UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`DEXCOM, INC.,
`Petitioner,
`
`v.
`
`ABBOTT DIABETES CARE INC.,
`Patent Owner.
`
`IPR2023-01409
`U.S. Patent No.: 11,202,591
`Issued: December 21, 2021
`Application No.: 17/221,154
`Filed: April 2, 2021
`
`Title: ANALYTE SENSOR AND
`APPARATUS FOR INSERTION OF THE SENSOR
`_________________
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`
`
`Page 1
`
`

`

`Patent 11,202,591
`
`TABLE OF CONTENTS
`
`Page(s)
`INTRODUCTION AND ENGAGEMENT .................................................... 6
`I.
`BACKGROUND AND QUALIFICATIONS ................................................. 6
`II.
`III. MATERIALS CONSIDERED AND
`
`INFORMATION RELIED UPON REGARDING ’591 PATENT ................. 9
`IV. UNDERSTANDING OF PATENT LAW ....................................................11
`V.
`THE ’591 PATENT .......................................................................................18
`A.
`The ’591 Patent’s Specification ..........................................................18
`B.
`The Prosecution History ......................................................................19
`VI. LEVEL OF SKILL IN THE ART, AND STATE OF THE ART .................20
`A.
`Person Of Ordinary Skill In The Art ...................................................20
`B.
`State Of The Art ..................................................................................20
`1.
`Inserters With Auto-Retracting Needles Were Known ............20
`2.
`Inserters Were Known To Reduce Subject Pain and Anxiety ..21
`3.
`Inserter Designs Were Interchangeably Used For
`Insertion Of Different Types Of Subcutaneous Devices ..........22
`Low-Profile On-Body Devices Were Known ...........................23
`It Was Known To Protect Needles And Avoid Needle Sticks .24
`It Was Known To Couple The On-Body Unit
`To The Inserter By Using Peripheral Apertures On
`The Unit That Engaged With Projections On The Inserter ......29
`VII. CLAIM CONSTRUCTION ..........................................................................30
`VIII. GROUND 1: CLAIMS 1-6, 9-14, 16-24, 27, 29-30
`
`ARE UNPATENTABLE OVER STAFFORD IN VIEW OF COTE ...........31
`
`4.
`5.
`6.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 2
`
`

`

`Patent 11,202,591
`
`A.
`B.
`C.
`
`Stafford ................................................................................................31
`Cote ......................................................................................................35
`Combining The Teachings Of Stafford And Cote ..............................43
`1.
`Claims 1/19 ...............................................................................49
`2.
`Claims 2/20 ...............................................................................69
`3.
`Claims 3/19 ...............................................................................73
`4.
`Claims 4/19 ...............................................................................78
`5.
`Claims 5/19 ...............................................................................79
`6.
`Claims 6/27 ...............................................................................81
`7.
`Claims 9/22 ...............................................................................82
`8.
`Claims 10/24 .............................................................................85
`9.
`Claims 11/24 .............................................................................87
`10. Claims 12/29 .............................................................................88
`11. Claims 13/30 .............................................................................90
`12. Claims 14/19 .............................................................................91
`13. Claims 16/23 .............................................................................92
`14. Claim 17 ....................................................................................94
`15. Claims 18/21 .............................................................................94
`16. Claim 19, 20-24, 27, 29-30 .....................................................101
`IX. GROUND 2:
`
`STAFFORD+COTE+SAY (CLAIMS 4, 7-8, 14-15, 19-30) ......................102
`A.
`Say .....................................................................................................102
`B.
`Combining The Teachings Of Stafford+Cote+Say ...........................103
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 3
`
`

