Trials@uspto.gov
`571-272-7822
`
`
`
`
`
` Paper No. 12
` Entered: November 16, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`VISIONSENSE CORP.,
`Petitioner,
`
`v.
`
`NOVADAQ TECHNOLOGIES INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01426
`Patent 8,892,190 B2
`____________
`
`
`
`Before HYUN J. JUNG, MICHAEL L. WOODS, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`JUNG, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
` Paper No. 12
` Entered: November 16, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`VISIONSENSE CORP.,
`Petitioner,
`
`v.
`
`NOVADAQ TECHNOLOGIES INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01426
`Patent 8,892,190 B2
`____________
`
`
`
`Before HYUN J. JUNG, MICHAEL L. WOODS, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`JUNG, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`IPR2017-01426
`Patent 8,892,190 B2
`
`
`I.
`
`INTRODUCTION
`
`Visionsense Corp. (“Petitioner”) filed a Petition (Paper 4, “Pet.”),
`
`requesting institution of an inter partes review of claims 1–3 of
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`U.S. Patent No. 8,892,190 B2 (Ex. 1001, “the ’190 patent”). Novadaq
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`Technologies Inc. (“Patent Owner”) timely filed a Preliminary Response
`
`(Paper 11, “Prelim. Resp.”). Under 35 U.S.C. § 314, an inter partes review
`
`may not be instituted “unless . . . there is a reasonable likelihood that the
`
`petitioner would prevail with respect to at least 1 of the claims challenged in
`
`the petition.”
`
`Upon consideration of the Petition and Preliminary Response and for
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`the reasons explained below, we determine that Petitioner has shown that
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`there is a reasonable likelihood that it would prevail with respect to at least
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`one of the challenged claims, and we institute an inter partes review of
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`claims 1–3 of the ’190 patent.
`
`A. Related Proceedings
`
`The parties indicate that there are no related litigation matters. Pet. 7;
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`Paper 6, 1 (listing only related patent applications).
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`B. The ’190 Patent (Ex. 1001)
`
`The ’190 patent issued November 18, 2014, from an application filed
`
`March 13, 2012, which claims priority through continuation applications to
`
`application number PCT/US00/22088, filed on August 11, 2000, and a
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`provisional application filed September 24, 1999. Ex. 1001, [22], [45], [60],
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`[63], 1:8–16.
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`The ’190 patent pertains to “procedures for observing blood flow
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`through the cardiovascular system.” Id. at 1:20–22. In one aspect, a method
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`provides for analysis of patency of a portion of a blood vessel. Id. at 4:18–
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`20. Patency refers to freedom from occlusions, which occur when a blood
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`vessel narrows to the point that it becomes completely blocked. Id. at 1:31–
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`32, 1:59–60. The method can be employed “for assessing blood flow in a
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`portion of animal tissue wherein the tissue . . . is being or has undergone an
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`invasive procedure.” Id. at 5:19–22; see also id. at 3:12–16. In an invasive
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`procedure, “one or more incisions are made in the tissue of an animal, or
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`entry of an instrument into an orifice of an animal is undertaken,” which
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`continues “until the incisions are sutured, or the instrument is withdrawn.”
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`Id. at 4:35–42. An illustrative treatment includes joining a blood graft to
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`vessel ends or bypass. Id. at 4:59–65. “Bypass includes . . . attaching ends
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`of a graft vessel at locations upstream and downstream of the stenosis,
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`occlusion or other problem,” and “an anastomosis, i.e., the junction of the
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`native and graft vessels, is created.” Id. at 5:1–3, 5:12–13.
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`The method would allow evaluating the “extent of blood flow through
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`vasculature located downstream of a treated vessel” to assess the success of
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`the treatment. Id. at 5:22–25. Such a method includes “administering a
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`fluorescent dye . . . , obtaining at least one angiographic image of blood
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`flowing through the tissue portion; and evaluating the at least one
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`angiographic image to assess blood flow in the tissue portion.” Id. at 5:25–
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`30. “Angiographic images may be obtained beneath the surface of these
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`tissues to a depth not exceeding that which permits the vasculature of
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`interest to be evaluated.” Id. at 5:52–53.
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`The ’190 patent states that “[f]luorescent dyes emit radiation of a
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`known wavelength when excited by radiation of a particular wavelength.”
