`
`Poeze et al.
`In re Patent of:
`U.S. Patent No.:
`10,258,266 Attorney Docket No.: 50095-0007IP1
`April 16, 2019
`Issue Date:
`Appl. Serial No.: 16/212,537
`Filing Date:
`December 6, 2018
`Title:
`MULTI-STREAM DATA COLLECTION SYSTEM FOR
`NONINVASIVE MEASUREMENT OF BLOOD
`CONSTITUENTS
`
`DECLARATION OF DR. THOMAS W. KENNY
`
`Declaration
`
`I declare that all statements made herein on my own knowledge are true and
`
`that all statements made on information and belief are believed to be true, and
`
`further, that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable under Section 1001 of Title 18 of
`
`the United States Code.
`
`By: ________________________________
`
`Thomas W. Kenny, Ph.D.
`
`1
`
`APPLE 1003
`
`
`
`Contents
`
`
`I. QUALIFICATIONS AND BACKGROUND INFORMATION ........................ 4
`II. OVERVIEW OF CONCLUSIONS FORMED ................................................. 10
`III. LEVEL OF ORDINARY SKILL IN THE ART ............................................... 11
`IV. LEGAL STANDARDS ..................................................................................... 12
`A. Terminology ................................................................................................... 12
`B. Legal Standards for Anticipation.................................................................... 13
`C. Legal Standards for Obviousness ................................................................... 13
`V. HISTORICAL AND TECHNICAL OVERVIEW ............................................ 18
`VI. The ’266 patent .................................................................................................. 19
`A. Overview of the ’266 patent ........................................................................... 19
`VII. SUMMARY OF THE PRIOR ART ................................................................. 23
`A. Overview of Aizawa ....................................................................................... 23
`B. Overview of Inokawa ..................................................................................... 26
`C. Overview of Ohsaki ........................................................................................ 30
`D. Overview of Mendelson-1988 ........................................................................ 32
`VIII. GROUND 1A – Claims 1-6, 8-16, 18, and 19 Are Rendered Obvious by
`Aizawa in view of Inokawa ..................................................................................... 34
`A. Claim 1 ........................................................................................................... 34
`B. Claim 2 ........................................................................................................... 52
`C. Claim 3 ........................................................................................................... 53
`D. Claim 4 ........................................................................................................... 54
`E. Claim 5 ........................................................................................................... 55
`F. Claim 6 ........................................................................................................... 56
`G. Claim 8 ........................................................................................................... 58
`H. Claim 9 ........................................................................................................... 58
`I. Claim 10 ......................................................................................................... 63
`J. Claim 11 ......................................................................................................... 65
`K. Claim 12 ......................................................................................................... 66
`L. Claim 13 ......................................................................................................... 66
`
`
`
`2
`
`
`
`M. Claim 14 ......................................................................................................... 67
`N. Claim 15 ......................................................................................................... 67
`O. Claim 16 ......................................................................................................... 68
`P. Claim 18 ......................................................................................................... 68
`Q. Claim 19 ......................................................................................................... 68
`IX. GROUND 1B – Claims 1-6, 8-16, 18, and 19 Are Rendered Obvious by
`Aizawa in view of Inokawa and Ohsaki .................................................................. 69
`A. Claims 1-6, 8-16, 18, and 19 .......................................................................... 69
`X. GROUND 2 – Claims 1-6, 8-16, 18, and 19 Are Rendered Obvious by
`Mendelson-1988 in view of Inokawa ...................................................................... 71
`A. Claim 1 ........................................................................................................... 71
`B. Claim 2 ........................................................................................................... 79
`C. Claim 3 ........................................................................................................... 80
`D. Claim 4 ........................................................................................................... 83
`E. Claim 5 ........................................................................................................... 84
`F. Claim 6 ........................................................................................................... 85
`G. Claim 8 ........................................................................................................... 87
`H. Claim 9 ........................................................................................................... 87
`I. Claim 10 ......................................................................................................... 91
`J. Claim 11 ......................................................................................................... 92
`K. Claim 12 ......................................................................................................... 93
`L. Claim 13 ......................................................................................................... 94
`M. Claim 14 ......................................................................................................... 94
`N. Claim 15 ......................................................................................................... 94
`O. Claim 16 ......................................................................................................... 95
`P. Claim 18 ......................................................................................................... 95
`Q. Claim 19 ......................................................................................................... 95
`XI. CONCLUSION .................................................................................................. 96
`
`
`
`
`
`
`
`3
`
`
`
`I.