`

`Patent 11,202,591
`
`Claims 7/25 .............................................................................104
`1.
`Claims 8/26 .............................................................................104
`2.
`Claims 15/28 ...........................................................................106
`3.
`Claims 4/19, 14/19 ..................................................................112
`4.
`Claims 20-30 ...........................................................................113
`5.
`X. GROUND 3:
`
`STAFFORD+COTE+BRENNEMAN (CLAIMS 18, 21-24, 27, 29-30) ....114
`A.
`Brenneman .........................................................................................114
`B.
`Combining The Teachings Of Stafford+Cote+Brenneman ..............115
`1.
`Claims 18, 21-24, 27, 29-30 ....................................................116
`XI. GROUND 4:
`
`STAFFORD+COTE+SHAH (CLAIMS 9, 22-24, 27, 29-30) ....................117
`A.
`Shah ...................................................................................................117
`B.
`Combining The Teachings Of Stafford+Cote+Shah .........................118
`1.
`Claims 9, 22, 23-24, 27, 29-30................................................119
`XII. GROUNDS 5-8 ............................................................................................121
`A. Ground 5: +Brenneman To Ground 2 (claims 21-30) .......................121
`B. Grounds 6-8: +Shah To Grounds 2, 3, And 5 ...................................121
`1.
`Ground 6: Stafford+Cote+Say+Shah (claims 25-26, 28) .......122
`2.
`Ground 7:
`Stafford+Cote +Brenneman+Shah (claims 22-24, 27, 29-30) 122
`Ground 8:
`Stafford+Cote +Say+Brenneman+Shah (claims 25-26, 28) ...122
`XIII. NO OBJECTIVE INDICIA OF NON-OBVIOUSNESS ............................123
`XIV. CONCLUSION ............................................................................................123
`
`3.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 4
`
`

`

`Patent 11,202,591
`
`XV. AVAILABILITY FOR CROSS-EXAMINATION ....................................123
`A.
`Right to Supplement ..........................................................................123
`B.
`Signature ............................................................................................124
`
`
`
`
`
`
`
`
`
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 5
`
`

`

`Patent 11,202,591
`
`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. 11,202,591 (hereinafter “the ’591 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 1-30 (each a “challenged claim” and collectively the “challenged
`
`claims”) of the ’591 patent would have been obvious to a person having ordinary
`
`skill in the art (“POSITA”) as of February 2009. 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, including
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 6
`
`

`

`Patent 11,202,591
`
`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.
`
`Page 7
`
`

`

`Patent 11,202,591
`
`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.
`
`Page 8
`
`

`

`Patent 11,202,591
`
`7.
`
`I am co-inventor on thirteen issued US Patents and ten issued 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 ’591 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 accompanies:
`
`LIST OF EXHIBITS
`Description
`U.S. Patent No. 11,202,591 (“’591 patent”)
`File History of U.S. Patent No. 11,202,591
`
`intentionally left blank
`U.S. Publication No. 2008/0097246 (“Stafford”)
`U.S. Publication No. 2005/0101932 (“Cote”)
`U.S. Publication No. 2007/0073129 (“Shah”)
`U.S. Publication No. 2007/0135774 (“Turner”)
`U.S. Patent No. 6,175,752 (“Say”)
`U.S. Publication No. 2009/0124979 (“Raymond”)
`U.S. Publication No. 2006/0095014 (“Ethelfeld”)
`PCT Publication No. WO2008/155377 (“Hasted”)
`
`No.
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 9
`
`

`

`Patent 11,202,591
`
`No.
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`Description
`U.S. Publication No. 2009/0076360 (“Brister-360”)
`U.S. Publication No. 2006/0155180 (“Brister-180”)
`U.S. Publication No. 2004/0133164 (“Funderburk 164”)
`U.S. Patent No. 6,560,471 (“Heller”)
`U.S. Patent No. 6,579,690 (“Bonnecaze”)
`U.S. Publication No. 2003/0225373 (“Bobroff-373”)
`U.S. Publication No. 2009/0240121 (“Bickoff”)
`PCT Publication No. WO2008/114223 (“Pesach”)
`U.S. Publication No. 2004/0002682 (“Kovelman”)
`U.S. Patent No. 7,381,184 (“Funderburk”)
`intentionally left blank
`
`intentionally left blank
`
`intentionally left blank
`U.S. Publication No. 2008/0319414 (“Yodfat-414”)
`U.S. Patent No. 7,207,974 (“Safabash”)
`U.S. Publication No. 2004/0204687 (“Mogensen-687”)
`U.S. Publication No. 2002/0022855 (“Bobroff-855”)
`U.S. Patent No. 9,566,384 (“Gyrn”)
`U.S. Patent No. 8,747,363 (“Nielsen”)
`U.S. Publication No. 2007/0093754 (“Mogensen-754”)
`intentionally left blank
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 10
`
`