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`Id. at 6:66–67. According to the ’190 patent, “wavelengths for both
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`absorption and emission radiation associated with such dyes” and “[d]evices
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`Patent 8,892,190 B2
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`capable of detecting emissions from . . . fluorescent dyes” are well known.
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`Id. at 7:12–13, 8:22–24. After administering a fluorescent imaging agent, “a
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`device capable of exciting any of the agent,” such as a laser, and “a device
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`capable of detecting the radiation emitted,” such as a camera capable of
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`obtaining multiple images over time, “are activated.” Id. at 7:51–54, 7:63–
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`65, 8:22–25. Leading and trailing images are acquired before and after the
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`images of interest, which can be used to determine the “rate and volume of
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`blood flow through the treated vessel and adjacent original vessel.” Id. at
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`10:2–17. The “camera and laser may be located external to the patient.” Id.
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`at 8:61–62.
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`The ’190 patent provides an example in which the fluorescence
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`imaging technique was used on a mouse femoral artery. Id. at 10:66–67.
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`The skin over the artery was “resected to expose the vasculature of interest,”
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`and a “camera was positioned so that the field of view included the femoral
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`artery and its branches.” Id. at 11:55–56, 12:9–10.
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`C. Illustrative Claim
`
`The ’190 patent has 3 claims, all of which Petitioner challenges.
`
`Pet. 7. Claims 1 and 3 are independent, and claim 1 is reproduced below:
`
`1. A method for assessing blood flow moving through
`a vessel graft anastomosed in fluid communication with an
`interconnected group of blood vessels in an animal, the vessel
`graft and at least a portion of the blood vessels being exposed
`during a surgical procedure on the animal, the method
`comprising the steps of:
`(a) administering a fluorescent dye to the animal such that
`the dye enters the vessel graft and the interconnected group of
`blood vessels;
`(b) exciting the fluorescent dye within the vessel graft and
`said exposed portion of the interconnected group of blood vessels
`
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`Patent 8,892,190 B2
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`with a source of illumination, thus causing the dye to emit
`radiation;
`(c) capturing the radiation emitted by the fluorescent dye
`with a camera capable of imaging a series of angiographic
`images within the vessel graft and said exposed portion of the
`interconnected group of blood vessels, the images including at
`least an image of a fluorescent wavefront corresponding to an
`interface between the flowing blood that first contains the
`fluorescent dye introduced, such image being captured by the
`camera as the fluorescent wavefront transitions through the
`exposed vessel graft and interconnected croup of blood vessels;
`and
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`(d) evaluating the angiographic images to assess blood
`flow through the vessel graft relative to blood flow through the
`interconnected group of blood vessels.
`
`Ex. 1001, 13:36–14:16.
`
`D. Asserted Grounds
`
`Petitioner challenges the claims as follows:
`
`Reference(s)
`
`Basis
`
`Claims Challenged
`
`Little1
`
`Little, Flower I2, and Flower
`II3
`Flower I, Flower II, and
`Little or Goldstein4
`
`§ 102(b)
`
`§ 103(a)
`
`§ 103(a)
`
`1 and 2
`
`1–3
`
`1–3
`
`
`1 John R. Little et al., Superficial Temporal Artery to Middle Cerebral Artery
`Anastomosis, 50 J. Neurosurg. 560–569, (1979) (Ex. 1002).
`2 US 6,351,663 B1, filed Sept. 10, 1999, issued Feb. 26, 2002 (Ex. 1003).
`3 US 5,394,199, filed May 17, 1993, issued Feb. 28, 1995 (Ex. 1005).
`4 James A. Goldstein et al., Intraoperative Angiography to Assess Graft
`Patency After Minimally Invasive Coronary Bypass, 66 Ann Thorac Surg
`1978–82, (1998) (Ex. 1007).
`
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`Reference(s)
`
`Basis
`
`Claims Challenged
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`Jibu5, Flower I, and Little or
`Goldstein
`
`§ 103(a)
`
`1–3
`
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`In support of its proposed grounds, Petitioner relies on a Declaration
`
`of David J. Langer, M.D. (Ex. 1017, “Langer Declaration” or “Langer
`
`Decl.”). Patent Owner relies on a Declaration of Brian Wilson (Ex. 2002).
