IPR2022-00605
`Patent 10,945,649
`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.: 10,945,649 B2
`Issued: March 16, 2021
`Application No.: 17/008,630
`Filed: August 31, 2020
`
`Title: MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING
`AND USING MEDICAL DEVICES
`_________________
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
`
`
`
`Page i
`
`
`Patent 10,945,649
`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.: 10,945,649 B2
`Issued: March 16, 2021
`Application No.: 17/008,630
`Filed: August 31, 2020
`
`Title: MEDICAL DEVICE INSERTERS AND PROCESSES OF INSERTING
`AND USING MEDICAL DEVICES
`_________________
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
`
`
`
`Page i
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`IPR2022-00605
`Patent 10,945,649
`
`TABLE OF CONTENTS
`
`Page(s)
`INTRODUCTION AND ENGAGEMENT .................................................... 1
`I.
`BACKGROUND AND QUALIFICATIONS ................................................. 1
`II.
`III. MATERIALS CONSIDERED AND
`INFORMATION RELIED UPON REGARDING ’649 PATENT ................. 4
`IV. UNDERSTANDING OF PATENT LAW ...................................................... 6
`V.
`LEVEL OF SKILL IN THE ART, AND STATE OF THE ART ................... 9
`A.
`Person Of Ordinary Skill In The Art ..................................................... 9
`B.
`State Of The Art ..................................................................................10
`VI. THE ’649 PATENT / CLAIM CONSTRUCTION .......................................12
`A.
`The ’649 Patent ...................................................................................12
`B.
`The ’649 Patent’s Specification ..........................................................13
`C.
`Claim Construction..............................................................................16
`VII. GROUND 1: CLAIMS 1-28 ARE
`OBVIOUS OVER GRAVESEN IN VIEW OF BRISTER ...........................16
`A. Gravesen ..............................................................................................16
`B.
`Brister ..................................................................................................20
`C.
`Combining Gravesen And Brister .......................................................22
`D.
`Claims 1-28 Are Unpatentable ............................................................26
`1.
`Claim 1 ......................................................................................26
`2.
`Claim 2 ......................................................................................60
`3.
`Claims 3/27 ...............................................................................63
`4.
`Claim 4/Claim 19 (first portion) ...............................................64
`DECLARATION OF GARY D. FLETCHER, Ph.D
`Page ii
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`Patent 10,945,649
`Claim 5/Claim 19 (second portion) ..........................................65
`5.
`Claims 6/20 ...............................................................................66
`6.
`Claim 7 ......................................................................................66
`7.
`Claims 8/21 ...............................................................................68
`8.
`Claims 9/22 ...............................................................................70
`9.
`10. Claims 10/23 .............................................................................71
`11. Claim 11 ....................................................................................72
`12. Claim 12 ....................................................................................75
`13. Claim 13 ....................................................................................78
`14. Claims 14/24 .............................................................................80
`15. Claims 15/25 .............................................................................82
`16. Claims 16/26 .............................................................................85
`17. Claims 17/28 .............................................................................88
`18. Claim 18 ....................................................................................88
`19. Claims 19-28 .............................................................................92
`
`
`
`
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page iii
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`VIII. [ALTERNATE] GROUND 2: CLAIMS
`7, 11, AND 18-28 ARE OBVIOUS OVER GRAVESEN
`IN VIEW OF BRISTER, IN FURTHER VIEW OF YODFAT ...................93
`A. Yodfat ..................................................................................................93
`B.
`Combining Gravesen, Brister, And Yodfat .........................................97
`C.
`Claims 7, 11, And 18-28 Are Unpatentable ......................................103
`1.
`Claim 7 ....................................................................................103
`2.
`Claim 11 ..................................................................................104
`3.
`Claim 18 ..................................................................................105
`4.
`Claims 19-28 ...........................................................................106
`IX. NO OBJECTIVE INDICIA OF NON-OBVIOUSNESS ............................107
`X.
`CONCLUSION ............................................................................................107
`XI. AVAILABILITY FOR CROSS-EXAMINATION ....................................107
`A.
`Right to Supplement ..........................................................................107
`B.
`Signature ............................................................................................108
`
`
`
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page iv
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`I, Gary D. Fletcher, Ph.D., do hereby 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. 10,945,649 (hereinafter “the ’649 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 and is in no way connected to the opinions I offer herein.
