Patent No. 9,039,718
`Petition for Inter Partes Review
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`PAIN POINT MEDICAL SYSTEMS, INC.
`d/b/a MIBO MEDICAL GROUP
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`Petitioner
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`v.
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`BLEPHEX, LLC
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`Patent Owner
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`Patent No. 9,039,718
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`Inter Partes Review No. 2016 –
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`DECLARATION OF WILLIAM J. BENJAMIN, O.D., Ph.D.
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`Exhibit 1002
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`Patent No. 9,039,718
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`I, William J. Benjamin, O.D., Ph.D., declare as follows:
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`I.
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`INTRODUCTION
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`1. Based on my background, being over the age of eighteen (18), and being of
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`sound mind, I am competent to make this Declaration.
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`2. MiBo Medical Group Inc. (“MiBo”) has retained me to provide my opinion on
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`U.S. Patent No. 9,039,718 (“the ‘718 patent”) for a Declaration in support of a Petition
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`for Inter Partes Review (“IPR”) of the ‘718 patent. The opinion set forth in this
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`Declaration addresses the ‘718 patent, the state of the art at the time of the ‘718 patent,
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`and the scope and content of the prior art to the ‘718 patent.
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`3. I have reviewed and am familiar with the '718 patent, which was filed on July
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`24, 2012 and issued on May 26, 2015, and its prosecution history.
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`4. I have reviewed and am familiar with: (1) the Alger Brush device (“Alger
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`Brush”); (2) the article “How to clean eyelids” by Sue Stevens, published by the
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`Community Eye Health Journal and republished by the National Institute of Health
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`(“Stevens”); (3) U.S. Patent Application Publication No. 2007/0049860 to Seminara
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`(“Seminara”); (4) U.S. Patent No. 4,883,454 to Hamburg (“Hamburg”); and (5) Japanese
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`Patent Publication No. JPH10108801 by Yamaura (“Yamaura”).
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`5. I am familiar with the technology at issue as of July 24, 2012, the earliest filing
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`date to which the ‘718 patent claims priority.
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`6. I have been asked to provide my technical review, analysis, insights, and
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`opinions regarding the above-noted references that form the basis for the grounds of
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`rejection set forth in the IPR Petition of the ‘718 patent.
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`A. Qualifications and Experience
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`7. I am the Director of Advanced Refractive Services at the Alabama Eye &
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`Cataract Center, P.C./Michelson Laser Vision, Inc., President of Material Performance
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`Assessments, L.L.C., and Professor emeritus of Optometry and Vision Sciences at the
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`University of Alabama at Birmingham.
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`8. I received Doctor of Optometry (1979) and a Doctor of Philosophy (1982)
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`degrees from the Ohio State University. My dissertation for the Doctor of Philosophy
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`was on the concentration of oxygen available to the closed-eye cornea and the superior
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`cornea as it is overlapped by the upper eyelid. This knowledge is related to the
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`physiology of the cornea of the eye and eyelids.
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`9. From 1985 to 1988, I was the Associate Director and then, later, Director of the
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`University of Houston Institute for Contact Lens Research. During this time, I developed
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`a novel method for assessing wettability of contact lenses on the eye. In addition to my
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`other duties, I was responsible for conducting clinical and laboratory studies related to
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`contact lens wear, contact lens care products, and eye dryness.
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`10. In August 1988, I became an associate professor of optometry at the
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`University of Alabama at Birmingham (“UAB”). I was promoted to tenured associate
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`professor of optometry in 1990. I became a Scientist in UAB’s Vision Science Research
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`Center in 1992. I was promoted to full professor of optometry in the School of
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`Optometry and a Senior Scientist at the Vision Science Research Center in 1995, and was
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`secondarily appointed as a Professor of Vision Sciences in 1998. I held the position of
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`Director of Clinical Eye Research at the School of Optometry from 1996 to 2005, Interim
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`Chair of the Department of Optometry from 2011 to 2014, Director of the Professional
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`Program from 2011 – 2014, and was the Associate Dean in 2013 and 2014.