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`II. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are
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`interpreted according to their broadest reasonable construction in light of the
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`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
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`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016)
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`(upholding the use of the broadest reasonable interpretation standard).
`
`Petitioner states that the “plain language of the claims appears
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`understandable under the broadest reasonable construction” but makes
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`comments regarding certain limitations. Pet. 19–20 (citing Ex. 1001, 1:36–
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`41, 4:15–17). Petitioner also “reserves the right to respond to any claim
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`construction arguments made by the patent owner.” Id. at 19. Patent Owner
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`states that it “agrees that the broadest reasonable construction of vessel graft
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`is not limited as to particular vasculature” (Prelim. Resp. 8) and proposes
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`interpretations for several other terms (id. at 8–12).
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`For the purposes of determining whether Petitioner demonstrates a
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`reasonable likelihood of prevailing in its challenges, we need only consider
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`5 Japanese Laid Open Patent Publication No. H9-309845, published Dec. 2,
`1997 (Ex. 1004).
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`Patent 8,892,190 B2
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`Patent Owner’s proposed interpretation of “exposed.” Vivid Techs., Inc. v.
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`Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (Only those
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`terms in controversy need to be construed, and only to the extent necessary
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`to resolve the controversy).
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`Patent Owner contends that the “ordinary meaning of ‘exposed’ is laid
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`open to view” and thus, “should be construed as meaning that the vessel
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`graft and at least a portion of the blood vessels are laid open to view,” that is
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`“any tissue covering the vessels is removed so that the vessels are viewable.”
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`Prelim. Resp. 8–9 (citing Ex. 1001, 11:55–56; Ex. 2004 (excerpt of Merriam
`
`Webster’s Medical Desk Dictionary)).
`
`On the current record, we are not persuaded that “exposed” requires
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`removing tissues so that the vessels are viewable. Patent Owner cites a
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`portion of the ’190 patent that comes from a section titled “Example” and
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`that is introduced with the statements “advantages of the present invention
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`are further illustrated by the following example” and “particular details set
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`forth therein should not be construed as a limitation on the claims.”
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`Ex. 1001, 10:38–42. In describing the example, the ’190 patent states “skin
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`over the femoral vasculature was resected to expose the vasculature of
`
`interest,” which is one of several measures taken to “facilitate imaging of the
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`vessels of interest.” See id. at 11:52–56. Also, before the example, the ’190
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`patent states that “[a]ngiographic images may be obtained beneath the
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`surface of these tissues to a depth not exceeding that which permits the
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`vasculature of interest to be evaluated” and that “the camera and laser may
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`be located external to the patient.” Id. at 5:52–55, 8:61–62.
`
`Furthermore, Patent Owner cites a definition of “expose,” specifically
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`“2: to lay open to view: as . . . b: to reveal (a bodily part) esp. by dissection.”
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`Patent 8,892,190 B2
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`Prelim. Resp. 8–9 (citing Ex. 2004); Ex. 2004, 3–4. The cited definition
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`indicates that a bodily part need not be laid open to view only by dissection.
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`The cited definition does not exclude being laid open to view by other
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`means.
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`In view of the foregoing, we preliminarily interpret “exposed” as
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`being “laid open to view” by any means.
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`B. Level of Ordinary Skill
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`Petitioner asserts a level of ordinary skill. Pet. 18 (citing Langer Decl.
`
`¶ 10). We adopt the Petitioner’s level of ordinary skill for purposes of this
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`Decision.
`
`C. Anticipation based on Little
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`Petitioner contends that claims 1 and 3 are anticipated by Little
`
`(Ex. 1002). Pet. 9, 26–31. In support of these contentions, Petitioner cites
`
`to Little and the Langer Declaration. See id. at 26–31.
`
`1. Little (Ex. 1002)
`
`Little states that fluorescein angiography was performed on patients
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`undergoing “superficial temporal artery (STA) to middle cerebral artery
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`(MCA) anastomosis.” Ex. 1002, 560. Little also states that fluorescein
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`angiography “provided immediate assessment of anastomotic patency and
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`clearly displayed the distribution of blood entering the epicerebral
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`circulation through the STA.” Id.
