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`
`Patent 11,298,056
`
`TABLE OF CONTENTS
`INTRODUCTION AND ENGAGEMENT .................................................... 3
`I.
`BACKGROUND AND QUALIFICATIONS ................................................. 3
`II.
`III. MATERIALS CONSIDERED AND
`INFORMATION RELIED UPON REGARDING THE ’056 PATENT ........ 7
`IV. UNDERSTANDING OF PATENT LAW ...................................................... 8
`V.
`STATE OF THE ART AND LEVEL OF SKILL IN THE ART ..................10
`VI. THE CLAIM SCOPE ....................................................................................11
`VII. THE GRANDPARENT APPLICATION AS FILED ...................................15
`
`
`
`
`
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 2
`
`
`
`Patent 11,298,056
`
`I, Morten O. Jensen, declare as follows:
`
`I.
`
`INTRODUCTION AND ENGAGEMENT
`
`1.
`
`I have been retained as an independent expert on behalf of Dexcom,
`
`Inc. in connection with the above-captioned Petition for Inter Partes Review
`
`(“IPR”) to provide my analyses and opinions on certain technical issues related to
`
`U.S. Patent No. 11,298,056 (hereinafter “the ’056 Patent”).
`
`2.
`
`I am being compensated at my usual and customary rate for the time I
`
`spend in connection with this IPR. My compensation is not affected by the
`
`outcome of this IPR.
`
`3.
`
`Specifically, I have been asked to provide my opinions regarding
`
`whether Mr. Harper’s patent application filed on December 21, 2018, U.S. Ser. No.
`
`16/228,910 (“the Grandparent application,” (Ex1202)) sufficiently described and
`
`enabled, from the perspective of an ordinarily skilled artisan, the claims of the ’056
`
`patent.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`I am an expert in the fields of biomedical engineering and electrical
`
`and computer engineering. In formulating my opinions, I have relied upon my
`
`training, knowledge, and experience in the relevant art. A copy of my curriculum
`
`vitae is appended to this declaration as Appendix A and provides a description of
`
`my professional experience, including my academic and employment history,
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 3
`
`
`
`Patent 11,298,056
`
`publications, conference participation, awards and honors, and more. The
`
`following is a brief summary of my relevant qualifications and professional
`
`experience.
`
`5.
`
`I graduated with honors from the Engineering College of Aarhus in
`
`Denmark in July 1997 with a B.Sc. (bachelor’s) degree in electrical and computer
`
`engineering with a focus on biomedical engineering. I graduated from the Georgia
`
`Institute of Technology and Emory University School of Medicine (joint program)
`
`in May 2000 with a M.Sc. (master’s) degree in biomedical engineering. I graduated
`
`from the University of Aarhus School of Medicine in Denmark in November 2008
`
`with a Ph.D. (doctorate) in medicine. The focus of my Ph.D. research was to create
`
`measurement equipment for physiological/biomedical monitoring. In March 2015,
`
`I was granted a Dr.Med (doctorate) in medical science from the University of
`
`Aarhus School of Medicine in Denmark. The Dr.Med degree is a higher-level
`
`doctorate that is awarded at certain universities in Northern Europe in the field of
`
`medicine. The Dr.Med degree is awarded after a candidate’s research and
`
`publications have proven to make a significant difference in the advancement of
`
`science. Historically, the Dr.Med degree has been given only to medical doctors,
`
`with rare exceptions. I was the third engineer in Denmark since 1479 to receive
`
`this degree.
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 4
`
`
`
`Patent 11,298,056
`
`6.
`
`I am currently employed as an Associate Professor of Biomedical
`
`Engineering at the University of Arkansas in Fayetteville, Arkansas. I have held
`
`this position since August 2015. I am also a Scholar of the Arkansas Research
`
`Alliance, a public-private partnership dedicated to elevating a fundamental belief
`
`that “research matters.” This Alliance provides financial support for my research at
`
`the university in the field of increasing the understanding of the mechanics of
`
`cardiovascular disease and intervention while creating solutions and dedicated
`
`devices. I also hold an Adjunct Associate Professorship at the University Hospital
`
`of Aarhus in Denmark where my main role has been to teach biomedical
`
`engineering to MD/PhD students and advise on projects where measurements and
`
`signal optimization is in focus. I have held that position since July 2009.