`

`Patent 11,202,591
`
`No.
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`Description
`
`intentionally left blank
`
`Steven W. Smith, The Scientist and Engineer’s Guide to Digital
`Signal Processing (2nd ed. 1999)
`
`B.A. Shenoi, Introduction to Digital Signal Processing and
`Filter Design (2006)
`U.S. Publication No. 2009/0099521 (“Gravesen”)
`U.S. Publication No. 2009/0216215 (“Thalmann”)
`U.S. Publication No. 2008/0255440 (“Eilersen”)
`intentionally left blank
`PCT Publication No. WO2008/115409 (“Brenneman”)
`Statement of Defense (Counterclaim), Dexcom Inc. v. Abbott
`Diabetes Care Inc., Case No. 21 O 6562/23 (Munich D. Ct. I),
`Sept. 1, 2023.
`U.S. Publication No. 2008/0114280 (“Stafford-280”)
`
`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.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 11
`
`

`

`Patent 11,202,591
`
`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 narrower than it
`
`would otherwise be. I applied these understandings when considering the scope and
`
`meaning of the claims of the ’591 patent.
`
`12.
`
`I understand that a claim is unpatentable if it would have been obvious.
`
`I understand that a patent claim is rendered obvious if the claimed subject matter as
`
`a whole would have been obvious to a person of ordinary skill in the art as of the
`
`date of invention. I understand that this determination is made after weighing the
`
`following factors: (1) the scope and content of the prior art; (2) the differences
`
`between the prior art as a whole and the claim at issue; (3) the level of ordinary skill
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 12
`
`

`

`Patent 11,202,591
`
`in the pertinent art; and (4) as appropriate, secondary considerations of non-
`
`obviousness.
`
`13.
`
`I understand that the knowledge of a person of ordinary skill in the art
`
`at the time of the alleged invention provides a reference point from which the prior
`
`art and claimed invention should be viewed. This reference point safeguards against
`
`use of improper hindsight in evaluating whether a claim is obvious. However, if a
`
`person of ordinary skill in the art could have implemented the claimed invention as
`
`a predictable variation of a known product, then the claim may be rendered obvious.
`
`I further understand that a person of ordinary skill in the art is presumed to have
`
`knowledge of relevant prior art at the time of the claimed invention, which includes
`
`any prior art that was reasonably pertinent to the particular problems the inventor
`
`faced.
`
`14.
`
`I understand that an obviousness evaluation can be made on a single
`
`reference or a combination of multiple prior art references. I understand that a proper
`
`obviousness analysis as to two or more references generally requires a reason that
`
`would have prompted a person of ordinary skill in the art to combine the elements
`
`of multiple prior art references in the way the claimed invention does. I understand
`
`that the prior art references themselves may provide a teaching, suggestion,
`
`motivation, or reason to combine, but that at other times such combinations can be
`
`based on simple common sense. I further understand that an obviousness analysis
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 13
`
`

