UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`ABBOTT DIABETES CARE INC.,
`Patent Owner.
`
`U.S. Patent No.: 11,298,056
`Issued: April 12, 2022
`Application No.: 17/411,154
`Filed: August 25, 2021
`
`Title: METHODS AND SYSTEMS FOR EARLY SIGNAL ATTENUATION
`DETECTION AND PROCESSING
`_________________
`
`DECLARATION OF BRIAN D. GROSS
`
`Page 1
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`

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`TABLE OF CONTENTS
`
`
`
`Page
`
`INTRODUCTION AND ENGAGEMENT .................................................... 8
`I.
`BACKGROUND AND QUALIFICATIONS ................................................. 8
`II.
`III. SCOPE OF OPINION ...................................................................................10
`IV. MATERIALS CONSIDERED AND INFORMATION
`
`RELIED UPON REGARDING THE ’056 PATENT ...................................11
`A.
`LIST OF EXHIBITS ...........................................................................11
`V. UNDERSTANDING OF PATENT LAW ....................................................14
`VI. THE ’056 PATENT .......................................................................................17
`A.
`Specification ........................................................................................18
`B.
`Prosecution History .............................................................................20
`VII. STATE-OF-THE-ART AND LEVEL OF SKILL IN THE ART .................20
`A.
`State-of-the-Art ...................................................................................20
`1.
`Sensors With Working and Counter Electrodes .......................21
`2.
`Sensor Sensitivity In Calibration ..............................................23
`3. Microprocessor Computations ..................................................25
`4.
`Bluetooth Communication ........................................................30
`B. Ordinary Level Of Skill In The Art .....................................................31
`VIII. GROUND 1: PATEL-2009 AND PARADIGM® REAL-TIME .................37
`A.
`Patel-2009 (Ex1012) Is Supported
`By Its Provisional Application (Ex1014) ............................................37
`The Medtronic Diabetes Website’s
`Publication Of Webpages And Other
`Information On Paradigm® REAL-Time (Ex1011)
`Was Publicly Accessible And Known By Positas ..............................45
`
`B.
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`C.
`
`Patel-2009 And Paradigm® Real-Time
`Disclose Glucose Monitoring Systems Easily Combined,
`And The Motivation To Do So With An Expectation Of Success .....47
`1.
`Patel-2009 .................................................................................47
`2.
`Paradigm® REAL-Time ...........................................................50
`3.
`Combination of Patel-2009 And Paradigm® REAL-Time ......51
`4. Motivation To Combine And Expectation Of Success.............53
`D. Ground 1 Claim Mappings ..................................................................56
`1.
`Claim 1 ......................................................................................56
`a)
`[1.A] (preamble) .............................................................56
`b)
`[1.B] ................................................................................59
`c)
`[1.C] ................................................................................61
`d)
`[1.D] ................................................................................63
`e)
`[1.E] ................................................................................65
`f)
`[1.F].................................................................................67
`g)
`[1.G] ................................................................................69
`h)
`[1.H] ................................................................................70
`i)
`[1.I] .................................................................................70
`j)
`[1.J] .................................................................................72
`k)
`[1.K] ................................................................................73
`l)
`[1.L] ................................................................................74
`Claim 2 ......................................................................................76
`Claim 3 ......................................................................................77
`Claims 5 and 6 ...........................................................................77
`Claim 7 ......................................................................................78
`
`2.
`3.
`4.
`5.
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`Claim 8 ......................................................................................79
`6.
`Claim 11 ....................................................................................79
`7.
`Claim 12 ....................................................................................80
`8.
`Claim 17 ....................................................................................81
`9.
`10. Claim 18 ....................................................................................81
`11. Claim 19 ....................................................................................82
`12. Claim 20 ....................................................................................83
`13. Claim 21 ....................................................................................84
`14. Claim 22 ....................................................................................85
`15. Claim 23 ....................................................................................86
`16. Claim 24 ....................................................................................87
`17. Claim 26 ....................................................................................87
`18. Claim 27 ....................................................................................88
`19. Claim 28 ....................................................................................88
`20. Claim 30 ....................................................................................88
`IX. GROUND 2: CLAIMS 4, 9-10, 15-16,
`
`AND 25 ARE OBVIOUS OVER PATEL-2009
`
`AND PARADIGM® REAL-TIME IN VIEW OF CAUSEY ........................89
`A.
`Causey .................................................................................................89
`B.