`
`QUALIFICATIONS AND BACKGROUND INFORMATION
`
`1. My education and experience are described more fully in my curriculum
`
`vitae (APPLE-1004). For ease of reference, I have highlighted certain information
`
`below.
`
`2. My academic and professional background is in Physics, Mechanical
`
`Engineering, Sensing, and Robotics, with a research specialization focused on
`
`microfabricated physical sensors, and I have been working in those fields since the
`
`completion of my Ph.D. more than 30 years ago. The details of my background
`
`and education and a listing of all publications I have authored in the past 35 years
`
`are provided in my curriculum vitae, attached as Exhibit A. Below I provide a
`
`short summary of my education and experience which I believe to be most
`
`pertinent to the opinions that I express here.
`
`3.
`
`I received a B.S. in Physics from University of Minnesota, Minneapolis in
`
`1983, and a Ph.D. in Physics from University of California at Berkeley in 1989. I
`
`was educated as a Physicist specializing in sensors and measurement. My Physics
`
`Ph.D. thesis involved measurements of the heat capacity of monolayers of atoms
`
`on surfaces, and relied on precision measurements of temperature and power using
`
`time-varying electrical signals, and also on the design and construction of
`
`miniature sensor components and associated electrical circuits for conditioning and
`
`conversion to digital format.
`
`
`
`4
`
`
`
`4.
`
`After completion of my Ph.D. in Physics at U.C. Berkeley in 1989, I joined
`
`the Jet Propulsion Laboratory (JPL) in Pasadena, CA, as a staff scientist, and began
`
`working on miniature sensors and instruments for small spacecraft. This work
`
`involved the use of silicon microfabrication technologies for miniaturization of the
`
`sensors, and served as my introduction to the field of micro-electromechanical
`
`systems (MEMS), or the study of very small mechanical sensors powered by
`
`electricity and used for detection of physical and chemical signals.
`
`5. While at JPL, we developed accelerometers, uncooled infrared sensors,
`
`magnetometers, seismometers, force and displacement sensors, soil chemistry
`
`sensors, miniature structures for trapping interstellar dust, and many other
`
`miniature devices. Some of these projects led to devices that were launched with
`
`spacecraft headed for Mars and for other interplanetary missions. Much of this
`
`work involved the use of physical sensors for detection of small forces and
`
`displacements using micromechanical sensors.
`
`6.
`
`I am presently the Richard Weiland Professor at the Department of
`
`Mechanical Engineering at Stanford University, where I have taught for the past 26
`
`years. I am also currently the Senior Associate Dean of Engineering for Student
`
`Affairs at Stanford.
`
`7.
`
`For 26 years, I have taught courses on Sensors and Mechatronics at Stanford
`
`University. The “Introduction to Sensors” course is a broad overview of all
`
`
`
`5
`
`
`
`sensing technologies, from thermometers, to inertial sensors, ultrasound devices,
`
`flow sensors, optical and IR sensors, chemical sensors, pressure sensors, and many
`
`others, and has included sensors based on changes in capacitance, resistance,
`
`piezoelectricity. This course specifically included different mechanisms for
`
`sensing heart rate, blood pressure, blood chemistry, cardiovascular blood flow and
`
`pressure drops, intraocular pressure and other physiological measurements, as well
`
`as activity monitoring (step counting, stair-counting, etc.). I first taught this course
`
`at Stanford in the Spring of 1994, and I offered this course at least annually until
`
`2016, when my duties as Senior Associate Dean made this impractical.
