Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 1 of 128 PagelD #: 20419
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOLOGIC, INC., and CYTYC SURGICAL
`PRODUCTS, LLC,
`
`Plaintiffs,
`
`C.A. No.: 15-1031-JFB-SRF
`
`V.
`
`REDACTED - PUBLIC VERSION
`
`MINERVA SURGICAL, INC.,
`
`Defendant.
`
`DECLARATION OF KARL R. LEINSING, MSME, PE, IN SUPPORT OF
`PLAINTIFFS' MOTIONS FOR SUMMARY JUDGMENT AND
`PLAINTIFFS' MOTION TO EXCLUDE EXPERT TESTIMONY
`
`Of Counsel:
`
`Matthew M. Wolf
`Marc A Cohn
`ARNOLD & PORTER KA YE SCHOLER LLP
`601 Massachusetts Ave., NW
`Washington, DC 20001-3743
`Telephone: (202) 942-5000
`matthew.wolf@aporter.com
`marc.cohn@aporter.com
`
`Ryan Casamiquela
`ARNOLD & PORTER KA YE SCHOLER LLP
`Three Embarcadero Center
`San Francisco, CA 94111-4024
`Telephone: (415) 471-3100
`ryan.casamiquela@apks.com
`
`David A Caine
`Philip W. Marsh
`Assad H. Raj ani
`ARNOLD & PORTER KA YE SCHOLER LLP
`Five Palo Alto Square
`3000 El Camino Real, Suite 500
`Palo Alto, CA 94306
`Telephone: (650) 319-4500
`david.caine@apks.com
`philip.marsh@apks.com
`as sad.raj ani@apks.com
`
`01:22724685 .1
`
`Karen L. Pascale (#2903)
`Pilar G. Kraman (#5199)
`YOUNG CONAWAY STARGATT& TAYLORLLP
`Rodney Square
`1000 North King Street
`Wilmington, Delaware 19801
`(302) 571-6600
`kpascale@ycst.com
`pkraman@ycst.com
`
`Attorneys for Plaintiffs Hologic, Inc.
`and Cyryc Surgical Products, LLC
`
`January 5, 2018
`Redacted Version: January 16, 2018
`
`Sanofi Exhibit 2172.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 2 of 128 PagelD #: 20420
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`HOLOGIC, INC., and CYTYC SURGICAL
`PRODUCTS, LLC,
`
`Plaintiffs,
`
`C.A. No. 15-1031-JFB-SRF
`
`V.
`
`REDACTED - PUBLIC VERSION
`
`MINERVA SURGICAL, INC.,
`
`Defendant.
`
`DECLARATION OF KARL R. LEINSING, MSME, PE, IN SUPPORT OF
`PLAINTIFFS' MOTIONS FOR SUMMARY JUDGMENT AND
`PLAINTIFFS' MOTION TO EXCLUDE EXPERT TESTIMONY
`
`Sanofi Exhibit 2172.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 3 of 128 PagelD #: 20421
`
`TABLE OF CONTENTS
`
`I.
`
`11.
`
`BACKGROUND AND QUALIFICATIONS .................................................................... 1
`
`COMPENSATION ............................................................................................................. 2
`
`III.
`
`SUMMARY OF OPINIONS .............................................................................................. 2
`
`IV.
`
`APPLICABLE LEGAL PRINCIPLES ............................................................................... 5
`
`A
`
`B.
`
`PATENT INFRINGEMENT ........................................................................................... 5
`
`PATENT VALIDITY ................................................................................................... 7
`1.
`The Law Of Enablement ............................................................................. 7
`The Law Of Written Description ................................................................ 9
`2.
`
`V.
`
`ONE OF ORDINARY SKILL IN THE ART ................................................................... 10
`
`VI.
`
`BACKGROUND OF THE RELEVANT TECHNOLOGY ............................................. 11
`
`A.
`
`B.
`
`C.
`
`D.
`
`ENDOMETRIAL ABLATION ...................................................................................... 11
`
`THE ASSERTED PATENTS ....................................................................................... 12
`
`HOLOGIC's NovASURE SYSTEM ............................................................................ 16
`
`MINERVA'S ENDOMETRIAL ABLATION SYSTEM .................................................... 17
`
`VII.
