`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LIFE SPINE, INC.
`Petitioner,
`
`v.
`
`GLOBUS MEDICAL, INC.,
`Patent Owner,
`
`
`Patent No. 9,956,087 to Seifert et al.
`Issue Date: May 1, 2018
`Title: INTERVERTEBRAL SPACER AND PLATE
`_______________
`
`Inter Partes Review No.: 2022-01602
`_______________
`
`Declaration of Prof. Troy D. Drewry
`
`
`
`
`
`
`
`
`
`Exhibit 1002
`LIFE SPINE, INC.
`IPR2022-01602
`
`000001
`
`

`

`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`TABLE OF CONTENTS
`
`INTRODUCTION ......................................................................................... 1 
`I. 
`II.  QUALIFICATIONS ...................................................................................... 2 
`III.  MATERIALS AND OTHER INFORMATION CONSIDERED ............. 5 
`IV.  SUMMARY OF MY OPINIONS ................................................................. 7 
`V. 
`LEGAL PRINCIPLES .................................................................................. 8 
`A. 
`Claim Construction ............................................................................... 8 
`B. 
`Anticipation ........................................................................................... 8 
`C. 
`Obviousness ......................................................................................... 10 
`VI.  OVERVIEW OF THE ’087 PATENT ....................................................... 13 
`A. 
`Specification ........................................................................................ 17 
`B. 
`Summary of the Prosecution History .................................................. 37 
`C. 
`Person of Ordinary Skill in the Art ..................................................... 40 
`VII.  OVERVIEW OF THE REFERENCES RELIED UPON BY
`PETITIONER .............................................................................................. 42 
`A.  Weiman................................................................................................ 42 
`1. 
`Overview ................................................................................... 42 
`The Weiman-Mozeleski Combination ................................................ 60 
`1. 
`Overview of Mozeleski ............................................................. 60 
`2. 
`The Combination of Weiman and Mozeleski was Predictable . 76 
`The Weiman-Mozeleski-Seifert Combination .................................... 81 
`1. 
`Overview of Seifert ................................................................... 81 
`2. 
`The Combination of Weiman, Mozeleski, and Seifert was
`Predictable ................................................................................. 87 
`The Seifert-Mozeleski Combination ................................................... 94 
`
`B. 
`
`C. 
`
`D. 
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`E. 
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`1. 
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`1. 
`The Combination of Seifert and Mozeleski was Predictable ... 94 
`The Seifert-Mozeleski-Weiman Combination .................................. 100 
`1. 
`The Combination of Seifert, Mozeleski, and Weiman was
`Predictable ............................................................................... 100 
`VIII.  ANALYSIS OF THE REFERENCES RELIED UPON BY
`PETITIONER ............................................................................................ 103 
`A. 
`Claims 1–3 and 8–10 are Anticipated by and/or Obvious Over
`Weiman ................................................................................... 103 
`Claim 1 .................................................................................... 103 
`i. 
`“A surgical system comprising:” ...................................... 104 
`ii.  “an implant comprising:” ................................................. 105 
`iii.  “a first endplate, wherein the first endplate comprises a
`planar portion with protrusions and an extension
`portion;” ............................................................................ 105 
`iv.  “a second endplate;” ......................................................... 110 
`v.  “a first ramped body extending between the first endplate
`and the second endplate, wherein the first ramped body
`comprises at least one upwardly facing ramp engaging the
`first endplate and at least one downwardly facing ramp
`engaging the second endplate;” ........................................ 111 
`vi.  “an actuator in engagement with the first ramped body,” 115 
`vii.  “wherein rotation of the actuator causes translation of the
`first ramped body, thereby causing expansion of the
`implant; and” .................................................................... 117 
`viii. “a first socket formed through the extension portion of the
`first endplate, wherein the first socket extends completely
`above the planar portion of the first endplate; and” ......... 120 
`ix.  “a first anchor configured to fasten the implant to the
`patient, wherein the anchor is received in the first
`socket.” ............................................................................. 123 
`Claim 2 – “the first socket is attached to the first endplate.” . 127 
`Claim 3 – “a second anchor to fasten the implant to the patient
`and wherein the implant further comprises a second socket,
`attached to the second endplate, configured to receive the
`second anchor.” ....................................................................... 128 
`Claim 8 .................................................................................... 129 
`i. 