`Combination Of Patel-2009,
`Paradigm® REAL-Time, And Causey ................................................92
`C. Motivation To Combine And Expectation Of Success .......................93
`D. Ground 2 Claim Mappings ..................................................................95
`1.
`Claim 4 ......................................................................................96
`2.
`Claim 9 ......................................................................................96
`3.
`Claim 10 ....................................................................................97
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`C.
`
`Claim 14 ....................................................................................98
`4.
`Claim 15 ....................................................................................99
`5.
`Claim 16 ....................................................................................99
`6.
`Claim 25 ..................................................................................100
`7.
`X. GROUND 3: CLAIMS 1-12, 14-18,
`
`20-28, AND 30 ARE OBVIOUS OVER
`
`PATEL-2008 AND INCORPORATED REFERENCES............................101
`A.
`Patel-2008 ..........................................................................................101
`B.
`Incorporation of Mastrototaro, Shahmirian, and Causey ..................103
`1. Mastrototaro ............................................................................104
`2.
`Shahmirian ..............................................................................109
`3.
`Causey .....................................................................................111
`Combination, Motivation To
`Combine, And Expectation Of Success ............................................111
`D. Ground 3 Claim Mappings ................................................................115
`1.
`Claim 1 ....................................................................................115
`a)
`[1.A] (preamble) ...........................................................115
`b)
`[1.B] ..............................................................................117
`c)
`[1.C] ..............................................................................117
`d)
`[1.D] ..............................................................................120
`e)
`[1.E] ..............................................................................123
`f)
`[1.F]...............................................................................125
`g)
`[1.G] ..............................................................................129
`h)
`[1.H] ..............................................................................130
`i)
`[1.I] ...............................................................................131
`j)
`[1.J] ...............................................................................132
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`[1.K] ..............................................................................133
`k)
`[1.L] ..............................................................................134
`l)
`Claim 2 ....................................................................................134
`2.
`Claim 3 ....................................................................................135
`3.
`Claim 4 ....................................................................................136
`4.
`Claims 5 And 6 .......................................................................136
`5.
`Claim 7 ....................................................................................137
`6.
`Claim 8 ....................................................................................137
`7.
`Claim 9 ....................................................................................138
`8.
`Claim 10 ..................................................................................139
`9.
`10. Claim 11 ..................................................................................139
`11. Claim 12 ..................................................................................140
`12. Claim 14 ..................................................................................141
`13. Claim 15 ..................................................................................141
`14. Claim 16 ..................................................................................142
`15. Claim 17 ..................................................................................142
`16. Claim 18 ..................................................................................143
`17. Claim 20 ..................................................................................143
`18. Claim 21 ..................................................................................145
`19. Claim 22 ..................................................................................146
`20. Claim 23 ..................................................................................146
`21. Claim 24 ..................................................................................146
`22. Claim 25 ..................................................................................148
`23. Claim 26 ..................................................................................148
`24. Claim 27 ..................................................................................148
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`25. Claim 28 ..................................................................................149
`26. Claim 30 ..................................................................................149
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`I, Brian D. Gross, BSEE, M.Sc., do hereby declare as follows:
`
`I.
`
`INTRODUCTION AND ENGAGEMENT
`
`1. My name is Brian D. Gross, and 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
`
`spent 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 claims 1-12, 14-28 and 30 of the ’056 Patent would have been obvious to
`
`persons having ordinary skill in the art (“POSITAs”) as of April 2009. After
`
`reviewing the prior art discussed herein, it is my opinion that each of claims 1-12,
`
`14-28 and 30 of the ’056 Patent would have been obvious to a POSITA.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`Among other qualifications elaborated in my CV (EX 1009), I receive
`
`my Bachelor of Science in Electrical and Biomedical Engineering (BSEE) in 1990
`
`and my Masters of Science in Biomedical Engineering (M.Sc.) in 1991.
`
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`5.
`
`In 1991 and 1992, I worked as a scientist in product development
`
`engineering at VivaScan. At VivaScan, my work included designing and building
`
`microprocessor-controlled
`
`instrumentation
`
`in many cases,
`
`from discrete
`
`components. The efforts at VivaScan focused on physiological monitoring and
`
`included research and development related to determining glucose and other analytes
`
`in the blood as manifest U.S. Patent No. 5,372,135 (“the ’135 Patent”) for “Blood
`
`constituent determination based on differential spectral analysis” of which I am a
`
`co-inventor.
`
`6.
`
`From 2003 through 2013, I was co-investigator of a bioengineering
`
`research partnership with the Massachusetts Institute of Technology focused on ICU
`
`patient monitoring and including the development and application of physiological
`
`monitoring concepts and algorithms.