`
`3.
`
`Specifically, I have been asked to provide my opinions regarding
`
`whether claims 1-28 (each a “Challenged Claim” and collectively the “Challenged
`
`Claims”) of the ’649 Patent would have been obvious to a person having ordinary
`
`skill in the art (“POSITA”) as of March 24, 2010. It is my opinion that each
`
`Challenged Claim would have been obvious to a POSITA after reviewing the prior
`
`art discussed herein.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`I am Founder and Principal Consultant at RnDDx Solutions LLC, a
`
`consulting firm founded in 2015, focused on industrial mechanical engineering,
`
`and research and product development, in medical devices, diagnostics, optical
`
`devices, point-of-care blood sample testing, and on expert witness patent litigation,
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 1
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`including subject matter expertise in medical device mechanical engineering, and
`
`subject matter expertise in medical devices for blood collection and blood sample
`
`processing for diagnostics and therapeutics. I have particular expertise in
`
`mechanical engineering design and development of non-invasive and minimally
`
`invasive biomedical diagnostics systems, blood collection and stabilization, blood
`
`separation, and blood and cell preparation for both diagnostic and therapeutic
`
`applications. I have expertise in the development of sample collection devices,
`
`including needles and lancets. A complete list of my patents, publications,
`
`professional activities, and honors that I have received is set forth in my
`
`curriculum vitae, attached hereto as Appendix A.
`
`5.
`
`I am also co-Founder of a startup biotech company, Raven
`
`Biomaterials, developing novel patented immunomagnetic blood cell separation
`
`technology, with both diagnostic and cell therapy manufacturing applications.
`
`6.
`
`I received my Bachelor of Arts degree in Physics and Mathematics
`
`from DePauw University, Greencastle, Indiana, in 1976, my Master of Philosophy
`
`degree in Physics from Yale University in 1978, and my Doctor of Philosophy
`
`degree in Physics, also from Yale University, in 1983. My doctoral research was in
`
`experimental atomic physics, where I gained experience in mechanical, electrical,
`
`and software engineering, optical physics, and vacuum engineering, developing
`
`and maintaining the experimental apparatus used in my research. I conducted
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
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`IPR2022-00605
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`postdoctoral research in experimental atomic and laser physics as a Postdoctoral
`
`Research Associate in Physics and Assistant Professor of Physics at the University
`
`of Virginia. At Lawrence Livermore National Laboratory I expanded my expertise
`
`in mechanical and optical engineering by developing x-ray spectroscopic and
`
`imaging instruments to measure x-rays emitted from laser-produced high-
`
`temperature plasmas. I have 23 years of senior industrial executive experience
`
`building new products and new businesses in the healthcare, life sciences, material
`
`sciences, medical device, imaging, and diagnostics space. That experience includes
`
`leading R&D and product development engineering teams of mechanical,
`
`electrical, optical, and software engineers. Among the positions described in my
`
`curriculum vitae, my industry experience includes engineering leadership role in
`
`1996 in a company attempting to develop a noninvasive glucose measurement
`
`sensor. From 1996 to 2001, I led Engineering and Advanced Technology,
`
`including teams of optical, mechanical, electrical, software imaging, and clinical
`
`laboratory engineers, developing a noninvasive human complete blood count
`
`diagnostic device and diagnostic blood perfusion assessment tool, for a medical
`
`diagnostic startup company. As technical manager at Sarnoff Corporation from
`
`2001 – 2004 I led a team developing and licensing a painless minimally invasive
`
`blood glucose monitor. While at Becton Dickinson (“BD”), from 2004 to 2014, I
`
`developed blood collection devices for point of care diagnostic testing.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
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`I am co-inventor on thirteen issued US Patents and ten issued
`
`7.
`
`European patents for devices and methods in the area of blood collection and
`
`processing including lancing devices and blood separation for diagnostic testing. A
`
`complete list of my patents is set forth in my curriculum vitae, attached hereto as
`
`Appendix A.
`
`III. MATERIALS CONSIDERED AND
`INFORMATION RELIED UPON REGARDING ’649 PATENT
`In preparing this declaration, I have reviewed the following materials
`8.