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`According to Little, the “technique of fluorescein angiography has
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`been described in detail elsewhere.” Id. at 562. Little describes sodium
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`fluorescein being injected rapidly through a catheter and serial photographs
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`being taken with a motorized camera. Id. Figure 1 of Little is reproduced
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`below.
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`Figure 1 is a “[f]luorescein angiography after anastomosis.” Id. at
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`563. “Fluorescein angiography showed the distribution of blood supplied by
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`the STA through anastomosis.” Id. at 564. “The superficial temporal artery
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`was covered by a generous cuff of connective tissue and fat (X).” Id. at 563.
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`“At 01:13 seconds following injection of fluorescein, filling of the cortical
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`receptor artery was observed.” Id.
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`2. Claims 1 and 2
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`Petitioner refers to the preamble of claim 1 as the “Vessel Graft
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`Preamble,” step (a) of claim 1 as the “Administering Step,” step (b) as the
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`“Illuminating Step,” step (c) as the “Wavefront Capture Step,” and step (d)
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`as the “Evaluation Step.” Id. at 26–30. This Decision also refers to the
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`preamble and steps of claim 1 using Petitioner’s labels.
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`Petitioner contends that Little discloses the limitations of claims 1 and
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`2. Pet. 26–31 (citing Ex. 1002, 560, 562–564, Figs. 1, 2; Langer Decl.
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`¶¶ 35, 37, 39, 41, 43–45, 47, 48); see also id. at 20–21 (asserting what Little
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`discloses). In particular, for the Evaluation Step, Petitioner cites Figure 1 of
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`Little and argues that its images show “filling of the cortical receptor artery,
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`the site of the vessel graft upstream of the anastomosis,” “the evaluation of
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`the cortical branches,” and “a comparison between the blood flow through
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`the vessel graft area and the flow in the interconnected vessels.” Id. at 29–
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`30 (citing Ex. 1002, 563, 564). Petitioner also argues that the caption of
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`Figure 1 “notes transition of blood with fluorescent dye to the artery
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`downstream of the graft, thus demonstrating the evaluation of the graft.” Id.
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`at 29 (citing Ex. 1002, 562, 563). Petitioner also cites to paragraphs 43–45
`
`of its Langer Declaration. Id. at 30. As for claim 2, Petitioner argues that
`
`Little discloses “modifying said anastomosed vessel graft based on results of
`
`said evaluation step, thereby improving resultant blood flow through said
`
`vessel graft.” Id. at 30–31 (citing Ex. 1002, 562; Langer Decl. ¶¶ 47, 48).
`
`Patent Owner responds that Little fails to disclose “capturing the
`
`radiation emitted by the fluorescent dye . . . within the vessel graft.” Prelim.
`
`Resp. 23–24. Patent Owner argues that Little does not image the blood flow
`
`in the vessel graft “due to the covering of the vessel graft by a generous cuff
`
`of connective tissue and fat.” Id. at 24 (citing Pet. 28–29 (citing Ex. 1002,
`
`Fig. 1)). Patent Owner contends that Little describes an STA-to-MCA
`
`anastomosis, in which the STA is the vessel graft that is attached to the
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`MCA. Id. at 25 (citing Ex. 1002, 560; Ex. 2002, 6–7). Patent Owner also
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`contends that Little states that the STA or vessel graft is covered by
`
`connective tissue and fat and thus, the vessel graft is not visible in any of
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`Figures 1–4 of Little. Id. at 25–27 (citing Ex. 1002, 562, Fig. 1; Ex. 2002,
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`6–8, 10, 11). Patent Owner further contends that no fluorescence radiation is
`
`captured in the area of the vessel graft. Id. at 27–30 (citing Ex. 2002, 8–11).
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`Patent Owner also asserts that Petitioner mischaracterizes Little. Id. at 28
`
`(citing Pet. 29; Ex. 1002, 562; Langer Decl., 19; Ex. 2002, 9)
`
`Based on similar arguments that Little does not image the blood flow
`
`in the vessel graft, Patent Owner also responds that Little fails to disclose
`
`“evaluating the angiographic images to assess blood flow through the vessel
`
`graft relative to blood flow through the interconnected group of blood
`
`vessels” because Little does not disclose images that capture blood flow
`
`through the vessel graft and that Little fails to disclose the “vessel graft . . .
`
`being exposed” because Little’s STA is not laid open to view. Prelim. Resp.