`
`CLAIM CONSTRUCTION .............................................................................................. 22
`
`VIII.
`
`INFRINGEMENT ANALYSIS ........................................................................................ 23
`
`A.
`
`B.
`
`THE ASSERTED CLAIMS ......................................................................................... 24
`
`US PATENT NO. 6,872,183 .................................................................................... 24
`1.
`Claim 1 ...................................................................................................... 24
`2.
`Claim 2 ...................................................................................................... 33
`3.
`Claim5 ...................................................................................................... 33
`Claim 6 ...................................................................................................... 34
`4.
`5.
`Claim 7 ...................................................................................................... 35
`Claim 9 ...................................................................................................... 36
`6.
`7.
`Claim 11 .................................................................................................... 3 7
`8.
`Claim 13 .................................................................................................... 38
`9.
`Claim 14 .................................................................................................... 38
`10.
`Claim 15 .................................................................................................... 38
`
`-11-
`
`Sanofi Exhibit 2172.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 4 of 128 PagelD #: 20422
`
`C.
`
`D.
`
`US PATENT No. 9,095,348 .................................................................................... 39
`Claim 1 ...................................................................................................... 39
`1.
`Claim 3 ...................................................................................................... 61
`2.
`3.
`Claim 12 .................................................................................................... 62
`
`US PATENT NO. 9,247,989 .................................................................................... 62
`Claim 1 ...................................................................................................... 62
`1.
`Claim 7 ...................................................................................................... 69
`2.
`
`IX.
`
`INVALIDITY ANALYSIS .............................................................................................. 70
`
`A
`
`B.
`
`C.
`
`DR TUCKER'S OPINIONS REGARDING ENABLEMENT AND
`WRITTEN DESCRIPTION ARE IRRELEVANT AND UNRELIABLE ............ 70
`
`THE ASSERTED CLAIMS OF THE '348 AND '989 PATENTS HA VE
`SUFFICIENT WRITTEN DESCRIPTION AND ARE ENABLED ..................... 80
`1.
`Dr. Tucker's Characterization Of The Teachings And Disclosures
`Of The '348 And '989 Patents Is Incomplete and Inaccurate ................... 80
`The Common Specification .......................................................... 80
`a.
`Titles, Abstracts, And Figures Of The Patents ............................. 81
`b.
`The Background Of The Invention ............................................... 83
`c.
`The Summary Of The Invention ................................................... 87
`d.
`The Detailed Description .............................................................. 87
`e.
`f.
`The Prosecution History ............................................................... 95
`Dr. Tucker's Characterization Of The Minerva EAS ............................... 96
`The Asserted Claims Of The '348 And '989 Patents Have
`Sufficient Written Description .................................................................. 98
`The Asserted Claims Of The '348 And '989 Patents Are Enabled ........ 101
`
`2.
`3.
`
`4.
`
`THE ASSERTED CLAIMS OF THE '183 PA TENT HA VE SUFFICIENT
`WRITTEN DESCRIPTION AND ARE ENABLED .......................................... 103
`1.
`Dr. Tucker's Characterization Of The Teachings And
`Disclosures Of The '183 Patent Is Incomplete And Inaccurate .............. 103
`State Of The Art .......................................................................... 104
`a.
`The Common Specification ........................................................ 105
`b.
`Minerva's UIT ........................................................................................ 111
`The Asserted Claims Of The '183 Patent Have Sufficient
`Written Description ................................................................................. 112
`The Asserted Claims Of The '183 Patent Are Enabled .......................... 118
`The "Thermal Ablation Device" Of Claim 15 Of The '183 Patent
`Is Enabled And Has Sufficient Written Description ............................... 120
`
`2.
`3.
`
`4.
`5.
`
`-111-
`
`Sanofi Exhibit 2172.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 5 of 128 PagelD #: 20423
`
`I, Karl R. Leinsing, declare as follows:
`
`1.