`“A surgical system comprising:” ...................................... 131 
`ii
`
`2. 
`3. 
`
`4. 
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`ii.  “an implant comprising:” ................................................. 131 
`iii.  “a first endplate, wherein the first endplate comprises a
`planar portion with protrusions and an extension
`portion;” ............................................................................ 131 
`iv.  “a second endplate;” ......................................................... 131 
`v.  “a first ramped body extending between the first endplate
`and the second endplate;” ................................................. 131 
`vi.  “an actuator in engagement with the first ramped body,
`wherein rotation of the actuator causes translation of the
`first ramped body, thereby causing expansion of the
`implant; and” .................................................................... 131 
`vii.  “a first socket formed through the extension portion of the
`first endplate, wherein the first socket extends completely
`above the planar portion of the first endplate; and” ......... 131 
`viii. “a first anchor configured to fasten the implant to the
`patient, wherein the anchor is received in the first
`socket.” ............................................................................. 132 
`Claim 9 – “the first socket is attached to the first endplate.” . 132 
`Claim 10 – “a second anchor to fasten the implant to the patient
`and wherein the implant further comprises a second socket,
`attached to the second endplate, configured to receive the
`second anchor.” ....................................................................... 132 
`Claims 4–7 and 11–13 are Obvious Over Weiman and Mozeleski .. 132 
`1. 
`Claim 4 – “at least one of the first anchor and the second anchor
`is curved and configured to pierce a bone of the patient to fasten
`the implant to the patient.” ...................................................... 132 
`Claim 5 – “at least one of the first anchor and the second anchor
`is configured to have a t-shaped cross-section and sharp edges
`to pierce the bone of the patient to fasten the spacer to the
`patient.” ................................................................................... 134 
`Claim 6 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are
`parallel.” .................................................................................. 142 
`Claim 7 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 144 
`
`5. 
`6. 
`
`2. 
`
`B. 
`
`3. 
`
`4. 
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`
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`5. 
`
`6. 
`
`7. 
`
`8. 
`
`Claim 11 – “at least one of the first anchor and the second
`anchor is curved and configured to pierce a bone of the patient
`to fasten the implant to the patient.” ....................................... 146 
`Claim 12 – “at least one of the first anchor and the second
`anchor is configured to have a t-shaped cross-section and sharp
`edges to pierce the bone of the patient to fasten the spacer to the
`patient.” ................................................................................... 147 
`Claim 13 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are
`parallel.” .................................................................................. 147 
`Claim 14 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 147 
`Claims 7 and 14 are Obvious Over by Weiman, Mozeleski, and
`Seifert ...................................................................................... 149 
`Claim 7 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 149 
`Claim 14 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 151 
`Claims 1–3 and 8–10 are Anticipated by and/or Obvious Over
`Seifert ...................................................................................... 152 
`Claim 1 .................................................................................... 152 
`i. 
`“A surgical system comprising:” ...................................... 152 
`ii.  “an implant comprising:” ................................................. 152 
`iii.  “a first endplate, wherein the first endplate comprises a
`planar portion with protrusions and an extension
`portion;” ............................................................................ 153 
`iv.  “a second endplate;” ......................................................... 158 
`v.  “a first ramped body extending between the first endplate
`and the second endplate, wherein the first ramped body
`comprises at least one upwardly facing ramp engaging the
`first endplate and at least one downwardly facing ramp
`engaging the second endplate;” ........................................ 158 
`vi.  “an actuator in engagement with the first ramped body” . 163 
`
`C. 
`
`D. 
`
`1. 
`
`2. 
`
`1. 
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`
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`vii.  “wherein rotation of the actuator causes translation of the
`first ramped body, thereby causing expansion of the
`implant; and” .................................................................... 165 
`viii. “a first socket formed through the extension portion of the
`first endplate, wherein the first socket extends completely
`above the planar portion of the first endplate; and” ......... 166 
`ix.  “a first anchor configured to fasten the implant to the
`patient, wherein the anchor is received in the first
`socket.” ............................................................................. 170 
`Claim 2 – “the first socket is attached to the first endplate.” . 173 
`Claim 3 – “a second anchor to fasten the implant to the patient
`and wherein the implant further comprises a second socket,
`attached to the second endplate, configured to receive the
`second anchor.” ....................................................................... 173 
`Claim 8 .................................................................................... 175 
`i. 
