IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent of: Massi E. Kiani
`U.S. Patent No.:
`6,771,994
`Issue Date:
`August 3, 2004
`Appl. Serial No.: 10/374,303
`Filing Date:
`February 24, 2003
`Title:
`PULSE OXIMETER PROBE-OFF DETECTION SYSTEM
`
` Attorney Docket No.: 50095-0005IP1
`
`DECLARATION OF DR. BRIAN W. ANTHONY
`
`I, Brian W. Anthony, of Cambridge, MA, declare that:
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`QUALIFICATIONS AND BACKGROUND INFORMATION
`
`1.
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`My name is Dr. Brian W. Anthony. I am an Associate Principal
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`Research Scientist at the Institute of Medical Engineering & Science at
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`Massachusetts Institute of Technology (MIT). I am also a Principal Research
`
`Scientist at MIT’s Mechanical Engineering department, Director of the Master of
`
`Engineering in Advanced Manufacturing and Design Program at MIT, a Co-
`
`Director of the Medical Electronic Device Realization Center of the Institute of
`
`Medical Engineering & Science, and Associate Director of MIT.nano. My current
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`curriculum vitae is attached and some highlights follow.
`
`2.
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`I earned my B.S. in Engineering (1994) from Carnegie Mellon
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`University. I earned my M.S. (1998) and Ph.D. (2006) in Engineering from MIT.
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`My research focused on high-performance computation, signal processing, and
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`electro-mechanical system design.
`
`1
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`APPLE 1003
`
`
`
`In re Patent of: Massi E. Kiani
`U.S. Patent No.:
`6,771,994
`Issue Date:
`August 3, 2004
`Appl. Serial No.: 10/374,303
`Filing Date:
`February 24, 2003
`Title:
`PULSE OXIMETER PROBE-OFF DETECTION SYSTEM
`
` Attorney Docket No.: 50095-0005IP1
`
`DECLARATION OF DR. BRIAN W. ANTHONY
`
`I, Brian W. Anthony, of Cambridge, MA, declare that:
`
`QUALIFICATIONS AND BACKGROUND INFORMATION
`
`1.
`
`My name is Dr. Brian W. Anthony. I am an Associate Principal
`
`Research Scientist at the Institute of Medical Engineering & Science at
`
`Massachusetts Institute of Technology (MIT). I am also a Principal Research
`
`Scientist at MIT’s Mechanical Engineering department, Director of the Master of
`
`Engineering in Advanced Manufacturing and Design Program at MIT, a Co-
`
`Director of the Medical Electronic Device Realization Center of the Institute of
`
`Medical Engineering & Science, and Associate Director of MIT.nano. My current
`
`curriculum vitae is attached and some highlights follow.
`
`2.
`
`I earned my B.S. in Engineering (1994) from Carnegie Mellon
`
`University. I earned my M.S. (1998) and Ph.D. (2006) in Engineering from MIT.
`
`My research focused on high-performance computation, signal processing, and
`
`electro-mechanical system design.
`
`1
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`APPLE 1003
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`3.
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`In 1997, I co-founded Xcitex Inc., a company that specialized in
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`video-acquisition and motion-analysis software. I served as the Chief Technology
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`Officer and directed and managed product development until 2006. Our first demo
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`product was an optical ring for human motion measurement used to capture user
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`hand motion in order to control the user’s interaction with a computer. Many of
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`the structural elements of our optical ring addressed the same system issues as
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`those described and claimed in the patent at issue. For example, our optical ring
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`included multiple light emitting diodes, multiple photodetectors, techniques for
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`modulation and synchronization, and noise reduction algorithms. We estimated
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`human hand-motion based on how that motion changed the detected light. In our
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`application, we did not try to eliminate motion artifact, we tried to measure it. In
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`developing our ring, we considered well-known problems such as ambient light
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`and noise. Motion Integrated Data Acquisition System (MiDAS) was our flagship
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`video and data acquisition product which relied upon precise synchronization of
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`multiple clocks for optical sensor and video acquisition, data acquisition, and
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`external illumination.