`
`7.
`
`Over the past two decades, I have developed and taught numerous
`
`courses at both the undergraduate and graduate level, as well as in medical schools,
`
`in the field of biomedical engineering, including medical device development,
`
`sensor design, measurements on biological and living systems, instrumentation,
`
`signal analysis, and presentation. As set forth on my CV (Appendix A hereto), I
`
`have published numerous articles relating to aspects of device interactions with
`
`living tissues, including device design, performance and specific features that
`
`allow these devices to function optimally. Amongst my publications are 118 papers
`
`and articles, 164 conference and seminar presentations, and 11 books/book
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 5
`
`
`
`Patent 11,298,056
`
`chapters. I have also received numerous awards for my research work, as outlined
`
`in Appendix A.
`
`8.
`
`As part of my approximately six years of work in industry at National
`
`Instruments, a global data-acquisition, -instrumentation, -analysis and -presentation
`
`company, my role as a consulting services engineer in the business development
`
`unit was to make customers using the company’s products successful. Many of the
`
`applications that I worked with were highly relevant to the ’056 patent. My work
`
`with customers was typically confidential in nature, although whenever possible I
`
`managed to publish on both specific projects as well as general topics in
`
`biomedical measurement and automation. For example, in 2002 I published two
`
`articles in the magazine “Scientific Computing & Instrumentation - SC&I”, and
`
`one of them became a cover article. See Appendix A for details. I also wrote a
`
`chapter on physiologic signals acquisition and analysis in a published book entitled
`
`“Virtual Bio-Instrumentation” during my time with the company.
`
`9.
`
`Given my experience in measurements and analysis from medical
`
`devices on data from the human body, about seven years ago I became responsible
`
`for our Senior Design program at the Department of Biomedical Engineering at the
`
`University of Arkansas in Fayetteville. I have since then joined my colleagues in
`
`electrical, mechanical, and computer engineering/data science to encourage and
`
`support our students to work together across departments in their senior design
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 6
`
`
`
`Patent 11,298,056
`
`projects. Several of the projects that I have advised and co-advised through the
`
`Department of Biomedical Engineering across multi-departmental collaborations
`
`have won first and second prizes at the annual College-wide Senior Design
`
`presentation competition. This is a highly anticipated event, open to the public,
`
`where members of the community and industry vote on projects.
`
`10.
`
`I have also actively participated, and worked alongside surgeons,
`
`radiologists, and anesthesiologists in more than one hundred large animal
`
`experimental surgeries and interventions on 60-80 kg. porcine and ovine models.
`
`The pig and sheep are well-known models for the human physiological system in
`
`many aspects of medicine, as also documented in literature during the last several
`
`decades. The relevant instruments, equipment, and monitoring systems used on the
`
`large animal porcine and ovine models are the same as those used for humans.
`
`Hence, the experience of working with these models is relevant to an in-depth
`
`understanding of how instruments interact with the human biomedical system.
`
`11. As a result of my background, education, and experience both in
`
`industry and academia, I believe that I am highly qualified to provide opinions
`
`from the standpoint of a person of skill in the art relating to the design and
`
`performance of biomedical monitoring systems, and the technology described in
`
`the ’056 patent and other references that I discuss in this Declaration.
`
`III. MATERIALS CONSIDERED AND
`INFORMATION RELIED UPON REGARDING THE ’056 PATENT
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 7
`
`
`
`Patent 11,298,056
`
`12. For this declaration, I have considered the ’056 patent, the
`
`Grandparent application, and the other materials I reference herein.
`
`IV. UNDERSTANDING OF PATENT LAW
`
`13.
`
`I am not an attorney. For the purposes of this declaration, I have been
`
`informed about certain aspects of the law that are relevant to my opinions. My
`
`understanding of the law was provided to me by the Petitioner’s attorneys as well
`
`as my experience from previous involvement in U.S. patent cases.
`
`14.
`
`I have been asked to analyze the disclosure of the December 21, 2018,
`
`patent application filed by Mr. Harper, referred to as the Grandparent application,
`
`and designated Ex1202, to compare it with the scope of the claims of the ’056
`
`patent.