`
`bearing Exhibit Nos. that I understand are being referenced in the IPR to which my
`
`declaration is also an exhibit:
`
`LIST OF EXHIBITS
`
`Ex. No. Description
` U.S. Patent No. 10,945,649 (“’649 patent”)
`1001
` File History of U.S. Patent No. 10,945,649 (“’649 FH”)
`1002
` U.S. Publication No. 2009/0099521 (“Gravesen”)
`1004
` U.S. Publication No. 2009/0076360 (“Brister”)
`1005
` U.S. Patent No. 7,207,974 (“Safabash”)
`1006
` U.S. Publication No. 2004/0204687 (“Mogensen”)
`1007
` U.S. Publication No. 2008/0319414 (“Yodfat”)
`1008
` U.S. Publication No. 2010/0145377 (“Lai”)
`1009
` U.S. Patent No. 7,223,276 (“List”)
`1010
` U.S. Publication No. 2008/0242962 (“Roesicke”)
`1011
` File History of U.S. Patent No. 10,292,632 (“’632 FH”)
`1012
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`
`1014
`1015
`1016
`1017
`
`1018
`
`1019
`1020
`1021
`1022
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
` U.S. Patent No. 6,175,752 (“Say”)
` U.S. Publication No. 2007/0027381 (“Stafford”)
` U.S. Application No. US12/250,760 (“Gravesen Application”)
` Dehez et al., “Development of a Spherical Induction Motor With
`Two Degrees of Freedom,” IEEE Transactions on Magnetics,
`42:8 (August 2006)
` Bonnett et al., “Squirrel-Cage Rotor Options for AC Induction
`Motors,” IEEE Transactions on Industry Applications, 37:4
`(July/August 2001)
` U.S. Publication No. 2004/0133164 (“Funderburk”)
` U.S. Patent No. 7,169,600 (“Hoss”)
` U.S. Publication No. 2002/0022855 (“Bobroff”)
` U.S. Patent No. 5,086,246 (“Dymond”)
` Jain et al., “Wound Rotor Induction Generator with Sensorless
`Control and Integrated Active Filter for Feeding Nonlinear
`Loads in a Stand-Alone Grid,” IEEE Transactions on Industrial
`Electronics, 55:1 (January 2008).
` “Rotor,” Dictionary of Mechanical Engineering, Fourth Ed.,
`Society of Automotive Engineers, Inc., Butterworth-Heinemann,
`G.H.F. Nayler (1996)
` “Rotor,” Random House Kernerman Webster’s College
`Dictionary, K Dictionaries Ltd. (2010), available at
`https://www.thefreedictionary.com/rotor
` “Rotate,” Random House Kernerman Webster’s College
`Dictionary, K Dictionaries Ltd. (2010), available at
`https://www.thefreedictionary.com/rotate
` The Merriam-Webster Dictionary, Merriam-Webster,
`Incorporated (2005) (“Merriam-Webster”)
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
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`IV. UNDERSTANDING OF PATENT LAW
`
`9.
`
`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.
`
`10.
`
`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.
`
`11.
`
`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 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
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`narrower than it would otherwise be. I applied these understandings when
`
`considering the scope and meaning of the claims of the ’649 patent.
`
`12.
`
`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).
`
`13.
`
`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.
`
`14.
`
`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.
`
`15.
`
`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
`
`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,
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`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.
`
`16.
`
`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.
`
`I also understand that contemporaneous and independent invention by others is a
`
`secondary consideration tending to show obviousness.
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`I am not aware of any allegations by the named inventors of the ’649
`
`17.
`
`patent or any assignee of the ’649 patent that any secondary considerations tend to
`
`rebut the obviousness of any Challenged Claim of the ’649 patent.
`
`18.
`
`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.
`
`19.
`
`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.
`
`20.
`
`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.
`
`21. The analysis in this declaration is in accordance with the above-stated
`
`legal principles.
`
`V. LEVEL OF SKILL IN THE ART, AND STATE OF THE ART
`
`A.
`
`Person Of Ordinary Skill In The Art
`
`22. The person of ordinary skill in the art as of the earliest possible
`
`effective filing date (“POSITA”) would have had a Bachelor’s degree in
`
`Bioengineering, Mechanical Engineering, Electrical Engineering, or a related
`
`subject, and one or more years of experience researching, developing and/or
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
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`designing insertable medical devices, including, e.g., systems for implanting
`
`wearable medical devices such as cannulas, infusion sets, and analyte sensors, or
`
`equivalent experience. Less work experience may be compensated by a higher
`
`level of education, such as a Master’s Degree, and vice versa.