`
`7.
`
`From 2006 through 2014, I was a Principal Scientist of Patient Care and
`
`Monitoring Solutions at Philips where my work related to physiological monitoring.
`
`For example, in February 2008, some of my work on recognizing that gaps in
`
`monitored data due to poor network quality could be resolved by caching missed
`
`data and transmitting this data when sufficient bandwidth became available was filed
`
`as U.S. Provisional Application 61/032,532 on “optimizing physiological
`
`monitoring based on available but variable signal quality,” which later became U.S.
`
`Patent Application 12/918,822 and published as U.S. Publication 2011/0002223
`
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`related to “physiological monitoring over a healthcare network.” From 2014 to 2022,
`
`I was a Fellow Scientist and Clinical System Architect at Philips where I taught,
`
`trained, mentored, and supervised, members of the organization with less
`
`experience, as well as drove risk management and design tradeoff decisions for the
`
`Businesses and Research groups.
`
`8.
`
`In 2014, I was appointed by the International Standards Association to
`
`serve on the IEC-TC62/SC 62D/JWG 22 as a technical and clinical expert in medical
`
`device design. There I participated and led multi-national and multi-domain experts
`
`in drafting global safety standards pertaining to medical devices and their design. As
`
`a final example of my experience, I participated in technical and clinical research,
`
`and co-authored scores of papers including an abstract on how “delayed intravenous
`
`insulin therapy initiation is associated with mortality in the ICU,” which was
`
`presented to the SCCM 40th Critical Care Congress in 2011.
`
`III.
`
`SCOPE OF OPINION
`
`9.
`
`I have been asked to provide my opinions regarding whether claims 1-
`
`12, 14-28, and 30 of the ’056 patent would have been unpatentable to a person of
`
`ordinary skill in the art (POSITA) as of April 2009 in view of:
`
`•
`
`U.S. Patent Publication 2009/0085768 to Patel (Ex1012, “Patel-
`
`2009”);
`
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`•
`
`An FAQ webpage, features and benefits fact sheet, and sensor features
`
`user guide for the Medtronic MiniMed Paradigm® REAL-Time
`
`System archive of the Medtronic Diabetes website in October 2007
`
`(Ex1011, “Paradigm® REAL-Time”);
`
`•
`
`•
`
`•
`
`•
`
`U.S. Publication 2008/0119705 to Patel (Ex1015, “Patel-2008”)
`
`U.S. Patent 6,641,533 to Causey (Ex1017, “Causey”);
`
`U.S. Patent Publication 2006/0202859 (Ex1019, “Mastrototaro”); and
`
`U.S. Patent Publication 2004/0122353 (Ex1023, “Shahmirian”).
`
`IV. MATERIALS CONSIDERED AND
`INFORMATION RELIED UPON REGARDING THE ’056 PATENT
`In preparing this declaration, I have reviewed the following materials
`10.
`
`bearing Exhibit Nos. that I understand are being referenced in the IPR which this
`
`declaration accompanies:
`
`A. LIST OF EXHIBITS
`
`No.
`1001
`1002
`
`1009
`1011
`
`1012
`
`Description
` U.S. Patent No. 11,298,056 (“the ’056 Patent”)
` Excerpts from Prosecution File History of U.S. Patent
`Application No. 17/411,154 (“Harper ’154 file history”)
` Curriculum Vitae of Brian Gross
` Exhibits A and B to Affidavit of Nathaniel E Frank-White
`(“Paradigm® REAL-Time Archive”)
` U.S. Patent Application Publication No. 2009/0085768 to Patel
`et. al. (“Patel-2009”)
`
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`
`
`1014
`
`1015
`
`1017
`1019
`
`1020
`
`1022
`
`1023
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`1031
`
` U.S. Provisional Patent Application No. 60/976,886 (“Patel-
`2009 provisional”)
` U.S. Patent Application Publication No. 2008/0119705 to Patel
`et. al. (“Patel-2008”)
` U.S. Patent No. 6,641,533 to Causey et. al. (“Causey”)
` U.S. Patent Application Publication No. 2006/0202859 to
`Mastrototaro et. al. (“Mastrototaro”)
` U.S. Patent Application 11/322,568 to Mastrototaro
`(“Mastrototaro ’568 Application”)
` U.S. Patent Application 10/335,256 to Shahmirian et al.