`
`15. Patent law requires that a patent application’s specification contain an
`
`adequate “written description” of the alleged invention claimed. Under this
`
`requirement, the application’s disclosure must clearly allow persons of ordinary
`
`skill in the art as of the application’s filing date (here, December 21, 2018),
`
`without foreknowledge of the later-drafted patent claims (here, the ’056 patent
`
`claims), to recognize that the patent applicant (here, Mr. Harper) invented what is
`
`claimed in those claims, such that the disclosure of the application relied upon
`
`reasonably conveys to those skilled in the art that the patent applicant had
`
`possession of the claimed subject matter as of the application’s filing date. To
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 8
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`
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`Patent 11,298,056
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`show such possession, the application’s disclosure of the claimed subject matter
`
`must be as broad as the claim. It is not enough for the application’s disclosure to
`
`describe something close to what is claimed even if what is claimed would have
`
`been an obvious extension of what is described. Instead, the application must
`
`describe the subject matter that is claimed. The application, however, need not use
`
`the verbatim language of the later-issued claims.
`
`16. Patent law requires that a patent application’s specification contain
`
`also an “enabling disclosure” of the subject matter claimed in the issued patent.
`
`This requires a description of the claimed subject matter and of the manner and
`
`process of making and using it, in such full, clear, concise, and exact terms as to
`
`enable any person skilled in the art to which it pertains, or with which it is most
`
`nearly connected, to make and use the same, by following the teachings of the
`
`application, without undue experimentation. A considerable amount of
`
`experimentation is permissible, if it is merely routine in the relevant field, or if the
`
`application’s disclosure provides a reasonable amount of guidance to the skilled
`
`artisan. The enabling disclosure must be provided in the specification. A patent
`
`applicant cannot rely on the knowledge of a person of ordinary skill to serve as a
`
`substitute for missing information in the application. The scope of the disclosure’s
`
`enablement must be as broad as the claims.
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 9
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`
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`Patent 11,298,056
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`17.
`
`I have been asked to assume that the ’056 patent claims are broad
`
`enough to encompass systems with the features identified in the section below
`
`entitled “The Claim Scope.” With that assumed claim scope, I have been asked to
`
`analyze and opine on whether the Grandparent application described and enabled
`
`such a breadth of later claimed subject matter in the manner required by the above
`
`written-description and enablement requirements, with a focus on the perspective
`
`of the skilled artisan in the relevant fields in December 2018.
`
`18. My analysis in this declaration is in accordance with the above-stated
`
`legal principles.
`
`V.
`
`STATE OF THE ART AND LEVEL OF SKILL IN THE ART
`
`19. The person of ordinary skill in the art pertinent to the ’056 patent in
`
`December 2018 (“POSITA”) would have had a Bachelor of Science degree in
`
`biomedical engineering, or a similar field, such as electrical or computer
`
`engineering, and two years of industry experience or research working with
`
`medical devices and systems for measuring biomedical signals, for example levels
`
`of blood analytes, such as glucose, in a patient and transmitting indications of such
`
`levels of analytes to a receiving device for reporting the measurements. Additional
`
`education, such as a Master’s degree in biomedical engineering could substitute for
`
`the industry experience as it typically involves at least two years of additional
`
`study, which can be focused on medical devices including data electronics and
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 10
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`
`
`analysis systems, as well as a thesis or project spanning several semesters to
`
`Patent 11,298,056
`
`implement a substantial project.
`
`VI. THE CLAIM SCOPE
`
`20. For purposes of this declaration, I have been asked to assume that the
`
`’056 patent claims include systems with the following capabilities. Listing a
`
`capability below does not mean that the claim requires that all systems covered by
`
`the claims must have that capability. Instead, it means that the claims are broad
`
`enough to include some systems having that capability. For example, only claim 22
`
`of the ’056 patent requires that the “receiver unit” component include a mobile
`
`phone. But all of the claims include systems in which the “receiver unit”
`
`component has the capability of being a mobile phone.
`
`21. Detect 17 adverse conditions: Claim 1 of the ’056 patent recites that
`
`the “glucose monitoring system is configured to detect an adverse condition.”