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`4.
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`I joined MIT in 2006 and was the Director of the Master of
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`Engineering in Advance Manufacturing and Design Program for over ten years.
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`The degree program covers four main components: Manufacturing Physics,
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`Manufacturing Systems, Product Design, and Business Fundamentals. Many of
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`2
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`the courses, projects, and papers my students undertake involve technologies
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`relevant to the patent at issue, for example, sensor devices including non-invasive
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`optical biosensors.
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`5.
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`In 2011, I co-founded MIT’s Medical Electronic Device Realization
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`Center (“MEDRC”) and currently serve as co-director. The MEDRC aims to
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`create and deploy revolutionary medical technologies by collaborating with
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`clinicians, the microelectronics, and medical devices industries. We combine
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`expertise in computation; communications; optical, electrical, and ultrasound
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`sensing technologies; and consumer electronics. We focus on the usability and
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`productivity of medical devices using, for example, image and signal processing
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`combined with intelligent computer systems to enhance practitioners’ diagnostic
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`intuition. Our research portfolio includes low power integrated circuits and
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`systems, big data, micro electro-mechanical systems, bioelectronics, sensors, and
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`microfluidics. Specific areas of innovation include wearable, non-invasive and
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`minimally invasive optical biosensor devices, medical imaging, laboratory
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`instrumentation, and the data communication from these devices and instruments
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`to healthcare providers and caregivers. My experience with these devices is
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`directly applicable to the technology in the patent at issue.
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`6.
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`I am currently the Co-Director of the Device Realization Lab at the
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`Medical Electronic Device Realization Center at the Institute of Medical
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`
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`3
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`
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`
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`Engineering & Science at MIT. The Device Realization Lab designs instruments
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`and techniques to sense and control physical systems. Medical devices and
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`manufacturing inspection systems are a particular focus. We develop and combine
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`electromechanical systems, complex algorithms, and computation systems to
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`create instruments and measurement solutions for problems that are otherwise
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`intractable.
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`7.
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`The research of the Device Realization Lab focuses on product
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`development interests cross the boundaries of computer vision, acoustic and
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`ultrasonic imaging, large-scale computation and simulation, optimization,
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`metrology, autonomous systems, and robotics. We use computation, and computer
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`science, as methodology for attacking complex instrumentation problems. My
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`work combines mathematical modeling, simulation, optimization, and
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`experimental observations, to develop instruments and measurement solutions.
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`8. My record of professional service includes recognitions from several
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`professional organizations in my field of expertise.
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`9.
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`I am a named inventor on 10 issued U.S. patents. Most but not all of
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`these patents involve physiological monitoring and other measurement and
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`instrumentation technologies.
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`10.
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`I have published approximately 85 papers, and have received a
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`number of best paper and distinguished paper awards. A number of papers that I
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`4
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`have published relate to physiological monitoring and other measurement
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`technologies.
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`11.
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`I have been retained on behalf of Apple Inc. to offer technical
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`opinions relating to U.S. Patent No. 6,771,994 (“the ’994 Patent”) and prior art
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`references relating to its subject matter. I have reviewed the ’994 Patent and
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`relevant excerpts of the prosecution history of the ’994 Patent. I have also
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`reviewed the following prior art references and materials, in addition to other
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`materials I cite in my declaration:
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` U.S. Patent No. 5,638,818 to Diab et al. (“Diab” or “APPLE-1006”)
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` U.S. Patent No. 4,015,595 to Benjamin, Jr. (“Benjamin” or “APPLE-
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`1007”)
`
` U.S. Patent No. 5,254,388 to Melby et al. (“Melby” or “APPLE-1008”)
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` WO Pub. No. 1996/41566 to Fine et al. (“Fine” or “APPLE-1009”)
`
` Webster, Design of Pulse Oximeters, Institution of Physics Publishing
`
`(1997) (“Webster” or “APPLE-1010”)
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` Tremper, Pulse Oximetry, Anesthesiology, The Journal of the American
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`Society of Anesthesiologists, Inc., Vol. 70, No. 1 (January 1989)
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`(“APPLE-1011”)
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`5
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` Mendelson, Skin Reflectance Pulse Oximetry: In Vivo Measurements
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`from the Forearm and Calf, Journal of Clinical Monitoring, Vol. 7, No. 1
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`(January 1991) (“APPLE-1012”)
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`
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` Excerpts from Bronzino, The Biomedical Engineering Handbook, CRC
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`Press, Inc. (1995) (“APPLE-1013”)
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` Konig, Reflectance Pulse Oximetry – Principles and Obstetric
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`Application in the Zurich System, Journal of Clinical Monitoring, Vol.