`
`B.
`
`State Of The Art
`
`23. The general concepts claimed in the ’649 patent – namely, insertion
`
`assemblies that use a spring-driven needle to transcutaneously insert a medical
`
`device (e.g., a cannula or glucose sensor), and retract the needle after insertion
`
`using another spring – were well-known. Brister provides an overview of a
`
`mechanism for inserting and removing a medical device (a sensor) using a needle
`
`and suggests that springs can be used to automatically insert the needle and sensor
`
`and/or retract the needle to leave the sensor in place. Brister, ¶ 0251. Gravesen
`
`describes a similar device for transcutaneous insertion of a medical device (a
`
`cannula) and a needle, and retraction of the needle after the cannula is situated in
`
`the subject’s skin. Gravesen also provides detail on how to perform spring-loaded
`
`insertion and retraction, in a system like Brister. Gravesen further discusses the
`
`advantages of performing such a retraction automatically (i.e., using springs) and
`
`provides implementation details including using separating slidable bodies, which
`
`speeds needle retraction and minimizes pain. Gravesen ¶¶ 0007-09. In view of this,
`
`a POSITA looking to minimize pain by providing automatic needle-based insertion
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`of a medical device (such as a glucose sensor) would have logically considered
`
`Gravesen’s apparatus.
`
`24. Substitution of a sensor for a cannula (or vice versa) was well known
`
`in the art prior to the earliest asserted priority date for the ’649 patent. See e.g.,
`
`Safabash, 1:33-40 (“In another common form, insertion needles are employed for
`
`transcutaneous placement of a soft and relatively flexible tubular cannula, followed
`
`by insertion needle removal and subsequent infusion of medical fluid to the patient
`
`through the cannula. More recently, insertion needles have also been used for
`
`transcutaneously placing other medical devices such as a subcutaneous sensor for
`
`monitoring specified patient parameters, such as blood glucose level.”); Mogensen,
`
`¶ 0079 (“Moreover, the injector device, provided with an insertion needle or not, is
`
`not exclusively suited for placing an infusion set but may also be used for placing a
`
`transcutaneous glucose sensor.”).
`
`25. Accordingly, a POSITA prior to March 24, 2010 would have
`
`understood that insertion devices were useable to insert analyte sensors, infusion
`
`sets, and cannulas interchangeably.
`
`26.
`
`Indeed, the ’649 patent itself acknowledges that an inserter device can
`
`be “configured to insert various medical devices into the subject, such as, for
`
`example, an analyte sensor, an infusion set, or a cannula” or even combinations of
`
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`such devices (’649 patent, 22:31-36), but includes little to no detail of how to
`
`modify the described inserter in order to insert these other medical devices.
`
`27. Accordingly, Patent Owner appears to acknowledge that a POSITA
`
`would understand how to modify an analyte sensor insertion apparatus to insert a
`
`cannula and/or an infusion set, or vice versa.
`
`VI. THE ’649 PATENT / CLAIM CONSTRUCTION
`
`A. The ’649 Patent
`
`28. The ’649 patent, titled “MEDICAL DEVICE INSERTERS AND
`
`PROCESSES OF INSERTING AND USING MEDICAL DEVICES” issued on
`
`March 16, 2021 from U.S. Patent Application No. 17/008,630 (the “’630
`
`Application”), filed on August 31, 2020, which alleges priority (through multiple
`
`intervening non-provisional applications) to four provisional applications, the
`
`earliest of which was filed on March 24, 2010.
`
`29. Like the prior art references that preceded it, the ’649 patent describes
`
`an apparatus for insertion of a medical device (e.g., an analyte sensor) into the skin
`
`of a subject. ’649 patent, Abstract. More specifically, it relates to an inserter
`
`assembly that uses a first spring in combination with a rotor to insert a needle
`
`carrying the medical device into the subject’s skin by simultaneously driving an
`
`on-body unit inserter and a needle retractor. Id., 29:65-30:1. The inserter includes a
`
`second spring positioned between the on-body unit inserter and needle retractor.