`
`(’056 15:65-66.) The ’056 patent expressly states that “an” refers to one or more:
`
`“as used herein and in the appended claims, the singular forms ‘a’, ‘an’, and ‘the’
`
`include plural referents unless the context clearly dictates otherwise.” (’056 3:50-
`
`52.) I have been asked to assume that each ’056 patent claim encompasses systems
`
`configured to detect all 17 of the “adverse conditions” identified in the dependent
`
`claims or the specification of the ’056 patent, namely: (1) “a sensor communication
`
`error” (’056 claim 3, 13:65), (2) “a signal error associated with the glucose sensor”
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 11
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`
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`Patent 11,298,056
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`(claim 4), (3) “a signal error associated with the data processing and transmitter
`
`unit” (claim 5), (4) “a signal error associated with the receiver unit” (claim 6), (5)
`
`“a system malfunction associated with the data processing and transmitter unit”
`
`(claim 7), (6) “a system malfunction associated with the receiver unit” (claim 7),
`
`(7) “an inability of the receiver unit to display or output at least a portion of [the]
`
`first line graph” (claim 8), (8) “a sensor instability condition” (claim 9, 13:61), (9)
`
`“a calibration failure condition” (claim 10, 13:61-62), (10) “a monitoring system
`
`failure condition” (claim 11, 13:62), (11) “a sensor misposition error” (claim 13,
`
`13:64-65), (12) “a temperature measurement outside a predetermined range”
`
`(claim 14, 13:65-66), (13) “an analyte level exceeding a predetermined threshold”
`
`(claim 15, 14:2), (14) “a rate of change of an analyte level exceeding a
`
`predetermined threshold” (claim 16, 14:2-4), (15) “a data unavailability condition”
`
`(claim 17, 14:5), (16) “a signal error associated with the blood glucose reference
`
`data” (claim 25, see 14:4), and (17) an “early signal attenuation condition of the
`
`sensor” (13:63).
`
`22. Several of the dependent claims state that “the adverse condition
`
`comprises” an identified condition. I have been asked to assume that “comprises”
`
`in these claims means “includes” and that these dependent claims also encompass
`
`systems configured to detect all 17 of the “adverse conditions.”
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 12
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`
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`Patent 11,298,056
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`23. Continuously monitor for and detect all 17 adverse conditions, and
`
`when they start and end: Claim 1 of the ’056 patent recites a first line graph that
`
`“has an end corresponding to a time associated with a start of the adverse
`
`condition” (id. 16:1-3) and recites a second line graph that has “a second end
`
`corresponding to a time associated with an end of the adverse condition” (id.
`
`16:16-20). Dependent claim 18 recites displaying data “immediately after the
`
`correction of the adverse condition.” I have been asked to assume that each claim
`
`encompasses systems in which the system’s processor(s) are programmed to
`
`continuously monitor for all 17 adverse conditions to detect when they start and
`
`when they end.
`
`24. Store data throughout 72-hour or longer adverse-condition period:
`
`Claim 1 requires certain data to be stored “during a time period corresponding to
`
`the adverse condition.” (’056 16:4-7.) The patent states that the sensor may be
`
`configured for calibration 72 hours after insertion. (Id. 11:8-13). I have been asked
`
`to assume that each claim encompasses storing data throughout a 72-hour or longer
`
`adverse condition period.
`
`25. Store calibrated sensor data derived from sensor data received during
`
`the adverse-condition time period but not store that uncalibrated sensor data: Claim
`
`1 recites that the “data processing and transmitter unit” (hereinafter, “transmitter”)
`
`is configured to “receive the sensor data from the glucose sensor …” (’056 15:39)
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 13
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`
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`Patent 11,298,056
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`and is configured to “process the sensor data using calibration data to provide
`
`processed sensor data …” (id. 15:42-43). I will refer to the former, received data as
`
`uncalibrated sensor data and the latter, processed data as calibrated sensor data. I
`
`have been asked to assume that “sensor data” referenced elsewhere in the claims at
`
`least includes this uncalibrated sensor data, and that “processed sensor data”
`
`referenced elsewhere in the claims at least includes this calibrated sensor data.