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`11. My clinical experience has been primarily in the contact lens area and primary
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`eye care related to my overall research effort in ocular surface physiology and prosthetic
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`eye devices. Ever since I graduated from Ohio State University, I was always a clinical
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`instructor at my respective institutions: University of Missouri, University of Houston,
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`and UAB. I oversaw third-year and fourth-year optometry students and post-graduate
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`contact lens residents. Currently, at the Alabama Eye & Cataract Center/Michelson Laser
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`Vision, I prescribe contact lenses of a variety of designs and perform eye examinations
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`on those who will undergo or have had cataract or refractive surgery, and those who are
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`presbyopic. My goal is to prescribe the best correction for the individual patient. I am a
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`clinical specialist in the fitting of patients with conditions that distort the cornea such as
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`keratoconus and with presbyopia.
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`12. I have particular expertise in the measurement of oxygen permeability of
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`contact lenses and have developed a theory that explains the most prevalent complaint
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`that wearers have about soft contact lenses, that is, the complaint of eye dryness. Contact
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`lens wearers have a lot in common with those who have eye dryness even without
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`wearing contact lenses. My research sponsors have been from 13 different countries and
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`15 different states in the USA. I have given presentations or conducted meetings in 15
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`different countries and 27 states in the USA. Recently, I was invited to give The Jeffrey
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`& Joyce Myers Lecture at the Ohio State University.
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`13. I have a particular expertise in the measurement of the wettability of rigid
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`contact lenses on and off the eye. In addition, as a clinician, I assess the wettability of
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`lenses in the clinical setting as a routine part of clinical contact lens evaluations.
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`Wettability is a necessary characteristic of contact lens surfaces for adequate performance
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`on the eye. It allows the tear fluid to form a thin, smooth layer, or film, on the surface of a
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`contact lens similar to that formed on the surface of the eye without a lens in place. The
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`smooth tear film is an optical surface that refracts light to focus images clearly on the
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`retina at the back of the eye, and that is required for excellent vision.
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`14. An intact tear film acts as a barrier to the adherence of coatings and deposits
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`on the surface of contact lenses that would reduce vision and cause inflammatory
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`reactions of the eyes and eyelids. It keeps microbes from adhering to the surface of the
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`lens so that their chances of causing an eye infection are minimized. A smooth tear film
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`is easily wiped by the eyelids without irritation when blinking so that contact lenses are
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`comfortable. Eyelid inflammation associated with contact lens wear, chronic and acute,
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`has much in common with eyelid inflammations of even non-wearers of contact lenses.
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`15. I have been closely involved in the drafting of American and international
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`standards for the reporting and measurement of contact lens properties. I drafted the
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`American National Standards Institute (“ANSI”) standard for contact lenses in 1992 and
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`carried the document to its eventual publication in 1998 as well as its revisions published
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`in 2004 and 2010. This standard includes terminology, tolerances, physicochemical
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`properties of materials, and measurement methods. These included measurement methods
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`of oxygen permeability, oxygen transmissibility, and wettability of rigid contact lenses. I
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`was heavily involved with the revision of ANSI Z80.20 that is now out for voting and
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`should become published in 2017.
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`16. I became involved with the International Organization for Standardization
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`(“ISO”) Working Group on contact lenses in 1986 and by the early 1990s was the leader
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`of the project group in charge of developing a draft ISO standard on coulometric
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`determination of oxygen permeability for contact lens materials and oxygen transmissi-
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`bility of contact lenses. I spent 15 years as Convenor of the ISO working groups on
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`contact lenses and stepped down from that position in 2009.
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`17. Since 2014, I have been the Secretary for the multidisciplinary American
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`National Standards Institute Z80 Committee on ophthalmic products, and am today the
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`Immediate Past President of the International Society of Contact Lens Specialists, another
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`multidisciplinary organization. Further details regarding my qualifications, background
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`and experience are provided in my Curriculum Vitae, which is attached to this declaration
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`as Exhibit WJB-A.
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`18. I have been an expert witness in four litigations. These were CIBA Vision
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`Corporation v. Bausch & Lomb, Inc. (Civil Action File No. 2:99-CV-0034-RWS, U.S.