`
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`Id., 30:1-3. As the rotor continues to rotate, cooperating slots in the on-body unit
`
`inserter and needle retractor allow the on-body unit inserter to travel toward the
`
`insertion site and be held down, at which point the needle retractor and the needle
`
`coupled thereto are retracted, leaving the medical device within the subject. Id.,
`
`30:3-6.
`
`B.
`
`The ’649 Patent’s Specification
`
`30. The ’649 patent includes two independent claims, claims 1 and 18,
`
`both of which most closely relate to inserter embodiment 1300, shown in FIGS.
`
`37-46, with some additional features said to be shown in FIGS. 1 and 17. File
`
`History of U.S. Patent No. 10,945,649 (“’649 FH,” Ex. 1002), at 137.
`
`31. The issued patent’s description of embodiment 1300 is brief, spanning
`
`only 24 lines. ’649 patent, 29:50-30:6.
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`’649 Patent, FIG. 45
`
`32.
`
`Inserter 1300, depicted, e.g., in FIG. 45, above, includes an “inserter”
`
`1334 arranged coaxially with and positioned outside of a “needle retractor” 1328.
`
`Also included is a torsion spring 1365, whose release rotates rotor 1308 with rotor
`
`follower 1364. Rotor follower 1364 engages both inserter 1334 via its slot 1360
`
`and needle retractor 1328 via its (unclaimed) slot 1362. As shown in FIG. 38, the
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`rotor follower 1364 extends through the outer slot 1360 to reach the inner slot
`
`1362. Id., 29:59-62.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 14
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`IPR2022-00605
`Patent 10,945,649
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`
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`’649 Patent, FIG. 38 (annotated)
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`33. Rotation of the rotor follower 1364 within these slots initially
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`advances both inserter 1334 and needle retractor 1328 down toward the skin but
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`later pulls only the needle retractor (and its engaged needle) up from the skin. Id.,
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`30:3-6.
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`34. More generally, the specification describes embodiments of an
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`apparatus, i.e., an insertion assembly, for inserting a medical device (such as an
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`analyte sensor, cannula, etc.) at least partially into the skin of a patient and
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`detecting an analyte (such as glucose) in the subject’s body fluid. Id., 7:41-45,
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 15
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`IPR2022-00605
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`22:29-31. Electronics can be coupled to the medical device to form an on-body
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`wearable that remains on the subject’s skin for the duration of use of the medical
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`device. Id., 10:6-17.
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`C. Claim Construction
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`35. Unless otherwise expressly discussed, my analysis herein applies the
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`plain and ordinary meaning of all claim terms in the grounds below.
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`36.
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`In the appropriate sections where they first appear, I identify terms
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`that may be relevant to the issues in this IPR.
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`VII. GROUND 1: CLAIMS 1-28 ARE OBVIOUS
`OVER GRAVESEN IN VIEW OF BRISTER
`37. Claims 1-28 are obvious over Gravesen in view of Brister.
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`A. Gravesen
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`38. U.S. Publication No. 2009/0099521 (“Gravesen,” Ex. 1004), entitled
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`“Cannula Insertion Device and Related Methods,” was published on April 16,
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`2009, from an application filed October 14, 2008 (Ex. 1016).1
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`39. Gravesen describes various embodiments of an inserter device for
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`inserting a medical device (e.g., a cannula) transcutaneously into a subject’s skin
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`while minimizing pain to the subject. Gravesen, ¶¶ 0007, 0049.
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`
`1 Gravesen’s published application, cited herein for ease of reference, appears to
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`contain the same disclosure as the earlier-filed non-provisional application.
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 16
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`40. Gravesen’s FIG. 9 embodiment, below, comprises a housing 202 that
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`houses a drive mechanism 210 for converting rotation of a lever 211 to linear
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`motion of a needle holder 204. “[L]ever 211 is subjected to clockwise rotation …
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`by the force of a driving spring 215.” Id., ¶ 0068. The lever 211 (via rod 213)
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`interacts with a needle holder 204 (a “first slidable body”) to insert a needle 203
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`carrying a medical device (“cannula2 205”) into the subject. Id., ¶ 0070.
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`Gravesen, FIG. 9 (annotated)
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`
`
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`2 “In this document, the terms “catheter” and “cannula” are used interchangeably
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`and without limitation to describe any tubelike implement to deliver fluids...”
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`Gravesen, ¶ 0048.