`(“Shahmirian ’568 Application”)
` U.S. Patent Application Publication No. 2004/0122353 to
`Shahmirian et Al. (“Shahmirian”)
` McGarraugh, Geoffrey. “The chemistry of commercial
`continuous glucose monitors.” Diabetes technology &
`therapeutics 11.S1 (2009): S-17.
` U.S. Patent Application Publication No. 2004/0193025 to Steil et
`al.
` Choleau, C., et al. “Calibration of a subcutaneous amperometric
`glucose sensor implanted for 7 days in diabetic patients: Part 2.
`Superiority of the one-point calibration method.” Biosensors and
`Bioelectronics 17.8 (2002): 647-654.
` Velho, G., et al. “In vivo calibration of a subcutaneous glucose
`sensor for determination of subcutaneous glucose
`kinetics.” Diabetes, American Diabetes Association 1.3 (1988):
`227-233.
` Mastrototaro, John J. “The MiniMed continuous glucose
`monitoring system.” Diabetes technology & therapeutics 2.1,
`Supplement 1 (2000): 13-18.
` U.S. Patent No. 6,424,847 to Mastrototaro et al.
` Poitout, V., et al. “A glucose monitoring system for on line
`estimation in man of blood glucose concentration using a
`
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`1032
`
`1033
`
`1035
`
`1036
`
`1037
`1038
`1039
`
`1040
`
`1042
`
`1043
`
`1044
`
`miniaturized glucose sensor implanted in the subcutaneous tissue
`and a wearable control unit.” Diabetologia 36 (1993): 658-663.
` U.S. Patent Application Publication No. 2006/0224109 to Steil et
`al.
` Keenan, D. Barry, et al. “Delays in minimally invasive
`continuous glucose monitoring devices: a review of current
`technology.” Journal of diabetes science and technology 3.5
`(2009): 1207-1214.
` Armstrong, Siân. “Wireless connectivity for health and sports
`monitoring: a review.” British journal of sports medicine 41.5
`(2007): 285-289.
` Pantelopoulos, Alexandros, and Nikolaos Bourbakis. “A survey
`on wearable biosensor systems for health monitoring.” 2008 30th
`Annual International Conference of the IEEE Engineering in
`Medicine and Biology Society. IEEE, 2008.
` Excerpts from Diabetes forecast, November 2007
` Excerpts from Diabetes forecast, February 2007
` Buckingham, Bruce, Kimberly Caswell, and Darrell M. Wilson.
`“Real-time continuous glucose monitoring.” Current Opinion in
`Endocrinology, Diabetes and Obesity 14.4 (2007): 288-295.
` Buckingham, Bruce. “Clinical overview of continuous glucose
`monitoring.” Journal of Diabetes Science and Technology 2.2
`(2008): 300-306.
` Excerpts from Smith, Steven W. The scientist and engineer’s
`guide to digital signal processing. California Technical Pub.,
`1997.
` Shenoi, Belle A. Introduction to digital signal processing and
`filter design. John Wiley & Sons, 2006.
` Breton, Marc D., et. al. “Optimum Subcutaneous Glucose
`Sampling and Fourier Analysis of Continuous Glucose
`Monitors.” Journal of Diabetes Science and Technology 2.3
`(2008): 495-500.
`
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`
`
`1045
`
` Burge, Mark R., et. al. “Continuous Glucose Monitoring: The
`Future of Diabetes Management.” Diabetes Spectrum 21.2
`(2008): 112-119.
`
`11.
`
`I have also relied on my professional experience in formulating the
`
`opinions expressed in this declaration.
`
`V. UNDERSTANDING OF PATENT LAW
`
`12.
`
`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.
`
`13.
`
`I understand that when considering the scope of the claims of a patent
`
`that the patent claim terms should generally be given the ordinary meaning that the
`
`terms would have to a person of ordinary skill in the art in question after reading the
`
`patent as of the earliest claimed priority date.
`
`14.
`
`I understand that the 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 term
`
`appears, but in the context of the entire patent, including the specification. I further
`
`understand that the principal considerations regarding the scope and meaning of the
`
`claims are the plain language of the claim (including the surrounding claim language
`
`and context), the patent specification, and the prosecution history. I understand that
`
`while a claim is to be read in light of the specification, one must generally avoid
`
`importing limitations into the claim from the specification. I am also informed that
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`the prosecution history can often inform the meaning of the claim by demonstrating
`
`how the inventor understood the invention and whether the inventor limited the
`
`invention in the course of prosecution, making the claim scope narrower than it
`
`would otherwise be. I applied these understandings when considering the scope and
`
`meaning of the claims of the ’056 patent.