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`14, No. 6 (August 1998) (“APPLE-1014”)
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`12. Counsel has informed me that I should consider these materials
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`through the lens of one of ordinary skill in the art related to the ’994 Patent at the
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`time of the earliest possible priority date of the ’994 Patent, and I have done so
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`during my review of these materials. The application leading to the ’994 Patent
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`was filed on February 24, 2003 and claims the benefit of priority to a provisional
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`application filed June 18, 1999 (“the Critical Date”). Counsel has informed me
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`that the Critical Date represents the earliest priority date to which the challenged
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`claims of ’994 Patent are entitled, and I have therefore used that Critical Date in
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`my analysis below.
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`13.
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`I have no financial interest in the party or in the outcome of this
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`proceeding. I am being compensated for my work as an expert on an hourly basis.
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`6
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`My compensation is not dependent on the outcome of these proceedings or the
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`content of my opinions.
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`14.
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`In writing this Declaration, I have considered the following: my own
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`knowledge and experience, including my work experience in the fields of
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`mechanical engineering, computer science, biomedical engineering, and electrical
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`engineer; my experience in teaching those subjects; and my experience in working
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`with others involved in those fields. In addition, I have analyzed various
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`publications and materials, in addition to other materials I cite in my declaration.
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`15. My opinions, as explained below, are based on my education,
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`experience, and expertise in the fields relating to the ’994 Patent. Unless otherwise
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`stated, my testimony below refers to the knowledge of one of ordinary skill in the
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`fields as of the Critical Date, or before. Any figures that appear within this
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`document have been prepared with the assistance of Counsel and reflect my
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`understanding of the ’994 Patent and the prior art discussed below.
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` TECHNICAL BACKGROUND
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`16. The ’994 Patent and the prior art references discussed herein are all
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`from the field of non-invasive optical biosensors. These devices have a wide range
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`of applications, for example, measuring blood characteristics such as blood oxygen
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`saturation, blood flow, blood pressure, and cardiac output. Non-invasive optical
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`biosensors are generally characterized as devices that pass light from a light source
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`7
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`through the skin (i.e., non-invasively) into a blood perfused area of body tissue and
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`then use a light sensor (e.g. photodetector) to capture the reflected or transmitted
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`light, and quantity the variable absorption of light by the tissue.
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`17. The earliest filed application from which the ’994 Patent claims
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`priority is U.S. Provisional Application No. 60/140,000, filed on June 18, 1999.
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`Thus June 18, 1999 (herein after “Critical Date” or “Earliest Effective Filing
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`Date”) is the earliest possible priority date for the ’994 Patent. The ’994 Patent
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`discloses a purported improvement to a “pulse oximeter probe to detect when the
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`probe becomes partially or completely dislodged from the patient, but continues to
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`detect” a signal within the normal operating range of the system. APPLE-1001,
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`Abstract. According to the ’994 Patent, the improved pulse oximeter “provides a
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`number of louvers placed in front of the probe’s photodetector” (id., 2:9-12) to
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`“prevent light from an oblique angle from reaching the photodetector” and creating
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`a “false signal” that could be interpreted as an actual physiological signal of a
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`patient. Id., 2:16-19.
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`18. However, the claimed device is not new. Indeed, the ’994 Patent was
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`granted without full consideration of the wide body of application art. As the ’994
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`Patent acknowledges in its “Description of the Related Art,” pulse oximetry is a
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`“widely accepted noninvasive procedure for measuring the oxygen saturation level
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`of arterial blood.” Id., 1:29-31. A pulse oximetry system “generally consists of a
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`8
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`probe attached to a patient” that includes multiple wavelengths of light “both red
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`and infrared (IR) light-emitting diode (LED) emitters and a photodiode detector.”