`
`8.
`
`The “Introduction to Mechatronics” course is a review of the mechanical,
`
`electrical and computing technologies necessary to build systems with these
`
`contents, which include everything from cars and robots to cellphones and other
`
`consumer electronics devices. In this class, we routinely use IR, LEDs, and
`
`photosensors as a way of detecting proximity to objects in the space around
`
`miniature robots. We also use inertial sensors to detect movement, and a number
`
`of sensors, such as encoders to measure changes in position and trajectory. I was
`
`one of the instructors for the first offering of this course in 1995, and this course
`
`has been offered at least once each year ever since, with plans already underway
`
`for the Winter 2021 offering. The 2020 offering was just completed, and was
`
`
`
`6
`
`
`
`highly-successful with 120 undergraduate and graduate students from many
`
`engineering and science disciplines.
`
`9.
`
`I am co-author of a textbook titled “Introduction to Mechatronic Design,”
`
`which broadly covers the topic of integration of mechanical, electronic and
`
`computer systems design into “smart products.” This textbook includes chapters
`
`on Microprocessors, Programming Languages, Software Design, Electronics,
`
`Sensors, Signal Conditioning, and Motors, as well as topics such as Project
`
`Management, Troubleshooting, and Synthesis.
`
`10. My research group has focused on the area of microsensors and
`
`microfabrication—a domain in which we design and build micromechanical
`
`sensors using silicon microfabrication technologies. The various applications for
`
`these technologies are numerous.
`
`11.
`
`I have advised 69 Ph.D. students that have completed Ph.D. degrees and
`
`many more M.S. and B.S. students in Engineering during my time at Stanford.
`
`12.
`
`I have published over 250 technical papers in refereed journals and
`
`conferences in the field of sensors, MEMS, and measurements. I have further
`
`presented numerous conference abstracts, posters, and talks in my field. I am a
`
`named inventor on 50 patents in my areas of work.
`
`13.
`
`I have previously served as an expert on a patent infringement case
`
`involving the mounting and use of pressure sensors on guidewire catheters for
`
`
`
`7
`
`
`
`cardiovascular procedures that included a number of sensing aspects, such as
`
`recording static and dynamic pressure signals, and compensating for electrical and
`
`mechanical errors. I have also previously served as an expert on a patent
`
`infringement case involving the design and use of miniature inertial sensors. That
`
`case involved the design and operations of micromechanical sensors, and
`
`particularly the use of inertial sensors for detection of states of movement and rest.
`
`I have also served as an expert in a patent infringement case involving the use of
`
`sensors on athletic shoes for determining athletic performance. More recently, I
`
`served as an expert in a patent infringement case involving optical proximity
`
`sensors in smartphones. My CV is included as APPLE-1004 and includes a full
`
`listing of all cases in which I have testified at deposition or trial in the preceding
`
`four years.
`
`14.
`
`I have been retained on behalf of Apple Inc. to offer technical opinions
`
`relating to U.S. Patent No. 10,258,266 (“the ’266 patent”) and prior art references
`
`relating to its subject matter. I have reviewed the ’266 patent, relevant excerpts of
`
`the prosecution history of the ’266 patent. I have also reviewed the following prior
`
`art references:
`
`
`
`
`
`
`
`
`
`8
`
`
`
`Prior Art Reference
`
`U.S. Pub. No. 2002/0188210 to Aizawa (“Aizawa”) (APPLE-1006)
`
`English translation of JP 2006-296564 to Inokawa et al. (“Inokawa”)
`(APPLE-1007, APPLE-1008)
`
`U.S. Pub. No. 2001/0056243 to Ohsaki et al. (“Ohsaki”) (APPLE-
`1014)
`
`“Design and Evaluation of a New Reflectance Pulse Oximeter
`Sensor,” Y. Mendelson, et al.; Worcester Polytechnic Institute,
`Biomedical Engineering Program, Worcester, MA 01609;
`Association for the Advancement of Medical Instrumentation, vol. 22,
`No. 4, 1988; pp. 167-173 (“Mendelson-1988”) (APPLE-1015)
`
`15.