`
`I have been asked by Hologic, Inc. ("Hologic") to provide expert opinions in the
`
`above captioned litigation regarding infringement and validity. Specifically, I have been asked
`
`to review U.S. Patent Nos. 6,872,183 ("the '183 patent"), 9,095,348 ("the '348 patent"), and
`
`9,247,989 ("the '989 patent") (collectively, the "patents-in-suit") and Minerva's accused
`
`Endometrial Ablation System ("EAS") and determine what claims are infringed by the accused
`
`product and give a detailed technical analysis of the patents and the accused product.
`
`I.
`
`BACKGROUND AND QUALIFICATIONS
`
`2.
`
`I am President and founder of ATech Designs, Inc., a medical device product
`
`development and consulting company based in Dover, New Hampshire. I am an engineer with
`
`substantial experience in the design and development of a wide variety of medical instruments
`
`and devices since 1992 from conception through regulatory approval and manufacturing
`
`including sales and marketing.
`
`3.
`
`I hold a Master's of Science Degree in Mechanical Engineering from North
`
`Carolina A&T State University and a Bachelor of Science Degree in Mechanical Engineering
`
`from the University of New Hampshire. I am a licensed professional engineer in New
`
`Hampshire (PE License No. 11437).
`
`4.
`
`I have designed or developed several medical instruments and devices including a
`
`needle-scopic surgical fastener (US Patent Application: US2004/0073237) that uses a curved
`
`nitinol wire to fasten tissue together. I have also worked on a reusable laparoscopic suturing
`
`device (US Patent Application: US2005/0070922) for Onux Medical, Inc. and developed a
`
`disposable version of the same device. I have also done consulting work on speculums and
`
`knitted tension-free vaginal tape (TVT) devices used for urinary incontinence.
`
`-1-
`
`Sanofi Exhibit 2172.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 6 of 128 PagelD #: 20424
`
`5.
`
`More closely related experience to this case is my experience with the function,
`
`design, and development of the NovaSure knitted endometrial ablation array that is made with
`
`eight (8) different yarns (both silver plated and non-plated). My company developed and
`
`patented the knitting machine that makes the NovaSure RF ablation array (US Patent No.
`
`6,158,250) and we manufactured two machines for N ovacept. It's my understanding that
`
`Hologic purchased the NovaSure technology from Novacept, but I have not done any consulting
`
`work for Hologic nor have we sold them any products or additional knitting machines.
`
`6.
`
`I have been named as an inventor on over twenty-snine (29) U.S. patents (many
`
`others pending). I have received many awards for my designs with one design published on the
`
`cover of LIFE Magazine and I was recognized as one of the top 100 medical device professionals
`
`in the country by MD&DI Magazine.
`
`7.
`
`My curriculum vitae (Ex. 38) 1 includes a list of publications that I have authored
`
`in the last 10 years, a list of the patents granted to me, and the cases in which I have testified as
`
`an expert at trial or deposition in the last 5 years.
`
`II.
`
`COMPENSATION
`
`8.
`
`I am being compensated for the time spent on this litigation at my customary rate
`
`of $450 per hour. My compensation does not depend in any way upon the outcome of this
`
`litigation.
`
`III.
`
`SUMMARY OF OPINIONS
`
`9.
`
`The Minerva EAS infringes at least claims 1, 2, 5, 6, 7, 9, 11, 13, 14, and 15 of
`
`the '183 patent, claims 1, 3, and 12 of the '348 patent, and claims 1 and 7 of the '989 patent.
`
`10.
`
`Use of the Minerva EAS infringes the asserted' 183 patent claims because it
`
`1 The Exhibits ("Ex.") herein refer to the Exhibits to the Declaration of Marc Cohn.
`
`-2-
`
`Sanofi Exhibit 2172.006
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 7 of 128 PagelD #: 20425
`
`performs the claimed step of "monitoring for the presence of a perforation in the uterus using a
`
`pressure sensor" -
`
`the only disputed limitation. The Minerva EAS's flow sensor in
`
`combination with its fixed orifice satisfies the pressure sensor limitation as construed by the
`
`Court because its input detects indirectly a force per unit area and outputs a corresponding
`
`electrical signal. The flow rate of gas through the flow sensor and orifice plate is proportional to
`
`the pressure differential between the CO2 source and the uterus. Because the source pressure is
`
`fixed, the flow sensor indirectly detects a force per unit area in the uterus and delivers an
`
`electrical signal corresponding to that pressure. The principle of indirectly sensing a force per
`
`unit area by using a flow sensor and orifice plate is known by a POSITA as Bernoulli's Principal
`
`and is confirmed in Minerva's core technical documents, through its direct testing and
`
`comparisons with Hologic's patented NovaSure device, as well as in Minerva's representations
`
`to the FDA and others.