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`Id., 1:31-36. The system “determines oxygen saturation by analyzing the
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`differential absorption by arterial blood of the two wavelengths emitted by the
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`probe.” Id., 1:44-49.
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`19. Similar to the devices described in the ’994 Patent’s description of
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`known systems and the references cited in this petition, the ’994 Patent describes
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`and claims a sensor that generates light of “at least first and second wavelengths”
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`and includes “at least one light emission device,” a “light sensitive detector.” Id.,
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`8:21-36 (claim 15). The ’994 Patent also claims “a plurality of louvers” that accept
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`light “originating from a general direction” of the light emission device. Id. The
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`’994 Patent itself describes these louvers, in one “preferred embodiment,” as
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`created from commercially available ‘3M Light Control Film.’” Id., 6:39-41.
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`20. However, as I explain in this declaration with respect to the applied
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`prior art and other references and systems that were well-known as of the Critical
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`Date, optical physiological sensors such as pulse oximeters and other
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`photoplethysmography sensors commonly included these features before the
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`Critical Date, and a sensor including each feature of claim 15 of the ’994 Patent
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`would have been obvious to a person of ordinary skill in the art relating to the
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`subject matter of the ’994 Patent as of the Critical Date. For the reasons I explain
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`9
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`below, claim 15 of the ’994 Patent was well-known in the art well in advance of
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`the Critical Date.
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`21. One common and well-understood non-invasive optical biosensor is a
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`pulse oximeter, an example of which is described in the ’994 Patent. Id., 1:24-57.
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`Pulse oximeters have been known since at least the 1970’s, and some technology
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`used in pulse oximeters dates back to the 1930’s. APPLE-1011, p. 98. Pulse
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`oximetry is a widely used method for monitoring arterial hemoglobin oxygen
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`saturation (SpO2). APPLE-1011, p. 98.
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`22. The system components of non-invasive optical biosensors, like pulse
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`oximeters, have been well-understood and in wide use for decades in first wired
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`and then wireless embodiments. Typical components include: one or more
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`electrically controlled optical light-sources; mechanical and optical elements to
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`guide and focus the light into the body; mechanical and optical elements to control
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`light within the sensing device; mechanical and optical elements to capture and
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`focus the light leaving the body; light detector(s) that generate an electrical signal
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`proportional to the amount of received light; processor(s) to control the light
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`sources and detectors; and processor(s) to analyze the electrical signals. For
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`example, a pulse oximeter described by Mendelson in 1991, shown below,
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`included multiple LEDs, multiple photodiodes, an optical shield, and an optically
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`clear epoxy, mounted on a silicon rubber base. APPLE-1012, p. 8, Figure 1.
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`10
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`23. The use of optical sensors to detect physiological parameters,
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`including photoplethysmography, has also been known for decades. Optical
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`techniques are commonly used in medical monitoring systems such as pulse
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`oximetry systems that measure a person’s pulse rate and blood oxygen saturation.
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`APPLE-1013 at 769-76, 1346-55 (discussing oximetry and other applications).
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`24. Photoplethysmography works by directing light into a person’s tissue
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`and measuring the light that is reflected back from or transmitted through the
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`tissue. APPLE-1013 at 764. Different components of blood or tissue absorb
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`11
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`different wavelengths of light. By measuring how much light is absorbed by the
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`tissue and how the absorption changes over time, a device can calculate parameters
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`that are related to the properties of the tissue or blood.
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`25. For example, hemoglobin (the protein molecule in blood that carries
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`oxygen to cells) reflects more red light when it is more oxygenated than when it is
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`deoxygenated; it absorbs more red light when it is deoxygenated. APPLE-1013 at
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`769. Hemoglobin reflects the same amount of infrared (IR) light whether
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`oxygenated or deoxygenated. APPLE-1013 at 769. If a device measures the
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`absorbed red and IR light multiple times per second, the device can determine
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`several things: (i) the ratio of oxygenated to deoxygenated hemoglobin (oxygen
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`saturation), and (ii) how the volume of blood in the tissue changes over time,
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`allowing detection of a person’s pulse. APPLE-1013 at 769, 771.