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`24, 30–34 (citing Pet. 20, 26–27, 30; Ex. 1002, 564; Ex. 2002, 10–12).
`
`Patent Owner’s arguments are persuasive. Petitioner provides
`
`insufficient evidence that Little discloses “capturing the radiation emitted by
`
`the fluorescent dye . . . within the vessel graft,” as required by claim 1. We
`
`agree with Patent Owner that the figures of Little do not show radiation from
`
`the dye within the vessel graft because, in Figure 1, the vessel graft “was
`
`covered by a generous cuff of connective tissue and fat” (Ex. 1002, 563).
`
`The other figures of Little also do not show radiation from within a vessel
`
`graft. See Ex. 1002, Figs. 2–4. Further, the cited paragraphs of Petitioner’s
`
`Langer Declaration state that Figure 1 shows “filling of the cortical receptor
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`artery, the site of the vessel graft upstream of the anastomosis” and
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`“transition of blood with fluorescent dye to the artery downstream of the
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`graft.” Langer Decl. ¶ 43. The Langer Declaration does not address
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`sufficiently “capturing the radiation emitted by the fluorescent dye . . .
`
`within the vessel graft,” as required by claim 1. Further, Petitioner’s
`
`arguments and evidence for claim 2 do not add to its arguments regarding
`
`the Wavefront Capture Step. See Pet. 30–31.
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`Thus, we determine that the information presented in the Petition fails
`
`to show a reasonable likelihood that Petitioner would prevail in proving
`
`claims 1 and 2 are anticipated by Little.
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`D. Obviousness Based on Little
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`Petitioner contends that Little (Ex. 1002), Flower I (Ex. 1003), and
`
`Flower II (Ex. 1005) would have rendered obvious claims 1–3 of the ’190
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`patent, with citations to these asserted references and the Langer Declaration
`
`(Ex. 1017). Pet. 31–39.
`
`1. Flower I (Ex. 1003)
`
`Flower I “relates generally to methods for diagnosing and treating
`
`conditions associated with abnormal vasculature.” Ex. 1003, 1:8–10.
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`According to Flower I, “[f]luorescent dyes . . . have been used for years in
`
`connection with angiography to diagnose and treat vascular abnormalities
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`that occur in the eye.” Id. at 1:12–15. “Angiograms are images of blood
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`vessels, obtained by injecting a fluorescent dye into the blood stream prior to
`
`obtaining an image.” Id. at 1:35–37. A “camera begins capturing images,
`
`i.e., angiograms . . . at specific time intervals” to “provide a record of the
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`extent of dye movement.” Id. at 1:45–47.
`
`Flower I provides a “method for enhancing clarity of fluorescent dye
`
`angiograms using relatively high dye concentrations” that “allows blood
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`vessels . . . to be more readily identified, and thereafter treated” or “for
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`determining the direction of blood flow within a vessel.” Id. at 2:19–25,
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`2:46–47. The enhancement is provided by introducing “relatively small, yet
`
`highly dye-concentrated, boluses of a fluorescent dye composition” at
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`spaced time intervals, which is believed to generate more photons upon
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`exposure to radiation at a dye “wave front.” Id. at 3:63–65, 4:26, 4:36–45.
`
`The preferred fluorescent dye is indocyanine green (“ICG”). Id. at 5:46.
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`2. Flower II (Ex. 1005)
`
`Flower II relates to a “pixel-by-pixel subtraction of an image from a
`
`succeeding image in an ICG angiographic sequence of images.” Ex. 1005,
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`3:56–59. According to Flower II, the resulting image sequence “shows
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`fluorescence arising only from structures where the most rapid movement of
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`blood occurs.” Id. at 3:59–61.
`
`Flower II states that “of great interest to scientists studying the eye, is
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`the choriocapillaris, one of three blood vessel layers of the choroid,” and
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`“with respect to clinical choroidal angiography, ICG angiography provides
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`the best temporal and spatial resolution.” Id. at 1:20–22, 2:13–15. After
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`injecting an ICG dye bolus, Flower II describes that ICG angiograms can
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`“show the complete cycle of dye passage.” Id. at 2:30–32. Flower II also
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`states that “progression of a sharply defined wavefront is more easily tracked
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`through the capillary network than an ill-defined one.” Id. at 2:40–42.