`

`Patent 11,202,591
`
`recognizes that market demand, rather than scientific literature, often drives
`
`innovation, and that a motivation to combine references may be supplied by the
`
`direction of the marketplace. I understand that prior art references used in
`
`obviousness analyses should be analogous to the claimed invention, which I
`
`understand to mean (1) the reference is from the same field of endeavor as the
`
`claimed invention (even if it addresses a different problem); or (2) the reference is
`
`reasonably pertinent to the problem faced by the inventor (even if it is not in the
`
`same field of endeavor as the claimed invention).
`
`15.
`
`I understand that a particular combination may be proven obvious
`
`merely by showing that it was obvious to try the combination. For example, when
`
`there is a design need or market pressure to solve a problem and there are a finite
`
`number of identified, predictable solutions, a person of ordinary skill has good
`
`reason to pursue the known options within that person’s technical grasp because the
`
`result is likely the product not of innovation but of ordinary skill and common sense.
`
`16.
`
`I further understand that a proper obviousness analysis focuses on what
`
`was known or obvious to a person of ordinary skill in the art, and not just to the
`
`patentee. Accordingly, I understand that any need or problem known in the field of
`
`endeavor at the time of invention and addressed by the patent can provide a reason
`
`for combining the elements in the manner claimed.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 14
`
`

`

`Patent 11,202,591
`
`17.
`
`In sum, my understanding is that prior art teachings are properly
`
`combined where a person of ordinary skill in the art, having the knowledge reflected
`
`in the prior art and motivated by the general problem addressed by the patent in
`
`question, would have been led to make the combination of elements recited in the
`
`claims. Under this analysis, the prior art references themselves, or any need or
`
`problem known in the field of endeavor at the time of the invention, can provide a
`
`reason for combining the elements of multiple prior art references in the claimed
`
`manner. I understand that at least the following rationales may support a finding of
`
`obviousness:
`
`a)
`
`Combining prior art elements according to known methods to yield
`
`predictable results;
`
`b)
`
`Simple substitution of one known element for another to obtain
`
`predictable results;
`
`c)
`
`Use of a known technique to improve similar devices (methods, or
`
`products) in the same way;
`
`d)
`
`Applying a known technique to a known device (method, or product)
`
`ready for improvement to yield predictable results;
`
`e)
`
`Choosing from a finite number of identified, predictable solutions, with
`
`a reasonable expectation of success (“obvious to try”);
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 15
`
`

`

`Patent 11,202,591
`
`f)
`
`Predictable variation of work in the same or a different field of
`
`endeavor if a person of ordinary skill would be able to implement the variation;
`
`g)
`
`Existence of a known problem for which there was an obvious solution
`
`encompassed by the patent’s claims;
`
`h)
`
`Known work in one field of endeavor that may prompt variations of it
`
`for use in either the same or a different field based on design incentives or other
`
`market forces if the variations would have been predictable to one of ordinary skill
`
`in the art; and
`
`i)
`
`Any teaching, suggestion, or motivation in the prior art that would have
`
`led one of ordinary skill to modify the prior art reference or to combine prior art
`
`reference teachings to arrive at the claimed invention.
`
`18.
`
`I further understand that an obviousness analysis includes considering
`
`whether a POSITA would have a “reasonable expectation of success”—not an
`
`“absolute predictability” of success—in achieving the claimed invention by
`
`combining prior art references.
`
`19.
`
`I have been informed and understand that secondary considerations of
`
`nonobviousness may include: (1) whether the invention proceeded in a direction
`
`contrary to accepted wisdom in the field; (2) whether there was a long felt but
`
`unresolved need in the art that was satisfied by the invention; (3) whether others had
`
`tried but failed to make the invention; (4) whether others copied the invention; (5)
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 16
`
`

`

`Patent 11,202,591
`
`whether the invention achieved unexpected results; (6) whether the invention was
`
`praised by others; (7) whether others have taken licenses to use the invention; (8)
`
`whether experts or those skilled in the art at the making of the invention expressed
`
`surprise or disbelief regarding the invention; (9) whether products incorporating the
`
`invention have achieved commercial success that is attributable to the invention and
`
`(10) whether or not others having ordinary skill in the field independently made the
`
`claimed invention at about the same time the inventor made the invention. I
`
`understand that for evidence of secondary considerations to be accorded substantial
`
`weight, there must be an established nexus between the evidence and the merits of
`
`the claimed invention.
`
`20.
`
`I am not aware of any allegations by the named inventors of the ’591
`
`patent or any assignee of the ’591 patent that any secondary considerations tend to
`
`rebut the obviousness of any challenged claim of the ’591 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.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 17
`
`