`
`11.
`
`The Minerva EAS infringes the asserted '348 patent claims because it includes
`
`"an indicator mechanism ... configured to indicate a dimension of the uterus" -
`
`the only
`
`disputed limitation. The Minerva EAS' s disposable handpiece includes a "PF A Width Indicator"
`
`that includes a Red/Green area, rows of dots, and a black indicator line. When the Minerva
`
`EAS' s applicator is deployed in a uterus, the PF A Width Indicator indicates uterine width. As
`
`confirmed by Minerva's core technical documents, its representations to the FDA, clinicians, and
`
`investors, and by my own testing, the boundary between the Red and Green areas indicates a
`
`uterine width of approximately 2.5 cm and the rows of three, four, and five dots indicate uterine
`
`widths of 3 cm, 4 cm, and 5 cm, respectively. Accordingly, the Minerva EAS's width indicator
`
`is configured to indicate the width of the uterus.
`
`12.
`
`Use of the Minerva EAS infringes the asserted '989 patent claims because it
`
`-3-
`
`Sanofi Exhibit 2172.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 8 of 128 PagelD #: 20426
`
`performs the claimed actuating step wherein actuating the handle includes "translating the inner
`
`sleeve relative to the proximal grip" -
`
`the only disputed limitation. The Minerva EAS's
`
`applicator is configured to be limited by the width of the uterus. Once the applicator is
`
`constrained by the walls of the uterus, there is no further distal movement of the inner sleeve. A
`
`force limiting spring, however, allows continued distal movement of the proximal grip. Thus,
`
`continued distal movement of the proximal grip results in translating the inner sleeve relative to
`
`the proximal grip when the applicator is constrained by the uterine width.
`
`13.
`
`Dr. Tucker's enablement and written description opinions are focused on a narrow
`
`set of claim limitations, i.e., "applicator head," "an energy applicator," "one or more electrodes,"
`
`"pressure sensor," and "thermal ablation device." Dr. Tucker has not opined that the asserted
`
`claims are invalid with respect to any other claim limitations.
`
`14. With respect to "applicator head," "an energy applicator," "one or more
`
`electrodes," "pressure sensor," and "thermal ablation device," in my view, each of those
`
`limitations is enabled and has sufficient written description under 35 U.S.C. § 112. Therefore, in
`
`my view, the asserted claims -
`
`claims 1, 2, 5, 6, 7, 9, 11, 13, 14, and 15 of the' 183 patent,
`
`claims 1, 3, and 12 of the '348 patent, and claims 1 and 7 of the '989 patent -
`
`are not invalid.
`
`15.
`
`The '183 patent's specification provides a detailed disclosure and figures
`
`specifying the components of exemplary perforation detection systems, schematics of an
`
`exemplary perforation detection system and an exemplary pneumatic subsystem, and a simplified
`
`state diagram illustrating an exemplary mode of operation. Further, pressure sensors that directly
`
`and indirectly detect a force per unit area are well-known in the art and the relationship between
`
`flow rate and pressure is a well-known, basic principle of fluid dynamics. Thus, the asserted
`
`claims of the '183 patent are not invalid for lack of written description or enablement.
`
`-4-
`
`Sanofi Exhibit 2172.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 9 of 128 PagelD #: 20427
`
`16.
`
`The '183 patent specification clearly discloses that the described perforation
`
`detection system can be used in combination with thermal ablation devices. Further, it is readily
`
`apparent to one of skill in the art how to combine the disclosed perforation detection system and
`
`components with a thermal ablation device. Accordingly, claim 15 of the '183 patent is not
`
`invalid for lack of written description or enablement.
`
`17.