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 17
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`41. Gravesen states in ¶ 0067 that the needle holder 204 may further
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`incorporate parts 17 and 18 of FIG. 1 (see id., ¶¶ 0048-56), shown below:
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`Gravesen, FIG. 1 (annotated)
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`
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`42. This combination with FIG. 1’s separate plunger and support
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`structures allows the needle to be retracted using a separate retraction spring
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`(retraction spring 22, also shown above), and advantageously minimizes the weight
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`of the body being retracted; that, in turn, increases the speed of Gravesen’s
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`automatic needle retraction, which further minimizes pain to the subject. Id., ¶¶
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 18
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`
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`IPR2022-00605
`Patent 10,945,649
`0007-12. The figure below illustrates an exemplary configuration of the combined
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`embodiment suggested by Gravesen. Id., ¶ 0067.
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`
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`Gravesen, FIG. 9, (annotated to show Gravesen’s suggested
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`incorporation of elements from FIGS. 1-3)
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`43.
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`In such an embodiment, the structure of parts 17 and 18 in FIG. 1 is
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`incorporated into FIG. 9’s needle holder 204 (“first slidable body”). A second
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`retraction spring 22 retracts a separate, smaller needle holder 4 (“second slidable
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 19
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`IPR2022-00605
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`body”) coupled to the needle, leaving the medical device within the subject. Id.,
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`FIG. 1, ¶¶ 0052, 0068.
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`B.
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`Brister
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`44. U.S. Publication No. 2009/0076360 (“Brister,” Ex. 1005), entitled
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`“Transcutaneous Analyte Sensor,” was published on March 19, 2009.
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`Brister, FIG. 8C (annotated)
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`
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`45. Brister describes a transcutaneous analyte sensor system 10 having a
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`sensor 32 “adapted for transdermal insertion through the skin of a host.” Brister, ¶¶
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`0148-50. This is used to measure glucose levels in a subject. Id., ¶¶ 0001, 0213,
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`0223, 0329. The sensor 32 can be inserted into the subject using a needle 72 which
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 20
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`IPR2022-00605
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`is actuated using an applicator 12. Id., ¶ 0151, FIGS. 7A-7D; see generally id., ¶¶
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`0246-79, FIGS. 6-8K. Brister expressly states that spring-loaded mechanisms may
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`be used to automatically insert the sensor and/or retract the needle. Id., ¶ 0251.
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`Brister, FIG. 4A (annotated)
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`
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`46. Brister further teaches that its sensor may be configured to bend
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`slightly to anchor the sensor within tissue (id., ¶ 0196) and/or “in order to maintain
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`the sensor within the needle by interference” (id., ¶ 0249), and/or may be bent
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`substantially “upon pivoting of the contact subassembly from the insertion to
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`functional position” to facilitate combination of the sensor with other on-skin
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`electronics mounted to the user’s skin. See id., FIG. 4A, ¶ 0294.
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`DECLARATION OF GARY D. FLETCHER, Ph.D
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`Page 21
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`IPR2022-00605
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`C. Combining Gravesen And Brister
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`47. Gravesen describes an insertion device that automatically (e.g., using
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`spring force rather than manual force) inserts a needle to place a medical device,
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`such as a cannula, beneath the skin of a subject, and retracts the needle quickly to
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`minimize pain. Gravesen, ¶¶ 0007-09. Brister teaches using such a “spring loaded
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`mechanism that can be triggered” for inserting a glucose sensor transcutaneously,
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`namely “to automatically insert and/or retract the sensor, needle, or other
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`cooperative applicator components.” Brister, ¶ 0251. Gravesen specifically details
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`complementary structures for affecting such automatic needle-based insertion, as
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`suggested by Brister. Thus, the teachings in these references complement one
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`another.
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`48. A POSITA looking to insert a medical device into a subject’s skin
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`with minimal pain would naturally turn to Gravesen as a solution to such a
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`problem. See e.g., Gravesen, ¶¶ 0004-05, 0007-11. Though Gravesen discusses
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`insertion of a cannula rather than a sensor, a POSITA would have been motivated
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`to use such an automated spring-driven device to insert a sensor, particularly in
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`view of Brister’s express suggestion to do so. Brister, ¶ 0251. A POSITA would
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`further understand the advantage of using Gravesen’s device to insert
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