`

`Patent 11,202,591
`
`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.
`
`V. THE ’591 PATENT
`25. The ’591 patent, titled “Analyte Sensor And Apparatus For Insertion
`
`Of The Sensor” issued December 21, 2021, from an application filed April 2, 2021,
`
`and claims priority through a series of continuing applications to a provisional
`
`application filed February 3, 2009.
`
`A. The ’591 Patent’s Specification
`
`26. The ’591 patent describes an inserter that inserts part of an on-body
`
`medical device (e.g., a cannula or an analyte sensor) into a subject using an
`
`automatically retractable sharp. E.g., EX1001, 2:13-36, 14:57-59 (“inserter can be
`
`configured to insert various medical devices to the subject, such as for example, an
`
`analyte sensor, an infusion set, a cannula, or a lancet.”), 16:20-28 (“inserter may
`
`include features or components which automatically retract the sharp”), FIGS. 8, 10,
`
`28-31. The ’591 patent describes an on-body unit that includes a data processing unit
`
`and an analyte sensor “constructed to be maintained ‘on the body’ of the subject for
`
`a period of time.” Id., 9:31-41, FIGS. 1-9.
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 18
`
`

`

`Patent 11,202,591
`
`’591 patent, FIG. 30
`
`
`
`B.
`
`The Prosecution History
`
`27. The application was filed April 2, 2021, along with a preliminary
`
`amendment canceling the original claims and adding new claims 21-50. EX1002,
`
`12-19, 124-25. Another preliminary amendment filed August 30, 2021, amended
`
`certain dependent claims. Id., 174-184. Following an Examiner-initiated interview
`
`on November 2, 2021, the Examiner entered minor amendments and applicant filed
`
`terminal disclaimers as to then-co-pending Application No. 17/221,169 and U.S.
`
`Patent Nos. 11,006,870 and 11,006,871. Id., 963, 876-885, 976 (indicating Examiner
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 19
`
`

`

`Patent 11,202,591
`
`amendments to claim 21, which issued as claim 1). The Examiner issued a Notice of
`
`Allowance on November 12, 2021. Id., 971-978.
`
`VI. LEVEL OF SKILL IN THE ART, AND STATE OF THE ART
`Person Of Ordinary Skill In The Art
`A.
`
`28. A 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 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
`
`1.
`
`Inserters With Auto-Retracting Needles Were Known
`
`29.
`
`Inserters that use automatically retractable sharps to insert part of an
`
`on-body unit (e.g., a cannula or glucose sensor) into a subject were well-known
`
`before 2009. For example, Cote describes a device comprising an automatically
`
`retractable needle for inserting a portion of a cannula into a subject. See, e.g.,
`
`EX1005, [0207], [0211]. Likewise, Raymond (EX1009) describes an insertion
`
`device including a needle with an “automatic retraction feature.” See, e.g., EX1009,
`
`[0127]; see also EX1014, [0108], [0110].
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 20
`
`

`

`Patent 11,202,591
`
`2.
`
`Inserters Were Known To Reduce Subject Pain and Anxiety
`
`30.
`
`It was known that manual use of a needle to insert a device through the
`
`skin causes a patient pain and anxiety. See, e.g., EX1036, [0004]-[0005] (“When
`
`performed manually, the penetration of the catheter-carrying needle into the body,
`
`however, may be considered uncomfortable for a patient, or may cause some other
`
`anxiety.”); EX1037, [0005] (“[T]he introduction of the infusion cannula or of the
`
`puncturing tip into the skin, is associated with a certain amount of pain.”).
`
`31.
`
`It was also known that more automatic inserters reduced the amount of
`
`pain and anxiety felt by subjects, e.g., by providing for faster needle puncturing
`
`and/or retraction. See, e.g., EX1036, [0007] (“[O]ne advantage of the invention is to
`
`increase the comfort of a patient during the insertion [by using an inserter in which]
`
`the needle, after reaching its extended state, can be withdrawn quickly and
`
`automatically by a retraction apparatus.”); EX1037, [0005] (“It is therefore
`
`important that such infusion sets, ports or sensor arrangements can be applied easily
`
`and safely, which is why many manufacturers have started designing their products
`
`as insertion heads for special insertion devices with the aid of which the insertion
`
`heads can be applied to the patient's body. Application is made easier in this way,
`
`and the pain occasioned by the application is reduced to a minimum, thanks to the
`
`quick and targeted puncturing procedure.”).
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 21
`
`