`
`26. Claim 1 recites storing “sensor data” and/or “processed sensor data”
`
`“during a time period corresponding to the adverse condition.” (’056 16:4-7). I
`
`have been asked to assume that both terms encompass data that is bad (inaccurate)
`
`on account of some adverse condition such as a sensor or transmitter malfunction
`
`or a calibration failure.
`
`27. Claim 1 recites that during the adverse-condition time period, “sensor
`
`data, processed sensor data, or both” are stored in the memory of the transmitter.
`
`(’056 16:4-7). I have been asked to assume that each claim encompasses systems
`
`configured for three different modes of operation during the adverse-condition
`
`time period: (1) uncalibrated sensor data is stored in the transmitter’s memory, but
`
`no calibrated sensor data is stored, (2) calibrated sensor data is stored in the
`
`transmitter’s memory, but no uncalibrated sensor data is stored, and (3) both
`
`uncalibrated sensor data and calibrated sensor data are stored in the transmitter’s
`
`memory.
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 14
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`
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`Patent 11,298,056
`
`28.
`
`Immediately after any detected adverse condition is corrected; display
`
`accurate glucose values for the entire adverse-condition time period on the screen
`
`of a mobile phone or other receiver unit: Claim 1 recites that “the receiver unit is
`
`configured to output to the display, after the adverse condition is corrected,”
`
`processed “sensor data for the time period corresponding to the adverse condition.”
`
`(’056 16:8-12.) Dependent claim 18 recites that this line graph is displayed
`
`“immediately after the correction of the adverse condition.” Dependent claim 22
`
`recites that “the receiver unit comprises a mobile phone” (’056 17:21). I have been
`
`asked to assume that each claim encompasses systems configured to display on a
`
`mobile phone accurate calibrated glucose sensor data, for the entire 72-hours or
`
`longer adverse condition, “immediately” after correction of the adverse condition.
`
`29.
`
`Immediately display accurate values despite having stored only
`
`inaccurate calibrated data or having not stored uncalibrated sensor data: I have
`
`been asked to assume that the claims encompass systems configured to display on
`
`the screen of a mobile phone accurate calibrated glucose sensor data, for an entire
`
`adverse-condition time period, “immediately” after correction of the adverse
`
`condition, despite having stored only inaccurate, calibrated sensor data during that
`
`time period, and not accurate, uncalibrated sensor data.
`
`VII. THE GRANDPARENT APPLICATION AS FILED
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 15
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`
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`Patent 11,298,056
`
`30.
`
`I have reviewed the Grandparent application (Ex1202), including its
`
`claims as filed on December 21, 2018, from the perspective of a skilled artisan in
`
`December 2018, without foreknowledge of the ’056 patent claims, to determine
`
`whether it provided the disclosure required by the written description requirement
`
`described above and the enabling disclosure requirement described above, for the
`
`above-identified scope of the ‘056 patent claims. I have not reviewed the materials
`
`said to be incorporated by reference.
`
`31. Detect 17 adverse conditions: The Grandparent application did not
`
`describe and enable systems configured to detect all 17 of the “adverse conditions”
`
`identified in the patent.
`
`32. As outlined above in ¶21, the ’056 patent identifies 17 “adverse
`
`conditions”: (1) “a sensor communication error” (’056 claim 3, 13:65), (2) “a
`
`signal error associated with the glucose sensor” (claim 4), (3) “a signal error
`
`associated with the data processing and transmitter unit” (claim 5), (4) “a signal
`
`error associated with the receiver unit” (claim 6), (5) “a system malfunction
`
`associated with the data processing and transmitter unit” (claim 7), (6) “a system
`
`malfunction associated with the receiver unit” (claim 7), (7) “an inability of the
`
`receiver unit to display or output at least a portion of [the] first line graph” (claim
`
`8), (8) “a sensor instability condition” (claim 9, 13:61), (9) “a calibration failure
`
`condition” (claim 10, 13:61-62), (10) “a monitoring system failure condition”
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 16
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`
`
`Patent 11,298,056
`
`(claim 11, 13:62), (11) “a sensor misposition error” (claim 13, 13:64-65), (12) “a
`
`temperature measurement outside a predetermined range” (claim 14, 13:65-66),
`
`(13) “an analyte level exceeding a predetermined threshold” (claim 15, 14:2), (14)
`
`“a rate of change of an analyte level exceeding a predetermined threshold” (claim
`
`16, 14:2-4), (15) “a data unavailability condition” (claim 17, 14:5), (16) “a signal
`
`error associated with the blood glucose reference data” (claim 25, see 14:4), and
`
`(17) an “early signal attenuation condition of the sensor” (13:63).