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`District Court for the Northern District of Georgia), CIBA Vision Corporation v. Johnson
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`& Johnson Vision Care, Inc. (Reported at 348 F. Supp. 2d 165, U.S. District Court for the
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`Southern District of New York), Johnson & Johnson Vision Care, Inc. v. CIBA Vision
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`Corporation (Civil Action File No. 3:05-CV-135-J-32TEM and No. 3:06-CV-301-J-
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`32TEM, U.S. District Court for the Middle District of Florida), and Dome Patent LLP v.
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`Michelle K. Lee / U.S. Patent and Trademark Office (Civil Action File No. 1:07-CV-
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`01695, U.S. District Court for the District of Columbia). The parties by whom I was
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`retained as an expert in each case are underlined above. I ultimately testified in all four
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`cases, in 2004, 2004, 2009, and 2013, respectively, and participated in proceedings
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`similar to the third case in various jurisdictions worldwide.
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`B. Basis of My Opinions and Materials Considered
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`19. The opinions set forth in this declaration are based on my entire background
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`including my education and professional experience as well as my knowledge and
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`research activities. In making these opinions, I reviewed the ‘718 patent, its file history,
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`the prior art and other background documents. A full list of the documents that I
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`considered in making these opinions is attached to this declaration as Exhibit WJB-B.
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`C. Legal Standards for Patentability
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`20. I understand that a patent claim is invalid if the differences between the
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`patented subject matter and the prior art are such that the subject matter as a whole would
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`have been obvious at the time the invention was made to a person of ordinary skill in the
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`art. I am informed that this standard is set forth in 35 U.S.C. § 103(a).
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`21. I have been advised that, when considering the issues of obviousness, I am to
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`do the following: (i) determine the scope and content of the prior art; (ii) ascertain the
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`differences between the prior art and the claims at issue; (iii) resolve the level of ordinary
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`skill in the pertinent art; and (iv) consider objective evidence of non-obviousness. I have
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`been informed and appreciate that secondary considerations must be assessed as part of
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`the overall obviousness analysis (i.e. as opposed to analyzing the prior art, reaching a
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`tentative conclusion, and then assessing whether objective indicia alter that conclusion).
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`22. In other words, my understanding is that not all innovations are patentable.
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`Even if a claimed product or method is not explicitly described in its entirety in a single
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`prior art reference, the patent claim will still be denied if the claim would have been
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`obvious to a person of ordinary skill in the art at the time of the patent application filing.
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`23. In determining whether the subject matter as a whole would have been
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`considered obvious at the time that the patent application was filed, by a person of
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`ordinary skill in the art, I have been informed of several principles regarding the
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`combination of elements of the prior art:
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`a. First, a combination of familiar elements according to known methods is likely
`to be obvious when it yields predictable results.
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`b. Second, if a person of ordinary skill in the art can implement a “predictable
`variation” in a prior art device, and would see the benefit from doing so, such a
`variation would be obvious. In particular, when there is pressure to solve a
`problem and there are a finite number of identifiable, predictable solutions, it
`would be reasonable for a person of ordinary skill to pursue those options that
`fall within his or her technical grasp. If such a process leads to the claimed
`invention, then the latter is not an innovation, but more the result of ordinary
`skill and common sense.
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`24. I have been advised that the “teaching, suggestion, or motivation” test is a
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`useful guide in establishing a rationale for combining elements of the prior art. This test
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`poses the question as to whether there is an explicit teaching, suggestion, or motivation in
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`the prior art to combine prior art elements in a way that realizes the claimed invention.
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`Though useful to the obviousness inquiry, I understand that this test should not be treated
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`as a rigid rule. It is not necessary to seek out precise teachings; it is permissible to
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`consider the inferences and creative steps that a person of ordinary skill in the art (who is
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`considered to have an ordinary level of creativity and is not an “automaton”) would
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`employ.
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`II.
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`DESCRIPTION OF THE RELEVANT FIELD AND THE RELEVANT
`TIMEFRAME
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`25. To determine the relevant field, I reviewed the ‘718 patent and its file history.
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`26. To determine the scope of the prior art, I understand the prior art must be
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`earlier than the earliest priority date for the ‘718 patent. The ‘718 patent issued from U.S.