`

`Patent 11,202,591
`
`32.
`
`Indeed, by 2007, other patents had recognized
`
`that “many
`
`manufacturers” had designed inserters to reduce the amount of pain felt by subjects
`
`during transcutaneous medical device insertion procedures. EX1037, [0005];
`
`EX1036, [0007].
`
`3.
`
`Inserter Designs Were Interchangeably Used For
`Insertion Of Different Types Of Subcutaneous Devices
`It was well-known in the art that various inserter designs were
`
`33.
`
`interchangeably used for inserting both an analyte (e.g., glucose) sensor or a cannula
`
`or other transcutaneous device. See, e.g., EX1010 (Ethelfeld), [0015] – [0016],
`
`[0020]–[0023] (teaching an inserter for either a cannula or a glucose sensor) and
`
`EX1011 (Hasted), 4:20-5:2 (teaching an inserter used to deliver either an infusion
`
`device or a sensor device: “a sensor device provided with a subcutaneously placed
`
`sensor which is in contact with the patient’s blood and able to register desired
`
`elements in the blood e.g. the sugar level.”).
`
`34. Numerous other background references confirm this interchangeability.
`
`See, e.g., EX1025, US2008/0319414 (“Yodfat-414”), [0070]; EX1026, US
`
`7,207,974 (“Safabash”), 1:33-40; EX1027, US 2004/0204687 (“Mogensen-687”),
`
`[0079]; EX1028 US 2002/0022855 (“Bobroff-855”), [0019]; EX1029, US
`
`9,566,384 (“Gyrn”), 2:23-26; EX1030, US 8,747,363 (“Nielsen”), 13:12-16. Indeed,
`
`the ’591 patent states that its “inserter can be configured to insert various medical
`
`devices to the subject, such as for example, an analyte sensor, an infusion set, a
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.
`
`Page 22
`
`

`

`Patent 11,202,591
`
`cannula, or a lancet” (EX1001, 14:54-59), yet provides no meaningful guidance on
`
`how to configure or adapt the inserter for the various types of devices. See also id.,
`
`1:21-31 (“an inserter device, for example, to insert an analyte sensor and/or an
`
`infusion set”), 2:13-20. This reflects the known interchangeability of inserter devices
`
`between infusion sets and analyte sensors and similar devices.
`
`4.
`
`Low-Profile On-Body Devices Were Known
`
`35. The desirability of “low profile,” “unobtrusive” on-body units was well
`
`known. E.g., EX1005, [0228]; see also EX1004, [0045] (describing benefits of
`
`“smaller profile” on-body unit). Specifically, on-body-units were known to have a
`
`height profile of 10 mm or below. See e.g., EX1012, [0334] (“the overall height of
`
`the sensor system, including the housing and electronics, is no more than about 0.350
`
`[8.89 mm], 0.300 [7.62 mm], 0.250 [6.35 mm], 0.200 [5.08 mm], 0.150 [3.81 mm],
`
`0.100 [2.54 mm], or most preferably 0.075 inches [1.905 mm] in its smallest
`
`dimension.”); EX1013, [0425] (“the mounting unit 316/electronics unit 314
`
`subassembly has … a thickness of less than about 10 mm.”); EX1014, [0074] (“the
`
`on-skin sensor control unit 44 has a height of … preferably 0.7 cm or less”); EX1015,
`
`29:63-64 (same); EX1016, 30:33-34 (same).
`
`DECLARATION OF GARY D. FLETCHER, Ph.D.