`
`33. Two disclosures in the Grandparent application might relate to
`
`techniques for detecting an adverse condition. One concerns sensor current leakage
`
`detection and the other concerns calibration failures.
`
`34. Sensor Leakage Current: Figure 2 of the Grandparent application
`
`has a box 214 labeled “leak detection” without anything inside the box describing
`
`how this function is performed. The only text description in the Grandparent
`
`application of this box is the following, in [0045]: “The leak detection circuit 214
`
`in accordance with one embodiment of the present disclosure may be configured to
`
`detect leakage current in the sensor unit 101 to determine whether the measured
`
`sensor data are corrupt or whether the measured data from the sensor 101 is
`
`accurate.” The Grandparent application did not describe this circuit or any
`
`algorithm performed by this circuit. It did not give an example of this circuit
`
`DECLARATION OF MORTEN O. JENSEN
`
`Page 17
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`
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`Patent 11,298,056
`
`detecting leakage current. It did not clearly point the reader to any external
`
`document to find a description of this “leak detection circuit.”
`
`35.
`
`It is not only leak-currents that can cause the sensor data to be corrupt
`
`or inaccurate. This can be caused by many factors with different properties, such as
`
`mechanical, chemical, electrical, etc.
`
`36. Skilled artisans were familiar with leak detection circuits by the
`
`application’s filing date of December 21, 2018. An electrical current leak detection
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`circuit is designed to identify unintended or abnormal leakage of electrical current
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`in a system. It is commonly used to detect faults or insulation breakdown in
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`electrical wiring, power cables, or electronic devices. The purposes of such a
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`circuit are numerous, such as to enable correct readings from a sensor, to ensure
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`safety by alerting users to potential electrical hazards, to prevent damage to
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`equipment, and also to reduce the risk of electrical fires. The circuit typically
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`comprises various components, including sensors, monitoring devices, and an
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`alarm system.
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`37. Some leak detection circuits are designed to continuously monitor for
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`leakage current, and others are not.
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`38. The key elements of an electrical current leak detection circuit
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`designed to monitor for leakage current are discussed below.
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`DECLARATION OF MORTEN O. JENSEN
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`39. A leak detection circuit can contain current sensors that are placed at
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`specific points in the electrical system where leakage is likely to occur. They detect
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`the flow of electrical current and any deviations from the expected values. Current
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`transformers or current sensors are commonly used for this purpose. If an
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`imbalance is detected, indicating a current leak, the residual current device (RCD)
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`“trips” and disconnects the power supply. A leak detection circuit can also contain
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`monitoring devices that receive signals from the current sensors and perform
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`analysis to determine if there is any abnormal current leakage. They can be
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`microcontrollers, programmable logic controllers (PLCs), or dedicated monitoring
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`circuits. The monitoring devices continuously assess the current levels and
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`compare them against predefined thresholds or reference values. When a current
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`leak is detected, the alarm system is typically activated to alert users or operators.
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`It can consist of audible alarms, visual indicators, or notifications sent to a control
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`panel or monitoring station. The alarm system serves as an immediate warning to
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`prompt appropriate actions, such as investigating the cause of the leakage and
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`taking corrective measures, such as alerting a glucose monitoring system of this
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`condition. More advanced current leak detection circuits may include data logging
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`and communication capabilities. This allows for the recording of historical data
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`related to current leakages, remote monitoring, and real-time notifications. It
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`DECLARATION OF MORTEN O. JENSEN
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`Page 19
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`Patent 11,298,056
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`facilitates proactive maintenance, troubleshooting, and analysis of these electrical
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`systems, that may contain sensors and other electrical equipment.