`
`I have also reviewed various supporting references and other documentation
`
`as further noted in my opinions below.
`
`16. Counsel has informed me that I should consider these materials through the
`
`lens of one of ordinary skill in the art related to the ’266 patent at the time of the
`
`earliest possible priority date of the ’266 patent, and I have done so during my
`
`review of these materials. The application leading to the ’266 patent was filed on
`
`December 6, 2018, and claims the benefit of priority to a provisional application
`
`filed July 3, 2008. However, support for the subject matter claimed in the ’266
`
`patent appears to have been first disclosed in a CIP application filed on July 2,
`
`2009 (“the Critical Date”). See APPLE-1038. Counsel has informed me that the
`
`Critical Date represents the earliest possible priority date to which the challenged
`
`
`
`9
`
`
`
`claims of ’266 patent are entitled, and I have therefore used that Critical Date in
`
`my analysis below.
`
`17.
`
`I have no financial interest in the party or in the outcome of this proceeding.
`
`I am being compensated for my work as an expert on an hourly basis. My
`
`compensation is not dependent on the outcome of these proceedings or the content
`
`of my opinions.
`
`18.
`
`In writing this declaration, I have considered the following: my own
`
`knowledge and experience, including my work experience in the fields of
`
`mechanical engineering, computer science, biomedical engineering, and electrical
`
`engineer; my experience in teaching those subjects; and my experience in working
`
`with others involved in those fields. In addition, I have analyzed various
`
`publications and materials, in addition to other materials I cite in my declaration.
`
`19. My opinions, as explained below, are based on my education, experience,
`
`and expertise in the fields relating to the ’266 patent. Unless otherwise stated, my
`
`testimony below refers to the knowledge of one of ordinary skill in the fields as of
`
`the Critical Date, or before. Any figures that appear within this document have
`
`been prepared with the assistance of Counsel and reflect my understanding of the
`
`’266 patent and the prior art discussed below.
`
`II. OVERVIEW OF CONCLUSIONS FORMED
`
`
`
`10
`
`
`
`20. This declaration explains the conclusions that I have formed based on my
`
`analysis. To summarize those conclusions, based upon my knowledge and
`
`experience and my review of the prior art publications listed above, I believe that:
`
` Claims 1-6, 8-16, 18, and 19 are rendered obvious by Aizawa and Inokawa.
`
` Claims 1-6, 8-16, 18, and 19 are rendered obvious by Aizawa, Inokawa, and
`
`Ohsaki.
`
` Claims 1-6, 8-16, 18, and 19 are rendered obvious by Mendelson-1988 and
`
`Inokawa.
`
`
`
`III. LEVEL OF ORDINARY SKILL IN THE ART
`21.
`In my opinion, one of ordinary skill in the art relating to, and at the time of,
`
`the invention of the ’266 patent would have been someone with a working
`
`knowledge of physiological monitoring technologies. The person would have had
`
`a Bachelor of Science degree in an academic discipline emphasizing the design of
`
`electrical, computer, or software technologies, in combination with training or at
`
`least one to two years of related work experience with capture and processing of
`
`data or information, including but not limited to physiological monitoring
`
`technologies. Alternatively, the person could have also had a Master of Science
`
`degree in a relevant academic discipline with less than a year of related work
`
`experience in the same discipline.
`
`
`
`11
`
`
`
`22. Based on my experiences, I have a good understanding of the capabilities of
`
`one of ordinary skill. Indeed, I have taught, participated in organizations, and
`
`worked closely with many such persons over the course of my career. Based on
`
`my knowledge, skill, and experience, I have an understanding of the capabilities of
`
`one of ordinary skill. For example, from my industry experience, I am familiar
`
`with what an engineer would have known and found predictable in the art. From
`
`teaching and supervising my post-graduate students, I also have an understanding
`
`of the knowledge that a person with this academic experience possesses.
`
`Furthermore, I possess those capabilities myself.
