Case No IPR2018-00268
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
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`ACCLARENT, INC.,
`Petitioner
`
`v.
`
`FORD ALBRITTON, IV,
`Patent Owner
`________________________
`
`Case IPR2018-00268
`Patent No. 9,011,412 B2
`________________________
`
`DECLARATION OF DOUGLAS K. HOLMES IN SUPPORT OF PATENT
`OWNER’S PRELIMINARY RESPONSE TO ACCLARENT’S PETITION
`FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,011,412
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`1
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`Albritton Ex. 2006
`Acclarent, Inc. v. Ford Albritton, IV
`IPR2018-00268
`
`
`
`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 No. 9,011,412 B2
`________________________
`
`DECLARATION OF DOUGLAS K. HOLMES IN SUPPORT OF PATENT
`OWNER’S PRELIMINARY RESPONSE TO ACCLARENT’S PETITION
`FOR INTER PARTES REVIEW OF U.S. PATENT NO. 9,011,412
`
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`1
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`Albritton Ex. 2006
`Acclarent, Inc. v. Ford Albritton, IV
`IPR2018-00268
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`
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`I, Douglas K. Holmes, MD FACS, declare as follows:
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`1.
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`I have been asked to evaluate and assess certain information in
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`connection with Dr. Albritton’s Preliminary Response to Acclarent’s second
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`petition for inter partes review. Specifically, I have been asked to form opinions on
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`the reasoning (or lack thereof) to combine the cited prior art references, including
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`U.S. Patent No. 8,747,389
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`(“Goldfarb”), U.S. Patent Publication No.
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`2007/0250105 (“Ressemann”), U.S. Patent Publication No. 2006/0063973
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`(“Makower”), and U.S. Patent No. 4,915,691 (“Jones”). All of the opinions and
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`conclusions found in this declaration are my own.
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`Compensation
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`2.
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`I am being compensated for my work at my normal consulting rate of
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`$600/hour for time spent in connection with this matter. My compensation is not
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`contingent on the results of my work or on the testimony I provide.
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`Qualifications and Experience
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`3.
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`I received a Bachelor’s of Science degree in Chemistry from the
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`University of North Carolina in 1976. I was a member of Phi Eta Sigma and Phi
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`Beta Kappa honor societies.
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`4.
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`I received my Doctor of Medicine degree from the University of
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`North Carolina in 1980. I was awarded “Honors performance” in my second, third,
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`2
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`and fourth years of medical school, and was inducted into Alpha Omega Alpha
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`honorary society as a third-year medical student.
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`5.
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`I completed my internship and residency at the University of Iowa
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`Hospital & Clinics. I served as Chief Resident
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`in
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`the Department of
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`Otolaryngology-Head and Neck Surgery from 1984 to 1985.
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`6.
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`I completed a Pediatric Otolaryngology Fellowship with Dr. Robin
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`Cotton of Children’s Hospital Medical Center in Cincinnati, Ohio from 1989 to
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`1990.
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`7.
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`Practicing medicine since 1985, I have performed sinus surgery in all
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`its forms, starting with open procedures, progressing to endoscopic procedures
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`with scopes and various handheld forceps, then progressing to powered shavers
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`and balloons. As a faculty member of the University of North Carolina, I taught
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`sinus surgery to residents from 1993 to 1999. I have carefully observed the genesis
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`and evolution of balloon surgery and am currently one of the most experienced
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`balloon sinus surgeons in North Carolina.
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`8.
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`I currently work in private practice as an otolaryngologist at ENT &
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`Audiology Associates in Raleigh, North Carolina.
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`Materials Considered
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`9.
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`In arriving at the opinions set forth in this declaration, I relied on the
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`following materials:
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`3
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`a. Acclarent’s Petition for Inter Partes Review and supporting exhibits;
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`b. Declaration of Randy Kesten and supporting exhibits;
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`c. Declaration of Howard Levine and supporting exhibits;
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`d. U.S. Patent No. 9,011,412 to Albritton, IV et al. (the “ʼ412 Patent”)
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`(Petition Ex. 1001);
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`e. U.S. Provisional Application No. 61/127,848;
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`f. File History of U.S. Patent No. 9,011,412 to Albritton, et al.;
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`g. U.S. Patent Publication No. 2007/0250105 to Ressemann et al.
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`(“Ressemann”) (Petition Ex. 1006);
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`h. U.S. Patent No. 8,747,389 to Goldfarb et al. (“Goldfarb”) (Petition
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`Ex. 1005);
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`i. U.S. Patent No. 4,915,691 to Jones et al. (“Jones”) (Petition Ex.