`“A surgical system comprising:” ...................................... 175 
`ii.  “an implant comprising:” ................................................. 175 
`iii.  “a first endplate, wherein the first endplate comprises a
`planar portion with protrusions and an extension
`portion;” ............................................................................ 175 
`iv.  “a second endplate;” ......................................................... 175 
`v.  “a first ramped body extending between the first endplate
`and the second endplate;” ................................................. 175 
`vi.  “an actuator in engagement with the first ramped body,
`wherein rotation of the actuator causes translation of the
`first ramped body, thereby causing expansion of the
`implant; and” .................................................................... 175 
`vii.  “a first socket formed through the extension portion of the
`first endplate, wherein the first socket extends completely
`above the planar portion of the first endplate; and” ......... 175 
`viii. “a first anchor configured to fasten the implant to the
`patient, wherein the anchor is received in the first
`socket.” ............................................................................. 176 
`Claim 9 – “the first socket is attached to the first endplate.” . 176 
`Claim 10 – “a second anchor to fasten the implant to the patient
`and wherein the implant further comprises a second socket,
`attached to the second endplate, configured to receive the
`second anchor.” ....................................................................... 176 
`
`2. 
`3. 
`
`4. 
`
`5. 
`6. 
`
`
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`E. 
`
`F. 
`
`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`Claims 4–7 and 11–14 are Obvious Over Seifert and Mozeleski ..... 176 
`1. 
`Claim 4 – “at least one of the first anchor and the second anchor
`is curved and configured to pierce a bone of the patient to fasten
`the implant to the patient.” ...................................................... 176 
`Claim 5 – “at least one of the first anchor and the second anchor
`is configured to have a t-shaped cross-section and sharp edges
`to pierce the bone of the patient to fasten the spacer to the
`patient.” ................................................................................... 177 
`Claim 6 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are
`parallel.” .................................................................................. 177 
`Claim 7 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 179 
`Claim 11 – “at least one of the first anchor and the second
`anchor is curved and configured to pierce a bone of the patient
`to fasten the implant to the patient.” ....................................... 179 
`Claim 12 – “at least one of the first anchor and the second
`anchor is configured to have a t-shaped cross-section and sharp
`edges to pierce the bone of the patient to fasten the spacer to the
`patient.” ................................................................................... 179 
`Claim 13 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are
`parallel.” .................................................................................. 180 
`Claim 14 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 180 
`Claims 7 and 14 are Obvious Over Seifert, Mozeleski, and
`Weiman ................................................................................... 180 
`Claim 7 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 180 
`Claim 14 – “the implant is configured to expand in a manner
`such that the first endplate and the second endplate are non-
`parallel.” .................................................................................. 182 
`IX.  CONCLUSION .......................................................................................... 184 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
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`7. 
`
`8. 
`
`1. 
`
`2. 
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`1.
`I, Troy D. Drewry, of Memphis, Tennessee, declare that:
`I. INTRODUCTION
`2.
`I have been retained as a technical expert by counsel on behalf of Life
`
`Spine, Inc. (“Petitioner”). I understand that Petitioner is requesting that the Patent
`
`Trial and Appeal Board institute an Inter Partes review (“IPR”) proceeding of U.S.
`
`Patent No. 9,956,087 (“the ’087 patent,” EX1001).
`
`3.
`
`I have been asked by Petitioner’s counsel (“Counsel”) to provide my
`
`independent analysis and consideration of whether certain references teach or
`
`suggest the features recited in claims 1–14 (the “challenged claims”) of the ’087
`
`patent. My opinions and the bases for my opinions are set forth below. My
`
`opinions are based on my education and experience.
`
`4.
`
`In writing this Declaration, I have considered the following: my own
`
`knowledge and experience, including my teaching and work experience in the
`
`fields of spinal implant design, spinal instrument design, and medical device
`
`design; and my experience of working with others involved in those fields.
`
`5.
`
`I am not, and never have been, an employee of Petitioner. I have no
`
`financial interest in either party or in the outcome of this proceeding. I am being
`
`compensated for my work as an expert on an hourly basis, for all tasks involved.
