, Inc., No. 3:16-cv-03340-D (filed Dec. 1,
`
`2016). Pet. 5; Paper 4, 2. Claims 1–7 and 14–20 of the ’412 patent—not
`
`challenged here—are the subject of a pending inter partes review, IPR2017-
`
`00498, instituted on July 10, 2017. Id.
`
`B. The ’412 Patent
`
`The ’412 patent is titled “APPARATUS, SYSTEM AND METHOD
`
`FOR MANIPULATING A SURGICAL CATHETHER AND WORKING
`
`DEVICE WITH A SINGLE HAND.” Ex. 1001, (54). The ’412 patent
`
`describes the functions performed by the handle structure in the following
`
`manner:
`
`2
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`

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`IPR2018-00268
`Patent 9,011,412 B2
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`
`The handle has a structure to allow a position of the guide
`catheter to be controlled by some or all of three fingers of one
`hand of an operator of the handle. The structure of the handle is
`adapted to permit the operator to position a thumb and index
`finger of the hand to manipulate a working device inserted into
`the lumen of the guide catheter, where the working device is
`manipulable via a portion of the working device immediately
`adjacent to the handle.
`
`Id. at Abstract.
`
`Figure 3 of the ’412 patent is reproduced below:
`
`
`
`Figure 3 shows surgical catheter 300 having handle 350 and guide 302. Id.
`
`at 3:51–56. Handle 350 includes opening 318, through which working
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`devices, such as “an endoscope, guidewire or other working device may be
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`inserted.” Id. at 4:4–9. Attaching a suction source at handle coupling 320
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`provides suction at the distal end of guide 302. Id. at 4:12–15. Opening 354
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`on handle 350 allows “the user to control the amount of suction present at
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`the distal end of the guide 302.” Id. at 4:18–21.
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`3
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`IPR2018-00268
`Patent 9,011,412 B2
`
`
`The specification explains that the user holds handle 350 using “some
`
`or all of the small finger, the ring finger and the middle finger,” while “[t]he
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`fore finger and thumb are left free to manipulate a working device inserted
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`into the opening 318.” Id. at 4:62–5:3. The upper and lower portions of
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`handle 350 form an angle that facilitates manipulation of the working device
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`while simultaneously allowing the remaining fingers to control the position
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`of guide 302. Id. at 5:8–18, 5:23–33.
`
`C. Claims
`
`Of the challenged claims, claim 8 is independent and is reproduced
`
`below:
`
`8. A method comprising:
`inserting a guide catheter through an external body passage of a
`subject, wherein the guide catheter comprises a substantially
`rigid shaft, a proximal opening, a distal opening and a lumen
`extending between the proximal opening and the distal
`opening;
`
`coupling a source of suction to the lumen through the handle;
`
`inserting a working device through a handle opening in a handle
`coupled to the guide catheter and into the lumen of the guide
`catheter;
`
`controlling a position of the guide catheter using the handle that
`is formed to allow the position of the guide catheter to be
`controlled by some or all of three fingers of a hand, while
`substantially simultaneously manipulating
`the working
`device with a thumb and index finger of the hand via a portion
`of the working device immediately adjacent to the handle
`opening; and
`
`controlling the position of the guide catheter using the handle,
`while substantially simultaneously controlling, by one of the
`thumb or index finger, an amount of suction coupled to the
`distal opening of the lumen.
`
`Ex. 1001, 6:34–55.
`
`4
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`

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`IPR2018-00268
`Patent 9,011,412 B2
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`
`D. The Prior Art
`
`Petitioner relies on the following prior art references:
`
`Reference
`
`Date
`
`Exhibit No.
`
`U.S. Patent Pub. No. 2007/0250105 A1
`issued to Ressemann et al. (“Ressemann”)
`U.S. Patent No. 8,747,389 B2 issued to
`Goldfarb et al. (“Goldfarb”)
`U.S. Patent Pub. No. 2006/0063973 A1
`issued to Makower et al. (“Makower”)
`U.S. Patent No. 4,915,691 issued to Jones
`et al. (“Jones”)
`
`
`E. Asserted Grounds of Unpatentability
`
`Oct. 25, 2007
`
`1006
`
`June 10, 2014
`
`1007
`
`Mar. 23, 2006
`
`1008
`
`Apr. 10, 1990
`
`1009
`
`Petitioner challenges claims 8–13 based on the following grounds
`
`(Pet. 24):
`
`Ground
`
`No.