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`3. Claims 1–3
`
`As discussed above, Petitioner argues that Little anticipates claims 1
`
`and 2. Pet. 31–35 (citing Ex. 1002, 560, 562, 563, 564, Fig. 1). Petitioner
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`also argues that, to the extent that Little does not disclose fully the
`
`Wavefront Capture Step and the Evaluation Step of claim 1, these steps
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`would have been obvious in view of Flower I and Flower II. Pet. 32–33
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`(citing Ex. 1003, 4:36–46; Ex. 1005, 2:28–29, 2:40–42; Langer Decl. ¶ 53),
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`34–35 (citing Ex. 1003, 8:46–49, 9:23–26, 10:8–19; Ex. 1005 Abstract,
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`2:40–42, 3:56–62; Langer Decl. ¶¶ 58–59); see also id. at 31 (arguing
`
`Flower I and Flower II use ICG dye which was well known to persons
`
`skilled in the art).
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`In particular, for the Wavefront Capture Step, Petitioner contends that
`
`Flower I teaches or suggests “angiographic observation of the wavefront of
`
`the fluorescent dye as it transmits through the blood vessels” (id. at 32
`
`(citing Ex. 1003, 4:36–46)) and that Flower II similarly recognizes
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`“angiographically tracking a sharply-defined fluorescent-dye wavefront
`
`through a vascular network” (id. at 32–33 (citing Ex. 1005, 2:40–42)).
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`Petitioner asserts that, in view of Flower I and Flower II, one of ordinary
`
`skill in the art would have been motivated to “angiographically capture the
`
`wavefront in tracking the flow of dye through a vascular graft.” Id. at 33
`
`(citing Langer Decl. ¶ 53).
`
`For the Evaluation Step, Petitioner contends that Flower I teaches or
`
`suggests “methods for using fluorescent dyes to evaluate vascular
`
`abnormalities” (id. at 34–35 (citing Ex. 1003, 8:46–49, 9:23–26, 10:8–19))
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`and Flower II teaches or suggests a “method for generating angiograms to
`
`show blood flow through certain blood vessels, including aberrant vessels”
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`(id. at 35 (citing Ex. 1005 Abstract, 2:40–42, 3:56–62)). Petitioner asserts
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`that, in view of Flower I and Flower II, one of ordinary skill in the art would
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`have understood that “widely-known fluorescent dye evaluative techniques,
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`could be used to track the flow of dye in a clinical situation such as that
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`described in Little.” Id. at 35 (citing Langer Decl. ¶¶ 58–59). Petitioner also
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`provides arguments for claim 3. Id. at 36–39 (citing Ex. 1003, 1:42–47,
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`5:41–55, 10:3–7; Ex. 1005, 4:64–65; Langer Decl. ¶¶ 62–64, 66–68).
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`Patent Owner responds that, for claims 1 and 2, Little fails to teach or
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`suggest “capturing the radiation emitted by the fluorescent dye . . . within
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`the vessel graft,” “evaluating the angiographic images to assess blood flow
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`through the vessel graft relative to blood flow through the interconnected
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`group of blood vessels,” and the “vessel graft . . . being exposed,” as
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`required by claim 1, for the same reasons asserted in connection with the
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`anticipation challenge based on Little. Prelim. Resp. 34–38.
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`Patent Owner also responds that Flower I and Flower II fail to cure
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`the deficiencies of Little. Id. In particular, Patent Owner contends that
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`Flower I and Flower II fail to cure the deficiencies because “they are not
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`directed to vessel graft procedures,” “do not provide any teaching that the
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`vessel graft should be imaged,” do not teach or suggest tracking dye through
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`a vascular graft, and do not teach or suggest exposing vessels for imaging.
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`Id. at 35–36, 38, 40.
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`At this stage, Petitioner provides sufficient argument and evidence
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`indicating that the combination of Little, Flower I, and Flower II teaches or
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`suggests “capturing the radiation emitted by the fluorescent dye . . . within
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`the vessel graft” and “evaluating the angiographic images to assess blood
`
`flow through the vessel graft relative to blood flow through the
`
`interconnected group of blood vessels.” See Pet. 32–35 (citing Ex. 1003,
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`4:36–46, 8:46–49, 9:23–26, 10:8–19; Ex. 1005 Abstract, 2:28–29, 2:40–42,
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`3:56–62; Langer Decl. ¶¶ 53, 58–59), 36–39 (arguments for claim 3) (citing
`
`Ex. 1003, 1:42–47, 5:41–55, 10:3–7; Ex. 1005, 4:64–65; Langer Decl.