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`Patent Application No. 13/556,729, which was originally filed on July 24, 2012. Based
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`on this history, the ‘718 patent has a claim to the July 24, 2012 filing date as its earliest
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`priority date. The following opinion relies on prior art that was available before the July
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`24, 2012 priority date.
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`27. Based on my review of this material, I believe that the relevant field for the
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`purposes of the ‘718 patent is, in general, conditions of the eye and, more specifically,
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`methods and devices for treating eye conditions such as blepharitis and dry eye.
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`III. THE PERSON OF ORDINARY SKILL IN THE RELEVANT FIELD IN
`THE RELEVANT TIMEFRAME
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`28. I have been informed that “a person of ordinary skill in the relevant field” is a
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`hypothetical person to whom an expert in the relevant field could assign a routine task
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`with reasonable confidence that the task would be successfully carried out. I have been
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`informed that the level of skill in the art is evidenced by prior art references. The prior art
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`discussed herein demonstrates that a person of ordinary skill in the field, at the time the
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`‘718 patent was filed, would have a medical degree (M.D. or D.O.) or a doctor of
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`optometry degree (O.D.) and three to five years of training and practical experience in the
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`field of eye care.
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`29. My background, education and professional experience provide me with a
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`strong understanding of the abilities and knowledge of a person of ordinary skill in the art
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`for the relevant field of the ‘718 patent. Not only do I have such abilities and knowledge,
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`but I have also worked with and overseen the work of others with such abilities and
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`knowledge.
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`IV.
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`STATE OF THE ART FOR THE ‘718 PATENT
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`30. Since 1970, eye care professionals have used electromechanical devices to
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`remove debris and other foreign objects from the eye. For example, the Alger Brush,
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`which was invented in 1970 by Dr. Leon Alger, is an electromechanical device used by
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`ophthalmologists and optometrists for removing “rust rings” from the eye. A rust ring is a
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`reddish brown ring formed by rust surrounding a metallic foreign body, the rust forming
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`due to oxidation of iron in the foreign body due to contact with moisture in the tissue.
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`Rust rings are better seen in a transparent tissue such as the cornea or a white tissue such
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`as the sclera of the eye. The Alger Brush has also been used to reduce elevated benign
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`growths of tissue on an eye known as pterygia and pingueculae.
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`(www.algercompany.com/brush/product-info, “Alger Brush”)
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`The ALGERBRUSH II is used by ophthalmologists, ER physicians and, in
`many states, optometrists who are trained and licensed to remove foreign
`bodies from the eye of a patient. Foreign bodies in the eye can leave rust
`rings when removed. These rust rings are normally caused by a ferrous
`foreign body accidentally striking the cornea or sclera of the patient. When
`the foreign body (usually from a spark produced by a grinding wheel or
`welding torch) strikes the eye it sticks to the eye and eventually produces
`rust when combined with the moisture in the eye. The ALGERBRUSH II
`is used for the expressed purpose of removing these rust rings from the
`eye of a patient.” (Alger Brush, www.algercompany/brush)
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`31. The Alger Brush, which is illustrated above (reproduced from Alger Brush,
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`www.algercompany/brush), has an electric motor that rotates a burr (usually made of
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`carbide) to brush away rust rings from the eye. “The ALGERBRUSH II has a very low
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`torque motor powered by a single AA battery.” (Alger Brush) “The burr in this rotary
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`instrument is used as a “brush” rather than a drill and the rust ring is thus “brushed” from
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`the cornea or sclera leaving a smooth surface which in turn heals much faster than with
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`other instruments which may be used for this purpose.” (Alger Brush) Contaminated
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`tissue is also removed with the rust ring. Thus, one may recognize that electromechanical
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`devices have been used since 1970 to brush away rust rings and debride tissue from the
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`eye.
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`32. Japanese Patent Publication No.: JPH10108801 by Yamaura (“Yamaura”)
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`discloses an electromechanical device similar to the device disclosed in the ‘718 patent.
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`The device of Yamaura is reproduced and illustrated below.