`
`My compensation is not dependent on the outcome of these proceedings or on the
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`content of my opinions. I will not receive any added compensation based on the
`
`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`outcome of any IPR or other proceeding involving the ’087 patent.
`
`II. QUALIFICATIONS
`6. My qualifications for forming the opinions in this report are
`
`summarized here and explained in more detail in my curriculum vitae (“CV”),
`
`which is provided as Appendix A appended hereto.
`
`7.
`
`As detailed in my CV, I have extensive experience in the design,
`
`development, and manufacture of spinal implants and instruments, with a career
`
`spanning over twenty-five years in this field. I have specific expertise in the design
`
`and development of spinal implants and have a sound understanding of the relevant
`
`biomechanical principles and constraints associated with the implantation of such
`
`devices into a living patient. My expertise further includes spinal implant design,
`
`including spinal systems, spinal screw systems, plates, vertebral body spacers, and
`
`spreader systems. I have also engaged in extensive consulting work, as founder and
`
`principal engineer of Ragin’ Cajun Consulting LLC, in the design and
`
`development of these types of medical devices.
`
`8.
`
`I earned my Bachelor of Science in Mechanical Engineering
`
`(CAD/CAM Option) from the University of Southwestern Louisiana in 1992. I
`
`completed a Masters of Biomedical Engineering from the University of Memphis
`
`
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`in 1994, and a Masters of Engineering Management from Christian Brothers
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`University in 2000.
`
`9.
`
`I am also a named inventor on over sixty U.S. patents spanning
`
`multiple types of spinal implant technologies. Broadly speaking, the inventions
`
`described in these patents relate to bone screw assemblies, spinal deformity
`
`reduction, fusion-less scoliosis treatment, connector assemblies, implant devices,
`
`shape memory alloy staples, vertebral body spacers, tensioning instruments,
`
`adjustable spine tethers, vertebral rod assemblies, vertebral stabilization
`
`assemblies, expandable anterior lumbar interbody fusion devices, and other similar
`
`subject matter. In addition to designing and inventing new technologies, I have,
`
`throughout my career, mentored, trained, and supervised young engineers and can
`
`easily appreciate how a less experienced engineer would perceive the prior art and
`
`approach the technical problems disclosed in the prior art.
`
`10.
`
`I also have extensive consulting experience in the design and
`
`development of medical devices. My consulting experience has involved project
`
`management, engineering design and development, design control and design
`
`history file (DHF) management, intellectual property landscape and analysis, and
`
`forensic engineering and expert witness services, all directed to medical devices.
`
`11.
`
`I am currently employed as a Professor of Practice in the Biomedical
`
`Engineering Department at the University of Mississippi in Oxford, Mississippi. I
`
`
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`teach BME 200 – Introduction to Biomedical Engineering and a two-course Senior
`
`Design Capstone series (BME 461 & BME 462) focused on medical device design.
`
`I am also the Operations Manager of the Center for Diagnostics, Design, Devices,
`
`and Biomechanics (D3B) at the University of Mississippi.
`
`12.
`
`I have previously served as an expert in patent infringement cases
`
`involving spinal devices. I also served as an expert in two IPR cases involving
`
`surgical instruments, knee replacement technologies, and tibial implants. I also
`
`served as an expert in two IPR cases involving surgical positioning blocks. I also
`
`served as an expert in two IPR cases involving bone plate fusion technologies. I
`
`also served as an expert in three IPR cases involving tibial plateau-leveling
`
`osteotomy. I also served as an expert in four IRP cases involving spinal surgical
`
`devices. I also served as an expert in an IPR case involving posterior cruciate
`
`ligament technology.
`
`13. Based on my experience and education, I believe that I am qualified to
`
`opine as to the knowledge and level of skill of one of ordinary skill in the art at the
`
`time of the alleged invention of the ’087 patent (“POSITA”; refer to Section VI.C,
`
`below) and what such a person would have understood at that time, and the state of
`
`the art during that time. Based on my experiences, I understand and know of the
`
`capabilities of persons of ordinary skill in this field during the late 1990s to mid
`
`2010s and specifically during the time before the time of the alleged invention of
`
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`the ’087 patent. Indeed, I worked closely with many such persons in the field
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`during that time frame.