`
`1
`
`2
`
`
`
`Reference(s)
`
`Basis Challenged Claims
`
`Ressemann and Goldfarb
`
`§ 103
`
`8 and 11–13
`
`Makower and Jones
`
`§ 103
`
`8–13
`
`A. Claim Construction
`
`II. ANALYSIS
`
`In an inter partes review, a claim in an unexpired patent shall be given
`
`its broadest reasonable construction in light of the specification of the patent
`
`in which it appears. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v.
`
`Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest
`
`reasonable interpretation standard). Consistent with the broadest reasonable
`
`construction, claim terms are presumed to have their ordinary and customary
`
`meaning as understood by a person of ordinary skill in the art in the context
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`IPR2018-00268
`Patent 9,011,412 B2
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`of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
`
`1257 (Fed. Cir. 2007).
`
`Petitioner proposes explicit constructions for the claim limitations
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`“formed to allow” and “manipulating the working device with a thumb and
`
`index finger.” Pet. 15–21. Patent Owner does not address claim
`
`construction in its Preliminary Response. We need not provide an explicit
`
`construction for the claim terms identified by Petitioner in order to resolve
`
`the issues presented in the Petition. See Vivid Techs., Inc. v. Am. Sci. &
`
`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be
`
`construed that are in controversy, and only to the extent necessary to resolve
`
`the controversy.”).
`
`B. Person of Ordinary Skill in the Art
`
`Petitioner contends that a person of ordinary skill in the art “would
`
`have had at least a bachelor’s degree in either electrical engineering or
`
`mechanical engineering, or equivalent, with at least four years’ experience
`
`designing surgical instruments, or a doctor of medicine (M.D.) and at least 2
`
`years of experience with laparoscopic or endoscopic surgical procedures.”
`
`Pet. 13. Patent Owner does not address Petitioner’s proposal. We adopt
`
`Petitioner’s proposal for purposes of this Decision. Additionally, we note
`
`that the prior art of record in this proceeding is indicative of the level of
`
`ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355
`
`(Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).
`
`C. Ground 1 — Obviousness Based on Ressemann and Goldfarb
`
`Petitioner alleges that claims 8 and 11–13 are unpatentable based on
`
`Ressemann and Goldfarb under 35 U.S.C. § 103(a). Pet. 24–42. We
`
`determine, on this record, that Petitioner has not established a reasonable
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`IPR2018-00268
`Patent 9,011,412 B2
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`likelihood of prevailing on its assertion that any of claims 8 and 11–13
`
`would have been obvious.
`
`1. Principles of Law
`
`A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
`
`between the claimed subject matter 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
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`question of obviousness is 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) where in evidence, so-called secondary
`
`considerations. Graham v. John Deere Co. of Kansas City, 383 U.S. 1,
`
`17–18 (1966).
`
`As the Supreme Court explained in KSR, an invention “composed of
`
`several elements is not proved obvious merely by demonstrating that each of
`
`its elements was, independently, known in the prior art.” 550 U.S. at 418.
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`Rather, “it can be important to identify a reason that would have prompted a
`
`person of ordinary skill in the relevant field to combine the elements in the
`
`way the claimed new invention does.” Id. In other words, “there must be
`
`some articulated reasoning with some rational underpinning to support the
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`legal conclusion of obviousness.” Id. (quoting In re Kahn, 441 F.3d 977,
`
`988 (Fed. Cir. 2006)). Accordingly, the U.S. Court of Appeals for the
`
`Federal Circuit has made clear that a petitioner in an inter partes review
`
`proceeding cannot “satisfy its burden of proving obviousness” by
`
`“employ[ing] mere conclusory statements” and “must instead articulate
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`IPR2018-00268
`Patent 9,011,412 B2
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`specific reasoning, based on evidence of record” to support an obviousness
`
`determination. In re Magnum Oil Tools Int’l, 829 F.3d 1364, 1380–81 (Fed.
`
`Cir. 2016).
`
`We analyze this ground based on obviousness in accordance with the
`
`above-stated principles.
`
`2. Overview of Ressemann
`
`Ressemann discloses “[a] method of treating a constricted sinus
`
`passageway” that employs an “elongate member having an inflation
`
`member.” Ex. 1006, Abstract. Expansion of the inflation member expands
`
`at least a portion of the constricted sinus passageway. Id.