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`33. Like the ‘718 patent, Yamaura discloses an electromechanical device
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`including an electric motor coupled to a shaft. A swab is attached to the shaft via a
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`holding pipe. (Solution to Problem, pp.1-2, and Claim 1, p. 2) Thus, the ‘718 patent and
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`Yamaura both disclose similar devices, i.e., an electromechanical device which rotates a
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`burr or swab. Although Yamaura teaches that the device is used for removing earwax
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`from the ear canal and does not specifically mention removing sebaceous buildup and
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`debris from the eyelid margin, it should be noted that ear canals and eyelids both have
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`sebaceous glands, and their delicate surface tissues are covered and coated with
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`adherent debris or buildup that can be hardened. A solution may be first applied
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`prior to use of these devices to help loosen or soften the adherent buildup. Because
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`of the similarity of the two devices and the similarities between ear canals and eyelids
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`regarding adherent sebaceous secretions, Yamaura’s device can be used for removing
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`debris or buildup from the eyelid with little or no modification.
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`34. Prior to the filing of the ‘718 patent, the use of swabs to remove crusting from
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`the eyelid margins was well known in the field of eye care, as acknowledged in the ‘718
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`patent itself. In an article entitled “How to clean eyelids” by Sue Stevens, published by
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`the Community Eye Health Journal and republished by the National Institute of Health,
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`September 2011 (“Stevens”), Stevens explained how to remove crusting on the eyelid
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`margins in cases of blepharitis using a swab:
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`Reasons for cleaning eyelids
`• Basic eye hygiene: to remove any discharge before instillation of eye drops
`or applying eye ointment, or before applying post-operative eye
`dressings.
`• Blepharitis: to remove crusting on the eyelid margins.
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` The lower eyelid
`• Ask the patient to look up.
`• With one hand, take a new swab or bud and moisten it in the solution.
`• With the index finger of the other hand, gently hold down the lower eyelid.
`• With the swab or bud, clean gently along the lower eyelid margin in one
`movement from inner to outer canthus (Figures 7 and 8).
`• Discard the swab or bud after use.
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`http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3218399/:
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`35. FIG. 9 of Stevens is reproduced and illustrated above. As shown here, a swab
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`is being used to remove crusting on the eyelid margins caused by Blepharitis.
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`36. The ‘718 patent uses the same method taught by Stevens to remove crusting
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`on the eyelid margin, the only difference being the use of an electromechanical device to
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`move the swab. However, as explained above, the use of an electromechanical device for
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`removing rust rings from the eye was disclosed by Alger Brush in 1970, and the ‘718
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`patent explicitly mentions the Alger Brush as an example of an electromechanical device
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`that could be adapted for cleaning of the eyelid. Also, as explained above, Yamaura
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`discloses an electromechanical device very similar to the device disclosed in the ‘718
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`patent. Therefore, although Yamaura teaches the use of its device for removing ear wax
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`from the surface of tissue lining the ear canal, the Yamaura device can easily be used to
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`remove crusting from the eyelid margin with little or no modification.
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`37. As explained by the prior art above and as further demonstrated by the prior
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`art described more particularity below, the use of electromechanical devices and swabs
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`for debriding tissue and removing debris or buildup from the eye was well known to eye
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`care professionals.
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`V.
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`OVERVIEW OF THE ‘718 PATENT
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`38. The ‘718 Patent discloses “[a] method and apparatus for treating ocular
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`disorders such as blepharitis, meibomitis, and dry eye syndrome.” (Abstract). “The
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`method includes using an electromechanical device to move a swab relative to the eye to
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`create cyclical movement that impacts debris present at the eyelid margin and effectively
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`removes the debris from the eye to encourage healing and prevent further digression of
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`the health of the eye.” (Id.) “The apparatus is an electromechanical device that includes a
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`mechanical drive unit operably connected to a swab to create a precise relative movement
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`of the swab to the eye to remove debris present therein.” (Id.)
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`39. FIG. 1 of the ‘718 patent illustrates the electromechanical device and is
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`reproduced above.