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`26. Photoplethysmography is an optical technique, and it uses basic
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`optical components or building blocks. The “basic building blocks” of optical
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`sensor systems include lenses, mirrors, reflective surfaces, filters, beam splitters,
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`light sources, fiber optics, light detectors, and other passive components and
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`various active components to convert light signals to electrical signals. APPLE-
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`1013 at 765.
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`12
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`APPLE-1013 at 765. In wearable or portable devices, the light sources are
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`typically light emitting diodes (LEDs) because they are small, inexpensive, and
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`have low power requirements. APPLE-1013 at 765. LEDs are manufactured with
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`a wide range of packaged form factors and are easily assembled into systems with
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`standard circuit board assembly processes; surface mount technology (SMT) is
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`widely used to mount the LED packages for practical application.
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`27. The light from the light sources is directed through a lens, or other
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`light guiding structures, and onto a sample. APPLE-1013 at 765. The sample, or
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`tissue, reflects back the light, which is filtered and sensed by a photodetector.
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`APPLE-1013 at 765. The photodetector outputs a signal proportional to the
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`measured light intensity, which is the measurable amount of light (number of
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`13
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`photons), and then analog-to-digital conversion and signal processing are
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`performed to extract information from, and analyze, the collected data. APPLE-
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`1013 at 766.
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`28. The detected signal may include signal and noise from, for example,
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`ambient light or motion induced artifacts. It has been long recognized that noise
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`sources such as stray and ambient light and movement of the subject corrupt the
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`information that is obtained from non-invasive optical biosensors. Motion artifacts
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`arise from kinematic variations, variable mechanical forces, changes in the
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`coupling of the sensor to the subject, local variation in patient anatomy, optical
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`properties of tissue due to geometric realignment or compression, or combinations
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`of these effects.
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`29. There are various well-known techniques used to reduce the amount
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`of noise in the detected signal and improve the signal-to-noise ratio. For example,
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`the light source is often modulated with a known periodicity or pattern, the known
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`periodicity or pattern increases the signal detectability, and therefore improves
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`signal-to-noise ratio. APPLE-1013 at 764. The detector may use synchronized
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`lock-in amplifier detection to isolate signals that occur at the modulation frequency
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`to improve signal-to-noise ratio by extracting information encoded at the
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`modulation frequency thereby reducing the impact of noise at other frequencies in
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`the detected signal. APPLE-1013 at 766. Another common method for reducing
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`14
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`noise or extracting information from a signal captured by sensors involved
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`calculating and processing the spectral content, or frequency-domain
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`representation, of the signals. The “traditional method of frequency analysis [is]
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`based on the Fourier transform” such as a fast Fourier transform (FFT) to
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`determine a signal’s spectral, or frequency-domain, components. APPLE-1013 at
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`846-47. Other signal processing techniques include, for example, removing the
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`artifact by generating two independent measurements with two light sources or
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`detectors and performing a subtraction, or through signal averaging. APL1011, p.
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`101; APL1014, pp. 404-405.
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` THE ’994 PATENT
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`30. The ’994 Patent relates to a “pulse oximetry monitor (pulse
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`oximeter).” APPLE-1001, 1:44-46. Specifically, the ’994 Patent is directed to a
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`pulse oximetry sensor that includes a first LED, a second LED, and a
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`photodetector, as shown in FIG. 1 (reproduced below). APPLE-1001, 3:21-55,
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`FIG. 1.
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`15
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`APPLE-1001, FIG. 1 (annotated)
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`31. The two LEDs are “preferably configured to produce different
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`wavelengths of light.” Id. Pulse oximetry “relies on the differential light
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`absorption of oxygenated hemoglobin, HbO2, and deoxygenated hemoglobin, Hb”
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`that is measured using two different wavelengths of light. Id., 3:3-20. For
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`example, blood oxygen saturation measurements can be “based upon a ratio of the
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`time-varying or AC portion” of the detected signals. Id.