`
`Ressemann’s Figures 11A–11C depict wire movement guide 130
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`“used to facilitate one-handed movement of both the wire guide 24 and
`
`guide catheter 18.” Id. ¶ 117. “The wire movement guide 130 may be
`
`formed as a recessed handle or the like.” Id.
`
`Ressemann’s Figure 11D is reproduced below.
`
`8
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`IPR2018-00268
`Patent 9,011,412 B2
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`
`
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`Figure 11D depicts use of wire movement guide 130 to move guide catheter
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`18 into a desired position. Id. ¶ 119. Wire movement guide 130 includes
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`wire recess 136 for receiving wire guide 24. Id. ¶ 117. Wire movement
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`guide 130 also includes recess 134 that receives steering device 26. Id. The
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`structure allows a user to use wire movement guide 130 to move guide
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`catheter 18 “while simultaneously advancing and/or rotating wire guide 24
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`with a single hand.” Id. ¶ 119.
`
`
`
`
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`9
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`IPR2018-00268
`Patent 9,011,412 B2
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`
`3. Overview of Goldfarb
`
`Goldfarb discloses devices for dilating passageways within the ear,
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`nose, and throat. Ex. 1007, Abstract. Goldfarb discloses a “dilation catheter
`
`device . . . that facilitates ease of use by the operator and, in at least some
`
`cases, allows the dilation procedure to be performed by a single operator.”
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`Id. The dilation catheter may be used in conjunction with an endoscope, and
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`“an optional handle may be used to facilitate grasping or supporting a
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`[dilation catheter] as well as another device (e.g., an endoscope) with a
`
`single hand.” Id.
`
`Goldfarb’s Figures 3A and 8A are reproduced below.
`
`
`
`
`
`
`
`
`
`
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`Figure 3A depicts handle 42a having fluid channel 52 extending from
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`lumen 47 downwardly through head 44a and through handle member 48a.
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`Id. at 11:14–17. “[I]rrigation and/or suction tube 54 may be attached” to
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`handle member 48a. Id. at 11:19–21. In some embodiments, handle 48
`
`“may have a suction hole where the user must cover the suction hole to
`
`actuate suction through the optional handle 42.” Id. at 11:6–12. Figure 8A,
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`reproduced above, depicts an example of how “handle 42 may be used to
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`10
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`IPR2018-00268
`Patent 9,011,412 B2
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`facilitate concurrent holding of an endoscope as well as the guide catheter”
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`with a single hand of the operator. Id. at 11:50–54. In Figure 8A, an
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`operator holds endoscope 60 and handle member 48 of guide catheter 40c in
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`one hand, while manipulating the guidewire GW and dilation catheter 10 in
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`the other hand. Id. at 11:58–12:3. An operator can bend malleable handle
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`member 48 to form an angle between the shaft of guide catheter 40c and
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`endoscope 60 to facilitate the operation. Id. at 12:17–32.
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`4. Discussion
`
`With respect to independent claim 8, Petitioner relies on the
`
`disclosures of Ressemann and Goldfarb and the declarations of Howard
`
`Levine, M.D. and Randy Kesten in support of its allegations. See Pet. 24–
`
`42; Ex. 1004 (“Levine Declaration” or Levine Decl.”); Ex. 1005 (“Kesten
`
`Declaration” or “Kesten Decl.”). For example, Petitioner relies on
`
`Ressemann as disclosing the preamble (Pet. 24 (citing Levine Decl. ¶ 52;
`
`Kesten Decl. ¶ 84)) and “inserting a guide catheter” limitation (Pet. 24–26
`
`(citing Levine Decl. ¶¶ 54–55; Kesten Decl. ¶¶ 28, 86–87; Ex. 1006 ¶¶ 12,
`
`99, 101, Fig. 11D)). Petitioner also relies on Ressemann as disclosing the
`
`“inserting a working device through a handle opening” limitation (id. at 31–
`
`33 (citing Levine Decl. ¶¶ 58–59; Kesten Decl. ¶¶ 89–90; Ex. 1006 ¶ 117,
`
`11D)); and the limitation requiring “controlling a position of the guide
`
`catheter . . . while substantially simultaneously manipulating the working
`
`device with a thumb and index finger of the hand.” Id. at 33–34 (citing
`
`Levine Decl. ¶¶ 60, 62–65, 91, 93; Kesten Decl. ¶¶ 91–95; Ex. 1006 ¶ 119,
`
`11D)).