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`1007); and
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`j. U.S. Patent Publication No. 2006/0063973 to Makower et al.
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`(“Makower”) (Petition Ex. 1009).
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`Lack of Motivation to Combine
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`10.
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`I have been informed that to establish obviousness, one must identify
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`a reason that would have prompted a person of ordinary skill in the relevant field to
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`combine the elements in the way the claimed new invention does. I do not believe
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`that a person of ordinary skill in the art would have been motivated or encouraged
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`4
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`to combine Ressemann with Goldfarb or Makower with Jones at the time of the
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`invention of the ’412 Patent.
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`11.
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`In many surgical environments, such as both nasal and abdominal
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`surgeries, two-handed manipulation of a working device and catheter and/or
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`suction was commonly used prior to 2012 and is still used today. This is because in
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`many surgical environments, the endoscope or other visualization means are
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`separately inserted into the patient’s body, and often operated by a scrub-nurse or
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`assisting physician. Moreover, in abdominal surgery, multiple laparoscopic
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`surgical instruments are typically inserted through punctures or incisions in the
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`body wall, and then either left at rest when not in use, or operated by a scrub-nurse
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`or assisting physician. A sinus surgeon before 2012 would be required to hold the
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`scope in one hand while using a separate suction device (such as Frazier) to apply
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`suction with the other hand.
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`12. One example of this surgery is laparoscopic cholecystectomy
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`(removal of gall bladder), in which the scope is inserted and held by an assistant,
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`while the surgeon uses both hands on surgical instruments such as graspers and
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`scissors to dissect out the gall bladder.
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`13.
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`If suction was necessary during these nasal surgery procedures, the
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`surgeon would need to remove the surgical devices and insert a suction device to
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`clear the surgical field. As a result, it was very common to use a separate suction
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`5
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`device that was operated by either a separate hand from the hand operating the
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`surgical instruments. With this background, it is clear there is no reason to combine
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`Ressemann with Goldfarb or Makower with Jones.
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`No Reason to Combine Ressemann with Goldfarb
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`14. Ressemann describes a series of devices used for treating sinusitis.
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`Ressemann at [0001]. Acclarent and its experts appear to rely on what they call a
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`“handle” in Figures 11A through 11D of Ressemann to suggest Ressemann could
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`be combined with Goldfarb to arrive at the inventions claimed in the ʼ412 Patent.
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`Pet. at 24-42.
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`15. First, a person of ordinary skill in the art would not be motivated to
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`combine Ressemann and Goldfarb because Ressemann shows a wire movement
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`guide made of solid material (i.e., it is not hollow), which does not communicate
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`with the catheter that enters the nose. Ressemann at Figures 11A-11B. Suction
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`cannot go through a solid material. As such, a person of skill in the art would not
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`look to Ressemann or combine Ressemann with another reference to arrive at a
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`device with suction through the handle.
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`16. Second, the Acclarent experts’ reasoning for combining Ressemann
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`with Goldfarb is not sound. Dr. Levine suggests it would be useful to suction saline
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`out of the nasal cavity based on the teaching of Ressemann. Ex. 1004 at ¶ 56. This
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`is incorrect. Ressemann does not disclose injecting saline, much less removing it
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`6
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`via suction. The products placed in the nasal cavity are therapeutic agents to
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`prevent adhesion. Ressemann at [0111]. A surgeon would not want to apply
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`suction to the surgical field after applying a therapeutic agent at the surgical site,
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`because suction would remove the medicine applied. The combination of
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`Ressemann and Goldfarb would not achieve the same benefits of the Albritton
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`device.
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`17. Even if suction were useful in Ressemann, a surgeon would not have
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`thought to combine suction into the same handle that manipulates the guide
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`catheter before the invention of the ’412 Patent. At that time, we used a Frazier
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`variable suction device and the technique of using separate suction to clear the
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`field was a well-known technique at the time. It would not have been obvious to
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`combine suction into a tool like Ressemann because this alternate means existed at
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`the time.
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`18. Third, there is no reason to combine Ressemann with Goldfarb to
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`allegedly create a “one-handed” device as suggested by Acclarent. Neither
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`Ressemann nor Goldfarb are a single-handed device with a stabilizing handle. The
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`Ressemann guide is not a stabilizing handle. As shown by the figures in
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`Ressemann, the guide would be fastened or otherwise attached to the patient’s
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`face.
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`7
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`In summary, the Ressemann guide would not provide the stability and
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`19.
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`range-of-motion required for one-handed use. This is because the Ressemann guide
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`does not need to provide stability as the stabilization devices shown in Figures 8, 9,
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`10A, and 18C do that for the surgeon. Thus, one skilled in the art would not look to
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`combine Ressemann with Goldfarb.