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`With reference to FIG. 1, an embodiment of the device 10 for treating an
`ocular disorder, particularly with respect to eyelid margin diseases,
`includes a mechanical drive unit 12 which operably moves a swab 14 to
`facilitate removal of debris from an eye 15 (see FIGS. 2A-2B). The swab
`14 is connected to a rigid member 16 having both a distal end portion and
`a proximal end portion 20. The swab 14 is affixed to the distal end portion
`18 of the rigid member 16 to create an instrument 22, which may be
`secured to the mechanical drive unit 12. As shown in FIG. 1, the proximal
`end portion 20 is removably secured to the mechanical drive unit 12,
`through the rigid member 16, and the swab 14…. (Col. 3, lines 35-47)
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`40. According to the ‘718 patent, the swab 14 is made from a medical grade
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`sponge, and has a base portion and a tip portion sized to access and remove debris from
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`the eye.
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`In one aspect of the instrument 22, the swab 14 includes a tip portion and a
`base portion 26. While the swab 14 may be of a size sufficient to access
`debris on the eye 15 as shown in FIGS. 1-2B, at least the tip portion 24 is
`of a size sufficient to access debris on the eye. For instance, the swab 14
`has an approximate length between 1.0-3.0 millimeters and an
`approximate width of 1 millimeter. It will be appreciated that the swab 14
`may be manufactured of any material suitable for contacting the eye 15
`without harming the eye 15. However, as shown in the embodiment of
`FIG. 1, the swab 14 is a sponge. As described herein, “sponge” broadly
`refers to any material that is soft, porous, and resilient. Particularly, the
`swab 14 is a medical grade sponge or a surgical grade sponge capable of
`removing debris from the eye 15 without harming the eye 15. As shown in
`the exemplary embodiment of FIGS. 1-2B, the swab 14 is a methyl
`cellulose sponge. It will be appreciated, however, that similar materials
`capable of removing debris from the eye 15 without harming the eye 15
`are readily apparent and may also be used. (Col. 3, line 56-Col. 4, line 11).
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`41. An operator targets the debris with the swab by inspecting the eye and
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`removes the debris from the eye.
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`In an exemplary embodiment, the operator preferably targets the debris
`present on the eye 15 with the swab 14 of the electromechanical device 10.
`The debris may be targeted by visually inspecting the eye 15 with or
`without the aid of a magnification device. Once the debris is targeted, the
`swab 14 contacts the portion of the eye 15 that includes the debris. For
`purposes of treating the ocular disorder, the debris may be removably
`attached on either the upper and lower eyelid margins 60, 62 the plurality
`of eyelashes 64 and the inner edge of the eyelid margins, 60, 62. Thereby,
`upon contacting the portion of the eye 15 with the debris, the swab
`impacts the debris to remove the debris from the eye 15. Furthermore, a
`liquid solution configured to loosen the debris may be absorbed within the
`swab 14 to further aid in removing the debris from the eye 15 and/or
`minimizing irritation to the eye 15. It will be appreciated that any liquid
`solution sufficiently capable of loosening the debris for further aid in
`removing the debris may be so used. (Col. 5, line 54-Col. 6, line 2).
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`VI. CLAIM INTERPRETATION
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`42. In proceedings before the U.S. Patent and Trademark Office, I have been
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`instructed that the claims of an unexpired patent are to be given their broadest reasonable
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`interpretation (“BRI”) in view of the specification from the perspective of one skilled in
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`the art. I have been informed that the ‘718 patent has not expired. In comparing the
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`claims of the ‘718 patent to the known prior art, I have carefully considered the ‘718
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`patent and the ‘718 patent file history based upon my experience and knowledge in the
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`relevant field. In my opinion, the broadest reasonable interpretation of the claim terms of
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`the ‘718 patent is generally consistent with the terms’ ordinary and customary meaning,
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`as one skilled in the relevant field would understand them, subject to the terms identified
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`below.
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`43. The ‘718 Patent includes two independent claims, Claim 1 and Claim 17.
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`Claims 2-16 are dependent claims that depend either directly or indirectly from Claim 1.
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`44. All clams of the ‘718 Patent are directed to “[a] method of treating an eye for
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`an ocular disorder with a swab operably connected to an electromechanical device.” All
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`claims of the ‘718 patent recite the limitation “swab.”