`
`For the limitation requiring “coupling a source of suction to the lumen
`
`through the handle,” Petitioner relies on Goldfarb’s disclosure of a suction
`
`11
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`IPR2018-00268
`Patent 9,011,412 B2
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`tube attached to Goldfarb’s handle to suction fluid through a fluid channel.
`
`Id. at 26 (citing Ex. 1007, 11:19–22). Petitioner argues that “[w]hile
`
`Ressemann does not teach the use of suction, it would have been obvious to
`
`modify Ressemann in view of Goldfarb to couple a source of suction to the
`
`lumen through the handle for suctioning fluid through the lumen of the guide
`
`catheter.” Id. at 26. Petitioner also relies on Goldfarb as disclosing the
`
`limitation requiring “controlling the position of the guide catheter using the
`
`handle, while substantially simultaneously controlling, by one of the thumb
`
`or index finger, an amount of suction coupled to the distal opening of the
`
`lumen.” Id. at 35. According to Petitioner, one of skill in the art “would
`
`have found it obvious to add a suction vent or hole in the handle (wire
`
`movement guide 130) of Ressemann, as taught by Goldfarb,” and “would
`
`have controlled the guide catheter and simultaneously controlled suction
`
`with the thumb . . . [and] index finger of the same hand.” Id. (citing Levine
`
`Decl. ¶¶ 66–68, Kesten Decl. ¶¶ 96–97).
`
`In Patent Owner’s Preliminary Response, Patent Owner argues that
`
`the references teach away from the combination and render the references
`
`inoperable. Prelim. Resp. 24–27. More specifically, Patent Owner argues
`
`that “it is impossible for the combination of Ressemann and Goldfarb to
`
`‘coupl[e] a source of suction to the lumen through the handle’ . . . because
`
`suction cannot go through solid material” forming Ressemann’s handle. Id.
`
`at 25. Patent Owner also argues that Petitioner relies on impermissible
`
`hindsight and conclusory statements to render the claims invalid. Id. at 28–
`
`33. For example, Patent Owner refers to Petitioner’s repeated reference to
`
`what one of ordinary skill in the art “could have” done, rather than focus on
`
`why one would have combined the references to render the claimed method
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`12
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`IPR2018-00268
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`obvious, raising “a specter of impermissible hindsight bias.” Id. at 31.
`
`Finally, Petitioner argues that objective indicia of nonobviousness support a
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`conclusion of nonobviousness. Id. at 33–38.
`
` After consideration of the parties’ arguments and evidence, we are
`
`not persuaded that Petitioner has established sufficiently how Ressemann
`
`and Goldfarb would have been combined to arrive at the claimed invention,
`
`and why one of skill in the art would have made the combination in a
`
`manner that renders the claimed method obvious. The lack of explanation
`
`and evidence are most apparent in relation to the limitations requiring
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`“coupling a source of suction to the lumen through the handle” and
`
`“controlling . . . the guide catheter . . . while substantially simultaneously
`
`controlling, by one of the thumb or index finger, an amount of suction.”
`
`Regarding the “coupling a source of suction” limitation, Petitioner
`
`acknowledges that Ressemann does not mention suction, and argues that
`
`adding the suction of Goldfarb remedies this deficiency, but does not explain
`
`adequately how one of ordinary skill in the art would incorporate the
`
`structure of Goldfarb into Ressemann’s structure. See Pet. 26–31. For
`
`example, Petitioner relies on Goldfarb’s “suction tube 54,” but Petitioner
`
`fails to explain adequately how it proposes to add such a tube to
`
`Ressemann’s handle to provide suction. Pet. 26, 28. The Petition also
`
`alleges that the “addition of a suction hole, as taught by Goldfarb, to the
`
`handle of Ressemann would allow the user to simply position the thumb or
`
`finger of the hand holding the device over the hole to control suction, while
`
`simultaneously controlling the position of the guide catheter.” Id. at 30–31
`
`(citing Levine Decl. ¶ 57). That statement is not persuasive because it does
`
`not describe how such a suction hole would have been added to Ressemann
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`IPR2018-00268
`Patent 9,011,412 B2
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`to couple a suction source to Ressemann’s handle. See 37 C.F.R. § 42.65(a)
`
`(“Expert testimony that does not disclose the underlying facts or data on
`
`which the opinion is based is entitled to little or no weight.”).