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`40. The Grandparent application did not clearly disclose its leak detection
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`circuit detecting at least the following adverse conditions: (1) “a sensor
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`communication error” (’056 claim 3, 13:65), (3) “a signal error associated with the
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`data processing and transmitter unit” (claim 5), (5) “a system malfunction
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`associated with the data processing and transmitter unit” (claim 7), (6) “a system
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`malfunction associated with the receiver unit” (claim 7), (7) “an inability of the
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`receiver unit to display or output at least a portion of [the] first line graph” (claim
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`8), (11) “a sensor misposition error” (claim 13, 13:64-65), (12) “a temperature
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`measurement outside a predetermined range” (claim 14, 13:65-66), (13) “an
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`analyte level exceeding a predetermined threshold” (claim 15, 14:2), (14) “a rate of
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`change of an analyte level exceeding a predetermined threshold” (claim 16, 14:2-
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`4), (16) “a signal error associated with the blood glucose reference data” (claim 25,
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`see 14:4), and (17) an “early signal attenuation condition of the sensor” (13:63).
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`41. Condition Unsuitable for Calibration: The Grandparent application
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`described disabling the display of glucose values in the event of a “condition
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`unsuitable for a sensor calibration event.” (Ex1202 [0052]; see also [0051]–[0058],
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`[0068].) It described such disabling mostly in outlining the methods of Figs. 4 and
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`5. The application stated that calibration converts the data signals received from
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`DECLARATION OF MORTEN O. JENSEN
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`Page 20
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`Patent 11,298,056
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`the sensor into corresponding analyte levels. It stated that the conditions unsuitable
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`for calibration include when a predetermined calibration event is triggered “but a
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`successful calibration does not result.” (Ex1202 [0052].) It did not describe,
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`however, an example, algorithm, or circuit for determining whether a “successful
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`calibration” has resulted. “Other conditions may also result in rendering the
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`condition unsuitable for sensor calibration including, but not limited to, detection
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`of a failure mode of a sensor, sensor data values being outside a predetermined
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`range, rate of change of sensor data values being above a predetermined
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`threshold, a temperature measurement outside a predetermined range, or any
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`combination thereof.” (Ex1202 [0053].)
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`42. The Grandparent application did not describe an example, algorithm
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`or circuit for detecting such a condition unsuitable for calibration when none of the
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`three out-of-range or above-a-threshold conditions italicized above are present. It
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`asserted that the receiver unit “determines whether the sensor is calibrated and is in
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`acceptable condition for further data processing.” (Ex1202 [0054]) and is
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`configured to “determine if calibration of the sensor data is suitable—that is,
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`whether the conditions necessary for sensor calibration are met” (Ex1202 [0056]).
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`But it did not describe how this is done, apart from the three conditions italicized
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`above. It did not show the skilled artisan that Mr. Harper possessed the knowledge
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`necessary to make these determinations or configure a processor to make them.
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`DECLARATION OF MORTEN O. JENSEN
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`Page 21
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`Patent 11,298,056
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`And it did not give the skilled artisan the steps to follow to configure a processor to
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`make these determinations.
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`43. The Grandparent application’s discussion of conditions unsuitable for
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`calibration did not clearly disclose detecting at least the following adverse
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`conditions: (4) “a signal error associated with the receiver unit” (claim 6), (6) “a
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`system malfunction associated with the receiver unit” (claim 7), and (7) “an
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`inability of the receiver unit to display or output at least a portion of [the] first line
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`graph” (claim 8).
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`44. Continuously monitor for and detect all 17 adverse conditions, and
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`when they start and end: The Grandparent application did not adequately disclose
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`systems programmed to continuously monitor for all 17 of the adverse conditions
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`to detect when they start and end.
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`45. Sensor Leakage Current: For a leak detection circuit to detect the
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`start and/or end of a period of inaccurate sensor-measured data caused by leakage
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`current it would need to continuously monitor for such leakage current. Not all
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`leak detection circuits continuously monitor for leakage current.
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`46. For example, U.S. Patent No. 8,112,240 to Abbott describes a leak
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`detection circuit that checks for sensor leakage current only intermittently by
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`sending a test signal to the sensor. For example, it states: “When it is desired to test
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`for the leakage current in the sensor 101, a leak detection test signal may be
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`DECLARATION OF MORTEN O. JENSEN
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`Page 22
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`Patent 11,
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