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`45. According to the specification of the ‘718 patent, the swab is made from a
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`medical grade sponge, and furthermore states that “[a] sponge broadly refers to any
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`material that is soft, porous, and resilient.”
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`In one aspect of the instrument 22, the swab 14 includes a tip portion and a
`base portion 26. While the swab 14 may be of a size sufficient to access
`debris on the eye 15 as shown in FIGS. 1-2B, at least the tip portion 24 is
`of a size sufficient to access debris on the eye. For instance, the swab 14
`has an approximate length between 1.0-3.0 millimeters and an
`approximate width of 1 millimeter. It will be appreciated that the swab 14
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`may be manufactured of any material suitable for contacting the eye 15
`without harming the eye 15. However, as shown in the embodiment of
`FIG. 1, the swab 14 is a sponge. As described herein, “sponge” broadly
`refers to any material that is soft, porous, and resilient. Particularly, the
`swab 14 is a medical grade sponge or a surgical grade sponge capable of
`removing debris from the eye 15 without harming the eye 15. As shown in
`the exemplary embodiment of FIGS. 1-2B, the swab 14 is a methyl
`cellulose sponge. It will be appreciated, however, that similar materials
`capable of removing debris from the eye 15 without harming the eye 15
`are readily apparent and may also be used. (Col. 3, line 56-Col. 4, line 11).
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`46. A person of ordinary skill in the art would also understand that the term
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`“swab” has a well-understood meaning, both in general and in the eye care field.
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`According to the Merriam-Webster online dictionary (http://www.merriam-
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`webster.com/dictionary/swab), the term “swab” is defined as “a wad of absorbent
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`material usually wound around one end of a small stick and used especially for applying
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`medication or for removing material from an area.”
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`47. The Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and
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`Allied Health, Seventh Edition. (2003, Saunders, an imprint of Elsevier, Inc.) defines a
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`swab as “a small pledget of cotton or gauze wrapped around the end of a slender wooden
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`stick or wire for applying medications or obtaining specimens of secretions and other
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`substances from body surfaces or orifices.”
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`48. Similarly, the American Heritage® Medical Dictionary (2007, 2004,
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`Houghton Mifflin Company) defines swab as a “small piece of absorbent material
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`attached to the end of a stick or wire and used for cleansing a surface, applying medicine,
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`or collecting a sample of a substance.”
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`49. Mosby's Medical Dictionary, 9th edition. (2009, Elsevier) defines a swab as “a
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`stick or clamp holding absorbent gauze or cotton, used for washing, cleansing, or drying
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`a body surface; for collecting a specimen for laboratory examination; or for applying a
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`topical medication.”
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`50. Millodot: Dictionary of Optometry and Visual Science, 7th edition. (2009,
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`Butterworth-Heinemann) defines a swab as a “small piece of absorbent material (e.g.
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`cotton) usually attached to the end of a stick or rod used to apply medication, to take
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`specimens for analysis (e.g. from the bulbar conjunctiva or eyelids), or in surgery for
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`cleaning a wound.”
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`51. Therefore, upon reviewing the ‘718 patent and its prosecution history, and in
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`light of the well-understood meaning shown by the dictionary definitions referenced
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`above, a person of ordinary skill in the art would understand the broadest reasonable
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`interpretation of the term “swab” to be “a piece of absorbent material capable of
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`removing debris from the eye without harming the eye.”
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`VII. THE PRIOR ART
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`A. Alger Brush
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`52. The Alger Brush (http://www.algercompany.com/brush/product-info/) was
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`invented in 1970. It is an electromechanical device used for removing rust rings (i.e. the
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`oxide in or on the tissue surrounding an iron-containing foreign body) from the eye that
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`form when the eye is struck by a metallic object such as a spark or shavings. The Alger
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`Brush has a low-torque electric motor that rotates a burr to brush away rust rings from the
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`eye. A small amount of the tissue contaminated by the ring of rust is also removed by the
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`procedure.
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`“The ALGERBRUSH II is used by ophthalmologists, ER physicians and,
`in many states, optometrists who are trained and licensed to remove
`foreign bodies from the ey