`
`The prior art does not fill these gaps, and instead includes structural
`
`differences that underscore the need for further evidence and analysis.
`
`Ressemann does not even mention suction. Goldfarb discloses a suction
`
`tube and the use of a hole relied on by Petitioner, but does not depict the
`
`hole in the related drawings or describe its location on the handle. See Ex.
`
`1007, 11:6–34, Figs. 3, 3A–3C. Moreover, Goldfarb’s handle 48 appears to
`
`be a hollow, “shapeable” tube surrounding suction tube 54. See id. at 10:49–
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`11:12, 11:19–22, Figs. 3, 3A–3C. Ressemann’s handle (wire movement
`
`guide 130), as Patent Owner points out, employs a half-circle shape with
`
`open recess 134 that accommodates steering device 26. Ex. 1006 ¶¶ 117,
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`119, Figs. 11B, 11D; see also Prelim. Resp. 24–25. It is not apparent from
`
`the Petition, without further explanation or evidence, how simply adding a
`
`hole to Ressemann’s half-circle wire movement guide 130 adds suction to
`
`the device. Similarly, it is not apparent how Petitioner proposes to add
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`Goldfarb’s suction tube 54 to Ressemann’s structure, especially when the
`
`recess 134 within Ressemann’s “handle” already houses steering device 26.
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`See Ex. 1006 Fig. 27D.
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`The accompanying expert declarations similarly lack any detailed
`
`analysis of the structure resulting from the proposed combination. See
`
`Levine Decl. ¶ 57; Kesten Decl. ¶ 88. Notably, Dr. Levine relies on Mr.
`
`Kesten’s opinion that the modification of Ressemann’s handle to include the
`
`valve or suction hole of Goldfarb would have been routine. Levine Decl.
`
`¶ 57. Mr. Kesten, however, refers to adding Goldfarb’s structure to “the
`
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`IPR2018-00268
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`guide catheter of Ressemann,” even though claim 8 requires coupling
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`suction to the handle, not the separately claimed guide catheter. Kesten
`
`Decl. ¶ 88.
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`The lack of detail provided regarding how to modify Ressemann to
`
`couple a suction source to its handle creates additional problems when
`
`considering the limitation requiring “substantially simultaneously
`
`controlling, by one of the thumb or index finger, an amount of suction.” The
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`manner and location of the added suction capability necessarily impacts the
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`ability to control suction using specific fingers while simultaneously
`
`controlling the guide catheter. The Petition does not explain adequately how
`
`the resulting structure allows a user to perform this step of the claimed
`
`method. See Pet. 35–38. Mr. Kesten opines that one of skill in the art
`
`“would have understood that Goldfarb’s suction hole could have been placed
`
`anywhere on the handle of Ressemann to control suction through the guide
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`catheter, and that, in accordance with Goldfarb, the thumb or index finger
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`would have been used to control an amount of suction.” Kesten Decl. ¶ 97.
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`A hole alone does not provide suction, and to the extent that Petitioner
`
`suggests adding Goldfarb’s suction tube 54 in fluid communication with a
`
`hole within Ressemann’s handle, the theory and details are not adequately
`
`laid out in the Petition and accompanying declarations. Moreover, without
`
`those structural details regarding the proposed combination, merely
`
`surmising that one “would have understood” that the hole “could have been
`
`placed anywhere” to allow one to practice the claimed method is too thin a
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`15
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`reed to support a conclusion of obviousness here.1 Rather, as Patent Owner
`
`asserts, the analysis suggests that improper hindsight was used rather than
`
`teachings from the prior art.
`
` As noted above, a petitioner in an inter partes review proceeding
`
`cannot “satisfy its burden of proving obviousness” by “employ[ing] mere
`
`conclusory statements” and “must instead articulate specific reasoning,
`
`based on evidence of record” to support an obviousness determination.
`
`Magnum Oil, 829 F.3d at 1380–81. The “factual inquiry” into the reasons
`
`for “combin[ing] references must be thorough and searching, and the need
`
`for specificity pervades . . . .” In re Nuvasive, Inc., 842 F.3d 1376, 1381–82
`
`(Fed. Cir. 2016) (internal quotations and citations omitted). A determination
`
`of obviousness cannot be reached where the record lacks “explanation as to
`
`how or why the references would be combined to produce the claimed
`
`invention.” Trivascular, 812 F.3d at 1066; see Nuvasive, 842 F.3d at 1382–
`
`85; Magnum Oil, 829 F.3d at 1380–81.