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`16
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`32. The ’994 Patent describes and depicts its photodetector as being
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`placed opposite the light emitters to detect transmitted light as it emerges from the
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`user’s body tissue. APPLE-1001, 1:41-43 (describing the configuration of known
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`pulse oximetry probes as positioning the detector “opposite the LED”), 4:19-25
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`(“the emitters located within the probe are spaced opposite the detector assembly
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`235…such that the light from the emitters passes…through the finger 250 and is
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`incident upon the detector assembly 235”), FIGS. 2A-B, 4, 5A-B.
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`33. The ’994 Patent also includes a number of louvers placed in front of
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`the sensor’s photodetector. Id., 6:24-41. The louvers “block light rays travelling
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`along an oblique path 410 (i.e., light that does not originate from in front of the
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`detector assembly 235….)” Id. By blocking light travelling along an oblique path,
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`or at an angle, from reaching the detector, the louvers prevent inaccurate reads that
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`can occur when rays of light travelling along the oblique path “generate an AC
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`signal that could be interpreted by the pulse oximeter 140 as a physiological
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`signal” (id.) even though the probe is not properly attached, which can lead to
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`missed desaturation events. Id., 4:35-45. The louvers are, “[i]n a preferred
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`embodiment…created from commercially available ‘3M Light Control Film.’’”
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`Id., 6:39-41.
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`17
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`APPLE-1001, FIG. 5B (annotated)
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`34. The ’994 Patent has not been the subject of any previous IPRs. No
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`Office Actions were issued during the prosecution of the application from which
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`the ’994 Patent issued. See generally APPLE-1002.
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`35. Prior to the Critical Date of the ’994 Patent, numerous products,
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`publications, and patents existed that implemented or described the functionality
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`claimed in the ’994 Patent. The methodology of the ’994 Patent was therefore
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`well-known in the prior art as of the Critical Date. Further, to the extent there was
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`any problem to be solved in the ’994 Patent, it had already been solved in the prior
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`art systems before the Critical Date of the ’994 Patent as I discuss below.
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`18
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` LEVEL OF ORDINARY SKILL IN THE ART
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`36.
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`In my opinion, a person of ordinary skill in the art relating to, and at
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`the time of, the invention of the ’994 Patent (“POSITA”) would have been
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`someone with a working knowledge of physiological monitoring technologies.
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`The person would have had a Bachelor of Science degree in an academic discipline
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`emphasizing the design of electrical, computer, or software technologies, in
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`combination with training or at least one to two years of related work experience
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`with capture and processing of data or information, including but not limited to
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`physiological monitoring technologies. Alternatively, the person could have also
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`had a Master of Science degree in a relevant academic discipline with less than a
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`year of related work experience in the same discipline.
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`37. Based on my experiences, I have a good understanding of the
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`capabilities of one of ordinary skill. Indeed, I have taught, participated in
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`organizations, and worked closely with many such persons over the course of my
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`career. Based on my knowledge, skill, and experience, I have an understanding of
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`the capabilities of one of ordinary skill. For example, from my industry
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`experience, I am familiar with what an engineer would have known and found
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`predictable in the art. From teaching and supervising my graduate students and
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`post-doctoral associates, I also have an understanding of the knowledge that a
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`19
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`person with this academic experience possesses. Furthermore, I possess those
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`capabilities myself.
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`
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`INTERPRETATIONS OF THE ’994 PATENT CLAIMS AT
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`ISSUE
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`38.
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`I understand that, for purposes of my analysis in this inter partes
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`review proceeding, the terms appearing in the patent claims should generally be
`
`interpreted according to their “ordinary and customary meaning,” except those I
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`discuss below. See Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005)
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`(en banc). I understand that “the ordinary and customary meaning of a claim term
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`is the meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention.” Id. at 1313. I also understand that the
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`person of ordinary skill in the art is deemed to read the claim term not only in the
`
`context of the particular claim in which the disputed term appears, but in the
`
`context of the entire patent, including the specification. Id.