`
`III. MATERIALS AND OTHER INFORMATION CONSIDERED
`14. All of the opinions contained in this declaration are based on the
`
`documents I have reviewed and my professional judgment, as well as my
`
`education, experience, and professional knowledge. I am not an attorney and I am
`
`not offering any legal opinions in this declaration.
`
`15.
`
`In forming the opinions expressed in this declaration, I relied upon my
`
`education, knowledge, and experience in the relevant field of the art, and have
`
`considered the viewpoint of a POSITA as of July 17, 2015, which I understand to
`
`be the earliest effective filing date of the claims. I have considered the materials
`
`referenced herein, including the ’087 patent (EX1001), excerpts of the prosecution
`
`history (EX1012) of the ’087 patent and the following materials:
`
` U.S. Patent Application Publication No. 2014/0067071 to Weiman et
`
`al. (“Weiman,” EX1004);
`
` International Patent Application Publication No. WO2015/009793 to
`
`Mozeleski et al. (“Mozeleski,” EX1006);
`
` U.S. Patent Application Publication No. 2014/0163683 to Seifert et al.
`
`(“Seifert,” EX1010);
`
`
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` U.S. Patent Application Publication No. 2013/0023994 to Glerum
`
`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`(“Glerum,” EX1018);
`
` International Patent Application Publication No. WO2012/121726 to
`
`Schoenly et al. (“Schoenly,” EX1020);
`
` U.S. Patent Application Publication No. 2013/0023993 to Weiman
`
`(“the ’993 publication,” EX1022);
`
` U.S. Patent Application Publication No. 2015/0012097 to Ibarra et al.
`
`(“Ibarra,” EX1024);
`
` U.S. Patent Application Publication No. 2008/0140207 to Olmos et al.
`
`(“Olmos,” EX1028);
`
` U.S. Patent Application Publication No. 2012/0185049 to Varela
`
`(“Varela,” EX1030);
`
` U.S. Patent No. 8,641,766 to Donner et al. (“Donner,” EX1032);
`
` U.S. Patent No. 7,867,277 to Tohmeh (“Tohmeh,” EX1034);
`
` U.S. Patent No. 5,609,635 to Michelson (“Michelson,” EX1036);
`
` Rick C. Sasso et al., Anterior Lumbar Fusion, Chapter 10 of “Surgical
`
`Management of Low Back Pain”, 2d Edition (2009) (“Sasso,”
`
`EX1038);
`
`
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`-6-
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` Medacta, MectaLIF Oblique & Posterior (2014) (“Medacta,”
`
`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`EX1040); and
`
` Other materials which I understand are attached to the Petition.
`
`16.
`
`I have considered these materials through the lens of a person of
`
`ordinary skill in the art (“POSITA,” which is discussed further in Section VI.C
`
`below) related to the ’087 patent as of the effective filing date, and I have done so
`
`during my review of these materials.
`
`IV. SUMMARY OF MY OPINIONS
`17. This Declaration explains the conclusions that I have formed based on
`
`my knowledge and experience and my review of the references (prior art) listed
`
`above. To summarize, I have concluded that:
`
` Claims 1–3 and 8–10 are anticipated by and/or obvious over Weiman;
`
` Claims 4–7 and 11–14 are obvious over Weiman and Mozeleski;
`
` Claims 7 and 14 are obvious over Weiman, Mozeleski, and Seifert;
`
` Claims 1–3 and 8–10 are anticipated by and/or obvious over Seifert;
`
` Claims 4–7 and 11–14 are obvious over Seifert and Mozeleski; and
`
` Claims 7 and 14 are obvious over Seifert, Mozeleski, and Weiman.
`
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`V. LEGAL PRINCIPLES
`18.
`In forming my analysis and conclusions expressed in this declaration,
`
`I have applied the legal principles described in the following paragraphs, which
`
`were provided to me by Counsel.
`
`A. Claim Construction
`19.
`I understand that a claim must be construed under the Phillips
`
`standard. Under that standard, words of a claim are given their plain and ordinary
`
`meaning as understood by person of ordinary skill in the art (also “POSITA”) at
`
`the time of invention, in light of the specification and prosecution history, unless
`
`those sources show an intent to depart from such meaning, as well as pertinent
`
`evidence extrinsic to the patent. For purposes of this declaration, I applied the plain
`
`and ordinary meaning of each term as would have been understood by a person of
`
`ordinary skill in art at the time of the alleged invention unless explicitly stated
`
`otherwise.