`
`
`
`1 In a similar vein, Dr. Levine opines that one “adding Goldfarb’s suction
`hole to Ressemann would have controlled the guide catheter and
`simultaneously controlled suction with the thumb or index finger of the same
`hand” because “[t]hat would have been the . . . motivation to add the hole to
`the handle.” Levine Decl. ¶ 68. This opinion lacks any citation for support
`and, like Mr. Kesten’s opinion, fails to explain how the general reference to
`adding a hole to Ressemann adds suction to Ressemann in a manner that
`allows for simultaneous suction control using a thumb or index finger while
`manipulating the guide catheter. See id. Without “a reasoned explanation
`that avoids conclusory generalizations,” Dr. Levin’s testimony, as well as
`Mr. Kesten’s, is not sufficient. See Arendi S.A.R.L. v. Apple Inc., 832 F.3d
`1355, 1362 (Fed. Cir. 2016) (quoting Perfect Web Techs., Inc. v.
`InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009)).
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`We are not persuaded by Petitioner’s argument and evidence that
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`claim 8 would have been obvious based on Ressemann and Goldfarb. Each
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`of dependent claims 11–13 depends directly or indirectly from independent
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`claim 8. Petitioner’s analyses of the dependent claims do not cure the
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`deficiencies noted above. Therefore, for the same reasons as discussed with
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`respect to claim 8, our determination concerning the insufficiency of
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`Petitioner’s evidence applies equally to the arguments addressed to
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`dependent claims 11–13.
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`D. Ground 2 — Obviousness Based on Makower and Jones
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`Petitioner alleges claims 8–13 are unpatentable based on Makower
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`and Jones under 35 U.S.C. § 103(a). Pet. 42–59. We determine, on this
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`record, that Petitioner has not established a reasonable likelihood of
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`prevailing on its assertion that any of claims 8–13 would have been obvious.
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`1. Overview of Makower
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`Makower discloses devices “for treating disorders of the ear, nose,
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`throat, . . . [and] . . . sinuses” and “hand held devices having pistol type grips
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`and other handpieces.” Ex. 1008, Abstract. Makower’s Figure 27C is
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`reproduced below.
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`Figure 27C depicts guidewire 2710 introduced through surgical hand tool
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`2700. Id. ¶ 223. A user can navigate guidewire 2710 through a patient’s
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`anatomy by using torqueing device 2712. Id. Proximal body 2702 includes
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`handle 2724, and a distal region of proximal body 2702 includes a “suitable
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`hub that allows a guide catheter 2714 to attach to proximal body 2702.” Id.
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`¶ 222.
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`Makower also contemplates the use of suction through the distal end
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`of the various guide catheters disclosed in Makower, “unless to do so would
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`render the device unuseable for its intended purpose.” Id. ¶ 167. When
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`describing suction, Makower refers to embodiments shown in Figures 8A
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`and 9. Id. ¶¶ 167, 170, Figs. 8A, 9.
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`2. Overview of Jones
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`Jones discloses a “self-contained hand held medical aspirating
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`device.” Ex. 1009, Abstract. Jones refers to the device as a “medical
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`suction apparatus” connected to a vacuum source with vacuum supply tube
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`15. Id. at 1:9, 3:48–50.
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`Figure 2 of Jones is reproduced below.
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`Figure 2 depicts catheter 11, vacuum line 15, and thumb control hole 28. Id.
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`at 4:21–23. Jones discloses a device that, when in use, positions a user’s
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`thumb near thumb control hole 28. Id. at 4:20–22, Fig. 2. When a user
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`desires suction at the end of catheter 11, thumb control hole 28 is covered by
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`the thumb. Id. at 4:26–30.