`
`
`“a plurality of louvers positioned over the light sensitive detector
`to accept light from the at least one light emission device originating from a
`general direction of the at least one light emission device and then
`transmitting through body tissue carrying pulsing blood, wherein the louvers
`accept the light when the sensor is properly applied to tissue of a patient.”
`
`39.
`
`In my opinion, one of ordinary skill would have construed this claim
`
`limitation as requiring the light sensitive detector to be positioned opposite the at
`
`least one light emission device such that the body tissue carrying pulsing blood
`
`
`
`20
`
`
`
`
`
`positioned between the light sensitive detector and the at least one light emission
`
`device. This construction is consistent with the specification and figures of the
`
`’994 Patent, which only depict and describe the placement of the body tissue
`
`carrying pulsing blood between the at least one light emission device and the light
`
`sensitive detector. APPLE-1001, 1:41-43 (the “photodiode is positioned opposite
`
`the LED so as to detect the LED transmitted light as it emerges from the [body]
`
`tissue.”)
`
`
`
`APPLE-1001, FIG. 5B (annotated)
`
`40.
`
`Indeed, one of ordinary skill would have understood the plain
`
`language of the claim to require such a configuration, as the light that is accepted
`
`by the louvers must originate “from a general direction of the at least one light
`
`
`
`21
`
`
`
`
`
`emission device,” and then transmit through the body tissue before “pass[ing]
`
`directly through the louvers 502 along a direct path 510.” Id., 6:30-34.
`
` THE COMBINATION OF DIAB, BENJAMIN, AND MELBY
`
` Overview of Diab
`
`41. Diab describes an “optical probe for measurements” (APPLE-1006,
`
`Abstract) for use in “non-invasive energy absorption (or reflection)” detection
`
`methods such as pulse oximetry. APPLE-1006, 3:12-43. The device includes a
`
`“light source, such as an LED” and a “detector, such as a photodetector.” APPLE-
`
`1006, 3:12-43. Diab’s light source includes, for example, two “LEDs 430a and
`
`430b,” one which emits “red wavelengths” and one which emits “infrared
`
`wavelengths.” APPLE-1006, 18:8-22.
`
`
`
`22
`
`
`
`
`
`
`
`APPLE-1006, FIG. 24 (excerpt, annotated)
`
`42. Non-invasive methods, as described by Diab, are “often desirable” in
`
`order to “monitor a patient without unnecessary drawing of blood or tissue.”
`
`APPLE-1006, 5:49-59. For example, “in the medical field, instead of extracting
`
`material from a patient’s body for testing,” non-invasive techniques often use
`
`“light or sound energy…incident on the patient’s body” that is transmitted or
`
`reflected. APPLE-1006, 1:13-22.
`
` Overview of Benjamin
`
`43. Benjamin describes an improved “photoplethysmograph,” or device
`
`that uses a “light source and a specifically selected photo-sensitive cell that
`
`
`
`23
`
`
`
`
`
`responds to light absorbed by the arterial blood in the peripheral vascular bed over
`
`which the sensor is placed.” APPLE-1007, 1:5-15. The photo-sensitive cell
`
`responds to the light absorbed by the blood such that the “amount of pulsating light
`
`it registers is proportional to the amount of pulsating arterial blood” within its field
`
`of detection and thus provides a measure of “pulsatile blood flow.” APPLE-1007,
`
`1:5-15. In order to “improve the accuracy of the photoplethysmographic pickup of
`
`the blood flow pulse,” Benjamin employs a “light control film” to collimate light
`
`passing through and “thereby make the photosensitive cell…more nearly
`
`dependent only upon the light beam directly reflected from the field being
`
`measured.” APPLE-1007, 2:42-61. Such light films were “known in the art
`
`and…commercially available.”