`
`The common specification of the '348 and '989 patents provides a detailed
`
`disclosure and 47 figures of exemplary applicators and electrodes. The specification teaches
`
`electrical conductors both on the surface of the applicator and inside the applicator. Further,
`
`non-permeable applicators and capacitive coupling were well-known in the art. Thus, the
`
`asserted claims of the '348 and '989 patents are not invalid for lack of written description or
`
`enablement.
`
`18.
`
`In my opinion, Dr. Tucker's invalidity opinions regarding enablement and written
`
`description are irrelevant and unreliable because Dr. Tucker ignored the Court's claim
`
`constructions and did not apply the applicable legal standards for enablement and written
`
`description as I understand them.
`
`IV.
`
`APPLICABLE LEGAL PRINCIPLES
`
`19.
`
`I understand that I am obliged to apply any pertinent legal principles in providing
`
`my opm10ns. I will not offer opinions of law as I am not an attorney. However, I have been
`
`informed of several principles concerning patent infringement, non-infringement, validity, and
`
`invalidity, which I used in arriving at my conclusions. The legal principles that I have been
`
`asked to apply are set forth below.
`
`A.
`
`Patent Infringement
`
`20.
`
`I have been instructed by counsel that a determination of patent infringement
`
`-5-
`
`Sanofi Exhibit 2172.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 10 of 128 PagelD #:
`20428
`
`involves a two-step process: (1) the Court determines the meaning of the claim terms according
`
`to a person of skill in the art; and (2) the properly construed claims are compared to the accused
`
`product to determine whether all of the elements of the claims are present.
`
`21.
`
`I understand that, in order for a patent claim to be directly infringed, an accused
`
`method must perform each step of the claimed method, or an accused product or instrumentality
`
`must embody each element of a claimed apparatus, structure, or compound.
`
`22.
`
`I understand from counsel that a single element or step of the accused product or
`
`method may satisfy more than one element of a claim. I further understand that multiple
`
`components together may satisfy a claim limitation so long as the claim does not require a
`
`single-component structure.
`
`23.
`
`Further, I understand that a party can be liable as an infringer if that party
`
`contributes to or induces others to infringe the patents-in-suit by aiding and abetting others to
`
`practice the patented invention.
`
`24.
`
`I understand that there are two types of claims: independent claims and dependent
`
`claims. I further understand that independent claims do not refer to any other claims and
`
`infringement is established when all the limitations of the independent claim have been met. I
`
`also understand that dependent claims add additional requirements to the independent claim.
`
`Therefore, in order to infringe a dependent claim, the allegedly infringing device or method must
`
`meet all limitations of that dependent claim as well as any other claims to which it refers.
`
`25. Whoever, without authority, makes, uses, offers to sell, or sells any patented
`
`invention during the term of the patent(s) is found to infringe the patent(s).
`
`26.
`
`It is my understanding that the patentee has the burden of proving infringement by
`
`a preponderance of the evidence. I understand this standard to require that the patentee present
`
`-6-
`
`Sanofi Exhibit 2172.010
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 11 of 128 PagelD #:
`20429
`
`evidence that as a whole shows that the fact sought to be proved is more probable than not.
`
`B.
`
`Patent Validity
`
`27.
`
`I understand that the patents-in-suit are presumed valid and Minerva has the
`
`burden to prove by clear and convincing evidence that the patents-in-suit are invalid.
`
`28.
`
`The first paragraph of 35 U.S.C. § 1122 provides that the "specification shall
`
`contain a written description of the invention, and of the manner and process of making and
`
`using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to
`
`which it pertains, or with which it is most nearly connected, to make and use the same[.]" I
`
`understand that these requirements are referred to as the enablement and written description
`
`requirements.
`
`1.
`
`The Law Of Enablement
`
`29.
`
`I understand that the patent specification must enable a person of ordinary skill in
`
`the art at the time of the invention to make and use the claimed invention without undue
`
`experimentation. Because enablement pertains to the claimed invention, I understand that the
`
`enablement inquiry depends on the claims as construed by the Court. Accordingly, my opinions
`
`below are based on the scope of the claimed inventions as construed by the Court.
`
`30.