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`3. Discussion
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`With respect to claim 8, Petitioner relies on Makower as disclosing all
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`of the limitations with the exception of “controlling the position of the guide
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`catheter using the handle, while substantially simultaneously controlling, by
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`one of the thumb or index finger, an amount of suction.” Pet. 42–53. For
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`that limitation, Petitioner relies on Jones, which discloses thumb control hole
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`28. Id. at 50 (citing Ex. 1009, 4:35–38). Petitioner notes that Makower
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`itself suggests the use of suction, Jones teaches control of suction while
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`manipulating a guide catheter, and Jones stresses the advantages of single-
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`handed operation. Id. at 50–52 (citing Ex. 1008 ¶¶ 167, 170; Ex. 1009,
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`1:26–28, 2:5–13, 2:49–50, 2:52–54, 3:17–19, 4:35–38). According to
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`Petitioner, it would have been obvious to one of ordinary skill in the art “to
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`include a suction hole in the handle [of Makower] at a location that would
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`allow for control using the thumb, as taught by Jones.” Id. at 52 (citing
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`Levine Decl. ¶¶ 103–104; Kesten Decl. ¶ 132). Petitioner contends that the
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`“addition of a thumb hole in the handle would have necessarily resulted in
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`the user controlling the guide catheter while simultaneously controlling, by
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`the thumb, an amount of suction coupled to the distal opening of the lumen.”
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`Id. (citing Levine Decl. ¶ 103).
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`Patent Owner raises similar arguments in the context of Makower and
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`Jones as it did with respect to the proposed combination of Ressemann and
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`Goldfarb. Prelim. Resp. 27–38. For example, Patent Owner argues that the
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`combination of Makower and Jones would render Makower inoperable. Id.
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`at 28 (citing Levine Decl. ¶ 118; Kesten Decl. ¶¶ 132–134; Ex. 1009 ¶ 149).
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`According to Patent Owner, the location of the thumb hole in Jones at the
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`rear of the handle occupies the same space as the hub in Makower that
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`receives the guidewire, and the guidewire would block access to the opening
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`for use as a suction-creating thumb hole as in Jones. Id. Attempting to use
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`the hub to control suction would also tend to dislodge the guidewire from its
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`intended location, contrary to the purpose of Makower, in Patent Owner’s
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`view. Id. Patent Owner further argues that the Petition and related
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`declarations rely on impermissible hindsight and conclusory statements, and
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`that objective indicia support a conclusion of nonobviousness. Id. at 29–38.
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`Petitioner’s analysis and evidence with respect to the proposed
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`combination of Makower and Jones suffers from several of the same
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`problems discussed above with respect to the proposed combination of
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`Ressemann and Goldfarb. For example, Petitioner seems to assume that the
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`combination of Jones’s thumb hole with Makower’s device would be
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`routine, but never describes precisely how the structures would have been
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`combined, and where the thumb hole would be located. See Pet. 50–53.
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`Petitioner merely states that it would have been obvious to add a suction
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`hole “at a location that would allow for control using the thumb,” but does
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`not describe that location or its impact on the existing Makower structure.
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`Pet. 52. Compounding the confusion regarding the nature of the combined
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`structure, Petitioner relies on Makower’s structure for providing a suction
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`source, but relies only on Jones, without mentioning Makower’s suction
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`structure, in relation to controlling the suction using one of the thumb and
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`index finger. See Pet. 44–45, 50–53. The resulting structure presumably
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`would include Makower’s lumen containing the guidewire and some other
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`structure tied to a suction source and a thumb hole while communicating
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`with Makower’s lumen. Such details are not included in the Petition. In
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`addition, in such a configuration, one may need to take into account the
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`opening for the guidewire and its impact on the suction function. The
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`Petition does not provide these details or explanations, or explain adequately
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`why it would be obvious to make all of these accommodations for a thumb
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`hole of Jones, when Makower already allows for suction without a thumb
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`hole.
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`The references themselves do not supply the missing information.
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`Makower suggests the use of suction generally, but notes that adding suction
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`only makes sense if doing so would not “render the device unuseable [sic]
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`for its intended purpose.” Ex. 1008 ¶ 167. Makower then describes the use
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`of suction with reference to embodiments distinct from the embodiment
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`shown in Figures 27B and 27C that Petitioner relies upon. Id. ¶¶ 167, 170
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`(referring to suction in connection with Figures 8A and 9), Figs. 8A, 9, 27B,
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`27C. To the extent that the embodiments shown in Figures 27B and 27C can
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`incorporate suction, that function may be accomplished by removing the
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`guidewire and simply applying suction to the hole at the back of the device.
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`See id. ¶ 16 (describing embodiments that include guidewires passing
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`through a lumen as permitting “fluids to be infused or suction applied
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`through that lumen”); Pet. 44 (citing Ex. 1008 ¶ 16). Such an arrangement
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`would not involve controlling suction using a thumb or index finger.
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`Makower’s lack of disclosure regarding how it might apply suction to the
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`embodiment Petitioner relies upon (in Figures 27B, 27C), unde