`
`B. Anticipation
`20.
`I understand that a patent claim is invalid if it is anticipated by a
`
`single item of prior art. I understand that an anticipation analysis involves two
`
`steps. First, the patent claims are construed to ascertain their scope. Second, each
`
`construed asserted claim is compared to the prior art reference on an element-by-
`
`element basis. If the prior art reference discloses or contains each and every
`
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`element of the claimed invention, either expressly or inherently, then it
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
`
`
`anticipates the claim.
`
`21.
`
`I understand that anticipation by inherent disclosure is appropriate
`
`only when a prior art reference necessarily includes or discloses the unstated
`
`claim element. I also understand that the discovery of a new or previously
`
`unreported or unappreciated property of a prior art composition, or of a scientific
`
`explanation for how a prior art composition operates, does not make the prior art
`
`composition patentably new to the entity or person that discovered the new
`
`property or mode of operation. I further understand that there is no requirement
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`that a POSITA would have recognized the inherent disclosure at the time of the
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`invention.
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`22. For anticipation by a prior art publication or document, I understand
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`that the reference’s description must enable a POSITA to practice the claimed
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`invention without undue experimentation. I further understand that the following
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`factors may be considered to determine whether any experimentation would have
`
`been undue:
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`a) The quantity of experimentation necessary;
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`b) The amount of direction or guidance presented;
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`c) The presence or absence of working examples;
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`d) The nature of the claimed invention;
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
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`e) The state of the prior art;
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`f) The relative skill of those in the art;
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`g) The predictability or unpredictability of the art; and
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`h) The breadth of the claims.
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`C. Obviousness
`23.
`I understand that a patent claim can be considered to have been
`
`obvious to person of ordinary skill in the art at the time the application was filed.
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`This means that, even if all of the elements of a claim are not found in a single
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`prior art reference, the claim is not patentable if the differences between the subject
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`matter in the prior art and the subject matter in the claim would have been obvious
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`to a person of ordinary skill in the art at the time the application was filed.
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`24.
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`I further understand that a determination of whether a claim would
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`have been obvious must consider several factors, including, among others:
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`a. the level of ordinary skill in the art at the time the application
`
`was filed;
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`b. the scope and content of the prior art; and
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`c. what differences, if any, existed between the claimed invention
`
`and the prior art.
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
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`I understand that the teachings of two or more references may be
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`25.
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`combined in the same way as disclosed in the claims, if such a combination would
`
`have been obvious to a person of ordinary skill in the art. In determining whether a
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`combination based on either a single reference or multiple references would have
`
`been obvious, it is appropriate to consider at least the following factors:
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`a. whether the teachings of the prior art references disclose known
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`concepts combined in familiar ways, which, when combined,
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`would yield predictable results;
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`b. whether a person of ordinary skill in the art could implement a
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`predictable variation, and would see the benefit of doing so;
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`c. whether the claimed elements represent one of a limited number
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`of known design choices, and would have a reasonable
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`expectation of success by a person of ordinary skill in the art;
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`d. whether a person of ordinary skill in the art would have
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`recognized a reason to combine known elements in the manner
`
`described in the claim;
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`e. whether there is some teaching or suggestion in the prior art to
`
`make the modification or combination of elements claimed in the
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`Declaration of Prof. Troy D. Drewry
`U.S. Patent No. 9,956,087
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`patent; and
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`f. whether the innovation applies a known technique that had been
`
`used to improve a similar device or method in a similar way.
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`26.
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`I understand that a person of ordinary skill in the art has ordinary
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`creativity, and is not an automaton.
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`27.
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`I understand that in considering obviousness, it is important not to
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`determine obviousness using the benefit of hindsight derived from the patent being
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`considered, and I have not done that in regards to my opinions expressed herein.
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`28.
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`I understand
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`that certain
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`factors—often called “secondary
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`considerations”—may support or rebut an assertion of obviousness of a claim. I
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`understand that such secondary considerations include, among other things,
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`commercial success of the alleged invention, skepticism of those having ordinary
`
`skill in the art at the time of the alleged invention, unexpected results of the alleged
`
`invention, any long-felt but unsolved need in the art that was satisfied by the alleged
`
`invention, the failure of others to mak