`
`15.
`
`I understand that a prior art reference anticipates an asserted claim, and
`
`thus renders the claim unpatentable, if all elements of the claim are disclosed in that
`
`prior art reference, either explicitly or inherently (i.e., necessarily present or
`
`implied).
`
`16.
`
`I further understand that a claim is unpatentable if it would have been
`
`obvious. Obviousness of a claim requires that the claim would have been obvious
`
`from the perspective of a POSITA at the time the alleged invention was made. I
`
`understand that a claim could have been obvious from a single prior art reference or
`
`from a combination of two or more prior art references.
`
`17.
`
`I understand that an obviousness analysis requires an understanding of
`
`the scope and content of the prior art, any differences between the alleged invention
`
`and the prior art, and the level of ordinary skill in evaluating the pertinent art.
`
`18.
`
`I further understand that a claim would have been obvious if it unites
`
`old elements with no change to their respective functions, or merely substitutes one
`
`element for another known in the field, and that combination yields predictable
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`results. While it may be helpful to identify a reason for this combination, I
`
`understand that there is no strict requirement of finding an express teaching,
`
`suggestion, or motivation to combine within the references. When a product is
`
`available, design incentives and other market forces can prompt variations of it,
`
`either in the same field or different one. If a POSITA can implement a predictable
`
`variation, obviousness likely bars its patentability. For the same reason, if a
`
`technique has been used to improve one device and a POSITA would recognize that
`
`it would improve similar devices in the same way, using the technique would have
`
`been obvious. I understand that a claim would have been obvious if common sense
`
`directs one to combine multiple prior art references or add missing features to
`
`reproduce the alleged invention recited in the claims.
`
`19.
`
`I further understand that certain factors may support or rebut the
`
`obviousness of a claim. I understand that such secondary considerations include,
`
`among other things, commercial success of the patented invention, skepticism of
`
`those having ordinary skill in the art at the time of invention, unexpected results of
`
`the invention, any long-felt but unsolved need in the art that was satisfied by the
`
`alleged invention, the failure of others to make the alleged invention, praise of the
`
`alleged invention by those having ordinary skill in the art, and copying of the alleged
`
`invention by others in the field. I understand that there must be a nexus—a
`
`connection—between any such secondary considerations and the alleged invention.
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`I also understand that contemporaneous and independent invention by others is a
`
`secondary consideration tending to show obviousness.
`
`20.
`
`I am not aware of any allegations by the named inventors of the ’056
`
`patent or any assignee of the ’056 patent that any secondary considerations tend to
`
`rebut the obviousness of any Challenged Claim of the ’056 patent.
`
`21.
`
`I understand that in considering obviousness, it is important not to
`
`determine obviousness using the benefit of hindsight derived from the descriptions
`
`found in the patent being considered.
`
`22.
`
`I understand that other challenges to the patentability of a patent,
`
`including patent ineligibility, enablement, written description, and definiteness or
`
`clarity of claim language, cannot be raised in IPR proceedings before the Board.
`
`23.
`
`I understand that Petitioner has the burden of proving unpatentability
`
`by a preponderance of evidence, which means that the claims are more likely than
`
`not unpatentable.
`
`24. The analysis in this declaration is in accordance with the above-stated
`
`legal principles.
`
`VI. THE ’056 PATENT
`
`25. As part of my analysis, I reviewed and considered the ’056 patent
`
`(Ex1001) titled “Methods and Systems for Early Signal Attenuation Detection and
`
`Processing” which Counsel for Petitioner informed me issued from U.S. Application
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`17/411,154 on April 12, 2022. The following highlights general aspects of the ’056
`
`patent and is not meant to describe my full understanding of the patent or its
`
`
`
`prosecution history.
`
`A.
`
`Specification
`
`26. The ’056 patent describes an analyte monitoring system including
`
`a sensor unit, a data processing and transmitter unit, and a primary receiver unit.
`
`(Ex1001, 4:56-61.)
`
`27. The transmitter unit “receives analyte related sensor data” from the
`
`sensor and transmits this data to the receiver unit. (Ex1001, 11:27-37.) The
`
`transmitter unit is described as operating on approximate radio frequency bands of
`
`315-322MHz or 400-470MHz. (Ex1001, 9:15-22.) The communication link between
`
`the transmitter and receiver is discussed as including various infrared, Bluetooth®,
`
`802.11x, or other wireless communication protocols. (Ex1001, 7:25-33.)