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`¶¶ 62–64, 66–68). Also, as discussed above, on the current record, we are
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`not persuaded to adopt an interpretation of “exposed” as requiring removing
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`tissues so that the vessels are viewable.
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`Furthermore, Petitioner provides sufficient argument and evidence
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`that one of ordinary skill would apply Flower I and Flower II to Little. See
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`Pet. 33, 35 (citing Langer Decl. ¶¶ 53, 58–59). Petitioner’s declarant
`
`testifies that Flower I and Flower II provide motivation because they
`
`disclose a known technique that can be applied to Little with predictable
`
`results. See Langer Decl. ¶¶ 53, 58–59 (citing Ex. 1003, 4:36–46, 8:46–49,
`
`9:23–26, 10:8–19; Ex. 1005 Abstract, 2:28–29, 2:40–42, 3:56–62); see also
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`Ex. 1003, 8:46–49 (stating “[i]llustrative of body tissues associated with
`
`suitable cavities” is the “heart.”), 9:23–27 (stating “[c]onventional . . .
`
`surgical intervention, may also be used . . . in combination with the
`
`treatment methods of the present invention.”), 10:12–19 (stating “the method
`
`of visualizing and treating blood vessels” is “equally applicable to . . .
`
`determining blood flow direction”); Ex. 1005, 2:40–41 (stating that a
`
`“progression of a sharply defined wavefront is more easily tracked”).
`
`Petitioner, thus, demonstrates a reasonable likelihood of prevailing in
`
`its challenge of claims 1–3 as rendered obvious by Little, Flower I, and
`
`Flower II.
`
`E. Obviousness Based on Flower I
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`Petitioner contends that Flower I (Ex. 1003), Flower II (Ex. 1005),
`
`and Little (Ex. 1002) or Goldstein (Ex. 1007) would have rendered obvious
`
`claims 1–3 of the ’190 patent, with citations to these asserted references and
`
`the Langer Declaration (Ex. 1017). Pet. 39–46.
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`1. Goldstein (Ex. 1007)
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`Goldstein studies intraoperative angiography performed to confirm
`
`graft patency during a minimally invasive coronary artery bypass grafting.
`
`Ex. 1007, 1978. It finds that “intraoperative identification of graft
`
`compromise facilitated timely graft revision . . . thereby ensuring a widely
`
`patent graft and excellent flow before chest closure.” Id. at 1981.
`
`Goldstein states that “[a]fter anastomosis was completed but before
`
`closure of the thoracotomy incision, graft angiography was performed.” Id.
`
`at 1979. The “graft, anastomoses, and native vessel were analyzed for
`
`patency and flow.” Id. Goldstein’s imaging system is a “digital x-ray
`
`imaging system” with a “pulsed fluoroscopic system . . . capable of 30
`
`frames per second dynamic acquisition and playback.” Id. The images “can
`
`be viewed . . . as still images.” Id. Figure 1 of Goldstein is reproduced
`
`below.
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`Figure 1 is an intraoperative angiogram showing an artery graft
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`(curved arrow) with anastomosis (dark, straight arrow) with excellent flow
`
`
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`into another artery (white arrows). Id. at 1980.
`
`2. Claims 1–3
`
`Petitioner contends that Flower I teaches or suggests the Vessel Graft
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`Preamble, the Administering Step, the Illuminating Step, the Wavefront
`
`Capture Step, and the Evaluation Step. Pet. 39–42 (citing Ex. 1003 3:4–17,
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`4:36–46, 8:46–49, 9:23–26, 10:8–19, 10:38–50; Ex. 1005 Abstract).