`
`APPLE-1007, FIG. 1 (annotated)
`
`
`
`
`
`24
`
`
`
`
`
` Overview of Melby
`
`44. Melby, a patent from nearly 30 years ago and almost 6 years prior to
`
`the Critical Date, assigned to the Minnesota Mining and Manufacturing Company
`
`(3M), discloses a light control film, or a “louvered plastic film.” APPLE-1008,
`
`Abstract. Melby describes a film that includes “louver elements” that can be
`
`canted to direct light that passes through. APPLE-1008, 1:9-22, 3:46-62.
`
` Analysis
`
`Claim 15
`
`[15pre]: “A sensor which generates at least first and second intensity signals from
`
`a light-sensitive detector which detects light of at least first and second
`
`wavelengths transmitted through body tissue carrying pulsing blood; the sensor
`
`comprising:”
`
`45. To the extent the preamble is limiting, in the combination, Diab
`
`teaches a sensor having a detector that detects “attenuated light energy signal [that]
`
`emerges from” a section of a subject’s body, “such as a finger, an earlobe, a toe, an
`
`organ, or a portion of tissue.” APPLE-1006, 3:12-43. Diab’s sensor includes “a
`
`probe for use in both invasive and non-invasive energy absorption (or reflection)
`
`measurements.” APPLE-1006, 3:11-47 (all emphasis is mine, unless indicated
`
`otherwise). The probe includes a “detector, such as a photodetector” and a “light
`
`source, such as an LED” that is affixed “opposite the photodetector.” Id. The
`
`
`
`25
`
`
`
`
`
`LED “emits light energy which propagates through and is absorbed by the material
`
`along the optical path length” and “an attenuated light energy signal emerges from
`
`the material.” Id. Diab’s “photodetector produces an electrical signal indicative
`
`of the intensity of the signal transmitted by the material,” such as a subject’s
`
`“finger 428.” Id. The subject’s finger, for example, contains body tissue carrying
`
`pulsing blood.
`
`46. As shown below, Diab’s device includes two “LEDs 430a and 430b”
`
`that “alternately emit[] energy which is absorbed by the finger 428 and received by
`
`the photodetector 426” such that the photodetector “produces an electrical signal
`
`which corresponds to the intensity of the light energy striking the photodetector
`
`426 surface.” APPLE-1006, 18:43-47.
`
`APPLE-1006, FIG. 24 (annotated)
`
`
`
`26
`
`
`
`
`
`
`
`47. Diab’s probe is “coupled to an oximeter…known in the art which
`
`utilizes light attenuation measurements,” such as a “pulse oximeter” that measures
`
`signals from “two measured signals at different wavelengths, one of which is
`
`typically red and the other of which is typically infrared, [that] are alternately
`
`passed through the finger 428.” APPLE-1006, 17:62-18:22. These signals are
`
`“processed to determine the amount of oxygen available to the body” by “finding
`
`the saturation of oxygenated hemoglobin in blood comprising both oxygenated and
`
`deoxygenated hemoglobin.” Id. The two signals are generated by “[t]wo LEDs
`
`430a and 430b, one LED 430a emitting red wavelengths and another LED 430b
`
`emitting infrared wavelengths” that are placed adjacent to the subject’s finger, for
`
`example, on top of the finger, and the photodetector is placed under the finger. Id.
`
`48. Accordingly, the combination of Diab, Benjamin, and Melby renders
`
`obvious “sensor which generates at least first and second intensity signals from a
`
`light-sensitive detector which detects light of at least first and second wavelengths
`
`transmitted through body tissue carrying pulsing blood.”
`
`[15a]: “at least one light emission device;”
`
`49. As I have previously discussed with respect to [15pre], in the
`
`combination, Diab teaches a sensor that measures first and second intensity signals
`
`using a photodetector to detect light from at least two LEDs emitting at two
`
`different wavelengths. APPLE-1006, 3:11-47, 17:62-18:22, FIG. 24.
`
`
`
`27
`
`
`
`
`
`50. As shown in FIG. 24 (reproduced below), Diab teaches two light
`
`emitting diodes (LEDs) that emit at two different wavelengths, and thus teaches at
`
`least one light emission device.
`
`
`
`APPLE-1006, FIG. 24
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