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`20. Finally, Goldfarb discloses a two-handed technique and therefore
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`teaches away from the claimed invention and combination with Ressemann into a
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`“one-handed” device. Instead, Goldfarb discloses a two-handed device, and does
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`not disclose using the same hand to both hold the handle to position the guide
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`catheter and to manipulate the working device as claimed in claim 1, as evidenced
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`by Figure 8A in Goldfarb:
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`8
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`21.
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`In Goldfarb, the scope hand is used to hold the endoscope and handle,
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`while the other hand is used to manipulate the dilation catheter. This is the two-
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`handed technique taught to, and used by, surgeons before 2012 (with the release of
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`Acclarent’s Relieva Spin devices). Therefore, Goldfarb leads away from
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`combination with Ressemann to create a “one-handed” device.
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`No Reason to Combine Makower with Jones
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`22. Makower teaches a set of tools for surgically treating the ear, nose,
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`throat, and paranasal sinuses. Makower at [0002, 0007]. Jones discloses a handheld
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`medical aspirating device. Jones at Abstract.
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`9
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`23. The device claimed by Jones would not have been used by a sinus
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`surgeon. Jones is a self-contained aspiration device. An ENT surgeon would not
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`have paid attention to the invention disclosed in Jones, because before the
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`invention of the ’412 Patent, ENT surgeons like myself were using two-handed
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`devices like that described in Goldfarb.
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`Secondary Considerations of Non-Obviousness
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`24. Before the invention of a single-handed device as claimed in the ʼ412
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`Patent, surgeons were required either to hold a device and scope in one hand while
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`manipulating the guidewire themselves with the other hand (as in Goldfarb), or to
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`hold the device steady while relying on the scrub-nurse to repeatedly advance or
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`withdraw the light fiber until the sinus ostium was cannulated.
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`25.
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`In many cases, up to 10 to 15 passes are required for each sinus prior
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`to successful cannulation. Before the invention of the ʼ412 Patent, this required
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`tedious and slow communication such as “advance, retreat, advance, retreat.” With
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`reaction time to the commands and reassessments, this procedure took significantly
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`more time than operating with a device operated by the surgeon alone, who could
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`advance or retreat the fiber instantly and seamlessly with his own hand.
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`26. Since the invention of the ’412 Patent, companies including Petitioner
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`have commercialized single-handed balloon dilation devices. The industry has
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`10
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`responded favorably, with surgeons abandoning the multi-device procedures and
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`seeking out single-handed devices.
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`27. Acclarent has been hugely successful with its single-handed device.
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`From my experience as an ENT surgeon, the praise in the industry for Acclarent’s
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`product has been widespread. I am also aware that other companies have attempted
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`to create a single-handed device, due to the success and functionality of such a
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`device.
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`28. But Acclarent had not developed a single-handed device until it
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`released its Relieva Spin device in 2012. Its prior sinuplasty device was the
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`“Sidekick,” pictured below, which was inferior to the Relieva Spin because it did
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`not allow for the one-handed use permitted by the Relieva Spin or rotation of the
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`working device.
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`29.
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`In my professional experience, I had not encountered a single-handed
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`balloon catheter device until Acclarent released the Relieva Spin in 2012. Since
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`2012, however, other brands have released similar devices. For example, Entellus
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`11
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`sells
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`the
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`XprESS
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`Multi-Sinus
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`Dilation
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`System.
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`See
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`http://www.entellusmedical.com/products/xpress-family. Medtronic
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`sells
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`the
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`NuVent EM Balloon Sinus Dilation System. See http://www.medtronic.com/us-
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`en/healthcare-professionals/products/ear-nose-throat/balloon-sinus-dilation/nuvent-
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`em-balloon-sinus-dilation-system.html. To my knowledge, no company in the
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`industry was selling these devices before 2012.
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`30.
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`In my opinion, a person of ordinary skill in the art would not have
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`combined Ressemann with Goldfarb or Makower with Jones. And if a person of
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`skill in the art were lead to these combinations, it is only through the benefit of the
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`ʼ412 Patent’s teaching and using hindsight to reconstruct such combinations. If the
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`combinations Petitioner suggests were actually obvious to a POSA, I believe
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`someone involved in sinus surgery would have made the combinations in the many
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`years before the invention of the ’412 Patent. No one successfully combined these
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`features until the invention of the ’412 Patent.
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`12
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`I declare under penalty of perjury underthe laws of the United States of America and the State of
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`North Carolina that the foregoing is true and correct.
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`Dated: March 6, 2018
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`
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`Douglas K. Holmes, MD FACS
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`13
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