`
`28. The ’056 patent defines “analyte related sensor data herein and
`
`throughout [the] specification” as both “current signal received from the analyte
`
`sensor” and “current signal which has undergone … processing routines including,
`
`for example filtering, clipping, digitizing,” encoding, conditioning, or further
`
`processing. (Ex1001, 11:37-44, 14:21-23.) For example, unprocessed or
`
`uncalibrated sensor data is processed with “calibration data such as [a] sensitivity
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`ratio.” (Ex1001, 12:54-61.) Calibration “ensure[s] the analyte related data signals …
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`are correctly converted to corresponding analyte levels,” but various conditions
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`render calibration unsuitable. (Ex1001, 10:62-66, 11:6-8.) The ’056 patent then
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`describes that “when a scheduled calibration event fails …, the output display of the
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`processed, calibrated sensor data is disabled” resulting in a gap “where the analyte
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`monitoring system was not properly calibrated [and] analyte related sensor data was
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`not processed:”
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`(Ex1001, 12:32-45, Fig. 7A.) The ’056 patent specification describes backfilling
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`gaps by processing unprocessed sensor data with the sensitivity ratio from a
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`subsequent calibration:
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`(Ex1001, 12:47-13:5, Fig. 7B.)
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`B.
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`Prosecution History
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`29. Counsel for Petitioner informed me that the ’056 Patent (Ex1001)
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`issued from U.S. Patent Application No. 17/411,154 filed August 25, 2021
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`(Ex1002), which claims priority to the April 29, 2009 filing of Provisional
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`Application 61/173,600 through a series of continuation applications.
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`30.
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` I have reviewed U.S. Patent Application No. 17/411,154 and its
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`prosecution files history. (Ex1002).
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`VII. STATE-OF-THE-ART AND LEVEL OF SKILL IN THE ART
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`A.
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`State-of-the-Art
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`31. The ’056 patent pertains to glucose monitoring systems, including:
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`•
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`two and three-electrode sensors that generate analyte signals
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`(Ex1001, 1:34-37);
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`•
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`•
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`•
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`calibration to determine a “sensitivity ratio” that is used to
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`convert sensor data to analyte levels (Ex1001, 12:47-61);
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`signal processing
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`(e.g.,
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`filtering,
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`clipping, digitizing,
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`conditioning) (Ex1001, 5:58-64, 11:37-44); and
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`RF transmission (e.g., 315-322MHz, 400-470MHz, Bluetooth,
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`802.11x/WLAN). (Ex1001, 7:25-33, 9:15-22.)
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`As discussed in this section, these were each well-known, fundamental concepts of
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`glucose monitoring by April 2009. (See Paragraphs 32-49.)
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`1.
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`Sensors With Working and Counter Electrodes
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`32. Analyte sensors with “two or three-electrode (work, reference, and
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`counter electrodes) configuration[s]” were well known to POSITAs by April 2009.
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`This knowledge is illustrated by the references in paragraphs 33-35 below.
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`33. For example, a May 2009 article on “The Chemistry of Commercial
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`Continuous Glucose Monitors” by McGarraugh provides:
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`•
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`a typical glucose sensor “includes three electrodes: a GOx working
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`electrode, a counter electrode, and an Ag/AgCl reference electrode”
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`(Ex1025, S-19); and
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`•
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`each of the Medtronic Guardian REAL-Time, DexCom™ STS™-7,
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`and Abbot FreeStyle Navigator® “measure[d] the current flowing from
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`an oxidation (electron-producing) reaction at a working electrode to a
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`reduction (electron-consuming) reaction at a counter electrode.”
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`(Ex1025, S-19.)
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`34. Medtronic’s U.S. Publication 2006/0202859 to Mastrototaro discloses
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`a sensor with three sensor electrodes 20:
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`(Ex1019, [0045], Fig. 6 (annotated in red).)
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`35. Medtronic’s U.S. Publication 2004/0193025 labels the counter (CNT)
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`electrode in a similar figure:
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`(Ex1026, [0038], Fig. 4 (annotated in red).)
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`36. Therefore, it is my opinion that skilled artisans were familiar with
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`sensor configurations including work and counter electrodes.
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`2.
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`Sensor Sensitivity In Calibration
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`37. Sensor calibration was well known to POSITAs by April 2009. As
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`illustrated by the references in paragraphs 38-39 below, glucose sensor calibration
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`was typically performed by using blood glucose reference values to determine a
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`sensitivity coefficient or ratio between sensor cu