`
`IV. LEGAL STANDARDS
`A. Terminology
`I have been informed by Counsel and understand that the best indicator of
`
`23.
`
`claim meaning is its usage in the context of the patent specification as understood
`
`by one of ordinary skill. I further understand that the words of the claims should
`
`be given their plain meaning unless that meaning is inconsistent with the patent
`
`specification or the patent’s history of examination before the Patent Office.
`
`Counsel has also informed me, and I understand that, the words of the claims
`
`should be interpreted as they would have been interpreted by one of ordinary skill
`
`at the time of the invention was made (not today). Because I do not know at what
`
`
`
`12
`
`
`
`date the invention as claimed was made, I have used the Critical Date of the ’266
`
`patent as the point in time for claim interpretation purposes.
`
`B.
`Legal Standards for Anticipation
`I have been informed by Counsel and understand that documents and
`
`24.
`
`materials that qualify as prior art can render a patent claim unpatentable as
`
`anticipated. I am informed by Counsel and understand that all prior art references
`
`are to be looked at from the viewpoint of a person of ordinary skill in the art.
`
`25.
`
`I am informed by Counsel and understand that a challenged claim is
`
`unpatentable as “anticipated” under 35 U.S.C. § 102 if it is determined that all the
`
`limitations of the claim are described in a single prior art reference. I am informed
`
`by Counsel and understand that, to anticipate a claim, a prior art reference must
`
`disclose, either expressly or inherently, each and every limitation of that claim and
`
`enable one of ordinary skill in the art to make and use the invention.
`
`26.
`
`I have been informed by Counsel and understand that in an inter partes
`
`review, “the petitioner shall have the burden of proving a proposition of
`
`unpatentability,” including a proposition of anticipation, “by a preponderance of
`
`the evidence.” 35 U.S.C. §316(e).
`
`C. Legal Standards for Obviousness
`I have been informed by Counsel and understand that documents and
`
`27.
`
`materials that qualify as prior art can render a patent claim unpatentable as
`
`
`
`13
`
`
`
`obvious. I am informed by Counsel and understand that all prior art references are
`
`to be looked at from the viewpoint of a person of ordinary skill in the art at the
`
`time of the invention, and that this viewpoint prevents one from using his or her
`
`own insight or hindsight in deciding whether a claim is obvious.
`
`28.
`
`I have been informed by Counsel and understand that a claim is unpatentable
`
`for obviousness under 35 U.S.C. § 103 (in the pre-AIA form of that statute that
`
`applies to the ’266 patent) “if the differences between the subject matter sought to
`
`be patented and the prior art are such that the subject matter as a whole would have
`
`been obvious at the time the invention was made to a person having ordinary skill
`
`in the art to which said subject matter pertains.” I am informed by Counsel and
`
`understand that obviousness may be based upon a combination of references. I am
`
`informed by Counsel and understand that the combination of familiar elements
`
`according to known methods is likely to be obvious when it does no more than
`
`yield predictable results. However, I am informed by Counsel and understand that
`
`a patent claim composed of several elements is not proved obvious merely by
`
`demonstrating that each of its elements was, independently, known in the prior art.
`
`29.
`
`I am informed by Counsel and understand that when a patented invention is
`
`a combination of known elements, a court must determine whether there was an
`
`apparent reason to combine the known elements in the fashion claimed by the
`
`patent at issue by considering the teachings of prior art references, the effects of
`
`
`
`14
`
`
`
`demands known to people working in the field or present in the marketplace, and
`
`the background knowledge possessed by a person having ordinary skill in the art.
`
`30.
`
`I am informed by Counsel and understand that a patent claim composed of
`
`several limitations is not proved obvious merely by demonstrating that each of its
`
`limitations was independently known in the prior art. I am informed by counsel for
`
`the Patent Owner and understand that identifying a reason those elements would be
`
`combined can be important because inventions in many instances rely upon
`
`building blocks long since uncovered, and claimed discoveries almost of necessity
`
`will be combinations of what, in some sense, is already known. I am informed by
`
`Counsel and understand that it is improper to use hindsight in an obviousness
`
`analysis, and that a patent’s claims should not be used as a “roadmap.”