`
`Petitioner also contends that Flower II teaches or suggests administering dye
`
`by way of boluses (id. at 40 (citing Ex. 1005, 9:39–43; Langer Decl. ¶ 71)),
`
`teaches or suggests the Illuminating Step (id. at 41 (citing Ex. 1005, 10:13–
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`16)), recognizes the “utility of angiographically tracking a sharply-defined
`
`fluorescent-dye wavefront through a vascular network” (id. (citing Ex. 1005,
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`2:40–42; Langer Decl. ¶ 73)), and teaches or suggests a “method of
`
`generating angiograms to show blood flow through certain blood vessels”
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`(id. at 41–42 (citing Ex. 1005, 2:40–42, 3:56–62)). Petitioner asserts that
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`Flower I and Flower II “provide a general teaching for using fluorescence
`
`imaging to evaluate blood flow through vessels and diagnosing abnormal
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`vasculature.” Id. at 42 (citing Langer Decl. ¶ 74).
`
`Petitioner argues that Little teaches or suggests extracorporeal
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`illumination (id. at 41 (citing Ex. 1003; Langer Decl. ¶ 72)) and evaluation
`
`of blood flow through a vessel graft relative to interconnected vessels (id. at
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`42 (citing Ex. 1002, 563, Fig. 1)). Petitioner cites Goldstein as also teaching
`
`the evaluation of blood flow through a vessel graft relative to interconnected
`
`vessels. Id. (citing Ex. 1007, 1980, Figs. 1–3).
`
`Petitioner contends that one of ordinary skill in the art would have
`
`concluded that the method of Flower I would be applicable to Little or
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`Goldstein. Id. at 40 (citing Ex. 1002, 560; Ex. 1007, 1979; Langer Decl.
`
`¶ 70). Petitioner also argues that the “[a]pplication of the evaluative
`
`techniques described in the Flower references to the clinical settings in Little
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`and Goldstein is obvious.” Id. at 42 (citing Langer Decl. ¶ 75).
`
`For dependent claim 2, Petitioner contends that both Little and
`
`Goldstein teach or suggest the Modifying Step. Id. at 42–43 (citing Ex.
`
`1002, 562; Ex. 1007, 1979, 1980; Langer Decl. ¶ 77). For claim 3,
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`Petitioner addresses only two limitations found in addition to those in claim
`
`1 and argues that Flower I teaches or suggests the 800–850 Wavelength
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`Requirement and 15 Image/Second Requirement. Id. at 43–44 (citing Ex.
`
`1003, 1:42–47, 5:41–55, 10:3–7). Petitioner also cites Flower II for the
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`800–850 Wavelength Requirement and 15 Image/Second Requirement. Id.
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`at 44 (citing Ex. 1005, 3:56–62). Petitioner contends that one of ordinary
`
`skill in the art would be motivated to use ICG, and that Flower I and Flower
`
`II would have rendered obvious the use of frame rates in excess of 15 frames
`
`per second. Id. at 44 (citing Ex. 1005, 1:63–2:9; Langer Decl. ¶¶ 79, 80).
`
`Petitioner provides reasons for combining Flower I, Flower II, and
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`Little so that claim 3 would have been obvious. Pet. 45–46 (citing Langer
`
`Decl. ¶¶ 82–85). According to Petitioner, one of ordinary skill in the art
`
`would be motivated to “use these in the experiments described in Little to
`
`simplify the imaging and enhance the recording and playback.” Id. at 45
`
`(citing Langer Decl. ¶ 82). Petitioner also asserts that Flower I and Flower
`
`II would motivate trying their process to look at grafts and that using the
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`ICG-based methods of Flower I and Flower II would yield predictable
`
`results. Id. at 45–46 (Ex. 1003, 3:14–17; Ex. 1005 Abstract; Ex. 1016, 272;
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`Langer Decl. ¶¶ 83, 84).
`
`On the current record, Petitioner provides sufficient argument and
`
`evidence to demonstrate a reasonable likelihood of prevailing on its
`
`challenge based on Flower I, Flower II, and Little or Goldstein.
`
`Patent Owner responds that Petitioner’s proposed combination of
`
`Flower I, Flower II, and Little or Goldstein fails to teach or suggest
`
`“evaluating the angiographic images to assess blood flow through the vessel
`
`graft relative to blood flow through the interconnected group of blood
`
`vessels.” Prelim. Resp. 40–41. In particular, Patent Owner argues that
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`Petitioner “fails to establish any teaching of comparing the degree of blood
`
`flow through the vessel graft to the degree of blood flow through the
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`interconnected group of blood vessels” because Li
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