`
`I have been informed that the enablement requirement is assessed from the
`
`perspective of a person of ordinary skill in the art ("POSIT A") at the time of the invention,
`
`which in this case is May 8, 1998 for the asserted claims of the '348 and '989 patents and
`
`November 10, 1999 for the asserted claims of the '183 patent. A POSIT A would assess the
`
`claims of the asserted patents in light of the patent specification together with the knowledge in
`
`the art as of the earliest effective filing date, to determine whether the enablement requirement is
`
`2 I understand that, because the patents-in-suit have an effective filing date before September 16,
`2012, the Pre-America Invents Act version of 35 U.S.C. § 112 applies.
`
`-7-
`
`Sanofi Exhibit 2172.011
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 12 of 128 PagelD #:
`20430
`
`satisfied. I have been advised by counsel that the enablement requirement is satisfied when the
`
`specification provides enough information for a POSIT A to make and use the claimed invention
`
`without undue experimentation. I have been instructed to consider the following factors to
`
`determine whether undue experimentation is required: (1) the quantity of experimentation
`
`needed to make or use the invention based on the content of the disclosure; (2) the amount of
`
`direction provided by the inventor; (3) the existence of working examples; (4) the nature of the
`
`invention; (5) the state of the prior art; (6) the level of one of ordinary skill; (7) the level of
`
`predictability in the art; and (8) the breadth of the claims. I understand that these factors are
`
`known as the Wands factors.
`
`31.
`
`I have also been informed that a patent disclosure need not convey information
`
`that is already within the knowledge of a POSIT A In addition, I understand a patent applicant is
`
`not required to test all the embodiments of his invention. Moreover, neither the time nor the
`
`money that may be required to complete testing necessitates a finding of undue experimentation.
`
`I understand that the fact that experimentation may be complex does not necessarily make it
`
`undue if the art typically engages in such experimentation. The test of enablement is not whether
`
`any experimentation is necessary, but whether the necessary experimentation is undue.
`
`32.
`
`I understand that as long as the specification discloses at least one method for
`
`making and using the claimed invention that bears a reasonable correlation to the entire scope of
`
`the claim, then the enablement requirement is satisfied. Failure to disclose other methods by
`
`which the claimed invention may be made or used does not render a claim invalid. Since
`
`enablement pertains to the scope of the claimed inventions, a patent specification does not have
`
`to enable unclaimed aspects present in an accused product. As such, I understand that it is
`
`generally irrelevant if the patent specification does not enable the making or using of the accused
`
`-8-
`
`Sanofi Exhibit 2172.012
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 13 of 128 PagelD #:
`20431
`
`product if it enables another mode of the practicing the invention. Similarly, I understand that in
`
`general a patent need not enable unclaimed features of the embodiments described in the
`
`specification.
`
`33.
`
`I understand that whether the inventor believes or does not believe that the patent
`
`specification sufficiently enables the full scope of the claims is usually irrelevant to the
`
`enablement conclusion because this inquiry must focus objectively on whether or not one of skill
`
`in the art would find the claims to be enabled. I understand that the subjective beliefs of an
`
`inventor may be subject to bias and need not always be considered. My opinions below are from
`
`the perspective of a POSIT A at the time of the invention.
`
`2.
`
`The Law of Written Description
`
`34.
`
`I am informed that the test for sufficiency of the written description is whether the
`
`disclosure of the application relied upon reasonably conveys to a POSIT A that the inventor(s)
`
`had possession of the claimed subject matter as of the filing date. I understand that "possession"
`
`is shown by the disclosure and that the specification must describe an invention understandable
`
`to a POSITA and show that the inventor actually invented the claimed invention. I am informed
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`that the level of detail required to satisfy the written description requirement varies depending on
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`the nature and scope of the claims and on the complexity and predictability of the relevant
`
`technology. I understand that applicable factors include the existing knowledge in the particular
`
`field, the extent and content of the prior art, the maturity of the science or technology, and the
`
`predictability of the aspect at issue.
`
`35.
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`As with enablement law, written description pertains to the claimed invention.
`
`Accordingly, my opinions below are based on the claims as construed by the Court.
`
`36.