`
`31.
`
`I am informed by Counsel and understand that an obviousness inquiry
`
`requires consideration of the following factors: (1) the scope and content of the
`
`prior art; (2) the differences between the claims and the prior art; (3) the level of
`
`ordinary skill in the pertinent art; and (4) any objective indicia of non-obviousness,
`
`such as commercial success, long-felt but unresolved need, failure of others,
`
`industry recognition, copying, and unexpected results. I understand that the
`
`foregoing factors are sometimes referred to as the “Graham factors.”
`
`32.
`
`I have been informed by Counsel and understand that an obviousness
`
`evaluation can be based on a combination of multiple prior art references. I
`
`
`
`15
`
`
`
`understand that the prior art references themselves may provide a suggestion,
`
`motivation, or reason to combine, but that the nexus linking two or more prior art
`
`references is sometimes simple common sense. I have been informed by Counsel
`
`and understand that obviousness analysis recognizes that market demand, rather
`
`than scientific literature, often drives innovation, and that a motivation to combine
`
`references may be supplied by the direction of the marketplace.
`
`33.
`
`I have been informed by Counsel and understand that if a technique has been
`
`used to improve one device, and a person of ordinary skill at the time of invention
`
`would have recognized that it would improve similar devices in the same way,
`
`using the technique is obvious unless its actual application is beyond his or her
`
`skill.
`
`34.
`
`I have been informed by Counsel and understand that practical and common
`
`sense considerations should guide a proper obviousness analysis, because familiar
`
`items may have obvious uses beyond their primary purposes. I have been
`
`informed by Counsel and understand that a person of ordinary skill looking to
`
`overcome a problem will often be able to fit together the teachings of multiple
`
`prior art references. I have been informed by Counsel and understand that
`
`obviousness analysis therefore takes into account the inferences and creative steps
`
`that a person of ordinary skill would have employed at the time of invention.
`
`
`
`16
`
`
`
`35.
`
`I have been informed by Counsel and understand that a proper obviousness
`
`analysis focuses on what was known or obvious to a person of ordinary skill at the
`
`time of invention, not just the patentee. Accordingly, I understand that any need or
`
`problem known in the field of endeavor at the time of invention and addressed by
`
`the patent can provide a reason for combining the elements in the manner claimed.
`
`36.
`
`I have been informed by Counsel and understand that a claim can be obvious
`
`in light of a single reference, without the need to combine references, if the
`
`elements of the claim that are not found explicitly or inherently in the reference
`
`can be supplied by the common sense of one of skill in the art.
`
`37.
`
`I have been informed by Counsel and understand that secondary indicia of
`
`non-obviousness may include (1) a long felt but unmet need in the prior art that
`
`was satisfied by the invention of the patent; (2) commercial success of processes
`
`covered by the patent; (3) unexpected results achieved by the invention; (4) praise
`
`of the invention by others skilled in the art; (5) taking of licenses under the patent
`
`by others; (6) deliberate copying of the invention; (7) failure of others to find a
`
`solution to the long felt need; and (8) skepticism by experts. I understand that
`
`evidence of secondary indicia of non-obviousness, if available, should be
`
`considered as part of the obviousness analysis.
`
`38.
`
`I have been informed by Counsel and understand that there must be a
`
`relationship between any such secondary considerations and the invention, and that
`
`
`
`17
`
`
`
`contemporaneous and independent invention by others is a secondary consideration
`
`supporting an obviousness determination.
`
`39.
`
`In sum, my understanding is that prior art teachings are properly combined
`
`where one of ordinary skill having the understanding and knowledge reflected in
`
`the prior art and motivated by the general problem facing the inventor, would have
`
`been led to make the combination of elements recited in the claims. Under this
`
`analysis, the prior art references themselves, or any need or problem known in the
`
`field of endeavor at the time of the invention, can provide a reason for combining
`
`the elements of multiple prior art references in the claimed manner.