`
`I have been informed that the written description requirement is assessed from the
`
`-9-
`
`Sanofi Exhibit 2172.013
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 14 of 128 PagelD #:
`20432
`
`point of view of a POSIT A at the time of the invention. A POSIT A would assess the claims in
`
`light of the patent specification together with the knowledge in the art as of the earliest effective
`
`filing date to determine whether the written description requirement is satisfied. I have also been
`
`informed that a patentee does not need to include that which is already known to and available to
`
`a PO SITA. What is conventional or well known to one of ordinary skill in the art need not be
`
`disclosed in detail. The written description requirement must be applied in the context of the
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`particular invention and the state of the knowledge. As each field evolves, the balance also
`
`evolves between what is known and what is added by each inventive contribution. If a skilled
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`artisan would have understood the inventor to be in possession of the claimed invention at the
`
`time of filing, even if every nuance of the claims is not explicitly described in the specification,
`
`then the written description requirement is met.
`
`37.
`
`I understand that to meet this requirement, the patentee is not required to describe
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`in the specification every conceivable and possible future embodiment of the claimed invention.
`
`A specification may contain a written description of a broadly claimed invention without
`
`describing all species that the claim encompasses. I also understand that unclaimed aspects of
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`the inventions or unclaimed aspects of the accused products do not need to be described.
`
`V.
`
`ONE OF ORDINARY SKILL IN THE ART
`
`38.
`
`I have approached my analysis of the Hologic patents from the perspective of a
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`POSIT A, which means the level of skill of a POSIT A at the time of the filing of each patent ( or
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`the effective filing date of the applications that led to each of the patents) analyzed.
`
`39.
`
`The patented technology relates to methods and systems for ablating the
`
`endometrial lining of uterine tissue in order to treat abnormal uterine bleeding, in addition to a
`
`method of checking for holes in the uterine cavity as a safety procedure before any ablation
`
`-10-
`
`Sanofi Exhibit 2172.014
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 15 of 128 PagelD #:
`20433
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`occurs. To determine who a POSIT A would be for purposes of my declaration, I considered the
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`problems encountered in working in the field, the nature of the prior art relating to the field, and
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`the complexity and speed of the development of the technology. Based on these factors, it is my
`
`opinion that a POSIT A would have, through education and/or professional experience, the
`
`equivalent of a bachelor's degree in biomedical engineering, mechanical engineering, or a related
`
`technical field, and at least two years' experience designing or working with devices for use in
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`the uterus. 3 Under this definition I would be considered a POSIT A since 1998.
`
`40.
`
`I understand that Minerva has proposed its own definition of a POSIT A I have
`
`considered this definition and although I disagree with it, my opinions in this declaration would
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`not change if I applied either definition of a POSIT A
`
`VI.
`
`BACKGROUND OF THE RELEVANT TECHNOLOGY
`
`A.
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`Endometrial Ablation
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`41.
`
`The technology of the asserted claims relates to the treatment of chronic bleeding
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`of the endometrial layer of the uterus, i.e., "menorrhagia." Ex. 2 at 1 :28-31. One treatment for
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`this condition is a surgical technique known as "endometrial ablation," in which the lining of the
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`uterus is destroyed and/or coagulated by heat or electrical energy. Id at 1 :25:28; Ex. 1 at 1 :22-
`
`28.
`
`42.
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`Prior art ablation techniques (such as the "heated fluid techniques" and then-
`
`existing RF ablation techniques) posed great risks. Ex. 2 at 1 :65-2:24; discussions with Dr.
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`Jamieson and Dr. Johns. For example, the heated fluid method "is a very passive and ineffective
`
`In my view, my opinions in this declaration would not
`change if I applied Dr. Tucker's definition of a POSIT A
`
`-11-
`
`Sanofi Exhibit 2172.015
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Case 1:15-cv-01031-JFB-SRF Document 309 Filed 01/16/18 Page 16 of 128 PagelD #:
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`heating process" because the "process does not account for variations in factors such as the
`
`amount of contact between the balloon and the underlying tissue, or cooling effects such as those
`
`of blood circulating through the organ." Id at 1 :54-59. Likewise, prior art RF ablation
`
`techniques provided no feedback as to actual ablation depth. Id at 1 :59-64. Accordingly, these
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`prior art techniques required great care to prevent over ablati