`
`40.
`
`I have been informed by Counsel and understand that in an inter partes
`
`review, “the petitioner shall have the burden of proving a proposition of
`
`unpatentability,” including a proposition of obviousness, “by a preponderance of
`
`the evidence.” 35 U.S.C. §316(e).
`
`V. HISTORICAL AND TECHNICAL OVERVIEW
`41. The ’266 patent and the prior art references discussed herein are all from the
`
`field of non-invasive optical biosensors. These devices have a wide range of
`
`applications, for example, measuring blood flow characteristics such as blood
`
`oxygen saturation, blood pressure, and cardiac output. Non-invasive optical
`
`biosensors are generally characterized as devices that pass light from a light source
`
`
`
`18
`
`
`
`through the skin (i.e., non-invasive) into a blood perfused area of body tissue and
`
`then use a photodetector to sense the absorption of light in the tissue.
`
`42. One common and well-understood non-invasive optical biosensor is a pulse
`
`oximeter, which is described in the ’266 patent. Pulse oximeters have been known
`
`since at least the 1970’s, with technology used in pulse oximeters dating back to
`
`the 1930’s. APPLE-1019, p. 98. Pulse oximetry is a widely used method for
`
`monitoring arterial hemoglobin oxygen saturation (SpO2). Id.
`
`VI. The ’266 patent
`A. Overview of the ’266 patent
`43. The ’266 patent generally relates to “noninvasive methods, devices, and
`
`systems for measuring a blood constituent or analyte … or for measuring many
`
`other physiologically relevant patient characteristics.” APPLE-1001, 2:22-28.
`
`44.
`
`In its background section, the ’266 patent explains that “[t]he standard of
`
`care in caregiver environments includes patient monitoring through spectroscopic
`
`analysis using, for example, a pulse oximeter,” and that “[d]evices capable of
`
`spectroscopic analysis generally include a light source(s) transmitting optical
`
`radiation into or reflecting off a measurement site, such as, body tissue carrying
`
`pulsing blood.” Id., 1:64-2:5. “After attenuation by tissue and fluids of the
`
`measurement site, a photo-detection device(s) detects the attenuated light and
`
`outputs a detector signal(s) responsive to the detected attenuated light.” Id., 2:4-7.
`
`
`
`19
`
`
`
`“A signal processing device(s)” then “process[es] the detector(s) signal(s) and
`
`outputs a measurement indicative of a blood constituent of interest, … other
`
`physiological parameters, or other data or combinations of data useful in
`
`determining a state or trend of wellness of a patient.” Id., 2:8-13.
`
`45.
`
`In this way, the ’266 patent confirms that prior art “devices capable of
`
`spectroscopic analysis” (“for example, a pulse oximeter”), generally included one
`
`or more light sources configured to emit light into user tissue, one or more
`
`detectors configured to detect light after attenuation by the user’s tissue and to
`
`output responsive signal(s), and one or more signal processors configured to
`
`process signals and to output measurements of physiological parameters. Id., 1:64-
`
`2:5.
`
`46.
`
`In the ’266 patent’s system, “the detectors 106 can capture and measure light
`
`transmitted from the emitter 104 that has been attenuated or reflected from the
`
`tissue in the measurement site 102,” and “[t]he detectors 106 can output a detector
`
`signal 107 responsive to the light captured or measured.” Id., 13:60-66. These
`
`signals can include, for instance, oxygenation and/or pulse rate information of the
`
`user. Id., 2:28-30.
`
`47. Referring further to FIG. 1 below, the ’266 patent generally describes a
`
`system that “include[s] a sensor 101 (or multiple sensors) that is coupled to a
`
`processing device or physiological monitor 109,” and where “the sensor 101 and
`
`
`
`20
`
`
`
`the monitor 109 are integrated together into a single unit” or alternatively “separate
`
`from each other and communicate one with another in any suitable manner, such as
`
`via a wired or wirele